This post is to update our readers about subsequent developments in matters covered in some of our prior blogposts.

First, slightly over a year ago we praised Gayle v. Pfizer, Inc., 452 F. Supp.3d 78 (S.D.N.Y. 2020), a prescription drug preemption decision holding, among other things, that a plaintiff could not claim “newly acquired information” simply by dumping a disorganized mass of hundreds of adverse event reports on the judge, and claiming that the burden shifted to the defendant to “analyze” them.  Id. at 88.  In the interim, the plaintiff in Gayle appealed, and recently the Second Circuit affirmed.  Gayle v. Pfizer, Inc., ___ F. Appx. ___, 2021 WL 1904338 (2d Cir. May 12, 2021).  Ordinarily, such an affirmance would merit its own post, but the Second Circuit’s memorandum affirmance is only three short paragraphs.  The second paragraph is what counts:

For substantially the reasons stated by the District Court in its April 7, 2020 opinion and order, we conclude that the Plaintiffs-Appellants’ state-law failure-to-warn claims are preempted by federal law to the extent that they arose after February 2012, and that they are untimely to the extent that they arose before April 2016.  Also for substantially the reasons stated by the District Court, we conclude that leave to amend the complaint is futile.

Id. at *1.  Thus, the opinion we liked before now has the added luster of the Second Circuit’s imprimatur.

Second, last September, we expressed our puzzlement at the ancien régime’s proposal to remove from Vaccine Act compensation something called “SIRVA” (Shoulder Injury Related to Vaccine Administration).  See 85 Fed. Reg. 43,791 (HHS July 20, 2020). We’ve had quite a few shoulder jabs in our day, but had never heard of this.  The oddest part of the proposal was its advocacy of civil tort negligence litigation against persons who administer vaccines as preferable to the Vaccine Act’s compensation system.  At the time, this aspect of the proposal struck us as weird and counterproductive.

[W]e are not exaggerating here.  An express purpose of the HHS proposal is to encourage litigation against health care professionals who administer vaccines, and thus to impose “the burden and expense” of litigation on others.

Well, the new administration apparently agrees with us.  A little over a month ago, it formally withdrew that proposalSee 86 Fed. Reg. 21209 (HHS April 22, 2021).  The idea of exposing persons administering vaccines to greater tort liability struck the new administration as counterproductive, just as we had concluded:

As a policy matter, HHS is rescinding the [previous] Final Rule because it is concerned that it would have a negative impact on vaccine administrators, which would be at odds with the Federal Government’s efforts to increase confidence in vaccinations in the United States, particularly in light of efforts to respond to the Coronavirus Disease 2019 (COVID-19) pandemic. . . .  Given this unprecedented vaccination effort and the concern that the [previous] Final Rule’s revisions to the Table could negatively impact the COVID-19 vaccination campaign, as well as other campaigns such as annual influenza vaccination efforts, and the January 21, 2021 Final Rule’s associated procedural issues, HHS is rescinding that rule.

86 Fed. Reg. at 21211.  HHS also cited the sort of administrative law shennanigans that were all too common under the now-departed ancien régime, “agree[ing] that there were irregularities in how HHS consulted with” the  vaccine advisory committee and “concerns . . . whether all public comments were adequately considered and addressed as required by the [Administrative Procedure Act].”  Id.  In that vein, we had previously concluded that “HHS’s entire discussion” struck us as “pretextual.”

Also of interest was HHS’s description of what would have to happen before COVID vaccine-related injuries could be compensated under the Vaccine Act (“VCIP”), as opposed to the more restrictive PREP Act compensation system (“CICP”) that we mentioned here and here.

COVID-19 vaccines are covered countermeasures under the Countermeasures Injury Compensation Program (CICP), not the VICP. . . .  [F]or a new category of vaccines to be covered under the VICP, the following three things must happen: (1) Congress must enact an excise tax on the vaccine, (2) the CDC must recommend it for routine administration to children or pregnant women, and (3) the Secretary must publish a notice of coverage in the Federal Register.

86 Fed. Reg. at 21211-12 (citation and footnote omitted).

Third, we commented in August 2019 that a recently promulgated “formal letter” by the Environmental Protection Agency concerning the pesticide Roundup should, under Merck Sharp & Dohme Corp. v. Albrecht, 139 S. Ct. 1668 (U.S. 2019), preempt cancer claims involving that product because “it seems blindingly clear that the EPA has “informed the [regulated entity] that the [agency] would not approve changing the [product’s] label to include that warning.”  Quoting Albrecht, 139 S. Ct. at 1678.

While we were right, it appears that we were also wrong – again due to the pervasive administrative law shenanigans of the ancien régime.  We simply took the EPA’s action at face value.  According to a recent Ninth Circuit decision, we shouldn’t have done that:

Nor does EPA’s 2019 letter, sent after the conclusion of [plaintiff’s] trial to all registrants of products containing glyphosate, carry the force of law. . . .  [T]he 2019 letter − stating that EPA believes any pesticide label with a cancer warning due to the presence of glyphosate will be misbranded − did not follow any “formal administrative procedure” that would give the letter the force of law.  The 2019 letter was issued without any written notice, gave no hearing or opportunity to respond, and lacked any sort of dispute-resolution process.

Hardeman v. Monsanto Co., ___ F.3d ___, 2021 WL 1940550, at *8 (9th Cir. May 14, 2021).

It appears that Hardeman was bound and determined to affirm that jury verdict no matter what, and since (as our prior post set out at length) there was no way around Albrecht’s implied preemption if the EPA’s letter was taken at face value, Hardeman came up with a rationale that nullified the letter altogether.  Is it right?  We don’t know the details, but we’ve commented before that the ancien régime often played fast and loose with administrative processes.

Fourth, we posted earlier this year about the Florida Supreme Court’s landmark decision to adopt the federal summary judgment standard.  In a recent subsequent ruling, that court decided that the best way to implement that decision was simply to adopt the language of Fed. R. Civ. P. 56 “wholesale” as the rule in Florida (which goes by Fla. R. Civ. P. 1.510).  So, effective May 1, 2021, “[t]he amendment we adopt . . . largely replaces the text of existing rule 1.510 with the text of federal rule 56.”  In re Amendments To Fla. Rule of Civ. Proc. 1.510, ___ So.3d ___, 2021 WL 1684095, at *2 (Fla. April 29, 2021).  Not only does the new rule apply to “pending case,” but parties that had summary judgment denied under the old rule get a do-over under the new rule:

In cases where a summary judgment motion was denied under the pre-amendment rule, the court should give the parties a reasonable opportunity to file a renewed summary judgment motion under the new rule.  In cases where a pending summary judgment motion has been briefed but not decided, the court should allow the parties a reasonable opportunity to amend their filings to comply with the new rule.  Any pending rehearing of a summary judgment motion decided under the pre-amendment rule should be decided under the pre-amendment rule, subject of course to a party’s ability to file a renewed motion for summary judgment under the new rule.

Id. at *4.

Fifth, in late 2019, we brought our readers the “good news”/“bad news” result in Fitzpatrick v. Wendy’s Old Fashioned Hamburgers of New York, Inc., 96 Mass. App. Ct. 410, 136 N.E.3d 355 (2019).  The good news was the court’s denunciation of the “reptile” litigation tactics engaged in by the plaintiff’s in the case.  The bad news was the toothlessness of that denunciation in practice, the trial judge’s mistrial was overturned on procedural grounds, and so was the overturning of the reptilian verdict, with instructions to give the plaintiff a do-over.

Well, last week the Massachusetts Supreme Judicial Court reversed and reinstated the trial judge’s mistrial.  Most of the opinion was about the knotty procedural question, with the bottom line being that a mistrial motion can’t be held in abeyance to await the verdict, but must be decided immediately.  Fitzpatrick v. Wendy’s Old Fashioned Hamburgers of New York, Inc., ___ N.E.3d ___,  2021 WL 2024453, at *4-5. (Mass. May 21, 2021).  However, that ruling was made prospective only, id. at *6, and the court threw out the tainted verdict altogether over the plaintiff’s improper Reptile Theory closing argument.  “We agree with the judge that certain of the statements made by the plaintiff’s counsel in closing involved an improper appeal to the jurors’ emotions, passions, prejudices, or sympathies.”  Id. (citation and quotation marks omitted).

So the Reptile Theory is well on its way to justified extinction in Massachusetts.

Sixth, in our “And Now for Something Completely Different” post last fall, we commented on the unusual analysis used in Gustafson v. Springfield, Inc., 2020 WL 5755493 (Pa. Super. Sept. 28, 2020), to hold the federal Protection of Lawful Commerce in Arms Act – and by implication all federal tort reform legislation – unconstitutional.  We called it “at once both paleolithically conservative and pro-plaintiffly radical.”  Well we can now call Gustafson “reargument granted, opinion withdrawn.”

Not too long ago we discussed the decision in In re Allergan Biocell Textured Breast Implant Products Liability Litigation, 2021 WL 1050910 (D.N.J. March 19, 2021) (“TBI”).  TBI addressed quite a few topics, one of which was the first nationwide (or close to it) analysis of whether a given jurisdiction permitted, under state law, a “warning”-based cause of action against a manufacturer of an FDA-regulated prescription drug or medical device for allegedly failing to report adverse events to the FDA.  See Id. at *27-31.  We might not agree with all (or even most) of the state-by-state results reached in TBI, but the hard work that this aspect of that decision represents has inspired us to engage in a similar exercise.

There is nothing new under the sun, so where failure-to-report allegations involving other government-mandated reporters have been made outside of the prescription drug area – and they have, with non-reporting of child abuse being the most common example – we include those.  After all, in federal court, predictions of state law “must consider,” among other things, “analogous decisions.”  E.g., Wolfe v. Allstate Property & Casualty Insurance Co., 790 F.3d 487, 492 (3d Cir. 2015) (citation and quotation marks omitted).  Further, under Erie, “[t]he rulings of intermediate appellate courts must be accorded significant weight and should not be disregarded absent a persuasive indication that the highest state court would rule otherwise.”  Earl v. NVR, Inc., 990 F.3d 310, 313 (3d Cir. 2021) (citation and quotation marks omitted).  Other state-law cases – particularly appellate cases − alleging liability for negligent failure to report to a government agency constitute the closest legal analogy to FDCA-based failure-to-report claims.  To us the worst failing of TBI is its ignoring altogether this “analogous” state-law failure-to-report precedent.  Since the great majority of this analogous precedent rejects rejects such common-law duties, TBI thereby (we think) put a thumb on the Erie scale in favor of plaintiffs in quite a few jurisdictions.  That is one of the things we hope that this memo helps correct.

As to FDCA-based adverse event reporting, this sort of allegation is relatively new.  It is contrary to the learned intermediary rule, for one thing, which limits the recipients of legally required warnings in product liability litigation involving prescription medical products to the plaintiff’s “prescribing [or] other health-care provider[].”  Restatement (Third) of Torts, Products Liability §6(d) (1998).  The FDA is a lot of things, but it neither prescribes products nor provides healthcare to anyone (and certainly doesn’t set the medical standard of care).  The learned intermediary rule is now recognized in all fifty states.

A warning claim predicated on FDCA reporting violations, as opposed to a product’s actual warnings, is also contrary to other parts of the Restatement of Torts.  For example, the negligent failure-to-warn theory is embodied in Restatement (Second) of Torts §388 (1965).  That section recognizes the liability of “[o]ne who supplies directly or through a third person” a product and does not “inform them” of a product-related risk.  Id.  Once again, a government agency like the FDA does not satisfy this black-letter law.  The FDA does not “supply” any product, directly or indirectly, to anyone.  A government regulator falls outside of the duty to warn contemplated by the Restatement:

Chattels are often supplied for the use of others, although the chattels or the permission to use them are not given directly to those for whose use they are supplied . . . .  In all such cases the question may arise as to whether the person supplying the chattel is exercising that reasonable care, which he owes to those who are to use it, by informing the third person through whom the chattel is supplied of its actual character.

Restatement §388, comment p (emphasis added).  The warning must pass along with the product.  There is simply nothing in any Restatement of Torts about a tort involving the provision (or not) of information to a regulatory body.

Unlike the learned intermediary rule, the §388 “sophisticated user” concept has not been widely adopted.  See In re 3M Combat Arms Earplug Products Liability Litigation, 2021 U.S. Dist. Lexis 100781, at *6-7 (N.D. Fla. May 27, 2021) (sophisticated user doctrine only adopted in nine states, not including Alaska).  So in many states, defendants could turn this argument around on plaintiffs, with the non-adoption of Restatement §388, comment n being yet another (of many) reasons not to allow failure-to-report claims.

The Third Restatement of Torts recognizes, as a general rule, that “[a]n actor whose conduct has not created a risk of physical or emotional harm to another has no duty of care to the other.”  Restatement (Third) of Torts:  Physical & Emotional Harm §37 (2012).  It provides a number of exceptions, of which §38 Affirmative Duty Based on Statutory Provisions Imposing Obligations to Protect Another, has sometimes been cited in failure-to-report cases.  That section provides:

When a statute requires an actor to act for the protection of another, the court may rely on the statute to decide that an affirmative duty exists and to determine the scope of the duty.

“This Section addresses the interstices left when statutes neither provide for nor negate private rights of action.”  Id. comment c.  Thus, any attempt to use Restatement (Third) §38 in the FDCA context would run headlong into the Supreme Court’s holding in Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001), that a section of the FDCA, 21 U.S.C. §337(a), is “clear evidence that Congress intended that the MDA be enforced exclusively by the Federal Government.”  531 U.S. at 352.  Section 38 also points out that:

[U]se of federal legislation as the basis for finding an affirmative duty is . . . analogous to a court determining that violation of a federal provision constitutes negligence per se in a tort case governed by state law.

Id. comment b.  We’re not covering preemption in this post, but this is also the basis for implied preemption of failure-to-report claims.

We also view failure-to-report theories as attempts by plaintiffs to replace the usual state-law causation standard, based on expert testimony to a “reasonable degree of medical certainty” (or “probability” in some states) with supposedly unreported adverse event reports that even the FDA admits are often scientifically worthless:

[T]his passive surveillance system has limitations, including the submission of incomplete, inaccurate, untimely, unverified, or biased data. In addition, the incidence or prevalence of an event cannot be determined from this reporting system alone due to under-reporting of events, inaccuracies in reports, lack of verification that the device caused the reported event, and lack of information about frequency of device use.

FDA, Medical Device Reporting (MDR): How To Report Medical Device Problems (2019).  The FDA recognizes that such reports reflect “incomplete, inaccurate, untimely, unverified, or biased data.”  Id.  FDA further cautions that adverse event reports “do[] not necessarily reflect a conclusion by the party submitting the report by FDA . . . that the device . . . caused or contribute to the reportable event.”  FDA, Manufacturer & User Facility Device Experience Database – (MAUDE) (2020).  We have an entire cheat sheet collecting and discussing this sort of precedent.  Thus, there is good reason why the FDA does not automatically make such reports public, and why the medical community is not in the habit of relying on voluntary event reporting.  Rather than base causation on valid science, failure-to-report claims divert attention to the presence or absence of “incomplete, inaccurate, untimely, unverified, or biased” adverse event reports.

In the FDA context, the idea of a “reporting” cause of action for failure to warn is almost never seen outside of situations where a manufacturer’s traditional duty to warn is preempted by federal law.  We can count on our fingers the number of pre-preemption FDCA-based failure-to-report cases, and still have quite a few fingers left over.  In medical device cases, such claims are presented to courts as supposed “parallel claims” not “different from or in addition to” federal obligations within the meaning of 21 U.S.C. §360k(a), the FDCA’s express preemption clause for medical devices.  In drug cases, particularly those involving generic drugs, such claims also pop up, as supposedly not in “conflict” with a defendant manufacturer’s “sameness” obligations.  These failure-to-report theories are merely preemption dodges, aiming for nuisance-value settlement, not trial – we’ve looked at a lot of cases and have yet to see an FDCA-based failure-to-report claim tried to a plaintiff’s verdict.

