Uniform Use of Pre-printed 'Informed Consent' Forms as Unfair Trade Practice: Landmark Judgment by NDCR Commission

Uniform Use of Pre-printed 'Informed Consent' Forms as Unfair Trade Practice: Landmark Judgment by the National Consumer Disputes Redressal Commission

Introduction

The case of Vinod Khanna v. R.G. Stone Urology And Laparoscopy Hospital And Others adjudicated by the National Consumer Disputes Redressal Commission (NCDRC) on July 6, 2020, presents a significant precedent in the realm of consumer rights and medical malpractice. The complainant, Vinod Khanna, alleged medical negligence and unfair trade practices against the hospital and the treating physician following post-surgical complications. This commentary delves into the intricacies of the case, the court's reasoning, and its broader implications on medical practices and consumer protection laws.

Summary of the Judgment

Vinod Khanna, a 65-year-old patient, underwent surgery at R.G. Stone Urology and Laparoscopy Hospital (OP-1) performed by Dr. Anil Varshney (OP-2) in January 2010. Post-surgery, Khanna experienced a rare complication of urinating from the rectum, attributed to a recto-urethral fistula. Despite incurring significant medical expenses seeking further treatment, Khanna filed a complaint in 2018, alleging negligence and seeking ₹1.88 crore in compensation.

The Opposite Parties (OPs) contested the complaint, raising issues of limitation and asserting that the patient’s pre-existing conditions mitigated their liability. Upon examination, the Commission found no evidence of medical negligence by OP-1 or OP-2. However, it criticized the hospital's use of a standardized pre-printed 'informed consent' form, deeming it an unfair trade practice under Section 2(1)(r) of the Consumer Protection Act, 1986. Consequently, the hospital was fined ₹10 lakh and directed to discontinue this practice.

Analysis

Precedents Cited

The Commission referenced standard surgical and urogenital pathology literature to assess the validity of the complaint. While specific case laws were not explicitly cited, the judgment aligns with established legal principles concerning medical negligence and consumer protection.

By establishing that the uniform use of pre-printed consent forms can constitute an unfair trade practice, the judgment builds upon existing consumer protection jurisprudence, reinforcing the necessity for personalized and transparent consent procedures in medical practices.

Legal Reasoning

The Commission meticulously analyzed the medical records, expert opinions, and affidavits from both parties. It concluded that:

  • No medical negligence was evident on the part of the hospital or the physician.
  • The complication experienced by the patient was a known rare outcome, adequately communicated and managed.
  • The pre-printed 'informed consent' form lacked personalization, leading to administrative arbitrariness and potentially misleading patients.

Under these considerations, while consumer claims related to medical negligence were dismissed, the improper use of consent forms was identified as an unfair trade practice warranting punitive action.

Impact

This judgment has profound implications for healthcare providers:

  • Informed Consent Practices: Hospitals and medical practitioners must adopt patient-specific consent forms, ensuring comprehensive and transparent communication of risks and procedures.
  • Consumer Protection Enforcement: It underscores the active role of consumer courts in regulating medical practices beyond direct negligence claims, extending to procedural fairness.
  • Administrative Accountability: Institutions may face penalties for standardized practices that do not cater to individual patient needs, promoting a shift towards more patient-centric approaches.

Future cases involving medical procedures will likely reference this judgment, particularly regarding the adequacy and customization of consent protocols.

Complex Concepts Simplified

Informed Consent

In medical terms, informed consent is a process by which a patient is educated about the potential risks and benefits of a treatment or procedure, allowing them to make an informed decision. It typically involves a dialogue between the patient and the healthcare provider, ensuring the patient's autonomy and understanding.

Unfair Trade Practice

Under the Consumer Protection Act, 1986, an unfair trade practice refers to any deceptive or fraudulent act committed by a seller or service provider that misleads consumers or violates their rights. In this case, the standardized consent form without adequate personalization was deemed to manipulate patient consent, qualifying as an unfair trade practice.

Recto-urethral Fistula

A recto-urethral fistula is an abnormal connection between the rectum and the urethra, leading to the passage of urine through the rectum. It is a rare complication that can arise due to surgical interventions, infections, or trauma.

Conclusion

The NCDRC's judgment in Vinod Khanna v. R.G. Stone Urology And Laparoscopy Hospital And Others serves as a pivotal reference point in the intersection of medical practice and consumer rights. While it absolved the medical professionals from negligence claims, it simultaneously emphasized the imperative for ethical and individualized patient consent protocols. This dual emphasis underscores the judiciary's holistic approach in safeguarding consumer interests, ensuring that medical institutions not only provide competent care but also engage in transparent and fair administrative practices.

Moving forward, healthcare providers must reassess their consent procedures to align with legal expectations, thereby fostering trust and upholding the standards of patient care. This judgment fortifies the framework within which medical practices operate, advocating for a balanced amalgamation of professional expertise and consumer protection.

Case Details

Year: 2020
Court: National Consumer Disputes Redressal Commission

Judge(s)

S.M. Kantikar, Presiding MemberDinesh Singh, Member

Advocates

Mr. G.P. Thareja, Mr. Satyam Thareja and Mr. Suyash Rawat, Advocates, for the Complainant;Mr. Jeevan Prakash, Advocate for OP No. 1 & 2Mr. A.K. Prasad, Proxy Counsel for OP No. 3, for the Opposite Parties.

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