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As we have discussed more times than we like, the plaintiffs’ class action cabal, in conjunction with their running-dog Valisure “if it doesn’t have it, we’ll cook it until it does” “testing” laboratory, has targeted various products supposedly containing benzene contaminants.  The result has been a plethora of no-injury class actions by plaintiffs who used these products without incident, but purportedly want their money back.

As is evident from our prior posts, most of them have been dismissed.

Here’s another one:  Navarro v. Walgreens Boots Alliance, Inc., 2025 WL 1411406 (Mag. E.D. Cal. May 15, 2025), adopted, 2025 WL 3485004 (E.D. Cal. Dec. 4, 2025).  The targets of opportunity in Navarro were several “acne treatment drug products.”  Id. at *1.  After keeping some of these products at ridiculously high temperatures (between 99 and 158°F) for extended periods of time (18 days), Valisure was able to detect “high levels of benzene” in some of the samples.  Id. at *2.  Citing those tests, a couple of plaintiffs (from California and Massachusetts) sued, bringing consumer protection, warranty, and unjust enrichment claims under the laws of various states – including states in which they neither lived nor purchased any products.  Id. at *5.

The magistrate judge threw out the entire kit and kaboodle, holding that while the plaintiffs had standing (at least in their states of residence) the claims were either preempted or failed to state a claim.  Unfortunately, Ninth Circuit standing precedents are woefully lax, allowing plaintiffs to sue whenever they allege that they “paid more for [the product] than [they] otherwise would have paid, or bought it when [they] otherwise would not have done so,” but for a defendant’s actionable statements or omissions.  Id. at  *8 (citation and quotation marks omitted).  So the plaintiffs got a pass on standing.

These anti-acne products are OTC drugs, and as we have discussed many times, the OTC section of the FDCA has a strong preemption clause – albeit with an exception for “product liability” that does not protect economic loss claims from preemption. That clause prohibits enforcement of state-law requirements “different from or in addition to, or . . . otherwise not identical with” FDA requirements.  Id. at *10 (quoting 21 U.S.C. §379r(a)).  Plaintiffs, of course, claimed that the various states’ laws required benzene-related warnings that the FDA had not required in its “monograph” governing these products.  Since the federal labeling requirements for these OTC products did not require any reference to benzene, those claims “are expressly preempted.”  Id. at *11.  Nor could plaintiffs evade preemption by claiming “misbranding.”  “The upshot of the regulations and the anti-acne monograph, described above, is that a drug that complies with all monograph requirements is not misbranded.”  Id. (citation omitted).  An applicable monograph “cannot be used as the basis to force a company to go above and beyond what that monograph prescribes because that is expressly preempted.”  Id.

Nor was benzene either an “inactive ingredient” or a “component” of these products.

There are no allegations that [defendant] intended to directly combine benzene into [these] products; rather, the allegations are that [they] can and do[] degrade into benzene.  Based on the forgoing, the Court concludes that benzene is not an inactive ingredient, and [defendant] was therefore not required to list it on its . . . labels. Plaintiffs have not pointed the Court to any authority to the contrary.

Id. at *13.

Navarro did not, however, extend preemption to purported “parallel” claims involving allegations of violations of FDA CGMPs – at least not yet.  Disturbingly, the decision imported the rationale in Davidson v. Sprout Foods, Inc., 106 F.4th 842 (9th Cir. 2024), a food case, into the OTC drug context, without even acknowledging the difference between the two.  Navarro, 2025 WL 1411406, at *13-14.  Even though that claim was an afterthought, with CGMPs never mentioned in the complaint, Navarro found these purported “parallel” claims sufficiently pleaded.  Id.

But parallel claims didn’t get these plaintiffs very far, because the state-law claims they brought all sounded in fraud, and plaintiffs “failed to allege how they were deceived.”  Id. at *14.

Plaintiffs have argued throughout their opposition (and alleged in their complaint) that [defendant] has potentially violated regulations or cGMPs.  Even with this reasonable inference, the Court finds that Plaintiffs have not alleged facts that either establish that [defendant] violated cGMPs, or even if [it] did violate the cGMPs, how those violations ultimately deceived Plaintiffs.

Id. at *15.  Vague allegations of “omissions” were not enough.  Id.  Therefore, the entire action was dismissed.

Plaintiffs predictably objected to the magistrate’s findings.  They lost again.  Navarro v. Walgreens Boots Alliance, Inc., 2025 WL 3485004 (E.D. Cal. Dec. 4, 2025), did more than just adopt the magistrate’s decision.  First, the district judge agreed that “claims based on a theory of failure to warn/disclose BPO degradation risk are categorically preempted by the [FDCA].”  Id. at *1.  On the adequacy of the pleadings, however, the judge went further.  Plaintiffs failed even to allege any purchase of purportedly benzene-contaminated products:

Plaintiffs assert parallel state duties and third-party free speech rights that assume benzene adulteration.  However, Plaintiffs have not made a colorable showing the product they purchased from Defendant contained benzene due to a failure to follow cGMP or otherwise.

Id.  Thus, this Valisure molehill will not become a class action mountain.

Good riddance.

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On April 28, Dechert will host its 3rd Annual Life Sciences Day, a half-day program for in-house counsel, executives, and investors. Featuring speakers from leading pharmaceutical and biotech companies, the program will deliver sharp insights on the legal, regulatory, and business challenges shaping the industry. Hear directly from practitioners on how to manage risk and stay ahead in a rapidly evolving landscape.

