Why Informed Consent is of utmost importance for Doctors ?

IMPORTANCE OF CONSENT FOR MEDICOS : A Short overview.

Few minutes to read may save you from subsequent anguish, pain and agony

A)   Introduction :

1.             Now days the Medical practice is not so simple and the relationship between the Doctor and Patient is being impinged by various factors. Doctor – patient relationship is a “Fiduciary relationship” in the eyes of law. The patients may get some information from the internet and may demand the Doctors to treat accordingly as per the information received or they might have overheard fro their friends or relatives about way of diagnosis and treatment of particular decease and this makes task of Doctors more difficult and thus it’s in the interest of Doctors to have informed consent.    

2.             A Doctor’s professional functions may be generally divided into 4 stages, I) Taking history from the patient, II) Diagnosis, III) To Advice patient according to the Diagnosis and IV) Treatment. All these stages involve interference with human body, which is hardly found with any other profession. The Treatment, most important stage, may produce the results, direct and/or indirect, which may be harmful to patient and it’s the duty of the Doctor to weigh such dangers / risks, before commencement of the Treatment. Thus in turn the Doctor again has to warn his/her patient of such risks inherent in the treatment which is being proposed and especially in the case of Surgery.

3.             The above said duty of the Doctor in turn is a right of the patient and thus the patient is entitled to accept or reject the recommended treatment. This aspect has been classically explained by well known American Jurist, Justice Cardozo in the case of Schoendorff v/s. Society of New York Hospital - (1914) 211 NY 125  that, “Every human being of adult years and sound mind has a right to determine what should be done with his body; and a surgeon who performs the operation without his patient’s consent, commits an assault for which he is liable in damages." This entitlement is the foundation of the Doctrine of Informed consent evolved in the landmark judgment of USA Court of Appeal in the case of Canterbury V/s. Spence (1972) 464 Fed Rep 2d 772.

B)   Types of consent :

1) Implied Consent :  The very act of a patient entering a doctor's chamber and expressing his problem is taken as an implied (or implicit) consent for general physical examination and routine investigations. For example, when a patient enters a Dentist’s clinic and sits in the Dental chair, his consent is implied for examination, diagnosis and consultation.

2) Express / Written Consent : Except where the consent can be clearly and obviously implied, there should be an express consent.

3) Real Consent : In UK, the elements of consent are defined with reference to the patient and a consent is considered to be valid and ’real’ when (i) the patient gives it voluntarily without any coercion; (ii) the patient has the capacity and competence to give consent; and (iii) the patient has the minimum of adequate level of information about the nature of the procedure to which he is consenting to.

4) Informed Consent : Doctrine of Informed consent has evolved in USA as we have seen above. While retaining the basic requirements consent, it shifts the emphasis to the doctor’s duty to disclose the necessary information to the patient to secure his consent. The information to be  given to patient includes :

i) nature and purpose of the proposed procedure or treatment;

ii) the expected outcome and the likelihood of success; the risks;

iii) the alternatives to the procedure and supporting information regarding those alternatives;

iv) the effect of no treatment or procedure, including the effect on the prognosis and the material risks associated with no treatment; and

v)  the instructions concerning what should be done if the procedure turns out to be harmful or unsuccessful.

          After such information, the patient must be given all the opportunity to get cleared his/her doubts. The patient must not be forced to give his/her consent. If consent is obtained by force or coercion, it’s not a valid consent in the eyes of Law.

C)   Who can give Consent ?

As the Patient should be competent  to give consent; must be an adult and of sound mind. In case of children, consent must be obtained from a parent. In case of incapacitated persons like insane or unsound mind or minor, close family members, a real friend or legal guardians can give consent. As per Sec.3 of the Indian Majority Act, a person attains majority at the age of 18, who is capable of giving consent and a person below age of 18 is treated as Minor. E.g. As per the provisions of Medical Termination of the Pregnancy Act, 1971, the pregnancy of a minor woman  or pregnancies in “lunatics” cannot be terminated except with the consent in writing of her guardian. Adequate information should be provided to a prudent patient during informed consent.

However in the Samira Kohli’s case (supra), it has been held  by Hon. Apex Court that When a patient is a competent adult and when there was no medical emergency during surgery, there is no question of someone else giving consent on behalf of the patient.

D)  Indian Perspective :

The Discussion on Informed consent is incomplete without referring to the Landmark 3 judges bench judgement of Hon. Apex court in the case of Samira Kohli V/s. Prabha Manchanda, AIR 2008 SC 1385. 
https://indiankanoon.org/doc/438423/

This judgment has settled the law on the point of Informed consent and how it should be taken and what should it include.

