We have expressed our opinion on “failure to update” claims and have not hidden that we don’t think much of them.  Failure to update claims were manufactured by plaintiffs in response to PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011) and Mutual Pharm. Co. v. Bartlett, 570 U.S. 472 (2013) which basically took the legs out from under products liability suits against generic drug manufacturers.  You know what we mean.  Federal law requires that generic drug manufacturers’ products have the same drug labeling and the same design as their innovator (brand) counterparts—the so-called “duty of sameness.”  Therefore, any claims for failure to warn or design defect are preempted by impossibility.

A “failure to update” claim is where a plaintiff alleges that a generic manufacturer did not update its labeling to match the most current FDA-approved changes to innovator labeling and that the failure caused an injury.  Because that involves an FDA-imposed duty, it is easy to conclude that it looks a lot like a disguised form of FDCA enforcement barred by Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001).  A few courts, however, disagree and have held such claims are not preempted.  In In re: Fluoroquinolone Prods. Liab. Litig., MDL 2642, 2020 WL 6489186 (D. Minn. Nov. 4, 2020), the court said maybe.

The relevant facts are simple.  On August 15, 2013, the FDA issued a Drug Safety Announcement requiring the warnings for all drugs containing fluoroquinolone be updated to “better describe the serious side effect of peripheral neuropathy.”  See https://www.fda.gov/media/86575/download.  In November 2013, plaintiff ingested generic ciprofloxacin and suffered an adverse reaction.  Plaintiff alleges that the generic manufacturer had not updated its label with the warning set forth in the FDA safety announcement at the time she used the drug.  Id. at *1.

The court started its analysis by finding that the failure to update claim differs from Mensing because unlike the issue before the Supreme Court, here plaintiff is not asking the court to require generic manufacturers to provide additional warnings beyond those required of their brand counterpart.  Because the claim is not about a stronger warning, it does not violate the duty of sameness and therefore does not implicate impossibility preemption.  Id. at *3.  For that reason, plaintiff’s failure to warn claim is limited.  She essentially must concede that the brand warning is adequate and therefore, if provided by the generic manufacturer, would have prevented her injuries.  Id. at *4.

As noted above, implied preemption is another obstacle to the failure to update claim.  After all, the requirement to update the warning label is one imposed by the FDCA.  Under Buckman, a private citizen does not have the right to enforce a federal labeling requirement. But the court was willing to entertain a scenario where plaintiff could demonstrate that the failure to update is based on state law as well as a being a violation of the FDCA.  In that case, the claim could thread the preemption needle.  Id.

In sum, the court concluded that if a generic manufacturer failed to update its label to match the brand label, and the claim is limited to the “inadequacies of the non-updated label compared to the updated label,” and there is a state law basis for the claim – it is “not conclusively preempted.”  Id.  In this case, plaintiff did not sufficiently plead any of those elements to survive a motion a dismiss.  Plaintiff did not limit her liability allegations only to the failure to update.  In other words, all failure to warn claims except failure to update must go.  Plaintiff also failed to allege how her failure to update claim is based in state law.  Id.  Because the court was saying “maybe” as opposed to “never,” plaintiff is getting a chance to re-plead her failure to update claim.

Perhaps most importantly, however, the amendment is going to need to address causation.  It is on this ground that other courts in the Eighth Circuit, and elsewhere, have dismissed failure to update claims.  See id. at *6n.3.  Where the learned intermediary has independent knowledge of the risk, the failure to update cannot be the proximate cause of plaintiff’s injury.  As the court noted, “even though failure to update claims are not necessarily preempted, they may be difficult to prove on the merits, particularly in terms of causation between the label and injury.”  Id.   Here the generic and brand labeling already including warnings about peripheral neuropathy.  Based on our own digging, we believe the brand manufacturer added the strengthened warning in July 2013.  The FDA then made its safety announcement for all brand and generic drugs in the class to strengthen their warnings in August 2013.  Regardless of whether it took the generic manufacturer had not updated its label by November, the information was out there.  It was in the medical community.  Further, we know from experience that physicians tend to rely on the brand labeling, not the generic.  Often, the prescribing physician would never have seen the generic label – updated or not.  So, “maybe” may get you over the first preemption hurdle, but causation looms large on the horizon.

It’s Delaware week here at the DDL Blog.  A couple of days ago we brought you a particularly clear-minded order rejecting innovator liability in the First State (so nicknamed because Delaware was the first of the original 13 colonies to ratify the Constitution in 1787), and yesterday we reported on a pair of Delaware orders granting summary judgment in failure-to-warn cases on proximate causation.

Today we highlight another particularly clear-minded application of warning causation in Delaware, and this case has a twist—the product at issue was a generic drug, and the alleged basis for liability was the generic manufacturer’s alleged “failure to update” its label to match the innovator drug.  In the end, however, none of that mattered because the prescribing physician did not read the label and had never heard of the generic company, which means that any “failure to update” could not possibly have made any difference.

