A year ago, Bexis thought this would be the last blogpost he would ever write, and that he would retire along with 2025.  Not gonna happen – at least not yet, thanks to Reed Smith making him an offer he couldn’t refuse.  Bexis will be stepping back from some things, but not from the Blog.  That will continue.

With the future of the Blog assured for at least another year, we turn to Bexis’ favorite holiday task, compiling our annual list of the top ten best prescription medical product liability litigation decisions.  For a judicial decision to be eligible for our annual top (or bottom) ten lists, it must:  (1) involve a prescription medical product, or an OTC drug, and (2) involve product liability claims, that is, the losing plaintiff must have claimed that there was something wrong with that product.

So, before we turn to the best of the best for 2025, we’re going to pay passing homage to those non-prescription medical product or non-product liability decisions in 2025 that we think will significantly impact our sandbox in years to come.  Non-prescription medical product decisions of significance in 2025 are:  Gustafson v. Springfield, Inc., 333 A.3d 651 (Pa. 2025) (nothing in the Tenth Amendment precluded Congress from enacting federal tort reform) (here); Smith v. Terumo BCT, Inc., ___ P.3d ___, 2025 WL 3029699 (Colo. App. Oct. 30, 2025) (rejecting non-injury medical monitoring as a basis for tort recovery under Colorado law) (here); EcoFactor, Inc. v. Google LLC, 137 F.4th 1333 (Fed. Cir. 2025) (en banc) (excellent expert exclusion decision applying amended Rule 702 in a patent case; failure to exclude expert was abuse of discretion) (here); Engilis v. Monsanto Co., 151 F.4th 1040 (9th Cir. 2025) (another good Rule 702 decision from previously problem-child circuit) (here); Messerli v. AW Distributing, Inc., 153 F.4th 1077 (10th Cir. 2025) (strongly reaffirming in pari delecto as an independent basis for dismissal) (here); Pable v. Chicago Transit Authority, 145 F.4th 712 (7th Cir. 2025) (sanctions against plaintiff spoliating ediscovery affirmed) (here); In re Subpoena No. 25-1431-014, ___ F. Supp.3d ___, 2025 WL 3252648 (E.D. Pa. Nov. 21, 2025) (defending off-label use of FDA approved products from government arguments that mere manufacturer knowledge of such use renders such products “unapproved new drugs”) (here); United States v. Novo Nordisk, Inc., 2025 WL 1696881 (W.D. Wash. June 17, 2025) (FCA governmental plaintiffs have to provide relevant discovery, too) (here); LLT Management, LLC v. Emory, 2025 WL 438100 (E.D. Va. Feb. 7, 2025) (talc defendant could pursue trade libel suit against p-side experts who allegedly deliberately lied in authoring a litigation-driven junk science medical journal article) (here).

But the potential impact of those decisions doesn’t in any way detract from the significance of our top ten decisions, as these ten are directly applicable to the arguments we make in defense of our prescription medical product clients.  This year’s Drug & Device Law Blog top ten decisions of the year reaffirmed vigorous vetting of would-be expert witnesses under recently amended Rule 702.  They applied preemption – our most powerful defense.  They rejected public nuisance claims against prescription medical products.  They enforced early vetting of MDL plaintiffs.  So we are chomping at the bit to get going with our 2025 top ten prescription medical product liability decisions.

