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We’ve written a lot of benzene posts on this blog over the years, and most of them share a common thread. Plaintiffs find a chemical decomposition byproduct nobody put on a label, dress it up as a corporate conspiracy, and ask a court to do what years of FDA rulemaking declined to do. Every so often, though, a court doesn’t just reject the theory — it takes the theory apart piece by piece, cites every reason it fails, and locks the door on the way out. That’s In re L’Oréal USA Benzoyl Peroxide Products Litigation, 2026 WL 2719653 (S.D.N.Y. Sept. 15, 2026), where the court granted the defendant manufacturer’s motion to dismiss with prejudice, essentially ending this MDL. If you’ve been waiting for the decision that says everything the defense bar has been saying about OTC benzene litigation for the last two years, this is it.

The case involved three benzoyl peroxide (“BPO”) acne treatment products that plaintiffs allege contained or degraded into benzene, a known carcinogen. Plaintiffs allege they would not have bought the products, or would have paid less for them, had that been disclosed. The complaint pleaded four state-law causes of action — deceptive trade practices, breach of implied warranty, negligent misrepresentation/omission, and unjust enrichment — all resting on the claim that the products were “adulterated and misbranded.” Id. at *1.

This litigation traces back to a March 2024 citizen petition asking the FDA to recall BPO products, followed by an FDA notice a year later confirming that the agency’s own testing found benzene contamination in some products, though less than third-party testing had suggested, and that a limited retail-level recall was warranted — a recall that, notably, did not instruct consumers to do anything with product already in their homes because, as the FDA itself said, the cancer risk from daily use over decades is very low. The manufacturer here agreed to a single voluntary recall of one lot of one product. No plaintiff alleged buying from that lot. Id. at *2.

The manufacturer moved to dismiss on the ground that the FDCA preempts all of it. The court agreed, and it did not take a narrow path to get there. It walked through the entire regulatory architecture and closed off every possible workaround plaintiffs tried to construct.

Start with the basics — OTC drugs like these get to market without individualized FDA review so long as they comply with the applicable monograph.  Here, the Acne Monograph, which functions as a regulatory recipe specifying the approved active ingredients and the labeling requirements for the category. The FDCA’s cosmetic labeling preemption provision, 21 U.S.C. § 379s(a), bars any state-law labeling requirement that is “different from or in addition to” the federal one. The Second Circuit has read that to mean that state law is preempted if it is not “exactly the same as” federal law. Id. at *4. A parallel provision, § 379r(a), does the same work for adulteration claims. Id.

The court examined the Acne Monograph and found that it says nothing about benzene. It permits BPO as an active ingredient, and it lists the required warnings, and benzene appears in none of them. That should have been the end of the misbranding theory. It was. But plaintiffs, being plaintiffs, did not stop there. They tried two workarounds, and the court shut down both.

First, plaintiffs argued that the Acne Monograph’s own “general conditions” incorporated 21 C.F.R. § 201.66’s requirement that OTC drugs list active and inactive ingredients on the label, and that benzene was an undisclosed ingredient that should have been listed. The court rejected this because benzene is not an “inactive ingredient” under the regulation, which defines a component as something a manufacturer “intended for use in the manufacture of a drug product.” Nobody alleged the manufacturer intended benzene to show up. It shows up, if at all, because BPO decomposes, not because anyone put it there. Id. at *7.

Second, plaintiffs invoked the FDCA’s general “misbranding” provision in chapter V, which prohibits false or misleading labeling, arguing it independently required a benzene warning. The court explained that chapter V is a backstop against affirmatively misleading statements — the “this product cures baldness” problem — not an engine for generating new disclosure obligations the FDA considered and declined to impose in a monograph it spent decades building. As the court put it, reading the general misbranding language to create a benzene-warning requirement the FDA never included would “directly contravene the Acne Monograph’s explicit labeling requirements.” Id. at *6. We’d go further than the court did and just call that reading absurd. The FDA looked at BPO for the better part of a century, decided the word “cancer” shouldn’t even appear on the label, and plaintiffs want a court to override that considered judgment using the FDCA’s general catch-all clause. No.

The court also made quick work of plaintiffs’ attempts to use two recent Second Circuit decisions — Rutledge v. Walgreen Co. and Yousefzadeh v. Johnson & Johnson Consumer Inc. — as escape hatches. Rutledge says manufacturers are permitted to add supplemental warnings; it does not say they are required to. And the dictum in Yousefzadeh about a monograph drug still being misbranded if it has “a dangerous effect on the user” was aimed at something like cyanide in a bottle, not a substance the FDA specifically evaluated and approved as an ingredient. Nice try, but citing a case for a principle it doesn’t actually support is not a strategy that wins in front of a court paying attention — and this court was paying attention. Id. at *8.

Next the court dismantled plaintiffs’ claimed “2 ppm federal benzene cap.” Plaintiffs alleged that a 2 parts-per-million cap on benzene existed under federal law, that the products exceeded it, and that this made the products “adulterated.” The court found no such cap exists anywhere in the FDCA or FDA regulations, and without it, the adulteration theory has nothing to stand on.

Plaintiffs tried three sources for this imaginary cap, and the court took each one out individually. The voluntary recall notice doesn’t establish it — a voluntary recall does not, by itself, establish a violation of federal requirements, and the notice itself never called the recalled product “adulterated.” Id. at *9. FDA guidance documents and warning letters don’t establish it either — they are expressly non-binding, don’t carry the force of law, and the FDA’s own Q3C Guidance says on its first page that it creates no rights and binds nobody. Id. at *9-10. And the USP doesn’t establish it. Chapter 467’s 2 ppm figure applies only to benzene as a “residual solvent,” meaning a chemical used or produced directly in manufacturing that isn’t fully removed by practical techniques. But plaintiffs’ own complaint described a multi-step decomposition process — BPO breaking down into benzoic acid radicals, which further decompose into benzene radicals, which then produce benzene — not a residual solvent. Plaintiffs’ own pleading defeated their theory. Id. at *10.

As a parting shot, the court noted that USP Chapter 467 repeatedly uses the word “should,” not “shall” — and under ordinary usage, “should” recommends, it doesn’t mandate. Even if plaintiffs had cleared every other hurdle, they were trying to build a federal requirement out of a document that speaks in suggestions. Id.

The court denied leave to amend and dismissed with prejudice, reasoning that plaintiffs had already amended once, had been given a further opportunity to amend before this motion was even fully briefed and declined to take it, offered no proposal for how a new complaint would fix anything, and — most importantly — were trying to plead around a preemption defect that no amount of additional facts can cure. Id. at *11. This isn’t a case getting narrowed for round two. It’s over.

