JAGANNATH INSTITUTE OF MANAGEMENT

STUDIES, SCHOOL OF LAW

(Affiliated to Guru Gobind Singh Indraprastha University)

RESEARCH PAPER ON
“Informed Consent and Patient Autonomy: A Legal Perspective on
Medical Negligence Cases”

SUBMITTED TO

Mr. Mudit Sir

SUBMITTED BY

Shivang Srivastava

BALLb 5th Year 9th sem

06125503820
 Abstract

Patient rights and confidentiality form the bedrock of ethical

medical practice, protecting individuals’ dignity, autonomy, and
privacy. In India, the legal framework concerning patient rights is
guided by multiple regulations and judgments, reflecting both global
and domestic standards. This paper explores the evolution,
significance, and challenges of patient rights, with a particular focus
on confidentiality. A detailed examination of relevant provisions
under Indian law, such as the Indian Medical Council (Professional
Conduct, Etiquette and Ethics) Regulations, 2002, and landmark
judgments like Poonam Verma v. Ashwin Patel and Mr. X v. Hospital
Z, highlights the jurisprudential progression in this area. The term
‘privacy’ and ‘confidentiality’ is important in the fiduciary
relationship between a doctor and a patient. This relationship of
trust arises when the fair expectation of mutual trust is there
between the doctor and his patients. Medical confidentiality is a
concept of doctors maintaining all the information received during
the course of the patient’s treatment. The paper concludes by
discussing the need for a more comprehensive legislative
framework to uphold patient confidentiality amidst emerging
medical technologies and data-sharing practices.

Key words: Patient rights, medical confidentiality, doctor-patient

relationship, privacy in healthcare, Indian Medical Council
Regulations, right to privacy, Indian Constitution Article 21,
healthcare regulations in India, landmark judgments, medical data
protection, breach of confidentiality, public health contexts, ethical
and legal frameworks.
Introduction

The doctrine of informed consent plays a foundational role in

ensuring the autonomy of patients in medical practice. It grants
patients the right to make informed decisions regarding their
treatment, armed with knowledge of all potential risks, benefits, and
alternatives. This concept aligns with the broader principle of
human dignity and personal freedom, which emphasizes the
individual's right to make decisions about their own body and
health. Informed consent, therefore, is not just an ethical obligation
but also a legal requirement in many jurisdictions, including India.

The legal significance of informed consent becomes particularly

evident in cases of medical negligence, where a healthcare
provider’s failure to obtain proper consent can lead to severe legal
consequences. Medical negligence is defined as the failure of a
healthcare provider to meet the expected standard of care, resulting
in harm to the patient. Informed consent, or the lack thereof, is a
crucial factor in many medical negligence claims. Courts often
examine whether the patient was provided with sufficient
information to make a knowledgeable decision and whether that
decision was voluntary and competent.

In India, the legal framework surrounding informed consent has

been shaped by several landmark judicial rulings. One notable case
is *Samira Kohli v. Dr. Prabha Manchanda* (2008), where the
Supreme Court of India laid down key principles governing the
obligation of doctors to obtain consent from their patients. The case
emphasized the importance of informed consent in protecting
patient rights and preventing negligence.

This paper aims to examine the legal framework surrounding

informed consent in India, with a specific focus on its role in medical
negligence cases. It will explore the standards used by courts to
determine whether consent was truly informed and discuss the
challenges faced in ensuring patient autonomy, particularly in a
country as diverse as India. Furthermore, the paper will assess the
legal remedies available to patients who suffer harm due to the
absence of informed consent and suggest potential reforms to
strengthen patient rights.

Historical Evolution of Informed Consent in Medical Practice

The concept of informed consent has evolved significantly over time,

shaped by both medical ethics and legal developments. Historically,
the medical profession operated under the principle of paternalism,
where doctors were seen as the ultimate authority on what was best
for their patients. The doctor-patient relationship was characterized
by a significant power imbalance, with little regard for patient
autonomy. However, the rise of human rights movements and
increasing recognition of individual autonomy brought about a shift
in this dynamic.

