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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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Baby formula is not a prescription drug. No doctor hands you a slip of paper for it. The FDA does not regulate it that way. And yet — when a premature newborn receives cow-milk-based preterm formula through a tube in a neonatal intensive care unit, administered by hospital staff, ordered by neonatologists, selected after individualized review of the infant’s gestational age, birth weight, comorbidities, and the risks and benefits of every available feeding option — what is that if not a prescription? Watson v. Mead Johnson & Company, LLC, 2026 IL App (5th) 240936, 2026 WL 1706992 (Ill. App. Ct. June 12, 2026), answers that question. In what we believe is the first ruling by any appellate court on the issue, an Illinois intermediate appellate court reversed a multi-million-dollar verdict and held that the learned intermediary doctrine applies to infant formula used exclusively in a hospital setting under physician oversight. The formal absence of an FDA prescription requirement does not determine the analysis. The clinical context does.

Plaintiff’s son was born more than two months premature. He spent his entire 25-day life in neonatal intensive care. His physicians discussed the risks of prematurity with his mother, including necrotizing enterocolitis (NEC), a potentially fatal inflammatory intestinal disease, before and after birth. During his hospitalization, the baby’s neonatologists ordered his feedings be supplemented with defendant’s cow-milk-based formula for preterm infants. The child developed NEC and underwent three unsuccessful surgeries. Plaintiff sued the formula manufacturer for strict liability design defect, strict liability failure to warn, and negligence. The jury found for plaintiff on the failure-to-warn and negligence counts. Defendant’s posttrial motions were denied.  Id. at *1-3.

Before the appellate court could reach the learned intermediary question, it had to address plaintiff’s threshold procedural argument—the general verdict rule. The general verdict rule provides that when a jury returns a general verdict on multiple theories of liability, the verdict will be upheld if there was sufficient evidence to support any one of those theories—and a defendant who failed to request special interrogatories cannot complain on appeal. Id. at *17. Plaintiff argued that the learned intermediary doctrine applied only to her strict-liability failure-to-warn claim, not to her four theories of negligence, and that because the jury returned a general verdict encompassing negligence as well, defendant was foreclosed from raising the issue on appeal.

The court was not persuaded. It reviewed plaintiff’s four negligence theories: (a) defendant knew or should have known its formula significantly increased NEC risk; (b) it placed a harmful product into commerce; (c) it marketed the product for premature infants despite the risk; and (d) it failed to disclose NEC risks to parents and healthcare providers. The court dissected each in turn. Theory (a) mirrored the strict-liability failure-to-warn claim. Theory (b) was a reframing of the design-defect theory. Theory (c) was a restatement of the failure-to-warn claim—Illinois does not recognize negligent marketing as an independent cause of action. Theory (d) was “effectively identical” to the strict-liability failure-to-warn count. Id. at *19. In the court’s words, plaintiff’s “negligence theories materially overlap with, and in several instances merely restate, the same factual grounds underlying her strict liability design-defect and failure-to-warn claims.” Id. at *18. The negligence count did not set forth four distinct theories but rather “repeated iterations of the same operative facts framed under multiple labels.” Id. at *20. Where negligence is re-packaged strict liability, it is not treated as a separate basis for recovery, and the general verdict rule does not bar appellate review.

With that threshold cleared, the central question was to whom defendant’s duty to warn ran. Defendant said: to the physicians. Plaintiff said: to the mother.

Plaintiff’s position had surface appeal. Baby formula is not an FDA-regulated prescription drug. Parents can, in principle, purchase it online. The learned intermediary doctrine, the argument went, belongs to prescription drugs and prescription devices. Baby formula is a food.

The appellate court disagreed. It started with the rationale underlying the learned intermediary doctrine as articulated by the Illinois Supreme Court—prescription drugs are complex; the prescribing physician weighs a drug’s propensities against the patient’s susceptibilities; the choice the physician makes is an “informed one, an individualized medical judgment bottomed on a knowledge of both patient and palliative.” Id. at *21. That rationale, the court observed, does not turn on whether the FDA has stamped “prescription only” on a label. It turns on whether individualized medical judgment was exercised in selecting and administering the product.

The undisputed evidence put the point beyond argument. The formula was obtained by the hospital directly from defendant. No infant in the NICU could receive it without a physician’s order. The neonatologists who ordered it for plaintiff’s son did so after evaluating his gestational age, birth weight, comorbidities, growth trajectory, the NEC risk associated with formula versus human milk, and the available alternatives. That is exactly “the individualized medical judgment of the type upon which the learned intermediary doctrine is based.” Id. at *22. The formal absence of a prescription requirement did not change what was actually happening in that NICU. The formula was, in the court’s words, “squarely within the class of products for which the learned intermediary doctrine applies.” Id.

Plaintiff pointed to the online availability of the product as evidence that the doctrine should not apply. The court dispatched that quickly. Plaintiff’s son never left the hospital. Plaintiff did not purchase the formula. “Considering the nature of [the formula] and the context in which the product was administered,” id., the court held that the learned intermediary doctrine applied as a matter of law. The duty ran to the physicians. We agree.