1. This entry is not from the Reed Smith side of the Blog.  In re Zantac (Ranitidine) Litigation, 342 A.3d 1131 (Del. 2025).  When plaintiffs in the Zantac MDL began losing major issues right and left (see our Zantac Chronicles (2020+10, 2020+18, 2022+4, 2024+19) plaintiffs bailed out of that federal forum in droves, even though they had promised not to.  Many of these litigation tourist refugees wound up in Delaware state court, where several of the defendants were incorporated.  There, they sought and received an expert do-over under what purported to be the Delaware Rules of Evidence.  The result was, in a word, horrible, our worst trial court opinion of last year (2024-5).  We’re not going to go through everything wrong with that opinion again.  You can read about it here.  But before the misdeeds of a single trial judge could do permanent damage to Delaware’s reputation, the Delaware Supreme Court stepped in, and in a rare move accepted an interlocutory appeal.  The outcome?  Our number one best decision of 2025.  The result was even bigger than this litigation, and the Delaware Zantac litigation involved some 75,000 plaintiffs.  Beyond that, the Delaware Supreme Court expressly adopted the standards of amended Federal Rule 702, including the 2023 amendment – completely repairing Delaware law in the expert arena, which is critical given the number of our clients incorporated there.  First, the court rejected the trial court’s overall expert admissibility standard for improperly favoring and presuming admissibility.  As in federal court, Delaware judges are “gatekeepers” and must examine proffered expert testimony critically.  Second, the Supreme Court specifically agreed that the bases of expert opinions are for the court, not the jury, to evaluate under Rule 702.  And with that, it reversed the trial court, found multiple abuses of discretion, and ordered the ten (count ‘em 10) causation witness for these 75,000 plaintiffs all be excluded for a variety of improper methodological lapses.  The worst of these lapses was relying on studies that, instead of involving the product the litigation was about, concerned the alleged toxic agent, in either occupational or dietary exposures that dwarfed anything that these plaintiffs could have received.  In so doing, it explicitly adopted the reasoning of the federal Zantac MDL’s exclusion decision (2022+4).  Since nine of the ten experts had improperly based their opinions on occupational/dietary studies, and the last one could not offer a complete opinion without the others, the trial court’s decision admitting plaintiffs’ expert testimony was reversed – the opinions were inadmissible under Rule 702, properly applied.  And recently, a postscript:  no expert-related mulligans; summary judgment was proper, and the only remaining question is which plaintiffs are bound by the summary judgment order.  See In re Zantac (Ranitidine) Litigation, 2025 WL 3459343 (Del. Super. Dec. 1, 2025).  We (some of us) zealously advocated the reasoning in Zantac here.
2. This entry is solely from the Holland & Knight side of the Blog.  Eastern Maine Medical Center v. Walgreen Co., 331 A.3d 380 (Me. 2025).  A good winning streak is a thing to behold, all the more if it starts with a series of setbacks.  Just about every feel good sports movie seems to follow that formula.  In the early years of opioid litigation, the plaintiffs seem to hold all the cards, pushing staggering potential liability for dozens of companies based primarily on the public nuisance theory of liability.  But with decisions by the Supreme Courts of Oklahoma (2021+1) and Ohio (2024+3) that rejected public nuisance as a prescription medical product liability litigation theory, it looked like public nuisance was in sharp retreat.  This year, a third state high court came out against the proposed application of public nuisance in opioid litigation.  In Eastern Maine, however, the plaintiffs were not local governments but hospitals claiming the opioid epidemic harmed them by increasing their provision of unreimbursed care.  Maine had adopted public nuisance (also called “common nuisance” Down East) under its common law and enacted a statute authorizing damages for private plaintiffs.  Neither mattered in the end.  Despite their 538-page complaint, plaintiffs in Eastern Maine could not “show an infringement of private rights resulting in special legal injury different in kind as well as degree from that suffered by others.”  Their attempt to glom onto “the broad public injury resulting from increased opioid misuse” did not get them past pleadings for public nuisance, negligence, fraud, or conspiracy.  We had hoped that as goes Maine, so goes the nation, but the favorable public nuisance appellate trend ended with Fourth Circuit’s mess purporting to apply West Virginia law (2025-1).  For us, however, three state supreme court decisions (and the Third Restatement of Torts) outweigh a single circuit court’s improper purported Erie prediction of state law.  A few of us exalted Eastern Maine here.
