Opioid Complaint
Opioid Complaint
ZOOM. Jury
For more information and Zoom Meeting IDs go to https://www.cookcountycourt.org/HOME/Zoom-Links/Agg4906_SelectTab/12
Remote Court date: 10/19/2022 9:30 AM
FILED
8/15/2022 4:37 PM
IN THE CIRCUIT COURT OF COOK COUNTY, ILLINOIS IRIS Y. MARTINEZ
CIRCUIT CLERK
LAW DIVISION COOK COUNTY, IL
FILED DATE: 8/15/2022 4:37 PM 2022L007352
2022L007352
Calendar, F
19090841
BOONE COUNTY, ILLINOIS,
BUREAU COUNTY, ILLINOIS,
CHAMPAIGN COUNTY, ILLINOIS,
COOK COUNTY, ILLINOIS,
DEKALB COUNTY, ILLINOIS,
DUPAGE COUNTY, ILLINOIS,
HENRY COUNTY, ILLINOIS,
KANE COUNTY, ILLINOIS,
KANKAKEE COUNTY, ILLINOIS, Case No.: 2022L007352
KENDALL COUNTY, ILLINOIS,
LOGAN COUNTY, ILLINOIS,
MACON COUNTY, ILLINOIS,
MACOUPIN COUNTY, ILLINOIS,
MCHENRY COUNTY, ILLINOIS,
PIATT COUNTY, ILLINOIS,
PUTNAM COUNTY, ILLINOIS,
ROCK ISLAND COUNTY, ILLINOIS,
JURY DEMANDED
STEPHENSON COUNTY, ILLINOIS, AND
WILL COUNTY, ILLINOIS
Plaintiffs,
VS.
CVS HEALTH CORPORATION; CVS
INDIANA L.L.C.; CVS RX SERVICES, INC.;
CVS TN DISTRIBUTION, LLC; CVS
PHARMACY, INC.; CVS PHARMACY
LIMITED OF ILLINOIS, LLC; WALGREEN
CO.; WALGREENS BOOTS ALLIANCE, INC.;
WALGREEN EASTERN CO. INC.; WALMART
INC.; F/K/A/ WAL-MART STORES, INC.;
WAL-MART STORES EAST; LP WSE
MANAGEMENT, LLC; WSE INVESTMENT
LLC; WAL-MART STORES EAST, LLC
(FORMERLY KNOWN AS WAL-MART
STORES, INC.); SAM’S EAST, INC.; SAM’S
WEST, INC.; THE KROGER CO.; KROGER
LIMITED PARTNERSHIP I; KROGER
LIMITED PARTNERSHIP II;
(cont.)
MEIJER INC.; MEIJER DISTRIBUTION, INC.;
MEIJER STORES LIMITED PARTNERSHIP;
ALBERTSONS COMPANIES, INC.
FILED DATE: 8/15/2022 4:37 PM 2022L007352
ii
TABLE OF CONTENTS
I. INTRODUCTION ...................................................................................................................... 1
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iii
iv. CVS Conspired with Cardinal and McKesson to Prevent
Suspicious Order Monitoring of Its Retail Pharmacies ... 54
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iv
i. Kroger Failed to Maintain Effective Controls Against
Diversion of Opioids It Distributed, Instead Oversupplying
Its Stores........................................................................... 96
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v
VI. CAUSES OF ACTION ........................................................................................................ 170
VII. PRAYER FOR RELIEF .................................... ERROR! BOOKMARK NOT DEFINED.
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vi
I. INTRODUCTION
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1. Plaintiffs in this action are Boone County, Illinois, Bureau County, Illinois,
Champaign County, Illinois, Cook County, Illinois, Dekalb County, Illinois, DuPage County,
Illinois, Henry County, Illinois, Kane County, Illinois, Kankakee County, Illinois, Kendall
County, Illinois, Logan County, Illinois, Macon County, Illinois, Macoupin County, Illinois,
McHenry County, Illinois, Piatt County, Illinois, Putnam County, Illinois, Rock Island County,
Illinois, Stephenson County, Illinois, and Will County, Illinois, each of which are political
bring this action to prevent future harm and to redress past wrongs against the following
1
The CVS Defendants are CVS Health Corporation, CVS Indiana L.L.C., CVS Rx Services,
Inc..; CVS TN Distribution, LLC, CVS Pharmacy, Inc. and CVS Pharmacy Limited of Illinois,
LLC.
2
The Walgreens Defendants are Walgreen Co., Walgreens Boots Alliance, Inc. and Walgreen
Eastern Co., Inc.
3
The Walmart Defendants are Walmart Inc., f/k/a/ Wal-Mart Stores, Inc.; Wal-Mart Stores East;
LP, WSE Management, LLC; WSE Investment LLC; Wal-Mart Stores East, LLC (formerly
known as Wal-Mart Stores, Inc.); Sam’s East, Inc.; and Sam’s West, Inc.
4
The Kroger Defendants are The Kroger Co.; Kroger Limited Partnership I; and Kroger Limited
Partnership II.
5
The Meijer Defendants are Meijer Inc., Meijer Distribution, Inc., and Meijer Stores Limited
Partnership.
6
The Albertsons Defendants are Albertsons Companies, Inc., formerly known as Albertsons
LLC; Albertson’s LLC; and Safeway, Inc.
1
2. Plaintiffs seek to hold accountable the Chain Pharmacies that oversupplied opioids
into Plaintiff Counties. The Chain Pharmacies failed to monitor and restrict the improper sale and
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3. This case arises from the worst man-made epidemic in modern medical history: an
epidemic of addiction, overdose and death caused by Defendants’ flooding the United States,
4. By now, most Americans have been affected, either directly or indirectly, by the
opioid epidemic. This crisis arose not only from the opioid manufacturers’ deliberate marketing
strategy, but from distributors’ and pharmacies’ equally deliberate efforts to evade restrictions on
opioid distribution and dispensing, while also helping spread the manufacturers’ false marketing
messages about prescription opioids and encourage their widespread use. These distributors and
pharmacies acted without regard for the lives that would be trammeled in pursuit of profit.
received a total of 3,112,236,443 doses of hydrocodone and oxycodone, according to the ARCOS
data (2006-2014), amounting to 242 doses for every man, woman and child in the State.
6. Since the push to expand prescription opioid use began in the late 1990s, the death
toll has steadily climbed, with no sign of slowing. The number of opioid overdoses in the United
States rose from 8,000 in 1999 to over 20,000 in 2009, and over 33,000 in 2015. In the twelve
months that ended in September 2017, opioid overdoses claimed 45,000 lives. Another 46,000
opioid overdose deaths occurred in 2018, and in 2019 the number of opioid overdose deaths rose
to over 49,000.
2
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7. Preliminary data indicates that the number of opioid related overdose deaths will
8. From 1999 through 2016, more than 350,000 people died from an overdose
involving any opioids. Well over half of those deaths—over 200,000 people—involved opioids
prescribed by doctors to treat pain. These opioids include brand-name prescription medications
like OxyContin, Opana ER, Vicodin, Subsys, and Duragesic, as well as generics like oxycodone,
9. Most of the overdoses from non-prescription opioids are also directly related to
prescription pills. As soon as prescription opioids took hold on a population, the logical and
devastating progression to illicit drugs followed. Many opioid users, having become addicted to
but no longer able to obtain prescription opioids or trapped in a cycle of addiction that causes those
who suffer from the disease to need stronger and more potent drugs, have turned to heroin,
fentanyl, and other illicit drugs. According to the American Society of Addiction Medicine, 80%
of people who initiated heroin use in the past decade started with prescription painkillers which—
at the molecular level and in their effect— closely resemble heroin. In fact, people who are
3
addicted to prescription painkillers are 40 times more likely to become addicted to heroin, and the
CDC identified addiction to prescription pain medication as the strongest risk factor for heroin
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addiction.
10. The conduct of the manufacturers, distributors, and Chain Pharmacies caused the
nation, and Illinois, to be awash in a flood of prescription opioids. This has had a profound impact
on both morbidity and mortality, and these drugs have created an epidemic of addiction that has
had severe and wide-ranging effects on public health and safety in Illinois and in communities
across the country. Indeed, from those suffering with the disease of addiction themselves, to
children whose parents who suffer from addiction to employers who employ an addicted
population, to the first responders, law enforcement, the court system and the prison system who
cannot handle the burdens placed on them, there is almost no area of the community that has not
11. As a result, in part, of the proliferation of opioid pharmaceuticals between the late
1990s and 2015, the life expectancy for Americans decreased for the first time in recorded history.
Drug overdoses are now the leading cause of death for Americans under 50.
12. In the words of Robert Anderson, who oversees death statistics at the Centers for
Disease Control and Prevention, “I don’t think we’ve ever seen anything like this. Certainly not
in modern times.” On October 27, 2017, the President declared the opioid epidemic a public health
emergency.
13. On September 6, 2017, Illinois Governor Bruce Rauner signed Executive Order 17-
05, creating the governor’s Opioid Prevention and Intervention Task Force to address the opioid
crisis that is ravaging the country and the State of Illinois and its citizens. At the time, Governor
Rauner stated, “The opioid crisis in Illinois affects people from all walks of life – small towns and
big cities, the wealth and the poor, young and old.”
14. The Illinois Department of Health reported a total of 21,226 opioid overdoses in
4
15. 2012 marked the height of opioid prescriptions dispensed in Illinois with 66.1
prescriptions dispensed for every 100 Illinois residents. This translates to nearly 8.5 million opioid
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16. The loss of each of these individuals cannot be adequately conveyed by statistics,
nor can the depth and breadth of the impact on those who survive. Because the addictive pull of
opioids is so strong, relapse is more common than with other drugs. Further, overdose deaths are
not the only consequence. Hundreds of people have been rushed to County emergency rooms or
17. The damage inflicted cuts across ages and generations. Many who have
succumbed to overdoses have overdosed more than once. Those who survive are often not alone
at the time. Family members, including young children, have watched their loved ones lose
consciousness or die. Young children, including toddlers, also have been the direct victims of
18. Children are being displaced from their homes and raised by relatives or placed in
the Counties’ care due to parents’ addiction. Others lose the chance to go home. Unable to be
discharged from the hospital with their mothers, babies born addicted to opioids due to prenatal
exposure are being placed in the care of the Counties or local citizens or non-profits who do their
19. This devastation in the Counties was created by opioid manufacturers, distributors,
and Chain Pharmacies, who worked together to systematically dismantle the narcotic conservatism
that had existed around prescription opioids for decades, opened the floodgates to an unreasonably
large and unsafe supply of opioids, improperly normalized the widespread use of opioid drugs,
violated laws and regulations designed to protect the public from the dangers of narcotic drugs like
7
CDC, “U.S. State Opioid Dispensing Rates, 2012” 2006-2019 Illinois, available at
https://www.cdc.gov/drugoverdose/rxrate-maps/state2012.html
[Calculation of number of dispensed prescriptions in 2012 (Pop. Illinois 2012 of 12.8 million/ per person
rate of 100)* number of per person prescriptions filled of 66.1=8,460,000]
5
opioids, and worked to dismantle protections designed to protect the public so more opioid drugs
could be sold and the manufacturers, distributors, and Chain Pharmacies could reap the profits
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therefrom.
20. This suit takes aim at a substantial contributing cause of the opioid crisis: The
Chain Pharmacies, the last link in the opioid supply chain and the critical gatekeeper between
dangerous opioid narcotics and the public, who utterly failed in their gatekeeper role, flouted their
duties to protect the public, violated the laws designed to protect the public and dismantled and
disregarded measures designed to protect the public health and safety. The Chain Pharmacies
failed to design and operate systems to identify suspicious orders of prescription opioids, maintain
effective controls against diversion, and halt suspicious orders when they were identified, and
instead actively contributed to the oversupply of such drugs and fueled an illegal secondary market.
They also played an active role in helping the manufacturers promote their false marketing about
opioids to health care providers, their own pharmacists, and the public.
21. The mission of pharmacy practice is “to serve society as the profession responsible
for the appropriate use of medications, devices, and services to achieve optimal therapeutic
outcomes.” 8 Defendants subverted that role and instead played a significant role in a public health
22. Defendants have contributed substantially to the opioid crisis by helping to inflate
the opioid market beyond any legitimate bounds and by flooding that market with far greater
quantities of prescription opioids than they know could be necessary for legitimate medical uses
while failing to report and take steps to halt suspicious orders and sales, thereby exacerbating the
23. In 2014, almost two million Americas were addicted to prescription opioids and
another 600,000 to heroin. From 1999 to 2015, more than 183,000 people died in the U.S. from
8
Vision and Mission for the Pharmacy Profession, American Pharmacists Association, adopted by the
APhA House of Delegates (March 1991).
6
overdoses related to prescription opioids—more than the number of Americans who died in the
Vietnam War. From 1999 to 2016, more than 200,000 people died in the U.S. from overdoses
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related to prescription opioids. Overdose deaths involving prescription opioids were five times
higher in 2017 than 1999. The number of drug overdose deaths increased by nearly 5% from 2018
to 2019.
24. As millions became addicted to opioids, “pill mills,” often styled as “pain clinics,”
sprouted nationwide and rogue prescribers stepped in to supply prescriptions for non-medical use.
These pill mills, typically under the auspices of licensed medical professionals, issue high volumes
of opioid prescriptions under the guise of medical treatment. Prescription opioid pill mills and
rogue prescribers cannot channel opioids for illicit use without at least the tacit support and willful
25. As a direct and foreseeable result of Defendants’ conduct, cities and counties
across the nation, including Plaintiffs, are now swept up in what the Centers for Disease Control
(“CDC”) has called a “public health epidemic” and what the U.S. Surgeon General has deemed an
“urgent health crisis.” 9 The increased volume of opioid prescribing—not all of which is for
legitimate use—correlates directly to skyrocketing addiction, overdose and death; black markets
for diverted prescriptions opioids; and a concomitant rise in heroin and fentanyl abuse by
individuals who could no longer legally acquire or could not afford prescription opioids.
26. This explosion in opioid use and Defendants’ profits has come at the expense of
patients and residents and has caused ongoing harm to and a public nuisance in the Illinois. As
the then CDC director concluded: “We know of no other medication routinely used for a nonfatal
9
Examining the Growing Problems of Prescription Drug and Heroin Abuse, Ctrs. For Disease Control
and Prevention (Apr. 29, 2014), http://www,cdc,give.washington/testimony/2014/t20140429.htm; see
also, Letter from Vivek H. Murthy, Surgeon General, Tide RX (Aug. 2016), http://turnthetiderx.org.
10
Id.
7
27. Defendants’ conduct in promoting opioid use and fueling diversion has had severe
and far-reaching public health, social services, and criminal justice consequences, including the
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fueling of addiction and overdose from illicit drugs such as heroin. The costs are borne by
Plaintiffs and other governmental entities. These necessary and costly responses to the opioid
crisis include the handling of emergency responses to overdoses, providing addiction treatment,
addicted newborns in neonatal intensive care units, burying the dead, and placing thousands of
28. The burdens imposed on Plaintiffs are not the normal or typical burdens of
government programs and services. Rather, these are extraordinary costs and losses that are related
directly to Defendants’ illegal actions. The Defendants’ conduct has created a public nuisance and
a blight. Governmental entities, and the services they provide their citizens, have been strained to
29. Defendants have not changed their ways or corrected their past misconduct but
instead are continuing to fuel the crisis and perpetuate the public nuisance.
30. Within the next hour, six Americans will die from opioid overdoses; two babies
31. Plaintiffs bring this suit to bring the devastating march of this epidemic to a halt
and to hold Defendants responsible for the crisis they caused.
32. This Court has personal jurisdiction over Defendants because they carry on a
continuous and systematic part of their general business within Illinois, have transacted substantial
business with Illinois entities and residents, and have caused harm in Illinois as a result of the
8
33. Venue as to each Defendants is proper in this Court under 735 ILCS 5/2-101 as
the transactions and occurrences that form the basis for this Complaint occurred in Cook County,
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Illinois.
34. There is no federal court jurisdiction in that there is not complete diversity of
citizenship because at least Defendant Walgreen Co. is a resident of the State of Illinois, and no
III. PLAINTIFFS
35. Plaintiffs Boone County, Bureau County, Champaign County, Cook County,
Dekalb County, DuPage County, Henry County, Kane County, Kankakee County, Kendall
County, Logan County, Macon County, Macoupin County, McHenry County, Piatt County,
Putnam County, Rock Island County, Stephenson County, and Will County are all organized
exiting under the laws of the state of Illinois. Each Plaintiff provides a wide range of services on
behalf of its residents, including services for families and children, public health, public
36. State’s Attorney of Boone County, Tricia Smith, is the chief legal officer of Boone
County and is authorized to bring suit on its behalf by and through the assistance of other counsel.
37. State’s Attorney of Bureau County, Geno J. Caffarini, is the chief legal officer of
Bureau County and is authorized to bring suit on its behalf by and through the assistance of other
counsel.
38. State’s Attorney of Champaign County, Julia Rietz, is the chief legal officer of
Champaign County and is authorized to bring suit on its behalf by and through the assistance of
other counsel.
39. State’s Attorney of Cook County, Kimberly M. Foxx, is the chief legal officer of
Cook County and is authorized to bring suit on its behalf by and through the assistance of other
counsel.
9
40. State’s Attorney of Dekalb County, Rick Amato, is the chief legal officer of
Dekalb County and is authorized to bring suit on its behalf by and through the assistance of other
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counsel.
41. State’s Attorney of DuPage County, Robert Berlin, is the chief legal officer of
DuPage County and is authorized to bring suit on its behalf by and through the assistance of other
counsel.
42. State’s Attorney of Henry County, Catherine L. Runty, is the chief legal officer of
Henry County and is authorized to bring suit on its behalf by and through the assistance of other
counsel.
43. State’s Attorney of Kane County, Jamie L. Mosser, is the chief legal officer of
Kane County and is authorized to bring suit on its behalf by and through the assistance of other
counsel.
44. State’s Attorney of Kankakee County, Jim Rowe, is the chief legal officer of
Kankakee County and is authorized to bring suit on its behalf by and through the assistance of
other counsel.
45. State’s Attorney of Kendall County, Eric Weis, is the chief legal officer of Kendall
County and is authorized to bring suit on its behalf by and through the assistance of other counsel.
46. State’s Attorney of Logan County, Brad Hauge, is the chief legal officer of Logan
County and is authorized to bring suit on its behalf by and through the assistance of other counsel.
47. State’s Attorney of Macon County, Scott Rueter, is the chief legal officer of Macon
County and is and is authorized to bring suit on its behalf by and through the assistance of other
counsel.
48. State’s Attorney of Macoupin County, Jordan J. Garrison, is the chief legal officer
of Macoupin County and is authorized to bring suit on its behalf by and through the assistance of
other counsel.
10
49. State’s Attorney of McHenry County, Patrick D. Kenneally, is the chief legal
officer of McHenry County and is authorized to bring suit on its behalf by and through the
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50. State’s Attorney of Piatt County, Sarah N. Perry, is the chief legal officer of Piatt
County and is authorized to bring suit on its behalf by and through the assistance of other counsel.
51. State’s Attorney of Putnam County, Christina Judd Mennie, is the chief legal
officer of Putnam County and is authorized to bring suit on its behalf by and through the assistance
of other counsel.
52. State’s Attorney of Rock Island County, Dora A. Villarreal-Nieman, is the chief
legal officer of Rock Island County and is authorized to bring suit on its behalf by and through
53. State’s Attorney of Stephenson County, Carl Larson, is the chief legal officer of
Stephenson County and is authorized to bring suit on its behalf by and through the assistance of
other counsel.
54. State’s Attorney of Will County, James W. Glasgow, is the chief legal officer of
Will County and is authorized to bring suit on its behalf by and through the assistance of other
counsel.
55. Plaintiff Counties provide a wide range of services and programs to their residents,
including an emergency call center, drug and alcohol services and programs, programs for
children, youth and families, other health and human services, law enforcement, and jails. Plaintiff
Counties also provide health insurance coverage for their employees and dependents, and
IV. DEFENDANTS
A. CVS
with its principal place of business in Rhode Island. CVS Health, through its various DEA-
11
registered subsidiaries and affiliated entities, conducts business as a licensed wholesale distributor
and also operates retail stores, including in and around Plaintiffs’ geographical area, that sell
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57. Defendant CVS Indiana L.L.C. is an Indiana limited liability company with its
principal place of business in Indianapolis, Indiana. For much of the period the identification of
and due diligence on suspicious orders for the entire country was to be performed at CVS Indiana
58. Defendant CVS Rx Services, Inc. is a New York corporation with its principal
with its principal place of business in Knoxville, Tennessee and distributed opioids into Illinois
60. Defendant CVS Pharmacy, Inc. is a Rhode Island corporation with its principal
place of business in Woonsocket, Rhode Island. CVS Pharmacy, Inc. is a wholly owned subsidiary
of CVS Health. Defendant CVS Pharmacy, Inc. is both a DEA registered “distributor” 11 and a
DEA registered “dispenser” 12 of prescription opioids and cocktail drugs and is registered to do
business in Illinois.
61. Defendant CVS Pharmacy Limited of Illinois, LLC is an Illinois Limited Liability
62. Defendants CVS Health Corporation; CVS Indiana L.L.C.; CVS Rx Services, Inc.;
CVS TN Distribution, LLC; CVS Pharmacy, Inc.; and CVS Pharmacy Limited of Illinois, LLC,
are collectively referred to as “CVS.” CVS conducts business as a licensed wholesale distributor
and dispenser. At all times relevant to this Complaint, CVS distributed and/or dispensed
11
21 U.S.C. §802(11) and §822(a)(1).
12
21 U.S.C. §802(10) and §822(a)(2).
12
prescription opioids throughout the United States, including in Illinois and the Counties
specifically.
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63. Defendants CVS Indiana, CVS Pharmacy Inc, CVS Rx Services, Inc. and CVS
TN Distribution, LLC, self-distributed prescription opioids and opioid cocktail drugs to CVS
pharmacies that it owned and operated in Illinois during the relevant time frame.
B. Walgreens
64. Defendant Walgreen Co. acted as a retail pharmacy in the United States, until
Walgreen Co. completed the acquisition of Alliance Boots, a British pharmacy giant, in 2014.
After this acquisition, the company simply became Walgreens Boots Alliance, Inc. traded on
65. Defendant Walgreens Boots Alliance, Inc. is a Delaware corporation that describes
itself as the successor of Walgreen Co., an Illinois corporation. Both Walgreens Boots Alliance,
Inc. and Walgreen Co. have their principal place of business in Illinois.
66. Walgreen Co. is portrayed as a subsidiary of Walgreens Boots Alliance, Inc. and
67. During the relevant time period, Walgreens self-distributed opioids and cocktail
drugs to its own pharmacies in Illinois from Walgreen Eastern Co., Inc., a distribution center which
68. Defendants Walgreens Boots Alliance, Inc., Walgreen Co. and Walgreen Eastern
above. Throughout the relevant time period, and as further alleged below, Walgreens entities also
owned and operated pharmacies in the Counties. At all times relevant to this Complaint,
Walgreens distributed and/or sold prescription opioids throughout the United States, including in
13
70. The DEA distribution registrations for Walgreens’s controlled substances
distribution centers that distributed opioids and cocktail drugs into the Illinois and the Counties
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71. Walgreen Co. created, implemented, and had the power to enforce policies,
practices, and training regarding distribution and sales in all Walgreens distribution and pharmacy
sales operations.
72. The DEA dispensing registrations for Walgreens’s pharmacies in Illinois and the
Counties were held by Walgreen Eastern Co. Inc., which operated each pharmacy as a “d/b/a/”
entity.
73. Collectively, Defendants Walgreen Co., Walgreens Boots Alliance, Inc. and
Walgreen Eastern Co., Inc., purchased and self-distributed prescription opioids and opioid cocktail
drugs to pharmacies that it owned and operated in Illinois during the relevant time frame.
C. Walmart
74. Defendant Walmart Inc., formerly known as Wal-Mart Stores, Inc., is a Delaware
75. Defendant Wal-Mart Stores East, LP is a Delaware limited partnership with its
76. Defendant Sam’s East, Inc., d/b/a Sam’s Club, is an Arkansas corporation with
its principal place of business in Arkansas. Sam’s East, Inc. is an indirectly, wholly owned
subsidiary of Walmart Inc. The sole shareholder of Sam’s East, Inc. is Defendant Sam’s West,
Inc. d/b/a Sam’s Club, which is a wholly owned direct subsidiary of Walmart Inc. and an Arkansas
corporation. Defendants Sam’s East, Inc. and Sam’s West, Inc. jointly operate Sam’s Club stores.
77. Walmart Inc. is the sole owner of Sam’s West, Inc. Sam’s West, Inc. is the sole
78. Defendant WSE Management, LLC, is a Delaware limited liability company, and
14
79. Defendant WSE Investment, LLC, is a Delaware limited liability company, and a
80. The sole owner and member of both WSE Management, LLC and WSE
Investment, LLC is Wal-Mart Stores East LLC (formerly known as Wal-Mart Stores East, Inc.),
81. The sole owner and member of Wal-Mart Stores East, LLC (formerly known as
Wal-Mart Stores East, Inc.) is Walmart Inc., f/k/a Wal-Mart Stores, Inc.
82. Defendants Walmart Inc., f/k/a Wal-Mart Stores, Inc., Wal-Mart Stores East, LP,
WSE Management, LLC, WSE Investment LLC, Wal-Mart Stores East, LLC (formerly known
as Wal-Mart Stores East, Inc.), Sam’s East, Inc., and Sam’s West, Inc., are collectively referred
to as “Walmart.”
83. Walmart, through its various DEA registrant subsidiaries and affiliated entities,
84. At all times relevant to this Complaint, Walmart distributed and/or sold
D. Kroger
85. Defendant Kroger Co. is an Ohio corporation with its principal place of business
in Cincinnati, Ohio. Defendant Kroger Limited Partnership I is an Ohio limited partnership with
its principal place of business in Cincinnati, Ohio. Defendant Kroger Limited Partnership II is an
Ohio limited partnership with its principal place of business in Columbus, Ohio. Kroger Co.,
Kroger Limited Partnership I, and Kroger Limited Partnership II are collectively referred to herein
as “Kroger.”
13
https://www.reuters.com/companies/KR
15
87. At all relevant times, Kroger dispensed prescription opioids in Illinois. Until at
least 2014, Kroger self-distributed certain drugs, including one of the most widely diverted
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E. Meijer
88. Defendant Meijer, Inc. has its principal place of business in Grand Rapids,
Michigan and upon information and belief, is a Michigan corporation. Defendants Meijer
Distribution, Inc. and Meijer Stores Limited Partnership are each based in Grand Rapids,
89. Meijer, Inc., through its various DEA registrant subsidiaries and affiliated entities,
substances came from Meijer Distribution, Inc. and other wholesalers. Meijer Stores Limited
Partnership, upon information and belief, operates each pharmacy in the Illinois as a “d/b/a/”
entity.
90. Defendants Meijer, Inc., Meijer Distribution, Inc., and Meijer Stores Limited
Partnership are collectively referred to as “Meijer.” Meijer operates over 200 stores across
Michigan, Ohio, Indiana, Illinois, and Kentucky. Upon information and belief, at all times
relevant to this Complaint, Meijer distributed and/or sold prescription opioids throughout these
F. Albertsons
(“Albertsons”), is a Delaware corporation with its principal place of business in Boise, Idaho.
92. Defendant Albertson’s LLC is a Delaware limited liability company with its
principal place of business in Boise, Idaho. Albertson’s LLC is a wholly owned subsidiary of
16
93. Defendant Safeway, Inc. is a Delaware corporation with its principal place of
Companies, Inc.
94. Albertsons Companies, Inc., Albertson’s LLC, and Safeway, Inc. are collectively
referred to as “Albertsons.”
various DEA-registered subsidiaries and affiliated entities. At all times relevant to this Complaint,
96. In addition, for a portion of the relevant time period, Albertsons operated as a
distributor of controlled substances, distributing certain prescription opioids to its own pharmacies
through Albertsons LLC Distribution Center #8720, located in Ponca City, Oklahoma.
97. Albertsons operates stores in 34 states and the District of Columbia under multiple
store “banners,” including Safeway, Vons, Jewel-Osco, Acme, Carrs, Randalls, Tom Thumb, and
Market Street.
Texas based United Supermarkets, LLC, doing business as The United Family, which operates
50 retail stores under three brands: United Supermarket, Market Street, and Amigos.
largest food and drug retailers in the country. Safeway stores include 266 Safeway-branded stores
in Northern California and Hawai‘i, 273 Vons stores in Southern California and Nevada, 107
Randalls and Tom Thumb stores in Texas, and 28 Carrs stores in Alaska.
100. Other store banners within the Albertsons Companies include Lucky, Shaws,
Haggen, and Star Market. “Albertsons” as used herein refers to all store banners used by the
Albertsons Companies.
17
G. Related Entities; Agency and Authority
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101. Defendants include the entities named above as well as their predecessors,
successors, affiliates, subsidiaries, partnerships and divisions to the extent that they are engaged
102. All of the actions described in this Complaint are part of, and in furtherance of, the
unlawful conduct alleged herein, and were authorized, ordered, and/or done by Defendants’
officers, agents, employees, or other representatives while actively engaged in the management of
Defendants’ affairs within the course and scope of their duties and employment, and/or with
103. Plaintiffs allege that the corporate parents named as Defendants in this Complaint
are liable as a result of their own actions and obligations in distributing and selling opioids, and
not solely because of their vicarious responsibility for the actions of their pharmacy stores.
V. FACTS
104. The term “opioid” refers to a class of drugs that bind with opioid receptors in the
brain and includes natural, synthetic, and semi-synthetic opioids. Natural opioids are derived from
the opium poppy. Generally used to treat pain, opioids produce multiple effects on the human
body, the most significant of which are analgesia, euphoria, and respiratory depression.
105. The medicinal properties of opioids have been recognized for millennia—as well
as their potential for abuse and addiction. The opium poppy contains various opium alkaloids,
three of which are used in the pharmaceutical industry today: morphine, codeine, and thebaine.
Early use of opium in Western medicine was with a tincture of opium and alcohol called laudanum,
which contains all of the opium alkaloids and is still available by prescription today. Chemists
first isolated the morphine and codeine alkaloids in the early 1800s.
18
106. In 1827, the pharmaceutical company Merck began large-scale production and
commercial marketing of morphine. During the American Civil War, field medics commonly used
FILED DATE: 8/15/2022 4:37 PM 2022L007352
morphine, laudanum, and opium pills to treat the wounded, and many veterans were left with
morphine addictions. By 1900, an estimated 300,000 people were addicted to opioids in the United
States, and many doctors prescribed opioids solely to prevent their patients from suffering
withdrawal symptoms. The nation’s first Opium Commissioner, Hamilton Wright, remarked in
1911, “The habit has this nation in its grip to an astonishing extent. Our prisons and our hospitals
are full of victims of it, it has robbed ten thousand businessmen of moral sense and made them
beasts who prey upon their fellows . . . it has become one of the most fertile causes of unhappiness
(obtained from acetylation of morphine) under the trade name “Heroin.” Bayer advertised heroin
as a non-addictive cough and cold remedy suitable for children, but as its addictive nature became
clear, heroin distribution in the U.S. was limited to prescription only in 1914 and then banned
108. Although heroin and opium became classified as illicit drugs, there is little
difference between them and prescription opioids. Prescription opioids are synthesized from the
same plant as heroin, have similar molecular structures, and bind to the same receptors in the
human brain.
109. Due to concerns about their addictive properties, prescription opioids have usually
been regulated at the federal level as Schedule II controlled substances by the DEA since 1970.
morphine milligram equivalents (“MME”). According to the CDC, doses at or above 50 MME/day
14
Nick Miroff, From Teddy Roosevelt to Trump: How Drug Companies Triggered an Opioid Crisis a
Century Ago, The Wash. Post (Oct. 17, 2017),
https://www.washingtonpost.com/news/retropolis/wp/2017/09/29/the-greatest-drug-fiends-in-the-world-
an-american-opioid-crisis-in-1908/?utm_term=.7832633fd7ca.