Before that, its important to look into the factual matrix of the case in short :

The Appellant, 44 years unmarried lady was having some menstrual problems and at one point, she had prolonged menstrual bleeding for nine days. After examining, she was advised to do USG and after the USG report, she was advised laparoscopy test under general anesthesia, for making an affirmative diagnosis. The consent was taken for “diagnostic and operative laparoscopy, Laparotomy, if needed. During Laparoscopic examination, when the appellant was still under G.A., the Asst. Doctor came out of O.T. and took the consent of the mother of Appellant, for performing hysterectomy on the ground that as the appellant was bleeding profusely and in order to save her life, hysterectomy was essential. Thereafter the hysterectomy (removal of uterus) and bilateral salpingo-oophorectomy (Removal of ovaries and fallopian tubes) was performed. Thus the Appellant filed a medical negligence case against the Doctors that without her consent her reproductive organs were removed and there was no need to do so when the consent was given only for diagnostic surgery. The Doctors refuted all the allegations and maintained their stand that they did it in order to save the life of the patient.

After hearing of the parties and after referring to various decisions of national/ international courts, the Court has summarized the following principles of consent.

i)             A doctor has to seek and secure the consent of the patient before commencing a ’treatment’ (the term ’treatment’ includes surgery also). The consent so obtained should be real and valid, which means that : the patient should have the capacity and competence to consent; his consent should be voluntary; and his consent should be on the basis of adequate information concerning the nature of the treatment procedure, so that he knows what is consenting to.

ii)           ) The ’adequate information’ to be furnished by the doctor (or a member of his team) who treats the patient, should enable the patient to make a balanced judgment as to whether he should submit himself to the particular treatment as to whether he should submit himself to the particular treatment or not. This means that the Doctor should disclose (a) nature and procedure of the treatment and its purpose, benefits and effect; (b) alternatives if any available; (c) an outline of the substantial risks; and (d) adverse consequences of refusing treatment. But there is no need to explain remote or theoretical risks involved, which may frighten or confuse a patient and result in refusal of consent for the necessary treatment. Similarly, there is no need to explain the remote or theoretical risks of refusal to take treatment which may persuade a patient to undergo a fanciful or unnecessary treatment. A balance should be achieved between the need for disclosing necessary and adequate information and at the same time avoid the possibility of the patient being deterred from agreeing to a necessary treatment or offering to undergo an unnecessary treatment.

iii)           Consent given only for a diagnostic procedure, cannot be considered as consent for therapeutic treatment. Consent given for a specific treatment procedure will not be valid for conducting some other treatment procedure. The fact that the unauthorized additional surgery is beneficial to the patient, or that it would save considerable time and expense to the patient, or would relieve the patient from pain and suffering in future, are not grounds of defense in an action in tort for negligence or assault and battery. The only exception to this rule is where the additional procedure though unauthorized, is necessary in order to save the life or preserve the health of the patient and it would be unreasonable to delay such unauthorized procedure until patient regains consciousness and takes a decision.

iv)           There can be a common consent for diagnostic and operative procedures where they are contemplated. There can also be a common consent for a particular surgical procedure and an additional or further procedure that may become necessary during the course of surgery.

v)             The nature and extent of information to be furnished by the doctor to the patient to secure the consent need not be of the stringent and high degree mentioned in Canterbury but should be of the extent which is accepted as normal and proper by a body of medical men skilled and experienced in the particular field. It will depend upon the physical and mental condition of the patient, the nature of treatment, and the risk and consequences attached to the treatment. 

The court at the end observed that the patient was 44 years old, had serious menstrual problems and the doctor thought that surgical removal of her uterus and ovaries would provide permanent relief. Holding that it was a case of the doctor acting in excess of consent but in good faith and for the benefit of the patient, the judgment denied the fee charged by Dr Manchanda and awarded Samira the rather low sum of Rs 25,000 as compensation and her medical bills were waived off.

E)             Few case laws underlying importance of informed consent :

a)    In an Australian case, (Rogers V/s. Whitaker 109 ALR 625), the patient had been blind with her right eye since age of nine, but she could lead normal life with her left eye. At the age of forty, when she got her eyes checked with an ophthalmologist, who advised her to undergo an operation of right eye for removing scar tissue, to gain back the vision significantly. After the surgical procedure, there was no improvement to right eye, but unfortunately she developed inflammation in her left eye as an element of sympathetic opthalmia and as a result she lost her left eye  sight too, to become blind.  It was alleged that the ophthalmic surgeon was negligence for failure to warn the risk of sympathetic opthalmia.

b)   In the landmark judgment in the case of Montgomery V/s. Lanarkshire Health Board, the UK Supreme court in 2015 has held that "Giving birth in the "natural" and traditional way or giving birth by caesarean section (unless she lacks the legal capacity to decide) " is the choice of a Pregnant woman. In that case the appellant contended that had she been informed about the problems of natural delivery in the case of baby with shoulder dystocia, she would have opted for caesarian. It was alleged that proper informed consent was not taken and the negligence was proved.

c)    In the case of SREE CHITHIRA THIRUNAL INSTITUTE OF MEDICAL SCIENCES (SCTIMS) THIRUVANANTHAPURAM V/s. R. VIPINA CHANDRAN & 2 ORS, by its judgment dated 21/08/2015 National Commission could save Doctors from the clutches of Medical Negligence allegations of Rs.25 laks as the proper consent was taken from the patient. The patient had the problem of diminution of vision. The Complainant with a hope of getting his 80% eyesight, consented for operation, but in vain. The Complainant alleged that as optic nerve got atrophied, placing of coil inside the head of the complainant was wholly unwarranted because of which he lost whatever minute vision he had. It was proved by medical records that the patient was not treated for the defective vision, but the patient was treated for Arterio Venous Malformation (AV Malformation). The patient was also having Papilloedema both sides and pale disc. The Neuro Radiology department performed angiogram and found to have Dural Arterio Venous Fistula. Hence, he was operated for coiling after proper “informed consent"
Here again proper consent saved Doctors . If the coiling is not done in such a case, patient will not only lose vision, but brain complications may also result and thus to save the life of patient was more important, rather than the improvement of vision of the patient..