This opinion is as complete a preemption win as you’ll see in the OTC benzene space, and it’s worth reading in full for the sheer discipline of it — every plaintiff argument gets a paragraph, and every paragraph ends the same way. But there is another part of this decision that we want to highlight. It’s the court’s recognition, running through the whole opinion, that the FDA already did the science here, and plaintiffs’ lawyers are trying to use an economic class action complaint to relitigate a regulatory judgment the agency reached after decades of study.

The court didn’t gloss over this. It noted that BPO’s tendency to decompose into benzene has been studied since 1936, that the FDA has been examining BPO’s safety since the early 1980s, that the agency concluded in 1982 that BPO at these concentrations is safe and effective. Further, when the FDA finalized the Acne Monograph in 2010, its own advisory committee unanimously decided the word “cancer” shouldn’t even appear on the label. That is not an agency that overlooked benzene. That is an agency that considered it, repeatedly, over the course of roughly ninety years, and made a judgment call. The court’s language on this point deserves to be quoted directly:

[W]here the FDA has constructed an elaborate labeling framework [in a monograph] specifying labeling requirements, and [a particular substance] appear[s] nowhere in that framework, the inference that the agency made a considered judgment about label content is substantially stronger than in cases where the regulatory scheme merely touches on the relevant product category.

Id. at *7 (quoting Brower v. Colgate-Palmolive Co., 2026 WL 1831253, at *5 (S.D.N.Y. June 25, 2026).

That’s the whole ballgame, and it’s an argument we’ve been making for years across every mass tort that tries to use a courtroom as a second regulatory agency. Litigation should not lead science, and it especially should not lead science that the actual scientific regulator has already led. Plaintiffs’ lawyers didn’t bring new data. They didn’t bring a new toxicological study. They brought a reading of “should” as “shall,” a warning letter with no legal force, and a recall notice that says the opposite of what they needed it to say — and asked a federal court to override the FDA’s considered, decades-long judgment anyway. The court said no. Score one for letting the people who actually do the science keep doing the science. We’ll take it.

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Nearly a decade ago we published the blogpost “Pre-Approval Design Defects – No Such Thing.”  As we discussed, “pre-approval” design (later joined by warning) claims were a transparent preemption dodge.  No such claims had ever been advanced before the Supreme Court’s holdings in the generic drug preemption cases (Mensing/Bartlett) that actions requiring FDA prior approval – which includes all design changes affecting safety – were necessarily preempted because the defendants could not unilaterally make those changes purportedly required by state law.  Our prior post wasn’t really about preemption, but rather the incompatibility of “pre-approval” defect claims with accepted state law:

The reason that [the case we discussed] was “unable to conceive of” a state law pre-approval duty is because such duties do not exist.  Design defects under Restatement (Second) of Torts §402A (1965) . . . [are] limited to products that are defective at sale. “The rule stated in this Section applies only where the product is, at the time it leaves the seller’s hands, in a condition . . . which will be unreasonably dangerous” to the ultimate consumer.  Restatement (Second) of Torts §402A, comment g (1965).  In the Third Restatement, this time in the black letter, . . . all “categories of product defect” are likewise determined “at the time of sale or distribution.”  Restatement (Third) of Torts, Products Liability §2 (1998).

That “pre-approval” defect claims are contrary to state law (and therefore aren’t available ab initio as a preemption dodge) was strongly reinforced by the California Supreme Court’s recent decision in Gilead Tenofovir Cases, ___ P.3d ___, 2026 WL 2223748 (Cal. 2026) (which we discussed generally, here).  Since Brown v. Superior Court, 751 P.2d 470 (1988), California has not allowed strict liability design claims against prescription medical products, so plaintiffs had to pitch the “duty to innovate” claims that the Gilead court rejected as “negligence.”

Plaintiffs in Gilead had every opportunity to pursue standard defect allegations in that litigation, but they declined to do so.  Instead, they pursued their novel theory that, regardless of any defect, the defendants were negligent when they elected to delay pursuing FDA approval of an allegedly “safer” version of their breakthrough anti-HIV drug, in favor of successfully obtaining FDA approval of a related drug – the drug the undoubtedly saved most of these ingrate plaintiffs from slow and inevitable death from AIDS.  But for our purposes, Gilead also illustrates why the law unanimously restricts defect allegations, and any other kind of tort claim, to conditions existing at the time of product manufacture and sale, as opposed to speculative pre-FDA-approval allegations.

Gilead recognized that, in California as elsewhere, product-based negligence “claims still require proof that the manufacturer’s negligence resulted in a defective product.”  Id. at *5 (citations omitted).  Divorcing negligence from product defect (what the Gilead plaintiffs advocated) “would create substantial tension with that [product liability] body of law.”  Id. at *6.  That’s because “products liability law employs specific tests to determine whether a product is defective.”  Id.  Such specificity is particularly necessary when the plaintiff’s allegations attack prescription medical product development:

Unlike product defect claims, which are evaluated based on contemporaneous and relatively complete scientific evidence available at the time of the product’s distribution, evaluating the reasonableness of drug-development decisions would require retrospective assessment of inherently provisional judgments made based on evolving scientific data.

Id. (citation omitted) (emphasis added).  Such development is a “multistep, highly regulated process.”  Id. at  *7.  FDA approval matters.  It prevents speculative and conjectural claims.

The plaintiffs’ claims in Gilead were based “on a flawed premise; namely, that a drug can be sufficiently developed, and its safety and efficacy sufficiently known, before completion of phase III clinical trials and FDA approval.”  Id.  Similarly, “pre-approval” defect claims assert that same false premise – that “defects” can be determined prior to a product’s FDA approval. 

That premise is inconsistent with the statutory and regulatory framework governing drug [and medical device] development.  It also underscores the difficulty of imposing negligence liability based on preliminary and evolving safety assessments of an alternative [design] still under development, rather than on a defect in the [product] currently being sold.

Id.

“[D]efinitive judgments regarding” yet-to-be approved products’ “risks and benefits ordinarily cannot be made before completion of phase III trials and FDA approval.”  Id. at *8.  For that same reason, state law provides no basis for alleging “pre-approval” defects.  Instead, the common-law limits product liability defect claims to those in existence at the time that the product at issue was sold.  Gilead recognized that “[p]roducts liability law has long tied a manufacturer’s duty of care to defects in the product placed into the stream of commerce.”  Id.

