Here’s another guest post, this time from Reed Smith‘s Elizabeth Graham Minerd. This post concerns PMA preemption, and a second opinion largely getting rid of a case that we blogged about before. As always, Elizabeth deserves all the credit, and any blame, for what follows. Without further ado:
In the recent decision of Marion v. Smith & Nephew, Inc., 2016 WL 4098608 (D. Utah July 27, 2016), the Court dismissed all but one of the plaintiffs’ claims relating to a premarket approved medical device from the amended complaint. This was the Court’s second time finding the plaintiffs’ pleading largely deficient. This blog previously discussed the Court’s first order dismissing plaintiffs’ original complaint with leave to amend here. In that order, the Court provided the plaintiffs with a road map to navigating the “Scylla and Charybdis” of pleading a legally viable claim related to a premarket approved device. But even with a road map, the plaintiffs were only able to navigate one of their nine claims through Scylla and Charybdis and that one claim did not escape unscathed.
In Marion, the plaintiff was implanted with the defendant’s hip resurfacing device—a device that received premarket approval a little over a year prior to the plaintiff’s surgery. 2016 WL 4098608, at *1. After six years, the device allegedly failed and the plaintiff had it surgically removed. Id. The plaintiffs filed a lawsuit asserting various claims against the defendant for the device’s purported failure. Id.
The Court dismissed the plaintiffs’ original complaint, but granted the plaintiffs leave to amend. Id. In doing so, the Court provided “clear guidance” regarding the three issues that the plaintiffs would need to address in the amended complaint in order to state a parallel claim that would survive both preemption and Twombly/Iqbal [editorial note: regular bloggers call this “TwIqbal“]:
First the court required the [plaintiffs] to identify with specificity the federal law requirements that parallel the state law claims. Second, the court required the [plaintiffs] to identify with specificity the state law duties that existed prior to but allegedly parallel the requirements for the [device] under federal law. Finally, the [plaintiffs] were required to plead adequate facts to make their parallel state law claims plausible on their face.
Id. at *3.
With this road map in hand, the plaintiffs filed their amended complaint asserting nine claims against the defendant. But again, all but one of the plaintiffs’ claims were left wrecked on the rocks or swallowed by the whirlpool.
Specifically, the plaintiffs’ claims for strict products liability – manufacturing defect ran into both Twombly/ Iqbal and preemption. Id. at *5. The Court dismissed the manufacturing defect claim because (1) the plaintiffs “offer[ed] only conclusory allegations of alleged regulatory violations without any factual support” and (2) it would be preempted anyway to the extent the plaintiffs allege that the device as approved by the FDA was unreasonably dangerous. Id. So too plaintiffs’ claims for strict products liability – failure to warn and negligent infliction of emotional distress ran into both Twombly/ Iqbal and preemption and were dismissed. Id. at *5-*6.
The plaintiffs’ claim for breach of implied warranties crashed into express preemption and was dismissed because the FDA deemed the device fit for the purpose for which it had been approved and the plaintiffs’ implied warranties claim necessarily attacked that determination. Id. at *6.
Meanwhile, the plaintiffs’ claim for breach of express warranty collided with Twombly/Iqbal and was dismissed because the plaintiff failed to plead what express warranty was actually made to her prior to implantation of the device. Id. at *5. The plaintiffs’ fraud based claims—negligent misrepresentation and fraudulent concealment—were smashed on the rocks of Rule 9 and were dismissed. Id. at *6. And the plaintiffs voluntarily dismissed their unfair and deceptive trade practices claim. Id.
The plaintiffs were only able to navigate their negligence claim through Scylla and Charybdis, but even it did not survive unscathed. The Court narrowed the plaintiffs’ negligence claim and rejected it to the extent that it was based on purported violations of regulations that the plaintiffs’ counsel admitted did not apply to the device. Id. at *4. The Court further narrowed the plaintiffs’ negligence claim and rejected it to the extent it was based on violations of regulations “asserted in conclusory fashion without any factual support to move the allegations from conceivable to plausible.” Id. And the Court narrowed the plaintiffs’ negligence claim even further and rejected it to the extent that it was based on “violations of federal regulations relate to conduct by the defendant during the PMA process prior to the final grant of PMA” because such allegations were no different than the fraud on the FDA theory rejected in Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341 (2001). Id.
The Court allowed a negligence claim based on alleged violations of the federal requirements relating to adverse event reporting to limp passed the defendant’s motion to dismiss. Id. The Court found that the plaintiffs had raised a plausible inference that the defendant violated federal regulations relating to adverse event reporting based on allegations that there was a delay in the defendant receiving reports of adverse events and the defendant issued a voluntary recall. Id. at 5. However, the Court recognized that this claim will require plaintiffs to prove that the plaintiff’s injuries would not have occurred or would have been mitigated had the defendant complied with these adverse event reporting regulations. Id. Since the plaintiff’s implant surgery was only a year after approval, this will likely be an insurmountable causation hurdle.
The Court also allowed, but did not analyze, plaintiffs’ negligence claim to the extent it is based on alleged violations of the federal requirements to train physicians and surgeons regarding the proper use of the device. Id. at *4. Notably, the Court did not mention any allegation that the device—which was in the plaintiff for six years before its alleged failure—had been implanted improperly by her surgeon.
Overall a solid win for the defense. Having had all but one of their claims wrecked by Scylla and Charybdis, the plaintiffs now face a likely insurmountable causation hurdle.