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. 

United States Supreme Court

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).

First Circuit

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.

Second Circuit

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 which their products cause serious injury or death. . . .  [W]e conclude that the claims set forth in the amended complaint are not premised on any alleged failure to report incidents to the FDA, but rather on defendants’ alleged failure to provide adequate warnings to plaintiff and his eye doctor.

Id. at 811 (citations omitted).

Federal cases reach the same result:

[A]ny state law negligence claim premised on [an FDCA] violation would fail, because implied preemption prohibits state-law claims that seek to privately enforce duties owed to the FDA, including state-law negligence claims based on a duty to file a report with the FDA.

Kulkarni v. Actavis Generics, 2023 U.S. Dist. Lexis 160730 (Mag. S.D.N.Y. Sept. 8, 2023), (citation and quotation marks omitted), adopted, 2023 WL 6289963 (S.D.N.Y. Sept. 27, 2023).

Tillet v. CooperSurgical, Inc., 2023 U.S. Dist. Lexis 127043 (W.D.N.Y. July 24, 2023), found both express and implied preemption.  Failure-to-report claims were expressly preempted because they were not parallel claims:

The duty to warn under New York law is “different from and in addition to” the duty to supply adverse event reports to the FDA because the duty under New York law runs to the patient.  While a medical device manufacturer can satisfy this duty under New York law by adequately warning a “learned intermediary,” the FDA is not a learned intermediary for this purpose.

Id. at *9-10 (citation omitted).  Moreover:

When adverse events are reported to the FDA, there is no reasonable assurance that the information will be disseminated to the appropriate professional with the treating relationship to the patient because the FDA is not required to publicly release such reports.

Id. at *11 (citation omitted).  The contrary result in the pre-Barone and pre-Glover I decision, Rosen v. St. Jude Medical, Inc., 41 F. Supp.3d 170, 185 (N.D.N.Y. 2014), was rejected as “in direct conflict with New York law.”  2023 WL 4704091, at *12.

The plaintiff in Tillet also argued that failure to report arose “directly from the MDA.”  Id. at *13.  If so, then “the claim falls squarely within the implied preemption doctrine,” because a private plaintiff may not seek to enforce FDCA duties.  Id.

In Manopella-Fletcher v. Bayer, Inc., 2022 U.S. Dist. Lexis 195084 (E.D.N.Y. Oct. 26, 2022), failure-to-report claims were “properly dismissed on preemption grounds” because the FDA has “exclusive authority to regulate medical devices and create a comprehensive regime of detailed federal oversight.”  Id. at *3 (citation and quotation marks omitted).  English v. Bayer Corp., 468 F. Supp.3d 573 (W.D.N.Y. 2020), found failure-to-report claims expressly preempted.  They could not be a parallel claim, because no such claim existed under New York law.  Id. at 580.  Further, “if they are characterized as a failure to warn, they are expressly preempted:  plaintiffs cannot maintain a claim that defendants were required to issue additional warnings beyond what the FDA prescribed and approved.”  Id.

Numerous older New York decisions have also found failure-to-report claims preempted:  Pearsall v. Medtronics, Inc., 147 F. Supp.3d 188, 199 (E.D.N.Y. 2015) (express preemption because no “parallel” state-law claim existed; “[t]o hold a defendant to a standard that does not track the federal requirement creates a duty that is ‘different from, or in addition to’ the federal requirements and is preempted”; implied preemption because plaintiff “seeks to enforce an FDA requirement”); Bertini v. Smith & Nephew, Inc., 8 F. Supp.3d 246, 256 (E.D.N.Y. 2014) (reporting-based claim preempted because the FDA’s regulations did not “require that defendant notify the public and physicians directly”); Gelber v. Stryker Corp., 788 F. Supp.2d 145, 161, 165 (S.D.N.Y. 2011) (implied preemption because the FDCA “prohibits a private party from enforcing the MDA”); Lake v. Kardjian, 874 N.Y.S.2d 751, 755 (N.Y. Sup. 2008) (implied preemption “because claims that a manufacturer has violated the MDA in some respect do not diminish or impair the applicability of the doctrine of federal preemption,” “such claims are impliedly preempted by federal law, because enforcement of the FDCA, including the MDA” is prohibited; express preemption “because such an allegation would merely be an attempt to recast plaintiff’s state law claims as violations of federal statutes”).

Finally, preemption of failure-to-report claims has also been recognized in Vermont.  In Lyman v. Pfizer, Inc., 2012 U.S. Dist. Lexis 13185 (D. Vt. Feb. 3, 2012), a generic drug case, a failure-to-report claim was impliedly preempted , as they were asserted in support of a “a claim of breach of a state tort duty to provide different or additional information or warnings than those approved by the FDA.”  Id. at *15.

Third Circuit

The Third Circuit has not yet encountered a FDCA-based failure-to-report claim, but has held identical allegations involving the Federal Aviation Administration are impliedly preempted under Buckman.  Sikkelee v. Precision Airmotive Corp., 907 F.3d 701 (3d Cir. 2018).  Reporting-based claims involved a “federal duty” and thus were not available to a state-law plaintiff.  Id. at 717.  Sikkelee quoted from Buckman:

[W]ere plaintiffs to maintain their fraud-on-the-agency claims here, they would not be relying on traditional state tort law which had predated the federal enactments in question[].  On the contrary, the existence of these federal enactments is a critical element in their case.

Id. (quoting Buckman, 531 U.S. at 353).  For that reason, summary judgment was “properly granted.”  Id.

The New Jersey Supreme Court has also held that reporting-based claims are preempted.  In Cornett v. Johnson & Johnson, 48 A.3d 1041 (N.J. 2012), the court discussed FDA reporting requirements, id. at 1052, explained that, under Buckman, “if the claim depends on the alleged violation of a federal requirement, it is functionally equivalent to a claim grounded solely on the federal violation, and is impliedly preempted.”  48 A.3d at 1054.  Only warning claims that are “based on other allegations of wrong-doing apart from defendants’ failure to comply with FDA disclosure requirements” are “not preempted.”  Id. at 1057.

An intermediate New Jersey appellate decision, Gomez v. Bayer Corp., 2020 N.J. Super. Unpub. Lexis 92 (N.J. Super. App. Div. Jan. 14, 2020), quoted the discussion above in Cornett, id. at *14, and relying on Cornett, affirmed dismissal of failure-to-report claims on the basis of the trial court’s decision:

[C]ertain claims do not fall within the PLA and are thus not permissible.  These include claims made by [p]laintiff for negligent training and failure to report adverse events.  As to the issue of the failure to report adverse events, . . . this [c]ourt is guided by the New Jersey Supreme Court decision of Cornett . . .[,] which ruled in part that such claims are impliedly preempted.

2020 N.J. Super. Unpub. Lexis 92, at *11 (quoting Gomez v. Bayer Corp., 2018 WL 10612946, at *2 (N.J. Super. L.D. Aug. 31, 2018)).  See also In re Allergan Biocell Textured Breast Implant Products Liability Litigation, 2021 N.J. Super. Unpub. Lexis 837, at *25 (N.J. Super. Law Div. May 4, 2021) (finding preemption because “New Jersey does not recognize a standalone failure-to-report-to-FDA claim”).

Many federal courts applying New Jersey law have likewise held that failure-to-report claims are preempted – often doing so in connection with also determining that state law does not allow such claims (see 50-state survey).  Roncal v. Aurobindo Pharma USA, Inc., 2022 U.S. Dist. Lexis 76429, at *18 (D.N.J. April 27, 2022) (“the duty Plaintiffs identify appears to be predicated on an obligation created by the FDCA and related regulations.  Such a claim, however, is preempted under Buckman.”) (citations omitted); In re Allergan Biocell Textured Breast Implant Products Liability Litigation, 537 F. Supp.3d 679, 710-11, 733 (D.N.J. 2021) (holding, similarly to the Second Circuit in Glover I, that preemption of failure-to-report claims depends on whether state law permitted such claims; concluding that New Jersey did not recognize such claims); Medford v. Eon Labs, Inc., 2021 U.S. Dist. Lexis 216411, at *17-19 (D.N.J. Nov. 9, 2021) (no parallel claim because no recognized state-law cause of action); Jankowski v. Zydus Pharmaceuticals USA, Inc., 2021 U.S. Dist. Lexis 102089, at *16 (D.N.J. May 28, 2021) (same), aff’d, 2023 WL 4700651 (3d Cir. July 24, 2023); Chester v. Boston Scientific Corp., 2017 U.S. Dist. Lexis 26676, at *27-28 (D.N.J. Feb. 27, 2017) (lack of viable state-law reporting-based claim meant that plaintiff’s “claims based upon such violations are impliedly preempted as impermissible attempts to enforce FDA reporting requirements”).

There are fewer cases from Pennsylvania, but most of them likewise find preemption.  The most recent is McGee v. Johnson & Johnson, 684 F. Supp.3d 371 (W.D. Pa. July 26, 2023).  In McGee, plaintiff asserted a reporting-based claim that she claimed was “conceptually different” from usual failure to warn claims.  Id. at 384.  McGee held the claim preempted, primarily because no such claim existed under Pennsylvania law (see 50-state survey).  Id. at 387-88.  The contrary precedent plaintiff cited had relied on the since discredited Stengel decision, which made an incorrect prediction of state law (see Ninth Circuit, below).  Id. at 388.  McGee instead followed the Third Circuit’s Sikkelee decision and found preemption:

[T]he Court finds that Plaintiff’s failure-to-report-based negligence claim −  as that portion of Plaintiff’s negligence claim is currently pled in the Amended Complaint − is not a “parallel” Pennsylvania state law claim that is exempt from federal preemption.  Accordingly, to the extent that Plaintiff’s negligence claim . . . is based on Defendants’ failure to report adverse events to the FDA, that claim is dismissed.

Id.  The McGee plaintiff thus was right about one thing − failure-to-report claims were “conceptually different” than recognized warning claims – and that’s why the claim failed.

In addition to Sikkelee, McGee agreed with Conley v. St. Jude Medical, LLC, 482 F. Supp.3d 268 (M.D. Pa. 2020), and White v. Medtronic, Inc., 2016 U.S. Dist. Lexis 117101 (E.D. Pa. Aug. 31, 2016).  684 F. Supp.3d at 388.  Conley held that a reporting-based claim, which plaintiffs made up as they went along, was preempted, as “many courts” had held.  482 F. Supp.3d at 279.  Such preemption could be express or implied.  “Failure to report claims have been found both expressly preempted under Riegel and impliedly preempted pursuant to Buckman [], which held that private parties do not have the authority to bring claims because of violations of FDCA requirements.”  Id. at 279 n.7 (citations omitted).