19
double the risk of overdose compared to 20 MME/day, and one study found that patients who died
111. Patients develop tolerance to the analgesic effect of opioids relatively quickly. As
tolerance increases, a patient typically requires progressively higher doses in order to obtain the
same perceived level of pain reduction. The same is true of the euphoric effects of opioids—the
“high.” However, opioids depress respiration, and at very high doses can and often do arrest
respiration altogether. At higher doses, the effects of withdrawal are more severe. Long-term
112. Discontinuing opioids after more than just a few weeks will cause most patients to
experience withdrawal symptoms. These withdrawal symptoms include: severe anxiety, nausea,
vomiting, headaches, agitation, insomnia, tremors, hallucinations, delirium, pain, and other serious
symptoms, which may persist for months after a complete withdrawal from opioids, depending on
113. As alleged throughout this Complaint, Defendants’ conduct has created a public
maintained by Defendants can be abated and further recurrence of such harm and inconvenience
can be abated by taking measures such as providing addiction treatment to patients who are already
addicted to opioids, making naloxone widely available so that overdoses are less frequently fatal,
115. Defendants have the ability to act to help end the public nuisance, and the law
recognizes that they are uniquely well-positioned to do so. All companies in the supply chain of
a controlled substance are primarily responsible for ensuring that such drugs are only distributed
and sold to appropriate patients and not diverted. These responsibilities exist independent of any
20
regulation, to ensure that their products and practices meet both federal and state laws and
placed in a position of special trust and responsibility and are uniquely positioned, based on their
knowledge of prescribers and orders, to act as a key line of defense. Defendants, however, instead
abused their position of special trust and responsibility within the closed system of opioid
distribution and dispensing and fostered a black market for prescription opioids.
116. Retail pharmacy chains earned enormous profits by flooding the country with
prescription opioids. They were keenly aware of the oversupply of prescription opioids through
the extensive data and information they developed and maintained as both distributors and retail
sellers of opioids. Yet, instead of taking any meaningful action to stem the flow of opioids into
117. Each of the Chain Pharmacies does substantial business across the United States.
118. Statewide ARCOS data confirms that the Chain Pharmacies distributed and
dispensed substantial quantities of prescription opioids in Illinois and/or the Counties. In addition,
they distributed and dispensed substantial quantities of prescription opioids in other states and
other counties, and these drugs were diverted from these other states and counties to Illinois and/or
the Counties. The Chain Pharmacies failed to take meaningful action to stop this diversion despite
their knowledge of it, and thus contributed substantially to the diversion problem.
119. The Chain Pharmacies developed and maintained extensive data on the opioids
they distributed and dispensed. Through this data, Chain Pharmacies had direct knowledge of
patterns and instances of improper distribution, prescribing, sale, and use of prescription opioids
21
in communities throughout the country, and in Illinois in particular. They used the data to evaluate
their own sales activities and workforce. The Chain Pharmacies also provided data regarding,
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inter alia, individual doctors to drug companies, which targeted those prescribers with their
marketing, in exchange for rebates or other forms of consideration. The Chain Pharmacies’ data is
a valuable resource that they could and should have used to help prevent diversion, but they failed
to do so. Defendants facilitated the supply of far more opioids that could have been justified to
serve a legitimate market. The failure of the Defendants to maintain effective controls, and to
investigate, report, and take steps to halt orders that they knew or should have known were
suspicious, as well as to maintain effective policies and procedures to guard against diversion from
their retail stores, breached both their statutory and common law duties.
120. For over a decade, Defendants aggressively sought to bolster their revenue,
increase profit, and grow their share of the prescription painkiller market by unlawfully and
surreptitiously increasing the volume of opioids they sold. However, Defendants are not permitted
to engage in a limitless expansion of their sales through the unlawful sales of regulated painkillers.
121. Each participant in the supply chain of opioid distribution, including the Chain
Pharmacies, is responsible for preventing diversion of prescription opioids into the illegal market
In 2015, on an average day, more than 650,000 opioid prescriptions were dispensed in the U.S.
Not all of these prescriptions were legitimate. Yet Defendants systemically ignored red flags that
they were fueling a black market and failed to maintain effective controls against diversion at both
the wholesale and retail pharmacy level. Instead, they put profits over the public health and safety.
Despite their legal obligations as registrants under the CSA, the Chain Pharmacies allowed
123. Upon information and belief, this problem was compounded by the Chain
Pharmacies’ failure to adequately train their pharmacists and pharmacy technicians on how to
22
properly and adequately handle prescriptions for opioid painkillers, including what constitutes a
proper inquiry into whether a prescription is legitimate and what measures and/or actions to take
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124. Upon information and belief, the Chain Pharmacies also failed to put in place
effective policies and procedures to prevent their stores from facilitating diversion and selling into
a black market, and to conduct adequate internal or external reviews of their opioid sales to identify
patterns regarding prescriptions that should not have been filled, or if they conducted such reviews,
125. Upon information and belief, even where Chain Pharmacies enacted policies and
procedures to prevent stores from facilitating diversion and selling into a black market, such
policies were merely window-dressing and were not employed in any meaningful way.
126. Upon information and belief, the Chain Pharmacies also failed to effectively
respond to concerns raised by their own employees regarding inadequate policies and procedures
regarding the filling of opioid prescriptions. Instead, Chain Pharmacies put in place policies that
required and rewarded speed and volume over safety and the care necessary to ensure that narcotics
were distributed and sold lawfully. Defendants consistently put profits over safety in their
127. The Chain Pharmacies were, or should have been, fully aware that the quantity of
opioids being distributed and dispensed by them was untenable, and in many areas patently absurd.
But they did not take meaningful action to investigate or to ensure that they were complying with
their duties and obligations under the law with regard to controlled substances.
2. Defendants Have a Duty to Report Suspicious Orders and Not to Ship
Those Orders Unless Due Diligence Disproves Their Suspicions
128. Multiple sources impose duties on the Defendants to report suspicious orders and
further not to ship those orders unless due diligence disproves those suspicions.
129. First, under the common law, Defendants had a duty to exercise reasonable care
in delivering dangerous narcotic substances. By flooding Illinois, and the Counties, with more
23
opioids than could be used for legitimate medical purposes by filling and failing to report orders
that they knew or should have realized were likely being diverted for illicit uses and by failing to
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maintain effective controls against diversion from their retail stores, Defendants breached that duty
130. Second, each of the Defendants assumed a duty, when speaking publicly about
opioids and their efforts to combat diversion, to speak accurately and truthfully.
131. Third, distributors and chain pharmacies are required to register with the DEA to
distribute and/or dispense controlled substances under the federal Controlled Substances Act. See
21 U.S.C. § 823(a)-(b), (e); 28 C.F.R. § 0.100; 28 C.F.R. § 1301.71. Recognizing a need for
greater scrutiny over controlled substances due to their potential for abuse and danger to public
health and safety, the United States Congress enacted the Controlled Substances Act in 1970. The
CSA and its implementing regulations created a closed system of distribution for all controlled
substances and listed chemicals. Congress specifically designed the closed chain of distribution
to prevent the diversion of controlled substances into the illicit market. Congress was concerned
with the diversion of drugs out of legitimate channels of distribution and acted to halt the
“widespread diversion of [controlled substances] out of legitimate channels into the illegal
market.” Moreover, the closed system was specifically designed to ensure that there are multiple
ways of identifying and preventing diversion through active participation by registrants within the
drug delivery chain. All registrants must adhere to the specific security, recordkeeping, monitoring
and reporting requirements that are designed to identify or prevent diversion. Maintaining the
closed system under the CSA and effective controls to guard against diversion is a vital public
health concern. Controlled substances, and prescription opioids specifically, are recognized as
posing a high degree of risk from abuse and diversion. When the supply chain participants at any
level fail to fulfill their obligations, the necessary checks and balances collapse. The result is the
against diversion” and to “design and operate a system to disclose . . . suspicious orders of
24
controlled substances.” 21 U.S.C. § 823(a)-(b); 21 C.F.R. § 1301.74. Defendants were further
required to take steps to halt suspicious orders. Defendants violated their obligations under federal
FILED DATE: 8/15/2022 4:37 PM 2022L007352
law. Defendants have additional duties under Illinois’s controlled substances laws and common
law.
133. Further, under the CSA, pharmacy registrants are required to “provide effective
controls and procedures to guard against theft and diversion of controlled substances.” See 21
C.F.R. § 1301.71(a). In addition, 21 C.F.R. § 1306.04(a) states, “[t]he responsibility for the proper
prescribing and dispensing of controlled substances is upon the prescribing practitioner, but a
corresponding responsibility rests with the pharmacist who fills the prescription.” Thus, regardless
of whether they are registrants, all dispensers must ensure that prescriptions of controlled
substances are “issued for a legitimate medical purpose by an individual practitioner acting in the
usual course of his professional practice.” 21 C.F.R. § 1306.04(a). The DEA has recognized that
“as dispensers of controlled substances, pharmacists and pharmacy employees are often the last
acting in the usual course of his professional practice.” 21 C.F.R. § 1306.06. As the Department
of Justice’s recent lawsuit against Walmart alleges, 21 C.F.R. § 1306.06 requires that a
pharmacist’s conduct, when filling controlled-substance prescriptions adhere to the usual course
of a pharmacist’s professional practice. The obligation to identify any red flags relating to a
controlled-substances prescription, to resolve them before filing the prescription, and to document
practice of pharmacy. United States of America v. Walmart Inc. et al., 1:20-cv-01744, (D. Del.
Dec. 22, 2020). Former DEA diversion investigator Demetra Ashley confirmed this proposition
in her testimony in a deposition in this MDL. And, as the Department of Justice’s complaint
alleges, when ‘Walmart pharmacists failed to comply with their own professional pharmacy
15
2012 Dear Registrant letter to pharmacy registrants, http://ppsconline.com/articles/2012/FL_PDAC.pdf.
25
standards’ in this respect, ‘Walmart ... violated 21 C.F.R. § 1306.06.’” United States of America
135. Under the CSA, the duty to prevent diversion lies with the Chain Pharmacies, not
the individual pharmacist. As such, although it acts through its agents, the pharmacy is ultimately
responsible to prevent diversion, as described above. 16 Further, as described above, the obligations
under the controlled-substances laws extend to any entity selling prescription opioids, whether it
is the registration holder or not. It is unlawful for any person knowingly to distribute or dispense
controlled substances other than in accordance with the requirements of the federal CSA and its
Chain pharmacies are responsible “persons” under the CSA. They also exert control over their
agents, including the responsibility to ensure they comply with applicable laws and regulations in
all dispensing of controlled substances. Pharmacy chains cannot absolve themselves of their own
136. In addition to their duties as distributors, the Chain Pharmacies also had a duty to
design and implement systems to prevent diversion of controlled substances in their retail
pharmacy operations. The Chain Pharmacies had the ability, and the obligation, to look for these
red flags on a patient, prescriber, and store level, and to refuse to fill and to report prescriptions
suggestive of potential diversion. They also have a crucial role in creating chain-wide systems to
identify and avoid filling “prescriptions” that are not issued for a legitimate purpose or by a
16
The Medicine Shoppe; Decision and Order, 79 FR 59504, 59515 (DEA Oct. 2, 2014) (emphasis added);
see also Holiday CVS, L.L.C., d/b/a CVS/Pharmacy Nos. 219 and 5195; Decision and Order, 77 FR 62316-
01 (“When considering whether a pharmacy has violated its corresponding responsibility, the Agency
considers whether the entity, not the pharmacist, can be charged with the requisite knowledge.”); Top RX
Pharmacy; Decision and Order, 78 FR 26069, 62341 (DEA Oct. 12, 2012) (same); cf. Jones Total Health
Care Pharmacy LLC and SND Health Care LLC v. Drug Enforcement Administration, 881 F.3d 82 (11th
Cir. 2018) (revoking pharmacy registration for, inter alia, dispensing prescriptions that prescriptions
presented various red flags, i.e., indicia that the prescriptions were not issued for a legitimate medical
purpose without resolving red flags).
26
137. Pharmacy Defendants’ obligations extend to monitoring, and documenting, the
steps they take in accessing state prescription drug monitoring programs, often referred to as
FILED DATE: 8/15/2022 4:37 PM 2022L007352
“PDMPs.” Yet, the Chain Pharmacies, upon information and belief, generally relied on their
pharmacists’ discretion in this area rather than setting forth requirements concerning PDMP
searches and implementing systems, at least for many years, to track and document PDMP
138. The CSA requires distributors and pharmacies, along with other participants in the
supply chain of controlled substances like opioids to: (a) limit sales within a quota set by the DEA
for the overall production of controlled substances like opioids; (b) register to distribute opioids;
(c) maintain effective controls against diversion of the controlled substances that they manufacture
or distribute; and (d) identify suspicious orders of controlled substances and halt such sales.
139. To ensure that even drugs produced within quota are not diverted, federal
regulations issued under the CSA mandate that all registrants “design and operate a system to
Registrants are not entitled to be passive (but profitable) observers, but rather “shall inform the
Field Division Office of the Administration in his area of suspicious orders when discovered by
the registrant.” Id. Suspicious orders include orders of unusual size, orders deviating substantially
from a normal pattern, and orders of unusual frequency. Id. Other indicia of potential diversion
may include, for example, “[o]rdering the same controlled substance from multiple distributors.”
140. These criteria are disjunctive and are not all inclusive. For example, if an order
deviates substantially from a normal pattern, the size of the order does not matter, and the order
should be reported as suspicious. Likewise, a distributor need not wait for a normal pattern to
develop over time before determining whether a particular order is suspicious. The size of an order
alone, regardless of whether it deviates from a normal pattern, is enough to trigger the
suspicious depends not only on the ordering patterns of the particular customer but also on the
patterns of the entirety of the customer base and the patterns throughout the relevant segment of
27
the industry. For this reason, identification of suspicious orders serves also to identify excessive
• DEA registrants are required to block all suspicious orders of prescription opioids.
• If a wholesale distributor blocks a suspicious order, they should terminate all future
sales to that same customer until they can rule out that diversion is occurring.
• After the fact reporting of suspicious orders has never been in compliance with
federal law. 17
142. Of course, due diligence efforts must also be thorough: “the investigation must
dispel all red flags indicative that a customer is engaged in diversion to render the order non-
suspicious and exempt it from the requirement that the distributor inform the DEA about the order.
Put another way, if, even after investigating the order, there is any remaining basis to suspect that
a customer is engaged in diversion, the order must be deemed suspicious, and the Agency must be
informed. Indeed, the DEA may revoke a distributor’s certificate of registration as a vendor of
controlled substances if the distributor identifies orders as suspicious and then ships them without
143. To comply with the law, wholesale distributors, including Defendants, must know
their customers and the communities they serve. Each distributor must “perform due diligence on
its customers” on an “ongoing [basis] throughout the course of a distributor’s relationship with its
customer.” Masters Pharms., Inc., 80 Fed. Reg. 55,418, 55,477 (DEA Sept. 15, 2015), petition
144. Pharmacy order data provides detailed insight into the volume, frequency, dose,
and type of controlled and non-controlled substances a pharmacy typically orders. This includes
17
See Prevoznik Dep. Vol II, April 18, 2019 (DEA 30(b)(6) designee).
28
non-controlled substances and Schedule IV controlled substances (such as benzodiazepines),
which are not reported to the DEA, but whose use with opioids can be indicative of diversion.
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Medicine, “[p]harmacies have a role to play in the oversight of prescriptions for controlled
substances, and opioid analgesics in particular.” Mitch Betses, R.Ph., and Troyen Brennan, M.D.,
369;11, Sept. 12., 2013, at 989-991. The DEA has identified “both pharmaceutical distributors
and chain pharmacies as part of the problem” contributing to opioid abuse and related deaths. Id.
146. The Chain Pharmacies have a particular “advantage” in meeting their obligations
under the CSA because these entities can use “aggregated information on all prescriptions filled at
the chain” in order to examine “patterns” of opioids and other “high-risk drugs” and target
“inappropriate prescribing.” Id. at 990. For example, a chain pharmacy should properly use its
chainwide dispensing data to identify “high risk prescribers” by “benchmarking” prescription data
based on “several parameters,” including “volume of prescriptions for high-risk drugs,” “the
proportion of the prescriber’s prescriptions that were for such [high-risk] drugs, as compared with
the volume and proportion for others in the same specialty and region,” cash payment, ages of
patients, and the prescriber’s ratio of “prescriptions for noncontrolled substances with
prescriptions for controlled substances.” Id. This “[a]nalysis of aggregated data” from chain
pharmacies can “target patterns of abuse,” in the face of “the growing use of controlled substances
and resulting illnesses and deaths.” Id. Accordingly, as CVS touts, “innovative use of transparent
147. As CVS counseled, Defendants may not ignore red flags of illegal conduct and
must use the information available to them to identify, report, and not fill prescriptions that seem
indicative of diversion. That would include reviewing their own data, relying on their observations
diversion.
29
148. In addition to their duties as distributors, Defendants also had a duty to monitor
and report suspicious activity in their retail pharmacy operations. Specifically, Defendants had a
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duty to analyze data and store-level information for known red flags such as (a) multiple
prescriptions to the same patient using the same doctor; (b) multiple prescriptions by the same
patient using different doctors; (c) prescriptions of unusual size and frequency for the same patient;
(d) orders from out-of-state patients or prescribers; (e) an unusual or disproportionate number of
prescriptions paid for in cash; (f) prescriptions paired with other drugs frequently abused with
that suggested that the prescriptions were likely being diverted or were not issued for a legitimate
medical purpose.
shall maintain, on a current basis, a complete and accurate record of each such substance . . .
received, sold, delivered, or otherwise disposed of by him.” 21 USC 827(a). “[A] registrant's
accurate and diligent adherence to [its recordkeeping] obligations is absolutely essential to protect
against the diversion of controlled substances.” Paul H. Volkman, 73 FR 30,630, 30,644 (2008).
possess. They must utilize their information to identify patterns of diversion and for auditing,
training, and investigation of suspicious activity in an effort to prevent diversion of controlled
substances.
151. As distributors and as pharmacies, Defendants have a duty, and are expected, to
be vigilant in ensuring that controlled substances are delivered only for lawful purposes.
152. State and federal statutes and regulations reflect a standard of conduct and care
below which reasonably prudent distributors and pharmacies would not fall. Together, these laws
and industry guidelines make clear that Defendants possess and are expected to possess,
30
specialized and sophisticated knowledge, skill, information, and understanding of both the market
for scheduled prescription opioids and of the risks and dangers of the diversion of prescription
FILED DATE: 8/15/2022 4:37 PM 2022L007352
153. Further, these laws and industry guidelines make clear that Defendants have a
responsibility to exercise their specialized and sophisticated knowledge, information, skill, and
understanding to prevent the oversupply of prescription opioids and minimize the risk of their
154. The privilege of holding a license to distribute and dispense controlled substances
comes with the responsibility of ensuring that the controlled substances distributed or sold are not
diverted and/or subject to abuse and misuse. State and federal laws also have developed fairly
uniform standards of practice across the country. It is both intuitive and understood that selling
drugs for non-medical purposes, or drugs which the dispenser knows or should know present a
significant risk for diversion falls outside the standards of care and is not a legitimate practice. As
part of usual and customary practice, prescriptions must be evaluated and determined to be valid
155. Pharmacies' evaluation process includes with what is known as “Drug Utilization
Review” or “DUR.” This practice is both part of traditional roles and duties and codified in federal
and state statutes. Notably, during the rulemaking practice for one authority, the Omnibus Budget
[R]econciliation Act of 1990 (OBRA 90), a commenter suggested that instructions for compliance
with prospective DUR should go to the pharmacist and not the pharmacy. In response, the
government stated that “the instructions for compliance with prospective DUR should be directed
to the pharmacies,” and that “[t]he owners or managers of pharmacies, as Medicaid providers, are
responsible for furnishing their staff with information pertaining to DUR.” States, seeking to
assure uniformity, have taken action to require the same mandates as this federal law. The DUR
process includes looking at over-utilization, drug interactions and identifying abuse and misuse of
dangerous drugs such as opioids. This process would have provided the Chain Pharmacies
31
156. Accordingly, states, including Illinois, revised and expanded practice acts and
rules and increased their support for, and reliance on, Prescription Drug Monitoring Programs
FILED DATE: 8/15/2022 4:37 PM 2022L007352
157. Defendants themselves recognized the value of the tools available to them through
PMDPs. An internal CVS document, for example, characterized PDMPs as an “invaluable tool
for Pharmacists to prevent controlled substances from being diverted or dispensed for non-medical
purposes ….” It also described PDMPs as “cut[ting] down on prescription fraud and ‘doctor
shopping’ by providing Prescribers and Pharmacists with more complete information about a
patient’s controlled substance prescription history.” Separately, data also suggests that PDMP
158. Additionally, Chain Pharmacies have operating systems and methods to store and
retain prescription dispensing data and records. The information they possess must be readily
retrievable, and they have an obligation to use it to identify patterns of diversion, conduct internal
audits and training programs, investigate suspicious prescribers, patients, and pharmacists, and
prevent diversion of controlled substances. Their hiring, training, and management of pharmacy
personnel, and their supporting policies, procedures, and systems should and must promote public
health and safety and assist in the identification and prevention of the diversion of controlled
substances.
3. Defendants Were Aware of and Have Acknowledged Their Obligations to
Prevent Diversion and to Report and Take Steps to Halt Suspicious Orders.
159. The regulations aim to create a “closed” system in order to control the supply and
reduce the diversion of these drugs out of legitimate channels into the illicit market, while at the
same time providing the legitimate drug industry with a unified approach to narcotic and dangerous
drug control. Both because distributors handle such large volumes of controlled substances, and
because they are uniquely positioned, based on their knowledge of their customers and orders, as
the first line of defense in the movement of legal pharmaceutical controlled substances from
legitimate channels into the illicit market, distributors’ obligation to maintain effective controls to
32
prevent diversion of controlled substances is critical. Should a distributor deviate from these
checks and balances, the closed system of distribution, designed to prevent diversion, collapses.
FILED DATE: 8/15/2022 4:37 PM 2022L007352
160. Defendants were well aware they had an important role to play in this system, and
also knew or should have known that their failure to comply with their obligations would have
serious consequences.
161. Indeed, the DEA has repeatedly informed Defendants about their legal obligations,
including obligations that were so obvious that they simply should not have required additional
clarification. As former DEA agent Joseph Rannazzisi recently testified under oath:
Q. Someone says “Don’t steal,” do you have to put in there “from
a supermarket”?
A. No.
A. No.
Q. Next, you got asked: “Well, you never instructed the companies
to keep their files.” Do you remember that?
A. Yes, sir.
162. For example, it is not an effective control against diversion to identify a suspicious
order, ship it, and wait as long as weeks to report it to law enforcement, potentially allowing those
33
163. During a 30(b)(6) deposition in this MDL, the DEA’s Unit Chief of Liaison was
asked whether the DEA made it “clear to industry that the failure to prevent diversion was a threat
FILED DATE: 8/15/2022 4:37 PM 2022L007352
164. And Defendants did understand. As described below, at least Walgreens has itself
acknowledged (internally) its understanding of the potential consequences of its failure to report
165. In fact, trade organizations in which Defendants have actively participated have
acknowledged that distributors have been responsible for reporting suspicious orders for more than
40 years. The National Association of Chain Drug Stores (“NACDS”) is a national trade
association that represents traditional drug stores, supermarkets, and mass merchants with
pharmacies—from regional chains with four stores to national companies. Its members and/or
affiliate members also include stakeholders such as manufacturers, other distributors and other
trade organizations as well. Most of the Defendants serve on the Board of Directors of NACDS.
As controlling members of NACDS, the Chain Pharmacy Defendants have served on and run key
governing committees within the organization. Chain Pharmacies have repeatedly chaired
NACDS’s Board of Directors, which determines the “strategic plan and positions” of the
organization. During the last 12 years, representatives of CVS, Walgreens, and Walmart have
always held Board of Directors or officer seats. Kroger and Meijer have acted as chairs.
34
166. The Healthcare Distribution Management Association (“HDMA,” now known as
the Healthcare Distribution Alliance (“HDA”), and prior to 2000, known as the National
FILED DATE: 8/15/2022 4:37 PM 2022L007352
distributors that has partnered with NACDS. The two groups viewed their relationship as a
167. In 2006, the NACDS issued a “Model Compliance Manual” intended to “assist
NACDS members” in developing their own compliance programs. The Model Compliance
Manual notes that a retail pharmacy may “generate and review reports for its own purposes” and
refers to the assessment tools identified by CMS in its Prescription Drug Benefit Manual chapter
168. In 2007 and 2008, the HDA, began developing “Industry Compliance Guidelines”
(“ICG”) that aimed to outline certain “best practices” for distributors of controlled substances. As
part of its development of the ICG, the HDA met with the DEA on at least three occasions. The
35
HDA also sought extensive input from its membership, as well as other groups such as the Pain
Care Forum. Internal discussions concerning the ICG further demonstrate the industry’s
FILED DATE: 8/15/2022 4:37 PM 2022L007352
knowledge of what was expected of them. For example, when deciding whether or not the
guidelines should permit a distributor to still ship a part of an order identified as suspicious, the
HDA noted that one potential downside of this approach was that “DEA
169. The HDA released the ICG in 2008 and, in doing so, it emphasized that distributors
were “[a]t the center of a sophisticated supply chain” and “uniquely situated to perform due
diligence in order to help support the security of the controlled substances they deliver to their
customers.” 18
170. More recently, in the appeal that arose from DEA’s enforcement action against
wholesaler Masters Pharmaceuticals, Inc. for its distribution of opioids, the HDA and NACDS
submitted a joint amicus brief regarding the legal duty of distributors that acknowledged that
“HDMA and NACDS members” had a duty to prevent diversion.” See Masters Pharmaceuticals,
Inc. v. U.S. Drug Enforcement Admin., 2016 WL 1321983 (D.C. Cir. April 4, 2016). As described
below, both the HDA and NACDS have both long taken the position that distributors have
responsibilities to “prevent diversion of controlled prescription drugs” not only because they have
statutory and regulatory obligations do so, but “as responsible members of society.”
171. The requirement to report suspicious orders at the time (not after the fact) has
always been clear and Defendants themselves have acknowledged as much through their various
trade groups and associations. As described above, correspondence between the NWDA and the
DEA, as early as 1984, illustrates that the DEA provided clear guidance well before the opioid
crisis was unleashed. For example, in one letter to the NWDA, DEA Section Chief Thomas
Gitchel emphasized that “the submission of a monthly printout of after-the-fact sales will not
18
Healthcare Distribution Management Association (HDMA) Industry Compliance Guidelines: Reporting
Suspicious Orders and Preventing Diversion of Controlled Substances, filed in Cardinal Health, Inc. v.
Holder, No. 12-5061 (D.C. Cir. Mar. 7, 2012), Doc. No. 1362415 (App’x B at 1).
36
relieve a registrant from the responsibility of reporting excessive or suspicious orders,” noting
“DEA has interpreted ‘orders’ to mean prior to shipment.” Consistent with that understanding,
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172. In addition, the DEA, for example, in April 1987, sponsored a three-day
“Controlled Substances Manufacturers and Wholesalers Seminar” that was attended by “over fifty
manufacturers and wholesalers.” According to the executive summary of the event, Ronald
173. The DEA also repeatedly reminded Defendants of their obligations to report and
decline to fill suspicious orders. Responding to the proliferation of internet pharmacies that
arranged illicit sales of enormous volumes of opioids, the DEA began a major push to remind
distributors of their obligations to prevent these kinds of abuses and educate them on how to meet
these obligations.
174. Specifically, in August 2005, the DEA’s Office of Diversion Control launched the
“Distributor Initiative.” The Distributor Initiative did not impose any new duties on distributors,
but simply reminded them of their duties under existing law. The stated purpose of the program
under the CSA by discussing their Suspicious Order Monitoring System, reviewing their
[Automation of Reports and Consolidated Orders System (“ARCOS”)] data for sales and
37
purchases of Schedules II and III controlled substances, and discussing national trends involving
the abuse of prescription controlled substances.” 19 The CSA requires that distributors (and
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manufacturers) report all transactions involving controlled substances to the United States
Attorney General. This data is captured in ARCOS, the “automated, comprehensive drug reporting
system which monitors the flow of DEA controlled substances from their point of manufacture
institutions,”20 described above, from which certain data has now been made public.
175. As part of the Distributor Initiative, the DEA gave several presentations to
distributors both individually and through presentations and discussions at Defendants’ trade
groups meetings directly targeted at some of the red flags of diversion that the Defendants were
obligated to consider and monitor as part of their requirements under the law.
19
Thomas W. Prevoznik, Office of Diversion Control, Distributor Initiative presentation (Oct. 22, 2013),
https://www.deadiversion.usdoj.gov/mtgs/distributor/conf_2013/prevoznik.pdf.
20
U.S. Dept. of Justice, Drug Diversion Administration, Diversion Control Division website,
https://www.deadiversion.usdoj.gov/arcos/index.html.
38
176. The DEA has hosted many different conferences throughout the years, including
about diversion trends and their regulatory obligations. The DEA also frequently presented at
various other conferences for registrants at the national, state, or local level.
177. Through presentations at industry conferences and on its website, the DEA
provided detailed guidance to distributors on what to look for in assessing their customers’
178. In addition, the DEA sent a series of letters, beginning on September 27, 2006, to
every commercial entity registered to distribute controlled substances, including chain pharmacy
179. The letter also warned that “even just one distributor that uses its DEA registration
to facilitate diversion can cause enormous harm.” 23
21
U.S. Dept. of Justice, DEA, Diversion Control Division website, Pharmaceutical Industry Conference
(Oct 14 & 15, 2009), Suggested Questions a Distributor should ask prior to shipping controlled
substances, Drug Enforcement Administration available at
https://www.deadiversion.usdoj.gov/mtgs/pharm_industry/14th_pharm/levinl_ques.pdf; Richard Widup,
Jr., Kathleen H. Dooley, Esq., Pharmaceutical Production Diversion: Beyond the PDMA, Purdue Pharma
and McGuireWoods LLC, available at https://www.mcguirewoods.com/news-
resources/publications/lifesciences/product_diversion_beyond_pdma.pdf.
22
Letter from Joseph T. Rannazzisi, Deputy Assistant Adm’r, Off. of Diversion Control, Drug Enf’t
Admin., U.S. Dep’t of Justice, to Cardinal Health (Sept. 27, 2006), filed in Cardinal Health, Inc. Inc. v.
Holder, No. 1:12-cv-00185-RBW (D.D.C. Feb. 10, 2012), ECF No. 14-51 (“2006 Rannazzisi Letter”);
see also CVS-MDLT1000091513; WAGMDL00757797.
23
Id.
39
180. The DEA sent a second letter to distributors on December 27, 2007. Again, the
letter instructed that, as registered distributors of controlled substances, they must each abide by
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statutory and regulatory duties to “maintain effective controls against diversion” and “design and
operate a system to disclose to the registrant suspicious orders of controlled substances.” 24 DEA’s
letter reiterated the obligation to detect, report, and not fill suspicious orders and provided detailed
guidance on what constitutes a suspicious order and how to report (e.g., by specifically identifying
181. In September 2007, the NACDS, among others, also attended a DEA
conference at which the DEA reminded registrants that not only were they required to report
suspicious orders, but also to halt shipments of suspicious orders. Walgreens, specifically,
182. The DEA’s regulatory actions against the three largest wholesale distributors
further underscore the fact that distributors such as Defendants were well aware of their legal
obligations. There is a long history of enforcement actions against registrants for their compliance
failures. For example, in 2007, the DEA issued an Order to Show Cause and Immediate
Suspension Order against three of Cardinal Health’s distribution centers, and on December 23,
2016, Cardinal Health agreed to pay the United States $44 million to resolve allegations that it
violated the CSA in Maryland, Florida, and New York. Similarly, on May 2, 2008, McKesson
entered into an Administrative Memorandum of Agreement (“AMA”) with the DEA related to its
McKesson entered into an AMA with the DEA wherein it agreed to pay a $150 million civil
penalty for, inter alia, failure to identify and report suspicious orders at several of its facilities.
Letter from Joseph T. Rannazzisi, Deputy Assistant Adm’r, Office of Diversion Control, Drug. Enf’t
24
Admin., U.S. Dep’t of Justice, to Cardinal Health (Dec. 27, 2007), filed in Cardinal Health, Inc. v.
Holder, No. 1:12-cv00185-RBW (D.D.C. Feb. 10, 2012), ECF No. 14-8 (“2007 Rannazzisi Letter”).
