Today’s case was decided back on April 23rd, but just showed up on our radar.  That made us look back to see first what we were posting about on that date (answer:  Lone Pine) and second, what was the world talking about on that date (answer:  Chauvin guilty verdict, surging Covid-19 cases in India, vaccinations; the DC statehood bill; and hate crimes against Asian Americans).  Gutierrez v. Ethicon, Inc., 2021 U.S. Dist. LEXIS 113262 (W.D. Tex Apr. 23, 2021) might not have made headlines like those other events/issues, but it’s a significant pelvic mesh win out of Texas and that warrants a little love from the DDL blog.

After voluntarily dropping some claims, plaintiff’s causes of action could basically be divided into claims based on a (1) failure to warn:  failure to warn, fraud, negligent misrepresentation, and violation of consumer protection laws and (2) design defect.  Defendant moved to dismiss all claims as barred by the statute of limitations which the court denied finding a genuine issue of material fact as to when plaintiff’s cause of action accrued.  Id. at *17-35.  As it’s a fact intensive discussion, we will not address it here.

Defendant also moved to dismiss both the failure to warn and the design defect claims on causation grounds.  On these arguments, the court agreed with defendant.  Texas has adopted the learned intermediary doctrine and in the case of a prescription pharmaceutical or medical device Texas has interpreted that to place two burdens on plaintiff.  First, plaintiff must demonstrate that the warnings were inadequate.  Second, plaintiff must show that had her physician received the alleged adequate warning, he would have changed his decision to use the device.  Id. at *38-39.  To establish the second prong, the causation prong, plaintiff in Gutierrez relied on the implanting surgeon’s testimony that had he been given additional information, he would have shared it with plaintiff as part of the informed consent process.  But under Texas law, that is a “legally irrelevant point.”  Id. at *47.  It does not matter whether the plaintiff would have changed her mind, only whether a different warning “would have changed the decision of the intermediary to prescribe the product.”  Id. at *48.  On that question, the evidence was clear.  Plaintiff’s surgeon testified that defendant’s device has fewer complications than other devices; that knowing what he knows today he would still prescribe the device; that he does not second guess his decision; that he would still present it as a viable option and would still do the procedure today; and that he has no reason to conclude the device is not the gold standard for treating plaintiff’s condition.  Id. at *47.

Plaintiff tried to get the court to follow the reasoning of the Fifth Circuit in McNeil v. Wyeth, 462 F.3d 364 (5th Cir. 2006) which allowed an informed consent-based way for plaintiff to prove warning causation (finding inadequate labeling could be a producing cause of injury if given more information the plaintiff would have rejected the drug).  But relying on McNeil’s prediction of Texas law overlooks that subsequent to that ruling, the Texas Supreme Court decided the issue and opted not to adopt the Fifth Circuit’s interpretation.  In fact, in Centocor, Inc. v. Hamilton, 372 S.W.3d 140 (Tex. 2012), the Texas Supreme Court cited McNeil as standing for a “different proposition” from Texas law.  Gutierrez, at *51.   As a court sitting in diversity, the Gutierrez court was obligated to follow the law as announced by the highest court in the state.  Therefore, plaintiff’s failure to warn claims were dismissed.  The same logic dictated dismissal of plaintiff’s fraud, misrepresentation, and consumer protection claims as they were all premised on defendant’s alleged failure to provide adequate and/or accurate information to the public.  Id. at *53-54.

Texas law forecloses the deployment of creative pleading to circumvent the learned intermediary doctrine. . . . Texas courts must discern the “gravamen” of claims to determine whether they, in truth, simply rehash failure-to-warn theories. Doing so is necessary because if the learned intermediary doctrine could be avoided by casting what is essentially a failure-to-warn claim under a different cause of action such as the DTPA [i.e., a consumer-protection law] or a claim for misrepresentation, then the doctrine would be rendered meaningless.

Id. at *54-55.  Therefore, because the “crux” of plaintiff’s fraud and misrepresentation claims “is really a failure-to-warn theory, the learned intermediary doctrine applies with equal force.”  Id. at *55.

That left plaintiff’s design defect claim.  To prove this claim under Texas law, plaintiff bears the burden of proving there was a safer alternative design and that the defect caused plaintiff’s injury.  Id. at *58.  Texas law further requires that plaintiff prove the safer alternative design reasonably would have “prevented or significantly reduced the risk of plaintiff’s injury and that it was economically and technologically feasible at the time the product left the control of the manufacturer.  Id. at *58-59.  Here, plaintiff lacked the necessary case-specific causation expert evidence that a safer alternative design, in reasonable probability, would have prevented plaintiff’s injuries.  Id. at *60.

Neither of plaintiff’s case-specific experts addressed the issue.  Id. at *61-64.  While the reports talked about plaintiff’s injuries, there was nothing to suggest that an alternative design would have prevented or lessened those injuries.  Evidence that the product injured plaintiff is not evidence that an alternative design would have prevented those injuries.  Plaintiff attempted to rely on her generic experts, but

[s]uch generalized opinions that apply to the entire MDL suit obviously do not suffice to show that alternative designs would have prevented specifically Mrs. Gutierrez’s injuries. Thus, the plaintiffs have failed to put forth evidence supporting the “necessary” showing that alternative designs could have prevented the harms to Mrs. Gutierrez.

Id. at *64.  In fact, plaintiff’s case-specific expert reports point to numerous comorbidities such as age, smoking, prior surgeries, and diabetes.  All factors that complicate her medical history, making proof that a different design would have led to a better outcome especially important in this case.  Id. at *65.

With the underlying claims gone, so too go loss of consortium and punitive damages.  Definitely a case worthy of the blog, even two months later.


The United States Supreme Court in Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001), determined that “off-label usage” is “accepted and necessary” by both the FDA and the medical community.  Id. at 350.  Thus, “[p]hysicians may prescribe drugs and devices for off-label uses.”  Id. at 351 n.5 (citation and quotation marks omitted).  Along these same lines, other courts have held that “[t]he decision to prescribe such ‘off-label usage’ . . . is regarded as a professional judgment for the healthcare provider to make.”  Nightingale Home Healthcare, Inc. v. Anodyne Therapy, LLC, 589 F.3d 881, 884 (7th Cir. 2009) (applying Illinois law).  “[D]octors are free to prescribe a drug for off-label use if they deem it medically appropriate for a patient.”  Bennett v. Teva Pharmaceuticals USA, Inc., 2021 WL 797834, at *2 (D. Del. March 2, 2021).  In light policy-laden holdings such as these, the question arises to what extent does – or should – state tort law presume to require the makers of FDA-regulated products to exercise control over this aspect of medical practice by imposing liability on manufacturers for not preventing medical professionals from engaging in off-label uses that turn out, in retrospect, to injure their patients.

We touched on this topic generally in our a couple of years ago, “Limits to Duty 2.0 − On Product Manufacturers Supervising Doctors,” which itself was an update of our earlier “Limits to Duty” post, so we’ll largely stick to off-label issues this time around.  We start with an older appellate off-label use decision, Swayze v. McNeil Laboratories, Inc., 807 F.2d 464 (5th Cir. 1987) (applying Mississippi law).  Even the term “off-label” hadn’t gained currency back in 1987, so it doesn’t appear in Swayze, but this case involved the claim about allegedly  widespread medical use of “excessive dose[s]” of the defendant’s anesthetic, id., at 470 – a type of off-label use − in operating rooms across the state of Mississippi.  Plaintiffs in Swayze claimed that common off-label use justified creation of a tort duty on the part of manufacturers to “enforce” their warnings against their physician customer, or else “remove its [product] from the market.”  Id. at 471.  Swayze rejected the contention that the defendant should have “compel[led] the medical community to properly supervise distribution of its drug.”  Id. at 465.

Swayze flatly rejected the idea of a tort-mandated negligence “duty” to ride herd over the what amounted to medical profession’s off-label standard of care in using this particular prescription medical products.  First, it was damaging to the physician-patient relationship.  “When the physician-patient relationship does exist, as here, we hesitate to encourage, much less require, a drug manufacturer to intervene in it.”  807 F.2d at 471.