In the cases that allow such claims to move forward, courts have found that a plaintiff must at least plausibly allege that had the defendant properly reported the adverse events to the FDA as required under federal law, that information would have reached [plaintiff’s] doctors in time to prevent [plaintiff’s] injuries.  In addition, a plaintiff must identify actual adverse events that [a defendant] did not report.  Plaintiffs here have not even made clear on the face of the amended complaint that this claim is intended as a claim for failure to report to the FDA, and they certainly have not attempted to allege a link between any supposed reporting failures and their injuries.  Accordingly, the Court finds that Plaintiffs have failed to state a parallel claim and will dismiss [the failure-to-report claim] as preempted.

Id. (citations and quotation marks omitted).  See White, 2016 U.S. Dist. Lexis 117101, at *7 (“To the extent that defendants failed to warn the FDA of the dangers, there is simply no parallel state law duty imposed on manufacturers and sellers to report to a federal agency.”).

In Delaware, Bennett v. Teva Pharmaceuticals USA, Inc., 2021 U.S. Dist. Lexis 38565 (D. Del. March 2, 2021), held that failure-to-report claims asserted against a generic drug manufacturer were preempted.  Plaintiffs tried to shoehorn that claim into a Delaware statute, but that statute (concerning drug “misbranding”) simply incorporated FDCA standards.  Any such claim was thus barred by Buckman, which “prohibited” any “private right of action” based on the FDCA.  Id. at *8.  Delaware common law “says nothing about an obligation to report adverse events to the FDA.”  Id.  Rather, “a claim based on a failure to report adverse events to the FDA would constitute a fraud-on-the FDA claim that Buckman expressly held is preempted.”  Id.  See Jordan v. Teva Pharmaceuticals USA, 2021 U.S. Dist. Lexis 122051, at *2 (D. Del. June 29, 2021) (following Bennett), aff’d, 2022 U.S. App. Lexis 25168 (3d Cir. Sept. 7, 2022).

Similarly, in Scanlon v. Medtronic, Inc., 61 F. Supp.3d 403 (D. Del. 2014), the plaintiff “superficially allege[d] that [defendant] did not report adverse events to the FDA.”  Id. at 412.  That claim “exist[ed] solely by virtue of the FDCA disclosure requirements,” and was thus “impliedly preempted” under Buckman.  Id. (citation and quotation marks omitted).  Nor could plaintiff “show that the reporting . . . would necessarily have resulted in a change in the [device’s] labeling.”  Id. at 412 n.15.

Fourth Circuit

No Fourth Circuit decision has directly addressed preemption of reporting-based claims, be it for prescription drugs, pre-market approved medical devices. or generic drugs.  More than a few Fourth Circuit district courts have, however.

North Carolina courts have been the most prolific.  In Watters v. CooperSurgical, Inc., 655 F. Supp.3d 376 (E.D.N.C. 2023), failure-to-report claims were both expressly and impliedly preempted.  Because North Carolina did not recognize any similar common-law claim (see 50-state survey), there was nothing for the plaintiff’s claims to be “parallel” to.  Id. at 386.  Further, the failure-to-report claims “assert[ed] a ‘fraud-on-the-FDA’ theory that the Supreme Court in Buckman explicitly held were preempted.”  Id.  Thus, “plaintiff[’s] use of the ‘parallel’ duty language . . . was squarely barred by the MDA’s implied preemption provision.”  Id. (citation and quotation marks omitted).  Indeed, the plaintiff:

admits that she seeks a jury finding that the FDA would have made different decisions if Defendants reported the true risk of migration to the FDA. . . .  Thus, [plaintiff] is pursuing fraud-on-the-FDA claims under state law.  Under Buckman. [those] claims are preempted.

Id. (citations and quotation marks omitted).  Still further, plaintiff’s “claiming that defendants owed a duty to [her] or her doctors functions to impose additional requirements and would be pre-empted” expressly under Riegel.  Id. at 387. 

Among the decisions Watters relied on was  McNeil-Williams v. Depuy Orthopaedics, Inc., 384 F. Supp.3d 570 (E.D.N.C. 2019).  McNeil-Williams likewise concluded that North Carolina did not recognize any reporting-based theories of common-law liability, id. at 575-77, which duly led to the conclusion that “plaintiff’s negligence claims as asserted in the instant matter are expressly and impliedly preempted.”  Id. at 577.  Another similar decision is Burrell v. Bayer Corp., 260 F. Supp.3d 485, 492 (W.D.N.C. 2017), which held that failure-to-report claims are based on FDCA requirements that cannot be privately enforced:

Plaintiffs allege negligence based largely on a failure-to-warn theory . . . that the [] defendants failed to warn of adverse events related to [their device]. . . .  The court . . . notes that the source of this continuing duty was federal law:  the FDCA, as amended by the MDA.  Under Buckman, the plaintiff cannot use a private suit to enable private party enforcement of the MDA.  A requirement to report adverse events exists under the FDCA, and plaintiff’s cause of action is being brought because the [] defendants allegedly failed to meet these reporting requirements.  Accordingly, the plaintiff’s failure-to-warn claim is preempted.

Id. at 492 (citations and quotation marks omitted).

In Chiapello v. Corin USA Ltd., 2024 U.S. Dist. Lexis 129332 (D. Md. July 23, 2024), a Maryland court followed suit and rejected a failure-to-report claim.

Plaintiff also asserts a series of failures to address complaints about the [device], adverse incident reports, device investigations, and reports of user error.  Several of these reporting duties are owed only to FDA, and Plaintiff cannot enforce those requirements of the MDA under Buckman.

Id. at *15.  Nor did the plaintiff in Chiapello identify any “duty existing under state law” or “allege[] any facts to substantiate a violation.”  Id.

Reporting-based claims have also been preempted in South Carolina.  Ellis v. Smith & Nephew, Inc., 2016 U.S. Dist. Lexis 193607 (D.S.C. Feb. 16, 2016), recognized that requirements to report to the FDA differed from state warning requirements, and were thus expressly preempted:

The federal requirements require that adverse events and other reports be made to the FDA.  Consequently, a common law duty to provide a warning to the public and medical community imposes a requirement additional to the federal regulations and is preempted.

Id. at *18 (citation omitted).  Further, “failure to warn claim[s that are] predicated on [defendant’s] alleged failure to provide required reports to the FDA” “would simply be an attempt by private parties to enforce the MDA” because “authority to enforce that claim rests with the FDA.”  Id. at *19 (citing Buckman).

Fifth Circuit

In the Fifth Circuit, defendants seeking preemption of failure-to-report claims must deal with Hughes v. Boston Scientific Corp., 631 F.3d 762 (5th Cir. 2011) (applying Mississippi law), which – after “[a]ssuming that a failure to warn claim may be pursued under Mississippi law” as a failure-to-report claim, id. at 769 (citing zero Mississippi law) – held that such reporting non-compliance allegations overcame preemption:

A factfinder could infer that a manufacturer’s failure to provide this information as required by FDA regulations is a parallel violation of the state duty to provide reasonable and adequate information about a device’s risks.  Thus, we are satisfied that [plaintiff’s] failure to warn claim is not expressly preempted to the extent that it is based on [defendant’s] violation of applicable FDA regulations requiring accurate reporting of serious injuries and malfunctions of the . . . device.

Id. at 770-71.

The express preemption ruling in Hughes stands in sharp contrast to several Fifth Circuit implied preemption decisions.  After Mensing, the Fifth Circuit recognized in a generic drug case, that failure-to-report claims functionally attacked product warnings, and thus impliedly preempted.

[A]ny “useful” reporting − at least from the standpoint of those injured − would ostensibly consist of some sort of warning.  This argument, then, is yet another attempt to circumvent disfavored failure-to-warn claims.

Morris v. Pliva, Inc., 713 F.3d 774, 778 (5th Cir. 2013) (applying Louisiana law).  This holding was repeated in Lashley v. Pfizer, Inc., 750 F.3d 470, 473 (5th Cir. 2014) (applying Mississippi law), which also distinguished Hughes as an express preemption case involving “parallel” claims.  Id. at 476 (“In these types of cases, the inquiry is not whether there is a ‘parallel’ claim . . .; the inquiry is whether the state law claim is impliedly preempted.”).

Another precedential Fifth Circuit decision held that fraud-on-the-FDA claims are preempted under Buckman unless the FDA itself has found fraud.  Lofton v. McNeil Consumer & Specialty Pharmaceuticals, 672 F.3d 372, 380 (5th Cir. 2012) (applying Texas law).  “[D]isclosures to the FDA are uniquely federal,” so claims involving such disclosures “invoke[] federal law supremacy according to Buckman.”  Id. at 379 (citation and quotation marks omitted).  See also Gomez v. St. Jude Medical Daig Division, Inc., 442 F.3d 919, 931-32 (5th Cir. 2006) (“later-acquired knowledge theory” against PMA device based on subsequent adverse events preempted for “interference with the federal regulatory scheme”; defendant had submitted a relevant label change; no claim of omitted reports) (applying Louisiana law).  Lofton was a prescription drug case and not adjudicate a reporting-based FDA fraud claim, and thus did not mention the express preemption rationale in Hughes.  Gomez predated both Riegel and Hughes.  Between them, however, Lofton and Gomez further indicate that, notwithstanding Hughes’ “assumption”-based disposition of express preemption, failure-to-report clams may nonetheless fall to implied preemption, since as Buckman (and several other Supreme Court cases) hold, the two forms of preemption operate independently of each other.

Fortunately, as is detailed in our 50-state survey, the product liability law of all three states in the Fifth Circuit rejects (contrary to the Hughes “assumption”) liability based on failure to report adverse events to the FDA or to other governmental agencies.  Thus, courts for each state have generated plenty of favorable preemption decisions in this area.

We start with Mississippi post-Hughes.  In Knoth v. Apollo Endosurgery US, Inc., 425 F. Supp.3d 678 (S.D. Miss. 2019), upon concluding that changes to Mississippi law belied the “assumption” that Hughes made, id. at 694-95, the court held that all failure-to-warn claims were preempted, and any other purported “warning” claim was beyond what state law required.  Id. at 695.  Gardley-Starks v. Pfizer, Inc., 917 F. Supp.2d 597 (N.D. Miss. 2013), a generic drug case, likewise held failure-to-report claim preempted.

Plaintiffs also allege that the Generic Defendants violated federal law by “fail[ing] to perform post-marketing surveillance for their drugs, to ensure the accuracy of statements appearing in their package insert, to review all adverse drug event information, and to report important information relating to the safety of their products.”  These types of claims have been repeatedly rejected as being preempted in light of Mensing.

Id. at 609.  Gardley-Starks “agree[d] with” those decisions and found preemption.  Id.

One of the decisions Gardley-Starks found persuasive was Truddle v. Wyeth, LLC, 2012 U.S. Dist. Lexis 114019 (N.D. Miss. Aug. 14, 2012).  Following Lofton rather than Hughes, Truddle held failure-to-report claims preempted as another form of fraud on the FDA.

Taking into account the preceding case law, this Court finds that the Plaintiffs’ fraud-on-the-FDA theory of recovery is preempted under federal law.  It is likely that the Plaintiffs’ fraud-on-the-FDA theory would be preempted under Buckman, as the theory concerns the “inherently federal” relationship between the FDA and the Generic Defendants, which are entities regulated by the FDA.

