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Last week this blogger was in Morgantown for a sophomore daughter and a Mountaineers game. This week it was Harrisonburg, Virginia, for the last parent weekend with our senior son at James Madison University. The weather did not cooperate nearly as well as it did in West Virginia, but the football did not disappoint. JMU has been on such a roll these last few seasons that other programs keep poaching its coaches, including the one who left to lead Indiana to its championship season. Dukes fans are used to watching their coaches get plucked right out from under them at this point. It is less flattering than it sounds, except, actually, it is exactly as flattering as it sounds.

There is also, as it turns out, a minor sibling rivalry brewing between a daughter at WVU and a son at JMU, and it centers on Country Roads. Students in Harrisonburg are delighted to point out that the two most iconic landmarks in John Denver’s ode to West Virginia, the Blue Ridge Mountains and the Shenandoah River, are both located in western Virginia, not West Virginia. John Denver, it seems, got his geography wrong, and JMU students never let an opportunity to mention it pass by.

We have news for both students — a little digging into the song’s actual history only makes the geography more confusing. Apparently, the idea for the song originated while driving down a country road in Maryland, a state that has nothing to do with either landmark. So, the honest answer is that neither Maryland, where the song was actually conceived, nor western Virginia, where those landmarks actually sit, is where the lyrics landed. Country Roads, it turns out, only sounds like a geography lesson. None of that is likely to wrestle the anthem away from West Virginia, and we would not bet on JMU students changing the words either. This blogger does not have a dog in that fight, but we do appreciate a good excuse for a callback, and last week’s post gives us one, because it was built around a decision that butchered the TwIqbal pleading standard. This week’s decision, out of the Northern District of Ohio, gets it right. Same song, better verse.

In Radtkin v. Medtronic, Inc., 2026 WL 2920207 (N.D. Ohio Sept. 29, 2026), the court granted defendant’s motion to dismiss in full, and notably, not on preemption.

Plaintiff sued the manufacturer of an implantable drug infusion pump, a Class III, PMA medical device that delivers pain medication directly to the intrathecal space of the spine. Plaintiff had the device implanted in February 2022, replacing an earlier model that had been in place since 2015. The surgery went off without complications. The next day, however, plaintiff showed up in the emergency room with symptoms of opioid withdrawal. When the device was explanted, plaintiff’s medical providers inspected it and found an “acute pump malfunction,” but no kinking or tubing issues and nothing else obviously wrong with it. Id. at *1.

Based on that malfunction, plaintiff brought claims for defective manufacturing and nonconformity with representation (breach of express warranty) under Ohio law. Defendants moved to dismiss on preemption grounds and, in the alternative, for failure to state a plausible claim.

Here is the first thing defense counsel should notice and appreciate — the court did not start with preemption, even though defendants led with it. Because preemption analysis implicates the Supremacy Clause, the court reasoned that it should first determine whether the claims survive under state law and only reach the preemption question if necessary. Having found that none of the claims clear the state-law bar, the court never had to decide the preemption issue at all. It expressly declined to express any opinion on it. Id. at *3, 8. This is a good reminder not to treat the state-law arguments as the undercard. A well-pleaded state-law failure can end the case all on its own, and courts applying constitutional avoidance will often look there first.

Under the Ohio Products Liability Act, a product is defective in manufacture if it deviated in a material way from the manufacturer’s own design specifications or from otherwise identical units, when it left the manufacturer’s control. Id. at *3. The court made clear that a plaintiff must plead sufficient factual content, beyond a mere malfunction, to plausibly allege that kind of material deviation.

Plaintiff tried several routes to get there, and the court closed off every one of them. First, plaintiff pointed to eight CGMP regulations they claimed defendants violated, including failures around design validation testing, production process controls, and corrective and preventive action procedures. The court was not impressed. Id. at *4. Plaintiff did not allege how those violations connected to anything specific about plaintiff’s own device, and a laundry list of regulatory citations, without factual support tying them to the device at issue, cannot plead a manufacturing defect claim.

Second, plaintiff leaned on FDA warning letters, inspection findings, and voluntary recalls between 2006 and 2013. The problem is that plaintiff’s device was implanted in 2022, nearly a decade after the most recently cited enforcement action. Nor did plaintiff allege the device was manufactured during any period those actions covered. The court held that historical violations do not support a reasonable inference that a device made years later, and not subject to those enforcement activities, suffered the same defect. Id. at *5. Calling the violations “systemic” did not bridge that gap either. Characterizing old problems as systemic is not the same as pleading facts connecting them to this device. Id.

Third, plaintiff noted that plaintiff’s prior pump had performed fine for years. The court held that the successful performance of a different device does not plausibly establish that a later unit materially deviated from otherwise identical units or caused the plaintiff’s injury. And fourth, although plaintiff identified several recall windows going back to 2008, he never alleged that his specific device was manufactured during any of them. Id.

What plaintiff never did, at any point, was identify a flawed physical condition of the actual device or a particular deviation from specifications. That is what a plausible manufacturing defect claim requires. An unexplained malfunction, standing alone, is simply not enough.

Plaintiff also brought a nonconformity-with-representation claim, Ohio’s version of an express warranty theory, based on marketing statements that the device was “safe, proven, and effective,” that it met design specifications, that it was designed to help eliminate systemic opioids, and that its battery would last four to seven years. Id. at *7. The court rejected all of it. Generic representations about a product’s safety do not, without more, plausibly establish nonconformity just because the product later malfunctioned. The specifications-compliance theory failed for the same reason as the manufacturing defect claim, because it rested on the same unsupported premise that the device deviated from specifications. The battery life representation was simply irrelevant, since plaintiff never alleged a battery failure. Id.

This application of TwIqbal to a medical device manufacturing defect claim stands in sharp contrast to the decision we covered last week, where a doctor’s letter saying a plaintiff “may have” received a contaminated product was somehow enough to plead causation. Here, the court held the line. A malfunction is not a manufacturing defect. A regulatory violation from a decade earlier is not a manufacturing defect in a device made years later. Prior successful use of other units is not evidence that this unit deviated. And calling old problems “systemic” is not a substitute for alleging facts about the device actually at issue.

We would also flag the court’s sequencing of issues. Because the court addressed the state-law claims first under constitutional avoidance principles, the entire case was resolved without the court ever having to wrestle with preemption. That is exactly why state-law arguments belong in every motion to dismiss, not as a fallback to preemption, but as a potential knockout punch in their own right. A defendant who argues preemption alone and skips the state-law pleading deficiencies is leaving a perfectly good argument on the table, and perhaps the whole case.

So here is where the Country Roads callback lands. John Denver put the Blue Ridge Mountains and the Shenandoah River in the wrong state, and generations of JMU students have been correcting the record ever since. The court in Radtkin v. Medtronic, Inc. did not make the same kind of mistake. It knew exactly where the pleading standard actually lives, and it kept the complaint on the right side of the line. Almost heaven is a nice sentiment, but almost plausible does not cut it under Rule 12(b)(6), and this court was not interested in splitting the difference.