The trial court’s refusal to give the learned intermediary instruction was therefore reversible error. “By rejecting the doctrine, the trial court fundamentally skewed the legal lens through which jurors evaluated the evidence because the jury instruction misstated to whom [defendant’s] duty was owed.” Id. at *23. The error was not a technicality. It directed the jury to evaluate whether plaintiff was adequately warned when, as a matter of law, the duty ran to her son’s physicians. Illinois precedent is clear that when a case is tried under an erroneous theory of law, reversal and a new trial are required. Id.

The court also addressed one evidentiary issue it expected to recur on remand—the admission of extensive financial evidence regarding defendant’s revenues, profit margins, and executive compensation, despite the fact that plaintiff sought only compensatory damages and asserted no claim for punitives.

Plaintiff had argued the evidence was relevant to motive, knowledge, and corporate priorities. The trial court agreed and admitted it. The appellate court did not. Under Illinois law, when only compensatory damages are recoverable, a party’s financial condition is irrelevant and often prejudicial — it appeals to the jury’s sympathy and invites a verdict based on the defendant’s ability to pay rather than on evidence of liability. Id. at *24. The financial evidence here was anything but incidental. It was introduced before the first witness was called, highlighted repeatedly during trial, and emphasized in opening statements and closing argument. The jury heard about defendant’s revenues, its parent company’s billions in global sales, and executive compensation packages — none of which bore on whether the product was defective, whether the warnings were adequate, or what the compensatory damages should be. Motive, in any event, was not an element of plaintiff’s burden of proof. On remand, such evidence is inadmissible absent a punitive damages claim. Id.

The learned intermediary doctrine has never been a creature of FDA classifications. It is a doctrine built on clinical reality—a medical professional stands between the manufacturer and the patient, exercises independent expert judgment, and makes an individualized decision to use a product for a specific patient. When a preterm infant formula is ordered by a neonatologist in a NICU, administered through a tube, and selected through precisely that kind of individualized medical assessment, calling it “food” rather than a “prescription drug” does not change the analysis. The label on the can does not determine the law.

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We’ve posted twice recently about the potential jurisdictional benefits of the congressionally expanded “federal officer” basis for federal jurisdiction in tort litigation:  28 U.S.C. §1442 (a)(1).  Our first post cited in passing Griffin v. Optum, Inc., ___ F.4th ___, 2026 WL 1239289 (8th Cir. May 6, 2026), as an example of courts already applying Chevron USA Inc. v. Plaquemines Parish, 146 S.Ct. 1052 (2026), “to cases involving other industries.”

On second thought, though, the “other industry” in Griffin − pharmacy benefits managers (“PBMs”) – is sufficiently adjacent to our sandbox that it warrants a post of its own.  Indeed, Griffin is an opioid case, which makes it even more relevant, since plaintiffs make similar allegations against others in the chain of distribution of prescription drugs.  One other salient feature of Griffin is that the plaintiff here was a state attorney general, and opioid cases brought by states have been particularly difficult to remove.

So here’s Griffin.

The state sued four PBMs for supposedly “contributing to an opioid epidemic.  2026 WL 1239289, at *1.

Pharmacy benefit managers enter into service agreements with their clients − federal and non-federal sponsors of health insurance plans − to administer prescription drug programs.  As part of their services, the managers develop formularies, which are lists of prescription drugs covered by a health plan.

Id.  A “central” function of a PBM is negotiating rebates – “post-sale discounts calculated based on the number of consumers that fill a prescription for the manufacturer’s drug.”  PBMs get a cut of these rebates and pass “the remainder” to the various insurance plans that they service.  Id.  PBMs also “determine[ each] beneficiary’s coverage and copayment information.”  Id.  Critically, a couple of the PBM defendants performed these functions under a contract with a federal agency.  Id.

For that reason, they removed the entire state AG action to federal court on the basis that some of their challenged activities were taken under the supervision of a federal officer.  Id.  The state claimed that, by “disclaim[ing] all federal claims, including claims against ‘any federal officer or person acting under any office of the United States for or relating to any act under color of such office,’” in its complaint, it had immunized the suit from federal jurisdiction.  Id. at *2.  The district court fell for that ruse, but the court of appeals did not, and ordered the suit to remain in federal court.  Id.

Federal officer removal was “liberally construed” and “the typical presumption against removal does not apply.”  2026 WL 1239289, at *2 (citations and quotation marks omitted).  The PBMs were “persons” within the meaning of the statute, “acted under the direction of a federal officer,” in a way that had “sufficient connection between those acts and the[plaintiff’s] claims for relief,” and had “a colorable federal defense.”  Id. (citation omitted).

The key in Griffin was “acting under.”  That statutory phrase was “broad, and must be liberally construed.”  Id. (citations and quotation marks omitted).  It includes assisting the government in conducting “basic governmental tasks” such as “providing “the government with a product that it needed or performing a job that the government would otherwise have to perform.”  Id. (citation and quotation marks omitted) (emphasis added).

A PBM working for a government health program qualifies.

[The removing PBMs], at a minimum, acted under the direction of [a federal agency].  The [relevant federal statute] established a comprehensive program of health insurance for federal employees.  Congress [intended] to improve the position of the government with respect to private companies in recruiting the best talent [by] . . . establish[ing] a partnership between [that agency] and private carriers.  The [agency] contracts with private carriers and authorizes the carriers to subcontract with [PBMs] to provide coverage.  The [PBMs] negotiate with manufacturers to obtain discounts, often in the form of rebates, for the drugs that are ultimately included on the plan’s formulary.  When the [PBMs] negotiate with drug manufacturers, they play a key role in the [agency’] effort to carry out its duties . . . to provide prescription drug benefits.  Accordingly, the [PBMs] perform a basic governmental task by performing a task that the government itself would otherwise have to perform.