While we’re not addressing preemption issues here − only the existence of a common law duty – preemption and state-law failure to state a claim are closely intertwined.  As the TBI decision observed, “[i]n states that recognize failure to report claims, . . . a manufacturer’s failure to report adverse events to the FDA can form the basis of a parallel claim that survives preemption.”  2021 WL 1050910, at *11.  Determining whether the allegedly “parallel” state-law claim exists ab initio is the essential first step in analyzing a parallel claim.

Similarly, under implied preemption as recognized in Buckman, lack of a concomitant state-law duty for a failure-to-report claim exposes that claim as purely federal, and thus barred as conflicting with the FDCA’s no private enforcement provision, 21 U.S.C. §337(a).  Thus, an implied preemption dismissal of a failure-to-report claim often encompasses an express or implicit holding that state law does not recognize such claims, and a denial of preemption is conversely predicated on a conclusion that a state-law duty does exist.

We mentioned the Erie doctrine already.  TBI, as required by extensive United States Supreme Court and Third Circuit precedent, recognized that “[w]here ‘two competing yet sensible interpretations’ of state law exist,’ a federal court ‘should opt for the interpretation that restricts liability, rather than expands it, until the Supreme Court of [the State] decides differently.’”  2021 WL 1050910, at *18 (citation and quotation marks omitted).  However, it also undertook, inconsistently we think, to view such novel causes of action “with leniency.”  Id. at *19.  TBI unfortunately went out of its way to allow reporting-based claims to survive whenever any precedent at all – even a wayward federal district court disregarding the same Erie considerations just discussed – could be found, and even where a de novo review of state law would reject such a claim.  We note such state-specific disagreements herein.

Finally, before turning to the individual states, we point out that disregard of Erie conservatism by courts evaluating failure-to-report claims is a longstanding and serious problem.  Perhaps the worst example is Stengel v. Medtronic Inc., 704 F.3d 1224 (9th Cir. 2013) (en banc), which purported to predict Arizona law.  As discussed below, the Arizona Supreme Court disapproved Stengel’s novel claim the first chance it got.  However, that took five years.  During that time, other courts in other states relied upon and multiplied Stengel’s error.  Since reliance on overturned precedent is particularly suspect, we point out when that has occurred.  Even Stengel, however, recognized the causation problems created by FDA-based failure-to-report claims, since the FDA is not itself a learned intermediary:

Because they predicate their claim on [defendant’s] reporting duty to the FDA, as they must to avoid express preemption, [plaintiffs] face a causation hurdle that would not otherwise exist.  To prevail, they will ultimately have to prove that if [defendant] had properly reported the adverse events to the FDA as required under federal law, that information would have reached [plaintiff’s prescribing] doctors in time to prevent his injuries.

704 F.3d at 1234 (citation omitted).

In this post, since there are some (not many) states that allow FDCA-based claims for failure to report, we’ll also address these causation issues.  After all, the problems with reporting claims go well beyond their nonrecognition in most states.


The Alabama Supreme Court has addressed liability for failure to make mandatory reports to government agencies, but not in the FDCA context.  In C.B. v. Bobo, 659 So.2d 98 (Ala. 1995), claims for failure to report child abuse were rejected.  “[T]he legislature did not intend to confer a private right of action for any breach of the duty to report imposed by the statute. . . .  While the Act imposes a duty on an individual to make such a report, there is no indication of any legislative intent to impose civil liability for failure to report.”  Id. at 102.  Private enforcement of a duty to report to the government cannot be inferred from silence.

The [reporting statute] creates a duty owed to the general public, not to specific individuals, and, consequently, it does not create a private cause of action in favor of individuals.  Therefore, to the extent that the plaintiffs rely on that statute, they fail to state a cause of action.”).

Id.  Accord Weissenbach v. Tuscaloosa City School System, 2018 WL 5848047, at *8 (N.D. Ala. Nov. 8, 2018) (“The Alabama Supreme Court has held that the mandatory reporting statute does not create a private right of action and that a plaintiff may not bring . . . claims based on violations of this statute.”).

FDCA-based failure-to-report claims met the same fate in Rice v. Allergan USA, Inc., 2018 WL 1618036 (N.D. Ala. April 4, 2018):

[Plaintiff’s] failure to report claim . . . rests on her allegation that [defendant] “failed to tell the FDA those things required by federal law.”  [She] alleges that [defendant] violated [the FDCA] by failing to perform post-market surveillance. . . .  [Plaintiff] has not identified a traditional state law cause of action for post-market surveillance that predated the MDA.

Id. at *7 (quoting Mink v. Smith & Nephew, Inc., 860 F.3d 1319, 1330 (11th Cir. 2017) (applying Florida law)) (other citations omitted).

In Barnhill v. Teva Pharmaceuticals USA, Inc., 819 F. Supp.2d 1254, 1263 (S.D. Ala. 2011), the district court rejected somewhat analogous claim of “negligen[ce] in monitoring other adverse events relating to” a generic drug – but not in failing to report them to the FDA.  Id. at 1263.  Barnhill dismissed that claim, finding no duty to keep track of “the adverse event experience of other [generic] manufacturers”  Id.  Absent directly on point precedent, TBI “opt[ed] for the interpretation that restricts liability, rather than expands it,” and held that Alabama would not allow FDCA-based failure-to-report claims.  2021 WL 1050910, at *31.  That result seems right to us, but there is more Alabama case law than TBI thought.


In Alaska failure to fulfil the requirements of a reporting statute designed to “ensur[e] that reports of harm are properly investigated and followed up by the state . . . does not create a private cause of action.”  Hymes v. DeRamus, 222 P.3d 874, 889 (Alaska 2010)  (rejecting private enforcement of elder abuse statute).  Cf. Christoffersen v. State, 242 P.3d 1032, 1036 (Alaska 2010) (rejecting claim of failure to report child abuse asserted against state actor on immunity grounds); Felger v. Smith & Nephew, Inc., 222 F. Supp.3d 746, 754 (D. Alaska 2016) (dismissing “conclusory” FDCA-based failure-to-report claim as “not sufficient to state a plausible claim” without addressing merits).

With no FDCA-related precedent either way, TBI “opt[ed] for the interpretation that restricts liability, rather than expands it,” and held that Alaska would not allow FDCA-based failure-to-report claims.  2021 WL 1050910, at *31.


The Arizona Supreme Court corrected the Ninth Circuit’s erroneous Stengel prediction when it expressly “disagree[d] with Stengel” and held that no state-law tort duty to make reports to FDA existed.  Conklin v. Medtronic, Inc., 431 P.3d 571, 578-79 (Ariz. 2018).  Conklin recognized that “only federal law, not state law, imposes a duty on [defendant] to submit adverse event reports to the FDA.”  Id. at 578.  It further pointed out that, because “FDA is not a health care provider and does not prescribe anything for patients,” the Agency cannot be a “learned intermediary” entitled to receive product warnings under state law.  Id. at 579.  Thus:

[State] law does not permit a manufacturer to satisfy its duty to warn end-user consumers by submitting adverse event reports to the FDA.  And conversely, a manufacturer does not breach its duty to warn end users under [state] law by failing to submit adverse event reports to the FDA. . . .  [The duty to warn] has not been extended to require a manufacturer to submit warnings to a governmental regulatory body. . . .  [E]stablished law does not recognize a claim merely for failing to provide something like adverse event reports . . . to a government agency that has no obligation to relay the information to the patient.

Id. at 577, 579 (citation omitted).  See TBI, 2021 WL 1050910, at *29 (acknowledging Conklin).

During Stengel’s five-year reign of error in Arizona, bound federal district courts dismissed failure-to-report claims repeatedly for lack of causation.  Martin v. Medtronic, Inc., 63 F. Supp.3d 1050 (D. Ariz. 2014), found reporting-based claims “insufficient to state a plausible claim” because causation was inadequately alleged:

What is missing from [plaintiff’s] adverse events claims is any connection between defendants’ alleged failure to report adverse events and her surgery.  Plaintiffs also have not alleged any factual support for these claims, such as any details (the date, nature of injuries, or method of implant) about any adverse events that should have been reported.

Id. at 1058.  Absent such facts, it was “not possible to tell if timely reporting would have affected the . . . use of the . . . device during [the] surgery.”  Id.  See Martin v. Medtronic, Inc., 32 F. Supp.3d 1026, 1043 (D. Ariz. 2014) (applying Arizona law) (earlier complaint in same case did “not allege that [plaintiffs] were damaged because of defendants’ failure to warn the FDA about adverse events“) (emphasis original); cf. Perez v. Medtronic, Inc., 2017 WL 11610298, at *5 (D. Ariz. May 26, 2017) (Stengel-era case throwing out failure-to-report claim on causation grounds; “if a recall of [the decedent’s] device was not sufficient to prompt action by his doctors,” then no failure to report could have been causal).


The Arkansas Supreme Court applied the “longstanding rule that this court construes statutes . . . imposing burdens and liabilities that do not exist at common law, in favor of the party sought to be penalized” and held that there was no civil liability against one “who has a statutorily-imposed individual duty to report . . . [but] fails to report.”  Cooper Clinic, P.A. v. Barnes, 237 S.W.3d 87, 91 (Ark. 2006) (reversing failure-to-report verdict under child abuse statute).  Thus, the Arkansas Supreme Court has viewed liability failure to report to a government agency as something that does “not exist at common law.”  Id.  Arkansas does, however, provide, an express statutory cause of action for failure to prevent child abuse.  Ark. C. §12-18-206.

FDCA-based failure-to-report claims were rejected in Green v. Bayer Corp., ___ F. Supp.3d ___, 2021 WL 687024 (E.D. Ark. Feb. 22, 2021).  Plaintiff could “not allege[] any Arkansas requirement that a manufacturer report adverse events to the FDA.”  Id. at *4.  Because the reporting-based claim had no basis in Arkansas law, “that theory of liability is simply an attempt by private parties to enforce the MDA, claims foreclosed by §337(a).”  Id. (citation and quotation marks omitted).  Finally, “Plaintiff ha[d] failed to plead a causal link between Defendants’ alleged regulatory reporting failures and the allegedly insufficient warnings given to her implanting physicians.”  Id.  TBI, which was decided before Green, “opt[ed] for the interpretation that restricts liability, rather than expands it,” and held that Arkansas would not allow FDCA-based failure-to-report claims.  2021 WL 1050910, at *31.


The TBI decision concluded that California “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.  Unfortunately, TBI is correct, under California law as it currently stands.  More than any other state, California courts swallowed the Stengel error – hook, line, and sinker.

Coleman v. Medtronic, Inc., 167 Cal. Rptr.3d 300, 312 (Cal. App. 2016), the earlier of the two California decisions cited in TBI, imported Stengel into California law:

We conclude Stengel provides the correct framework for analysis, and we are not persuaded by [defendant’s] argument that Stengel is wrongly decided.  We recognize, of course, that Stengel is not binding on this court, but it is persuasive authority that we elect to follow. . . .  We see no distinction between the present case and the allegations at issue in Stengel, other than the fact that [plaintiff’s] claim is a strict liability failure to warn claim under California law, while the plaintiff in Stengel alleged a negligence claim under Arizona law.

167 Cal. Rptr.3d at 311-12 (citations standardized).

In the second case cited in TBI, Mize v. Mentor Worldwide LLC, 265 Cal. Rptr.3d 468 (Cal. App. 2020) (which we discussed at some length, here), the court was offered the opportunity to retreat from the by-then-discredited Stengel rationale, but declined to do so:

The Arizona Supreme Court subsequently rejected Stengel’s latter conclusion:  “[E]stablished law does not recognize a claim merely for failing to provide something like adverse event reports . . . to a government agency.”  But that does not mean that Coleman is no longer good law in California.  Conklin . . . simply rejected the conclusion that Arizona law recognizes such a duty.  Unlike Arizona, California does recognize a duty to report adverse events to the FDA.  Coleman thus remains good law.

265 Cal. Rptr.3d at 479 (Conklin citations omitted).

Nor has California law generally rejected failure-to-report claims in other contexts.  Unlike most jurisdictions, the California Supreme Court allowed a failure-to-report child abuse claim in Landeros v. Flood, 551 P.2d 389 (Cal. 1976).  The “charged statutory violations” – failure to report – supported a personal injury claim and “raise[d] a presumption that by omitting to report plaintiff’s injuries to the authorities as required by law, defendants failed to exercise due care.”  Id. at 396.  Subsequent decisions have expanded Landeros beyond medical malpractice.  Randi W. v. Joint Unified School Dist., 929 P.2d 582, 594-95 (Cal. 1997); Pipitone v. Williams, 198 Cal. Rptr.3d 900, 917 (Cal. App. 2016); Garcia v. Clovis Unified School Dist., 627 F. Supp.2d 1187, 1205 (E.D. Cal. 2009).  The California Unfair Competition Law, which has been construed to authorize private actions for a great many statutory violations, has also supported failure-to-report claims concerning federal statutes that do not otherwise allow private rights of action.  Mercado v. Audi of America, LLC, 2019 WL 9051000, at *10 (C.D. Cal. Nov. 26, 2019) (failure to make TREAD Act reports).

Coleman also recognized the causation difficulties that Stengel discussed with a claim based on alleged deficiencies in FDCA-mandated adverse event reporting:

[T]he duty to warn should not be so narrowly defined as to exclude a requirement to file adverse event reports with the FDA if that is the only available method to warn doctors and consumers.  As the concurrence pointed out in Stengel, construing this duty in that way creates a causation hurdle that plaintiffs would not otherwise face.  “To prevail, they will ultimately have to prove that if [defendant] had properly reported the adverse events to the FDA as required under federal law, that information would have reached [the plaintiff’s] doctors in time to prevent his injuries.”

167 Cal. Rptr.3d at 312 (citations standardized).  Because they involved demurrers (the California equivalent of motions to dismiss), neither Coleman nor Mize evaluated causation beyond accepting the plaintiffs’ allegations as true.  Mize, 265 Cal. Rptr.3d at 481 (plaintiff’s “version of the facts is sufficiently pled” on causation); Coleman, 265 Cal. Rptr.3d at 312 (plaintiff “alleged facts sufficient” to plead causation).

California pleading, however, does not approach what TwIqbal requires in federal court.  Mize, 265 Cal. Rptr.3d at 478 (“[u]nder California law, a plaintiff may allege facts in a conclusory fashion” concerning causation) (citation and quotation marks omitted).  Conversely, in federal court under TwIqbal, California failure-to-report allegations have often failed because essential elements – particularly causation – are not pleaded or (at the summary judgment stage) cannot be proven.