3. Sprafka v. Medical Device Business Services, Inc., 139 F.4th 656 (8th Cir. 2025).  From the beginning, we’ve believed that the December, 2023 amendments toughening Fed. R. Evid. 702 − and calling out “liberal” admissibility decisions as “incorrect” – could be a game changer in favor of defendants.  Given the lag time in litigation, 2024 is the first year with significant amended Rule 702 appellate decisions.  Sprafka, which affirmed an excellent district court decision (2024+11), is the best in the drug/device space, so it’s number three on our annual nice list.  The Eighth Circuit has been a Rule 702 problem child (2021-1) for quite some time, but Sprafka cited the amended rule in affirming the exclusion of a notorious p-side frequent flyer “expert” from testifying in a medical device case.  While we would have preferred a frank recognition that the amended rule superseded that circuit’s past bad decisions, Sprafka gave us the next best thing:  a published decision discussing the impact of the 2023 amendments and a detailed affirmance of the trial court’s exclusion order.  The opinions at issue flunked Rule 702 because they were solely litigation-driven, had inadequate support that failed to establish any failure rate, were not supported by reliable data, and failed to offer any causal alternative design/modifications to the device.  The purported opinion that this design had a higher failure rate than other similar devices was based on anecdotes that were flatly contradicted by relevant registry data.  The expert’s defect opinion was thus “properly disregarded” due to unreliable methodology.  We saluted Sprafka here.
4. In re Gardasil Products Liability Litigation, 151 F.4th 178 (4th Cir. 2025).  What did the plaintiffs in the first-ever MDL involving a Vaccine Act-protected vaccine try to do?  They tried to destroy the Vaccine Act itself.  Fortunately, they failed miserably.  They didn’t have any worthwhile claims that were not preempted by the Act, so they claimed that the Act was unconstitutional because the process by which every new vaccine (including Gardasil) was added to the list of covered vaccines for the last 40-years supposedly violated the constitution’s Presentment Clause.  They failed, and in this Gardasil decision that failure was affirmed.  Because Congress explicitly created the Act’s listing  process and set defined criteria for its use, it did not grant improper  executive branch authority to make statutory amendments.  But that’s not all.  Gardasil affirmed a second, unrelated pro-defense ruling also being appealed.  This ruling is less important, but still significant.  On their way through the Vaccine Court, special masters held that several plaintiffs’ claims were not timely filed (no surprise since MDL solicitation inevitably dredges up stale and otherwise meritless claims).  In the MDL, these plaintiffs unsuccessfully tried to collaterally attack the masters’ decision (2024+14).  Dismissal of these plaintiffs’ cases based on the collateral estoppel effect of the special master decisions affirmed.  The Vaccine Act vests timeliness decisions in the special masters, and plaintiffs never properly appealed to the Federal Court of Claims.  Having taken no appeal, plaintiffs cannot avoid the special master decisions in subsequent civil litigation.  For rejecting both of these MDL-inspired attacks on the Vaccine Act, the Fourth Circuit’s Gardasil decision ranks high among our best cases of the year.  We greeted Gardasil here.
5. Wilson v. CooperSurgical, Inc., ___ F. Supp.3d ___, 2025 WL 2606086 (S.D. Ill. Sept. 9, 2025).  We rank Wilson as our best trial court decision of the year because it correctly recognized that failure-to-report claims do not state a claim under Illinois law.  Thus, the plaintiff’s claims against the manufacturer of a pre-market approved contraceptive device were entirely preempted.  Supposedly “parallel” failure-to-report claims have emerged as a preemption dodge of choice for device, and even drug, plaintiffs faced with extinction through preemption.  Wilson is also noteworthy for the judge’s complete about face on preemption once the plaintiff’s case moved beyond the pleadings.  We criticized the prior bad decision as our sixth worst case of 2023.  It’s only fair that we reward this favorable turn of events.  2025 will go down as the year that anti-choice plaintiffs’ attacks on yet another form of contraception got clobbered on summary judgment, and Wilson heads that list.  Illinois failure-to-report law has been murky because of a couple of early and adventurously bad federal court decisions.  But a 2017 published Illinois appellate decision rejected reporting-based claims.  In an extensive discussion, Wilson analyzed the conflicting precedents and determined that “there is no Illinois requirement that parallels the federal requirement to report to the FDA.”  There being no state-law parallel duty, the claim was expressly preempted for being “different from or in addition to” FDA requirements.  The reporting claim was also impliedly preempted under the Buckman rationale that private plaintiffs have no ability to enforce purported FDCA violations.  Like the fraud-on-the-FDA claim at issue in Buckman, plaintiff’s reporting claim sought to second-guess the completeness of the defendant’s submissions to the FDA.  The reporting claims being the linchpin of all the Wilson plaintiff’s allegations (typical of litigation over this product), negligence and gross negligence also bit the dust.  We welcomed Wilson here.
