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Now that all three parts of our 50-state survey examining the state of state law concerning allegations that a defendant  can state a common-law cause of action where the allegedly liability creating conduct is failure to make a statutorily mandated report to a governmental agency has been published, we have consolidated all fifty states under the first of the three posts.  We only separated them into parts as a convenience, given how long it took us to research and write it, and how long it would take our readers to review it.  Going forward, we think our readers will find a single post more convenient.  Also, this issue is important enough that we intend to maintain the currency of our research, and that’s more convenient to do in one place

So, while you’re welcome to read this part of the post, be aware that:  (1) the whole thing is here, and (2) that post is updated, while this one is not.


Citing Waltenburg v. St. Jude Medical, Inc., 33 F. Supp.3d 818 (W.D. Ky. 2014), TBI held that Kentucky would recognize FDCA-based failure-to-report claims.  2021 WL 1050910, at *28.  We disagree, but do so for an additional reason beyond Waltenburg having been hornswoggled by the now discredited Stengel decision (see Arizona).  33 F. Supp.3d at 839-40.  Besides general Kentucky precedent on failure to warn equally applicable to any product, id. at 838, Waltenburg is devoid of Kentucky state-law analysis of the reporting-based claim.

That was a mistake, because uniquely among the states, Kentucky has codified negligence per se, Ky. Rev. Stat. §446.070, and Kentucky courts have repeatedly held that this statute precludes reliance on any federal statutes and regulations.  E.g., St. Luke Hospital, Inc. v. Straub, 354 S.W.3d 529, 534 & n.14 (Ky. 2011); T & M Jewelry, Inc. v. Hicks, 189 S.W.3d 526, 530 (Ky. 2006).  See here for more examples.

In the introduction to this post, we mentioned that Restatement Third §38, comment b, recognized negligence per se as “analogous” to claims based on federal statutes.  That’s especially true in Kentucky, where there is no left-over common-law negligence theory beyond the statute that allows use of statutory standards.  Harrison Memorial Hospital, Inc. v. Wellcare Health Insurance Co., 509 S.W.3d 69, 75 (Ky. App. 2016) (no negligence per se or other private recovery allowed for claimed federal law violations); Young v. Carran, 289 S.W.3d 586, 589 (Ky. App. 2008) (same); Sadler v. Advanced Bionics, Inc., 929 F. Supp.2d 670, 681 n.10 (W.D. Ky. 2013) (no “lingering” common-law to support FDCA-based negligence per se).  Thus, unlike other states, Kentucky state-law failure-to-report claims (such as child abuse) based on state law are not the flip side of otherwise equivalent federal-law claims.  Given Kentucky’s proven hostility to use of federal enactments to shape state-law duties, we think both the TBI and Waltenburg decisions are erroneous insofar as they purport to allow any sort of common-law FDCA-based failure-to-report claim under Kentucky law.

In addition, other Kentucky state and federal precedent rejects common-law failure-to-report claims purportedly based on FDCA requirements.  Roberts v. Stryker Corp., 2014 WL 12911070, at *9-10 (W.D. Ky. Aug. 7, 2014), found no state-law duty to report, rejecting the plaintiffs’ attempted analogy to the learned intermediary rule:

More importantly, the Court can find no instance in which Kentucky courts have described this doctrine with regard to anyone other than physicians.  Larkin [v. Pfizer, Inc., 153 S.W.3d 758 (Ky. 2004)] adopts the Restatement (Third)’s formulation of the rule, which allows warnings to “prescribing and other health-care providers.”  Moreover, the Kentucky Supreme Court finds the “first and best rationale” for the rule to be “the prescribing physician is in a superior position to impart the warning and can provide an independent medical decision as to whether use of the drug is appropriate for treatment of a particular patient.”  Not once does Larkin mention a potential application to a third party who is not a medical provider.  The Court does not find it appropriate to impose an unsupported extension of this doctrine to the facts of this case.

Id. at *10 (other Larkin citations omitted) (rejecting analogy to Stengel).

Cales v. Medtronic, Inc., 2014 Ky. Cir. Lexis 1 (Ky. Cir. Nov. 21, 2014), aff’d, 2017 WL 127731 (Ky. App. June 8, 2017), reached the same result.  There was no independent state-law claim, only allegations about violations of FDA reporting requirements:

Plaintiffs do not identify any requirement under Kentucky law.  Rather, they cite two decisions from other states that a manufacturer must submit such reports to a federal agency.

Id. at *30 (presumably referring to Stengel and Hughes).

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. . . .  [T]he duty to report adverse events to the FDA exists solely because of the FDCA disclosure requirement.

Id. at *42 (citations and quotation marks omitted).  While Cales was affirmed on appeal, plaintiffs had not appealed dismissal of their product liability claims.  2017 WL 127731, at *2 n.2.

Given that Kentucky has statutorily prohibited reliance on federal standards to set Kentucky standards for tort liability, we see no basis for Kentucky law allowing such liability with respect to allegations of failure to report adverse events to the FDA.


The lack of any Louisiana state-law cause of action for failure to report to the FDA has been recognized in the first instance by the United States Supreme Court in PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011) (“Mensing”), which was an appeal from Louisiana (and Minnesota) trial court decisions.  The Mensing Court recognized that Louisiana state law concerned warnings, not interactions with the FDA.  “State law demanded a safer label; it did not instruct the Manufacturers to communicate with the FDA.”  Id. at 619.  The Fifth Circuit acknowledged this aspect of Mensing in Morris v. Wyeth, Inc., 713 F.3d 774 (5th Cir. 2013) (applying Louisiana law), viewing FDCA-based failure-to-report claims as “yet another attempt to circumvent disfavored failure-to-warn claims.”  Id. at 778.  Again, a failure-to-report claim did not exist in Louisiana outside of the duty-to-warn claim permitted by the state’s product liability statute (“LPLA”):

Nor can a violation be used as evidence of a breach of duty.  While any . . . 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.”  Finally, any “useful” reporting − at least from the standpoint of those injured − would ostensibly consist of some sort of warning.

Id. (Mensing citation omitted).  Morris affirmed dismissal of FDCA-based failure to report, also in a generic drug case, claims for the same reasons, distinguishing Hughes (see Mississippi) because the LPLA does not recognize failure to report as a warning claim:

The Court finds that Hughes is distinguishable from the lawsuit here.  First, Hughes concerns . . . a failure to warn claim under Mississippi products liability law.  Here, Plaintiffs fail to identify an analogous duty under the LPLA. . . .  [T]o the extent that Hughes may apply here, Mensing overruled it.  Plaintiffs’ reliance on Hughes is misplaced for the purpose of determining a generic pharmaceutical manufacturer’s liability under the LPLA. . . .  Plaintiffs do not allege a colorable claim under the LPLA and the FDCA does not grant a private right of action.

Morris v. Wyeth, Inc., 2012 WL 601455, at *4-5 (W.D. La. Feb. 23, 2012), aff’d, 713 F.3d 774 (5th Cir. 2013).  Cf. Vesoulis v. Reshape Lifesciences, Inc., 2021 WL 1909725, at *5-6 (E.D. La. May 12, 2021) (failure-to-report claim could not be pursued as a warning claim under Louisiana law and was therefore an improper attempt to enforce the FDCA); Cenac v. Hubbell, 2010 WL 4174573, at *5-6 (E.D. La. Oct. 21, 2010) (holding FDCA-based failure-to-report claim impliedly preempted as private FDCA enforcement without discussing its status as a Louisiana state law cause of action).

On the other hand, Gavin v. Medtronic, Inc., 2013 WL 3791612 (E.D. La. July 19, 2013), reached the opposite conclusion, relying on the same rationale that the Fifth Circuit rejected only months before in Morris:

Similarly [to Hughes], the LPLA recognizes that the manufacturer has a duty to use reasonable care to provide an adequate warning to users and handlers of the device. . . .  Hughes determines that the state law duty to provide adequate warnings and the federal reporting requirements . . . are parallel.  Thus, insofar as Plaintiff inadequate warning claim is premised on a violation of FDA reporting requirements, he has adequately alleged a valid parallel claim, sufficient to withstand a motion to dismiss.

Id. at *14 (citation and footnote omitted).  Gavin failed to cite Mensing or Morris, and their controlling (unless and until state courts rule otherwise) holdings that the LPLA does not encompass a failure-to-report claim.

For some reason TBI opted to follow Gavin, rather than Morris (or, for that matter, the Supreme Court in Mensing).  2021 WL 1050910, at *28.  Needless to say, we disagree.  Other than TBI, no court applying Louisiana law has followed Gavin.

