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Editor: Katharine Van Tassel
Akron Univ. School of Law

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Sunday, December 23, 2007

FDA Preemption Lawsuits

Law.com reports on the latest in pre-emption lawsuits in the drug products liability arena.  It states,

In two appeals that could have a huge impact on the litigation of drug product liability cases, the 3rd U.S. Circuit Court of Appeals heard arguments this week on the issue of whether plaintiffs should be pre-empted from suing over allegedly inadequate warnings on prescription drugs because the warning labels were approved by the Food & Drug Administration.

Lower court judges have reached opposite conclusions, with U.S. District Judge Michael M. Baylson in the Eastern District of Pennsylvania holding that such claims are pre-empted, and U.S. District Judge Jerome B. Simandle in the District of New Jersey holding that they are not.

Both cases stem from suicides in which the plaintiffs claim that manufacturers of antidepressant drugs failed to warn of the increased risk of suicide.

In Colacicco v. Apotex Inc., Baylson found that the plaintiffs' state law tort claims are pre-empted because Congress granted control to the FDA to regulate the prescription drug industry, including the authority to regulate "the specifics of drug labeling."

But in McNellis v. Pfizer Inc., Simandle concluded that a state tort claim was not pre-empted because the FDA's regulations "empower drug manufacturers to enhance the labeling warnings beyond the approved text when new risks emerge." . . .

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