Third Circuit Rejects Failure To Report Claims

Author:Ms Michelle Yeary
Profession:Reed Smith
 
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Failure to warn claims premised on a failure to report incidents to a federal governing agency are preempted in the Third Circuit. Sikkelee v. Precision Airmotive Corporation, — F.3d -, 2018 WL 5289702 (3d. Cir. Oct. 25, 2018). And this would be a DDL Blog drop the mic moment if the ruling had come in a prescription drug case instead of in an opinion involving airplanes. However, throughout the decision, the court analogizes to drug preemption decisions making us feel safe to say that Sikkelee's Buckman-based rationale applies to all governmental agencies - FDA included. This isn't the first time we've blogged about Sikkelee (see here and here). It's bounced back and forth from the Middle District of Pennsylvania to the Third Circuit a couple of times with preemption at the forefront.

And, in the unanimous portion of the decision, the Third Circuit upheld the district court's decision to grant defendant's summary judgement motion dismissing plaintiff's failure-to-notify-the-FAA claim. Id. at *11. FAA regulations require manufacturers to "report any failure, malfunction, or defect in any product . . . that it determines has results in any of the [listed] occurrences." Id. Plaintiff argued that the alleged defect at issue was the type required to be reported, that defendant failed to report, and if it had reported, the FAA would have taken action. Id. Sound familiar? Replace "defect" with "adverse event" and "FAA" with "FDA" and you've got a Stengel claim. But unlike the Ninth Circuit, the Third Circuit found that what plaintiff was doing was trying "to use a federal duty and standard of care as the basis for this state-law negligence claim." Id. Right. We say that all the time in pharmaceutical cases. Federal law does not require warnings to plaintiffs or their doctors. State law does not require warnings to the FDA. In the absence of a state-law duty to make reports to a government agency, a failure to report claim is an improper private attempt to enforce the FDCA (or...

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