The topics will include:

  • Health Apps in the Cross Hairs: Winning the First Big Tech Privacy Class Action and What It Means for Your Business
  • Active and Engaged: What Government Enforcers Want Life Sciences Companies to Know
  • Antitrust R&D: What’s in the Pipeline?
  • The Life Sciences Executive: The New Rules for Leadership

Click here to register.

Detailed agenda and additional speaker announcements will be shared soon. We hope to see you there!

Event Details:

Location: Dechert LLP, Cira Centre, 2929 Arch Street, Philadelphia, PA 19104

Date: Tuesday, April 28, 2026

1:30 p.m. | Registration

2:00 p.m. | Program

5:30 p.m. | Networking Reception

CLE Information:

CLE credit for this program is pending for California, Connecticut, Illinois, New Jersey, New York, North Carolina, Pennsylvania and Texas.

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It’s hard to think of any recent litigation where plaintiffs didn’t seek overblown discovery about adverse event reports and then have their experts rely on those reports in an effort to establish causation.  But as we’ve blogged about repeatedly, reports from the FDA’s Adverse Event Reporting System (“FAERS”) do not establish causation (and, for good measure, they don’t constitute newly acquired information). Today’s decision, Taylor v. Dixon, 2026 WL 865183 (M.D. Fla. Mar. 30, 2026), is a little different since it involves a federal habeas petition.  But we couldn’t resist blogging about it given the court’s comprehensive take-down of the attempted use of an adverse event report to show causation. 

Continue Reading Adverse Event Reports May Not Be Used to Establish Causation
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The latest medical device express preemption decision, Wieder v. Advanced Bionics LLC, 2026 U.S. Dist. LEXIS 70645, 2026 WL 880370 (S.D.N.Y. Mar. 31, 2026), comes out of the Southern District of New York and involves a Class III, PMA‑approved cochlear implant. 

Fluid allegedly worked its way into the device and caused a short‑circuit and device failure.  Then, a replacement surgery only partially succeeded because of scarring attributed to the original device, allegedly leading to permanent impairment of the infant patient’s ability to hear, speak, and learn.

In this opinion, the District Court adopted almost all of a solid Report and Recommendation by Magistrate Judge Gorenstein, and the result is that all the classic product‑liability theories—manufacturing defect, design defect, implied warranty, consumer protection, fraud, and failure to warn—were dismissed, largely on preemption grounds, while three negligence‑based counts and derivative loss‑of‑services claims live on.

The court followed the familiar Riegel v. Medtronic, Inc. framework:  For PMA‑approved Class III devices, state‑law claims are expressly preempted if they would impose requirements “different from, or in addition to” the federal requirements.  To escape preemption, plaintiffs must plead a “parallel” claim: a traditional state‑law duty that mirrors a federal requirement applicable to the device without imposing anything more or different.  (We realize the parallel terminology is de rigueur, but would not mind if more courts adopt the “mirror and ceiling” framework instead.)

We heartily approve of some themes that run through the opinion:

  • It is plaintiffs’ burden to allege a specific deviation from applicable FDA requirements.
  • General references to Current Good Manufacturing Practice regulations (or “CGMPs”) do not supply the needed specificity.
  • Voluntary recalls, alleged high failure rates, and alleged under‑reporting to FDA also are not, without more, enough either.

As to strict liability manufacturing defect, the plaintiffs did not merely regurgitate the elements in a conclusory way.  They at least added some alleged facts to the mix—that the manufacturing defect resulted from hand-application of a silicone sealant around the implant’s electrode, which allegedly was not subject to proper quality control, as the CGMPs allegedly require and as a voluntary recall and high failure-rate study allegedly established.

While that perhaps would be enough to state an ordinary manufacturing defect claim for a regular product, it was not enough to plead and adequate, non-preempted one for a PMA medical device.  The complaint did not allege any specific  CGMP violation, it wasn’t clear that hand application was a CGMP violation, and asserting “no quality control” is too conclusory to withstand our old friend Twiqbal.

In objecting to the Magistrate Judge’s Report and Recommendation, Plaintiffs did raise a specific alleged CGMP violation for the first time (21 C.F.R. § 820.70(a) regarding process validation and reproducibility), but the District Court refused to consider arguments not presented to the magistrate judge. 

Nevertheless, we will raise another CGMP argument of our own here for the first time in response.  PMA applications “are required to include” descriptions of their compliance with Current Good Manufacturing Practices (“CGMP”) requirements, which are promulgated in the Quality System Regulation (“QSR”), and “approval of a PMA application for a device can be denied if a manufacturer does not conform to the QS regulation requirements.”   See FDA’s Compliance Program Guidance Manual related to Medical Device PMA Preapproval and PMA Postmarket Inspections, at Part I, p. 1-2.

Putting it another way, the FDA reviewed and approved the hand-painted silicone step and the quality control procedures as part of the PMA process.  Therefore, a plaintiff claiming that the quality control process didn’t measure up, or that the manufacturer’s systems did not satisfy 21 C.F.R. § 820.70(a)’s process validation and reproducibility requirements, necessarily is using a state law claim to second-guess the FDA’s grant of premarket approval and inherent determination that the manufacturer’s processes were appropriate.  Preemption should result regardless.

