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Supreme Court Rules Vaccine Lawsuits Are Federally Preempted

WASHINGTON, D.C. --(Mealey's)  A 6-2 U.S. Supreme Court majority on Feb. 22 ruled that the National Childhood Vaccine Injury Act of 1986 (NCVIA) preempts tort claims asserting design defect against vaccine manufacturers (Russell Bruesewitz, et al. v. Wyeth LLC, et al., No. 09-152, U.S. Sup.). 

Hannah Bruesewitz was born in 1991 and in 1992 received a diphtheria, tetanus and pertussis (DTP) vaccine made by Lederele Laboratories.  Within 24 hours, she experience seizures and was diagnosed with permanent residual seizure disorder and developmental delay. 

Russell and Robalee Bruesewitz filed a compensation petition under the NCVIA with the U.S. Court of Federal Claims.  A special master denied the petition, and the Bruesewitzes exercised their statutory right to reject the program decision and sue Wyeth, which succeed Lederle, in court. 

The U.S. District Court for the Eastern District of Pennsylvania granted summary judgment to Wyeth, finding that strict liability and negligence design-defect claims are preempted by federal law.  The Third Circuit U.S. Court of Appeals affirmed, and the Supreme Court granted certiorari.   

Writing for the majority, Justice Antonin Scalia said Congress' use of the word "unavoidable" in the NCVIA to describe vaccine side effects is key to understanding legislative intent. 

"Provided that there was proper manufacture and warning, any remaining side effects, including those resulting from design defects, are deemed to have been unavoidable," Justice Scalia wrote.  "State-law design-defect claims are therefore preempted.  If a manufacturer could be held liable for failure to use a different design, the word 'unavoidable' would do no work.  A side effect of a vaccine could always have been avoidable by use of a differently designed vaccine not containing the harmful element.  The language of the provision thus suggests that the design of the vaccine is a given, not subject to question in the tort action." 

Justice Scalia was joined by Chief Justice John G. Roberts Jr. and Justices Anthony M. Kennedy, Clarence Thomas and Samuel A. Alito Jr.  Justice Stephen G. Breyer filed a separate concurring opinion. 

Justice Sonia Sotomayor filed a dissenting opinion, joined by Justice Ruth Bader Ginsburg.  The dissenters said the majority "imposes its own bare policy preferences" on the act by excising language from and misreading the text. 

"Its decision 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," the dissenters said.

 Justice Elena Kagan did not take part in the case since she was U.S. solicitor general at the time the case was filed with the court.  The solicitor general represents the federal government and participated in oral argument. 

[Editor's Note:  Full coverage will be in the March 3 issue of Mealey's Emerging Drugs & Devices.  In the meantime, the opinion is available at or by calling the Customer Support Department at 1-800-833-9844.  Document #28-110303-002Z.  For all of your legal news needs, please visit] 

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