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Johnson v. Ridge Tool Manufacturing Co., 186 F.4th 478 (7th Cir. 2026), is a product liability decision involving a drain cleaning machine, not a prescription medical product.  But that doesn’t mean that our clients won’t find it useful.  A unanimous Seventh Circuit panel, interpreting Illinois law, affirmed summary judgment on both the plaintiff’s design and warning claims.  Both affirmances have holdings that potentially apply to prescription medical product liability litigation.

First, the design aspect.  That involves the quantum of alternative design evidence required by Illinois law.  “In Illinois, a plaintiff’s case against a product manufacturer is supported by showing that a safer alternative product design was feasible.”  Johnson, 184 F.4th at 485 (citation omitted).  Plaintiff’s expert witness opined simply “pointed to competitor machines that already have the alternative design,” and asserted he needed to do no more.  Id.  We see that all the time.  Johnson said “no” – that’s not enough.  Somebody must have tested the claimed alternative.

We disagree.  To be sure, testing an alternative design is unnecessary if it is already used in the marketplace. . . .  But [our precedent] do[es] not hold that just pointing to competitor products is enough to admit an expert’s opinion.  That a design exists, without more, cannot be the sole basis for an expert’s opinion.  Yet that describes [this expert’s] report.  To him, three comparators prove that an alternative design is feasible, so [defendant] should have incorporated that design when manufacturing the machine.

Id. at 486 (emphasis added).  An expert that fails to test the alternative design s/he advocates needs to do a lot more to make up for that deficiency, such as:  (1) evaluating the costs of the supposed alternative design, (2) the alternative’s “compatibility with existing systems,” (3) practical benefits of the existing design, (4) “publications” that “conclude that [the alternative] is important or necessary, and (5) comparative safety rates.  Id.

Another possible way of validating a claimed alternative design without testing is whether the alternative, as opposed to the challenged design, conformed to industry standards.  Once again, the plaintiff’s expert report in Johnson flunked the test:

[The expert] pointed to three other competitors that used [the alternative design].  The district court asked the right question:  three out of how many machines?  Three out of four with [the alternative] likely means that design is the industry standard; but three out of four hundred proves little. . . .  [The expert’s report] lacks the denominator, which the district court correctly held against him.

Id.

As to warnings, the plaintiff offered an expert’s opinion attacking the adequacy of the instructions in the product manual.  Johnson, 186 F.4th at 487.  Slight problem with that – plaintiff “had not read the manual.  So, he cannot establish that the alleged flaws caused his injury.”  Id.  So Johnson goes into our failure-to-read 50-state survey.  But even more important, the Seventh Circuit recognized that an expert warning opinion is inadmissible unless the expert proposes an alternative warning:

[There is] a second deficiency with [this expert’s] report:  it does not propose an alternative warning that she believes would have prevented [plaintiff’s] injury. Without discussing what designs would have effectively warned a user, any opinion about the ineffectiveness of the current warning is akin to talking off the cuff and not acceptable methodology.  Though no single factor is dispositive under Rule 702, an expert’s failure to design or suggest to the court an alternative warning that would have been appropriate signals unreliability.

Id. (following Bourelle v. Crown Equipment Corp., 220 F.3d 532, 539 (7th Cir. 2000)).  That holding favorably addresses another problem that we have encountered all too often in our defense of prescription medical product liability litigation – moving target warning “experts” that never identify what an adequate warning would have stated.

Illinois substantive law produced the same result on the warning claim:

Illinois courts have ruled that in failure-to-warn suits, alternative warnings are necessary to survive summary judgment. “To prevail,” a plaintiff “must establish that greater warnings would have prevented [the] injuries.”  Said another way, plaintiffs cannot defeat something with nothing.

Johnson, 186 F.4th at 488 (quoting and following Muhammad v. Abbott Laboratories, Inc., 203 N.E.3d 1001, 1018 (Ill. App. 2022) (a case we couldn’t discuss because Bexis was working on it)).  Alternative warnings also go to causation.  “Without an alternative warning, we are left guessing whether a better one would have prevented [plaintiff’s] accident.”  186 F.4th at 489.  Since the plaintiff didn’t read the existing warnings, “a more descriptive, and thus longer, label may have discouraged [plaintiff] from reading it.”  Id.

So there you have it.  Precedential Seventh Circuit holdings that:  (1) under Rule 702 alternative design opinions that do no more than point to a competing design are inadmissible; and (2) under Illinois law, warning claims fail where the plaintiff does not offer an alternative warning.

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If Wile E. Coyote sued the Acme Products Co. over a defective anvil that fell on his head, would he get to take discovery on Acme rocket sleds?  Or Acme explosives?  Or Acme spring-loaded shoes meant to propel the shoes’ wearers to soaring heights at stupendous speeds?  We ask these questions because a federal court in New York recently and correctly denied a (human) plaintiff discovery into products different from the one that allegedly harmed him. 

We ask these questions also because we recently saw the movie Coyote vs. Acme, a surprisingly entertaining send-up of product liability litigation.  As you know, Wile E. Coyote is the persistent and very resilient cartoon coyote who chases a lightning-fast roadrunner around the American Southwest.  In his endless quest to capture a meal, Coyote devises elaborate schemes that invariably involve Acme products—rocket-powered roller skates, giant magnets, sharpened bear traps, fast vehicles, explosives of all kinds, and loads and loads of birdseed.  The use of Acme products always ends with Coyote suffering great bodily injury and, presumably, substantial emotional distress. 

Hence, we have the movie Coyote vs. Acme, in which Mr. Coyote sues Acme for injuries caused by allegedly defective products.  Parts of the movie rang true (Coyote hires a plaintiff’s lawyer whom he saw advertising on TV, played by the always likeable Will Forte); and others did not (no, if you lose your case in state court, there is no de novo appeal to Congress). 

But perhaps the best nugget we took from the film was in the credits, where we learned that the movie is based on a New Yorker article from 1990 in which humorist Ian Frazier parodied products litigation by presenting an “opening statement” in the fictional case of “Coyote v. Acme.”  This very funny piece includes laugh-out-loud moments like this one involving Coyote’s use of an Acme rocket sled:  As Coyote rode astride the sled at breakneck speed,

the animal he was pursuing veered sharply to the right. Mr. Coyote vigorously attempted to follow this maneuver but was unable to, due to poorly designed steering on the Rocket Sled and a faulty or nonexistent braking system. Shortly thereafter, the unchecked progress of the Rocket Sled brought it and Mr. Coyote into collision with the side of a mesa.

And this about Acme rocket skates: 

Again, Defendant sold over the counter, without caveat, a product which attached powerful jet engines (in this case, two) to inadequate vehicles, with little or no provision for passenger safety. . . .  Mr. Coyote lost control of the Rocket Skates soon after strapping them on, and collided with a roadside billboard so violently as to leave a hole in the shape of his full silhouette.

Alleged injuries include “Severe singeing of the hair on the head, neck, and muzzle” and “Fracture of the left ear at the stem, causing the ear to dangle in the aftershock with a creaking noise.”