Anyway, next up was the design‑defect claim, and that was quickly dispatched.  State‑law design‑defect claims challenging the safety or efficacy of the PMA‑approved design are categorically preempted because they would impose different design requirements than those the FDA approved.  Even though a plaintiff lacks access to confidential PMA documents at the motion to dismiss phase, those practical difficulties do not excuse plaintiffs from meeting their burden of alleging a specific deviation from PMA requirements. 

The New York implied warranty of merchantability claim went the same way.  Such claims also necessarily second‑guess the FDA’s safety and effectiveness determination by asserting the product was not “merchantable” (i.e., not fit for its ordinary purpose) despite being approved.

Plaintiffs’ New York consumer protection and fraud claims, and part of their failure to warn claim, targeted the device’s labeling, marketing, or promotional materials as deceptive and misleading.  But those materials were FDA‑approved, so these theories were preempted.  (Plaintiffs also failed to identify the allegedly fraudulent statements, which itself is always a problem.)

Weider also addressed a failure to warn claim premised on an alleged failure to report adverse events to the FDA.  The Magistrate Judge, quite correctly, recommended dismissal of this claim because New York law does not recognize a state law duty to report adverse events to FDA. 

The District Court unfortunately disagreed on this point, concluding that New York law might allow this theory in some circumstances.  In particular, because the learned intermediary doctrine requires manufacturers to take “adequate steps” to alert prescribing or implanting physicians to device risks, those steps may include notifying the FDA of adverse events, which the FDA may then disseminate to the universe. 

That allowance did not save plaintiffs’ claim here, however, because these plaintiffs alleged that the FDA received “multitudes of adverse event reports,” undermining the whole “there was a failure to report” idea.  

The claims that made it through were narrower negligence and loss of consortium-type claims that the manufacturer did not attack with preemption. 

The District Court’s order smartly closed the door on further amended complaints, and directed the parties to get to work on a discovery and case management plan for the case as narrowed. 

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Foster v. Nestle USA, Inc., 2026 WL 893348 (N.D. Ill. March 31, 2026), is not a drug or device case, but it is noteworthy because the court held that there was no private right of action under the Illinois Food, Drug, and Cosmetic Act.  Then again, the case is about chocolate, and chocolate has an effect on neurotransmitters as powerful as some drugs.  Chocolate can induce feelings of love. Or satisfaction. Or guilt.  It is pretty powerful stuff.  

But what exactly is chocolate? That is the question in Foster.  Answering that question is Judge Steven Seeger, whose logic is exceeded only by his prose style.  Here is the first paragraph in Judge Seeger’s Foster opinion: “Stephanie Foster has a sweet tooth, and she wanted to sink her teeth into a mouthful of chocolate. By the sound of things, Foster is a foodie. She didn’t want just any chocolate. She wanted 100% real chocolate.”  The opinion draws the reader in, like the smell of toll-house cookies.  Note the present tense, the short words, and short sentences. There is alliteration, but it is not overly done. Judge Seeger could probably write better ad copy than most Madison Avenue agencies.  

Advertising, in a sense, is what the Foster case is about.  It is yet another food false advertising case, in which a plaintiff (really the plaintiff lawyer) is playing a hyper technical game of Gotcha.  The plaintiff bought several bags of Nestle chocolate chips. (Judge Seeger mentions that it is a little strange that the plaintiff bought her bags from different retailers – as if “she was claim shopping while chocolate shopping.”) Judge Seeger tells us that the labels on the bags promised “any hungry consumer that the bag contained ‘100% real chocolate.’” 

The plaintiff cried foul upon discovering that the chocolate chips contained soy lecithin and natural flavors.  (Of course those ingredients were plainly listed on the back of the bag.) She claimed that the soy lecithin and natural flavors made the “100% real chocolate” statement a 100% lie. She filed a class action complaint containing six claims.  The first three claims fall under consumer protection statutes.  The last three were a couple of breach of warranty claims along with negligent misrepresentation.  

The defendant filed a 12(b)(6) motion, which the court granted, concluding that the “complaint is half-baked and is 100% dismissed.” As part of what we perceive to be a welcome and growing trend, the opinion includes pictures of the bag of chocolate chips. The court, while plainly having fun with the case, faithfully recited the plaintiff’s damages theory, which was that chocolate chips boasting 100% authenticity were priced higher than chips lacking that boast. But the court also faithfully followed the laws supporting the claims, which “require a false or misleading statement that deceives a reasonable consumer.” The court concluded that “No reasonable consumer would need protection from Nestle’s bag of chocolate chips.” The reasonable consumer standard is objective, not subjective. No reasonable consumer thinks that chocolate contains only the byproduct of cacao beans. Maybe Forrest Gump said that life is like a box of chocolates because you never know what you’ll get, but any consumer of chocolate knows that they are getting a composite product. Sugar is just one example of something added to chocolate. There is a decent chance that, as a kid, you once made the mistake of gobbling some pure cacao powder. If you did so, you grew alarmed at the unpleasant, bitter sensation. That stuff plainly needed something else to make it luscious. Modern chocolates contain milk solids, added flavors, modifiers, and preservatives. The common, everyday understanding of what is in chocolate is confirmed by FDA regulations, which list a variety of constituents of chocolate foods, many of which have nothing to do with cacao beans. The National Confectioners Association is in accord, as are many other authorities (including public health journals and MIT).

