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Lately, weirdly, sadly, some people have suggested that the Enlightenment was a mistake. They contend that an overemphasis on rationality robbed humanity of feeling, faith, etc. What drivel. Every day of the week, we’ll take Voltaire over any pretend-King, data over dogma, and science over stupidity. 

Thus, we are pleased with Miller v. McDonald, 2026 WL 1871521 (2d Cir. June 30, 2026), another appellate win for mandatory school vaccination requirements.  

The opinion begins with a recitation of New York’s history of regulating immunization in schools. In 1860, New York empowered school officials to deny admission of unvaccinated students. There were exemptions for students who could not be vaccinated for medical reasons or those whose parents held religious objections. Much more recently, in 2018-19, New York became the epicenter of a measles outbreak. Following that outbreak, the legislature repealed the religious belief exemption but not the medical exemption. Various Amish community schools and their officials brought this lawsuit under 42 USC section 1983, alleging that the immunization law infringed their free exercise rights under the First and Fourteenth Amendments. The plaintiffs also argued that the law impaired the right of parents to control the religious upbringing of their kids. 

The plaintiffs relied on Wisconsin v. Yoder, 406 U.S. 205 (1972), a case studied by pretty much everyone who attended law school over the last 50 years. In Yoder, the Supreme Court held that the First Amendment free exercise right of Amish parents outweighed the state’s interest in compelling school attendance beyond eighth grade. That precedent might not be precisely on point, but it is pretty helpful for the plaintiffs. But it was not helpful enough.  

The district court in Miller granted the state’s motion to dismiss and the Second Circuit affirmed. But then the United States Supreme Court granted certiorari, vacated the judgment, and sent the case back for reconsideration in light of Mahmoud v. Taylor, 606 U.S. 522 (2025). In Mahmoud, the Supreme Court overturned a school board’s refusal to allow parents to opt their young children out of classroom instruction using storybooks that conveyed messages contrary to the parents’ religious briefs.  

Thus, the Miller plaintiffs got a do-over. But after going through an analysis of the free exercise claims and the interplay of Mahmoud with Yoder, the Second Circuit decided it had been right all along and, again, affirmed dismissal of the case. Again, the Second Circuit held that New York did not act unconstitutionally when it repealed its religious exception to mandatory vaccination following a measles outbreak.  

The Second Circuit began its analysis with the observation that generally applicable vaccination requirements do not unconstitutionally burden the free exercise of religion. For the umpteenth time, we are treated to a citation to the Jacobson (1905) case in which the Supreme Court upheld a Massachusetts law requiring vaccination against smallpox. A neutral vaccination mandate need pass only rational basis review.  By contrast, a vaccination law animated by hostility to a particular religious sect would face fatal-in-fact strict scrutiny. As in Jacobson, the New York vaccination mandate was religiously neutral, and addressed a legitimate governmental interest in preventing communicable disease. It was an easy rational basis case. “Government is generally free to place incidental burdens on religious exercise so long as it does so pursuant to a neutral policy that is generally applicable.”  Repealing a religious exemption does not transmute an otherwise neutral law into one that targets religious belief.  The legislative history, read as a whole, does not show religious bias. (There might have been some isolated bits supporting the plaintiffs’ suspicion of bias, but they were isolated and unrepresentative, and serve as reminders of why Justice Scalia was deeply skeptical of legislative history.) Providing medical exemptions does not require providing religious ones.  The two are not comparable.  The medical exemption is the same as other vaccination exemptions that are constitutionally permissible.  

Further, mandatory vaccination does not unconstitutionally burden parental rights.  It is a general health requirement that does not seek to change any child’s religious belief. The burden of mandatory vacination “is not remotely of the same character as those imposed in Yoder and Mahmoud. The law is a public health measure, not an instrument of ideological indoctrination. It does not expose children to values or beliefs that might be hostile to their parents’ religious beliefs.”

Score one for public health. And while we’re at it, score one for leading figures of the Enlightenment, such as Montesquieu, Adam Smith, and, yes, John Adams and Thomas Jefferson. 

Post-script: On June 29, the Supreme Court denied certiorari in another vaccine-related appeal, Doe v. Hochul, from another Second Circuit/NY decision, that made similar religiously based attacks on mandatory vaccination, in that case, employment-related.  Doe had been hanging around all term, with more than the average amount of activity,  https://www.scotusblog.com/cases/does-1-2-v-hochul/.

The day after the denial, the Second Circuit handed down Miller.  Maybe a coincidence, maybe not.

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We have written before about the Taxotere eye injury MDL — and we wish we could say things were getting better. They are not.

Last December, we noted the fundamental absurdity at the heart of this litigation. Cancer patients — many of them breast cancer patients — were given Taxotere, a chemotherapy drug. The label warned that excessive tearing “may be attributable to lacrimal duct obstruction.” Plaintiffs’ lawyers, never ones to let adequate warnings stand in the way of a good MDL, decided that was not good enough. They wanted the label to say the tearing may be caused by “stenosis of the nasolacrimal drainage system.” And so we have, as we put it before, thousands of lawsuits, nearly a decade of litigation, and only the lawyers reaping anything other than minimal benefit.

Now the same MDL court has denied the defendant’s motion for summary judgment on warning adequacy. In re Taxotere (Docetaxel) Eye Injury Products Liability Litigation, 2026 WL 1839097 (E.D. La. June 25, 2026). The court managed to find genuine disputes of material fact lurking in what is, at bottom, a series of complaints that could be described as the medical terminology equivalent of arguing about whether a “hot dog” is a “sandwich.” The court did not even bother to apply the law of any particular state, applying instead a kind of generalized, multi-jurisdictional soup of failure-to-warn principles. The result is a roadmap for how to nitpick a warning to death.

Let us count the ways plaintiffs were permitted to pick apart an otherwise adequate warning.

Number 1. The label warned of “lacrimal duct obstruction.” Plaintiffs argued it should have said “nasolacrimal drainage system.” The defendant’s regulatory expert opined there was no material distinction between the two — that “nasolacrimal” and “lacrimal” do not “inherently change the characterization of the condition or impart additional or more useful information for the prescriber.” Id. at *5. On the other side, one of plaintiffs’ experts opined that “lacrimal duct obstruction is not terminology he uses in his practice.” Id. He didn’t say he didn’t understand the term, just that he personally does not use it. The court found a jury question. We find an eye roll.

Number 2. The defendant pointed to Stedman’s Medical Dictionary, which defines “obstruction” as a “blockage or clogging, e.g., by occlusion or stenosis.” Id. at *4. Stenosis, in other words, is one of the things that causes obstruction. Obstruction is the thing the label warned about. So the label warned about the thing caused by the thing plaintiffs say should have been mentioned. Plaintiffs countered with a different edition of the same dictionary that defines stenosis as a “narrowing” and cautions not to confuse it with “occlusion.” Id. The court found a jury question. We find it hard to keep a straight face.

Number 3. The label did not specifically say the condition could become permanent. Plaintiffs say it should have. To compound matters, the label noted that certain visual disturbances were “reversible upon discontinuation of infusion.” Defendant argued, correctly, that this referred to the immediately preceding sentence about transient visual disturbances during infusion — not to lacrimal duct obstruction, which appeared several sentences earlier. The court disagreed. Viewing everything in the light most favorable to plaintiffs, the court found a jury could conclude the label misleadingly implied the tearing risk was also reversible. Id. at *6.

Number 4. Plaintiffs’ expert opined the label should have warned physicians to promptly refer patients to an ophthalmologist upon signs of excessive tearing and mentioned the potential need for surgical intervention. This, as we have noted before, is the pharmaceutical equivalent of requiring a car manufacturer to tell drivers how to parallel park. Labels are not required to instruct physicians on how to practice medicine. The court acknowledged that manufacturers generally need not instruct physicians how to manage disclosed side effects, but found this wasn’t necessarily a “management instruction” and again found a jury question. Id. at *6.

And number 5. On top of all of that, plaintiffs’ expert opined the warning should have appeared in the “Warnings and Precautions” section rather than in the “Adverse Reactions” section. The court let that theory survive too. Id. at *7. This, again, is a theory we have seen before and continue to find unpersuasive — especially for a risk that is, let’s remember, associated with a chemotherapy drug being given to cancer patients.

Before getting to the merits of the warning claims, the court noted something worth flagging: it wasn’t going to apply the law of any particular state. Plaintiffs didn’t argue for an individualized choice-of-law analysis, and the court was apparently content to proceed under a generalized “common principles” approach. Id. at *4.