6. In re Valsartan, Losartan, & Irbesartan Products Liability Litigation, 2025 WL 1024048 (D.N.J. April 7, 2025) (“Valsartan 2025”).  The Valsartan MDL, during its first five years, was notable for several bad decisions (2024-8, 2021-4, 2020-10), culminating in the jaw-dropping certification of no fewer than three nationwide class actions (2023-1).  Fortunately for the defense, in 2025, there was a new sheriff in town – and boy did it matter with Valsartan 2025 making our “best of” list.  The plaintiffs first tried to argue that the new judge was somehow constrained by “law of the case” and had to follow a previous ruling finding an expert’s testimony admissible in the context of class certification.  Nope, the merits are wholly different, being in the “world of proof and evidence.”  Then the Valsartan 2025 plaintiffs lost badly on said proof and evidence.  The class representative in the third-party payor class action could not prove anything because it could not prove cancer causation.  Drugs that successfully treated the conditions for which they were prescribed could not be “worthless” because of a trivial level of claimed contamination by an alleged carcinogenic break-down product.  Plaintiffs could not avoid the “elephant in the room” – could this medicine, in the doses prescribed, cause cancer – by seeking only economic loss damages.  The economist that the class plaintiffs proffered was neither qualified to address cancer causation, nor did she purport to do so.  Given this “stark lack of scientific or economic basis,” Valsartan 2025 reject the expert’s opinions as virtually all ipse dixit:  assuming, rather than proving dangerous levels of contamination.  Icing on the cake was provided by the court’s favorable references to the 2023 amendments to Rule 702.  We viewed the virtues of Valsartan 2025 here.
7. In re Gardasil Products Liability Litigation, 770 F. Supp.3d 893 (W.D.N.C. 2025).  The plaintiffs in the Gardasil MDL, being bound by the preemptive limits of the Vaccine Act, see  above #4), were stuck with warning claims.  But even putting aside the Act’s presumption that FDA-approved warnings were adequate, the Gardasil plaintiffs had another, ultimately insurmountable problem − impossibility preemption.  Plaintiffs had not, and could not, dispute the nearly 100% effectiveness of the vaccine in preventing a once common form of cancer.  Instead, they alleged that the vaccine caused either of two relatively minor conditions.  The evidence that it did so was pathetically slim – no more than a couple dozen largely unverified reports.  Thus, without even bothering with the statutory presumption, the warning claims were entirely preempted.  An FDA-approved warning can only be challenged if, under applicable FDA standards of evidence, a plaintiff has “newly acquired information” of some new or more frequent/serious medical risk.  The scraps that plaintiffs relied on didn’t come close.  Because preemption, and thus the existence or the requisite information, was a question of law, plaintiffs couldn’t rely on paid “experts” spouting ridiculous theories (although they tried).  For one thing, all of the information, sparse as it was, had been provided to the FDA.  Thus, there was nothing “new.”  Nor were case reports, published or not, sufficient evidence.  They resided at the bottom of the scientific weight scale.  Still worse were “fewer than ten” adverse event reports.  Even putting aside their completely unverified nature “these reports would be far below the background rate” of the complained-of conditions – nothing more frequent.  Medical literature that didn’t even mention the relevant conditions simply didn’t count.  Because plaintiffs had nothing approaching the necessary FDA evidentiary standard for unilateral label changes, all plaintiffs’ warning claims were impliedly preempted as “impossible” under the governing FDCA framework.  To allow such claims “would effectively make the regulatory standard meaningless.”  Another great Gardasil decision in an MDL the plaintiffs probably regret ever starting.  We gloried in Gardasil here.
8. In re Depo-Provera (Depot Medroxyprogesterone Acetate) Products Liability Litigation, 2025 WL 1618995 (N.D. Fla. May 12, 2025).  As many of our readers know, a new federal rule, Fed. R. Civ. P. 16.1, pertaining specifically to MDLs, went into effect at the beginning of this month.  We are admittedly skeptical about the new rule, because it didn’t directly address what to us is the overwhelming problem with MDLs – the filling of thousands of utterly unvetted claims gathered by widespread attorney solicitation.  The new rule’s one saving grace on the issue of early vetting of MDL claims was that “early exchange of information” about the basis of claims (and defenses) is a mandatory topic to be addressed early on under new Rule 16.1.  That was why we considered the new rule “better than nothing,” but nothing could give it a run for its money.  