40
183. The DEA has also repeatedly affirmed the obligations of pharmacies to maintain
effective controls against diversion in regulatory action after regulatory action. 25 The DEA,
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among others, also has provided extensive guidance to pharmacies on how to identify suspicious
184. DEA has repeatedly emphasized that retail pharmacies, such as Defendants, are
required to implement systems that detect and prevent diversion and must monitor for and report
red flags of diversion. When red flags appear, the pharmacy's “corresponding responsibility”
under 21 C.F.R. § 1306.04(a) requires it either to take steps (and document those steps) to resolve
the issues or else to refuse to fill prescriptions with unresolvable red flags. 26 DEA has identified
several types of “unresolvable red flags” which, when present in prescriptions presented to a
pharmacist, may never be filled by the overseeing pharmacist. These unresolvable red flags
the controlled substances; multiple prescriptions presented by the same practitioner to patients
from the same address; prescribing the same controlled substances in each presented prescription;
a high volume of patients presenting prescriptions and paying with cash; and, a prescription
presented to by a customer who has traveled significant and unreasonable distances from their
185. DEA guidance also instructs pharmacies to monitor for red flags that include: (1)
prescriptions written by a doctor who writes significantly more prescriptions (or in larger quantities
or higher doses) for controlled substances as compared to other practitioners in the area, and (2)
prescriptions for antagonistic drugs, such as depressants and stimulants, at the same time. Most
25
See, e.g., Holiday CVS, L.L.C., d/b/a CVS/Pharmacy Nos. 219 and 5195; 77 Fed. Reg. 62,316 (DEA
Oct. 12, 2012) (decision and order); East Main Street Pharmacy, 75 Fed. Reg. 66,149 (DEAOct. 27,
2010) (affirmance of suspension order); Holiday CVS, L.L.C. v. Holder, 839 F.Supp.2d 145 (D.D.C.
2012); Townwood Pharmacy; 63 Fed. Reg. 8,477 (DEA Feb. 19, 1998) (revocation of registration);
Grider Drug 1 & Grider Drug 2; 77 Fed. Reg. 44,069 (DEA July 26, 2012) (decision and order); The
Medicine Dropper; 76 Fed. Reg. 20,039 (DEA April 11, 2011) (revocation of registration); Medicine
Shoppe-Jonesborough; 73 Fed. Reg. 363 (DEA Jan. 2, 2008) (revocation of registration).
26
Pharmacy Doctors Enterprises, Inc. v. Drug Enf't Admin., No. 18-11168, 2019 WL 4565481, at *5
(11th Cir. Sept. 20, 2019).
41
of the time, these attributes are not difficult to detect and should be easily recognizable by
186. The DEA has also explained these red flags in individual meetings with
Defendants. For example, in December 2010, DEA hosted a meeting with CVS’s representatives
and counsel and advised CVS of the “red flags . . . that a pharmacy should be familiar with in order
to carry out its corresponding responsibility to ensure that the controlled substances are dispensed
187. Examples of red flags that the DEA identified during its meeting with CVS
include:
• many customers receiving the same combination of prescriptions (i.e.,
oxycodone and alprazolam);
188. Similarly, in 2011, the DEA took Walgreens “to the woodshed” over its dispensing
cocktail drugs and opioids to questionable out of state customers, customers with the duplicate
diagnoses, young people, and customers only paying cash. Many of these same red flags were
highlighted in the 2009 Walgreens Order to Show Cause and resulting 2011 Memorandum of
Agreement.
27
Declaration of Joe Rannazzisi in Holiday CVS, L.L.C. v. Holder, 839 F. Supp.2d 145 (D.D.C. 2012).
28
Id.
42
189. As another example, in a 2016 presentation to the American Pharmacists
Association, the DEA reiterated that retail pharmacies must watch for red flags such as: large
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numbers of customers who: receive the same combination of prescriptions, receive the same
strength of controlled substance prescription (often for the strongest dose), have prescriptions from
190. Red flags are common sense warning signs that have always been an important
component of controlled substance pharmacy best practices, not a novel concept to pharmacies.
Relevant guidance concerning narcotics dispensing dates back to at least since the 1930's and
1940's there has been guidance given to pharmacies and pharmacists related to the creation of
systems and programs to guard against diversion and lists of don'ts when dispensing narcotics.
DEA enforcement actions such as the Holiday decision, Medicine Shoppe-Jonesborough and
United Prescription Services, Inc. also hold pharmacies responsible for failing to fulfill their
191. Many of many of the Chain Pharmacies, including CVS, Walgreens, Walmart, and
their trade organizations, including the HDMA and the NACDS, also participated in creating a
"Stakeholders" memorandum that acknowledges many of these red flags. These include for
example, traveling unexplainable and/or unreasonably long distance to a physician office and/or
the pharmacy, a controlled substance refill pattern inconsistent with regular refill patterns for non-
controlled substances, or a prescription that a pharmacist knows or reasonably believes another
"therapeutic duplication of two or more long-acting and/or two or more short-acting opiates
(cocktails)" and "patient presents prescriptions for highly abused 'cocktails' (combination of opiate,
"cocktail" often referred to as the "Holy Trinity" consists of an opioid, a benzodiazepine, and a
feeling similar to heroin and other illicit drugs. Medical literature has long recognized the special
43
dangers posed by cocktails composed of drugs of abuse which lack any documented medical
efficacy." Similarly, the East Main Street Pharmacy action acknowledged that “the combination
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[was] not controlled under Federal law, it is controlled under various state laws and is highly
popular with drug abusers, especially when taken as part of a drug cocktail that includes an opiate
and a benzodiazepine.” See Your Druggist Pharmacy, 73 Fed. Reg. 75,774, 75,775 n.1 (DEA Dec.
2008). Other DEA and judicial decisions likewise acknowledge well-known and highly abused
cocktails. See, e.g., U.S. v. Evans, 892 F.3d 692, 706 (5th Cir. 2018).
193. As described above, red flags indicative of diversion includes suspicious behavior
customers coming and appearing like they may not need the medication, or requesting drugs by
brand name or street slang such as "blues" (a term referencing Mallinckrodt opioids). Pharmacies’
training materials and controls should assist pharmacists and technicians in the identification of
such behaviors.
194. Pharmacies must resolve red flags before a prescription for addictive and
195. Not only do Chain Pharmacies often have firsthand knowledge of dispensing red
flags – such as distant geographic location of doctors from the pharmacy or customer, lines of
seemingly healthy patients, cash transactions, and other significant information – but they also
have the ability to analyze data relating to drug utilization and prescribing patterns across multiple
retail stores. As with other distributors, these data points give the Chain Pharmacies insight into
prescribing and dispensing conduct that enables them to prevent diversion and fulfil their
44
196. Indeed, CVS Health president and CEO Larry Merlo has described the company
as “America’s front door to health care with a presence in nearly 10,000 communities across the
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country,” which allowed it to “see firsthand the impact of the alarming and rapidly growing
197. Chain Pharmacies not only make observations through their local front doors but
have extensive data to which an individual pharmacist would not have access. They are uniquely
positioned to monitor, for example, the volume of opioids being dispensed in their pharmacies
relative to the size of the communities they serve. This is particularly important given that it is
recognized that as to the supply of opioids increases, so does the incidence of over-dose and death.
They could also use this information to monitor potentially suspicious prescribers. Pharmacies
must use the information available to them to guard against supplying controlled substances for
non-medical use, identify red flags or potential diversion and should share this information with
their agents, as well as provide clear guidance and training on how to use it. A former DEA
diversion investigator, whose testimony is also referenced above, agreed in a deposition that as
part of their obligation under Section 1301.71, pharmacies corporately have an obligation to
develop policies to train pharmacists to comply the CSA regulations. She further agreed that the
defendants had an obligation to develop and implement systems to provide the necessary tools for
Pharmacies also had a duty to design and implement systems to prevent diversion of controlled
substances in their retail pharmacy operations. Specifically, the Chain Pharmacies had a duty to
analyze data and the personal observations of their employees for known red flags such as those
described above. The Chain Pharmacies had the ability, and the obligation, to look for these red
29
See, e.g., David Salazar, CVS Health Unveils New PBM, Pharmacy Efforts to Curb Opioid Abuse,
(Sept. 21, 2017), https://drugstorenews.com/pharmacy/cvs-health-unveils-new-pbm-pharmacy-efforts-
curb-opioid-abuse
45
flags on a patient, prescriber, store, and chain level, and to refuse to fill and to report prescriptions
199. They were particularly well-positioned to do so given the dispensing data available
to them, which they could review at the corporate level to identify patterns of diversion and to
create policies and practices to proactively identified patterns of diversion. Each could and should
have also developed tools and programs to alert their pharmacists to red flags and to guard against
diversion.
200. As described above and further below, the Chain Pharmacies also possessed
sufficiently detailed and valuable information that other companies were willing to pay them for
it. In 2010, for example, Walgreen’s fiscal year 2010 SEC Form 10-K disclosed that it recognizes
Walgreens’s own advertising has acknowledged that Walgreens has centralized data such that
201. Similarly, CVS’s Director of Managed Care Operations, Scott Tierney, testified
that CVS’s data vendors included IMS Health, Verispan, and Walters Kluwers and that CVS used
the vendors for “analysis and aggregation of data” and “some consulting services.” He also
testified that CVS would provide the vendors with “prescriber level data, drug level data, plan
202. Each of the Chain Pharmacies had complete access to all prescription opioid
dispensing data related to its pharmacies in the County, complete access to information revealing
the doctors who prescribed the opioids dispensed in its pharmacies in and around the County, and
complete access to information revealing the customers who filled or sought to fill prescriptions
for opioids in its pharmacies in and around the County. Each of the Chain Pharmacies likewise
30
https://www.sec.gov/Archives/edgar/data/104207/000010420710000098/exhibit_13.htm
31
Joint Appendix in Sorrell v. IMS Health Inc., No. 10-779, 2011 WL 687134 (U.S.) *245-46 (Feb. 22,
2011).
46
had complete access to information revealing the customers who filled or sought to fill
prescriptions for opioids in its pharmacies in and around the Counties, complete access to
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information revealing the opioids prescriptions dispensed by its pharmacies in and around the
Counties, and complete access to information revealing the opioids prescriptions dispensed by its
pharmacies in and around the Counties. Further, each of the Chain Pharmacies had complete
access to information revealing the geographic location of out-of-state doctors whose prescriptions
for opioids were being filled by its pharmacies in and around the Counties and complete access to
information revealing the size and frequency of prescriptions written by specific doctors across its
203. As described further below, the Chain Pharmacies failed to fulfill their legal duties
and instead, routinely distributed and/or dispensed controlled substances while ignoring red flags
of diversion and abuse. The unlawful conduct by these Defendants is a substantial cause for the
volume of prescription opioids and the public nuisance plaguing the Counties.
a. CVS
204. CVS distribution centers, in tandem with outside wholesalers, such as Cardinal
and McKesson, supplied opioids to CVS pharmacy stores until October 2014. CVS self-
distributed hydrocodone and hydrocodone combination products and cocktail drugs to its own
stores, of which CVS had approximately 6,000 by 2006 and 9,700 by 2014. Hydrocodone
combination products (HCPs) were previously classified as Schedule III controlled substances, but
hydrocodone and HCPs the same day the rescheduling took effect but continued to distribute
47
205. CVS pharmacies nationwide placed orders with CVS distribution centers through
206. Before 2009, CVS, which stocked and sold opioids at more than 9,000 stores
across the country, lacked any meaningful suspicious order monitoring (“SOM”) system. Instead,
CVS relied on the gut instincts of Pickers and Packers of the drugs in the distribution center –
workers responsible for pulling items off distribution shelves for delivery to pharmacy stores – to
identify “really big” orders that they believed were simply too large. This, of course, was not an
207. Moreover, CVS lacked a training program to train its pickers and packers how to
identify unusual orders of size, frequency, or pattern. CVS also did not have any written policies,
procedures, or protocols with respect to the pickers’ and packers’ obligations until August, 2013.
And, there were no formal job requirements to be employed as a picker and packer.
208. In 2007, with the help of an outside consultant, CVS began work on a Standard
Operating Procedure Manual (“SOP”) that was intended to cover all facets of DEA controlled
substances compliance, including suspicious order monitoring. However, by the Summer of 2010,
neither the final manual nor the SOM section was complete. Internal documents from that time
acknowledge that CVS was “still in the process of writing the suspicious order monitoring section
of this standard operating procedure.” In fact, the section of the Standard Operating procedures
for Suspicious Order Monitoring states “BEING DEVELOPED AND WRITTEN.”
209. Drafts of the SOP Manual, meanwhile, show CVS understood, or should have
understood, that this was unacceptable. The draft manual provides that: “CVS is responsible for
ensuring compliance with DEA regulatory requirements, and that responsibility cannot be
abdicated or transferred to anyone else.” Despite this acknowledgement, when the first version of
the SOP Manual was issued in December 2007 and for multiple revisions thereafter, the SOM
section still remained incomplete. It was not completed until August of 2010. Completion of the
48
210. As John Mortelliti, CVS’s Director of Loss Prevention, wrote in November 2009,
this had become “a big issue with CVS and the DEA,” and he was “trying to get a rough draft
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SOM SOP” before a DEA meeting. CVS only incorporated the final missing SOMS section
211. CVS’s Indiana distribution center was audited and investigated by the DEA for its
distribution practices on August 24, 2010. The distribution center was responsible for portions of
the relevant period for identifying and performing due diligence on nationwide orders that flagged
on the IRR. The day after the DEA’s audit of CVS’s distribution practices began, CVS Pharmacy,
Inc. sent a new Standard Operating Procedure, which included for the very first time a policy on
suspicious order monitoring. CVS Pharmacy, Inc. internally posted the SOP at 1:35 pm on August
212. On September 1, 2010, John Mortelliti sent an e-mail to Terrance Dugger who was
present during the DEA audit. The subject of the e-mail and the attachment is “DEA Speaking
Points,” the importance was listed as high. He writes: “Terrence, This is for the DEA. The
corrections listed below have been updated. It is ok to review this with the agents.”
213. Mr. Mortelitti then sent the same presentation on the same day to another group of
CVS employees writing: “These are the final approved speaking points for the DEA agents if they
come to one of your facilities and question suspicious monitoring. It is ok to share this document.
Please be sure your team understands it before presenting so it doesn’t look like a prop instead
of a tool.” The presentation sent by Mr. Mortelitti to be shared with the DEA was not correct and
214. In a September 2010 e-mail, Mr. Mortelliti circulated an August 27, 2010
document titled “Suspicious Order Monitoring for PSE/Control Drugs: Summary of Key Concepts
& Procedures,” which he described as “final approved speaking points for the DEA” should DEA
agents question suspicious order monitoring at a CVS facility. In the correspondence, he asked
that the recipients “be sure [their team] understands [the material] before presenting so it doesn’t
49
215. CVS had a “CVS DEA compliance coordinator” in name only. A CVS employee
who held the position from 2008 to 2014 said that her title was only “for reference in SOPs,” not
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her real job. For “personnel purposes,” she was never considered the CVS DEA compliance
coordinator. Moreover, she had nothing to do with suspicious order monitoring, other than
“updating the SOP with what was provided for the program.” This is according to CVS’s “DEA
Compliance Coordinator.”
216. CVS claims that in 2009 it began using a computer algorithm that flagged
potentially suspicious orders needing additional investigation. The automated program was
delivered by an outside vendor to CVS in December of 2008. CVS called the output of the flagged
217. The SOM algorithm delivered in December of 2008 was designed to “pend” (or
identify) an order with a score of 0.15 or higher as potentially suspicious. The higher the score the
more likely the order was potentially suspicious. In July 2009 CVS reported to the algorithm
designer that the SOM model was pending a large number of orders that CVS believed were “not
suspicious on their face” and it requested that the model be changed. As a result, revised
coefficients for the algorithm were delivered to CVS on August 27, 2009 and the pend score of .15
remained the same. Between June 2010 and August 2010, Mortelliti adjusted the IRR pend score
from .15 to .65. The higher the score, the less sensitive the model, flagging fewer potentially
suspicious orders for investigation. On February 8, 2011, the algorithm designer delivered a
completely retuned SOM algorithm with another set of coefficients. The February 2011 changes
returned the pend score to .15. CVS again changed the pend score to .65.
218. IRRs were the primary SOM process. A CVS corporate representative explained,
on behalf of the company, “for the most part,” if an order was not flagged as suspicious under the
50
IRR system, there would be no due diligence of that order. Yet, CVS neglected to provide written
instructions to its employees for how to perform that critical review until February 29, 2012.
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219. CVS’s IRR system was deficient and failed in many respects to meet CVS’s
obligations as a distributor.
220. CVS also learned in 2010 that its SOM algorithm was not working properly
because it monitored by drug, not active ingredient, meaning that changes in a drug’s description
or name caused historical data to be lost. Thus, the system was unable to determine that orders for
221. CVS’s SOM algorithm also failed to consider outside vendor orders. In other
words, CVS’s SOM system would not track how many opioids CVS was ordering from third-party
distributors such as Cardinal when evaluating whether to distribute opioids to one of its
pharmacies. CVS knew this was a problem, as a “[s]tore may order a little from both the OV
[outside vendor] and DC [CVS distribution center] to stay under the radar.” It also knew that
excluding outside vendor data meant CVS “may ship a potentially reportable suspicious order from
[its] DC.” Stores, including one that had a “68,000 hydrocodone pill loss,” could also place
telephone orders to outside vendors, into which there was “no visibility . . . until a later time.”
This deficiency is particularly glaring because, at a corporate level, CVS had full access to the
hired new consultants in 2012 to troubleshoot its existing SOM systems for the purpose of either
fixing the deficient system or developing a new SOM system so as to attempt to become compliant
223. Still, as late as July 2013, internal e-mail reflects that CVS’s primary tool for
investigating suspicious orders relied on data that was months or even years old and made any
224. Not until mid to late 2014 did CVS fully implement a new SOM system. Even
then, CVS encountered problems in evaluating suspicious orders for opioids and its SOMS was
51
entirely lacking. The deployment was further delayed due to system data feed issues that created
inaccuracies in the SOM historical data. A risk analysis of the new system was conducted in June
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2014. The risk level was determined to be high for the SOM system in the following categories
covering seemingly every aspect of its operation: inconsistent due diligence in SOM analysts
reaching out to stores to investigate suspicious orders; inconsistency in documenting due diligence
communication between the SOM Management Team and SOM Analysts; lack of resources to
handle the rollout of the new SOM system to all distribution centers; and lack of clarity in how the
new SOM system is identifying suspicious orders. Essentially, these are the key components of a
compliant and effective SOM system. That same year, CVS stopped distributing opioids at the
225. Meanwhile, on August 5, 2013, the DEA began another audit and investigation of
the CVS distribution center in Indiana. CVS’s own documents acknowledge that the DEA’s
investigation was focused on its failure to maintain a SOM program for controlled substances.
226. In response to queries from the DEA, CVS wrote a letter to the DEA revealing that
it had only stopped seven suspicious orders across the entire country. Right before sending the
letter, the author, Mark Nicastro, head of the CVS distribution center in Indiana, conceded
internally that “I wish I had more stopped orders that went back further.” Sadly, while Mr. Nicastro
was writing the letter on CVS’s behalf to the DEA, he could not even locate the SOP for the SOM,
writing to Pam Hinkle, “For the life of me I can’t find the SOP for SOM. Can you send me an
electronic copy please? I have been on the logistics website, looked through hundreds of e-mails,
nothing. I’m surprised it is not on the website.” Ms. Hinkle, Sr. Manager for Logistics, Quality
and Compliance for CVS, responds that she too is unsure of the final version of the SOP SOM.
CVS sent the wrong version of the SOP SOM to the DEA.
227. In May of 2014, CVS had a closing meeting with the DEA related to the
distribution center audit. According to handwritten notes from a CVS employee who attended the
meeting, the “most serious” violation is “failure to design” a SOM system. An internal CVS e-
52
mail summarizing the meeting made a similar statement: DEA determined that CVS “faile[d] to
maintain an [sic] SOM program.” The head of CVS’s distribution center in Indiana described
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Betsy Ferguson’s, CVS’s in-house counsel, confrontation with the DEA during the meeting,
writing: “Dan [DEA Agent] finally pushed Betsy’s button and the gloves came off. . . . Betsy made
it very clear that a letter of admonishment was one thing. Anything other than that and she wanted
an opportunity to do a presentation to his boss and her boss about what we do with SOM. Anything
more than a letter and we would meet in D.C. in courts just like Walgreens did.”
228. The DEA issued its closing letter concluding that CVS failed to design and
maintain a system to detect and report suspicious orders for Schedule III-V Controlled Substances
as required by Title 21 United States Code (USC) 821, Title 21 USC 823(e)(1), and Title 21 Code
229. All orders that appeared on the IRR required a thorough due diligence
investigation, but only a very small percentage were subjected to appropriate due diligence. From
early/mid-2009 through early 2011, one employee, John Mortelliti, the Director of Loss
Prevention, “was taking the first pass through the IRR himself.” According to CVS’s corporate
witness, “Mr. Mortelliti’s practice would have been to review the report on a daily basis and
determine whether items on the report warranted further review and due diligence and conduct
review and due diligence as he deemed appropriate.” At select times in 2013, CVS had only one
full-time employee in the position of “SOM analyst” reviewing all potentially suspicious orders
for every pharmacy in the country. The SOM system would identify orders as potentially
suspicious based on a number of factors and “pend” the order. Even though the orders had been
identified as potentially suspicious, the CVS SOM analysts would conduct an “in depth” dive on
only select orders. In fact, even though the SOM program could identify as many as 1,000
suspicious orders a day, the CVS employee would only do a “deep dive” on one to six orders per
day.
53
230. Even as late as 2012 CVS’s SOM policy was clearly little more than window
dressing. For example, CVS’s own SOM policy specified that if multiple orders for the same store
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are flagged during the same month, all orders after the first order will not be investigated and will
231. As noted above, as of November 21, 2013, CVS had only reported seven
suspicious orders to the DEA across all of its distribution centers and pharmacies in the United
States. The first suspicious order CVS ever reported was on February 29, 2012. CVS reported no
232. CVS’s collaboration with distributors went from lobbying to actually preventing
adequate due diligence investigations of suspicious opioid orders. CVS knew that Cardinal and
McKesson have independent due diligence obligations under the CSA to monitor all sales of
controlled substances for orders which deviate in size, pattern or frequency. CVS understood that,
to do so effectively, Cardinal and McKesson would require access to its dispensing information.
CVS did not provide dispensing information to Cardinal or McKesson. In an email from Paul
Farley to Michael Mone, both Cardinal employees, Farley wrote, “I spoke with Brian Whalen at
CVS a couple of times this morning… They will not provide the doctor or patient information you
requested unless it is requested by the DEA. He was quite adamant about this.” CVS prevented
Cardinal and McKesson from obtaining access to critical dispensing information for its pharmacies
to enable Cardinal and McKesson to conduct adequate due diligence of its pharmacies. Prior to
54
2013, Cardinal and McKesson did not investigate CVS by calling its pharmacists or visiting CVS
stores as they did with other pharmacies. Instead, distributors were instructed to contact CVS’s
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loss prevention offices at corporate headquarters to inquire about suspicious orders, ensuring that
any investigation into CVS ordering of opioids was conducted by CVS alone.
233. As a result, CVS controlled all “due diligence investigations” of its opioid orders.
This chart produced by Cardinal depicts the due diligence “investigations” of CVS orders:
234. CVS also prevented Cardinal from independently determining the appropriate
order thresholds for opioids at CVS stores. CVS contractually protected its right to establish and
change its threshold requirement for Schedule II controlled substances with Cardinal. The
agreement expressly states that CVS has the discretion under the contract to set its threshold
55
v. CVS Failed to Maintain Effective Controls Against Diversion in
the Illinois
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235. According to the data from the DEA's ARCOS database, between the years 2006
and 2014, CVS distributed more than 270 million dosage units of hydrocodone to its pharmacies
in Illinois. The volume of opioids CVS brought into Illinois and ultimately dispensed from its
pharmacy locations was so high as to indicate to CVS that not all of the prescriptions distributed
to and dispensed out of its Illinois stores could be for legitimate medical uses.
knew or should have known that an excessive volume of pills was being sold into Illinois, and
ultimately onto its streets. CVS’s activities as a distributor and a seller or dispenser of opioids are
inextricably linked.
237. CVS violated the standard of care for a distributor by failing to: (a) control the
supply chain; (b) prevent diversion; (c) report suspicious orders; and (d) halt shipments of opioids
in quantities it knew or should have known could not be justified and signaled potential diversion.
238. The sheer volume of prescription opioids distributed to and dispensed by CVS
pharmacies in and around Illinois, with a population of approximately 12.8 million residents as of
the 2010 census, is indicative of potential diversion and required appropriate due diligence.
239. CVS funneled far more opioids into Illinois, and out of its pharmacy doors, than
could have been expected to serve legitimate medical use, and ignored other red flags of diversion,
240. It cannot be disputed that CVS was aware of the suspicious orders that flowed
from its distribution facilities into its own stores. CVS simply refused to identify, investigate, and
report suspicious orders even though CVS knew, or should have been fully aware, that opioids it
distributed and sold were likely to be diverted. Conversely, CVS failed to report suspicious orders,
failed to meaningfully investigate or reject suspicious orders, and failed to prevent diversion, or
56
241. Upon information and belief, CVS failed to analyze: (a) the number of opioid
prescriptions filled by its pharmacies relative to the population of the pharmacy’s community; (b)
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the increase in opioid sales relative to past years; and (c) the number of opioid prescriptions filled
242. CVS was, or should have been, fully aware that the opioids being distributed and
dispensed by it were likely to be diverted. Yet it did not take meaningful action to investigate or
to ensure that it was complying with its duties and obligations with regard to controlled substances,
including its responsibility to report suspicious orders and not to ship such orders unless and until
243. Given CVS’s retail pharmacy operations, in addition to its role as a wholesale
distributor, CVS knew, or reasonably should have known, about the disproportionate flow of
opioids into Illinois and the operation of “pill mills” that generated opioid prescriptions that, by
their quantity or nature, were red flags for, if not direct evidence of, illicit supply and diversion.
244. In addition, CVS knew, or deliberately turned a blind eye to, its pharmacies’ role
in diversion of dangerous drugs. At the pharmacy level, discovery will reveal that CVS knew, or
should have known, that its pharmacies in Illinois, and the surrounding area, were (a) filling
multiple prescriptions to the same patient using the same doctor; (b) filling multiple prescriptions
by the same patient using different doctors; (c) filling prescriptions of unusual size and frequency
for the same patient; (d) filling prescriptions of unusual size and frequency from out-of-state
patients; (e) filling an unusual or disproportionate number of prescriptions paid for in cash; (f)
filling prescriptions paired with other drugs frequently abused with opioids, like benzodiazepines,
suggested that the prescriptions were likely being diverted or were not issued for a legitimate
medical purpose; and (h) filling prescriptions for patients and doctors in combinations that were
32
According to definitions applied by CVS for suspicious order monitoring purposes, “cocktails for
opioids are methadone, muscle relaxants, stimulants and benzodiazepines.”
57
indicative of diversion and abuse. CVS had the ability, and the obligation, to look for these red
flags on a patient, prescriber, and store level, and to refuse to fill and to report prescriptions that
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245. Failures regarding dispensing in CVS’s Florida stores also allowed diverted
opioids to be funneled into Illinois and demonstrated the failures of CVS systems. And, CVS saw
huge increases in the quantity of oxycodone it dispensed in Florida from 2006 to 2010. For
example, starting with an already high baseline, a single CVS store ordered in 2006 approximately
four times the amount of oxycodone a typical pharmacy orders in one year. By 2010, the same
pharmacy’s 10-month history showed quantities more than thirty times the amount of oxycodone
a typical pharmacy orders in one year, and the pharmacy’s supervisor could not explain why the
volume was so high. During that time, Cardinal was the pharmacy’s main distributor, and two of
CVS’s Florida pharmacies were among Cardinal’s top four retail pharmacy customers, dispensing
with employees of these pharmacies revealed that they routinely observed red flags and obvious
signs that they were filling illegitimate prescriptions. One set a daily limit of oxycodone 30mg
prescriptions the pharmacy would fill each day, basing the limit on the amount in stock that day,
so as to ensure that the “real pain patients” could get their prescriptions filled. 33 The pharmacy
usually reached its limit by lunchtime each day, and at times within 30 minutes of opening.
Customers, aware that prescriptions were first come, first served, would line up outside the store
as early as 7:45 AM. An employee acting as a “bouncer” included among his job duties escorting
off the premises customers who were “hooked” on opioids and became belligerent if their
prescriptions were refused. 34 Although CVS had in place dispensing guidelines for controlled
substances prescriptions, these guidelines were not followed at these stores. Rather, they
33
Declaration of Joseph Rannazzisi, Holiday CVS, LLC d/b/a CVS/Pharmacy Nos. 5195/219 v. Eric
Holder, Jr. et al., No. 1:12-cv-191, Doc. 19-6 ¶¶ 38-41 (D.D.C. Feb. 24, 2012).
34
Id. ¶ 41.d.
58
dispensed controlled substances prescriptions despite the existence of “warning signs” in the
guidelines. 35
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246. Because of its vertically integrated structure, CVS has access to complete
information regarding red flags of diversion across its pharmacies in and around Illinois, but CVS
chose not to utilize this information and failed to effectively prevent diversion.
247. By 2009, CVS Pharmacy, Inc. owned and/or operated more than 9,000 pharmacies
in the United States. According to its website, CVS now has more than 9,900 retail locations. At
all times relevant herein, CVS pharmacies sold controlled substances, including FDA Schedule II
and FDA Schedule III controlled substances otherwise known as opiate narcotics or opioids.
248. “CVS Corporation,” not any individual CVS store, is the DEA registrant for each
of CVS’s pharmacies across the country. CVS renews the DEA licenses for its pharmacies
through a “Registration Chain Renewal.” From October 2013 through December 2016, CVS
headquarters paid more than $5 million to renew the licenses for 7,597 CVS locations.
249. As described above, until October 6, 2014, CVS pharmacies ordered and were
supplied FDA Schedule III hydrocodone combination products (HCPs) from a combination of
outside vendors and CVS distribution centers. CVS pharmacies also received Schedule II opioids
from outside vendors, with Cardinal and McKesson acting as its outside suppliers for the entire
250. CVS Pharmacy, Inc. instituted, set-up, ran, directed and staffed with its own
employees the majority of the SOM functions for its pharmacy stores.
251. CVS also lacked meaningful policies and procedures to guide its pharmacy staff
in maintaining effective controls against diversion, even as they evolved over time. Not until 2012
35
Id. ¶¶ 48 & 56.
59
did CVS create guidelines explaining in more detail the “red flags” or cautionary signals that CVS
pharmacists should be on the lookout for to prevent diversion and to uphold their corresponding
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responsibilities to ensure that all dispensed controlled substances are issued for a legitimate
medical purpose.
252. Even so, CVS’s conduct, and the volume it dispensed in the State thereafter
indicates that its policies were not applied. In addition, as discussed further below CVS had
performance metrics in place that pressured pharmacists to put profits ahead of safety.
253. CVS failed to use data held at the corporate level to assist pharmacists in
evaluating red flags of diversion. CVS’s later dispensing policies and procedures make clear that
for the majority of the time CVS had been engaged in the sale and dispensing of opioids, there was
no meaningful integration of data and information that was within the possession and control of
b. Walgreens
254. Acting as both a distributor and a retail pharmacy chain, Walgreens self-
distributed opioids to its own individual Walgreens pharmacies. Although Walgreens had
visibility into indicia of diversion due to its vertically integrated distribution and dispensing
practices, it failed to take these factors into account in its SOM program during the vast majority
of the time it was distributing prescription opioids. Moreover, its program was wholly inadequate
and did not fulfill its duties to prevent diversion. Likewise, Walgreens also failed to maintain
255. Though Walgreens had access to significant information about indicia of diversion
due to its vertical integration with its stores, Walgreens failed to use available information to
60
256. At least as early as 1998, and perhaps as early as 1988, Walgreens began to utilize
a series of formulas to identify orders that Walgreens deemed to be suspicious based on the orders’
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extraordinary size. These orders were listed on a report called the Suspicious Control Drug Order
report.
257. Walgreens used two different formulas: one formula from (at least) 1998-2007 and
one formula from March 2007 through 2012. These formulas were alike in that they each utilized
an average number based on historical orders, applied a three times multiplier to that base number,
and then deemed certain orders which were greater than that number to be suspicious. Under the
later formula, orders were only listed on the report as being suspicious if the orders exceeded the
three times multiplier for two consecutive months in a given time period. Walgreens based this
second formula on the DEA’s Chemical Handler’s Manual’s order monitoring system for listed
chemicals.