Alas, (spoiler alert) movie Coyote did not get his payday—it turns out the defense of product misuse is alive and well in cartoon litigation.  But we all learned a valuable lesson about commitment to a cause and the nobility of picking yourself up off the ground (or a railroad track, or the side of a mountain, or the bottom of a desert canyon) and trying again. 

So in our hypothetical anvil case, would Coyote get discovery into other products?  If the order in the very real case of Ryger v. Sunbeam Products, No. 1:25-cv-08876, 1026 U.S. Dist. LEXIS 216474 (S.D.N.Y. Sept. 11, 2026), is any indication, the answer is no.  The plaintiff in Ryger filed his product liability lawsuit over a mattress pad, but he sought discovery concerning other of the defendant’s products, including heating pads.  We are all familiar with the rule that evidence of other incidents can be admissible only if substantially similar to the incident at issue, and while plaintiffs get some leeway in discovery, they should not get much.

That is what a federal judge in New York ruled in Ryger.  Heating pads are different from mattress pads.  “[T]hey are subject to different UL standards; different FDA classifications, if any; different warnings and instructions; different intended uses; different controls and circuitry; and different temperature regulation.”  Id. at *1-*2.  Thus, “[t]o the extent, Plaintiff seeks discovery concerning other . . . heating products, including Heating Pad products, those discovery requests seek information that is not relevant to Plaintiff’s claims because the request concern unrelated products.”  Id. at *1.  Put another way, information regarding the performance of “those unrelated and different products is irrelevant.”  Id. at *2. 

Those last two sentences are the ones you will want to use to resist discovery into other products, and kudos to the defense lawyers here for marshaling a list of compelling differences that made this a no-brainer, in our biased view. 

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Several years ago, the Blog started posting fairly regularly about decisions challenging vaccine mandates and policies enacted by a range of public and private entities.  The reason why there was a spate of such decisions starting around mid-2001 is pretty obvious.  A range of restrictions had been imposed in response to the COVID-19 pandemic in 2020, and the roll-out of COVID vaccines following the first emergency use authorization in December 2020 was accompanied by many vaccine mandates and policies.  By mid-2021, the challenges were producing decisions that caught our attention.  But why would the Blog care about these decisions, given that we do not pay much attention to employment law, education law, or injunctions in general?  A few reasons.  We do discuss decisions from litigation about vaccines and a number of the legal issues in the vaccine mandate cases, a term used here to describe cases not strictly about mandates, come up in our cases, such as the interplay of federal and state requirements in the area of public health.  We also clearly do not like junk science, and it was always clear to us that one side of these cases was likely to need to rely on decidedly junky “science.”  It was also clear to us that some courts would struggle with applying the controlling law given possible public pressure and/or personal preferences.  Part of this likely dynamic, from our perspective, was that the parties challenging public health laws and policies might be less constrained by ethics and rules than the typical plaintiff in a product liability case, which is saying something.

The basic law in this space was established by Jacobson v. Massachusetts, 197 U.S. 11 (1905), way before the Blog was even a twinkle in Bexis’s eye.  In 1905, the smallpox vaccine discovered in England in 1796 had not yet wiped out smallpox in the U.S.  Eventually, smallpox became one of several fatal and severely debilitating diseases curbed by widespread vaccination in the U.S., especially of infants and children.  We will skip the segue into the logic of the Vaccine Act.  We will also not delve into the many challenges to the Public Readiness and Emergency Preparedness Act (“PREP Act” ) and its use to preempt other claims that we have also covered over the last few years.  Those are federal laws covered by the Supremacy Clause, as opposed to state laws and actions reserved for the states under the Tenth Amendment.  Challenges to state laws and their application have been the subject of many posts that talked about how Jacobson was applied.  From this to this and also here, here, here, here, here, and here.  In general, the plaintiffs have lost challenges to vaccine mandates because Jacobson is still the law of the land.

Along the way, we have seen a number of cases where the plaintiffs took unsupported positions and cut some corners.  The case was dispensed on standing, but the lawsuit over a public service message about the COVID vaccine from Elmo on Sesame Street is probably not even the worst one.  Yet we still have not seen a court handling one of these cases take a strong stand to deter frivolous litigation and abuse of the legal system.  Doe v. Oceanside Union Free Sch. Dist., No. 25-2304 (GRB)(ST), 2026 WL 2883406 (E.D.N.Y. Sept. 23, 2026), does not reverse that streak, but it should have and maybe the court will take further action to send a message before the case is gone.  As we recite the case facts and history, we invite the reader to consider what penalties or referrals would have been ordered if a drug company defendant in a product liability case, its counsel, and its experts behaved like Doe’s did.

Doe originally brought suit to enjoin her minor daughter’s public school from requiring a third hepatitis B vaccine before she could attend eleventh grade.  In 2025, the court granted a preliminary injunction overriding the school’s denial of a medical exemption.  2026 WL 2883406, *1.  Once plaintiff came back in 2026 for a similar preliminary injunction for the denied exemption for twelfth grade, the court realized that it had been duped last year.  Somewhere in between, the court realized that plaintiff’s counsel had sent a September 1, 2025, letter to every school district in New York “threaten[ing] legal action based on the [Doe] preliminary injunction determination.”  Id. at *1 n.1. The letter “grossly mischarteriz[es] the express terms” of the “narrow” prior decision as broadly applicable to other students and situations.  In denying the second injunction, the court expressly found that the actions of the plaintiff’s counsel who signed the letter “were both factually incorrect and professionally inappropriate.”  Id.  No sanctions or referrals for bar proceedings accompanied that determination, however.  (We will not include links that show the plaintiff lawyer’s letter or broader marketing efforts, but they make the inappropriate behavior look worse.)  Plaintiff’s original exemption request had been based in large part of a doctor’s vague assertions of risks posed to plaintiff’s minor due to her particular health problems, which are not described in the opinion exempt to characterize them as being of mysterious origin.  The doctor also apparently offered that the plaintiff’s minor had some protection from the first two hep B vaccines and that the risk of transmission to other students was low, but did not address the risks she faced from attending school with so many unaddressed health issues.  Id. at *1.

On the second round, the plaintiff also had to address her failure to get the required meningococcal vaccine for her daughter.  She tried to rely on the same doctor rather than one of her actual treaters.  Id. at *2.  This individual had never treated plaintiff’s minor in any capacity, but merely spoke with her mother to determine what he was supposed to put in the exemption application.  Predictably, the state had determined that he had a history of submitting fraudulent applications and put him on its suspended list.  Id.  He also lied about his interaction with the school to make it seem like they refused to provide him with information, when the opposite was true.  Then plaintiff herself lied about the same issues in a sworn affidavit.  Id.  Thus, the school was never actually provided with any information supporting a risk of harm from either vaccine the plaintiff’s minor had not received, which was grounds to deny the exemption request.  (It is implicit in the history that many of these same issues of proof and honesty were present but unknown at the time of the 2025 preliminary injunction.)  The plaintiff then tried to switch to a second doctor as the basis for her exemption request, presumably because the state had not listed him as purveyor of vaccine fraud.  Id. at *3.  Yet, his submission was “highly similar” to what the other doctor had written, relying on lab results that were contrary to his assertions.  Id.  To top it off, he also ignored requests for information from the school and failed to show as the court hearing to testify.  Id.

