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Last year we reported on Plourde v. Sorin Group USA, Inc., 2021 WL 736153 (D. Mass. 2021), which held that the plaintiff’s failure-to-warn claims were expressly preempted by 21 U.S.C. § 360k(a) because those claims were based on an alleged failure to report adverse events to the FDA and the plaintiff had not shown that Massachusetts recognizes a duty to submit such reports.

The plaintiff appealed that ruling to the First Circuit.

Earlier this week, the First Circuit side-stepped the question of whether Massachusetts recognizes a duty to submit adverse-event reports to the FDA. Rather than answer itself, the First Circuit asked the Massachusetts Supreme Judicial Court, the state’s highest court, to answer the question. In particular, the First Circuit asked the Supreme Judicial Court to answer the certified question of whether “a manufacturer’s failure to report adverse events to a regulator—such as one like the FDA—give[s] rise to liability under Massachusetts law.” Plourde v. Sorin Grp. USA, Inc., — F.4th —-, 2022 WL 99508, at *7 (1st Cir. 2022).

The Supreme Judicial Court is not obligated to accept the certified question, but it will likely do so—just as the Connecticut Supreme Court several months ago accepted a similar question certified by the Second Circuit in Glover v. Bausch & Lomb Inc., 6 F.4th 229 (2d Cir. 2021).

Without a substantive decision in Plourde, there isn’t much to say at this point. Nonetheless, a few brief observations…

First, it should be noted that the question certified by the First Circuit in Plourde is relevant only to the question of whether failure-to-report claims are expressly preempted by 21 U.S.C. § 360k(a), which bars states from imposing safety or effectiveness requirements on medical devices that are “different from, or in addition to,” the requirements imposed by federal law. If Massachusetts does recognize a state-law duty to report adverse events to the FDA, then a failure-to-report claim brought under Massachusetts law would constitute a “parallel” claim that avoids express preemption. That, however, says nothing about whether such a claim would also escape implied preemption under 21 U.S.C. § 337(a).  As the Supreme Court made clear in in Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341 (2001), a claim can be impliedly preempted by § 337(a) even if it is not expressly preempted by § 360k(a).

Second, as readers of this blog are aware, after a string of unfortunate decisions allowing failure-to-report claims to proceed—specifically, Stengel v. Medtronic, Inc., 704 F.3d 1224 (9th Cir. 2013) (en banc), Hughes v. Boston Scientific Corp., 631 F.3d 762 (5th Cir. 2011), and Coleman v. Medtronic, Inc., 223 Cal. App. 4th 413 (2014)—the tide has turned. Since then, appellate decisions—including Mink v. Smith & Nephew, Inc., 860 F.3d 1319 (11th Cir. 2017), Conklin v. Medtronic, Inc., 431 P.3d 571 (Ariz. 2018), and Norabuena v. Medtronic, Inc., 86 N.E.3d 1198 (Ill. App. Ct. 2017)—have repeatedly held that failure-to-report claims are expressly or impliedly preempted by the FDCA, as Bexis’s 50-state survey shows.  In particular, this survey shows that the Massachusetts high court has already expressly rejected the imposition of reporting based tort liability in a non-product liability setting.  Roe No. 1 v. Children’s Hospital Medical Center, 16 N.E.3d 1044, 1052 (Mass. 2014) (failure to file mandatory child abuse reports).

Finally, in deciding whether Massachusetts recognizes a duty to report adverse events to the FDA, the Supreme Judicial Court will likely address the learned-intermediary doctrine, which holds that drug and device manufacturers have a duty to warn physicians not patients, and Restatement (Second) of Torts § 388 cmt. n, which states that a manufacturer can satisfy its duty to warn an end user by warning a third-party intermediary if the manufacturer can reasonably rely on the third party to convey the warning. Given that the FDA makes adverse-event reports public, if at all, by posting them to a passive database that must then be affirmatively searched for whatever information it contains, manufacturers cannot reasonably rely on the FDA to convey to physicians the information found in adverse-event reports—which, as held in Aaron v. Medtronic, Inc., 209 F. Supp. 3d 994 (S.D. Ohio 2016), are not warnings in any event.

We await word from the Massachusetts Supreme Judicial Court.