Photo of Bexis

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.


TBI found no “legal authority” from North Dakota on FDCA-based failure-to-report claims, and thus “opt[ed] for the interpretation that restricts liability, rather than expands it.”  2021 WL 1050910, at *31 (holding that North Dakota would not allow FDCA-based failure-to-report claims).  That’s 100% right.  We searched diligently and found no North Dakota precedent concerning failure-to-report allegations, either in the FDA context or involving mandatory reports owed to any other governmental entity.

All we can add is that the North Dakota child abuse reporting statute, N.D. Cen. C. §50-25.1-13 (thoroughly updated in 2021), provides an express cause of action for filing a false report − but no civil liability for failing to file a required report.


TBI placed Ohio among the states that do not permit FDCA-based failure-to-report claims, 2021 WL 1050910, at *30, on the strength of the Aaron v. Medtronic, Inc., 209 F. Supp.3d 994, 1005 (S.D. Ohio 2016), decision.  Aaron certainly supports that designation.  First:

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. . . .  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.

*          *          *          *

There is, conversely, no state-law requirement that medical-device manufacturers submit adverse-event reports to the FDA.  Plaintiffs’ Omnibus Complaint does not identify any Ohio (or other state) authority that recognize[s] a state common-law failure-to-warn claim based on a failure to properly issue reports to a federal agency, such as the FDA. . . .  Accordingly, an alleged failure to submit adverse-event reports to the FDA cannot support a state-law failure-to-warn claim.

209 F. Supp.3d at 1005-06 (citations and quotation marks omitted).  Second:

Adverse-event reports are not warnings.  Although the FDA “may disclose” adverse-event reports, it is not required to do so.  Thus, adverse-event reports, unlike the warnings on a device label, are not automatically made public [and t]he FDA’s disclosure of adverse-event reports to the public is not guaranteed.

Id. at 1005 (citations and quotation marks omitted) (emphasis original).  Third:

[A]dverse-event reports do not necessarily result in labeling changes and cannot be used by a manufacturer to unilaterally change the label.  Labeling changes require FDA approval, and the FDA may not approve a safety-related labeling change absent “valid scientific evidence,” a category that specifically excludes “[i]solated case reports” and “reports lacking sufficient details to permit scientific evaluation.”  Because adverse-event reports are anecdotal and do not necessarily reflect a conclusion by FDA that the device caused or contributed to the reportable event (FDA, Manufacturer and User Facility Device Experience Database), adverse-event reports are not by themselves sufficient grounds for a labeling change.  [Thus] adverse-event reports are regulatory submissions, not warnings, that must be submitted to the FDA, not to patients or their physicians.

Id. at 1005-06 (citations and quotation marks omitted).  Aaron represents as comprehensive a refutation of the concept of FDCA-based failure-to-report claims as any case we’ve seen anywhere in the country.

That’s hardly all there is in Ohio.  Two Sixth Circuit opinions under Ohio law are also relevant, 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).  Moreover, just recently – since the TBI decision – Reynolds v. Medtronic, Inc., 2021 WL 1854968 (S.D. Ohio May 10, 2021), followed Aaron and dismissed similar failure-to-report allegations:

The Court finds that Count 2 must be dismissed. . . .  It fails to state a parallel claim because, in the context of this inadequate warning claim, [plaintiff’s] allegations do not . . . identify state law that parallels federal regulations or requirements that [defendant] allegedly violated. . . .  [T]he 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.

Id. at *10 (citations, quotation marks, and footnote omitted).  See Tibbe v. Ranbaxy, Inc., 87 N.E.3d 838, 840, 845 (Ohio App. 2017) (affirming summary judgment in generic drug case against all plaintiff’s warning-related claims, including failure to report); Mories v. Boston Scientific Corp., 494 F. Supp.3d 461, 476 (S.D. Ohio 2020) (“Plaintiff has not identified any Ohio state-law requirement to make reports to the FDA, thus critically weakening her parallel-claim allegation.”); Simpson v. Johnson & Johnson, 2020 WL 5629092, at *5 (N.D. Ohio Sept. 21, 2020) (holding failure-to-report allegations abrogated by Ohio product liability statute); Warstler v. Medtronic, Inc., 238 F. Supp. 3d 978, 989 (N.D. Ohio 2017) (“Unlike the FDA’s adverse event reporting requirement, Ohio law imposes no duty to report adverse events to the FDA.”; “a manufacturer’s mandatory adverse event report to the FDA does not function as a warning”); Hawkins v. Medtronic, Inc., 909 F. Supp.2d 901, 911 (S.D. Ohio 2012) (no Ohio state law claim for failure to report adverse events to FDA; claim would be preempted if it did exist).

In analogous non-FDCA cases, Ohio has enacted statutory liability for failure to report child abuse.  Ohio Rev. C. §2151.421(N).  However, before and outside of that statute, “[t]here was no common-law duty to report child abuse.”  Roe v. Planned Parenthood Southwest Ohio Region, 912 N.E.2d 61, 70 (Ohio 2019); accord Court Appointed Guardians v. Children’s Hospital Medical Center, 2016 WL 4063886, at *3 (Ohio App. July 27, 2016) (“There is no common-law duty to report or prevent child abuse.”).  Ohio common law likewise does not provide relief to persons alleging injury from failure to report suspicious activity under the federal Bank Secrecy Act.  Towne Auto Sales, LLC v. Tobsal Corp., 2017 WL 5467012, at *2 (N.D. Ohio Nov. 14, 2017) (rejecting negligence per se action predicated on Bank Secrecy Act violations); Spitzer Management, Inc. v. Interactive Brokers, LLC, 2013 WL 6827945, at *2 (N.D. Ohio Dec. 20, 2013) (reporting duty “owed to the government of the United States,” not to injured third parties).


TBI identified no Oklahoma “legal authority” pertaining to FDCA-based failure-to-report claims, and thus “opt[ed] for the interpretation that restricts liability, rather than expands it.”  2021 WL 1050910, at *31 (concluding that Oklahoma would not allow FDCA-based failure-to-report claims).  While we agree with the ultimate result, our research confirms that Oklahoma law affirmatively supports rejection of this sort of claim.

We start with something we don’t like, but as defense lawyers, we’re realists.  In Howard v. Zimmer, Inc., 299 P.3d 463, 473 (Okla. 2013), Oklahoma’s highest court applied that state’s negligence per se standards to the FDCA.  But not everything can be negligence per se, since that doctrine does not create new tort duties, but only defines reasonable care where a duty already exists.  “The negligence per se doctrine is employed to substitute statutory standards for parallel common law, reasonable care duties.”  Id. at 468.

Thus, in Littlebear v. Advanced Bionics, 896 F. Supp.2d 1085 (N.D. Okla. 2012), the court recognized that “adverse event reporting requirements are not substantive safety requirements under state [Oklahoma] law, but rather administrative requirements.”  Id. at 1092 (N.D. Okla. 2012).  There being no corresponding state law duty, Littlebear held “[a]ll claims predicated on the failure to comply with adverse event reporting requirements are impliedly pre-empted.”  Id.