Id. at *3 (citations and quotation marks omitted).  The removing PBMs thus were subject to a variety of federal “regulations” and “guidelines” concerning “a variety of topics.”  Id. at *4.  These included mandatory contract terms providing federal “access to information at each claim and aggregate level” between the [PBMs] and pharmacies” so that the government could conduct audit “quarterly rebate guarantees, annual reconciliation and payments, actual billing and allocation of rebates, administrative fees, claim payments, fraud and abuse standards, performance guarantees, [and] pharmacy rebates.”  Id. at *4.

Since the state’s claims in Griffin broadly attacked the PBMs’ handling of various rebates, the claims obviously “sufficiently related” to the services the moving defendant was performing for the government.  Id. at *5.  “The State claims that the rebates and fees induced the alleged collusion” to promote opioid overprescription.  Id.  Indeed, the complaint went on and on about rebates.  Id.  So in that sense, the state was hoist on its own petard.

Nor could the state immunize itself from federal officer jurisdiction with boilerplate “disclaimers”:

[N]o disclaimer, however worded, can help the State avoid a causal nexus between [the removing PBMs’] conduct on behalf of the federal government and the State’s] claims.  [The removing PBMs] conduct[] rebate negotiations indivisibly for both plans under the [federal statute] and plans outside of [it].  [They] do[] not have separate rebate agreements with drug manufacturers for [federal] and non-[federal] plans, and none of the resulting discounts or rebates from the negotiations are exclusive to either [type of] plans.  If [the removing PBMs] were liable for negotiating rebates on behalf of private clients, [they] would necessarily also be liable for negotiating rebates on behalf of the federal government—because it is the same negotiation.”  Therefore, the State’s disclaimers do not, and could not, waive claims based on [the removing PBMs’] rebate negotiations undertaken on behalf of both the federal government and private clients.

Griffin, 2026 WL 1239289, at *5 (citations and quotation marks omitted) (emphasis added).  Thus, the remand order was reversed, and the case remains in federal court.

Governmental involvement in the nation’s health care system is ubiquitous.  Thus, we invite our clients and other readers to look for other examples where defendants sued in state court supply either products or services (see our first use of emphasis above) on the same terms and under the same overall regulatory scheme to both federal and non-federal purchasers.  Plaintiffs cannot attack defendants’ (and not just PBMs’) conduct with respect to non-federal purchasers without also implicating federal procurement as well – and disclaimers “do not and [can]not” separate the two for federal jurisdictional purposes.

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This post is off-topic – it has nothing to do with prescription medical product liability litigation, or even the law.  Bexis recently took a vacation on the island of Kauai, in Hawai’i, for the sixteenth time.  He hiked, for the tenth time, the first two miles of the Kalalau Trail, to Hanakapiai Beach.  That’s nice, but it’s not really an adventure.  The actual adventure begins at the beach itself.  Bexis is memorializing it here because he is getting old for this kind of thing, and he has not seen any description of this particular adventure in any travel book – even the Ultimate Kauai Guidebook − or online.

Bexis does not want his discovery to disappear without a trace, so he is detailing it here, on his blog.

To replicate Bexis’ adventure, first, do not bother with the difficult stream crossing where the trail meets the Hanakapiai Stream.  Instead make your way down the well-established, albeit unmarked, somewhat rough (big rounded rocks) path along the near (eastern) side of the stream.  You will pass some pleasant day lunch sites and freshwater pools.  Then you must clamber over the last of the large rocks to reach the sandy beach.

Note:  Hanakapiai Beach exists only in the summer months.  The ocean is far too rough and dangerous at any other time of the year to attempt this adventure.  It is also best pursued at low tide.

Facing the ocean (makai in Hawai’ian), adventurers should turn right (east) and follow the Hanakapiai Beach.  The cliffs gradually get closer to the ocean.  Some 50 yards to the east is a large, horizontal cave, perhaps what’s left of a million-year-old or more lava tube.  From the beach you will not see the back of this cave.  There may be a shelf of sand that you have to climb onto before entering the cave.  The amount of sand in the cave varies from visit to visit.

Once inside the cave, your eyes will adjust, and you can see the roof of the cave above.  Walk about 15 yards into the cave.  The ceiling in this part of the cave is quite high, and there is no need to stoop (yet).

After your vision is fully adjusted to the darkness of the cave, turn to the left (again, an easterly direction), facing away from the ocean (mauka in Hawai’ian).  In the distance you should see sunlight from the back entrance to the cave.  The sunlight will be quite distinctive against the cave’s darkness.  If there is no sunlight – abort the adventure.  That means the other end of the cave is filled with sand, and thus passage is impossible.

If, as Bexis did, you can see sunlight, move cautiously towards it.  Keep your hiking stick, or hand, in front of and above your head, because the roof of this part of the cave is much lower.  Bexis had to crawl on his stomach to get through the cave’s back entrance. (here’s a 2018- vintage video of the cave – but the sand was higher in 2026).