258. The first variation on this formula was in place until March 2007, even though the
DEA warned Walgreens that the “formulation utilized by the firm for reporting suspicious ordering
of controlled substances was insufficient,” via a May 2006 Letter of Admonition. The Letter cited
Walgreens for controlled substances violations at its Perrysburg, Ohio Distribution Center, but
259. The DEA also reminded Walgreens that its suspicious ordering “formula should
be based on (size, pattern, frequency),” though Walgreens failed to even examine anything other
than the size of an order. When Walgreens did update its program some ten months later, however,
it still did not perform the size, pattern, and frequency analysis prescribed by the DEA, continuing
260. Even with its ample threshold, each Walgreens Suspicious Control Drug Order
261. Walgreens did not perform any due diligence on the thousands of orders identified
as “suspicious” on the Suspicious Control Drug Order reports, but instead shipped the orders
without review.
61
262. Walgreens did not report the suspicious orders listed on the Suspicious Control
Drug Order report until after the orders were already filled and shipped. The report was generated
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on a monthly, nationwide basis, directly contravening the regulatory requirement that suspicious
orders be reported when discovered. 21 C.F.R. 1301.74(b). In some instances, months may have
elapsed between an order’s shipment and its subsequent reporting to the DEA, given the
requirement, described above, of two consecutive months of exceeding the three times multiplier
to trigger reporting.
263. In September 2012, the DEA issued an immediate suspension order (“ISO”)
distribution practices constituted an “imminent danger to the public health and safety” and were
“inconsistent with the public interest.” The DEA further found that Walgreens’s Jupiter
distribution center failed to comply with DEA regulations that required it to report to the DEA
suspicious drug orders that Walgreens received from its retail pharmacies, resulting in at least
There, the DEA stated: “Notwithstanding the ample guidance available, Walgreens has failed to
maintain an adequate suspicious order reporting system and as a result, has ignored readily
identifiable orders and ordering patterns that, based on the information available throughout the
Walgreens Corporation, should have been obvious signs of diversion occurring at [its] customer
pharmacies.”
264. In the ISO, the DEA also specifically considered the Suspicious Control Drug
Order reports and made the following further findings of fact and conclusions of law regarding
the reports and Walgreens’s suspicious order monitoring system—applicable across Walgreens’s
operations:
• “[Walgreens’s] practice with regard to suspicious order reporting was to send to the
local DEA field office a monthly report labeled ‘Suspicious Control Drug Orders.’”
aggregate of completed transactions, did not comply with the requirement to report
62
suspicious orders as discovered, despite the title [Walgreens] attached to these
reports.”
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• Upon review of an example of the Suspicious Control Drug Order report for
December 2011, “[Walgreens’s] suspicious order report for December 2011 appears
to include suspicious orders placed by its customers for the past 6 months. The report
for just suspicious orders of Schedule II drugs is 1712 pages and includes reports on
approximately 836 pharmacies in more than a dozen states and Puerto Rico.”
• Finding that the reports failed to appropriately consider the population and area
being served by the pharmacy: “This report from the Jupiter [Florida] Distribution
Center covers pharmacies in multiple states and Puerto Rico, yet the average order
and trigger amount is the same for a particular drug regardless of the pharmacy’s
location, the population it serves, or the number of other pharmacies in the area.”
• “As made clear in 21 CFR§ 1301.74(b), Southwood, and the December 27, 2007
letter to distributors from the Deputy Assistant Administrator for the Office of
obligation to identify and report suspicious orders as they are discovered is the
being used to fulfill legitimate medical needs. This analysis must take place before
demonstrates that [Walgreens] has failed to maintain effective controls against the
63
diversion of controlled substances into other than legitimate medical, scientific, and
failed to conduct adequate due diligence of its retail stores, including but not limited
to, the six stores identified above, and continued to distribute large amounts of
than a legitimate medical purpose by practitioners acting outside the usual course of
• “[DEA’s] concerns with [Walgreens’] distribution practices are not limited to the
registration].”
265. Walgreens knew its procedures were inadequate well before the 2012 ISO issued.
In addition to the guidance described above, in 1988, the DEA specifically advised Walgreens that
“[t]he submission of a monthly printout of after-the-fact sales does not relieve the registrant of the
responsibility of reporting excessive or suspicious orders.” The DEA further advised Walgreens
that, while “[a]n electronic data system may provide the means and mechanism for complying with
the regulations...the system is not complete until the data is carefully reviewed and monitored by
the registrant.”
266. Despite this instruction, there is no evidence that Walgreens ever took any action
related to the Suspicious Control Drug Order report besides generating it and mailing it out.
Walgreens has admitted that there is no evidence that Walgreens ever performed a due diligence
review on any of the orders listed on the Suspicious Control Drug Order report before shipment.
64
One of the managers for Walgreens’s Pharmaceutical Integrity (“RX Integrity”) Department stated
that, when he was with the Loss Prevention Department, he “basically burned the data on a CD
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and sent it off. I didn’t dive into each individual report or CD” and that he “would look at it briefly,
but just to see if the data transferred to the CD, but that’s about the extent.” In an errata submitted
in connection with a deposition in the MDL, Walgreens acknowledged that it “is currently unaware
267. As described above, in May 2006, the DEA told Walgreens again that the formula
Walgreens was using to identify suspicious orders for the Suspicious Control Drug Order reports
Pinon, Senior Attorney; James Van Overbake, Auditor; and Irene Lerin, Audit Manager) attended
the DEA Office of Diversion Control’s 13th Pharmaceutical Industry Conference in Houston,
Texas. Michael Mapes, Chief, DEA, Regulatory Section, gave a presentation at this Conference
relating to suspicious orders, which included the reminder that the CSA “requirement is to report
suspicious orders, not suspicious sales after the fact.” Participant notes from this meeting indicate
that Mr. Mapes advised the audience not to “confuse suspicious order report with an excessive
269. Similarly, handwritten notes on an internal document from July 2008 state that
“DEA really wants us to validate orders and only report true suspicious orders or what was done
to approve orders.” They go on to state that “[j]ust reporting these orders is not good enough –
270. Though Walgreens claims that it implemented the three times formula based on
DEA guidance, DEA never approved Walgreens’s SOM system, or any use of the Appendix E-3
formula, during the course of DEA’s cyclic or scheduled investigations of Walgreens’s distribution
centers. As DEA 30b6 witness Clare Brennan testified, while DEA investigators are trained to
ensure a SOM system is in place, they are also trained not to approve any SOM system. This non-
approval, the impropriety of any attempt by Walgreens to rely on prior purported approval, and
65
the compliance failures of Walgreens’s then utilized system, were re-emphasized by the letter
271. Upon information and belief, Walgreens’s knew that its post-2006 SOM system
did not comply with CSA requirements. Walgreens did not maintain an effective system to stop
272. The Walgreens controlled substances Distribution Center personnel who spoke to
the DEA during the DEA’s inspections of Walgreens’s controlled substances distribution centers
did not recall ever telling the DEA that Walgreens internally determined that Walgreens’s SOM
system contained no monitoring process, that the SOM system did not stop suspicious orders from
being shipped, that Walgreens could be filling illicit orders, or that the orders Walgreens was
Pharmacy Services reported to Kermit Crawford, Walgreens’s President of Pharmacy, Health and
Wellness, his notes from meeting with the DEA about reporting suspicious orders, which included
centers; however, these systems did not address the failings of the Suspicious Control Drug Order
reports. These distribution center systems were not designed to detect suspicious orders of
controlled substances, but rather were designed to detect typos or errors in order entry by the stores.
Walgreens admits that its Distribution Centers are “more akin to supply warehouses,” are “not
designed to be a backstop to pharmacists,” and that they are not well “equipped to ensure
compliance” or to “assist in combatting controlled substance abuse,” and “do not have the ability
66
275. The Distribution Center (“DC”) level procedures are documented in a 2006
Questionable Order Quantity policy, which had two facets: first, it instructed DC personnel to
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review orders and contact the pharmacy with questions regarding quantities. The policy did not
mention reporting suspicious orders until 2010, when it was updated to state that the Corporate
Office Internal Audit Department would handle suspicious store orders and inquiries. There is no
evidence that the Internal Audit department had any involvement in reporting suspicious orders.
276. The second aspect of this DC level procedures required “pickers,” the DC
personnel who actually retrieved pill bottles off the shelves and placed them into totes for shipping,
277. The only review of the orders identified by the DC level procedures was calling
the pharmacy to make sure the order had not been entered in error. Walgreens admitted this
procedure was not intended to detect suspicious orders. There is no evidence that any orders were
ever reported as suspicious or halted as a result of Walgreens’s distribution-center level policies.
There is no evidence these procedures resulted in timely reporting of, due diligence on, or non-
shipment of any order, including those listed as being “suspicious” on the Suspicious Control Drug
Order reports.
278. Walgreens’s documents effectively acknowledge that these were not true anti-
diversion measures, and it recognized internally that it did not begin creating a SOM system until
March 2008. Specifically, in March 2008, Walgreens finally formed a five department “team” to
“begin creating” a SOM program. The new SOM program was not piloted until more than a year
later, in August 2009, and even then, the pilot included orders form just seven stores. Not until
September 2010 would the program, implemented in pieces and phases, be rolled out chain-wide,
and from that point it took several more years to fully implement.
279. Through 2012, Walgreens continued to populate the Suspicious Control Drug
Order report with thousands of orders that exceeded Walgreens’s “three times” test, showing that
Walgreens’s post-2009 SOM program did little to mitigate the extraordinary volume of controlled
67
iv. Even as it Rolled Out its New SOM Program, Walgreens Left
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280. Walgreens did not prioritize compliance when instituting its SOM system. Sworn
testimony from the Senior Director of the Walgreen’s Pharmaceutical Integrity Department, which
is charged with supervising Walgreens’s SOM system, revealed that even as late as 2012, 2013,
and 2014, Walgreens’s viewed the SOM system as an inventory control mechanism rather than as
It was put in place to ensure that the stores had the proper quantities.
Not necessarily to . . . detect a red flag. The whole idea was to make
sure that the stores were getting the quantities that they needed based
on their peer group.
281. Perhaps because keeping supply moving, as opposed to preventing diversion, was
Walgreens’s primary focus, the SOM program Walgreens slowly developed had significant gaps
or loopholes. For example, for the first few years, the program did not include orders that
Walgreens stores were also placing to outside vendors, like Cardinal and AmerisourceBergen,
allowing stores to order opioids from Walgreens distribution centers and from Cardinal and
AmerisourceBergen, effectively permitting double dipping. It also did not prevent stores from
placing an order to an outside vendor if the store attempted to place the order to a Walgreens DC,
282. The new SOM-lite system also allowed Walgreens’s stores to transfer controlled
substances between stores and did not review these transfers (known as “interstores”) within the
SOM program, so that these transfers were not factored into SOM analytics. Additionally, stores
could also place ad hoc “PDQ” (“pretty darn quick”) orders for controlled substances outside of
68
their normal order days and outside of the SOM analysis and limits. Walgreens could even remove
283. Further, although the new SOM algorithm identified more than 389 pages of
suspicious orders per week as of August 2010, it failed to identify all the orders that Walgreens
had marked as suspicious under its “three times” formulas and previously listed on its Suspicious
Control Drug Order reports and submitted to the DEA “on a monthly basis.” This “discrepancy”
Walgreens’s Vice President, Distribution Centers and Logistics, suggesting that “the new system
should be tested further and enhanced to provide broader coverage of controlled substance activity.
The same e-mail stated that “we are not equipped to handle the 389+ pages of ADR4 [suspicious
order monitoring] data which are compiled nationwide each week,” and asked if his department
had “a resource available” to assist. An email in response “recall[ed] the old paper report as being
inches thick” and an instruction “in 1985 not to review or contact anyone on the data,” and
inquired, among other things, “[w]ho from your group has been reviewing the data collected for
the past twenty-five years?” and “[a]t present is anyone doing any review on what would be
considered suspicious quantities that are physically ordered and are releasing to stores?”
284. Starting in 2010, certain orders that exceeded store-based limits imposed by
Walgreens’s new SOM system were reduced to the store limit and shipped out. These orders were
not reported to the DEA as suspicious, nor were they halted for review. The DEA found that
Walgreens’s policy of reducing and then filling and shipping suspicious orders without reporting
69
285. Walgreens’s post-2009 SOM system flagged thousands of items per month as
being suspicious. Internal Walgreens documents indicate that, in July 2011 alone, as many as
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20,699 orders for controlled substances were “marked suspicious” by the new algorithm.
However, very few of these orders received any review, and any review performed was nominal
at best. Meanwhile, Walgreens failed to adequately staff the program and to train its employees
286. Walgreens cited two people as being primarily responsible for performing due
diligence on suspicious orders in the 2009-2012 time period under the new SOM system. The
first was a representative from the Loss Prevention department who said her department was “not
equipped” to handle review and data analysis for the hundreds of pages of reports being compiled
nationwide each week. The second was Barbara Martin, who estimated that she spent somewhere
between one and three hours a week reviewing suspicious orders, reviewing only between 10 to
100 of the thousands of orders that were deemed suspicious under the new algorithm. Walgreens
did not provide Ms. Martin access to information about the area the store was serving, the order
history for comparable stores, or any other data beyond the sales and order history for that store.
If an order did not “make sense” to her based on those limited resources, she testified that she
would call the store or district manager or pharmacy supervisor. She lacked authority to take
her deposition testimony as exemplars of its due diligence procedures under the post-2009 SOM
program. In the emails, which date from January 10–11, 2011, and are between Ms. Martin and a
Walgreens DC employee, the DC employee notes that “several stores that are ordering huge
quantities of 682971 [30 mg oxycodone] on a regular basis.” The DC employee continued, with
respect to a single store, “we have shipped them 3271 bottles [of 30 mg oxycodone] between
12/1/10 and 1/10/11. I don’t know how they can even house this many bottles to be honest. How
do we go about checking the validity of these orders?” Ms. Martin noted that the store had average
weekly sales of 36,200 dosage units, which was equal to 362 bottles per week, stating, “I have no
70
idea where these stores are getting this type of volume. The last pharmacy I was manager at did
about 525 rxs/day and we sold about 500 tabs a month (5 bottles).” Ms. Martin then told the DC
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employee that she could call the district pharmacy supervisor to see if he “may be able to shed
some light on the subject.” Despite the fact that questions had been raised about this store ordering
volume in January 2011, the very next month, Walgreens filled and shipped orders totaling another
285,800 dosage units of 30 milligram oxycodone to the same pharmacy, which was located in a
288. In her deposition, Ms. Martin stated that she never even attempted to determine
the size of the community that was receiving these “huge quantities” of oxycodone. She further
testified that she was not near that store, did not have access to the store’s prescriptions or patient
information, and as noted above, couldn’t take any “direct action.” Approximately 18 months
after this email exchange, as a result of DEA action, Walgreens agreed to surrender its DEA
registration for this same store that Ms. Martin reviewed as part of her exemplary “due diligence.”
289. In the ISO regarding the Distribution Center, the DEA found specifically regarding
the orders that were the subject of these email exchanges, that “[b]ased on the evidence available
to DEA, none of these orders were reported to DEA as suspicious and all appear to have been
shipped, without any further due diligence to verify their legitimacy.” The DEA further found
regarding this purported “due diligence,” that Walgreens “failed to conduct any meaningful
investigation or analysis to ensure that the massive amounts of commonly abused, highly addictive
controlled substances being ordered by these pharmacies were not being diverted into other than
legitimate channels.” The DEA noted that “[Walgreens] has been unable to provide any files
related to any effort to adequately verify the legitimacy of any particular order it shipped to its
customer stores.”
290. These failures were not limited to the specific Florida pharmacies and distribution
center described above; instead, they reflect systemic failures of Walgreens’s SOM system that
impacted its distribution in Illinois as well. Walgreens admits that the SOM systems and
procedures at all of its DCs were the same, including those at the facilities that continued shipping
71
opioids into Illinois. Accordingly, it is not surprising that, in February 2013, the DEA issued
similar Subpoenas and Warrant of Inspection on the Perrysburg DC in Ohio to those issued to the
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Jupiter DC in Florida. Walgreens employees made plans in preparation for the Perrysburg DC
being “shut down” by the DEA, like the Jupiter DC. Within weeks of receiving the six subpoenas
and warrant, Walgreens decided to “discontinue distribution of controlled substances from the
Perrysburg facility” in order to “eliminate any immediate need for further DEA administrative
291. Further, after the DEA began its investigation, Walgreens held meetings with and
informed the DEA that it was implementing “new changes” to “enhance” its SOM program.
Internal documents reveal that Walgreens improved its SOM program only “in an effort to
292. Even so, by November 2012, the program still did not halt the orders for due
diligence evaluation or report the orders as suspicious. Further, at that time, the program began to
293. There also is no evidence that these flagged or cut orders were reported as
294. As a result of the DEA investigation, Walgreens formed the “Rx Integrity Team”
in 2012, purportedly to make sure that those types of failures did not continue. However, the
group’s true role was protecting Walgreens’s Distribution Centers and stores from losing their
DEA licenses. The effort was only for show. Walgreens never provided the Rx Integrity group
the resources needed to achieve due diligence on the large number of orders identified by
295. In December 2012, the further enhanced SOM system flagged “14,000 items that
the stores ordered across the chain that would have to be investigated” before they could be
shipped. Walgreens admitted that yet again it did not have sufficient resources to timely review
these orders. Walgreens noted that “[t]he DEA would view this as further failures of our internal
processes, which could potentially result in additional pharmacies and distribution centers being
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subjected to regulatory actions and ultimately prohibited from handling controlled substances.”
At the time these 14,000 orders were flagged Walgreens Rx Integrity Team was comprised of
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fewer than five people. Even at its height, Rx Integrity had only eleven employees. Instead of
sufficiently staffing the SOM program, Walgreens recognized it had the ability to control its due
diligence workload by increasing the stores’ ceiling levels, and thereby reducing the number of
monitoring prior to 2012. Comparing the 2013 SOM system to the previous system, one of
297. Yet, even in 2013, orders being flagged as suspicious for review before shipment
were “a week old” before they made it to the review team, often “ha[d] already been shipped,” and
298. Walgreens never equipped its distribution operations to properly monitor for,
report, and halt suspicious orders, or otherwise effectively prevent diversion. When it became
clear Walgreens would need to devote significant resources to achieve compliance, Walgreens
chose instead to cease controlled substance distribution all together. Walgreens stated that “while
the financial impact of no longer . . . [self distributing] from the Walgreens DCs was taken into
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consideration, there is a greater risk to the company in fines and loss of licenses if we continue to
299. Although Walgreens purported to have in place “Good Faith Dispensing” (“GFD”)
Policies for many years, it failed to meaningfully apply policies and procedures, or to train
300. Despite knowing that prescribers could contribute to diversion, and having a
separate and corresponding duty with respect to filling prescriptions, from at least 2006 through
2012, Walgreens’s dispensing policies, which it titled “Good Faith Dispensing”, or “GFD”,
“unable to dispense a prescription in good faith” to “contact the prescriber” and, if “confirm[ed]”
as “valid” by the prescriber, to then “process the prescription as normal.” Further, though
frequency of prescriptions for the same or similar controlled drugs by one prescriber[,] for large
numbers of patients [,] for quantities beyond those normally prescribed,” it is unclear what, if any,
resources Walgreens made available to its pharmacists for checking these vague criteria, which, in
any event, became meaningless if a prescriber “confirm[ed]” the prescription as “valid,” by calling
the prescriber. For example, in 2010 when a pharmacy manager expressed concern about
significant numbers of opioid prescriptions from pain clinics, and being help responsible for
“excessive c2 rx dispensing,” her district supervisor instructed her “not [to] refuse script for large
quantities” but simply to “call the MD’s, document it on the hard copy[,] and that is all that is
needed to protect your license.” Despite internally recognizing that “a prescriber of a controlled
substance prescription [may be] involved in diversion”, Walgreens’s GFD policies continued to
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301. In 2012, Walgreens finally removed the “process the prescription as normal”
language from its formal GFD policies, admitting that under the law “it is not enough to get
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confirmation that the prescriber wrote the prescription.” However, Walgreens still failed to ensure
302. Walgreens failed to adequately train its pharmacists and pharmacy technicians on
how to prevent diversion, including what measures and/or actions to take when a prescription is
identified as phony, false, forged, or otherwise illegal, or when other suspicious circumstances are
present, and failed to provide them the means of doing so. To be clear, this required no inquiry
into whether an opioid prescription was the proper treatment for a particular patient; instead, as a
registrant, Walgreens was obligated, and failed, to implement policies and procedures at a
303. Indeed, during the course of a 2009 DEA investigation into Walgreens dispensing
noncompliance, Walgreens internally noted that it currently had “no training” for employees
dispensing controlled substances. Meanwhile, Walgreens corporate officers turned a blind eye to
these abuses. In fact, a Walgreens corporate attorney suggested, in reviewing the legitimacy of
prescriptions coming from Florida, that “if these are legitimate indicators of inappropriate
prescriptions perhaps we should consider not documenting our own potential noncompliance,”
underscoring Walgreens’s attitude that profit outweighed compliance with the law or protecting
public health.
Agreement regarding all “Walgreens . . . pharmacy locations registered with the DEA to dispense
in its operations. Walgreen Co. was required to create a nationwide “compliance program to detect
and prevent diversion of controlled substances as required by the … (CSA) and applicable DEA
regulations.” Pursuant to the MOA, the “program shall include procedures to identify the common
signs associated with the diversion of controlled substances including but not limited to, doctor-
shopping and requests for early refills” as well as “routine and periodic training of all Walgreens
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walk-in, retail pharmacy employees responsible for dispensing controlled substances on the
elements of the compliance program and their responsibilities under the CSA.” Further, Walgreens
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was required to “implement and maintain policies and procedures to ensure that prescriptions for
controlled substances are only dispensed to authorized individuals pursuant to federal and state
305. Walgreens would also make more promises in a 2013 Memorandum with the
DEA, described further below, related to failures to that lead to the ISOs described above.
306. Even after development and a relaunch of its GFD policy in response to
settlements with the DEA, however, Denman Murray, Director of Rx Supply Chain Retail,
provided sworn deposition testimony that, “traditionally, we’ve always treated a controlled
307. Further, after the June 2012 GFD “relaunch” in April 2014, a Walgreens
“RxIntegrity” presentation focused on Walgreens “Market 25,” but also assessing “average
market” trends, reported that “pharmacists [were] not being too strict with GFD, nor [were] they
losing volume.” 36
dispensing compliance and supervision. Walgreens has approximately 26,000 pharmacists, each
of whom may receive as many as 400-500 prescriptions a day. In 2013, however, Walgreens
internally reported that its District Managers and Pharmacy Supervisors were “challenged to get
into the stores” and in a 90-day period, more than a thousand stores did not receive a visit from the
managers or supervisors. These supervisory personnel were assigned a “high number of stores”
and their time was consumed with “people processes, business planning, market and district
meetings,” such that supervision in store was being handled informally by “community leaders”
36
Market 25 consisted of Indiana, Kentucky, and West Virginia. Similar results reported for Market 3,
Florida.
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309. Even where Walgreens’s policies recognized red flags, Walgreens failed to
provide its pharmacists with effective tools for assessing them. For example, Walgreens’s policies
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and internal documents acknowledged that distance between the patient, pharmacists, and/or
prescriber constituted a red flag, however, Walgreens did not even begin piloting an automated
process for flagging such distances through common and long available technological solutions
310. Walgreens knew its much touted good faith dispensing, or “GFD,” policies were
ineffective, and, in 2013, it launched a “Target Drug GFD” program to purportedly “put teeth
around GFD for high-risk products.” The policies required pharmacists to perform extra checks
on red flags and to complete TD GFD checklists when presented with certain opioid prescriptions.
311. However, the TDGFD procedures were largely window dressing. Walgreens
deliberately omitted hydrocodone from its TDGFD process, despite knowing in 2013 that HCPs
were the most abused of all prescription opioids, and in 2019 was still considering whether to add
hydrocodone, even though it had been a Schedule II opioid since 2014. Walgreens further failed
to make the TDGFD checklist an electronic form until 2020, despite knowing that doing so would
make compliance and supervision more effective. A review of Walgreens’s TDGFD forms in
certain jurisdictions reveals Walgreens failed to even complete a TDGFD form for as many as half
of the prescriptions for which Walgreens’s own policies stated such a form was required.
312. A Walgreens internal audit performed after the 2013 DEA settlement confirms that
Walgreens’s supervision and compliance failures continued. Among other failings, the audit team
noted no formal monitoring program existed to confirm that pharmacies across the chain are
outside of the deficient “store walk program” existed to monitor target drug good faith dispensing
requirements and no corporate reporting was being generated, and employees were failing to
timely complete Good Faith Dispensing training, such that, at the time of the audit, over 35,000
employees had not completed their required training for that year. Management’s response largely
was to seek to incorporate additional compliance measures into the store walk procedure.
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However, documents from 2016 regarding monthly store compliance walks indicate that during
the monthly “Compliance Walks” to “verify compliance … [with] regulatory requirements in…
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ensuring the pharmacy was verifying the patient’s address on five sample prescription fills.
313. Unsurprisingly, compliance with GFD and TD GFD has been poor. For example,
in 2014 Walgreens discovered a pharmacist who failed to follow GFD for five to six months
without being discovered by supervisors. In 2014, Rx Integrity noted dozens of stores dispensing
opioids without performing the required checks. In certain cases, the pharmacists were unaware
of approximately 2,400 pharmacies to determine whether Walgreens was “compliant with the
the DEA. As the audit progressed, Walgreens internally noted “put your seatbelts on” because the
audits were “not going great” and they would need to implement a “mitigation plan … to satisfy
the MOA” for the non-compliance revealed by the audit. In Walgreens’s own words, “Results
were unfavorable.” Fewer than 60% of stores were complying with TD GFD with respect to filled
prescriptions, 1,160 stores did not have a single refused prescription, and an additional 1,182 stores
had refused fewer than 25 prescriptions total in a nine-month period. Only 63 out of 2,400
pharmacies had refused 26 or more prescriptions during that same nine months in 2015.
profit goals has continued. When a Walgreens consultant interviewed Walgreens pharmacy
employees, they drafted a report finding that employees “sometimes skirted or completely
ignored” proper procedures to meet corporate metrics and committed “errors resulting from
stress.” The consultants reported that they “heard multiple reports of improper behavior” that was
“largely attributed to the desire” to meet a corporate metric known as “promise time,” which
ensures that patients get prescriptions filled within a set amount of time. Upon reviewing a draft
of the report, senior leaders at Walgreens directed the consultants to remove some of the damaging
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findings, which the consultant company ultimately did, even though the consultant’s employees
stated requests to remove information from slides conflicted with their business ethics. At around
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this same time, Walgreens awarded the consultant company a $1.5 billion contract.
316. The “Big Three” wholesalers: Cardinal, McKesson, and AmerisourceBergen, gave
deferential treatment to chain pharmacies. An internal Cardinal document for example, stresses
that “certain chain pharmacies refuse to allow any sort of administrative inspection by Cardinal or
to make certifications” and that large, national chains can “take their billions upon billions of
317. Thus, for example, in 2008, Cardinal prepared talking points for a NACDS
Conference about its planned retail chain SOM program, making it clear that the program would
“minimize the disruption” to retail chains and that they would “work together” with the pharmacies
“to ensure that our Suspicious Order Monitoring program for retail chains does not interrupt”
business. Cardinal also provided warnings to chain pharmacies, including Walgreens, that they
were approaching thresholds so that the chains could avoid triggering SOM reporting and adjust
ordering patterns by, for example, delaying orders or, more often, obtaining a threshold increase.
Such “early warnings” were so helpful to Walgreens that as of 2012 Walgreens adopted the
concept for its own SOM system for self-distribution, noting internally that by “flagging the stores
at 75%,” it could “avoid cutting/reducing orders and subsequently not have to report a SOM to the
DEA.”
318. Preferential treatment of Walgreens ultimately was not enough for Cardinal to
keep Walgreens’s business, however. In 2013, Walgreens entered a ten-year agreement with
prompted Cardinal to complain: “we bailed you guys out when you had your [DEA] issues.”
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319. By 2017, Walgreens accounted for 30% of AmerisourceBergen’s revenue. 37
AmerisourceBergen was similarly deferential, allowing Walgreens to “police their own orders
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and block any order to [AmerisourceBergen (“ABC”)] that would exceed ABC’s threshold thus
triggering a suspicious order being sent to DEA from ABC. Additionally, when AmerisourceBergen
received orders from Walgreens “outside the expected usage,” Walgreens and AmerisourceBergen
met to discuss adjusting thresholds or using “soft blocking.” Contrary to DEA guidance and its own
stated policy, AmerisourceBergen also shared the threshold limits set by its “order monitoring
program” with Walgreens, and also provided Walgreens with weekly SOM statistics.
AmerisourceBergen generally would not take action on Walgreens orders that exceeded its
320. Walgreens also owns 26% of AmerisourceBergen’s stock. In 2018, after a coalition
of AmerisourceBergen shareholders sought greater transparency from its Board related to the
“financial and reputational risks associated with the opioid crisis,” Walgreens, together with other
insiders, reportedly leveraged this position to defeat the proposal, which enjoyed majority support
321. As described above and further below, as both a distributor and a dispenser,
322. According to the data from the DEA's ARCOS database, between the years 2006
and 2014, Walgreens distributed more than 906 million dosage units of oxycodone and
hydrocodone to its pharmacies in Illinois. The volume of opioids Walgreens brought into Illinois
37
As a part of its distribution agreement, Walgreens gained purchase rights to AmerisourceBergen equity,
allowing it to further participate in the prescription opioid shipment boom in America. Walgreens
subsequently exercised these purchase rights, ultimately owning approximately 26% of
AmerisourceBergen. As part of the transaction, Walgreens has the ability to nominate up to two members
of the Board of Directors of AmerisourceBergen. Currently, Walgreen’s Co-Chief Operating Officer sits
on the AmerisourceBergen Board of Directors.
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and ultimately dispensed from its pharmacy locations was so high as to indicate to Walgreens that
not all of the prescriptions distributed to and dispensed out of its Illinois stores could be for
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323. Walgreens violated the standard of care for a distributor by failing to: (a) control
the supply chain; (b) prevent diversion; (c) report suspicious orders; and (d) halt shipments of
opioids in quantities it knew or should have known could not be justified and signaled potential
diversion.
324. The volume of opioids Walgreens shipped into, and dispensed from locations in,
the County was so high as to raise a red flag that not all of the prescriptions being ordered could
325. Yet, upon information and belief, Walgreens did not make any suspicious order
report of an order in the County between 2007 and 2014. Instead, Walgreens funneled far more
opioids into Illinois and the Counties than could have been expected to serve legitimate medical
use and ignored other indicia of suspicious orders. This information, along with the information
known only to distributors such as Walgreens (especially with its pharmacy dispensing data),
prescription opioids in other states, and these drugs were diverted from these other states to Illinois.
Walgreens failed to take meaningful action to stop this diversion despite its knowledge of it, and
327. Walgreens also developed and maintained highly advanced data collection and
analytical systems. These sophisticated software systems monitor the inventory and ordering
needs of customers in real-time and depicted the exact amounts of pills, pill type, and anticipated
328. Through this proprietary data, Walgreens had direct knowledge of patterns and
instances of improper distribution, prescribing, and use of prescription opioids in Illinois, including
in the Counties. It used this data to evaluate its own sales activities and workforce. Walgreens
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also was in possession of extensive data regarding individual doctors’ prescribing and dispensing
to its customers, the percentage of a prescriber’s prescriptions that were controlled substances,
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individual prescription activity across all Walgreens stores, and the percentages of prescriptions
purchased in cash. Such data are a valuable resource that Walgreens could have used to help stop
329. Walgreens, by virtue of its data analytics, was actually aware at a corporate level
of indicia of diversion, such as (1) individuals traveling long distances to fill prescriptions; (2)
prescriptions for drug “cocktails,” known for their abuse potential, such as oxycodone and Xanax;
(3) individuals who arrived together with identical or nearly identical prescriptions; (4) high
percentage of cash purchases; and (5) doctors prescribing outside the scope of their usual practice
or geographic area. However, Walgreens failed to effectively make the data demonstrating these
obvious flags available to its pharmacists and failed to properly address the red flag dispensing
patterns.