Id. at *22 (citation omitted).

There are numerous favorable decisions from Texas courts preempting failure-to-report claims.  Foremost is Baker v. St. Jude Medical, S.C., Inc., 178 S.W.3d 127, 137-39 (Tex. App. 2005), a pre-Riegel decision that (like many courts) treated the plaintiffs’ failure to report claim as a form of fraud on the FDA preempted under Buckman:

In this case, [plaintiffs] fraud claim is not based on a “parallel federal safety requirement.”  Rather, appellants are essentially alleging that [defendant] withheld, or unreasonably delayed, in providing the FDA with information that it had regarding adverse effects associated with the [device].  As such, we hold that [plaintiffs’] fraud claim is really a “fraud-on-the-FDA claim,” and is, therefore, impliedly preempted.

178 S.W.3d at 139.

For federal courts, we start with Bulox v. Coopersurgical, Inc., ___ F. Supp.3d ___, 2025 U.S. Dist. Lexis 56370 (Mag. S.D. Tex. March 6, 2025), adopted, Bulox v. Coopersurgical, Inc., 2025 U.S. Dist. Lexis 54755 (S.D. Tex. March 25, 2025).  Bulox disposed of Hughes simply enough with reference to extensive Texas law rejecting failure-to-report claims, both in the FDCA context and elsewhere.  Id. at *15-16 & n.7.  Even under Hughes, purported “parallel” claims with no state-law parallel were preempted:

Under federal law, device manufacturers must report any incident to the FDA where their device may have caused or contributed to a death or serious injury. . . .  Texas law provides no such parallel duty.  Indeed, under Texas law, manufacturers owe a duty to warn consumers, not the FDA, of potential dangers.

Id. at *14-15 (emphasis original).  The FDA also didn’t qualify as a “learned intermediary,” “which means that Texas failure-to-warn claims impose a different requirement from federal law:  warning consumers or prescribing physicians instead of warning the FDA.  As a result, this claim is preempted.”  Id. at *16 (citations omitted).  Also due to the lack of any state-law equivalent,

Plaintiffs’ contention that Defendants’ failure to warn via failure to report adverse event complaints is simply an attempt by private parties to enforce FDA reporting requirements, which is foreclosed under §337(a), as construed in Buckman.

Id. (citations and quotation marks omitted).  These holdings by the magistrate judge in Bulox were expressly adopted by the district court.  2025 U.S. Dist. Lexis 54755, at *5 (“no parallel duty exists under Texas law to report adverse events to the FDA) (citing, inter alia, Baker); *6 (“failure to report adverse events to the FDA are simply an attempt by private parties to enforce FDA reporting requirements”); at *7 (“Plaintiffs have not identified an independent and parallel source of liability in Texas law for violating federal reporting requirements”) (citations omitted).  In sum, the district court held:

Without an independent basis for liability under state law, Plaintiffs’ failure-to-report claims are simply an attempt by private parties to enforce FDA reporting requirements.  The claims are therefore impliedly preempted by Section 337(a).

Id. at *9 (citation and quotation marks omitted).

Hawkins v. Bayer Corp., 2022 U.S. Dist. Lexis 126360 (Mag. W.D. Tex. Feb. 1, 2022), adopted, 2022 WL 2718541 (W.D. Tex. Feb. 23, 2022), likewise followed Baker and recognized failure-to-report claims as just another form of preempted fraud-on-the-FDA claim:

Texas law provides no such parallel duty. . . .  Because there is no “parallel” state requirement under Texas law, [plaintiff’s] failure-to-report claim is simply an attempt by private parties to enforce federal reporting requirements, which is foreclosed by §337(a) as construed in Buckman.

2022 U.S. Dist. Lexis 126360, at *15-16 (citations and quotation marks omitted).  See also Willis v. Hospira, Inc., 2014 U.S. Dist. Lexis 76041, at *16 (Mag. E.D. Tex. May 5, 2014), adopted, same citation (E.D. Tex. June 3, 2014) (plaintiff’s “failure to communicate/report with the FDA claim . . . breached a federal labeling obligation sounds exclusively in federal (not state) law, and is preempted”) (following Morris and Lashley).

We also note that the Allergan Biocell decision,537 F. Supp.3d at 706, laughably allowed Texas failure-to-report claims to survive based on a citation to Schouest v. Medtronic, Inc., 13 F. Supp.3d 692 (S.D. Tex. 2014).  Bulox neatly summed up why Schouest doesn’t stand for any contrary position:

Schouest adds nothing. . . .  There, while holding that most of the plaintiff’s state-law claims were preempted by the FDCA, the court recognized a possible exception to preemption for the plaintiff’s “negligence allegation predicated on the defendant’s failure to submit adverse-event reports to the FDA. . . .”  The court held that “to the extent [plaintiff] can point to a state law duty to report adverse events,” then “this claim could escape preemption.”  But the claim ultimately did not escape preemption because − as the district court held in a later order dismissing the claim – “[plaintiff’s] amended complaint d[id] not point to a duty to report adverse events” under state law.

2025 U.S. Dist. Lexis 54755, at *8 (discussing subsequent decision in Schouest v. Medtronic, Inc., 92 F. Supp.3d 606, 609 (S.D. Tex. 2015)).

Several Louisiana cases also hold that failure-to-report claims are preempted, but none of them are particularly recent.  See Jacobsen v. Wyeth, LLC, 2012 U.S. Dist. Lexis 116887, at *36 & n.137 (E.D. La. Aug. 20, 2012) (“post-market monitoring efforts must necessarily result in warnings”; “a duty to report . . . would exist only as a matter of federal law, and only the federal government may bring an action to enforce the [FDCA]”); Cooper v. Wyeth, Inc., 2012 U.S. Dist. Lexis 29209, at *16-17 (M.D. La. March 6, 2012) (failure-to-report claim “undoubtedly preempted” because “the best result for plaintiffs that could have ensued . . . would have been a stronger label”), reconsideration granted on other grounds, 2013 U.S. Dist. Lexis 174228 (M.D. La. Dec. 11, 2013); Bush v. Thoratec Corp., 837 F. Supp.2d 603, 608-09 (E.D. La. 2011) (“Plaintiff is arguing that [defendant] breached disclosure duties owed to the FDA, not that [it] breached a disclosure duty owed to Plaintiff by failing to comply with FDA regulations.  Under Buckman, such a claim is preempted.”) (distinguishing Hughes); Cenac v. Hubble, 2010 U.S. Dist. Lexis 114733, at *16-17 (E.D. La. Oct. 21, 2010) (failure-to-report claims impliedly preempted under Gomez).  Given the restrictive enumeration of permissible causes of action in the Louisiana product liability statute, most post-Hughes cases from Louisiana have been decided on state-law grounds.  See 50-state survey.

Sixth Circuit

The Sixth Circuit, in Marsh v. Genentech, Inc., 693 F.3d 546 (6th Cir. 2012) (applying Michigan law), held that failure-to-report claims are based on purported violations of the FDCA, not pre-existing common law, and thus are preempted under Buckman.

[Plaintiff] alleges that [defendant] failed to submit updated safety information to the FDA as required of all applicants by . . . generally applicable FDA regulations, and thus relies on “federal enactments [a]s a critical element in [her] case.”  Moreover, this alleged wrong was perpetrated upon the agency, and thus implicates the “inherently federal” relationship described in Buckman. . . .  The FDA regulates post-marketing reporting, requiring manufacturers to report, inter alia, “adverse drug experience information”. . . .  Having a court determine whether any non-disclosed information may reasonably affect the statement of contraindications, warnings, precautions or adverse reactions in the draft labeling, would both usurp the agency’s role and go beyond the court’s institutional expertise.

Id. at 553-54 (Buckman and regulatory citations omitted).  See also In re Aredia & Zometa Products Liability Litigation, 352 F. Appx. 994, 995 (6th Cir. 2009) (allegations of “post-approval” withholding of information from the FDA likewise preempted as disguised fraud-on-the-FDA claims) (applying Michigan law).  Other Sixth Circuit cases applying Buckman but not involving reporting-based claims, that district courts have found persuasive in the reporting context are:  Cupek v. Medtronic, Inc., 405 F.3d 421 (6th Cir. 2005); Garcia v. Wyeth-Ayerst Laboratories, 385 F.3d 961, 965-66 (6th Cir. 2004); and Kemp v. Medtronic, Inc., 231 F.3d 216, 236 (6th Cir. 2000).

Numerous district court decisions also hold that failure-to-report claims are preempted.  Other cases applying Michigan law are:  Hill v. Bayer Corp., 485 F. Supp.3d 843, 852 (E.D. Mich. 2020) (plaintiff’s “failure-to-warn claim premised on [defendant’s] alleged failure to report adverse events to the FDA” “is a disguised fraud on the FDA claim is preempted under Buckman”); White v. Medtronic, Inc., 2019 U.S. Dist. Lexis 49259, at *13 (Mag. E.D. Mich. Feb. 20, 2019) (the “federal requirement that manufacturers report adverse events to the FDA has no state law analog, and thus there is no parallel state cause of action”), adopted, 2019 U.S. Dist. Lexis 48570 (E.D. Mich. March 25, 2019), aff’d, 808 F. Appx. 290, 296 (6th Cir. 2020); Thorn v. Medtronic Sofamor Danek, USA, Inc., 81 F. Supp.3d 619, 630 (W.D. Mich. 2015) (“[T]he claim is impliedly pre-empted.  Plaintiff points to no adverse event reporting requirements under Michigan law, and the Court agrees that the requirements are administrative requirements of the FDCA.”); Muniz v. Genentech, Inc., 2011 U.S. Dist. Lexis 123758, at *14-15 (W.D. Mich. Oct. 26, 2011) (allegations “that Defendants failed to comply with the FDA’s post-approval safety, surveillance and warning requirements” held preempted as a form of fraud-on-the-FDA claim); Blair v. Genentech, Inc., 2011 U.S. Dist. Lexis 123720, at *15 (W.D. Mich. Oct. 26, 2011) (same); Marsh v. Genentech, Inc., 2011 U.S. Dist. Lexis 123713, at *15 (W.D. Mich. Oct. 26, 2011) (same); Tiefenthal v. Genentech, Inc., 2011 U.S. Dist. Lexis 123712, at *14-15 (W.D. Mich. Oct. 26, 2011) (same)

In Ohio, recent decisions from the Filshie clip litigation have held in favor of  preemption of failure-to-report claims.  In Arnold v. CooperSurgical, Inc., 2025 U.S. Dist. Lexis 34520 (S.D. Ohio Feb. 26, 2025), the plaintiff failed to come forward with non-compliance evidence, which proved fatal to her reporting-based claims:

[Plaintiff’s] argument is necessarily premised on an assertion that Defendants complied with federal warning requirements and even so are liable under state tort law.  Therefore, the state law duty she asserts exists is not merely “parallel” to federal requirements.  Indeed, such a duty necessarily would be “different from” or “in addition to” the FDA’s . . . warning requirements issued in accordance with its post-PMA reporting and approval process. . . .  [A]rguments regarding independent “post-sale” duties . . . are expressly preempted.