The back entrance of the cave leads to a small beach close to the ocean.  If the waves completely cover this beach, don’t go further, because the ocean at Hanakapiai is dangerous.

If this beach at the back of the cave is passable, the next part of the adventure is to climb up the rocks to the shelf that runs along the cliff face to the east of Hanakapiai Valley.  You will need a pair of water-resistant shoes for this next part.  The shelf is rough, but walkable, for about the next 300 yards or so.  Other than occasional spray, the waves should not be much of an issue, although it is never a good idea to turn your back entirely on the ocean.  Most of this part of the adventure involves walking and climbing across bare, sometimes jagged, lava rock.  The rest is residual patches of sand.  The winter storms prevent any plants from growing on the shelf.

Picking your way across this moonscape by the ocean will take 15-20 minutes.

The adventure reaches its destination when the shelf ends at a good-sized – but not nearly as large as Hanakapiai – beach.  The descent from the shelf to this beach is relatively easy, and the sand is every bit as soft as the sand on Hanakapiai Beach.  Here’s a picture:

Depending on the waves, and your inclination, you can spend an hour on this beach.  Bring snacks.  The near side of the beach features another good-sized sea cave (a bit of which is visible on the right side of the picture), which is home to numerous small sea birds, that will undoubtedly be annoyed by any human presence.  Beyond the cave, at the other end of the beach, is the waterfall that drops from the cliff above and cascades down the rocks.  The waterfall lands a pile of rocks rather than on the beach itself, so you can’t stand under it (probably a good idea, since that’s where the rocks came from) but as the picture shows the rocks are covered with lush inter-tidal vegetation.  That area is also home to numerous good-sized, but harmless, black crabs.  Except possibly in the early morning, the towering cliffs provide plenty of shade.

Repeat the process in reverse to return to Hanakapiai Beach.

That’s Bexis’ adventure.  A trip through a cave and then around a rocky, but quite passable point, to a deserted beach with its own cave and a lovely waterfall.  Bexis has successfully done this four times, with his family.  Bexis is now 70 years old, so if he can do it, so can any reasonably fit person who would like to experience a truly deserted beach in Hawai’i.

Hiking through caves and clambering over rocks to secluded beaches may or may not make me a better lawyer, but it’s fun.

Aloha.

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We’ve wondered if the widespread use of generative AI was going to produce an increase in the filing of pro se complaints and a marked change in their content. While the results are preliminary, at least one study shows a significant increase in pro se filings following the general availability of AI tools. And our own anecdotal experience suggests that, with the benefit of AI, pro se filings are moving from handwritten one-pagers to lengthy and more sophisticated complaints.

If AI is helping pro se plaintiffs prepare more sophisticated pleadings, we would hope that courts would become less deferential. After all, if generative AI helps pro se litigants bring their claims on a more level playing field, and if they’re bombarding courts with complaints, shouldn’t we see an end to the type of judicial indulgence in favor of pro se plaintiffs that leads to bizarrely pro plaintiff results? While we will continue to hold out hope, today’s case is an example of a court giving a pro se plaintiff the benefit of the doubt and, unfortunately, potentially expanding Texas product liability law into enterprise software.

Continue Reading Pro Se Blues in Texas
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Recently, towards the end of a post about preemption and the FDA’s Current Good Manufacturing Practices (“cGMPs”) – also known as Quality Management System Regulations (“QMSRs”) − we noted a “significant change” last February.  “[T]he FDA issued a final rule” that replaced all existing cGMPs “by incorporating by reference an international standard specific for device quality management systems.”  The purpose of the FDA’s changeover was “harmonizing to align more closely with the international consensus standard for devices.  Id.

Thus, as of February, 2026, the cGMPs are no more.  They are now solely known as QMSRs, and the FDA no longer drafts them (and no longer has to bother with the niceties of the Administrative Procedure Act).  Instead, the Agency has incorporated by reference the set of model medical device quality standards created by the International Standards Organization, specifically ISO 13485:2016:

The QMSR incorporates by reference the international standard, ISO 13485:2016, Medical devices – Quality management systems – Requirements for regulatory purposes and clause 3 of ISO 9000:2015, Quality management systems – Fundamentals and vocabulary.  This allows U.S. medical device quality management system requirements to align with internationally recognized standards and reduce burden on regulated industry.

Incorporating by reference ISO 13485:2016 as the foundational quality management system framework for medical device manufacturers promotes consistency in design, production, and lifecycle controls across global markets and now specifically requires risk management.

Incorporating by reference the terms and definitions set forth in Clause 3 of ISO 9000:2015 supports a common understanding of quality management system fundamentals.  However, to the extent any clause of ISO 13485 conflicts with any provision of the FD&C Act and its implementing regulations, the FD&C Act and/or its implementing regulations will control.

FDA, Quality Management System Regulation (QMSR) (updated Feb. 2, 2026).  The FDA also has – but has yet to finalize – one of its infamous “draft guidances” concerning “Quality Management System Information for Certain Premarket Submission Reviews.”  Among other things, this draft guidance makes clear that the QMSRs apply to PMA approved devices, and thus will be relevant to preemption.  Id. at Introduction.