The actual determination that plaintiff was not entitled to a preliminary injunction because she could not show irreparable hard or a likelihood of success on the merits was pretty easy on this record.  The Second Circuit had upheld New York school vaccine mandates requires a few times, including in the Miller case discussed here.  Id. at *3-4.  Miller discussed what needs to be shown to satisfy the statutory requirements for a waiver.  Plaintiff’s applications did not come close, even if plaintiff did not rely on “vaccine fraud” and had not lied under oath.  There was no basis to overturn its denial.  Id. at *4.

So the preliminary injunction was rightly denied.  The defendants’ motion to dismiss remains pending and the court requested briefing on whether plaintiff had exhausted state administrative remedies before suing in federal court.  Id.  On this record, it is hard to see that a dismissal is not coming.  However, as we have said more than a few times, such as here in the context of hallucinated citations, we think courts need to do more to deter frivolous litigation, false court filings, false statement under oath, and other shenanigans that seem to be much more common on the plaintiff side of the civil v.  A footnote that plaintiff lawyers’ “actions were both factually incorrect and professionally inappropriate” will not change their behavior in other cases, especially if they benefited from the misconduct.  On their own, it is unlikely that the plaintiff lawyers will pull down their prior letter to the New York school districts and post this Doe decision with an apology.  If there were a sanctions hearing, then perhaps those school districts could submit evidence of the harm they suffered from the false and unprofessional letter and its publicization.  The defendants in Doe surely can link their own litigation costs to the specific bad acts by plaintiff, her lawyers, and their experts.  With substantial costs to shift, the court could take steps to deter future bad conduct by these individuals and others.  After all, even parties with good cases are not supposed to engage in this sort of misconduct.  If bad conduct by parties with frivolous cases is not deterred, then one could say that it is really being encouraged.

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We can hardly think of a more useful recent law review article than D. Capra & L. Richter, “The Difference a Year Makes: The Admissibility of Expert Opinion Testimony under the 2023 Amendment to Federal Rule of Evidence 702,” 111 Cornell L. Rev. 127 (2026). Here is an online link. The authors are affiliated with the Advisory Committee on Evidence Rules, so their qualifications are not in doubt. Neither is their methodology. The article offers “an insider’s account of the process and thinking that generated the 2023 amendment to Rule 702.” Interestingly, we learn that a catalyst behind the amendment was a broad concern that forensic expert opinions in criminal cases (e.g., feature comparisons, such as fingerprints) were being presented with a degree of certainty that outstretched scientific support. Then the project became both sharper and broader. 

The “long journey to the 2023 amendment” included some false starts and blind alleys. The Advisory Committee considered directly calling out court decisions that had misapplied Rule 702, but ultimately decided against it. As the article points out, it is hardly surprising that so many courts misapplied the gatekeeping role, because Daubert “offered litigants a potpourri of pronouncements regarding a trial court’s evaluation of expert opinion testimony. There is language in Daubert for everyone.” In any event, we eventually got the amendment, which provided necessary clarification of the proponent’s burden of proving that the expert’s testimony more likely than not met the 702 requirements, and that the trial court must gatekeep against insufficient factual bases and errant applications of the purported methodology. 

The article then reviews every Rule 702 decision in the first year after the 2023 amendments.  This is the part of the article you will want to keep close at hand in your office the next time you are briefing a Rule 702 motion. 

While finding some progress, the article laments that litigants and courts continue to rely on the “antiquated” Daubert opinion (now superseded by two Rule amendments) and/or Rule 702 opinions that predate and are not compatible with the 2023 amendments.  Some courts “remain mired in the mixed messages of the now-dated Daubert opinion and risk admitting unreliable expert opinion testimony that threatens to alter outcomes of criminal and civil actions in federal court.”

The article contains a detailed examination and critique of hundreds of Rule 702 opinions. A pie chart shows 801 cases sorted into helpful categories. The article offers an interesting taxonomy of judicial attitudes toward amended Rule 702, including “Who, Me? Courts that Need No Correction,” “Old Habits Die Screaming: Federal Courts that Cannot Let Go of the Erroneous Tropes about ‘Liberal’ Admissibility,” and “Ignorance is not Bliss: Federal Courts that have Failed to Recognize the 2023 Amendment.” We feel we have encountered entirely too many courts in those last two categories. Too many courts still rely on “tropes” like “liberal thrust,” “presumption” of admissibility, and “questions of weight not admissibility,” “shaky opinions” and cross-examination that are no longer part of the rule.  

The article makes the key point that Rule 702 is not “synonymous” with Daubert.  Too many courts have failed to acknowledge the 2023 amendments at all.  Fifty-six opinions did not even cite the current language of Rule 702, but only the “defunct” prior version.  The authors express regret that the Advisory Committee failed to reject these “tropes” specifically.  The Committee “incorrectly” thought that courts would reach the proper conclusions themselves.  But some courts did arrive at proper conclusions.  Here is one of our favorite examples (not surprising given our Pennsylvania/Third Circuit focus): “The trial court in Knight v. Avco Corp. noted that Third Circuit precedent instructing that the Rule 702 standard is ‘not that high’ and that ‘the reliability and believability of expert testimony … is exclusively for the jury to decide’ was inconsistent with the preponderance requirement subsequently added to the Rule in 2023.”  Just so. 

A tone of exasperation creeps into the article. “The potential futility of painstaking efforts to lead horses to water is the rule makers’ lament. And the multitude of federal opinions that have failed to recognize the 2023 amendment to Rule 702, or that have flagrantly ignored its clear mandate, is disheartening to say the least.” More and better judicial education is recommended. It would also be helpful to get the citation services to red-flag Daubert as being superseded by Rule 702 amendments.  Counsel also need to get rid of outdated precedent in their motions and briefs. “[T]here were a stunning 316 cases in the year following the amendment to Rule 702 in which both the lawyers and the court were seemingly in the dark about the important amendment.”  

With the help of this article, and your briefing, that darkness can be dispelled. 

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This blogger spent the weekend in Morgantown, and West Virginia did everything right except the football score. The leaves were doing their early turn, that first crisp snap was in the air, and the drive in on 68 delivered exactly the scenery you hope for — ridge after ridge of Appalachian foothills rolling out in every direction, gold and green under a sky so blue it looked photoshopped. There to visit a sophomore daughter and catch a Mountaineers game, and while the football gods did not cooperate this particular Saturday, the vibe could not have been better.