Id. at *24 (citations omitted) (emphasis original).  Plaintiff was also forced to provide “more precise contours of her [warning] theory,” and it also turned out to be a failure-to-report theory that was “fully preempted by federal law.”  Id. at *25.  That theory fell to Buckman under the reasoning in Marsh, supra.  Id. at *26.

In addition to the reasons cited above, [plaintiff’s] failure-to-warn claim regarding Defendants’ failure to report adverse events to the FDA is preempted because she does not identify a parallel duty under state law to report adverse events to the FDA. . . .  Thus, in her failure-to-warn claim, in essence, she asserts that Defendants should be liable merely because they violated the ongoing adverse event reporting requirements of the FDCA, as amended by the MDA.  Such a claim is impliedly preempted.

Id. at 26-27 (citations omitted).  Preemption had previously done in the Arnold plaintiff’s design defect claim that had also been based on speculation and failure to report allegations.  Id. at 25 (discussing prior decision.  That prior decision held:

Simply put, Plaintiff has failed to allege a factual basis for her design defect claim that is independent of Defendants’ alleged failure to make certain disclosures to the FDA. . . .  Under Sixth Circuit precedent, this claim is impliedly preempted. . . .  [T]he Federal Government, rather than private litigants . . . are authorized to file suit for noncompliance with the medical device provisions. . . .  [T]he Sixth Circuit emphasized that a state law claim that is a disguised fraud on the FDA claim is preempted under Buckman.  That is precisely the type of claim before this Court:  Plaintiff seeks to hold Defendants liable for their alleged misrepresentations and withholding of information to the FDA. . . .  [I]t is for the federal government to prosecute suits for noncompliance with the MDA − not private plaintiffs.

Arnold v. Coopersurgical, Inc., 681 F. Supp.3d 803, 828 (S.D. Ohio 2023) (citations to and quotation marks from Kemp and Cupek omitted).  We also omitted a footnote, but defense counsel should remember it, since it is an extended discussion of favorable precedent establishing that “courts across the United States” are in “substantial agreement with the Sixth Circuit.”  Id. at 828 n.7.

Farson v. CooperSurgical, Inc., 2023 U.S. Dist. Lexis 136384 (N.D. Ohio Aug. 4, 2023), an earlier decision from the same litigation, reached the same conclusion “that all claims premised on Defendants’ failure to report adverse events to the FDA are impliedly preempted.”  Id. at *20.

Woven throughout Plaintiff’s arguments is a claim that all Defendants deliberately withheld correct data on the rate of [device] migration from the FDA . . . after its approval.  Such a “failure to report adverse events” violates a requirement of the FDCA, but the FDCA does not provide a private right of action.  Plaintiff argues she does not assert a cause of action for failure to report adverse events, but rather uses the violation of federal regulations as a measure of standard of care. . . .  But when reliance on a failure to report adverse events is a critical element in a plaintiff’s case, the plaintiff would not be relying on traditional state tort law, even if the plaintiff states that is what she is doing. . . .  [A]n assertion that Defendants did not properly report adverse events to the FDA is central to Plaintiff’s claims in this case; she places this failure at the heart of the injuries she suffered.  Because these state-law fraud-on-the-FDA claims conflict with, and are therefore impliedly pre-empted [sic] by, federal law, Plaintiff’s claims are preempted.

Id. at *30-31 (citations and quotation marks omitted).

And it’s not just Filshie clip cases.  Cline v. Medtronic, Inc., 2021 U.S. Dist. Lexis 163318 (S.D. Ohio Aug. 30, 2021), first held “that a violation of reporting requirements applicable to a product” was not “a material deviation of that product from it design specifications” – thereby rejecting another attempt to import reporting allegations into design claims.  Id. at *20.  It then quoted extensively from prior “analysis of a near-verbatim complaint” alleging failure-to-report claims, and held they were preempted because they “fail[ed] to state a parallel claim.”  Id. at *23.  Plaintiff did not “identify state law that parallels federal regulations.”  Id.  Rather failure-to-report allegations “are different from, or in addition to the federal requirements applicable to the device” because they would have required divergent warnings.  Id. (all quoting Reynolds v. Medtronic, Inc., 2021 U.S. Dist. Lexis 88385, at *10 (S.D. Ohio May 10, 2021)) (other citations and quotation marks omitted).

In Mories v. Boston Scientific Corp., 494 F. Supp.3d 461 (S.D. Ohio 2020), a failure-to-report claim failed to state a parallel claim, resulting in express preemption.  Id. at 476 (“Plaintiff has not identified any Ohio state-law requirement to make reports to the FDA, thus critically weakening her parallel-claim allegation”) (distinguishing Hughes).  But even if a state-law claim had been identified, the claim would still have been impliedly preempted:

Even if such a state cause of action had been identified, the claim would still be preempted under the MDA.  The Supreme Court has held that a “state-law-fraud-on-the-FDA claim[ would] conflict with, and [is] therefore impliedly pre-empted by federal law.”

Id. (quoting Buckman).  See also Warstler v. Medtronic, Inc., 238 F. Supp.3d 978, 989 (N.D. Ohio 2017) (“Simply put, the federal reporting duty is not equal to, or substantially identical to and, therefore, not parallel to the state law duty to warn patients or their physicians.”) (“a manufacturer’s mandatory adverse event report to the FDA does not function as a warning”) (citation and quotation marks omitted); Aaron v. Medtronic, Inc., 209 F. Supp.3d 994, 1005 (S.D. Ohio 2016) (“the federal duty to report certain information to the FDA is not identical, and thus not parallel, to the state-law duty to provide warnings to patients or their physicians”) (“Adverse-event reports are not warnings.”) (citations and quotation marks omitted) (emphasis original); Hawkins v. Medtronic, Inc., 909 F. Supp.2d 901, 911 (S.D. Ohio 2012) (“Even assuming that [state] law provides a cause of action . . ., such a claim would be preempted by the MDA.  The Supreme Court has held that a ‘state-law fraud-on-the-FDA claim[ would] conflict with, and [is] therefore impliedly pre-empted by federal law.’”) (quoting Buckman).

Kentucky preemption decisions are similar, if not as prolific, as Michigan and Ohio.  One twist is a well-reasoned and thorough state-court decision, Cales v. Medtronic, Inc., 2014 Ky. Cir. Lexis 1 (Ky. Cir. Nov 21, 2014), aff’d on other grounds, 2017 Ky. App. Lexis 10 (Ky. App. Jan. 13, 2017), finding failure-to-report claims preempted.

Nor do Plaintiffs offer any persuasive reason why this Court should permit them to pursue a failure-to-warn claim premised on [defendant’s] alleged failure to submit (unidentified) adverse-event reports to the FDA.  Any such claim is impliedly barred by §337(a).  Because the duty to report adverse events to the FDA exists solely because of the FDCA disclosure requirement, the existence of the FDCA is a critical element in any such claim, and any such claim is therefore simply an attempt by private parties to enforce the FDCA, something plainly barred by §337(a).

Id. at *42 (citations and quotation marks omitted).

In Roberts v. Stryker Corp., 2014 U.S. Dist. Lexis 202089, at *26 (W.D. Ky. Aug. 7, 2014), the plaintiffs’ failure-to-report claim fell to express preemption, because a duty to report to the FDA was different from a duty to warn physicians.  Roberts rejected the plaintiffs’ novel reliance on the FDA as a supposed “learned intermediary.”

[T]he key here is that none of these provisions require [defendant] to report to the public, patients, or health care professionals.  Therefore, . . . this amounts to an additional requirement, which § 360k expressly preempts.

*          *          *          *

Plaintiffs argue that the FDA is a learned intermediary in this case. . . .  However, Kentucky case law does not support the application of the learned intermediary doctrine to this case. . . .  [T]he Court can find no instance in which Kentucky courts have described this doctrine with regard to anyone other than physicians.

Id. at *24-26 (citations omitted).  A Kentucky court has also invoked implied preemption against reporting-based claims.  Sadler v. Advanced Bionics, Inc., 929 F. Supp.2d 670, 683-84 (W.D. Ky. 2013) (FDA requirement of “continuous updates” cannot be enforced as a state-law “fraudulent omission”; “[t]o the extent Plaintiffs are alleging fraudulent misrepresentations or omissions in [defendant’s] disclosures to the FDA, Buckman preempts these claims”)

In Tennessee, Hafer v. Medtronic, Inc., 99 F. Supp.3d 844 (W.D. Tenn. 2015), dismissed multiple plaintiffs’ claims “to the extent that Plaintiffs seek recourse for Defendants’ failure to file adverse event reports with the FDA,” because “such claim impliedly preempted under Buckman.”  99 F. Supp.3d at 860 (citations omitted).  Accord Hullander v. Boston Scientific Corp., 2019 U.S. Dist. Lexis 243088, at *8 n.3 (E.D. Tenn. Feb. 13, 2019) (“any [state-law] claim premised on Defendant’s failure to warn the [FDA] is impliedly preempted” under Buckman); Potolicchio v. Medtronic, Inc., 2016 U.S. Dist. Lexis 71723, at *12 (E.D. Tenn. June 2, 2016) (failure-to-report claim not “parallel” because “[n]o Tennessee law requires [defendant] to warn the FDA about adverse events”); Purchase v. Advanced Bionics, LLC, 896 F. Supp.2d 694, 696-97 (W.D. Tenn. 2011) (“private rights of action to enforce FDA administrative and reporting requirements are prohibited”; “even if a claim survives express preemption, it may be impliedly preempted if it amounts to a disguised fraud-on-the-FDA claim”; “claims premised on reporting requirements are disguised fraud-on-the-FDA claims and, therefore, impliedly preempted”).

Seventh Circuit

The Seventh Circuit has never been called upon to decide whether failure-to-report claims are preempted, either expressly or impliedly.  However, the horrendous Bausch v. Stryker Corp., 630 F.3d 546 (7th Cir. 2010) (applying Illinois law), decision, although having nothing to do with reporting-based claims, casts a general pall over preemption in the Seventh Circuit.  Two of the three states in the Seventh Circuit, Illinois and Indiana, have appellate state-law authority rejecting failure-to-report claims (see 50-state survey), so a two-pronged approach to such claims is recommended.  To date, there is no favorable law from Wisconsin on FDCA-based failure-to-report claims, but the state does have a fairly strong and recent general tort reform statute.  All three Seventh Circuit states have appellate authority rejecting failure-to-report claims in the non-FDCA context.