In particular, Gilead held that sufficient knowledge of the risks and benefits of FDA-regulated products for those risks to be “foreseeable” does not exist “before completing phase III clinical trials and obtaining FDA approval.”  Id. at *9.  “[T]he difficulty of making comparative judgments, the structure of the [FDA]-approval process, and the governing statutory and regulatory framework demonstrate that such knowledge ordinarily cannot be established at earlier stages of development.”  Id.  “[O]nly about one-third of drugs evaluated in phase II clinical trials yield results promising enough to proceed to phase III testing,” and “fewer than one out of eight will obtain FDA approval.”  Id. at *10, 11. (citations omitted).  Thus, as a matter of law, Gilead held that “a manufacturer cannot truly know of a drug’s safety and efficacy before phase III testing and FDA approval,” making such risks unforeseeable.  Id. at *10.

Any such injury [to a plaintiff] would depend on speculation regarding the independent conduct and discretionary decisions of multiple third party actors, as well as the uncertain outcomes of additional clinical trials and scientific research required to develop, approve, and market the new drug.

Id. at *11.  No outside “assessment of a drug’s safety and efficacy” can “make FDA approval certain.”  Id. (citation omitted).  Pre-approval risk/benefit assessment is, as a practical matter, impossible:

[B]ecause of this high failure rate, . . . drug manufacturers must make complex strategic decisions about where to devote finite resources based on limited information.  These decisions are often provisional, iterative, and contingent on preliminary laboratory or clinical studies that may later prove incorrect.  As a result, they do not readily lend themselves to retrospective evaluations of reasonableness armed with the benefit of hindsight.

Id. at *16.

For these reasons, prescription medical product liability claims are not evaluated prior to FDA approval.  Rather, like all product defect claims, defect are only measured “at the time of manufacture and distribution.”

Product defect claims are judged based on contemporaneous and relatively complete scientific evidence available at the time of manufacture and distribution. . . .   [A] retrospective inquiry creates a substantial risk that hindsight will supplant the manufacturer’s contemporaneous judgment, even when its decisions were reasonable when made.

Id. at *17 (emphasis added).  Thus, the “novel theory” in Gilead that would have required a jury’s evaluation of a defendant’s pre-approval conduct and information was rejected:

That inquiry asks fact finders to reconstruct years of research and development decisions made in the face of evolving scientific evidence and uncertain outcomes, rather than to evaluate the safety of a product that actually reached the market.  Neither the plaintiffs nor the dissent have identified a single case wherein a fact finder has been tasked with making such determinations.

Id. (emphasis added).  Gilead emphasized that product liability is limited to those prescription products “that are already on the market,” not “decisions made long before a drug is approved or marketed.”  Id. at *20 (emphasis original), 21.

Although the plaintiffs stayed away from the term “defect,” Gilead involved a disguised “pre-approval” design defect claim.  To avoid preemption, such claims propose to shift the defect inquiry from the time that a drug or device was actually manufactured and sold, to some indeterminate time before FDA approval, when some alternative, purportedly safer, unapproved design was theoretically possible without FDA review.  Evaluating purported design defects prior to any FDA approval is a bad idea for all of the reasons Gilead discussed – which is why no state’s common law that we know of allegations of “defects” to any other time than traditional requirement of defect at sale.

And, as Gilead noted, plaintiffs in that high-stakes litigation were unable to cite “a single case” supporting a “defect” existing prior to FDA approval.

“Pre-approval” defect claims are figments of plaintiffs’ perfervid imagination, lacking any basis in existing tort law.  They are alleged solely for the purpose of avoiding preemption.  The doctrine of constitutional avoidance counsels against reaching constitutional arguments when non-constitutional issues are dispositive.  Defense counsel should respond to such made-up claims by establishing that they have no legal support in the relevant jurisdiction.

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Time for another shameless plug. The 31st Annual ACI Drug & Medical Device Litigation Conference takes place December 2–3, 2026 at the New York Marriott Marquis, and several of our Reed Smith bloggers are planning to be there. The full agenda is here.

We’re especially pleased that our own Lisa Baird is speaking on “Putting the Offense in the Preemption Defense” – exploring whether the time has come to go on the offense with preemption, including leveraging the Supreme Court’s FIFRA opinion in Monsanto v. Durnell and whether the reasoning in Medtronic v. Lohr has finally been undermined enough for courts to take notice.

The conference features 75+ speakers, including in-house leaders from Medtronic, Bristol-Myers Squibb, Novo Nordisk, Johnson & Johnson, Gilead Sciences, and many more, alongside top defense firms and members of the judiciary. The conversations you have here can genuinely shift your practice.

ACI has once again invited the blog to serve as a media sponsor, and they’re offering our readers a special 10% discount on registration. Just be sure to use the code D10-999-DDLB27 when you sign up.

You can register here. We hope to see you in New York!

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No, your DDL bloggers are not offering a money-back guarantee—although we suppose offering one would not cost us anything, since reading the blog is free.  For enterprises that actually sell products though, the story is sometimes different, and many product sellers do guarantee satisfaction—or your money back.  Moreover, when those guarantees are unrestricted, we have a difficult time seeing how consumers could ever file lawsuits claiming they were overcharged.  All they had to do was ask for refunds, without the need for litigation or exorbitant claims for attorneys’ fees.  Case closed.

That is what happened a little while back in a short-but-smart order from a New York trial court.  In Scott v. Walmart, Inc., No. EF012051-2025, 2026 WL 2561736 (N.Y. Sup. Ct. July 28, 2026), the court dismissed a consumer class action brought by the purchaser of an over-the-counter sleep aid.  Because the seller offered a money-back guarantee, the purchaser/plaintiff had no standing to sue.  And, federal law preempted the claims to boot.

In Scott, the OTC product’s label said the product was “non-habit forming.”  The plaintiff alleged that statement was misleading because the product’s active ingredient allegedly could elevate the user’s mood, which could cause the user to want to use the product more.  Now mind you, this plaintiff did not allege that he actually experienced these sensations, or experienced any alleged injury at all.  He alleged instead that he paid more for the product because of the “misleading representations” and thus sought a partial refund for himself and his proposed class.

The court was having none of it.  First, the product seller offered an unrestricted money-back guarantee under which purchases could return the package for a full refund.  Sure, if there were strings attached, perhaps the purchaser could allege an injury in fact under New York’s consumer protection statutes.  But here the guarantee was unrestricted.  As a result, the court concluded that “Plaintiff herein would likewise be fully compensated by virtue of [the defendant’s] unrestricted money-back guarantee for the Product and therefore, having suffered no injury on fact, he lacks standing.”  Scott, at *4.

