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There’s a certain romance to the idea that if one courthouse door closes, another—perhaps with better lighting and more favorable precedent—must surely be open somewhere else. But as one group of particularly determined preemption refugees recently learned, civil procedure is not a game of judicial Whac-A-Mole.

The story begins in Utah, where 50 plaintiffs brought a products liability lawsuit against the manufacturer of Filshie clips—a medical device used in tubal ligation. The Utah court dismissed all claims as preempted and that decision became the 669th entry on our PMA preemption scorecard. Not a big surprise. A quick search of the blog for “filshie” will reveal a plethora of Filshie clip preemption dismissals. In dismissing the case, the Utah court concluded that it lacked subject matter jurisdiction, that the plaintiffs’ claims were dismissed with prejudice, and that the “[o]rder fully and finally resolves this matter.” Allen v. Coopersurgical, Inc., 2025 WL 3641538, *5 (Ct. Sup. Dec. 10, 2025). Game over, right? Res judicata?

Well, the plaintiffs latched on to the Utah court’s use of the phrase lack of subject matter jurisdiction.  Rather than filing an appeal, 49 of the Utah-plaintiffs, hoping that a fresh venue plus a semantic loophole would resurrect the case, joined another multi-plaintiff complaint against the same defendants filed in state court in Connecticut. The most likely reason for the cross-country trek is that Connecticut is one of the few states that allows failure-to-report claims—a claim the Utah court specifically rejected.

Yes, the Utah court said “lack of subject matter jurisdiction.” But labels don’t override reality. What matters is what the court actually decided. And what it actually decided was that federal law preempted the plaintiffs’ claims. That’s a determination on the merits. The re-litigation of which is precisely what the doctrine of res judicata is designed to prevent. The Connecticut court agreed.

Analyzing the elements of res judicata, the court found it was undisputed that the Utah state court was a court of competent jurisdiction and that the parties to the dispute were the same. Id. at *8, *11. Nor was there much dispute that the claims arose from the same transaction. Both cases were premised on allegations that the medical device was dangerous and defective, that defendants failed to warn, and that plaintiffs suffered injury. Id. at *14.

Plaintiffs’ primary argument was that the Utah decision was not a ruling on the merits, relying on Connecticut precedent holding that “jurisdictional dismissals are not final judgments on the merits,” and therefore are exempt from the doctrine of res judicata. But, even if preemption is a jurisdictional question, res judicata still bars issues that “have been fully and fairly litigated and finally decided”—as the issue of federal preemption was by the Utah court. Id.at *9.

More importantly, however, the Connecticut court held that

whatever label placed on it by the Utah court—a dismissal based on federal MDA preemption goes to the merits of the action and is not jurisdictional in nature. This court declines to elevate form over substance in the context of its res judicata analysis under Connecticut law, and ascribe talismanic significance to the Utah court’s “subject matter jurisdiction” description of its dismissal.

Id. (emphasis in original).

The court had ample justification for their conclusion. First, Connecticut courts have expressly rejected characterizing federal preemption as jurisdictional in nature. See id. at *9-10. Second, the Utah court dismissed the case with prejudice, making it a final adjudication on the merits. Id. at *10. Third, the cases relied on by plaintiffs refusing to apply res judicata to jurisdictional matters were “clearly distinguishable.” This is not a case where the claim was dismissed for lack of standing or ripeness. See id. at *11 (distinguishing cases).

Plaintiffs’ final argument was that the claims in the two lawsuits are different. The Utah complaint did not include a cause of action under the Connecticut Unfair Trade Practices Act (“CUTPA”). For res judicata to apply, “there must have been an adequate opportunity in the prior action to litigate the omitted claim fully.” Id. The key being opportunity. Plaintiffs failed to show that they lacked an opportunity to assert a CUPTA claim in the Utah action. They chose not to, but they certainly could have. States are asked to apply the laws of other states all the time. Because the Utah decision satisfies all the other elements for res judicata to apply, the CUPTA claims were extinguished “because they could have been asserted in [the prior action].” Id. at *13.

Res judicata means that once a court of competent authority renders a final judgment on the merits, the parties don’t get a do-over just because they’ve discovered a new courthouse or a more optimistic outlook. Connecticut was not a legal reboot. If plaintiffs believed the Utah court got preemption wrong, the remedy was an appeal, not a relocation. Preemption is still preemption, “with prejudice” still means with prejudice, and res judicata has an excellent memory.

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It’s time for our annual parade of horribles.  It’s no fun, but somebody needs to do it, if only to make sure that the other side, and those who aid and abet them, know that we are paying attention.  So here is our annual naughty list, the bottom ten worst prescription medical product liability litigation decisions of 2025.  And we stress both “product liability” and “litigation.”  Otherwise, we’d have to include Medical Marijuana, Inc. v. Horn, 604 U.S. 593 (2025), where the Supreme Court further expanded recovery under RICO to include business losses that allegedly were causally connected to a prior personal injury (here).  We’re still waiting for this purportedly “conservative” Court to apply the same “it says what it says” logic to statutory language, such as the medical device preemption clause, that benefit our clients.  Another stinker that could affect what we do was Zyla Life Sciences, L.L.C. v. Wells Pharma, L.L.C., 134 F.4th 326 (5th Cir. 2025) (here), restricting Buckman’s applicability in a commercial case.  We also wish we could forget Briskin v. Shopify, Inc., 135 F.4th 739 (9th Cir. 2025) (en banc), where the majority took the extreme pro-plaintiff decision that foreign product manufacturers cannot structure their American distribution systems to limit personal jurisdiction to their distributors (here).  Also bad enough to warrant bottom ten treatment, had it been a product liability case, was GenBioPro, Inc. v. Raynes, 144 F.4th 258 (4th Cir. 2025), an abortion case holding that the infamous presumption against preemption precluded an in-effect FDA REMS from having preemptive effect (here).  Our final bizarrely bad decision was Happel v. Guilford County Board of Education, 913 S.E.2d 174 (N.C. 2025) (here), which construed the PREP Act to allow state constitutional claims against municipal actors.

Even without obnoxious decisions like those, there’s more than enough empty-headed, or Erie-violating, decisions out there to fulfill our unfortunate task of collecting the ten worst prescription medical product liability decisions of this year.  We’ve been acting as the sanitation engineers of prescription medical product liability litigation since 2007, assembling this annual list, so nobody else has to.  Bad decisions, like good ones, should be called out for what they are.  While it’s always possible that an eleventh-hour holiday horror could arise, as happened here and here, last-minute adverse precedent has so far been thankfully uncommon.

So lets get on with it.  Coming up are ten 2025 “Mister Yuk” decisions.  If you drew that end of the stick in any of these ugly muglies, believe us, we sympathize since our own cases have made this list before (see, e.g., 2013-2 and 2021-10).  Just keep on keeping on.  It’s always darkest before the dawn.  Next week we’ll be presenting the top ten best decisions of 2025.

