Recently, the Enviably Youthful Drug and Device Law Mother has been pushing us to plan a mother/daughter vacation.   Her longtime companion no longer enjoys travel, and few of her friends share her sense of adventure. So we set about finding a suitable trip for next spring. Threshold categorical decisions proved troublesome. Our normal instinct, given the pace of our everyday life, is to sit still on vacation. We are fond of cruises, and we don’t care to where because we don’t get off of the boat.   The EYDDM prefers an eight-cities-in-seven-days pace. If we have to move, we prefer to rent a car and explore – we are not fond of printed itineraries. And we lean toward countries with national languages other than English. So, in the spirit of compromise, we booked eight days on a bus in Ireland over Memorial Day. Yeah, we know. But you should have seen the EYDDM’s smile. Sometimes, the answer is simple.

As it was in today’s case.   In Romer v. Corin Group, PLC, et al., 2018 WL 4281470 (M.D. Fla. Sept. 7, 2018), the plaintiff alleged that he was injured by when the defendant’s artificial hip implant released metallic contaminants into his body, causing pain and malfunction of the device and ultimately requiring another surgery. He sued in state court on the usual product liability theories, and the defendants removed the case on diversity grounds. After removal, the defendants moved to dismiss the negligence, negligence per se, and strict liability claims.

Listing seven alleged manufacturing defects in the hip implant, the negligence per se claim alleged that the defendants failed to comply with the manufacturing standards the FDA approved as “conditions of FDA’s approval [as well as] the general regulations applicable to Class III medical devices.” Romer, 2018 WL 4281470 at *3. A second negligence per se count alleged that the defendants’ simulator testing of the device was inadequate and violated federal regulations related to the compliance with Approved Design Standards. Id.   The defendants argued that both counts failed as a matter of law because Florida does not recognize a claim for negligence per se based on alleged violations of the federal FDCA or its implementing regulations. The court agreed, holding that, “[u]nder Florida law, the violation of a federal regulation does not create civil liability based upon a theory of negligence per se in the absence of a legislative intent to create a private cause of action.”   Id. at *4 (citations omitted). Because the FDCA and its implanting regulations do not “expressly create civil liability for non-compliance, strongly suggesting a legislative intent not to create a private cause of action,” id., the plaintiffs could not base negligence per se claims on the violations they alleged.

The defendants argued that the design defect claims sounding in both strict liability and negligence were preempted under Riegel because the hip implant device was a Class III medical device subject to pre-market approval (“PMA”) by the FDA. While the plaintiffs argued that the design defect claims escaped preemption because the claims were “based on defendants’ alleged failure to comply with federal laws after the FDA already approved the design of the device,” id. at *5, they made no allegation that the defendants had altered the design approved by the FDA during the PMA process.   The court concluded, “To the extent plaintiffs are asserting parallel claims, . . . . a valid parallel claim cannot challenge the rigorous PMA process itself or the requirements imposed by the FDA pursuant to that process. However, plaintiffs’ design defect claim does just that,” id at *6, and it was therefore expressly preempted.

Similarly, the defendants argued that the plaintiff’s negligence claims, based on the defendants’ alleged failure to warn of defects in the hip implant device or to report adverse events to the FDA, were expressly preempted because they sought “to second-guess the FDA’s determination that the warning language [was] adequate and [to] force [the defendant] to meet an additional standard beyond what the FDA requires.” Id. The defendants also argued that the reporting violations claims were impliedly preempted.

The court held that the warnings claims “imposed requirements that [were] different from, or in addition to, the federal requirements under the MDA,” and were thus expressly preempted. To the extent that the plaintiffs claimed that the defendants failed to comply with FDA reporting requirements, the claim was “simply an attempt to recast a claim for violation of the FDCA as a state law negligence claim.” Id. at *7. As such, it was “premised upon an FDA-reporting requirement that [was] not paralleled by a Florida law duty,” and was impliedly preempted under Buckman, which permits such claims to survive only to the extent that they “do not seek to privately enforce a duty owed to the FDA.” Id.

And so the court dismissed the plaintiffs’ design defect, failure to warn, and “failure to report” claims, leaving manufacturing defect claims pending. The dismissal was without prejudice, and the plaintiffs were given fourteen days to file an amended complaint. We’ll keep you posted