Preemption Round Up – Failure to Report

Recently, when putting together our “Staple Suit Cropped” blogpost about Kane v. Covidien LP, 2025 U.S. Dist. Lexis 25718 (E.D.N.Y. Feb. 12, 2025), we realized that, while we had a comprehensive 50-state survey on the questionable status of failure-to-report claims under state law, we did not have a similarly complete reference for preemption of the same reporting-based claims.

We’re rectifying that here.

Failure-to-report claims have been asserted against every product that has a preemption defense – branded drugs, generic drugs, and PMA medical devices. Thus, there are different ways that failure-to-report claims end up preempted.

• First, reporting-based claims against drugs or medical devices are impliedly preempted under Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001), and 21 U.S.C. §337(a), because they would not exist without the FDA reporting obligations that they claim were violated. Therefore, “the existence of these federal enactments is a critical element” of the cause of action, and implied preemption applies. 531 U.S. at 353.
• Second, and relatedly, in the majority of states where no state-law claim exists for failure to make mandatory reports to a governmental agency (see the 50-state survey), Buckman further precludes such claims as purely private attempts to enforce the FDCA/FDA regulations concerning adverse event reporting.
• Third, in cases involving pre-market approved medical devices, the same absence of any state-law reporting-based claims leads to express, as well as implied, preemption because there is no recognized “parallel” state-law theory of liability that could support a “parallel claim” exception to express preemption under 21 U.S.C. §360k(a).
• Fourth, generic drugs enjoy their own implied preemption defenses under PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011), and can take similar advantage of Buckman-based preemption precedent.

Obviously, there can be overlap between these three categories, and not all courts keep them separate.

Since the issue is preemption, a federal issue, our primary division of cases is by federal circuit rather than by state. Of the circuits, the Second, Third, Sixth, Eighth, Tenth, and Eleventh all have precedential decisions holding failure-to-report claims preempted, although the Second has only dealt with express preemption. The Second, Fifth and Ninth allow “parallel” failure to warn claims to escape preemption if state common law allows them, with the Second being stricter than the others. The Seventh Circuit has been hostile generally to FDCA-based preemption, but hasn’t decided a reporting-based case. The First, Fourth, and District of Columbia circuits have yet to decide the question. We note that no precedential decision from any federal court of appeals has flatly denied preemption in a failure-to-report case since 2013, the 2013 decision was repudiated by the highest court of the state in question (see Ninth Circuit, below), and the United States Supreme Court abolished any “presumption against preemption” in express preemption cases in 2016. See Commonwealth of Puerto Rico v. Franklin California Tax-free Trust, 579 U.S. 115, 125 (2016). Thus, defendants have good grounds to seek reconsideration of what adverse appellate authority exists.

Finally, we don’t do the other side’s research for them, so be advised, that while we try to be comprehensive in collecting favorable cases, we aren’t including all adverse decisions.

The Supreme Court has yet to consider directly the preemption of failure-to-report claims. However, PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011), reversed two decisions that, among other things, involved such claims, and a p-side attempt at rehearing in Mensing that raised failure to report was summarily denied. PLIVA, Inc. v. Mensing, 564 U.S. 1058 (2011). Thus, it is certainly arguable to view Mensing as holding reporting claims were barred by implied preemption in generic drug cases, and one appellate court has so held:

[T]he Federal Food, Drug, and Cosmetic Act (“FDCA”) provides no private right of action for these violations. “[A]ll such proceedings for the enforcement, or to restrain violations of [the FDCA] shall be by and in the name of the United States.” 21 U.S.C. §337. Nor can a violation be used as evidence of a breach of duty. While any testing and reports could have been used to alert the FDA of the need to strengthen labels and warnings, the Supreme Court specifically addressed this argument in Mensing. A federal duty to ask for such help might have existed but state tort law “did not instruct the Manufacturers to communicate with the FDA about the possibility of a safer label.”

Morris v. Pliva, Inc., 713 F.3d 774, 778 (5th Cir. 2013) (quoting Mensing, 564 U.S. at 619).

The First Circuit has never decided a preemption case involving failure-to-report claims. Plourde v. Sorin Group USA, Inc., 517 F. Supp.3d 76 (D. Mass. 2021), concluded, after a thorough discussion, that Massachusetts law did not recognize a common-law duty to report adverse events to the FDA. Id. at 91.

[A]bsent a showing of a state law that parallels the requirements under federal law, Plaintiffs’ claims that Defendants had a duty to warn the FDA of harm is different from federal law and therefore preempted.