Morgantown itself is a hilly little marvel. Every walk from campus to downtown, downtown to campus, or to literally anywhere, is somehow uphill. Both directions. This blogger is fairly certain the entire town was designed by someone who has never heard of a flat surface, and yet nobody there seems to mind, possibly because the view from the top of every hill makes the climb worth it. And yes, at some point during the weekend, in a car, on a porch, somewhere, John Denver’s Take Me Home, Country Roads made an appearance, because it is basically illegal to spend forty-eight hours in that state without it playing at least once. It is the state anthem in every way that matters, official designation or not.

Unfortunately, this blogger also had to bring some work along, in the form of a new decision out of the Southern District of West Virginia. And here is where the good vibes take a detour, because the ruling we are about to discuss does not treat federal pleading standards nearly as gently as West Virginia treated us this weekend. If Morgantown was almost heaven, the TwIqbal analysis in Davis v. Sagent Pharmaceuticals, Inc., 2026 WL 2797358 (S.D.W. Va. Sept. 18, 2026), is more like almost pleading. Let’s take the drive through it.

This is a generic drug product liability case arising from a recalled injectable steroid. Plaintiff alleged she received an injection of a methylprednisolone acetate suspension that was later subject to a recall due to contamination, and that she developed a serious infection leading to an amputation. Id. at *1. She sued the generic manufacturer and the distributor, asserting manufacturing defect, failure to warn, negligence, negligence per se, and breach of express and implied warranty claims. Id. at *2. Both defendants moved to dismiss.

Defendants opened with a shotgun pleading argument, pointing out that the complaint repeatedly referred to the defendants collectively without much differentiation. Id. at *3. The court rejected it, finding the complaint adequate because it identified, early on, which defendant was the manufacturer and which was the distributor, which the court found sufficient to put each defendant on notice of its role. Id. This one is defensible enough on its own terms. It is a low bar, but shotgun pleading doctrine has always been a low bar, aimed at truly indecipherable complaints rather than ones that merely lump defendants together in some paragraphs while differentiating their roles elsewhere.

The manufacturing defect claim is where things really start to get bumpy. Plaintiff’s own alleged evidence of exposure was a letter from her doctor stating only that she “may have been given one of the affected injections.” Id. at *5 (emphasis added). That is about as wishy-washy as causation allegations get, yet the court found it plausible that she received a contaminated unit and that the contamination caused her injury, relying on the temporal proximity between the injection and her symptoms and the fact that her prior injections apparently did not cause the same reaction. Id.

We have said it before and we will keep saying it — Twombly and Iqbal were supposed to mean something. Plausibility is supposed to require more than a “sheer possibility that a defendant has acted unlawfully.” Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009). A complaint alleging that a plaintiff might have received a contaminated product, without any allegation actually linking her specific unit to the recalled lots, ought to be closer to that sheer possibility than to the plausible side of the line. We’ve seen sturdier bridges built out of duct tape. The court’s reasoning that a bad outcome following an injection, plus a recall notice phrased in the conditional, equals a plausible manufacturing defect claim is exactly the kind of res ipsa-by-complaint reasoning that TwIqbal was designed to prevent.

West Virginia’s innocent seller statute fared no better. It generally shields distributors from product liability suits unless a specific statutory exception applies. W. Va. Code § 55-7-31(b); Davis, at *4. Plaintiff invoked the actual knowledge exception, alleging that the distributor “knew” the product was contaminated. Id. at *5. No supporting facts. No allegations about how, when, or from whom the distributor supposedly gained this knowledge. Just the word “knew,” dropped into the complaint like a landmine plaintiffs hope the court will not notice is basically a legal conclusion masquerading as a fact.

The court noticed, and let it through anyway, accepting the bare assertion as sufficient to plead the exception plausibly and denying the motion to dismiss the manufacturing defect claim against the distributor. Id. This is Iqbal read backward. “Threadbare recitals of the elements of a cause of action, supported by mere conclusory statements, do not suffice.” Iqbal, 556 U.S. at 678. A single word alleging a state of mind, with zero factual enhancement, is about as threadbare as recitals get. If this is what plausibility requires, the pleading standard has been effectively repealed for one-word conclusions dressed up as knowledge allegations.

The one bright spot in the decision was failure to warn. Credit where due, because the court did get the preemption analysis right here. Relying on Mensing, the court held that failure to warn claims against the generic manufacturer were preempted because federal law requires generic drug labeling to remain identical to the corresponding brand-name label, making it impossible for the manufacturer to unilaterally add warnings. Davis, at *6. More notably, the court extended that preemption to the distributor as well, holding that state law warning claims are preempted whenever the defendant “lacked the ability to alter the drug’s label,” and that distributors, lacking any authority over labeling content, fall into that category regardless of the fact that Mensing technically addressed manufacturers. Id. The court rejected plaintiff’s argument that Mensing’s impossibility rationale should not extend to intermediate sellers, reasoning that a distributor cannot be liable for failing to do something the manufacturer itself is legally forbidden to do. Id.

The court also dismissed the negligence per se count outright, because West Virginia simply does not recognize an independent cause of action for negligence per se. A statutory violation is, at most, prima facie evidence of negligence. Id. at *8. No surprises here, and no complaints from us. This is settled West Virginia law, applied correctly.

Last stop on this tour of pleading standards gone soft — the express warranty claim survived even though plaintiff never identified any specific affirmation, promise, or representation the defendants supposedly made about the product. Id. at *9. The court found generic allegations that the defendants warranted the product would be “sterile, safe, and reasonably fit and suitable for its intended purpose” sufficient at the pleading stage, reasoning that plaintiff need not produce evidence of the warranty language this early in the case. Id.

Except an express warranty claim requires, at minimum, identifying the affirmation of fact that formed the basis of the bargain. W. Va. Code § 46-2-313(1)(a). Plaintiff did not quote any express language because there apparently was not any pled with particularity, just a generalized assertion that a warranty existed. Letting that survive a motion to dismiss is not accepting factual allegations as true, it is accepting a conclusion as true. Between this and the actual knowledge holding, the opinion is having a rough day for anyone hoping Rule 8 still has teeth in the Southern District of West Virginia.

This is a genuinely mixed bag, and not the good kind of mixed. The failure to warn preemption analysis, including the extension to the distributor, is a nicely reasoned application of Mensing that defense lawyers in generic drug cases should keep in their back pocket. But the rest of the opinion reads like plausibility pleading was optional homework. A causation theory resting on a doctor’s letter that only said the plaintiff “may have” gotten the recalled product, a knowledge exception satisfied by the word “knew” standing alone, and an express warranty claim that never identifies an express warranty, are not close calls under TwIqbal. They are the fact patterns those cases exist to weed out.

So we will take the preemption win, gladly, and file the rest of this one under “TwIqbal, we hardly knew ye.”

West Virginia gave this blogger perfect weather, a scenic drive, a promising football team, a very hilly campus, a much-needed daughter hug, and an unavoidable dose of Country Roads. It did not, unfortunately, give us a court willing to hold the line on federal pleading standards. Almost heaven only gets you so far when the complaint is held together with “may have” and “knew.” Country roads, take us home, but maybe drop the causation allegations off first.