On the upside, Depo-Provera promises more, much more, if the terms of this order become the norm for MDLs, which is why this order makes our top ten list.  It represents an excellent model for MDL early vetting with teeth under Rule 16.1, even though it preceded the effective date of the rule by several months.  Defendants in other MDLs should seek similar orders.  It imposed pleading requirements.  Every complaint in the MDL must have (or be amended to have) a statement of “requisite physical injury” from a specified list and also specific allegations of causation by the plaintiff’s use of a “requisite product,” again from a list.  Enforcement was both quick (two days for a deficiency finding and seven days for an order to show cause) and effective (deficient complaints cannot be filed).  If Depo-Provera becomes the model for Rule 16.1 “exchange” requirements, then the rule will have indeed accomplished something significantly useful, and we will happily eat our words.  We delightedly presented Depo-Provera here.
9. This entry is not from the Butler Snow side of the Blog.  Silverstein v. CoolsSculpting Zeltiq Aesthetics, Inc., 229 N.Y.S.3d 44 (N.Y. App. Div. 2025).  Silverstein is a relatively rare published state-court opinion flatly rejecting an increasingly common, and thoroughly obnoxious, plaintiff argument – that product liability defendants have duties to warn about the risk of products made by others.  For one thing, consider innovator liability, which at its core is precisely that kind of theory.  Asbestos cases rejecting the so-called “bare metal defense” are another example.  Silverstein rejects the same arguments in a one-off medical device case, and did so in the best possible procedural posture, unanimously reversing the denial of summary judgment (an appealable order in New York).  Use of the defendant’s product in cosmetic surgery was commonly followed by application of ice packs to the affected area.  Unfortunately, extreme cold, like extreme heat, can burn the skin.  However, the defendant that was sued did not make or sell icepacks, and its device by itself did not have a burn risk.  Relying on one of the bad asbestos cases, the trial court in Silverstein denied summary judgment, finding the frequent combined use of the two products supported a duty to warn.  Reversing, the appellate court held that ice packs were not essential to the defendant’s device function.  Nor did the defendant’s warnings recommend use of ice packs.   Finally, the defendant didn’t make ice packs and thus received no economic benefit from their sale.  The general rule confining the duty to warn to products the manufacturer made (and profited from) thus applied.  And there’s more.  Because the device required a prescription, the learned intermediary rule also applied.  To a physician who regularly used this sort of device, the danger of burns from ice packs was obvious – “basic medical knowledge.”  There was thus no need to warn in the first place of this risk and even if there were, no causation, since the doctor using the device was well aware of that risk.  We salivated over Silverstein here.
10. In re Glucagon-Like Peptide-1 Receptor Agonists Products Liability Litigation, 2025 WL 2396801 (E.D. Pa. Aug. 15, 2025).  With this year’s overall emphasis on enforcement of amended Rule 702, it is only fitting that another favorable MDL-wide expert ruling should make the top ten, while several other excellent decisions receive honorable mentions.  The GLP-1 MDL is essentially a strike MDL; because the drugs are widely used, plaintiffs went looking for some claimed injury – didn’t matter what − to tag it with.  The MDL judge seems to have similar thoughts, since from the beginning she limited MDL proceedings to “cross-cutting” issues, one of which was medical: “whether a physician can reliably diagnose a patient with gastroparesis without performing a gastric emptying study.”  While that sounds obscure, 95% of the claims in the MDL involve this alleged injury.  Plaintiffs, of course, viewed any objective criteria as anathema.  Fortunately for the right side of the “v.,” this test is precisely what consensus medical practice required.  Thus, plaintiffs’ experts’ unconstrained “differential diagnoses” (actually etiologies) failed Rule 702’s methodology test.  The aforementioned medical consensus was virtually unanimous, and their experts stretched the only two even arguably supportive studies “further than the authors themselves were willing to go.”  Those experts also used case studies, which were simply not “an accepted method of diagnosis.”  Other litigation-created hypotheses that these experts generated were excluded as completely unsupported speculation or as constantly moving targets.  With no scientific basis for avoiding objective testing, plaintiffs claimed “regulatory estoppel” (which sounds like a new name for fraud on the FDA), but even if such a thing existed, plaintiffs had taken the statements out of context.  So any plaintiff that didn’t have the requisite objective test at the time of diagnosis is out.  A similar Rule 702 specific-test requirement (2024+7) successfully cut the Zostavax MDL down to size.  May the same thing happen here.  We were gladdened by GLP-1 here.

