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As if our reputation as curmudgeonly and heartless defense lawyers needed burnishing, our post today gripes about how the Fifth Circuit affirmed the dismissal of two related cases brought by a decedent’s estate.  This griping arguably ignores the sage advice we have received from a few trial judges to sit down and stop arguing after we have won some contested issue.  Still we persist.  Our non-heroic querulous efforts here are directed to a different sort of equality than those of more storied persistence—the equality of the parties in civil litigation in the eyes of the law.  In literature, television, and film, the plucky little-guy plaintiff recovers against the big-guy corporate defendant despite the system being stacked against him.  In our experience over the last three decades, many things favor the product liability plaintiff, especially when her case proceeds in a plaintiff-friendly jurisdiction against a deep-pocket medical product manufacturer from somewhere else.  One of the least sensational and tangible of these factors is that judges tend to sympathize with injured plaintiffs.  Relatedly, in our experience, they are very hesitant to hold the mistakes of the plaintiff lawyers—even those made quite consciously—against the plaintiffs.

“Hey, grump, what is wrong with having some sympathy or even a little empathy?” you may be asking.  Nothing, we would say.  These are fine qualities for humans to exhibit.  (“Empathy” was even a pangram on Spelling BeeTM earlier this week.)  They just are not supposed to play a role in who wins a motion or trial.  While we are not so naive as to believe all juries push aside their sympathies in the face of relentless emotional overtures from the plaintiff lawyers, model civil jury instructions advise them to do so.  In California, for instance, both the preliminary instructions and the ones about the duties of the judge and jury are emphatic:  “Do not let bias, sympathy, prejudice, or public opinion influence your verdict” and “You must not let bias, sympathy, prejudice, or public opinion influence your decision.”  Federal Rule of Evidence 403 and state equivalents also empower judges to exclude relevant evidence based on its risk of “unfair prejudice, confusing the issues, misleading the jury, undue delay, wasting time, or needlessly presenting cumulative evidence.”  The notes of the federal rule from back in 1932 link “unfair prejudice” to playing on a jury’s sympathy:  “These circumstances entail risks which range all the way from inducing decision on a purely emotional basis, at one extreme, to nothing more harmful than merely wasting time, at the other extreme” and “‘Unfair prejudice’ within its context means an undue tendency to suggest decision on an improper basis, commonly, though not necessarily, an emotional one.”

Judges are also urged not to let sympathy and emotional appeal enter their decision making.  The United States Courts issue something called the Code of Conduct for United States Judges.  We find a number of its provisions interesting and relevant to several decisions we have panned over the last year or so, but the one most relevant here is Canon 3A(1), which provides “A judge should be faithful to, and maintain professional competence in, the law and should not be swayed by partisan interests, public clamor, or fear of criticism.”  Relatedly, “The duty under Canon 2 to act in a manner that promotes public confidence in the integrity and impartiality of the judiciary applies to all the judge’s activities, including the discharge of the judge’s adjudicative and administrative responsibilities.”  Just as a judge should clearly not offer in an opinion that claims about failure to warn with prescription drugs tend to be bogus, statements of sympathy for the extent of injuries allegedly suffered by plaintiffs run contrary to these precepts even if sympathy actually plays no role in the judge’s ultimate decision.  After all, Canon 2 referenced in the second quote is “A Judge Should Avoid Impropriety and the Appearance of Impropriety in All Activities.”  Superfluous statements of sympathy are avoidable and may support the appearance of impropriety depending on how the court rules.

In Phillips v. Ethicon Endo-Surgery, Inc., — F.4th –, 2026 WL 2969090 (5th Cir. Oct. 2, 2026), an estate brought two separate suits for implied warranty, neither of which satisfied the well-known and easily met requirement of pre-suit notice for such claims in Texas.  Plaintiff then acceded to having a final judgment entered in defendants’ favor in the first suit, which precluded her claims in the second suit.  The overall record below was even worse for plaintiff than the thumbnail sketch here suggests, yet the conclusion of the Fifth Circuit’s decision affirming defendants’ judgment in both cases was apologetic:

Our sympathies are with Plaintiffs, who have suffered a horrible loss. Given Plaintiffs’ concessions and forfeiture, we find that they have not shown any reversible error in Phillips I or Phillips II.

Id. at *5.  We have never seen a court write something akin to “we regret that we cannot exclude plaintiff’s general causation testimony that is utterly unsupported and unreliable” or “the law requires us to grant summary judgment to the defendant given plaintiff’s failure to come forward with admissible evidence to support any of her claims, but our sympathies demand that we rule otherwise.”  Part of the issue here is that a court’s ruling on a Rule 12(b)(6), 56, or 702 motion should not depend on whether the plaintiff has suffered a “horrible loss” or is suing over a “tragic death,” as the first paragraph of Phillips writes.  A plaintiff with modest injuries or whose decedent’s death was not tragic—if there is such a thing—has the same burdens.  Pleading standards and state law prerequisites for warranty claims do not change based on the extent of sympathy for the plaintiff, just as they do not change based on whether the plaintiff has some immutable characteristic. 

