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Law.com’s Daily Business Review recently published an article by Hollingsworth LLP attorneys Grant W. Hollingsworth and Ann Czyzewski Farr that examines how Depo-Provera plaintiffs are attempting to escape preemption via impermissible expert testimony.

An important decision on FDA preemption of prescription drugs is pending in the Northern District of Florida in the In re Depo-Provera MDL. Over 1,000 plaintiffs in that MDL allege Depo-Provera labels failed to warn of the increased risk of meningiomas (a type of brain tumor). Preemption arguments implicating the entire MDL inventory turn on whether there is “clear evidence that the FDA would not have approved a proposed label change.”

For decades, the plaintiffs’ bar has argued that courts can only preempt prescription pharmaceutical state law failure-to-warn claims when the FDA formally rejects a proposed label change. Faced with that exact scenario, plaintiffs in the Depo-Provera MDL now argue that is not enough.

The plaintiffs bringing state law failure-to-warn claims against prescription pharmaceuticals face an uphill battle to avoid preemption in the setting of the FDA formally rejecting a proposed label change, as every court confronting that scenario has held the plaintiffs’ claims preempted.

The plaintiffs’ reliance on the opinion testimony of an FDA expert to concoct an inadequate warning when the FDA’s CRL provides no foundation for that opinion not only contravenes the FDA preemption jurisprudence, but also Daubert and Amended Rule 702 progeny. In short, the plaintiffs cannot substitute the opinion of their FDA expert that the Depo-Provera label is inadequate, or that the FDA was not fully informed, when the FDA conducted a lengthy review of a robust dataset and issued a CRL suggesting just the opposite.

if the district judge overseeing the Depo-Provera MDL finds that the plaintiffs’ claims are not preempted, then the avenues to avoid preemption of FDA-approved drugs will be expanded well beyond that countenanced by U.S. Supreme Court jurisprudence.

Law.com subscribers may view the full story online.