Outside of the FDCA, a failure-to-report child abuse claim was held to be actionable under Louisiana Civil Code provisions that “[e]very act whatever of man that causes damage to another obliges him by whose fault it happened to repair it,” and “[e]very person is responsible for the damage he occasions not merely by his act, but by his negligence.”  La. Stat. Civ. C. Arts. 2315, 2316.  Parents of Minor Child v. Charlet, 135 So.3d 1177, 1178 (La. 2013).  Unlike other states, Louisiana does not appear to have common law, at least in the tort field.


TBI, found no “legal authority” from Maine on point, “opt[ed] for the interpretation that restricts liability, rather than expands it,” and held that Maine would not allow FDCA-based failure-to-report claims.  2021 WL 1050910, at *31.  We agree.  We have found no Maine precedent concerning failure-to-report cases, in the FDA context or involving reports to any other governmental entity.  The closest we found – which isn’t very close − is Fortin v. Roman Catholic Bishop of Portland, 871 A.2d 1208 (Me. 2005), which recognized a “fiduciary” duty to report priestly child abuse.  Id. at 1220-21.


Maryland is another example of federal courts hijacking state law for their anti-preemption agendas in disregard of the Supreme Court’s Erie standards for predicting state law.  Maryland appellate decisions outside the FDCA context are as best equivocal, but a federal court purporting to interpret Maryland law plowed ahead with allowing FDCA-based failure-to-report claims to avoid preemption.  Williams v. Smith & Nephew, Inc., 123 F. Supp.3d 733, 742-43 (D. Md. 2015).  Sure, Maryland state courts may well do the same thing (so far they haven’t), but the difference is that’s their right as state courts.

A Maryland child abuse case, Bentley v. Carroll, 734 A.2d 697 (Md. 1999), allowed a jury to be charged on statutory reporting requirements in a medical malpractice case, as relevant to the overall medical standard of care.  Id. at 706 (by “[p]lac[ing] a statutory reporting duty on physicians” the statute “is thus incorporated as part of the general standard of care”).  In that situation, the Court of Appeals of Maryland held “the violation of such a statute by a physician constitutes evidence of negligence.”  Id.  Other Maryland failure-to-report claims – involving claimed “duties” beyond those (like the medical standard of care) traditionally recognized − have failed.  Lemon v. Stewart, 682 A.2d 1177 (Md. 1996), rejected a claim that a physician or a hospital could be liable for failure to report someone’s HIV status to a local government agency that, like the FDA, had “no obligation” to the plaintiffs.

[W]e conclude that appellants have no vicarious cause of action based on the defendants’ failure to report [someone’s] condition to the . . . Health Department. . . .  [T]he health department . . . would have had no obligation to inform [plaintiffs].

Id. at 1185.  See Lamb v. Hopkins, 492 A.2d 1297, 1306 (Md. 1985) (probation officers’ statutory duty to report drunk driving offenses “runs from the supervising officer to the court, not from the supervising officer to the general public”; no common-law duty to third persons).

In Sheridan v. United States, 969 F.2d 72 (4th Cir. 1992), “naval regulations . . . required Navy personnel to report infractions” by other servicemen.”  Id. at 73.  Under Maryland common law, failure to report an infraction created no new duty owed to members of the general public:

The two regulations upon which plaintiffs rely pertain only to the conduct of the employment relation between [a third party] and the Government. . . .  [They] require[] persons in the Department of the Navy to report only infractions of any type by other Navy employees.  Neither of the regulations set forth general requirements applicable to all who come into contact with [naval personnel].

Id. at 75 (citations, quotation, and footnote omitted).  Nor was there “an acceptable nexus between the negligent act [the] failure to report] and the ensuing harm.”  Id.

Without citing any of the above Maryland state precedent – or any reporting-related Maryland precedent at all − Williams, 123 F. Supp.3d 733, 742 (D. Md. 2015), decided to recognize FDCA-based failure-to-report under Maryland law.  Its discussion of the novel aspect of that reporting claim, involving information provided to a third-party governmental entity rather than to the “learned intermediary,” consisted of one sentence:  “And reasonable efforts would, in some circumstances, entail a warning to a third party such as the FDA.”  Id.  That statement is starkly unsupported and as just shown, simply ignores Maryland law.

Then there’s In re Smith & Nephew Birmingham Hip Resurfacing (BHR) Hip Implant Products Liability Litigation, 300 F. Supp.3d 732 (D. Md. 2018), which we discuss here only because the decision is not at all clear what state’s law was being applied.  The failure-to-report claims in Birmingham Hip got the MDL treatment.  Citing nothing but Stengel (see Arizona), that court let those claims proceed:

As already stated, [defendant] was required by the FDA to report adverse incidents.  Thus, state failure to warn claims that support holding [defendant] liable for its alleged failure to report specific information to the FDA are not expressly preempted.

Id. at 745 (citations omitted).  That’s it – two sentences devoid of any discussion of any supposedly “parallel” reporting duty imposed under any given state’s law.  As much as we disagree with some of the conclusions in TBI, at least that decision made the effort.  Birmingham Hip didn’t even try, and instead invented supposed state-law duties that the states themselves have not recognized.

Thus, we find fault with TBI’s decision to include Maryland as a state allowing FDCA-based failure to report.  2021 WL 1050910.  Citing something that cites nothing, to us, is still nothing – particularly under Erie.


In Plourde v. Sorin Group USA, Inc., ___ F. Supp.3d ___, 2021 WL 736153 (D. Mass. Feb. 5, 2021), the “Plaintiffs . . . failed to identify a parallel duty under Massachusetts law that would have required Defendants to make reports to the FDA coextensive with the requirements imposed by federal law.”  Id. at*12.  Plaintiffs did “not identif[y] binding or persuasive authority that manufacturers of medical devices have a common law or statutory duty to report advents to the FDA.”  Id. at *11.  Moreover, given that Massachusetts follows the learned intermediary rule, plaintiffs did “not identif[y] any basis for extending the learned intermediary doctrine under a failure to warn theory so as to require manufacturers to report to or warn the FDA of dangers.”  Id.  Thus:

The Court . . . conclude[d] that Plaintiffs have not met their burden of demonstrating that there is a Massachusetts law that requires manufacturers to make reports to the FDA, nor is the Court aware of such a law.


Likewise, Phillips v. Medtronic, Inc., 2012 2012 WL 3641487 (Mass. Super. July 10, 2012), held:

[A] claim based on failure to report adverse events . . . is premised solely on a duty created by the MDA which did not exist in the common law:  the duty to provide information to a regulatory agency to enable it to determine whether to take enforcement action with respect to a device approved through the PMA process.

Id. at *10 (citations omitted).  TBI relied on Phillips (Plourde had not yet been decided) to hold correctly that Massachusetts did not allow FDCA-based failure-to-report claims.  2021 WL 1050910, at *30.

A contrary decision, that has not been followed is Scoggins v. Boston Scientific Corp., 2010 WL 8911977, at *28-29 (Mass. Super. Oct. 18, 2010), because Scroggins “failed to analyze whether a claim for failure to report information to the FDA was cognizable under Massachusetts law.”  Plourde, 2018 WL 1542361, at *5 n.4.

Conducting the Massachusetts law analysis referenced by Plourde reveals that, in Massachusetts, failure to make mandatory child abuse reports is “a crime.”  In re Grand Jury Investigation, 772 N.E.2d 9, 19 (Mass. 2002) (citation omitted).  But that is all.  In Roe No. 1 v. Children’s Hospital Medical Center, 16 N.E.3d 1044 (Mass. 2014), the Supreme Judicial Court held that reporting statutes do not create common-law causes of action for non-reporting:

[T]he mere existence of a statute or regulation does not automatically give rise to a legal duty for the purpose of a negligence action.  Rather, it is only where a duty of care exists that the violation of a statute, ordinance, regulation, or policy is relevant. . . .  [E]vidence that [defendant] violated those statutes . . . might be relevant in a tort action by patients alleged to have been abused . . . [but only] because [defendant] already has a legally cognizable duty to prevent harm . . ., not because the existence of the statutes created that duty.

In any event, the statutes referenced by the plaintiffs do not support a conclusion that . . . [defendant] owes a duty of care to the plaintiffs.  To be certain, they require that [defendant] report abuse to the [government].  They do not, however, create a duty to protect potential future plaintiffs.

Id. at 1052 (citation and quotation marks omitted).  See Hollis v. JPMorgan Chase Bank, 2014 WL 12792255, at *8 (D. Mass. Dec. 10, 2014) (failure-to-report claim alleging violation of Bank Secrecy Act dismissed; “no one is entitled to the benefit of regulatory intervention”); Doe v. Dubeck, 2006 WL 1704261, at *6 (D. Mass. June 19, 2006) (following Doe v. D’Agostino); (“these two reporting statutes, which are generally intended to protect the public, do not extend and create a legal duty owed . . . for a claim in negligence”); Doe v. D’Agostino, 367 F. Supp.2d 157, 176 (D. Mass. 2005) (child abuse statute “does not provide a private right of action against mandatory reporters who fail to report”; failure-to-report claim “grounded in negligence” “simply a recasting” of impermissible “fail[ure] to protect” claim).