Second, even if the plaintiff had alleged a cognizable injury, federal law preempted his claims in any event.  As the court explained, Congress has created a national and uniform scheme to protect consumers from fraud or misrepresentations in the sale of food, drugs, and cosmetics.  Moreover, the FDCA contains an express preemption clause that bars states from establishing any requirement for OTC drugs that is “different from or in addition to, or that is otherwise not identical with” federal requirements.

Here, the FDA regulates the OTC product at issue through an FDA Monograph, which sets forth federal requirements for product labeling.  Because the plaintiff’s lawsuit would require the product seller to include different or additional information on a federally approved drug label, the plaintiff’s state-law claims were preempted.  In so holding, the court rejected precedent from our home district, the Northern District of California, which ruled that similar claims were not preempted because the Monograph did not explicitly address whether the “non-habit-forming” statement is misleading.  The New York court correctly saw it differently, and it held that if the FDA regulates a given subject matter—here, dependency on a certain active ingredient—then federal law “preempts all non-identical state laws within that subject matter.”  Scott, at *5.  Regulation of particular or specific statements within that subject matter is not required. 

The court closed with some choice words for the plaintiff’s counsel, who evidently favors exaggerated punctuation (lamely echoed in the title to this blogpost!!).  The court did not appreciate counsel’s attempt to denigrate defense counsel, nor counsel’s “specious attempt to cast aspersions on his adversary and to detract from the issues raised in the motion, especially in light of the disjointed and excessively punctuated submissions by Plaintiff’s counsel.”  Scott, at *5.  We will accept the court’s admonition on behalf of law bloggers everywhere.  Will our analysis be disjointed?  Usually not.  Will we excessively punctuate our pithy observations?  Never!!!!  Guaranteed, or your money back. 

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A mere two weeks ago, we praised a California federal court for dismissing preempted claims against a prescription drug manufacturer and not giving the plaintiff a third chance to plead a non-preempted claim.  We noted that allowing three strikes seems to be the default rule on serial amendments in response to motions to dismiss or orders granting them, but that some courts have allowed a fourth complaint rather than dismiss all the claims with prejudice on the failed third try.  This week, we have a different California federal court dispensing a well-reasoned dismissal of all the claims in the third complaint against the manufacturer of a prescription blood glucose monitoring system, but the dismissal was somewhat sullied by the unexplained decision to give the plaintiffs a chance to file a fourth complaint.  The fourth strike, much like the fifth down that the Chiefs were afforded in the 2023 AFC Championship Game, is hard to justify, inviting speculation about possible undue bias or sympathy.  In Higginbottom v. Dexcom, Inc., No. 24-cv-0195-WQH-BLM, 2026 WL 2658079 (S.D. Cal. Sept. 9, 2026), the plaintiffs were the representatives and heirs of their deceased teenage son, so some sympathy is understandable.  In this case, however, another amendment seems patently futile and it is time for finality.  The case has been around for more than two and a half years without getting past pleadings; it has been more than two years since the claims against the manufacturer in the second complaint were dismissed without prejudice as expressly preempted and plaintiffs were permitted to file a third complaint. We discuss that dismissal here, along with other issues decided at the same time.  When the plaintiffs amended, the manufacturer moved to dismiss again.  After a stay and unsuccessful mediation, the manufacturer refiled its motion in October 2025 and the motion was ripe in early December 2025.  There are multiple cases around the country involving the device at issue that have not been consistent on preemption.  See here for a notable early preemption win with the same device.  Based on the two preemption decisions in Higginbottom it seems that the only way plaintiffs could plead around preemption would be to add completely new claims, which should not be happening at this stage.  The 2024 decision finding plaintiffs’ claims to be expressly preempted clearly put plaintiffs on notice of what their third complaint needed to accomplish but it fell short.  We would have expected that to be the end of the case.

Otherwise, Higginbottom is pretty good on the merits.  Plaintiffs’ minor son was diagnosed with type 1 diabetes and prescribed defendant’s glucose monitor and another company’s insulin pump.  After almost two years of successful control of his diabetes with the aid of these devices, the decedent changed a sensor in glucose monitor.  2026 WL 2658079, *3.  Within a day, it allegedly began to malfunction, registering high readings that led to the over-administration of insulin by the pump and decedent’s own hand.  He then drove himself on a rural road, allegedly experienced hypoglycemia from the excess insulin, passed out, and suffered a fatal automobile accident.  His estate initially sued both manufacturers, but ultimately settled with the pump manufacturer.  We infer that the allegations in the complaints shifted over time to focus on the alleged malfunction of the remaining defendant’s glucose monitor as being solely responsible for the hypoglycemia.  Although there were four counts in the third complaint, there was really a single theory that the defendant had failed to warn FDA of adverse events suggesting the monitor could lead to the over-administration of insulin.  It appears that plaintiffs must not have ever tried to articulate a potentially non-preempted warnings claim that the Instructions for Use failed to inform prescribing physicians of the device’s risk of contributing to hyperglycemia.  That was probably because they thought that the dubious judicial creation of a state law duty to warn FDA would carry the day.

As we have said before, ascertaining if the state law claims asserted actually exist and have been pleaded properly is a good starting point for deciding express and implied preemption.  Sometimes, that requires a choice of law analysis.  Plaintiffs wanted California law.  They sued there, presumably both because the glucose monitor’s manufacturer is based there and because California is one of the few states whose courts have made up a nonsensical state law duty to report adverse events to FDA.  The plaintiffs were from Wyoming, which is also where the prescription, use, and alleged malfunction of the device occurred and where their decedent’s fatal accident occurred.  Under California choice of law rules, Wyoming law was clearly the one to apply.  We will not dwell much on that analysis, but it did involve an Erie prediction as to whether Wyoming would adopt the same state law duty as California.  Although it did not cite Erie, Higginbottom cited cases that cited Erie and discussed the concept of Erie deference.  (Yes, we did mention Erie three times in one sentence.)  Citing an MDL’s survey of state law on the discussed here that found no support for Wyoming adopting the relatively novel duty, Higginbottom found no authority either and noted plaintiffs’ admission that Wyoming has made a “decision not to recognize a failure warn claim[ ] based on a failure to report adverse events.”  Id. at *8.  (Had the court looked to our surveys on the issue, it would have gotten the same absence of support in Wyoming.)  Thus, the court “decline[d] to recognize such a claim under Wyoming law at this stage of the proceedings.”  Id.  That established the conflict between California and Wyoming law, but it also mattered to the express preemption analysis.