Most basically, actual unreported events must be alleged.  A plaintiff must “allege actual adverse events that [defendant] did not report to the FDA.”  Vieira v. Mentor Worldwide, LLC, 845 F. Appx. 503, 505 (9th Cir. 2021).  “[C]onclusory and speculative allegations” based on unpleaded or hypothetical unreported adverse events are “insufficient” to state a failure-to-report claim.  Id. at 506.  Accord Sewell v. Mentor Worldwide, LLC, 847 F. Appx. 380, 383 (9th Cir. 2021) (same as Vieira); Billetts v. Mentor Worldwide, LLC, 847 F. Appx. 377, 379-80 (9th Cir. 2021) (same as Vieira); Nunn v. Mentor Worldwide, LLC, 847 F. Appx. 373, 376 (9th Cir. 2021) (same as Vieira).  See Kline v. Mentor Worldwide, LLC, 2021 WL 1173279, at *5 (E.D. Cal. March 29, 2021) (complaint dismissed that “merely contains general allegations that Defendant failed to report adverse events to the FDA without any specific examples”); Collette v. Wyeth Pharmaceuticals, Inc., 2020 WL 3414701, at *2 (N.D. Cal. June 22, 2020) (“vague and conclusory allegations that defendants ‘failed to report thousands of serious adverse medical events’” dismissed), affd, ___ F. Appx. ___, 2021 WL 3126742 (9th Cir. July 23, 2021); Jacob v. Mentor Worldwide, LLC, 393 F. Supp.3d 912, 924 (C.D. Cal. 2019) (dismissal when “Plaintiffs’ Complaint lacks any reference to the specific adverse events that [defendant] failed to report”), reconsideration denied, 2019 WL 5616958 (C.D. Cal. Oct. 29, 2019), aff’d, 847 F. Appx. 373 (9th Cir. 2021); Ebrahimi v. Mentor Worldwide LLC, 2018 WL 2448095, at *3 (C.D. Cal. May 25, 2018) (dismissing complaint that “fails to identify any unreported ailment or injury”), aff’d, 804 F. Appx. 871 (9th Cir. 2020); Paturzo v. Boston Scientific Corp., 2017 WL 8220600, at *6 (C.D. Cal. April 21, 2017) (a “complaint ‘must include allegations of actual adverse events that Defendants did not report’”) (quoting Weaver v. Ethicon, Inc., 2017 WL 680725, at *7 (S.D. Cal. Feb. 21, 2017), aff’d, 737 F. Appx. 315 (9th Cir. 2018)); Grant v. Corin Group PLC, 2016 WL 4447523, at *7 (S.D. Cal. Jan. 15, 2016) (dismissing complaint that “lacks allegations of actual adverse events that Defendants failed to report”); Caton v. Stryker Sustainability Solutions, Inc., 2015 WL 12426110, at *8 (C.D. Cal. May 12, 2015) (“Plaintiff failed to show that Defendants had any reports concerning these issues that required FDA submittal”); Knoppel v. St. Jude Medical, Inc., 2013 WL 12116393, at *5 (C.D. Cal. Sept. 24, 2013) (“Plaintiffs have not alleged facts sufficient to establish that Defendant failed to report adverse events in violation of federal regulations”); In re Amiodarone Cases, 2020 Cal. Super. Lexis 70, at *6 (Cal. Super. May 22, 2020) (mere “statistical inference that defendants concealed AERs is inappropriate”); In re Amiodarone Cases, 2019 WL 9048827, at *6 (Cal. Super. Nov. 14, 2019) (dismissing “claims are based on speculation and not factual allegations of unreported adverse events”).  Of course, when the reporting allegations are proven false – the events in question actually having been reported to the FDA – the failure-to-report claim fails.  Lawrence v. Medtronic, 791 F. Appx. 679, 680 (9th Cir. 2020) (affirming dismissal where defendant “did in fact file the reports at issue”).

Plaintiffs must also plead how, under Coleman’s causation standard, “if [defendants] had properly reported the adverse events to the FDA as required under federal law, that information would have reached [the plaintiff’s] doctors in time to prevent his injuries.”  Collette, 2020 WL 3414701, at *2 (quoting Coleman, 167 Cal. Rptr.3d at 312).  In Hawkins v. Medtronic, Inc., the complaint was TwIqballed for precisely this reason:

What is not alleged is any factual content that would support the causal nexus.  The only specific example provided in the complaint of Defendants’ failure to report an adverse event notes that the event was ultimately reported three months after the fact.  No dates are provided that might allow the inference that timely reporting could have affected the [use of the product] during Plaintiff’s surgeries.

2014 WL 346622, at *8 (E.D. Cal. Jan. 30, 2014).  See Ebrahimi, 2018 WL 2448095, at *3 (complaint dismissed where plaintiff “has not shown that [defendant’s] failure to report adverse events to the FDA resulted in her injury”); Martin v. Medtronic, Inc., 2017 WL 4574160, at *7 (E.D. Cal. Oct. 13, 2017) (complaint dismissed where “plaintiff has not alleged facts identifying the nature of any such adverse events or addressing how any such failure to report ultimately caused plaintiff’s injury”); Eidson v. Medtronic, Inc., 981 F. Supp.2d 868, 889 (N.D. Cal. 2013 (plaintiff “does not allege how the one reporting violation which he actually identifies . . . had a causal effect on his injuries”); Knoppel, 2013 WL 12116393, at *5 (plaintiffs “have also not alleged a causal connection . . . i.e., that had Defendant adhered to its requirements to report to the FDA, [the] physicians would have received the information . . . in time to prevent the . . . injuries alleged”); Simmons v. Boston Scientific Corp., 2013 WL 1207421, at *5 (C.D. Cal. March 25, 2013) (“bald[] assert[ion]s that Defendants failed to report adverse events . . ., without more, are insufficient state a claim”).

Failure to plead physician reliance thus defeats causation in California failure-to-report cases.  Causation fails as a matter of law when the plaintiff’s physician “had access to that [supposedly unreported event] on a public database maintained by the FDA” and thus “could have viewed the report independently.”  Weaver v. Ethicon, Inc., 737 F. Appx. 315, 318 (9th Cir. 2018).  In Vieira, the plaintiffs also failed to allege any “facts showing that their treating physicians even relied on information in the adverse event database making decisions.”  Vieira v. Mentor Worldwide, LLC, 392 F. Supp.3d 1117, 1131-32 (C.D. Cal. 2019), reconsideration denied, 2019 WL 5616960 (C.D. Cal. Oct. 29, 2019), aff’d, 845 F. Appx. 503 (9th Cir. Feb. 5, 2021).  Thus, causation can be defeated by testimony that prescribing physicians/implanting surgeons were not in the habit of reviewing publicly available FDA adverse event databases.  See Connelly v. St. Jude Medical, Inc., 2018 WL 732734, at *4 (N.D. Cal. Feb. 6, 2018) (given that plaintiff’s surgeon did not remove the device in response to a recall, no basis to believe that a few more adverse events would have made a difference).

California failure-to-report claims have also been dismissed on causation grounds where the plaintiff claims that his/her own incident was not reported.  For reasons of simple logic, it is impossible for any person’s injury to have been caused by a subsequent failure to report it.  Weaver, 737 F. Appx. at 318.  “An allegation that a defendant failed to report the adverse event giving rise the plaintiff’s injuries to the FDA fails to demonstrate a causation connection between the failure to report and her injuries.”  Weaver, 2017 WL 680725, at *8.  See Lawrence, 791 F. Appx. at 680 (plaintiff “cannot plausibly allege that the purported absence of adverse-event reports regarding her own [device] caused her any injury”); Johnson v. Hologic, Inc., 2015 WL 75240, at *4 (Mag. E.D. Cal. Jan. 6, 2015) (“Any failure to report this particular adverse event to the FDA could not have caused the injuries alleged . . . because it was necessary for plaintiff’s injuries to have occurred before defendant’s duty to report that event could arise.”), adopted, 2015 WL 4745264 (E.D. Cal. March 6, 2015); Malonzo v. Mentor Worldwide, LLC, 2014 WL 2212235, at *3 (N.D. Cal. May 28, 2014) (“Any failure to report [plaintiff’s] injuries or any defects with her [device] could not have caused her injury.”) (emphasis original); Simmons, 2013 WL 1207421, at *5 (“failure to notify the FDA of [plaintiff’s] injury could have no causal relationship to the injury she suffered”).

A similar timing question precludes causation where the only alleged failure to report involves other adverse events that likewise happened after plaintiff’s use of the product, and thus could not possibly be causal.  See Connelly v. St. Jude Medical, Inc., 2017 WL 3619612 (N.D. Cal. Aug. 23, 2017):

[Plaintiff’s] allegations refer exclusively to adverse events that occurred after the [devices] were implanted in him. . . .  None of these allegations suggest that [defendant] failed to report known adverse events before [plaintiff’s devices] were implanted. . . .  As such, the Court finds that [plaintiff] has failed to establish a causal connection between [the] injuries and [defendant’s] failure to warn.

Id. at *4-5.  See Connelly, 2018 WL 732734, at *3 (disregarding “allegations in the FAC refer[ring] to adverse events that occurred after the [devices] were implanted”); Caton, 2015 WL 12426110, at *6 (alleged adverse event “could not have been [reported] until, at the earliest, two months after Plaintiff’s surgery,” and thus “it could not have influenced his decision to surgically implant the [device]. . . .  Plaintiff has not alleged a causal nexus.”); Hawkins v. Medtronic, Inc., 62 F. Supp.3d 1144, 1166 (E.D. Cal. 2014) (“only examin[ing] failures to report prior which plaintiff alleges should have taken place prior to” the use of the device);  Mize v. Mentor Worldwide LLC, 2018 WL 1364257, at *1 (Cal. Super. March 13, 2018) (no reports “subsequent to [plaintiff’s surgery] could have affected the doctor’s duty to inform Plaintiff of potential risks of the surgery”).

A different causally fatal fact pattern arises after adverse events are belatedly reported.  Did the FDA do anything with them?  For this reason, several of the complaints in Jacobs, 393 F. Supp.3d 912, and Vieira, 392 F. Supp.3d 1117, were dismissed for failure to plead causation “because they do not allege facts showing that the FDA would have exercised its discretion to include additional adverse events in its publicly-accessible adverse-event database had [defendant] reported the events.”  Jacobs, 393 F. Supp.3d at 926; Vieira, 392 F. Supp.3d at 1131.  In De La Paz v. Bayer Healthcare LLC, 159 F. Supp.3d 1085 (N.D. Cal. 2016), the FDA’s inaction after the events at issue were (belatedly) reported sunk the plaintiff’s claim:

[T]he FDA became aware of these adverse events more than a year before [plaintiff] underwent the procedure. . . .  The FDA did not require [defendant] to take any action to further warn physicians or patients of the possibility of perforations, beyond the warnings already in place.  Thus, [plaintiff] has failed to plausibly show that her injuries would have been prevented if [defendant] had properly reported the perforation events − a necessary element of her failure-to-warn-the-FDA claim.

Id. at 1097 (citation omitted).  See Caton, 2015 WL 12426110, at *6-7 (because “the risks discussed in the [allegedly unreported events] were already disclosed, Defendants’ failure to notify the FDA . . . did not affect subsequent disclosures . . . and could not have affected Plaintiff’s decision to use the device”).

Similarly in Connelly, another fatal flaw of the complaint was a plaintiff’s reliance on allegedly unreported events that involved risks that this particular plaintiff never suffered.  2018 WL 732734, at *3 (supposedly unreported adverse events “relating to perforation − not abrasion” – the claimed defect in plaintiff’s device).  See Kilmer v. Medtronic USA, Inc., 2021 WL 1405198, at *9 (E.D. Cal. April 13, 2021) (reporting allegation dismissed because plaintiff “never specifically alleges that she suffered injuries because her [device]” caused the same injuries mentioned in FDA warning letter); Caton, 2015 WL 12426110, at *7 (alleged failure to disclose adverse events concerning “design components that do not pertain to the version of the [product] that Plaintiff used” could not possibly be causal).


In Golden v. Brown, 2017 WL 4239015 (Colo. Dist. Sept. 24, 2017), the court found no Colorado “state law duty identical to the federal requirement that a device manufacturer report adverse events to the FDA.”  Id. at *2.  Similarly, in Vieira v. Mentor, 392 F. Supp.3d 1117 (C.D. Cal. 2019), aff’d, 845 F. Appx. 503 (9th Cir. Feb. 5, 2021), the court also held that Colorado would not recognize any FDA-based failure-to-report claim.

Here, Plaintiff . . . resided in Colorado at all relevant times − her alleged injuries all occurred there.  Colorado 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 of Colorado does not recognize such claims.

Id. at 1130.  Likewise, TBI concluded that Colorado law did not support a failure-to-report claim.  2021 WL 1050910, at *29 (relying on Golden).  Similarly, Wheeler v. Frank, 2012 Colo. Dist. Lexis 2832, at *9-10 (Colo. Dist. April 14, 2012), held that failure-to-report allegations could not be “recast . . . as violations of state common law.”


The Second Circuit has certified the question whether Connecticut recognizes such a claim to the Connecticut Supreme Court.  Glover v. Bausch & Lomb Inc., 6 F.4th 229, 244  (2d Cir. 2021) (certifying “[w]hether a cause of action exists under . . .  Connecticut law, based on a manufacturer’s alleged failure to report adverse events to a regulator like the FDA following approval of the device”).  The Connecticut Supreme Court has accepted certfication, so a definitive ruling is pending.

In Ward v. Greene, 839 A.2d 1259 (Conn. 2004), the Connecticut Supreme Court rejected a plaintiff’s attempt to create a tort-based duty “where a mandated reporter fails to report instances of suspected child abuse to designated officials or agencies.”  Id. at 1264.  The court found no merit in the plaintiff’s argument for a failure-to-report duty beyond what the child reporting statute allowed.  Id. at 1267.

[W]e conclude that the [statute] appears to be directed at the child, or children in the case of multiple children placed at risk in a singular incident, who should be the subject of a report of abuse or neglect under the statute and are, accordingly, in need of services.  The policy statement thus suggests that the legislature intended to focus on children who already have been exposed to conduct that amounts to a reportable event, and we do not find merit in the plaintiff’s argument that the statute creates a duty of care to every child who has been in the care of the defendant.

Id. at 1266-67.  Such a claim “depends on the intervening acts of administrative agencies and is, therefore, remote and speculative.”  Id. at 1270.  Therefore, “we cannot say that a mandated reporter owes a legally enforceable duty to children . . . where the benefit would depend entirely on the intervening acts of administrative agencies.”  Id. at 1271.  See also Lundstedt v. Deutsche Bank National Trust Co., 2016 WL 3101999, at *5 (D. Conn. June 2, 2016) (no failure-to-report claim under Bank Secrecy Act).

The same result was reached in Norman v. Bayer Corp., 2016 WL 4007547 (D. Conn. July 26, 2016):

A tort for failure to warn a victim exists under Connecticut law.  But this is a duty to the plaintiff herself, not to some third party, who might then report the danger to the plaintiff.  There is no general or background duty under Connecticut law to report risks to a regulatory body.

Id. at *4 (emphasis original).  Norman recognized the inapplicability of Restatement §388 to this situation and criticized Stengel for attempting to analogize the two:

[I]t does not follow from this principle [Restatement §388, comment n] that defendants had a state-law duty to warn the FDA, a third party with no relationship to plaintiff.  The analogous party to the shop owner in [comment n] is plaintiff’s doctor − who had a direct relationship with plaintiff and provided the device − not the FDA.  Further, because of the FDA’s independence and bureaucratic process, defendants hardly would have had any “reasonable assurance” that the reported information would have reached plaintiff.  Absent the specific reporting requirements of the FDCA, no Connecticut court would have imposed a duty on defendants to report adverse events to the FDA, rather than alter the warning label or communicate with plaintiff and her doctor.

Id.  Accord Pratt v. Bayer Corp., 2020 WL 5749956, at *8 (D. Conn. Sept. 25, 2020) (“there is no general or background duty under Connecticut law to report risks to a regulatory body”) (quoting and following Norman); Doe v. Bausch & Lomb, 443 F. Supp.3d 259, 273 (D. Conn. 2020) (failure-to-report claim was “wholly derivative of the FDCA”; finding no “duty under Connecticut law that required the Defendants to warn or communicate adverse events to the FDA”) (following Norman), certifying question sub nom. Glover v. Bausch & Lomb Inc., 6 F.4th 229 (2d Cir. 2021); D’Addario v. Johnson & Johnson, 2020 WL 3546750, at *5 (D.N.J. June 30, 2020) (finding “no separate state law duty to warn the FDA”) (citation omitted) (applying Connecticut law); Simoneau v. Stryker Corp., 2014 WL 1289426, at *10 (D. Conn. March 31, 2014) (plaintiff “identifies no separate state law duty to warn the FDA”).  See also TBI, 2021 WL 1050910, at *29 (following Norman).

The claim in Norman also failed the causation element.  “the FDA was aware of these reporting issues years before plaintiff’s device was implanted,” but “did not change any of the warnings’ substance” about which the defendant was “already required to advise physicians about.”  Id.