Michigan is another state that TBI had to call for the right side of the “v.”  2021 WL 1050910, at *30.  TBI cited Hill v. Bayer Corp., 485 F. Supp.3d 843 (E.D. Mich. 2020), reconsideration denied, 2020 WL 5903892 (E.D. Mich. Oct. 5, 2020), and White v. Medtronic, Inc., 2019 WL 1339613, at *6 (Mag. E.D. Mich. Feb. 20, 2019), adopted, 2019 WL 1330923 (E.D. Mich. March 25, 2019), aff’d, 808 F. Appx. 290 (6th Cir. 2020).

We start, however, with Marsh v. Genentech, Inc., 693 F.3d 546 (6th Cir. 2012) (applying Michigan law), where the plaintiffs alleged failure to report in an attempt to avoid Michigan’s strict compliance presumption of non-defectiveness.  The Sixth Circuit rejected that claim.  “[T]his alleged wrong was perpetrated upon the agency, and thus implicates [an] inherently federal relationship.”  Id. at 553 (quotation marks omitted).  “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 (citations and quotation marks omitted).  “Although [plaintiff’s] allegations of failure to report are a ‘claim’ against immunity rather than the substantive basis of her tort claim, . . . the nature of [plaintiff’s] underlying substantive claim [wa]s immaterial.”  Id. at 554.  The Marsh decision binds Michigan federal district courts.

Turning to the cases cited in TBI, Hill held that, in light of Michigan’s adoption of the learned intermediary rule, “any duty [to warn] in this case would be one owed to [plaintiff’s] physicians, not [plaintiff] herself, and not the FDA.”  485 F. Supp.3d at 855.  There was no state-law duty to file adverse event reports with the FDA:

[Plaintiff’s] negligent failure to warn claim is only viable to the extent she seeks to recover for a claimed violation of a traditional state tort law that aligns with a federal requirement.  Here, [plaintiff] has not alleged any Michigan requirement that a manufacturer report adverse events to the FDA.  And based upon her response brief, Plaintiff relies solely on [defendant’s] alleged failure to warn the FDA of adverse events in support of her failure to warn claim.

Id.  Further, because “the FDA-required warnings have not changed,” there was no causation as a result of the allegedly unreported events.  Id.

Hill relied on two Sixth Circuit decisions that applied Ohio law in concluding that the plaintiff’s FDCA-based claims did not reflect state law:  Cupek v. Medtronic, 405 F.3d 421, 424 (6th Cir. 2005) (it “is the Federal Government, not private litigants who are authorized to file suit for [FDCA] noncompliance”); Kemp v. Medtronic, Inc., 231 F.3d 216, 236 (6th Cir. 2000) (no claim “premised on false representations to the FDA” is viable).  Reconsideration was denied.  Hill v. Bayer Corp., 2020 WL 5903892, at *1 (E.D. Mich. Oct. 5, 2020) (“Michigan applies the learned intermediary doctrine, wherein any duty to warn is owed to the physician and not to the patient or the FDA”).

Similarly, White held that “the federal requirement that manufacturers report adverse events to the FDA has no state law analog.”  2019 WL 1339613, at *6.

Although federal law requires device manufacturers to report certain adverse events to the FDA, there is no state-law duty to report adverse events to the FDA. . . .  Because the state-law duty to warn is not genuinely equivalent to a duty imposed by the FDCA, Plaintiffs’ allegations that [defendant] failed to report adverse events to the FDA do not state a parallel claim.  Doctors are warned of the risks associated with a medical device through the device’s labeling, not through adverse-event reports submitted to the FDA.

Id. (citations and quotation marks omitted).  See Trees v. Pfizer, Inc., 2018 WL 6710594, at *4 (Mich. App. Dec. 20, 2018) (reporting-based claim for “failure to conduct post-marketing safety surveillance” fails under Michigan compliance presumption since the label itself was FDA approved); Thorn v. Medtronic Sofamor Danek, USA, Inc., 81 F. Supp.3d 619, 630 (W.D. Mich. 2015) (“Plaintiff points to no adverse event reporting requirements under Michigan law, and the Court agrees that the requirements are administrative requirements of the FDCA.”).

Outside FDCA-land, in Murdock v. Higgins, 559 N.W.2d 639 (Mich. 1997), the court rejected any civil claims for failure to report child abuse beyond the statutory cause of action enacted by the legislature at Mich. Comp. Laws §722.633(1).  Since the statute imposed “deliberate limits to the scope of” liability, “there was no duty owed by [defendant] to this particular plaintiff.” Id. at 647.  See Brent v. Wenk, 555 F. Appx. 519, 537-38 (6th Cir. 2014) (extra-statutory failure-to-report claim dismissed sua sponte for lack of standing) (applying Michigan law); Marcelletti v. Bathani, 500 N.W.2d 124, 127-28 (Mich. App. 1993) (“the Legislature intended that liability under the statute be limited to claims for damages” meeting statutory requirements; no causation because plaintiff “would not necessarily have been protected” by a report).  See also El Camino Resources, Ltd. v. Huntington National Bank, 722 F. Supp.2d 875, 923 (W.D. Mich. 2010) (“If the [defendant] did violate its [reporting] obligations under the Bank Secrecy Act . . . no duty arises to plaintiffs for any such failure”), aff’d, 712 F.3d 917 (6th Cir. 2013).


Evaluation of failure-to-report claims in Minnesota is complicated by a disconnect between Minnesota precedent concerning the FDCA and precedent concerning other failure-to-report allegations.

The lack of any Minnesota state-law cause of action for failure to report to the FDA was been recognized, in the first instance, by the United States Supreme Court in PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011), which an appeal from Minnesota (and Louisiana).  The Court held that Minnesota state law concerned warnings, not interactions with the FDA.  “State law demanded a safer label; it did not instruct the Manufacturers to communicate with the FDA.”  Id. at 619.

Similarly, in In re Medtronic, Inc. Sprint Fidelis Leads Products Liability Litigation, 592 F. Supp.2d 1147, 1161 n.17 (D. Minn. 2009), a failure-to-report claim brought as a “generalized common law theor[y],” we believe under Minnesota law (the complaint contained other, expressly Minnesota law claims), fell to summary judgment as a disguised FDCA claim:

[W]hat Plaintiffs are really alleging is that [defendant] violated the FDCA by failing to inform the FDA in a timely fashion of adverse lead events.  Such a claim necessarily fails, because no private right of action exists under the FDCA.

Id. at 1160-61 * n.17.  In affirming, In re Medtronic, Inc., Sprint Fidelis Leads Products Liability Litigation, 623 F.3d 1200 (8th Cir. 2010), drew the same conclusion, “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 not state-law claims, but “simply an attempt by private parties to enforce the MDA.”  Id. at 1205.

But on matters of state law, the state courts trump even the United States Supreme Court.  Thus, Angeles v. Medtronic, Inc., 863 N.W.2d 404 (Minn. App. 2015), recognizing that a “claim that defendant failed to warn the FDA of adverse events is based in traditional state tort law,” id. at 419, is more important, even though it relied primarily on the since-discredited Stengel (see Arizona) decision.  So the TBI decision was on relatively firm ground concluding that Minnesota allows FDCA-based failure-to-report claims.  2021 WL 1050910, at *28.

However, that conclusion is not 100% solid, since the Angeles holding has never been reconciled with other, conflicting appellate Minnesota precedent.  First, the same court in Flynn v. American Home Products Corp., 627 N.W.2d 342 (Minn. App. 2001), rejected common-law causes of action alleging “failure to fulfill [defendant’s] legal reporting duties to the FDA.”  Id. at 346.  Flynn viewed such claims as a form of “fraud on the FDA,” and held that such claims are “preempted by federal law and are not actionable in Minnesota.”  Id. at 349.

[Plaintiff] alleges that respondents committed fraud on the FDA by failing to comply with a number of agency regulations requiring disclosure of adverse drug experiences. . . .  [T]he existence of the federal regulations is critical to [plaintiff’s] claims that those regulations were violated and caused her injuries.

Id.  Inexplicably, Angeles never mentions, let alone distinguishes, Flynn.

More generally, in another case nowhere addressed in Angeles, the Minnesota Supreme Court in Becker v. Mayo Foundation, 737 N.W.2d 200 (Minn. 2007), refused to permit a failure-to-report claim in the child abuse context.  That statute “does not create a civil cause of action for failure to report suspected child abuse.”  Id. at 211.  “The plain language of the statute indicates that the legislature chose to impose criminal, but not civil, penalties on mandatory reporters who fail to report.”  Id. at 208.