As we discussed at length with the Dickson case that involved the same defendant’s glucose monitors, see here, here, and #6 in our list here, there is a middle ground between Lohr and Riegel that includes Class II devices cleared under de novo 510(k) applications that have special controls codified in a regulation.  Without diving into the issues with broadly applying Lohr to much more recently cleared Class II devices, it is obvious that the glucose monitor was not a “regular” Class II device.  Back in 2024, the first Higginbottom decision had relied heavily on Dickson in finding that the device’s specific regulatory history meant that express preemption applied to plaintiffs’ claims.  Id. at *13.  Plaintiffs urged a different result in 2026 based on the timing of the Final Rule (that is, the CFR section for this kind of device) in relation to the death of plaintiffs’ son.  However, the third complaint actually alleged that the same special controls applied when the device was cleared:

Unlike general requirements, which may be imposed through substantial-equivalence review, the SAC supports the inference that the FDA classified the G6 System subject to device-specific special controls for the purpose of assuring the safety of the medical device.  The allegations that the G6 System underwent subsequent § 510(k) reviews for various aspects of its system—including new interfaces for elements, such as its mobile application and an adhesive patch—do not indicate that the special controls reflected in its initial classification no longer applied.

Id. at *14.  That meant the FDCA’s express preemption provision applied. 

Because Wyoming does not have a state law claim for failure to warn the FDA, plaintiffs could not utilize the largely fictitious parallel claim under Stengel.  Id. at *15.  We have had too many posts on Stengel and parallel claims to link them here.  Many of those posts have talked about how claims that were held not to be expressly preempted could still be impliedly preempted under Buckman.  Higginbottom did not analyze implied preemption.  Maybe that will come up in the inevitable ruling on the motion to dismiss plaintiffs’ fourth complaint that tries to plead a single non-preempted claim.

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Our entering class of C.D. Cal. federal prosecutors back in 1992 was made up of an interesting cast of characters. Those Assistant United States Attorneys went on to become general counsels, judges, professors, and lowly bloggers. Most of the cohort came from BigLaw. Young lawyers were willing to halve their Skadden/Munger/Gibson/A&P etc. salaries so that they could acquire trial experience. But one of our classmates had taken a different route. He had labored for a while in the asset forfeiture division of the U.S. Attorney’s Office. That division was just across the plaza, but a million miles away in terms of the nature of the experience. What did we know about asset forfeiture cases in those salad days? Pretty much nothing. Our colleague regaled us with tales of successful forfeiture actions against drug kingpins, showering the U.S. Treasury with millions of dollars and lots of flashy cars. Who knew that the USAO could be a profit center? It seemed both righteous and cool.

Now that we mostly operate on the defense side of the v, we have developed skepticism about the government’s aggressive deployment of asset forfeiture actions. That brings us to today’s case, United States v. Ahmed, 2026 WL 2654883 (D. R.I. Sept. 9, 2026). Ahmed is an interesting Food Drug, and Cosmetic Act criminal ruling by a magistrate judge. The plaintiff had entered into a plea deal involving a misdemeanor drug misbranding charge. The government was attempting to enforce a $100,000 forfeiture provision in the plea agreement. Obviously, our ears perked up when we heard that drug misbranding might lead to asset forfeiture.

It turns out that the government can be mighty aggressive when it comes to asset forfeiture. Maybe too aggressive. The court in Ahmed held that forfeiture is not authorized against defendants like Ahmed who introduced misbranded drugs into interstate commerce in violation of 21 U.S.C. section 331(a). And even if forfeiture was authorized, the government had not established by a preponderance of the evidence that $100,000 was the true value of the property that was unavailable due to acts or omissions by the criminal defendant.

How did we get to those results? A statutory puzzle had to be pieced together, and then the government’s math appeared to be sloppy and inconsistent. Let’s start with the puzzle:

Fed. Crim. Pro. 32.2(b) requires the court to determine whether forfeiture is authorized in a particular case, if so, what property is subject to forfeiture, and the amount of money to be paid.  

21 U.S.C. section 334, is part of the FDCA, and is entitled “Seizure.” It provides that misbranded drugs may be ordered to be disposed of by destruction or sale.

28 U.S.C. section 2461(c) authorizes criminal forfeitures against defendants charged with crimes for which civil forfeiture of property is authorized.

21 U.S.C. section 853(p) authorizes forfeiture of substitute property when the actual property is unavailable as a result of any act or omission of the defendant.

The problem with the government’s argument is in that first step. It all depends on whether 21 U.S.C. section 334 is a civil forfeiture statute. Only if it is does 28 U.S.C. section 2461 swoop in to apply it in a criminal case, and then 21 U.S.C. section 853(p) allows substitution of property for forfeiture.  The Ahmed court was “unconvinced that 21 U.S.C. section 334 is a civil forfeiture statute.” The only federal court that had analyzed this issue was the Second Circuit in United States v. Fishman, 157 F.4th 143 (2d Cir. 2025). In Fishman, the court vacated a forfeiture order and held that “21 U.S.C. section 334 is not a civil forfeiture statute within the meaning of 28 U.S.C. section 2461(c).” The court reasoned that forfeiture statutes are typically intended to enable the “disgorgement of the fruits of illegal conduct” to penalize unlawful conduct and make it unprofitable and to compensate the government for investigation and enforcement expenditures, whereas the FDCA, by contrast, permits both the destruction of condemned goods and an owner’s retention of those goods after bringing them into regulatory compliance. The very different remedies took section 334 out of forfeiture land.

Now it is true that when the government comes calling, it can be hard to push back on their positions and requests. But if the government starts threatening asset forfeiture based on alleged FDCA violation, push back you must.

As for the government’s sloppy math, it seems like $100,000 was a nice, round, attention-getting number, but not one that was grounded in reality. It literally did not add up. The government asserted that the defendant had realized approximately $80,500 of sales of the misbranded drugs. To suggest that $80K is in the neighborhood of $100K really does illustrate the old saw of “close enough for government work.” But the court thought it was not close enough. Nor was the court impressed by the government’s position that $100,000 was the “negotiated amount” reached by the parties. A court will not order an asset forfeiture that lacks proof.

Accordingly,  the Ahmed court denied the government’s motion for an order of forfeiture.

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This case is from the non-Butler Snow side of the blog.