Thus, a Howard-based negligence per se claim could only exist for an FDCA-based failure-to-report claim if similar failure-to-report claims otherwise exist under Oklahoma law.  They don’t appear to.  In particular, “the child abuse reporting statutes do not create a private right of action.  Knowing and willful failure to report is a criminal misdemeanor.  There is no provision, however, for civil liability.”  Paulson v. Sternlof, 15 P.3d 981, 984 (Okla. App. 2000).  Similarly, Public Service Co. v. A Plus, Inc., 2011 WL 3329181 (W.D. Okla. Aug. 2, 2011), held, as to negligence per se-based reporting claims Bank Secrecy Act:

[T]he Act and its implementing regulations do not create a private right of action; in fact, it is well settled that the . . . Bank Secrecy Act[] obligate[s] banks to report certain customer activity to the government but do not create a private cause of action. . . .  Courts have repeatedly rejected negligence claims based on a bank’s [reporting] duty arising under the Act. . . .  Because the Bank Secrecy Act does not create a private right of action, the Court can perceive no sound reason to recognize a duty of care that is predicated upon the statute’s monitoring requirements.

Id. at *8 (citations and quotation marks omitted).  See Kochick v. Hanna, 2010 WL 1752577, at *3 (W.D. Okla. April 29, 2010) (“the Defendant Doctors’ duty to the motoring public does not include reporting [a patient’s] seizure disorder to the Oklahoma Department of Public Safety”).

Thus we agree that Oklahoma law does not support an FDCA-based failure-to-report claim, but our conclusion is based on more than mere absence of directly-on-point precedent.  Rather, the state’s rejection of negligence claims alleging several types of failure to report to governmental authorities establishes that there is no extant corresponding state-law duty that could support a FDCA-based negligence-per-se claim of the sort allowed in Howard.


TBI put Oregon in the no-duty category on the strength of Alton v. Medtronic, Inc., 970 F. Supp.2d 1069, 1089 (D. Or. 2013).  2021 WL 1050910, at *30.  Alton held that failure-to-report claims were “effectively” fraud-on-the-FDA claims and therefore preempted:

[T]o the extent the claim was construed as premised on alleged misrepresentations and/or omissions in [defendant’s] mandatory reports to the FDA regarding the risk of adverse outcomes . . ., the claim was clearly impliedly preempted under the reasoning of Buckman, as effectively constituting a claim of fraud on the FDA.

970 F. Supp.2d at 1089 (citation omitted).

Oregon is the only state where our review of the law is less friendly to the defense position than TBI.  That’s because we cast a broader net substantively and accord relatively more weight to state intermediate appellate decisions.  Which leads us to Axen v. American Home Products Corp., 974 P.2d 224 (Or. App. 1999).  Axen is one of those very rare pre-preemption decisions where a plaintiff alleged a failure to report under the FDCA.  The alleged failure was a failure to report a medical article, which isn’t exactly the same thing – but close enough to make Axen’s decision to allow a “negligence” claim relevant.  974 P.2d at 236.  The alleged negligence in Axen was 100% FDCA-based, and thus probably preempted now, but the case did make a statement as to what could be negligence under Oregon state law:

[S]uccessful applicants for FDA approval to market a new drug are required to make certain reports to the FDA. . . .  [Defendant] was required to review reports in the scientific literature, as well as unpublished scientific papers, for references to adverse drug experiences . . . and to notify the FDA of those reports. . . .  We conclude that, under [FDA] definitions, post-marketing reports of blindness brought about by [the drug] would be both serious and unexpected and, therefore, would fall under the reporting requirements.

Id. at 235 (citations, quotation marks, and footnote omitted).  The defendant in Axen did not contest its non-reporting of two articles, but challenged causation.  Id. at 236.  Because the same article caused a foreign regulater to require a label change, Axen found that causation was a jury question.  Id.

While Axen is old (pre-Buckman) and distinguishable (involving a drug and not involving individual adverse event reporting), it doesn’t appear to have been considered by TBI, so there’s more to Oregon law.  Cf. Santoro v. Endologix, Inc., 2020 WL 6295077, at *10 (Mag. D. Or. Oct. 6, 2020), adopted, 2020 WL 6287473 (D. Or. Oct. 27, 2020), and Lakey v. Endologix, Inc., 2020 WL 6295080, at *11 (Mag. D. Or. Oct. 6, 2020), adopted, 2020 WL 6287472 (D. Or. Oct. 27, 2020) (both allowing FDCA-based failure-to-report claims on the bizarre and incorrect conclusion that “there is a duty for device manufacturers to report defects not only to the FDA . . . but also to the physicians directly”) (emphasis original).

Axen, Santoro, and Lakey (and for that matter, Alton as well) are all unusual and not very well reasoned, so we wanted to see if there was any non-FDCA-based common-law basis for a failure-to-report claim in Oregon.  We didn’t find anything indicating there was, but we didn’t find anything indicating there wasn’t, either.  Because we’re not quite clear where to classify Oregon, we’ll go with the result in TBI.


Pennsylvania, like New York, is one of those states with enough law, and enough litigation, that one can usually find something on any side of any issue.  TBI, as it did whenever there are conflicting decisions, went with the case that favored the plaintiff.  See 2021 WL 1050910, at *29 (citing Silver v. Medtronic, Inc., 236 F. Supp.3d 889 (M.D. Pa. 2017), and McLaughlin v. Bayer Corp., 172 F. Supp.3d 804 (E.D. Pa. 2016).  These citations are accurate.  Silver found “no binding jurisprudence” and opted to “rel[y] primarily on . . . Stengel.”  236 F. Supp.3d at 899.  McLaughlin did the same, but also relied on the Fifth Circuit decision in Hughes.  We’ve already discussed both Stengel (see Arizona) and Hughes (see Mississippi) in detail and explained why neither of them accurately applies state law.  For completeness sake, we’ll also mention Bull v. St. Jude Medical, Inc., 2018 WL 3397544 (E.D. Pa. July 12, 2018), which relied solely on Hughes (Stengel having by then been overruled on the state law issue) − and did not discuss relevant Pennsylvania law at all – in allowing a failure-to-report claim to survive Rule 12.  Id. at *8-9.

With respect to Pennsylvania law, both Silver and McLaughlin pointed to Phillips v. A.P. Refractories Co., 630 A.2d 874, 882 (Pa. Super. 1993), which purported to adopt the “sophisticated user doctrine” of Restatement (Second) of Torts §388, comment n (1965), as Pennsylvania law.  As we’ve also already discussed (see introduction) that doctrine is expressly limited to transmission of warnings “to the third person through whom the chattel is supplied” – not through a governmental actor like the FDA.  Id.  Significantly, in affirming, the Pennsylvania Supreme Court specifically refrained from endorsing Restatement §388.  Phillips v. A-Best Products Co., 542 Pa. 124, 665 A.2d 1167 (1995) (§388 “must await a future case”).