[T]his relationship encompassed much more than the dosage of [the drug that the decedent] would receive. Although in retrospect this decision . . . dwarfed all others, it was an integral part of [a physician’s responsibility. . . .  [I]t is the physicians who have undertaken the responsibility of supervising [drug usage], and that responsibility cannot be shunted onto, or shared with, drug manufacturers.

Id. at 470.

Nor would Swayze “impose upon defendant an additional duty to intrude itself into the hospital operation.”  Id. at 468.  This particular off-label use of “excessive” anesthetic:

does not occur in every operating room in [the state].  The practice appears to be a variable one that depends on the particular diligence of the supervising physician and the resources of the hospital. . . .  It is both impractical and unrealistic to expect drug manufacturers to police individual operating rooms to determine which doctors adequately supervise their surgical teams.

Id. at 471.  Nor was removing the product from the market a workable alternative, since the off-label use “lies with individual physicians” so a manufacturer “cannot control the individual practices of the medical community, even if it is the prevailing practice, and we decline to impose such a duty.”  Id. at 472.

Under the learned intermediary doctrine generally, product manufacturers are not legally required to intervene in medical decision-making.

One in a serious medical condition . . . as a general matter faces unwanted, unsettling and potentially harmful risks if advice, almost inevitably involved and longwinded, from non-physicians, contrary to what the doctor of his choice has decided should be done, must be supplied to him during the already stressful period shortly before his trip to the operating room.

Brooks v. Medtronic, Inc., 750 F.2d 1227, 1232 (4th Cir. 1984) (applying South Carolina law).  Accord Glennen v. Allergan, Inc., 202 Cal. Rptr. 3d 68, 83-84 (Cal. App. 2016) (a “manufacturer of a prescription medical device has no to train a physician” because a it “is not responsible for the practice of medicine”) (citations and quotation marks omitted); Small v. Amgen, Inc., 134 F. Supp.3d 1358, 1372 (M.D. Fla. 2015) (manufacturer has “no duty to provide guidance” to prescribers); Chao v. Smith & Nephew, Inc., 2013 WL 6157587, at *4 (S.D. Cal. Oct. 22, 2013) (There is no “duty, beyond providing a warning, to dissuade a physician from using a device on a particular patient.”); Greenwood v. Tehrani, 2017 WL 4083099, at *2 (N.Y. Sup. Sept. 15, 2017) (“the manufacturer is not responsible for how the physician uses the device and renders the medical care”) (citation omitted).

Cases explicitly addressing off-label use make the same point – that a physician’s choice to use a prescription medical product off-label does not expand a manufacturer’s liability or create any obligation to prevent off-label use from occurring.  Lack of FDA labeling “for that use did not bar Defendants from selling the device to . . . other physicians who could then decide how and when to use [it].”  Healey v. I-Flow, LLC, 853 F. Supp. 2d 868, 880 (D. Minn. 2012).  There was “ “no authority . . . that it was inappropriate for [defendant’s] sales representative to educate an orthopedic surgeon who chose to use the [device] in this off-label manner.”  Id. at 881

Under the FDCA, manufacturers can continue marketing products they know could be put to off-label uses.  “FDA would not regard a firm as intending an unapproved new use for an approved or cleared drug or device based solely on that firm’s knowledge that its product was being prescribed or used by healthcare providers for such use.”  82 Fed. Reg. 14319, 14320 (FDA March 20, 2017).  The common law has been similar.  “[K]nowledge that the prescribing doctor intends an off-label use” is ordinarily an insufficient basis for imposing liability on a manufacturer.  Carson v. Depuy Spine, Inc., 365 F. Appx. 812, 815 (9th Cir. 2010) (applying California law).  In Davenport v. Medtronic, Inc., 302 F. Supp. 2d 419 (E.D. Pa. 2004), the court likewise found no duty to prevent off-label use:

[The Court finds no basis for [plaintiff’s] secondary negligence claim that [defendant] was negligent in “allowing bilateral implantation . . . when [it] knew that the FDA had allowed only unilateral implantation of the device.” . . . This aspect of the negligence claim also fails because [plaintiff] has failed to produce any evidence or authority that shows that [defendant] was prima facie negligent in allowing [plaintiff’s surgeon] to perform a bilateral implant. . . .  Neither party disputes that the bilateral implant of the [product] qualified as an “off-label” usage (i.e. use of a device for a purpose that has not been approved by the FDA). . . .  While the FDA controls the marketing and labeling of medical devices, it does not attempt to interfere with the practice of medicine. . . .  Courts have dismissed similar claims at summary judgment that were based on a manufacturer allowing a physician to use a medical device in an “off-label” manner.

Id. at 439-40 (citations and quotation marks omitted).  Davenport cited Little v. Depuy Motech, Inc., 2000 WL 1519962, at *9 (S.D. Cal. June 13, 2000) (a doctor’s “decision to use [a manufacturer’s] device in an ‘off-label’ manner does not subject the manufacturer to liability, even if it knows of the off-label use”; a manufacturer “cannot be held liable for [a physician’s] decision to implant the [manufacturer’s] device in an off-label manner”); and Cox v. Depuy Motech, Inc., 2000 WL 1160486, at *8 (S.D. Cal. March 29, 2000) (“[a] seller is not liable even if it knows of the off-label use”).

Similarly, courts have refused to impose any legal duty on prescription medical product manufacturers to take affirmative measures to prevent their physician customers from using their products off-label.  This issue was presented most starkly in Kennedy v. Medtronic, Inc., 851 N.E.2d 778, 786 (Ill. App. 2006), where a physician placed a left-side pacemaker lead on the right-hand side of the heart.  Id. at 780.  Plaintiff sued, alleging that the device manufacturer – through a representative who attended the implantation − had a duty to stop the surgery (done on an out-patient basis at the decedent’s insistence) from being performed.  Id. at 785.  The court found no such duty.  First, “[f]ind[ing] the burden and consequences of imposing the duty proposed by plaintiff to be substantial.  It would be a significant burden to require [defendant] to monitor the conditions under which a doctor performs surgery.”  Id. at 786.  Second, “a licensed physician . . ., has the knowledge of his patient’s medical history and background, and, therefore, he is in a better position, utilizing his medical judgment, to determine a patient’s needs and what medical care should be provided.”  Id.  Third, “[i]t would be unreasonable, and potentially harmful, to require a [manufacturer’s representative] to delay or prevent a medical procedure. . . .  To hold otherwise would place a medical device manufacturer . . ., in the middle of the doctor-patient relationship.”  Id.  And fourth, “the consequences of requiring such screening by [a manufacturer] would run the risk of imposing additional liability . . . in the event it determined a physician was not in a position to properly implant a device, refused to provide one, and the patient suffered adverse medical consequences because he did not have access to a needed device.”  Id.

Thus a prescription medical product manufacturer has no duty to interfere with physician’s “practice of medicine” in using its product in an off-label manner.  Davenport, 302 F. Supp. 2d at 439-40.  “[A] manufacturer has no affirmative duty to intervene in order to prevent off-label use of [a] product by a surgeon.”  Seavey v. Globus Medical, Inc., 2014 WL 1876957, at *9 (D.N.J. March 11, 2014).  “Once the doctor’s clinical judgment is introduced as the determinative factor in the decision making process, it must be apparent that this data [in the label] serves as a recommendation, not a limitation or prohibition.”  United States ex rel. Polansky v. Pfizer, Inc., 914 F. Supp. 2d 259, 264 (E.D.N.Y. 2012), aff’d, 822 F.3d 613 (2d Cir. 2016).  “[T]he decision as to use a medication as a first-line treatment is uniquely up to the prescribing medical professional.”  In re Chantix (Varenicline) Products Liability Litigation, 881 F. Supp.2d 1333, 1340 (N.D. Ala. 2012).  The same is true of non-physicians.  In Tavilla v. Blue Cross & Blue Shield, Inc., 2014 WL 4473638 (Ariz. App. Sept. 11, 2014), a health insurer was not required to prevent its insureds from receiving off-label therapy.