The case is Boros v. Pfizer, Inc., No. N15C-04-029, 2019 WL 1558576 (Del. Superior Ct. Mar. 25, 2019), and here is how things played out.  In February 2013, the FDA approved a stronger warning about QT interval prolongation for the innovator version of a common antibiotic.  The agency later requested that the defendant generic manufacturer update its label to match, and it published a Drug Safety Communication about the change.  Id. at *1.  The generic manufacturer complied, and the FDA approved its updated label three months later.  Id. at *2.

In the meantime, the patient at issue was prescribed the antibiotic, and the pharmacy dispensed the Defendant’s generic version.  The next day, the patient died.  Id. at *1.  Because he was prescribed the drug after the innovator changed its label, but before the generic defendant—the manufacturer that actually made and sold the drug the patient allegedly ingested—updated its label to match, the plaintiffs claimed that a “failure to update” caused the decedent’s death.  Id. at *2.

We have expressed our opinion on “failure to update” claims.  We don’t think much of them.  We don’t, however, need to get into all that today because the Delaware court granted summary judgment on warning causation.  The following facts are all you really need to know:

The parties do not dispute that [the prescribing physician] does not recall ever reviewing a package insert for [Defendant’s] generic azithromycin or for any other [Defendant] produced drug.  [He] has never spoken to or had any written communications with any [Defendant] representative.  [He] has never heard of [Defendant].

Id. at *2.  That’s right.  The prescriber did not read the label, never communicated with the Defendant, and never heard of the Defendant.  On those undisputed facts, it was a short way to holding that a “failure to update” the generic label did not cause any harm:

[The prescribing physician’s] failure to review the package insert prevents the Plaintiffs from establishing that the warnings in [the] package insert proximately caused the Decedent’s death.

Id. at *3.  Like other plaintiffs in similar situations, the Plaintiffs tried to get around this stark inability to prove their case.  First, they emphasized the prescriber’s testimony that if he had seen additional warnings, he would have changed his prescribing practices.  This is a version of the “Doctor, wouldn’t you have like to have known” testimony that plaintiffs’ lawyers commonly elicit, usually with an affirmative response.  After all, what doctor will deny that he or she would “liked to have known” additional information about drugs they prescribe?  Be that as it may, the testimony did not prevent summary judgment in this case because the facts were so clear—the doctor never reviewed or received any information from the Defendant.  Under those circumstances there is simply no way that “updated” information would have had any impact on the decision to prescribe the drug.  Id. at *4.

Second, the Plaintiffs argued that the learned intermediary doctrine may be “eroded or even nullified by over promotion of the drug.”  But even if there is an “over-promotion” exception to the learned intermediary doctrine—and Delaware does not have one—it would not apply here because the prescriber never interacted with the Defendant.  Id. at *5.

Third, the plaintiff argued that the learned intermediary doctrine did not apply because the decedent was himself a medical professional and not a “lay person.”  That is a new one on us, and we have never seen any authority that a “learned patient” negates a “learned intermediary.”  Neither had the plaintiffs, nor the Delaware court.  Id.

Finally, the Plaintiffs argued that the Defendant should have sent a Dear Doctor Letter about the strengthened warning to all physicians.  For one thing, since the FDA had already sent a Drug Safety Communication on this topic, we are not sure what difference a Dear Doctor Letter would have made.  Regardless, the court rejected this argument because the Plaintiffs did not plead it, and they raised the alleged failure to send a Letter for the first time at the summary judgment hearing.  Id. at *5.  Moreover, on the merits, because federal law prohibits generic drug manufacturers from sending Dear Doctor Letters unilaterally, any claim based on the failure to send a Letter was preempted under Pliva v. MensingId. at *6.

It would be tempting to think that warnings-based orders like this have little impact on “failure to update” claims generally, but that would be a mistake.  Failure to read as a basis for negating warning causation is well-established nationwide, as our post here demonstrates.  Significantly, Boros is the first Delaware law decision to address this variant of warning causation.  Moreover, because generic manufacturers do not typically promote their products or otherwise communicate directly with doctors, and because physicians commonly do not read package inserts, the exceptionally clear facts of this case are likely to recur.  The Delaware court’s treatment of the law and evidence was right on the money, and other courts would be wise to follow.  Hats off to Delaware.

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

“Failure to update” claims have multiple problems.  You probably already know what we are referring to.  Federal law requires that generic drug manufacturers ‎distribute their products with drug labeling that is the same as their innovator counterparts—the so-called “duty of sameness.”  A “failure to update” claim is where a plaintiff alleges that a generic manufacturer did not update its labeling to match the most current FDA-approved changes to innovator labeling and that the failure caused an injury.  Because that involves an FDA-imposed duty, it is easy to conclude that it looks a lot like a disguised form of FDCA enforcement barred by Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001), as we pointed out here.

