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Supreme Court rules vaccine makers immune from design defect suits

By Ashley Hileman

[JURIST] The US Supreme Court [official website; JURIST news archive] on Tuesday ruled [opinion, PDF] 6-2 in Bruesewitz v. Wyeth [Cornell LII backgrounder; JURIST report] that section 22(b)(1) [text] of the National Childhood Vaccine Injury Act of 1986 provides blanket immunity to vaccine manufacturers from all tort actions filed in state or federal court alleging design defects. The issue in this case arises from the text of the section itself, which expressly preempts certain design defect claims against vaccine manufacturers "if the injury or death resulted from side effects that were unavoidable even though the vaccine was properly prepared and was accompanied by proper directions and warnings." Petitioners argued that their suit, alleging poor design, should not be preempted, as the side effects were avoidable. However, the court affirmed the ruling of the US Court of Appeals for the Third Circuit, which held [opinion, PDF] that section 22(b)(1) preempts all vaccine design defect claims, regardless of whether the vaccine's side effects were avoidable. Relying on textual interpretation and the ultimate purpose of the act, Justice Antonin Scalia wrote for the majority:

The "even though" clause clarifies the word that precedes it. It delineates the preventative measures that a vaccine manufacturer must have taken for a side-effect to be considered "unavoidable" under the statute. Provided that there was proper manufacture and warning, any remaining side effects, including those resulting from design defects, are deemed to have been unavoidable. State-law design-defect claims are therefore preempted.

Justice Stephen Breyer, concurring with the majority, recognized the validity of its textual argument but called its reliance on the textual question alone a "close one" and emphasized the use of other sources including legislative history, statutory purpose and the views of the federal administrative agency to reinforce the court's conclusion. In contrast, Justice Sonia Sotomayor, in her dissenting opinion joined by Ruth Bader Ginsburg, interpreted the text quite differently and referenced other uses of similarly worded clauses within the act to reinforce her view that the "even though" clause sets forth a condition, which in this case has not been met, to invoke section 22(b)(1)'s defense to tort liability. Justice Elena Kagan took no part in deciding the case.

This is one of many court cases that have stemmed from the use of vaccines. In September, the US Court of Appeals for the Federal Circuit affirmed a decision issued last year by the US Court of Federal Claims finding insufficient evidence [JURIST reports] to establish a link between childhood vaccines and autism in three test cases. The decision focused on the case of 15-year-old Michelle Cedillo, who received the MMR vaccine [NIH backgrounder] when she was 15 months old and was subsequently diagnosed with autism and various gastrointestinal disorders. Michelle's parents alleged that Thimerosal [FDA backgrounder], the mercury-based preservative found in Michelle's MMR vaccine, damaged her immune system, rendering her unable to defend against the measles virus contained in the vaccine, which spread throughout her body and caused her current problems. The family sought compensation under the no-fault National Vaccine Injury Compensation Program [HRSA backgrounder]. The court found petitioners were unable to establish that the MMR vaccine was a substantial factor in bringing about Michelle's injuries and that the lower court did not err in placing this burden on petitioners. The court also affirmed the lower court's finding that the Department of Health and Human Services (HHS) [official website] experts proved petitioners' laboratory results establishing the connection between the vaccines and illnesses were "severely flawed."

Full post as published by JURIST - The Paper Chase on February 22, 2011 (boomark / email).