In Illinois, Norabuena v. Medtronic, Inc., 86 N.E.3d 1198 (Ill. App. 2017), was not bound by Bausch and held that absent a parallel state-law liability theory, failure-to-report claims were expressly preempted in a PMA medical device case:

Plaintiffs argue that their claims are not preempted because . . . they allege [defendant] failed to report adverse events to the FDA as required as a condition to the [device’s] premarket approval.  However, although plaintiffs have identified a federal requirement that their complaint alleges [defendant] violated, there is no Illinois requirement that parallels it. . . .  Although Illinois recognizes that a manufacturer may satisfy its duty to warn by conveying information to third-party learned intermediaries, this is not synonymous with an affirmative duty to warn a federal regulatory body. . . .  We cannot find that this duty is parallel to the federal requirement.

Id. at 1206-07 (citations omitted).  See Vincent v. Medtronic, Inc., 221 F. Supp.3d 1005, 1009 (N.D. Ill. 2016) (“claims rooted in violations of federal administrative and reporting requirements, but not traditional state tort law, are impliedly preempted”); See also Dietz v. Allergan, Inc., 2020 WL 6220125 (Ill. Cir. Oct. 8, 2020).

The Indiana Court of Appeals reversed a trial court’s denial of a preemption motion against failure-to-report-based warning claims in Bayer Corp. v. Leach, 153 N.E.3d 1168 (Ind. App. 2020).  The Indiana product liability statute required plaintiffs to “show that warnings on the labeling or packaging were inadequate,” but that would require juries to find that FDA approved device labels were inadequate – a claim preempted by federal law:

[T]o prevail for a defect due to a failure to warn . . ., a litigant must show that warnings on the labeling or packaging were inadequate.  Here, [plaintiffs] claim that the approved labeling and packaging was rendered inadequate due to [defendant’s] omissions − i.e., the failure to comply with federal reporting requirements.  Yet, even assuming that [defendant] failed to comply with federal reporting requirements, other federal law nevertheless required that [it] use the approved labeling and packaging.  Under the MDA, a state cannot impose a different or additional requirement.  Thus, the claims that [defendant] is liable for a failure to warn . . . are expressly preempted.

Id. at 1186-87 (citations omitted).  However, in a unique ruling, Leach went on to “clarify that the alleged violation of reporting requirements is potentially actionable as a manufacturing defect,” id. at 1187 – a theory we’ve never articulated anywhere else.

Bledsoe v. Medtronic, Inc., 2020 U.S. Dist. Lexis 683 (N.D. Ind. Jan. 3, 2020), found a reporting-based claim expressly preempted.

[T]here are conflicting federal requirements that are directly applicable to the [device], namely that a medical device manufacturer is only required to report adverse findings to the FDA.  Indeed, the duty on which the Plaintiff’s failure to warn claim is based exists only at the state and not the federal level.  This necessarily means that the state requirement is in addition to the federal requirement and, therefore, is preempted by the MDA.

Id. at *16. (citations omitted).

Eighth Circuit

The Eighth Circuit held that failure-to-report claims were preempted in In re Medtronic, Inc., Sprint Fidelis Leads Products Liability Litigation, 623 F.3d 1200 (8th Cir. 2010) (MDL decision involving multiple states’ laws).  Affirming the district court, Sprint Fidelis held that “alleg[ations] that [defendant] failed to provide the FDA with sufficient information and did not timely file adverse event reports, as required by federal regulations” were preempted under Buckman:  “[a]s the district court concluded, these claims are simply an attempt by private parties to enforce the MDA, claims foreclosed by §337(a) as construed in Buckman.  623 F.3d at 1205 (citations omitted).  The district court’s opinion laid out its preemption reasoning at greater length:

[T]he reporting requirements Plaintiffs point to . . . were promulgated by the FDA in accordance with the FDCA. . . .  Hence, what Plaintiffs are really alleging is that [defendant]  violated the FDCA by failing to inform the FDA in a timely fashion of adverse . . . events.  Such a claim necessarily fails, because no private right of action exists under the FDCA.  Plaintiffs cannot make an end run around this rule by recasting violations of the FDCA as violations of state common law. . . .  [C]laims alleging violations of the FDCA . . . are impliedly preempted by 21 U.S.C. §337(a).

In re Medtronic, Inc. Sprint Fidelis Leads Products Liability Litigation, 592 F. Supp.2d 1147, 1160-61 (D. Minn. 2009) (citations omitted) (emphasis original).

Another influential decision is Riley v. Cordis Corp., 625 F. Supp.2d 769, 789-790 (D. Minn. 2009), decided prior to Sprint Fidelis.  Riley independently came to the conclusion that reporting-based claims are impliedly preempted:

[Plaintiff] alleges that [defendant] failed to comply with its PMA because it [did not] . . . ma[k]e timely reports to the FDA of clinical outcomes and adverse events. . . .  [Plaintiff] does not identify any state-law cause of action under which he would have the right to recover for these failures if the FDCA and its implementing regulations did not exist; it is nonsensical to speak of a state-law claim for “failure to follow the conditions of the PMA” in the absence of the federal regulatory structure that provides for that PMA.  Thus, under the logic of Buckman, any such state-law claim would be preempted.  The Court therefore dismisses these claims with prejudice.

Id. at 789-90 (citations omitted).  See also In re Medtronic Sprint Fidelis Lead Products Liability State Court Litigation, 2009 Minn. Dist. Lexis 111, at *60 (Minn. Dist. Oct. 20, 2009) (quoting and following Riley).

Also in Minnesota, class action plaintiffs in ASEA/AFSCME Local 52 Health Benefits Trust v. St. Jude Medical, LLC, 362 F. Supp.3d 642 (D. Minn. 2019), brought a reporting-based claim.  Id. at 645.  The court held that this claim, and all others, were impliedly preempted.  Id. at 650.  In addition to the Sprint Fidelis decisions, ASEA/AFSCME relied on Kinetic Co. v. Medtronic, Inc., 2011 U.S. Dist. Lexis 42398 (D. Minn. April 19, 2011), and Pinsonneault v. St. Jude Medical, Inc., 953 F. Supp.2d 1006 (D. Minn. 2013).  362 F. Supp.3d at 649-50 (“under Sprint Fidelis, Kinetic, and Pinsonneault, the court is constrained to conclude that plaintiff’s claims are preempted”).  Kinetic held, with respect failure-to-report claims:

Obviously, a claim premised on a defendant’s violation of an FDA regulation requiring that information be reported to the FDA is not a claim that would give rise to liability under state law even if the FDCA had never been enacted.  It is, instead, simply an attempt by private parties to enforce the MDA − an attempt that is preempted under Buckman.

2011 U.S. Dist. Lexis 42398, at *11 (citations and quotation marks omitted).  Similarly, Pinsonneault declared, after a lengthy discussion, 953 F. Supp.2d at 1015-17:

In sum, the failure to properly or timely to warn the FDA via the [adverse event reporting] process, as opposed to warning doctors or patients of a device’s dangers, is not the type of conduct that would traditionally give rise to liability under state law even if the FDCA had never been enacted. . . .  [P]laintiffs are alleging that their claims are based on [defendant’s] failure to provide reports required under the regulations to the FDA . . . .  While a parallel state claim that is based on a separate state duty may survive preemption, a claim that exists solely because of the FDCA disclosure requirement, such as the [reporting] requirements in this case, is impliedly preempted.

Id. at 1017 (citations and quotation marks omitted).  See also Moretti v. Mutual Pharmaceutical Co., 852 F. Supp.2d 1114, 1118 (D. Minn. 2012) (“the essence of” a failure-to-report claim “is that important safety information as to [the drug] was not disseminated, or made clear, to the public or to the medical community” which implicates FDA-approved warnings , aff’d, 518 F. Appx. 486 (8th Cir. 2013).

However, defendants should be aware that, in reliance on the since-discredited Stengel decision (see Ninth Circuit) decision, Angeles v. Medtronic, Inc., 863 N.W.2d 404 (Minn. App. 2015), recognized a common-law failure-to-report claim.  Id. at 419 (see 50-state survey).  However, even if Angeles provided a “parallel” claim under Minnesota law, that claim nevertheless remains totally dependent on the existence of the FDA’s reporting obligations.  Thus, the implied preemption holdings in Sprint Fidelis, Riley, Kinetic, and Pinsonneault should still prevail, at least in federal court.

Failure-to-report claims have likewise been held preempted in cases under Missouri law.  Most recently, in Bergdoll v. CooperSurgical, Inc., 2025 U.S. Dist. Lexis 38300 (W.D. Mo. March 4, 2025), implied preemption did in such claims in accordance with Sprint Fidelus:

Plaintiffs’ claims that “Defendants essentially robbed the FDA of the opportunity to ensure that the labeling on the [device] were up-to-date and accurate,” including the allegation that Defendants never reported a journal article . . ., are also preempted.  Similar failure to report claims have been found to be preempted as an attempt to privately enforce FDA requirements.  As a result, the Court finds Plaintiffs claims that Defendants somehow failed to provide information to the FDA, including adverse events or [other] publications, are preempted.

Id. at *18-19 (citations omitted).  Similarly, Schnulle v. Somatics, LLC, 2022 U.S. Dist. Lexis 11293, at *8 (E.D. Mo. Jan. 21, 2022), held:

Plaintiff is essentially claiming that [defendant] was negligent by failing to adhere to the requirements of the FDCA, which requires device manufacturers to investigate and evaluate the cause of all reported adverse events.  As there is no common law duty in Missouri to do so, this allegation is based on a federal requirement with no correlative state law duty, and is impliedly preempted.

Id. at *8.  See Antonacci v. Allergan USA, Inc., 2021 U.S. Dist. Lexis 145850, at *9 (E.D. Mo. Aug. 4, 2021) (“insofar as Plaintiff bases her failure to warn or negligence claims on the [] Defendants’ alleged violation of FDA reporting requirements, her claim is preempted pursuant to Buckman”); Zaccarello v. Medtronic, Inc., 38 F. Supp.3d 1061, 1068 n.2 (W.D. Mo. 2014) (“to the extent Plaintiff bases this [warning] claim on Defendants’ alleged failure to file an adverse event report with the FDA, the claim is impliedly preempted”) (citation omitted); Blankenship v. Medtronic, Inc., 6 F. Supp.3d 979, 989 (E.D. Mo. 2014) (“these claims are simply an attempt by private parties to enforce the MDA, claims foreclosed by §337(a) as construed by Buckman”); but see Williams v. Bayer Corp., 541 S.W.3d 594, 606 (Mo. App. 2017) (state court not bound by Sprint Fidelis analogizing failure to report to general failure to warn).

An Iowa court followed Sprint Fidelis and found failure-to-report claims impliedly preempted in Brown v. Medtronic, Inc., 2021 U.S. Dist. Lexis 262681, at *13 (S.D. Iowa March 10, 2021):

Like the claim at issue in [Sprint Fidelis], this claim “allege[s] that [defendant] failed to provide the FDA with sufficient information and did not timely file adverse event reports, as required by federal regulations.”  Thus, like the warning claims in [Sprint Fidelis], [plaintiff’s] warning claims “are simply an attempt by [a] private part[y] to enforce the MDA,” and such claims are “foreclosed,” that is, impliedly preempted, “by §337(a) as construed in Buckman.”