In addition to the preemption issues, “failure to update” claims are highly contrived.  We never saw them before the Supreme Court found most claims against generic drug manufacturers preempted by federal law, and the key principle under tort law is whether drug labeling adequately warns of known and reasonably knowable risks.  Sameness might be relevant to adequacy, but it also might not.  In this regard, “failure to update” claims are nothing more than plaintiffs’ lawyers trying to thread the eye of a needle after Mensing and Bartlett.

True, the duty of sameness does not seem all that onerous to our uneducated eyes:  Just follow the leader.  And it is not like we are talking about absolute liability.  As we have discussed, the plaintiffs still have to prove all the elements of their claims, including (but not limited to) causation.  On days when we are in this generous frame of mind, “failure to update” claims are something we can live with.

Continue Reading Warnings Causation Sinks “Failure to Update” Claim

Today’s post comes from the non-Dechert side of the DDL blog.

This week is the anniversary of the beginning of Facebook.  The question of whether Zuckerberg et al. could successfully “monetize” that platform has apparently been answered.  There are almost as many ads and push notifications as there are things that we actually care about, such as pictures and updates from friends and family.  Even worse than the ads are the political rants, stalker high school classmates, and suggestions to join stupid games.   After a nephew invited us to play Farmville for the fifth time, we unfriended him.  It was an easy call, especially since most of his entries involved home-made backyard mixed martial arts films and his f-bomb quotient would have made the makers of Scarface and Midnight Run blush.   Why isn’t there a “Dislike” button we can click?

But today we will “Like” a pair of decisions out of the Southern District of Texas.  The cases are Jackson v. Wyeth LLC, 2015 U.S. Dist. LEXIS 9286 (S.D. Tex. Jan. 27, 2015), and Garza v. Wyeth LLC, 2015 U.S. Dist. LEXIS 9292 (S.D. Tex. Jan. 27, 2015). The cases involve the same judge, the same defendants, and the same claim that ingestion of Reglan/metoclopramide caused tardive dyskinesia.  They were issued on the same date.  Both opinions are short, well-reasoned, and follow settled Fifth Circuit law.

Continue Reading S.D. Texas Upholds Texas Presumption of Non-liability for FDA-approved Drugs and Rejects Failure to Update Claim

Last week, the Eighth Circuit put the final seal on Pliva’s victory in Brinkley v. Pfizer, Inc., 2014 U.S. App. LEXIS 22742 (8th Cir. Dec. 2., 2014), upholding the district court’s dismissal with prejudice under Mensing and Bartlett.  The case involved a doctor who prescribed Reglan and a pharmacist who, when filling the prescription, switched it out for Pliva’s generic metoclopramide.  Id. at *2.  While the Reglan label had been changed in 2004 to add a warning on long-term use, Pliva, plaintiff claimed, failed to make the corresponding update to its label.  So she pursued a failure to update claim.

In some sense, that’s a good starting point.  By styling her failure to warn claim as a “failure to update,” Plaintiff was conceding that she could not bring a standard failure to warn claim.”  Generic manufacturers can only change their label to match a corresponding change in the branded label, and plaintiff hoped that her “failure to update” claim would avoid Mensing preemption.

But this claim had problems too, and they centered on the learned intermediary doctrine.  Pliva’s duty to warn, if any, ran to plaintiff’s prescribing doctor.  But, as plaintiff alleged, her doctor prescribed Reglan, not Pliva’s generic metoclopramide.  Consistent with that, the doctor consulted the Reglan label, not the Pliva label.  Id. at 2-3.  In short, the doctor never read Pliva’s label.  So no matter what Pliva put there, it could not have affected the doctor’s decision to prescribe the drug to plaintiff.  We lawyers call that a failure of proximate causation.

Continue Reading Learned Intermediary Doctrine Gets an Assist in Preempting a Failure to Update Claim

It’s only a small piece of what product liability claims are all about, but the Sixth Circuit in Fulgenzi v. PLIVA, Inc., No. 12-3504, slip op. (6th Cir. March 13, 2013), has ruled (creating something of a circuit split with the 5th Circuit’s nonprecedential Morris decision from last month), that “failure to update” claims are not preempted in a case involving a generic drug.  Everything else is gone, and Fulgenzi goes to great pains to state that even evidence of any other possible warning isn’t admissible, but this one claim remains.

As is typical with any court that rejects a preemption argument, Fulgenzi references a “presumption against preemption,” slip op. at 8, even though the Supreme Court majority in Mensing did not rely  on any such thing (and four justices would have eliminated it altogether).  Mensing impossibility preemption did not apply because there was nothing impossible – the updating in question had already been ordered by the FDA:

In our case, not only could PLIVA have independently updated its labeling to match that of the branded manufacturer through the CBE process . . . but it had a federal duty to do so.  As a result, compliance with federal and state duties was not just possible; it was required. Impossibility preemption is inappropriate in such a case.

Slip op. at 9 (citations omitted).