But even assuming Restatement §388, comment n is the law of Pennsylvania in cases like Phillips, prescription medical product liability litigation involves the learned intermediary rule, not the sophisticated user doctrine, under Pennsylvania law.  E.g., Lance v. Wyeth, 85 A.3d 434, 438 n.6 (Pa. 2014) (“Per the learned intermediary doctrine, the manufacturer’s duty to warn is directed to physicians.”).  The FDA isn’t a plaintiff’s physician either.

But none of these three district courts is any longer (if they ever were) an accurate prediction of Pennsylvania law.  Since the latest of them (Bull) was decided, the Third Circuit ruled that Pennsylvania law does not recognize failure-to-report claims based on alleged failure to comply with an obligation to report product failures to the Federal Aviation Administration.  Sikkelee v. Precision Airmotive Corp., 907 F.3d 701 (3d Cir. 2018), flatly rejected a failure-to-report claim under Pennsylvania law predicated on noncompliance with the reporting requirements of the Federal Aviation Act.  Id. at 707.  In so doing Sikkelee relied entirely on FDCA precedents.  The Third Circuit dismissed that claim because no “traditional” Pennsylvania state-law equivalent duty existed, only a purported federal obligation:

[Plaintiff] argues the District Court erred in granting [defendant] summary judgment on her failure-to-notify-the-FAA claim. . . .  [Defendant] is entitled to summary judgment on this claim.  [Plaintiff] has attempted to use a federal duty and standard of care as the basis for this state-law negligence claim.  However, . . . Congress has not created a federal standard of care for persons injured by defective airplanes. . . .  “[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.”  The District Court therefore properly granted summary judgment to [defendant] on this claim.

907 F.3d at 716-17 (quoting Buckman, 531 U.S. at 353 (other citations and quotation marks omitted) (emphasis added).

Similarly, Conley v. St. Jude Medical, LLC, 482 F. Supp.3d 268 (M.D. Pa. 2020), pointed out that the learned intermediary rule, not Restatement §388, comment n, governs in prescription medical product liability litigation.  Id. at 279 n.6.  Conley went on to reject any analogy to Pennsylvania product liability theories, and held that “Plaintiffs have failed to state a parallel claim.”  Id. at 280.  See White v. Medtronic, Inc., 2016 WL 4539494, at *3 (E.D. Pa. Aug. 31, 2016) (“there is simply no parallel state law duty imposed on manufacturers and sellers to report to a federal agency”); Shuker v. Smith & Nephew PLC, 2015 WL 1475368, at *16 (E.D. Pa. March 31, 2015) (finding “nothing . . . to suggest that Defendants failed to report such events to the FDA at any point”), aff’d, 885 F.3d 760 (3d Cir. 2018).

As far as non-FDCA-based allegations of failure to report, Pennsylvania law is all over the lot.  Most on point is Walters v. UPMC Presbyterian Shadyside, 187 A.3d 214 (Pa. 2018), where a plurality of the Pennsylvania Supreme Court split the baby.  It rejected a general common-law duty to report theft of controlled substances that resulted in harm to third persons:

[A] generalized duty to inform law enforcement . . . unbounded by the terms or requirements of a federal regulation and subject to innumerable potential controversies regarding how to report, to whom to report, and how aggressively to act to ensure an adequate response by law enforcement, simply is too amorphous, the potential consequences of doing so too difficult to anticipate.

Id. at 792.  A broad duty to report “could expand in future cases into something that confounds sound public policy and defies principled limitation.”  Id.  Thus the court imposed a “narrow” duty to report – less than that required by federal reporting requirements.  “[W]hile complying with the federal reporting obligation may be sufficient to discharge the duty, an analogous action to similar effect may suffice.”  Id. at 790 (footnote omitted).  Cf. Gabriel v. Giant Eagle, Inc., 2015 WL 13240267, at *7 (Pa. C.P. June 30, 2015) (“members of a group of people harmed by the diversion of controlled substances” could not sue drugstore for failure to report thefts of such substances because “these reporting requirements are intended to protect the interests of the general public”).

Other Pennsylvania decisions that have recognized civil liability for failure to make mandatory reports to government agencies are:  K.H. v. Kumar, 122 A.3d 1080, 1095-96 (Pa. Super. 2015), in which a physician’s failure to report child abuse were allowed to form the basis of a medical malpractice claim.  Nace v. Faith Christian Academy, 2019 WL 1429575, at *5 (E.D. Pa. March 29, 2019), in which failure to report child abuse was allowed as a form of negligence per se.  Doe v. Liberatore, 478 F. Supp.2d 742, 763-64 (M.D. Pa. 2007), in which a similar alleged failure to report child abuse was allowed to form the basis of a negligence claim against a clergyman.

Conversely, a physician’s failure to report to the state a patient’s medical condition that allegedly rendered the patient unfit to drive did not create liability in Estate of Witthoeft v. Kiskaddon, 733 A.2d 623 (Pa. 1999):

[W]e believe that it is an unreasonable extension of the concepts of duty and foreseeability to broaden a physician’s duty to a patient and hold a physician liable to the public at large within the factual scenario of this case. . . .  [The] decedent is simply not a foreseeable victim that this court will recognize.  We will not stretch foreseeability beyond the point of recognition for to do so will be to make liability endless.  To allow liability in this case would be to make physicians absolutely liable for the various acts of their patients. This we will not countenance.

Id. at 630.  Rather than the common law, “it is for the General Assembly to determine the appropriate penalty for noncompliance” with the reporting requirement.  Id. n.7.  See Hospodar v. Schick, 885 A.2d 986, 989-90 (Pa. Super. 2005) (following Witthoeft; no liability for a physician’s failure to report epilepsy to the state); Lerro v. Upper Darby Township, 798 A.2d 817, 821-22 (Pa. Commw. 2002) (no civil liability for failure to report dog attacks; “where the General Assembly commits the enforcement of a regulatory statute to a government body or official, this precludes enforcement by private individuals”); J.E.J. v. Tri-County Big Brothers/Big Sisters, Inc., 692 A.2d 582, 585-86 (Pa. Super. 1997) (rejecting negligence per se claim for failure to report child abuse); Crosby v. Sultz, 592 A.2d 1337, 1344 (Pa. Super. 1991) (“Reporting the patient to the proper authorities when necessary is very different from imposing upon a treating physician the duty of protecting the entire public from any harm that might result from his/her patient’s actions.”).

Also on the “no duty” side of the balance is Regional Produce Cooperative Corp. v. TD Bank, N.A., 2020 WL 1444888 (E.D. Pa. March 24, 2020), dismissing as “improper” a “negligence claim [that] relies on the Bank Secrecy Act for a standard of care” for alleged failure to report under Pennsylvania law.  Id. at *12.

Given Sikkelee, we think it is improper for any district court in the Third Circuit purporting to apply Pennsylvania law to recognize a FDCA-based duty to report unless and until such a duty is recognized by a Pennsylvania appellate court.  Pennsylvania courts have been reluctant to do this, and even where deciding to permit some sort of reporting duty, Pennsylvania courts have not blindly followed federal regulatory duties.  Looking at the issue more broadly than TBI, we don’t think there is, as yet, a valid basis for an affirmative FDCA-based failure-to-report prediction under Pennsylvania law.


