On Tuesday, February 22, the Supreme Court of the United States ruled in Bruesewitz v. Wyeth that manufacturers of childhoold vaccines cannot be sued by individuals who claim that they suffered vaccine-related injuries as a result of an alleged "design defect" in the vaccine (i.e., a theory that a manufacturer should have distributed a vaccine designed differently from the one that the child received.)

 In that case, the parents of Hannah Bruesewitz claimed that her residual seizure disorder was caused by her vaccination with a whole-cell DTP vaccine.  The parents argued that Wyeth should be liable for distributing the whole-cell vaccine because, they claimed, a split-cell or acellular DTP vaccine would not have caused the injuries.  The US Supreme Court ruled that Congress had preempted such design defect claims as part of the National Childhood Vaccine Injury Act of 1986 (the "Vaccine Act").

 In a 6-2 decision, the Supreme Court ruled that the Vaccine Act only allows suits against vaccine manufacturers for vaccine-related injures where the injuries are claimed to result from an improper manufacturing process or from the manufacturer's failure to provide adequate warnings and directions.  Justice Scalia, writing for the Court, held that allegations that the injury would have been avoided by a differently designed vaccine cannot be a basis of liability, under the plain language of the Vaccine Act.  Justice Breyer concurred, noting that permitting tort suits based on design defect claims would "undermine" a basic purpose of the Vaccine Act by threatening a resurgence of the litigation crisis of the 1980s that prompted Congress to pass the Act.  That, in turn, would jeopardize the futur production and development of childhood vaccines.  Justice Elena Kagan recused herself because, during her tenure as Solicitor General, her office filed an amicus brief for the United States recommending that the Supreme Court accept the Bruesewitz case for review, and rule on the merits in Wyeth's favor.

The Vaccine Act includes a "no fault" vaccine compensation program that allows individuals claiming an injury from childhood vaccines, or their representatives, to file a petition for compensation in a specialized office within the US Court of Federal Claims ("Vaccine Cour").  Compensation decisions depend only upon a showing that a childhood vaccine caused the injury; no showing need be made that the manufacturer was somehow at fault, or that the vaccine was defective.  This simplified compensation system is funded by an excise tax that manufacturers pay on each dose of vaccine that is administered.  Hanna Bruesewitz's claim was initially brought in the compensation program, but was denied by the Vaccine Court, which found that her injuries were not caused by her immunization.

To access the text of the full Supreme Court decision, please visit: http://www.supremecourt.gov/opinions/10pdf/09-152.pdf

To access an American Academy of Pediatrics press release about the Supreme Court decision, please visit: http://www.aap.org/advocacy/washing/AAPPressReleaseBruesewitzRuling_2_22_11.pdf

To access the New York Times article, please visit: http://www.nytimes.com/2011/02/23/business/23bizcourt.html

Source: Immunization Action Coalition