We have noted a number of times that an opinion’s description of plaintiff’s injuries and why the prescription medical product was used in the case can be indicators for how a court will rule.  In Phillips, the court notes that the prescription surgical stapler was used in connection with the reapproximation of the decedent’s bowel after a length was resected, but it does not say why he had the surgery, which is relevant in a case where a bowel perforation led to sepsis.  A more noteworthy omission from the opinion, however, is any criticism of plaintiff’s counsel.  (There is criticism of defense counsel.)  The first case against the manufacturer defendants was brought in federal court almost two years after the decedent’s injury began, yet plaintiff’s counsel never bothered to provide the required pre-suit notice on the two implied warranty claims asserted along with a design defect claim.  After defendants raised the lack of notice in a motion to dismiss the first complaint, plaintiff merely filed an amended complaint that dropped the design defect claim without fixing the other issues.  Id. at *1.  This was at a point within the statute of limitations for implied warranty claims.  Ultimately, a magistrate recommended that a motion to dismiss the second complaint be granted with prejudice as to a patently inapplicably claim for warranty of fitness for a particular purpose and without prejudice as to a claim for implied warranty of merchantability, which lacked sufficient factual allegations and pre-suit notice.  Id. at *2.  With dismissal on the horizon, plaintiff filed a new state court case against the hospital where the surgery occurred and a slightly different mix of manufacturer defendants.  Then, in sequence, plaintiff did not oppose the adoption of the magistrate report and recommendation, the second case was removed to federal court, the judge in the first case adopted the report and recommendation but made it all with prejudice, the defendants moved to dismiss the second case, the magistrate recommended dismissal based on the prior judgment, and the court adopted it.  Id. at *2-3.  Along the way, plaintiff offered nothing suggesting a further amended complaint could fix the issues with the first two complaints, did not tell the federal court about the second case, and did not seek a voluntary dismissal to provide pre-suit notice or make sure the proper manufacturer entities had been sued.  Plaintiff’s counsel even had “additional relevant facts” asserted in the second case that were not asserted in the first.  Id. at *5.

In affirming the various decisions of the district court, the Fifth Circuit offered no rebuke to the plaintiff’s counsel for their various choices and gaffes.  Surely, filing a second case in state court while the first is still pending in federal court and not informing the federal court could have been called out in starker terms, such as by invoking the duty of candor to a tribunal.  It may be that losing two cases and a published appeal will provide some deterrence for plaintiff-lawyering like this.  As outsiders, we can both express sympathy for the death of plaintiff’s decedent and decry the waste of judicial resources in the two cases she brought and lost.  Courts have their own canons, though.

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Last week we blogged about the Seventh Circuit’s affirmance of a dismissal of yet another case challenging a vaccine mandate. We predicted that our inbox would be visited by dissenters. We were not wrong. One reader rebuked us for our snarky tone. And that reader was not wrong. 

Look: to our mind, it is perfectly obvious that Jacobson is binding precedent, and employers and governments can take reasonable measures to protect people.  To our mind, following the medical consensus is reasonable. Frankly, we think the other side is mostly unreasonable. But, yes, our language was intemperate.  

We have a Joycean memory of a Thanksgiving dinner a couple of years ago when a political argument erupted and we found ourselves calling an uncle, who was a sweet, intelligent man, stupid.  Others at the table gasped.  We were rude and unkind. We do not mean to inflict that sort of unpleasantness on our readers, or anyone else. 

Still, most of the folks who insist on doing their own research are merely scrolling until they find something that is in accord with their predilections.  Reason scouts and spies for the passions. Tom Nichols wrote about the Death of Expertise, and he was on to something. Maybe it is due to the internet or political polarization, but there is profound skepticism about experts.  Any defense lawyer who files plenty of Rule 702 motions must acknowledge that experts can be wrong. But a medical consensus is more likely to be right than a keyboard warrior. So we plead guilty to deploying a dismissive tone when we consider vaccine cases.  To be fair, most courts are literally dismissive.  We cannot help it; we harbor doubts about the good faith and rationality of most of the challengers. But we have no such doubts about the reader who took the time to write to us. He has ample reserves of smarts and integrity.  We just disagree. And we agree with most of the courts that have wrestled with vaccine mandates. 

This week we find ourselves agreeing with Schmidt v. City of Pasadena, et al., 2026 WL 2980130 (9th Cir. Oct. 5, 2026). Schmidt counts as a major, published, appellate application of immunity under the Public Readiness and Emergency Preparedness (PREP) Act, this time against a plaintiff challenging governmental COVID vaccination requirements.  This decision should put an end to attacks on employment-related vaccination and related requirements, since they are barred by the PREP Act. Should, but probably won’t. 

The plaintiff in Schmidt was a forensic specialist with the Pasadena Police Department. Pasadena implemented a COVID-19 vaccination policy for its employees to “stem the rapid increase in Covid-19 transmission” resulting from the Delta variant of the virus. Employees who successfully invoked exemptions based on religion or sincere beliefs would then be subject to testing and masking requirements.  The plaintiff refused the Covid-19 vaccination, eventually complied with the alternative masking and testing requirements, but contended that those requirements created a “hostile work environment.” He sued, setting forth no fewer than 21 claims (some federal and some state) against the masking and testing requirements.  Both the district and circuit courts had little difficulty holding that all those claims were barred by the PREP Act preemption (state claims) or immunity (federal claims) provisions.  We should point out that the plaintiff also filed motions for recusal of the trial judge and for reconsideration.  (Maybe we are not alone in being intemperate on this topic.)