[A]lthough [defendant] retained the right to refuse to pay for off-label prescriptions, the [policy] did not obligate [it] to do so.  Through their argument, [plaintiffs] attempt to place on [defendant] an obligation it did not expressly or impliedly assume − that of protecting [them] from the decisions of their medical providers or otherwise interfering with their medical care.

Id. at *5.  “[T]here is no duty for [defendant] to deny coverage of a medication because the medication could be harmful or addictive. T o impose such a duty would put [it] squarely between the insured and the insured’s own physician.”  Id. at *5 n.10 (citation and quotation marks omitted).

This rationale extends to manufacturer’s representatives.  A manufacturer’s representative is not subject to liability merely for knowing that intended treatment would involve off-label use:

“[O]ff label use,” within the context of medical treatment is not prohibited, as the FDCA does not regulate the practice of medicine. . . . [The prescribing surgeon’s] exercise of medical judgment was within [his] discretion, and [he] was free to do what [he] did. . . . [E]ven if such a claim [for off-label promotion] were present in this case, there is no private right of action for violations of the FDCA. There is a complete absence of evidence as to any claim for negligence based on “off label” marketing and promotion by [the sales representative].

Wolicki-Gables v. Arrow International, Inc., 641 F. Supp. 2d 1270, 1292 (M.D. Fla. 2009), aff’d, 634 F.3d 1296 (11th Cir. 2011).  Thus, such a representative’s alleged “calculated silence” during off-label treatment is not actionable:

Plaintiff’s claim that [defendant’s] representative allowed “the misuse of the product through calculated silence” is insufficient to create an issue of material fact for trial as to failure to warn.  Plaintiff . . . has cited no law indicating that “calculated silence” that fails to prevent a doctor from using a device off-label, is the equivalent of off-label marketing.

Seavey, 2014 WL 1876957, at *9.  See also Rohlik v. I Flow Corp., No. 7:10-CV-173-FL, 2011 WL 2669302, at *3 (E.D.N.C. July 7, 2011) (finding no fraud where sales representative “watched” off-label surgery being performed).

Thus, as Bexis explained in his recent off-label use law review article:

A physician’s choice to use a prescription medical product off-label does not expand a manufacturer’s liability or create any obligation to prevent off-label use from occurring. . . .  No legal duty is imposed on FDA-regulated manufacturers to take affirmative preventive measures against physicians’ off-label use of their products.

James M. Beck, “Off-Label Use in the Twenty-First Century:  Most Myths & Misconceptions Mitigated,” 54 UIC J. Marshall L. Rev. 1, 102 (2021) (footnotes omitted).

We close with a recent case that, like Swayze, was about off-label use but did not use that terminology.  Teva Parenteral Medicines, Inc. v. Eighth Judicial District Court, 481 P.3d 1232 (Nev. 2021), involved a physician’s improper reuse of “single patient vials,” thereby causing an infection risk.  Id. at 1238.  As a result, several hundred plaintiffs – none of whom was actually injured, id. (“all tests came back negative”) − sued for medical monitoring-type injuries.  This litigation has been around, in one form or another, for a while.  The offending doctor was dead, and the clinic bankrupt, so the plaintiffs targeted the manufacturers of the generic drugs allegedly “misused.”  Generic drug litigation equals preemption, so to avoid dismissal, plaintiffs invented a novel theory that defendants “knew” of the off-label use and thus had a duty not to sell the larger of two drug sizes to this particular customer because the larger size was more likely to be reused.  “Under plaintiffs’ negligence theory, [defendants] had a duty under state law not to package, market, or sell [larger] vials . . . to [this particular doctor’s clinics].”  Id. at 1242.

Literally without citing any Nevada, or other state-law, precedent at all – only the Supreme Court’s generic preemption cases – the court in Teva allowed the theory to proceed.  It held the claim was “not preempted even if it required [defendants] to change their vial size . . . because petitioners already have approval for that smaller vial size.”  Id.

But does such a duty, on the part of a prescription medical product manufacturer, to take the drastic step of refusing to deal with a customer “known” to be using the product off-label actually exist under state law?  We don’t know.  There’s not a sentence, or a citation, in the entire Teva decision addressing state-law ramifications of the novel (we’ve read a lot of cases and have never seen this theory before) duty that the plaintiffs claimed.


We’re not sure, but the reason may be the limited issue before the court in Teva, which was a mandamus action rather than an ordinary appeal:

This original petition for a writ of mandamus arises from lawsuits brought against generic drug manufacturers. . . .  The question presented to us is whether the plaintiffs’ state-law tort claims are preempted by federal drug regulations.

Id. at 1237.  It could be that (although never clearly expressed) the Teva court simply assumed that whatever bizarre duty the plaintiffs made up existed under state law.  In this respect, Teva resembles Hughes v. Boston Scientific Corp., 631 F.3d 762 (5th Cir. 2011) (discussed in more detail in our second failure-to-report post), in that the court simply “assumed” the relevant state law duty for preemption purposes, id. at 769, only for it to turn out later that the assumed duty did not actually exist (having been legislatively abolished).  See Knoth v. Apollo Endosurgery US, Inc., 425 F. Supp.3d 678, 694 (S.D. Miss. 2019) (discussing abolition).  One can hope, anyway.

What is certain is that Teva was not argued or decided as an off-label use case, although the use of the product alleged was precisely that.  Thus, all of the law cited above weighs against actually recognizing the hypothetical duty to prevent off-label use postulated in Teva.

No good deed goes unpunished.  One of our very first cases was a pro bono case for the Red Cross following a Northern California earthquake.  The Red Cross gave a local homeowner money to repair her home.  It was a gift.  No strings attached.  Please, take our money and fix your house.  Live long and prosper.  Well, the homeowner used a contractor who promised to hire the homeowner’s kids, and when the work was lousy (predictably), what did the homeowner do?  She sued the Red Cross.

We won on a motion to dismiss, but the charitable organization defendant in Hagerman v. Pfizer, Inc., No. 3:20-05108, 2021 WL 2383718 (W.D. Mo. June 10, 2021), was not so lucky.  The Hagerman plaintiff was bitten by a dog on her middle finger, and after a couple months of treatment, the plaintiff’s doctor concluded that she probably had a bone infection (osteomyelitis).  Id.  The doctor therefore recommended an antibacterial drug, for which peripheral neuropathy is a known complication.  Id.

It is a pretty unremarkable story so far, but here is the rub.  The plaintiff had no medical insurance, so the doctor’s office contacted the drug manufacturer’s “RSVP” program to get the drug for free.  We don’t know much about the “RSVP” program, but we see commercials on TV where they say “if you can’t afford your medication, [fill in the company] can help.”  That is what the plaintiff received here—a free 28-day supply, with a later extension of up to 12 months.  Id.  When the plaintiff later experienced symptoms of peripheral neuropathy, she sued the drug manufacturer for strict liability-failure to warn and negligence.  Id.

She also sued the manufacturer-affiliated foundation that runs the RSVP program—which neither made nor sold the drug and, like our former pro bono client the Red Cross, arranged for the plaintiff to receive something from someone else for free.

We have no doubt that the RSVP program will get out of this case at some point (and so too should the manufacturer if the evidence shows that peripheral neuropathy is a known complication).  But for the time being, the plaintiff’s boilerplate allegations carried the day, and the Missouri-based federal court denied both defendants’ motions to dismiss.  Id.

On strict liability-failure to warn, the RSVP program argued, obviously, that it is a charitable foundation that did not make, did not sell, and did not distribute the drug.  Id.  The plaintiff’s complaint, however, said otherwise, making “such questions . . . better reserved for summary judgment after a factual record has been established.”  Id.  The court also rejected the argument that charitable organizations cannot be strictly liability because they lack profit motives.  Id.  We understand these rulings, but they seem so unnecessary.  There must have been something in the complaint or available through judicial notice established that the foundation did not make the product.  It is not like the plaintiff was lacking for a defendant—she named the manufacturer in this civil action, and she also filed “a previous lawsuit” presumably against her doctor.  Instead, the foundation is stuck developing a “factual record,” which means discovery.