  1. This entry is solely from the Holland & Knight side of the Blog.  City of Huntington v. AmerisourceBergen Drug Corp., 157 F.4th 547 (4th Cir. 2025).  It will be a surprise to nobody who is a regular reader of the Blog that Bexis comes up with the themes for our annual Top Ten and Bottom Ten lists.  Like song lyrics, the themes can be light and fluffy, layered, or even quite dark.  Near the end of the song “Running on Empty,” Jackson Browne sang “You know I don’t even know what I am hoping to find.”  In Huntington, we suspect that the panel knew it was going to reverse and hoped to find reasoning to justify that outcome.  It had initially taken the procedurally proper step of certifying a question about West Virginia’s public nuisance law to the West Virginia Supreme Court of Appeals, but that court declined certification and sent the case back to the Fourth Circuit without clear guidance.  The result was strained decision with reasoning designed to dictate a plaintiff win on remand.  Compared to the district court’s detailed decision finding in favor of the distributor defendants after a long bench trial in a high-profile opioid case (2022+8), the Fourth Circuit’s reasoning was quite weak.  The trial court’s Findings of Fact and Conclusions of Law had enumerated multiple major evidentiary holes in plaintiffs’ public nuisance claim, in addition to ruling that West Virginia’s existing public nuisance and abatement law was not broad enough to encompass plaintiffs’ claim for monetary damages related to the sale and distribution of legal prescription medical products.  The Fourth Circuit applied none of the Erie restraint that the district court had, even going so far as to interpret the West Virginia high court’s rejection of a referred question as somehow weighing in favor of the expansion plaintiffs wanted.  Also, rather than following the correct standard of review and deferring to the trial court’s factual determinations when they were “plausible in light of the record reviewed in its entirety,” the decision effectively applied a de novo standard to conclude that the plaintiffs had offered some evidence to make out a prima facie case for public nuisance and abatement damages.  Very little of the Fourth Circuit’s analysis followed the proper legal standards and less showed that the causation issues found by the district court should not have been fatal to plaintiffs’ claims.  Unless plaintiffs get a complete do-over on evidence − the Fourth Circuit did not identify any excluded evidence that might be added to the mix on remand, so that would not seem needed − the link between the defendant distributors’ alleged failures and the plaintiffs’ alleged harms for increased costs of governmental services remains unproven.  So clear was the record on lack of proof of causation that the decision below should have been affirmed even if the Fourth Circuit was intent on abandoning Erie restraint.  For these reasons, and because City of Huntington is the first ever appellate decision anywhere to allow public nuisance in the context of FDA-approved products, this decision was a no-brainer for worst case of 2025.  We flogged the Fourth Circuit’s fiasco here.
  2. Hall v. Walgreens Boots Alliance, Inc., 565 P.3d 564 (Wash. 2025).  The Washington legislature presumably meant what it said when it enacted a broad safe harbor provision applicable to its consumer protection statute.  Since consumer protection statutes are usually broad and vague, carve-outs for governmentally authorized activity are necessary not to deter benign activity, as occurred here.  The statute facially exempts “actions or transactions otherwise permitted, prohibited or regulated” by certain specified agencies (not including the FDA) as well as those “permitted by any other regulatory body or officer acting under statutory authority of … the United States.”  However, in allowing this OTC drug class action to proceed, Hall defaced the safe harbor clause to exclude FDA-approved labeling for those drugs.  That is despite the relevant FDA monograph specifically providing that products containing the active ingredient at issue can be labeled as “nondrowsy,” the language the plaintiffs attacked.  To disregard the safe harbor language Hall interpreted it “liberally” in light of the statute’s “beneficial purposes of protecting the consumer.”  Thus, it was not enough for a governmental agency, such as the FDA to have “permitted” the defendant’s action – the agency “must take overt affirmative actions specifically to permit the [defendant’s] actions.”  That gloss was simply made up; it has no basis in statutory text.  Other consumer fraud acts include such limiting language where the legislature desired it.  Washington’s legislature did not, so Hall added that limitation by judicial fiat.  Hall’s taking a sharpie to a legislative enactment is strongly reminiscent of the number that the Supreme Court claimed it was doing on Chevron deference to an FDA statutory interpretation.  But Hall can’t even claim that fig leaf.  We hammered Hall (here). 
  3. Dibble v. Torax Medical, Inc., 148 F.4th 601 (8th Cir. 2025).  The forum non conveniens doctrine is designed to prevent exactly what it says – defendants from being forced to litigate in inconvenient forums, since plaintiffs get to choose where to file suit.  Nearly 50 years ago, the Supreme Court rejected arguments that:  (1) federal courts should be opened to any suit involving an American defendant, no matter how unrelated to anything that happened here, and (2) that some amorphous interest existed in deterring American companies from marketing purportedly “defective” products overseas.  The discretionary nature of forum non conveniens determinations is also well established.  Dibble involved a Japanese plaintiff having surgery in the UK with a medical device that allegedly failed and was explanted in Colorado.  After the plaintiff moved to Thailand, he sued – in Minnesota – a defendant that had moved from there to Ohio and a second defendant from New Jersey.  Weighing the various factors, the district court concluded that suit was only proper in the UK, since the plaintiff had been a UK resident when receiving the implant.  The Eighth Circuit, ignored this discretionary decision (similarly to what it did in Bair Hugger (2012-1)), and chastised the district court for viewing non-Minnesota evidence as favoring the UK.  Effectively, Dibble viewed any contact in the United States as favoring Minnesota when, in fact, the only tie to Minnesota related to a defendant that was no longer there.  Instead, Dibble stacked the deck in favor of a foreign litigation tourist that suffered no injuries at all in the United States.  We doubled down dissing Dibble here.
  4. This entry is not from the Reed Smith or Dechert sides of the Blog.  In re Rantidine [sic] Cases, JCCP 5150, slip op. (Cal. Super. Sept. 15, 2025).  Rarely does a state trial court decision rank this high, but rarely has a state trial court decision more brazenly ignored the law of the state where it sits.  That state is California, and the law is the fundamental distinction between design defects – involving allegations that implicating all of a defendant’s product line – and manufacturing defect – involving allegations of a defect unique to the unit of the product that allegedly injured the plaintiff.  There are only three types of strict liability defects in California, and the Supreme Court of that state has reaffirmed that point a half-dozen times.  The problem was that the plaintiff’s actual design defect claim was both preempted and barred by California state law (which precludes strict liability design claims in prescription medical product case), and warnings were not at issue, so unless plaintiff could assert a “manufacturing” claim there would be no claim at all.  The Ranitidine opinion made up, on summary judgment no less, something that the plaintiffs had not even pleaded, that the defendant’s manufacturing process (which was common to all cases and relevant products) allegedly facilitated the claimed chemical breakdown of intended ingredients to carcinogenic contaminants, and that such a claim could be brought as an unpreempted “manufacturing defect” claim.  Because all the plaintiffs’ claims otherwise would fail, Ranitidine deliberately created a novel “hybrid” claim supposedly halfway in between.  The result was a tautology that, because no manufacturer “intends” to make a carcinogen-contaminated drug, that every pill necessarily deviated from what the manufacturer must have “intended,” which was one way that California courts had described manufacturing defects.  That tour de farce uniquely placed that description of manufacturing defect in opposition to all of the other California precedent that also required that such defects be unit specific.  Then the court denied summary judgment so that plaintiffs could essentially go back to the drawing board and try to put together a case for this novel theory that was not in any of the plaintiffs’ four prior complaints.  That result is both substantively and procedurally flawed, particularly because two precedential California appellate cases (one for the trial court’s own district) had specifically considered and rejected the concept of “process defects” under California law.  We ranted about Ranitidine here, and devoted a second post, here, to rounding-up the California precedent (controlling and otherwise) that rejects what Ranitidine wrought.
  5. In re Avandia Marketing, Sales Practices & Products Liability Litigation, 2025 WL 1479618 (E.D. Pa. May 22, 2025).  This time last year we had allowed ourselves to hope that the nearly 20-year absurdity that was the Avandia MDL was reaching its end.  Why is it absurd?  Because the entire MDL was based on a false premise.  The purported increase in cardiac risk posed by the drug, which prompted an FDA boxed warning, has been entirely debunked.  The FDA removed the boxed warning in 2013, and any personal injury allegations are long gone.  Silly us.  In the Avandia decision that we are listing as the worst federal district court decision of the year, the pendulum swung back in favor of absurdity, with a relatively rare result, actual certification of a third-party payor (TPP) class action in prescription medical product liability litigation.  Instead of the earlier claims that the drug had adverse health effects, the TPPS now claim that the defendant manufacturer’s claim that the drug improved cardiovascular outcomes was not supported – at least during the 2005-07 class period.  Given the massive market effect of the addition, and then retraction, of the boxed warning, we don’t see how causation can possibly be established.  And then there are the learned intermediary prescribing physicians, that this Avandia decision simply ignores.  Regardless of the purported “marketing fraud,” each physician made a patient-specific decision to prescribe, so reliance is also a classic individualized issue that alone should have precluded class certification.  Despite the court having already excluded the plaintiff’s statistical analyses (2024+12) certification was based on the TPPs somehow being able to prove class-wide reliance through statistical modeling.  So it looks like this ridiculous litigation may well reach the age of majority.  We argued the awfulness of Avandia here.
