U.S. Judge Lawrence F. Stengel of the Eastern District of Pennsylvania retained design defect and inadequate testing claims against Bayer Pharmaceutical Corp.’s Rhogam immune globulin product and transferred the case to the Eastern District of Virginia.

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The defendants raised two preemption arguments, one of express preemption under the Vaccine Act and a second of conflict preemption under the Food and Drug Administration’s position expressed Jan. 24, 2006, as the Preamble to the Final Rule. Judge Stengel disagreed with the express preemption argument, but said the legislative history of the Vaccine Act as set forth in Blackmon v. Am. Home Prods. Corp (328 F. Supp. 2d 659, 663-66 [S.D. Tex. 2004]) shows that Congress intended to preempt claims asserting strict liability and design defect based on negligence, but not failure to warn.

However, the judge ruled that failure to warn on all products is conflict preempted by the FDA’s Preamble/Final Rule, which says state laws requiring stronger or different labels conflict with the FDA’s authority over the contents of drug labels.

“The failure to warn claims seek to hold the defendants liable for failing to include labeling that was not scientifically supported and would have been false and misleading under federal law,” the judge said. “The defendants could not have altered the labeling without FDA approval; the additional labeling would have posed a threat to the federal regulatory objectives of the FDA.”

Not so the design defect and testing claims for Rhogam, the judge said. Bayer could have reformulated Rhogam without thimerosal, the judge said, although it would have had to seek FDA approval for the redesign, and it could have conducted additional safety testing without running afoul of any FDA regulation.

The plaintiffs had alleged that Wesley Sykes, now 11, was injured by thimerosal in Rhogam administered to his mother when she was pregnant with him and in vaccines he received after birth.

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