Ordinarily, a copy of ISO 13485:2016 would cost you it’s $250 a pop, payable in Swiss Francs, from the ISO’s website.  But as our prior post helpfully mentioned, read-only copies are available for free here through ANSI (but you would have to register).  We suspect (but aren’t sure) that the availability of free copies is required by the government’s incorporation by reference, since the same website also offers copies of other ISO standards that have been federally adopted.  Ordinarily we would link directly to the document itself, but this one contains a copyright notice.  While there may well be some law out there that forbids American citizens from being forced to pay for copies of the laws that they are supposed to follow, we aren’t going to be the guinea pigs, so you’ll have to download from the above link yourselves.

We did that and have reviewed the actual ISO standards, and have the following mostly preemption-oriented comments:

  • The FDA’s incorporated by reference “requirements” for PMA (and related) devices are extensive, “including design and development, production, storage and distribution, installation, servicing and final decommissioning and disposal of medical devices, and design and development, or provision of associated activities (e.g. technical support).”  The inclusion of “associated activities,” such as “technical support,” should bring many if not all of the activities of “authorized representatives” within the ambit of the MDA’s broad “different from or in addition to” preemption clause, thereby closing a loophole that plaintiffs have exploited.
  • The standard’s inclusion of “other” parties’ that supply “raw materials, components, subassemblies, medical devices, sterilization services, calibration services, distribution services, [and] maintenance service” should reinforce Biomaterials Access Act preemption and perhaps expand preemption to new entities, depending on whether the ISO creates binding “requirements” as to them.
  • ISO 13485:2016 creates a “process approach” to device regulation, and “[a]ny activity that receives input and converts it to output can be considered as a process.”  Thus, the FDA’s blanket incorporation by reference of this standard would seem to create a very broad basis for preemption.
  • ISO 13485:2016 extends to a regulated entity’s “advisory notice” – “subsequent to delivery” – concerning the “use,” “modification,” “return,” or “destruction” of such devices.  Thus, its requirements extend to DHCP letters and recalls.
  • The definition of “labelling” (ISO 13485:2016 uses European spellings) is as broad as the FDA’s traditional definition:  “label, instructions for use, and any other information that is related to identification, technical description, intended purpose and proper use of the medical device.”
  • We’re not sure what to make of the standard’s application in multi-component off-label use situations.  A “note” to the definition of “manufacturer” states:  “Any person who assembles or adapts a medical device that has already been supplied by another person for an individual patient, in accordance with the instructions for use, is not the manufacturer, provided the assembly or adaptation does not change the intended use of the medical device.”  But whatever it means, the incorporated requirements certainly extend to this situation, and thus should be preemptive.
  • The definitions of “medical device” and “product” both expressly include “software.”  We don’t know how that will influence, if at all, the common-law definition of “product,” but for preemption purposes, the incorporated requirements clearly extend to device software.
  • ISO 13485:2016 includes a definition of “service”:  “Service is the result of at least one activity necessarily performed at the interface between the supplier and customer and is generally intangible.”  Services are not products for purposes of strict liability.  The standard includes examples, but they are unhelpful, since none of the examples relate to medical devices.
  • The standard’s “documentation” requirements are notably non-specific.  Take, for example, the “medical device file” (4.2.3).  That file is to include:  a “general description of the medical device, intended use/purpose, and labelling, including any instructions for use,” product “specifications,” “specifications or procedures for manufacturing, packaging, storage, handling and distribution,” “procedures for measuring and monitoring,” “as appropriate, requirements for installation,” and “as appropriate, procedures for servicing.”
  • The other ISO device requirements are just as generalized.  For instance, “design and development inputs (7.3.3)” consist of “functional, performance, usability and safety requirements, according to the intended use,” “applicable regulatory requirements and standards,” “applicable output(s) of risk management,” “as appropriate, information derived from previous similar designs,” and “other requirements essential for design and development of the product and processes.”  They are to “be reviewed for adequacy and approved.”
  • One last example, since it arises frequently in preemption cases, is reporting to the FDA.  Here is the sum total of the applicable ISO language (8.2.3):

If applicable regulatory requirements require notification of complaints that meet specified reporting criteria of adverse events or issuance of advisory notices, the organization shall document procedures for providing notification to the appropriate regulatory authorities.  Records of reporting to regulatory authorities shall be maintained.

That’s it – “document” the “procedures.”

Actually, that’s not it.  What’s most important is what we mentioned in the prior post:  “[A]s part of the PMA process, the FDA actually examines the manufacturer’s proposed processes and then mandates (through premarket approval) what those processes must entail.”  That’s how these general device requirements become specific to each device.  The FDA reviews and approves exactly what and how each device manufacturer proposes to satisfy those general standards for each submitted device.  That approval is preemptive.

The FDA’s online statement and draft guidance both reference “harmonization” with international standards.  Whether that will have any impact on preemption, we don’t know, but it might create an additional argument for preemption of bizarre state-law duties that don’t harmonize with anything – such as the purported duty to innovate one’s products claimed in the pending Gilead litigation.  The draft guidance states:

If FDA finds there has not been a demonstration that the methods used in, and the facilities and controls used for, manufacturing, processing, and packing a device conform to the QMSR, including because there is insufficient information submitted in the PMA, FDA is required to deny approval of the application under the Act.

Id. at p.3 (footnote omitted).  This is further confirmation that the FDA reviews each of these things during pre-market approval, and thus that any divergent state-law requirements are preempted.