  6. In re Philips Recalled CPAP, Bi-Level PAP, & Mechanical Ventilator Products Litigation, 2025 WL 1322162 (W.D. Pa. May 7, 2025).  For whatever reasons, MDL courts seem unable to refrain from using the lack of MDL-specific procedural rules as a basis for disadvantaging defendants.  Bad things happen when MDL practices cut procedural corners that the drafters of the Federal Rules of Civil Procedure put there for good reasons.  That’s what happened in CPAP.  After settling the plaintiffs’ personal injury claims, the original target defendant brought a third-party action in the MDL against makers of other products that allegedly made things worse.  An extra-procedural MDL shortcut, a census registry, to which the defendant had unfortunately acquiesced, cost it a significant chunk of its would-be third-party claims.  In the third-party action, only state-law claims (contribution) were asserted, and Delaware corporations were on both sides of the “v.”  Thus, subject matter jurisdiction was at issue.  In the name of “efficiency” the MDL court was willing to entertain supplemental jurisdiction, but that MDL shortcut got in the way.  In order for supplemental jurisdiction to exist, there first had to be a “action,” and mere claimants in an MDL census registry never filed suit.  The lesson taught by CPAP is what we’ve already advocated:  MDL census registries are potentially toxic, and defendants should think long and hard, and then think again, any time such registries are proposed.  The risk/benefit ratio is lousy.  Census claimants save filing fees and toll the statute of limitations.  Defendants get a little information that the claimants would have to provide anyway.  Any promise not to file elsewhere is illusory, since plaintiffs will break those promises should the MDL ever looks like a loser for them, at best requiring additional litigation.  And that’s not all, direct filing – another pro-plaintiff MDL shortcut – further bollixed jurisdiction due to “unintended consequences,” since the third-party defendant never agreed to there being a “home court” for remand purposes, and now objects to jurisdiction.  We found CPAP completely puzzling, here.
  7. CLF 007 v. CooperSurgical, Inc., 2025 WL 975175 (D. Or. March 31, 2025).  Last year, we extensively researched purported claims for “failure to recall” and concluded that it was a “Non-Existent Tort.”  The Restatement of Torts (§11) specifically rejects it, in the absence of a government recall order.  Ten state high courts, four state intermediate appellate courts, and literally scores of federal cases interpreting the laws of 29 states have all reject claims that a wide variety of products should have been recalled.  CLF 007 (the odd party name being the Oregon version of “John Doe” pleading) is the outlier.  Admittedly, Oregon, had “not recognized a distinct duty to recall” for any product.  For a federal court exercising diversity jurisdiction, that should have been the end of the matter.  Unfortunately, not.  Entirely disregarding the principle of Erie conservatism, and not even mentioning all the extensive contrary precedent, CLF 007 asserted that the plaintiffs’ unsupported assertion of failure to recall was “consistent with” “broader” state product liability law because “a product recall is a warning.”  That’s both speculative, as a matter of state law, and dead wrong as a matter of general law, since most courts view failure to recall as a form of a stop selling claim and reject it on that basis.  That was especially true of CLF 007 since the product had been recalled, so the claim was only that it should have been recalled earlier, that is, it should never have been available to cause the clamed harm.  We find that indistinguishable from a stop-selling claim.  For its gross violation of the right of state courts to decide whether to expand state law, CLF 007 makes our worst-of list.  We criticized loudly CLF 007 here.
  8. Boncher v. 3M Co., 2025 WL 511116 (E.D. Pa. Feb. 14, 2025).  As we’ve discussed many times, in December, 2023 Fed. R. Evid. 702 was amended to add language the federal rules committee found necessary to fix widespread “incorrect” judicial decision making that let all sorts of unsound expert opinions into evidence.  A blatant example of these “incorrect” decisions was the Eighth Circuit’s Bair Hugger decision (2021-1).  Boncher makes this year’s list because, on remand from the Bair Hugger MDL, it embraces all of the Eighth Circuit’s flaccid reasoning – notwithstanding the intervening rule amendment.  After correctly determining that the Eighth Circuit’s Bair Hugger abomination was not law of the case, Boncher goes on to re-abominate all of the Eighth Circuit’s terrible holdings – importing them into Third Circuit jurisprudence.  Boncher repeats the now problematic pre-amendments language, throwing in occasional fig leaves like “liberal admissibility,” but purportedly only insofar as only Rule 702’s “requirements are met.”  Otherwise, 2023 amendments are dismissed as not making any “substantive” changes.  Yuk.  From there, Boncher basically reprises all the holdings that we detested when made by the Eighth Circuit, repeating the old saws about “weight, not admissibility” and “vigorous cross-examination” that the rules committee determined were incorrect.  Only this time it sampled the Third Circuit’s grossest hits.  If you are a glutton for punishment, go read our post about that decision.  Much of the ensuing summary judgment denial follows from the Rule 702 rulings, but not all.  In denying summary judgment on the statute of limitations, Boncher cranks out this gem of a litote:  “It is not undeniably clear to the Court that Plaintiff did not use reasonable diligence in timely ascertaining the cause of her injury.”  That neither applies the summary judgment standard, nor is the double negative grammatical.  We blasted Boncher here.
  9. This entry is not from the Reed Smith side of the Blog.  Hollenstein v. St. Jude Medical, Inc., 2025 U.S. Dist. Lexis 121547 (D.N.J. June 26, 2025).  The New Jersey entry in our duty-to-report 50-state survey establishes pretty definitively that the Garden State rejects purported “warning” claims predicated on alleged failure to file adverse event reports with the FDA.  The New Jersey Supreme Court so held, both in the FDA and the non-FDA context.  So have the appellate and trial divisions of lower New Jersey state courts, and five federal court decisions.  This year, however, Hollenstein became the sole New Jersey outlier.  Not surprisingly, Hollenstein was a PMA preemption case, so the plaintiff had little else to argue.  The design claim was preempted; no surprise there.  The manufacturing defect claim was not, because the court refused to look beyond the pleadings and follow summary judgment decisions involving the same product that had determined the plaintiff’s claimed “requirements” did not exist.  Bad, but not bottom ten bad.  Hollenstein’s rationale for letting a reporting-based claim survive preemption is not just bad, but bizarre.  While agreeing that New Jersey law does not recognize any “separate duty” to “warn the FDA,” Hollenstein then drew an unprecedented distinction between that and failure to warn “the general public through the [MAUDE] public, searchable database.”  That is a distinction completely without a difference.  Why?  Because who operates MAUDE?  The FDA.  The only way for adverse events to appear on MAUDE is for the FDA to upload them to that site, and that would require reporting to the FDA.  In short, there is no distinction failure to warn the FDA, and failure to warn the public through an FDA website.  That’s why we heckled Hollenstein here.
  10. This entry is not from the Butler Snow side of the Blog.  Thacker v. Ethicon, Inc., 2025 WL 2028082 (E.D. Ky. July 21, 2025).  As already mentioned, Rule 702 was recently amended specifically to correct a judicial trend towards inordinately liberal admission of bogus expert testimony.  Thus, decisions that ignore the amendment and continue to admit junk science are particularly obnoxious because they do exactly what Rule 702 was amended to prevent.  Thacker is such a case.  The opinion is noteworthy because it nowhere mentions the burden of proof – one of the Rule 702 amendments.  But then, Thacker doesn’t mention the 2023 amendments at all.  Actually, it’s worse than that because the opinion quotes Rule 702 but omits the newly amended language.  After eliding the proper burden of proof, Thacker admitted an opinion about the defendant’s “risk management” despite the expert never having reviewed the defendant’s actual systems, because “it is up to opposing counsel to inquire into the expert’s factual basis.”  Thacker thus flipped the burden of proof.  The amended rule was changed precisely to state, in the rule’s text, the proponent’s burden to establish the facts supporting an expert opinion.  The same thing happened in Thacker with foreign standards.  Thacker allowed the opinion because the defendant failed to establish irrelevancy, rather than the proponent having to establish relevancy.  Thus, an ipse dixit opinion, with only the expert vouching for these foreign standards, was admitted.  Maybe in some other year a different stinker of an opinion would have occupied our final spot, but given the critical need to enforce the recent Rule 702 amendments and ensure that proponents of expert testimony meet their burdens of proof, we went with Thacker.  We thumped Thacker here)