The more problematic aspect Fulgenzi is how it dealt with what we’ve always thought of as the strongest argument against failure to update, which is that under Buckman a duty to update claim is an improper disguised attempt to enforce an FDCA updating duty that doesn’t exist under federal law.  We’ve read Fulgenzi twice on this point, and we still don’t see the rationale, so we’ll let our readers noodle over it:

[T]he result of this violation does raise concerns that [plaintiff] is simply attempting to enforce a federal-law violation through state litigation.  Where, as here, the statute specifically excludes a private cause of action, 21 U.S.C. §337(a), state tort suits premised on violations of federal law may be impliedly preempted . . . if the claims “exist solely by virtue of” the regulatory scheme . . . .  Here, [plaintiff’s] suit is not even premised on violation of federal law, but rather on an independent state duty.   The alleged breach arises from the same act, but the legal basis is different. This is simply not grounds for preemption.  The federal duty of sameness is not a “critical element” in [plaintiff’s] case.  Failure to update from one adequate warning to another would violate the FDCA, but not Ohio law.  Her suit instead relies upon the adequacy of the warnings and the causation of her injuries.

Fulgenzi, slip op. at 12-13 (emphasis original).  But state law does not have anything to do with “sameness,” one way or the other.  That’s an entirely federal concept.  That “duty” exists only by virtue of the FDCA.  For plaintiffs to substitute that duty (the only one that survives Mensing express preemption), is to put state law in the position of enforcing federal law, which the FDCA explicitly prohibits.  As even Fulgenzi is forced to admit, “violation of the federal duty of sameness is essential to [plaintiff’s] case.  Id. at 13.  Whether or not there’s a “violation” is irrelevant to §337(a), the duty is unquestionably federal.  Only the federal government may enforce it.  Whether the “same” warning is, or is not, also “adequate” under state law amounts to nothing more than coincidence.  At least that’s how we see it.

The court also rejected “purposes and objectives” preemption, holding that no generalized congressional intent to encourage generic drugs prevented any and all product liability claims against their manufacturers.  “A vague policy of encouraging use of generic drugs, untethered from the structure of the Act, is not enough to support purposes-and-objectives preemption.”  Fulgenzi, slip op. at 11.

So what’s left?  A small piece of a claim.  Apparently, after preemption is overcome, the “duty of sameness” drops from the case altogether:

On the merits, whether [defendant] has violated its federal duties is irrelevant to the adequacy of its warnings.  A jury need not know about the duty of sameness at all.

Fulgenzi, slip op. at 13.  The FDA goes unmentioned at trial (even though it is simultaneously “essential”), but the plaintiff is forbidden from challenging the “adequacy” of the generic warning under state law with anything other than the FDA-approved “update.”  Id.

So there’s not that much left, and even the duty to update claim is factually specific to this one generic drug.  We don’t know of any other generic drug litigation where there’s any factual basis for a failure to update claim.  That’s why what bothers us the most about Fulgenzi is the mess the court made when as it tries to fit something into Ohio law that has no basis in Ohio precedent.  The opinion states: “[T]here is nothing in the Ohio product-liability law inconsistent with a claim that a defendant failed to warn, even inadequately.”  Slip op. at 13.  That litodes is just the double negative way of stating that there’s not a scrap of Ohio product liability law affirmatively recognizing a viable claim for failure to give an inadequate warning.

We go on until we’re blue in the face that federal courts sitting in diversity are not supposed to predict expansions of state law that have no support in that law.  It’s not enough that no court might have had occasion to reject a novel and bizarre theory like failure to give an inadequate warning nonetheless being a basis for liability.  There must be state-law precedent somewhere affirmatively supporting a claim for a federal court to predict its adoption.  Ohio imposes a “reasonable care” statutory standard for warning claims.  Nothing supports the proposition that a concededly “inadequate” warning nonetheless constitutes “reasonable care,” and Fulgenzi cites nothing.  This double negative approach is inconsistent with Erie.

[F]ederal courts must proceed with caution when making  pronouncements about state law. Sitting in diversity, we are not commissioned to take a position regarding the advisability or fairness of the state rule to be applied, but must determine the issue as would the highest court of the state.   This Court’s proper reluctance to speculate on any trends of state law applies with special force to a plaintiff in a diversity case. . . .  When given a choice between an interpretation of state law which reasonably restricts liability, and one which greatly expands liability, we should choose the narrower and more reasonable path.

Combs v. International Insurance Co., 354 F.3d 568, 577 (6th Cir. 2004) (citations and quotation marks omitted); see Ventas, Inc. v. HCP, Inc., 647 F.3d 291, 328 n.15 (6th Cir. 2011 (quoting and following Combs); Kurczi v. Eli Lilly & Co., 113 F.3d 1426, 1429 (6th Cir. 1997) (“A federal court in a diversity case is not free to engraft onto … state rules exceptions or modifications which may commend themselves to the federal court, but which have not commended themselves to the State in which the federal court sits”) (quoting Day & Zimmermann, Inc. v. Challoner, 423 U.S. 3, 4 (1975)).