330. Walgreens also failed to adequately use data available to it to identify doctors who
doses of opioids, or to adequately use data available to it to prevent the filling of prescriptions that
were illegally diverted or otherwise contributed to the opioid crisis. While Walgreens periodically
implemented programs that would identify the most suspicious prescribers, it failed to make this
data readily available to its pharmacists, and either terminated or failed to act on them at the
corporate level.
331. Upon information and belief, Walgreens failed to adequately analyze and address
its opioid sales relative to: (a) the number of opioid prescriptions filled by its pharmacies relative
to the population of the pharmacy’s community; (b) the increase in opioid sales relative to past
years; and (c) the number of opioid prescriptions filled relative to other drugs.
332. At the store level, Walgreens did not make any controlled substance metrics
available to pharmacists for specific prescribers. Further, despite the fact that at the corporate level
Walgreens utilized many tools, including IMS, for descriptive statistics around prescriber patterns,
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Walgreens was not aware of any consistent reports written using that data. Instead, when a
pharmacist or Walgreens team member had a concern about a particular prescriber, ad hoc
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prescriber profiles were pulled. However, these reports were difficult to interpret so corporate
would have to assist with the analysis and interpretation of the reports.
333. Walgreens failed to adequately analyze and address its opioid sales relative to: (a)
the number of opioid prescriptions filled by its pharmacies relative to the population of the
pharmacy’s community; (b) the increase in opioid sales relative to past years; and (c) the number
of opioid prescriptions filled relative to other drugs. For example, Walgreens ran reports known
as “GFD Opportunities reports,” generated from data on its individual pharmacies and
pharmacists. A “GFD Opportunities” tool included information such as “Cash rank, Oxycodone
IR rank, “target” drug quantity rank, and target drug rate rank. With the information available to
it, Walgreens thus knew which pharmacists filled more controlled substances prescriptions that
others, however, Walgreens failed to meaningfully act to curtail red flag dispensing.
334. Upon information and belief, based on other enforcement actions against the
company, Walgreens also failed to conduct adequately analyze and address its opioid sales to
identify patterns regarding prescriptions that should not have been filled and to create policies
accordingly, or if it conducted such reviews, it failed to take any meaningful action as a result.
335. Discovery will reveal that Walgreens knew or should have known that its
pharmacies in Illinois, and the surrounding area, were (a) filling multiple prescriptions to the same
patient using the same doctor; (b) filling multiple prescriptions by the same patient using different
doctors; (c) filling prescriptions of unusual size and frequency for the same patient; (d) filling
prescriptions of unusual size and frequency from out-of-state patients; (e) filling an unusual or
disproportionate number of prescriptions paid for in cash (f) filling prescriptions paired with other
drugs frequently abused with opioids, like benzodiazepines, or prescription “cocktails”; (g) filling
prescriptions in volumes, doses, or combinations that suggested that the prescriptions were likely
being diverted or were not issued for a legitimate medical purpose; and (h) filling prescriptions for
patients and doctors in combinations that were indicative of diversion and abuse. Also, upon
83
information and belief, the volumes of opioids distributed to and dispensed by these pharmacies
were disproportionate to non-controlled drugs and other products sold by these pharmacies, and
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disproportionate to the sales of opioids in similarly sized pharmacy markets. Walgreens had the
ability, and the obligation, to look for these red flags on a patient, prescriber, and store level, and
336. Walgreens admits its role in the opioid epidemic, stating it has the “ability – and []
critical responsibility – to fight the opioid crisis” as the “nation’s largest pharmacy chain” in a time
when “[a]ddiction to prescription painkillers, heroin, and other opioids has surged, with opioid
overdoses quadrupling in this decade” and “drug overdose deaths – the majority from prescription
and illicit opioids” resulting in “more fatalities than from motor vehicle crashes and gun homicides
combined.” Walgreens also admits the “opioid crisis” is caused by “misuse, abuse and addiction”
that result from the “flow of opioids that fuel the epidemic.”
c. Walmart
337. During most of the time period relevant to Plaintiffs’ claims, Walmart acted as
both a distributor of controlled substances to its own Walmart pharmacies and a retailer dispensing
controlled substances at Walmart pharmacies and Sam’s Club pharmacies. While operating under
different brand names, both Walmart and Sam’s Club pharmacies were subject to the same flawed
policies, lack of oversight, and inadequate implementation emanating from Walmart’s Home
Office. In both its capacity as a distributor and as a dispenser of controlled substances, Walmart
failed to implement effective policies and practices to prevent diversion of opioids in and around
Plaintiff’s communities. By the time Walmart implemented a system for monitoring suspicious
orders or policies allowing corporate blocks of known pill mill doctors, the opioid epidemic had
338. Walmart is the largest private employer in the United States, employing over 1.5
million people. But for years, Walmart chose not to assign a single employee to design or operate
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a system to detect suspicious orders of controlled substances. Despite Walmart’s obligations as a
distributor of controlled substances, it was not until 2014 that Walmart began to take any
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339. Walmart operated registered distribution centers to supply its own pharmacies
340. Prior to 2011, Walmart did not have any written policy or procedure in place to
341. In the absence of an established policy or procedure, Walmart relied on its hourly
employees and associates filling orders at the distribution centers to subjectively monitor the orders
they were filling for anything unusual. These associates were responsible for filling and reviewing
342. Walmart did not provide any guidance or training to its associates as to what
constitutes a suspicious order or how to evaluate an order for unusual size, frequency, or pattern.
344. Although Walmart did create a procedure for identifying suspicious orders of
controlled substances beginning in 2011, this procedure was insufficient to identify suspicious
orders of controlled substances. Walmart’s program flagged only very large orders of controlled
substances. Specifically, it flagged weekly orders for controlled substances of 50 bottles (5,000
dosage units) or more and orders for more than 20 bottles (2,000 dosage units) that were 30%
higher than a rolling four-week average for that item. Orders under 2,000 dosage units per week
were never flagged, meaning that a pharmacy could order 8,000 dosage units per month without
ever being flagged. Moreover, that meant that even if an order was more than 30% greater than
the four-week average, it could not draw an alert unless it also was more than 20 bottles.
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345. Under this system, an alert did not mean Walmart would report the order to the
DEA or halt it pending necessary due diligence. To the contrary, upon information and belief,
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Walmart never reported an order flagged by its monitoring program to the DEA as suspicious. In
addition, rather than halting the order, Walmart simply cut the order to the amount of the 50-bottle
threshold and shipped it. Walmart never reported cut orders to the DEA. Although the distribution
centers sent information regarding flagged orders daily to Walmart’s corporate headquarters in
Arkansas (the “Home Office”), no system existed for follow-up on flagged orders by employees
product, 30 mg oxycodone (“Oxy 30”). Under this approach, an order for over twenty bottles of
Oxy 30 was automatically reduced to twenty bottles. Walmart would not report these excessive
347. At the same time, Walmart’s distribution center began generating a daily report of
all the pharmacies placing orders for over twenty bottles of various oxycodone medications,
although Walmart did not place a “hard limit” on any dosage strength or product other than Oxy
30. This report, called the “Over 20 Report” later included other controlled substances as well.
Although the report was generated and circulated on a daily basis, Walmart did not have an
adequate system in place to review and follow up on these excessive orders beyond investigating
for indicators of internal theft, and it did not have a system in place to address stores that repeatedly
appeared on the Over 20 Report. Regardless of having been identified on the Over 20 Report, these
orders were filled and shipped. Upon information and belief, there is no evidence of any order in
bottles, nothing prevented a Walmart or Sam’s Club pharmacy from making up the difference by
ordering opioids from an outside distributor, such as McKesson and AmerisourceBergen. Not only
could Walmart pharmacies place another order with these outside vendors to make up the
difference, but they could also have orders fulfilled by both Walmart and a third-party distributor
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at the same time. Even though Walmart had the ability to monitor orders to outside vendors for
suspicious orders, it did not, which allowed Walmart pharmacies to exceed the already high
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349. Walmart knew that these policies and procedures were insufficient to fulfill its
acknowledged in an internal presentation that it had not yet designed a compliant system for
suspicious order identification, monitoring, and reporting. It also stated that it was “TBD” when
Walmart would develop such a system. In 2014, Walmart acknowledged that it still lacked a
compliant monitoring program and that it had “no process in place” to comply with government
regulations and that this created the “severe” risk of “financial or reputational impact to the
company.” At this point, Walmart still had no written policies and procedures required orders of
implementing store-specific thresholds. Upon information and belief, it based these thresholds on
the standard deviation of a specific pharmacy’s order history for each controlled substance. The
thresholds also included minimum amounts, below which no orders were flagged under any
351. For almost all Walmart pharmacies, this minimum was set at 2,000 dosage units
per week (or 8,000 dosage units per month). An order under this minimum threshold would not be
flagged regardless of changes in ordering patterns. A pharmacy could, for example, go from
ordering 10 dosage units of Oxycodone 10 mg per month to 7,999 per month without any order
being flagged or reviewed. Thus, even Walmart’s “enhanced” order monitoring program failed to
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352. According to the data from the DEA's ARCOS database, between the years 2006
and 2014, Walmart distributed more than 218 million dosage units of oxycodone and hydrocodone
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to its pharmacies in Illinois. The volume of opioids Walmart brought into Illinois and
ultimately dispensed from its pharmacy locations was so high as to indicate to Walmart that not
all of the prescriptions distributed to and dispensed out of its Illinois stores could be for legitimate
medical uses.
353. Yet, upon information and belief, Walmart did not report a single suspicious order
in the County between 2007 and 2014. Instead, Walmart funneled far more opioids into Illinois
than could have been expected to serve legitimate medical use and ignored other red flags of
suspicious orders. This information, along with the information known only to distributors such as
Walmart (especially with its pharmacy dispensing data), would have alerted Walmart to potential
diversion of opioids.
354. In addition, Walmart, upon information and belief, also distributed and dispensed
substantial quantities of prescription opioids in other states, and these drugs were diverted from
these other states to Illinois. Walmart failed to take meaningful action to stop this diversion despite
its knowledge of it, and it contributed substantially to the opioid epidemic in Illinois.
355. In the Counties, Walmart violated the standard of care for a distributor by failing
to: (a) control the supply chain; (b) prevent diversion; (c) report suspicious orders; and (d) halt
shipments of opioids in quantities it knew or should have known could not be justified and signaled
potential diversion.
356. As a vertically integrated, national retail pharmacy chain, Walmart had the ability
to detect diversion in ways third-party wholesale distributors could not by examining the
357. Given the volume and pattern of opioids distributed in Illinois and in the Counties,
Walmart was, or should have been aware that opioids were being oversupplied into the state and
should have detected, reported, and rejected suspicious orders. Yet, the information available
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358. Upon information and belief, Walmart, by virtue of the dispensing data available
to it, had actual knowledge of indicia of diversion, such as (1) individuals traveling long distances
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to fill prescriptions; (2) prescriptions for drug “cocktails” known for their abuse potential, such as
oxycodone and Xanax; (3) individuals arriving together with identical or nearly identical
prescriptions; (4) high percentage of cash purchases; and (5) doctors prescribing outside the scope
of their usual practice or geographic area. However, Walmart ignored these obvious red flags.
359. Walmart, therefore, was aware of the suspicious orders that flowed from its
distribution facilities. Walmart refused to identify, investigate, and report suspicious order despite
its actual knowledge of drug diversion. Rather, Walmart failed to report suspicious orders, prevent
360. Upon information and belief, Walmart failed to analyze: (a) the number of opioid
prescriptions filled by its pharmacies relative to the population of the pharmacy’s community; (b)
the increase in opioid sales relative to past years; and (c) the number of opioid prescriptions filled
361. Walmart was, or should have been, fully aware that the opioids being distributed
and dispensed by it were likely to be diverted; yet, it did not take meaningful action to ensure that
it was complying with its duties and obligations with regard to controlled substances, including its
responsibility to report suspicious orders and not to ship such orders unless and until due diligence
allayed the suspicion.
362. Given Walmart’s retail pharmacy operations, in addition to its role as a wholesale
distributor, Walmart knew or reasonably should have known about the disproportionate flow of
opioids into Illinois and the operation of “pill mills” that generated opioid prescriptions that, by
their quantity or nature, were red flags for, if not direct evidence of, diversion.
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363. Walmart, throughout the relevant time period, owned and operated pharmacies
throughout the United States, including pharmacies in the Counties. Through its wholly owned or
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controlled subsidiary companies, Walmart operates over 4,500 retail pharmacies across the U.S.,
a mail-order pharmacy, a specialty pharmacy, and six pharmacy distribution centers that distribute
364. Walmart set policies for its pharmacies at the corporate level. Walmart also
presented, through nationwide advertising, a public image of the safety and excellence of all the
pharmacists the company hired. In a recruitment video for pharmacists on Walmart’s YouTube
channel, the company shows Walmart pharmacists speaking about working at the company: “the
safety and the excellence we carry to our patients is phenomenal,” adding that “the culture that our
company has [is] respect for the individual, service, and excellence, and, of course, we always
have integrity.” 38 The commercial also states that Walmart’s pharmacists “strive for excellence”
from Walmart’s distribution centers and from other wholesale distributors, which enabled these
pharmacies to have the same orders filled by both Walmart and a third-party distributor.
around Illinois is indicative of potential diversion and required appropriate due diligence.
Walmart had unique insight into all distribution and dispensing level data and knew or should have
368. Discovery will reveal that Walmart knew or should have known that its
pharmacies in Illinois, and the surrounding area, were: (a) filling multiple prescriptions to the same
38
Walmart, Your Career as a Walmart Pharmacist (Sept. 25, 2014), available at
https://www.youtube.com/watch?v=9VD12JXOzfs (last visited May 13, 2020).
39
Id.
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patient using the same doctor; (b) filling multiple prescriptions by the same patient using different
doctors; (c) filling prescriptions of unusual size and frequency for the same patient; (d) filling
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prescriptions of unusual size and frequency from out-of-state patients; (e) filling an unusual or
disproportionate number of prescriptions paid for in cash; (f) filling prescriptions paired with other
drugs frequently abused with opioids, like benzodiazepines or prescription “cocktails”; (g) filling
prescriptions in volumes, doses, or combinations that suggested that the prescriptions were likely
being diverted or were not issued for a legitimate medical purpose; and (h) filling prescriptions for
patients and doctors in combinations that were indicative of diversion and abuse. Also, upon
information and belief, the volumes of opioids distributed to and dispensed by these pharmacies
were disproportionate to noncontrolled drugs and other products sold by these pharmacies, and
disproportionate to the sales of opioids in similarly sized pharmacy markets. Walmart had the
ability, and the obligation, to look for these red flags on a patient, prescriber, and store level, and
369. Walmart had complete access to all prescription opioid distribution data related to
370. Walmart had complete access to all prescription opioid dispensing data related to
371. Walmart had complete access to information revealing the doctors who prescribe
the opioids dispensed in Walmart pharmacies in and around Illinois.
372. Walmart had complete access to information revealing the customers who filled
or sought to fill prescriptions for opioids in Walmart pharmacies in and around Illinois.
373. Walmart had complete access to information revealing the opioid prescriptions
374. Walmart had complete access to information revealing the geographic location of
out-of-state doctors whose prescriptions for opioids were being filled by Walmart pharmacies in
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375. Walmart had complete access to information revealing the size and frequency of
prescriptions written by specific doctors across Walmart pharmacies in and around Illinois.
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376. Yet, on information and belief, Walmart did not begin to use this information to
identify prescribers of concern or signs of diversion until 2017. Walmart, however, always had the
ability to do so. Walmart also failed to put in place effective policies and procedures for the
identification of red flags when dispensing opioids and failed to provide adequate guidance or
377. Even when Walmart pharmacists suspected that an individual prescriber was
consistently writing prescriptions for other than a legitimate medical purpose, they could not, for
most of the relevant time period, use a “blanket” refusal to fill to refuse all prescriptions from that
prescriber. Instead, Walmart pharmacists were required to evaluate and refuse to fill prescriptions
on a case-by-case basis. A 2011 document from Walmart Regulatory Affairs regarding the “Proper
determine that it was not issued based on a valid prescriber-patient relationship or a valid medical
reason before refusing to fill.” The prescription-by-prescription refusal to fill procedure was time-
consuming and placed the burden on Walmart and Sam’s Club pharmacists, who were already
under pressure to fill prescriptions quickly. Moreover, many red flags for diversion are based on
prescribing patterns that are readily apparent from aggregate data—for example, the percentage of
could request such blanket refusals, which would permit the pharmacist to refuse to fill future
prescriptions from that prescriber without evaluating each prescription individually. In addition,
Walmart also always had the ability to “centrally block” problematic prescribers across all
Walmart and Sam’s Club pharmacies but did not establish a procedure to do so until 2017. In the
“Practice Compliance” document describing this policy, Walmart recognized that its Home Office
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may, “in certain situations,” have information about prescribing practices that is not available to
individual pharmacists:
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was at odds with a culture and practice of compliance. Incentive awards were tied to the number
of prescriptions a pharmacy filled and profit that the pharmacy generated. Upon information and
belief, controlled substances were included in Walmart’s pharmacy incentive program for most of
the relevant time period. In addition, pharmacists were under constant pressure to increase the
number of prescriptions they filled, and to increase the overall percentage of pharmacy sales. As a
result, upon information and belief, because of Walmart’s drive for speed, pharmacists often did
not have enough time to sufficiently review a prescription and conduct the appropriate due
diligence.
381. These systemic issues are reflected in numerous enforcement actions and
investigations that demonstrate the Walmart put profits and sales ahead of compliance, its
customers and communities, and public safety. In 2009, for example, the DEA issued a Show
Cause order seeking to revoke the registration of a Walmart pharmacy in California. The order
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substances to individuals that [the pharmacy] knew or should have
known were diverting the controlled substances.
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382. In addition, a 2011 Memorandum of Agreement (“2011 MOA”) arising out of the
investigation states that the DEA also learned that the same pharmacy was allegedly dispensing
controlled substances based on prescriptions that lacked valid DEA numbers and allegedly refilling
383. Upon information and belief, the failures described in the 2011 MOA were not
limited to California but reflected systemic failures at the corporate level. Indeed, the 2011 MOA,
which required Walmart to maintain a “compliance program” states that it is applicable to “all
current and future Walmart Pharmacy locations.”
384. Following the 2011 MOA, Walmart was supposed to revamp its dispensing
compliance program, but still, its policies and procedures remained deficient.
385. Instead, systemic failures continued, and Walmart’s national corporate office not
only failed to insist that Walmart implement adequate controls against diversion, they ignored
386. One internal document from 2015, for example, notes concerns from a Walmart
pharmacist that “his leadership would not support his refusing to fill any ‘legitimate’ (written by a
Dr) prescriptions and he stated that his current volume/staffing structure doesn’t allow time for
controlled substance prescription because the customer was attempting to fill it too soon, the
Market Health & Wellness Director for that store complained to management that the pharmacist
“sent a customer to a competitor” and “expressed significant concern about how ‘sending
customers away’ would impact the sales figures for the store,” and insisted that “the store needs to
387. In December 2020, the U.S. Department of Justice (“DOJ”) filed a lawsuit against
Walmart over its opioid dispensing and distribution practices. United States of America v. Walmart
Inc. et al., No. 1:20-cv-01744, ECF No. 1 (D. Del. December 22, 2020) (“DOJ Compl.”). After a
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multi-year investigation, and based on a review of millions of pages of documents, the DOJ alleged
that Walmart pharmacists filled prescriptions issued by “known pill-mill prescribers” and filled
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“numerous prescriptions that, on their face, showed such obvious red flags . . . that Walmart
pharmacists would have known that the prescriptions had a very high probability of being invalid,”
22-23, 35. Pharmacists or pharmacy managers would contact Walmart’s central compliance
personnel for guidance on handling suspected pill mill doctors but felt that their “concerns are
falling upon deaf ears.” Id. ¶ 237. Pharmacists repeatedly sought help from Walmart’s corporate
office, to no avail. Walmart compliance officials failed to take action in response to these alarms.
Instead, they repeatedly sent the same boilerplate response, stating that pharmacists must use their
professional judgment but that they must continue to evaluate and refuse to fill on an individual,
prescription-by-prescription basis, even in situations where other retail pharmacies had stopped
filling any prescriptions from particular prescribers. As a result, Walmart and Sam’s Club
pharmacies often became channels for illegitimate controlled substance prescriptions from known
pill mills. Even in circumstances where a prescriber was under investigation by the DEA,
Walmart’s compliance department informed pharmacists that would not be a reason to refuse to
frequently diverted and abused, was not limited to handful of Walmart and Sam’s Club
pharmacies. Rather, Walmart had a systemic, national problem. Walmart pharmacists from across
the country, including Maine, Massachusetts, Kansas, Washington, Texas, and North Carolina,
contacted Walmart’s national compliance directors about problem prescribers and suspect
prescriptions. One Walmart pharmacist in North Carolina wrote to a Market Health and Wellness
Director, in an email subsequently sent to the national compliance department, that “there is no
way that many 25 year olds need 120 to 240 oxycodone per month.” DOJ Compl. ¶ 324. Regarding
one Texas doctor who was later convicted of illegal distribution of opioids, a Walmart pharmacy
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manager wrote; “Other chains are refusing to fill for him which makes our burden even greater.
Please help us.” Id. ¶174 (emphasis added). Another described the same doctor as a “risk that
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keeps [him] up at night.” Id. ¶ 236. Similarly, in September 2016, a Walmart pharmacy manager
in Illinois advised that a doctor was “under investigation by the DEA for what we believe is a pill
mill operation,” and that Rite Aid had begun refusing to fill his prescriptions. Id. 296. The
pharmacy manager requested that Walmart put in place a similar “blanket denial,” but Walmart’s
compliance department responded that all prescriptions from that doctor must be evaluated
individually. Id. Before this particular doctor was indicted in 2017 on nineteen counts including
unlawful distribution and dispensing of controlled substances and violations of federal drug laws
resulting in the death of five patients, Walmart pharmacies dispensed over 8,000 of his controlled
389. Upon information and belief, Walmart also failed to adequately use data available
to it to identify doctors who were writing suspicious numbers of prescriptions and/or prescriptions
of suspicious amounts or doses of opioids, or to adequately use data available to it to prevent the
filling of prescriptions that were illegally diverted or otherwise contributed to the opioid crisis.
390. Upon information and belief, Walmart also failed to adequately analyze and
address its opioid sales to identify patterns regarding prescriptions that should not have been filled
and to create policies accordingly, or if it conducted such reviews, it failed to take any meaningful
action as a result.
d. Kroger
391. Although Kroger had access to significant information about red flags due to its
vertical integration with its stores, it failed to use this information in order to more effectively
prevent diversion.
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392. Kroger failed to implement an effective suspicious order monitoring program.
393. According to the data from the DEA's ARCOS database, between the years 2006
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and 2014, Kroeger distributed more than 32 million dosage units of hydrocodone to its pharmacies
in Illinois. The volume of opioids Kroger brought into Illinois and ultimately dispensed from its
pharmacy locations was so high as to indicate to Kroger that not all of the prescriptions distributed
to and dispensed out of its Illinois stores could be for legitimate medical uses.
394. Kroger funneled far more opioids into Illinois than could have been expected to
serve legitimate medical use and ignored other indicia of suspicious orders. This information,
along with the information known only to distributors such as Kroger (especially with its pharmacy
395. Kroger appears to have assigned responsibility for reviewing “unusual orders” to
the Pharmacy Manager, who had the ability to release the order. Kroger had computer-assisted
ordering systems aiming to ensure it had enough supply of controlled substances and other drugs
“Pharmacy Coordinator,” who would either file a report internally or alert the Division
purposes of “pending” orders for evaluation, but it contracted with an outside consultant in 2013.
Even with that system in place, however, it still appears to allow release of orders based simply on
contacting the pharmacy coordinator and obtaining a reason such as “[n]ew customers” to clear an
order. This occurred even though Kroger understood that its “SOM system will fail if individuals
clear orders without adequate investigation.” As of October 2013, an internal document described
“rolling out the SOM program to all” distribution centers and acknowledged it currently lacked
any system to prevent a pharmacy from going to Kroger’s outside vendor, Cardinal Health, to
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397. A Suspicious Order Monitoring Training Material notes the ability of analysts to
review “Business Objects” reports with sales trends and purchase history, and to clear orders based
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on that history.
398. Upon information and belief, Kroger by virtue of the data available to it, was
actually aware of indicia of diversion, such as (1) individuals traveling long distances to fill
prescriptions; (2) prescriptions for drug “cocktails,” known for their abuse potential, such as
oxycodone and Xanax; (3) individuals who arrived together with identical or nearly identical
prescriptions; (4) high percentage of cash purchases; and (5) doctors prescribing outside the scope
of their usual practice or geographic area. However, Kroger ignored these obvious red flags.
399. Upon information and belief, Kroger failed to report suspicious orders, prevent
diversion, or otherwise control the supply of opioids flowing into Illinois and the Counties.
400. Upon information and belief, Kroger failed to analyze: (a) the number of opioid
prescriptions filled by its pharmacies relative to the population of the pharmacy’s community; (b)
the increase in opioid sales relative to past years; and (c) the number of opioid prescriptions filled
401. Kroger was, or should have been, fully aware that the opioids being distributed
and dispensed by it were likely to be diverted; yet, it did not take meaningful action to investigate
or to ensure that it was complying with its duties and obligations with regard to controlled
substances, including its responsibility to report suspicious orders and not to ship such orders
402. Given Kroger’s retail pharmacy operations, in addition to its role as a wholesale
distributor, Kroger knew or reasonably should have known about the disproportionate flow of
opioids into Illinois and the operation of “pill mills” that generated opioid prescriptions that, by
their quantity or nature, were red flags for, if not direct evidence of, illicit supply and diversion.
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403. Before 2005, the inadequacy of Kroger’s policies and procedures was particularly
glaring. DEA began investigating King Soopers and City Market, part of the “Kroger Co. Family
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pharmacies revealed “a pattern of non-compliance” with the CSA and federal regulations. Because
of record-keeping and security problems, the DEA could not determine from the audit “how many
drugs had been lost or diverted,” but could tell that “many of the CSA violations were the result
of systemic weaknesses present in all King Soopers and City Market pharmacies.”
404. Ultimately, the parent corporation, Kroger Co., agreed in October 2005 to a then
record $7 million settlement for the “systemic violations of the Controlled Substances Act (CSA)
program estimated to cost over $6 million dollars in all 1,900 of its pharmacies nationwide.” The
changes included the Kroger stores in the County. Upon information and belief, Kroger promised
national reforms because it imposed its procedures at a national level across its “family” of stores,
405. A DEA press release concerning the settlement highlighted the trust American
place in “corporations like Kroger” to “ensure that controlled substances aren’t diverted to the
illicit market.” Kroger understood the vital importance of its role as the last line of defense. “As
the last person that has the opportunity to speak with a patient or caregiver prior to handing over a
medication that has been known to end the lives of so many when diverted or misused, no one can
overestimate the responsibility of the pharmacist.” Kroger also recognized the “legislative and
social intent of regulating controlled substances” as consistent with its mission in “serving the
public good.”
406. Discovery will reveal that Kroger knew or should have known that its pharmacies
in Illinois and the surrounding area were (a) filling multiple prescriptions to the same patient using
the same doctor; (b) filling multiple prescriptions by the same patient using different doctors; (c)
filling prescriptions of unusual size and frequency for the same patient; (d) filling prescriptions of
unusual size and frequency from out-of-state patients; (e) filling an unusual or disproportionate
99
number of prescriptions paid for in cash; (f) filling prescriptions paired with other drugs frequently
abused with opioids, like benzodiazepines, or prescription “cocktails”; (g) filling prescriptions in
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volumes, doses, or combinations that suggested that the prescriptions were likely being diverted
or were not issued for a legitimate medical purpose; and (h) filling prescriptions for patients and
doctors in combinations that were indicative of diversion and abuse. Also, upon information and
belief, the volumes of opioids distributed to and dispensed by these pharmacies were
disproportionate to noncontrolled drugs and other products sold by these pharmacies, and
disproportionate to the sales of opioids in similarly sized pharmacy markets. Kroger had the ability,
and the obligation, to look for these red flags on a patient, prescriber, and store level, and to refuse
a. Meijer
407. According to the data from the DEA's ARCOS database, between the years 2006
and 2014, Meijer distributed more than 3.9 million dosage units of hydrocodone to its pharmacies
in Illinois. The volume of opioids Meijer brought into Illinois and ultimately dispensed from its
pharmacy locations was so high as to indicate to Meijer that not all of the prescriptions distributed
to and dispensed out of its Illinois stores could be for legitimate medical uses.
408. In Illinois, Meijer violated the standard of care for a distributor and dispenser by
failing to: (a) control the supply chain; (b) prevent diversion; (c) report suspicious orders; and (d)
halt shipments of opioids in quantities it knew or should have known could not be justified and
409. For years, per capita opioid prescriptions in Illinois increased in ways that should
have alerted Meijer to potential diversion. Indeed, as an operator of retail pharmacies, Meijer had
the ability to detect diversion in ways that included examining the dispensing data from its own
100
410. Given the volume and pattern of opioids distributed in Illinois, Meijer was, or
should have been, aware that opioids were being oversupplied into the state and should have
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411. Meijer was, or should have been, fully aware that the opioids and “cocktail”
combinations being distributed and dispensed by it were likely to be diverted, yet it did not take
meaningful action to ensure that it was complying with its duties and obligations with regard to
controlled substances, including its responsibility to report suspicious orders and not to ship such
412. Given Meijer’s retail pharmacy operations, in addition to its role as a wholesale
distributor, Meijer knew or reasonably should have known about the disproportionate flow of
opioids into Illinois, and the operation of “pill mills” that generated opioid prescriptions that, by
their quantity or nature, were red flags for, if not direct evidence of, diversion.
413. Meijer throughout the relevant time period, owned and operated pharmacies
414. As described above, the volume of prescription opioids ordered and dispensed by
Meijer pharmacies in and around Illinois is indicative of potential diversion and required
appropriate due diligence.
415. As a distributor and dispenser of prescription opioids, Meijer had visibility into all
distribution and dispensing-level data, and Meijer knew or should have known that it was
416. Upon information and belief, Meijer, by virtue of the dispensing data available to
it, had actual knowledge of indicia of diversion, such as (1) individuals traveling long distances to
fill prescriptions; (2) prescriptions for drug “cocktails” known for their abuse potential, such as
oxycodone and Xanax; (3) individuals arriving together with identical or nearly identical
101
prescriptions; (4) high percentage of cash purchases; and (5) doctors prescribing outside the scope
of their usual practice or geographic area. However, Meijer ignored these obvious red flags.
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417. Upon information and belief, Meijer failed to analyze: (a) the number of opioid
prescriptions filled by its pharmacies relative to the population of the pharmacy’s community; (b)
the increase in opioid sales relative to past years; and (c) the number of opioid prescriptions filled
418. Discovery will reveal that Meijer knew or should have known that its pharmacies in
Illinois, and the surrounding area were: (a) filling multiple prescriptions to the same patient using the
same doctor; (b) filling multiple prescriptions by the same patient using different doctors; (c) filling
prescriptions of unusual size and frequency for the same patient; (d) filling prescriptions of unusual
size and frequency from out-of-state patients; (e) filling an unusual or disproportionate number of
prescriptions paid for in cash; (f) filling prescriptions paired with other drugs frequently abused with
opioids, namely benzodiazepines or muscle relaxers; (g) filling prescriptions in volumes, doses, or
combinations that suggested that the prescriptions were likely being diverted or were not issued for a
legitimate medical purpose; and (h) filling prescriptions for patients and doctors in combinations that
were indicative of diversion and abuse. Also, upon information and belief, the volumes of opioids
distributed to and dispensed by these pharmacies were disproportionate to non-controlled drugs and
other products sold by these pharmacies, and disproportionate to the sales of opioids in similarly sized
pharmacy markets. Meijer had the ability, and the obligation, to look for these red flags on a patient,
prescriber, and store level, and to refuse to fill and to report prescriptions that suggested potential
diversion.
419. Meijer had complete access to all prescription opioid distribution data related to
420. Meijer had complete access to all prescription opioid dispensing data related to its
421. Meijer had complete access to information revealing the doctors who prescribed
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422. Meijer had complete access to information revealing the customers who filled or
sought to fill prescriptions for opioids in its pharmacies in and around Illinois.