Ugh!  Finally, we’re done, and not a moment too soon.  Having cleaned ourselves up and made use of our preferred topical antibiotic, we’re more than ready to turn to something more pleasant – our blogpost, next week, about the top ten best drug/device decisions of 2025.

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As we head into the longest night of the year, we wade into an MDL decision addressing fraudulent misjoinder.  We previously posted about some unfavorable happenings in the Philips CPAP MDL, and today’s decision continues that unfortunate trend. In re Philips Recalled CPAP, Bi-Level PAP, & Mechanical Ventilator Products Litigation, 2025 WL 3534807 (W.D. Pa. Dec. 10, 2025). But as we reach the winter solstice this weekend, we know that the days will get longer, the sun will shine brighter, and we’re sure to see some positive developments more to our liking.

The decision involves the unusual combination of medical device and environmental exposure claims against different defendants. The complaint alleged that exposure to ethylene oxide through a CPAP device caused plaintiff’s acute myeloid leukemia and, ultimately, death.  But the complaint also claimed that the plaintiff lived near a manufacturing facility that emitted ethylene oxide, and that exposure to those emissions contributed to the development of the disease and death.  The CPAP defendant was diverse; the environmental emissions defendants were not.  Philips (the diverse, CPAP defendant) removed and claimed the defendants in the environmental claims were fraudulently misjoined.

Continue Reading Even the Darkest Night Will End and the Sun Will Rise
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In case our title was too subtle, we think that a stack of purported inferences should neither state a claim for strict liability with a prescription medical device nor sidestep express preemption in the case of a Class III device.  We have long been dubious of the idea of a true parallel claim as articulated by Riegel and some of its misguided progeny.  Most of the state law duties that plaintiffs push in these cases are bogus.  Existing state law is rarely going to require what the FDCA requires of devices approved pursuant to a PMA.  These same plaintiffs almost always urge that their device was defective because it did not comply with FDA requirements.  Predicating claims on violations of the FDCA, including failing to submit required materials to FDA during or after the approval process, should run headlong into Buckman implied preemption.  When it comes to Class III devices, two of the three species of product liability, design defect and warnings (or informational) defect claims, are almost never going to be legitimate routes to avoid both express and implied preemption.  The third, manufacturing defect, has a shot.  The main problems with those claims, however, are that plaintiffs can rarely plead them with TwIqbal-compliant factual support and that they are properly limited to deviations from approved specifications, which are rarely provable and usually logically inconsistent with design defect theories.  Shortcutting manufacturing defect allegation requirements by making a res ipsa loquitur argument also should not work.

These dynamics played out in Purohit v. Abbott Labs., Inc., No. 2:25-cv-01026-JAD-EJY, 2025 WL 3527245 (D. Nev. Dec. 8, 2025), a case about an alleged manufacturing defect in a bioprosthetic heart valve, a Class III device that the manufacturer withdrew from the market in 2023.  Predictably, the plaintiff tried to avoid picking one of the types of defects recognized by Nevada law.  We previously reported on Schmidt v. C.R. Bard, Inc., a class II device product liability decision out of the same court.  In Schmidt, the plaintiff dropped his manufacturing defect claim before the court granted summary judgment on his warnings and design defect claims.  Probably because of the obvious preemption of warnings and design claims, the Purohit plaintiff advanced only a manufacturing defect claim when forced to articulate something more than a defect in the air claim.  His anti-preemption argument was that his valve being replaced nine years after implant meant that it had “deteriorated faster than expected,” which meant it had been defectively manufactured, which meant it violated FDA requirements, which meant that he had asserted a mythical parallel claim that dodged the FDCA’s express preemption of state law requirements that are “different from, or in addition to, any requirement” under the FDCA.  Plaintiff also offered an alternative insertion in between first and second “which” clauses above:  “which was similar to why the manufacturer withdrew the device from the market in 2023.”  Nice try, we guess.

