Wyeth, in Autism Case, Again Stars in Preemption Issue at Supreme Court

Last Updated Jun 9, 2009 4:09 PM EDT

Wyeth has again found itself at the center of a U.S. Supreme Court case on whether drug companies can be held liable for injuries suffered by patients who took their drugs.

The Supremes on Monday asked the Obama administration for its position on American Home Products v. Ferrari, a case about whether thimerosal vaccines cause autism.

In March, Wyeth lost a case on preemption. The court ruled that FDA rules do not preempt claims based on individual state laws.

In the current case, Wyeth (as the acquirer of AHP) is arguing that the Vaccine Act prevents anyone from claiming injury unless they can demonstrate that there was a design defect in the vaccine. The family of the plaintiff, Stefan Ferrari, alleges he became autistic after taking Wyeth's vaccines. They claim the Vaccine Act -- which prevents people from suing if there was no defect in the vaccine -- does not stop their claim if they can demonstrate that Wyeth knew of a safer way to make vaccines.

The case revolves around the rather boring issue of preemption, but that will be eclipsed by the much more emotional autism issue. No court has so far found that thimerosal causes autism. But that has not stopped parents from believing that it does. The case is American Home Products Corp. v. Ferrari, 08-1120.

Here's a selection from Wyeth's brief to the Supremes:

[The] provision expressly preempts all civil liability "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."
... every court to rule on the Vaccine Act's preemption provision has correctly interpreted it to categorically preempt all claims for vaccine-related injuries unless the vaccine at issue contained a manufacturing defect ...
... however, the Georgia Supreme Court rejected the prevailing categorical rule. It held that Section 22(b)(1) does not preclude design defect claims unless the manufacturer demonstrates, case by case, that there was no safer design that could have avoided the injury.
Here's a section from the Ferrari brief:
[A ruling for Wyeth] would create an enormous loophole by insulating vaccine manufacturers from liability even where the injurious side effects could have been avoided by better product design.
... courts had long construed to require a product-specific analysis of whether a particular product is actually incapable of being any safer. The court below thus correctly held that Respondents' design defect claims were not preempted absent such a showing, which has not been made in this case.
Here's the Georgia Supreme Court's ruling.