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423. Meijer had complete access to information revealing the opioid prescriptions
424. Meijer had complete access to information revealing the geographic location of
out-of-state doctors whose prescriptions for opioids were being filled by its pharmacies in and
around Illinois.
425. Meijer had complete access to information revealing the size and frequency of
prescriptions written by specific doctors across its pharmacies in and around Illinois.
426. Upon information and belief, Meijer failed to adequately use data available to it to
identify doctors who were writing suspicious numbers of prescriptions and/or prescriptions of
suspicious amounts or doses of opioids, or to adequately use data available to it to prevent the
filling of prescriptions that were illegally diverted or otherwise contributed to the opioid crisis.
427. Upon information and belief, Meijer also failed to adequately analyze and address
its opioid sales to identify patterns regarding prescriptions that should not have been filled and to
create policies accordingly, or if it conducted such reviews, it failed to take any meaningful action
as a result.
a. Albertsons
429. According to the data from the DEA's ARCOS database, between the years 2006
and 2014, Albertsons distributed more than 203 million dosage units of oxycodone and
hydrocodone to its pharmacies in Illinois. The volume of opioids Albertsons brought into Illinois
and ultimately dispensed from its pharmacy locations was so high as to indicate to Albertsons that
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not all of the prescriptions distributed to and dispensed out of its Illinois stores could be for
430. On information and belief, for some of the relevant time period, Albertsons
through its distribution center in Ponca City, Oklahoma, registered as Albertsons LLC Distribution
Center #8720. 40
system for most of the time it operated its self-distribution network, relying on its employees’
432. On information and belief, when Albertsons did implement an objective measure
for detecting suspicious orders, it was based on a simple threshold that would be triggered by the
size of the order only and not the frequency or pattern of the orders.
diversion with respect to its self-distribution of opioids was compounded by its failures to
434. In Illinois, Albertsons violated the standard of care for a distributor and dispenser
by failing to: (a) control the supply chain; (b) prevent diversion; (c) report suspicious orders; and
(d) halt shipments of opioids in quantities it knew or should have known could not be justified and
40
On information and belief, Albertsons pharmacies also ordered controlled substances through
McKesson, while Safeway pharmacies prior to 2015 ordered controlled substances primarily through
Cardinal Health.
104
435. For years, per capita opioid prescriptions in Illinois increased in ways that should
Albertsons had the ability to detect diversion in ways third- party wholesale distributors could not
by examining the dispensing data from its own retail pharmacy locations.
436. Given the volume and pattern of opioids distributed in Illinois, Albertsons was, or
should have been, aware that opioids were being oversupplied into the state and should have
437. Albertsons was, or should have been, fully aware that the opioids and “cocktail”
combinations being distributed and dispensed by it were likely to be diverted, yet it did not take
meaningful action to ensure that it was complying with its duties and obligations with regard to
controlled substances, including its responsibility to report suspicious orders and not to ship such
wholesale distributor, Albertsons knew or reasonably should have known about the
disproportionate flow of opioids into Illinois, and the operation of “pill mills” that generated opioid
prescriptions that, by their quantity or nature, were red flags for, if not direct evidence of, diversion.
439. Albertsons, throughout the relevant time period, owned and operated pharmacies
throughout the United States, including in Illinois. Through its wholly owned or controlled
subsidiary companies, Albertsons operates over 1,700 retail pharmacies across the United States.
440. As described above, the volume of prescription opioids ordered and dispensed by
Albertsons pharmacies in Illinois is indicative of potential diversion and required appropriate due
diligence.
441. Upon information and belief, Albertsons, by virtue of the dispensing data available
to it, had actual knowledge of indicia of diversion, such as (1) individuals traveling long distances
105
to fill prescriptions; (2) prescriptions for drug “cocktails” known for their abuse potential, such as
oxycodone and Xanax; (3) individuals arriving together with identical or nearly identical
FILED DATE: 8/15/2022 4:37 PM 2022L007352
prescriptions; (4) high percentage of cash purchases; and (5) doctors prescribing outside the scope
of their usual practice or geographic area. However, Albertsons ignored these obvious red flags.
442. Upon information and belief, Albertsons failed to analyze: (a) the number of
opioid prescriptions filled by its pharmacies relative to the population of the pharmacy’s
community; (b) the increase in opioid sales relative to past years; and (c) the number of opioid
443. Discovery will reveal that Albertsons knew or should have known that its
pharmacies in Illinois, as well as nearby states were: (a) filling multiple prescriptions to the same
patient using the same doctor; (b) filling multiple prescriptions by the same patient using different
doctors; (c) filling prescriptions of unusual size and frequency for the same patient; (d) filling
prescriptions of unusual size and frequency from out-of-state patients; (e) filling an unusual or
disproportionate number of prescriptions paid for in cash; (f) filling prescriptions paired with other
drugs frequently abused with opioids, namely benzodiazepines or muscle relaxers; (g) filling
prescriptions in volumes, doses, or combinations that suggested that the prescriptions were likely
being diverted or were not issued for a legitimate medical purpose; and (h) filling prescriptions for
patients and doctors in combinations that were indicative of diversion and abuse. Also, upon
information and belief, the volumes of opioids distributed to and dispensed by these pharmacies
were disproportionate to noncontrolled drugs and other products sold by these pharmacies, and
disproportionate to the sales of opioids in similarly sized pharmacy markets. Albertsons had the
ability, and the obligation, to look for these red flags on a patient, prescriber, and store level, and
444. Albertsons had complete access to all prescription opioid distribution data related
445. Albertsons had complete access to all prescription opioid dispensing data related
106
446. Albertsons had complete access to information revealing the doctors who
447. Albertsons had complete access to information revealing the customers who filled
448. Albertsons had complete access to information revealing the opioid prescriptions
449. Albertsons had complete access to information revealing the geographic location
of out-of-state doctors whose prescriptions for opioids were being filled by its pharmacies in
Illinois.
450. Albertsons had complete access to information revealing the size and frequency
451. Upon information and belief, Albertsons failed to adequately use data available to
it to identify doctors who were writing suspicious numbers of prescriptions and/or prescriptions of
suspicious amounts or doses of opioids, or to adequately use data available to it to prevent the
filling of prescriptions that were illegally diverted or otherwise contributed to the opioid crisis.
452. Upon information and belief, Albertsons also failed to adequately analyze and
address its opioid sales to identify patterns regarding prescriptions that should not have been filled
and to create policies accordingly, or if it conducted such reviews, it failed to take any meaningful
action as a result.
453. Not only did the Chain Pharmacies lack (and fail to implement) adequate policies
and procedures to guard against diversion, but CVS, Walgreens, and Walmart, and upon
information and belief, the other Chain Pharmacies compounded this problem by implementing
performance metrics and prescription quotas for retail stores that contributed to supplying of a
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454. Defendants also had a responsibility to create a work environment that enables its
pharmacy staff to detect and prevent diversion, or at the very least does not undermine the ability
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of staff to carry out these functions or direct emphasis toward increased sales instead of legal
compliance. Accordingly, former DEA diversion investigator Demetra Ashley testified that she
believed the duty to provide tools to prevent diversion under Section 1301.71 includes providing
a work environment that allows pharmacists to fulfill their corresponding responsibility to fill only
legitimate prescriptions. She further agreed as to the importance of adequate staffing and testified
that both strict time limits that deprived pharmacists of enough time to investigate red flags and
455. In connection with the DEA’s investigations described above, the DEA found
evidence that Walgreens had a corporate policy encouraging increased sales of oxycodone. As the
DEA’s September 2012 Order to Show Cause and Immediate Suspension of Registration explains:
continued even after the DEA investigation and $80 million fine. For example, in 2014, the RX
108
to “identify pharmacists that are dispensing a low rate of controlled substances,” and help
hydrocodone,” and the cocktail drugs comprising the rest of the “holy trinity” of abuse, such as
457. Walgreens also had a bonus program that factored prescription volume into bonus
calculations and served as an incentive for pharmacies and pharmacy technicians to ignore the “red
flags” of diversion. The corporate push for speed (or volume) deterred pharmacists from taking
the time to properly examine the prescriptions before them and exercising their corresponding
458. Walgreens emphasized in its policies for pharmacist and pharmacy managers:
“The best evidence of a well-run pharmacy is the increase in prescriptions and pharmacy sales.”
One former Walgreens pharmacist described management critiques for “not going fast enough” in
dispensing prescriptions and believed “[t]hey’d like you to fill one a minute if you could.” She
recalled there was even a timer to alert her if she was falling behind, and threats of reduced hours
or a move to a different store or location. 41 Indeed, Walgreens had a tool, the “PhLOmometer”
that tracked the time to fill a prescription. A March 2013 memo confirms that volume targets
included controlled substances as late as 2013 and even after the adopting of the GFD policy.
Specifically, the memo states, as the response to an “[a]nticipated question” that “GFD concerns
doesn’t relieve you from trying to attain the numbers that have been set for you.” When
considering high schedule 2 dispensing at a particular pharmacy in New Jersey in 2012, as the
opiate crisis raged, the pharmacy supervisor pushed back against any attempt to reduce supply of
oxycodone, focusing on the impact the reduction would make on filled prescriptions and “the
41
Are Business Tactics at Some Pharmacies Risking Your Health? (Nov. 8, 2017),
https://reachmd.com/news/are-business-tactics-at-some-pharmacies-risking-your-health/1610793/
109
459. Such corporate goals obstruct the performance of pharmacists’ professional
obligations. There is an inherent conflict between performance metrics that pressure pharmacists
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to fill certain volume of prescriptions, limit customers’ wait time, or base pharmacists’ incentive
pay on customer satisfaction, on the one hand, and the ability to conduct appropriate due diligence
to guard against diversion of controlled substances and refuse to fill illegitimate prescriptions even
if a customer is dissatisfied, on the other. Defendants have a duty to maintain a corporate culture
460. Defendants maintained no such corporate cultures. Walmart even pushed back
when, in 2013, the DEA expressed concerns that bonus incentives for dispensing controlled
substances could “lead to bad pharmacist decisions because they know they get will something out
of filling scripts.” Even though Walmart agreed it should not provide “special” incentives
from incentives also applied with respect to other drugs and does not appear to have excluded
461. In February 2012, Richard Ashworth, then the Vice President of Walgreens’
Western Division, supervising over 2,000 Walgreens stores, encouraged stores “to drive for the
activities that drive incremental scripts. There are metrics we can improve, today, that we will
demonstrate the ‘doing whatever it takes’ to achieve 100% of FY2011 Script volume,” noting “we
are not doing whatever it takes,” and particularly that in the “Top 2 complaints” was “Pharmacy
462. As described further below, pharmacists were expected to meet volume and speed
goals. With respect to the volume-based bonus policy, a March 2013 memo confirms that volume
targets included controlled substances as late as 2013 and even after the adopting of the GFD
policy. Specifically, the memo states, as the response to an “[a]nticipated question” that “GFD
concerns doesn’t relieve you from trying to attain the numbers that have been set for you.”
463. Only as part of its 2013 settlement with the DEA did Walgreens agree to exclude
controlled substances calculations from bonus calculations from 2014 forward. This resulted in a
110
21% reduction in the number of stores purchasing the 80mg OxyContin – evidence that a minimal
effort to implement common sense controls had a tangible impact on sales of the most potent
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controlled substances (although that reduction did not last, as described above, and Walgreens’s
464. Even though controlled substances were removed from direct bonus calculations
for pharmacists, pharmacists still felt pressured by management to fill prescriptions they were
uncomfortable filling, as refusals to fill would impact other store metrics – like customer
satisfaction – that impacted management compensation. As one Walgreens pharmacist noted: “As
long as Walgreens allows their pharmacists to be evaluated by store managers (who are trained by
the Company to be concerned with profit, customer service, and resolving customer complaints),
store managers will assert their authority over the pharmacists and will naturally confuse good
faith dispensing issues with customer service issues. This is a clear conflict of interest.”
465. Walgreens also lobbied against imposition of caps or limits on the volume of
prescriptions a pharmacist may fill. As the New York Times reported last year, pharmacists at
chain pharmacies, including Walgreens have “said it had become difficult to perform their jobs
safely, putting the public at risk of medication errors,” as they “struggle to fill prescriptions, give
flu shots, tend the drive-through, answer phones, work the register, counsel patients, and call
doctors and insurance companies … all the while racing to meet corporate performance metrics
that they characterized as unreasonable and unsafe ….” 42 Instead of reducing performance targets,
chain pharmacies including Walgreens seek to assign more dispensing tasks to less qualified—and
466. Walgreens Pharmacy Managers provided feedback stating that pharmacists did not
have enough time to do their work effectively and that a lack of resources kept them from being
effective and consistent. The feedback also indicated that pharmacy managers were “[s]truggling
42
See Ellen Gabler, How Chaos at Pharmacies Is Putting Patients at Risk, New York Times, (Jan. 31,
2020), https://www.nytimes.com/2020/01/31/health/pharmacists-medication-errors.html.
111
to keep our heads above water let alone manage.” A consultant hired by Walgreens interviewed
pharmacy staff and reported “High Stress” and “errors resulting from stress” and stated, “we heard
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multiple reports of improper behavior” that was “largely attributed to the desire” to meet a
corporate metric known as “promise time,” which ensures that patients get prescriptions filled
467. As early as 2006 CVS judged a pharmacist’s performance based on metrics that
would motivate employees to exceed top line results and maximize store profits. These metrics,
would rely, in part, upon the number of prescriptions dispensed. By 2010, CVS had implemented
performance metrics that remain publicly available online. CVS’s metrics system lacked any
measurement for pharmacy accuracy or customer safety. They did, however, prioritize speed and
volume, including by requiring pharmacists to meet wait- or fill-time expectations. Moreover, the
bonuses for pharmacists are calculated, in part, on how many prescriptions that pharmacist fills
within a year. Even in 2020, pharmacists described CVS as the “most aggressive chain in imposing
performance metrics.”
468. As noted above, former pharmacists at both Walgreens and CVS have publicly
complained about pressure to put speed ahead of safety. Concerning the metrics at CVS, one
pharmacist commented that “You get stressed, and it takes your mind away from the actual
prescriptions.” Another former CVS pharmacist recalled that “[e]very prescription [wa]s timed,”
and a backlog would pop up in color on pharmacists’ computer screens if they fell behind. 43
Additionally, CVS has faced discrimination complaints alleging that the company’s “Metrics”
system set unobtainable goals—or at least, goals that could not be obtained without violating the
laws and practice rules governing pharmacists’ professional responsibilities, edging out older
pharmacists.
43
Sam Roe, Ray Long, and Karisa King, Contract Reporters, Pharmacies Miss Half of Dangerous Drug
Combinations, Dec. 15, 2016, http://www.chicagotribune.com/news/watchdog/druginteractions/ct-drug-
interactions-pharmacy-met-20161214-story.html.
112
469. More recently, a former CVS pharmacist in North Carolina described being driven
to leave his position and open his own pharmacy, where he could work safely. He described
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working a 13-hour shift with no breaks for lunch or dinner at CVS the day before he left in
December 2018; a day on which he filled “552 prescriptions—about one every minute and 25
seconds—while counseling patients, giving shots, making calls and staffing the drive-through.” 44
In departing, he let his manager know that he would not “work in a situation that is unsafe.” 45 One
pharmacist was so alarmed that he wrote anonymously to the Texas State Board of Pharmacy to
470. As further evidence of the complaints by CVS pharmacists, the State of Ohio
Board of Pharmacy (“Board of Pharmacy”) disseminated in July of 2020 a workload survey to all
pharmacists working in Ohio. 47 The Board of Pharmacy published its survey results, described
below, in April of 2021.
471. One survey comment from a CVS pharmacist states: “As a pharmacist for CVS
the working conditions are very dangerous. They are constantly cutting hours and expecting us to
do more with less. I feel like there are at least 1‐2 dispensing errors every month in my pharmacy.
If we were allowed to work at a safe pace, this would be completely avoidable. All of the retail
pharmacists I work with feel like they need to cut corners to finish all of the work in time. Many
cvs [sic]stores had over a hundred pages in their queues at the beginning of 2020 because they
were so far behind (15 prescriptions per page so this equates to over a weeks [sic] worth of work).”
472. Another CVS pharmacist comments: “At CVS, work load [sic] increase every year
and staffing don’t [sic] increase always decreasing hours on staffing, we pharmacists are counted
to help techs on their jobs to be able to make the pharmacy work and try to finish work load [sic]
44
Ellen Gabler, How Chaos at Pharmacies Is Putting Patients at Risk, New York Times, (Jan. 31,
2020), https://www.nytimes.com/2020/01/31/health/pharmacists-medication-errors.html.
45
Id.
46
Id.
47
State of Ohio Board of Pharmacy’s Pharmacist Workload Survey, April 2021. See
https://www.pharmacy.ohio.gov/Documents/Pubs/Reports/PharmacistWorkloadSurvey/2020%20Pharmac
ist%20Workload%20Survey.pdf.
113
for the day. No breaks or lunchs [sic] for pharmacist. No time to do a proper counsel, mtm [sic]
and patient care. I think with the work load we should have over lap [sic] with pharmacist. Some
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473. Still another CVS pharmacist complains about CVS’s metrics: “I do want to point
out several years ago I worked at CVS and that was the worst experience I had as a retail
pharmacist. Too much focus on metrics and each Rx ends up not being given due attention.
Extreme workload , corporate pressure , [sic]low staff resulted in RPh having not even 5 mins in
a day of 10hrs [sic] to eat! [sic] Its time someone stopped CVS making a factory out of Pharmacy.”
474. While another CVS pharmacist complains about the work hours and a lack of a
break: “CVS makes pharmacist work 14 hrs [sic] days with no lunch break or schedule break. If
you complain they warn that there are hundreds of new grads who can’t find a job bc [sic] there
are so many pharmacy schools opened in Ohio who they can pay less to do your job d/t [sic] over
saturation.”
475. Another CVS pharmacist asserts CVS cares only about money: “CVS only cares
about money and numbers. Their customers and employees are the least of their concern. They cut
technician hours to the point where pharmacists are working alone on a consistent basis processing,
filling, checking, and dispensing a prescription every 2 minutes while also answering the phone,
assisting customers with questions out in the aisles and managing all the administrative
requirements on a day to day[sic].”
476. It is difficult to contemplate how any pharmacist could and/or would be able to
meaningfully comply with any corporate policy regarding red flag analyses or any anti-diversion
the media that the pace and pressure of prescription quotas appeared to be having an impact on
accuracy. “The frequency of these errors is increasing greatly,” Hussar said; “I’ve heard some
114
pharmacists say, ‘It’s a blur as to what happened during the day and I can only pray I didn’t make
478. This pressure and focus on profits would not only lead to mistakes, it also would
necessarily deter pharmacists from carrying out their obligations to report and decline to fill
legitimate.
479. Indeed, “a survey by the Institute for Safe Medication Practices (ISMP) revealed
that 83% of the pharmacists surveyed believed that distractions due to performance metrics or
measured wait times contributed to dispensing errors, as well as that 49% felt specific time
resolution which cited this survey and additionally stated that “performance metrics, which
measure the speed and efficiency of prescription work flow by such parameters as prescription
wait times, percentage of prescriptions filled within a specified time period, number of
prescriptions verified, and number of immunizations given per pharmacist shift, may distract
pharmacists and impair professional judgment” and “the practice of applying performance metrics
or quotas to pharmacists in the practice of pharmacy may cause distractions that could potentially
decrease pharmacists’ ability to perform drug utilization review, interact with patients, and
maintain attention to detail, which could ultimately lead to unsafe conditions in the pharmacy.” 50
pharmacies increasingly promote quick service, “pharmacists frequently race through legally
required drug safety reviews—or skip them altogether,” missing dangerous drug combinations in
48
Are Business Tactics at Some Pharmacies Risking Your Health?, ReachMD citing ksdk.com (Nov. 8,
2017), https://reachmd.com/news/are-business-tactics-at-some-pharmacies-risking-your-health/1610793.
49
NAPB, Performance Metrics and Quotas in the Practice of Pharmacy (Resolution 109-7-13) (June 5,
2013), https://nabp.pharmacy/performance-metrics-and-quotas-in-the-practice-of-pharmacy-resolution-
109-7-13.
50
Id.
115
the process. 51 A pharmacist too rushed to check for a potentially deadly drug interaction is also
likely to be too rushed to check for red flags of diversion, such as prescription “cocktails” or other
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pharmacists would dispense dangerous drug combinations without warning patients 30 percent of
the time. 52 In reporting on the results of its investigation, the Tribune quoted Bob Stout, president
of the New Hampshire Board of Pharmacy, stating that “‘They’re cutting corners where they think
they can cut.” 53 As the report itself explained: “some pharmacies emphasize fast service over
patient safety. Several chain pharmacists, in interviews, described assembly-line conditions in
483. “The National Coordinating Council for Medication Error Reporting and
Prevention (NCCMERP), also passed a statement advocating for the “elimination of prescription
time guarantees and a strengthened focus on the clinical and safety activities of pharmacist within
51
Sam Roe, Ray Long, and Karisa King, Contract Reporters, Pharmacies Miss Half of Dangerous Drug
Combinations, Dec. 15, 2016, http://www.chicagotribune.com/news/watchdog/druginteractions/ct-drug-
interactions-pharmacy-met-20161214-story.html.
52
Id.
53
Id.
54
Id.
55
National Coordinating Council for Medication Error Reporting and Prevention. Statement Advocating
for the Elimination of Prescription Time Guarantees in Community Pharmacy,
http://www.nccmerp.org/statement-advocating-elimination-prescription-time-guarantees-community-
pharmacy.
116
484. An April 2021 workload survey from the Ohio Board of Pharmacy, 56 referenced
above, revealed a contrast between the responses of pharmacists at chain pharmacies and
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pharmacists at other locations concerning the time available to do their job safely:
485. The same was true concerning whether standards or metrics were perceived as
56
https://www.pharmacy.ohio.gov/Documents/Pubs/Reports/PharmacistWorkloadSurvey/
2020%20Pharmacist%20Workload%20Survey.pdf
117
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reflected a belief that chain pharmacies place profit over safety. A common refrain heard from
pharmacists was being asked to do more with less: carrying more responsibilities and facing
increased prescription volumes while staffing levels have decreased. In a job market filled with
new graduates, pharmacists were reminded that they were replaceable. A Walmart pharmacist
complained that “CVS and Rite [A]id will fill anything” and expressed frustration that Walmart was
“under the microscope for filling opioids and benzodiazepines” and being told by DEA to “do more,”
who reported the following: “I received my first lunch break last week in the 7 years I have been
a pharmacist. I literally have almost passed out multiple times from lack of breaks.” 57 “Anytime I
would ask for more help or complain, I was told if you don’t want this job there are plenty of
unemployed pharmacists who will do your same job for less money.” 58 “The supervisors are
57
Id. at 61.
58
Id. at 83.
118
always bending the rules to achieve certain metrics for the company. For instance, Pharmacists
make patient calls throughout the day and are expected to reach a certain percentage of people. To
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help reach this number we are asked to leave messages on patient voicemails telling them if they
don’t call us back, we are to call them again later that day. Many compliance issues are ignored.”59
488. Kroger pharmacists reported the following: “I specifically left retail pharmacy at
Kroger because of the complete and utter disregard for patient safety.” 60 Kroger pharmacies lacked
staffing, inadequately trained their employees, and committed “abundant” errors, which “lead to
punishment” when reported. 61 Concerns about “unsafe” staffing levels were rebuffed.” 62 “The
culture within Kroger is to look the other way.” 63 “The workload is unrealistic and unsafe.” 64
489. Beginning as early as the 1990s, outside distributors, largely through the HDA,
began to get together with the Chain Pharmacies through NACDS to discuss “concerns regarding
statutory requirements to report to DEA what are commonly referred to as suspicious orders.”
490. The DEA’s suspensions of the registrations of three major distributors in 2007 lit
a fuse within the industry. The very real threat of DEA enforcement prompted a flurry of
communications between NACDS members and members of the HDA, described above, as well
as the now-notorious Pain Care Forum (“PCF”), a forum run by opioid manufacturers. A goal of
HDA, which it shared with NACDS, was to “develop a comprehensive DEA strategy” to avoid
59
Id. at 89.
60
Id. at 80.
61
Id
62
Id.
63
Id. at 104.
64
Id. at 150.
119
491. The NACDS and Defendants’ other trade groups saw their role in influencing
diversion policy as being one that was absolutely critical, considering all that was at stake. At
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times, these groups adopted militaristic strategies and used terminology ironically similar to the
“War on Drugs,” developing “task forces” and viewing the DEA’s crackdown on distributors and
chain pharmacies as an assault on the companies themselves. Only this time, the war was being
waged against the very regulatory authorities and government entities fighting to deal with the
favorable policies is clear when evaluated in the context of how Defendants and other stakeholders
120
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493. Walgreens, like the other Defendants, recognized the importance of being able to
control and influence trade groups such as the NACDS in the context of influencing policy related
to opioid drug abuse and diversion. The efforts taken by the NACDS and other trade groups on
behalf of Defendants were so important to their bottom line that Defendants spared no expense in
supporting such groups. Walgreens took a particularly aggressive view of this mutually beneficial
494. NACDS worked with the HDA, the Alliance to Prevent the Abuse of Medicines
(“APAM”), and the PCF to support the Marino Blackburn Bill, also known as S.483 or the “Marino
Bill.” NACDS and Defendants intended the Marino Bill to “tie the hands” of the DEA to actively
and aggressively address diversion and compliance with the CSA.” NACDS worked together with
others in the opioid supply chain to influence the language in the bill to make it most favorable for
them and more restrictive on the DEA. Notably, masking the influence of industry, when the
APAM was asked to sign on to a 2014 letter of support it was “signed by the Alliance, not the
individual members.” The final letter that was sent to Senators Hatch and Whitehouse was signed
by the members of the Pain Care Forum as well as the Alliance, the NACDS, American Academy
121
495. The Marino Bill effectively removed the DEA’s ability to issue immediate
compliant registrant an opportunity to cure its noncompliance before the DEA could take
enforcement action and changed the standard upon which revocation occurred. In the midst of a
growing opioid crisis, the Marino Bill removed the most effective deterrent and constrained DEA
enforcement actions. With respect to its efforts to tie the hands of the DEA in its ability to pursue
and hold accountable Defendants and other stakeholders for violations of law related to the sale
496. CVS as a member of the HDA, NACDS and the APAM was actively involved in
efforts to curb the enforcement power of the DEA in its support of the Marino Bill. Its history and
497. The APAM is a trade group launched in the fall of 2013 and compromised of
members of the American Medical Association, Cardinal, CVS, HDMA, Prime Therapeutics and
Teva Pharmaceuticals.
122
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498. CVS and Defendants used trade groups like the HDA, NACDS and APAM to gain
favorable results when it came to regulations and roadblocks that were seen as being in the way of
the Defendants ability to capitalize on the opioid business. In particular CVS would often hide
behind the APAM when it knew its position could be controversial as it related to abuse and
diversion. This particular letter was one in support of the controversial Marino Bill, a bill that
499. In August of 2011, NACDS worked with others on a joint letter opposing DEA
fee increases for registrants that were intended to fund the “hir[ing of] more agents and do[ing]
more inspections.”
123
500. HDA’s Crisis Playbook, developed in 2013, was a direct response to the “threats”
perceived by HDA’s members and affiliates, including Defendants, to their bottom line: profits
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derived from the distribution and sale of prescription opioids. Defendants did and continue to rely
on and employ the strategies discussed in the Crisis Playbook. Curiously, there are no slides on
how best HDA and its members, including Defendants, might work to curb the crisis that is the
opioid epidemic.
124
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125
501. In 2016, the NACDS Policy Council discussed ongoing efforts to shape opioid
legislation, including their success in removing a requirement that pharmacists have to check their
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state drug monitoring program before filling controlled prescriptions. NACDS also fought
regulatory efforts to require Defendants to use available dispensing related data and red flags to
prevent diversion, opposing what it described as “recent DEA actions in which DEA is expecting
502. NACDS and HDA sought to slow down and impede DEA enforcement activities by
requiring the DEA to “work with the [Food and Drug Administration] FDA on all drug diversion
issues,” ostensibly on the grounds that the DEA’s diversion enforcement activities – including
“clos[ing] drug distribution centers and pharmacies” and “actions against pharmacies” were harmful
in “leading to patients not being able to receive their medications.” This purported concern, however,
503. NACDS and HDA agreed that the pharmacies should “be more aggressive” and
“lead the charge” with respect to certain DEA issues. NACDS members coordinated regarding
pharmacy diversion and “DEA red flags” through a “DEA Compliance Workgroup.” Defendants
further used a NACDS “Pharmacy Compliance Roundtable” to discuss avoiding criminal and civil
liability for issues related to controlled substances, SOM, and diversion. And, in May 2012, the
NACDS formed a Policy Council “Task Group” to “discuss issues and develop strategies”
concerning “ongoing problems that NACDS members are having with DEA enforcement actions,”
through which it sought to influence the government and media set meetings with legislators
seeking to “address the problems with DEA actions,” and “collaborate with, and support others’
504. NACDS members coordinated regarding pharmacy diversion and “DEA red flags”
Compliance Roundtable” to discuss avoiding criminal and civil liability for issues related to
controlled substances, SOM, and diversion. And, in May 2012, the NACDS formed a Policy
Council “Task Group” to “discuss issues and develop strategies” concerning “ongoing problems
126
that NACDS members are having with DEA enforcement actions,” through which it sought to
influence the government and media, set meetings with legislators seeking to “address the
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problems with DEA actions,” and “collaborate with, and support others’ efforts” including HDA.
F. Defendants Also Entered into Joint Ventures that Further Undermined their
Outside Vendors’ Incentive to Conduct Due Diligence, While Increasing their
Own Access to Information.
505. The collaboration between Defendants and other industry partners extended
beyond their mutual interest in limiting regulations and enforcement that constrained their ability
to sell opioids. Indeed, the companies had direct financial relationships that, quite literally,
and a seat on its Board. As part of a three-year extension of that arrangement, in 2016, the two
investments in the relationship and will proceed with additional capital investments in its
distribution network.”
507. The merger between Walgreens and AmerisourceBergen had begun in 2012, when
the two formed Walgreens Boots Alliance Development, a joint venture based in Switzerland.
AmerisourceBergen was described as being able to gain from Walgreens’s “purchasing synergies,”
508. In 2014, CVS entered into a 50/50 joint venture with Cardinal to create Red Oak
Sourcing, LLC (“Red Oak”). Red Oak uses the combined generic purchasing power of CVS and
Cardinal to negotiate with generic drug manufacturers, and its website touts its management of a
“multi-billion dollar pharmaceutical portfolio.” To fund the venture, Cardinal would make
quarterly payments of $25.6 million to CVS, and also would contribute additional funds if the
127
509. Given that Walgreens and CVS on the one hand, the largest wholesalers, on the
other, considered themselves partners invested in one another’s success, they had even less
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incentive to turn away from the blind deference the Chain Pharmacies received when buying and
510. The Chain Pharmacies not only failed to check the oversupply of opioids by
violating laws and ignoring available safety measures, they were also a critical participant in the
manufacturers’ and distributors’ campaign to create a sea change in the way opioid were utilized
in the United States. This campaign included spreading false messaging about the addictive nature
of prescription opioids, creating the false perception that opioids should be widely utilized, actively
promoting widespread opioid utilization, improperly increasing opioid sales beyond legitimate
uses, and dismantling and undermining the last line of defense that was supposed to exist at the
pharmacy level.
511. As Purdue astutely recognized, the Chain Pharmacies were critical to the campaign
The pharmacist is the ultimate gate keeper. At times, they can make
or break the effective use of Oxycontin. We are running into several
cases of legal and regulatory issues, which has resulted in counter
detailing of Oxycontin. Much of this is borne out of ignorance.
128
512. Instead of playing the critical gatekeeper role that the Chain Pharmacies were
supposed to play, they instead helped open the floodgates of dangerous opioid narcotics flooding
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into communities like the County. The Chain Pharmacies participated in the multi-faceted
campaign to spread misinformation about opioids and improperly increase the utilization and
4. Use of financial incentives such as coupon programs, rebate programs, and loyalty
programs designed to drive opioid sales; and
5. Driving the sale of opioid products through patient adherence programs designed
to generate long-term opioid use.