The fact that the other ingredients are listed on the back of the bag is important, though not necessarily dispositive. There is Seventh Circuit authority that an accurate fine-print list of ingredients on the back does not foreclose as a matter of law a claim that an ambiguous front label deceives reasonable customers. But the reference to 100% chocolate on the front of the bag does not deceive reasonable customers. Judge Seeger reasoned that “Courts don’t have to treat consumers like eggshell-skull plaintiffs, wandering bewildered down the grocery aisle in the Land of Confusion. And at some point, it is not asking too much to expect a reasonable consumer to read the list of ingredients if they’re unsure.” The court refused “to check common sense at the door.” Courts should not “bend over backwards to find ambiguities.” A “true chocolate lover” would not be hoodwinked by the reference to “100% chocolate” “and a reasonable consumer wouldn’t either.” There are far too many consumer fraud lawsuits that dance on the head of a pin. The Foster opinion offers a blueprint for emptying those lawsuits into the garbage can.

We also enjoyed the Foster opinion’s sweet prose and delicious common sense. Our profession could use s’more of such clarity.

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As one court succinctly put it over a decade ago: “No federal appellate court has approved a nationwide personal injury, product liability or medical monitoring class.” Durocher v. NCAA, 2015 WL 1505675, at *10 (S.D. Ind. Mar. 31, 2015). That remains true today—and the plaintiff in Lester v. Abiomed, Inc., 2026 WL 874051 (N.D. Ohio Mar. 31, 2026), didn’t come close to changing it.

Plaintiff brought a putative nationwide personal injury class action arising from a recalled medical device. Defendant moved to dismiss several claims and to strike the class allegations. The court granted both motions—unsurprisingly, and for good reason.

Start with the pleadings. Ohio’s Products Liability Act (“OPLA”) explicitly abrogates all common law product liability claims. If you are seeking damages for injury allegedly caused by a product’s design, manufacture, warnings, or representations (warranty), your claim lives (and dies) under OPLA.

Plaintiff tried to plead around that reality with claims for fraudulent concealment, fraudulent misrepresentation, and violation of the Ohio Consumer Sales Practices Act. But labels don’t control—allegations do. And here, the allegations told a familiar story. Defendant knew about alleged defects and either concealed them or misrepresented the product’s safety. That is failure to warn. Id. at *2-3.

On the two fraud claims, the court looked past the plaintiff’s attempt to recast those allegations as breaches of a “general common law duty not to deceive,” id. at *3, and found them squarely within the heartland of product liability law. Because they were, they were abrogated by OPLA.  Id.

The consumer protection claim fared no better. It rested on the same alleged concealment and misrepresentation of product defects, making it “intrinsically intertwined” with the product liability claims. That, too, meant OPLA governed and displaced it. Id. at *4.

With the non-OPLA claims out of the way, the court turned to the class allegations. And here is where things went from unlikely to impossible.

Courts can strike class allegations at the pleading stage where it is clear from the complaint itself that Rule 23 cannot be satisfied. Id. This was one of those cases.

The problem, as always with products liability claims, is predominance. Rule 23(b)(3) requires “that the questions of law or fact predominate over any questions affecting only individual members.” Id. at *5. The Sixth Circuit frames the predominance inquiry simply: put common issues on one side of the scale and individual issues on the other. In personal injury product cases, the scale doesn’t just tip—it collapses.

Plaintiff’s own allegations made that clear. There was no single defect theory—there were three. No single causal pathway—each claim required an individualized inquiry. As the court explained, proving liability would require delving into “each class member’s individual medical history, conditions, medical procedures, and other potentially relevant contributory factors.” Id. at *6. Warnings were also individualized. They changed over time, and some putative class members received the very warnings plaintiff claims were lacking. Id.

And then there’s the nationwide class problem. Different states, different laws. Not just in nuance, but in ways that would make instructing a jury on a classwide basis “impossible.” Id.

Put it all together, and the conclusion was inevitable–individualized issues overwhelmingly predominate over common ones. The class allegations were stricken.

Which brings us back to where we started. Despite persistent efforts, the scoreboard hasn’t changed. There is still no approved nationwide personal injury products liability class action. And this court wasn’t about to be the first.

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Today’s guest post is by Reed Smith‘s Jamie Lanphear. She has long been interested in tech issues, and particularly in how they might intersect with product liability. This post examines product liability implications of using artificial intelligence (“AI”) for medical purposes. It’s a fascinating subject, and as always our guest posters deserve 100% of the credit (and any blame) for their work.

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Artificial intelligence is rapidly moving into domains traditionally occupied by physicians, medical devices, and clinical software. That shift raises a familiar question for product liability lawyers: when new technology begins performing functions that look like medical judgment, how will existing tort doctrines respond?

Earlier this year, a major AI company introduced a new AI health feature designed to review users’ medical records and provide personalized health guidance. Users can upload electronic medical records, sync data from other wellness platforms, and ask health-related questions about symptoms, medications, and lab results. The company describes its new feature as informational and emphasizes that it is “not intended for diagnosis or treatment.” The tool is currently available only to a limited group of early users while the company continues refining its safety and reliability.

Even with those limitations, the legal implications are easy to see. If a user experiencing symptoms of a serious condition asks the system whether emergency care is necessary—and receives guidance that later proves incomplete or inaccurate—disclaimers alone may not resolve the liability analysis.