[T]here is no manifest incongruity in imposing criminal, but not civil, liability on mandatory reporters.  Here, the legislature chose to encourage reporting of suspected child abuse with the threat of criminal liability alone, and we must assume that the legislature had good reason for doing so.

Id. at 210.  Because the defendants were physicians, however, Becker allowed evidence of non-reporting as probative of the medical standard of care.  Id. at 216 (“use of reporting-related evidence and testimony implicates both the standard of care and causation elements”).  See Becker v. Mayo Foundation, 2010 WL 346382, at *8-9 (Minn. App. Feb. 2, 2010) (admitted failure to report not conclusive of duty); Meyer v. Lindala, 675 N.W.2d 635, 641 (Minn. App. 2004) (the statute “does not create a private cause of action for violation of its reporting requirements or create a duty which could be enforced through a common-law negligence action”); Kuelbs v. Williams, 609 N.W.2d 10, 14-15 (Minn. App. 2000) (failure-to-report liability “does not exist at common law” and “Minnesota courts have been reluctant to recognize private causes of action under reporting acts”); Valtakis v. Putnam, 504 N.W.2d 264, 266-67 (Minn. App. 1993) (“there was no underlying civil cause of action for failure to report suspected child abuse”).

As Becker mentioned, though, failure-to-report evidence also implicates causation.  737 N.W.2d at 216.  Thus, FDCA-based failure-to-report claims should – and have − faced the same causation hurdles in Minnesota that they have in California.  Angeles further held that, to pursue a failure-to-report claim, a plaintiff “must show how [the defendant’s] alleged failure to warn the FDA about adverse events concerning [the product] contributed to their injuries” and “must allege factual support for their claims, such as details about adverse events that should have been reported in order to determine if timely reporting would have affected” physician prescription decisions.  863 N.W.2d at 419.  “Without such detail, . . . it would be difficult if not impossible to determine whether timely reporting would have” prevented a plaintiff’s injuries.  Id.

Along these lines, in Pinsonneault v. St. Jude Medical, Inc., 953 F. Supp.2d 1006, 1016 (D. Minn. 2013), the court dismissed for lack of causation, even assuming a reporting-based cause of action existed in the first place.  Id. at 1017 n.4.  The plaintiffs invalidly assumed that the allegedly unreported events would become known to treating physicians:

Such a state law claim would necessarily imply that a warning provided by an MDR would automatically reach a physician and then reach affected patients.  However, . . . under the FDA regulatory scheme, MDRs that are submitted by a manufacturer to the FDA are not automatically made public, and plaintiffs concede that making MDRs public or the timing of making them public is within the FDA’s discretion.

Id. at 1016.  See Riley v. Cordis Corp., 625 F. Supp.2d 769, 789-90 (D. Minn. 2009) (dismissing failure-to-report claim pre-Angeles; finding no “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”).

In Walsh v. Upsher-Smith Laboratories, Inc., 2021 Minn. Dist. Lexis 8 (Minn. Dist. Jan. 5, 2021), while plaintiffs generally alleged “large numbers of adverse events not reported,” they “d[id] not specify a single adverse event [defendant] failed to report to the FDA.”  Id. at *28-29.  Since the necessary causation “allegations are absent from the [complaint], . . . the claim of failure to report adverse events to the FDA must be dismissed.”  Id. at *29 (quoting and following Angeles).  See Roberts v. Medtronic, Inc., 2016 Minn. Dist. Lexis 5, at *25 (Minn. Dist. Nov. 4, 2016) (reporting claim dismissed for failure to allege causation); Stiltner v. Medtronic, Inc., 2016 Minn. Dist. Lexis 4, at *15 (Minn. Dist. Nov. 4, 2016) (same); Lutz-Cummings v. Medtronic, Inc., 2016 Minn. Dist. Lexis 3, at *18 (Minn. Dist. Nov. 4, 2016) (same).


Applying Mississippi law, Hughes v. Boston Scientific Corp., 631 F.3d 762 (5th Cir. 2011), considered a failure-to-report claim brought “pursuant to the products liability code, Miss. Code Ann. §§11-1-63(a)(i)(2), (c)(i), [that] has been construed . . . as a duty to provide ‘reasonable warnings’ of risks.”  Id. at 769.  “Assuming that a failure to warn claim may be pursued under Mississippi law as [plaintiff] argues,” id., Hughes held that reporting non-compliance allegations were viable.

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.

Is Hughes dispositive of the substantive content of Mississippi law?  TBI thought so.  2021 WL 1050910, at *28.  But Hughes was a preemption case, not a common-law case.  “The only issue presented to us on this appeal is whether the district court correctly determined that [plaintiff’s] suit is preempted.”  631 F.3d at 771.  And guess what?  The Mississippi legislature has since abolished the cause of action that the plaintiff in Hughes had relied on (we do not know if these two events were causally related).  This sequence of events is described in Knoth v. Apollo Endosurgery US, Inc., 425 F. Supp.3d 678 (S.D. Miss. 2019).

[T]he Fifth Circuit’s decision in Hughes occurred prior the 2014 MPLA [Mississippi Product Liability Act] amendments and the Mississippi Supreme Court’s decision in Elliott.  The Fifth Circuit premised its holding in Hughes on the assumption “that a failure to warn claim may be pursued under Mississippi law . . . .”  [T]he 2014 amendments and Elliott clarified the scope and exclusivity of the MPLA.  Significantly for this particular claim, the 2014 amendments included “negligence” as a cause of action for which the MPLA applies.

Id. at 694 (citation and quotation marks omitted) (emphasis added).  The Elliott case referenced in Knoth is Elliott v. El Paso Corp., 181 So.3d 263 (Miss. 2015), which held:

[T]he MPLA provides the exclusive remedy’ for products-liability claims, and since [its] enactment . . ., products-liability claims have been specifically governed by statute. . . .  [T]he MLPA has abrogated products-liability claims based on strict-liability or negligence theories, and the MPLA now provides the roadmap for such claims.

Id. at 268 (citation and quotation marks omitted).  We checked, and Knoth appears to be correct.   The bill in question, H.B. No. 383 (available on Westlaw at MS Legis 383 (2014)) did indeed add the following language to the first paragraph of §11-1-63:  “including, but not limited to, any action based on a theory of strict liability in tort, negligence or breach of implied warranty.”

So, according to Knoth, there is no longer any separate Mississippi state-law cause of action for “negligence” or “strict liability” as Hughes “assumed,” and §11-1-63(c)(1), governing warning claims, contains nothing about the FDCA generally or “reporting” specifically.  “Under the MPLA, the defendant can bring a products liability claim for failure to warn if the “product was defective because it failed to contain adequate warnings or instructions.” 425 F. Supp.3d at 695.  As per Hughes, that claim is preempted.  631 F.3d at 768-69 (“traditional state products liability claims [are] expressly preempted . . . includ[ing plaintiff’s] products liability claim for failure to provide adequate warnings”).  Because “the MPLA does not include” a failure-to-report “cause of action for failure to warn, so it must be dismissed for stating an independent tort claim” outside of the exclusively applicable Mississippi product liability statute.  425 F. Supp.3d at 695.

Since Hughes by its own terms did not decide the underlying content of Mississippi law, its “assumption” has been overtaken by events.  Thus, the proper result is that FDCA-based failure-to-report clams, at least in cases filed since March 17, 2014 (the effective date of the previously described MPLA amendments), do not state a cause of action in Mississippi.

Outside of product liability, Mississippi common law has not permitted tort claims predicated on failure to make reports to government agencies.  We have not found any Mississippi case going one way or the other about child abuse or other state-law reporting obligations.  Douglas v. Trustmark National Bank, 201 F. Supp.3d 800 (S.D. Miss. 2016), rejected such a claim under the federal Bank Secrecy Act:

Courts addressing the issue have consistently held that the Bank Secrecy Act requiring such reports does not create a private right of action or establish a duty of care to private parties.  Accordingly, this Court finds that [plaintiff] cannot base the negligence claim asserted in this case on an alleged failure by Trustmark or Regions to file an SAR [suspicious activity report].

Id. at807-08 (citations omitted).

Finally, the same causation issues that bedevil Stengel-based failure-to-report claims in California would likewise preclude any similar Hughes-based claim – should they actually exist.  Thus, Bryant v. Thoratec Corp., 343 F. Supp.3d 594 (S.D. Miss. 2018), held:

The Plaintiffs here have only alleged that Defendants did not report her own incident.  As Defendants have pointed out, such cannot give rise to a failure to warn claim, as there is no causation between the alleged violation of FDA regulations and Plaintiffs’ purported injury.