The doctrine of informed consent first gained prominence in the

early 20th century in Western legal systems, particularly in the
United States and the United Kingdom. A landmark case that helped
define the legal contours of informed consent was *Schloendorff v.
Society of New York Hospital* (1914), where the court famously
stated, "Every human being of adult years and sound mind has a
right to determine what shall be done with his own body." This case
laid the foundation for the modern understanding of patient
autonomy and the need for informed consent in medical practice.

In India, the legal evolution of informed consent has been relatively

recent. The country’s diverse socio-cultural landscape and varying
levels of medical literacy have posed unique challenges to
implementing a uniform standard of informed consent. While earlier
cases in Indian courts focused primarily on general medical
negligence, the issue of informed consent became more prominent
in the late 20th century. In *Samira Kohli v. Dr. Prabha Manchanda*,
the Indian Supreme Court made significant strides in clarifying the
obligations of healthcare providers concerning informed consent.
3.1 Legal Requirements for Informed Consent in India
In India, the legal requirements for informed consent are largely
derived from case law, particularly the Samira Kohli judgment. In
this case, the Supreme Court laid down the essential elements of
informed consent:
1. Disclosure of Information: The doctor must disclose all material
risks involved in the treatment, alternative options available, and
the consequences of non-treatment. The information provided must
be in a manner that the patient can understand.
2. Competency to Consent: The patient must be of sound mind and
capable of understanding the nature of the treatment and its risks.
Minors and mentally incapacitated individuals require the consent
of a legal guardian.
3. Voluntariness: The consent must be given freely and without
coercion. Patients must not be pressured or unduly influenced into
consenting to a procedure.

The Consumer Protection Act, 2019 further provides patients with

the right to seek compensation for harm caused due to lack of
proper consent, treating medical negligence as a deficiency of
service.

3.2 Comparative Legal Frameworks

In other jurisdictions, such as the U.S. and U.K., informed consent is

governed by a more formalized legal framework. The U.S. legal
system follows the doctrine of patient autonomy strictly, with laws
such as the *Health Insurance Portability and Accountability Act
(HIPAA)* ensuring patient privacy and consent. In the U.K., the
*Montgomery v. Lanarkshire Health Board* (2015) case established
the standard that doctors must take reasonable care to ensure that
patients are aware of material risks in their treatment.

4. Elements of Valid Informed Consent

For informed consent to be considered valid, several critical

elements must be present:
4.1 Disclosure of Information
The doctor must provide detailed information about the nature of
the proposed treatment, including:
- The diagnosis
- The purpose of the treatment
- Potential risks and side effects
- Possible alternatives, including the option of no treatment

The patient must receive this information in clear, comprehensible

language. The complexity of medical jargon can often hinder
effective communication, which makes this element particularly
challenging in countries like India, where linguistic diversity and
varying levels of literacy may affect a patient’s ability to understand
medical procedures.

4.2 Understanding and Comprehension

It is not enough for the doctor to simply disclose information; the

patient must also understand it. Courts assess whether the
information was provided in a way that allowed the patient to grasp
the material risks and alternatives. In cases where patients are
unable to fully comprehend due to language barriers or low literacy
levels, the duty lies on the medical provider to ensure
understanding through adequate means, such as translators or
simplified explanations.
4.3 Voluntariness
For consent to be valid, it must be given voluntarily. Any form of
coercion or undue influence by the healthcare provider or family
members invalidates the consent. Courts closely examine whether
the patient was given adequate time to make a decision without
pressure, especially in high-risk procedures or situations involving
life-and-death decisions.
4.4 Documentation and Proof
While oral consent may suffice in some cases, written consent is
considered the gold standard in legal disputes. Properly
documented consent forms provide strong evidence that the patient
was informed and voluntarily agreed to the treatment. In the
absence of documentation, healthcare providers may struggle to
prove that consent was obtained, which can lead to findings of
negligence.