Id. at *13 (Sprint Fidelis citations omitted).

Similarly, in Green v. Bayer Corp., 522 F. Supp.3d 492, 499-500, 502 (E.D. Ark. 2021), an Arkansas court held that failure-to-report claims purporting to apply that state’s law were impliedly preempted:

[Plaintiff] alleges negligent “risk management,” which appears to me to attempt to assert a claim that Defendant did not notify the FDA about problems.  This does not state a valid cause-of-action.  It is based on Defendants’ alleged failure to comply with federal reporting and regulatory conditions. . . .  Plaintiff argues that Defendants are liable for failing to report adverse events to the FDA, which she claims is a state law cause of action.  Defendants argue that a claimed violation of the FDCA is enforceable only by the government under 21 U.S.C. §337(a), and is subject to preemption. . . .  I agree.

Furthermore, under the “narrow gap” requirement, Plaintiffs’ risk management claim is valid only to the extent she seeks to recover for a claimed violation of a traditional state tort law that aligns with a federal requirement.  She has not alleged any Arkansas requirement that a manufacturer report adverse events to the FDA.  Therefore, Plaintiff’s negligent risk management claim is impliedly preempted.

Id. at 499-500 (footnotes omitted).

We have found nothing, either pro or con, concerning preemption of reporting-based claims in Nebraska or the Dakotas.

Ninth Circuit

In the Ninth Circuit, defendants have to deal with Stengel v. Medtronic Inc., 704 F.3d 1224 (9th Cir. 2013) (en banc), abrogated in part on state-law grounds, Conklin v. Medtronic, Inc., 431 P.3d 571 (Ariz. 2018).  Stengel purported to apply Arizona law, claimed that state law would permit such claims, id. at 1233, and then held that the “new” claim Stengel had just invented was not preempted:

[W]e do hold, under Lohr, Buckman, and Riegel, that this claim is not preempted, either expressly or impliedly, by the MDA.  It is a state-law claim that is independent of the FDA’s pre-market approval process that was at issue in Buckman.  The claim rests on a state-law duty that parallels a federal-law duty under the MDA, as in Lohr.  In holding that the [plaintiffs’] failure-to-warn claim is not preempted, we join the Fifth and Seventh Circuits, which reached the same conclusion with respect to comparable state-law claims in Hughes and Bausch.

704 F.3d at 1233.

It took five years, but the Arizona Supreme Court in Conklin v. Medtronic, Inc., 431 P.3d 571 (Ariz. 2018), declared that Stengel was full of baloney.  For a discussion of state-law issues, see our 50-state survey; see also McNeil-Williams v. DePuy Orthopaedics, Inc., 384 F. Supp.3d 570, 576-77 (E.D.N.C. 2019) (detailed discussion of Conklin’s rejection of Stengel).  As for preemption, Conklin held not only that failure-to-report claims didn’t exist in the first place, but also that they were “impliedly preempted under federal law.”  431 P.3d at 576.

Because only federal law, not state law, imposes a duty on [defendant] to submit adverse event reports to the FDA, [plaintiff’s] failure-to-warn claim is impliedly preempted under 21 U.S.C. §337(a). Absent an independent state law duty to submit adverse event reports to the FDA, [plaintiff’] failure-to-warn claim, at bottom, is an attempt to enforce a federal law requirement. That claim is impliedly preempted under the MDA. . . .

*          *          *          *

We disagree with Stengel and consequently with the court of appeals’ reasoning and conclusion in this case. . . .  Because Stengel incorrectly recited and applied Arizona law, we decline to follow it.

Id. at 578-79 (citations omitted).  See also Skinner v. Small Bone Innovations, Inc., 2024 U.S. Dist. Lexis 137103, at *12 (D. Ariz. Aug. 2, 2024) (failure-to-report claim expressly preempted; no parallel claim because “Plaintiff has not specifically identified a state law claim that is parallel to the federal requirements”) (citation and quotation marks omitted); Scovil v. Medtronic, Inc., 2014 U.S. Dist. Lexis 95060, at *2 (D. Ariz. June 27, 2014) (failure-to-report claim “is preempted as a clear attempt to privately enforce the [FDCA’s] continuous reporting requirements”).

Unfortunately, during Stengel’s five year reign of error, California courts adopted exactly what the Arizona Supreme Court ultimately rejected.  See 50-state survey.  That includes two California intermediate appellate decisions and multiple non-precedential Ninth Circuit opinions applying Stengel to California law.  Fortunately, failure-to-report claims are difficult to plead and even more difficult to prove.  Our 50-state survey details several non-preemption grounds for defeating failure-to-report claims in California, however, preemption is currently not a strong defense, particularly in PMA medical device cases..

What about preemption of reporting-based claims in other states in the Ninth Circuit?

In Nevada, a pre-Stengel decision holds “that claims based on a generic’s failure to report incident information to the FDA are preempted.”  Moretti v. Wyeth, Inc., 579 F. Appx. 563, 565 (9th Cir. 2009) (applying Nevada law).  But see Scovil v. Medtronic, Inc., 2015 U.S. Dist. Lexis 25708, at *19 (D. Nev. March 2, 2015) (failure-to-report claim not preempted under Stengel).

In Montana, Noel v. Bayer Corp., 481 F. Supp.3d 1111, 1120-21 (D. Mont. 2020), held reporting-based claims preempted because “Montana law provides no such parallel duty.”  Id. at 1120.  Therefore, the plaintiff’s failure-to-warn-the-FDA claims are impliedly pre-empted.”  Id. at 1121.

In Oregon, Phelps v. Wyeth, Inc., 857 F. Supp.2d 1114 (D. Ore. 2012), recognized in a generic drug case that the Hughes anti-preemption rationale was inapplicable:

Plaintiffs’ reliance on Hughes . . . is misplaced.  Hughes involved a medical device and whether the plaintiff’s claims were expressly preempted. . . .  Hughes does not change the preemption analysis outlined in Mensing.  Here, plaintiffs’ claims are preempted by impossibility; they are not expressly preempted as the claims in Hughes were.  Moreover, Hughes was decided before Mensing, and Mensing specifically held that a failure to provide information to the FDA . . ., assuming such a duty existed, did not change its preemption analysis.  Accordingly, plaintiffs may not proceed on similar claims here.

857 F. Supp.2d at 1126.

Before Stengel was repudiated, courts in Idaho and Hawai’i made similarly expansive – and unsupported by state law, see 50-state survey – applied the Stengel rationale to preemption in those states.  Richardson v. Bayer Healthcare Pharmaceuticals, Inc., 2016 U.S. Dist. Lexis 117702, at *21-23 (D. Idaho Aug. 30, 2016); Beavers-Gabriel v. Medtronic, Inc., 2015 U.S. Dist. Lexis 2522, at *33-36 (D. Haw. Jan. 9, 2015).  While obviously impaired, these decisions have not yet been overruled.

Tenth Circuit

The Tenth Circuit affirmed that failure-to-report claims are impliedly preempted in Brooks v. Mentor Worldwide, LLC, 985 F.3d 1272, 1281 (10th Cir. 2021) (applying Kansas & Missouri law).

[Plaintiffs] claim that Defendant did not properly . . . report negative results.  Plaintiffs also theorize that this reporting would have indirectly warned physicians of the implants’ dangers.  But Plaintiffs have not identified a state-law duty to comply with FDA-imposed post-approval requirements such . . . reporting.  Buckman made clear that only the federal government may enforce reporting requirements and investigate and respond to suspected fraud. . . .  Federal law thus impliedly preempts Plaintiffs’ claims based on alleged failures to properly conduct post-approval . . . reporting as attempts to enforce the MDA.

Id. at 1280-81 (ellipses involve similar dismissal of failure-to-test claim).  Further, characterizing such violation claims as “negligence per se” did not work either.  “Any negligence per se action premised on an MDA violation necessarily seeks to enforce the MDA rather than a parallel state-law duty.”  Id. at 1280.  See also Pontious v. Medtronic, Inc., 2011 U.S. Dist. Lexis 140717, at *6 (D. Kan. Dec. 7, 2011) (“Claims that a defendant failed to make a report to the FDA as required by the [MDA] are among those that are preempted and cannot give rise to a state law cause of action.”) (citation omitted).

Colorado courts, both state and federal, have repeatedly held that failure-to-report claims are preempted:  Blanar v. Prager, 2024 Colo. Dist. Lexis 325, at *20 (Colo. Dist. June 25, 2024) (”to the extent Plaintiffs allege that [defendant] failed to report adverse events to the FDA . . ., those allegations are impliedly preempted.  Plaintiffs have not alleged any state law basis for these claims, so they are necessarily brought pursuant to the FDCA and are therefore precluded by Buckman.”); Golden v. Brown, 2017 Colo. Dist. Lexis 2470, at *6 (Colo. Dist. Sept. 24, 2017) (“There is no state law duty identical to the federal requirement that a device manufacturer report adverse events to the FDA, as required to state a parallel claim.  Thus, allegations that Defendant failed to report adverse events to the FDA do not state a parallel claim.”) (citations omitted); Wheeler v. Frank, 2012 Colo. Dist. Lexis 2832, at *7-9 (Colo. Dist. April 14, 2012) (failure-to-report claim dismissed as a preempted fraud-on-the-FDA theory); Franklin v. Medtronic, Inc., 2010 U.S. Dist. Lexis 71069, at *21-22 (D. Colo. May 12, 2010) (“Plaintiff’s negligence per se and misrepresentation claims go on to assert additional allegations that Defendant failed to comply with its obligations pursuant to federal regulations” in that “Defendant failed to duly report information to the FDA” are “impliedly preempted” . . . because there is “no private cause of action under the FDCA”) (citation and quotation marks omitted).  Cf. Vieira v. Mentor Worldwide, LLC, 392 F. Supp. 3d 1117, 1131 (C.D. Cal. 2019) (“Plaintiff . . . is preempted from making a failure to warn claim, because her home state of Colorado does not recognize such claims”), aff’d, 845 F. Appx. 503 (9th Cir. 2021).

New Mexico courts have reached similar results.  “[T]he Tenth Circuit has squarely held that only the federal government may enforce reporting requirements, and such claims are therefore impliedly preempted.”  Garcia v. Bayer Essure, Inc., 2023 U.S. Dist. Lexis 112416 (D.N.M. June 28, 2023) (citation, footnote, and quotation marks omitted).  Following Buckman and Brooks, Ferguson v. Bayer Essure, Inc., 2023 U.S. Dist. Lexis 177501 (D.N.M. Sept. 29, 2023), held that failure-to-report claims are preempted:

Law concerning implied preemption generally labels failure to report claims as “fraud-on-the-FDA.”  The United States Supreme Court barred claims for such fraud under implied preemption. . . .  [O]nly the federal government may enforce reporting requirements and investigate and respond to suspected fraud.  In other words, claims based on alleged failures to properly conduct post-PMA reporting are therefore impliedly preempted as improper private attempts to enforce the MDA.  Thus, [plaintiff’s] failure to report claim is impliedly preempted and will be dismissed.