So completely apart from preemption, we think that Fulgenzi‘s plucking of a failure-to-give-an-inadequate-warning theory of liability from thin air is more than simply wrong – it’s a usurpation of the rights of the Ohio state courts to determine, in the first instance, what Ohio law is supposed to be.  It’s not merely a matter of causation (not being able to say “that a severely inadequate warning would never cause an injury that a moderately inadequate warning would have prevented,” slip op. at 14), it’s a matter of whether such a duty – that not giving a legally inadequate warning is required as a matter of “reasonable care” – exists in the first place.  No federal court should make that prediction in the first instance.

We’ve said it before, tort preemption makes courts do strange things; but that doesn’t make it right.

Still, what’s left, even after violence has been done to both §337(a) and Ohio law, isn’t very much.  Another “narrow gap” – this time between Mensing and Buckman must be navigated.  Slip op. at 14.

The arguments [plaintiff] makes, the proofs she offers, and the evidence she submits are all subject to limitation by preemption principles. . . .  [Plaintiff] must use the language of the 2004 FDA-approved label in her proximate-cause argument, not (or not merely) the fact of the failure to update.

Fulgenzi, slip op. at 14-15.  That’s all that’s left, and in a generic preemption case involving a different drug where there hasn’t been any failure to update, not even that.

Thus, while to some extent Fulgenzi is a hash, it’s also a tempest in a teapot – unless and until some other court in some other case involving some other product picks up that dead cat of a failure-to-give-an-inadequate-warning claim and tries to run with it.

In terms of the legal gyrations plaintiffs try to avoid preemption, we’ve already expressed our opinion that so-called “failure to update” claims take the booby prize. There are good reasons, discussed in these prior posts, why plaintiffs not faced with preemption never bring claims for failure to update a warning – they’re simply lousy claims. The latest example of this fact is Woods v. Wyeth, LLC, 2016 WL 1719550 (N.D. Ala. April 29, 2016).

Woods is yet another metoclopramide case – that’s the generic drug that produced PLIVA v. Mensing, 131 S. Ct. 2567 (2011). Stuck between a rock and a hard place, the plaintiff:

Argue[d] that her claims are not preempted because they are based on the generic defendants’ “failure to update” their labels to be consistent with the brand name labeling.

Woods, 2016 WL 1719550, at *1. Woods, after examining various non-binding precedents, concluded that plaintiff “has set out a narrow claim that falls outside the scope of federal preemption” – the failure to update claim involving no more than the FDA-approved labeling. Id. at *8.

OK, so take generic preemption out of the mix entirely – what happens with Woods?

Same ultimate result as if the claim had been preempted; that is to say, judgment on the pleadings for the generic defendants.

Continue Reading Yet Another Failure-To-Update Claim Bites the Dust

Before we turn to today’s case, a quick update:  when last we spoke, we were about to board a plane for Peoria – our first work trip in sixteen months.  We were excited about it.  We regret to report that we stepped out of the plane into something resembling a weird post-apocalyptic Mad Max movie.  We pulled up our Uber app to get to our hotel and saw “no cars available.”  Same for Lyft.  We walked around to the taxi area, and there were no cabs.  We called the hotel, and there was no shuttle.  Luckily, a very nice person took pity on us and gave us a ride to our hotel.

By now, it was dinnertime.  We had checked the website, and the hotel proudly trumpeted the quality of its restaurant and room service.  We asked about these, and the answer was, “Sorry, ma’am, the restaurant hasn’t reopened yet and there’s no room service.”  “No problem,” we said, “surely there are pizza places that deliver?”  We were handed menus from three.   We called them.  All were closed.  On to Plan C.  On the way in, we noticed a fast food restaurant a couple of blocks away.  We laced up our sneakers and walked down, to learn that we could procure food only by utilizing the drive-through window.  In a car.  You get our drift.  Suffice it to say that things did not improve in the ensuing 24 hours.

At least we have a good appellate decision to report.  In Cleeton v. SIU Healthcare, Inc., et al., 2021 Il. App. 4th 200490-U (June 3, 2021), Illinois’s intermediate appellate court reviewed a lower court decision granting summary judgment in favor of a medical device manufacturer and two of its employees.  First, some background.  The appellant (the plaintiff below), as executor of her son’s estate, sued over events that led to the death of her son.  Years earlier, the son had suffered an accident that left him a quadriplegic.  He was implanted with a programmable pump, which delivered a medication – baclofen – that reduced his involuntary muscle spasms.  The pump was a Class III medical device, which means that it underwent the FDA’s full premarket approval (“PMA”) process before it was approved for marketing.  More later about why that matters.