Pharmacies played a critical role in that campaign. Indeed, for that campaign to work, the
thousands of pharmacists employed by the Chain Pharmacies and the patients they serviced had to
be conditioned to accept the sea change in the use of opioids and be “re-educated” about their
dangers. In order for prescription opioids to achieve the blockbuster sales that occurred, their
widespread had to be normalized not only with doctors but also with patients and pharmacists.
campaign orchestrated by opioid manufacturers to pharmacists and patients across the country,
including the false messaging surrounding the use of opioids for the treatment of chronic pain and
the true addictive nature of opioids, all in an effort to increase profits for all stakeholders.
515. For example, as early as 2001, CVS worked closely with Purdue and its un-
branded marketing arm, Partners Against Pain (“PAP”) to “fight back” against allegations (later
129
proved to be true) that Purdue’s Oxycontin was being abused at alarming rates. It was Purdue’s
Partner’s Against Pain website that Purdue, and its “Partners,” including CVS, utilized to make
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the claims that the risk of addiction associated with Oxycontin was very small.
516. Purdue worked together with CVS to ensure that CVS’s own pharmacists were
trained by Purdue on many of the misleading marketing messages that would later form the basis
for a 2007 criminal guilty plea and $600 million fine between Purdue and the Department of Justice
for misleading regulators, doctors, and patients about Oxycontin’s risk of addiction and its
potential for abuse. CVS’s ties to PAP were so deep that CVS even went so far as to put CVS’s
130
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517. CVS was so eager to ally itself with Purdue that it solicited Purdue for its
131
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518. Upon information and believe, CVS and Purdue’s interests were so aligned that in
519. CVS’s refusal to take responsibility for its role in the crisis, including pointing the
finger at manufacturers like Purdue, has been part of its game plan all along.
520. One would have to seriously question the accuracy of any training CVS
pharmacists received from Purdue and Partners Against Pain on abuse and diversion, yet there has
been no evidence provided by Defendants that CVS undertook any measures to re-educate its
132
pharmacists on how or why Purdue and PAP training might be lacking in the area of diversion and
abuse of opioids.
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521. CVS’s role was not limited to expanding the market for prescription opioids. CVS
worked hard to ensure that demand for prescription opioids was not only sustained but multiplied.
It did so through its marketing, advertising, and promotion efforts both on its own and in concert
522. Contrary to what CVS has stated under oath in other litigations, including the
MDL, CVS helped to grow the demand for prescription opioids and contributed to the public
nuisance by participating in the marketing, advertising and promotion of opioid products with and
523. CVS’s marketing and promotion of opioids was not limited to its involvement with
Purdue and Partners Against Pain. CVS did not draw lines when it came to promoting opioids, and
524. One example can be found in CVS’s work with Endo to increase patient adherence
to continuing their use of opioids. In fact, CVS had such an important role in the promotion of
Endo’s Opana ER, that it was included as having a crucial role in carrying out one of key sales
133
525. Through a company called Catalina Health (“Catalina”), Endo Pharmaceutical
(“Endo”) helped CVS to target Oxycontin patients in areas where Opana ER, a highly abused
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opioid manufactured by Endo, had preferred formulary status. Catalina in turn worked to create a
brand loyalty program that kept new patients on their opioids. CVS, through its pharmacy
retention programs, sent letters to the patients’ homes to encourage them to stay on Opana – even
though prolonged use of opioids increases the risk of addiction, and even though patients in pain
presumably need no reminder to continue to take their pain medications. CVS formalized its
agreement to promote, market and advertise Endo’s opioid products via its “CVS Carecheck Plus
Patient Education Service.” Under this Agreement, CVS not only contractually agreed to promote
Opana ER to its customers (patients) at the point of sale, but it even insisted upon reviewing and
526. Similarly, CVS contracted with manufacturers like Endo to prepare and
527. CVS likewise helped Actavis promote its opioids by participating with Cardinal’s
Marketing and Business Development team in programs designed to offer rebates and off-invoice
528. Marketing, advertising and promoting opioids was not a new practice for CVS. In
fact, CVS had been advertising these services to manufacturers for years. For example, CVS made
at least one pitch to Insys, a company whose senior executives were recently criminally convicted
134
for their unlawful marketing, to help sell its incredibly potent opioid, Subsys, a liquid form of
fentanyl.
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529. CVS also touted the reach of its communications and explained the science behind
135
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530. Hardly novices, CVS recognized its expertise in ensuring that opioid
manufacturers like Insys were able to reach their intended market by using CVS’s promotional
136
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531. Through CVS’s NEWScript program, CVS claimed to be perfectly poised to assist
137
532. CVS even offered Insys the chance at having a literature display in its patient
waiting rooms and to help Insys “target patients” using its signature ExtraCare consumer loyalty
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card database.
533. Working with Purdue as early as 2001, Walgreens played a pivotal role in
expanding the market and ensuring the demand and supply for prescription opioids would grow to
tragic proportions. Purdue was particularly interested in using what Walgreens described to Purdue
as its Regional Level Market Programs to educate pharmacists and patients on the benefits of
Purdue’s OxyContin.
138
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534. In fact, Purdue leveraged its relationship with Walgreens and their mutually
beneficial goal of growing the opioid business to ensure that Purdue had input into Walgreens
“corporate guidelines” to which Walgreens pharmacists were “expected to follow” when it came
535. Walgreens also used its corporate oversight abilities to identify stores it believed
were not filling enough oxycodone to make sure they weren’t “turning away good customers” and
encouraging stores to utilize continuing education created by opioid manufacturers to inform their
education programs designed to encourage stores to “get on the Pro Pain Management Band
Wagon.” Purdue was thrilled with the response and assistance it received from Walgreens when
139
Purdue presented on “Pain Management for the Pharmacist.” At the beginning of each Purdue
sponsored meeting, a Walgreens pharmacist made a presentation on his store and the program
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implemented. His store actively advertised to area doctors and patients that they were a “full-
service” pain management pharmacy. This service included providing a list to physicians’ offices
of all CIIs they had in stock (and they had everything), accepting “verbal orders” for Class II
analgesics prior to presentation of the original prescription at the store to decrease “waiting time”,
allowing partial fills on CII prescriptions in terminal patients, and accepting after hours
“emergency CII prescriptions” without a hassle. Purdue praised the pharmacist’s actions as
“fantastic.”
537. Walgreens’s use of pro-opioid continuing education continued as the opioid crisis
grew. For example, Walgreens’s Market Director of Pharmacy Operations recommended that
Walgreens District Managers and Pharmacy Supervisors attend a continuing education program
titled “The Pharmacists' Role in Pain Management: A Legal Perspective,” which was available on-
line at RxSchool.com. This program was one in a long line of pharmacist “education” programs,
or CEs, that opioid manufacturer Purdue developed as part of its strategy to disseminate “a new
school of thought” about opioids. Through these programs, Purdue and the Chain Pharmacies
disseminated fraudulent information that redefined the red flags of abuse or diversion in an effort
to correct pharmacists’ “misunderstanding” about pain patients and the practice of pain
management. Purdue took what it called an “aggressive role” in the education of Walgreens’s and
continuing education program titled “Navigating the Management of Chronic Pain: A Pharmacist's
Guide.” The second “CE” incorporated into Walgreens’s dispensing training program,
“Navigating the Management of Chronic Pain: A Pharmacist’s Guide” was sponsored by opioid
broaden the market for opioids. For example, it stated, “according to most reports, approximately
30% of the population lives with chronic pain” and citing, inter alia, another CE presentation
140
sponsored by the American Pain Society (another known front-group). It also claimed that “most
opioid adverse effects can be managed with careful planning and patient education.” It went on to
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discuss “fears and prejudices” related to addictive behaviors that “unnecessarily limit” opioid use,
described as “opiophobia” which the piece claimed was the result of “misunderstandings regarding
539. One of the presenters for this Endo sponsored CE was Kenneth C. Jackson. Mr.
Jackson was a frequent speaker and Key Opinion Leader (“KOL”) for Purdue. Mr. Jackson also
co-authored the CE program titled “Use of Opioids in Chronic Noncancer Pain,” which was
sponsored by Purdue. Released in April 2000, it was designed to eliminate “misconceptions about
addiction, tolerance and dependence” and contained many of the same messages as the pharmacist
guide he authored.
540. Walgreens also presented the video, The Pharmacist’s Role in Pain Management
- A Legal Perspective, at mandatory meetings for pharmacy managers. This continuing education
program (“CE”) was also sponsored by Purdue, was similar to the earlier presentations, and was
further disseminated to Walgreens pharmacists in June 2011. Released in 2009, the program was
presented by Jennifer Bolen, JD. Ms. Bolen was a frequent speaker for Purdue and other opioid
manufacturers, served as Special Counsel for the American Academy of Pain Medicine (a known
front group for opioid manufactures), acted as a Key Opinion Leader (“KOL”) for Purdue, and
541. Armed with information gleaned from Purdue sponsored CE, the Walgreens
accept them again. 65 It is no surprise that in 2013 Walgreens acknowledged that several of the
stores that touted this CE as part of their controlled substance action plan dispensed “certain
65
WAGFLDEA00001011 (“After having received the CE presentation that you put on, along with the
presentation by the Pain Clinic at our pharmacy manager meeting, Megan went and visited the pain clinics
surrounding her store. Of the three, she feels very comfortable with two of the clinics, and accepts all
prescriptions from them (minus any natural concerns: early refills, patient condition, etc that occurs with
all stores”).
141
controlled substances in a manner not fully consistent with its compliance obligations under the
CSA.”
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542. Kroger welcomed Purdue’s marketing into its stores. Following an NACDS
as “very positive as to what Purdue is doing” and “interested in doing programs . . . a regional
level,” with Purdue’s “various brochures included.” He also described making another new contact
at Kroger, who had agreed to send Purdue’s brochure and letter out electronically. An “account
contact report” from Purdue further described the results of communication with Purdue’s
Pharmacy Category Manager, who “was very supportive and understanding” about Purdue’s
“ongoing OxyContin media battle” in 2001. Not only would Purdue’s “Pharmacy brochure and
letter” be sent out to all Kroger Pharmacy Directors in each division — when Kroger’s employee’s
“co-sign the letter” it would have “better impact.” Purdue would also send out its continuing
543. The Chain Pharmacies coordinated marketing efforts to their pharmacists and staff
regarding opioids at trade shows and through email blasts, mailers, and brochures to promote the
idea that opioids were safe for widespread utilization, that pain was undertreated, and the
544. Opioid manufacturers paid the Chain Pharmacies to conduct internal marketing to
pharmacists and pharmacy staff. For example, internal documents from Janssen illustrate the reach
the Chain Pharmacies could offer for opioid manufacturers’ marketing messages:
142
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545. These are but some examples. Since acting as a key participant in the expansion
of the market and normalization of prescription opioids in the 1990s and 2000s, for decades, the
Chain Pharmacies continued to offer “education” programs designed to grow and maintain the
market for prescription opioids by changing perceptions of pharmacists and staff so that the “last
line of defense” to increased opioid supply would be relaxed and sales would occur without
restriction.
546. This pervasive misinformation campaign was critical to the dramatic shift in the
way opioids were utilized in the United States and was a key factor in creating the dramatic
oversupply of opioids into the United States and Plaintiffs’ communites. The Chain Pharmacies
547. When a distributor does not report or stop suspicious orders, or a pharmacy fails
to maintain effective policies and procedures to guard against diversion, prescriptions for
143
controlled substances may be written and dispensed to individuals who abuse them or who sell
them to others to abuse. This, in turn, fuels and expands the illegal market and results in opioid-
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related overdoses. Without reporting by those involved in the supply chain, law enforcement may
548. Despite their conduct in flooding Illinois and other states with dangerous and
working with law enforcement, opioid manufacturers, and others to prevent diversion.
549. In its 2011 MOA, Walgreens agreed to undertake several different anti-diversion
measures. Yet, as a DEA official explained in a subsequent Order to Show Cause and Immediate
Suspension of its registration that was issued a mere month later and pertained to Walgreens’s
primarily self-serving:
144
550. Despite the behavior described above, Walgreens nevertheless publicly portrayed
itself as committed to working with law enforcement, opioid manufacturers, and others to prevent
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551. In August of 2018, after journalists at the Washington Post disclosed information
gleaned from the ARCOS data regarding the staggering number of opioids Walgreens distributed
and sold, Walgreens again publicly promoted itself as being and “ha[ving] been an industry leader
in combatting this crisis in the communities where our pharmacists live and work.” Walgreens
further asserted that “Walgreens pharmacists are highly trained professionals committed to
552. Yet, in January 2020, Walgreens released a Board Report on Oversight of Risks
Related to Opioids. There, it claimed that: “In recent years, the Company has implemented a
number of operational changes that it believes have helped to reduce its risk with respect to its
and mitigate the risk of non-compliance with federal and state legal requirements.” 67 It went on
to tout its “Good Faith Dispensing policy,” as “provid[ing] the foundation for our pharmacists to
understand their roles and responsibilities when dispensing prescriptions for controlled
substances.” 68 It also claimed that “the Company conducts its own voluntary, independent review
of controlled substance purchase orders placed by our pharmacies, providing an additional layer
of review above and beyond the legally required monitoring performed by the wholesalers.”69
66
Aaron C. Davis & Jenn Abelson, Distributors, pharmacies and manufacturers respond to previously
unreleased DEA data about opioid sales, Washington Post (Aug. 8, 2019),
https://www.washingtonpost.com/investigations/distributors-pharmacies-and-manufacturers-respond-to-
previously-unreleased-dea-data-about-opioid-sales/2019/07/16/7406d378-a7f6-11e9-86dd-
d7f0e60391e9_story.html.
67
https://s1.q4cdn.com/343380161/files/doc_downloads/governance_guidelines/Board-Report-on-
Oversight-of-Risk-Related-to-Opioids-June-2019-rev.-August-2019.pdf.
68
Id.
69
Id.
145
compliance program include,” among other things, “[w]ritten policies, procedures, and standards
of conduct setting forth the Company’s expectations and requirements for operating all business
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activities in an ethical and compliant manner”; “[o]versight of the Compliance Program by the
Global Chief Compliance and Ethics Officer, Compliance and Ethics Officers for each operating
division, and Compliance and Governance Committees”; and, “[a]uditing and monitoring.” 70
553. With respect to compensation, the Board stated: “[w]e have a strong pay-for-
Committee,” the Board explained, “aims to incent leaders to support the Company’s culture and
model desired behaviors, ensuring ethical behavior and mitigating risks, through ongoing
not reformed its policies putting speed ahead of safety and pharmacists continued to feel pressed
to do more with less. According to the article, pharmacists at Walgreens and Rite Aid stores
“described understaffed and chaotic workplaces where they said it had become difficult to perform
their jobs safely, putting the public at risk of medication errors.” 72 The article explained that these
pharmacists “struggle to fill prescriptions, give flu shots, tend the drive-through, answer phones,
work the register, counsel patients and call doctors and insurance companies,” while “racing to
meet corporate performance metrics that they characterized as unreasonable and unsafe in an
555. Citing company documents, the article showed that Walgreens continues to tie
bonuses to achieving performance metrics. Walgreens, in response stated that errors were rare and
that “it made ‘clear to all pharmacists that they should never work beyond what they believe is
70
Id.
71
Id.
72
Ellen Gabler, How Chaos at Pharmacies Is Putting Patients at Risk, New York Times, (Jan. 31,
2020), https://www.nytimes.com/2020/01/31/health/pharmacists-medication-errors.html.
73
Id.
146
advisable.’” 74 Similarly, CVS assured that “[w]hen a pharmacist has a legitimate concern about
working conditions, we make every effort to address that concern in good faith.” 75
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556. Meanwhile, the New York Times’s coverage disclosed that a CVS form for staff
members to report errors internally asked whether the patient poses “a ‘media threat.’” 76
According to the article, “[t]he American Psychiatric Association is particularly concerned about
CVS, America’s eighth-largest company, which it says routinely ignores doctors’ explicit
instructions to dispense limited amounts of medication to mental health patients.” 77 The group’s
president further observed that “[c]learly it is financially in their best interest to dispense as many
communities and” other “companies like” its outside supplier “Cardinal Health to help solve the opioid
epidemic.” 78
558. Moreover, in furtherance of their effort to affirmatively conceal their conduct and
avoid detection, all Defendants through the joint amicus brief filed by the HDA and NACDS in
74
Id.
75
Id.
76
Id.
77
Id.
78
https://www.cardinalhealth.com/en/about-us/corporate-citizenship/combating-opioid-
misuse/news/kroger-and-cardinal-health-to-co-host-drug-take-back-events.html
79
Brief for HDMA and NACDS, 2016 WL 1321983, at *3-4, 25.
147
559. NACDS, in response to media coverage concerning pharmacy working conditions
and safety concerns, said that “‘pharmacies consider even one prescription error to be too many’
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and ‘seek continuous improvement.’” 80 NACDS also claimed one should not “assume cause-
effect relationships” between errors and the workload of pharmacists such as “distraught
pharmacists” who conveyed concerns to state boards and associations “in at least two dozen
states.” 81
560. The NACDS also filed an amicus brief supporting Walmart’s motion to dismiss in
561. Through the above statements made on their behalf by their trade association, and
other similar statements assuring its continued compliance with their legal obligations, Defendants
not only acknowledged that they understood their obligations under the law, but further affirmed
that their conduct was in compliance with those obligations. In doing so, Defendants further
562. The Chain Pharmacies have long been on notice of their failure to abide by state
and federal law and regulations governing the distribution and dispensing of prescription opioids.
Indeed, several of the Chain Pharmacies have been repeatedly penalized for their illegal
prescription opioid practices. Upon information and belief, based upon the widespread nature of
these violations, these enforcement actions are the product of, and confirm, the failures of national
80
Ellen Gabler of the New York Times, Pharmacists at CVS, Rite Aid and Walgreens Are Struggling
With Understaffed and Chaotic Workplaces, Chicago Tribune (Feb. 3, 2020),
https://www.chicagotribune.com/business/ct-biz-nyt-pharmacy-mistakes-20200201-
wp2ftrt2sjhfvjwnmwbtnl3y3i-story.html
81
Id.
148
a. CVS
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563. CVS is one of the largest companies in the world, with annual revenue of more
than $250 billion. According to news reports, it manages medications for nearly 90 million
customers at 9,700 retail locations. CVS could be a force for good in connection with the opioid
crisis, but like other Defendants, CVS sought profits over people.
564. CVS is a repeat offender and recidivist: the company has paid fines totaling over
$40 million as the result of a series of investigations by the DEA and the United States DOJ. It
nonetheless treated these fines as the cost of doing business and has allowed its pharmacies to
continue dispensing opioids in quantities significantly higher than any plausible medical need
would require, and to continue violating its recordkeeping and dispensing obligations under the
CSA.
565. Confirming its systemic failures to implement and adhere to adequate controls
against diversion, CVS has repeatedly faced enforcement actions. In May 2020, CVS’s Omnicare
subsidiary agreed to pay a $15.3 million civil penalty as part of a settlement with the DEA
resolving allegations that it improperly dispensed opioids and other controlled substances to long-
566. In March 2019, CVS Pharmacy, Inc. (including all of its relevant subsidiaries and
affiliates) entered into a $535,000 settlement with the U.S. Attorney’s Office for the District of
Rhode Island, acting on behalf of the United States and the DEA’s Providence Office. In
connection with the settlement, a DEA agent stated: “Pharmacies put patients at risk when they
dispense Schedule II narcotics, which have the highest potential for abuse, without a valid and
legal prescription.” 82
567. In August of 2018, CVS paid $1 million to resolve allegations that CVS
82
https://www.dea.gov/press-releases/2019/04/16/cvs-pay-535000-filling-invalid-prescriptions.
149
under the CSA and its implementing regulations, the largest civil fine paid in Alabama by a DEA
registrant.
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568. In June of 2018, CVS paid $1.5 million to resolve allegations that CVS pharmacies
in Long Island, New York failed to timely report the loss or theft of controlled substances,
including hydrocodone, recognized as one of the most commonly diverted controlled substances.
569. In July 2017, CVS entered into a $5 million settlement with the U.S. Attorney’s
Office for the Eastern District of California regarding allegations that its pharmacies failed to keep
and maintain accurate records of Schedule II, III, IV, and V controlled substances. 83
570. This fine was preceded by numerous others throughout the country.
571. In February 2016, CVS paid $8 million to settle allegations made by the DEA and
the DOJ that from 2008-2012, CVS stores and pharmacists in Maryland violated their duties under
572. In October 2016, CVS paid $600,000 to settle allegations by the DOJ that stores
573. In September 2016, CVS entered into a $795,000 settlement with the
Massachusetts Attorney General wherein CVS agreed to require pharmacy staff to access the
state’s prescription monitoring program website and review a patient’s prescription history before
574. In June 2016, CVS agreed to pay the DOJ $3.5 million to resolve allegations that
50 of its stores violated the CSA by filling forged prescriptions for controlled substances—mostly
575. In August 2015, CVS entered into a $450,000 settlement with the U.S. Attorney’s
Office for the District of Rhode Island to resolve allegations that several of its Rhode Island stores
83
Press Release, U.S. Attorney’s Office E. Dist. of Cal., CVS Pharmacy Inc. Pays $5M to Settle Alleged
Violations of the Controlled Substance Act, U.S. Dep’t of Just. (July 11, 2017),
https://www.justice.gov/usao-edca/pr/cvs-pharmacy-inc-pays-5m-settle-alleged-violations-controlled-
substance-act.
150
violated the CSA by filling invalid prescriptions and maintaining deficient records. The United
States alleged that CVS retail pharmacies in Rhode Island filled a number of forged prescriptions
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with invalid DEA numbers, and filled multiple prescriptions written by psychiatric nurse
practitioners for hydrocodone, despite the fact that these practitioners were not legally permitted
to prescribe that drug. Additionally, the government alleged that CVS had recordkeeping
deficiencies.
576. In May 2015, CVS agreed to pay a $22 million penalty following a DEA
investigation that found that employees at two pharmacies in Sanford, Florida, had dispensed
prescription opioids, “based on prescriptions that had not been issued for legitimate medical
purposes by a health care provider acting in the usual course of professional practice. CVS also
acknowledged that its retail pharmacies had a responsibility to dispense only those prescriptions
577. In September 2014, CVS agreed to pay $1.9 million in civil penalties to resolve
expired.
578. In 2013, CVS agreed to pay $11 million to resolve allegations it violated the CSA
and related federal regulations at its retail stores in Oklahoma and elsewhere by: (1) creating and
using “dummy” DEA registration numbers on dispensing records, including records provided to
state prescription drug monitoring programs; (2) filling prescriptions from prescribers who lacked
current or valid DEA numbers; and (3) substituting the DEA number of non-prescribing
579. Dating back to 2006, CVS retail pharmacies in Oklahoma and elsewhere
intentionally violated the CSA by filling prescriptions signed by prescribers with invalid DEA
registration numbers.
580. The DEA hosted a December 8, 2010, meeting attended by CVS' Head of
Pharmacy Professional Services, Papatya Tankut, and the CVS district supervisor before initiating
an enforcement action. CVS's counsel acknowledged at that time "that CVS was aware of the pill
151
mill and/or pain clinic situation and the diversion of controlled substances, primarily oxycodone,
in Florida," and that it received an October 2010 plea from a local sheriff "to work with law
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enforcement and closely scrutinize the prescriptions they receive." 84 The DEA advised CVS “that
the diversion of oxycodone, primarily originating from purported pain clinics, involves fraudulent
prescriptions, doctor shoppers, and unethical doctors.” 85 “CVS was further advised of the typical
'red flags' associated with the diversion of controlled substances that a pharmacy should be familiar
with in order to carry out its corresponding responsibility to ensure that the controlled substances
are dispensed for a legitimate medical purpose.” 86 “Some of the 'red flags' discussed included: (a)
many customers receiving the same combination of prescriptions (i.e., oxycodone and
alprazolam); (b) many customers receiving the same strength of controlled substances (i.e., 30
many customers paying cash for their prescriptions; (d) many customers with the same diagnosis
codes written on their prescriptions ([e.g.], back pain, lower lumbar, neck pain, or knee pain); and
(e) individuals driving long distances to visit physicians and/or to fill prescriptions.” 87
581. CVS also acknowledged its awareness of an increase in oxycodone prescriptions
at Florida CVS stores during the December 2010 meeting. DEA discussed with CVS an ARCOS
summary which showed a “huge” increase at one CVS store, which was already ordering “more
than four times the amount of oxycodone a typical pharmacy orders in one year” in 2006; a more
recent 10-month history showed that it ordered “more than thirty times what a typical pharmacy
ordered in one.” 88 During the same meeting, DEA also made clear that CVS’s instruction to its
pharmacists to call the prescriber to verify that a physician wrote the prescription was not the same
thing as making an independent determination that the prescription was written for a legitimate
84
Decl. of Joseph Rannazzisi, Holiday CVS, L.L.C., v. Holder, Civ. No. 1:12-cv-191 (D. D.C Fed. 24, 2012).
85
Id.
86
Id.
87
Id. ¶ 28.
88
Id. ¶ 31.
152
582. The DEA then hosted a second meeting with CVS at the DEA Weston Resident
Office on August 12, 2011. Some 24 supervisors/managers from various South Florida CVS
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pharmacies attended that meeting. At that meeting, the DEA again reminded CVS of its
583. The meeting also stressed the importance of CVS’s obligations: a presentation
included “statistical information” that “showed drastic increases in prescription drug overdose
deaths.” 89
584. After the DEA executed Administrative Inspection Warrants at two Florida CVS
stores discussed in the meetings, interviews with CVS pharmacists revealed that no one spoke with
the pharmacist in charge of one store about the staggering amounts of oxycodone discussed in
CVS’s December 2010 meeting with the DEA and the pharmacist was unfamiliar with multiple
red flags. Further, other CVS employees believed that “polic[ing] the patients” was outside their
job description and they were filling prescriptions that were “probably were not legitimate.” 90 The
CVS employees “consistently ignored the red flags of controlled substance diversion,” and, until
89
Id. ¶ 34.
90
Id. ¶ 41.
153
CVS faced heightened DEA scrutiny, filled prescriptions for more than twenty prescribers who
later faced enforcement action themselves, none of whom were located in the same city as the
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b. Walgreens
585. Walgreens is the second-largest pharmacy store chain in the United States behind
CVS, with annual revenue of more than $118 billion. According to its website, Walgreens
operates more than 8,100 retail locations and filled 990 million prescriptions on a 30-day adjusted
586. Walgreens also has been penalized for serious and flagrant violations of the CSA.
Indeed, Walgreens agreed to the largest settlement in DEA history at the time—$80 million—to
violations of the CSA, including negligently allowing controlled substances such as oxycodone
and other prescription painkillers to be diverted for abuse and illegal black market sales. These
actions demonstrate Walgreens’s knowledge of, and disregard for, its obligations to prevent
diversion.
587. On September 30, 2009, the DEA issued an Order to Show Cause against a
Walgreens retail facility in San Diego, California based in part on allegations that it was
dispensing controlled substances, including opioids, to individuals that it knew or should have
known were diverting the controlled substances. Although the Order addressed this specific
location, the response, including Walgreens’s internal assessment of its compliance, or lack
thereof, revealed systemic failures from which its pharmacies in the County would not have been
exempt.
Agreement (“2011 MOA”) with the DEA arising from the San Diego OTSC and expressly agreed
that it would “maintain a compliance program to detect and prevent diversion of controlled
91
Id. ¶¶ 43 & 54-55.
154
substances as required under the CSA and applicable DEA regulations” including regarding the
589. On September 14, 2012, however, the DEA also issued an Order to Show Cause
and Immediate Suspension Order (“ISO”), described above against Walgreens’s Distribution
Center in Jupiter, Florida, as well as Orders to Show Cause related to certain Walgreens
pharmacies. Evidencing the existence of systemic failures, the ISO stated that, “[DEA’s] concerns
with [Walgreens’] distribution practices are not limited to the six Walgreens pharmacies [discussed
in the ISO].”
590. In 2013, Walgreens agreed to the largest settlement in DEA history at the time—
and dispensing violations of the CSA, including negligently allowing controlled substances such
as oxycodone and other prescription painkillers to be diverted for abuse and illegal black-market
sales. In addition to the monetary payment, the Jupiter, Florida distribution center lost its authority
to distribute or dispense controlled substances, including opioids, for two years. The Department
of Justice, in describing the settlement, explained that the conduct at issue included Walgreens’s
“alleged failure to sufficiently report suspicious orders was a systematic practice that resulted in
at least tens of thousands of violations and allowed Walgreens’s retail pharmacies to order and
receive at least three times the Florida average for drugs such as oxycodone.” 92
591. The settlement resolved investigations into, and allegations of, CSA violations in
Florida, New York, Michigan, and Colorado that resulted in the diversion of millions of opioids
592. As part of the 2013 MOA described above, Walgreens “acknowledge[d] that
certain Walgreens retail pharmacies did on some occasions dispense certain controlled substances
92
Press Release, U.S. Attorney’s Office S. Dist. of Fla., Walgreens Agrees To Pay A Record Settlement
Of $80 Million For Civil Penalties Under The Controlled Substances Act, U.S. Dep’t of Just. (June 11,
2013), https://www.justice.gov/usao-sdfl/pr/walgreens-agrees-pay-record-settlement-80-million-civil-
penalties-under-controlled.
155
in a manner not fully consistent with its compliance obligations under the CSA . . . and its
implementing regulations.” The 2013 MOA required Walgreens to, among other things, “maintain
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required by law.
593. Walgreens’s Florida operations at issue in this settlement highlight its egregious
allegedly ordered more than one million dosage units of oxycodone in 2011—more than ten times
594. They increased their orders over time, in some cases as much as 600% in the space
of just two years, including, for example, supplying a town of 3,000 with 285,800 orders of
oxycodone in a one-month period. Yet Walgreens corporate officers not only turned a blind eye
but provided pharmacists with incentives through a bonus program that compensated them based
on the number of prescriptions filled at the pharmacy. Yet Walgreens corporate officers turned a
blind eye to these abuses. In fact, the long term Controlled Substance Compliance Officer at
Walgreens suggested, in reviewing the legitimacy of prescriptions coming from pain clinics, that
“if these are legitimate indicators of inappropriate prescriptions perhaps we should consider not
documenting our own potential noncompliance,” underscoring Walgreens’s attitude that profit
Walgreens’s distribution center in Jupiter, Florida, which was responsible for significant opioid
diversion in Florida. According to the Order to Show Cause, Defendant Walgreens’s corporate
headquarters pushed to increase the number of oxycodone sales to Walgreens’s Florida pharmacies
and provided bonuses for pharmacy employees based on number of prescriptions filled at the
pharmacy in an effort to increase oxycodone sales. In July 2010, Defendant Walgreens ranked all
of its Florida stores by number of oxycodone prescriptions dispensed in June of that year and found
that the highest-ranking store in oxycodone sales sold almost 18 oxycodone prescriptions per day.
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All of these prescriptions were filled by the Jupiter Center, a distribution center that also distributed
596. An August 2013 email shows Walgreens understood the consequences of its
actions, explaining that Walgreens’s “previous system would continue to send additional product
to the store without limit or review which made possible the runaway growth of dispensing
597. Walgreens has also settled with a number of state attorneys general, including
598. The Massachusetts Attorney General’s Medicaid Fraud Division found that, from
2010 through most of 2015, multiple Walgreens stores across the state failed to monitor the opioid
that some Walgreens pharmacies failed to monitor patients’ drug use patterns and didn’t use sound
professional judgment when dispensing opioids and other controlled substances—despite the
context of soaring overdose deaths in Massachusetts. Walgreens agreed to pay $200,000 and
600. The actions against Walgreens as both a distributor and a retail pharmacy
demonstrate it routinely, and as a matter of standard operating procedure, violated its legal
obligations under the CSA and other laws and regulations governing the distribution and
601. In addition to the actions described herein against Walmart, a prosecution against
a Virginia prescriber revealed failures at Walmart pharmacies from 2007 to 2012. A Decision and
Order in that case revealed that a Walmart pharmacy would fill prescriptions pursuant to a
telephone message from a staff member of the prescriber, purportedly on behalf of the prescriber,
even though she failed to provide the prescriber’s DEA number. Despite the absence of
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information required by DEA regulations, the Walmart pharmacy would fill the prescription. 93 By
mid-November of 2008, three Walmart pharmacies had dispensed more than 200 hydrocodone
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prescriptions and refills on behalf of the prescriber. In 2012, the prescriber learned that someone was
fraudulently using his DEA number. He called a Walmart pharmacy regarding refill requests faxed
from his office and advised “that somebody was fraudulently using [his] DEA number.” 94 Although he
asked that his DEA number be blocked, the same pharmacy still filled two prescriptions on his behalf
after this alert. Although Walmart did not face sanctions for its conduct, the Opinion and Order
described “the fact that prescriptions which were missing [the] Respondent’s DEA number were
routinely filling notwithstanding that they were facially invalid,” and “that the prescriptions were for
hydrocodone in quantities and dosings that were clearly outside the scope of what is usually prescribed
602. Federal prosecutors had also taken action against five Walmart and Sam’s Club
Pharmacies in Texas, alleging that they failed to keep records required to help prevent diversion of
controlled substances as required by the CSA. Specifically, “accountability audits did not match the
drugs on hand, revealing major overages and shortages in the accountability of controlled substances,
and there were missing invoices for controlled substances all in violation of the CSA.” 96 A U.S.