Id. at *19.  A few months earlier, Garcia v. Bayer Essure, Inc., 631 F. Supp.3d 1026, 1036-37 (D.N.M. 2022), held failure-to-report claims preempted − first impliedly:

Only the federal government may enforce reporting requirements and investigate and respond to suspected fraud.  Claims based on alleged failures to properly conduct post-PMA reporting are therefore impliedly preempted as improper private attempts to enforce the MDA.

Id. at 1036 (citations and quotation marks omitted).  Then, since the plaintiff’s claims involved a PMA medical device, they were also expressly preempted:

Plaintiff argues her state tort claims are parallel to federal law. . . .  However, Plaintiff cites no state law cause of action for failure to report adverse events to the FDA, and . . . fraud-on-the-FDA claims are barred.  Additionally, to the extent that Plaintiff argues the federal regulations parallel the state tort duty-to-warn, these duties are not truly parallel as the federal regulations invoke a duty to the FDA, not to consumers, healthcare professionals or other foreseeable users of the product.

Id. (citations omitted).

Before Brooks settled the question in the Tenth Circuit, Littlebear v. Advanced Bionics, 896 F. Supp.2d 1085 (N.D. Okla. 2012), reached the same conclusion.

All claims predicated on the failure to comply with adverse event reporting requirements are impliedly pre-empted.  The adverse event reporting requirements are not substantive safety requirements under state law, but rather administrative requirements.  Thus, the claim is impliedly pre-empted.

Id. at 1092 (citation omitted).  See Warmoth v. Medtronic, Inc., 2023 U.S. Dist. Lexis 100667, at *14 (W.D. Okla. June 9, 2023) (“to the extent Plaintiff argues his failure to warn claim is solely premised on failure to report to the FDA, such a claim would be impliedly preempted”) (citation omitted).

Finally, for completeness – it doesn’t matter after Brooks − but the backhanded allowance of a reporting-based claim in Marion v. Smith & Nephew, Inc., 2016 U.S. Dist. Lexis 99449, at *13-14 (D. Utah July 27, 2016), which did not even consider implied preemption, has yet to be directly overruled.

Eleventh Circuit

The Eleventh Circuit held that “the failure to report theory is impliedly preempted” in Mink v. Smith & Nephew, Inc., 860 F.3d 1319, 1329 (11th Cir. 2017) (applying Florida law).

Applying Buckman, [plaintiff’s] failure to report theory is impliedly preempted.  [That] theory relies on [plaintiff’s] allegation that [defendant] “failed to adequately investigate adverse events and complaints and failed to properly report these issues to the FDA.”  Because this theory of liability is based on a duty to file a report with the FDA, it is very much like the “fraud-on-the FDA” claim the Supreme Court held was impliedly preempted in Buckman.  In both cases, a plaintiff alleged a manufacturer failed to tell the FDA those things required by federal law.  And here, like Buckman, we conclude that federal law preempts these claims insofar as [defendant’s] duty is owed to the FDA and [plaintiff’s] theory of liability is not one that state tort law has traditionally occupied.

Id. at 1330.  See Tsavaris v. Pfizer, Inc., 717 F. Appx. 874, 877 (11th Cir. 2017) (following Mink; dismissal of failure-to-report claim involving different federal statute affirmed).

Favorable precedent abounds in Florida district courts.  The decision in In re Zantac (Ranitidine) Products Liability Litigation, 546 F. Supp.3d 1284, 1311-16 (S.D. Fla. 2021), holding all reporting-based claims preempted is comprehensive.  First Zantac identified all the ways in which the MDL plaintiffs’ failure-to-report were identical to the claims held preempted in Mink:

• As in Mink, the Plaintiffs bring state common-law claims for failure to warn.
• As in Mink, the Plaintiffs seek to hold the Defendants liable for failing to provide product safety information to the FDA.
• As in Mink, the Plaintiffs fault the Defendants for failing to provide information that is required under federal regulations.
• As in Mink, the Plaintiffs contend that they are enforcing state common-law duties that the Defendants owe to them.
• And as in Mink, the Plaintiffs allege that, had the Defendants provided the safety information to the FDA, the FDA would have taken action that would have prevented the Plaintiffs’ injuries.

546 F. Supp.3d at 1313.  Mink “declined to draw a distinction between claims for telling the FDA something that was wrong (the fraud claims in Buckman) and claims for not telling the FDA something (the failure-to-warn claim in Mink).”  Id.  Since “the Supreme Court’s rationales for holding the claims pre-empted in Buckman pertain in this context as well, this approach makes sense.”  Id.  There follows a thorough discussion of exactly how, in each instance, Buckman’s rationale leads to the same result in a failure-to-report case.  Id. at 1313-14.

Given these similarities to the Supreme Court’s rationales for finding pre-emption in Buckman, it is unsurprising that the Eleventh Circuit ruled in Mink that a state-law failure-to-warn claim that is based on a failure to provide information to the FDA is pre-empted.

546 F. Supp.3d at 1314.  The inherent nature of failure-to-report claims, not whether state law allowed them or not, required preemption under Buckman.  Id. (“The Court cannot conclude that the Eleventh Circuit’s holding was based on any particularities of Florida law.”).  Nor could the MDL plaintiffs run from their own pleadings, which were replete with allegations of regulatory reporting violations.  Id. at 1315.  Zantac thus concluded:

The Court is bound by the Eleventh Circuit’s holding in Mink, and the Plaintiffs’ claims are indistinguishable from the plaintiff’s claim in Mink.  For these reasons, the Plaintiffs’ claims for failure to warn consumers through the FDA are pre-empted.

Id. at 1316 (citation omitted).  In In re Zantac (Ranitidine) Products Liability Litigation, 548 F. Supp.3d 1225, 1241 (S.D. Fla. 2021), the same ruling was extended to the plaintiffs’ failure-to-report claims directed against generic drug manufacturers.

Here are other favorable Florida court preemption cases dismissing reporting-based claims:  Thelen v. Somatics, LLC, 672 F. Supp.3d 1216, 1226 (M.D. Fla. 2023) (claim that defendant “failed to adequately report adverse events to the FDA . . . seeks to enforce a duty that runs to the FDA and is therefore impliedly preempted”) (citation omitted); Hernandez v. Aurobindo Pharma USA, Inc., 582 F. Supp.3d 1192, 1212 & n.14 (M.D. Fla. Jan. 24, 2022) (allegation that generic manufacturer “failed to reveal” or “concealed” its testing from the FDA was a preempted warning claim); Jacob v. Mentor Worldwide, LLC, 389 F. Supp.3d 1024, 1028 (M.D. Fla. 2019) (failure-to-report “claims are preempted” because “Plaintiff is seeking to enforce federal requirements that are not grounded in traditional state-tort law”); Tinkler v. Mentor Worldwide, LLC, 2019 U.S. Dist. Lexis 223656, at *21 (S.D. Fla. Dec. 30, 2019) (“To the extent Plaintiff’s theory is that [defendant] failed to report or underreported to the FDA information . . ., this theory cannot support a state-law failure-to-warn claim due to implied preemption.”); Westerfield v. Corin Group, PLC, 2019 U.S. Dist. Lexis 42458, at *3 (M.D. Fla. March 15, 2019) (“claims based on a defendant’s alleged failure to make required disclosures to the FDA . . . are impliedly preempted by the MDA”); Rowe v. Mentor Worldwide LLC, 297 F. Supp.3d 1288, 1296, 1300 (M.D. Fla. 2018):

[Plaintiff’s] failure to report theory of liability is also preempted, albeit impliedly. . . .  [Plaintiff] alleges that [defendant] should have reported adverse events, presumably to the FDA as required by federal regulations.  As the Eleventh Circuit explained in Mink, a failure to report claim like this is “very much like the ‘fraud-on-the FDA’ claim the Supreme Court held was impliedly preempted in Buckman” because [plaintiff] is alleging [defendant] “failed to tell the FDA those things required by federal law.”  So [plaintiff] cannot pursue negligence based on this theory of liability.

(Citation omitted); Romer v. Corin Group, PLC, 2018 U.S. Dist. Lexis 152752, at *17-18 (M.D. Fla. Sept. 7, 2018) (reporting-based claim “imposes requirements that are different from, or in addition to, the federal requirements under the MDA that defendants are required to adhere to”; “Because plaintiffs’ failure to warn claim is premised upon an FDA-reporting requirement that is not paralleled by a Florida law duty, plaintiffs’ claim is impliedly preempted.”) (citation omitted);

Parks v. Howmedica Osteonics Corp., 2016 U.S. Dist. Lexis 188069, at *31-32 (M.D. Fla. March 11, 2016) (IDE device; fraud claims attacking defendant’s “reporting disclosures” “are impliedly preempted under Buckman”); Marmol v. St. Jude Medical Center, 132 F. Supp.3d 1359, 1369-70 (M.D. Fla. 2015) (“Because Plaintiff’s failure-to-warn claim is premised upon an FDA-reporting requirement that is not paralleled by a Florida-law duty, Plaintiff’s claim is impliedly preempted”; it “is merely an attempt to recast a claim for violation of the FDCA as a state-law negligence claim”) (citations and quotation marks omitted); Byrnes v. Small, 60 F. Supp.3d 1289, 1297 (M.D. Fla. 2015) (“to the extent that the claim is based on [defendant’s] failure to report adverse events to the FDA, it is impliedly preempted . . ., as it is merely an attempt to recast a claim for violation of the FDCA as a state-law negligence claim”) (citation and quotation marks omitted); McClelland v. Medtronic, Inc., 944 F. Supp.2d 1193, 1200-01 (M.D. Fla. 2013):

[T]o the extent that Plaintiff’s negligence claim can be construed as alleging a breach of duty owed by Defendant to the FDA, such a claim is impliedly preempted by §337(a).  The thrust of Plaintiff’s claim is that Defendant violated the FDCA and its implementing regulations by failing to inform the FDA about incidents where the [device] may have contributed to a death or serious injury.  As with Plaintiff’s claims in her Amended Complaint for negligence per se and failure to warn, Plaintiff’s attempt to recast a claim for violation of the FDCA as a state-law negligence claim is impliedly barred by §337(a).  Accordingly, Plaintiff may not assert a claim based on Defendant’s alleged breach of a duty to file timely reports with the FDA.