We disagree with TBI about Delaware.  It lists Delaware as a state recognizing failure-to-report claims, 2021 WL 1050910, at *27, relying on a footnote in Freed v. St. Jude Medical, Inc., 364 F. Supp.3d 343, 358 n.13 (D. Del. 2019).  Freed, however, made an expansive prediction of Delaware law, based not on Delaware law, but on the inapplicable Restatement §388 and the discredited Stengel decision.  Id. at 360.  In any event, Freed is arguably dictum, since the claim was dismissed in any event for failure plead causation:

The [complaint] does not allege that had [defendant] reported certain adverse events to the FDA, this information would have reached [plaintiff’s] physicians (and ultimately her) and would have impacted [plaintiff’s] decision to have the . . . device implanted in her body.  Relatedly, the [complaint] does not explain how the reporting of such adverse events to the FDA would have prompted the FDA to take an action that would have made the information available to [plaintiff] and her physician.  Courts recognize that a plaintiff making this type of failure to warn claim must allege that the plaintiff would not have utilized the medical device at issue had the manufacturer disclosed the allegedly withheld information.  Thus, the claim is insufficiently pleaded.

364 F. Supp.3d at 361 (citation and footnote omitted).

Freed is contrary to all other Delaware precedent, and this holding has never been cited by any other Delaware court.  Also in Delaware, a doctor cannot be liable to an automobile accident victim for failing to report an epileptic driver of the other vehicle to the state.  Harden v. Allstate Insurance Co., 883 F. Supp. 963, 971-72 (D. Del. 1995).  Delaware law, Harden concluded, has “not only held that [mandatory reporting] statutes such as the one at bar could not be used as a basis for per se liability, but that such statutes could not be used as a standard of care whatsoever.”  Id. at 971-72 (D. Del. 1995).  Delaware “law is clear that it is inappropriate to utilize a [mandatory reporting] statute such as the one at issue in this litigation, either for establishing negligence per se, or for any indication of negligence.”  Id. at 972.  The same is true of common-law claims of failure to report child abuse to governmental authorities.  Doe 30’s Mother v. Bradley, 58 A.3d 429, 452 (Del. Super. 2012) (“the statutory obligation to report [suspected child abuse] does not equate to a common law duty to act”; applying Restatement Third §38); Doe v. Bradley, 2011 WL 290829, at *10 (Del. Super. Jan. 21, 2011) (medical society not be liable for alleged failure to comply with child abuse reporting statute).  That’s three general Delaware law cases.

Further, Bennett v. Teva Pharmaceuticals USA, Inc., 2021 WL 797834 (D. Del. March 2, 2021), the court rejected, in a generic drug case, the same §388-based rationale that Freed had followed:

Section 388 also says nothing about an obligation to report adverse events to the FDA.  Such an obligation, to the extent it exists, would arise from the FDA’s own regulations.  (Neither party cites a statute or regulation that imposes an obligation to report adverse events, but both parties state that federal law imposes such an obligation on drug manufacturers.)

Id. at *4 (finding Buckman implied preemption).  Likewise in Scanlon v. Medtronic Sofamor Danek USA Inc., 61 F. Supp.3d 403 (D. Del. 2014), the court held that a purportedly Delaware law claim alleging failure to report adverse events concerning a Class III medical device “would not exist apart from the FDCA”:

While such conduct . . . might violate the FDCA, such conduct would not exist apart from the FDCA. The same analysis applies to plaintiff’s allegations that [defendant] did not report adverse events.15

15Moreover, plaintiff does not and cannot show that reporting adverse events would necessarily have resulted in a change in the labeling or warnings of the . . . device.

Id. at 412 & n.15.

Viewing the totality of Delaware law, we conclude that the precedent against failure-to-report claims in Delaware, both generally and specifically concerning the FDCA, substantially outweighs the alternative holding in Freed that violated Erie conservatism and permitted such a claim.


In the District of Columbia, it is an “undisputed fact that there is no D.C. common law claim that imposes liability for a manufacturer’s failure to report to the FDA adverse incidents concerning an approved medical device.”  Kubicki v. Medtronic, Inc., 293 F. Supp.3d 129, 183 (D.D.C. 2018).  Common-law inadequate warning claims are “not, in fact, the functional equivalent of a manufacturer’s failure to report adverse incidents to the FDA in violation of federal law.”  Id. at 184.  Further, such claims suffer from inherent and fatal causation problems:

[A failure-to-report claim] ultimately relies on sheer speculation:  Plaintiffs contend that, if [defendant] had complied with the federal requirement to report adverse events to the FDA, and if the FDA had directed [defendant] to update the label of the [product] based on these reported events, then [defendant] would have had the duty to provide adequate warnings to consumers, as D.C. common law requires.

Id.  But whether the FDA would have acted in this fashion “is by no means certain.”  Id.  Given that any action by the FDA is discretionary, a reporting-based claim cannot be equivalent to an absolute state-law duty to change a product warning.

[U]nless such label changes would necessarily have occurred as a result of [defendant’s] failure to notify the FDA, Plaintiffs’ contention that [defendant’s] failure to notify the agency is the functional equivalent of failing to warn consumers in violation of state law cannot be sustained.

Id.  Thus, an FDCA-based failure-to-report claim “does not actually equate with the D.C. common law failure to warn claims that [plaintiffs] allege.”  Id. at 185.  See Webster v. Pacesetter, Inc., 259 F. Supp.2d 27, 36 (D.D.C. 2003) (“plaintiffs cannot bootstrap their arguments regarding defendant’s alleged failure to report and to investigate adverse incidents to the FDA into a defective warning case”).  On the basis of Kubicki, TBS held that the District does not recognize common-law claims for alleged failure to report adverse events to the FDA.  2021 WL 1050910, at *29.


Florida is another state that does not recognize FDCA-based failure to report as a state-law cause of action.  An FDCA-based failure-to-report claim is not a “traditional state tort law cause[] of action” and such a “theory of liability is not one that state tort law has traditionally occupied.”  Mink v. Smith & Nephew, Inc., 860 F.3d 1319, 1330 (11th Cir. 2017) (applying Florida law).  A failure-to-report claim “seeks to enforce a duty owed to a federal agency and [that] cause of action would not exist in the absence of that duty.”  Tsavaris v. Pfizer, Inc., 717 F. Appx. 874, 877 (11th Cir. 2017) (applying Florida law).  “Florida law lacks a parallel duty to file adverse reports with the FDA.”  Marmol v. St. Jude Medical Center, 132 F. Supp.3d 1359, 1370 (M.D. Fla. 2015):

Florida does not provide a duty to file such reports with the FDA. . . .  Plaintiff has not provided the Court with any Florida law which recognizes a duty to warn an agency such as the FDA.  Thus, the holdings in Stengel and Hughes are inapplicable to the present case.

Id. at 1369-70.  The absence of any private FDCA right of action is well-established, and Florida “[p]laintiffs cannot make an end run around this rule by recasting violations of the FDCA as violations of state common law.”  McClelland v. Medtronic, Inc., 944 F. Supp.2d 1193, 1200 (M.D. Fla. 2013).

Plaintiff’s attempt to recast a claim for violation of the FDCA as a state-law negligence claim is impliedly barred by §337(a). . . .  Accordingly, Plaintiff may not assert a claim based on Defendant’s alleged breach of a duty to file timely reports with the FDA.

Id. at 1200-01 (citations omitted).  See Brown v. DePuy Orthopaedics, Inc., 978 F. Supp.2d 1266, 1275 (M.D. Fla. 2013) (FDA reporting claims dismissed; “Florida law does not provide such a remedy”).

Numerous more recent – post Stengel’s repudiation – Florida decisions agree.  In Romer v. Corin Group, PLC, 2018 WL 4281470 (M.D. Fla. Sept. 7, 2018), the court held:

Plaintiffs claim that defendants failed to report adverse events to the FDA in contravention of the FDA’s Manufacturing Reporting Requirements.  Under Florida law, the duty to warn requires a manufacturer to adequately warn consumers of a particular risk that was known or knowable in light of the generally recognized and prevailing best scientific and medical knowledge available at the time of manufacture and distribution.  Although the MDA requires manufacturers to report adverse events associated with a medical device to the FDA, plaintiffs have not identified a duty under Florida law that requires manufacturers to warn an agency such as the FDA of potential dangers associated with a medical device.

Id. at *7 (footnote, citations and quotation marks omitted).  Rowe v. Mentor Worldwide LLC, 297 F. Supp.3d 1288 (M.D. Fla. 2018), reached a similar result.

[Plaintiff] alleges that [defendant] should have reported adverse events, presumably to the FDA as required by federal regulations.  As the Eleventh Circuit explained in Mink, a failure to report claim like this is . . . is alleging [that defendant] “failed to tell the FDA those things required by federal law.  So [plaintiff] cannot pursue negligence based on this theory of liability.

Id. at 1296 (other citations omitted).  See Tinkler v. Mentor Worldwide, LLC, 2019 WL 7291239, at *5 (S.D. Fla. Dec. 30, 2019) (FDCA-based failure-to-report claim “cannot support a state-law failure-to-warn claim”; following Mink and McClelland); Bernasek v. Gatz, 2021 WL 2152968, at *4 (Fla. Cir. May 20, 2021) (failure-to-report claims “implicate[] violations of [defendant’s] obligations to the FDA, enforceable only by the FDA”).  Cf. Jacob v. Mentor Worldwide, LLC, 389 F. Supp.3d 1024, 1028-29 (M.D. Fla. 2019) (vague failure-to-report allegations TwIqballed).  Not surprisingly, TBI held that Florida did not permit FDCA-based duty to report claims.  2021 WL 1050910, at *29.

These court’s view of “traditional” Florida law is correct.  Florida courts have consistently rejected private failure-to-report claims in the non-FDCA context, where other mandatory statutory reporting duties were allegedly violated.  These include:

  • Failure to report known or suspected child abuse. Estate of Rotell v. Kuehnle, 38 So. 3d 783, 786 n.3 (Fla. App. 2010) (child abuse reporting statute “does not give rise to a civil cause of action”); Welker v. Southern Baptist Hospital, Inc., 864 So. 2d 1178, 1182 (Fla. App. 2004) (refusing to recognize private negligence action for violation of statute that “says nothing about the availability of a cause of action for damages”), quashed on other grounds, 908 So. 2d 317 (Fla. 2005); Mora v. South Broward Hospital Dist., 710 So. 2d 633, 634 (Fla. App. 1998) (“Florida courts have consistently refused to impose civil liability for the failure to report suspected child abuse”); Freehauf v. School Board of Seminole County, 623 So. 2d 761, 764 (Fla. App. 1993) (failure-to-report claim “would create a large and new field of tort liability beyond what existed at common law without clear legislative direction”), dismissed, 629 So. 2d 132 (Fla. 1993); J.B. by & Through Spivak v. Dep’t of Health & Rehabilitative Services, 591 So. 2d 317, 318 (Fla. App. 1991) (“A civil cause of action is not afforded for the failure to report child abuse.”); Fischer v. Metcalf, 543 So. 2d 785, 790 (Fla. App. 1989) (“the legislature intends that such protection be provided through increased supervision and regulation . . . rather than through implication of a private remedy”) (en banc).
  • Failure to report known or suspected elder abuse. Mora v. South Broward Hospital Dist., 710 So. 2d 633, 634 (Fla. App. 1998) (“a violation of the reporting requirement . . . does not result in a civil cause of action”; no legislative intent); Martin v. Wood, 648 F. Appx. 911, 918 (11th Cir. 2016) (no “civil remedy” for failure to make statutorily required elder abuse report) (applying Florida law).
  • Failure to report suspicious transactions mandated by the Bank Secrecy Act. Wiand v. Wells Fargo Bank, N.A., 86 F. Supp.3d 1316, 1322 (M.D.  2015) (no Florida authority for plaintiff’s “contention that the federal banking laws and regulations give rise to a duty of care to monitor customer accounts and investigate suspicious account activity”; duties owed to government “not a bank’s customers”); Pupke v. McCabe, Inc., 2014 U.S. Dist. Lexis 192298, at *17 (S.D. Fla. Jan. 29, 2014) (“Plaintiffs’ allegation that [defendant] owes a duty to Plaintiffs to comply with those statutory and regulatory [reporting] duties is incorrect as a matter of law.”); Nesbeth v. Mastercard Worldwide, 2010 WL 11601168, at *10 (S.D. Fla. July 19, 2010) (statute “includes no language expressly authorizing or even suggesting a private right of action”).


Like Florida, the TBI decision correctly put Georgia in the list of states not recognizing FDCA-based failure-to-report claims.  2021 WL 1050910, at *30.  “[A] negligence claim based on a manufacturer’s failure to investigate adverse events and report them to the FDA” is not a “traditional state-law tort claim[]” because it “seek[s] to enforce a duty owed to the FDA.”  Frey v. Bayer Corp., 499 F. Supp.3d 1283, 1288 (M.D. Ga. Oct. 9, 2020).  Cases under Georgia law mostly follow the Eleventh Circuit’s holding in Mink (see Florida) that failure-to-report claims arise solely from the FDCA, and are therefore preempted.  Sharp v. St. Jude Medical, S.C., Inc., 396 F. Supp.3d 1250, 1260 (N.D. Ga. 2019) (“Plaintiff’s theory of liability is based on a duty to file a report with the FDA,” which fails under Mink, and “the fact that the device at issue was subject to a recall does not change the Court’s conclusion”), rev’d on other grounds, 838 F. Appx. 462 (11th Cir. 2020) (plaintiff pleaded a manufacturing defect) (applying Georgia law); Williams v. St. Jude Medical, S.C., Inc., 2017 WL 11113322, at *9 (N.D. Ga. Oct. 19, 2017) (rejecting claim that defendant “failed to report to the FDA information required by federal law”).  The only Georgia state court to have considered failure-to-report claims reached the same conclusion:  “[T]here is no duty under Georgia law to report adverse events to the FDA.”  Latimer v. Medtronic, Inc., 2015 WL 5222644, at *9 (Ga. Super. Sept. 4, 2015) (citation omitted).  Rather, a “claim that [the defendant] was negligent for not timely filing adverse event reports . . . [i]s simply an attempt by private parties to enforce the MDA.”  Id. (citation and quotation marks omitted).

These case are congruent with general Georgia law.  Georgia has never recognized common-law negligent failure-to-report claims in any context.  Absent a statutorily created private right of action, a defendant “ha[s] no common law duty to report child abuse.”  Fulton-DeKalb Hospital Authority v. Reliance Trust Co., 608 S.E.2d 272, 273 (Ga. App. 2004).  Otherwise, “failure to comply with the [reporting] statute d[oes] not result in any civil liability.”  Id. at 724.

[T]here may well be a moral duty to report child abuse, if it is reasonably suspected.  The legal duty to report, however, is imposed in Georgia by statute, and . . . this statute does not give rise to a private cause of action for damages.

McGarrah v. Posig, 635 S.E.2d 219, 222 (Ga. App. 2006) (emphasis original).  See Cechman v. Travis, 414 S.E.2d 282, 284 (Ga. App. 1991) (affirming summary judgment on child abuse failure-to-report claim after concluding the reporting statute did not create a private right of action); Vance v. T.R.C., 494 S.E.2d 714, 716 (Ga. App. 1997) (“nothing within the provision of the law purports to create, or indicates an intention to create, a private cause of action in tort in favor of a child whose abuse is not detected or reported”); Govea v. City of Norcross, 608 S.E.2d 677, 683 (Ga. App. 2004) (negligence per se cannot create a failure-to-report claim since “[t]he legal duty to report” incidents involving police officers is solely statutory and the “statute does not give rise to a private cause of action for damages”).

While TBI cited Cline v. Advanced Neuromodulation Systems, Inc., 17 F. Supp.3d 1275, 1287 (N.D. Ga. 2014), for its conclusion that failure to report was not recognized in Georgia, 2021 WL 1050910, at *30, we read Cline as more of a causation decision.  Cline discussed the causation problems inherent in failure-to-report claims at some length:

[Failure to report] allegations are insufficient to plausibly allege causation for a number of reasons.  First, the FDA’s disclosure of MDRs to the public is not guaranteed.  Thus, there is no guarantee that the FDA would have disclosed MDRs that were timely filed by Defendant.  Second, Plaintiff does not clearly allege that Defendant outright failed to file [reports]; only that they were not timely filed.  Defendant may have subsequently reported each incident to the FDA . . . outside with enough time for the FDA to publicly disclose this information and inform Plaintiff.  Third, . . . Plaintiff has not alleged that the FDA’s disclosure of Defendant’s timely filed MDRs would necessarily provide Plaintiff with specific, actionable information. . . .  The Court can only speculate whether, following Defendant’s . . ., the FDA would or would not ultimately disclose information from these MDRs that could be plausibly linked to [the claimed problem with the product].