The PREP Act precludes liability against any “covered person” on “any claim for loss that has a causal relationship with the administration to or use by an individual of a covered countermeasure.”  The local government was a covered person under the Act since it was administering covered countermeasures and was a “program planner” for such countermeasures. So far, so good. 

Vaccination, masking, and testing are all covered countermeasures under applicable emergency use authorizations.  (The plaintiff argued that the saliva tests were particularly out of bounds, but the court disagreed.) “Both the PREP Act and the HHS Secretary’s Declaration plainly extend immunity for the administration of COVID-19 tests and masks.”

The plaintiff attempted to use Loper Bright to get the court to disregard the HHS Secretary’s definition of “covered countermeasure.” But the court held that even in the wake of Loper Bright the court “must respect when Congress has ‘expressly delegated to an agency the authority to give meaning to a particular statutory term.'” 

The Act’s causation language is exceedingly broad, and is satisfied by any of “caused by, arising out of, relating to, or resulting from” use of countermeasures.  The Act’s scope is not limited to any particular category of causes of action.  The plaintiff’s alleged emotional distress damages and purported “property interest” in his DNA are all “losses” under the Act and the claims are therefore preempted. 

The recusal motion was based on the district judge’s ownership of mutual funds. But ownership  in a mutual fund is not considered a “financial interest in such securities unless the judge participates in the management of the fund.”

Finally, the court considered the plaintiff’s motion for Rule 11 sanctions based on the defendants’ disparagement of the plaintiff’s expert for indulging in a “conspiracy theory” and other “outlandish conspiracies.”  The court held that such “word choice simply does not meet the criteria for being made without reasonable, competent inquiry.” 

The case was dismissed and the plaintiff’s sanctions request was denied. 

Is it churlish of us to feel doubly vindicated?

Or should we say triply vindicated? After the Ninth Circuit issued its opinion, the plaintiff filed an emergency motion to vacate the opinion “based on lies, misstatements, false statements, material omissions, and sophistry in the rendered opinion.”  Earlier we confessed to being intemperate.  But compared to this litigant, we look like Fred Rogers.  

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Every so often, the song nobody wanted turns out to be the one that lasts. Radiohead almost left “Creep” off their debut album because the band itself was embarrassed by it; it became their defining hit. Prince wrote “Nothing Compares 2 U” and gave it away as album filler for a side project he was producing, and it sat largely unnoticed for years before someone else’s cover turned it into a standard. Fleetwood Mac’s “Dreams” was reportedly written in about ten minutes, tucked in among songs the band thought were the real singles, and it ended up their only number one hit. Nobody plans for the afterthought to be the survivor. A Lap-Band preemption decision out of the Southern District of West Virginia this week tells a similar story, except in reverse — almost the entire album got cut, and the one track still standing was never much of a contender to begin with.

The Lap-Band is a Class III device that received premarket approval from the FDA in 2001. The defendant manufacturer acquired the device in 2006 and marketed it until at least 2015. Plaintiff had hers implanted in 2009. Fifteen years later, the device eroded into her stomach and bowel, requiring surgical removal. Plaintiff sued the manufacturer and a string of corporate successors and affiliates asserting failure to warn, design defect, negligence, gross negligence, a state consumer protection claim, negligent misrepresentation, and punitive damages — seven tracks on the album, so to speak. Defendants moved to dismiss on preemption and pleading-sufficiency grounds. The resulting decision in Branch v. Allergan, Inc., 2026 WL 2939572 (S.D.W. Va. Sept. 30, 2026), is a useful refresher on just how far PMA preemption reaches when a plaintiff tries to dress up a different-or-additional-requirements claim as something else.

Plaintiff’s warning claim argued that defendants should have disclosed higher erosion, removal, and failure rates than the FDA-approved labeling reflected. No matter how plaintiff tried to frame it — as a labeling problem or as a marketing-and-advertising problem — the court saw it for what it was — a demand for greater warnings than the FDA required, which is squarely preempted. Id. at *6. The court also found the claim independently inadequate under TwIqbal because plaintiff never pointed to specific facts showing how the advertising actually deviated from the PMA-approved conditions. Id. at *7. Conclusory allegations that advertising was “inconsistent” with the PMA approval do not cut it; a plaintiff has to identify an actual fact-based regulatory violation, not just assert one.

The design defect claim fared no better, and for a reason that should surprise nobody who has followed PMA preemption for more than five minutes. West Virginia requires a plaintiff asserting design defect to prove a feasible alternative design existed. But any alternative design is, by definition, a different design than the one the FDA approved through the PMA process. That is exactly the kind of “different from, or in addition to” federal requirement that Riegel v. Medtronic forecloses. Id. at *6–7. The court lined this ruling up with a chorus of sister-court authority holding the same thing — you cannot use state design-defect law to relitigate the FDA’s own risk-benefit calculus on a Class III device.