It’s a relatively new term (at least for us Gen Xers) – but we have all been ghosted. A second date that never gets confirmed. A contractor who quotes the job and then vanishes. A group text that just stops. It stings, but usually the only casualty is your ego. In Sarmiento-Tenecela v. Teva Pharmaceuticals USA, Inc., No. ESX-L-002653-20, slip op. (N.J. Super. Ct. Law Div. Aug. 31, 2026), the casualty was the entire case.

Plaintiff sued over a Paragard IUD that fractured on removal a decade after it was placed, and she planned to prove her claims with two experts — David Kessler, the former FDA Commissioner and go-to plaintiff’s expert in pharmaceutical mass torts, and Dr. Jimmy Mays, a polymer chemistry PhD who has done general causation work in the Paragard MDL on the device’s materials and design. These are not fly-by-night witnesses pulled off a for-hire circuit. They are the same experts other Paragard plaintiffs have relied on nationwide. Small problem — neither one ever sat for a deposition in this case. Defendants asked for dates. Plaintiff did not respond. The court ordered depositions to happen by a date certain and warned that noncompliance could mean preclusion of expert testimony or worse. Plaintiff still did not produce them. When the motion for sanctions finally landed, plaintiff’s excuse amounted to “we could not reach them” and “counsel had a family medical situation.” The court was sympathetic to the latter as a human matter and unmoved by it as a legal one. You cannot rely on an expert to beat summary judgment while simultaneously keeping that expert unreachable for the other side. That is not litigation, that is hide and seek.

Plaintiff’s defense was that Kessler and Mays are general experts in the Paragard MDL and that plaintiff’s counsel does not control their calendars. That much may be true. These experts likely are booked across dozens of cases and answer to MDL leadership, not to any one plaintiff’s firm, but it cuts against plaintiff, not for her. Nationally prominent, frequently deposed experts are not hard to find or schedule; they have existing deposition protocols, standing availability windows, and counsel who negotiate their calendars as a matter of routine. Plaintiff also cited counsel’s mother’s hospitalization for cardiac procedures as a reason the deadline slipped. The court did not dismiss those circumstances, but it also did not let them do the work plaintiff needed them to do. Personal hardship might explain a missed phone call. It does not explain months of silence on a court-ordered deposition schedule, and it certainly does not explain why they could not be produced even after the court compelled compliance.

Defendants asked for dismissal outright as a sanction. The court declined to go that far, noting that dismissal as a discovery sanction is reserved for cases where the misconduct goes to the very foundation of the claim or is deliberate and contumacious. Id. at 5. Instead, the court went with the lesser remedy of preclusion. Id. at 6-7. Kessler and Mays were barred from offering testimony at trial. But benching the experts turned out to be the ballgame anyway because plaintiff needed them to survive summary judgment.

To defeat preemption of a failure to warn claim, a plaintiff has to show the manufacturer could have made a unilateral label change under the FDA’s changes being effected regulation (“CBE”). Which requires plaintiff to produce evidence of “newly acquired information” that reveals risks of a “different type or greater severity or frequency” than what was available to the FDA at the time of approval.  Id. at 7.  In this case that meant, plaintiff needed to show defendant possessed qualifying newly acquired information before plaintiff’s IUD was implanted in April 2008. She did not. The adverse event reports she pointed to were already reflected in the FDA-approved label before her IUD was placed, and a study done in 2015 was simply seven years too late to support a CBE label change before 2008.  The court noted, tellingly, that it did not even know what Kessler would have said about newly acquired information as of 2008, because his MDL report never addressed the question. Funny how that works when you will not produce your expert for a deposition. The court found no genuine dispute of material fact and held the warning claims preempted. Id. at 18.

Plaintiff also argued the IUD’s breakage warning did not adequately cover fracture during routine removal without preexisting embedment. The court did not need to resolve that dispute because plaintiff’s only medical expert testified the device was in fact embedded at the time of removal. The precise risk plaintiff says the label failed to disclose is not the risk that happened to her. And having conceded she would not offer her case-specific medical expert on label adequacy at all, plaintiff was left with no warning expert whatsoever. Id. at 19.

The design defect claim fared no better. Plaintiff’s two design theories, the type of resin used and the barium sulfate concentration, required evidentiary support plaintiff simply did not have. She offered no evidence her own device used the disfavored resin, and no expert testimony that a different barium sulfate concentration would have prevented the fracture. Nor did she offer any expert evidence of a feasible alternative design.  Under New Jersey law, a design defect claim without an alternative design is not a design defect claim. Id. at 18.

This is a defense win on preemption, but our focus is on the preclusion ruling. Discovery gamesmanship around expert witnesses has consequences, even when a court is not willing to nuke the whole case as an outright sanction. A plaintiff who will not make her experts available for deposition simply does not get to use them, full stop, and courts should not need to hear the phrase “we could not reach them” more than once before losing patience.  Ghosting has consequences. In this case, plaintiff’s experts skipped the date, and the whole case got left standing at the altar.

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Last month we published a thought piece, Medical Monitoring and the Limits to Equity, pointing out how no-injury medical monitoring claims asserted in federal court could well fall outside the foundational limits on those courts’ equitable powers, given the holding in Grupo Mexicano de Desarrollo S.A. v. Alliance Bond Fund, Inc., 527 U.S. 308 (1999), limiting federal equity powers to the “the jurisdiction in equity exercised . . . in England at the time of the adoption of the Constitution and the enactment of the original Judiciary Act,” that being, of course, 1789.  Id. at 318.  We also concluded that the Judicial Act’s limits to federal equitable powers likely applied in diversity cases, given, Guaranty Trust Co. v. York, 326 U.S. 99, 104-06 (1945), and its progeny.

We cautioned, however, “that this argument seems never to have been tried before in the medical monitoring context,” given that we found no “opinion in any court citing to either Grupo Mexicano or Guaranty Trust that also included the phrase ‘medical monitoring.’”

That’s no longer true.

In Bio-Lab, Inc. v. Tartt, ___ S.E.2d ____, 2026 WL 2395789 (Ga. Aug. 18, 2026) – decided less than two weeks after our post – the Georgia Supreme Court came to the same result as the second part of our analysis – that the limits of equitable jurisdiction exercised by federal courts in diversity cases are federal in nature, given the Guaranty Trust line of cases.  Id. at *5-6.  Bio-Lab involved a medical monitoring claim, the state high court having accepted certified questions from a federal district court:

The Defendants moved to dismiss that request for equitable relief, arguing that, under Georgia law, the requested remedy is unavailable in the absence of allegations of present physical injury. . . .  [G]iven the dearth of Georgia case law on medical monitoring in connection with mass torts, [the federal court] was “left with considerable uncertainty as to whether Georgia law permits medical monitoring as a tort remedy absent a current physical injury.”