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Last month Bexis filed his 134th, and probably last, amicus brief in the Pennsylvania Superior Court in a non-drug/device product liability case involving firearms.  Now edging into semi-retirement, Bexis is no longer in the business of drafting documents with footnotes.  Bexis final won/loss total is:

            Wins – 65       Losses – 38     Other – 29      Pending 2

            Wins Reversed On Further Appeal – 2      Losses Reversed On Further Appeal – 4

            Unpublished Wins – 11                                Unpublished Losses – 10

            Final, Published Wins – 52                        Final, Published Losses – 24

Anyone interested can see the complete list of Bexis’ 134 amicus briefs, dating back to 1992, with parties represented and issues briefed, here.

Here are some principles that Bexis has learned in over thirty years of writing and filing amicus briefs in significant pieces of litigation:

Number one:  Make sure to say something that is likely to contribute materially to winning the case.  Too many amicus briefs are filed by organizations and their counsel that do little more than wave the flag.  The presence of “me too” amicus briefs only devalues all amicus briefs, so would-be “me too” amici should simply sign onto amicus briefs written by someone else rather than file separately.

Number two:  Don’t expect to make any money directly from filing amicus briefs.  Writing an impactful amicus brief is often expensive, so amicus counsel should enter into their representations with their eyes open – realization rates for meaningful amicus briefs are likely to be very low.  Bexis rarely topped 25% for his amicus filings, that is, when he was paid at all.  Amicus briefs are loss leaders, with their value to their authors and their firms measured in gratitude from supporting industries – such as drug/device manufacturers – as a whole, and whatever publicity comes with helping win important cases.

Number three:  Act quickly, particularly if supporting the appellant.  Briefing schedules are short and, unless aided by the party they support, amici are very unlikely to obtain any extensions.  A second reason to act quickly is that early circulation of a persuasive draft amicus brief is the best way for an amicus to influence the arguments that the party it is supporting will make.  In amicus work, plagiarism is the ultimate form of flattery.  Amici will never be as influential as parties, so if a supported party wants to lift something that an amicus drafted, by all means the amicus brief writer should let that happen.

Number four:  Make sure that your amicus’ arguments are appropriate for the amicus organization.  If the amicus party is a nationwide organization, it’s brief should offer a nationwide perspective on the issue(s) being briefed.  If the amicus party is a state or local organization, that party’s brief should select and focus on an appropriate state or local issue.  In any event, most state and local amicus parties, at least on the defense side, are not in the financial condition to undertake extensive research on their own, so see item 3.

Number five:  The amicus brief writer must thoroughly research whatever legal issues are the subject of the filing.  Amicus briefs are important mainly because they focus on a particular issue in more depth than the party being supported can give it in this era of strictly enforced word-counts.  A comprehensive argument on the targeted issue is job one for any amicus.  A prospective amicus writer needs to know from the outset exactly what issue(s) will be covered, and needs to coordinate with the supported party.  Amici must also be careful not to bite off more than they can chew.

Number six:  Amicus curiae research must be both thorough and professional.  AI slop has negative value, so stay away from any use of AI in actually drafting an amicus brief.  While AI can be useful in an early round of research, no AI program yet exists that is better than legal research – and writing – performed by an experienced and dedicated lawyer.  AI does not understand the difference between recent and old cases.  In amicus (and most other) legal argument, reliance only on a pre-2000 precedent often looks like a tacit admission that the proposition in question lacks recent support.

Number seven:  Be a team player.  The more important the case, the more amici it will attract.  Experienced defense counsel in major litigation will have developed an amicus strategy for the appeal, in order to maximize perceived amicus impact and to reduce overlap and repetitive briefing.  Amicus brief writers may be able to influence this strategy, particularly if they have experience in the area, but should in all but the most extreme situations, stay in their designated lanes.

Number eight:  Write decisively.  Use declarative sentences.  Avoid passive voice.  Do not say something is “clear” or “obvious” – show that with research and argument.  Get rid of unnecessary words.  “In order to” almost always can be shortened to “to.”  Avoid starting sentences with “and” or “but.”  Break up long sentences and paragraphs.  Once a sentence has more than forty words, or a paragraph has more than five sentences, it is a candidate for splitting in two.  Do not start successive sentences or successive paragraphs with the same word.  The same holds true for using the same relatively distinctive word more than once in the same sentence. 

Number nine:  Block quotes are perfectly proper, but should be used sparingly and kept as short as possible.  Remember that the longer block quotes are, the more likely the reader is to pass over them.  The ellipsis is a friend, so long as it is used to shorten, rather than change, the meaning of, the text.  Using an ellipsis to alter a quote’s meaning is asking for trouble.  An introductory sentence to a block quote, with a few key words in quotes, is always good idea, and that idea gets better the longer the quote.

Number ten:  Make sure the brief is, and looks, professional.  This is a blogpost, so it’s fine to use contractions.  Stay away from them in briefs.  Likewise, avoid legal slang.  Yes, the Blog helped coin the portmanteau “TwIqbal,” but it’s not appropriate for an amicus (or any other) brief.  Use a standard font, such as Times New Roman, or Century Schoolbook, except on the cover, where putting the name of the court in Old English Text MT helps make the brief look as if it were professionally published.  Ditto with full justification of the text of the brief.  Ragged right side margins look like ragged teeth.  Footnotes should be in the same size text as the rest of the brief and should also be fully justified.  A justified text brief with unjustified footnotes just looks weird. 

Number eleven:  We’re not in law school anymore, so to hell with blue-book citation style.  Keep abbreviations in case citations to a minimum – limit them to “Co.,” Inc.,” “Assn,” and terms of that ilk.  Do not abbreviate directions.  Do not abbreviate anything that creates uncertainty, such as “Com.” or “Con.” or “Elec.”  The only exception that comes to mind is the names of law reviews.  Also, the most worthless word in any citation is “Ct.” in the closing parenthetical.  Of course, it’s a court; otherwise the brief would not be citing it.  String citations are OK if, and only if:  (1) every citation contains a jump citation to the relevant page of the opinion, and (2) every citation includes a parenthetical describing or quoting the relevant holding.  In briefs that are presenting nationwide research, it is a good option to replace long string citations with state-specific bullet points.

Number twelve:  Look like a local, particularly in state court.  Respect local citation forms, such as only using state reporters in New Jersey and following California’s placement of citation parentheticals before the actual citation.  Some jurisdictions require docket numbers for Westlaw/Lexis citations. If you are representing an amicus in an unfamiliar jurisdiction, it is always helpful – and frequently required – to have local counsel for advice on peculiar court rules or customary practices that affect how an amicus brief is written.

Number Thirteen:  A professional’s proof-reading is essential, and should not be left to secretaries, and never, ever to computers.  Read through the brief aloud before finalizing it.  Orally stumbling over words in the text is a dead giveaway that, even if grammatical, the text of the brief is not sufficiently clear.  A professional should be responsible for the final review of the table of authorities, and should do so manually, going page by page and checking off every citation.  Computers can only do so much; unusual citations will be missed.  Computers often treat numeric typos in citations as if they involve a new case.  Bexis’ last brief included a 50-state collection of standard jury instructions.  The computer omitted every one of them.