17 F. Supp.3d at 1286 (citations and footnote omitted).  Further, the alleged failure to report was trivial, since the general risk was something “the FDA knew when it approved” the device.  Id. at 1287.  “[I]it is implausible that either the FDA’s or Plaintiff’s medical providers’ opinion of the [product] would be affected by the failure of one device.”  Id.

Other Georgia cases have also rejected plaintiffs’ pleading of causation allegations involving alleged failure to report.

[T]he FDA’s disclosure of reports to the public is not mandatory.  Plaintiff does not explain if or how the FDA would disclose the [defendants’] reportable information to the decedent or his physician. . . .  Plaintiff has made no allegations that the decedent ever consulted FDA disclosures in making his decision about implantation.

Williams, 2017 WL 11113322, at *9 (citations omitted).  See Henderson v. Sun Pharmaceuticals Industries, Ltd., 809 F. Supp.2d 1373, 1380 (N.D. Ga. 2011) (“[c]omplaint fails to identify any causal connection between any specific act or omission, including Defendants’ failure to properly report, and . . . any injury suffered by Plaintiff”); Latimer, 2015 WL 5222644, at *9 n.5 (“Plaintiff’s claim necessarily fails because the complaint does not allege a causal connection between any purported failure to report adverse events and Plaintiff’s alleged injury”).


Prior to Stengel, a Hawai’i court rejected any common-law basis for a cause of action predicated on failure to report child abuse to the government:

Having undertaken an analysis of the factors the [Supreme Court of Hawai’i] considered relevant . . ., the Court concludes that based upon the legislative purpose and history of [the child abuse reporting statute], the level of detail provided for by [it], and authority from other jurisdictions, the Hawai’i legislature did not intend to create a duty that would subject a private party . . . to tort liability based upon a failure to report.

Williams v. United States, 711 F. Supp.2d 1195, 1206-07 (D. Haw. 2010).

However, during the Stengel rein of error in the Ninth Circuit, a federal district court in Hawai’i allowed a plaintiff to proceed with a failure-to-report claim.

Defendants argue that their duty to report adverse events to the FDA is wholly separate from Defendants’ duty to warn physicians under Hawaii law.  So, the argument goes, this allegation is based solely on a violation of federal law, not a traditional state tort law. . . .  Based on Stengel [citation omitted], the court rejects this argument.

Beavers-Gabriel v. Medtronic, Inc., 2015 WL 14394440, at *11 (D. Haw. Jan. 9, 2015).  As far as we can tell, no Hawai’i court has ever addressed this issue, and certainly none since the relevant state supreme court told the Ninth Circuit that its prediction was incorrect (see Arizona).

So, while TBI relied on Beavers-Gabriel to conclude that failure-to-report claims are allowed in Hawai’i, 2021 WL 1050910, at *27, we disagree.  Given Erie conservatism, the utter absence of any on-point state appellate court authority, the subsequent repudiation of Stengel, and the reported status of Williams versus the unreported Beavers-Gabriel decision, we think the right call is that Hawai’i cannot reliably be said to have adopted failure to report to a government agency as a state-law cause of action.


In some respects, Idaho is a lot like Hawai’i when FDCA-based failure to report claims are considered.  The only support for such a claim existing under Idaho law (like Hawai’i) is an unreported, Stengel-era federal district court case.  Richardson v. Bayer Healthcare Pharmaceuticals, Inc., 2016 WL 4546369, at *8 (D. Idaho Aug. 30, 2016) (finding “an independent, but ‘parallel’ remedy for the failure of a manufacturer of a MDA device to properly report known dangers of its product to the FDA” under Idaho law; citing Stengel repeatedly).

Given Erie conservatism, we don’t think that Richardson should be sufficient to support a prediction, given the total any appellate Idaho authority allowing any kind of claim for failure to report to a government agency.  We also think that the judicial climate in Idaho is closer to Arizona than to California.  Still, given that Richardson is only Idaho case out there, we can see where TBI was coming from, 2021 WL 1050910, at *28, even though we disagree.


TBI put Illinois in the list of states allowing FDCA-based failure-to-report claim, citing two federal district court cases:  2021 WL 1050910, at *28 (citing Gravitt v. Mentor Worldwide, LLC, 2018 WL 2933609, at *10 (N.D. Ill. June 12, 2018), and Laverty v. Smith & Nephew, Inc., 197 F. Supp.3d 1026, 1035 (N.D. Ill. 2016)).  We disagree because abundant Illinois appellate authority holds to the contrary.

Directly on point, Norabuena v. Medtronic, Inc., 86 N.E.3d 1198 (Ill. App. 2017), held (directly contrary to Gavitt) that a state-law duty to warn a physician “is not synonymous with an affirmative duty to warn a federal regulatory body.”  Id. at 1207.  Illinois law does not recognize a duty to report adverse events to the FDA.  “[A]lthough plaintiffs have identified a federal requirement that their complaint alleges [defendant] violated, there is no [state] requirement that parallels it.”  Id. at 1206.

The learned intermediary doctrine states that a manufacturer has a duty to warn prescribing physicians of a drug’s known dangerous propensities under the understanding that those physicians will use their expert knowledge in adequately warning the patient.  We cannot find that this duty is parallel to the federal requirement.

Id. at 1207 (citation omitted).  TBI does not even mention Norabuena (nor do the cases it cites), and its failure to do so flies in the face of the Erie rule of conservative prediction that TBI professes to follow.  2021 WL 1050910, at *18 (“where two competing yet sensible interpretations’ of state law exist, a federal court “should opt for the interpretation that restricts liability, rather than expands it” quoting Travelers Indemnity Co. v. Dammann & Co., 594 F.3d 238, 253 (3d Cir. 2010)).

Moreover, Norabuena is fully supported by general Illinois law, which has consistently rejected failure to warn tort claims based on failure to make reports to government agencies.  In a child abuse case, the Illinois Supreme Court held:

[W]ith regard to the appellate court’s holding that defendants had a duty to report [the] conduct to authorities, the common law does not recognize an affirmative duty to act for the protection of another in the absence of a special relationship between the parties.

Jane Doe-3 v. McLean County Unit Dist. No. 5 Board of Directors, 973 N.E.2d 880, 889 (Ill. 2012).  Further, the Illinois Supreme Court has rejected the FDCA as a source of state tort obligations because to do so would have been contrary to Congressional intent.  Martin v. Ortho Pharmaceutical Corp., 661 N.E.2d 352 (Ill. 1996).

Federal legislative intent . . . forecloses plaintiff’s cause of action.  Federal courts have uniformly refused to imply a private cause of action under the Food, Drug and Cosmetic Act (FDCA). . . .  [P]laintiffs cannot provide any independent basis for their cause of action.

Id. at 355-56 (citations omitted).

Numerous state and federal appellate courts applying Illinois law have likewise rejected purported common-law claims based on failure to make mandatory reports to a government agency.  Doe-2 v. McLean County Unit Dist. No. 5 Board of Directors, 593 F.3d 507, 514 (7th Cir. 2010), likewise found no common-law duty to report child abuse to government agencies under Illinois law:

But [defendant’s] mandate to report child abuse does not create any duty to the abused child enforceable under Illinois tort law. . . .  [Failure to report] does not give rise to a private tort action unless the violation also breaches a common law duty of care owed to the plaintiff. . . .  [Plaintiff] cannot rely on the defendant’s] alleged violation of [statutory] reporting requirements to support her private tort claims; she must identify a common law duty owed to her by the defendants.

Id. at 514 (citations omitted).  After examining all of plaintiff’s common-law arguments, the Seventh Circuit rejected them.  “[Plaintiff] does not cite, and we are not aware of, any Illinois case imposing a duty to protect under these circumstances.”  Id. at 515.  See also:

  • Doe 1 v. North Central Behavioral Health System, Inc., 816 N.E.2d 4, 7-8 (Ill. App. 2004) (no private claim for failure to make mandatory reports where no evidence supported the statute establishing the duty being “designed to . . . impose civil liability on those who fail to report”).
  • Varela v. St. Elizabeth’s Hospital of Chicago, Inc., 867 N.E.2d 1, 11 (Ill. App. 2006) (“there is no duty under the Illinois common law of torts or the Reporting Act to rescue others from being injured by third parties”; “a plaintiff proceeding under the common law must first establish that the defendant owed a common law duty of care to the person he injured before a court will look to a statute to define the specific level of care that was owed”).
  • Sheetz v. Norwood, 608 F. Appx. 401, 406 (7th Cir. 2015) (dismissing “meritless” child abuse failure-to-report claim because the statute “does not create a private right of action).
  • E.L.T., Inc. v. Wachovia Corp., 403 F.3d 474, 476 (7th Cir. 2005) (“even though Illinois requires people to report apparent child abuse to child-welfare officials, failure to do this does not support a claim by persons who might have been alerted by such reports”; “no one is entitled to the benefit of regulatory intervention”).
  • Cuyler v. United States, 362 F.3d 949, 952-53 (7th Cir. 2004) (neither a reporting statute nor “Illinois common law . . . impose on [defendant] a tort duty” to report abuse; mandated reporters who don’t report held analogous to bystanders who don’t intervene to prevent third-party injuries) (Posner, J.).

Accord Necheles v. Board of Education of Dwight Twp. High School Dist. #230, 2020 WL 1905967, at *4 (C.D. Ill. April 17, 2020) (dismissing negligence claim for failure to report sexual abuse for lack of duty); Doe v. White, 627 F. Supp.2d 905, 920 (C.D. Ill. 2009) (“there is no underlying common law duty to report”).

Neither Gavitt nor Laverty cited to any Illinois case allowing any sort of common-law failure-to-report claim.  Neither did Comella v. Smith & Nephew, Inc., 2013 WL 6504427, at *4 (N.D. Ill. Dec. 11, 2013), which is likewise devoid of any discussion of state law).  In essence, Those case made up law that did not previously exist, in direct violation of Erie conservatism.  The only other decision from an Illinois court granted summary judgment against an FDCA-based failure-to-report claim in the generic drug context.  In re Testosterone Replacement Therapy Products Liability Litigation Coordinated Pretrial Proceedings, 2018 WL 2416239, at *6 (N.D. Ill. May 29, 2018) (“plaintiffs have not identified genuine disputes of material fact on each element of their failure to report claim”; establishing neither duty, breach, nor causation).


Indiana is another of those states where federal courts have tried to run amok, purporting to recognize state-law failure-to-report claims in the absence of any Indiana law supporting such a claim.  Like Illinois, Indiana state appellate cases say “no” – repeatedly – to failure-to-report claims, both FDCA and generally.  Yet TBI erroneously chose to follow an older federal district court decision, unmoored from Indiana law, that instead relied on now-discredited court of appeals predictions (see Arizona; Mississippi).  2021 WL 1050910, at *28.

Directly on point is Bayer Corp. v. Leach, 153 N.E.3d 1168 (Ind. App. 2020), which held that FDCA-based failure-to-report claims are inconsistent with Indiana’s product liability statute, Ind. Code §34-20-4-2, which limits failure to warn claims to attacks on product labeling itself:

[T]o prevail for a defect due to a failure to warn under the IPLA, a litigant must show that warnings on the labeling or packaging were inadequate.  Here, [plaintiffs] claim that the approved labeling and packaging was rendered inadequate due to [defendant’s] omissions − i.e., the failure to comply with federal reporting requirements.  Yet, even assuming that [defendant] failed to comply with federal reporting requirements, other federal law nevertheless required that Bayer use the approved labeling and packaging.

Id. at 1186-87 (citations omitted).  While “there is a federal duty to report, . . . we discern no viable claim for a failure to warn under the IPLA.”  Id. at 1187.

Likewise, Indiana has refused to impose liability for failure to make mandatory reports under that state’s child abuse statute, as well as under the federal Bank Secrecy Act, precisely because is no underlying common-law reporting-based cause of action.  “Because there can be no private right of action for a violation of the [Bank Secrecy Act] and its . . . reporting requirements, [defendants’] failure, if any, to file such reports would not support the [plaintiffs’] cause of action.”  EngineAir, Inc. v. Centra Credit Union, 107 N.E.3d 1061, 1073 (Ind. App. 2018).

Ditto for failure to make child abuse reports.  “[T]here is no private right of action stemming from a failure to report.”  Weikart v. Whitko Community School Corp., 134 N.E.3d 484, 485 (Ind. App. 2019).  “[S]uch an action is not authorized at common law and its maintenance would raise substantial questions of causation.”  Borne v. Northwest Allen County School Corp., 532 N.E.2d 1196, 1203 (Ind. App. 1989). “Like the majority of states, Indiana does not recognize a private right of action for failure to report.”  Sprunger v. Egli, 44 N.E.3d 690, 693 (Ind. App. 2015).  This is true “whether plaintiffs predicate their claim upon a negligence theory or a freestanding private right of action.”  Id. (citation and quotation marks omitted).  Sprunger followed C.T. v. Gammon, 928 N.E.2d 847 (Ind. App. 2010), which held that, as with the FDCA, “the legislature did not intend to confer a private right of action for any breach of the duty to report imposed by the reporting statutes.”  Id. at 853.  C,T. also found “no discernible claim” that “Indiana recognizes a common law duty to report child abuse or neglect.”  Id. at 844 n.5.  See also A.W. v. Roberts, 627 N.E.2d 802, 813 (Ind. App. 1994) (“absent codification,” refusing to “extend[] a civil remedy to a victim of abuse or neglect against all persons who know of child abuse and fail to report child abuse”; following Borne).

The decision TBI did cite, McAfee v. Medtronic, Inc., 2017 WL 4247983 (N.D. Ind. Sept. 25, 2017), reconsidered, 2016 WL 2588807 (N.D. Ind. May 5, 2016), does not even stand for the cited proposition.  McAfee did not actually decide whether the Indiana product liability statute allowed failure-to-report claims, because “[n]either party” addressed it.  Id.  All it did was “give[ plaintiff] the benefit of imagination” – hardly a ringing or reasoned endorsement.  Id. (citation and quotation marks omitted).  Further, on reconsideration, the reporting based claim was dismissed for failure to allege causation:

[Plaintiff] still hasn’t suggested how any delay in filing a report (or reports) with the FDA caused or contributed to his injuries, i.e., that had [defendant] filed the report . . . before his surgery, his physician would have received notice of that filing, and would have considered and used a different [product].  [Plaintiff] simply alleges that the failure to file adverse reports with the FDA “proximately caused [his] injuries and damages.”  Conclusory allegations are insufficient.

McAfee v. Medtronic, Inc., 2016 WL 2588807, at *2 (N.D. Ind. May 5, 2016) (citations omitted).  Cf. Fisk v. Medtronic, Inc., 2017 WL 4247983, at *6 (N.D. Ind. Sept. 25, 2017) (blindly following Stengel where the defendant did “not develop . . . at all” the argument that “state law does not impose a duty to convey this information to a third party like the FDA”).  Even without all the contrary Indiana appellate precedent, McAfee (with or without Fisk) is simply not the kind of persuasive precedent that supports recognition of an entirely new failure-to-report cause of action.


TBI found no Iowa “legal authority” on point and “opt[ed] for the interpretation that restricts liability, rather than expands it,” holding that Iowa would not allow FDCA-based failure-to-report claims.  2021 WL 1050910, at *31.  We essentially agree.  There has yet to be any FDA-related Iowa decision.  Nor are there any relevant child-abuse-related failure-to-report claims out of Iowa, because that state’s statute includes an express private right of action.  Iowa Code §232.75(2).  There is one case, however, of an Iowa court rejecting a failure-to-report claim in the context of the federal Bank Secrecy Act.  Armstrong v. American Pallet Leasing, Inc., 678 F. Supp.2d 827 (N.D. Iowa 2009).  Armstrong noted that the act’s “reporting requirements” had not been found “by an Iowa court, or any other court,” to give rise to  recognizing “such a duty” and thus followed out-of-state cases that “uniformly rejected such an argument.”  Id. at 875. Because the federal statute “does not permit a private right of action, it follows that it cannot be construed as giving rise to a duty of care flowing to plaintiffs.”  Id.