Attorney further explained that “[b]ecause of the pharmacies’ lack of proper record keeping, a variety
of Schedule II, III, IV and V controlled substances were lost or stolen and possibly diverted.” 97
meeting reflect that an Oklahoma “Wal-Mart Pharmacy was charged with multiple violations of state
93
DOJ, DEA, Docket No. 15-26, [FR Doc. No. 2017-13158] Peter F. Kelly, D.P.M.; Decision and
Order, https://www.deadiversion.usdoj.gov/fed_regs/actions/2017/fr0623.htm.
94
https://www.deadiversion.usdoj.gov/fed_regs/actions/2017/fr0623.htm
95
Id.
96
Associated Press, Wal-Mart Settles Drug Records Accusation, (Jan 7, 2009),
http://prev.dailyherald.com/story/?id=262762
97
Id.
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and federal regulations and rules including establishing and maintaining effective controls against
diversion of prescription drugs.” 98 Walmart agreed to pay a fine to resolve the seven alleged violations.
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d. Kroger
604. In addition to the 2005 settlement described above, Kroger in 2019 reached another
settlement arising out of its failure to control against unlawful diversion and use of dangerous opioid
drugs. The settlement resolved allegations that a Virginia store violated the CSA sixteen separate times
in 2015-2016 “by improperly filling ‘office use only’ prescriptions for Schedule II controlled
substances,” failing “to make and keep DEA 222 order forms[,] improperly distribut[ing] a Schedule
II controlled substance absent the required DEA 222 form,” and “fail[ing] to provide effective controls
e. Albertsons
605. Albertsons is one of the largest food and drug retailers in the United States, with
annual revenues of approximately $70 billion. As of February 2021, it operated 1,727 pharmacies
allegations that the company failed to timely report controlled substances that were missing from
when the DEA learned in 2014 that Safeway pharmacies in North Bend, Washington, and Wasilla,
Alaska, did not notify the DEA of losses of tens of thousands of hydrocodone tablets until months
after Safeway discovered the losses. DOJ then broadened its investigation to review practices at
all Safeway pharmacies nationwide between 2009 and 2014 and found a widespread practice of
98
https://www.ok.gov/pharmacy/documents/Min%20September%202018.pdf.
99
https://www.justice.gov/usao-wdva/pr/kroger-pay-us-government-225000-settle-civil-allegations-
it-violated-controlled
159
607. In January 2020, Albertsons agreed to pay $1 million to resolve the DOJ’s
allegations that one of its pharmacies had committed numerous violations of the CSA. The DEA
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began investigating Albertsons Osco Pharmacy #60 in Casper, Wyoming, during the course of
investigating a Casper-based prescriber who prescribed over 2 million pills between 2011 and
2016 and was eventually sentenced to 25 years in prison for prescribing oxycodone without a
legitimate medical purpose, including prescriptions that caused the death of an Arizona resident.
While investigating this doctor’s practices, the DEA began investigating the pharmacies filling his
prescriptions and found numerous alleged violations by the Albertsons Osco Pharmacy between
October 2015 and February 2017. According to DOJ, “[i]nvestigators uncovered 128 instances of
patients filling prescriptions for unusually large quantities and dosages of narcotics; patients
utilizing multiple pharmacies to fill prescriptions; or third parties filling prescriptions for out-of
state patients. Additional record keeping violations were also discovered.” 100
J. The Opioids the Defendants Sold Migrated into Other Jurisdictions
608. As the demand for prescription opioids grew, fueled by their potency and purity,
interstate commerce flourished: opioids moved from areas of high supply to areas of high demand,
609. First, prescriptions written in one state may, under some circumstances, be filled
in a different state. But even more significantly, individuals transported prescription opioids from
610. When authorities in the certain states cracked down on opioid suppliers, out-of-
state suppliers filled the gaps. Florida in particular assumed a prominent role, as its lack of
regulatory oversight created a fertile ground for pill mills. Residents of other states area would
simply drive to Florida, stock up on pills from a pill mill, and transport them back to home to
100
U.S. Attorney’s Office, District of Wyoming, Casper Pharmacy Agrees to $1 Million Settlement of
Allegations of Violations of the Controlled Substances Act (Jan. 28, 2020),
https://www.justice.gov/usaowy/
pr/casper-pharmacy-agrees-1-million-settlement-allegations-violations-controlled-substances.
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sell. The practice became so common that authorities dubbed these individuals “prescription
tourists” who would travel their “oxycodone pipelines” between their home states and Florida for
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their prescription opioid supplies. In fact, the route from Florida to other states was so well
traveled that it became known as the “Blue Highway,” a reference to the color of the 30mg
611. Abundant evidence, thus, establishes that prescription opioids migrated between
cities, counties, and states, including into Illinois from other states. As a result, prescription data
from any particular jurisdiction does not capture the full scope of the misuse, oversupply and
diversion problem in that specific area. As the criminal prosecutions referenced above show, if
prescription opioid pills were hard to get in one area, they migrated from another. Distributors of
opioids were fully aware of this phenomenon and profited from it.
614. In addition, and on an even broader level, all Defendants took advantage of the
industry structure, including end-running its internal checks and balances, to their collective
advantage. Defendants agreed among themselves to increase the supply of opioids and
fraudulently increase the quotas that governed the manufacture and supply of prescription opioids.
Defendants did so to increase sales, revenue, and profit from their opioid products.
615. The interaction and length of the relationships between and among the Defendants
reflects a deep level of interaction and cooperation between Defendants in a tightly knit industry.
Defendants operated together as a united entity, working together on multiple fronts, to engage in
interrelated network in the following ways, as set forth more fully below, including, for example,
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617. Defendants utilized their membership in the NACDS and HDA and other forms of
collaboration to form agreements about their approach to their duties under the CSA to report
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suspicious orders. The Defendants overwhelmingly agreed on the same approach—to fail to
identify, report or halt suspicious opioid orders, and fail to prevent diversion. Defendants’
agreement to restrict reporting provided an added layer of insulation from DEA scrutiny for the
entire industry as Defendants were thus collectively responsible for each other’s compliance with
their reporting obligations. Defendants were aware, both individually and collectively, of the
618. Defendants knew that their own conduct could be reported by other Defendants
and that their failure to report suspicious orders they filled could be brought to the DEA’s attention.
As a result, Defendants had an incentive to communicate with each other about the reporting or
619. The Defendants also worked together to ensure that the opioid quotas allowed by
the DEA remained artificially high and ensured that suspicious orders were not reported to the
DEA in order to ensure that the DEA had not basis for refusing to increase or decrease production
620. The desired consistency, and collective end goal was achieved. Defendants
achieved blockbuster profits through higher opioid sales by orchestrating the unimpeded flow of
opioids.
621. The Chain Pharmacies all distributed and dispensed opioids in Illinois and failed
622. Although they act through their agents, the Chain Pharmacies, as the registrants,
623. The Chain Pharmacies owe duties to the Counties as licensed “registrants” under
the Federal Controlled Substances Act (21 U.S.C.A. § 321 et seq) and under Illinois state law. The
Illinois legislature has enacted The Illinois Pharmacy Practice Act (225 ILCS 85/ et seq.), and the
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Illinois Controlled Substances Act (720 ILCS 570/ et seq.), which impose duties on the Defendants
by regulating the distribution and the retail dispensing of dangerous drugs in the state.
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624. The Illinois Pharmacy Practice Act authorizes the Department of Financial and
Professional Regulation, along with the Illinois State Board of Pharmacy, to regulate the practice
of pharmacy, including the sales, use and distribution of drugs and devices at retail. The Illinois
State Board of Pharmacy is empowered to refuse, revoke, or suspend the permit of any pharmacy
upon proof satisfactory to it that it has violated any of the provisions of the Act or applicable
Federal regulations, or has ordered a pharmacist in its employ to engage in any aspect of the
regulations.
625. As distributors, the Illinois Pharmacy Practice Act, and the Illinois Controlled
Substances Act impose safety and record-keeping requirements on the Defendants as well as
mandate compliance with all other applicable local, state or federal laws, including 21 U.S.C. §
823 et seq. (requiring “maintenance of effective controls against diversion . . . into other than
lawful medical, scientific, or industrial channels” and “compliance with applicable State and local
law”) and 21 C.F.R. § 1301.74 (imposing duty to monitor, detect, investigate, refuse to fill, and
626. In addition to their duties as distributors, both state and federal laws impose duties
on Defendants as dispensers of controlled substances. The Illinois Pharmacy Practice Act and the
Illinois Controlled Substances Act, and all other applicable local, state, or federal laws, require the
Defendants to maintain records of, and to design and implement systems to prevent diversion of
controlled substances in their retail pharmacy operations. The Illinois Pharmacy Practice Act and
the Illinois Controlled Substances Act mandate that a prescription for a controlled substance can
be dispensed only if it is issued for a legitimate medical purpose by a licensed practitioner in the
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627. The Chain Pharmacies had the ability, and the obligation, to look for “red flags”
on a patient, prescriber, and store level, and to refuse to fill and to report prescriptions that
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628. The Chain Pharmacies knew, or should have known, that their pharmacies in
Illinois, and the surrounding area were (a) filling multiple prescriptions to the same patient using
the same doctor; (b) filling multiple prescriptions by the same patient using different doctors; (c)
filling prescriptions of unusual size and frequency for the same patient; (d) filling prescriptions of
unusual size and frequency from out-of-state patients; (e) filling an unusual or disproportionate
number of prescriptions paid for in cash; (f) filling prescriptions paired with other drugs frequently
abused with opioids, like benzodiazepines, or prescription “cocktails”; (g) filling prescriptions in
volumes, doses, or combinations that suggested that the prescriptions were likely being diverted
or were not issued for a legitimate medical purpose; and (h) filling prescriptions for patients and
doctors in combinations that were indicative of diversion and abuse. The Chain Pharmacies had
the ability, and the obligation, to look for these red flags on a patient, prescriber, and store level,
and to refuse to fill and to report prescriptions that suggested potential diversion.
629. Every day, 91 people die across the country from an opioid-related overdose and
over 1,000 patients are given emergency treatment for misusing them. Many others are swept into
a cycle of addiction and abuse with which they will struggle their entire lives. As many as 1 in 4
patients who receive prescription opioids long-term for chronic pain in primary care settings
struggle with addiction. In 2014, almost 2 million Americans were addicted to prescription opioids
and another 600,000 to heroin. From 1999 to 2015, more than 194,000 people died in the U.S.
from overdoses related to prescription opioids—more than the number of Americans who died in
630. The Chain Pharmacies either were on notice, or should have been on notice, that
the diversion of opioids was likely occurring in Illinois communities, should have investigated,
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631. In addition, the increase in fatal overdoses from prescription opioids has been
632. The majority of the fatal drug-related overdoses are attributable to prescription
opioids or the illicit opioids that patients often began abusing after becoming addicted to
prescription opioids. The CDC estimates that for every opioid-related death, there are 733 non-
medical users. The Chain Pharmacies thus had every reason to believe that illegal diversion was
occurring in Illinois.
633. The Chain Pharmacies had information about suspicious orders that they did not
report, and also failed to exercise due diligence before filling orders from which drugs were
diverted into illicit uses in communities across Illinois deepening the crisis of opioid abuse,
634. Each of the Chain Pharmacies participated in growing the market for prescription
opioids in the United States and in Illinois far beyond reasonable limits and fueling the improperly
635. The volume of opioids distributed and sold in Illinois is so high as to raise a red
flag that not all of the prescriptions being ordered and sold could be for legitimate medical uses.
636. By helping to improperly inflate the opioid market, continuing to fill and failing
to report suspicious orders of opioids, and by continuing to dispense opioids and “cocktails” of
opioids and other drug despite indicia of diversion, the Chain Pharmacies have contributed to an
oversupply of opioids in Illinois generally, and the Counties specifically. This oversupply allowed
non-patients to become exposed to opioids and facilitated access to opioids for both patients who
could no longer access or afford prescription opioids and individuals struggling with addiction and
relapse. The Chain Pharmacies had financial incentives to sell higher volumes of opioids and not
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to report suspicious orders or guard against diversion, and to dispense opioids despite indicia of
diversion.
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637. The diversion of opioids into the Counties fueled a spike in the illicit market for
heroin. Individuals addicted to prescription opioids often transition to heroin due to its lower cost,
ready availability, and similar high. Despite the large number of individuals prescribed opioid drugs,
there has been a decline in opioid prescriptions in recent years with a concurrent increase in heroin use.
638. Despite these efforts, the demand for opioids is still strong, and with the
of fentanyl, a dose the size of a grain of salt can rapidly lead to deadly overdose in humans), use
and overdoses continue to rise as users will adapt to supply when necessary.
639. The epidemic is still on-going as the 2021 data reports that, as compared to 2020,
opioid overdose deaths in the state have increased by 2.3%. In 2021, Illinois Opioid overdose
640. The oversupply of opioids also has had a significant detrimental impact on
children throughout the state and in Illinois and the Counties. Young children have access to
opioids, nearly all of which were prescribed or supplied to adults in their household. If parents
become addicted and turn to illicit opiates, children risk overdose from these drugs as well.
Toddlers are particularly at risk, as they routinely put things in their mouths as they crawl and
explore their world. Tragically, Illinois and the Counties have seen their share of children exposed
to opioids, some of which have lost their lives because of such exposure.
641. Even infants have not been immune to the impact of opioid abuse. There has been
a dramatic rise in the number of infants who are born addicted to opioids due to prenatal exposure
and suffer from neonatal abstinence syndrome (“NAS,” also known as neonatal opioid withdrawal
syndrome, or “NOWS”). These infants painfully withdraw from the drug once they are born, cry
non-stop from the pain and stress of withdrawal, experience convulsions or tremors, have difficulty
sleeping and feeding, and suffer from diarrhea, vomiting, and low weight gain, among other
serious symptoms. The long-term developmental effects are still unknown, though research in
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other states has indicated that these children are likely to suffer from continued, serious neurologic
and cognitive impacts, including hyperactivity, attention deficit disorder, lack of impulse control,
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and a higher risk of future addiction. When untreated, NAS can be life-threatening. Recent reports
suggest that the incidence of NAS in the U.S. increased by 433 percent from 2004 to 2014. In
2009, more than 13,000 infants in the United States were born with NAS, or about one every hour.
As a result, Plans of Safe Care are now required by federal and state laws to be developed when
642. Rising opioid use and abuse have negative social and economic consequences far
University economist, approximately one out of every three working age men who are not in the
labor force take daily prescription pain medication. The same research finds that opioid
prescribing alone accounts for 20% of the overall decline in the labor force participation for this
group from 2014-16, and 25% of the decline in labor force participation among women. Many of
643. In 2007, the economic burden of prescription OUD on the Criminal Justice System
(CJS) in the United States was over $5.1 billion. This cost grew to over $7.8 billion by 2016. The
majority of these costs are born by the agencies within the local and state governments. Results
of a 2017 report suggest that the annual costs associated with combating the opioid epidemic will
have approximately doubled across all societal sectors, including the CJS, by 2020. 101
644. The total costs to Illinois’s CJS attributable to the opioid epidemic from 2007 to
2016 amounts to approximately $500 million, or approximately $50 million per year (adjusted to
2017 value).
101
Rhyan CN. The potential societal benefit of eliminating opioid overdoses, deaths, and substance use
disorders exceeds $95 billion per year. Altarum website. altarum.org/sites/default/files/uploaded-
publication-files/Research-Brief_Opioid-Epidemic-Economic-Burden.pdf. Published November 16, 2017.
Accessed February 27, 2019.
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645. Opioid-related stories describe a public health crisis of epidemic proportions in
Illinois and the Counties. As a practical and financial matter, the Counties have been saddled with
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646. This human tragedy cannot be calculated or compensated. But the financial
burden to the Counties is staggering. The Counties have expanded their own services and worked
collaboratively with local communities to confront this public health epidemic. Narcan
administration has saved the lives of hundreds of its residents. Expanded addiction treatment
services, recovery housing, and innovative programs have sought to help people heal. The
Counties would further expand these efforts, but have only so much funding, which the demands
of this unprecedented epidemic have overwhelmed. The Counties are also faced with increased
costs of drug crimes and other public services because of this epidemic. Meanwhile, Defendants
have not changed their ways or corrected their past misconduct, but instead are continuing to fuel
the crisis.
647. While the Counties have committed substantial resources to address the crisis, the
a. Continuing Conduct
648. The Counties continue to suffer harm from the ongoing unlawful actions of the
repeated or continuous injury. The damages have not occurred all at once but have continued to
occur and have increased as time progresses. The tort is not completed nor have all the damages
been incurred until the wrongdoing ceases. The wrongdoing and unlawful activity by the Chain
Pharmacies has not ceased. The public nuisance remains unabated. The conduct causing the
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b. Equitable Estoppel and Fraudulent Concealment
650. The Chain Pharmacies are equitably estopped from relying upon a statute of
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limitations defense because each has undertaken active efforts to deceive the Counties and to
purposefully conceal their unlawful conduct. Defendants, in an ongoing effort protect their
registered distributor and/or dispenser status and continue earning record profits, have falsely and
fraudulently assured the public, including the Counties, that they were undertaking the necessary
efforts to comply with all applicable state and federal controlled substances laws to curb the opioid
epidemic.
651. The Chain Pharmacies were deliberate in taking steps to conceal their
conspiratorial behavior and active role in the deceptive marketing and the oversupply of opioids,
652. The Chain Pharmacies further concealed the existence of any potential claims
through their repeated false assurances that they were properly reporting all suspicious opioid
sales. The Chain Pharmacies publicly portrayed themselves as being committed to working
diligently with law enforcement agencies and others to prevent the diversion of these dangerous
drugs when, in fact, they were not committed. These repeated misrepresentations misled
regulators, prescribers, and the public, including the Counties, and deprived the Counties of actual
or implied knowledge of facts sufficient to put the Counties on notice of the Defendants’ unlawful
conduct as alleged herein.
653. The Counties did not discover the nature, scope and magnitude of the Chain
Pharmacies’ misconduct, and its full impact on the Counties, and could not have acquired such
654. The Chain Pharmacies intended that their actions and omissions would be relied
upon, including by the Counties. The Counties did not know and did not have the means to know
the truth, due to the Chain Pharmacies’ actions, omissions, and concealment.
655. The Counties reasonably relied on the Chain Pharmacies’ repeated false
representations that they were complying with their obligations under the law.
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VI. CAUSES OF ACTION
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COUNT I
Public Nuisance (By All Plaintiffs Against All Defendants)
656. Plaintiffs incorporate the allegations of all prior paragraphs of this Complaint
657. A public nuisance is something that negatively affects the public’s health, safety,
658. The Counties and its residents have a public right to health, safety, peace and
comfort. Those rights are a matter of great interest and of legitimate concern to the Counties, which
has a duty to protect the health, safety, and well-being of its residents. The State’s Attorneys of
each County has the power and authority to bring suit to abate a public nuisance.
659. Defendants, as distributors and dispensers, have, individually and acting through
their employees and agents, and in concert with each other, have intentionally, recklessly, or
negligently engaged in conduct or omissions which endanger or injure the property, health, safety
dispensing, and selling opioids in ways that unreasonably interfere with the public health, welfare,
and safety in Plaintiffs’ communities, and Plaintiffs and the residents of Plaintiffs’ communities
have a common right to be free from such conduct and to be free from conduct that creates a
661. Defendants had control over their conduct in the Counties and that conduct has
had an adverse effect on the public right. Defendants had sufficient control over, and responsibility
for, the public nuisance they created – Defendants were in control of the “instrumentality” of the
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nuisance, namely prescription opioids, including the process of distribution, dispensing,
marketing, and promotion and creation and maintenance of the demand for prescription opioids at
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and/or violated statutes which established specific legal requirements for the protection of others.
Specifically, Defendants are required to abide by the Illinois Controlled Substance Act, in which
the General Assembly specifically recognized, “the rising incidence in the abuse of drugs and other
dangerous substances and its resultant damage to the peace, health, and welfare of the citizens of
663. Defendants, individually and together, have created and maintained a public
nuisance through their ongoing conduct of marketing, distributing, dispensing, and selling opioids,
which are dangerously addictive drugs, in a manner which caused prescriptions and sales of
opioids to skyrocket in the Counties, flooded Plaintiffs’ communities with opioids, and facilitated
and encouraged the flow and diversion of opioids into an illegal, secondary market, resulting in
664. In light of the information, knowledge, skill, and sophistication they possessed,
Defendants know, and have known, that their intentional, unreasonable, negligent, and unlawful
conduct will cause, and has caused, opioids to be used and possessed illegally and that their
conduct has produced an ongoing nuisance that has had, and will continue to have, a detrimental
effect upon the public health, welfare, safety, peace, comfort, and convenience of Plaintiffs and
Plaintiffs’ communities.
unreasonable interference with rights common to the general public, including the public health,
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welfare, safety, peace, comfort, and convenience of Plaintiffs and Plaintiffs’ community. See
a. Involves a significant interference with the public health, the public safety,
the public peace, the public comfort, and/or the public convenience;
b. At all relevant times was and is proscribed by state and federal laws and
regulations; and/or
to have a significant effect upon rights common to the general public, including the
public health, the public safety, the public peace, the public comfort, and/or the
public convenience.
667. The significant interference with rights common to the general public is described
opioids;
deaths;
iv. Infants being born dependent on opioids due to prenatal exposure, causing
v. Employers having lost the value of productive and healthy employees; and
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vi. Increased costs and expenses for Plaintiffs relating to healthcare services,
law enforcement, the criminal justice system, social services, and education
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systems.
promote the false messaging about the treatment of pain and the addictive nature of opioids, to
encourage their use by health care providers and patients, and to encourage their pharmacists to
fill as many opioid prescriptions as possible in the face of indicia of diversion. The Chain
Pharmacies worked in concert with opioid manufacturers and distributors to ensure that the false
messaging surrounding the treatment of pain and the addictive nature of opioids was consistent
and geared to increase profits for all stakeholders. The Chain Pharmacies invited manufacturers
to train and provide messaging to the Chain Pharmacies’ pharmacists to ensure that those
pharmacists would continue to fill as many prescriptions as possible despite indicia of diversion.
as many opioids onto the market as possible, fueling addiction to and diversion of these powerful
narcotics, resulting in increased addiction and abuse, an elevated level of crime, death and injuries
to the residents of Plaintiff’s community, a higher level of fear, discomfort and inconvenience to
the residents of Plaintiff’s community, and direct costs to Plaintiffs and Plaintiffs’ communities.
670. Each Defendant is liable for creating the public nuisance because the intentional
and unreasonable, negligent, and/or unlawful conduct of each Defendant was a substantial factor
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671. In the sale distribution, and dispensation of opioids in Illinois and Plaintiffs’
communities, Defendants violated federal law, including, but not limited to, 21 U.S.C.A. § 823
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facilitated and encouraged their flow into the illegal, secondary market;
suspicious orders;
suspicious orders;
Defendants knew or should have known the opioids were being prescribed by “pill
mills;”
suspicious red flag prescriptions, and to otherwise prevent or reduce the risk of
diversion; and
about the treatment of pain and the addictive nature of opioids, to encourage their
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use by health care providers and patients, and to encourage their pharmacists to fill
conduct, for which the gravity of the harm outweighs the utility of the conduct, includes:
suspicious orders;
Defendants knew or should have known the opioids were being prescribed by “pill
mills;”
suspicious red flag prescriptions, and to otherwise prevent or reduce the risk of
diversion; and
about the treatment of pain and the addictive nature of opioids, to encourage their
use by health care providers and patients, and to encourage their pharmacists to fill
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674. Defendants’ conduct violates federal law, including, but not limited to, 21
and sold opioids that Defendants knew would be diverted into the illegal, secondary market and
prescription drugs, including opioids, which are specifically known to Defendants to be dangerous
because inter alia these drugs are defined under federal and state law as substances posing a high
677. Indeed, opioids are akin to medical-grade heroin. Defendants’ wrongful conduct
of deceptively marketing and pushing as many opioids onto the market as possible led directly to
the public nuisance and harm to Plaintiffs—exactly as would be expected when medical-grade
heroin in the form of prescription opioids are deceptively marketed, flood the community, and are
marketed and pushed as many opioids onto the market as possible, fueling addiction to and
b. a duty to exercise reasonable and ordinary care and skill in accordance with
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c. a duty not to breach the standard of care established under Illinois laws and
the federal Controlled Substances Act (“CSA”) and their respective implementing
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obligated to rein in their supply, prevent diversion, and mitigate the harms from opioid overuse
and abuse, but intentionally and unreasonably and/or negligently failed to do so.
681. The degree of care the law requires is commensurate with the risk of harm the
dangerously addictive drugs requires a high degree of care and places them in a position of great
682. Each Defendant breached its duty to exercise the degree of care, prudence,
watchfulness, and vigilance commensurate with the dangers involved in selling dangerous
controlled substances.
683. The Counties not only allege that Defendants were negligent for failure to protect
from harm, but that each Defendant engaged in affirmative conduct, the foreseeable result of which
684. Defendants know, and should have known, that their unreasonable and unlawful
conduct does cause, has caused, and will continue to cause, excessive availability of opioids in the
Counties and that their conduct has produced an ongoing nuisance that has had, and will continue
to have, a detrimental effect upon the public health, welfare, safety, peace, comfort, and
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685. Despite this knowledge, Defendants intentionally, negligently, unreasonably
and/or unlawfully marketed and pushed as many opioids onto the market as possible, fueling
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686. Defendants had control over their conduct in Plaintiffs’ communities and that
conduct has had an adverse effect on rights common to the general public. Defendants had control
over their own shipments of opioids and over their reporting, or lack thereof, of suspicious
prescribers and orders. Each of the Defendants controlled the systems they developed to prevent
diversion, whether they filled orders they knew or should have known were likely to be diverted
687. It was reasonably foreseeable that Defendants’ actions and omissions would result
688. Reasonably prudent distributors and dispensers of prescription opioids would have
anticipated that the conduct alleged herein would create a public nuisance in the Counties, and that
the public nuisance created would unreasonably interfere with the public health, safety, comfort
689. Because of Defendants’ special positions within the closed system of opioid
distribution, without Defendants’ actions, opioid use would not have become so widespread, and
the enormous public health hazard of prescription opioid and heroin overuse, abuse, and addiction
690. The public nuisance created, perpetuated, and maintained by Defendants’ actions
is substantial and unreasonable. It has caused and continues to cause significant harm to Plaintiffs’
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691. The externalized risks associated with Defendants’ nuisance-creating conduct as
692. As a direct and proximate result of Defendants’ tortious conduct and the public
nuisance created by Defendants, the Counties have taken proactive measures to abate the public
693. As a direct and proximate result of Defendants’ tortious conduct and the public
nuisance created by Defendants, Plaintiffs have suffered and will continue to suffer stigma
696. Defendants’ misconduct alleged in this case does not concern a discrete event or
discrete emergency of the sort a political subdivision would reasonably expect to occur, and is not
part of the normal and expected costs of a local government’s existence. Plaintiffs allege wrongful
acts which are neither discrete nor of the sort a local government can reasonably expect.
697. Plaintiffs have incurred expenditures for special programs over and above
698. Plaintiffs seek to abate the nuisance created by the Defendants’ unreasonable,
unlawful, intentional, ongoing, continuing, and persistent actions and omissions and unreasonable
699. Plaintiffs are asserting their own rights and interests and Plaintiffs’ claims are not
700. The tortious conduct of each Defendant was a substantial factor in producing harm
to Plaintiffs.
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701. Plaintiffs have suffered an indivisible injury as a result of the tortious conduct of
Defendants.
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702. Because the Counties did not contribute in any way to creating the public nuisance,
each Defendant is joint and severally liable for creating the public nuisance.
703. Defendants acted intentionally and with actual malice because Defendants acted
with a conscious disregard for the rights and safety of other persons, and said actions had a great
704. Plaintiffs seek an order that provides for abatement of the public nuisance
Defendants have created, enjoins Defendants from further wrongful and unfair conduct, and
awards Counties the costs associated with abatement of the nuisance and harm to the Counties in
WHEREFORE Plaintiffs respectfully demand that this Honorable Court enter judgment
against Defendants in a dollar amount to satisfy the jurisdictional limitation of this Court and such
additional relief and amounts as the jury and the Court shall deem equitable and proper, and
COUNT II
Negligence (By All Plaintiffs Against All Defendants)
705. Plaintiffs incorporate the allegations of all prior paragraphs of this Complaint
706. Defendants have a duty to exercise reasonable care in marketing, selling, and
707. Upon information and belief, each of the Defendants repeatedly breached their
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a. Selling prescription opioids in the supply chain when they knew, or should have
known, that there was a substantial likelihood the sale was for non-medical purposes and that
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opioids are an inherently dangerous product when used for non-medical purposes;
c. Failing to comply with all state and federal laws as described above;
d. Failing to acquire or utilize special knowledge or skills that relate to the dangerous
f. Failing to report suspicious orders and failing to refuse to fill them; and
g. Failing to provide effective controls and procedures to guard against the theft and
708. Defendants’ acts and omissions imposed an unreasonable risk of harm to others
separately and/or combined with the improper or unlawful acts of third parties.
Defendants and its agents have caused damages to the Counties in an amount to be determined at
trial.
WHEREFORE Plaintiffs respectfully demand that this Honorable Court enter judgment
against Defendants in a dollar amount to satisfy the jurisdictional limitation of this Court and such
additional relief and amounts as the jury and the Court shall deem equitable and proper, and
COUNT III
Unjust Enrichment (By All Plaintiffs Against All Defendants)
710. Plaintiffs incorporate the allegations of all prior paragraphs within this Count III
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711. Defendants have unjustly retained a benefit to the Counties’ detriment, and the
Defendants’ retention of the benefit violates the fundamental principles of justice, equity, and good
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conscience.
712. The Counties have expended substantial amounts of money in an effort to remedy
713. These expenditures include the provision of healthcare services and treatment
715. The Counties have conferred a benefit upon Defendants by paying for Defendants'
externalities: the cost of the harms caused by Defendants' improper distribution practices.
716. The Counties have also conferred a benefit upon Defendants by paying for
purchases by unauthorized users of prescription opioids from the Defendants' supply chain for
non-medical purposes.
717. By distributing and dispensing a large volume of opioids within the Counties and
by acting in concert with third parties, Defendants have unjustly enriched themselves at the
Counties’ expense. By engaging in the unlawful and unfair practices described in this Complaint,
diversion, Defendants obtained enrichment they would not otherwise have obtained. The
enrichment was without justification and Plaintiffs lack an adequate remedy provided by law.
719. These Defendants have unjustly retained a benefit to the Plaintiffs' detriment, and
the Defendants' retention of the benefit violates the fundamental principles of justice, equity, and
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good conscience. The enrichment was without justification and Plaintiffs lack an adequate remedy
provided by law.
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720. Defendants have been unjustly enriched at the expense of the Counties. It would
be inequitable for Defendants to retain the profits and benefits they have reaped from the improper
722. The misconduct alleged herein does not concern a discrete event or discrete
emergency of the sort a county would reasonably expect to occur and is not part of the normal and
expected costs of a county’s existence. The Counties allege wrongful acts which are neither
723. The Counties has incurred expenditures for special programs over and above its
ordinary services.
WHEREFORE Plaintiffs respectfully demand that this Honorable Court enter judgment
against Defendants in a dollar amount to satisfy the jurisdictional limitation of this Court and such
additional relief and amounts as the jury and the Court shall deem equitable and proper, and
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JURY DEMAND
Jayne Conroy
Sarah Burns
Holly Nighbert
SIMMONS HANLY CONROY, LLC
112 Madison Avenue
New York, NY 10016
212-784-6401
jconroy@simmonsfirm.com
sbunrs@simmonsfirm.com
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