Number Fourteen:  Finally, be electronically literate.  Every part of every filing should be word searchable, since in the computer age text searches have reduced the importance of the table of authorities.  If the amicus brief contains Internet links, make sure that they all work.  Efiling has improved, but remains glitchy in many jurisdictions.  Therefore, waiting until the last minute to file your brief is asking for trouble.

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Today’s opinion, Digan v. Luxco, Inc., 2026 U.S. Dist. LEXIS 209391 (D. Mass. Sept. 16, 2026), arises from the bad combination of an open flame, a fraternity party, and Everclear alcohol. For those who’ve never encountered Everclear, it’s a 95% ethanol, 190-proof alcoholic beverage. Stiff and obviously flammable stuff. A frat-member poured a bottle of Everclear on a backyard fire during a party, creating a fireball that badly burned the plaintiff. Plaintiff sued the manufacturer of Everclear alleging a variety of claims, most of which would not make the opinion blog-worthy for us. But one aspect of the opinion caught our eye—the court’s rejection of “negligent undertaking” liability. 

We’ve blogged about some troubling aspects of negligent undertaking liability before, and we don’t want to see it creep into our practice area. Here the court held that marketing a product does not create a special duty to ensure the protection of its consumers, and that’s worth a post.

Continue Reading Dismissal of Negligent Undertaking Claim in Massachusetts
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Having clerked for a federal district judge and cut our litigation teeth in MDLs, federal court practice has burrowed deep.  When we think of procedural issues, our brains reflexively think in FRCP terms, and sometimes in state court the mental shift takes a beat.

Most of the time, it is a pretty short beat.  Sometimes, say in Louisiana or Pennsylvania state court, when they start throwing around the “dilatory exceptions” and “praecipes”, that beat takes a tad longer.  Things are similar but not quite the same.

Now think about product liability litigation in the U.S.—the general substantive legal principles we work with daily, as well as the broader litigation framework entailing document discovery, depositions, dispositive motion practice, the whole enchilada. 

It would be a mistake to take a brain stewed in the U.S. product liability milieu over to the European Union and not pause it to think through whether E.U. discussions of “strict liability” or “disclosure” or even “presumptions” mean what we think they do. 

We bring this up now because the new E.U. Product Liability Directive (aka “E.U. PLD” or Directive (EU) 2024/2853) will replace the nearly 40-year-old Product Liability Directive 85/374/EEC and take effect in less than 3 months, on December 9, 2026. 

Once it takes effect, all of us in the U.S. may do well to take a beat and figure out if the Directive’s language and procedures really mean what one might assume on first glance.

As an initial matter, we talk about “the” Directive, but it isn’t really one thing.  We rely on the English version of the E.U. PLD because we are essentially monolingual, but the European Union’s Official Journal has published the Directive in all E.U. languages, so the Polish version might be your touchstone for the E.U. PLD, or the Portuguese.  It’s a fair guess that there may be significant differences amongst the various translations, and no one version is more authoritative than the others.  That alone presents a definite opportunity for definitional arbitrage.

Then there is transposition.  Each E.U. member nation is obliged to transpose the Directive into national law by December 9, 2026.  A few have done so, and those presumably were able to figure out where the Directive best fit into their existing national law (both substantive and procedural) and had time to think through and resolve potential conflicts and inconsistencies.  Others have just started, and yet other countries have not yet begun (see here for a tracker regarding implementation).  The procrastinators likely will have no time to attend to where the Directive may create ambiguities or problems with laws already in force.  The point being that the E.U. Product Liability Directive may be a pretty clunky fit with existing national law in any particular country, so particular member states’ transposition laws are another place to look for differences and distinctions that may work to a defendant’s advantage once litigation commences under the new regime.

Turning back to the language of the E.U. PLD itself (English version), we cannot stress this enough:  The E.U. set out to increase the number of lawsuits, increase the number of product liability claimant victories, and increase the monetary recoveries, and they designed legislation to accomplish those goals. 

But while we are confident that the E.U. PLD will increase the number of lawsuits, we also think that whether the E.U. PLD meets the rest of the drafter’s stated goals will turn on the vigorousness of the defense once litigation begins.  That means not giving in to quick glosses on, or AI summaries of, the various E.U. PLD provisions (in whatever language you are litigating in).  The Directive itself has inconsistencies and knowing these exist will allow the unfortunate first few defendants to argue for the best possible version of conflicting language.

For example, take the term “defect.”

If you are in the U.S., you hear the term defect and you immediately wonder, manufacturing, design, or warning?  Under the E.U. PLD, there is just “defect” and no sub-categories. 

Do good warnings help a defendant avoid a finding of defect under the E.U. PLD?  No.  Or, maybe. Yes, definitely? 

In one place, the drafters declare that “warnings or other information provided with a product cannot be considered sufficient to make an otherwise defective product safe.” See Whereas Para. 31.  On the other hand, Article 7(2) declares:  “In assessing the defectiveness of a product, all circumstances shall be taken into account, including: (a) the presentation and the characteristics of the product, including its labelling….”  Right there is one gap, and we’d fight for the Article precluding a finding a defect because of good labeling, and a rejection of the inconsistent (and incomprehensible) prefatory language.

The standard for “defect” presents other openings for the defense as well. 

Under Article 7(1):  “A product shall be considered defective does not provide the safety that a person is entitled to expect or that is required under Union or national law”.  (Set aside the first part for a minute, but let’s not assume it automatically signifies a U.S.-style consumer expectations test). 

Look at the second part, “safety…that is required under [E.U.] or national law.”  It is written in a one-way fashion—non-compliance equals defect. 

But there are cracks.  Article 7(2) makes “relevant product safety requirements, including safety-relevant cybersecurity requirements” one of the “all circumstances” taken into account in “assessing the defectiveness of a product”.  That’s good.  Article 10(2(b) makes defectiveness a presumption upon the claimant’s demonstration “that the product does not comply with mandatory safety requirements laid down in Union or national law that are intended to protect against the risk of the damage suffered by the injured person.”  That’s less good.

But which is it?  If we are representing the defendant facing this word salad (in whatever language, and through and with qualified local counsel of course) we might decide to take a run at just arguing that Article 7(1) contains an implicit, and automatic, regulatory compliance defense that Articles 7(2) and 10(2)(b) do not foreclose. 

The infamous E.U. PLD presumptions provide additional openings for defendants to try to take back some ground.  Even within the U.S., how presumptions work is always a complicated matter.  They might help a plaintiff survive a dispositive motion and then disappear for trial purposes, they might form part of a jury instruction, they might be rebuttable, or not, or something else. 

We are guessing here, but we suspect that most E.U. member nations do not have a well-established and developed practices regarding the effect and operation of presumptions, so defendants should have a real opportunity—country to country, judge-by-judge—to advocate for what these presumption parts of the E.U. PLD mean, and how they should function. 