In an MDL involving thousands of plaintiffs from dozens of states, that is a curious thing. The whole point of Erie is that federal courts sitting in diversity apply state law — not a blended smoothie of principles that happen to be shared by most states. Different states have different standards for warning adequacy. Some apply the learned intermediary doctrine more rigorously; some have statutory presumptions; some are more forgiving of general warnings; some require specific causal language. A ruling that deliberately declines to engage with any of that is a ruling built on a foundation that can shift at any moment — which is bad for everyone, including plaintiffs, though they may not see it that way right now.

Even setting aside all of the above, we are compelled to return to the point we made in December, because it has not gotten any less true: these plaintiffs still have to prove warnings causation.

Under the learned intermediary doctrine — which the court acknowledges applies here — adequacy is measured by whether the prescribing physician would have reasonably understood the risk. Id. at *3. And even if the jury somehow finds the warning inadequate, each plaintiff must then show that a different warning would have changed her oncologist’s prescribing decision.

So. How many oncologists are going to take the stand and testify: “Yes, I would not have prescribed potentially life-saving chemotherapy to this very sick cancer patient had I only been formally instructed that the excessive tearing due to duct obstruction was because of stenosis of the nasolacrimal drainage system, and that I should refer to an ophthalmologist promptly”?

In a non-insane world, this should be something very difficult to prove. Oncologists treat cancer. They weigh the risks of chemotherapy — real risks, like neutropenia, neuropathy, and secondary malignancies — against the risk of dying from cancer. The suggestion that the difference between “lacrimal duct obstruction” and “stenosis of the nasolacrimal drainage system” would have led any oncologist to withhold chemotherapy from a cancer patient strains credulity past the breaking point.

But here we are. Thousands of cases. Nearly a decade. And counting.

If beauty is in the eye of the beholder, this MDL court seems to see beauty in every alleged gap in a warning label — no matter how fine the distinction, no matter how unlikely it would have changed anything, and no matter what state’s law is supposed to govern.

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We don’t normally discuss patent/intellectual property issues on the Blog, even though they arise all the time in prescription medical product litigation.  The reason is simple − our clients (and target audience) can be found on either side of the “v.”  So, it’s best that we leave the offering of opinions on patent/IP issues to others.

That certainly wasn’t a problem with the recent Hikma “skinny label” patent decision, Hikma Pharmaceuticals USA, Inc. v. Amarin Pharma, Inc., 146 S. Ct. 1391 (U.S. 2026).  Hikma touched off a torrent of patent-related commentary – see, e.g., here, here, here, here, here, here, here, here, and here.  We wouldn’t have been able to match that, since we’re product liability, not patent, lawyers.

But we do think that Hikma has implications for product liability litigation as well.  For one thing, it has off-label use issues throughout, even though that phrase is not directly mentioned (the decision uses “off-patent” as the equivalent).  Hikma involved the drug Vascepa, manufactured by the plaintiff/respondent Amarin Pharma.  That’s a tip off right there.  The same drug, and the same manufacturer, produced the landmark off-label use decision, Amarin Pharma, Inc. v. FDA, 119 F. Supp.3d 196 (S.D.N.Y. 2015), that we named our sixth best case of 2015.  Amarin beat the FDA on First Amendment grounds after the agency threatened to take enforcement action against the company for truthful off-label speech:

Plaintiff  . . . Amarin[] manufactures . . . Vascepa.  The FDA has approved Vascepa for one use, but doctors have widely, and lawfully, prescribed it for another.  Amarin wishes to make truthful statements to doctors relating to Vascepa’s off-label use. . . .  [that] the FDA largely but not wholly concedes . . . are truthful and non-misleading.  However, the FDA, recognizing that Amarin’s purpose . . . would be to promote an unapproved use of Vascepa, has threatened to bring misbranding charges against Amarin (and, presumably, its employees) if it does so.

119 F. Supp.3d at 198.  The initial, limited, FDA approval for Vascepa – that also made off-label use possible − occurred in 2012.  Id. at 209.

Fast forward ten years.  As Hikma discussed, “[i]n 2019, . . . the FDA approved Vascepa for a second, much more common use.”  146 S. Ct. at 1398.  The use approved in 2019 was the same use that was off-label in 2015 and was the subject of Amarin’s win over the FDA.  The more limited Vascepa use originally approved in 2012 was the same one allowed by the “skinny label” for the generic competitor in Hikma, since Amarin’s original patent for that use − but not for the more lucrative use ultimately approved in 2019 – had expired.  Id. (“Hikma [the generic defendant] now sought approval of a skinny label that included only the [more limited use that was] no longer protected by [the relevant] patent”).

Thus, the same off-label use issue existed between the parties in Hikma that had been litigated between the FDA and Amarin in 2015 – only the interested parties were different.  The FDA had been defanged and took no action against any off-label generic promotion of the same, broader use.  Instead, Amarin, the branded manufacturer, sued the generic (Hikma) on a patent-based theory that paralleled the FDA’s threatened enforcement action from 2015:

Soon after [the generic defendant] began marketing its generic drug, Amarin filed suit . . ., alleging that [defendant] had actively induced others to infringe Amarin’s patent for the [more lucrative] method of use.  Amarin alleged that the totality of [defendant’s] statements across several documents encouraged infringing uses.

Id.  Since, as Buckman has taught us, private parties cannot enforce the FDCA, the patent claim in Hikma was phrased differently – as “induced infringement” – but functionally it involves “encouragement” via speech, which is closely parallel to the FDA’s concept of “off-label promotion.”  Indeed, given the “skinny label,” the use that the generic defendant allegedly sought to induce was necessarily also off-label, since the omission of “the carved-out use” is what made the generic defendant’s label “skinny” in the first place.  Id. at 1401.

Which leads us to what the Supreme Court found lacking about the induced infringement that was pleaded in Himka.  It is not enough under Rules 8 and 12 simply to “allege a plausible chain of events through which statements made by [the defendant] could lead a healthcare provider to prescribe or dispense [defendant’s] drug” for an off-label/off-patent use.  146 S. Ct. at 1400 (quotation marks omitted).  Instead:

  • A defendant must take “affirmative steps to encourage infringement.”  Id. at 1401.
  • Statements that “comply[] with the law or with standard industry practice” are insufficient to create inducement liability.  “[A]dherence to the law and industry standards” are not “building blocks for illegal conduct.”  Id.
  • Plaintiffs “may not rely on mere omissions, inactions, or nonfeasance” to allege active inducement.”  Id. at 1402 (citation and quotation marks omitted).
  • “[W]e look for affirmative statements or actions . . . to avoid trenching on regular commerce based on such a contingent chain of events.  Otherwise, ordinary merchants could become liable for any misuse of their goods and services [by their customers], no matter how attenuated their relationship with the wrongdoer.”  Id.
  • “[V]ague statements combined with speculation about how medical providers may act in response to those statements” “come[] up short” as pleadings.  Id. (citation and quotation marks omitted).
  • Since the relevant statute “requires active not passive, inducement . . ., the question is not merely whether the statements could be plausibly understood to induce infringement, but whether they plausibly constitute affirmative steps to bring about the desired result of infringement.”  Id. (citation and quotation marks omitted).
  • Statements such as “a warning and a disclaimer” cannot be “active inducement of infringement” because they “are implausibly roundabout ways to induce medical providers to infringe” by engaging in off-label use.  Id.

The FDA’s intended use regulations, 21 C.F.R. §§201.128 (drugs), 801.4 (medical devices), as amended in 2021 (see our post here) contain similar language.  They rely on “objective” intent as “shown by labeling claims, advertising matter, or oral or written statements.”  Id.  Specifically, “intent” cannot exist “based solely on [a regulated entity’s] knowledge that such drug [or device] was being prescribed or used by health care providers for such use.”  Id.  Thus, we think that the pleading requirements for induced infringement” through encouragement of off-label use that the Court imposed in Hikma should be equally applicable to allegations that off-label speech affects a product’s “intended use” under these regulations.  It’s the same speech, subject to an equivalent affirmative intent legal element, concerning identical conduct – alleged encouragement of physician off-label use.