Id. at 606.


Missouri resembles Minnesota, above, in that state appellate decisions addressing tort claims for failure to make mandatory reports to governmental bodies are in conflict, with an intermediate appellate decision allowing an FDCA-based claim without even considering extensive Missouri appellate precedent (both state and federal) finding no tort liability based on similar allegations involving other breaches of mandatory reporting obligations.

Williams v. Bayer Corp., 541 S.W.3d 594 (Mo. App. 2017), permitted a “warning” claim for failure to report adverse events to the FDA under Missouri law, under the guise of “negligence per se.”

[Defendant] now argues that [plaintiff’s] claim is similarly based exclusively on federal requirements and fails to invoke any traditional state law tort claim.  We disagree. [Plaintiff’s claim] does not rely solely on the MDA and [device’s] PMA reporting requirements and instead properly invokes a traditional state law tort cause of action; specifically, a strict liability failure to warn claim. . . .  [which is] grounded on a well-established duty imposed on manufacturers by Missouri state law to warn consumers about the risks of using their product, which [plaintiff] argues [defendant] breached by failing to meet the post-premarket approval reporting requirements listed in the MDA and the [device’s] PMA.

Id. at 606.  As other similar decisions have done, Williams did not discuss Missouri precedent addressing similar theories of liability, but only the now-discredited Stengel (see Arizona) and now-obsolete (see Mississippi) Hughes federal court decisions.  Id.  Williams agreed that “ultimately” plaintiff would have to prove causation, id. (quoting Stengel), but declined to “address the ultimately efficacy” of the FDCA-based failure-to-report theory on a motion to dismiss.  Id.

Had Williams looked to prior Missouri law, the picture would have been much different.  That court’s own prior precedent has twice rejected tort liability under Missouri law for failure to make mandatory child abuse reports.  Most recently, E.M. v. Gateway Region Young Men’s Christian Ass’n, 613 S.W.3d 388 (Mo. App. 2020), affirmed dismissal of the same sort of negligence per se rationale that Williams permitted.

In Missouri, a duty to the individual complaining must exist before an act can be said to be negligent.  Generally, no duty flows from one individual to another to protect the other from harm unless the person harmed was placed in danger by the first individual.  Here, [plaintiff] asserts that [the Missouri statute] created a duty for [defendant] to report  . . .  However, [the statute] creates a duty owed to the general public, rather than a duty owed to any particular individual. Without a specific duty to particular individuals, [the statute] does not support a private cause of action in favor of individuals.

*          *          *          *

Therefore, to the extent that [plaintiff] seeks to rely on the reporting requirements of [the statute] to establish that [defendant] owed a duty to her individually, she fails to state a claim against [defendant].

Id. at 397-98 (citations and quotation marks omitted).

E.M. relied on several federal district court decisions reaching the same result.  Chief among them was Doe A v. Special School Dist. of St. Louis County, 637 F. Supp. 1138 (E.D. Mo. 1986), which rejected a claim “that defendants had a common law duty − independent of the statutory duty − to report abuse.”  Id. at 1148.  Further, “the Missouri child abuse reporting statute creates a duty owed to the general public, not to specific individuals, and consequently the statute does not support a private cause of action in favor of individuals.”  Id.  E.M. also found persuasive Thelma D. v. Board of Education of City of St. Louis, 669 F. Supp. 947, 950 (E.D. Mo. 1987) (“the Court finds [defendant] owed plaintiffs neither a statutory nor a common law duty to report . . . alleged sexual abuse”), and Nelson v. Freeman, 537 F. Supp. 602, 605-06 (W.D. Mo. 1982) (“no cause of action has been stated under Missouri law” for alleged violations of child abuse mandatory reporting statute; statute “created only a public duty and not a duty to individuals”).

Bradley v. Ray, 904 S.W.2d 302 (Mo. App. 1995), reached the same result as E.M. as to a similar child abuse reporting provision directed at medical personnel:

There is no doubt that [plaintiff] is within the class to be protected by the Act.  However, because the Act makes individuals who do not report abuse subject to criminal penalties but does not provide a civil remedy, we do not believe Plaintiff has demonstrated a clear legislative intention to provide for civil remedies.  Because this Court finds no private cause of action can be implied under the [statute], the alleged breach of the Act also does not amount to negligence per se.

Id. at 314 (citation omitted).

The Eighth Circuit, applying Missouri law, reached the same result as E.M. and Bradley.  In American Home Assurance Co. v. Pope, 591 F.3d 992 (8th Cir. 2010) (applying Missouri law), the court held:

[Plaintiff] alleged that [a doctor] violated Missouri law by failing to report [child] abuse to authorities.  To the extent that [plaintiff] asserted a private cause of action arising out of [a] violation of the criminal statute, Missouri has prohibited such an action.  The Missouri child abuse reporting statute creates a duty owed to the general public, not to specific individuals, and consequently the statute does not support a private cause of action in favor of individuals.

Id. at 997 (citations and quotation marks omitted).  See also American Home Assurance Co. v. Pope, 360 F.3d 848, 851 n.7 (8th Cir. 2004) (following Doe A); Letlow v. Evans, 857 F. Supp. 676, 678 (W.D. Mo. 1994) (same result; “it is inappropriate for a court, particularly a federal court, to create a large and new field of state tort liability beyond what existed at common law”).

The Brooks decision cited previously (see Kansas), 2019 WL 4628264, also applied Missouri law to one of the plaintiffs.  Id. at *3.  Notwithstanding Williams, it rejected both plaintiffs’ claims based on failure to report adverse events to the FDA:

Plaintiffs have not identified any state law that required [defendant] to report adverse events to the FDA.  Accordingly, like their other claims relating to FDA reporting, plaintiffs are not seeking to enforce state law, but are attempting to enforce federal requirements.

Id. at *6.  On appeal, Brooks was affirmed.  “Missouri law limits negligence per se to violations of a statute where the legislature intended to replace the ordinary negligence standard of care,” which Congress did not intend when it enacted the FDCA.  Brooks v. Mentor Worldwide, LLC, 985 F.3d 1272, 1280 (10th Cir. 2021).

Plaintiffs alleged that Defendant violated its duty to warn the FDA.  They 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 as testing and reporting. . . .  [T]he district court properly dismissed Plaintiffs’ failure-to-warn claims.

Id. at 1280-81 (citation omitted).

Given Williams, we can’t state with confidence that TBI was flat-out wrong in holding that Missouri would allow FDCA-based failure-to-report claims.  2021 WL 1050910, at *28.  But we can say that Missouri law is currently a morass, with both appellate and trial court decisions on both sides of the issue failing to cite or consider prior significant precedent.  Our assessment of Missouri law on this subject is “up in the air.”


TBI correctly identified Montana as a state not recognizing FDCA-based failure-to-report claims.  2021 WL 1050910, at *30.  There is not much law, but Noel v. Bayer Corp., 481 F. Supp.3d 1111 (D. Mont. 2020), recognized that no Montana court has ever “h[e]ld that a manufacturer must warn the FDA (or government regulators generally) of known dangers.”  Id. at 1121.  Thus, “Montana law does not recognize a claim for failing to report [a product’s] issues to the FDA.”  Id. at 1126.  “A government regulator is not a foreseeable user or consumer of a product.”  Id. at 1121.


Applying Nebraska law, Monroe v. Medtronic, Inc., ___ F. Supp.3d ___, 2021 WL 66294 (D. Mass. Jan. 6, 2021), held that a negligence per se claim predicated on failure to file “certain reports” with the FDA was “not viable” and that, at most, alleged reporting deficiencies “may be evidence of negligence.”  Id. at *7-8 (allegations also “wholly conclusory and unsupported by sufficient facts”).  Thus, TBI was incorrect when it held, as to Nebraska, that there was no “relevant legal authority.”  2021 WL 1050910, at *31.  However, its conclusion that Nebraska would not allow FDCA-based failure-to-report claims, id., was nevertheless correct.

Monroe is also congruent with Nebraska precedent rejecting common-law claims for failure to make statutorily required child abuse reports, given Bell v. Grow With Me Childcare & Preschool LLC, 907 N.W.2d 705 (Neb. 2018), which held:

[I]f we were to recognize a legal duty to protect others from harm based exclusively on the failure to report . . ., such a duty could expose every citizen in Nebraska who witnesses possible abuse or neglect and fails to report it, to potentially limitless civil tort liability for the future criminal acts of abusers over whom they have no control, and with whom they have no special relationship.

Id. at 730 (“as a matter of law, the [defendant] childcare centers owed no legal duty” to plaintiffs).