(Citations omitted); Guenther v. Novartis Pharmaceutical Corp., 2013 U.S. Dist. Lexis 123696, at *17 (M.D. Fla. Aug. 29, 2013) (prescription drug; “the Plaintiffs will not be permitted to argue that [defendant] violated FDA regulations by withholding information from the agency”); Metz v. Wyeth LLC, 872 F. Supp.2d 1335, 1342 & n.7 (M.D. Fla. 2012) (generic drug; “Plaintiffs’ claims relating to . . ., failure to report adverse events . . . are also preempted”; “fail[ure] to supply relevant information to the FDA” is a preempted fraud-on-the-FDA claim), aff’d, 525 F. Appx. 893 (11th Cir. 2013); McClelland v. Medtronic, Inc., 2012 U.S. Dist. Lexis 152197, at *18 (M.D. Fla. Sept. 27, 2012) (“claims based upon FDCA disclosure requirements, rather than traditional state tort law are impliedly preempted”); Metz v. Wyeth, LLC, 2011 U.S. Dist. Lexis 121549, at *7-8 (M.D. Fla. Oct. 20, 2011) (generic drug; “similar to the Plaintiffs’ allegations in this case,” Mensing preempted claims that the defendant “failed to report safety information”); Wheeler v. Depuy Spine, Inc., 706 F. Supp.2d 1264, 1270 n.4 (S.D. Fla. 2010) (claim that defendant did “not accurately disclos[e] to the FDA the number and extent of complications . . . of which it was aware” was a preempted fraud-on-the-FDA claim under Buckman); see also Bernasek v. Gatz, 2021 Fla. Cir. Lexis 831, at *9-10 (Fla. Cir. May 20, 2021) (allegation that the defendant “fail[ed] to monitor the Device and report Device malfunctions or adverse health consequences” “implicates violations of [defendant’s] obligations to the FDA, enforceable only by the FDA, and is therefore impliedly preempted”).

Georgia courts have reached the same conclusions.  The FDCA “impliedly preempts fraud-on-the-FDA claims, even if they are labeled as something else, like a negligence claim based on a manufacturer’s failure to investigate adverse events and report them to the FDA.”  Frey v. Bayer Corp., 499 F. Supp.3d 1283 (M.D. Ga. 2020) (citation omitted).

A review of the Complaint shows that, like the complaint in Mink, Plaintiff’s theory of liability is based on a duty to file a report with the FDA, which is very much like a fraud-on-the FDA claim and is preempted.  Contrary to Plaintiff’s arguments (the fact that the device at issue was subject to a recall does not change the Court’s conclusion.

Sharp v. St. Jude Medical, S.C., Inc., 396 F. Supp.3d 1250, 1260 (N.D. Ga. 2019) (citations and quotation marks omitted), rev’d in part on other grounds, 838 F. Appx. 462 (11th Cir. 2020) (solely as to manufacturing defect claims).  See Swinney v. Mylan Pharmaceuticals, Inc., 2023 U.S. Dist. Lexis 27033, at *13-14 (N.D. Ga. Feb. 17, 2023) (generic drug case; “courts in Georgia consistently reject as preempted claims based only on the defendant’s purported failure to comply with FDA reporting requirements”; plaintiff’s “allegation that Defendants violated FDA’s reporting requirements . . . fails” under Buckman); Williams v. St. Jude Medical, S.C., Inc., 2017 U.S. Dist. Lexis 227477, at *27 (N.D. Ga. Oct. 19, 2017) (“Plaintiff alleges that the . . . Defendants failed to report to the FDA information required by federal law.  Such a claim is impliedly preempted.  A duty to file a report with the FDA is akin to a ‘fraud-on-the-FDA’ claim”) (citations and quotation marks omitted); Connolly v. Sandoz Pharmaceuticals Corp., 2014 U.S. Dist. Lexis 190163, at *12-14 (N.D. Ga. Dec. 23, 2014) (claim that defendant “failed to disclose to the FDA . . . the information they possessed concerning the incidents and actual adverse medical events . . . clearly is preempted by federal law”) (citation and quotation marks omitted).  Cf. In re Bard IVC Filters Products Liability Litigation, 2017 U.S. Dist. Lexis 193442, at *22-25 (D. Ariz. Nov. 22, 2017) (negligence per se claim that defendant did “not maintain[] accurate adverse event reports” preempted under Buckman because “Plaintiff alleges no violation of any state” law; Buckman applies to Class II devices) (applying Georgia law).

In addition, a Georgia trial court has held:

In opposition to [defendant’s motion to dismiss, Plaintiff argued that his failure-to-warn claims are based on a state-law duty that parallels 21 C.F.R. §803.50, the federal regulation requiring that device manufacturers report certain adverse events to the FDA. . . .  [A]n alleged violation of 21 C.F.R. §803.50 cannot support a parallel claim because there is no duty under Georgia law to report adverse events to the FDA.  Thus, . . ., allegations that [defendant] failed to report adverse events to the FDA do not state a parallel claim.  Moreover, regardless whether such claims are expressly preempted, all claims predicated on the failure to comply with adverse event reporting requirements are impliedly preempted . . . as simply an attempt by private parties to enforce the MDA.

Latimer v. Medtronic, Inc., 2015 Ga. Super. Lexis 8893, at *19-21 (Ga. Super. Sept. 4, 2015) (citations and quotation marks omitted). 

In Alabama, a thorough discussion of why failure-to-report claims are preempted is found in Froman v. Coopersurgical, Inc., 2022 U.S. Dist. Lexis 120725 (N.D. Ala. July 8, 2022):

Critically, the FDCA’s requirement for truthfully and completely reporting incidents of adverse events is a duty that medical device companies owe to the FDA instead of to consumers.  Consequently, all claims premised on the breach of this duty are squarely barred by the MDA’s implied preemption provision. . . .  [Plaintiffs] protest that they carefully pleaded their claims so they do not rest on violation of duties the Defendants owed only to the FDA, and that Buckman’s implied preemption holding is not nearly broad enough to encompass Plaintiffs’ claims.  But the Court in Buckman was explicit in holding that a plaintiff’s claims are preempted where they are based on the theory that a defendant caused her injuries by failing to make accurate representations to the FDA.  The court thus discerns no basis for distinguishing [plaintiff’s] claims from those found implicitly preempted in Buckman and Mink.

Id. at *15-17 (citations and quotation marks, including block quote from Mink we have already quoted, omitted).  Another extensive exposition on preemption of reporting-based claims is in Mack v. CooperSurgical, Inc., 2024 U.S. Dist. Lexis 181699 (M.D. Ala. Oct. 4, 2024):

[Plaintiffs] claim that the Defendants failed to report to the FDA . . . hundreds of adverse events reports. . . .  [Plaintiffs] point to no Alabama law that parallels the federal requirement to report adverse events to the FDA. . . .  Therefore, such an assertion here under the [plaintiffs’] state law theories would impose requirements on the Defendants that are different from or in addition to the requirements imposed by the FDA.  As such, they are preempted.  This “failure to report” theory of liability recently was addressed by the Eleventh Circuit in Mink. . . .  The Eleventh Circuit held that this theory was impliedly preempted, stating:  “Because this theory of liability is based on a duty to file a report with the FDA, it is very much like the ‘fraud-on-the FDA’ claim the Supreme Court held was impliedly preempted in Buckman”. . . .  Under the clear authority of Mink and Buckman and because [plaintiffs] have not provided sufficient evidence supporting a failure to warn claim beyond the Defendants’ alleged failure to report adverse events to the FDA, those claims are impliedly preempted.

Id. at *18-21 (other citations omitted).  See Wilhite v. Medtronic, Inc., 2024 U.S. Dist. Lexis 39248, at *15 (Mag. N.D. Ala. March 6, 2024) (failure-to-report claims “seek[] to enforce a duty owed only to the FDA, and [those] claims are impliedly preempted by the MDA”) (citations omitted); Grubbs v. Medtronic, Inc., 2019 U.S. Dist. Lexis 121216, at *9 (N.D. Ala. July 22, 2019) (“only the FDA can bring a cause of action for a manufacturer’s failure to make disclosures to the Agency”; “similar to the impliedly preempted claims in Mink, [plaintiff’s] failure to warn claims are based on allegations that [defendant] . . . failed to properly report these [adverse events] to the FDA”) (citations and quotation marks omitted); Rice v. Allergan USA, Inc., 2018 U.S. Dist. Lexis 57361, at *21 (N.D. Ala. April 4, 2018) (“the MDA impliedly preempts [plaintiff’s] failure to report claim because her claim rests on her allegation that Allergan failed to tell the FDA those things required by federal law”).

District of Columbia Circuit

Finally, a couple of district court decisions in the DC Circuit have held reporting-based claims preempted.

In Ward v. Zoll Lifevest Holdings LLC, 2021 WL 7907066, at *6 (D.D.C. Sept. 20, 2021), the court held failure-to-report claims expressly preempted:

Plaintiff’s second failure-to-warn theory, based on Defendants’ federal reporting obligations, is preempted. . . .  The problem for Plaintiff is that a state-law duty to warn consumers is a different requirement from the federal duty to report to the FDA. . . .  [S]uffice it to say that unless both the state-law claim and the applicable federal law contain a requirement that Defendants report adverse incidents to the FDA, there is no parallel claim.  Plaintiff alleges only the possibility, under state law, that manufacturers may discharge their duty to warn by reporting to a third party. . . .  That is not enough to make a state-law claim parallel.

Id. at *19-20 (citations omitted).

Earlier, Kubicki v. Medtronic, Inc., 293 F. Supp.3d 129 (D.D.C. Feb. 5, 2018), held similarly:

[T]his Court does not accept Plaintiffs’ argument that [defendant’s] established reporting failures are truly parallel to the complaint’s claims that Medtronic is liable for failing to provide adequate warnings to [plaintiff] and her physicians. . . .  [A] defective-labeling state law claim that is tied to the manufacturer’s alleged failure to disclose new information it discovered after the FDA’s premarket approval of its medical device falls squarely within the preemptive scope of Riegel.

*          *          *          *

[T]he one claimed violation of federal law that is sufficiently specific to support a parallel state law claim . . . [ − ]failure to report subsequent adverse events to the FDA in a timely manner, as the adverse reporting regulations require − does not actually equate with the D.C. common law failure to warn claims . . ., and as a result, the MDA’s express preemption provision bars these state law claims.

Id. at 184-85 (citations and quotation marks omitted).

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In case you haven’t guessed, we at the Blog can’t stand failure-to-report claims.  They didn’t exist prior to the advent of FDCA preemption and are nothing more than preemption dodges designed to give pro-plaintiff judges an excuse to evade the Supreme Court’s clear preemption decisions in Mensing, Riegel, and Buckman.  Moreover, as a practical matter, they are almost impossible to prove, since the FDA doesn’t have to make adverse event reports public (and often does not), and doctors don’t scrutinize the FDA’s FAERS, MAUDE, or VAERS databases before making their prescription decisions.  All reporting-based claims accomplish is to avoid the efficient dismissal of obviously preempted claims and thus contribute to excessive litigation delays and costs.  Between this post addressing preemption issues, and our 50-state survey addressing state-law issues, we hope to provide “one-stop shopping” for defense counsel confronted with reporting-based claims and to increase as much as possible the creation of favorable precedent concerning this annoying and recurring issue.