In addition, we think that the requirement of “active” inducement enforced in Hikma means that the latest ridiculously pro-plaintiff law review article that we’ve read, D. Simon, “Off-Label Inducement,” 111 Iowa L. Rev. 1181 (2026), is dead on arrival.  The entire premise of that article is application of “intellectual property” inducement concepts to tort law in order to create “a new theory of liability” − off-label inducement − that would hold a manufacturer liable if its speech “induces a provider to negligently prescribe, administer, or use its drug or device off-label.”  Id. (at abstract).  The article would allow liability on “evidence of a general awareness of a role in an improper activity.”  Id. at 1196.  Its “negligence” standard would not require “that the manufacturer actually knew that the promoted use was malpractice” – only that it was “foreseeable . . . regardless of the manufacturer’s intent.”  Id. at 1198.  Specifically relying on cases (including the decision reversed in Hikma), the article proposes:

[P]romotional activities can be a legal cause of the underlying tort, even if the promotion is not explicit about what it wants the infringer to do. . . .  [W]hat is problematic is the underlying behavior the speech encourages, rather than the speech itself[ such as] truthful commercial speech [that] accurately described the generic as “therapeutically equivalent to the brand product.”  But . . . in so doing, it implied that physicians should prescribe it for all uses, including the patented ones.  Even though it was truthful, the advertising could be prohibited because it encouraged tortious behavior.

Id. at 1208-09 (footnotes omitted).  But that is exactly what Hikma held was insufficient – right down to “therapeutically equivalent” claim.  See Hikma, 146 S. Ct. at 1401 (“it is normal industry practice to truthfully describe a generic drug as ‘equivalent’ to the brand-name comparator.”) (citation omitted).

Initially, we thought the “Off-Label Inducement” article was so far off the wall we weren’t going to bother with it – until Hikma obliterated the article’s core proposition less than three months after the article was published.  That’s a mercifully quick interment of a bizarre and unprecedented theory of liability.

*          *          *          *

However, there is a second, and broader way that we think Hikma is important to our sandbox.  It’s a Supreme Court application of TwIqbal’s “well-established federal pleading standard” specifically in the pharmaceutical context.  146 S. Ct. at 1399.  

[TwIqbal’s] plausibility standard asks for more than a sheer possibility that a defendant has acted unlawfully.  If the complaint pleads facts that are merely consistent with a defendant’s liability, it stops short of the line between possibility and plausibility of entitlement to relief.  Instead, to nudge a claim across the line from conceivable to plausible, a plaintiff must plead facts that, if true, allow the court to draw the reasonable inference that the defendant is liable for the misconduct alleged, and to rule out obvious alternative explanations for the defendant’s conduct.

This case requires us to apply these familiar pleading standards to the third element of an induced-infringement claim: that the inducer took active steps to encourage direct infringement.

Id. (numerous TwIqbal citations and accompanying quotation marks omitted).  So, maybe “TwIqbal” should become “Twiqbalma.”

Nah.

But this standard does apply to all pleadings.  Hikma should mean, for example, that for any liability theory premised on “affirmative, as opposed to passive, steps,” Rules 8 and 12 cannot be satisfied by allegations of “mere omissions, inactions, or nonfeasance.”  146 S. Ct. 1400, 1402.  Hikma should apply to the pleading of any claim (such as providing information or aiding and abetting) that seeks to impose liability on a defendant for conduct that purportedly encourages others to engage in supposedly tortious conduct.  For one thing, the pleading standards listed above should apply to motions to dismiss allegations involving sales representatives, which are a common preemption dodge in prescription medical product liability litigation.

Thus, for all these reasons, we think that Hikma should have significant impact on litigation not involving patents or intellectual property – and its toughened pleading standards are particularly applicable to prescription medical product liability litigation.

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If you are a regular blog reader, you may have seen some of our prior posts about the new Product Liability Directive adopted by the European Union and going into force this December.  

Two weeks ago, we had the pleasure of Co-Chairing the inaugural forum on Life Sciences Product Liability Europe in Brussels, and it was everything you want in a conference:  informative, interesting, great presentations, great informal interactions.  We left having been better for attending and with more ideas to think about—and advise clients about.

The European Union Product Liability Directive: A Quick Backgrounder

The formal name of what we call the “EU PLD” is Directive (EU) 2024/2853 of the European Parliament and of the Council of 23 October 2024 on liability for defective products and repealing Council Directive 85/374/EEC (Nov. 18, 2024).  Here is a high level overview:

  • The 27 EU member countries must transpose (adopt) the EU PLD into their national law by December 9, 2026 and it will apply to any “products” sold or put into service in the EU as of December 10, 2026.
  • “Products” means tangible goods plus commercial software, AI, electricity, raw materials, digital manufacturing files, and digital services that a product needs to function.
  • The EU PLD is designed to ensure there always is an EU-based defendant (“economic operator”) to sue.  If not the manufacturer, the importer, an authorized representative, or a fulfillment service provider.  Even distributors and some online platforms can get tagged if they don’t identify an upstream economic operator.  Substantial modifiers of a product also may be liable.
  • A product is defective when it doesn’t provide “the safety that a person is entitled to expect” or that is required by some other regulation or law.
  • A product is defective if there was an “obvious malfunction” in ordinary or foreseeable use.
  • Defects also include post-sale problematic software updates and failures to patch cybersecurity vulnerabilities.
  • Causation is presumed when defect is established and the damage is “of a kind typically consistent with the defect in question”.
  • Both defect and/or causation must be presumed where the claimant faces excessive difficulties—in particular due to technical or scientific complexity (as with AI and pharmaceutical “black boxes”)—in proving the elements of defect and/or causation, and those elements are “likely”.  (What is likely?)  
  • Damages caps are gone, and medically recognized psychological harm is recoverable.  Data loss and corruption are now compensable damages.
  • New disclosure obligations: Even if a given EU country never previously provided for discovery, the EU PLD will now require defendants to disclose documents and information. Supposedly the disclosure will just be what is “necessary and appropriate”.  
  • In addition, the defendant can be ordered to produce documents and information in a manner reasonably understandable to the claimant.  (What does that mean?  Unclear.).  
  • Also, a presumption of defect arises if a defendant fails to disclose evidence it was obliged to.
  • Longer limitations period (3 years) and statute of repose/long-stop period for latent injuries (25 years).
  • Works alongside the newer EU collective-redress/representative-action mechanism.

Take-Aways From The Inaugural Life Sciences Product Liability Europe Conference

One of the presenters we looked most forward to hearing from was Katrin Saaremӓel of the European Commission, who is working on implementation of the EU PLD and provides support to the EU countries working on transposing the Directive into national law.  

During her presentation, Ms. Saaremӓel indicated that the European Commission’s intent in proposing the new EU PLD was four-fold:

  1. To adapt to the digital age.

The EU PLD wound up written as it is in part because of how it was developed—initially in conjunction with a potential AI Directive.  Eventually the AI Directive project was dropped and software and AI concerns worked their way into the EU PLD.  As a result, the EU PLD is intended to impose liability after products are placed on the market if there are problems with software updates or upgrades, or if there is some failure to address cybersecurity risks.

  • To adapt to the circular economy.

To the extent products are increasingly going to be reused and recycled, the drafters concluded that those who make substantial modifications should be liable for introducing new defects.

  • To adapt to global value chains and “level the playing field” between EU and non-EU manufacturers.

The European Commission wanted to make sure that if they were increasing liability, that it would not only apply to EU manufacturers.  Many of the provisions were incorporated to make sure there always will be someone in the chain of distribution in the EU who could be tagged for litigation.

  • To make it easier for injured people to prove liability and get full compensation.

It was interesting to hear that an expressly-stated goal of the new EU PLD is to “make it easier for injured people to prove liability and get full compensation”.  There are so many assumptions and policy judgments embedded in that statement.  

But this goal, of increasing product liability and verdicts, is directly reflected in the EU PLD:  The new disclosure obligations, all the presumptions of defect and/or causation, the extension of the long-stop period for latent injuries to 25 years, and the removal of financial ceilings.   

The European Commission plans programs to train judges in the courts of the EU nations, and to prepare materials to be distributed about the EU PLD.  Query what the emphasis of that training will be and whether it will address the issues we have and the EU business community may well have as well.

The European Commission also intends a campaign to raise the general public’s awareness of the PLD, including creating a website about the European Commission with a FAQ page.

One key revelation:  The European Commission has set up an email box for comments on the EU PLD.  It was mentioned for the purpose of collecting information about Member States’ efforts to transpose the EU PLD into national law (and whether there were any errors made in the transposition process).  But this email address is apparently operational, so we suggest considering submission of other comments and questions also.  The address:

GROW-EU-PRODUCT-LIABILITY@ec.europa.eu

EU Product Liability Opinions

Ms. Saaremӓel noted that one hurdle the European Commission had in studying the prior EU PLD was that until now, product liability opinions from throughout the EU are hard to find.  What opinions are available apparently reside with Professor Duncan Fairgrieve (a keynote speaker at the conference) who has collected about 650 cases from 1985 to present into a database.