Brooks v. Mentor Worldwide, LLC, 2019 WL 4628264 (D. Kan. Sept. 23, 2019), concluded that no FDCA-based failure-to-report claim existed under Kansas (and Missouri, see below) law.

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.  Brooks also addressed the inherent causation problems in failure-to-report claims.  They are entirely “speculative” because they “assume[]” that FDA would have publicized unreported adverse events − but “it [FDA] is not required to do” that.  Id.  The Tenth Circuit affirmed on essentially the same ground:

Plaintiffs alleged that Defendant violated its duty to warn the FDA.  They claim that Defendant did not properly conduct post-approval, FDA-mandated testing and 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.

Brooks v. Mentor Worldwide, LLC, 985 F.3d 1272, 1280-81 (10th Cir. 2021).  See Pontious v. Medtronic, Inc., 2011 WL 6091749, at *2 (D. Kan. Dec. 7, 2011) (failure-to-report claim “cannot give rise to a state law cause of action”).  Based on Brooks, TBI correctly concluded Kansas does not recognize FDCA-based failure to report.  2021 WL 1050910, at *30.

Likewise, Kansas has not recognized torts for other types of reporting-based claims.  In Kansas State Bank & Trust Co. v. Specialized Transportation Services, Inc., 819 P.2d 587 (Kan. 1991), the Kansas Supreme Court rejected a negligence per se-based claim for failure to report child abuse.  “[V]iolation of a statute alone does not establish negligence per se.  The plaintiff must also establish that an individual right of action for injury arising out of the violation was intended by the legislature.”  Id. at 603.  Accord Adams v. Board of Sedgwick County Commissioners, 214 P.3d 1173, 1188-90 (2009) (reaffirming Kansas State Bank; finding no statutory or common-law duty to report child abuse); Portenier v. United States, 520 F. Appx. 707, 717 (10th Cir. 2013) (‘[plaintiff’s] claim relies on a duty that Kansas law does not (and would not) recognize − viz., a duty for healthcare professionals to report child abuse”).


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.  In McKenzie v. Abbott Laboratories, 2021 WL 4392079, at *6 n.68 (M.D. La. Sept. 24, 2021), the court questioned whether Gavin was decided under Louisiana law, given the learned intermediary rule, but did not decide the issue because the claim failed to plead causation.

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., 517 F. Supp.3d 76 (D. Mass. 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 92.  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 91.  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., 511 F. Supp.3d 26 (D. Mass. 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 39 (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., 844 F. Appx. 444, 447 (2d Cir. 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).


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); Cline v. Medtronic, Inc., 2021 WL 3860194, at *8 (S.D. Ohio Aug. 30, 2021) (quoting and following Reynolds); 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.

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).  See Essure Product Cases, 2019 WL 5873725, at *7 (Cal. Super. Oct. 2, 2019) (concluding on the basis of Alton that Oregon would allow an FDCA-based failure-to-report-claim).

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 were 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); Essure Product Cases, 2019 WL 5873725, at *5 (Cal. Super. Oct. 2, 2019) (rejecting McLaughlin approach; failure to report (called “negligent risk management” was merely “negligence in the air” unless it resulted in a failure to warn) (applying Pennsylvania law).

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 Worldwide LLC, 393 F. Supp.3d 912 (C.D. Cal. 2019), reconsideration denied, 2019 WL 5616958 (C.D. Cal. Oct. 29, 2019), aff’d sub. nom. Nunn v. Mentor Worldwide LLC, 847 F. Appx. 343 (9th Cir. 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).  Further, it is unlikely that Washington follows the sort of “sophisticated user” doctrine (Restatement (Second) of Torts §388, comment n (1965)) that come courts have invoked in allowing failure-to-report claims.  See In re 3M Combat Arms Earplug Products Liability Litigation, 2021 WL 2476651, at *2 (N.D. Fla. June 17, 2021) (applying Washington law).

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.

Those of you following the fortunes of COVID-19-related litigation should check out these two recently decided cases:  Garcia v. Welltower OpCo Group LLC, 2021 WL 492581 (C.D. Cal. Feb. 10, 2021), and Fields v. Brown, 2021 WL 510620 (E.D. Tex. Feb. 11, 2021).

Garcia, the older of the two (by one day), addressed the ability of the PREP Act, 42 U.S.C. §§247d-6d, et seq., to create federal question jurisdiction in nursing home litigation over the alleged rationing of anti-COVID “covered countermeasures” in cases where there is no diversity of citizenship.  Regular readers will remember our post last December about the Department of Health & Human Services (“HHS”) declaration that significantly expanded PREP Act immunity to, inter alia, cases alleging failure to employ such countermeasures.  Garcia involved such allegations.  2021 WL 492581, at *1-2.  Even though there was no diversity of citizenship, the “senior living” defendants removed to federal court on the ground that PREP act immunity created federal question jurisdiction.  Id. at *2.

Plaintiffs in Garcia argued the PREP Act immunity did not apply to “negligence claims unrelated to vaccine administration and use.”  Id. at *4.  They also asserted that “fail[ure] to adhere to infection control protocols . . . do[es] not receive PREP Act immunity.”  Id. at *5.  Both contentions failed.  Contrary precedent preceded, and thus could not have considered, more recent HHS declarations expanding the scope of PREP Act immunity.

[E]ach of these cases precedes more recent guidance from [HHS] which suggests that when a party attempts to comply with federal guidelines – in this case, concerning the COVID-19 pandemic – the PREP Act would provide complete preemption. . . .  [A]s recently as February 2, 2021, a court within this district found that the PREP Act does not provide for complete preemption.  However, it is not clear from that order if [that] court even considered the [more recent] Advisory Opinion. Therefore, the Court declines to defer to that decision.

Id. at *6 (citations omitted).  “That the Advisory Opinions are not binding law or formal rules issued via notice and comment does not render them irrelevant.”  Id.  Decisions imposing a “black and white” distinction between “use or non-use of a covered countermeasure” were erroneous – as pointed out by HHS – because they ignored “the plain language of the PREP Act, which extends immunity to anything ‘relating to’ the administration of a covered countermeasure.”  Id. (citation and quotation marks omitted).  PREP Act immunity can be defeated only where the defendant did nothing at all, not where the adequacy of its COVID response is at issue.  Id. (exception only for “total inaction”).

For all of these reasons, Garcia held that the PREP Act was a “complete preemption” statute that created federal question jurisdiction.

While the Court acknowledges that certain allegations [in the complaint] relate to a failure to abide by local or federal health guidelines, those allegations related to momentary lapses. Taken as true, all [the complaint] discloses are possible unsuccessful attempts at compliance with federal or state guidelines – something which the PREP Act, the Declaration, and the January 8, 2021 Advisory Opinion cover. . . .  Therefore, because [HHS] stated that the PREP Act is a complete preemption statute, the Court finds that an adequate basis for federal question jurisdiction exists.

Id. at *9 (citations omitted).

Thus, should Garcia’s rationale prevail, just about all nursing home litigation involving alleged failure to use countermeasures in a way that could have prevented COVID infections will be heard in federal court – regardless of how many questionable, non-diverse defendants plaintiffs try to add.

Our second case, Fields, involves the application of federal question jurisdiction arising from the defendant “acting under” the authority of a federal officer under 42 U.S.C. §1442.  We suggested the defense counsel give that basis for removal another look last year in this post, which was about the Latiolais v. Huntington Ingalls, Inc., 951 F.3d 286 (5th Cir. 2020), decision – which is the precedent on which Fields turned.  Fields involved allegations about COVID infections in meat packing plants.  2021 WL 510620, at *1.  However, when COVID appeared to be posing a threat to the nation’s food supply, the government invoked the Patriot Act, and declared the defendant’s facilities to be “critical infrastructure.”  Id. at *2.

As defendants note, after this designation, [defendant plant owner] interacted with multiple government agencies, namely by being “in close contact with officials at the U.S. Department of Homeland Security and the U.S. Department of Agriculture regarding continued operations.” [It] also participated in a meeting between [the administration] and other food industry executives “to discuss the stability of the supply chain.”  Part of the collaboration between [owner defendant] and the federal government involved it working directly with the United States Food Safety and Inspection Service (FSIS).

Id. at *3 (record citations omitted).

This critical infrastructure designation meant that the owner defendant was subject to more than just general federal regulation.  Id.

[D]efendants here exhibited an effort to help assist, or carry out, the duties and tasks of the federal superior.  Defendants did so by working directly with the Department of Agriculture and the FSIS to guarantee that there was an adequate food supply.

Id. (citation omitted).  Indeed, Congress “allocated additional funding” to the relevant agency “to ensure that [it] had the resources to adequately supervise” facilities that had received the “critical infrastructure” designation.  Id.

Accordingly, the court now finds that, based on the critical-infrastructure designation, defendants were “acting under” the directions of federal officials when the federal government announced a national emergency.

Id. (footnote omitted).

Then, Fields judged the connection between federal oversight and the plaintiffs’ claims under the new, “more relaxed” standard discussed in Latiolis.  2021 WL 510620, at *4.  That step was relatively easy:

The purported act under color of federal authority is the decision to maintain operations despite the pandemic.  Naturally, the choice of what safety precautions should be taken . . . connects to the broader decision to keep the plant open during the pandemic in the first place.


Finally, step three – a “colorable” federal defense to the plaintiffs’ claims – was satisfied by defendants raising two forms of preemption:  (1) express preemption under meat inspection statutes, and (2) implied conflict preemption with governmental oversight under the Defense Production Act.  Id. at *4-5.  Defendants did not have to win preemption at this point; they only had to have a “plausible” basis for the defense, which they did.  Id. at *5.

Thus, should Fields’ rationale prevail, all COVID-related litigation over infections allegedly arising from meatpacking and other facilities designated as “critical infrastructure” during the pandemic would likewise be heard in federal court.

Between Garcia and Fields, precedent now exists for the exercise of federal jurisdiction over the vast majority of COVID-related personal injury litigation.

We have a long, 50-state survey post entitled “Don’t Forget About A Prescribing Physician’s Failure To Read Warnings,” about a subject as to which we feel strongly enough that we keep it updated on an ongoing basis.  Its proposition is simple, and powerful:  Under the learned intermediary rule, it is impossible to prove causation from purportedly inadequate drug or device labeling when the prescribing doctor to whom the material is directed did not read it.  That fact pattern happens quite often.  Physicians are smart and busy people.  Their familiarity with product risks usually comes from their training and their professional education.  Equally often, they are intimately familiar with the risks of the products they prescribe or use, and thus don’t bother reading what our clients’ FDA-approved labeling has to say.

So, if an allegedly inadequate labeling is never read, it can’t cause anything.

Well, how about physician testimony that almost, but not quite, establishes a prescribing physician’s failure to read?  The fact pattern we address today is:  Instead of denying that s/he ever read the product labels in questions, a prescriber will sometimes testify that s/he doesn’t “remember”/”recall” reading it.  Do the same causation principles apply?

The answer is, usually yes.  See Celotex Corp. v. Catrett, 477 U.S. 317, 322 (1986) (“the plain language of Rule 56(c) mandates the entry of summary judgment . . . against a party who fails to make a showing sufficient to establish the existence of an element essential to that party’s case, and on which that party will bear the burden of proof at trial”).

As long as the plaintiff retains the usual burden of proving causation, this kind of “don’t recall” testimony means that the plaintiff has more work to do to establish causation, and if the plaintiff doesn’t do that work, then the plaintiff loses, just as when the prescriber affirmatively denies having read the label.  That’s the bottom line from what appears to be the leading case on this fact pattern, Pustejovsky v. PLIVA, Inc., 623 F.3d 271 (5th Cir. 2010) (applying Texas law).  In Pustejovsky, the plaintiff’s prescribing physician “did not recall ever reading the package insert for the drug or consulting the Physician’s Desk Reference” concerning it.  Id. at 277.  While such testimony – unlike an explicit “I never read” statement – is not necessarily fatal to the plaintiff, neither does it satisfy the plaintiff’s burden of proving causation.  The prescriber’s “lack of memory, of course, does not preclude the possibility that she had read these materials, but neither can it sustain [plaintiff’s] burden.”  Id.  What defeated the plaintiff’s claim in Pustejovsky was her failure to adduce any other evidence, which meant the causation element was speculative:

Lacking any evidence that [the prescriber] was aware of [defendant’s] warnings, [plaintiff] instead speculates about other ways an adequate warning might have reached [the prescriber] and altered her decision.  She suggests, for example, that a modification to [the] warning label might have come up in conversations with other physicians or been discussed at a continuing-education seminar.  Certainly, these scenarios are possible.  Ultimately, however, without any summary-judgment evidence to support them, they remain nothing more than possibilities.

Id. (emphasis added).  One “can imagine any number of scenarios,” but without affirmative evidence, none of those castles in the clouds can satisfy a plaintiff’s burden of proof.  “Unsubstantiated assertions  and unsupported speculation are not sufficient to defeat a motion for summary judgment.”  Id. (citation and quotation marks omitted).  Summary judgment affirmed.

Lewis v. Johnson & Johnson, 601 F. Appx. 205 (4th Cir. 2015) (applying Texas law), is a more recent application of Pustejovsky.  On appeal from summary judgment granted in the Pelvic Mesh MDL, the court affirmed for lack of causation evidence under Texas law.

[Plaintiff] presented no evidence that [her surgeon] relied on the warning in [defendant’s] patient brochure in deciding to prescribe the [product].  [The surgeon] testified that she did not recall whether she had a [product] patient brochure at the time of [plaintiff’s] surgery. . . .  [The surgeon] further stated that she would not have verified the accuracy of the information in the brochure.  None of this testimony establishes that [the surgeon] considered the patient brochure warning, let alone relied on it.

Id. at 208.  Following Pustejovsky, Lewis held that the plaintiff “did not offer sufficient evidence to create a dispute as to material fact regarding whether a different warning would have changed [her surgeon’s] decision to prescribe the [the product].”  Id. at 209.

In a recent case controlled by Pustejovsky the relevant testimony of the plaintiff’s surgeon was that while she “sometimes [did] read through” product labeling, she did “not recall for this case or at the time regarding this device.”  Castillo v. Boston Scientific Corp., 2020 WL 2771193, at *7 (W.D. Tex. May 28, 2020) (citations and quotation marks omitted).  Following Pustejovsky, summary judgment was granted in Castillo.  Plaintiff “has not established that a proper warning would have changed [the surgeon’s] decision” because “[h]ypothetical situations . . . do not suffice.”  Id. at *8.  “While it remains possible that [the surgeon] did review the [warnings] . . ., [plaintiff] has not presented the evidence that [the surgeon] did in fact do so.”  Id.  See also Robles v. C.R. Bard, Inc., 2015 WL 11120857, at *2 (N.D. Tex. March 23, 2015) (also following Pustejovsky and granting summary judgment based on prescriber testimony “that he does not recall whether or not he read the instructions”; with no other evidence plaintiff “cannot establish causation”).

The oldest case we’ve found holding that “do not recall” physician testimony is insufficient, without more, to establish a prima facie case of warning causation is Oppenheimer v. Sterling Drug, Inc., 219 N.E.2d 54 (Ohio App. 1964), in which the prescribing physician “specifically said-‘I don’t recall specifically reading the precautions.’”  Id. at 58.  Oppenheimer held:

His recollection was not clear as to the readings in Physicians’ Desk Reference and defendant’s literature circulated to physicians and druggists.  It can hardly be said that he relied upon anything produced by the defendant or found in the general literature.

Id. at 59.  This lack of prescriber reliance was dispositive of plaintiff’s warranty claim, which was the only claim at issue in OppenheimerId. (discussing reliance element of warranty).