TBI didn’t even consider Puerto Rico, but since that territory has a larger population than many states (and by all rights, should be a state itself), we will.  There appears no basis to conclude that Puerto Rico would recognize a state-tort cause of action for failure to report to a government agency.  Such a claim, under the Bank Secrecy Act, was rejected in Martinez Colon v. Santander National Bank, 4 F. Supp.2d 53, 57 (D.P.R. 1998).  There is “no basis for implying a duty to the customer on the part of the bank to file Currency Transaction Reports under the Bank Secrecy Act.”  Id. at 59 (emphasis original).  Rather, “a defendant’s only liability [for failure to report] is to the government, and, in particular, to the Secretary of the Treasury.”  Id. at 57.

That’s all the Puerto Rico law we found.  So we don’t think a duty to report exists in Puerto Rico law, and certainly there is no basis for a federal court to predict such a thing.


TBI listed Rhode Island as a state that allowed FDCA-based failure-to-report claims, based on a pre-Riegel decision, Hodges v. Brannon, 707 A.2d 1225, 1228 (R.I. 1998).  Hodges doesn’t stand for that at all, since the case has nothing to do with failure to report.  Quite the opposite.  Hodges was about the evidentiary use of actual adverse event reports for “notice” – not failure to report.  Moreover, the defense prevailed in Hodges:

The plaintiffs next argue that the trial justice erred in restricting the jury’s use of the evidence it introduced concerning certain government reports filed by [defendant] that detailed patients’ negative experiences after taking [the drug].  [Defendant] had submitted these reports to the FDA, but the trial justice limited their evidentiary use to the duty-to-warn and notice issues. . . .  We do not believe that the trial justice abused her discretion in so ruling.  The trial justice was entitled to conclude that the various patients mentioned in these reports were not necessarily similarly situated to each other or to [the decedent].

Id. at 1228. (emphasis added).  Hodges simply doesn’t stand for the proposition for which TBI cited it.

The truth is, there’s not much relevant Rhode Island law.  There are no FDCA-related failure-to-report cases at all, and since Rhode Island is another of those states that expressly provides a civil cause of action of action for failure to report child abuse, R.I. Gen. L. §40-11-6.1, the courts have not had to grapple with failure-to-report claims in that context, either.  So once again, we don’t think that there is any basis under Rhode Island law for imposition of reporting-based civil liability, and a fortiori nothing to justify a federal court inventing such an Erie prediction out of whole cloth.


TBI accurately cited (2021 WL 1050910, at *30) Ellis v. Smith & Nephew, Inc., 2016 WL 7319397 (D.S.C. Feb. 16, 2016), as precedent for South Carolina’s rejection of FDCA-based failure-to-report claims.  Ellis held:

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. . . .  [S]ince Plaintiff’s remaining failure to warn claim is predicated on [defendant’s] alleged failure to provide required reports to the FDA, authority to enforce that claim rests with the FDA.

Id. at *6-7 (citations omitted).  Cf. Bean v. Upsher-Smith Pharmaceuticals, Inc., 2017 WL 4348330, at *7 (D.S.C. Sept. 29, 2017) (similar rationale; finding no South Carolina common-law duties analogous to FDCA requirements regarding off-label promotion and supply of medication guides).  Plainly, no South Carolina court has ever found a tort duty to report adverse events to the FDA.

Beyond the FDCA, the South Carolina Supreme Court has rejected civil liability claims predicated on failure to report child abuse to governmental authorities.  In Doe v. Marion, 645 S.E.2d 245 (S.C. 2007), a negligence per se claim asserting breach of an alleged duty to report child abuse failed because the statutory reporting obligation “does not support a private cause of action for failing to report alleged abuse.”  Id. at 563.

The statute is concerned with the protection of the public and not with the protection of an individual’s private right.  This is consistent with other jurisdictions’ interpretations of similar statutes. . . .  Accordingly, we rule that [mandatory reporting] does NOT give rise to a private cause of action.  We further conclude [mandatory reporting] does NOT support a claim for negligence per se.

Id. at 563 (citations omitted) (emphasis original).  A second attempt to impose civil liability for failure to report child abuse likewise failed in Doe v. Wal-Mart Stores, Inc., 711 S.E.2d 908 (S.C. 2011).  A “duty to report under the Reporter’s Statute cannot give rise to civil liability.”  Id. at 912.  “[T]here can be no civil liability under the Reporter’s Statute and [defendant] owed no duty to the victim.”  Id.  Also, “consonant with Doe v. Marion, there can be no private cause of action under” the statute for failure to report.  Id. at 246.


TBI determined that no South Dakota “legal authority” existed concerning FDCA-based failure-to-report claims, and therefore “opt[ed] for the interpretation that restricts liability, rather than expands it.”  2021 WL 1050910, at *31 (concluding that FDCA-based failure-to-report claims were not recognized under South Dakota law).  That seems right to us.

There’s certainly no South Dakota law at the moment allowing private FDCA-related failure to report litigation.  Otherwise, the only decision we’ve found that is at all relevant is yet another Erie violating flight of fancy from a federal district court “predicting” that a failure to report child abuse claim is permissible as “negligence per se” despite identifying no analogous South Dakota tort duty.  Aman v. Cabacar, 2007 WL 2684866, at *2-3 (D.S.D. Sept. 6, 2007).  But even under Aman’s disturbing rationale that legislature must affirmatively “prohibit” a private right of action to preclude negligence per se, id. at *3 – Congress did just that in the FDCA with 21 U.S.C. §337(a).


Potolicchio v. Medtronic, Inc., 2016 WL 3129186 (E.D. Tenn. June 2, 2016), held, as to an FDCA-related failure-to-report claim:

Plaintiff’s failure-to-warn claim also fails. . . .  Plaintiff argues that [defendant’s] failure to report adverse events to the FDA violates [its] duties under the MDA and suffices for proof of a failure-to-warn claim.  But Plaintiff’s argument avoids the issue of whom [defendant] had a duty to warn.  No Tennessee law requires [defendant] to warn the FDA about adverse events.  Tennessee law requires manufacturers to warn physicians, but not the FDA.

Id. at*4 (citation omitted).  TBI relied on Potolicchio to conclude that Tennessee does not recognize such claims.  2021 WL 1050910, at *31.  We think that’s correct.  Failure-to-report “claims are simply an attempt by private parties to enforce the MDA.”  Hafer v. Medtronic, Inc., 99 F. Supp.3d 844, 860 (W.D. Tenn. 2015) (citation and quotation marks omitted). “Annual reporting requirements are administrative requirements, not substantive safety requirements.  Thus, claims premised on reporting requirements are disguised fraud-on-the-FDA claims.”  Purchase v. Advanced Bionics, LLC, 896 F. Supp.2d 694, 697 (W.D. Tenn. 2011).  Cf. Spence v. Dexcom, Inc., 2019 WL 302504, at *8 (M.D. Tenn. Jan. 23, 2019) (dictum in remand case that “allegations that [defendant] failed to comply with PMA or FDA requirements do not, and do not purport to, state causes of action”).