In rejecting this daisy chain, the Purohit court had the advantage of the strong Ninth Circuit decision in Weber v. Allergan, which we discussed here.  Weber firmly rejected that an alleged misrepresentation about failure rate in the approved labeling for a Class III device was the same as a deviation from FDA requirements.  When it came time to articulate a particular deviation from FDA requirements, the Purohit plaintiff flailed.  He tried the circular argument that the purported failure of the prostheses in his case was itself proof of a violation of the specifications required by the PMA approval of the device.  2025 WL 3527245, *4.  Failure, without more, does not establish defect.  It certainly does not establish that a device was manufactured contrary to specs.  Plaintiff offered no factual allegations to support his reductionism.

Plaintiff next claimed that the voluntary withdrawal of the device in 2023—sometimes equated in Purohit to a recall—established that his device deviated from FDA requirements.  There is an extensive collection of cases that say the opposite, including a number from and within the Ninth Circuit.  See here and here for some of them.  You cannot infer a deviation from a recall or from an alleged malfunction.  You also cannot infer a defect from either.  Purohit followed this law and reasoning.  As it said, “The FDA approves products knowing that there is a possibility that a full compliance product can fail.  So the withdrawal of a product from the market does not automatically mean the product [did not] meet FDA requirements.”  Id.  (We also think that there was another problem with plaintiff’s recall argument.  His prostheses lasted nine years before its alleged failure.  The market withdrawal, from information on FDA’s website, was driven by the rate of particular structural failures within five years of implant.  Maybe nine years is not so bad for a tissue-based aortic valve.  After all, aortic valves are subject to quite a bit of pressure and stress; back when we did litigation relating to aortic valves, replacements with tissue, as opposed to artificial materials, typically lasted less than ten years before another surgery was indicated.  If a recall or withdrawal is ever going to be proof of a parallel claim, then it should be all fours with the case-specific allegations.)

Plaintiff also offered a Lance-like argument that the company should have withdrawn the product earlier, which was purportedly a state law obligation and somehow proof of a deviation from FDA requirements for his valve.  The Purohit court held this claim, to the extent it had been asserted at all, preempted.  Id.  “Purohit does[ not] point to any FDA requirement or any relevant statute or regulation that imposes such a requirement [and] such an allegation is irrelevant for a products-liability claim in which Purohit must allege that the manufacturing of the product deviated from a particular FDA requirement.”  Id.  Interestingly—at least to us—the court elected to rule on preemption and not whether the complaint stated a valid Nevada claim for failure to withdraw.  Id. at *4 n.56.  We do not think Nevada has such a claim, based on Lance or otherwise.  So, there was another reason why plaintiff’s complaint should have been dismissed, arguably before addressing preemption.  The court’s approach, though, probably helped it reach the next step that courts are often reluctant to take:  denying a request to amend the complaint.  An amendment would have been futile, largely because plaintiff’s request to amend did not identify what allegedly violated requirement would be addressed in a proposed amendment and the court was not going to allow plaintiff to shift to a new theory of liability.  Id. at *5.  Indeed, this may have been our favorite part of Purohit.  If parallel claims are unicorns and the plaintiff cannot plead one up front, then there should be some good basis offered before the plaintiff gets another chance to offer factual allegations supporting a myth.

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Today’s guest post is from Reed Smith‘s Matt Jacobson. His post is not (primarily) about British comedy, but rather about fraudulent joinder. The specific topic is most interesting if you practice in Wisconsin, but as to removal generally, it introduces a provision of the statute that many of our readers will be unfamiliar with, so you’ll probably learn something from this post. As always our guest posters deserve 100% of the credit (and any blame) for their writings.

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Mr. Bean is celebrating its 35th anniversary this year.  For those of you who have lived under a rock for the past 35 years—or do not have television—Mr. Bean is a British comedy that follows Mr. Bean, who often seems unaware of basic aspects of the way the world works.  The creator of the show described the title character as “a child in a grown man’s body,” as he solves various problems presented by everyday tasks and often causes disruption (and many laughs) in the process.

One of my favorite episodes from the animated series (which debuted seven years after the live-action series ended) involves Mr. Bean putting a fake pair of legs and wrench under his car to make it look like a mechanic was lying under the car to fix it.  He does this so he can avoid getting a parking ticket while parking on the street.  And it worked!  Avoidance was a key theme in many of Mr. Bean’s antics, whether he was actively trying to dodge a situation, task, person, or in this particular episode, a parking ticket.

Today’s post involves a case with a Ms. Bean, but as far as I can tell there is no relation.  In Bean v. Smith & Nephew, Case No. 25-C-184, 2025 WL 2945560 (E.D. Wis. Oct. 17, 2025), the Plaintiff originally filed her case in Wisconsin state court against the manufacturer of the device used in her knee replacement surgery, alleging a product defect.  She also named a fictional manufacturing company, fictional insurance companies, and her employer and its self-insured worker’s compensation carrier.  Like Mr. Bean used his fake legs to avoid a parking ticket, Ms. Bean was actively trying to avoid removal to federal court with her fake companies.  However, that plan would not work out as well as Mr. Bean’s and certainly is not as funny.

The non-fictitious medical device company removed the case to the Eastern District of Wisconsin under 28 U.S.C. § 1332 on the basis of fraudulent joinder.  Plaintiff moved for remand, arguing that her case was a non-removable worker’s compensation action under 28 U.S.C. § 1445(c) and that complete diversity did not exist, as her employer was properly joined as a defendant.  The court denied her motion and Plaintiff filed a motion requesting that the court certify the question of whether her claim arose under Wisconsin’s worker’s compensation law for immediate appeal and stay the case.

Plaintiff’s use of § 1445(c) was creative, if not comedic.  Bean is the Blog’s first occasion to mention it in its 19-year existence.  The court found that under 28 U.S.C. § 1445(c), a case cannot be removed to federal court that arises under a state’s worker’s compensation laws.  See 28 U.S.C. § 1445(c) (“A civil action in any State court arising under the workmen’s compensation laws of such State may not be removed to any district court of the United States.”)  The court said that it had denied Plaintiff’s motion for remand “because, contrary to her assertions, her claims do not arise under the State’s worker’s compensation laws . . . [W]hile she may have injured her knee while employed . . . her claims in this action are for damages arising out of the failure of a medical device used to replace her knee—claims that arise out of the common law of tort.”  Bean at *1.  Not only did the court deny her motion for remand, but it also realigned her employer and the worker’s compensation entity (to the extent it actually existed) as plaintiffs, since they would have subrogation rights.  Id.

The court’s reasoning went back to statutory interpretation from “what Congress would have understood the term ‘workmen’s compensation laws’ to mean in 1958, the year in which Congress enacted § 1445(c).”  Id. at *2.  Citing other decisions, the court found that “worker’s compensation laws at the time was ‘liability without fault (and with limited recovery) for injuries in the course of employment.’”  Id. (citations omitted).  Here, the Plaintiff alleged that she was implanted with a defective knee implant, which were routine product liability claims, not worker’s compensation claims, since they arose out of a claimed device failure.  Id.