Nevada is another state in the Ninth Circuit, like Hawai’i, where federal district courts, during the Stengel reign of error (see Arizona), attempted to hijack state law in favor of allowing FDCA-based failure-to-report claims despite no state law supporting such an expansion of liability.  The case that TBI cited, 2021 WL 1050910, at *28, to put Nevada in the claim-allowed category is a prime example.  Scovil v. Medtronic Inc., 2015 WL 880614 (D. Nev. March 2, 2015) – citing no precedent, Nevada or otherwise – declared that the plaintiff “alleged a plausible claim for relief.  [Plaintiff] has alleged non-conclusory allegations that [defendant] had a duty to report adverse events to the FDA.”  Id. at *6.  Donning Rule 12 blinders, Scovil considered neither causation nor even “whether [defendant] actually failed to report adverse events.” Id.  As far as Nevada law was concerned, it was enough in Scovil that the plaintiff “asserted the same claim as the Stengel plaintiff based on [defendant]’s alleged failure to report adverse events to the FDA.”  Id. at *7.  Other than Stengel, no precedents concerning failure to report was cited in Scovil.

Actual Nevada law is sparse, but contrary to the conclusion reached in Scovil.  The Nevada Supreme Court rejected a failure-to-report claim in Mangeris v. Gordon, 580 P.2d 481 (Nev. 1978).  Plaintiff alleged the decedent had been murdered because the defendants allegedly know ahead of time about the murderer’s “admitted and suspected (sic) criminal activities” but failed to warn either the decedent or the local police department.  Id. at 483.  Absent a “special relationship,” Mangeris found no duty to report crimes:

[Plaintiffs] also allege [defendants] breached a duty to inform the police of [the murderer’s] criminal conduct.  However, neither the common law nor our . . . statute requires a citizen to report a crime; mere silence is insufficient to establish liability.

Id. at 483-84 (citations omitted).

Furthermore, Moretti v. Wyeth, Inc., 579 F. Appx. 563 (9th Cir. 2014) (applying Nevada law), affirmed dismissal a failure-to-report claim involving a generic drug.  There could be no “claims based on a generic’s failure to report incident information to the FDA” because any “label change” based on such reports “was dependent on the FDA’s discretionary action.”  Id. at 565 (citing Mensing (see Louisiana and Minnesota)).  See also Ansara v. Maldonado, 2020 WL 2281476, at *3 (D. Nev. May 7, 2020) (dismissing claim that sought “imposition of a duty to report child abuse” on defendant “under a theory of negligence solely because it was the landlord of the property” even though a reporting “statute does list landlords as parties required to report suspected child abuse”).  But see Doe v. Nevada, 356 F. Supp.2d 1123, 1125-26 (D. Nev. 2004) (while negligence per se based on failure to report child abuse may not be “viable,” it was “premature to characterize Plaintiffs’ amended complaint as futile”).

Finally, even if Stengel were an accurate statement of Nevada law (which we don’t think is the case), a plaintiff has to plead causation to have a viable claim.  See Brandt v. Medtronic, Inc., 179 F. Supp.3d 963, 968 (D. Nev. 2016) (failure-to-report claim dismissed because “Plaintiff does not specify when [defendant] learned of those safety risks”; only “if they arose after the Device’s PMA,” could plaintiff “make out a claim”).


According to TBI, there is no “relevant legal authority” concerning failure-to-report claims in New Hampshire.  2021 WL 1050910, at *31.  Only if one ignores analogous legal precedents.  In New Hampshire, liability “should never be triggered by the mere failure of a citizen to report actual or suspected criminal conduct to law enforcement authorities.”  Berry v. Watchtower Bible & Tract Society of New York, Inc., 879 A.2d 1124, 1130 (N.H. 2005).  This rejection of failure-to-report liability began with Marquay v. Eno, 662 A.2d 272, 278 (N.H. 1995), which definitively ended negligence claims based on failure to report in the child abuse setting.  “If no common law duty exists, the plaintiff cannot maintain a negligence action, even though the defendant has violated a statutory duty.”  Id. at 277.  Due to the “sharp break from the common law” that a statutory duty to report represented, it could not support recovery in tort:

We hold that the reporting statute does not support a private right of action for its violation because we find no express or implied legislative intent to create such civil liability. . . .  [C]onsidering that imposition of civil liability for all reporting violations would represent a sharp break from the common law and neither the statute nor the legislative history directly reveal any such intent, we are unwilling to say that violation of the child abuse reporting statute supports a private right of action.

. . . [U]se of a statute to establish the standard of care is limited to situations where a common law cause of action exists. . . .  Because the duty to which the statute speaks − reporting of abuse − is considerably different from [existing] duty . . . we hold that a violation of the reporting statute does not constitute negligence per se.

Id. at 278 (citations omitted).  Accord Berry, 879 A.2d at 1128 (“assuming . . . that [defendants] had an obligation to report suspected child abuse to law enforcement authorities, the plaintiffs have no cause of action for damages based on [their] failure to do so”); Ahrendt v. Granite Bank, 740 A.2d 1058, 1064 (N.H. 1999) (“Even if [defendant] was required to report under the statute, its failure to do so cannot be the basis for civil liability where no common law duty exists and the legislature has not expressly or implicitly created such liability.”).

Gauthier v. Manchester School Dist., 123 A.3d 1016 (N.H. 2015), followed Marquay and likewise refused to recognize private liability for failure to report bullying, as required by another statute.  Like the FDCA, the statute in Gauthier precluded private enforcement.  Id. at 1019.  Following Marquay, the court again refused “to create a duty to report bullying.”  The plaintiff was attempting “artful pleading to circumvent a bar against private actions, would allow such an end-run around the legislature’s apparent intent.”  Id. at 1021 (citation and quotation marks omitted).

Similarly, in Bartlett v. Mutual Pharmaceutical Co., 731 F. Supp. 2d 135 (D.N.H. 2010), aff’d on other grounds, 678 F.3d 30 (1st Cir. 2012) (design defect), rev’d on other grounds, 570 U.S. 472 (2013) (design defect), a generic drug case, the court rejected an FDCA-based failure-to-report claim.  “Based on the sources and considerations discussed above, this court’s view is that the New Hampshire Supreme Court would not treat [defendant’s alleged failure to report] as establishing a per se breach of its duty of care.”  Id. at 155.

Thus, while we agree with the ultimate conclusion in TBI that New Hampshire does not permit FDCA-based failure-to-report claims, we reach that conclusion via a different route – that lots of New Hampshire precedent, including no fewer than four high court decisions, affirmatively rejects such attempts to expand the common law/


The New Jersey Supreme Court addressed the viability of a cause of action for failure to report adverse events to the FDA in Cornett v. Johnson & Johnson, 48 A.3d 1041 (N.J. 2012).  One of the plaintiff’s “surviving failure to warn claim[s]” alleged “failure to satisfy federal disclosure requirements” involving adverse events.  Id. at 1051.  Cornett concluded that failure-to-report claims were “grounded solely on the federal [reporting] violation,” having no state-law content.  Id. at 1054.  Because FDA reporting claims were entirely federal, they were preempted under Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001), as a form of disguised private FDCA enforcement.  48 A.3d at 1054.  The Appellate Division in Gomez v. Bayer Corp., 2020 WL 215897 (N.J. Super. App. Div. Jan. 14, 2020), refused to let plaintiffs relitigate failure-to-report issues after Cornett.  As “[o]ur Supreme Court has spoken on the subject . . . we follow its guidance here”).  Id. at *12.  In re Allergan Biocell Textured Breast Implant Products Liability Litigation, 2021 N.J. Super. Unpub. Lexis 837 (New Jersey Super. Law Div. May 4, 2021), similarly determined:

Plaintiffs advance two different theories as the basis of their failure to warn claim: . . . (2) a purported failure-to-report-to-FDA theory premised on the method, means, and manner of reporting risks to FDA.  While the distinction between the two theories is nuanced, as a matter of law . . . New Jersey does not recognize a standalone failure-to-report-to-FDA claim.

Id. at *25 (citation omitted).  See Id. at *26 n.7 (“absent the FDCA, New Jersey would not recognize a standalone failure-to-report-to-FDA claim”); *31 n.9 (“A failure to report to FDA is not a traditional basis of state law because such a theory is aimed to vindicate the rights of FDA.”).  Cf. Rose v. Bayer Corp., No. MRS-L-265-20, at p. 16 (N.J. Super. Law Div. Oct. 7, 2020) (finding a “clear” basis for preemption of “any claims of the Plaintiff which are premised on failure to report post-PMA risks and dangers to the FDA”; implied result being that no parallel state-law claim exists).