Like the former cGMPs, the QMSRs themselves do not specify the details of any of the processes that applicants for approval must use.  To the contrary, they are intentionally very broad and capacious, allowing applicants to decide what each new device needs.  For example, the guidance section on “design and development requirements” is four pages long and – like the ISO itself − does not contain a single specific requirement, leaving that choice to the applicant.  Id. at 10-13.  These contain requirements for “identification,” “description,” “traceability,” keeping “records,” “reviews,” and the like.  While the applicant must “describe” “Any test methods, protocols, acceptance criteria, and as appropriate, statistical techniques with sample descriptions/sizes and supporting rationale,” id. at 11, the guidance never dictates what any of these items must be.  That is reserved for individual PMAs.  Thus, to our way of thinking, any attempt by a plaintiff to dictate specifics would necessarily be “different from or in addition to” what the QMSRs require, and therefore preempted.  All of the other requirements listed in the FDA draft guidance are similarly general.

It will no doubt be a while before medical devices subject to the FDA’s new QMSR/ISO 13485:2016 regime start appearing in prescription medical product liability litigation, but it is never too early to start thinking about how these regulatory changes will affect our efforts to defend those devices when litigation inevitably reaches them.

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Our title comes from a famous scene in the movie, A Bronx Tale. Rowdy bikers tear up a bar in the Bronx. The proprietor, played by Chaz Palmientieri, proceeds to administer old school mob justice. Enjoy the fun here. 

When you live in a place with a climate as splendid as California’s, where do you go on vacation? We used to wonder about that, and then we moved there.  The answer was straightforward: explore the wonders of the Bear State, which are super abundant. Or maybe venture to Hawaii or Mexico. Or maybe maybe head up to Oregon.  Not once did we moon over Delaware as a potential destination.  Even tax-free shopping was not going to coax us from Disneyland to Wilmington.  But some people are built differently, we guess.

Paddock v. Novartis Pharms. Corp., 2026 U.S. Dist. LEXIS 130141 (D. Del. June 10, 2026), is an interesting transfer decision decided against obviously forum shopping California plaintiffs. Those plaintiffs originally sued in Delaware state court as a litigation aggregation tactic.  The plaintiffs alleged that the defendant pharmaceutical company wrongfully promoted the off-label used of an asthma drug to treat preterm labor in pregnant women. According to the plaintiffs, the result was that babies born to the women suffered from autism. The plaintiffs’ causes of action included negligence, negligent misrepresentation, intentional misrepresentation, and concealment. 

Without knowing much about the case (and when did that ever stop us?), we harbor deep skepticism about its merits. Decrying off-label promotion is usually a weak claim and a signal that the plaintiff lawyers are desperate. There also seems to be a strong felt need among some to blame all sorts of things for autism. And the blah misrepresentation, blah blah misrepresentation, and blah blah blah misrepresentation claims do not impress us. 

Anyway, the bad news began for the plaintiffs when the defendant removed the Delaware action to federal court on the basis of diversity of citizenship. The defendant fended off the inevitable remand motion and then, building success upon success, convinced the Delaware federal judge to sever the non-diverse plaintiffs and keep the rest in federal court.  As is so often the case, winning the procedural wrangling is at least as important as whatever happens with the substantive issues. Such wrangling is an example of smart litigation. It is not spending the other side into the ground (that is an old, overworn accusation against corporate defendants that is hardly ever true anymore); it is thinking the other side into the ground. 

At this point, the California plaintiffs belatedly decided that if they had to be in federal court, they would rather be in California. Whether this was animated by a preference for the Pacific Ocean over the Christina River, the Red Hot Chili Peppers over George Thorogood, the Dodgers over the Blue Rocks, sushi over scrapple, or left coast, corporate-hating jurors over more open-minded citizens of the First State, we simply do not know. The Californians moved to sever their claims under Federal Rule of Civil Procedure 22 and transfer them to our former home jurisdiction, the Central District of California, under 28 U.S.C. Section 1404(a). Another, similar action was pending there. 

Nope, held the Delaware  magistrate-judge. Mind you, the defendant did not oppose severance. But it did oppose transfer to C.D. Cal. Therefore, the court confined its analysis to the transfer issue under section 1404. 

Third Circuit law sets out six private interests and six public interests that should be taken into account when deciding a transfer request.  The six private interests are: (1) plaintiff forum choice “as manifested in their original choice,” (2) defendant preference, (3) where the claim arose, (4) convenience of the parties, (5) convenience of witnesses, and (6) locations of books and records.  The six public interests are: (1) enforceability of the judgment, (2) practical considerations making trial easier or harder, (3) relative court congestion between the possible jurisdictions, (4) a preference for deciding local interests, (5) public policies of the fora, and (6) familiarity of the trial judges with applicable law in diversity cases. 

Note that the first private interest, plaintiff forum choice, looks to the “original choice.”  Here, plaintiffs originally plumped for Delaware. But when a plaintiff subsequently  seeks to transfer a case, the plaintiff’s choice of forum no longer is of any weight. The plaintiff needs to show a change in circumstances since filing the original suit. But being in federal court was not the sort of change of circumstances that supports transfer. Nor was the severance of two plaintiffs from New Jersey, whose claims remained in Delaware state court as opposed to federal court. 

