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Preemption in the In Box

By James M. Beck and Mark Herrmann

A tip of the cyberhat to Ed Gerecke and Dave Walz and of Carlton Fields for passing along news of another preemption win, in Wolicki-Gables v. Arrow International, Inc., ___ F. Supp. 2d ___, 2009 WL 2190069 (M.D. Fla. July 22, 2009). That's a quick decision to publish by West (and one we didn't lobby for), so they obviously think it's an important case.

We'll let Dave describe it for you himself:

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Following up on Thursday's Riegel post, attached is a recent summary judgment that we won in the M.D. Fla. (along with counsel for Arrow) in Wolicki-Gables v. Arrow International, Inc., --- F. Supp. 2d ----, 2009 WL 2190069 (M.D. Fla. July 22, 2009). The case involved an implantable pain pump. The gist of the preemption decision, which covered strict-liability and negligence claims against the manufacturer defendants and a negligence claim against the sales representative, is that the jury could find a defect even if the manufacturer followed and complied with the FDA's practices and regulations for manufacture, design, and labeling. Hence, the claims imposed requirements "different from, or in addition to" the FDA requirements.

Aside from preemption, the court also disposed of parts of the strict liability and negligence claims under the learned-intermediary doctrine, the lack of expert proof, and no evidence of causation. For the manufacturer defendants that did not actually make or distribute the pump implanted in the plaintiff, the court held that such defendants were not subject to strict liability and were not vicariously liable for the sales representative who acted as an independent contractor.

The court also disposed of some rather novel negligence claims against the sales representative alleging that he should have intervened in a revision procedure to stop the operating surgeon from using the product off-label. Plaintiff also alleged that the sales representative violated informed consent by attending the revision procedure and disposed of a catheter connector removed during the revision procedure.

Those claims failed because the sales representative had no duty regarding the medical decisions made during the revision procedure and breached no duty because the surgeon made all the medical decisions. Likewise, informed consent failed because the doctrine does not apply to non-medical practitioners, the sales representative did not know about the lack of consent, and his presence in the operating room caused no injury to the plaintiff. Off-label use failed because it is not prohibited, was not pleaded properly, no private right of action exists to enforce the FDCA, and no evidence showed that the sales representative promoted off-label use. Finally, disposal failed because no evidence showed that the sales representative did anything other than return the catheter connector to the manufacturer, the manufacturer had no obligation under the regulations to retain the connector, and plaintiff's expert rendered an opinion even without the catheter connector.

All in all, pretty comprehensive. Plus, this is the same case in which we also successfully whittled down the negligence claims against some of the manufacturer defendants under Twombly (previous order attached (2008 WL 2773721)). So, the combination of a dose of Twombly followed by a dose of Riegel equaled summary judgment here.

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Looks good to us. We'd love to have attached copies, but we respect West's copyright. So send us the actual slip opinion next time, guys. And congratulations on a great result.

Full post as published by Drug and Device Law on August 03, 2009 (boomark / email).