Analogous failure-to-report claims have also been rejected under Tennessee law.  “In short, the common law of Tennessee does not impose a duty on a treating physician to either report suspected child abuse or to prevent any such child abuse.”  Ham v. Hospital of Morristown, Inc., 917 F. Supp. 531, 534 (E.D. Tenn. 1995); see Cline v. United States, 2014 WL 4667118, at *8 (M.D. Tenn. Sept. 18, 2014) (a “[c]omplaint [that] merely alleges violations of Tennessee’s mandatory reporting statutes” “does not allege an applicable legal basis for liability as to negligence”).  However, the Tennessee child abuse reporting statute itself has been interpreted to create a private right of action.  Ham, 917 F. Supp. at 537; Doe v. Coffee County Board of Education, 852 S.W.2d 899, 909 (Tenn. App. 1992).

Similarly, a purported “common-law” duty to make reports to the federal government as required by the Bank Secrecy Act failed to state a claim in Belle Meade Title & Escrow Corp. v. Fifth Third Bank, 282 F. Supp. 3d 1033 (M.D. Tenn. 2017):

Numerous courts have held that the statutes upon which the plaintiff relies do not create a private right of action.  This court likewise holds that the federal statutes and regulations upon which the plaintiff relies do not create a common law duty on the part of banks to non-customers. The plaintiff’s claim fails on that basis.

Id. at 1039-40 (citations omitted).


Texas, according to TBI, “allow[s] a failure to warn claim based on a device manufacturer’s inadequate reporting to the FDA under state law tort principles.”  2021 WL 1050910, at *27, 29 (citing Schouest v. Medtronic, Inc., 13 F. Supp.3d 692, 706 (S.D. Tex. 2014)).

Well, bless its heart.

In reality, Texas common law is probably more unalterably opposed to failure-to-report liability than any state in the union (except perhaps Arizona post-Conklin).  “Texas courts rarely imply a civil tort duty from a criminal statute.”  Allen v. Walmart Stores, L.L.C., 907 F.3d 170, 180 (5th Cir. 2018).  That’s because, every which way but loose, the Texas Supreme Court unanimously rejected common-law claims for failure to make mandatory reports to a government agency in Perry v. S.N., 973 S.W.2d 301 (Tex. 1998).  “The sole issue” in Perry, was “whether plaintiffs may maintain a cause of action for negligence per se based on the Family Code, which requires any person having cause to believe a child is being abused to report the abuse to state authorities.”  Id. at 302.

Umm . . . no.  Like that Texas saying involving a polecat, butter, and a red-hot poker – it can’t be done.

“[W]e will not apply the doctrine of negligence per se if the criminal statute does not provide an appropriate basis for civil liability.”  Id. at 304 (footnote omitted).  An injured plaintiff supposedly being within ambit the statute’s protection wasn’t nearly enough.  Id. at 305.  Primarily that was because a reporting-based claim “corresponds to no common law duty.”  Id. at 306.  That is “fundamental” Texas law.  “It is fundamental that the existence of a legally cognizable duty is a prerequisite to all tort liability.”  Id. at 304 (citation and quotation marks omitted).  Perry was loathe to create any sort of broad, new tort claim:

[R]ecognizing a new, purely statutory duty can have an extreme effect upon the common law of negligence when it allows a cause of action where the common law would not.  In such a situation, applying negligence per se brings into existence a new type of tort liability.  The change tends to be especially great when, as here, the statute criminalizes inaction rather than action.

Id. at 306 (citations and quotation marks omitted).  “[T]he indirect relationship between violation of [a reporting] statute and the plaintiff’s ultimate injury is a factor against imposing tort liability.”  Id. at 309.

[A] reporting statute by definition places a fourth party between the defendant and the plaintiff:  the person or agency to whom the defendant is required to make the report.  Thus, the connection between the defendant’s conduct and the plaintiff’s injury is significantly more attenuated in a case based on failure to report. . . .  We are not aware of any Texas case applying negligence per se to a statute that, like the child abuse reporting provision, interposes not one but two independent actors between the plaintiff and the defendant.

Id. (citations omitted).  Similarly, in an FDCA-based failure-to-report claim, the “third” and “fourth” parties would be the learned intermediary, and the FDA, respectively.

Putting it all together, Perry held:

[W]e have considered the following factors regarding the application of negligence per se to the . . . child abuse reporting provision:  (1) whether the statute is the sole source of any tort duty from the defendant to the plaintiff or merely supplies a standard of conduct for an existing common law duty; (2) whether the statute puts the public on notice by clearly defining the required conduct; (3) whether the statute would impose liability without fault; (4) whether negligence per se would result in ruinous damages disproportionate to the seriousness of the statutory violation, particularly if the liability would fall on a broad and wide range of collateral wrongdoers; and (5) whether the plaintiff’s injury is a direct or indirect result of the violation of the statute.  Because a decision to impose negligence per se . . . would impose immense potential liability under an ill-defined standard on a broad class of individuals whose relationship to the abuse was extremely indirect, we hold that [liability] is not appropriate.

Id. at 309.

Given Perry’s forceful and authoritative statement of Texas law, Schouest nothing to hang your hat on.  Schouest didn’t cite a single Texas case about failure-to-report claims – only Hughes (see Mississippi).  13 F. Supp.3d at 706.  Moreover, the plaintiff in Schouest didn’t even pursue that baseless claim further.  See Schouest v. Medtronic, Inc., 92 F. Supp.3d 606, 612-13 (S.D. Tex. 2015) (renewed motion to dismiss granted because plaintiff “has not alleged facts to show that the failure to report adverse events creates some kind of legal or equitable liability”).  Schouest provides no basis to mess with Texas law, as stated in Perry.

While Perry is certainly enough – being a flat rejection of failure-to-report liability from Texas’ highest court, without dissent – there’s plenty more where that came from.  For example, Baker v. St. Jude Medical, S.C., Inc., 178 S.W.3d 127 (Tex. App. 2005), affirmed dismissal of an FDCA-based failure to report “fraud” claim, finding it to be a disguised fraud-on-the-FDA claim with no common-law basis:

In this case, appellants’ 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 appellants’ fraud claim is really a “fraud-on-the-FDA claim.”

Id. at 139.  Further, in Jacob v. Mentor, 393 F. Supp.3d 912 (C.D. Cal. 2019), reconsideration denied, 2019 WL 5616958 (C.D. Cal. Oct. 29, 2019), aff’d, ___ F. Appx. ___, 2021 WL 406304 (9th Cir. Feb. 5, 2021), the court held that Texas would not recognize any FDA-based failure-to-report claim.

Here, Plaintiff . . . resided in Texas at all relevant times − her alleged injuries all occurred there.  Texas has the greatest interest in the application of its law to [plaintiff’s] claims and its law therefore applies.  Thus, Plaintiff . . . is preempted from making a failure to warn claim, because her home state . . . does not recognize such claims.