The pump ran out of baclofen and needed to be refilled at a neurology clinic.  The nurse on duty tried three times to refill the pump, without success.  At one point, she inserted the full length of the refill needle into the decedent’s abdomen without making contact with the pump.  Eventually, she sought the assistance of a nurse practitioner, who eventually succeeded in refilling the pump.

Several days later, the decedent presented to an emergency room with abdominal pain, a headache, and a history of a recent UTI.   On the advice of a neurology resident, the emergency room nurse called the pump manufacturer’s sales representative to request so-called “interrogation” of the pump.  This involves “using an electronic device to read the pump to see how the pump was functioning and whether an alarm had been activated.”  Cleeton, 2021 Il. App. 4th 200490-U at ¶ 6.   The sales representative drove to the hospital and “interrogated” the pump, confirming that there was no “functional error” with the pump and that it was programmed correctly.  She informed the doctor of these results but did not provide him with information about baclofen withdrawal and did not discuss possible issues with the catheter that delivered baclofen from the pump to the spinal cord.

The next day, the hospital requested assistance from the manufacturer in troubleshooting the pump.  In response, an employee of the manufacturer faxed the emergency procedures for baclofen withdrawal to the hospital.  A clinical specialist employed by the manufacturer also was contacted and was informed that the hospital was contemplating a dye study of the pump and catheter.  But the study wasn’t performed, and the decedent deteriorated rapidly and died a few hours later.  Post-mortem testing revealed that there were holes in the catheter.

The plaintiff/appellant originally sued several healthcare defendants, but she added wrongful death and survival claims against the manufacturer’s employees, a respondeat superior claim against the manufacturer, and an additional healthcare defendant eight months later.  In her claim against the sales representative, the plaintiff asserted that the sales rep “undertook the duty to troubleshoot the . . . pump” to verify its proper functioning, “including the consideration of the disclosure of the [manufacturer’s] literature addressing emergency procedures” to be followed in the event that the patient was experiencing withdrawal syndrome.  Id. at ¶ 9.  (The latter was styled as a failure-to-warn claim.)  The claim against the manufacturer’s clinical specialist similarly asserted that she “undertook to troubleshoot” the pump and catheter.

The manufacturer filed for summary judgment.  With respect to the “voluntary assumption of duty” claims, the trial court held that the sales representative’s “limited role did not involve her assuming additional duties of a health-care provider as suggested by plaintiff.”  With respect to the clinical specialist, the court held that, because she “never saw [the] decedent,” it “failed to see how she could be responsible for [his] care.”  Id. at ¶ 19.  The court also “emphasized [that] the physician was responsible for providing medical care” and that the manufacturer’s employees did not owe a duty to “insert themselves into the middle of the doctor/patient relationship and affirmatively intervene in [the] decedent’s care.”  Id.   The court “concluded [that the] plaintiff had not alleged any facts from which a reasonable trier of fact could draw an inference” that the defendants “had or voluntarily undertook any legal duty beyond those they took at the request of [the] decedent’s healthcare providers.”  Id.  

With respect to the failure-to-warn claim, the court commented that, “no matter how [the] plaintiff’s counsel set forth the argument, the argument essentially was [that] the [manufacturer’s employees] had a duty to advise [the] decedent’s medical providers of known information regarding the medical device that was already contained within the” product’s labeling.  Id. at ¶ 20.   This would “impose additional requirements,” not required by federal law, “above and beyond the on-label warning approved by the [FDA]; thus, those claims were preempted.  The plaintiff appealed both holdings.

Failure to Warn

On appeal, the court explained that, after Riegel v. Medtronic, state failure-to-warn claims seeking to impose requirements that were “different or in addition to” federal requirements were preempted for Class III (“PMA”) medical devices.  The plaintiff/appellant argued that her allegations did not trigger preemption because they did not involve the labeling of the device.  The court disagreed, stating

Plaintiff alleged in her complaint [that the sales representative and clinical specialist] should have given decedent’s healthcare providers the emergency procedures contained in the label for the device.  The information in the label is clearly controlled by the [FDA].  To suggest employees had to supply the emergency procedures in addition to the label suggests the label approved by the [FDA] was insufficient, or, stated differently, that additional warnings were required.  We agree with the circuit court [that] plaintiff’s claim would impose additional requirements above the warnings approved by the [FDA].

The court held that the failure-to-warn claims were preempted by federal law, and that that there was “no reason why [the doctor’s] lack of knowledge should alter” that conclusion.  Id. at ¶ 34.