For defense lawyers tracking AI litigation trends, this new use of AI presents an emerging test case. The issue is not whether plaintiffs will attempt to frame AI-generated health advice as a product liability problem. They will. That’s what they do. The real question is how courts will apply existing tort doctrines to technology that blurs the line between software tools and medical decision-making.

First Things First

The threshold issue in any product liability claim is whether the thing that allegedly caused harm is a “product” at all. As the Blog has discussed here, here, here, and here, the legal treatment of software and AI is shifting. Traditionally, courts were reluctant to classify software as a product for purposes of strict liability, reasoning that software is intangible, often licensed or available for free rather than sold, and its defects resemble service failures more than manufacturing flaws. But that view is eroding.

Recent decisions reveal three emerging approaches to when software should be deemed a product. Under the defect-specific approach, courts examine particular functions alleged to be defective and evaluate whether each can be analogized to tangible personal property. In In re: Social Media Adolescent Addiction, for example, the Northern District of California analyzed specific features like parental controls and algorithmic content delivery, concluding that each had a tangible analogue sufficient to allow design defect claims to proceed. In re: Social Media Adolescent Addiction/Personal Injury Prods. Liab. Litig., 702 F. Supp. 3d 809 (N.D. Cal. 2023). Under the platform-as-a-whole approach, courts ask whether an app or platform in its entirety is analogous to a product, emphasizing the policy rationale for strict liability. In T.V. v. Grindr, the Middle District of Florida held that a dating app was a product because, as with most products and many services (including lawyers), it was “designed, mass-marketed, placed into the global stream of commerce and generated a profit.” T.V. v. Grindr LLC, No. 3:22-cv-864-MMH-PDB, 2024 U.S. Dist. LEXIS 143777 (M.D. Fla. Aug. 13, 2024). Of course, so are books and newspapers. And under the content-versus-medium distinction, courts permit product liability claims based on design or functionality defects while dismissing those based on expressive content.  Cf. Defense Distributed v. Att’y Gen. of New Jersey, 167 F.4th 65, 83-84 (3d Cir. 2026) (“whether code enjoys First Amendment protection requires a fact-based and context-specific analysis”).

These approaches have direct implications for AI health tools. AI operators have asserted in pending litigation that generative AI is a service and/or not a product for purposes of product liability law. That is how amusement parks and taxi dispatchers were treated before they morphed into social media and ride sharing. But if courts continue following the trend seen in the social media and chatbot cases, that defense may not hold.

Meanwhile, legislators are pushing in the same direction. The AI LEAD Act, recently introduced by Senators Durbin and Hawley, but unlikely to be enacted, would define AI systems as “products” and establish a federal product liability framework. And in the EU, the new Product Liability Directive explicitly treats software and AI as products—even when delivered as a service. The global momentum is unmistakable: the product line is moving.

Potential Theories of Liability

If AI health tools are products, what theories of liability might plaintiffs bring when their advice is alleged to have caused harm? The ongoing wave of litigation over AI chatbots offers a preview of the causes of action plaintiffs are deploying—and the factual predicates they are developing.

Strict liability for design defect. Under the consumer expectations test adopted by many jurisdictions, a product is defectively designed when it fails to perform as safely as an ordinary consumer would expect. Under the risk-utility test, a product is defective when the risk of danger inherent in the design outweighs its benefits. Plaintiffs in the existing chatbot cases allege that these bots cultivate emotional dependency, fail to terminate dangerous conversations, and provide harmful guidance during mental health crises. Generative AI with medical triage functionality could become a focus of similar claims.

A recent study published in Nature Medicine examined a recently introduced AI health tool’s performance in simulated emergency triage scenarios and identified cases where the system recommended routine care for conditions the researchers classified as emergencies. AI triage tools continue to evolve, but plaintiffs will undoubtedly cite early research of this kind to argue that triage logic constitutes a design defect when users delay care in reliance on a system’s recommendations.

Strict liability for failure to warn. Manufacturers have a duty to warn about dangers known or knowable at the time of distribution. A disclaimer that an AI health tool is “not intended for diagnosis or treatment” is a warning, but plaintiffs will inevitably argue it is inadequate because the product’s design invites that use, and therefore disregard of the warning should not be considered superseding cause. The existing complaints allege that ordinary consumers “could not have foreseen” that generative AI chatbots would cultivate dependency and provide dangerous guidance, “especially given that it was marketed as a product with built-in safeguards.” The same logic could apply to AI health tools: if the product is designed to ingest medical records, analyze symptoms, and suggest whether to seek care, a disclaimer alone may not suffice.

Negligent design. Plaintiffs also bring negligence claims alleging that the defendant failed to exercise reasonable care in designing its AI offering. Negligence is not limited to products. The evidence from the chatbot cases is instructive: moderation technology capable of detecting harmful content and terminating conversations exists and is deployed to protect copyrighted material—plaintiffs argue that the failure to deploy similar safeguards for user safety evidences a breach of duty. For AI health tools, inconsistent crisis safeguards may also become a focus of litigation. Early research on AI health tools has noted variability in how crisis-detection safeguards perform across different scenarios. These are the type of findings plaintiffs will undoubtedly cite to support arguments that safety features were not adequately calibrated before they were deployed.

