CAUTIONARY POINTS WHILE TAKING PATIENT CONSENT

SOME RED FLAG ALERTS 

All doctors are aware that no procedure or intervention should be done on a patient without obtaining valid, written and informed consent (except in cases of dire emergency or life-threatening situations).Though not common, not doing so could even attract the criminal charge of the offence known as ‘assault and Battery’ which implies unauthorized invasion on the body of a person when a doctor performs a non-consented medical procedure. A few important medical judgments in our country have categorically said so. In the USA it is not uncommon for a patient’s counsel to allege the tortuous act of ‘assault and battery’ in addition to the charge of negligent treatment.

Theoretically, the only thing that does not need written consent of a patient is the examination of a patient----the reason being that the consent is implied. This too has been endorsed by Indian courts in some SC judgments.

Hence it is imperative that valid, written and informed consent of a patient is taken unfailingly before doing any procedure. I do not wish to go into the various concepts of informed consent.

However ,  I would like to red-flag certain areas  which are commonly missed out and can cause disproportionate trouble subsequently .These are based on real-life cases whose judgments have highlighted these points and could  be used as  precedents by way of case laws for future cases.

 

 

PERFORMING SURGERY / PROCEDURE NOT INCLUDED IN THE ORIGINAL CONSENT

An unmarried female age 44 consulted a gynecologist for menorrhagia. USG revealed some fibroids and chocolate cysts in both ovaries Right > Left. A diagnosis of endometriosis was made. Written consent for diagnostic and operative Laparoscopy was taken. Patient claimed that the doctor told her that she would remove the chocolate cysts and fulgurate the endometric areas and follow-up with medical (hormonal) treatment.

During laparoscopy the doctor found that the chocolate cysts of both ovaries were severely adherent to the bowels and there were severe adhesions. She described it as ‘frozen pelvis’. The doctor sent her assistant outside the OT to inform the mother of the patient the laparoscopic findings and the advisability of doing a hysterectomy since this would have to be done , in any case . A second surgery could be avoided. The mother of the patient said “Please do what is best for my daughter” and thereupon signed a consent form.

Accordingly, a hysterectomy and bilateral salpingo-oopherectomy was carried out.

This was informed to the patient after she came out of anesthesia. On hearing this , the patient was furious and demanded to know why her uterus had been removed without her consent. She said she was planning to get married in a month’s time   and wanted to become a mother. Conservative treatment could have been tried. Severe mental trauma and damage to her health had been caused. Her friend, one Commander Zutshi abused and threatened the doctors, made a Police complaint alleging criminal negligence for removing her reproductive organs without her consent. He forcibly took discharge of the patient without paying the bill of Rs 39,325/-

The doctor sent the patient a legal notice to recover her bill.

Meanwhile, the patient filed a complaint before the NCDRC demanding a compensation of Rs 25 lakhs claiming that the removal of her uterus was unauthorized, unlawful and unwarranted.

The defense of the doctor was that it was a case of Grade IV endometriosis and conception would not have been possible any way and removing the uterus did not matter.

The National Commission dismissed the complaint of the patient observing that hysterectomy was necessitated as the patient had grade IV endometriosis and if not operated the lesion would have extended to the intestines and bladder and damaged them. It was the discretion of the surgeon to decide about the course of action deemed best for the patient.

The patient challenged the order of the National Commission and filed an appeal before the Supreme Court. The SC upheld the appeal.

The sum and substance of the Supreme Court judgment was as follows:

It is quite possible that if the patient had been conscious, and informed about the need for the additional procedure, the patient might have agreed to it. It may be that the additional procedure is beneficial and in the interests of the patient. It may be that postponement of the additional procedure (say the removal of an organ) may require another surgery, whereas removal of the affected organ during the initial diagnostic or exploratory surgery would save the patient from the pain and cost of a second operation. Howsoever practical or convenient the reasons may be, they are not relevant. What is relevant and of importance is the inviolable nature of the patient's right in regard to his body and his right to decide whether he should undergo the particular treatment or surgery or not. Therefore at the risk of repetition, we may add that unless the unauthorized additional or further procedure is necessary in order to save the life or preserve the health of the patient and it would be unreasonable (as contrasted from being merely inconvenient) to delay the further procedure until the patient regains consciousness and takes a decision, a doctor cannot perform such procedure without the consent of the patient.