Id. at 925.  See Gonzalez v. Bayer Healthcare Pharmaceuticals, Inc., 930 F. Supp.2d 808, 819-20 (S.D. Tex. 2013) (“alleg[ation] that [defendant] failed to report or file literature with the FDA” dismissed because it “cannot be used to rebut [the Texas] presumption of non-liability for failure to warn”).  Nor does Texas law consider compliance with FDCA reporting requirements as satisfying the duty to warn.  “Defendants cannot discharge their duty to disclose material facts to the Plaintiff simply by disclosing those facts to the FDA when that disclosure is not publicly available and readily accessible to the Plaintiff.”  Massa v. Genentech, Inc., 2012 WL 956192, at *9 (S.D. Tex. March 19, 2012).

The same is true of real Texas law – apart from the sort of all-hat-no-cattle, FDCA-based reporting claims our opponents assert.  Perry rejected negligence liability for failure to report “being used as a duty and standard, in any context.”  Doe v. Apostolic Assembly of Faith in Christ Jesus, 452 F. Supp.3d 503, 529 (W.D. Tex. 2020).  “If we were to impose negligence ‘per se’ for a failure to report, a physician could be subjected to broad and wide-ranging civil liability for breaching an ill-defined duty.”  Praesel v. Johnson, 967 S.W.2d 391, 396 (Tex. 1998) (accident victim had no claim against physician who failed to report epileptic patient to state drivers’ license authorities).

[T]he factors weigh against finding a state common-law duty to report child abuse in this case.  Neither Texas law nor the sources of law to which Texas courts look supports the creation or recognition of such a duty.  This court declines to impose a common-law duty that Texas courts have not imposed.

John Doe I v. Roman Catholic Diocese of Galveston-Houston, 2007 WL 2817999, at *32 (S.D. Tex. Sept. 26, 2007) (no clergy liability for failure to report child abuse).  Accord Moghtader v. GEO Group, Inc., 2020 WL 1557770, at *5 (W.D. Tex. March 31, 2020) (“Texas courts would not recognize a claim for medical negligence based on a failure to report abuse because the law does not recognize a duty for physicians to protect adult patients from the harmful acts of others”); Dodd v. Dodd, 2015 WL 1467108, at *3 (E.D. Tex. March 31, 2015) (“while violations of the Texas Family Code requiring reporting of child abuse or neglect can result in criminal sanctions, no civil liability attaches for such violations”) (citations omitted); S.N.B. v. Pearland Independent School Dist., 120 F. Supp.3d 620, 632 (S.D. Tex. 2014) (“no civil liability attaches for such [reporting] violations”); Doe v. St. Stephen’s Episcopal School, 2010 WL 11601327, at *2 (W.D. Tex. Feb. 26, 2010) (“Texas law does not recognize a common law civil duty to report child abuse to the authorities.”) (citations omitted); Doe v. Catholic Society of Religious & Literary Education, 2010 WL 345926, at *13 (S.D. Tex. Jan. 22, 2010) (“To the extent this is an ordinary negligence claim, it fails because there is no common-law duty to report child abuse.”); Doe v. S & S Consolidated Independent School Dist., 149 F. Supp.2d 274, 299 (E.D. Tex. 2001) (“the Court finds no authority to suggest any civil actions arise from” a statutory duty to report abuse of a student), aff’d mem., 309 F.3d 307 (5th Cir. 2002); Marlin v. Moody National Bank, N.A., 2006 WL 2382325, at *7 (S.D. Tex. Aug. 16, 2006) (the “obligation under that statute is to the government rather than some remote victim”), aff’d, 248 F. Appx. 534 (5th Cir. 2007) (Bank Secrecy Act).

Failure-to-report claims in Texas?  That dog won’t hunt.


TBI didn’t find any Utah “legal authority” about FDCA-based failure-to-report claims, and “opt[ed] for the interpretation that restricts liability, rather than expands it.”  2021 WL 1050910, at *31 (deciding that FDCA-based failure-to-report claims were not recognized under Utah law).  That result is right, but there is Utah authority on point, only not concerning the FDCA.

Specifically, in Owens v. Garfield, 784 P.2d 1187 (Utah 1989), the Utah Supreme Court rejected a claim that child abuse reporting statute “can be read to create a legally enforceable duty on the part of the [mandated reporter] to protect all children from child abuse.”  Id. at 1191. in all circumstances.”  Without a “legal right to control” the abuser, “they owed no duty to unidentified potential victims.”  Id.  Wood v. World Wide Ass’n of Specialty Programs & Schools, Inc., 2007 WL 1295994 (D. Utah April 30, 2007), rejected an argument that child abuse reporting statutes could “provide the standard of care for civil claims.”  Id. at *4.

Plaintiffs bring claims for Breach of Statutory Duty to Prevent Child Abuse under [statutes] providing criminal penalty for failure to report suspected child abuse.  Defendants seek to dismiss these claims on the ground that these statutes do not provide a private cause of action. . . .  The Court agrees with Defendants.  Plaintiffs are attempting to recover on a private cause of action under these statutes.  Because, as a matter of law, none of these statutes provide such a private cause of action, the claims . . . are dismissed for the failure to state a claim.

Id. at *4-5 (statutory citations omitted).

Given Utah law, TBI correctly declined to credit Marion v. Smith & Nephew, Inc., 2016 WL 4098608 (D. Utah July 28, 2016), which nowhere identified the state common-law duty to which the plaintiff’s reporting-based claim that “scoured the heap of federal law” supposedly “paralleled.”  Id. at *4-5.


Based on Halsey v. Smith & Nephew, 2014 WL 12717702 (D. Vt. Feb. 4, 2014), TBI determined that Vermont would allow FDCA-based failure-to-report claims.  2021 WL 1050910, at *29.  We took a look at Halsey, and it doesn’t stand for that proposition.  Halsey specifically stated that “[p]laintiff has not pled a violation of a federal reporting requirement.”  2014 WL 12717702, at *11.  Halsey’s discussion of the now-discredited Hughes (see Mississippi) and Stengel (see Arizona) decisions is purely dictum about a theory that was never actually raised in that case.  Not only that, the warning-related claim that was raised in Halsey was dismissed as preempted.  2014 WL 12717702, at *11.

Nor does the discussion in Halsey have anything to do with Vermont law.  Halsey cited no Vermont cases.  So let’s look at actual Vermont law, rather than unmoored dictum.  In Lyman v. Pfizer, 2012 WL 368675 (D. Vt. Feb. 3, 2012), plaintiffs attempted to avoid generic drug preemption with allegations, inter alia, “that the Generic Defendants failed to review and report on adverse drug event information.”  Id. at *2.  Didn’t work.

[Plaintiffs] also state that the Generic Defendants violated “numerous other provisions of federal law,” including “failure to perform post-marketing surveillance for their drugs, . . . and to report important information relating to the safety of their drug products.”  To the extent that these contentions support a claim of breach of a state tort duty to provide different or additional information or warnings than those approved by the FDA . . ., the claim is precluded. . . .  If these contentions are intended to support a different theory of relief, they are inadequately pled.

