United States: Tennessee Trial Court Holds Claims Preempted Notwithstanding Alleged Off-Label Use Of A Medical Device

Today we discuss Sherrod v. Smith & Nephew, Inc., 2021 Tenn. Cir. LEXIS 74 (Tenn. Cir. Ct. 2021), a recent Tennessee trial court decision granting the defendant device manufacturer summary judgment on preemption grounds. Notwithstanding one quibble, there is much to like about the decision.

The plaintiff, who asserted a plethora of product-liability and consumer-protection claims, alleged that he was injured after undergoing two total hip replacements. He alleged that each surgery involved a hip implant that comprised four parts. One of those parts-an acetabular cup approved as a component of the Birmingham Hip Resurfacing (BHR) System-was a Class III device that had received premarket approval from the FDA. The remaining parts were Class II devices that had received 510(k) clearance.

The court granted the defendant manufacturer's motion for summary judgment on preemption grounds.

The court began its analysis with a discussion of 21 U.S.C. § 360k(a), which-as readers of this blog surely know-expressly preempts any state-law claim that would impose any requirement on a medical device that is "different from, or in addition to," the federal requirements imposed on the device. Citing Riegel v. Medtronic, Inc., 552 U.S. 312 (2008), and Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996), the court stated that claims implicating Class III devices with premarket approval are subject to preemption under § 360k(a) but that devices with 510(k) clearance are not.

That brings us to our quibble, which is actually a point of considerable recurring frustration. Even if Lohr had been correctly decided at the time (which it was not), the decision is by now clearly outdated given intervening changes to the 510(k) process. Nonetheless, courts continue to mechanically recite its holding as if nothing has changed in the past quarter-century.

Fortunately, and correctly, the Sharrod court found Riegel, not Lohr, controlling on the facts presented.

The plaintiff argued that his claims were not subject to preemption under § 360k(a), both because his hip implant was "a hybrid device" comprising four components, three of which had not received premarket approval, and because the component that had received premarket approval had been used in an off-label manner (i.e., in a manner not indicated on its FDA-approved label).

The court rejected each of the arguments.

First, citing 21 U.S.C. § 396, which expressly allows doctors to use approved devices as they deem appropriate, and various cases interpreting that provision-namely, Shuker v. Smith & Nephew, PLC, 885 F.3d 760 (3d Cir. 2018), Caplinger v. Medtronic, Inc., 784 F.3d 1335 (10th Cir. 2015), White v. Medtronic, Inc., 808 F. App'x. 290 (6th Cir. 2020), and Hafer v. Medtronic, Inc., 99 F. Supp. 3d 844, 853 (W.D. Tenn. 2015)-the court held that § 360k(a) "applies regardless of how [a] device is used by ... doctors." 2021 Tenn. Cir. LEXIS 74, at *10.

Second, relying on 21 U.S.C. § 321(h), which defines the term "device" to include any "component," and several cases interpreting it in analogous circumstances, the court held that § 360k(a) is to be applied at the component level. Given that the plaintiff alleged that his injuries were caused by the component with premarket approval, the court found that § 360k(a) applied to the plaintiff's claims. 2021 Tenn. Cir. LEXIS 74, at *12.

Having determined that the plaintiff's claims were subject to § 360k(a), the court proceeded to analyze whether they were in fact expressly preempted by it. It concluded that they were preempted because they would necessarily impose state-law requirements "different from, or in addition to," the federal requirements imposed on the device at issue.

The court began by rightly holding that "[r]egardless of the theory of liability," the plaintiff's variously styled claims were "subsumed by the plain language of the" Tennessee Product Liability Act (TPLA), which "was written to provide the exclusive remedy for injuries caused by products." 2021 Tenn. Cir. LEXIS 74, at *18. To establish liability under the TPLA, a plaintiff must show that the product in question either "defective or unreasonably dangerous." Id. But, absent evidence of a violation of the applicable federal requirements, finding a device with premarket approval "defective or unreasonably dangerous" would, said the court, not only "impose requirements on the device different from or in addition to" the federal requirements, which is exactly what § 360k(a) forbids, but also "undermine Congress's decision to leave such questions to the FDA." Id. at *19. Accordingly, the court found "all of [the plaintiff's] claims ... expressly preempted." Id.

The court acknowledged that "parallel" claims-i.e., claims predicated on the violation of a federal requirement applicable to a device-are not expressly preempted by § 360k(a), but found that the plaintiff had not sufficiently alleged (nor, presumably, proven) such a violation. 2021 Tenn. Cir. LEXIS 74, at *23.

Moreover, although the plaintiff had conclusorily alleged the violation of unidentified federal regulations, he did not identify any state-law duty that paralleled those unidentified federal requirements. Consequently, the plaintiff was in effect "seeking to enforce the FDCA," which, the court recognized, is not permitted under Buckman Co. v. Plaintiff's Legal Committee, 531 U.S. 341, 353 (2001).

Game, set, match.

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