The new EU PLD seeks to make all EU product liability opinions more readily available going forward.  Each EU member nation will be required to publish any final appellate its own opinions touching on the EU PLD. From there, the European Commission will collect those into an easily accessible and publicly available database.

Having those decisions more readily available should be helpful for defense lawyers looking to help propagating good rulings across the EU.  But it just as easily could help spread the bad ones, so there is work to do.

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If preemption were an independent basis for federal subject matter jurisdiction, almost all of our drug, device, and vaccine product liability litigation would be in federal court.  We’ve long been resigned that preemption is a defense, not grounds for jurisdiction.   E.g., Merrell Dow Pharmaceuticals, Inc. v. Thompson, 478 U.S. 804, 811 (1986).  A recent decision, United States v. California, ___ F. Supp.3d ___, 2026 WL 784514 (C.D. Cal. March 18, 2026), confirmed that distinction in a rather unusual manner.  It’s worth paying attention to.  If the result in US v. CA had been different, it could have been a very big deal.

In US v. CA the United States, that is to say the current federal regime, was the plaintiff.  It sued the state of California, that is to say a current state regime, over state legislation “prohibit[ing] the sale of eggs from hens confined under certain ‘cruel’ conditions.”  Id. at *1.  The constitutionality of this type of statute was recently affirmed by the United States Supreme Court in National Pork Producers Council v. Ross, 598 U.S. 356, 376 (2023), holding that the “dormant commerce clause” doesn’t “question . . . the ability of a State to project its power extraterritorially” so long as they don’t discriminate.

So, the federal government took another approach in US v. CA.  The feds claimed that the state egg statute was preempted by a federal statute, the Egg Products Inspection Act.  This preemption claim, the government argued, created a basis for it to sue California – even though the government itself was not damaged in the slightest by the California law.  That would have  been a big change.  Imagine our clients being able to bring a federal claim – or a counterclaim (in a public nuisance suit) – based solely on federal preemption.

However, the lack of any particularized injury caused dismissal of US v. CA for lack of standing.  “Under Article III of the Constitution, a plaintiff needs a ‘personal stake’ in the case.”  2026 WL 784514, at *2 (citation and quotation marks omitted).  That includes the federal government as a plaintiff.

This principle extends to the federal government at large, which similarly must establish its standing to bring a civil suit in federal court.  Because the United States is not the target of the challenged government action, as it does not allege it is a participant in the . . . marketplace to which the subject [state] laws and regulations apply, the federal government’s ability to bring suit is substantially more difficult to establish.

Id.  There is no such thing as governmental standing by reason of “injury to its sovereignty.”  Id. at *3.  “[T]he mere existence of a preempted state law” has never “create[d] a sovereign injury to the federal government.”  Id. (footnote omitted) (emphasis original).  The government did not argue that “enforcement” of the state statute actually “impeded” its “operations or functions” – only that the statute was preempted.  Id.

Instead, preemption can be pursued as a defense to enforcement by persons harmed by the statute in question.

[P]reemption provisions . . . should be read to confer on private entities a federal right to engage in certain conduct subject only to certain (federal) constraints.  This is because preemption principles derived from the Supremacy Clause provide a rule of decision, not an independent grant of legislative power to Congress.

Id. at *4 (citations and quotation marks omitted).  A preemption clause “is neither directed to nor violable by any State, and the Supremacy Clause does not itself conjure a substantive right that Congress or the United States may vindicate through suit.”  Id. (citation omitted).

Moreover, the jurisprudential ramifications of converting preemption into an affirmative cause of action were significant.  The government could involve itself as a party in any private litigation (such as prescription medical product liability litigation) where preemption is at issue.  Id.  Worse – and probably the actual motivation of this particular suit – “[t]he potential for abuse of the federal courts for political purposes is manifest.”  Id.

[S]uppose the executive or the decisionmakers at the Department of Justice simply do not like a state law because it is in tension with their policies.  Without requiring the United States to show some redressable injury, the federal government might initiate a campaign of preemption suits under the aegis of its sovereignty to bring state laws in line with its own political agenda.

Id.

We don’t know whether there are other similar federal attempts out there seeking to convert preemption into an affirmative basis for jurisdiction.  If we find any, we’ll of course let our readers know.  Because anything that the federal government may succeed in asserting regarding preemption certainly bears analysis to see if our clients could make the same, or analogous arguments.

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June 25, 2026 was a very good day for preemption. While one hand of the judiciary was busy with the Supreme Court handing down its 7-2 ruling in Monsanto Co. v. Durnell — establishing that FIFRA expressly preempts Roundup state-law failure-to-warn claims, the other hand was quietly doing the same thing with toothpaste. Specifically, the Southern District of New York issued Brower v. Colgate-Palmolive Co., 2026 WL 1831253 (S.D.N.Y. June 25, 2026), a partial dismissal of an OTC economic loss class action that drew a clean line between preempted omission claims and surviving affirmative misrepresentation claims under the FDCA.

Plaintiffs — a geographically scattered group of consumers from New York, Minnesota, Illinois, New Jersey, Arizona, and California — sued Colgate-Palmolive on behalf of a putative nationwide class, alleging that Colgate’s toothpastes contained heavy metals, specifically lead and mercury, that Colgate knew about but chose not to disclose to consumers. Id. at *1. The complaint ran to thirteen claims: eleven state consumer protection counts, a common law fraud by omission claim, and unjust enrichment. Defendant moved to dismiss on four grounds: (1) express preemption under the FDCA; (2) lack of standing; (3) failure to state a claim; and (4) statute of limitations. The court granted the motion in part, and the preemption analysis is where the real action is.

Before diving in, we have to acknowledge the timing — and its significance. As we discussed in our post on Durnell, the Supreme Court’s ruling established that FIFRA’s express preemption clause — which the Court described as “materially identical” to the FDCA’s device preemption provision at 21 U.S.C. § 360k(a) — bars state-law claims that would impose requirements “in addition to or different from” what federal law demands. The Brower court wasted no time citing Durnell in its preemption analysis of the FDCA’s OTC drug preemption clause, 21 U.S.C. § 379r(a). That is no coincidence. As we noted in our Durnell post, § 379r(a), appears on the Supreme Court’s own list of FDCA provisions with preemption language “similar or identical” to FIFRA’s. See Durnell, 2026 WL 1825691, at *8.

The upshot: the Supreme Court’s interpretation of what “in addition to or different from” means in the FIFRA context — that it means exactly what it says — applies with equal force to the FDCA’s express preemption clauses. Brower v. Colgate is, in part, a same-day proof of concept.

Plaintiffs alleged that defendant’s voluntary safety-related statements — including that its products promote “Whole Mouth Health,” “Protect teeth, tongue, cheeks [and] gums,” and are “Responsibly Made” — were false and misleading because the products actually contained lead and other heavy metals. Id. at *3. The court held these claims were not preempted. The FDCA itself prohibits false or misleading labeling under 21 U.S.C. § 352(a)(1), and plaintiffs’ state-law claims ran parallel to that federal prohibition rather than imposing requirements different from or in addition to it. Because the challenged statements were voluntary marketing claims not addressed by the FDA’s monograph, they were fair game for challenge under state consumer protection law. Id. at *4.

The key piece of the court’s analysis is that the existence of the monograph does not give manufacturers blanket immunity over every statement that appears on their label. Here, the monograph authorizes specific decay-prevention claims and prescribes labeling requirements for the anti-cavity drug component. It does not, as the court put it, “broadly immunize all advertising or labeling statements made by manufacturers.” Id.

The story is different for omission claims. Plaintiffs also argued that defendants should have disclosed the presence of heavy metals on its labeling. The court held those claims expressly preempted under § 379r(a). Id. at *5. The reasoning is straightforward. Because the FDCA imposes no obligation to disclose the presence of heavy metal contaminants anywhere on a toothpaste label, any state-law claim premised on that omission creates requirements “in addition to” what federal law demands. And that is precisely what § 379r(a) forbids.

Central to this conclusion was the court’s characterization of the FDA monograph as “comprehensive and granular.” The monograph prescribes, with considerable specificity, the required active ingredient disclosures, warning language, directions for use, indications, and format requirements for anti-cavity drug products. This level of regulatory detail, the court found, reflects a considered exercise of the FDA’s comprehensive authority over OTC drug labeling. When the FDA has constructed an elaborate labeling framework and heavy metal disclosures appear nowhere in that framework, the inference that the agency made a deliberate judgment about label content is “substantially stronger” than in cases where the regulatory scheme only lightly touches the relevant product category. Id. As the court memorably put it:

To allow state omission claims to supplement this comprehensive scheme would be to substitute judicial judgment for agency judgment in precisely the domain Congress assigned to the FDA.