Negligence, gross negligence, and negligent misrepresentation got a partial reprieve — but only partial. Id. at *8. To the extent those claims were really failure-to-warn claims in a different costume, they were preempted for the same reasons as above. The one sliver that survives is any claim resting on affirmative misrepresentations about the device, as opposed to a failure to disclose more than the FDA required. The court was careful to note that a manufacturer does not violate federal law merely by saying its FDA-approved device is safe — that is the whole point of approval. It is only when a manufacturer makes other affirmative claims, like superiority over competing devices, that it steps outside the protected zone. Notably, the court never identifies any specific affirmative misrepresentation that plaintiff actually pled. Rather, this is a claim that survives the motion more on the theory that it could exist than on any specific factual allegation that it does.

The next part of the decision is West Virginia specific but noteworthy. The court held claims brought under the West Virginia Consumer Credit and Protection Act are barred for Class III medical devices. Id. at *8–9. This ruling extends the West Virginia Supreme Court’s decision in White v. Wyeth, 705 S.E.2d 828 (W. Va. 2010) — previously applied to prescription drugs — to a Class III device for the first time. Id. at *9. “White stands for the common-sense proposition that where there is a protective intermediate decision-making buffer[,] the patient-consumer is insulated from the wrongs the WVCCPA seeks to redress.” Branch, 2026 WL 2939572, at *10. Plaintiff argued that West Virginia’s high court had never extended White to medical devices and would not do so here. The court disagreed, reasoning that the plaintiff was never a consumer left to navigate a complex medical decision on her own. Id. at *10–11. In fact, she went through not one but two physicians before her Lap-Band was implanted. Class III devices are about as heavily regulated as products get and implanting surgeons are certainly decision-making buffers. Id.

Fifteen years is a long time, and corporate ownership of the Lap-Band changed hands more than once in that stretch. Plaintiff tried to rope all of the successors and affiliates in under a successor liability theory. The court was not having it. West Virginia only permits successor liability where there was an express or implied assumption of liability, a fraudulent transaction, or bad faith in the transaction — and plaintiff did not plead facts supporting any of those narrow grounds, except against one co-promoter. Id. at *11. Call it a one-hit wonder — of four corporate defendants targeted on a successor or affiliate theory, only one made the final cut.

There is really only one sour note in this decision. The negligent misrepresentation claim survives in theory, but the court never points to any specific affirmative misrepresentation that plaintiff actually pled, leaving the door open for defendants to revisit the issue on summary judgment. Seven tracks went into this motion, and only a fragment of one came out the other side still standing. Unlike “Creep” or “Dreams,” though, this survivor was not a hidden gem waiting to be discovered — it is an undeveloped claim that escaped the cutting room floor on a technicality, and it may well not make the final cut either once the record is actually developed. Most of this album got cut exactly where it should have — at the PMA preemption line.

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We have been complaining about the purported “presumption against preemption” ever since the Blog started.  Our first major research post demonstrated that, back in 2006, such precedents were primarily on the express side of preemption.  In our sandbox, that changed with Riegel v. Medtronic, Inc., 552 U.S. 312 (2008), in which the majority simply ignored any purported presumption against preemption, id. at 326, despite the dissent’s vociferous assertion of one.  Id. at 334.

In the nearly twenty years since Riegel, the Supreme Court has not relied on any “presumption” against preemption in an express preemption case.  See Coventry Health Care of Missouri, Inc. v. Nevils, 581 U.S. 87, 97 (2017) (rejecting presumption as “blind” to statutory context); Puerto Rico v. Franklin California Tax-Free Trust, 579 U.S. 115, 125 (2016) (where a “statute contains an express pre-emption clause, we do not invoke any presumption against pre-emption”) (citation and quotation marks omitted); Gobeille v. Liberty Mutual Insurance Co., 577 U.S. 312, 325-26 (2016) (finding preemption notwithstanding “[a]ny presumption against pre-emption, whatever its force in other instances”); POM Wonderful LLC v. Coca-Cola Co., 573 U.S. 102, 111 (2014) (“[b]ecause this is a preclusion case, any ‘presumption against pre-emption’ has no force”) (citation omitted); Arizona v. Inter Tribal Council, Inc., 570 U.S. 1, 2 (2013) (rejecting an anti-preemption presumption urged by the dissent; finding “no reason to invoke the presumption”); Tarrant Regional Water District v. Herrmann, 569 U.S. 614, 631 n.10 (2013); Cuomo v. Clearing House Assn, L.L.C., 557 U.S. 519, 534 (2009) (“[w[e have not invoked the presumption against pre-emption, and think it unnecessary to do so in giving force to the plain terms of the [statute at issue]”).  But see Altria Group, Inc. v. Good, 555 U.S. 70, 77 (2008) (invoking a presumption against preemption without mentioning the word “presumption”) – discussed below.