5. Challenges in Determining Informed Consent in Negligence

Cases
Several challenges complicate the determination of whether
informed consent was adequately obtained in medical negligence
cases:

5.1 Patient Literacy and Understanding

In a country like India, where healthcare access is often uneven,

patients from rural or underprivileged backgrounds may struggle to
comprehend medical procedures due to low literacy rates or
language barriers. This presents a significant hurdle in ensuring that
consent is truly informed.
5.2 Complexity of Medical Information

The technical nature of many medical procedures can make it

difficult for patients to fully grasp the potential risks and benefits,
even when information is provided in a simplified form. Medical
professionals may struggle to balance the need for detailed
information with the patient’s ability to understand it, leading to
potential misunderstandings about the treatment.
5.3 Cultural and Social Barriers
Cultural norms can also affect how patients approach medical
decisions. In many cases, patients may defer to the authority of the
doctor or their family members, leading to consent that is not fully
autonomous. Courts must carefully consider the socio-cultural
context in which consent was given to determine its validity.

Standard Used to Determine Negligence

In the complex arena of medical negligence law, determining

whether a healthcare provider has breached their duty of care
requires a nuanced and carefully calibrated approach. The legal
system has developed sophisticated standards and tests to assess
medical conduct, recognizing the inherent complexities and
uncertainties of medical practice while still holding professionals
accountable for their actions and decisions.
At the heart of this assessment lies the "reasonable person
standard," a fundamental benchmark in determining medical
negligence. This standard asks whether a healthcare provider acted
with the same level of skill, care, and diligence that a reasonably
competent practitioner in the same field would have exhibited
under similar circumstances. It's a concept that acknowledges the
varied nature of medical specialties and the fact that what might be
considered negligent in one context could be acceptable or even
necessary in another.
The application of this standard requires a nuanced understanding
of medical practices, often necessitating expert testimony to
establish the accepted norms within specific medical specialties.
Courts must navigate the delicate balance between holding
healthcare providers to high standards and recognizing the inherent
risks and uncertainties in medical practice. This balance is crucial in
ensuring that the legal system does not inadvertently promote
defensive medicine – a practice where healthcare providers order
excessive tests or avoid high-risk procedures out of fear of litigation,
potentially compromising patient care in the process.
A significant tool in this assessment is the Bolam Test, which
originated from the English case Bolam v. Friern Hospital
Management Committee (1957) and has been widely adopted in
Indian medical jurisprudence. According to this test, a medical
professional is not considered negligent if they act in accordance
with a practice accepted as proper by a responsible body of medical
opinion, even if other professionals might have taken a different
approach. This test acknowledges the reality that in medicine, there
can often be more than one accepted approach to diagnosis or
treatment.
In the Indian context, the Bolam Test was affirmed and adapted in
the landmark case of Jacob Mathew v. State of Punjab. The Supreme
Court's ruling in this case emphasized that while the Bolam Test
provides a valuable framework, it should not be applied rigidly. The
court suggested that Indian judges should scrutinize expert opinions
and consider whether the medical practice in question logically
withstands analysis. This nuanced approach allows for a more
contextual application of the standard, taking into account the
specific circumstances of each case and the evolving nature of
medical knowledge and practice.
In Kusum Sharma & Ors. v. Batra Hospital & Medical Research
Centre & Ors. (2010), the Supreme Court added another layer to the
application of the Bolam Test in India. The court emphasized that
while the Bolam Test is a good working rule, it is not a rule of law.
This distinction is crucial as it allows for flexibility in the application
of the standard, taking into account the rapidly evolving nature of
medical science and the unique circumstances of each case.
The role of expert testimony in these cases cannot be overstated.
Medical experts provide invaluable insights into the accepted
standards of care within specific fields of medicine, helping the court
understand complex medical procedures and decisions. Their
testimony is instrumental in determining whether a healthcare
provider's actions aligned with or deviated from the expected
norms. Experts help establish the standard of care applicable to the
specific medical situation, analyze whether the defendant healthcare
provider's actions met this standard, explain complex medical
procedures and decision-making processes to the court, and offer
opinions on causation – whether the alleged negligence directly
resulted in the patient's harm.
However, it's important to note that while expert testimony plays a
crucial role, judges retain the ultimate authority in weighing the
credibility and relevance of this testimony. Courts must navigate the
delicate balance between relying on medical expertise and
maintaining judicial independence in interpreting the law and facts
of each case.
As medical practices continue to evolve and new technologies
emerge, the standards used to determine negligence must also
adapt. The legal system faces the ongoing challenge of ensuring that
these standards remain relevant and effective in protecting patient
rights while also fostering an environment where medical
professionals can practice without undue fear of litigation. This
balance is crucial for the overall health of the medical system and
the quality of care provided to patients.
The evolving nature of these standards reflects the dynamic
interplay between law and medicine. As our understanding of health
and disease progresses, and as new treatments and technologies
become available, the legal framework must remain flexible enough
to accommodate these changes while still providing clear guidelines
for medical practice. This ongoing evolution underscores the need
for continued dialogue between the legal and medical communities
to ensure that the standards used to determine negligence remain
both fair and effective in the ever-changing landscape of modern
healthcare.
6. Legal Consequences of Lack of Informed Consent in
Negligence Cases

