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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.

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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. 

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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. 

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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