Id. at *4.

Nor does Vermont common law otherwise support failure-to-report claims.  Sheldon v. Ruggiero, 202 A.3d 241 (Vt. 2018), rejected a “common-law duty of care created and shaped by the mandated-reporter statute.”  Id. at 247.  Quoting and following Marquay (see New Hampshire), the Vermont Supreme Court affirmed summary judgment for lack of duty:

Where a plaintiff seeks to use a safety statute as the standard of care under the prima facie negligence rule, there must be an existing duty recognized by the common law. . . .  The doctrine of prima facie negligence plays no role in the creation of common law causes of action.  Thus, in many cases, the common law may fail to recognize liability for failure to perform affirmative duties that are imposed by statute.

Recognizing this distinction, we first inquire whether the plaintiff could maintain an action at common law. . . .  If no common law duty exists, the plaintiff cannot maintain a negligence action, even though the defendant has violated a statutory duty. . . .  Here, plaintiffs argue that defendant had a common-law duty . . . arising from defendant’s status as a mandatory reporter. . . .  But even assuming they could establish a special relationship sufficient to create a common-law duty of care, plaintiffs argument still rests on the claim that the standard of conduct required pursuant to that duty is defined by [the statute].

Id. at 44 (Marquay citation and quotation marks omitted).

Finally, we note two Halsey-like cases that mention reporting claims but do not decide the issue under Vermont law.  They are just a relevant (or not) as the dictum in HalseySaltis v. NuVasive, Inc., 2020 WL 4689822, at *4 (D. Vt. Aug. 3, 2020) (citing the holding in McNeil-Williams (see North Carolina) that failure-to-report claims are not “parallel” because no reporting-based duty existed under state (not Vermont) law); Otis-Wisher v. Fletcher Allen Health Care, Inc., 951 F. Supp.2d 592, 600 (D. Vt. 2013) (mentioning reporting-based allegations, but dismissing them as insufficiently pleaded), aff’d, 616 F. Appx. 433 (2d Cir. 2015).

Could Vermont adopt a “parallel” failure-to-report duty?  Perhaps.  Has any Vermont precedent – state or federal – done so?  Plainly not.  Thus, under TBI’s own evaluation, it should have “opt[ed] for the interpretation that restricts liability, rather than expands it,” 2021 WL 1050910, at *31, with respect to Vermont.


Virginia is the largest (population-wise) of all the states that TBI lists as not having “relevant legal authority.”  2021 WL 1050910, at *31.  Not so.  Talley v. Danek Medical, Inc., 179 F.3d 154 (4th Cir. 1999), another of the aforementioned handful of pre-preemption cases to address the impact of failure-to-report allegations, held under Virginia law that FDCA reporting obligations are insufficient to support tort duties:

Where a statutory provision does not define a standard of care but merely imposes an administrative requirement, such as the requirement to obtain a license or to file a report to support a regulatory scheme, violation of such requirement will not support a negligence per se claim.

Id. at 159 (emphasis added).  The only other Virginia case addressing FDCA-based reporting claims in any context, Evans v. Medtronic, Inc., 2005 WL 3547240 (W.D. Va. Dec. 27, 2005), rejected a plaintiff’s argument that an alleged violation of an “FDA reporting requirement can serve as a premise for imposing an inference adverse to the Defendant.”  Id. at *16.

Moreover, as with a number of other states as to which PBI found no precedent, there is dispositive non-FDCA precedent − from the Virginia Supreme Court that Virginia will not recognize failure-to-report claims predicated on violations of mandatory reporting statutes.  A purported common-law negligence claim for failure to report child abuse was rejected in A.H. v. Church of God in Christ, Inc., 831 S.E.2d 460, 475 (Va. 2019), precisely because no underlying duty to report exists in Virginia;

[T]he negligence per se doctrine does not create a duty of care but merely sets a standard of care by which the defendant may be judged in the common-law action, and thus, the absence of an underlying common-law duty renders the presence of a statutory standard of care irrelevant.”  [Plaintiff] alleges no common-law duty to report suspected child abuse. . . .  We have expressly rejected the proposition that a statute setting a standard of care also creates the duty of care.  Without a common-law antecedent to the duty to report suspected child abuse, [plaintiff’s] negligence per se claim . . . cannot survive.

Id. at 475 (citations and quotation marks omitted).

Thus, while we concur with TBI’s bottom line, we think Virginia law is much more definitively contrary to failure-to-report claims, both FDCA-based and otherwise.


TBI concluded that Washington State allows FDCA-based failure-to-report claims in reliance on O’Neil v. St. Jude Medical, Inc., 2013 WL 6173803 (W.D. Wash. Nov. 22, 2013).  2021 WL 1050910, at *29.  O’Neil did indeed so hold – in a conclusory fashion relying on Stengel (see Arizona.), and the general warning cause of action enacted by Washington’s product liability statute.  2013 WL 6173803 at *3.

We’d chalk O’Neil up as another federal court running amok over state law and Erie principles, except that Washington law has allowed failure-to-report claims in other situations.  Beggs v. State, Dept. of Social & Health Services, 247 P.3d 421 (Wash. 2011), allowed a failure-to-report claim in the child abuse context.

Under this test, [the child abuse reporting statute implies a cause of action against a mandatory reporter who fails to report suspected abuse.  First, victims of child abuse are certainly within the class for whose special benefit the legislature enacted the reporting statute. . . .  Second, the statute implicitly supports a civil remedy. . . .  A grant of immunity from liability clearly implies that civil liability can exist in the first place. . . .  The statutory scheme supports an implied cause of action for a failure to fulfill that duty.  Finally, an implied cause of action is consistent with the underlying purpose of the statute. . . .  Implying a civil remedy as a means of enforcing the mandatory reporting duty is consistent with this intent.

Id. at 425-26 (citations and quotation marks omitted).  Then, in Kim v. Lakeside Adult Family Home, 374 P.3d 121 (Wash. 2016), the court repeated the process, recognizing a failure-to-report claim for a second time, with respect to a reporting statute concerning vulnerable adults.  Id. at 126-27 (“The [statute] is similar to the [child abuse reporting statute], and thus Beggs is persuasive.”).  Accord Evans v. Tacoma School Dist. No. 10, 380 P.3d 553, 560-62 (Wash. App. 2016) (following Beggs implied cause of action rationale concerning another mandatory reporting statute); Doe v. Corp. of President of Church of Jesus Christ of Latter-Day Saints, 167 P.3d 1193, 1201 (Wash. App. 2007) (holding, pre-Beggs, that “it is reasonable to imply an intended remedy for child victims . . . when those required to report the abuse fail to do so”).  Given this precedent, we can’t say with any certainty that Washington’s highest court would not try something similar as to the FDCA.

