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.