Informed Consent cum Undertaking Form by Hospitals: Unfair Trade Practice

INFORMED CONSENT CUM UNDERTAKING FORM BY HOSPITALS: UNFAIR TRADE PRACTICE

NATIONAL CONSUMER DISPUTES REDRESSAL COMMISSION, NEW DELHI

CASE NO. 428 OF 2018

VINOD KHANNA   ………..Complainant(s)
Versus
1. R.G. STONE UROLOGY AND LEPROSCOPY HOSPITAL & 2 ORS.
Through its Chairman F-12, East Of Kailash, New Delhi-110065

2. DR. ANIL VARSHNEY
S/o Shri SN Varshney R/o 58, Engineers Enclave, Pitampura, New Delhi.

3. THE NEW INDIA ASSURANCE CO.LTD.
Regional Office At R.G City Centre, 2nd Floor, LSC, Block-B, Lawrence Road, New Delhi-110035
…………………………..Opp.Party(s)

 

On 6th July 2020, the National Consumer Dispute Redressal Commission (“NCDRC”) passed an order that pre-printed and fixed “informed consent cum undertaking” form(s) being signed and obtained by hospitals from its patients amounts to unfair trade practice within the meaning of section 2(1)(r) of the Consumer Protection Act, 1986. This could have far reaching consequences in the manner of hospital treatment and care for patients. A look at the case.

Facts of the case:

The 65 year old Complainant Mr. Vinod Khanna (“patient”) was residing in Delhi. In the second week of January 2010, he experienced pain in the abdomen and related difficulties and was rushed to Fortis Hospital.

Due to financial constraints, he approached Dr. Anil Varshney at RG Stone Urology and Laproscopy Hospital. The doctor examined and diagnosed with grade III benign enlargement of prostate (BEP) with multiple abscess cavities. He advised surgery to rectify the same. The surgery was performed on 13th January 2010. On 18th January 2010, the patient approached the doctor and the hospital with post-surgery difficulties. On examination, the doctor informed that a complication had occurred and the same would heal naturally over a period.

Dissatisfied, the patient approached Indraprastha hospitals and after some time and considerable expenditure later, he reverted to Fortis hospitals. Aggrieved, the complainant moved the consumer court against the Dr. Anil Varshney and RG Urology alleging negligent treatment and seeking compensation of approximately Rs. 2 lakhs. It was for the consumer court to consider whether there was negligent in treatment on the part of Dr. Anil Varshney and RG Stone Urology and Laproscopy Hospital.

Argument(s)

The Complainant (Patient) alleged negligence and deficiency in services on the part of the doctor and the hospital.

The Respondents submitted that:

  1. The instant case was filed in 2018 – 8 years after the cause of action which arose in 2010. Hence it is barred by limitation
  2. The patient had pre-existing co-morbidities and health conditions. He was a known case of HIV positive, cryptococcal meningitis, Kaposi’s sarcoma and tuberculosis. Despite this the surgery was uneventful. Sufficient post-operative care was taken and only then the patient discharged. On a follow up visit, when the patient explained post operation difficulties, the doctor examined him and duly counselled him of the rare complication. He further informed the patient that it would on its own over a period of time and the healing depends upon patient’s immunity. Since the patient had several pre-existing health issues, his immunity was low and hence the recovery was bound to be slow. Further treatment was advised / provided. Patient was asked to come for review two weeks later. However, the patient did not come back and instead went to another hospital.

Observations by the NCDRC
The 2- member National Consumer Dispute Redressal Commission perused the consent form given by the patient, the diagnosis, procedure / surgery, and report of the patient. They also took on record the report given by a 3-member medical Board constituting 3 independent doctors at Maulana Azad Hospital, New Delhi. The members of the Commission were of the view that:

  1. A petition was filed by the patient before the State Consumer Dispute Redressal Commission in July 2010. However, the complaint was disposed of in August 2017 on grounds of lack of pecuniary jurisdiction. It took 7 years for the State Commission to dispose of the case and the case was filed before the National Commission in February 2018. Considering the facts of the case and that the cause of action was continuous, the Commission condoned the delay and held this petition was maintainable.
  2. The surgery was performed by the doctor after taking due informed consent from the patient. The medical reports issued by hospitals that the patient subsequently went back to also clearly indicated that the fistula (post-operative difficulty) would heal over a period of 6 weeks by way of conservative management of the problem with medicines over a period of time. Doctors in both hospitals clearly indicated in their report that the fistula has reduced and closed within 6 weeks. This clearly indicated that the complaint of post operation difficulty ceased to exist in the patient. This clearly establishes that there was no negligence or deficiency in service on the part of Dr. Anil Varshney and the RG Stone Urology and Laproscopy hospital. The report of the medical board also established the same.
  3. However, while perusing details of the case, the members analyzed the “informed consent” form that was signed by the patient and his sister (as witness). The Commission noted that the form was pre-printed. It was an “informed consent cum undertaking” form for the patient and family to sign. It had limited blank spaces for selective handwritten entries and signatures. There was hardly any space in the preprinted form. The forum noted that the main body of the form is fixed. The content of the form fits into any procedure, doctor and patient. The forum was of the view that this was administrative arbitrariness and one-sided high handedness. It would be unfair and deceptive on the part of the hospital (though in the present case the complainant was not prejudiced).

The Judgment

The Commission ruled that:
The patient was suffering from pre-existing health issues such as HIV and skin cancer. His immunity was compromised due to this. Despite that the doctor and the hospital operated the patient with due care and reasonable skill. The intention of the patient is open to suspicion. The patient published an article against the hospital in a newspaper. This seem to be with the intention to coerce the hospital for an out of court settlement. The allegations seemed to be made as an after thought based on assumptions, surmise and perverse beliefs. The Commission noted that the patient was treated as per standard norms. The patient failed to establish breach of duty of the treating doctor. Hence the Commission ruled that there was no negligence or deficiency in service on the part of the doctor and the hospital.

The Commission however ruled that the “informed consent cum undertaking” form, which was a fixed, pre-printed form provided by the hospital was an unfair trade practice within the meaning of section 2(1)(r) of the Act 1986. The Commission directed the hospital to pay a sum of Rs. 10 lakhs to be deposited with the Consumer Legal Aid Account of the Commission within 4 weeks and discontinue this practice with immediate effect.

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