The court analogized its reasoning to two other cases (neither of which involved a drug or device):  Houston v. Newark Boxboard Co., 597 F. Supp. 989 (E.D. Wis. 1984), and Hartford v. Schindler Elevator Corp., No. 09-CV-132, 2009 WL 3246670 (N.D. Ind. Oct. 6, 2009).  Both cases involved a plaintiff who was injured at work by an allegedly defective machine (laminating machine and elevator).  Bean at *3.  The plaintiffs sued the machine manufacturers, and the cases were properly removed to federal court, because the claims arose under tort law and not worker’s compensation laws.  Id.  As the court in Hartford found, “it is clear that while Plaintiff’s subrogation claim against a third-party tortfeasor for monies paid to an injured employee on behalf of its insured touches on Indiana worker’s compensation law, it does not arise under those laws for the purposes of applying 28 U.S.C. section 1445(c).”  Bean at *3 (citing Hartford, 2009 WL 3246670, at *3).  That same reasoning applied here.

The rest of the court’s opinion focused on Wisconsin-specific worker’s compensation law, which for this blog, is likely not as helpful.  For that reason,  I will not dive into it, but it was the reason why the court certified Plaintiff’s question for an interlocutory appeal.  

Just like Mr. Bean, Ms. Bean does not really understand how the world works.  Making up fictious companies and trying to make a straightforward product liability case fall under worker’s compensation laws just will not work.  And while it is not as funny as a Mr. Bean episode, understanding this section of the U.S. Code that deals with worker’s compensation cases is one more peculiarity that removing defendants should be aware of.  The end.

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There is a special kind of optimism—some might call it magical thinking—that animates the modern failure-to-warn claim against prescription drug manufacturers. It goes something like this: Yes, the FDA-approved label warned about the exact risk that happened to me, but the manufacturer still failed to warn.

Which is a pretty accurate summary of plaintiff’s argument in True v. AbbVie, Inc., 2025 WL 3560299 (N.D. Ga. Sep. 9, 2025). Let’s start with the inconvenient truth (sorry, True)–prescription drug labels are not written by vibes. They are the product of exhaustive clinical data, regulatory scrutiny, and FDA approval. When a label says, in plain English, that a drug carries a risk of X, and X is exactly what happened, it is difficult to argue—without blushing—that the manufacturer failed to warn. But that is exactly what plaintiff True did.

Plaintiff was prescribed an eyedrop to treat her presbyopia—not a disease so much as a rite of passage for anyone over forty or the time when your arms become mysteriously too short.  The active ingredient in the drug is pilocarpine hydrochloride, a member of a class of drugs called miotics. The label on the eyedrops plainly states that retinal detachment has been reported with the use of miotics.  Plaintiff used the drops as directed and within several weeks suffered retinal detachment. Her suit alleges claims for strict liability design defect, strict liability failure to warn, and negligence. Defendants moved to dismiss all claims.  

As the court explains in True, the approval of a New Drug Application (“NDA”), is an “onerous and lengthy” process, that includes the approval of the exact text of the approved label.  Id. at *4. Once approved, a drug manufacturer cannot unilaterally change a product’s label and warnings—with one narrow exception. The “changes being effected” (“CBE”) regulation allows a manufacturer to add or strengthen a warning without prior FDA approval where there is “newly acquired information about the evidence of a causal association between the drug and a risk of harm.” Id.  So, to avoid conflict preemption, a plaintiff must plausibly allege that there is a warning deficiency that the manufacturer could have corrected using the CBE process.

None of the information plaintiff cited to qualified as “newly acquired” information of a new or greater risk. She cited medical literature, case reports, and clinical studies. But none indicated that the risk of retinal detachment is any more severe or frequent than the risks already reviewed by the FDA and warned of in the labeling. Plaintiff also tried to rely on adverse event reports reported in the FDA reporting database (FAERS). But numerous courts, including True, hold that FAERS data is not newly acquired information that would support a CBE label change absent evidence of a causal association between the drug and the risk. Id. at *5. Even the FDA cautions that adverse event reports are not conclusions or admissions “that the drug caused or contributed to an adverse effect.” Id. (citing 21 CFR § 314.80(1).  

Without evidence of a causal link, the best plaintiff could do was put together a graph showing an uptick in adverse event reports. But the plaintiff provided no context, no time parameters, no explanation as to how the graphs demonstrated newly acquired information. Finally, plaintiff argued that defendant could have warned about the risk via its sales representatives and promotional materials, but the allegations of the complaint rest “solely on the inadequacy of the FDA-approved Label.” Id. at *6. Since the argument was “disconnected” from the allegations of the complaint, it could not save plaintiff’s failure to warn claim.

Failure-to-warn claims like this implicitly assume the manufacturer had a legal obligation to do the impossible: change an FDA-approved warning without legal authority to do so. Federal preemption exists precisely to prevent juries from deciding that drug manufacturers should have ignored federal law and rewritten labels on their own initiative.

The court also summarily dismissed plaintiff’s design defect and negligence claims. Plaintiff did not defend either cause of action. Plaintiff’s only design defect claim went to the drug’s formulation which the manufacturer cannot change without FDA approval. Therefore, like failure to warn, it was preempted. Id. To the extent plaintiff’s negligence claims were premised on the same design and warning allegations, they also failed. Id. at *7-8. Which left only negligent failure to research and test which Georgia law does not recognize as an independent cause of action. Id. at *8.   

Because plaintiff’s claims were either preempted or failed as a matter of law, the case was dismissed with prejudice.

And while we always celebrate a preemption win, we can’t overlook that in this case, the label warned of the risk; the risk occurred. End of story. Or at least it should be. The subtext of a claim like this is not that the warning was absent, but that the plaintiff wishes it had been more reassuring. The truth is that a warning can be adequate even if the risk materializes. Warnings are not guarantees. They are disclosures. And when a label discloses the very risk at issue, the failure-to-warn claim should collapse under the weight of its own contradiction.

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It’s been a been a while – some five years – since we discussed cross-jurisdictional class action tolling.  That’s mostly because, aside from the occasional result-oriented atrocity that occurred in the Valsartan MDL, class actions are no longer a top-shelf problem in prescription medical product liability litigation.  But it’s still nice to report on a major appellate decision from a large state giving that novel theory the boot.

That’s precisely what happened in on Halloween in Ackerman v. Arkema, Inc., 157 F.4th 715 (5th Cir. 2025).  Ackerman involved allegations of environmental pollution, not prescription medical product liability litigation.  Shortly after the event, some attorney purporting to represent residents filed a class action in federal court seeking both damages and injunctive relief less than a month after the explosions that allegedly caused the pollution.  Id. at 716.  The federal district court only certified the class for injunctive relief – hardly what the lawyers were primarily after – since monetary relief for different property damage claims isn’t the sort of common injury that supports a class action.  Id.

In 2024, some two years after the injunctive class settled, “800 members of [that] class filed individual actions in Texas state court seeking monetary damages.”  Id.  These claims were admittedly filed “almost six years after they had accrued,” long after the applicable two-year statute of limitations had expired.  Id.  But the plaintiffs claimed that the federal class action – which had never been certified as to property damage claims – somehow trumped the Texas statute and tolled Texas state-law claims brought in  state court.