Discerning no clear answer to that question, the district court opted to seek our input and certified the following questions to this Court:

(1) Under Georgia law, can a plaintiff exposed to toxic substances which may cause future disease obtain equitable relief in the form of medical monitoring costs absent an allegation of present physical injury; and

(2) If so, what standard must the plaintiff meet to obtain such relief?

Id. at *2 (emphasis added).

The Georgia Supreme Court interpreted the first question “as implicating two broader legal issues with relevance beyond the specific facts,” the first being “under what circumstances is equitable relief available.”  Id. at *3.  That was a question governed by state law.  Id.  To be entitled to equitable relief, a plaintiff “must first identify some legally cognizable ‘wrong’ or ‘injury’ that needs to be remedied.”  Id. (citation and quotation marks omitted).  That is a “separate question whether that plaintiff is entitled to some form of relief.”  Id.

Bare fears of injury will not authorize equitable relief.  Rather, where a plaintiff seeks an equitable remedy for a threatened legal injury, that injury must be imminent, not remote, before equitable relief is authorized.

Id. at *4 (citations omitted).  Because “equity follows law,” equitable relief cannot be afforded “contrary to the law.”  Id. (citation and quotation marks omitted).

Given the pleadings-based status of the case, the Tartt court refused to go any further, and did not directly address medical monitoring.

[R]esolving the issue of whether equitable relief is available will first involve a thorough and intensive evaluation of whether the Plaintiffs’ complaint includes sufficient factual allegations to demonstrate both a legally cognizable injury and the necessity of equitable relief to remedy that injury.  But this Court, when answering questions certified to us by a federal court, does not reach the merits of the underlying case; instead, we answer the questions posed to us only in a general sense. . . .  Thus, we respectfully decline to answer the district court’s questions to the extent that it calls on us to decide the ultimate issues raised by the Defendants’ motion to dismiss.

Id. (citation and quotation marks omitted).

If the court had stopped there, Tartt would have been a non-event, since it did not reach the issue of whether no-injury medical monitoring was an available equitable remedy under Georgia law.

What made Tartt bloggable was the court’s treatment of the second question – “when equitable relief is available, what is the appropriate form and scope of that relief?”  Id. at *5.  That question, Tartt recognized, was “largely” a federal question under Guaranty Trust:

Unlike the question of entitlement to equitable relief (something we agree with the district court that state law governs), the form of equitable relief that a federal court sitting in diversity may grant may (we believe) be largely a question of federal law.  [citing Guaranty Trust and progeny decisions]  We acknowledge that this is a surprisingly thorny issue.  But we think the best reading of the relevant decisional law − which is not exactly a beacon of clarity − is that the appropriate form and scope of equitable relief must be determined as a matter of federal law.

Id. (other citations omitted) (emphasis added).  Why?  “[S]tate law clearly cannot commit the federal courts to grant equitable relief [in a diversity case] contrary to restraints imposed by the Constitution or an Act of Congress.”  Id. (Wright & Miller citation omitted).  “[C]rucially, some have interpreted Guaranty Trust to mean that state law does not govern the scope of the equity powers of the federal court, even when state law supplies the rule of decision.”  Id. at *6 (citation and quotation marks omitted) (emphasis original).

The referenced “some” cases include those that we had collected in the Guaranty Trust portion of our post not two weeks earlier.  Don’t worry, we’re not getting too full of ourselves – Tartt did not cite the same actual cases we did; ours were considerably more recent, so there’s no reason to believe that anybody involved in Tartt had ever read our post.

But, as to the second issue in our post, that federal law governed the scope of available equitable relief in diversity cases, Tartt reached the same conclusion we did:

So − as we understand the current state of the admittedly ambiguous law − a federal court, although limited by state jurisprudence on the question of whether the injunction remedy may be granted, is free to decide for itself what the scope and content of that injunction should be as befits the historically discretionary character of equity jurisprudence.  State law provides the basis for relief; it does not necessarily constrain the scope of that relief.  And that seems especially true where, as here, state law supplies no clear answer as to the availability of a specific form of injunctive relief.

2026 WL 2395789, at *6 (citation and quotation marks omitted).  Tartt thus “declined to opine” on the availability of any “specific form of equitable relief,” such as medical monitoring.  Id. at *7 (“We therefore respectfully decline to address whether Plaintiffs are entitled to a medical monitoring injunction.”).  Before that could happen, the federal court hearing the case would have to “determine[] that equitable relief is appropriate (or properly asserted).”  Id.

And that brings us back to the first, and most intriguing, point of our prior “Limits to Equity” blogpost – that “equitable” medical monitoring claims in federal court are subject to the United States Supreme Court’s Grupo Mexicano holding that federal equitable relief is limited to those powers recognized by the English courts of equity back in 1789.  We have no reason to believe that any English chancellor in equity during the reign of King George III (or before) had permitted uninjured persons to recover for medical testing expenses based on mere exposure to a purportedly toxic substance.  That’s something that we hope that the defendants in Tartt (and defendants in any medical monitoring litigation in federal court) will raise as a defense in the future.

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About four years ago we posted about a decision in which the Wisconsin Court of Appeals reversed a trial court’s injunction requiring the administration of a certain medication to treat a patient suffering from COVID-19. In that decision, the party seeking the injunction relied on an unsworn declaration from a physician who stated that he was “generally considered the foremost authority” on the proposed treatment. Gahl v. Aurora Health Care, Inc., 403 Wis. 2d 539, 554-55 (Wis. Ct. App. 2022). That decision rejected the assertions in the declaration and noted that the declaration was “conspicuously devoid of any discussion of the patient in [the] case.” Id.  Today’s decision, Kory v. Waters, 2026 WL 2507087 (2d. Cir. Aug. 26, 2026), comes full circle—the physician who offered the declaration in Gahl supporting what might be considered unorthodox treatment was named as a defendant in a medical malpractice claim related to his treatment of a patient with COVID-19.  The dismissal of the malpractice claims underscores the broad scope of immunity under the Public Readiness and Emergency Preparedness Act (the PREP Act), 42 U.S.C. § 247d-6d.  Even if the treatment might be considered “counter-culture,” if the Act’s requirements are satisfied, it is subject to immunity from suit.