On the other hand, it might not.  The FDCA’s exclusive enforcement clause, 21 U.S.C. §337(a), should preempt the sort of implied right of action rationale employed in Beggs and Kim.  And, as held elsewhere in the TBI decision, “[i]n Washington, the violation of a statute or the breach of a statutory duty is not considered negligence per se.”  2021 WL 1050910, at *24 (citations and quotation marks omitted).  See Wash. Rev. C. §5.40.050 (abolishing negligence per se except for irrelevant exceptions).

So while we can’t say that TBI is wrong about Washington state, we can’t say for sure that it’s right, either.


West Virginia is another state where TBI didn’t find any “legal authority” concerning FDCA-based failure-to-report claims and thus “opt[ed] for the interpretation that restricts liability, rather than expands it.”  2021 WL 1050910, at *31.  That result is right, but as in other states, there is affirmative precedent supports the lack of failure-to-report claims in the jurisdiction.

Following Talley (see Virginia), In re Digitek Products Liability Litigation, 2009 WL 2433468, at *12 (S.D.W. Va. Aug. 3, 2009), held that the plaintiffs’ FDCA-based failure-to-report allegations did not support a negligence duty in tort.  “A statute will be deemed not to define a standard of care where it only imposes an administrative requirement, such as the mandate . . . to file a report to support a regulatory scheme.”  Id. at *12 (Talley citation and quotation marks omitted).

Outside of the FDCA, West Virginia law is crystal clear that tort claims cannot be predicated on claimed violation of statutory reporting requirements.  Arbaugh v. Board of Education, 591 S.E.2d 235 (W. Va. 2003), so held in the context of child abuse reporting.

[W]e conclude that [the mandatory reporting statute] does not give rise to an implied private civil cause of action, in addition to criminal penalties imposed by the statute, for failure to report suspected child abuse where an individual with a duty to report under the statute is alleged to have had reasonable cause to suspect that a child is being abused and has failed to report suspected abuse.  The same conclusion has been reached by a decided majority of states.

Id. at 241 (citations omitted).  In particular, Arbaugh considered “whether a private cause of action is consistent with the underlying purpose not just of the reporting statute but the entire legislative scheme of which the reporting statute is a part,” id., and concluded that “we do not see that a private cause of action would meaningfully further the purposes of the article so as to find that such was intended by the Legislature.”  Id.

The plaintiff in Barbina v. Curry, 650 S.E.2d 140 (W.Va. 2007), attempted to get around Arbaugh by asserting an action “based on negligence” with failure to report “as evidence” of the claimed negligence.  Id. at 146.  The court unanimously rejected that dodge:

Arbaugh stands for the proposition that no type of private civil cause of action exists [for violation of the statutory reporting obligation].  The dicta language that [plaintiff] seeks to rely upon states only that in a properly brought negligence action, a plaintiff may introduce evidence regarding failure to report.  However, such evidence is not the basis for a cause of action; rather, it is evidence to support a legally recognized cause of action.

Id.  Thus, in West Virginia, a statutorily imposed duty to report something to the government simply cannot be “the basis for a cause of action.”  There is no “legally recognized cause of action” for failure to make a statutorily mandated report.


Citing Garross v. Medtronic, Inc., 77 F. Supp.3d 809 (E.D. Wis. 2015), TBI concluded that Wisconsin would allow FDCA-based failure-to-report claims.  2021 WL 1050910, at *29.  Garross held exactly what TBI described:

[P]laintiff’s . . . claims are based on [defendant’s] alleged failure to report adverse events to the FDA. . . .  Class III medical device manufacturers are required to report adverse events to the FDA, 21 C.F.R. §803.50, investigate serious adverse events and submit follow-up reports, 21 C.F.R. §803.56. . . .  Plaintiff may rely on these alleged violations as evidence that [defendant] violated a state common law duty to warn patients of the risks of the off-label use.  Plaintiff does not claim that state law imposes an additional requirement on [defendant] to warn patients directly, but rather that a breach of these various federal requirements alone is enough to establish liability under her various common law claims.

77 F. Supp.3d at 815-18 (non-reporting-related FDCA citations omitted).

What Garross didn’t do is cite a single case, let alone a decision applying Wisconsin law, for its novel holding.  Rather Garross flagrantly violated the same Erie principles that TBI applied by ginning up a novel state-law tort duty from nothing at all.  As much as any decision we’ve cited anywhere in this entire overly long post, Garross exemplifies out-of-control judicial tort activism.

Nothing else in Wisconsin law supports tort liability for failure to make a mandatory report to a governmental agency, state or federal.  Isely v. Capuchin Province, 880 F. Supp. 1138 (D. Mich. 1995), dismissed a negligence action based on alleged violations of the Wisconsin child abuse reporting statute – surveying (unlike Garross) relevant case-law nationwide:

Although no Wisconsin state or federal court has been called upon to decide specifically whether a civil negligence action can be maintained for violation of the Wisconsin Reporting Statute, several courts have been called upon to decide this issue in the context of child abuse reporting statutes with virtually identical language. . . .  All of these courts have concluded that no private right of action can lie for failure to report.

These cases make clear that in deciding whether a violation of the reporting statute can support a private negligence cause of action, the court should consider the provisions of the statute as a whole to determine whether the legislature intended to authorize a civil action. Having reviewed the entire text of [the Wisconsin statute], this Court finds nothing to indicate that the Wisconsin legislature intended to authorize a private cause of action for failure to report.

Id. at 1148-49 (citations omitted) (emphasis original).

An unreported Wisconsin appellate opinion, Grad v. Associated Bank, N.A., 801 N.W.2d 349 (Table), 2011 WL 2184335 (Wis. App. June 7, 2011), likewise held that there was no Wisconsin tort theory to support claims based on failure to make Bank Secrecy Act reports:

[Plaintiff] also relies heavily upon [defendant’s] alleged violations of federal banking regulations to support his claim that [defendant] had a duty to detect and prevent [third-party] fraud.  Yet, there is no private right of action for violation of the relevant federal banking regulations.  Indeed, [plaintiff] does not contend that the federal banking regulations create a private right of action.  Instead, [plaintiff] argues that the federal regulations impose a common law duty of care upon [defendant].  We disagree. . . .  [B]ecause the federal banking regulations do not authorize a private right of action, they cannot be used to create a common law duty of care.

*          *          *          *

[If]f the [regulated] industry should be subjected to the type of lawsuits that would be suggested in this case, such a decision “should be made by the legislature. . . .  [W]e therefore decline to hold that federal banking regulations create a common law duty of care.

Id. at *6-7.

While we can see why TBI relied on Garross, we nevertheless think it’s the wrong call.  Garross was an egregious violation of the very Erie conservatism that TBI professed to follow, and nothing else in Wisconsin law supports the “duty” Garross so blithely recognized.  Thus TBI should not have done indirectly what it conceded it could not have done directly.


TBI found no “legal authority” from Wyoming on FDCA-based failure-to-report claims, therefore “opt[ing] for the interpretation that restricts liability, rather than expands it,” and denying any such cause of action under Wyoming law.  2021 WL 1050910, at *31.

That’s exactly right  We tried, and failed, to locate any Wyoming precedent addressing failure-to-report claims, whether involving the FDCA or otherwise.