Id. In other words, when the FDA has spoken comprehensively about what belongs on a label, a state court cannot supplement that judgment by compelling additional disclosures the agency never required.

The court also took care to distinguish (and politely part ways with) the District of Connecticut’s analysis in Clinger v. Edgewell Personal Care Brands, 2023 WL 2477499 (D. Conn. Mar. 13, 2023), which had addressed omission claims in a similar OTC drug context. The Clinger court acknowledged the full text of § 379r(a) — with its “different from” and “in addition to” prongs — but then analyzed only the former in applying the standard. By asking only whether federal law prohibited the omitted disclosure (rather than whether it required it), Clinger effectively collapsed the two prongs into one, treating the absence of a federal prohibition as sufficient to defeat express preemption. Brower, 2026 WL 1831253, at *5. That, the court explained, drains the “in addition to” language of its independent force. The two prongs are distinct, and the Brower court rightly gave both their due.

This is good ammunition for future preemption arguments. The “in addition to” prong — which asks whether a state requirement exceeds the federal floor rather than whether it conflicts with federal law — is an independent basis for preemption that plaintiffs’ counsel has too often been allowed to paper over.

Having preempted the omission claims, the court turned to standing and trimmed the plaintiff roster further. The problems were predictable, but instructive for those fighting contamination class actions. Several plaintiffs were dismissed for failure to meaningfully link their testing allegations to the products they personally purchased. Plaintiffs relied on two sources of testing data. Both were found wanting for deficiencies like failing to state the number of samples tested, the geographic proximity of testing to plaintiffs’ purchases, the date of testing, or who performed it. Id. Without those details, the court could not infer that heavy metals were systematically present in the products each plaintiff actually bought. “Some study found lead in something” does not establish that your tube of toothpaste had lead in it.

One additional standing point that deserves emphasis: the court rejected plaintiffs’ argument that one named plaintiff’s standing confers standing on other named plaintiffs. Id. Each plaintiff in a class action must establish their own Article III standing. That principle is sometimes honored more in the breach, and it was good to see it applied here with rigor.

So as to provide a complete picture of the decision, here are also the key points on the other issues addressed by the court:

  • Failure to state a claim. On the surviving affirmative misrepresentation claims, plaintiffs sufficiently alleged that the challenged statements were false or misleading and that there was a material safety risk from the trace amounts of heavy metals at issue. Whether statements like “Whole Mouth Health” and “Responsibly Made” are misleading to a reasonable consumer is a question of fact for the jury, and the court declined to resolve it on a 12(b)(6) motion. Id. at *9. The court similarly refused to look behind plaintiffs’ “any exposure to heavy metals is harmful” theory of injury; whether those trace amounts actually pose a health risk is reserved for summary judgment.
  • Consumer fraud elements by state. The New York GBL §§ 349 and 350 claims survived, as did the California CLRA and UCL claims, for the same reasons. Id. at *9-10. On the Minnesota claims: the MFSAA and MCFA survived (the public benefit requirement was satisfied given the breadth of the alleged marketplace deception), but the MDTPA claim was dismissed because plaintiff Brower — the only Minnesota named plaintiff — failed to adequately allege irreparable injury or a genuine threat of future harm necessary for injunctive relief under that statute. Id. at *11.
  • Unjust enrichment. Dismissed as duplicative. The unjust enrichment claim rested on the exact same facts and sought the exact same relief as the remaining statutory claims, without identifying any independent quasi-contractual basis for recovery. Id. at *12.
  • Statute of limitations. Defendant argued that New York’s three-year statute of limitations for consumer protection claims bars any recovery for purchases predating 2022. The court declined to dismiss on that basis because the complaint did not plead facts sufficient to determine when particular purchases were made. The issue is preserved, so it’s a fight for another day. Id. at *13.

Two decisions on the same day (one by the Supreme Court) reinforcing the same concept: “in addition to” and “different from” mean exactly what they say, and courts should not let plaintiffs collapse those two prongs into one. And, while this is not a complete preemption win, for defendants it ultimately leaves a manageable battlefield — the surviving affirmative misrepresentation claims are limited to specific voluntary marketing puffery, not the full universe of possible labeling challenges. A good day indeed.

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New Jersey law requires that trial courts conduct a “rigorous gatekeeping” analysis when assessing the admissibility of expert opinions.  That’s the Accutane standard, named for the New Jersey Supreme Court’s opinion in In re Accutane, 234 N.J. 340 (2018).  To the extent there was any ambiguity on whether Accutane applies to all civil cases, the New Jersey Supreme Court has now revolved it  Accutane applies in every civil case.  Moreover, the “rigorous analysis” requirement applies to all purported methodologies, including differential diagnoses.

The case is Beavan v. Allergan U.S.A., Inc., 355 A.3d 1201 (N.J. 2026), which involved an FDA-approved steroid pellet used to treat certain eye conditions. In 2018, the manufacturer advised the FDA that during assembly a tiny silicone particulate could detach from the needle’s sleeve and be ejected with the pellet.  This issue ultimately led to a recall covering twenty-two lots in which sample testing showed that two of ninety units—2.2 percent—contained a silicone particulate.

The plaintiff was treated with an injection from a recalled lot and alleged that she lost vision in one eye as a result.  To prove this, she relied on two experts, whose opinions were based on . . . well, not much.  Both reasoned that because the plaintiff had received prior injections without complications, the recalled unit must have been defective and most likely caused the injury.  But notably, neither could cite evidence that a silicone particulate was actually generated or injected during the plaintiff’s procedure.  As one expert (the treating physician) acknowledged, “the only thing we were going by” was that “it was a recalled lot.”  Beavan, 355 A.3d at 1210. 

The trial court found these opinions sufficiently reliable to raise triable issues of fact, but did so without conducting the Accutane gatekeeping inquiry.  The Appellate Division reversed and ordered entry of summary judgment for the defendant, in an opinion that we reported on here. 

The New Jersey Supreme Court took a different tack and remanded for the trial court to conduct the proper “rigorous gatekeeping” under Accutane.  According to the Supreme Court any dispute about the reliability of expert testimony in a civil case must be resolved by the trial court acting as gatekeeper, applying the Accutane framework.  Here is the quote you will want to use:

Our view of proper gatekeeping in a methodology-based approach to reliability for expert scientific testimony requires the proponent to demonstrate that the expert applies . . . scientifically recognized methodology in the way that others in the field practice the methodology. When a proponent does not demonstrate the soundness of a methodology, both in terms of its approach to reasoning and to its use of data, from the perspective of others within the relevant scientific community, the gatekeeper should exclude the proposed expert testimony on the basis that it is unreliable.

Beavan, 355 A.3d at 1216 (quoting Accutane).  There are no exceptions.  Nor is Accutane’s mandate confined to the mass tort context, which the Supreme Court made clear:

The procedural framework adopted in Accutane is not limited to the specific setting in which that case arose; it applies to all civil cases in which the parties dispute the reliability of expert testimony under N.J.R.E. 702 and 703.

Id. (emphasis added). 

Accutane likewise carved out no exception for differential diagnosis. To the contrary, when an expert uses a differential diagnosis to opine on the cause of an injury, the gatekeeping inquiry must be applied to both steps of the analysis: the “rule in” step, in which the expert compiles plausible causes, and the “rule out” step, where the expert eliminates factors to reach a conclusion as the most likely cause. The trial court must scrutinize each component of the opinion to confirm it rests on a methodology satisfying Accutane.

Applying these principles, the Supreme Court held that the trial court erred by admitting the testimony without “rigorous gatekeeping,” and the Appellate Division got it wrong too by directing entry of summary judgment.  The proper outcome, in the Supreme Court’s view, was to remand for the trial court to properly assess the admissibility of plaintiffs’ experts.

So the plaintiff gets a do over.  The Supreme Court encouraged the trial court to hold an evidentiary hearing, and it also held that the plaintiff’s retained expert’s opinion was not a “net opinion,” which is a New Jersey thing.  A “net opinion” is one that is unsupported by facts or data, but the retained expert here adequately explained the “why and wherefore” of his opinions in his report.  That does not, however, mean that the retained expert’s opinions will be admissible after scrutiny under Accutane, which is a separate inquiry. 

Finally, the Court also flagged that a treating physician designated to offer expert causation testimony must, like a retained expert, serve a written report when an adversary requests one through interrogatories. The treating physician here did not prepare a report.  On remand, the trial court will determine whether the plaintiff will be allowed to serve one. 

The New Jersey Supreme Court vacated a good outcome for the defendant in the Appellate Division, but the good news is that it solidified the trial court’s gatekeeping role and closed off any uncertainty on whether and how broadly Accutane applies.  Rigorous gatekeeping is required, in all civil cases. 

