Supreme Court Upholds NCDRC Order Refusing to Hold Glaxo Smithkline Liable For Not Declaring Adverse Reaction of Vaccine

Supreme Court Upholds NCDRC Order Refusing to Hold Glaxo Smithkline Liable For Not Declaring Adverse Reaction of Vaccine

States it was up to the doctors to advise the patient

The Supreme Court has upheld an order of the National Consumer Disputes Redressal Commission (NCDRC), which held that no case of deficiency of service could be made against the drug manufacturer, Glaxo Smithkline Pharmaceuticals Ltd on the administration of Engerix-B vaccine.

The appellant complained that along with his family members, he had got the vaccine administered by their family doctor. But as an adverse reaction, he developed ‘myositis.’

However, the bench of Justice A.S. Bopanna and Justice Prashant Kumar Mishra noted that the complainant had failed to establish that he had suffered an adverse reaction due to the vaccination.

The Court stated, “Except for the appellant assuming that he suffered ‘myositis’ and the cause was the Engerix-B vaccine, the same has not been established with the minimal required evidence to conclude even on the preponderance of probability.”

The Apex Court held that non-mentioning of ‘myositis’ as an adverse reaction in the literature accompanying the injection or on the ‘vial’, did not amount to ‘deficiency of service’ on the part of the pharmaceutical company. This was particularly true when the adverse reaction was to the minimal level, i.e., 0.02 in one million. It also observed the manufacturer’s affidavit, which indicated that a detailed procedure was followed in the certification of the drug.

The Judges noted that the drug was not available for administration without the doctor's prescription. They held that the family doctor also owed a duty to his patient. If he prescribed the drug, it was incumbent on him to know more details about the vaccination before prescribing or administering it.

Thus, the allegations raised in the complaint would also make the family doctor responsible. He should have been a party to the proceedings rather than filing his affidavit. Also, if the same drug was administered to all family members and after the third dose was administered to the appellant, he suffered discomfort, which he complained of, it would raise a question of whether it was administered in the manner and the spot indicated to be administered.

In its 25 April 2012 order, the NCDRC had dismissed the consumer complaint seeking compensation of over Rs.90 lakhs from Glaxo Smithkline. The Commission concluded that the complainant failed to establish his case regarding the alleged defect in the drug, or negligence amounting to deficiency in service. It added that not indicating ‘myositis’ as an adverse reaction in the literature accompanying the vaccination or on the ‘vial’ did not amount to deficiency, since it was an adverse reaction to the ‘minimal level’.

In the petitioner’s appeal filed against the NCDRC decision, the Top Court observed that there was no documentary evidence on record to indicate the very basic issue of purchasing the vaccine and it being administered. There was only an affidavit from the family doctor stating that the injection was administered by him to the complainant.

The bench held that there was no material based on which the family doctor had reached the conclusion that the complainant suffered a reaction of the Engerix-B vaccine. The Court thus found that the doctors’ affidavits filed in the case were not of any evidentiary value.

The Judges ruled, “The said doctors, except vaguely stating about the incident, have not authentically provided any details based on their medical expertise or on their research on the subject from medical literature or commentaries about the adverse reaction of the vaccine in question nor have they brought on record any authentic material. In the absence of such medical evidence, the Courts on their own will lack the expertise to come to a conclusion, more particularly in a case of the present nature where the cause itself is required to be unraveled.”

The bench held that the complainant failed to discharge the initial burden of substantiating the allegations made in the complaint.

Justice Bopanna and Justice Mishra remarked, “The affidavit filed by the family doctor and the uncle of the appellant, who is also a doctor, except referring to the fact of the vaccine being administered to the appellant and the appellant complaining of the discomfort, subsequent thereto, does not bring on record the aspect in medical terms or with reference to any medical records to co-relate that the pain suffered by the appellant was in fact ‘myositis’ and it was due to the vaccine being administered.”

The bench added that the burden was on the complainant to substantiate the allegations, more particularly since the entire family had gotten the same vaccination administered from the same source and the complainant himself did not undergo any difficulty when the first two doses were administered.

The Court further noted that the muscle biopsy was not furnished by the complainant despite being asked by the pharmaceutical company. Thus, it should be held adversely against the complainant.

Thus, the bench dismissed the complainant’s appeal and upheld the NCDRC order.