The failure to obtain informed consent can lead to severe legal

consequences for healthcare providers. Under Indian law, the
absence of informed consent is considered a breach of duty of care,
which is a key element in establishing medical negligence. Courts
consider whether the healthcare provider met the requisite legal
and ethical obligations to inform the patient adequately. If not, the
healthcare provider can be held liable for any harm suffered by the
patient as a result of the treatment.
6.1 Civil Liability and Compensation Claims
One of the primary legal remedies available to patients in cases of
medical negligence involving lack of informed consent is
compensation. Under the *Consumer Protection Act, 2019*, patients
are classified as consumers, and medical services are considered a
form of service. If there is a deficiency in service, such as failing to
obtain proper consent, patients can seek compensation through
consumer courts. This law is crucial in providing patients with a
platform to claim damages without going through the complexities
of civil suits.

In *Samira Kohli v. Dr. Prabha Manchanda* (2008), the court

awarded compensation to the patient after finding that the doctor
had performed a hysterectomy without her informed consent. The
court held that the patient must be fully informed about the nature
of the procedure, its risks, and any available alternatives, and the
failure to do so amounted to medical negligence.

6.2 Criminal Liability

In cases of gross negligence or willful misconduct, healthcare

providers may face criminal charges under the *Indian Penal Code
(IPC)*. Section 304A of the IPC, which deals with causing death by
negligence, can be invoked in cases where a patient dies due to a
procedure performed without informed consent. However, criminal
liability is less commonly pursued in medical negligence cases, as
courts are generally more focused on compensating the patient for
harm rather than punishing the healthcare provider.
6.3 Role of Expert Testimony
In medical negligence cases involving informed consent, expert
testimony plays a crucial role in determining whether the doctor
adhered to the appropriate standard of care. Courts often rely on
medical experts to assess whether the information provided to the
patient was adequate and whether the treatment was conducted
according to accepted medical practices. However, expert testimony
can be a double-edged sword, as conflicting expert opinions can
make it difficult for courts to reach a conclusive decision.

6.4 Proving Lack of Consent

Proving that a patient did not give informed consent can be

challenging, especially in cases where oral consent was given. As
discussed earlier, written consent forms are the gold standard in
such cases, but even written documentation can be contested if it is
shown that the patient did not fully understand the information
provided. Courts typically look for evidence that the patient was
given enough time to ask questions and make an informed decision,
and that the doctor provided clear explanations about the risks and
alternatives.