On negligence, the RSVP program owed this plaintiff no duty.  (That is the basis on which we got the Red Cross off the hook in our post-earthquake pro bono case.)  The district court, however, again treated the program the same as the manufacturer and cited a duty to warn doctors of drug risks.  Id.  The court also credited the plaintiff’s “allegations and arguments . . . that the defendants through their actions, assumed a duty.”  Id.  The court did not further describe those “allegations and arguments,” but we suspect it is some version of a duty based on negligent undertaking.  In the end, the court acknowledged that “[w]hile the additional negligence claims asserted by Plaintiff may be foreclosed for lack of duty, the Court believes such determination is better suited at summary judgment.”  Id.

Again, we expect that these defendants will return with a strong summary judgment motion, but in the meantime, we will chalk this up to one of Bexis’ oldest aphorisms:  “Nothing good ever comes out of Missouri.”  At least Missouri has fewer earthquakes.

Today we report on Black v. DJO Glob., Inc., — P.3d —-, 2021 WL 2346038 (Idaho 2021), a short and sweet decision rejecting yet another plaintiff’s attempt to maintain a product-liability claim without evidence of a defect in the medical device at issue. Holding that neither the “malfunction theory” nor the related res ipsa loquitur doctrine excused the plaintiff’s failure to produce evidence of a defect, the court affirmed summary judgment in favor of the defendant manufacturer.

The Black plaintiff claimed that she suffered burns when undergoing interferential current therapy, which treats patients by electrically stimulating nerves and muscles. The plaintiff alleged that her injury was caused by defective electrode pads.

Because the electrode pads were disposed of after their use, the plaintiff had no direct evidence that the electrode pads were defective. The plaintiff argued that she did not need to produce such evidence to avoid summary judgment because a defect could be inferred under the “malfunction theory” or the res ipsa loquitur doctrine. As already noted, the court rejected the plaintiff’s contention.

Under Idaho’s “malfunction theory,” a plaintiff who lacks “direct evidence of an identifiable, specific defect” can still prove a defect through “evidence of a malfunction … and the absence of evidence of abnormal use and the absence of evidence of reasonable secondary causes which would eliminate liability of the defendant.” Black, 2021 WL 2346038, at *4. To invoke the malfunction theory, however, a plaintiff must “demonstrate that the product ‘malfunctioned.’” Id. at *5. To do so, “the product at issue must be of a type which permits a jury to infer that an injury would not have occurred had there not been a defect attributable to the manufacturer.” Id.

The Black plaintiff’s reliance on the malfunction theory foundered on that requirement. She conceded that—as stated in the relevant operating manual—“burns are a known side effect associated with electric stimulation therapy and carbon electrode pads.” 2021 WL 2346038, at *5. But the fact that she “suffered an injury that is the precise type of injury that is known to result from” use of the device at issue “precludes a jury from inferring that ‘an injury would not have occurred … had there not been a defect attributable to the manufacturer.’” Id. (quoting Farmer v. Int’l Harvester Co., 553 P.2d 1306 (Idaho 1976)). Consequently, the court concluded, the plaintiff had failed to “carry her burden of demonstrating that the electrode pads malfunctioned” and summary judgment was properly entered against her.

Moreover, the court held that the result would be identical under the res ipsa loquitur doctrine. The court explained that “[t]he doctrine of res ipsa loquitur is applicable when two elements co-exist: (1) the agency or instrumentality causing the injury was under the exclusive control and management of the defendant; and (2) the circumstances were such that common knowledge and experience would justify the inference that the accident would not have ordinarily happened in the absence of negligence.” The court found that the plaintiff failed to establish either of these necessary conditions. Indeed, the plaintiff could not get past the first hurdle because “the electrode pads were not under the exclusive control and management of” the defendant manufacturer. 2021 WL 2346038, at *6. And, even if they had been, the plaintiff’s injury was, as the court previously found, not the sort that “would not have occurred had there not been a defect attributable to the manufacturer.” Id. Accordingly, summary judgment was justified on this ground too.

As noted, the Black court is the latest court to rightly reject a plaintiff’s attempt to use the malfunction theory or the res ipsa loquitur doctrine to avoid dismissal of product-liability claims involving a medical device. For discussions of previous cases holding the malfunction theory and the res ipsa loquitur doctrine inapplicable in such cases, see our earlier posts here, here, here, here, here, here, here, and here, for example.

We are recovering from a near-trial experience. It settled at the beginning of jury selection, and with that settlement came the usual mixture of relief and letdown. Colleagues congratulate you on the resolution, and you’re not sure what to say. It was certainly a good settlement for the client. But our team had worked up a hearty contempt for the plaintiff lawyer’s arguments and the plaintiff experts’ prevarications, and we were looking forward to setting some traps. In any event, we’re past that emotional stew now, and have turned to reflection.

The case was in California state court and was a “preference” matter. That means that the plaintiff submitted a doctor’s affidavit that she could die fairly soon and, therefore, needed a trial date much earlier than would ordinarily be assigned. We can see the fairness of the preference category. People should get their day in court. Nevertheless, there is a problem. You would expect the preference schedule to result in a compression of discovery and briefing, but it gets much worse than that. In our case, the plaintiff lawyer filled the back-end of the schedule with new theories of exposure, new evidence of alleged product defects, and new varieties of injuries. It was sandbagging at its worst. The judge understood the plaintiff lawyer’s manipulations and didn’t like them one bit. He recognized that the plaintiff lawyer’s eleventh hour somersaults created unfairness and meant that the case was not truly trial ready by the preference date, but what could he do? He did his best.

But today’s post is not meant to be a screed against the California preference system. Rather, we are going to share some ruminations on Zoom litigation. As the late, great Aretha Franklin asked,”Who’s Zoomin’ Who?” The answer is darned near everybody, including courts in jurisdictions concerned about its Covid numbers. This trial was going to be conducted on Zoom. It had already been a throughly-Zoomed litigation. Meetings, depositions, and hearings had all taken place via Zoom. We tied our half-Windsor knot at 11:50 am each day, fired up the computer in our home office 3,000 miles away from the courthouse, and logged into morning (Pacific time) festivities.

What are our impressions of Zoom law? As Larry David would say, “pretty, pretty, good.” Of course, we did not stick around for trial, so we cannot offer observations on that. One of our partners was a defense lawyer in what might have been the very first Zoom trial. He won. So you’d think he’d adore Zoom trials. Not so. He thinks Zoom trials amount to deprivations of due process. There will always be technical issues afflicting lawyers, witnesses, or jurors, adding up to delays and confusion. Moreover, juror inattention is unavoidable. That is true for in-person trials as well, but folks now are too prone to view a monitor as something that accompanies, not supplants, the rest of life’s entertainments.

We got a whiff of this problem during juror hardship hearings. We saw jurors driving. We saw jurors wandering around their houses. Some seemed distracted by something else. We bet a couple of them were watching Below Deck or Impractical Jokers on another screen. One way the court employed to combat Zoom fatigue was to limit the trial day to 9-1:30, four days per week. That meant, of course, that the length of trial would inevitably increase significantly. Consequently, more jurors claimed hardship exclusions. If that tilted the jury pool at all, it was probably not good for the defense. Then again, some jurors begged off because they lacked either the requisite technology or tech knowledge. The court would permit jurors to come to the courthouse if they needed help. All jurors would be loaned chrome books, scrubbed clean of anything that might distract.

It is by no means self-evident that juror distraction would hurt the defense more than the plaintiff. It occurred to us that the literal remoteness of the trial might drain some of the emotion out of the case. Family and friends would not be visible except when they testified. But for us, whether Zooming ends up being a net plus or minus for the defense resides in the realm of mere speculation.

We do not need to speculate about depositions. In our estimate, Zoom depositions are at least 70% as good as in-person depositions. The absence of physical proximity turns out not to be such a big deal. Rarely do we intimidate anyone anyway.