Id. (citation omitted). Plourde relied on rationales two and three, above, and cited decisions nationwide that held failure-to-report claims preempted after concluding that no “genuinely” equivalent claim existed under state law. Id. at 91-92. Plaintiffs appealed Plourde, and the First Circuit responded by certifying the underlying state-law question to the Massachusetts Supreme Judicial Court. Plourde v. Sorin Group USA, Inc., 23 F.4th 29, 37 (1st Cir. 2022). While that appeal was pending, Plourde settled.

Most of the rest of the First Circuit failure-to-report-related preemption decisions are likewise from Massachusetts. See Muoio v. Livanova Holding USA, Inc., 2021 U.S. Dist. Lexis 225403, at *4 (D. Mass. Oct. 15, 2021) (finding Plourde “persuasive” and that failure-to-report allegations cannot be “parallel”); Phillips v. Medtronic, Inc., 2012 Mass. Super. Lexis 3435, at *28 (Mass. Super. July 10, 2012) (failure-to-report claim held “impliedly preempted because it is premised solely on a duty created by the [FDCA] which did not exist in the common law”). The only non-Massachusetts case, Franks v. Coopersurgical, Inc., 722 F. Supp.3d 63 (D.R.I. 2024), is not in direct conflict, since it relied upon a strained interpretation of state law (see 50-state survey) to reject preemption rationales two and three, and did not address rationale one. Id. at 88-89.

The only Second Circuit decisions addressing preemption of a failure-to-report claim are, Glover v. Bausch & Lomb, Inc., 43 F.4th 304 (2d Cir. 2022) (“Glover II”), and Glover v. Bausch & Lomb, 6 F.4th 229 (2d Cir. 2021) (“Glover I”). Glover I, which certified the question of the existence of a common-law failure-to-report claim to the Connecticut Supreme, held:

[I]t is clear that [plaintiffs’] claims can proceed, if at all, only if [state law] provides a cause of action based on a manufacturer’s failure to report adverse events to a regulator like the FDA, or to comply with post-approval requirements set by that regulator.

6 F.4th at, 239 (2d Cir. 2021).

Glover II, which was decided on remand from the Connecticut Supreme Court’s decision (see 50-state survey) expressly recognizing failure to report as a common-law cause of action. Glover rejected a preemption argument contending that, regardless of state law, all reporting-based were preempted because they “exist[ed] solely by virtue of the FDCA.” Id. at 307. Rather, the Second Circuit held that, in light of the state of Connecticut common law, “the role of that agency under federal law renders it the entity best able to take or recommend precautions against the dangers posed by certain medical devices.” Id. Thus, the duty was not “solely” federal, and that preemption argument was rejected. Id.

We don’t think that’s entirely correct, because preemption under Buckman does not require that a purported legal duty to arise “solely” from the FDCA. Instead, as Buckman held, implied preemption applies whenever “the existence of these federal enactments is a critical element” of the cause of action, 531 U.S. at 353 – and the FDCA’s reporting obligation is certainly a “critical element of any failure-to-report claim. Nonetheless, Glover rejected the “solely” federal argument and the “critical element” argument apparently wasn’t made. So what Glover held is the law in the Second Circuit.

This state of affairs means that the pre-Glover decisions finding preemption in Connecticut-law cases are badly impaired. We list them here simply for completeness: Pratt v. Bayer Corp., 2020 WL 5749956, at *8 (D. Conn. Sept. 25, 2020); Norman v. Bayer Corp., 2016 WL 4007547 at *4 (D. Conn. July 26, 2016) (note, however, that this decision comes close to the one remaining preemption argument, that the claim “give rise to liability under state law even if the FDCA had never been enacted”); Simoneau v. Stryker Corp., 2014 WL 1289426, at *11 (D. Conn. March 31, 2014).

As we discuss in our 50-state survey, the bulk of New York precedent, including the only appellate decisions, rejects failure-to-report claims based on failure to make mandatory reports to government agencies, including the FDCA specifically. Taking that common-law conclusion as true, means that, under Glover I, failure-to-report claims are preempted.

Numerous New York decisions have come to this conclusion, both before and after Glover I nailed it down.

In Barone v. Bausch & Lomb, Inc., 141 N.Y.S.3d 808 (N.Y. App. 2021), the Fourth Department of the Appellate Division held, in light of the learned intermediary rule:

Plaintiff points to FDA regulations that require a manufacturer to report to the FDA known incidents in...