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 FAA as the case may be). The Third Circuit based its decision primarily on Buckman as analogous to a fraud-on-the-FDA claim and rendering it impliedly preempted.
After Sikkelee, we also feel it's safe to say that the horrendous decision a few months ago in Bull v. St. Jude Medical, Inc., 2018 WL 3397544 (E.D. Pa. Jul. 12, 2018) (recognizing failure-to-report-to-FDA claim), is now just bull. (Decision discussed here).
We can't completely ignore that the Third Circuit also overturned, in a 2-1 decision, the district court's decision finding plaintiff's other claims were conflict preempted. The majority found the regulatory framework to be more like Wyeth v. Levine, 555 U.S. 555 (2009) – finding FAA regulations would have allowed defendant to make a change without prior FAA approval and therefore concluding that the claim was not preempted absent "clear evidence" that FAA would have rejected the change. Whereas the Middle District and dissenting Third Circuit opinions found PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011) and Mutual Pharmaceutical Co. v. Bartlett, 570 U.S. 472 (2013) controlled interpreting FAA regulations as not allowing independent design changes. Since this discussion really turns on distinguishable FAA-based regulatory facts, we don't think it has much impact on our drug and device world except the continued recognition of Mensing and Bartlett outside the generic drug arena. Also, the clear evidence aspects of the decision likely will be affected by the Supreme Court's decision in the pending Fosamax appeal.
This article is presented for informational purposes only and is not intended to constitute legal advice.
