BusinessAccent

Take Consent for Blood Transfusion: Avoid Negligence

The decision to transfuse blood or blood products must be based on a careful assessment—indicating they are necessary for saving life or for preventing a major morbidity

Dr Suganthi Iyer

Consent is essentially an agreement between two or more persons and where provisions of Indian Contract Act are applicable. When two or more persons agree upon the same thing in the same sense, they are said to be in consent. Action taken in absence of consent amounts to assault as is illustrated in the below mentioned case.

In late 1990's, 'L'—a complainant—suffered from bleeding of uterus and was admitted to 'G' Hospital wherein hysterectomy was performed. Subsequently, two units of blood was transfused to the patient which was brought from 'QM' clinical laboratory, which did not conduct any test to satisfy itself that it was free from infections like HIV and more. The Hospital authorities also did not cross check whether there is a certificate in this regard.

The consent taken for the surgery stated: "I am hereby giving my consent for conducting operation on my wife for removal of her uterus after giving anaesthesia." There was no consent expressed for blood transfusion. In mid-1994, 'L' developed recurrent loose motion, weight loss, respiratory infection and difficulty in swallowing, for which a blood test was done by the second opposite party which showed that HIV antibodies were present. In July 1995, she developed left sided hemiparesis, oral candiasis and pulmonary tuberculosis. She was hospitalised when she became unconscious and expired in August 1995.

Any blood bank/laboratory supplying blood is duty-bound to ensure that the blood supplied is free from HIV and other infections. The second opposite party had failed to carry out the test required to ensure that the blood was not infected. The blood supplied by the second opposite party to the first opposite party for transfusion had HIV antibodies. The first opposite party also owed a duty to the patient to ensure that the blood which it was transfusing her was free from HIV/AIDS. There was thus a gross and patent negligence on the part of both the opposite parties while transfusing the blood with the result that the complainant's wife lost her life on account of this negligence and deficiency in service on the part of the opposite parties.

Out of the three modes of transmission of HIV/AIDS, the most dangerous one is through the transfusion of blood having the virus. The sole reason for the complainant's wife developing HIV/AIDS was the transfusion of the blood contaminated with the HIV virus done by the opposite parties after the operation in December 1990. The complainant's wife and the complainant had absolutely no reason for getting HIV infection. The infection developed into full blown AIDS three-and-a-half years later. It is well-known that persons who are infected with HIV develop complications subsequently after the gestation period/window period.

Some Case Studies Reibl Vs Hughes

In Reibl Vs Hughes, the patient was operated for major occlusion in the artery and the patient suffered massive stroke during surgery. It was stated that an action for damages lies for trespass to person and hence negligence. It is the duty of the surgeon to explain problems and specific risks of surgery and also risks of continuing without surgery. The doctor had informed the patient only the mechanics of surgery and had failed to communicate purpose or gravity of operation or risks involved and hence the defendant was negligent in failing to carry out his duty. Hence, damages were awarded.

Malette v/s Shulman

In Malette v/s Shulman, the case reflects that a doctor is liable in law for administering blood transfusion to an unconscious patient when the patient is carrying a card stating that she is a Jehovah's witness and as a matter of religious belief rejects blood transfusion under any circumstances, fully realising the implications of the situation and no objection to the use of non-blood alternatives like Dextran. In this case, despite the card found on lady Malette, blood transfusion was given when condition deteriorated. The Court held that: The doctrine of informed consent has developed in the law as the primary means of protecting a patient's right to control his or her medical treatment. Under the doctrine, no medical procedure may be undertaken without the patient's consent obtained after the patient has been provided with sufficient information to evaluate the risks and benefits of the proposed treatment and other available options. The doctrine presupposes the patient's capacity to make a subjective treatment decision based on her understanding of the necessary medical facts provided by the doctor and on her assessment of her own personal circumstances. A doctor who performs a medical procedure without having first furnished the patient with the information needed to obtain an informed consent will have infringed the patient's right to control the course of her medical care, and will be liable even though the procedure was performed with a high degree of skill and actually benefited the patient.

It was held that:

• Consent of the patient is required for transfusion of blood. In this case, it is clear from the records that the complainant has given his consent only for hysterectomy operation to be performed under general anaesthesia and not for transfusion of blood. Surgery involves risk and blood transfusion involves additional risk. There is a strong force in the argument that the consent should have been taken or there should have been explained to the complainant of the risk of blood transfusion by the attending surgeon.
• The laboratory was duty-bound as per the Drugs and Cosmetics Rules duly amended on July 11, 1989. Rule 66 (A) which clearly stipulates a mandatory condition of conducting HIV antibody test before certifying the purity of blood. This was not complied with by the blood bank and clinical laboratory. The doctor merely stated that she relied on the clinical report of the blood bank who conducted the test but she did not insist for the blood test certificate. There is no mention about the clinical record maintained by the doctor that the blood was bound to be free from infection. This is a clear case of negligence on the part of both opposite parties.

The complaint was allowed and compensation of Rs 4 lakh awarded as it was clear from the records that blood transfused resulted in contracting HIV infection which ultimately after gestation period became full blown AIDS and the patient succumbed to her terminal illness.

The writer is Assistant Director (Medical) PD Hinduja Hospital Mumbai
E-mail: drsiyerin@yahoo.co.in