The conclusion that New Jersey law does not rest product liability on alleged failure to make required FDA adverse event reports has also been reached by federal courts.  Jankowski v. Zydus Pharmaceuticals USA, Inc., 2021 WL 2190913 (D.N.J. May 28, 2021), relied in part on TBI in holding:

New Jersey is a jurisdiction that declines to recognize a separate state law duty to warn the FDA.  Accordingly, Plaintiffs’ allegation that Defendant failed to appropriately report adverse events to the FDA fails as a matter of law.

Id. at *5 (citations and quotation marks omitted).  A claim in in Chester v. Boston Scientific Corp., 2017 WL 751424 (D.N.J. Feb. 27, 2017), was similarly dismissed because the plaintiff “fail[ed] to identify a state cause of action based on those [reporting] violations.”  Id. at at *10.  The TBI decision relied on D’Addario v. Johnson & Johnson, 2020 WL 3546750, at *5 (D.N.J. June 30, 2020), to conclude that no “separate state law duty to warn the FDA” existed under New Jersey law.  2021 WL 1050910, at *30.

The response of New Jersey law to FDA-based failure-to-report claims is consistent with its prohibition of failure-to-report liability in other areas.  New Jersey courts have considered, and rejected, tort liability for failure to make mandatory reports to any government agency in several circumstances.  In J.S. v. R.T.H., 714 A.2d 924 (N.J. 1998), the New Jersey Supreme Court rejected a negligence claim based on the defendant’s alleged failure to comply with a mandatory child abuse reporting statute, holding that the statute “d[id] not expressly attempt to resolve [duty] for purposes of civil liability.”  Id. at 934.

Accordingly, we do not conclude that the Legislature intended that the child-abuse reporting statute constitute an independent basis for civil liability or that its violation constitute negligence per se.

Id.  In G.A.H. v. K.G.G., 210 A.3d 907, 916 (N.J. 2019), the court cited J.S. with approval in rejecting similar failure-to-report liability asserted under a different reporting statue.  See also Zelnick v. Morristown-Beard School, 137 A.3d 560, 568 (New Jersey Super. Law Div. 2015) (“Child abuse reporting statutes do not typically create a duty of care or a basis for civil liability.”).  Nor has New Jersey law permitted negligence liability against a bank for failure to file “suspicious activity reports” mandated by federal banking laws.  Fogarty v. Household Financial Corp. III, 2015 WL 852071, at *19-20 (D.N.J. Feb. 25, 2015); Shtutman v. TD Bank, N.A., 2014 WL 1464824, at *2 (D.N.J. April 15, 2014).

Another basis for dismissal of the failure-to-report claims in Jankowski was the plaintiff’s failure to plead actual unreported claims, but only an increase in reported adverse events “correlating to the litigation surrounding” the drug.  2021 WL 2190913, at *5.  Such allegations “fail to allege actual adverse events that [defendant] did not report to the FDA,” and are “conclusory and speculative.”  Id. (citation and quotation marks omitted).


TBI concluded that, because  there is no “relevant legal authority” under New Mexico law permitting failure-to-report claims that the state does not recognize such a liability theory.  2021 WL 1050910, at *31.  We agree.  The only at all relevant New Mexico precedent is Johnson v. Holmes, 377 F. Supp.2d 1084, 1098 (D.N.M. 2004), holding in a §1983 action that a federal child abuse reporting statute did not imply a private right to recover money damages for an alleged failure to report due to lack of congressional intent.  Id. at 1098.  Since Johnson was not even clearly applying New Mexico (as opposed to federal) law, it’s not all that close.  Thus, we think TBI got it right on New Mexico.


New York is one of those states that’s big enough, diverse enough, and has enough litigation, that one can expect to find something on both sides of an issue like failure to report.  TBI, with its “lenient” view of the plaintiffs’ claims, 2021 WL 1050910, at *19, relied on a couple of trial court decisions (one of which was reversed), allowing FDCA-based failure-to-report claims to survive.  Id. at *29 (citing Barone v. Bausch & Lomb, Inc., 2019 N.Y. Misc. Lexis 6423, at *6-7 (N.Y. Sup. Dec. 6, 2019), rev’d, 141 N.Y.S.3d 808 (N.Y.A.D. 2021), and A.F. v. Sorin Group USA, Inc., 346 F. Supp. 3d 534, 544 (S.D.N.Y. 2018)).

While TBI lists Barone as “reversed on other grounds,” 2021 WL 1050910, at *29, that is being extremely charitable, since the Appellate Division unanimously held that the failure-to-report claim asserted in Barone was preempted.  Barone v. Bausch & Lomb, Inc., 141 N.Y.S.3d 808, 811 (N.Y.A.D. 2021) (failure-to-report claims preempted since “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”).  Thus, Barone is not valid precedent that a failure-to-report claim targeting the FDA either does, or does not, exist under New York law, since the plaintiff in Barone did not actually raise such a claim.  See also Barone v. Bausch & Lomb, Inc., 372 F. Supp.3d 141, 155 (W.D.N.Y. 2019) (plaintiff raises a “New York State [reporting] duty that may or may not exist”).

That leaves A.F., which did permit an actual FDCA-based failure-to-report claim, equating a reporting claim with a general duty “to warn the medical community.”  346 F. Supp.3d at 543.  A.F. in turn relied on Rosen v. St. Jude Medical, Inc., 41 F. Supp. 3d 170, 184 (N.D.N.Y. 2014), which followed – you guessed it, Stengel (see Arizona) and Hughes (see Mississippi).  Cf. Wholey v Amgen, Inc., 2017 N.Y. Misc. Lexis 852, at *30 (N.Y. Sup. March 8, 2017) (failure-to-report claim adequately pleaded; no discussion of duty), modified, 86 N.Y.S.3d 16 (N.Y.A.D. 2018).  So, yes, there is some New York precedent allowing reporting based claims in the FDCA context.

Those decisions, however are substantially outweighed by New York precedent rejecting tort/warning claims based on failure to make mandatory reports to governmental agencies.  To start with, over a half-dozen New York cases reject failure-to-report claims specifically under the FDCA.

Starting with the most recent, English v. Bayer Corp., 468 F. Supp.3d 573 (W.D.N.Y. 2020), flatly held that no such claim exists under New York law:

[A]s a standalone claim, failure to report adverse events to the FDA is not a cognizable cause of action under New York law.  Although plaintiffs alternatively allege that failure to report adverse events supports a claim for “negligent risk management,” plaintiffs identify no state law supporting the existence of such a cause of action in New York.

Id. at 580 (citations omitted).

The omitted citations include Mitaro v. Medtronic, Inc., 900 N.Y.S.2d 899, 899 (N.Y.A.D. 2010), which affirmed dismissal of a failure to report claim as preempted.  See Mitaro v. Medtronic, Inc., 2009 WL 1272398, at *3 (N.Y. Sup. April 9, 2009) (“adverse event reporting” claim dismissed), aff’d, 900 N.Y.S.2d 899 (2010).  The other New York case English cited is Pearsall v. Medtronics, Inc., 147 F. Supp. 3d 188 (E.D.N.Y. 2015), which discussed the non-existence of reporting-based claims under New York law at some length:

This Court disagrees that the New York state duty to warn is parallel to the federal requirements.  Under New York law, a drug manufacturer’s duty is not to warn the patient, but to warn the medical profession of dangers inherent in its biological drugs. . . .  The federal requirements require that adverse events and other reports be made to the FDA.  While New York law may require manufacturers to warn the medical profession, that is not the same as a duty to report to the FDA. . . .  [T]here must be an actual state-law duty, beyond the federal duty, to have a parallel claim. . . .  [S]ince Plaintiff’s failure to warn claim is predicated on Defendant’s alleged failure to provide the required reports to the FDA, authority to enforce that claim rests with the FDA.

Id. at 201-22 (numerous citations omitted).

In addition to English, Mitaro, and Pearsall, seeTrisvan v. Heyman, 305 F. Supp.3d 381, 402 n.16 (E.D.N.Y. 2018) (New York requirement to warn prescribing physicians cannot be satisfied “solely providing information to the FDA”; refusing to “assume” that “information provided to the FDA is also provided to prescribing physicians”); Teixeria v. St. Jude Medical, Inc., 2015 WL 902616, at *8 (Mag. W.D.N.Y. March 3, 2015) (while the New York warning duty “is somewhat expansive and relates directly to the public at large,” plaintiff “has not cited any federal regulations that impose a similarly broad duty”; FDA regulations “impose no reporting requirements directly to users”), adopted in part and rejected in part on other grounds, 193 F. Supp.3d 218 (W.D.N.Y. 2016) (plaintiff did not object to dismissal of warning claims); Lake v. Kardjian, 874 N.Y.S.2d 751, 755 (N.Y. Sup. 2008) (“alleged failure of [defendant] to comply with the MDA’s reporting requirements does not constitute a ‘parallel claim’ . . . because such an allegation would merely be an attempt to recast plaintiff’s state law claims”) (citations omitted).  There is thus no New York common-law duty to report adverse events to the FDA:

[Defendant] did not owe the plaintiffs a duty to report or warn. . . .  Even if [it] had been retained . . . for the sole purpose of reporting the adverse drug events in other counties, it would have had no duty to these plaintiffs.  The New York Court of Appeals has defined the duty of care to third parties in such situations narrowly, more narrowly than other jurisdictions.  Absent, at the very least, a showing that reliance by the plaintiffs on the data was the “very purpose” of [defendant’s] reporting requirement, there could be no duty.

