The Tenth Circuit issued an opinion on Tuesday, finding that state law claims asserted against Medtronic, manufacturer of the InFuse bone growth stimulator were preempted by FDA approval of the medical device under the Medical Device Act (“MDA”).
Plaintiff in the case alleged that Medtronic representatives promoted an off-label, posterior surgical approach for the device, which had been approved specifically for implantation with an anterior surgical approach.
The Tenth Circuit’s opinion includes an exploration and explanation of the development of preemption jurisprudence, particularly with regard to the regulation of medical devices, aptly noting, “the difficulty of crafting a complaint sufficient to satisfy all these demands has been compared to the task of navigating between Scylla and Charybdis.” Caplinger v. Medtronic, Inc., Case No. 13-6061, 10th Cir. (decided April 21, 2015) (citing Jean Macchiaroli Eggen, Navigating Between Scylla and Charybdis: Preemption of Medical Device “Parallel Claims,” 9 J. Health & Biomedical L. 159, 161 (2013)).
The Court’s opinion relies upon the lack of a dispute as to device-specific federal requirements that apply to the device, having endured the FDA pre-market approval process. The Court reasoned that under applicable law, the MDA would preempt all of the plaintiff’s claims unless”federal requirements impose duties that are at least as broad as those she seeks to vindicate through state law.” The plaintiff did not identify a federal parallel to her design defect and breach of warranty claims. She identified federal regulations as parallel to her failure to warn, negligence, and negligent misrepresentation claims, but the Court found these regulations insufficient insofar as they only dealt with the labeling of a medical device, beyond the ambit of her state law claims. The Court found that those parts of her state law claims that were paralleled by the federal regulations were preempted by the FDA’s premarket approval of the device and the device labeling. The Tenth Circuit thus concluded that the District Court did not err in dismissing the plaintiff’s claims for failure to state a claim premised upon preemption.
However, the Court noted:
That’s not to say another plaintiff won’t ever be able to succeed where Ms.Caplinger has failed. For example,we don’t question the possibility that buried somewhere in the heap of federal law parallel provisions exist to save claims like Ms. Caplinger’s. After all, the FDA’s medical device regulations alone cover 592 pages of eight-point type and the Supreme Court has suggested that in searching for a parallel federal duty a plaintiff may scour them all as well as the statute itself. And lurking in there somewhere might be some answer to the apparent conundrum of how a plaintiff might use state law to require more label warnings that federal law seems to prohibit.
Overall, the Tenth Circuit’s opinion is clearly a win for Medtronic and for preemption — but perhaps the Court has provided guidance in navigating those straits.