It is however quite heartening that the judgment also made the following observations:

In view of our finding that there was no consent by the appellant for performing hysterectomy and salpingo-oopherectomy, performance of such surgery was an unauthorized invasion and interference with appellant's body which amounted to a tortious act of assault and battery and therefore a deficiency in service. But as noticed above, there are several mitigating circumstances. The respondent did it in the interest of the appellant. As the appellant was already 44 years old and was having serious menstrual problems, the respondent thought that by surgical removal of uterus and ovaries she was providing permanent relief. It is also possible that the respondent thought that the appellant may approve the additional surgical procedure when she regained consciousness and the consent by appellant's mother gave her authority. This is a case of respondent acting in excess of consent but in good faith and for the benefit of the appellant.. Even assuming that AH-BSO surgery was not immediately required, there was a reasonable certainty that she would have ultimately required the said treatment for a complete cure. On the facts and circumstances, we consider that interests of justice would be served if the respondent is denied the entire fee charged for the surgery and in addition, directed to pay Rs.25, 000 as compensation for the unauthorized AH-BSO surgery to the appellant.55. We accordingly allow this appeal and set aside the order of the Commission.

(Important: The patient had claimed Rs 25 lakhs as compensation)

This became a landmark judgment which is cited as Samira Kohli vs. Dr Prabha Manchanda and was delivered by Justice Raveendran. It is now a benchmark on issues relating to informed consent as it has dealt with the same comprehensively.

 

 

RED FLAG 1

 DO NOT CARRY OUT  AN ADDITIONAL  PROCEDURE FOR WHICH EXPRESS INFORMED CONSENT HAS NOT BEEN TAKEN UNLESS IT COMES UNDER THE CATEGORY OF LIFE-SAVING, AND NEVER MIND IF THE PATIENT HAS TO UNDERGO ANOTHER SURGERY ON ANOTHER DAY AND SPEND MORE MONEY.

ALTERNATIVELY, INFORMED CONSENT SHOULD BE TAKEN FOR A POTENTIAL PROCEDURE IN ADVANCE ALONG WITH THE ORIGINAL CONSENT.

SIGNATURE ON CONSENT FORM THAT OF PATIENT HIMSELF OR HERSELF

A gynecologist performed an MTP successfully after taking all precautions and following all guidelines and thought that was the end of it.

However, a year later, as it turned out, there was severe marital discord between the couple and divorce proceedings were initiated by them.

The father of the lady was an advocate and decided for some reason, to introduce the matter of the MTP in the judicial proceedings.  Hence he made an application for a copy of the case papers pertaining to the MTP.These were duly supplied to him by the operating doctor. Being a sharp advocate , he scrutinized  the case paper meticulously and detected that the consent form for the MTP had been signed only by the husband of his daughter and nowhere could his daughter’s signature be seen. In other words, there was no evidence of his daughter’s authorization for the procedure.

Apparently, the staff of the gynecologist, who was entrusted with taking the signature of the patient, thought the husband’s signature was good enough and hence the patient’s signature was not taken.This kind of situation is not uncommon and I believe , even today such things might be happening ,though inadvertently.

Soon after, the father of the patient filed a criminal case against his son-in-law and the doctor under section 314 ---the charge being “intentionally killing the unborn child of a woman” with the doctor being a partner and abettor in the crime.

The case went on for several years after which the doctor got an acquittal.

RED FLAG 2

ALWAYS CONFIRM AND RE-CONFIRM THAT THE CONSENT FORM IS NOT ONLY DULY SIGNED BUT SIGNED FIRST BY THE PATIENT HIMSELF OR HERSELF AND THEN HAVE SIGNATURE OF A RELATIVE AS WITNESS. This should form part of your check-list.

 

An Ophthalmologist advised a 26 year old girl to undergo a lachrymal sac wash as an OPD procedure. This was duly done and the patient was asked to wait in the waiting room for a little while for observation. Within a couple of minutes, the patient complained of giddiness and suddenly collapsed . Immediate resuscitative measures were initiated and the patient was shifted to a nearby ICU where she was treated for 2 days. She succumbed on the 3^rd day. Probable diagnosis was indicated as Vaso- vagal attack.

Post-event, a customary inquiry was carried out and the main deficiency cited was that no consent had been taken for the procedure. Fortunately, the doctor was exonerated on account of circumstantial evidence and the matter did not progress further.

RED FLAG 3

EVEN TODAY THERE IS A TENDENCY TO SKIP WRITTEN INFORMED CONSENT FOR MINOR PROCEDURES---BIOPSIES, FLUID TAPPING, CLW SUTURING , ETC.

IT WOULD BE A GOOD IDEA TO STRUCTURE IT IN YOUR CHECK-LIST

 

 

RED FLAGS

 

 Question 

While doing an ovarian cystectomy under S.A. , the patient suddenly collapsed all attempts at resuscitation were futile and the patient died. On examing the case papers the surgeon realised that consent of the patient had not been taken.

What should he do now? 

You can leave your answers in the comments section