The Vaccine Act Does Not Preempt All Design Defect Claims
By Amita A. Sanghvi

Recently the Georgia Supreme Court affirmed a decision of the Court of Appeals relating to the liability of pharmaceutical companies for drug vaccines.  In American Home Products Corp. v. Ferrari, S07G1708 (Oct. 6, 2008), the Court unanimously ruled that the National Childhood Vaccine Injury Compensation Act of 1986¹ (the “Vaccine Act”) does not pre-empt state law.  Marcelo and Carolyn Ferrari sued several vaccine manufacturers, alleging that their minor suffered neurological damage caused by vaccines containing thimerosal, a mercury-based preservative. 

The trial court, in November 1995, granted partial summary judgment to the vaccine manufacturers ruling that the design defect claims were preempted by the Vaccine Act.  However, the Georgia Court of Appeals, relying on a 2005 Supreme Court decision², reversed the trial court ruling holding that despite legislative history and Congressional intent, it was the Court of Appeals’ duty to accept any plausible reading of the statute that avoided pre-emption.

Section 22(b) of the Vaccine Act states that “[n]o vaccine manufacturer shall be liable in a civil action for damages arising from a vaccine related injury or death... 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.”  The Court of Appeals ruled that there were two plausible alternative interpretations of the Vaccine Act.  One interpretation was that all vaccine injuries were unavoidable and subject to preemption under the Act if the vaccine was properly prepared and accompanied by proper directions and warnings. The other interpretation was that design defect claims were preempted only if the side effects were determined to be unavoidable by a jury on a case-by-case basis. 

Although the Supreme Court affirmed the Court of Appeals adoption of the second interpretation that the Vaccine Act does not preempt all design defect claims, they, unlike the Court of Appeals, focused on Congressional intent to reach their decision. The Supreme Court determined that the legislative history does not show a “clear and manifest” congressional purpose of the federal law to supersede state tort law with respect to all defective design claims. Instead, the Supreme Court provided that a vaccine manufacturer could not be held liable for defective design if it was determined, on a case-by-case basis, that the side effects of the particular vaccine were unavoidable. The question of whether the side effects were unavoidable is a question of fact for a jury to decide.  

The holding of this case paves the way for the Ferraris to pursue their case in trial court and has important implications on federal pre-emption issues arising in pharmaceutical litigation. However, Georgia is the first state to challenge the Vaccine Act giving immunity to vaccine manufacturers. Recently, prior to the Ferrari holding, a Philadelphia judge relied on Congress’s intent to find that the Vaccine Act did pre-empt all state law design defect claims without a case-by-case assessment of whether the side effects of the particular vaccine were unavoidable. Congress’s intent in this case was based on the presumption that there would be instability in the vaccine market caused by numerous suits over vaccine injuries if the Vaccine Act did not pre-empt state law. Although both the Pennsylvania and Georgia courts examined Congressional intent to reach their decisions, the courts did not agree on the actual intent of Congress suggesting that the United States Supreme Court may be asked to consider this issue.

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