There you have it – our top ten prescription medical product liability litigation decisions of 2025.  We think it’s a good mix of substantive law, preemption, Rule 702, and procedural rulings, most of which were magnified by occurring in the mass tort context.  If you were responsible for any of these gems, your grateful bloggers offer our congratulations.  Otherwise, we will wait together for next year.

But we’re not done yet.  Recognizing defense wins is fun, so here is our annual list of runners up − those decisions that we consider to be the next ten most significant wins of 2025.

Honorable Mentions:  (11) Bulox v. Coopersurgical, Inc., 773 F. Supp.3d 351 (S.D. Tex. 2025) (it was a good year for arguments that failure-to-report claims in the Filshie clip litigation were preempted; this is another outstanding summary judgment decision) (here); (12) In re Gardasil Products Liability Litigation, 2025 WL 1782576 (W.D.N.C. Feb. 20, 2025) (the Gardasil MDL has become a disaster for the plaintiffs; this decision applied amended Rule 702 to give another set of lousy experts a well-deserved bum’s rush) (here); (13) Saulsby v. Amphastar Pharmaceuticals, Inc., 919 S.E.2d 727 (N.C. App. 2025) (excellent appellate affirmance of dismissal of an OTC drug plaintiff who ignored warnings; would have ranked higher if framed in terms of warning causation rather than North Carolina’s peculiar retention of “contributory negligence” as a complete defense) (here); (14) Paddock v. Novartis Pharmaceuticals Corp., 2025 WL 1908806 (D. Del. July 11, 2025) (good on snap removal, but even better for recognizing fraudulent misjoinder as grounds for removal) (here); (15) In re Taxotere (Docetaxel) Products Liability Litigation, 2025 WL 655796 (5th Cir. Feb. 28, 2025) (non-precedential affirmance of with-prejudice non pros of an MDL plaintiff who couldn’t be bothered even to effect service of process on the defendants) (here); (16) In re Valsartan, Losartan & Irbesartan Products Liability Litigation, 2025 WL 3131002 (D.N.J. Nov. 10, 2025) (first MDL bellwether plaintiff dismissed because his specific causation expert could not reliably exclude other strong and established cancer risk factors) (here); (17) Searcy v. Pfizer, Inc., __ F. Supp.3d __, 2025 WL 2713736 (M.D. Ala. Sept. 23, 2025) (because the PREP Act effectively shut down product liability claims involving COVID-19 vaccines, this plaintiff claimed the Act was unconstitutional in various ways – and lost them all) (here); (18) Thelen v. Somatics, LLC, 156 F.4th 1115 (11th Cir. 2025) (published appellate affirmance of defense trial win on adequate warnings that also governed a consumer expectation-based design claim and evidentiary rulings; ranked lower because of application of Nebraska law by a Florida court) (here); (19) Hill v. Medical Device Business Services, Inc., 2025 WL 1950300 (6th Cir. July 16, 2025) (broken device case that produced another favorable Rule 702 affirmance, but unpublished) (here); (20) Watts v. Maryland CVS Pharmacy, LLC, 142 F.4th 233 (4th Cir. 2025) (excellent published affirmance of dismissal based on 50/50 causation being inherently speculative, but involving a rare fact pattern of two simultaneous vaccinations, only one being subject to Vaccine Act preemption) (here).