Voluntary Undertaking

The court explained that “the duty of care imposed upon the defendant under a voluntary undertaking theory is limited to the extent of the undertaking and is narrowly construed.”  Id. at ¶ 43.  In her deposition, the sales representative explained that she was asked only to “interrogate” the pump, during which “her role was specifically to identify whether the pump itself, the computer that drives delivery of the drug” was intact and programmed correctly.”  Id. at ¶ 45.  The court concluded that the sales rep undertook only to interrogate the pump and that she met the standard of care in doing it.  The plaintiff protested that the sales rep “did not use reasonable care in reporting the interrogation findings because [she] failed to communicate to [the doctor] the significance and limitations of the interrogation’s findings.”  Id. at ¶ 45.  The court responded, “[Though the] plaintiff emphasizes [the sales rep’s] superior knowledge about the pump” as compared to the doctor, “[t]hat argument overlooks the fact [that] it was [the doctor] who was the person responsible for decedent’s care at the time of the interrogation and he was aware of his own limited knowledge about the pump.  [He] could have asked . . . more questions about the pump and the interrogation,” or he could have talked to a more senior doctor.

The court concluded, “To require [the sales rep] to explain the limitations of the test and possible catheter issues would require a medical device sales representative with no medical training to volunteer theories about the cause of the patient’s symptoms and thus intervene in the patient’s treatment. . . . [We] disagree [that] reasonable care includes informing the ordering physician” about issues involving a patient’s medical treatment “or sua sponte educating the physician about the pump.”  Id. at ¶ 46.  (The court relied on Kennedy v. Medtronic, 366 Ill. App. 3d 298, 851 N.E.2d 778 (2006) for this proposition.  We have discussed Kennedy in numerous “no duty to intervene in medical care” cases, as far back as here.)  Because “the plaintiff . . . failed to identify a genuine issue of material fact showing [that the sales rep] did not use reasonable care in exercising her assumed duty to interrogate” the pump, the sales rep was entitled to summary judgment on the “voluntary undertaking” claim.   Similarly, the plaintiff failed to show that the manufacturer’s clinical specialist owed a duty to the decedent.  Finally, because the plaintiff’s respondeat superior claims against the manufacturer were entirely derivative of the claims against the employees, affirmance of summary judgment in favor of the employees was fatal to this claim as well.

We really like this decision.  In the face of some troubling facts, the appellate court never lost sight of the reality that it is doctors who are responsible for the care of their patients.  This is the principle that underlies the learned intermediary doctrine and frames the analysis in drug and device litigation.  Here, it resulted in a solid decision that resisted the plaintiff’s attempts to impose liability where no legal claim supported it.  And the court got the preemption decision right, to boot.  Would that all judges were so clear-eyed.

Meanwhile, we are planning another work trip.  The destination is Dallas, a bona fide metropolis, and we are hopeful that the “awakening” will be further along.  We will keep you posted.  In the meantime, stay safe out there.

Note:  This case has since been published.  See Cleeton v. SIU Healthcare, Inc., ___ N.E.3d ___, 2021 WL 3399851, at *6 (Ill. App. Aug. 3, 2021).  Add one number to each paragraph citation.  Otherwise the published decision is substantively identical to that discussed here.

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

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


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

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


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

Although federal law requires device manufacturers to report certain adverse events to the FDA, there is no state-law duty to report adverse events to the FDA. . . .  Doctors are warned of the risks associated with a medical device through the device’s labeling, not through adverse-event reports submitted to the FDA.

*          *          *          *

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

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

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

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

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

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

That’s hardly all there is in Ohio.  Two Sixth Circuit opinions under Ohio law are also relevant, Cupek v. Medtronic, 405 F.3d 421, 424 (6th Cir. 2005) (it “is the Federal Government, not private litigants who are authorized to file suit for [FDCA] noncompliance”); Kemp v. Medtronic, Inc., 231 F.3d 216, 236 (6th Cir. 2000) (no claim “premised on false representations to the FDA” is viable).  Moreover, just recently – since the TBI decision – Reynolds v. Medtronic, Inc., 2021 WL 1854968 (S.D. Ohio May 10, 2021), followed Aaron and dismissed similar failure-to-report allegations:

The Court finds that Count 2 must be dismissed. . . .  It fails to state a parallel claim because, in the context of this inadequate warning claim, [plaintiff’s] allegations do not . . . identify state law that parallels federal regulations or requirements that [defendant] allegedly violated. . . .  [T]he federal duty to report certain information to the FDA is not identical, and thus not parallel, to the state-law duty to provide warnings to patients or their physicians.

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

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


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

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

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

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

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

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

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


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

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

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

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

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

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

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

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


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

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

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

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

[Plaintiff] argues the District Court erred in granting [defendant] summary judgment on her failure-to-notify-the-FAA claim. . . .  [Defendant] is entitled to summary judgment on this claim.  [Plaintiff] has attempted to use a federal duty and standard of care as the basis for this state-law negligence claim.  However, . . . Congress has not created a federal standard of care for persons injured by defective airplanes. . . .  “[W]ere plaintiffs to maintain their fraud-on-the-agency claims here, they would not be relying on traditional state tort law which had predated the federal enactments in question. On the contrary, the existence of these federal enactments is a critical element in their case.”  The District Court therefore properly granted summary judgment to [defendant] on this claim.