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Ever since we reviewed the Environmental Protection Administration’s (“EPA”) 2019 decision reaffirming its prior conclusion that glyphosate does not cause cancer and, therefore, the “Roundup” herbicide did not warrant any cancer warnings, we have been convinced that state-law claims demanding such warnings were (or should be) preempted – regardless of how pro-plaintiff decisions might seek to muddy the waters.

It took a while, but yesterday the United States Supreme Court, in a strong 7-2 decision held precisely that:

[Plaintiff’s] state tort claim would require [defendant] to add a cancer warning to Roundup’s label even though federal law requires [defendant] to use the EPA-approved label without a cancer warning.  Because [plaintiff]’s state tort claim would impose a pesticide labeling requirement “in addition to or different from” the label required by EPA, FIFRA expressly preempts [plaintiff]’s claim.

Monsanto Co. v. Durnell, 609 U.S. ___, 2026 WL 1825691, at *3 (slip op.) (U.S. June 25, 2026) (emphasis added) (hereafter “Durnell”).

We add “emphasis” to the statutory language because, as the Supreme Court observed, the express preemption clause that Congress enacted in FIFRA, 7 U. S. C. §136v(b), is “materially identical” to the FDCA’s preemption clause for medical devices, 21 U.S.C. §360k(a).  Durnell, 2026 WL 1825691, at *10.  See Id. at *8 (“nearly identical”); cf. id. at *8 (listing 21 U. S. C. §§678 (meat); 1052(b) (eggs); 467e (poultry); 379s(a) (cosmetics), 379r(a)(2) (OTC drugs); and 343-1(a)(2)-(4) (food)) as having “similar or identical labeling preemption provisions”).  The only difference from §360k(a) is inversion of the order of the phrases “different from” and “in addition to.”  The ordering of this identical language meant nothing in Durnell.  Thus, the numerous pro-preemption holdings in Durnell should apply with equal force to medical devices and other federally regulated consumables.  It becomes our job as defense counsel to ensure that this happens.

Turning to those pro-preemption holdings, we first address something that’s not found in the majority opinion at all – that is any reference to a “presumption,” or even an “assumption” against preemption.  That’s important because a 20+-year-old FIFRA opinion, Bates v. Dow Agrosciences LLC, 544 U. S. 431 (2005), had relied on such a presumption, despite the statute’s express preemption clause.  Id. at 449-50.  In the interim (as the Blog has repeatedly discussed), the Court abolished any such presumption in express preemption cases.  Puerto Rico v. Franklin-California Tax-Free Trust, 579 U.S. 115, 125 (2016).  But in Durnell, despite what Bates had held about preemption presumptions, the majority opinion said not a word about it, even while discussing Bates itself.  Instead, the “textual conclusion” in Durnell gave force to the literal meaning of §136v(b)’s language:

In sum, federal law requires [defendant] to sell Roundup with the label that EPA approved at the initial registration and that EPA has subsequently re-approved on multiple occasions − that is, the label without a cancer warning.  [Plaintiff]’s state tort claim, by contrast, would require [defendant] to add a cancer warning to its labels.  That [state]-law requirement is “in addition to” and “different from” [defendant]’s federal-law labeling obligations.

2026 WL 1825691, at *8.  Hence the title of this post, that “‘different from’ and ’ in addition to’ mean what they say.”  Particularly in the recalcitrant Third Circuit, Durnell is further proof that, yes, the Supreme Court’s abolition of any presumption against express preemption applies to product liability litigation.

As for Bates, Durnell distinguished its adverse aspects as involving a claim rarely seen in product liability – challenging the product’s “efficacy” rather than its safety.  Id.  Far more pertinent, the Court held, was its later preemption decision in Riegel v. Medtronic, Inc., 552 U. S. 312 (2008) (see, e.g., our discussions of Riegel here, here, and here).  Riegel, as all regular Blog readers well know, is the basis for broad preemption of tort claims against FDA pre-market approved (“PMA”) medical devices.  Seven justices in Durnell held that “Riegel further confirms that [plaintiff]’s failure-to-warn claim is expressly preempted,” 2026 WL 1825691, at *8, because §360k(a)’s nearly identical language likewise preempted claims challenging the FDA’s “review [of] the device’s label and [its] determin[ation] that the label is neither false nor misleading.”  Id.  The Durnell court viewed an FDA medical device PMA as equivalent (“just as”) to the EPA’s approval (called “registration”) of regulated chemicals.  Id.  Thus,

Riegel is dispositive here.  If FDA’s premarket approval of medical devices preempted additional state-law requirements, so too must EPA’s registration of pesticides and approval of pesticide labels.

Id. at *9.  Both statutes “reflect Congress’s judgment that the ability to sell a product throughout the country with a single label can be important to maintaining an efficient nationwide market.”  Id.  That’s an important concept for us to remember – uniformity in labeling is an economic virtue that Congress has chosen to protect through preemption.

The Court’s view of Riegel as “dispositive” also has implications for non-warning claims in Roundup litigation.  We expect the other side to disagree, but they are whistling past the preemption graveyard.  Why?  Riegel.  Based on the same “different from”/”in addition to” preemption language, Riegel held that numerous non-warning claims were also preempted by the FDA’s device approval.  552 U.S. at 320-21 (preemption extends to “strict liability; breach of implied warranty; . . . negligence in the design, testing, inspection, distribution, labeling, marketing, and sale of the [product; and] . . . negligent manufacturing”).  To the extent that Roundup plaintiffs try to fall back on non-warning-related claims, the “dispositive” Riegel decision should bar those claims as well.

As to Riegel, we also were also heartened by Durnell’s footnote 9, which reiterated something that the lower courts have been forgetting in medical device litigation – Riegel did not create an exception for so-called “parallel claims”:

Riegel did not consider state-law claims that were parallel to an applicable federal requirement, apart from the FDA’s premarket approval process. . . .  It is true that Riegel did not assess whether the state-law claims at issue were “different from, or in addition to” the relevant federal-law requirements.

Id. at *12 n.9 (emphasis added).  Too many courts seem to view Riegel as affirmatively authorizing “parallel” claims, when in fact the Court did no such thing, since it never considered that issue at all.  Durnell did, and the existence of purportedly “parallel” claims did not defeat preemption, because “EPA’s analogous registration and label approval determinations” were nevertheless “‘requirements’ under FIFRA.”  Id.  We should be reminding courts, first, that Riegel did not endorse the waived concept of parallel claims, and second, that such claims are still “requirements” that can be “additional to” governmentally imposed requirements.

The good news for defendants does not stop with the Court’s applying Riegel and finding preemption.  Durnell went on to demolish a number of anti-preemption arguments that plaintiffs in prescription medical product liability litigation have also frequently raised.

Number 1 – That tort law and FDA regulation are compatible because both promote safety.  Not good enough.  “[T]hat argument operates at far too high a level of generality and disregards the central and comprehensive role that [the agency] performs in making labeling determinations under [the statute’s] registration provisions.”  Durnell, 2026 WL 1825691, at *9.

Number 2 – Reliance on general “misbranding” or “adulteration” provisions to attack product-specific labeling.  The general does not control the specific.  “Reliance on [the statute’s] general standard for misbranding rather than the specific requirements imposed under federal law would nullify [the] preemption clause and the uniformity that Congress sought for safety warnings on [product] labels.”  Id.

[Plaintiff’s] failure-to-warn claim does not fault [defendant] for using a label different from the [agency]-approved labeling.  [Plaintiff] instead faults [defendant] for not using a label different from the [agency]-approved label.  But [the statutory] preemption clause expressly preempts any state tort claim that would require a [regulated] manufacturer to use a label “in addition to” or “different from” federal requirements imposed under [the statute], which, as explained above, include the [agency]-approved label.

Durnell, 2026 WL 1825691, at *10.  This holding in Durnell should be particularly useful in OTC drug litigation, where some courts have erroneously credited such arguments.

Number 3 – Product-specific requirements not having preemptive force.  That argument was worse than wrong; it was “implausible.”  Id.  “[B]y its text, [the statute] affords preemptive force to federal requirements imposed ‘under’ [it], not merely those imposed ‘by’ the actual statute.”  Id.  The same is true of §360k(a), thus this argument also “contravenes Riegel.”  Id. at *10.  The statute also authorizes the agency to “prescribe regulations” and “make registration and labeling decisions.”  Id. at *9.  “There is no good argument for treating FDA’s premarket approval as ‘requirements’ ‘under’ the Medical Device Amendments, but not treating EPA’s regulations and registration determinations as requirements under FIFRA’s materially identical preemption clause.”  Id. *10.