Unlicensed practice claims. Plaintiffs in the existing chatbot cases have brought claims alleging that providing therapeutic services without adequate licensure violates state licensing statutes. An AI health tool that acts as a medical adviser—capable of interpreting lab results, flagging drug interactions, and recommending urgency levels for care—could invite similar theories in the medical context, particularly if plaintiffs argue that the service constitutes the unlicensed practice of medicine.

The Regulatory Layer

Plaintiffs in medical device cases routinely use regulatory evidence to bolster their claims—arguing that defendants withheld information from FDA, failed to report adverse events, or should have sought premarket clearance when they did not. AI health tools present a novel twist on this theme.

Under the Federal Food, Drug, and Cosmetic Act, a “device” includes software intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease. FDA guidance clarifies that certain software functions may be regulated as medical devices, while others fall outside the agency’s oversight. For example, clinical decision support software may fall outside FDA regulation when it supports recommendations for a healthcare professional rather than providing guidance directly to patients. Similarly, FDA’s “general wellness” framework applies to low-risk products that do not reference diagnosis, treatment, or specific diseases.

Whether a particular AI health tool falls within or outside these exemptions is highly fact-specific—and often genuinely unclear. But that ambiguity may become a litigation narrative.  Plaintiffs might argue that an AI health tool should have been submitted to FDA for review and that the developer avoided regulatory scrutiny before launching the product to anyone on the Internet. Whether or not that argument ultimately succeeds, it could resonate with juries.

For defense lawyers, the takeaway is that companies deploying AI health tools should carefully evaluate whether their product’s functionality brings it within FDA’s jurisdiction, and if there is genuine ambiguity, consider engaging with the agency proactively rather than waiting for plaintiffs to make the argument first. And remember Buckman – private enforcement of claimed FDCA violations, such as failure to submit a medical device to the FDA, is not allowed.

Building the Defense

What defenses are available to developers of AI health tools? The pending chatbot litigation offers a preview of the arguments defendants are raising—and how courts may receive them.

Service, not product. A threshold defense is that AI health tools are more analogous to the provision of informational or advisory services than to the sale of a tangible product. Courts have long distinguished between products—subject to strict liability—and services, which typically sound in negligence. An AI system that reviews medical records, analyzes symptoms, and offers guidance about whether to seek care arguably performs a function closer to a triage or health advisory service, or even a healthcare provider, than to a manufactured device placed into the stream of commerce. Framed that way, the alleged defect is not a flaw in a product but an alleged failure in the provision of information or judgment, making strict liability an awkward fit at best.

Disclaimer and contract. Terms of use for AI services typically state that users should not rely on outputs as a substitute for professional advice and may include limitation-of-liability and “as-is” warranty disclaimers.” As the Blog recently pointed out, the FDA’s newly revamped online adverse event database requires users to execute a signed disclaimer before using. Similar requirements, including arbitration agreements, could be used by medical AI providers, if they are not seen as too much of a deterrent to their prospective audience. Such provisions will be central to any defense, but their effectiveness may depend on how the AI responds when users ask directly whether it is providing medical advice—if in-session responses are inconsistent with the terms, plaintiffs may argue the disclaimer was effectively disclaimed. Plaintiffs have also attacked the enforceability of such terms by alleging that sign-up processes use “dark patterns” that prevent meaningful consent. In the U.S., litigation over clickwrap and browsewrap can offer some guidance. In Europe, the EU’s new Product Liability Directive expressly bars contractual waivers of product liability.

Section 230. Section 230 of the Communications Decency Act shields providers from liability for third-party content. But the statute is designed to protect platforms from being treated as the publisher of user-generated speech; it has historically not shielded claims based on a platform’s own design choices or information. AI-generated outputs are produced by the model itself rather than third-party speech, so the defense may have a limited application in the AI health context.

State of the art. Defendants may assert that their methods, standards, and techniques complied with the generally recognized state of the art—pointing to safety processes, red-teaming, and expert advisory councils. Compliance with industry standards is evidence of non-defectiveness, even if not dispositive.

Lack of causation. Causation may be the strongest defense available. Defendants can point to users’ pre-existing conditions, their use of other information sources, and their failure to seek professional care. In the health context, causation will be fact intensive. Additionally, because AI outputs depend heavily on user inputs—prompts and contextual information—defendants may also argue that user conduct contributed to the outcome.

Misuse and user conduct. Usage policies typically prohibit certain uses and warn users not to rely on AI as a substitute for professional advice. But courts have been skeptical of misuse defenses where the product’s design is viewed as inviting the reliance users are warned against.

Where the Law May Be Headed

AI health tools raise many of the same liability questions already emerging in chatbot litigation, while adding the additional complexity of medical decision-making. Recent AI health tools offer a useful case study, but the questions they raise will recur across the industry as more companies develop AI-powered symptom checkers, triage tools, and wellness assistants.

Are these products? Are they medical devices? Are they services? What duties do developers owe to users who rely on them?

The answers are still being written. Courts are increasingly willing to treat software and AI as products for purposes of strict liability. Legislators—in the EU and now in Congress—are pushing in the same direction. And FDA’s regulatory perimeter may not remain static as consumer-facing AI health tools proliferate.

For defense lawyers, the existing chatbot litigation is worth watching closely. The theories plaintiffs are deploying will translate readily to medical contexts. The defenses being raised will be tested. And the outcomes will shape the landscape for years to come.