7. Ethical Considerations and Patient Rights

The concept of informed consent goes beyond mere legal

compliance; it is also a fundamental ethical principle in medical
practice. The ethical dimensions of informed consent revolve
around respecting patient autonomy, ensuring transparency in
communication, and promoting trust in the doctor-patient
relationship. Medical professionals are bound by both legal and
ethical obligations to ensure that patients are empowered to make
decisions about their own healthcare.
7.1 Balancing Medical Paternalism and Patient Autonomy
In medical practice, there is often a tension between the principle of
patient autonomy and the concept of medical paternalism, where
doctors make decisions on behalf of patients based on what they
believe to be in the patient’s best interests. While doctors are
experts in medical science, patients have the right to decide what
happens to their bodies, even if their decisions go against medical
advice. The shift from medical paternalism to patient autonomy
represents a broader societal move toward respecting individual
rights and freedoms.

The challenge for healthcare providers is to balance these two

principles. While doctors may have superior knowledge of medical
procedures, they must respect the patient’s right to make informed
decisions about their own health. Informed consent serves as a
critical mechanism for achieving this balance by ensuring that
patients are given the information they need to make autonomous
decisions while still benefiting from the expertise of their doctors.

7.2 Ethical Dilemmas in Informed Consent

In practice, doctors often face ethical dilemmas in obtaining

informed consent. For example, in emergency situations where
immediate action is required to save a patient’s life, it may not be
possible to obtain full informed consent. In such cases, doctors may
need to act in the patient’s best interests without explicit consent,
raising ethical questions about the limits of patient autonomy.

Another common dilemma arises when patients are unable to fully

comprehend the risks and benefits of a proposed treatment due to
language barriers, cognitive impairments, or lack of medical
knowledge. In these cases, doctors must navigate the ethical
challenges of providing adequate information without
overwhelming or confusing the patient.

7.3 The Impact of Informed Consent on the Doctor-Patient

Relationship

Informed consent is not just a legal requirement; it also plays a

crucial role in fostering trust between doctors and patients. When
doctors take the time to explain procedures, risks, and alternatives,
patients are more likely to feel that their rights and autonomy are
being respected. This transparency can lead to greater patient
satisfaction and improved healthcare outcomes.
On the other hand, when doctors fail to obtain proper informed
consent, it can erode trust and damage the doctor-patient
relationship. Patients who feel that they were not adequately
informed or were pressured into a decision may be less likely to
trust their healthcare providers in the future, potentially leading to
poorer health outcomes.

8. Conclusion

The principle of informed consent is a cornerstone of both medical

ethics and the legal framework surrounding patient rights. It
ensures that patients are empowered to make informed decisions
about their healthcare, thereby upholding their autonomy and
dignity. In the context of medical negligence, informed consent plays
a pivotal role in determining whether healthcare providers have met
their duty of care.

Indian law, particularly through judicial precedents such as *Samira

Kohli v. Dr. Prabha Manchanda*, has established clear guidelines for
what constitutes valid informed consent. These guidelines require
doctors to provide sufficient information about the risks, benefits,
and alternatives of a treatment, ensure that the patient understands
the information, and obtain voluntary consent. Failure to meet these
requirements can lead to legal liability for medical negligence, with
patients entitled to seek compensation through consumer courts or
civil suits.

However, the implementation of informed consent in India faces

significant challenges, particularly in a diverse country with varying
levels of literacy, linguistic barriers, and cultural norms. Healthcare
providers must navigate these challenges while ensuring that
patients’ rights are respected.

In the future, legal reforms and better education for both patients
and healthcare providers can help strengthen the practice of
informed consent. By improving communication between doctors
and patients, healthcare systems can ensure that informed consent
is not just a legal formality but a meaningful process that enhances
patient autonomy and promotes better health outcomes.

References
1. Samira Kohli v. Dr. Prabha Manchanda & Anr, (2008) 2 SCC 1
2. Consumer Protection Act, 2019.
3. Schloendorff v. Society of New York Hospital, 211 N.Y. 125, 105
N.E. 92 (1914).
4. Montgomery v. Lanarkshire Health Board, [2015] UKSC 11.
5. Indian Penal Code (IPC), Section 304A.
6. Health Insurance Portability and Accountability Act (HIPAA),
1996.