The last time a Supreme Court justice (Kennedy, who is no longer on the Court) was so bold at to include a “presumption against preemption” in an opinion of the Court, was CTS Corp. v. Waldburger, 573 U.S. 1, 7 (2014), which resulted in only two other justices joining that part of the opinion – and four concurring justices specifically refusing to join that aspect of the opinion.  Id. at 19-20 (“The contrary notion − that express pre-emption provisions must be construed narrowly − was extraordinary and unprecedented when this Court announced it two decades ago, and since then our reliance on it has been sporadic at best”) (citations and quotation marks omitted).

The same has been true – if less explicit − in implied preemption cases.  See Mutual Pharmaceutical Co. v. Bartlett, 570 U.S. 472, 503 & n.1 (2013) (like Riegel, ignoring the dissent’s reliance on a presumption against preemption); Hillman v. Maretta, 569 U.S. 483, 490186 L. Ed. 2d 43 (2013) (finding preemption notwithstanding an anti-preemption presumption in domestic relations case); Arizona v. United States, 567 U.S. 387, 451 (2012) (giving what the dissent viewed was “short shrift” to any presumption against preemption in a field preemption case); PLIVA, Inc. v. Mensing, 564 U.S. 604, 638 (2011) (like Riegel and Bartlett, ignoring the dissent’s reliance on a presumption against preemption).  Indeed, the last Supreme Court implied preemption decision that actually invoked a “presumption against preemption” as part of its reasoning was the benighted Wyeth v. Levine, 555 U.S. 555 (2009), decision.  And as we discussed in this post, the Court spent four pages extensively reworking Levine in Merck Sharp & Dohme Corp. v. Albrecht, 587 U.S. 299 (2019), and “conspicuously absent from that description is any express reference to any ‘presumption’ (as opposed to the older ‘assumption’) against preemption.”

But as mentioned above, there is that one exception, Altria Group, Inc. v. Good, 555 U.S. 70 (2008), a tobacco case decided less than a year after Riegel.  By a 5-4 vote, the court used a presumption against preemption to import a “predicate duty” gloss on the textually absolute preemption clause (15 U.S.C. §1334) of the Cigarette Labeling Act.  Id. at 76-77.  Thus, the majority concluded that “the phrase ‘based on smoking and health’ fairly but narrowly construed does not encompass the more general duty not to make fraudulent statements.”  Id. at 87.  That holding allowed plaintiffs to sue over approved labeling simply by calling their claims “fraud” rather than failure to warn so that their claims were purportedly “predicated on the duty not to deceive.”  Id. at 91.  The four-justice dissent (the same four as in CTS) was having none of it:

In light of Riegel, there is no authority for invoking the presumption against pre-emption in express pre-emption cases.  The majority here thus turns to Lohr to revive the presumption and, in turn, to justify its restrictive reading of the Labeling Act’s express pre-emption provision.  But, as Riegel plainly shows, the Court is no longer willing to unreasonably interpret expressly pre-emptive federal laws in the name of “congressional purpose,” or because “Congress has legislated in a field traditionally occupied by the States.”  The text of the statute must control.

Id. at 102-03 (citations omitted) (Thomas, J., the Chief Justice, Scalia, and Alito, JJ. dissenting).

Well, three of the four Good dissenters are still on the Court, as opposed to … well, none of the five who supported a presumption against preemption in its (hopefully) last hurrah in Good.  That’s significant because the Good presumption against preemption recently led to the decision in Fontaine v. Philip Morris USA Inc., 277 N.E.3d 585 (Mass. 2026), which affirmed a large cigarette-related verdict:

The preemptive scope of the Labeling Act is governed entirely by the express language . . ., which is to be read narrowly in light of the presumption against the pre-emption. . . .  Both statutory and common-law State claims based on theories that a defendant should have included additional, or more clearly stated, warnings than those required by the Labeling Act, or that are based on theories that a defendant’s advertising neutralized the effect of federally mandated warning labels, are preempted. . . .  But the Labeling Act does not preempt claims that are “predicated not on a duty ‘based on smoking and health’ but rather on a more general obligation, such as “the duty not to deceive.  In other words, the Labeling Act “pre-empts only requirements and prohibitions − i.e., rules − that are based on smoking and health,” not claims that assert “harms related to smoking and health.”  Altria Group, Inc. v. Good, 555 U.S. 70, 84 (2008).

Id. at 608 (other citations omitted) (emphasis original).  As in Good, that meant that warning claims repackaged as “fraud” escaped preemption.  Id. at 609 (admitting that the same “evidence might have also been relevant to an unasserted preempted [warning] claim”).

But there’s hope for us product liability preemption afficionados.  Fontaine is being appealed to the United States Supreme Court, with the defendants/petitioners expressly arguing that Good should be overruled, and the presumption against preemption rejected across the board in express preemption cases (and perhaps entirely).  Bexis coordinated PLAC’s amicus curiae brief in Fontaine (if he wasn’t semi-retired he probably would have written it).