That’s called “cross-jurisdictional class action tolling,” and Texas (like most states) had never permitted a class action filed in some other court system (here, a federal court) to toll its own statute of limitations in its own courts.  After these 800 claims were removed on diversity grounds to federal court, the trial court rejected their tolling arguments “because Texas law does not recognize cross-jurisdictional tolling of the statute of limitations.”  Id.

The Fifth Circuit has affirmed, rejecting the plaintiffs’ proposed reliance on “policy considerations” to justify their claimed federal procedural impingement on the Texas state statute of limitations.  As our cross-jurisdictional class action tolling scorecard indicates, while the issue has never reached the Texas Supreme Court, state and federal appellate courts have unanimously rejected such tolling.  See Bell v. Showa Denko K.K., 899 S.W.2d 749, 757-58 (Tex. App. 1995); Newby v. Enron Corp., 542 F.3d 463, 472 (5th Cir. 2008); Vaught v. Showa Denko K.K., 107 F.3d 1137, 1147 (5th Cir. 1997).  Adhering to this “binding precedent,” Ackerman, refused plaintiffs’ invitation to expand Texas law.  157 F.4th  at 717.  “state rules for tolling are based on state, not federal, law,” thus “Texas courts would not toll the state statute of limitations in light of a federal class action.”  Id. at 718 (citation and quotation marks omitted).

Plaintiffs “policy” claims were simply reprises of arguments that prior decisions had already considered and rejected:

Appellants’ arguments that there are exceptions to this bar on cross-jurisdictional tolling − such as when certain types of claims are at issue or when defendants have fair notice of the claims − are unavailing.  Newby considered and rejected such arguments, expressly abrogating district court cases holding that Texas courts would allow cross-jurisdictional tolling for property-related claims or where defendants had fair notice.  In the absence of any subsequent Texas decisions rendering our Erie guesses in Vaught and Newby clearly incorrect, we adhere to their holdings.

Id.  Nor was cross-jurisdictional class action tolling a “close question” that would warrant certification to the Texas Supreme Court where neither party sought such relief.  Id. at 718 n.2.

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We recently attended the ACI Drug & Medical Device Seminar in New York, where we always enjoy catching up with old friends, making new acquaintances, and hearing what’s new in our drug and device sandbox.  This year we spoke on the extensive and active litigation that is currently going on over the 340B drug pricing program.  We product liability litigators don’t often focus on drug pricing, but litigation over 340B discounts has become big enough that it has grabbed our attention, in a major way.  The stakes are substantial:  Spending under the 340B program was estimated at $66 billion in 2023, and it is expected to become the largest federal prescription drug program by 2028. 

Today we provide an update on litigation over the use of “contract pharmacies” to dispense prescription drugs purchased at steep 340B discounts.  We described the contours of that litigation here and here, and the latest development is from a lawsuit challenging Utah’s law mandating that manufacturers sell medicines at 340B discounts to unlimited numbers of pharmacies.  In Abbvie, Inc. v. Brown, No. 2:25-cv-00271, 2025 U.S. Dist. LEXIS 228160 (D. Utah No. 19, 2025), a federal court in Utah recently ruled that federal law preempts Utah’s contract pharmacy law and also that the Utah law enacted an unconstitutional taking. 

To recap, prescription drug manufacturers who want to participate in Medicare and Medicaid spending have to offer drugs under the 340B program at steep discounts to certain safety net healthcare providers—so-called “covered entities.”  Because not all covered entities have in-house pharmacies, they are allowed to contract with outside pharmacies to dispense medicines to their patients.  These “contract pharmacies” are thus eligible to purchase drugs at the 340B discounted prices.  For a variety of reasons, the use of contract pharmacies has exploded over the last 15 years, and many manufacturers have concluded, with substantial justification, that this exponential growth threatens the integrity of the program.  So, several of them have tried to apply the brakes by imposing reasonable limitations. 

Multiple states have struck back by passing laws mandating that manufacturers continue to sell 340B discounted drugs to unlimited numbers of pharmacies—including Utah.  In Brown, a group of prescription drug manufacturers sued to enjoin Utah’s law under which manufacturers are not allowed to limit delivery of discounted drugs to contract pharmacies, nor can manufacturers require the submission of claims data or other information as a condition of delivery.  2025 U.S. Dist. LEXIS 228160, at *12-*13. 

In challenging that law, the manufacturers argued (1) that federal law preempts the Utah law, (2) that the Utah law enacted an unconstitutional taking, and (3) that the Utah law violates Due Process and the Commerce Clause.  In denying the state’s motion to dismiss, the district court agreed with the manufacturers on preemption and the Takings Clause.  On preemption, the district court observed that the federal 340B statute did not necessarily occupy the entire field.  But regardless, the Utah statute conflicted with federal law because the Utah statute permits the transfer of drugs at 340B prices to entities that do not serve vulnerable populations.  As the court observed, “under [the Utah statute], entities that potentially do not dispense drugs to patients at all may acquire . . . drugs at 340B prices.”  Because that is “directly contrary” to the 340B program’s purpose, federal law preempts the state law.

On takings, the manufacturers argued that the Utah statute forced them to transfer property for the benefit of private parties “without serving any valid purpose,” including allowing diversion of drugs to ineligible providers.  The district court agreed.  Sure, the manufacturers’ participation in the 340B program is voluntary, but they did not voluntarily accede to the wider parameters imposed by Utah’s law.  In other words, Utah “may not broaden the bargain by riding the coattails of a federal benefit.”  Id. at *28.

The district court did, however, grant the state’s motion to dismiss the manufacturers’ claims based on the Due Process Clause and Commerce Clause.  On due process, the statute’s language—and particularly its use of the terms “interfere” and “pharmacy”—were not so vague as to make the law unconstitutional, and although the statute did not expressly include a scienter requirement, its penalties provision included one by referenced to another law.  Id. at *28-*33.

Finally, the manufacturers’ Commerce Clause failed because, even though Utah’s statute had extraterritorial effects, “[s]tates retain authority under their general police powers to regulate matters of legitimate local concern, even though interstate commerce may be affected.”  Id. at *33.  The Utah statute is limited in application to pharmacies in Utah, and the manufacturers did not allege facts demonstrating discrimination against other states. 

This is a good outcome for prescription drug manufacturers, but it is not the last word.  Stay tuned. 

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There are two main issues that make the eyes of your dutiful Drug and Device Law bloggers well up in frustration over In re Taxotere (Docetaxel) Eye Inj. Prods. Liab. Litig., No. 3023, 2025 U.S. Dist. LEXIS 233514, 2025 WL 3442731 (E.D. La. Dec. 1, 2025).

The first is a gut-level, “this is an example of something wrong with our civil justice system” point:

There have been thousands of lawsuits filed in two MDLs (MDL-2740 and MDL-3023) stretching back nearly a decade and involving the chemotherapy drug Taxotere—which is essential for the treatment of certain breast, lung (non-small cell), prostate, stomach (gastric), and head and neck cancers.  The newer MDL involves allegations that the Taxotere label did not provide full and detailed enough warnings about a potential risk that the drug might make patients cry; the earlier Taxotere MDL involved allegations that this chemotherapy drug caused hair loss. 