Continue Reading PREP Act Comes Full Circle for “Counter-Culture” Expert in COVID-19 Treatment
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Today’s guest post comes from three Reed Smith colleagues and fellow European Union Product Liability Directive nerds, Jamie Lanphear, Greg Speier, and Wim Vandenberghe. As always, our guest posters get all the cheers for their work along with any jeers, though those are hardly likely.

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The Blog has been sounding the alarm on the EU’s new Product Liability Directive (“PLD”) for almost two years now—and with good reason.

For those just tuning in, the PLD is the most sweeping reform of EU product liability law in four decades—expanding the definition of “product,” introducing claimant-friendly presumptions of defect and causation, broadening disclosure obligations, and extending the categories of recoverable damage. The Directive requires all 27 EU Member States to transpose it into national law by December 9, 2026. It applies to products placed on the market or put into service after December 8, 2026 (a typo was recent corrected in the original text, which had stated December 9).

Over the past year and a half, the Blog has covered the Directive’s overhaul of EU product liability law (see, e.g., here, here, here, and here, ), including its implications for software and digital products (here), its expanded disclosure obligations and the risks they pose to privileged communications (here), and what the European Commission itself has said about its goals for the new regime (here).  

This post is about implementation—where each Member State stands with fewer than four months to go, and where meaningful national divergences are emerging that will shape litigation risk on day one. The short version: three Member States have completed transposition, twelve more have draft legislation in the pipeline, and the rest are somewhere between initial steps and radio silence.

Where Things Stand

Member State transposition efforts fall into four categories.

Completed Transposition: Hungary, Croatia, and Lithuania have completed transposition. Hungary was first, with its parliament adopting the implementing law on December 16, 2025. Croatia followed on July 7, 2026, amending its Civil Obligations Act and notifying the Commission. Lithuania’s Seimas adopted its bill on June 25, 2026, as Act XV-1080, with an entry-into-force date of December 9, 2026.

Well Underway: Twelve Member States have prepared draft legislation: Belgium, Cyprus, Czech Republic, Denmark, Finland, Germany, Italy, the Netherlands, Poland, Slovakia, Slovenia, and Sweden. Germany, Slovakia, and the Netherlands are furthest along—each is in parliamentary process and tracking toward adoption this fall. Belgium, Italy, and Slovenia entered the pipeline more recently but are moving. The remainder have drafts in various stages of consultation and review.

Early Stages: Austria, Bulgaria, Estonia, France, the Republic of Ireland, Latvia, and Romania have taken initial steps toward transposition but have not yet published draft legislation. Austria expects to submit a draft to parliament this fall. Bulgaria is preparing draft legislation, with submission to the Council of Ministers expected in September. Estonia expects a government proposal to reach parliament in September 2026. France has confirmed an interministerial working group and stakeholder consultations, but no published text yet.

No Known Public Movement: Greece, Luxembourg, Malta, Portugal, and Spain have made no known public progress toward transposition.

Key Divergences to Watch

This is where it gets interesting. The PLD is a maximum-harmonization directive, meaning that Member States generally may not adopt more or less stringent rules than those set forth in the Directive. But the PLD expressly leaves room for national discretion in certain areas. In others, differences emerging in national implementing legislation raise questions about whether Member States have gone beyond the discretion the Directive allows.

Development Risk Defense: This defense—also known as the “state-of-the-art” defense—protects manufacturers from liability if the scientific and technical knowledge at the time the product was released was such that the defect could not have been discovered. Article 18 expressly permits Member States to depart from this defense. Most drafts retain it, but there are some exceptions: Finland will continue its longstanding exclusion of the defense. Hungary limits the defense for medicinal products used as instructed. Germany retains the defense, subject to its existing carve-out for genetic engineering products.

Non-Material Damages: The PLD expressly leaves aspects of damages to national law. Recital 23 provides that non-material losses—such as pain and suffering—are compensable to the extent permitted under national law. As a result, the availability and calculation of non-material damages will continue to vary across Member States, even under the PLD’s maximum-harmonization framework. That variable will likely shape forum-shopping decisions.

The “Excessive Difficulties” Threshold: This one is particularly concerning. Article 10(4)(a) allows courts to presume defectiveness and causation where a claimant faces “excessive difficulties” in proving those elements due to technical or scientific complexity. Finland and Sweden have removed the word “excessive” in their implementing proposals, arguably lowering the threshold for claimants to trigger the presumptions.

However, unlike the development risk defense and non-material damages, the PLD does not expressly authorize Member States to vary this threshold. Whether these divergences represent permissible implementation choices or conflict with the Directive’s maximum-harmonization requirement may ultimately require judicial resolution. But in the meantime, they create exactly the kind of patchwork that encourages forum shopping—claimants filing in the jurisdiction with the most favorable presumption standard.

Disclosure: As we discussed in a prior post, the PLD’s disclosure requirement is a significant development, particularly for jurisdictions that have historically had little or no pre-trial discovery. Member States are taking different approaches. Some are adopting new, PLD-specific disclosure provisions, while others are relying on existing procedural rules.

Regardless of approach, Article 9 requires courts to have authority to order that disclosed evidence be presented in an easily accessible and understandable manner. Belgium’s government has expressly acknowledged that the PLD disclosure requirement goes beyond existing document production under Article 877 of the Judicial Code. The Directive also contemplates that compliance may require compiling or classifying evidence into a comprehensible presentation—not simply producing documents as they exist. That is an obligation that will be new to many defendants.

Distributor Liability: Denmark proposes to keep its existing fault-based distributor liability rules within the PLD framework. Once the injured party proves defect, damage, and causal link, the burden shifts to the distributor to prove it did not make the product dangerous. Whether those rules fall entirely outside the PLD’s maximum-harmonization requirement may become an important issue as distributors defend claims under the new framework.

What This Means

The PLD’s transposition process is unfolding largely as expected: most Member States are hewing close to the Directive’s text, and late movers will likely copy-paste their way to compliance. But the divergences that are emerging—on defenses, the “excessive difficulties” threshold, and disclosure—are important to note. They will create different litigation environments across the EU, and they will shape where claimants choose to file.

For defense lawyers, the practical takeaway is straightforward: do not treat the PLD as a single, uniform regime. Map the differences. Monitor the late transposers. And prepare for the likelihood that the first wave of litigation under the new rules will be as much about testing the boundaries of national implementation as it is about the underlying claims.

December 9 is coming. The question is no longer whether the PLD will change the landscape. It is how—and where—the changes will land first.

Drug & Device Resources

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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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