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Nevada courts have long applied the learned intermediary rule to pharmacists filling prescriptions, and now another federal district court has ruled that the doctrine applies to drug manufacturers, too.  This is not surprising, since other federal judges have similarly predicted that Nevada’s Supreme Court would apply the learned intermediary rule to drug and medical device manufacturers.  But as we have said in our learned intermediary state survey, Nevada’s a little strange.  It is helpful to have one more.

The case is Stephens v. Zoetis, Inc., No. 2:25-cv-00989, 2026 WL 837353 (D. Nev. Mar. 25, 2026), where a federal judge in Nevada dismissed an economic loss class action brought by a dog owner against the manufacturer of a veterinary medicine after her pet experienced harmful side effects.  She claimed that the manufacturer failed to warn of either those side effects or “hundreds of additional incidents,” and she sought to recover economic losses on the theory that neither she nor the putative class of dog owners would have purchased the medicine if the manufacturer had adequately warned.  She likewise alleged that no reasonable, properly warned veterinarian would have prescribed the medicine, either. 

The district judge first ruled that the learned intermediary doctrine applies to drug manufacturers, following others in the district.  Although the court mistakenly called the doctrine an “affirmative defense,” it accurately described the rule, which “defines the scope of a manufacturer’s duty to warn in the context of prescription drugs or medical devices . . . by providing that the manufacturer’s duty to warn runs to the physician, not to the patient.”  Id. at *2 (emphasis in original, citations omitted). 

The Nevada Supreme Court applied the learned intermediary rule to pharmacists in 2011, in a case called Klasch v. Walgreen Co., on the well-established reasoning that the doctrine prevents drug dispensers from “constantly second-guessing a prescribing doctor’s judgment simply in order to avoid his or her own liability to the customer.”  Id.  The same rationale applies to drug manufacturers:  “A drug manufacturer, like the pharmacist, is not in the best position to weigh the risks and benefits of a drug in a particular patient, while a learned intermediary like a doctor or veterinarian has the benefit of knowing the patient’s specific situation.”  Id. (citations omitted). 

The learned intermediary doctrine therefore applied, and it barred the plaintiff’s claims.  To start, the product’s labeling listed every side effect and symptom alleged in the complaint.  In fact, the plaintiff did not identify any specific risk or symptom that was not included. 

Moreover, a stronger or different warning would not have altered the veterinarian’s decision to prescribe the drug.  The plaintiff alleged that the labeling did not adequately convey the severity of the risk, citing “hundreds” of adverse event reports.  But veterinarians have prescribed tens of millions of doses of this particular product, so warning of “hundreds” of additional events would raise the potential risk by something like a thousandth of a percent.  As the court concluded, “It is simply not plausible that such an imperceptible increase in risk would be relevant information to a prescribing physician or that this missing information would’ve altered the veterinarian’s decision.”  Id. at *3. 

This is a classic application of the learned intermediary rule and a dead-on example of warnings causation:  A stronger warning would not have made a difference, so any alleged inadequacy in the warnings could not have caused any harm.  As the court put it, this plaintiff could not tie the alleged inadequacy in the warning to her theory of recovery.  And, in Nevada (and elsewhere), the plaintiff in a product liability failure-to-warn case “carries the burden of proving, in part, that the inadequate warning caused [her] injuries.”  Id. (citation omitted).  This is the correct allocation of the burden—i.e., despite the court’s loose language, the learned intermediary rule is not a defense.  The cherry on top is that the court denied leave to amend.  The plaintiff did not explain how any amendment could fix her “learned-intermediary-doctrine or causation issues.”  And more specific allegations could not show how a veterinarian’s knowledge of a “near-imperceptible increase in risk” would have altered prescribing decisions.  Id. at *4.  We award Stephens v. Zoetis a blue ribbon. 

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This post comes from the non-RS side of the Blog.

Prescription medications for psychiatric conditions fill an important role in modern healthcare.  They tend to have labels with lots of information about the risks of various emotional, psychological, and neuroreceptor-mediated conditions, including worsening of the underlying conditions being treated, interactions with other medications or substances, issues during starting or stopping the medication, and the risks of conditions that are also known to occur at increased rates with the underlying conditions.  There has also been plenty of litigation over the risks of these medications, along with the risk of psychological injuries with medications that affect brain chemistry (e.g., Parkinson’s medications, smoking cessation medications).  While we certainly do not minimize the gravity of the psychiatric conditions being treated or allegedly caused by the medications in these litigations, we do have some recurring concerns about how they fit within broader product liability law.  One of its bedrock principles is that the plaintiff needs to have suffered a physical injury or injury to property.  That makes sense given standing requirements, which usually require a tangible injury and not just something fuzzy like taking offense to something the plaintiff observed.  In addition, statutes of limitations work better with tangible, physical injuries than with intangible injuries and subclinical injuries.  Damages can be measured for loss caused by an injury, but you cannot really skip ahead to damages without the injury.  We have seen this play out over and over as the vast majority of courts to have considered proposed actions for medical monitoring without present physical injury, subclinical injuries, increased risk of injury, and fear of future injury have rejected them as incompatible with centuries of common law.  Even causes of action expressly for emotions distress, whether inflicted intentionally or negligently, still typically require physical contact or at least being in the “zone of danger” (not to be confused with “danger zone” from which one should strongly consider flying away).