And the presumption provisions (Article 10) are particularly messy and confusing.  

Article 10(2) says a product is presumed defective where:

  • (a) The defendant fails to comply with Article 9(1), newly requiring defendants to cough up evidence;
  • (b) The claimant demonstrates that the product does not comply with mandatory safety requirements under E.U. or national law (as noted above); or
  • (c) The claimant demonstrates that the damage was caused by an “obvious malfunction” of the product during reasonably foreseeable use or under ordinary circumstances—whatever that means. 

Article 10(3) says that a causal link between defectiveness and damage is presumed where the product has been established as defective and the damage is “of a kind typically consistent with the defect in question”.  Again, whatever that means.

Article 10(4) says that where, despite disclosure of evidence, the claimant faces “excessive difficulties, in particular due to technical or scientific complexity,” in proving defectiveness or the causal link, the court shall presume defectiveness, causation, or both — provided the claimant “demonstrates” it is likely that the product was defective or that there is a likely causal link.

Frankly, we think these all are awful.  But nothing about these presumptions is self-apparent, and so every term, every phrase, presents an opportunity to imagine what they could mean, or should mean, under this entirely new regime.  Why litigate Article 10(2)’s “obvious malfunction” as some form of U.S.-style res ipsa loquitur when the Directive’s “obvious malfunction” is so undefined that it calls for some new definition of its own?  At most, the drafters gave “a glass bottle that explodes in the course of reasonably foreseeable use” (Whereas para. 46) by way of explanation, but that hardly answers the question of what “obvious malfunction” means.  Maybe “obvious malfunction” in the E.U. PLD means the claimant must come forward with proof that the product deviated from its manufacturing specifications in a way that caused it to work improperly and caused harm.  We could live with that.

There are more E.U. PLD inconsistencies, ambiguities, and internal tensions worth exploring and defining for the better.  Additional ones include:

  • The “excessive difficulties” presumption standard of Article 10(4), which is utterly vague.  The Directive states that a claimant who “demonstrates” excessive difficulties in proof gets a presumption of defect, causation, or both.  What does “demonstrate” mean?  Article 10(4) does not say, but the prefatory language suggests it won’t take much—elsewhere the Directive says the claimant “should provide arguments to demonstrate excessive difficulties” but that “proof of such difficulties should not be required.” (Whereas, para. 47).  We see no reason to roll over on the proof of requirement, particularly because the concept of “technical or scientific complexity” is left entirely to case-by-case judicial interpretation.
  • Article 3 mandates “maximum harmonization” in that E.U. countries “shall not” diverge from the Directive.  But at the same time, national law and each country’s judicial system provides an overlay that will help determine the standard of proof for the claimant’s prima facie case, rules on calculating compensation and damages (including “non material” damages like pain and suffering), how the disclosure requirements work, and procedural rules for bringing claims.
  • The “development risk defense”, which countries are expressly allowed to reject or modify pursuant to Article 18.

All of the above thoughts go to things to think about once the Directive takes effect and the first lawsuits are filed under it.  You have 76 days left until then, and the action items for now remain the same:

  1. Audit your supply chain to figure out who is an economic operator subject to liability the Directive;
  2. Review and update any indemnification, distribution, and software integration agreements;
  3. Review and update any product liability insurance coverage for E.U. activities;
  4. Audit regulatory compliance and systems;
  5. Prepare for new disclosure obligations by reviewing document and data creation and retention practices, and consider both the GDPR and the Directive’s provisions about “excessive difficulties” of proof; and
  6. Look closely at software components and digitally-connected products, including lifecycle management and expectations for updates under the Directive.
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Perez v. Apyx Medical Corp., 2026 WL 2691359 (N.D. Cal. Sept. 14, 2026), is a product liability suit alleging misrepresentations about off-label use of a company’s cosmetic surgery §510(k) device. That, at least, is how we read the complaint.  The court read the complaint a bit differently. The opinion was authored by the Judge Tigar, who possesses a burning bright intelligence, so we must allow for the possibility (unlikely as it might be) that we are wrong.  Even so, Judge Tigar dismissed the complaint (sparing us the need for despair or to pursue the Blake-ian inquiry of “What immortal hand or eye/Dare frame they fearful symmetry?”)

The plaintiff in Perez claimed that she suffered severe burns and scarring from the defendant’s medical device when it was used on her to perform skin resurfacing and body contouring procedures. The plaintiff’s causes of action included (1) strict liability under the risk-expectation theory, (2) strict liability under the consumer expectation theory, and (3) negligent design, manufacturing, marketing, and sale of the device. The defendant moved to dismiss based on preemption and failure to state a claim. 

The court held that the claims were not preempted.  It held that express preemption went nowhere because the device had gone through the 510(k) process, not premarket approval. We, along with at least one of our faithful readers, must grit our teeth at this semi-spurious distinction, but then we will move on to the implied preemption argument, which needed a bit more analysis.  The defendant argued that the complaint was preempted because it was based on allegations of misrepresentations about off-label use in violation of the Food,  Drug, and Cosmetics Act (FDCA), but the FDCA prohibits private enforcement.  The court rejected that argument, reasoning that the complaint travelled on traditional state claims, not disguised attempts to enforce the FDCA.  The court opined that the defendant “misreads Perez’s complaint. At heart, Perez’s claims are design defect and negligence claims, not off-label marketing claims, and therefore not preempted.” To our eyes, the court fell for the oft-used plaintiff lawyer trick of couching claims at a higher level of abstraction to avoid specific defenses.  That trick did not work in the recent SCOTUS Monsanto case, and it should not have worked here.  

But that high level of abstraction did end up costing the plaintiff in this case. The court dismissed the entire complaint, with leave to amend. The decision dismissed the design defect claims for failures to plead, but not because California law prohibits such claims against prescription medical products – because the defendant did not raise that argument in a timely fashion.  Rather, the court focused on how the allegations that physicians misused the product in a dangerous fashion did not plead that the product had any defect.  Foreseeable misuse is not enough to sustain a defect claim, whether design, warning, or manufacturing.  Because the plaintiff did not identify any product defect, the negligence claim also failed: “Perez does not identify what design defect affected Apyx’s Renuvion product and only contends in conclusory fashion that the foreseeable use or misuse of the product and the fact that it caused her injury sufficiently pleads the existence of a defect.” The complaint “does not identify the design defect that caused her injury.”  Goodbye, complaint (but try again). 

The defendant made a couple of other arguments, on causation and consumer expectation defect, but they were denied. The court thought the causation argument was more suitable for summary judgment, after factual development, and not so much as a way to test the pleadings. The Perez court held that the consumer expectation issue would not be ripe until jury instructions would be determined.

Of course, depending on whether the plaintiff can fix her complaint, there might not ever be jury instructions. 

Drug & Device Resources

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FDA-regulated products now account for an estimated one-fifth of overall economic activity in the U.S. They have also been the focus of a litigation explosion. This timely guide covers all aspects of litigation involving drugs, medical devices, vaccines and other FDA-regulated prescription products.
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