That being said, we are not very satisfied with the deployment of document exhibits in a Zoom deposition. It is inherently a clunky process. It is a pain if you are the interrogator, but it is much worse when you are defending. The questioner does the usual pointing to a particular sentence in a document. You probably did a good job of training your witness to flip through the entire document and see whether the witness wrote it or received it, whether the document was a draft, whether the document was complete, whether it was acted upon, or whether there is something else in the document supplies crucial context. But flipping through a document on screen is a hard slog. We typically seek either advance notice of documents or provision of hard copies. The other side typically resists. The oft-cited concern is the elimination of surprise. One solution is to send the witness a sealed box, with instructions not to open until directed to do so during the deposition. But that does not do much to help the defending attorney (assuming he or she is in a different location than the witness).

For these and other reasons, we are inclined to try to attend in person for particularly important depositions. For example, prescriber depositions might push us to board a plane. Think back on our feeling that Zoom depositions are 70% as good. Maybe we can do 70% of our depositions remotely, but insist on doing 30% in person. That is assuming that Covid-19 really is releasing its hold on us.

Zoom hearings were mostly just fine. Occasionally people spoke over one another. Or some dunce (including the author of this post) would blather on without realizing the mute button was lit. We recently attended one hearing – not for the California trial – in which an apparent hiccup in the technology fooled a lawyer into inadvertently interrupting the judge. The judge grew inordinately angry and threatened to revoke the lawyer’s pro hac admission. It was a plaintiff lawyer who prompted the judicial ire, so we sat at home in our blazer, tie, and shorts, brimming with schadenfreude. And yet, it could have been us. In fact, once it was us. In a particularly important Zoom motion hearing, we hit the red “leave meeting” button prematurely. The court recessed to afford time for us to get a clue and get back onto the Zoom hearing. Our blush was completely visible even in gallery view.

The issue of appearance on the Zoom screen is not trivial. You want your face to be in the center of the screen, and not be scarily huge or pin-sized. The plaintiff lawyer in our case used separate Zoom setups for hearings vs actual trial. For hearings, he was in his office, looking at the camera at an odd angle. His head would be way over on the left side of the screen. Good. It seemed to be a visual reflection of the fact that his arguments were one-sided and off the mark. Once a jury was involved, the plaintiff lawyer was well centered in front of a white board. We imagined he would make splendid use of that white board, but the stark contrast of his head against it when it was not in use reminded us of a mugshot. Again, good. Another plaintiff lawyer had the camera way down low, looking up at him against a black background. He looked like the Prince of Darkness. It was beautiful. But someone must have talked with him, because the Lucifer look was rectified just as voir dire commenced.

You need to be well lit on Zoom. That means you must be lit from the front, not the back. Buy a halo light (or two), clip it onto the monitor or position it on a tripod over or alongside the monitor, and start looking more like an authoritative Sunday morning TV talking head and less like a member of the federal witness protection program.

Those TV talking heads are usually very careful about their backgrounds. Too many offer cheesy advertisements of their books, positioned cover frontside on their shelves in a way that no one would do if they were normal. We resisted the impulse to fill our back wall with DDL posts or our lawyer softball league participation plaque. Let’s get real: the best background is no background. Our trial graphics consultant took a look at the background in our home office and suggested massive decluttering. Goodbye, Phillies pennant. Goodbye, oddly positioned red milk crate overflowing with printer cartridges. Hello, blandness. You do not want to communicate anything distracting or potentially off-putting. (The consultant also advised us not to drink from Poland Spring water bottles, as some jurors would consider us wasteful. Yikes.) The best Zoom background, and the one used by many of our codefense lawyers, was the blurred effect. For whatever reason, our MacBook did not offer that option.

And then there is the etiquette question of when one can go off the video. Out of sight is out of mind. Maybe you want a low profile. Or is it disrespectful? Clearly, we need an Emily Post book with rules regarding Zooming in various settings.

We are hardly suited to author such a rule book. All we can do is endorse Zoom as a decent tool for most aspects of litigation. In a year when cutting back on travel was mandatory, Zoom was vital. Further, pandemic or no, Zoom simply has to be considered as a way of reducing inconvenience and expense. Will reduced expense lead to more efficient litigation? Or will it actually promote proliferation of litigation? Will more plaintiff lawyers notice and attend Zoom depositions to run up the ridiculous “common benefit” bill? Who’s Zoomin’ who, indeed.

Lots of cases get parked in MDLs.  There is no denying it.  It’s built into the system.  Individual cases get brought together in a single court for the purpose of consolidated pretrial proceedings.  For the most part, except for cases selected as bellwethers, that means MDLs are focused on general discovery, general experts, and general legal rulings.  Things that apply to cases across the litigation.  With the lack of case-specific discovery and work-up, for some plaintiffs MDLs may seem like little vacations.  Someplace to kick back, check out the sights, and wait to see how things shake out.  But plaintiffs should be paying close attention because MDLs are not Vegas — what happens in an MDL does not stay in an MDL.  Does it really stay in Vegas either?

If a litigation reaches the point of remanding cases to their home jurisdictions, those cases come with baggage – the rulings from the MDL.  In fact, MDL judges prepare remand orders precisely to let remand judges know what happened during the MDL and what is left to accomplish post-remand.  Imagine someone documenting your Vegas excursion and then preparing a concise and precise accounting of the key events of that trip for all your family and friends back home.  No keeping Michael Bolton karaoke night swept under the rug.  Likewise in an MDL, what is past is in fact prologue.

That brings us to today’s case – Blackwell v. C.R. Bard, 2021 WL 2355393 (N.D. Tex. Jun. 9, 2021).  We’ll start with a prologue ourselves.  Following surgery, plaintiff was implanted with an IVC filter to aid in preventing blood clots from traveling to the heart and lungs.  Id. at *1.  A few weeks after implant, plaintiff returned to the hospital where he was diagnosed as having a clot “at, near, or directly on the IVC filter.”  The clot prevents the filter from being removed and plaintiff will likely have chronic pain and swelling.  Id.

While the case was part of the In re: Bard IVC Filters Products Liability Litigation, the parties conducted general fact and expert discovery.  The remand order advised that “courts receiving these [transferred] cases need not be concerned with facilitating general expert, corporate, and third-party discovery,” as that had already been completed.  Id. at *2.  There was a narrow exception.  General experts could supplement their reports to “add medical literature published since 2017 . . . and expand their MDL trial testimony to include a discussion of such new literature.”  May 10, 2021 Order in Blackwell at p. 2.

Post-remand, plaintiff in Blackwell identified one of the MDL general experts, Dr. Garcia, as a general expert in this case.  However, plaintiff also introduced a new general expert report from Dr. Garcia.  In his new report, Dr. Garcia added a new opinion that IVC filters can cause clots on and around the device itself.  Id. at p. 3.  Because that opinion was not disclosed in the MDL, Dr. Garcia’s new report was not a “supplement,” and therefore violated the MDL’s order closing general expert discovery.  Id. at p. 4.   The court excluded Dr. Garcia’s new opinion.   This sounds to us like while plaintiff was “parked” or “vacationing” in the MDL, he had not paid attention to the fact that the general causation evidence offered by plaintiffs collectively failed to include the type of injury he suffered. His attempt to modify that post-remand was blocked, correctly, by the remand court.  Without general causation evidence, this case was already on shaky ground, but the ultimately, the court had numerous other avenues to reach summary judgment.

First, plaintiff’s warning claims failed because plaintiff suffered an injury that defendant warned about.  The instructions for use (IFU) that accompanied the IVC filter specifically included a warning identifying thrombosis and occlusion as potential complications that “have been associated with serious adverse events.”  Blackwell, 2021 WL 2355393 at *4.   Therefore, the court found defendant’s warning adequate as a matter of law.  Id.  Plaintiff’s argument that other courts had ruled differently was brushed aside because plaintiff offered no evidence of how the record before the other courts was similar to the one in this case.  Id.

Further, plaintiff chose not to depose his implanting surgeon.  The court makes clear that it was a choice, noting the doctor is still practicing at the same hospital and was easily found.  Id. at *6n.5.  Because of that choice, plaintiff had no evidence that his surgeon ever saw or read defendant’s warning.  Therefore, regardless of adequacy, the warning could not have been the cause of plaintiff’s injury.  Id. at *5.  Plaintiff tried to rely on a patient brochure that his surgeon allegedly gave him, but that is still not evidence that the doctor himself read or relied on the brochure.  Id.