For the new MDL, the label warned of “excessive tearing which may be attributable to lacrimal duct obstruction,” but in the plaintiffs’ lawyers’ opinion, this warning also should have said that the “excessive tearing” was due to “stenosis” and patients should specifically consult “a lacrimal specialist at the first sign of excessive tearing.”

Got that? The drug label advised oncologists that their cancer patients might have “excessive tearing” due to tear “duct obstruction,” but because the label did not also say that the cause of the excessive tearing was “stenosis” and to immediately consult a “lacrimal specialist,” we have an MDL, thousands of lawsuits, and almost a decade of obscenely expensive litigation grinding on, with only the lawyers involved reaping anything other than minimal benefit.

Is it any wonder why we generally favor a high-regulation/low-litigation model?  (Or, at least we do when the regulators are actual scientists and doctors who follow the standards of those respective professions. Ahem.)

Which brings us to the second issue, preemption.

The Fifth Circuit already has had to correct the Taxotere MDL District Court once regarding preemption, in a case arising from the hair loss MDL, Hickey v. Hospira, Inc., 102 F.4th 748 (5th Cir. 2024). As Bexis explained about that decision, Taxotere came onto the market through the so-called “paper NDA” process, 21 U.S.C. §355(b)(2). In this earlier Taxotere decision, the Fifth Circuit rejected the District Court’s conclusion otherwise, and held that PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011) applied just the same for paper NDA medications as for any other. Thus, because of federal preemption, plaintiffs cannot challenge the sufficiency of a drug’s label warning unless they can show that the manufacturer had “newly acquired” information that “reveal[ed] risks of a different type or greater severity or frequency than previously included in submissions to FDA” such that the manufacturer could have initiated a label change using the changes being effected (or “CBE”) regulation, 21 C.F.R. § 314.70(c)(6)(iii).

In fact, Hickey went further, and reviewed five items of medical literature that supposedly formed the “newly acquired information” that supposedly gave rise to a duty on the part of the Taxotere manufacturer to add the plaintiff-lawyer proposed language about hair loss.

According to the Fifth Circuit, four of the five items of medical literature identified by the plaintiffs could not constitute newly acquired information as a matter of law on the appellate record because they failed to meet the “different type or greater severity or frequency” requirement for the CBE regulation to apply, and because the overall degree of risk was essentially the same.

As to the fifth item of “medical literature”—an “abstract,” not even a full-fledged study—the Fifth Circuit left the door open by only the slimmest of cracks, remanding to the District Court to reconsider this evidence using the proper legal standard.

In this newest In re Taxotere preemption decision, from the excessive tearing MDL, the plaintiffs and District Court plowed through that narrow opening like the door wasn’t even there.

Once again, the manufacturer moved for summary judgment, arguing (similar to the argument in Hickey) that plaintiffs’ claims are preempted because it could not have invoked the CBE regulation—that no “newly acquired information” existed to justify a unilateral label change.

The District Court held that the manufacturer bears the ultimate burden of persuasion on preemption (but deferred whether the plaintiffs bear a limited burden of production to identify evidence of newly acquired information, because the plaintiffs here in fact did that).

The District Court also held that the question of whether information constitutes “newly acquired information” is a matter of law for the judge, not the jury and, as a result, expert testimony on that “ultimate issue” is inadmissible.

Because of this, the District Court’s entire decision—that the manufacturer did have newly acquired information of the necessary import to require a label change—is based entirely on its own assessment of the significance of one small study (the 2003 Esmaeli Cancer Study), without consideration of the affidavit by that study’s author, Dr. Bita Esmaeli, submitted by the manufacturer.

What makes all this troubling is that the District Court makes some pretty dramatic claims about the medical significance of the 2003 Esmaeli Cancer Study, even though that study was really small (it only involved 148 patients), and was duplicative of pre-label approval studies (the 2001 Esmaeli Article and the 2000 Kneuper Hall Abstract) that, as the District Court itself says, “reported on similar injuries and surgical interventions and penned similar warnings regarding the need for referral to an ophthalmologist and/or prompt intervention.”

There is a lot we can say about the significance, or lack thereof, of the conclusions of the 2003 Esmaeli Cancer Study, but the most notable thing the District Court seemed to miss is that, if anything, the study showed that the alleged condition (lacrimal duct obstruction due to stenosis) appears more common in use of Taxotere at a higher, off-label dosage (weekly instead of every three weeks)—in other words, how oncologists would use Taxotere for sicker cancer patients.

Thus, this single, small, repetitive study reflects, at most, new information reflecting a risk of a “different type or greater severity or frequency” regarding excessive tearing for the sickest cancer patients, and nothing about new information for most Taxotere patients receiving the usual treatment doses at the usual pace.  That matters because (at least, perhaps, until further review by the Fifth Circuit), the only Taxotere MDL plaintiffs who should have a non-preempted failure to warn claim are those that received the higher dosage.

And these plaintiffs will still have to prove warnings causation—that their treating oncologists would have declined to prescribe chemotherapy to them as cancer patients, had those oncologists only known about the incrementally different language of the plaintiffs’ lawyers proposed excessive tearing warning. Which, in a non-insane world, should be something very difficult to prove. How many physicians are going to testify, “Correct, I would not have prescribed potentially life-saving chemotherapy to this very sick cancer patient had I only been formally instructed that the excessive tearing due to duct obstruction was because of stenosis, and that a lacrimal specialist consult should be considered.”

Which brings us back to our first point—does this litigation make any sense?

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If it’s Wednesday, it’s plainly time to talk about removal. Today’s case, In re Depo Provera Prods Liab. Litigation, 2025 WL 3252445 (N.D. Fla. Nov. 13, 2025), upholds one of the defense bar’s favorite procedural maneuvers,snap removal. The case was snapped in California, in the Ninth Circuit, and transferred to the Multidistrict Litigation in the Eleventh Circuit.  There was complete diversity (no party on one side of the v shared citizenship with anyone on the other side), and the case was removed before a forum defendant was served.  That should be, and was, a plain case of proper snap removal. 

Just as plain was the fact that the plaintiff did not help her case by never serving the forum defendant, even after removal to federal court.  The plaintiff moved to remand the case to state court, relying on the old chestnut that federal courts are courts of limited jurisdiction. But even with the principle that federal jurisdiction is narrowly construed, the relevant statute plainly allows snap removals, as three circuits (Second, Third, and Fifth) have held, and another (Sixth) had so indicated in a footnote.  Here, the court noted that other courts within the Eleventh Circuit had “come out both ways regarding the propriety of snap removal.”  At the same time, there was some language in an Eleventh Circuit case that “strongly suggests” that “absent gamesmanship on a removing defendant’s part, the Eleventh Circuit believes the statute means what it says.”  

We’re not sure what amount of “gamesmanship” could overcome the plain — there’s that word again — language of 28 U.S.C. section 1441(b)(2)). Snap removal is “at least rational,” and its result does not bump against the “absurdity bar.” In any event, no such gamesmanship was hinted at in this case. 

Accordingly, the court denied the remand motion. That is plainly the right result. 

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