But we still can’t stop ourselves from patting victorious defendants on the back.  Our 2025 collection of cases also features these near misses – another group of useful victories, listed mostly in chronological order:

Summers v. Medtronic, Inc., 2025 WL 863576 (D. Mass. March 18, 2025) (complete dismissal on PMA preemption; suffering only from “making rubble bounce” issue) (here); Warner v. Amgen, Inc., 2025 WL 490720 (D. Mass. Feb. 13, 2025) (refusing to recognize the PMA preemption dodge of “pre-approval” warning claims) (here); Arnold v. CooperSurgical, Inc., 2025 WL 622075 (S.D. Ohio Feb. 26, 2025) (another summary judgment Filshie clip preemption win, flipping an adverse Rule 12 decision and finding no viable failure-to-report liability theory in Ohio) (here); Scholl v. Walgreens Specialty Pharmacy, LLC, 2025 WL 950866 (N.D. Okla. March 28, 2025) (pharmacy that allegedly delayed filling a prescription had no state-law duty requiring it to fill any particular prescription) (here); Laucella v. Medtronic, Inc., 2025 WL 1018414 (C.D. Cal. April 4, 2025) (fraudulent joinder found where plaintiff purported to join an in-state non-treating physician who consulted with the defendant about the device, followed by PMA preemption dismissal of entire action) (here); Doyle v. Bayer Corp., 2025 WL 1666261 (W.D. Wash. June 12, 2025) (“threadbare” complaint against IUD manufacturer dismissed on multiple grounds, from preemption to pleading) (here); Aguila v. RQM+ LLC, 2025 WL 2322438 (S.D. Fla. Aug. 12, 2025) (American registered agent for FDA purposes not an agent for service of legal process on foreign manufacturer) (here); Bacher v. Boehringer Ingelheim Pharmaceuticals, Inc., 2025 WL 2463143 (Conn. Super. Aug. 22, 2025) (another horde of refugees from the Zantac MDL gets dismissed; this time on personal jurisdictional grounds) (here).

Looking to the future, we are all waiting with bated breath for the California Supreme Court’s decision in the Gilead duty-to-innovate case (2024-1), but oral argument has yet to be scheduled.  The longer it takes, the more nervous we get.  2026 should see the Second Circuit deciding the appeal from the Rule 702 dismissal in the Acetaminophen (2023+4) MDL litigation.  Also on appeal is the hideous Dressen (2024-9) PREP Act decision.  Multiple Zantac appeals (2022+4) (2021+10) (2021+18) remain pending in what has turned into a procedural morass.  We didn’t see any appeal in Bueno/Parker (2024+5) on PACER, so we assume those wins are final.  Finally, there will be no Michigan Supreme Court learned intermediary rule decision, as the litigation that produced a certification order has been dismissed.

The Supreme Court will decide whether a defendant that successfully removes a case to federal court is always at risk that, should the basis for removal later be found invalid on appeal, all subsequent activity would be nullified, essentially giving plaintiffs who lose in removed cases (and would be the only appellants) a free do-over (here).  The Eleventh Circuit will opine on whether the False Claims Act’s qui tam provision unconstitutionally vests executive power in private plaintiffs (here).

The new MDL rule, Fed. R. Civ. P. 16.1 just became effective, so in 2026 should see whether it will have the beneficial effects on multi-district litigation that we hope (see Depo-Provera, above) – especially on early vetting of claims − as opposed to the minimal effect that we fear could be the case.  Another potentially interesting new rule, proposed Fed. R. Evid. 707, regarding admissibility of machine-generated evidence, remains pending before the relevant civil rules subcommittee.

Looking back, we addressed the Delaware Zantac (2024-5) reversal above and discussed last week (2025-1), how the City of Huntington decision (2022+8) was reversed.  The “unprecedented” use of the political question doctrine in Caston (2024+13) also unfortunately did not survive appeal.  Certiorari was denied in Fosamax (2024-2), review was denied in Herzog (2024-7), and transfer was denied in O’Haver (2024+18), so those are over.  Beaver (2024+20) was affirmed by a one-paragraph order.  Beaver v. Pfizer, Inc., 2024 WL 3617570 (4th Cir. Aug. 1, 2024).

Finally, there is one piece of pending national legislation – the so-called “Lead Act” that would overturn the current majority rule that intangible electronic information is not a “product” for strict liability purposes – that bears watching.  We will have a post about that in the new year (actually, we beat that).

See you in 2026.

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.