Finally, plaintiff’s only remaining claim was for design defect.  On this claim, plaintiff relied on his case specific expert.  That expert submitted an original, timely report and then submitted one seven months later, the day before plaintiff’s motion for summary judgment was due.  In the new report, plaintiff’s expert for the first time opined that a different type of filter was a safer alternative design – an essential element of a design defect claim under Texas law.  Id. at *6.  But, in an earlier decision, the court had already struck the new report as untimely.  Therefore, plaintiff did not have the necessary expert evidence of a safe alternative design to support his design defect claim.

Plaintiff missed general causation while the case was in the MDL, missed deposing the surgeon after remand, and failed to include a key element in his case specific report.  So, while he was trying to undo what was already done in the MDL, he neglected to do the case specific work he was supposed to do.  If vacation mistakes are going to follow you home (like getting your nose pierced), at least you should try not to compound it with more mistakes at home (as if bangs were going to distract from the nose ring!).

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.  Gaross 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.

We are going to Peoria next week.  On an airplane.  Ordinarily, this would not be newsworthy, but we are irrationally excited to be taking this step toward normalcy.  We have long comforted apprehensive young lawyers by assuring them that any event provoking fear would soon recede into the past tense.  The last year did not lend itself to that advice, and we are overjoyed and grateful to be looking backward at it.

Perhaps this mood contributed to our pleasure when we read today’s case.  But we think Johnson v. C.R. Bard Inc., 2021 U.S. Dist. LEXIS 97665 (W.D. Wisc. May 24, 2021) would have made us happy in any event.  Johnson is a decision on motions in limine in a remanded IVC (inferior vena cava) filter case.  Both sides filed motions, most of which will sound familiar to anyone working in the mass tort space, and many of the holdings are really good, with some nice rhetoric to boot.  Here are some highlights:

Defendants’ Motions

  •  Motion to Exclude Evidence of Reports of Deaths Associated with a Different Filter and Evidence of Marketing, Communications, and “Bad Acts” Related to That Filter

The defendants moved to exclude evidence related to reports that their earlier first-generation filter (this case involved the fifth-generation filter) allegedly caused death by migrating to patients’ hearts.  The defendants argued that the plaintiff was not implanted with the implicated filter and that her filter had not migrated to her heart or to any other organ, making any reference to the earlier filter “both irrelevant and highly prejudicial.”  Johnson, 2021 U.S. Dist. LEXIS 97665 at *4.  The plaintiffs countered that the implicated filter was “the first in a series of [the defendant’s] filters that failed in ‘substantially similar’ migrations.”  Id.  (Under Wisconsin law, a court may admit evidence of “other accidents” but only if the accident occurred under ‘substantially similar’ circumstances.)  Citing a string of cases holding that reports of deaths caused by migration of the earlier filter were not ‘substantially similar’ to claims of non-fatal fracture of later generations of filters, the court “likewise concluded” that the alleged migration deaths and the plaintiff’s alleged injuries “did not occur under substantially similar circumstances.  As such, “any marginal relevance would be outweighed by the danger of unfair prejudice to defendants,” and the court denied the motion unless the defendants opened the door by disputing notice of the potential for the plaintiff’s filter to migrate.

The defendants filed a related motion to exclude “irrelevant and prejudicial” evidence of marketing, communications, and other purported ‘bad acts’ responding to deaths allegedly involving the earlier filter.  The court concluded, “Having decided that [the earlier] deaths are not substantially similar to the incident in the present case, the court will not admit efforts to explain them away, however ham-handed the attempt, given the prejudicial confusion that would likely engender.”   Id. at *8-9.   We love “ham-handed.”  Even more, like everyone who represents medical device manufacturers with long histories of marketed products, we love this result.

  • Motion to Exclude References to Other Lawsuits and Trials

The defendants moved to exclude evidence of other lawsuits involving its filters, along with evidence that witnesses had testified in multiple cases.  The plaintiff objected, arguing that this evidence would be relevant to show that [the] defendants knew or should have known about the risks associated with their filter “and to explore the credibility of witnesses by using their prior statements.”  Id. at *9-10.   The court held, “Plaintiff’s argument is not just disingenuous but bolsters defendants’ motion. . . . The mere existence of other related lawsuits, including ones in which no judgment was entered against defendants, has minimal if any probative value as to the foreseeable risk of harm posed by the . . . filter, although the risk of unfair prejudice is great.”   Id. at *10.  Moreover, the court held, the parties could explore witnesses’ credibility by making general references to their “prior testimony,” without mentioning specific prior lawsuits.

  • Motion to Exclude Testimony Related to Damages During the Liability Phase of Trial

Earlier, the magistrate judge had bifurcated the trial into liability and damages phases.  The defendants moved to preclude the plaintiff from introducing evidence about her alleged damages during the liability phase.  The court held, “Although seemingly unnecessary given [the magistrate’s] earlier ruling, defendant’s motion is perhaps wise, as plaintiff’s opposition indicates that she believes that the bifurcation extends only to the issue of punitive damages.”  Motion granted.

Plaintiff’s Motions

  •  Motion to Preclude Any Suggestion that the Defendant’s Filter Saved the Plaintiff’s Life or that the Filter Was a “Lifesaving Device”

The plaintiff moved to preclude the defendants from arguing that the filter was a “lifesaving device,” because she was implanted with the defendant’s filter “as a precaution,” and there was no evidence that the filter ever caught a blood clot.  The defendants countered that they “should be able to reference the . . . [filter’s] general ability to save lives to contextualize the product and to establish the medical benefits of the filter, as well as to introduce evidence of [the plaintiff’s] medical history and the reason the filter was implanted.”  Id. at *23.  The court agreed, holding, “. . . [D]efendants’ proposed evidence is probative and is not outweighed by unfair prejudice or other considerations. . . . [E]vidence is not irrelevant and unduly prejudicial merely because it conflicts with one party’s side of the story.”  Id. at *23-24 (internal punctuation and citation omitted).  Motion denied.

In a related motion, the plaintiff moved to preclude the defendants from introducing evidence that their filter “save[d] lives or provided a clinical benefit.”  The defendants countered that they should be permitted to reference the filter’s “ability to save lives to contextualize the product and to establish the medical benefits of the filter.”  Id. at *39.  The court sided with the defendant, holding the defendants should be permitted to respond the plaintiff’s “design defect” and “inadequate warnings” arguments with evidence of the filter’s medical benefits.  The court went on to comment that the plaintiff had not demonstrated that the probative value of the evidence was outweighed by unfair prejudice, and that the alleged weakness of the “medical benefit” evidence went to the evidence’s weight and not to its admissibility.

  •  Motion to Preclude Medical Witnesses’ Anecdotal Testimony

The plaintiff moved to exclude anecdotal testimony by medical witnesses “about their experience with patients who have died of pulmonary embolism,” the condition the filter is designed to prevent.  The court denied what it characterized as “another vague motion,” holding that, “since an issue in the case [was] whether the [filter] was ‘unreasonably dangerous,’ the benefit of the filter,” along with “the clinical experience of physicians or experts of patients dying of pulmonary embolisms,” were “directly relevant to this issue.”  Id. at *25.

  • Motion to Preclude References to Plaintiffs’ Experts’ Testimony in Cases Against Other Filter Manufacturers

The plaintiff argued that “any reference to the number of times an expert [had] testified in cases against other medical device manufacturers” was irrelevant.  The court disagreed, holding that the information might be relevant to the bias of the plaintiff’s experts.

  • Motion to Preclude Reference to Fault or Negligence of Non-Parties

The plaintiff moved to preclude the defendants from suggesting that non-parties, including plaintiff’s physicians, “had any responsibility” for the plaintiff’s injuries.  The court denied the motion, holding that “the medical treatment that [the plaintiff] received [was] highly relevant to the jury’s determination of causation” and would not be excluded.  Id. at *34-35.  The court also held that Wisconsin law permitted the defendants to blame an “empty chair.”