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

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

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

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

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

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

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

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

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

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

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


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

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


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

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

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

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


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

The federal requirements require that adverse events and other reports be made to the FDA.  Consequently, a common law duty to provide a warning to the public and medical community imposes a requirement additional to the federal regulations. . . .  [S]ince Plaintiff’s remaining failure to warn claim is predicated on [defendant’s] alleged failure to provide required reports to the FDA, authority to enforce that claim rests with the FDA.

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

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

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

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


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

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


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

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

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

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

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

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

Id. at 1039-40 (citations omitted).


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

Well, bless its heart.

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

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

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

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

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

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

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

Putting it all together, Perry held:

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

Id. at 309.

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

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

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

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

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

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

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

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

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

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


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

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

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

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

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


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

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

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

Id. at *4.

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

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

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

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

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

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


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

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

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

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

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

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

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


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

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

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

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

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

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


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

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

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

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

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

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

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

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


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

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

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

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

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

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

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

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

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

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

*          *          *          *

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

Id. at *6-7.

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


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

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

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

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


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

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

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

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

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

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

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

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

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

Nor do Plaintiffs offer any persuasive reason why this Court should permit them to pursue a failure-to-warn claim premised on [defendant’s] alleged failure to submit (unidentified) adverse-event reports to the FDA. . . .  [T]he duty to report adverse events to the FDA exists solely because of the FDCA disclosure requirement.

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

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


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

Nor can a violation be used as evidence of a breach of duty.  While any . . . reports could have been used to alert the FDA of the need to strengthen labels and warnings, the Supreme Court specifically addressed this argument in Mensing.  A federal duty to ask for such help might have existed but state tort law “did not instruct the Manufacturers to communicate with the FDA about the possibility of a safer label.”  Finally, any “useful” reporting − at least from the standpoint of those injured − would ostensibly consist of some sort of warning.

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

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

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

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

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

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

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

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


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


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

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

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

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

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

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

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

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

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

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

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

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


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

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


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

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

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

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

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

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

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

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


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

We start, however, with Marsh v. Genentech, Inc., 693 F.3d 546 (6th Cir. 2012) (applying Michigan law), where the plaintiffs alleged failure to report in an attempt to avoid Michigan’s strict compliance presumption of non-defectiveness.  The Sixth Circuit rejected that claim.  “[T]his alleged wrong was perpetrated upon the agency, and thus implicates [an] inherently federal relationship.”  Id. at 553 (quotation marks omitted).  “Having a court determine whether any non-disclosed information may reasonably affect the statement of contraindications, warnings, precautions or adverse reactions in the draft labeling, would both usurp the agency’s role and go beyond the court’s institutional expertise.”  Id. at 553-54 (citations and quotation marks omitted).  “Although [plaintiff’s] allegations of failure to report are a ‘claim’ against immunity rather than the substantive basis of her tort claim, . . . the nature of [plaintiff’s] underlying substantive claim [wa]s immaterial.”  Id. at 554.  The Marsh decision binds Michigan federal district courts.

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

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

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

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

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

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

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

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


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

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

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

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

Id. at 1160-61 * n.17.  In affirming, In re Medtronic, Inc., Sprint Fidelis Leads Products Liability Litigation, 623 F.3d 1200 (8th Cir. 2010), drew the same conclusion, “alleg[ations] that [defendant] failed to provide the FDA with sufficient information and did not timely file adverse event reports, as required by federal regulations” were not state-law claims, but “simply an attempt by private parties to enforce the MDA.”  Id. at 1205.

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

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

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

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

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

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

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

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

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

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

Id. at 1016.  See Riley v. Cordis Corp., 625 F. Supp.2d 769, 789-90 (D. Minn. 2009) (dismissing failure-to-report claim pre-Angeles; finding no “state-law cause of action under which he would have the right to recover for these failures if the FDCA and its implementing regulations did not exist”).

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


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

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

Id. at 770-71.

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

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

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

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

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

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

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

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

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

Id. at807-08 (citations omitted).

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

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

Id. at 606.


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

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

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

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

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

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

*          *          *          *

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

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

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

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

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

Id. at 314 (citation omitted).

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

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

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

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

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

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

Plaintiffs alleged that Defendant violated its duty to warn the FDA.  They claim that Defendant did not properly . . . report negative results.  Plaintiffs also theorize that this reporting would have indirectly warned physicians of the implants’ dangers.  But Plaintiffs have not identified a state-law duty to comply with FDA-imposed post-approval requirements such as testing and reporting. . . .  [T]he district court properly dismissed Plaintiffs’ failure-to-warn claims.

Id. at 1280-81 (citation omitted).

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


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


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

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

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

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


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

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

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

Id. at 483-84 (citations omitted).

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

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


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

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

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

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

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

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

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


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

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

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

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

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

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

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

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

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

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


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


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

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

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

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

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

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

Id. at 580 (citations omitted).

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

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

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

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

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

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

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

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

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

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

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


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

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

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

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

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

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

Id. at *12.

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