In re Consolidated Fen-Phen Cases, 2003 WL 22682440, at *6-7 (E.D.N.Y. Nov. 12, 2003) (citation and quotation marks omitted).

This weight of precedent concerning FDCA-based failure-to-report claims is supported by general New York law.  Would-be reporters of information are not “held to limitless liability to an indeterminate class of persons,” but rather “negligent” reporting “require[s] actual privity, or something approaching privity.”  Eiseman v. State, 511 N.E.2d 1128, 1135 (N.Y. 1987) (holding “that liability was erroneously imposed . . . for the conduct of [a] physician in completing [a third-person’s] health report”).  See Heim v. Board of Education of North Tonawanda School Dist., 2001 WL 1606800, at *3 (N.Y. Sup. Oct. 26, 2001) (under Eiseman physician had no common-law “to report to school authorities” information concerning plaintiff’s alleged physical frailty); Ruotolo v. State, 532 N.Y.S.2d 668, 671 (N.Y. Cl. 1988) (under Eiseman, statutory “duty to report parole violations ran in favor of the [government] and only indirectly to the claimants’ benefit” and “creates no independent duty or cause of action”), aff’d, 549 N.Y.S.2d 22 (N.Y.A.D. 1990).

A New York statute, Social Services Law §420, authorizes civil liability if a mandated reporter “willfully” fails to report child abuse.  Failure-to-report claims beyond the scope of this statutory liability are not permitted under New York common law.  E.g., Catherine G. v. County of Essex, 818 N.E.2d 1110, 1113 (N.Y. 2004) (“[t]he Legislature could have required mandatory reporting for each and every instance of abuse . . . but chose not to do so”); Young v. Campbell, 929 N.Y.S.2d 249, 253 (N.Y.A.D. 2011) (reporting claim dismissed; “defendants do not fall within the limited class of persons subject to liability”); Zimmerman v. United States, 171 F. Supp.2d 281, 294 (S.D.N.Y. 2001) (dismissing claim for “negligent” failure to report); R.C. v. Diesfeld, 785 N.Y.S.2d 325, 327 (N.Y. Sup. 2004) (rejecting common-law duty to report child abuse “such an extension could potentially make a [defendant] liable to huge numbers of people”); Lurene F. v. Olsson, 740 N.Y.S.2d 797, 800 (N.Y. Sup. 2002) (statutory cause of action for failure to report does not “abrogate the common law rules limiting the scope of liability”).  Outside of the statute, “the [defendant] owed no common-law duty to report the suspected case of child sexual abuse to anyone.”  Kimberly S.M. v. Bradford Central School, 649 N.Y.S.2d 588, 590 (N.Y.A.D. 1996) (citing Marquay (see New Hampshire)).

The existence of reporting duties under a federal statute, the Bank Secrecy Act, without any private right of action, provides “no sound reason to recognize a duty of care [under New York law] that is predicated upon the statute’s monitoring requirements.”  In re Agape Litigation, 681 F. Supp. 2d 352, 360 (E.D.N.Y. 2010).  Accord Aiken v. Interglobal Mergers & Acquisitions, 2006 WL 1878323, at *2 (S.D.N.Y. July 5, 2006) (rejecting “an expansion of the scope of the [common-law] duty of care based upon the monitoring and reporting requirements imposed under the Bank Secrecy Act”; “[t]his Court may not announce a duty of care where the New York courts have declined to do so”).

Even if a failure-to-report claim could exist under New York law, it must be based on actual unreported incidents.  “A broad statistical allegation” not tied to actual events known to the defendant and not reported does not state a plausible claim.  Frei v. Taro Pharmaceutical U.S.A., Inc., ___ F. Appx. ___, 2021 WL 1541141, at *3 (2d Cir. April 20, 2021) (applying New York law).  Likewise, an failure-to-report claim fails for lack of causation when the alleged failure involves the plaintiff’s own incident, or otherwise occurs after the plaintiff’s injury.  Babayev v. Medtronic, Inc., 228 F. Supp.3d 192, 220 (E.D.N.Y. 2017) (alleged failure to report the “incident involving Plaintiff” could not be causal); Franzese v. St. Jude Medical, Inc., 2014 WL 2863087, at *6 (E.D.N.Y. June 23, 2014) (as to alleged non-reporting three years after the alleged injury, “[p]laintiffs have specifically failed to allege proximate cause.”).

Since:  (1) general New York law does not recognize common-law claims for failure to make mandatory reports to government agencies; (2) the FDCA-related precedent rejecting such claims under New York law, is both more numerous and better reasoned than contrary case law; and (3) the requirement of Erie conservatism in federal court, we think the proper conclusion is that FDCA-based failure-to-report allegations do not state a claim in New York.


TBI correctly classified North Carolina as a state that “does not recognize a parallel duty on manufacturers to report to the FDA.”  2021 WL 1050910, at *30 (quoting McNeil-Williams v. DePuy Orthopaedics, Inc., 384 F. Supp.3d 570, 575 (E.D.N.C. 2019)).  McNeil-Williams held that to allow FDCA-based failure-to-report claims “expands [the] law in a manner not consistent with North Carolina law.”  Id. at 576.

Plaintiff’s primary asserted theory of negligence liability fails, however, because North Carolina law does not recognize a parallel duty on manufacturers to report to the FDA as plaintiff asserts.  Rather, North Carolina law recognizes a duty to warn only users or medical practitioners in certain circumstances. . . .  Plaintiff cites no case, and the court has found none, where North Carolina courts have recognized a duty under North Carolina law to inform the FDA of adverse reactions, defects, and other injury information.

Id. (citations omitted).  McNeil-Williams refuted plaintiff’s reliance on Williams v. Smith & Nephew, 123 F. Supp. 3d 733, pointing out (as we did, see Maryland) that Williams “did not cite to any Maryland case law for such proposition.”  384 F. Supp.3d at 576.  Similarly, McNeil-Williams nixed reliance on Stengel, observing (as we did, see Arizona) that “the Arizona Supreme Court expressly disavowed the reasoning of Stengel on the very proposition that is at issue in this case.”  Id.

That’s not all.  Burrell v. Bayer Corp., 260 F. Supp.3d 485 (W.D.N.C. 2017), held failure-to-report claims preempted because of their dependence on federal, rather than state, law.  “A requirement to report adverse events exists under the FDCA, and plaintiff’s cause of action is being brought because . . . defendants allegedly failed to meet these reporting requirements.  Accordingly, the plaintiff’s failure-to-warn claim is preempted.”  Id. at 492 (citations omitted).  Secondarily, Burrell pointed out that any failure-to-report claim could not be causal because the FDA did nothing once it learned of the allegedly unreported adverse events.  “[T]he claims must also survive plausibility challenges. . . .  [T]he adverse event reports were provided to the FDA by the time the plaintiff had her surgery.”  Id. at 495.

A similar no-duty conclusion was reached under North Carolina law in Wilkerson v. Christian, 2008 WL 483445 (M.D.N.C. Feb. 19, 2008):

[Defendant’s] alleged failure to file a . . . report with the FDA is not grounds for the application of fraudulent concealment.  Even assuming, as Plaintiff alleged, that the federal regulations required [defendant manufacturer] to submit certain information to the FDA, the duty [defendant] owed was to the FDA.  Accordingly, [defendant] violated no preexisting duty to Plaintiff to disclose this information when it failed to file a . . . report.

Id. at *12.

Outside the FDCA context, failure-to-report claims have been rejected under North Carolina law.  These include reporting of child abuse.  See Ostwalt v. Charlotte-Mecklenburg Board of Educ., 614 F. Supp.2d 603, 608 (W.D.N.C. 2008) (finding no common-law duty to report abuse).  Similarly, no failure-to-report liability is recognized in North Carolina for failure to comply with reporting requirements imposed by the Bank Secrecy Act.  See Taylor & Co. v. Bank of America Corp., 2014 WL 3557672, at *3 (Mag. W.D.N.C. June 5, 2014) (joining those courts “unwilling to create a common law duty of care” predicated on failure to make mandatory suspicious activity reports), adopted, 2014 WL 3557679 (W.D.N.C. July 18, 2014).