Claims of plaintiff inconvenience (making autistic California kids cross the country) rang hollow. First, it was plaintiffs who initially filed their lawsuits in Delaware.  Second, there were other plaintiffs from far away who were not seeking transfer. The other private interest factors were neutral on the issue of transfer. Except, of course, the defendant’s preferred forum weighed against transfer. 

The public factors did not help the plaintiffs’ transfer motion. Delaware’s interest in claims brought against a local defendant were as strong as California’s interest in vindicating the interests of its plaintiffs.  Meanwhile, a transfer of the Californians to their home state would not allow them to join the existing case without disrupting the discovery and trial schedule. 

Consequently, these California plaintiffs ended up with the worst of both worlds, now severed from all the other plaintiffs, and stuck in federal court in Delaware.  “Now youse can’t leave.” 

But there is a consolation prize for the misbegotten California tourists: try a Bobbie hoagie at Capriotti’s Sandwich Shop. It’s Thanksgiving tucked in bread.  It’s at least as good as a Phillipe’s French dip sandwich in downtown LA.

Meanwhile, congrats to the defense team at McCarter & English, many of whose members we count as good friends and esteemed colleagues. 

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Gadolinium is a heavy metal. Sounds ominous. But it is also the active component in contrast agents used in more than 100 million MRI procedures — and its accumulated safety record is, in the words of plaintiff’s own literature, “extraordinarily positive.” Combs v. Bayer AG, 2026 WL 1693470, at *11 n.19 (Okla. App. Ct. May 11, 2026). But that didn’t stop plaintiff from arguing that gadolinium retention causes a condition known as Gadolinium Deposition Disease (GDD) and that defendants failed to warn her of that risk. The Oklahoma appellate court’s affirmance of defendants’ summary judgment win is a welcome addition to the body of decisions finding those claims preempted. It also has some Oklahoma law bonuses worth noting.

Plaintiff received an injection of a gadolinium-based contrast agent (GBCA) manufactured by defendants in March 2016, as part of an MRI following a motor vehicle accident. After her injection, she experienced a wide range of symptoms she attributed to gadolinium retention in her body, including hives, migraines, muscle pain, swelling, and vision injury. She also eventually alleged she developed GDD. Id. at *1.

The crux of her case was that the FDA-approved warning for the GBCA addressed the risk of gadolinium retention only in patients with kidney disease — specifically, the risk of developing nephrogenic systemic fibrosis (NSF). Plaintiff had no kidney disease. The warning she wanted — one addressing the risk to patients with normal renal function — was not an FDA-approved warning. Id. at *2. So, plaintiff needed the CBE regulation to save her. It didn’t.

As regular readers of this blog know well, failure-to-warn claims brought against prescription drug manufacturers are preempted unless the manufacturer could have unilaterally changed its label under the Changes Being Effected (CBE) regulation. And the CBE has teeth: it requires newly acquired information showing reasonable evidence of a causal association between the drug and the alleged harm. Id. at *5.

What did plaintiff offer? First, she showed that the FDA was aware of gadolinium retention before her injection by pointing to adverse event reports. Adverse event reports alone do not establish a causal association. We have said this many times. And, as the court found, “[plaintiff] provided nothing to demonstrate that reasonable evidence of a causal association between [GBCAs] and these events existed before her injection.” Id. at *6.

Next, she argued that because gadolinium is “toxic” and is retained in the body, that was enough to trigger a CBE label change. But neither the toxicity nor the retention was newly acquired evidence and they certainly were not evidence of any causal association. Id. at *7.  Knowing a substance is retained in the body is not the same as knowing that retention causes clinical harm. That’s basic science. It is also the CBE standard.

Plaintiff also tried to undermine the FDA’s own conclusions. In 2017 and 2018, the FDA conducted a multi-year review of the literature on gadolinium retention. The agency found no direct link to adverse health effects in patients with normal kidney function. In 2018, the FDA approved a revised label stating precisely that: “clinical consequences of gadolinium retention have not been established in patients with normal renal function.” Id. at *7. Even though those events took place after plaintiff’s injection, they supported defendants’ argument that no newly acquired evidence existed in 2016 to allow a unilateral label change. Id. If it didn’t exist in 2018, it certainly didn’t exist in 2016. Rather than reckon with the FDA’s conclusions, plaintiff argued the FDA’s analysis was “tainted” by defendants’ influence. She provided no evidence of this. Id.  And — as courts have repeatedly recognized, and as we have pointed out in numerous posts — attacking FDA decision-making through state court litigation is exactly what Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341 (2001), prohibits. Plaintiff offered no evidence of newly acquired information pre-2016 that would have allowed defendants to change the label, so the court affirmed summary judgment on the grounds of preemption. Id.

Preemption alone was sufficient to end this case, but the court also addressed two additional, independent grounds for summary judgment.

First, Oklahoma law provides a statutory rebuttable presumption that a manufacturer is not liable for harm caused by a product that complied with mandatory federal safety standards at the time of manufacture. 76 O.S. 2021, § 57.2(A). Defendants’ GBCA was FDA-approved, so the presumption was established. To rebut it, plaintiff needed to show either that the federal standards were inadequate or that defendants withheld information from or misrepresented information to the FDA. She argued neither on summary judgment. Those arguments were therefore waived. Id. at *8. But the court went further: even reaching the merits, what plaintiff offered was not evidence of fraud or inadequacy. It was, in the court’s pointed description, “hyperbolic speculation” about defendants’ motives. Id. at *11 n.7. That is not how you rebut a statutory presumption.