Sherman v. Pfizer, Inc., 440 P.3d 1016 (Wash. App. 2019), is substantially more recent state appellate authority than Oppenheimer.  In Sherman, the plaintiff’s prescriber testified that he “did not read package inserts and did not recall ever reading a package insert.”  Id. at 1023.  That testimony was fatal to the plaintiff’s inadequate warning claims.

Based on these undisputed facts, . . . Defendants’ alleged failure to update the package inserts cannot be the proximate cause of [plaintiff’s] condition as a matter of law because even if they had updated the package inserts, [the prescriber] would not have read them.

Id. (citation omitted).

Most recently, in Russell v. Ethicon, Inc., 2020 WL 5993774 (M.D. Pa. Oct. 9, 2020), the implanting surgeon’s “admissions that he does not recall reading the [instructions for use] and that he does not use the IFU when consenting patients are fatal to [plaintiff’s warning] claim.”  Id. at *6.  This failure to recall did not meet the plaintiff’s burden of proof.  “Plaintiff argues that the mere fact that [her surgeon] did not remember whether he had read the IFU creates a genuine dispute of material fact.  It does not.”  Id.

[The surgeon’s] lack of memory, of course, does not preclude the possibility that he read these materials, but neither can it sustain Plaintiff’s] burden.  Plaintiff was not foreclosed from pointing to contrary evidence in the record that would suggest that [her surgeon] did read and rely upon [defendant’s] inadequate warning, but she has failed to do so.  Therefore, even if [defendant’s] warning was inadequate, Plaintiff has not provided evidence that the warning was a proximate cause of her injuries.  Accordingly, the Court grants summary judgment as to the failure to warn claims.

Id. (quotation marks and footnotes citing Pustejovsky omitted).  See Ebert v. C.R. Bard, Inc., ___ F. Supp.3d ___, 2020 WL 2332060, at *7 (E.D. Pa. May 11, 2020) (surgeon could not “recall whether he read [the product label] before implanting the [product]”; “even assuming that the warnings were inadequate, more detailed warnings . . . would have made no difference”) (we blogged about Ebert here).

Another recent case along the same lines is Morris v. Biomet, Inc., 2020 WL 5849482, at *10 (D. Md. Sept. 30, 2020), where the plaintiff’s surgeon “did not specifically recall whether he read the IFU prior to Plaintiff’s surgery” (citation omitted).  “Because Plaintiff cannot establish that [her surgeon] would have relied on more adequate warnings, she cannot prove her failure to warn claims.”  Id.

Similarly, in In re Wright Medical Technology Inc., Conserve Hip Implant Products Liability Litigation, 127 F. Supp.3d 1306 (N.D. Ga. 2015) (applying Utah law), the implanting surgeon testified that he did not “recall” ever reading the product’s package insert.  Id. at 1360.  In the absence of any affirmative evidence of some other way the allegedly inadequate information could have affected the plaintiff’s course of treatment, causation was not proven:

The question here is whether the learned intermediary doctrine precludes Plaintiff’s failure to warn claim based on the package insert warning.  The Court concludes that it does.  [Plaintiff’s surgeon] was unequivocal in his testimony about how he determined the risks and benefits of devices he implants.  He prefers to “educate himself” on the product, and review the studies and what went into a design.  He applied that same approach when evaluating the implanted device at issue in this case.  [He] did not recall reading the insert included in the packaging.

Id.  Thus “the evidence here does not support a failure to warn claim based on the warning provided for the implant at issue in this case.”  Id.

In In re Cook Medical, Inc. IVC Filters Marketing, Sales Practices & Products Liability Litigation, 2018 WL 6415585 (S.D. Ind. Dec. 5, 2018) (applying Georgia law), the “[p]laintiff fail[ed] to raise a genuine issue of material fact on the proximate causation element of . . . failure to warn claims.”  Id. at *4.  This result was required because the implanting surgeon “could not recall whether he read the [product] IFU.  If he could not recall reading [it], he could not have relied upon the warnings and other information set forth in it.”  Id. at *3 n.2 (citation omitted).

In In re Mentor Corp. ObTape Transobturator Sling Products Liability Litigation, 2015 WL 5468712 (M.D. Ga. Sept. 16, 2015), the court, applying Arkansas law, granted summary judgment against warning claims where the implanting surgeon “does not recall reading the . . . product information data sheet, and he does not recall speaking with a [sales] representative about [the product].”  Id. at *1.  Not only did this testimony fail to establish causation, it also rebutted the Arkansas heeding presumption:

[Plaintiff] did not point to any evidence that [her surgeon] would have taken a different approach had [defendant] provided additional warnings.  [Plaintiff] argues that the Court should presume that [the surgeon] would have read and heeded adequate warnings in the product insert data sheet.  But it is undisputed that [the surgeon] did not recall reading the . . . product insert data sheet. . . .  Given this evidence − and the lack of any evidence that [the surgeon] would have altered his treatment . . . had the [product] warnings been different – [plaintiff’s] failure to warn claim fails.

Id. at *2 (citation omitted).  See In re C.R. Bard, Inc., 2013 WL 5591948, at *6 (S.D.W. Va. June 4, 2013) (implanter remembered neither the product’s instructions for use nor reviewing same; summary judgment granted for lack of evidence that the surgeon “would have altered his conduct if adequate warnings were given”) (applying Mississippi law).

In California, the plaintiff in Latiolais v. Merck & Co., 2007 WL 5861354 (C.D. Cal. Feb. 6, 2007), aff’d, 302 F. Appx. 756 (9th Cir. 2008), lost where the prescriber’s “do not recall” testimony was paired with a statement of non-reliance.

[The prescriber] could not recall receiving any information from [defendant] concerning [the drug] that affected his decision to prescribe it to Decedent.  [He] stated that he saw sales representatives from drug companies only “rarely” and could not recall any interaction with [defendant’s] representative. . . .  He could not recall being influenced by any information from [defendant] or any other source concerning [the drug, and] stated that he could not recall if he ever read the package insert regarding [the drug], but, most importantly, stated conclusively that the inserts played no role in his decision to prescribe [the drug] to Decedent.

Id. at *2 (citations omitted).  This do not recall “minus” (as opposed to the “plus” discussed in Pustejovsky) evidence completely failed to establish causation.  Id. at *3 (the prescriber “could not recall if he ever read the package insert, or warnings, regarding [the drug].  Further, [he] stated he could not recall being influenced in this regard by any information from [defendant]”).

Earlier, Harris v. McNeil Pharmaceutical, 2000 WL 33339657 (D.N.D. Sept. 5, 2000), reached a similar conclusion.  The facts were unfortunate – the plaintiff was a physician who was also a drug addict and who “self-prescribed” the drug in question.  Id. at *1-2.  He answered “no” to whether he “recall[ed] . . . reviewing any information about the drug having a potential for abuse or dependence.”  Id. at *2.  Plaintiff therefore lost his case for “lack of causation.”  Id. at *5.

[Plaintiff] testified that he does not recall reading the package insert. . . .  He does not recall reading anything about the mechanism of action . . . or a discussion of the drug having a potential for abuse or dependence, until after he recognized he was addicted.  Nor does [plaintiff] recall reading the package insert portion which [discussed drug dependency], or that portion which [discusses prior opioid use]. . . .

Proximate cause is such an element [essential to plaintiff’s case].  It is this court’s opinion that [plaintiff’s] failure to review the contents of the package insert pertaining to precautions and dependency potential accompanying the [drug] provided to him is fatal to his claims under all theories of liability.

Id. at *4 (citation and footnote omitted).

Finally, what is the kind of additional evidence that, when added to prescriber “do not recall” testimony, can satisfy a plaintiff’s burden of proof?  We’re not going to do the other side’s research for them, but In re Taxotere (Docetaxel) Products Liability Litigation, 2020 WL 4228387 (E.D. La. July 23, 2020), is illustrative.  While the prescriber “could not recall reading the [product’s] label,” the plaintiff adduced evidence that the prescriber “stays informed of drug labels through several third-party sites.”  Id. at *1-2.  That was enough to create a fact question.

Thus, while “not recall reading” testimony is obviously not as definitive as “did not read” testimony, it often can and should be dispositive, given the usual burden of proof, unless the plaintiff can develop some other affirmative testimony that establishes a causal link to purportedly inadequate labeling information.

Most of the controversy in the recent decision, Hill v. Bayer Corp., 2020 WL 5367334 (E.D. Mich. Sept. 8, 2020), revolved around whether the plaintiff could assert a cause of action for failure to report adverse product events to the FDA.  Like the great majority of decisions (particularly since Conklin v. Medtronic, Inc., 431 P.3d 571 (Ariz. Dec. 18, 2018), exposed Stengel v. Medtronic Inc., 704 F.3d 1224 (9th Cir. Jan. 10, 2013) (en banc), as an erroneous decision) Hill refused to allow such a claim.

Plaintiff’s chief problem in Hill was that the contraceptive device she was suing over was FDA pre-market approved, thus providing the defendant with a strong preemption defense.  As a purported “parallel” claim that could escape preemption, the plaintiff in Hill alleged failure-to-report as a “negligent failure-to-warn”:

Despite the heading “negligent failure-to-warn,” the Amended Complaint cites to a lengthy list of alleged federal regulatory violations, the vast majority of which do not involve warning requirements at all, but rather involve the alleged failure to make certain reports including adverse events to the FDA.

2020 WL 5367334, at *4.

Hill wasn’t buying what the plaintiff was selling.  “The law is well established that there is no parallel federal requirement that [defendant] had a duty to warn the general public or the medical community, and thus, those claims are expressly preempted because they are different from, or in addition to,’ the Medical Device Amendments (“MDA”) requirements.”  Id. (citations and quotation marks omitted).  Any duty to report was created solely by the Food, Drug & Cosmetic Act (“FDCA”):

[I]t is the Federal Government, not private litigants who are authorized to file suit for noncompliance with the medical device provisions. . . .  [A] state law tort claim that is “a disguised fraud on the FDA” claim is preempted. . . .  That is exactly what [plaintiff] seeks to do here: to hold [defendant] liable for alleged misrepresentations and withholding of information to the FDA.

Id. at *5 (citations and quotation marks omitted).

The learned intermediary rule is a traditional restriction on warning claims involving prescription medical products, and that rule means that the FDA is not a common-law learned intermediary.

Under the learned intermediary rule, the physician is the proper recipient of necessary information or warnings, not plaintiff.  Thus, under Michigan law, any duty in this case would be one owed to [plaintiff’s] physicians, not [plaintiff] herself, and not the FDA.

Id. at *7 (citations and quotation marks omitted).  Nice and simple – where the learned intermediary rule applies, there is no common-law duty to warn anyone else, including the FDA.  Because plaintiff “has not alleged any Michigan requirement that a manufacturer report adverse events to the FDA” but instead “relies solely on [defendant’s] alleged failure to warn the FDA of adverse events in support of her failure to warn claim,” the claim is preempted.  Id.

Hill is representative of most recent precedent (except for the case we discussed here).  Just since August, three other cases had held reporting-based warning claims preempted when asserted against manufacturers of PMA devices.  In Bayer Corp. v. Leach, ___ N.E.3d ___, 2020 WL 4811506 (Ind. App. Aug. 19, 2020) (discussed here), the court held:

[E]ven assuming that [defendant] failed to comply with federal reporting requirements, other federal law nevertheless required that [defendant] use the approved labeling and packaging.  Under the MDA, a state cannot impose a different or additional requirement.  Thus, the claims that [defendant] is liable for a failure to . . . are expressly preempted.

Id. at *10 (regulatory citations omitted).

Next, in Noel v. Bayer Corp., 2020 WL 5038782 (D. Mont. Aug. 26, 2020) (discussed here), failure-to-report claims failed under Montana law.  First, “no FDA requirement for Bayer to report consumer complaints directly to healthcare providers and consumers or to update its warnings and labeling.”  Id. at *4.  Second, “Montana law provides no such parallel duty” to the federal requirement that “device manufacturers must report any incident to the FDA where their device may have caused or contributed to a death or serious injury.”  Id. (citation and quotation marks omitted).  Under the learned intermediary rule:

A government regulator is not a foreseeable user or consumer of a product.  Nor is it a healthcare professional responsible for a patient’s care.  In neither case did the Montana Supreme Court hold that a manufacturer must warn the FDA (or government regulators generally) of known dangers.

Id. (emphasis original).

Likewise, Conley v. St. Jude Medical, LLC, ___ F. Supp.3d ___, 2020 WL 5087889 (M.D. Pa. Aug. 28, 2020) (discussed here), joined the “[m]any courts [that] have found claims based on alleged reporting failures preempted.”  Id. at *7 (citations omitted).  Given the learned intermediary rule, Conley rejected the plaintiff’s argument and held that Pennsylvania common law imposed no “general[] . . . duty to warn third parties.”  Id. at *5-6 nn. 5-6.  Without any parallel common-law duty preemption could not be avoided.  Thus, the reporting claim in Conley “failed to state a parallel claim” and was “preempted.”  Id. at *7.

Depending on how a court chooses to view the issue, a failure-to-report claim against a PMA device manufacturer can be expressly preempted (Leach, Conley), impliedly preempted (Noel), or both (Hill).

Recently, largely related to the dubious pleasure of home ownership, we have had multiple occasions on which we were forced to shrug our shoulders and proclaim, “Nothing’s perfect.”  To wit, we recently noticed a small wet spot on our bedroom ceiling.  The roofing company discovered that the corresponding section of the roof was too shallow to be shingled and replaced the section with the correct material.  That spot dried up and stayed dry, but we walked into our bedroom during the next big storm to find water dripping from a recessed light in a different location under the brand-new section of roof.  Nothing’s perfect.

We could go on (trust us).  But we will move, with a similar sense of resignation, to today’s case.  Vardouniotis v. Pfizer, Inc., 2020 WL 3890928 (N.Y. Sup. July 7, 2020), begins as a rare and lovely example of a court applying the correct standard to dismiss a failure-to-warn claim on federal preemption grounds.  In Vardouniotis, the plaintiff took the defendant’s prescription drug to help her quit smoking.  She alleged that it caused her to suffer injuries that included a number of symptoms related to pain in her back, neck, abdomen, legs, and hips, along with movement disorders, “difficulty lifting items, persistent exhaustion, labored breathing, depression; and anxiety.”  Vardouniotis, 2020 WL 3890928 at *1.  She asserted the usual panoply of product liability claims, including a claim that the defendant had not adequately warned of the risks of “movement disorders, serious injury, or death.”  Id.  In its motion to dismiss, the defendant argued that the warnings claims were preempted by the FDCA.

The court explained that, to “update a label without prior FDA approval, a manufacturer must comply with the ‘changes being effected’ (‘CBE’) regulation, which allows manufacturers to add or strengthen label warnings unilaterally to “reflect newly acquired information.”  Id. at *2, citing 21 CFR § 314.70(c)(6)(iii).  The only time the FDCA and its implementing regulations do not preempt a state law failure-to-warn claim is when the manufacturer could have changed the label pursuant to the CBE regulation.  Under that circumstance, “the burden shifts to the party asserting a preemption defense to demonstrate that there is clear evidence that the FDA would not have approved” the label change.  Id. at *2-3 (citation omitted).  This is the Levine “clear evidence” rule that has confounded courts – and produced singularly bad decisions – since 2009.  Not so here.

The defendant argued that the plaintiff had not alleged that the defendant had “information that . . . revealed risks of a different type or severity or frequency than warned of in the . . . label and [that the defendant] had not previously submitted to the FDA.”  Id. at *3.  In other words, according to the defendant, the plaintiff had not alleged the existence of “newly acquired information” that would have triggered the defendant’s ability to change the label without prior FDA approval.  The plaintiff countered with citations to newspaper articles and journal publications describing risks not listed in the label, and she argued that she didn’t know, before discovery, whether or not those risks were identified to the FDA as part of the defendant’s New Drug Application.

