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.