  • Motion to Preclude Evidence of the Surgeon General’s “Call to Action”

The plaintiff moved to exclude references to the Surgeon General’s 2008 “Call to Action to Prevent Deep Vein Thrombosis and Pulmonary Embolism,” arguing that the publication was hearsay and that it was irrelevant and prejudicial.  Guided by earlier decisions, the court held that the document was not hearsay, because it fell within the “public records” exception to the hearsay rule.  Moreover, the publication was “relevant to the plaintiff’s claim that the filter was not reasonably safe, which necessarily involve[d] a risk-benefit analysis.”  Id. at *41.

  • Motion to Preclude Reference to Plaintiff’s Surgical Consent Form 

Finally, the plaintiff argued that any probative value of her signed surgical consent form was outweighed by unfair prejudice, since the judge had held, in an earlier summary judgment decision, that the learned intermediary doctrine governed the warnings analysis and rendered irrelevant the question of what warnings the defendants had provided to the plaintiff herself.   The judge (who called it “refreshing” that the plaintiff referenced the summary judgment order) held that the consent form was relevant to what the plaintiff’s doctors knew about the risks of the filter, “which, at least indirectly, [spoke] to the sufficiency of the warning provided to the physician and . . . to the physician’s understanding of [those] risks.”  Id. at *42-43.

There are other rulings, and not all fall into the “win” column for the defendants.  Notably, identifying a split of authority, the court reserved its rulings on the admissibility of evidence that the FDA cleared the filter for marketing through its 510(k) process and that there were no FDA enforcement actions against the defendants.  But there are nuggets of victory even in some of the ostensible defeats.  For example, though the judge precluded the defendants from arguing that they couldn’t issue warning letters without the FDA’s consent (the defendants did not contest this), he refused to preclude them from presenting evidence that warnings about failure rates and increased risks could not be based only on anecdotal medical device reports (“MDR”) or on data from the FDA Manufacturer and User Facility Device Experience (“MAUDE”) database that collects these reports.  The opinion is carefully reasoned throughout, and we love its unapologetic betrayal of the judge’s impatience with the plaintiff’s lawyers and of his determination to shield the jury from ubiquitous mass-tort-plaintiff tactics.

We will let you know if we hear more about this trial.  Meanwhile, we haven’t worn “work shoes” in fifteen months, and we need to go find them for Peoria.  Stay safe out there.

First of all, get your minds out of the gutter.  Second, remember two weeks ago when we noted how rarely we discuss lawsuits against FDA?  We are doing it again.  Third, although we have talked about the strange regulatory shadowland in which homeopathic drugs have resided, they have not seen much action in litigation.  When they have, the level of historic FDA oversight has generally not resulted in preemption of state law claims.

Things with homeopathic drugs, an arguably oxymoronic term, are changing.  We discussed a while back how the Federal Trade Commission was increasing its oversight and enforcement of ads relating to these products.  That was under the Obama administration and efforts to up FDA’s oversight of these products that began at the same time are now playing out in litigation.  The case is MediNatura, Inc. v. FDA, — F.3d –, 2021 WL 2172540 (D.C. Cir. May 28, 2021), the facts are a bit wacky (to our DDL eyes), and the proposed shift in the regulatory scheme for these products is at stake.

With the aid of the internet, we start with some facts about the defendant and its products.  Headquartered in Philadelphia, with operations in Albuquerque, it is the U.S. subsidiary of a large German company with an oblique name.  Not Madrigal of Breaking Bad and Better Call Saul fame.  Another one.  It has many products, some imported from abroad and some manufactured in the U.S.  Although none of its “drugs” has ever been approved under an NDA or ANDA (or any other regulatory route), some of them are intended to used only under prescription or get injected.  The company’s website touts its “FDA Compliance,” in reference to inspections of its facilities, and that “Our leading Rx products are backed by rigorous published research” under the heading of “Clinical Research.”  This seems a bit weird, even from our side of the “v.”  If there is clinical research establishing safety and efficacy and the manufacturing facilities meet FDA standards for manufacturing pharmaceuticals, then why would the manufacturer not want FDA approvals for its “leading” prescription drugs?  The answer may have something to do with the regulatory scheme and its history.

According to the FDCA, a homeopathic drug listed on the “official Homeopathic Pharmacopoeia of the United States” must be approved as a new drug, regardless of whether it is made in the U.S. or imported.  Id. at *1.  The only exception to that is for drugs that are generally recognized as safe and effective (“GRAS/E”), something mostly applicable to older drugs—recall, the FDCA was enacted in 1938 and the Kefauver Amendment that revamped the approval process was in 1962—and a detour we will not take here.  FDA has a range of powers related to unapproved drugs, including specific to their importation.  For decades, homeopathic drugs have existed in a sort of regulatory limbo.

The FDA has never approved an NDA for a homeopathic drug nor found a homeopathic drug to be GRAS/E and thus not a “new drug” requiring an NDA. Instead, the FDA has exercised its enforcement discretion regarding the sale of homeopathic drugs through its 1988 Compliance Policy Guide 7132.15 § 400.400 “Conditions Under Which Homeopathic Drugs May be Marketed” (CPG 400.400).

Id. at *2 (record citation excluded).  We discussed 400.00 in the prior posts.  It allowed the sales of these unapproved homeopathic drugs under certain conditions, but “did not exempt homeopathic drugs from approval requirements and, while CPG 400.400 was in place, the FDA took enforcement steps against certain unapproved homeopathic drugs,” including warning letters related to risks.  Id.

Because of reports of “[n]egative health effects from drug products labeled as homeopathic”—a fairly ominous statement—FDA invited public comment on revamping its enforcement policies in regard to homeopathic drugs to better “protect and promote public health.”  Id.  That was in March 2015.  In December 2017, FDA unveiled a draft guidance called “Drug Products Labeled as Homeopathic” to essentially replace CPG 400.00.  In addition to setting out a new risk-based scheme, it warned that FDA would take enforcement action against unapproved homeopathic drugs.  Id.  In July 2018, a group called Americans for Homeopathy Choice filed a citizen petition that called for ditching the new draft guidance in favor of the old CPG 400.400.  In October 2019, FDA rejected the petition and formally withdrew CPG 400.00, noting the increase in homeopathic products and concerns about their risks.  It also issued an updated draft guidance and reiterated its intent to enforce.

The story picks up with the manufacturer getting a warning letter in June 2020 about six imported injectable prescript products that complied with CPG 400.00 but had not been approved.  Id. at *3.  (Because warning letters are not a first step, we assume there was some back and forth before then.)  FDA also added the products to an Import Alert so that they could not be imported legally.  A month later, the manufacturer sued FDA in federal court to enjoin the withdrawal of CPG 400.00 and preclude enforcement of the Import Alert as to its products.  We are neither admin lawyer nor import-export lawyers, so we pay less attention as we proceed.  The drama continued, though, because FDA moved to dismiss the case and the manufacturer plowed ahead and ordered a total of ten shipments of the subject products, nine of which got detained in a port.  (That the other got through is a different concern.)  The district court denied the injunction, finding the withdrawal of CPG 400.400 was within FDA’s discretion and the Import Alert was not a final agency action on which it could rule under the APA.  Meanwhile, the manufacturer followed the steps to get FDA to end the detention of its imported unapproved products, but FDA refused in February 2021, declaring that the drugs did not comply with the GRAS/E exception.

The appeal to the D.C. Circuit followed.  We will dispense with the affirmance on the Import Alert issue summarily.  What was challenged was a non-final decision under the APA, even though there was later a consistent final decision.  The manufacturer can challenge the February 2021 decision in the district court on remand, but the district court was correct to dismiss the original challenge to the Import Alert.  Id. at *5.  The remaining issue, withdrawing CPG 400.400 in favor of the expected finalization of a new regulatory scheme, is more interesting to us and, we suspect, impactful on the industry.

The requirements for a preliminary injunction, which are reviewed de novo, are familiar to many lawyers:

To obtain a preliminary injunction a plaintiff must establish [1] that he is likely to succeed on the merits, [2] that he is likely to suffer irreparable harm in the absence of preliminary relief, [3] that the balance of equities tips in his favor, and [4] that an injunction is in the public interest.