There’s more.  Beyond cigarette preemption, a circuit conflict – one of the things that the United States Supreme Court exists to adjudicate – has opened up on the presumption against preemption in our sandbox.  Three years ago, in our post “Trying to Make Some Sense Out of OTC Economic Loss Decisions,” we pointed out that the distinctly pro-plaintiff approach to OTC preemption in such cases can be traced to the pre-PR v. Franklin (but not by much) decision in Astiana v. Hain Celestial Group., Inc., 783 F.3d 753, 758 (9th Cir. 2015).  Astiana justified allowing plaintiffs to use the FDCA’s generalized “misbranding” and “adulteration” provisions to make blatantly non-“identical” labeling claims based on a presumption against preemption:

In analyzing express preemption, we start with the assumption that the historic police powers of the States were not to be superseded by the Federal Act unless that was the clear and manifest purpose of Congress.  The FDCA proscribes any . . . labeling that is false or misleading in any particular.

783 F.3d at 757.  Thus, the use of broad, vague “false or misleading” statutory language as an express preemption dodge is allowed in the Ninth Circuit in direct reliance on the now non-existent anti-preemption presumption in express preemption cases.  It’s what we call “zombie” presumption against preemption precedent. 

Recently, however, in Yousefzadeh v. Johnson & Johnson Consumer Inc., 184 F.4th 130 (2d Cir. 2026), the Second Circuit expressly rejected any presumption against preemption in the same statutory context – OTC preemption.

When a federal law contains an express preemption clause − as here  − we focus on the plain wording of the clause, which necessarily contains the best evidence of Congress’ preemptive intent.  In other words, when an express preemption clause exists, the plain text of the statute begins and ends our analysis, and courts should not invoke the presumption against preemption.

Id. at 145 (citing, inter alia, PR v. Franklin).  Moreover, Yousefzadeh specifically disagreed with the Ninth Circuit’s “opposite route” approach to OTC preemption.  Id. at 148 n.12 (“we do not agree” with that circuit’s “reason[ing] that the plaintiffs were enforcing the FDCA’s . . . misbranding provision”).  If the United States Supreme Court does not accept the petition in Fontaine (always a iffy proposition at best), then perhaps OTC preemption becomes the next, best shot at overturning left-over anti-preemption presumptions in prescription medical product liability litigation.

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Our clients generally prefer arbitration to litigation. Arbitration is less expensive, has much more balanced discovery, and it’s faster. It’s probably not statistically significant, but we think we’ve seen an uptick in cases in our practice footprint involving arbitration clauses. The cases we’ve blogged about recently involve some kind of direct interaction with a patient where a manufacturer can include an arbitration clause in the terms of a contract. Examples include the on-line sale of dental aligners and a glucose monitoring app for a patient’s smartphone. Today’s decision, Johnson v. Luminary Genetics, 2026 WL 2886002 (S.D. Cal. Sept. 25, 2026), is another instance where a manufacturer included an arbitration clause in its contract with a consumer—this time in the context of genetic testing.

Continue Reading Arbitration and Genetic Testing
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The Blog has written about a J&J subsidiary’s litigation against the other side’s junk-science talc “experts” on several occasions.  Recently, however, those experts managed to obtain summary judgment against the trade libel action brought by the subsidiary over the expert’s blatantly false “scientific” article about talc.  Pecos River Talc LLC v. Emory, 2026 WL 2431332 (E.D. Va. Aug. 19, 2026).  While we think that summary judgment was improper − the opinion reads throughout like a pro-plaintiff juror drawing inferences in favor of the movant seeking summary judgment – as a broader matter, it doesn’t really matter.  By becoming a plaintiff, the defendant was able to discover enough about both the junk data that these “experts” used and the “junk” study that they produced to render both the witnesses and their study useless (or worse) in any trial.  The cross-examination would be devastating.

Just looking at the Pecos Talc opinion, which is hardly favorable to the subsidiary, we learn the following about these “experts” and their study:

