Plourde v. Sorin Group USA, Inc., 23 F.4th 29

Allison Plourde, born with DiGeorge syndrome and congenital heart defects, received a Sorin Mitroflow Model LX bioprosthetic heart valve in June 2012.
The Mitroflow is a Class III device that received FDA premarket approval (PMA); FDA-approved labeling warned of accelerated calcification in younger patients.
About 18 months after implantation the valve failed, Allison underwent emergency replacement surgery, never regained consciousness, and subsequently died.
Plaintiffs (Allison’s parents) sued Sorin in Massachusetts state court asserting negligence and failure-to-warn claims premised on Sorin’s alleged failure to report adverse events to the FDA; Sorin removed to federal court.
The district court granted summary judgment for Sorin, concluding plaintiffs failed to identify a Massachusetts duty parallel to federal reporting requirements and that the claims were preempted.
The First Circuit found Massachusetts law unsettled on whether a manufacturer’s failure to report adverse events to a regulator gives rise to tort liability and certified the question to the Massachusetts Supreme Judicial Court rather than resolving the matter itself.

Issue	Plaintiff's Argument	Defendant's Argument	Held
Whether Massachusetts law recognizes a manufacturer’s duty to report adverse events to a regulator (e.g., FDA) that can support tort liability	Plaintiffs: Massachusetts common law (duty to warn/manufacture carefully; Restatement §388 and cases like Rafferty) supports a parallel duty to report to the FDA	Sorin: Massachusetts does not recognize an independent duty to report to the FDA; learned‑intermediary doctrine and case law do not support relying on the FDA as the intermediary	First Circuit declined to decide and certified the question to the Massachusetts SJC for an authoritative answer
Whether such claims are preempted by federal law (FDCA §360k and implied preemption under §337)	Plaintiffs: If state duty merely parallels federal FDA reporting requirements, claims are not expressly preempted and are outside implied‑preemption scope	Sorin: Claims are either expressly preempted (if they add/differ from federal requirements) or impliedly preempted as suits premised solely on FDCA violations	First Circuit did not resolve preemption; certification to SJC intended to clarify whether a state duty exists (which controls the preemption analysis)

Lehman Bros. v. Schein, 416 U.S. 386 (U.S. 1974) (federal courts may certify unsettled state law questions to state high courts)
Medtronic, Inc. v. Lohr, 518 U.S. 470 (U.S. 1996) (§360k does not bar state common‑law duties that parallel federal requirements)
Riegel v. Medtronic, Inc., 552 U.S. 312 (U.S. 2008) (state-law requirements that add to or differ from PMA requirements are expressly preempted by §360k)
Buckman Co. v. Plaintiffs' Legal Comm., 531 U.S. 341 (U.S. 2001) (FDCA enforcement is the province of the federal government; state claims premised solely on FDCA violations are impliedly preempted)
Dumont v. Reilly Foods Co., 934 F.3d 35 (1st Cir. 2019) (articulating the narrow gap a state claim must fit between §360k and §337)
In re Engage, Inc., 544 F.3d 50 (1st Cir. 2008) (certification particularly appropriate where answers hinge on state policy judgments)
Rafferty v. Merck & Co., 93 N.E.3d 1205 (Mass. 2018) (Massachusetts manufacturer's duty to warn consumers of known dangers)
Dunn v. Genzyme Corp., 161 N.E.3d 390 (Mass. 2021) (SJC noted plaintiff’s claims could be interpreted as coextensive with federal FDCA requirements)
MacDonald v. Ortho Pharm. Corp., 475 N.E.2d 65 (Mass. 1985) (learned‑intermediary doctrine and limits on manufacturer reliance on intermediaries)