Id. at *6 (internal quotation and citation omitted).  The plaintiff manufacturer’s main argument was that it and other manufacturers of homeopathic drugs had relied on CPG 400.400 for a long time and it would be unfair to change the rules.  Given that agency rules, especially something as soft as an enforcement policy, change all the time, the “reliance interest” standard spelled out in multiple Supreme Court cases is pretty soft.  Basically, agencies should assess reliance interests and have a reasoned explanation for why it would change a policy in the face of reliance interests.  While the Federal Register notice from October 2019 did not address reliance interests, the denial of the citizen’s petition a day earlier did.  Under these circumstances and in the particular procedural posture here, the court concluded that it could consider the rationales in the denial of the citizen petition.  As we have noted often in the context of preemption of drug warnings claims, what FDA says in response to a citizen petition can provide a clear enunciation of its reasoning.

Here, viewing the petition denial together with the notice of withdrawal, FDA provided an “adequate and reasonable” explanation for withdrawing CPG 400.400 despite how long it had been in place.  Id. at *7.  There were four rationales, starting with how reliance never could have been strong when FDA had always declared, even in CPG 400.400, that these products were not exempt from FDA approval requirements.  Id. at *8.  Next, both the petition denial and the notice of withdrawal emphasized an increase in safety concerns with this class of products.  Id.  Relatedly, they both noted the expansion of the industry, meaning increased exposure to the products (that had these increasing safety concerns).  Id.  Last, both stressed how FDA wanted to apply its general “risk-based approach to enforcement” to these products as well.

The next argument plaintiff raised—in the context of trying to show it would win on the merits—was that FDA allegedly did not consider alternatives like promulgating new regulations for homeopathic drugs or delaying the withdrawal of CPG 400.400.  Under Supreme Court authority, the only alternatives that should be considered have to be “within the ambit of the existing standard.”  Id. at *8 (citations omitted).  This standard clearly did not apply, as changing an enforcement policy is quite different than creating a whole regulatory scheme for homeopathic drugs.  Plaintiff’s position was based on the incorrect supposition that “FDA must leave open an opportunity for legal marketing of homeopathic drugs” but FDA had no such obligation.  Id. at *9.  Nor was there a reason to delay withdrawing the old enforcement policy to allow manufacturers to adapt.  The coming change had been broadcast since 2015 with repeated reminders than enforcement of FDCA requirements for drugs was possible.  There was no reason for further delay:

The FDA sought to replace “outdated policy” that no longer reflected its thinking in light of recent public health concerns.  In doing so, the FDA reasonably concluded that it was more important to subject homeopathic drug manufacturers to a risk-based regime than to perpetuate a non-risk-based regime.

Id. at *9 (internal citation omitted).  That dispensed with first requirement, a probability of success on the merits.

In terms of the rest of the requirements for getting a preliminary injunction, the plaintiff clearly failed.  There was no irreparable harm, because FDA could have taken enforcement actions against the products at issue based on safety concerns even if CPG 400.400 remained in place.  Id.  There was also a strong public interest in enforcing the FDCA “to protect public health.”  Id.

What does this mean for drug and device manufacturers?  For manufacturers of homeopathic drugs, it does seems like the limbo has ended and they will need new legislation, NDA approvals, or determinations under GRAS/E to keep their drugs on the market.  The Dante scholars can argue over what to call this post-limbo place.  For the sort of cases we normally do, it may be a bit of a stretch, but this is another federal circuit waxing on about FDA’s commitment to public health and its enforcement options.  For us as occasional consumers of health products and full-time believers in science, it would be good to have firm requirements in place that drugs, whether labeled as homeopathic or not, need to meet.

The Ninth Circuit recently answered a preemption question that we had seen arise intermittently, mostly in food litigation, over the past couple of years.  Because the relevant preemption clause closely resembles the language of the Medical Device Amendments (“MDA”), we thought it was worth a look.

In Webb v. Trader Joe’s Co., ___ F.3d ___, 2021 WL 2275265 (9th Cir. June 4, 2021), the plaintiff attempted to maintain a class action (what else) based on claims (under various consumer protection statutes, express warranty, implied warranty, theft by false pretenses, and unjust enrichment) that the defendant sold meat with “misleading” labeling concerning that amount of “retained water” in the product..  Id. at *1.  They based these claims on their own testing of these products.  “[Plaintiff] took the Products to a [local] food testing laboratory to determine whether the Products’ labels correctly reflected the retained water content.”  Id. at *2.

However, after filing suit, plaintiff was unable to plead (or otherwise allege) that the tests they had run were identical to those required by the federal government to determine water content.  Not only did “she fail[] to specify whether the . . . process utilized in her independent examination of the Products was identical to the protocol utilized by [defendant] pursuant to [federal]regulation,” but when given a second chance at oral argument, plaintiff’s “counsel was unable to confirm that [plaintiff] used [defendant’s] protocol to arrive at her retained water numbers.”  Id. at *2, 6.

Failure to establish utilization of testing standards identical to what the federal government required was fatal to all plaintiff’s state claims.  The relevant federal statute, the Poultry Products Inspection Act (“PIPA”), included a preemption clause very similar to the MDA, with only the order of the clauses reversed, and subject to the same general preemption standards

[Plaintiff’s] claims are preempted under 21 U.S.C. §467e, which establishes that states may not impose requirements “in addition to, or different than those” described in the PPIA.  Where the intent of a statutory provision that speaks expressly to the question of preemption is at issue, we do not invoke any presumption against pre-emption but instead focus on the plain wording of the clause.

Id. at *4 (citations and quotation marks omitted) (emphasis added).

First, under this preemption clause, state-law plaintiffs could not force the defendants to use a “data collection process” that varied from the tests required by the federal government.  “[A]llowing [plaintiff] to impose her [testing] protocol on [defendant] via state law would require [it] to conform to a different data collection process than the protocol that was properly developed . . . as required by federal law.”  Id.  The defendant’s protocol was made available to the relevant federal agency, and not objected to, which “constitutes federal approval of [the defendant’s] protocol.”  Id.  Thus, “[b]ecause the retained water data supporting the claims made on the Products’ labels were validated by federal regulators according to the federally proscribed [sic] method, [plaintiff’s] claims that [the] labels are in fact invalid and misbranded are federally preempted.”  Id. at *5 (citation omitted).

Second, the “permissive” nature of the federal scheme did not impede preemption.  The “in addition to”/”different than” preemptive language “sweeps widely,” leaving “simply no way to rule in [a plaintiff’s] favor without contradicting the certification decision, and, through it, the certification scheme that Congress enacted.”  Id. (citations and quotation marks omitted).

The federal regulatory scheme is permissive and allows a broad method of compliance, in that it allows the company to craft its own data collection process and make it available for [federal agency] review.  Requiring [defendant] to follow [plaintiff’s] process, or be penalized unless it follows a process different from the one it developed pursuant to regulation, would be more restrictive than the federal scheme.


Third, and finally, the labels themselves “were reviewed [by the agency] for approval in their entirety.”  Id.  Therefore, the language plaintiff challenged was “approved,” and “[a]ny additional label requirements [plaintiff] seeks to place on” the label “would necessarily be ‘different than’ those required by the PPIA” – and therefore preempted.  Id.

In food litigation, Webb answered “yes” to the recurrent question whether plaintiffs are required, upon pain of dismissal, to plead that their testing methods are identical to what the federal government requires.  Webb was decided on a motion for judgment on the pleadings.

Webb has broader implications for preemption of FDCA-based claims as well.  Like the PPIA, many of the FDA’s regulations are similarly “permissive” − particularly with regards to the details of how manufacturers conduct testing, collect data, and report it to the FDA.  The preemption clauses are likewise almost identical, with no substantive difference in terminology.  Thus Webb is favorable precedent for the proposition that plaintiffs cannot dictate the details of such processes in purportedly “parallel” claims where the FDA had provided manufacturers with discretion as to how to conduct what Webb referred to as “data collection protocols.”  Biocompatibility and life cycle testing are two examples that come immediately to mind.