Preprinted forms have very much become the norm in all healthcare institutions and organisations, so it should come as a surprise when the usage of these can land you in medicolegal trouble. Dr. Purvish Parikh recounts one such case and urges doctors and institutions to understand the fine print before using these.

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Most of us take for granted the sanctity of a preprinted consent form. This is mandated by law for clinical trials, organ transplants and management of vulnerable patients. Hence, most doctors are using this on a daily basis. So it comes as a rude shock when a judicial authority calls it 'unfair trade practices'. This order by the NCDRC highlights the finer points that doctors should be aware of.

Case No. 428 of 2018 in the national consumer disputes redressal commission (NCDRC)

Mr. Vinod Khanna filed this case against RG Stone Urology and Laproscopy Hospitals, Dr. Anil Varashney and New India Assurance Co. Ltd. for an illness that commenced in 2010.

Dr. SM Kanitkar, Presiding Member of the NCDRC pronounced the order on 6th July 2020.

Vinod Khanna developed urinary retention in January 2010 and received emergency treatment at Fortis Hospital, Vasant Kunj.

He then went to Dr. Anil Varshney at RG Stone. After investigations, surgery (including de-roofing of prostate) was done for benign prostatic enlargement, prostatic abscesses with retention of urine, and the patient was discharged on day 5 with urinary catheter. Vinod Khanna developed rectal fistula that was treated conservatively.

The patient then took treatment from Dr. Ajit Saxena at Indraprastha Apollo Hospital and Fortis Hospital at Vasant Kunj

Vinod Khanna's original complaint against Dr. Anil and RG Stone was for injury and complications as negligence. He claimed compensation of ₹1,88,37,602/-.

Defendents denied all allegations. They also showed that the patient had prior history of significant illnesses - surgery of hernia and appendix, tuberculosis and acquired immune deficiency syndrome (HIV), cryptococcal meningitis and kaposi's sarcoma. His grade III benign enlargement of prostate (BEP) was associated with multiple abscess cavities, including communicating to posterior side of nodules which might be due to immuno-compromised status of the patient.

During the surgery, cystoscopy had been done and the urethra was found to be normal. On removal of Foley’s catheter, rectal fistula was identified - which is a rare complication. He was offered treatment for diversion of urine and faeces by suprapubic cystotomy and colostomy. But, the patient abandoned further treatment with Dr. Anil and RG Stone. Instead, he went to Apollo Hospital and Fortis Hospital.

In spite of the seven years delay between occurrence and filing of case, the commission considered the cause of action as continuous, considered the complaint as maintainable and condoned the delay.

That complainant had hidden material fact regarding recovery from rectal fistula. Records of Fortis Hospital, had documented on 02/08/2010 that there was “No urine per rectally, fistula healed”. Healing within six weeks was also confirmed by records of Fortis Hospital.

Maulana Azad Hospital, New Delhi medical board (three independent doctors) concluded that there was no medical negligence.

NCDRC accepted that a proper informed consent had been taken. Consent form had signatures of the patient and his sister as witness. The affidavit of Dr. Anil and RG Stone as well as the expert opinion of the medical board of Maulana Azad Medical College, confirned the integrity of the process of ‘informed consent’.

It also concluded that the 1st complaint filed before the State Commission was on false ground and wrong premise. NCDRC found no deficiency in service or medical negligence in this case.

It also recorded the "ill intention" of the complainant wherein a story was published against the hospital in the Hindustan Times in order to influence the court. It was clear that the complainant wanted to coerce the hospital into an out of court settlement.

It was clear that all allegations of the complainant were an afterthought based on assumptions and perverse beliefs, even though he was treated according to standard practices.

NCDRC conclusion was that the complainant had miserably failed to establish any breach of duty by either of the accused. There was neither medical negligence nor deficiency of service. Hence the complaints was dismissed.

Then came the twist!

Even though the complainant had not raised any issue regarding this, NCDRC observed that "a pre-printed form- ‘informed consent cum undertaking’ having blank spaces for limited selective handwritten entries" is "administrative arbitrariness and one-sided high handedness" which was considered as "unfair and deceptive" on the part of RG Stone. This was interpreted as unfair trade practice (as defined by section 2(1)(r) of the Act 1986).

Therefore, NCDRC chose to impose a cost of Rs. 10 lakh on RG Stone - which would go to the Consumer Legal Aid Account of NCDRC. RG Stone was also directed to stop this so called ”unfair trade practice with immediate effect".

Disclaimer- The views and opinions expressed in this article are those of the author's and do not necessarily reflect the official policy or position of M3 India.

The author, Dr. Purvish Parikh is a Precision & Medical Oncologist from Mumbai.