Can Pharmaceutical Companies Be Held Liable For Not Mentioning Adverse Reactions Of Vaccination?
SUPREME COURT UPHOLDS THE NCDRC ORDER DENYING COMPENSATION TO THE COMPLAINANT WHO HAS FAILED TO ESTABLISH EXERGIX-B VACCINE BY THE PHARMACEUTICAL COMPANY AS THE CAUSE OF HIS “MYOSIS”.
WHAT ARE THE FACTS OF THE CASE?
- In order to achieve immunity against contracting Hepatitis B, on 10.08.1998, the appellant approached his family physician Dr. Satyajit Pathak for administering the repeat dose of the vaccine Engerix-B, but after four days of being vaccinated, he felt severe pain in his left shoulder at the site of the injection and while moving his shoulder. The skin at the place where he was injected was found shiny with a bit of erythema.
- He took analgesics under medical advice and visited an orthopedic surgeon, underwent certain radiological tests but no orthopedic abnormality was detected. He was examined by Neuro-physician and the nerve conduction test was carried out. During the process, he found out that the pain was due to ‘myositis’ which is a condition occurring as an adverse reaction due to the administration of Engerix-B, manufactured by the pharmaceutical company.
- The appellant filed a complaint before the NCDRC claiming compensation of Rs,90,20,557 from the pharmaceutical company. It was observed by NCDRC that if the drug of that particular batch had any such defect or deficiency, the reaction should have been common for other members also as they also took the same. Also, the reported frequency has a minimal incidence i.e. 0.02 per million doses. The muscle biopsy was never sent to the pharmaceutical company. Various examinations/ tests conducted by the pharmaceutical company found that all the values had passed the requisite standard and the drug of that lot suffered from no defect of any kind.
WHAT ARE THE LEGAL ISSUES RAISED?
- Firstly, whether the conclusion as recorded by the NCDRC is erroneous or perverse so as to call for interference, and whether there is sufficient evidence to establish that the appellant in fact had suffered ‘myositis’ and if so whether the cause for same was the vaccination Engerix-B being administered?
- Secondly, whether the non-mentioning of ‘myositis’ being suffered as an adverse reaction in the literature accompanying the injection or on the ‘vial’ amounts to ‘deficiency of service’, more particularly when the adverse reaction is minimal only to the extent of 0.02 in one million?
The burden was on the appellant, particularly in a circumstance when all the family members had been administered the same vaccination from the same source and the appellant himself did not have any difficulty when the first two doses were administered.
- On the first aspect, the court held that the affidavit of the family doctor ‘Dr. Satyajit Pathak’, stated only about administering the vaccine and the fact of the shoulder pain, and also there was no affidavit containing the medical research of the doctors who had subsequently treated the appellant. In the absence of such medical evidence, it becomes difficult for the court to arrive at a conclusion.
- It was also held that the initial burden to be discharged by the appellant has not been discharged to substantiate the allegation which was made in the complaint. Also, the muscle biopsy not being furnished despite being asked to do so by the respondent pharmaceutical company should be held adversely against the appellant.
- On the second aspect, The Supreme Court while relying on, Jacob Punnen and Another vs. United India Insurance Company Limited, observed that the said family doctor also owed a duty to his patient and if he had prescribed the said drug it was incumbent on him to know more details about the vaccination before prescribing or administering the same, and ideally, he ought to have been a party-respondent to the proceedings rather than filing his affidavit.
- Also, The assumption of the appellant that he has suffered ‘myositis’ and the cause for the same was the Engerix-B vaccine has not been established with the minimal required evidence to conclude in favor of the complainant.
Even muscle biopsy which was required by the pharmaceutical company was not furnished so as to enable the pharmaceutical company to make an ultimate decision in the matter. Therefore, considering all the aspects, the court held that NCDRC has not committed any error so as to call for interference with the impugned order
WHAT ARE THE VIEWS OF THE SUPREME COURT?
- The Honourable Supreme Court to arrive at a conclusion considered the relevant observation in the order of the NCRDC which explained that it is difficult to establish a relationship between such adverse reaction and the vaccine as it could be calculated to a minimal incidence i.e., 0.02% only. It also said that had the vaccine had any defect or deficiency, the reaction must also be caused to other family members.
- Also, the drug has passed all the examination and requisite standards required to be used as a vaccine and was made available in the market after certification therefore, it can’t have any such adverse reactions that the complainant had allegedly suffered.
- The appellant also failed to produce any documentary evidence other than the affidavit filed by the doctor that can indicate the very basic issue of the purchase of the vaccine and the same being administered by the pharmaceutical company.
- The Apex court said that the non-mentioning of ‘myositis’ being suffered as an adverse reaction in the literature on the ‘vial’ did not amount to “a deficiency of service” on the part of a pharmaceutical company- Glaxo SmithKline Pharmaceuticals Ltd. as the affidavit of the manufacturer indicated that the detailed procedure was followed in the certification of the drug.
- Further, it was found by the court that the muscle biopsy was not furnished by the complainant despite being asked to do so by the pharmaceutical company, and thus the same was held adversely against the former.
- Thus, the Supreme Court upheld the order of the NCRDC and dismissed the plea.
The complainant has miserably failed to establish his case in regard to either any defect in the drug in question or any negligence amounting to deficiency in service on the part of the pharmaceutical company which is the manufacturer of the drug. In that view, the complaint filed by the appellant was dismissed by the NCDRC.
Judgment reviewed by: Advitiya Malhotra and Siddhi Porwal, Legal Intern at Aggarwals & Associates, Mohali