Pfizer vaccine ruling strengthens makers' immunity to lawsuits

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The Supreme Court bolstered a law shielding vaccine makers from injury lawsuits.

Six of the court's justices ruled against a Pennsylvania family seeking to sue Pfizer for their daughter's seizure disorder, which they allege was caused by Wyeth predecessor Lederle Laboratories' diphtheria-tetanus-pertussis vaccine, which was discontinued in 1998. The court found that the National Childhood Vaccine Injury Act of 1986, which was designed to keep pharmas from bailing out of the vaccine market by creating a no-fault system of compensation for vaccine-related injury or death, prohibited such a suit. The parents' initial claims were denied by a Federal adjudicator under the 1986 Act. They then filed suit in Pennsylvania.

Writing for the majority, Justice Antonin Scalia said: “Provided that there was proper manufacture and warning, any remaining side effects, including those resulting from design defects, are deemed to have been unavoidable.”

Justices Sonia Sotomayor and Ruth Bader Ginsburg dissented, while Justice Elena Kagan recused herself.  In her dissent, Sotomayor said the decision ignores the intent of Congress and “leaves a regulatory vacuum in which no one ensures that vaccine manufacturers adequately take account of scientific and technological advancements when designing or distributing their products.”

Pfizer hailed the decision as “a win for public health.” EVP and general counsel Amy Schulman said in a statement: “The Vaccine Act that Congress enacted nearly 25 years ago appropriately places the responsibility for determining the optimal design of life-saving childhood vaccines in the hands of expert federal agencies, not a patchwork of state tort systems.”



 

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