Plaintiff also tried a creative path around the presumption entirely. Section 57.2(D) of Oklahoma’s statute provides that the presumption does not apply when a product has been withdrawn from the market pursuant to an order or agreement with “any federal agency.” Id. at *9. Plaintiff pointed to the European Medicines Agency’s 2018 decision to suspend sale of the drug. The argument: if a “federal” agency — even a foreign one — takes action, the presumption evaporates. The court did not take long with this. “Federal agency” in the context of Oklahoma law means a federal agency of the United States of America. “We see nothing in the statute that signals an intent of the Oklahoma Legislature to defer to the judgment of the EU or its agencies.” Id. at *9. We see nothing either.

Plaintiff’s failure-to-warn claims also failed on causation under the learned intermediary doctrine. Plaintiff’s prescribing physician provided clear and consistent testimony in 2024: gadolinium retention from GBCAs does not cause clinical consequences in patients with normal renal function; GBCAs do not cause long-term negative symptoms in such patients; and — the pivotal question — knowing everything he knows today about the risks of retained gadolinium, he would not have changed his treatment. Id. at *10. That is exactly the kind of testimony that satisfies defendants’ burden on learned intermediary causation. The burden shifted to plaintiff to discredit her physician or show the undisclosed risk was sufficiently high that it would have altered his decision. She could not. The physician’s own answers said the opposite. Id.

Three grounds. All affirmed. Gadolinium may stay in the body. These claims should not.

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Some of us of a certain age were fans of Parliament/Funkadelic back in the day.  The group even released an album entitled “Medicaid Fraud Dogg.”  That was the most drug/device adjacent rock-and-roll since the Rolling Stones released “Mother’s Little Helper.”  One classic Parliament line was “make my funk the p-funk.”  Every time we think about PFAS litigation, our first response is “make my FAS the PFAS.”  That’s appropriate because that litigation is – as we’ve already observed – a whole lotta nuthin.

The FDA evidently thinks so, too.

Last year, in August, the agency issued a report on “PFAS in Medical Devices,” which detailed an “independent safety review” it conducted together with the patient safety organization ECRI.  The bottom line:  “The ECRI review found no conclusive evidence of patient health issues associated with PTFE as a material.”  Id.

Other significant points from the FDA safety review are:

  • “The PFAS materials used in medical devices (known as fluoropolymers) have a long history of use. The best-known of these materials is polytetrafluoroethylene (PTFE).”
  • “Many medical devices rely on plastic materials . . ., which are part of the PFAS family and have been safely used for decades.”
  • “Medical devices [that] . . . rely on the unique properties of PFAS . . . are necessary to save and sustain lives.”
  • “Currently, no other materials exist that can perform the critical roles of fluoropolymers in these devices.  The materials have unique properties that are essential for devices to function.”

Id.

The FDA conducted a second evaluation of PFAS in connection with its oversight of cosmetics.  In late 2025 the agency released its “Report on the Use of PFAS in Cosmetic Products & Associated Risks.”  PFAS are used in cosmetics “because they are water- and oil-resistant, and are long-lasting.”  Id. at 8.  In response to the same overblown allegations of purported health risks that we’ve seen in litigation, the FDA evaluated the safety of the 25 most commonly used PFAS compounds in cosmetics.  Id. at 9.  First, it concluded that, because:

There are currently no federal regulations that specifically address the use of PFAS in cosmetic products in the U.S.[,] PFAS that are intentionally added to cosmetic products as an ingredient are not currently prohibited and do not, based on presence alone, render the cosmetic product adulterated or misbranded,

Id. at 8 (footnote omitted).

As to the 25 particular PFAS compounds specifically evaluated, the FDA concluded, based on a “comprehensive search of PubMed, . . . [the] Web of Science, [and] existing official safety assessments from government agencies and scientific advisory groups,” id. at 9, that five of them had a “[l]ow safety concern based on available data,” 19 others had “insufficient data for safety conclusion,” and only one showed even a “potential safety concern based on available data at highest concentration of use.”  Id. at 9-10.  That’s a far cry from the hysterical bleatings of the plaintiffs’ bar and their hired gun “experts.”

Given the conclusions in these two 2025 FDA reports, any attempts to assert PFAS-related product liability claims in prescription medical product liability litigation should be both expressly and impliedly preempted.  To the extent products are governed by the MDA’s “different from or in addition to” express preemption clause in 21 U.S.C. §360k(a), the FDA has evaluated the PFAS used in medical devices and expressly concluded that no safety-based basis for either design changes or new warnings exists.  To the extent that implied preemption under Merck Sharp & Dohme Corp. v. Albrecht, 587 U.S. 299 (2019), is involved, the FDA has expressly concluded that no available evidence suggests any basis for requiring different warnings.  So at least through the end of 2025, there is no basis to conclude that any “newly acquired information” exists that could support any warning-based claim.

In sum, we haven’t seen any product liability litigation in our drug/device sand box based on the presence of PFAS in prescription medical products.  These FDA evaluations establish that there is a good reason for the absence of such claims – they, too, would amount to a “nuthin.”

Drug & Device Resources

Bexis’ Book

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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