  • Their study’s claim that “[e]xposures were identified through sworn deposition testimonies and answers to interrogatories provided from subjects, parents, and spouses” − is “false.”
  • The study hid the use of “concise statements of exposure received from attorneys” concerning talc exposure.
  • “[T]he [study’s] no overlap claim is literally false because discovery in this case revealed that eight of the 75 subjects do in fact overlap with [a prior] paper.”
  • The “experts”/study authors admitted the falsity of the no overlap claim in their depositions in this case.
  • One of the overlapping cases was “egregious,” and the only explanation was that one of the “experts” “missed it” and “didn’t notice some of the closeness” of the overlapping study subjects.
  • One of the “experts” “reached out to a law firm to determine whether particular subjects were overlaps.”
  • The “experts” “fail[ed] to investigate” their data before publishing the article.
  • “Even if an overlap was objectively ‘apparent,’” that could be due “careless acts of publication,” “clumsy editing,” or “a mistake … due to haste.”
  • The “expert” who knew “subject names” refused to reveal them, even to her own co-authors.
  • The article admittedly failed to consider “tissue digestions” or coded “brand names” in claiming there were no overlaps.
  • It is possible to “conclude[] that [the principal author] made mistakes, was careless, and did not investigate sources or data that could seem obvious after the fact.”
  • The “experts”/authors used “Helsinki criteria” to discount the study subject’s actual asbestos exposures.
  • The lead author was “unwilling . . . to ‘even say that someone who indisputably ‘inhaled asbestos from changing a brake’ would be excluded from the [a]rticle.’”
  • The “experts”/authors used “known exposure” in the article, but actually “meant significant exposure,” thereby discounting actual exposures that they knew of but claimed were not “significant” under the Helsinki criteria.
  • The “experts” admitted, after discovery in this case,” that several subjects actually had significant exposure that they had omitted.
  • “[T]he [“experts”] sought to prevent the identities of the subjects from being released in litigation by . . . [one of them] instructing [another] to lie during a deposition in another case and say that she did not have the list of 75 subjects names when she did.”
  • The lead author “swore it would be a HIPPA violation if she divulged the identities, but she sent the names to a plaintiffs’ asbestos law firm.”
  • [Two of the “experts”] swore in another case that several of the supposed subject matches were not plausible, when in fact they were, and that they never served as expert witnesses in any case filed in any state or federal court in New Jersey, when in fact they did.”
  • One of the “experts,” despite regularly testifying in court, had a practice of “delet[ing] all his emails immediately after sending or receiving them” to avoid leaving a paper trail.
  • The lead author “had never previously published anything in the peer-reviewed literature about asbestos or mesothelioma.”
  • Another “expert” delegated the entire process of reviewing the subjects to his wife (also his administrative assistant) who is not a medical doctor and has no experience related to mesothelioma or asbestos.”
  • The lead author “relied on the review efforts of [the other two] and did not assess the raw data herself.”
  • “It is also undisputed that the [“experts’] understood their role was not to gather exposure information and that they knew there was ‘always a possibility’ that an additional exposure would come to light after the expert report had been drafted.”
  • In assessing non-talc exposures, the “experts” “ignored” “sources of information . . . like interrogatory responses, deposition transcripts, complaints, medical records, trial transcripts, expert reports, verdicts, and other documentation.”

2026 WL 2431332, at *3-12 (citations and some quotation marks omitted).

The Pecos River decision accepted all of this evidence as true and still entered summary judgment for the defendants.  Why?  Two reasons, mostly.  First the scienter standard for trade label is very high.  Falsity is not enough.  For first amendment reasons, “actual malice” is required.  2026 WL 2431332, at *2.  That is a tough standard to meet:

This standard requires proof either that the defendant in fact entertained serious doubts about the truth of the statement or that the defendant had a subjective awareness of the statement’s probable falsity.  In other words, a plaintiff may prove either knowledge or reckless disregard of the statement’s falsity.

Id. (citations and quotation marks omitted).  Further, malice must be proven with “convincing clarity,” New York Times Co. v. Sullivan, 376 U.S. 254, 285-86 (1964), which Pecos River interpreted as meaning “clear and convincing” evidence.  2026 WL 2431332, at *2.  That also appears to be a correct statement of New Jersey law, under the cited authority,  Durando v. Nutley Sun, 37 A.3d 449, 458-60 (N.J. 2012).

Second, and we believe incorrectly, the opinion oversteps the bounds of summary judgment and usurped the role of the jury.  Repeatedly, the opinion weighs evidence and makes its own procedurally improper judgment calls and credibility determinations about which “inferences” are reasonable and which are too attenuated.  Pecos River, 2026 WL 2431332, at *3 (“[s]uch inferences do not rise to the level of clear and convincing evidence”); *6 (determining the “only reasonable “reading” of disputed communications); *8-9 (concerning “exposure”; declaring the defendants efforts “genuine”); *9 n.12 (finding “inferences” from one “expert’s” spoliation of emails “not ‘concrete’ enough”); *10 (finding “tenuous inferences”); *11 (“though it’s possible a jury could infer such a conclusion, it would require multiple successive inferences”) (emphasis original)); *11 (declaring inferences in favor of liability “a stretch” and “not complete enough”).  With all due respect, the Pecos River opinion does not read like any summary judgment decision we have ever read, but instead resembles the thought processes of a juror reaching a defense verdict on the merits.

The opinion also relies on numerous occasions on the obviously interested testimony of the defendants themselves, although it tries to claim that it doesn’t.  See id. at *4-6 (concerning “knowledge”), *5, 6 (concerning “reckless disregard”), *11 (also concerning “reckless disregard”) .  If this opinion were truly not “relying” on this testimony, then why cite and quote it so extensively?  Indeed, Pecos River even held the evidence of malice was only “minimally probative” given the defendant “experts’” own “emails and internal documents.”  2026 WL 2431332, at *9.  That reads like classic weighing of evidence that should be reserved for the jury.

But in the end we don’t think any of that matters very much.  While these stumblebum “experts” may have escaped liability for their faked, junk science, the discovery that the manufacturer plaintiffs were able to obtain has destroyed the credibility of both in the larger talc litigation.  Look at the bullet point list above again.  Their slapdash methodology for their result-oriented study was so bad that even a court ruling in their favor found it “careless,” “clumsy,” “mistake[n],” incomplete, and downright false on key points.  We can’t see how these “experts’” methodology could possibly satisfy Rule 702 gatekeeping.  Nor can we see, under the same rule, their study, with its admittedly false results, being able to serve as a valid basis for any other expert’s opinion, either.