The court commented that, although the plaintiff “cite[d] newspaper articles in her memorandum of law, [the] articles were not annexed to the complaint or her opposition to [the defendant’s] motion to dismiss.” Id.  The court also declined to take judicial notice of “materials derived from a Federal Aviation Administration website or a Wall Street Journal article,” because “[j]udicial notice of facts is reserved for matters of common knowledge, well-established and settled.”  Moreover, “[judicial notice of a fact may not properly be based upon a factual assertion simply because the assertion is contained in a newspaper article.” Id. (internal punctuation and citations omitted).“  Thus,” the court stated, “the plaintiff has not identified any newly acquired information that could have justified [the defendant’s] revising the . . . label unilaterally through the CBE regulation without FDA approval.”  Id.  Nor was the court swayed by the plaintiff’s argument that she needed discovery to defeat preemption, commenting that “the mere hope that discovery may reveal facts essential to justify opposition does not warrant denial [of a motion to dismiss].”  Id. at *4 (internal punctuation and citation omitted).  The court held, “As the plaintiff has failed to make a sufficient showing that such facts could be obtained in discovery, the plaintiff’s failure to warn claims are dismissed.” Id.

We remember the days leading up to the Levine decision and our disappointment when the decision came down.  In the ensuing years, we have been frustrated, far more often than not, by courts’ refusal or inability to approach preemption motion-to-dismiss decisions with open-minded rigor.  It’s pretty simple: if a plaintiff properly alleges that a manufacturer failed to change a label in the face of “newly acquired information” about a new or heightened risk, she may be able to defeat dismissal on preemption grounds.  Otherwise, her failure-to-warn claims should be dismissed as preempted by federal law.  So many courts get it wrong, and we were delighted to read a decision that gets it right.

But nothing’s perfect.  The court granted the defendant’s motion with respect to some of the plaintiff’s remaining claims and denied it with respect to others.  But here is where the decision really went off the rails: the court held that the plaintiff had adequately pled her negligence claim when she alleged that she was injured as a result of the defendant’s “failure to adequately test” its drug.  The court also declined to dismiss the plaintiff’s gross negligence and “wanton and malicious conduct” claims based on the same allegations.  Here’s the thing: our “duty to test” cheat sheet includes four cases, including a Second Circuit case, holding that there is no such duty under New York law.  The Vardouniotis court didn’t even discuss the issue when it allowed these claims to proceed.  We are disturbed by this.  The concept of “failure to test” intrudes on territory that is framed by FDA’s comprehensive regulatory scheme.  Our drug and device clients don’t need common-law “failure to test” claims, especially in jurisdictions that have already rejected them.

Nevertheless, we love the preemption portion of this decision. We will continue to keep you posted on the good, the bad, and the merely imperfect.  In the meantime, stay safe out there.

Being that it was the Sixth Circuit that allowed a failure-to-update claim to proceed against a generic manufacturer, when we got the recent decision in McDaniel v. Upsher-Smith Labs, 2018 U.S. App. LEXIS 17884 (6th Cir. June 29, 2018), knowing it was about whether a claim for failure to distribute a medication guide was preempted, we flipped straight to the end looking for “affirmed” or “reversed.” We wanted to get into the proper frame of mind for reading the opinion. Were we going to be disheartened like we were by Fulgenzi v. Pliva, 711 F.3d 578 (6th Cir. 2013). Or pleased by the court’s distancing itself from its prior ruling. Fortunately, it’s the latter.

While failure to distribute medication guide claims have been previously ruled on by district courts, it was a matter of first impression on appeal. The Eleventh Circuit had the issue before it just a couple of months ago, but decided the case on learned intermediary rather than preemption grounds. See our post on that case here. And while we’re at it, here is where you can find our discussion of Fulgenzi. The Sixth Circuit took just the opposite approach deciding not to reach the learned intermediary question but instead to focus all of its attentions squarely on preemption.

At issue was plaintiff’s husband’s use of a generic form of amiodarone. Plaintiff alleged that her husband did not receive the Medication Guide for the drug when he filled his prescriptions because the manufacturer failed to make sure they were available. McDaniel, at *3. This failure to provide the Medication Guide was the sole basis for plaintiff’s strict liability and negligence failure to warn claims.

So, to be clear, nowhere in plaintiff’s complaint does she allege that the warning that was provided with the drug (in its accompanying labeling) was insufficient or inadequate. Her only allegation is that the Medication Guide, the substance of which she also does not take issue with, was not provided to her husband as required by the FDCA. Which the Sixth Circuit determined was the pleading of a federal duty without any Tennessee state court parallel duty. “Said differently, the claims would not exist in the absence of the FDCA.” Id. at *4. And, that’s Buckman implied preemption territory.

The court starts by directly citing Buckman for the ruling that there is no private cause of action for enforcing the FDCA. Id. at *5. The court then quotes quite heavily from plaintiff’s complaint to demonstrate that she has not pleaded a traditional state law failure to warn to claim – indeed neither plaintiff’s complaint nor briefing even mentions the Tennessee Products Liability Act. Id. at *8-9. Instead, her allegations talk about the defendant’s failure to provide the guide “as required by the FDA.Id. at *6-7 (emphasis added). As if that wasn’t enough, in her briefing, plaintiff explicitly disclaimed any inadequate content basis for her failure to warn claims:

The allegation is not one of adequacy or “content” failure to warn, (i.e., the verbiage or even the format fails), but an actual and physical negligent failure of [defendant] to fulfill its federally mandated responsibility to ensure Medication Guides are available for distribution directly to patients with each prescription.

Id. at *8 (quoting plaintiff’s brief). So, we think the basis for the claim is quite clear. Failure to distribute the Medication Guide as required by the FDCA. Nothing more.

The court next moves to the decisions by various district courts finding failure to distribute claims preempted. See id. at *10-11. To which plaintiff responded by relying on Fulgenzi. Like we mentioned above, Fulgenzi was a failure to update case. Plaintiff alleged that the generic manufacturer defendant failed to update its labeling to include new warnings added by the brand manufacturer thereby violating both the federal duty of sameness required of generic labeling and Ohio state law requiring adequate warnings. The Fulgenzi court found that because it was the adequacy of the warning that was at issue – a traditional state law claim – rather than the failure to update, the claim wasn’t preempted. In other words, the allegation of the violation of the federal duty of sameness was not a “critical element” of the claim in Fulgenzi. It was pleaded by plaintiff to demonstrate that her state law failure to warn claim was not preempted because it paralleled a federal requirement. Plaintiff in McDaniel, tried to argue that she too only pleaded the federal-law violation to avoid impossibility preemption. In fact, the only element of her failure to warn claim was failure to comply with a federal duty. Id. at *11-12. The court was not willing to “ignore the language of [plaintiff’s] allegations simply so that [it could] shoehorn her claims into Fulgenzi’s realm.´ Id. at *14.

While we disagree with where Fulgenzi came out, we agree that even if you found Fulgenzi’s reasoning sound, it doesn’t apply to McDaniel. In this case, the court correctly concluded that the FDA requirements regarding distribution of Medication Guides was a “critical element” – actually only element — of plaintiff’s case, and therefore the claim was impliedly preempted.

Note that there is a dissenting opinion that argues the McDaniel case does fit within the Fulgenzi framework by finding that Plaintiff McDaniel also pleaded a failure to warn claim alleging inadequacy of the warning. We certainly think the language cited by the majority demonstrates that’s not the case, but we aren’t going to spend time quibbling over it because we don’t think adequacy should be outcome determinative. As we said back when we posted on Fulgenzi, there is no question that the duty at issue (to update or to distribute) is federal. Only the federal government may enforce it. Whether the updated warning and/or Medication Guide is, or is not, also “adequate” under state law amounts to nothing more than coincidence. At least that’s how we saw it then and still see it now.

We update our cheat sheet devoted to ediscovery for defendants differently than the others.  Because of the broad nature of the topic – these cases arise in a wide variety of non-drug/device contexts – other personal injury, employment, civil rights, occasionally even criminal litigation.  That means we have to research them separately to find what we need to include.  That is more taxing than our usual routine because it means looking through hundreds of cases to find the ones that are:  (1) on point, and (2) favorable to our side of the “v.”  Thus, it has been a while since we last updated, but we just did it now.  The new opinions are below, and every one of them either allows access to a plaintiff’s social media activity or imposes sanctions (often for spoliation) on plaintiff for resisting such discovery.

Once again, although we’ve read all the relevant social media discovery cases, we include only the good ones – because we don’t believe in doing the other side’s research for them.  A couple of words to the wise arising from the rest are appropriate.  First and foremost, if you’re representing a defendant and are considering making a broad request for social media discovery at the very outset of the case – DON’T.  Without anything more solid than generalized suspicions as reason for a deep dive into an opponent’s social media, courts are not impressed and are likely to treat it as a “fishing expedition.”  Most of the time a blanket social media discovery demand will succeed only when the defendant has caught the plaintiff in a lie – with contradictory public social media evidence − or the plaintiff has attempted to delete or otherwise hide social media activity.  The key word is “investigate.”  Once the tip of the spear penetrates a plaintiff’s shenanigans, the rest follows more easily.

Second, in the absence of such hard evidence, the defense is well advised to start small, with less intrusive discovery.  Instead of asking for everything at once, check with an ediscovery specialist and consider proposing sampling – 5% or 10% of all posts – as something less intrusive, but statistically likely to find contradictory evidence if it exists.  An active social media user (the type most likely to generate useful information) will usually have published thousands of posts and other types of entries.  In that situation, sampling is very likely to reveal something significant present in a plaintiff’s social media.  The sampling can then support a broader discovery demand.

With those caveats, here is the latest favorable set of cases in which defendants have successfully engaged in discovery of plaintiffs’ electronic activities:

  • Shawe v. Elting, 157 A.3d 142 (Del. Feb. 13, 2017). Plaintiff properly sanctioned for deliberate and reckless deleting email and text messages by being ordered not only to pay all expenses of recovery but also a percentage of defendant’s total counsel fees, due to the spoliation complicating the conduct of the litigation general.
  • State v. Johnson, 2017 WL 1364136 (Tenn. Crim. App. April 12, 2017). Although the Shared Communications Act prohibited criminal defendants from obtaining a witness’ social media content from social media platforms, the defendant had established good cause to obtain such evidence directly from the witnesses who were social media users. They are not privileged. The subpoenae to the witnesses were not oppressive.
  • Lawrence v. Rocktenn CP LLC, 2017 WL 2951624 (Mag. W.D. La. April 19, 2017). Plaintiff must produce all text messages, photographs and videos that concern: (1) plaintiff’s physical capabilities; (2) that allegations in the complaint; (3) emotional distress; (4) any decline in plaintiff’s marriage; (5) alternative causes of the injuries; and (f) plaintiff’s activities during the claimed period of disability.
  • Flowers v. City of New York, 55 N.Y.S.3d 51 (N.Y. App. Div. June 20, 2017). Evidence from plaintiff’s public social media contradicted the plaintiff, thereby justifying discovery from plaintiff’s private social media accounts, including deleted material, relating to the same subject matter. Plaintiff shall provide a release to obtain material, including metadata, from the provider.
  • Walker v. Carter, 2017 WL 3668585 (S.D.N.Y. July 12, 2017). Plaintiff sanctioned for failure to produce relevant text messages. Must pay defendant’s increased attorney’s fees.
  • Ottoson v. SMBC Leasing & Finance, Inc., ___ F. Supp.3d ___, 2017 WL 2992726 (S.D.N.Y. July 13, 2017). Plaintiff sanctioned for failure to preserve text messages and emails concerning the events at issue. The jury will be instructed on an adverse spoliation inference.
  • Jones v. U.S. Border Patrol Agent Gerardo Hernandez, 2017 WL 3525259 (Mag. S.D. Cal. Aug. 16, 2017). Plaintiff must produce a GPS-based map generated by his fitness watch.
  • Ehrenberg v. State Farm Mutual Automobile Insurance Co., 2017 WL 3582487 (Mag. E.D. La. Aug. 18, 2017). With respect to social media, plaintiffs must produce posts and photos: (1) relating to the accident, (2) relating to all physical injuries whether or not caused by the accident, (3) reflecting plaintiff’s physical activity, (4) relating to plaintiff’s emotional distress; (5) relating to alternative emotional stressors; (6) concerning plaintiff’s vacations.
  • Calleros v. Rural Metro, Inc., 2017 WL 4391714 (Mag. S.D. Cal. Oct. 3, 2017). In class action over alleged deprivation of rest breaks, defendant is entitled to social media discovery of any activity plaintiffs engaged in while on company time.

As we blogged at the time, we believe that the Ninth Circuit made a historic error in Stengel v. Medtronic Inc., 704 F.3d 1224 (9th Cir., 2013) (en banc), when it equated routine product liability inadequate warning claims with indirect third-party warning claims where the third party is a governmental agency – that is, the FDA.  Validating such allegations could have much broader implications – on everything from statements made to insurance regulators to child abuse reporting requirements – but, even limited to the FDA, it creates precisely the same perverse incentive “to submit a deluge of information that the [FDA] neither wants nor needs” that supported preemption of other tort claims challenging the accuracy/completeness of FDA submissions in Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341, 351 (2001). But the Supreme Court denied certiorari in Stengel, so life goes on.

To the extent that Stengel had any redeeming feature, it is found in the 7-judge concurrence (a majority opinion, really, since 11 judges were sitting for the en banc decision), which recognizes that causation is particularly problematic where a federal agency with preemptive power is a middle-man in state-law litigation:

Because they predicate their claim on [defendant’s] reporting duty to the FDA, as they must to avoid express preemption, [plaintiffs] face a causation hurdle that would not otherwise exist.  To prevail, they will ultimately have to prove that if [defendant] had properly reported the adverse events to the FDA as required under federal law, that information would have reached [the prescribing] doctors in time to prevent [plaintiffs’] injuries. But at this juncture − a request for leave to amend their complaint – [plaintiffs’] allegations of causation are adequate.

Stengel, 704 F.3d at 1234-35 (concurring opinion). Stengel cited to the causation theory described in Hughes v. Boston Scientific Corp., 631 F.3d 762 (5th Cir. 2011):

[Plaintiff’s] primary causation theory is that if [defendant] had reported the true number of injuries and malfunctions related to [the risk] caused by the [device], this information would have appeared on the FDA’s MAUDE internet database [of adverse events reported about medical devices] and in medical journals, and with this information [the prescriber] would not have recommended the [device] to [plaintiff] for treatment.

Id. at 776.

Continue Reading Causation Issues in Failure-To-Report Cases – Post-Stengel Precedent

This post is not from the Dechert side of the blog.

The United States Supreme Court has said it – the test for implied preemption under 21 U.S.C. §337(a) (the FDCA’s no-private-enforcement provision) is whether the purported state-law cause of action would exist even in the absence of the FDCA/FDA: Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341, 353 (2001) (preemption applies to “claims exist solely by virtue of the FDCA disclosure requirements” and to all claims where “existence of these federal enactments is a critical element”).  So have federal courts of appeals.

If the claim would not exist in the absence of the FDCA, it is impliedly preempted. In other words the conduct on which the claim is premised must be the type of conduct that would traditionally give rise to liability under state law − and that would give rise to liability under state law even if the FDCA had never been enacted.

Loreto v. Procter & Gamble Co., 515 F. Appx. 576, 579 (6th Cir. 2013) (citations and quotation marks omitted). Accord Caplinger v. Medtronic, Inc., 784 F.3d 1335, 1339 (10th Cir. 2015) (“§337(a) preempts any state tort claim that exists ‘solely by virtue’ of an FDCA violation”); Perez v. Nidek Co., 711 F.3d 1109, 1119 (9th Cir. 2013) (preempting a “fraud by omission claim [that] exists solely by virtue of the FDCA  requirements”) (citation and quotation marks omitted); Lofton v. McNeil Consumer & Specialty Pharmaceuticals, 672 F.3d 372, 379 (5th Cir. 2012) (following Buckman; “tort claims are impermissible if they existing solely by virtue of the FDCA disclosure requirements”).

Continue Reading Another Make Work Project In New Jersey – Duty To Update Claims