d)   In the case of SUMAN TANEJA V/s. METRO HOSPITAL & HEART INSTITUTE & 3 ORS, decided on 02/02/2016, the National Commission dismissed the case for damages to the tune of Rs 2.5 crores and observed that It’s in the interest of Patients that Doctors. should not be dragged to the Court unnecessarily. The primary (Percutaneous Coronary Intervention) PCI was not done due to non-availability of cardiologist, with explained consent and patient was referred to higher center and referring to higher center is not negligence.

e)    The National Commission while deciding the revision petition of GOVIND SHAMRA V/s. SEVAYATAM HOSPITAL SODALA, bearing R.P.. No.3540/2008, held the Doctors negligence on facts by its judgment dated 15th march, 2016, thereby imposing damages of Rs. 4,50,000/.  Proper informed consent for forceps delivery, knowing all consequences was not taken by the Hospital.  The patient had delivered twins, but her hemoglobin was only 7.5 gm and though she was anemic, proper care was not taken because of which she died due to postpartum hemorrhage (PPH).

f)     Undue delay in diagnosis and treating the patient, (which was the cause of Death) and irrespective of Consent, it is the bounden duty of the Doctor to decide the line of treatment, which the Doctor did not do, amounts to breach of duty on part of Doctor and it costed the Doctor Rs.5 lakhs + interest towards compensation for Medical Negligence" 
These are the observations of the National Commission in its judgment dated 13/10/2015 in the case of ASHA ABBHI V/s. KANPUR MEDICAL CENTRE PVT. LTD. & 2 ORS. The commission also denied the allegations of the Doctor that as the relatives of the patients refused to give consent. Doctor should have taken the consent of the Wife-Complainant instead of waiting for consent of the patient's relatives. It was the bounden duty of the doctor to decide, the correct line of treatment as in the interest of saving the life of patient, the doctor should act. Blindly accepting the words of relatives itself would be unethical, the commission further observed.

g)    Informed Consent taken from relatives and not from the patient herself, who was otherwise in a position to give consent, cost Drs. Rs.5 lakhs.

The National Commission in its recent judgment dated 4th July, has given the important verdict in the case of SURESH CHANDRA MYTLE & ANR V/s. NEW INDIA INSURANCE CO. LTD. & 4 ORS. Please see the following link

http://cms.nic.in/ncdrcusersWeb/GetJudgement.do…

In the present case, the patient or her relatives were not explained pros and cons of the colonoscopy to be performed with or without sedation and as a result, they did not get an opportunity to take an informed decision in this regard.

It was held that had a choice been given to her or even to her family members they would have opted for colonoscopy under sedation, so as to avoid pain which the patient necessarily has to suffer in a case of colonoscopy without sedation.

h)   "The consent to operate Uterus does not include Consent to remove it ".

A Doctor Couple was held negligent by National Commission  for removing uterus of a 25 years patient, without her consent, in the case of

DR. RAVINDER VERMA & ANR. V/s. SALMA BEGAM, U.P.

REVISION PETITION NO. 968 OF 2015, decided on 14 Feb 2017. You may see the link.

http://cms.nic.in/ncdrcusersWeb/GetJudgement.do?method=GetJudgement&caseidin=0%2F0%2FRP%2F968%2F2015&dtofhearing=2017-02-14

i)     Proper Informed Consent for DNR ( Do Not Resuscitate) saved Drs from Rs.20 lakhs of compensation... !

The National Commission gave a great relief to Doctors In the case of APOLLO SPECIALTY HOSPITAL & ANR., CHENNAI V/s. R. MUTHUKRISHNAN. Judgment dated : 31 Aug 2016

http://cms.nic.in/ncdrcusersWeb/GetJudgement.do?method=GetJudgement&caseidin=0%2F0%2FFA%2F586%2F2015&dtofhearing=2016-08-31,

F)   Conclusion :

          The informed consent is of utmost importance. Always remember that “No documentation is no proof and poor documentation is poor proof”. But mind well, ones Doctor takes consent forms filled, it is not a certificate that can save Doctors from the medical negligence liability, but it acts as a mitigating factor while deciding the liability under MLC. 
If the Doctors could give more time for patient and have few words with patient, that’s what any patient wants. Good relationship with the patient is the key to success. Ultimately all the problems including court cases are the outcome of Ego clashes. So try to avoid clashes with patients, that will save cases against you. But if a false case is being filed and once its deiced in favour of Doctors, then Doctors should file cases for damages for malicious prosecution. Merely venting emotions on social media is not going to help.

Thanks & Regards

Adv. Rohit U. Erande

Pune.©