Beyond that, the discovery that the Pecos River litigation made possible has shot the credibility of these “experts” to hell.  One of them had to admit that he deliberately deletes all his emails about his litigation work.  We’ve seen the other side blow their tops and demand spoliation sanctions over much less.  The others were caught in repeated falsehoods or deliberate avoidance of at least retrospectively “obvious” sources of information likely to contradict their opinions.  All of them were forced to reveal how much they were operating in cahoots with the lawyers who were paying them.  Not only does that make them problematic witnesses in any talc litigation, but these revelations will continue to haunt them in any other litigation where they ask juries or judges to believe what they are saying.

That’s why, even though the corporate plaintiffs in Pecos River, may have lost the liability battle, they won the war against these would-be talc “experts.”

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It is vaccine season, and, at least since 2021, it is never not vaccine litigation season. Court opinions rejecting the positions of vaccine-resistors are refreshingly consistent. (Also consistent is the fact that no other blogposts are more likely to elicit complaints from the idiocracy. Just like how we get notifications/pings when certain types of complaints are filed, vaccine-resistors must get notifications whenever someone has the temerity to write that vaccine requirements actually make sense. There are folks out there who are keen to express their unhappiness with the DDL blog’s position on the subject of vaccines. That is okay with us. Bring on the criticisms. We welcome more readers, even when they have to move their lips to make their way through the text.)

Mason v. Cook County, Illinois, 2026 WL 2902330 (7th Cir. Sept. 28, 2026), is, perhaps, a little bit more interesting than most decisions. It comes from the Seventh Circuit, a court we have admired since our University of Chicago Law school days. It affirms a decision by District Judge Kennelly, who is as smart as they come. Finally, it contains a dissenting opinion, so we get some conflict, which is needed to drive any decent drama.

In Mason, a government pharmacist was fired for refusing to get the COVID-19 vaccine, “purportedly for religious reasons.”  She sued for religious discrimination in violation of Title VII of the Civil Rights Act of 1964 (see 42 U.S.C. 2000e-2(a)). Judge Kennelly granted summary judgment in favor of the defense, finding no dispute of material fact that the County would have faced undue hardship by exempting the plaintiff from the mandatory vaccine policy.  That decision was affirmed by the Seventh Circuit in a 2-1 published opinion. 

Failure to Accommodate Claim

The plaintiff did not have a lot of legal authority to support her claim. But she did cite what she doubtless considered a higher authority: 1 Corinthians 6:19 (“Or do you not know that your body is a temple of the Holy Spirit whom you have from God? You are not your own for you were bought with a price. So glorify God in your body.”) Title VII is somewhat more nuanced than Corinthians. To sustain a failure to accommodate claim under Title VII, a plaintiff must show that (1) her belief was religious and conflicted with the employer’s requirements, (2) she notified her employer of her religious belief, and (3) her need for a religious accommodation was a motivating factor in the adverse employment decision. If the plaintiff establishes that prima facie case, the burden shifts to the employer to “show that any reasonable accommodation would have resulted in undue hardship.” Both the Mason district and appellate courts assumed that the plaintiff had made out a case of failure to accommodate based on a sincerely held religious belief, and then the courts dove into the issue of undue hardship. The County demonstrated that there was no religious accommodation possible for someone whose workplace was a room with 60 other people, who also counseled patients face-to-face, and who brought drugs to hospital floors where COVID patients were treated.  Her job could not be done remotely, and there were no remote positions available.  Therefore, the defendant had established undue hardship as a matter of law.  Healthcare workers had a high risk of contracting and transmitting COVID.   Outbreaks had already strained the defendant’s ability to provide necessary services to patients and to avoid infecting medically vulnerable patients.  The plaintiff not only worked in close quarters, but also regularly was in contact with patients. 

The dissent suggested that the County could have done more to support its claim of undue hardship. (The dissent characterized the County’s explanation of hardship as a “good start.”) Yes, the majority acknowledged, the County could have done more.  One could always do more.  But the County had done enough (via several affidavits) to demonstrate that less restrictive alternatives, such as masking and social distancing, would not have adequately reduced the risk of Covid transmission. The plaintiff presented no contrary evidence that reasonable accommodations were possible. 

Disparate Treatment Claim

The plaintiff mounted a “conclusory” challenge to the district court’s determination that she could not identify an apt comparator to make out a disparate treatment claim of religious discrimination.  The defendant’s treatment of another unvaccinated employee was not a similar circumstance to the plaintiff’s since that other employee was a blinded clinical trial subject in a Covid-19 vaccine study and that employee did not know whether a vaccine or a placebo had been administered.  Further, that other employee had not sought an exemption. When the study was unblinded, that employee promptly got a vaccine.  There was hardly any similarity at all. (The Mason dissent agreed with the majority that the plaintiff had given “short shrift” to the disparate treatment theory, but argued that it should survive for the same reasons as accommodation claim.)

Score another blow for vaccine rationality. The Enlightenment and science, for the moment, survive. Now bring on the nastygrams.

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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. 

Drug & Device Resources

Bexis’ Book

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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