The U.S. Supreme Court is once again being asked to consider when personal injury suits are pre-empted by federal law. This time the focus is on vaccine-related injuries.

Wyeth and GlaxoSmithKline filed a petition for certiorari with the court asking it to determine whether the National Childhood Vaccine Injury Act of 1986 expressly pre-empts a state law tort claim alleging a vaccine-related injury could have been avoided by a vaccine design allegedly safer than the one approved by FDA.

A trial court in Georgia ruled in the case, American Home Products v. Ferrari, that the law expressly pre-empted design defect claims. An appeals court reversed the order and in October 2008 the Georgia Supreme Court affirmed the appeals court decision finding that the Vaccine Act "clearly does not pre-empt all design defect claims against vaccine manufacturers."

Instead, the court said design defect claims are pre-empted only "if it is determined, on a case-by-case basis, that the injurious side effects of the particular vaccine were unavoidable."

Defense lawyers contend that the ruling is an anomaly.

Third Circuit Disagrees With Georgia Ruling

"Every court to consider the issue, other than the appellate courts in Georgia, has found that the only claims that can be brought against vaccine manufacturers after exhaustion of Vaccine Court remedies are claims based on alleged improper manufacturing or improper warning under specific conditions, such as a failure to provide all relevant information to FDA," said Daniel Thomasch, a partner at Orrick, Herrington & Sutcliffe and counsel for AHP, now Wyeth.

The Third Circuit U.S. Court of Appeals rejected the Georgia appeals court decision in its ruling in another case, Bruesewitz v. Wyeth. In a March 27 order the Third Circuit affirmed a lower court's summary judgment for Wyeth, thereby creating a split between a federal appeals court and the highest state court. The Third Circuit denied plaintiffs' request for a rehearing on May 6.

The 1986 Vaccine Act was enacted to shield vaccine manufacturers from certain tort litigation. In the 1980s several manufacturers left the market as a result of the costs of product liability suits. The law established a vaccine injury compensation program as a no-fault alternative to litigation. Claims for vaccine-related injuries go before the Vaccine Court, a part of the U.S. Court of Federal Claims. If the court rules against the claim, the petitioner can pursue certain claims in federal or state court.

In AHP v. Ferrari, Marcelo and Carolyn Ferrari claim FDA-approved vaccines, specifically the preservative thimerosal used in the formulations, caused their child to become autistic. In February the Vaccine Court issued opinions in the first three test cases to consider the theory that the measles-mump-rubella vaccine, in combination with thimerosal-containing vaccines, could cause autism. The court concluded that there was no link between the two (¹ Also see "A Legal Win For Vaccine Industry: Federal Court Finds No Link To Autism" - Pink Sheet, 16 February, 2009., p. 30).

Wyeth and GSK argue in their petition that the case has profound national importance. "The court should grant this petition because the Georgia Supreme Court's rule threatens public health by inviting a litigation deluge even bigger than the one that spurred Congress to urgent action in 1986," they state.

They say the ruling could lead to potentially devastating vaccine shortages and stall the development of new life-saving vaccines. A law enacted in 2006 appears to provide tort immunity for vaccines and other products used for public health emergencies, such as the swine flu outbreak (see ² Also see "Swine Flu Vaccines Likely to Be Shielded From Tort Claims" - Pink Sheet, 11 May, 2009.).

The companies note that civil suits against vaccine manufacturers now number over 350 with most alleging vaccine design defect. In Georgia alone, there are more than 20 cases pending.

The American Academy of Pediatric and 10 other physician and public health organizations filed an amicus brief in support of the petitioners.

- Brenda Sandburg (b.sandburg@elsevier.com)

Vaccine Makers Ask Supreme Court To Assess Their Liability In Tort Claims

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