Number 4 – Loper Bright.  Given the statute’s express delegation of power to prescribe regulations and to “determine” labeling compliance, Loper Bright Enterprises v. Raimondo, 603 U. S. 369 (2024), is completely inapplicable to preemption.

[The statute] empowers [the agency] to “prescribe regulations. . . .”  And [it] expressly directs [the agency] to register [products] and determine that the [their] labeling complies with [the statute’s] many specific requirements.  During that extensive registration process, [the agency] critically evaluates the [product] label to ensure that the label contains all warnings necessary to protect human health.  After [the agency] makes a determination about the appropriate warnings for a [product’s] label, a manufacturer is legally required to use that label unless and until [the agency] subsequently approves or requires a new label.

Durnell, 2026 WL 1825691, at *10 (citations and quotation marks omitted).  Change “register” to “approve” and, again, you have the FDCA (for both drugs and devices).  As we’ve argued before, Loper Bright only applies to agency statutory interpretation (like that wrongly credited in Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996)), and not to delegated agency power to regulate particular products. The Supreme Court so held in Durnell.

Number 5 – Hindsight-based “unilateral” label change arguments.  That didn’t cut it either.  It doesn’t appear that the EPA has any equivalent to the FDA’s “changes being effected” regulations, so this aspect of Durnell does not map exactly to the FDCA.  But Durnell reiterated that federal law preempts any state-law demand for a label change when a manufacturer has no ability to change it unilaterally:

[I]f the manufacturer unilaterally changed the label, as [plaintiff] says [defendant] should have done, the manufacturer would be flouting [agency] regulations and exposing itself to potentially severe federal penalties.  So [plaintiff’s] argument also triggers potential retroactivity and estoppel questions.  The law is not ordinarily read to retroactively penalize persons for doing what the Government had required them to do.

Id. at *11 (citations omitted).  More broadly, Durnell rejected arguments that “would negate [the] express preemption clause, expose manufacturers to potentially massive tort liability for doing what [the agency] required them to do, and eviscerate the ‘uniformity of [agency] labeling determinations.”  Id. (citation omitted).

Number 6 – Failure to report new information.  That the government “was statutorily authorized to withdraw premarket approval for a medical device based on newly reported data or existing information” did not prevent preemption.  Id. at *12.  That power was solely vested in the government, not private plaintiffs.  That the government might determine that an “approved” label “had in essence become misbranded over time due to new evidence does not deprive [existing] registration decisions of their preemptive force.”  Id.  “[E]xtensive processes” for gathering and reporting of new risk information did not reduce the scope of preemption.

[Plaintiff’s] policy concern about regulatory lag is amply addressed by the extensive processes that [the statute and its] implementing regulations have established to respond to new or evolving safety information.  For example, manufacturers must apprise [the agency] of new information ‘regarding unreasonable adverse effects’ of their [products].  That obligation is backed by civil and criminal penalties.

Durnell, 2026 WL 1825691, at *12.  Conspicuously absent from the Court’s discussion of the “many ways of ensuring a [product’s] continued compliance” is any allowance of private litigation concerning purported failures to report.  Id.  Instead, “if third parties (like [plaintiff]) want to bring new information to [agency’s] attention or if they believe that [the agency] has failed to consider relevant information, those third parties are free to petition [the agency].”  Id. at *13.  The same is true of the FDA.  Thus:

[The agency] possesses a variety of tools to learn of and address new safety information.  And as a matter of law, state tort law may not impose labeling requirements “in addition to” or “different from” federal requirements imposed under [the statute].

Id.

That’s a lot of valuable new preemption ammunition that defendants in prescription medical product liability litigation can now rely upon.

Obviously, Durnell is a huge win for the defendants in the Roundup litigation.  But almost as obviously, it is also a big win for our medical device, OTC drug, and other clients who manufacture and market products that Congress intended to be regulated by the FDA, not by the states, and that are accordingly protected by the various preemption clauses in different parts of the FDCA.

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Like many, many people around the world, we have spent a good chunk of the last two weeks following the World Cup.  Not just the U.S. team or even the clips of first-time visitors to the U.S. reveling in its regional cuisine and cultural quirks.  We have found ourselves watching intently as teams from two countries about which we otherwise have no strong feelings clash.  Naturally, the disinterested viewer takes on at least a mild rooting interest for one of the teams, usually the underdog.  In part because the field has expanded to 48 teams/countries, there are some real underdogs in the field.  There also have been some very surprising results that might make you decide that you are going to support one of those underdog teams for the rest of its run in the tournament.  (We eschew the international soccer announcing/reporting convention that a team takes on a plural verb form.)  In other words, you might choose to hop on the bandwagon of, for example, tournament “debutantes” Cape Verde or Curacao.  These island nations each tied a soccer power from a nation with more than 90 times as large a population.  So, feel free to hop on one of these bandwagons without hurting yourself.  However, please do not try to convert your new interest into the implausible claim that you were “always a fan” of the soccer team of a country you may have had trouble finding on a map.  If you want to claim longstanding fandom or even a pre-tournament prediction for a longshot’s success, then you better bring receipts.

We offer this public service message in part because today’s decision from Leon v. Zydus Pharms. Inc., No. 22-cv-7636 (JGK), 2026 WL 1758825 (S.D.N.Y. June 17, 2026), concerns implausible product identification claims that ended a product liability suit after it lingered around much longer than it should have.  First, the facts without commentary.  The plaintiff took some version of the prescription antihypertensive carvedilol for his hypertension for roughly two years before he had a stroke.  He may or may not have skipped his once daily dose of the medication the morning of his stroke.  Id. at *1.  Around the same time, the defendant learned that one lot of its carvedilol tablets somehow had a small percentage of tablets of the antidepressant paroxetine, which it also manufactured, included in what was released for distribution, so it recalled that lot.  Id.  Plaintiff, or his lawyers, connected the stroke to the recalled lot and sued the manufacturer.  After almost four years, including fact and expert discovery, the defendant moved for and won summary judgment because plaintiff never had any evidence that he unwittingly took paroxetine because of the issues with the recalled lot.  Id. at *3.  To the contrary, defendant offered uncontradicted evidence that the recalled lot was not distributed to where plaintiff lived and there were 299 non-recalled lots distributed.  Id.  So, defendant won, as it should have.  We will get back to the Leon court’s analysis, but first some commentary on the facts, particularly facts that are missing from the decision and we assume were brought out over the course of a case that should not have survived motions to dismiss.  (We found this basic information in minutes, so it surely was part of the record.)

Carvedilol has been around for a long time, so there are branded and generic versions.  The defendant is one of ten companies with an approved ANDA to sell generic carvedilol tablets of different dosages; it got its ANDA approved in 2007.  Other companies had ANDAs for generic tablets that were discontinued.  There is also an extended release carvedilol capsule in branded and generic forms, but the defendant never got an ANDA to sell those.  All of these are prescription medications in the U.S., so the plaintiff should have been able to specify the pharmacy or pharmacies where he filled his prescriptions in the weeks leading up to his stroke.  He also had to have a doctor or other licensed healthcare provider with prescribing authority who wrote and refilled his prescriptions for carvedilol over the course of two years.  The record of these prescriptions and dispensations should have indicated 1) what dose and version of carvedilol plaintiff was prescribed, 2) what company made the tablets or capsules he was dispensed leading up to his stroke, and 3) the lot information for them.  None of this information was included in the Leon decision.  In regard to the statement that plaintiff was supposed to take the medication once per day, it should be noted that the tablets defendant made were indicated to be taken twice a day and only the extended release capsules that defendant did not make were indicated to be taken once a day.  Plaintiff did not save his pill bottle or, apparently, any other pertinent records.  If plaintiff had any proof that he was taking defendant’s carvedilol tablets at all, then he would have had records to indicate if his tablets were dispensed from the one of the 300 lots with a recall for the pill mix-up, even though it was not distributed to where he lived and presumably got his prescriptions filled.  (If his prescriptions were filled by mail, then there also would have been clear records on manufacturer, dosage, lot, etc., also.)  Thus, plaintiff had no product ID evidence to offer because he likely was not dispensed defendant’s carvedilol tablets near the time of his stroke at all, let alone from the single lot with a known issue.  So, unless plaintiff’s complaint offered false factual assertions supporting that he received tablets from defendant’s recalled lot, then this case should have been dismissed at the pleading stage, perhaps with the aid of a motion for more definite statement.

Part of this, of course, is that the defendant made generic carvedilol (and paroxetine), although the Leon decision did not say that.  Any design and warnings claims, however framed, are preempted.  The only potentially viable non-preempted claims would have been manufacturing defect and an affirmative misrepresentation to the plaintiff outside of product labeling.  To satisfy TwIqbal, however, each of these claims required support from detailed factual assertions that plaintiff probably could not have offered in good faith.  There was also the problem that plaintiff claimed he had a stroke because he accidentally took one or more doses of paroxetine instead of his prescribed carvedilol, setting aside that his medical records indicated he skipped his carvedilol on the day of his stroke.  Nobody claims a few tablets of paroxetine causes stroke; this is a drug that has been widely used for more than thirty years without a stroke risk even with chronic use.  Rather, it seems that plaintiff claimed that not having the antihypertensive effect of carvedilol for one or more days caused his stroke.  However, carvedilol is not indicated to prevent stroke and lack of efficacy claims cannot be a basis for recovery for an injury under a fact pattern like this.  Indeed, plaintiff did not even name any experts on medical causation when he had the chance.  Yet, this case lasted for almost four years before defendant won summary judgment.  Such a waste of judicial resources.

We suspect that this case was always just the sort of bad bandwagoning that needs to be checked early.  Plaintiff probably never had a prescription filled with defendant’s carvedilol.  Or whatever carvedilol he was supposed to be taking at the time of his stroke was not made by defendant, possibly because he had been switched to the once daily extended release version.  Assuming he had a current script and was not taking someone else’s medications (a bar to recovery under New York law), records existed that indicated that whatever carvedilol he received leading up to his stroke was not from the recalled lot.  Instead, he merely referenced an apparently completely coincidental recall and muddied the waters for as long as he could.  This also seems like an ideal case for limited early discovery on product ID.  Make plaintiff “show his receipts” before he wastes plenty of time and money with a frivolous case.

On the bright side, the Leon court did stand firm on plaintiff’s argument that defendant’s motion required it to disprove the possibility that plaintiff could have received a tablet of paroxetine mistakenly included in a carvedilol lot, such as from the recalled lot.  Id. at *3 n.2.  This is a fairly straightforward application of the old summary judgment trilogy from 1986.  Defendant’s evidence that the lot was not distributed to where plaintiff lived, which was presumably buttressed by evidence about the circumscribed scope of the issue identified in the recall, was enough to shift the burden to plaintiff.  Id. (citing Celotex and the 2010 advisory committee notes to Fed. R. Civ. P. 56).  Plaintiff had no evidence in the record to carry his burden that he was dispensed defendant’s paroxetine instead of defendant’s carvedilol as he claimed.  That is how Rule 56 is supposed to work.  Plaintiff also lost on lack of proof of causation and just about every other element of his causes of action.  Id. at *4-5.  Plaintiff was shut out, but it could have been even worse as the court did not even address what would have been a winning preemption argument.

While plaintiff did not bring the receipts to show product ID, defendant surely saved some receipts that it would need to seek costs as the prevailing party.  That would help some, but it would probably take fee shifting to deter the next potential plaintiff who considers bringing a suit without any semblance of proof of product ID.  This would be a good case for that too.

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Few issues are as currently controversial as gender affirming care. For some people, the incongruence between gender identity and sex assigned at birth can cause clinically significant distress, recognized as “gender dysphoria” by the American Psychological Association. Treatment can come in various forms, such as social transitioning or medical intervention, which might include chemical treatments or surgery.

There is no doubt where the Trump administration stands on the controversy. Eight days into his second term, the President issued an Executive Order (EO) that sought to end such medical treatment. The Department of Justice (DOJ) followed up with memoranda (DOJ Memos) that set forth how, with certain interpretations of existing law, including the Food, Drug, and Cosmetics Act (FDCA), the EO goal would be achieved. The EO and DOJ Memos refer to gender affirming care as “mutilation.”

In Massachusetts v. Trump, 2026 WL 1584837 (D. Mass. June 3, 2026), fifteen states, the Governor of Pennsylvania, and the District of Columbia sued the President, the then United States Attorney General (AG), and the DOJ challenging the EO and the DOJ Memos. Most of those states had enacted laws mandating insurance for gender affirming care and shielding patients and providers from criminal and civil liability for the provision of such care. The plaintiffs alleged that the EO and DOJ Memos were arbitrary and capricious under the Administrative Procedure Act (APA), and contrary to constitutional right, power, or privilege under the Tenth Amendment. The plaintiffs sought a declaratory judgment.

The defendants moved to dismiss the action, arguing that the plaintiffs lacked standing, that the Memos were not final agency actions, that those Memos announced policies committed to agency discretion by law, and that the claims failed under the Tenth Amendment. The court denied the government’s motion to dismiss. Thus, the federal government lost this initial skirmish involving the off-label use-related showdown over gender affirming care.

Standing

The standing issue arose in the context of the government’s motion under Rule 12(b)(1) challenging the court’s subject matter jurisdiction. Jurisdictional matters come first, so standing led off the festivities. The court held that the plaintiffs had standing to challenge, inter alia, the government’s novel interpretations of the FDCA. The government was not merely articulating enforcement policies, but announced a new interpretation of the FDCA. For example, the EO prioritized investigations and actions against “deception” of consumers about the “long-term side effects of chemical and surgical mutilation.” In one of the Memos, the AG directed investigations of any violations of the FDCA by “manufacturers and distributors engaged in misbranding by making false claims about the on- of off-label use of puberty blockers, sex hormones, or any other drug used to facilitate a child’s so-called ‘gender transition.’” We have discussed the government’s novel attack on off-label use here and here. Those earlier matters took place in the context of subpoenas, whereas this case is a direct challenge to the entire underlying policy.

The government’s EO and DOJ memoranda assert that healthcare providers’ statements regarding gender dysphoria treatments are false claims prosecutable under the FDCA, regardless of whether they are made in conjunction with on- or off-label uses of medication. The federal government has never before made it illegal for healthcare providers to consult with their patients about, and prescribe medication for, treatment of a recognized medical condition.

The court held that the plaintiffs had established an injury in fact. First, the plaintiffs had a legitimate fear of future prosecution (which establishes standing under the APA) because the risk of prosecution here was readily apparent in the record, since the government has already initiated enforcement actions. Second, the plaintiff governments also alleged direct harm that confers standing. Healthcare facilities in the states were expending significant time and resources responding to patient questions, the Memos prompted many facilities to limit the provision of gender affirming care to adolescents, and the delay of such healthcare would lead to more expensive care down the road. Where plaintiffs challenge an FDCA interpretation that would prohibit their conduct, the injury can be traced to the government’s actions. The court also held that the plaintiffs had standing to seek a declaratory judgment and to vindicate their rights under the Tenth Amendment (more on the latter momentarily).

Final Agency Action

The Memos are “rules” under the APA because they announce a new interpretation of statutes. They also “bind and direct inferior employees.” Further, the government’s own statements, which direct enforcement, establish the finality of its actions. There has never been anything remotely clever or subtle about anything the Trump Administration has said or done. Call it transparency or something else, but the Administration’s bluster certainly has the effect of making things easier for the courts. Indeed, the court reasoned that “[b]ased upon the government’s inflammatory rhetoric … and the Memos’ pronounced goals, the purpose of the Memos is to intimidate and harass.” Mission accomplished.

Agency Discretion

Under APA section 701(a)(2), a plaintiff may not obtain judicial review for an agency action “committed to agency discretion by law.” But the Memos’ announce statutory interpretation that would “provide clear standards for enforcement.” The defendants’ “actions are not committed to agency interpretation by law.” Again, lack of subtlety has a price.

The Tenth Amendment

The Tenth Amendment provides: “The powers not delegated to the United States by the Constitution, nor prohibited by it to the States, are reserved to the States respectively, or to the People.” To put it mildly, “Tenth Amendment jurisprudence ‘has traveled an unsteady path.’” But it is now well established that the Tenth Amendment is violated when the federal government acts in excess of its statutory authority in an area traditionally reserved to the states. Medical practice is an area traditionally reserved for the states. Interestingly, the court supported this proposition by citing the recent SCOTUS Skrmetti case, which permitted a state to limit gender affirming care. Turnabout is fair play. Or something like that. The federal government’s FDCA interpretations directly conflict with the plaintiff states’ laws concerning the same type of medical procedures. “Accordingly, Plaintiffs have stated a claim under the Tenth Amendment.”

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FDA-regulated products now account for an estimated one-fifth of overall economic activity in the U.S. They have also been the focus of a litigation explosion. This timely guide covers all aspects of litigation involving drugs, medical devices, vaccines and other FDA-regulated prescription products.
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