For purely psychological injuries allegedly caused by taking a prescription medication for a psychiatric condition, we add our concern about the subjective nature of evidence used to prove or contest injury and causation.  If a plaintiff’s alleged injury is “I felt a certain way” or “I felt compelled to do a certain thing” and the alleged damages are either that the feeling was upsetting or that medical expenses were incurred to treat that feeling, then is this really a compensable personal injury?  Setting aside that the plaintiff probably gave informed consent about just such a possibility and sued anyway, this a far cry from the sort of injury usually at issue in a product liability case.  Of course, it is quite different if there is a clear injury to person or property that resulted from a psychological “side effect” (e.g., confusion causing a car accident) or psychological damages following a significant physical injury (e.g., depression following the loss of a limb).  While we have dealt with some of these issues in various litigations over the years, we see the overarching issue of “what is a compensable issue for purposes of product liability” percolating behind a number of cases recently.

In Stockwell v. Sumitomo Pharma America, Inc., No. 2:25-cv-00492-RAJ, 2026 WL 791614 (W.D. Wash. Mar. 20, 2026), the court did not address these big issues in dismissing all the claims in the case, albeit with leave to amend three counts.  They are clearly there, though, especially if you pay attention to what information was omitted from the complaint (as inferred from the decision) and peruse the label of the medication at issue.  (The plaintiff is a lawyer who is representing himself.  We have heard an aphorism about that situation.) 

The Stockwell plaintiff was prescribed an antipsychotic medication, presumably for his schizophrenia and/or bipolar disorder—the decision does not say for which or by whom.  Perhaps predictably, the decision is not terribly clear about which of the thoughts or feelings described during his short time titrating up his dose of the medication, his short time tapering down and discontinuing the medication, and the period after discontinuation was being claimed as an injury as opposed to something else.  Given the focus of the alleged failure to warn arguments, though, the case is about two intangible feelings:  akathisia (a feeling of an urge to move) and suicidal ideation (thinking about suicide without attempting it).  These conditions, like the “panic attack” and insomnia also mentioned in plaintiff’s history in the decision, are all over the labeling for the antipsychotic medication, including that akathisia may occur during titration up and that suicidal ideation may persist after discontinuation.  Of course, suicidal ideation and, unfortunately, suicide are greatly increased with both schizophrenia and bipolar disorder.  Plaintiff’s akathisia did not result in physical injuries and his suicidal ideations did not result in any attempt or physical injuries, but he did get some care for both, adjust his job (without loss of income), and discontinue his medication.  While some patients in his position may be relieved at the lack of actual injury, which could arguably be connected to the flow of risk information on the antipsychotic medication through his physicians to him, the plaintiff sued the manufacturer of the prescription medication a few years later, throwing out fairly predictable but poorly developed causes of action.  The defendant moved to dismiss all of them.

Plaintiff’s complaint asserted exceedingly boilerplate allegations under general headings, and he focused them ever so slightly during briefing.  First up, using our characterization of the purported cause of action at issue in each count, was a claim for design defect under the Washington Product Liability Act.  Relying heavily on a case from the same court we discussed here, the court held that claims based on changing an approved drug’s formulation are preempted.  2026 WL 791614, *3.  So, the design defect claim in Stockwell, which clearly turned on the drug’s formulation, was dismissed with prejudice.  That this is now so well-established, when we still remember back when it was anything but, warms our Blogging hearts.

Next up was a count based on the allegation that the defendant’s “product was not reasonably safe in construction or because it did not conform to the manufacturer’s express or implied warranties.”  Id.  The court generously construed the first part as an attempt to assert a manufacturing defect claim.  Taking a look at the WPLA, that may be the closest recognized claim to what plaintiff asserted, but his count was not supported by factual allegations to satisfy TwIqbal.  In particular, what was missing is precisely what would be needed to get in the ballpark of a manufacturing defect claim, “how the treatment Plaintiff received deviated from its design or performance standards or what specific aspect of the product posed a danger.”  Id. (internal punctuation and citation omitted).  Plaintiff was permitted to try to replead this claim because the court determined that it was not a preempted design claim.  Id. at *3 n.3.  As we have discussed elsewhere, though, it the challenge to the drug’s construction is general, then it really is a design defect claim.

Plaintiff also asserted a warnings claim, variously characterized as sounding in negligence and strict liability.  Without diving into abrogation under the WPLA—which the Stockwell decision did not do—it looks like a hybrid statutory claim is all that exists in Washington.  The Stockwell court first analyzed whether the claim was preempted before turning to whether the complaint properly asserted a claim at all.  We think that is the wrong order of analysis, but the court got the right result anyway.  The complaint did not assert any failure to warn the prescribing physician of the risks of akathisia or suicidal ideation, and Washington follows the learned intermediary doctrine, so the claim failed.  Id. at *5.  Plaintiff would have been permitted to amend, except that any warnings claim he asserted would have been preempted anyway.  Citing Albrecht and some of the cases that displayed a greater understanding of the CBE process than was butchered in Levine, the court accepted the position that the plaintiff had to plead a non-preempted warnings claim based on newly acquired information about the relevant risks since the last approved label that could have permitted an independent change to the label through the CBE process.  Id. at *4.  Again, we harken back to the dark days after Levine before enough decisions, including Mensing and Albrecht, made it clear that facts supporting a CBE labeling change for the right issue during the right time would be the exception rather than the rule.  Here, plaintiff pled nothing about newly acquired information in the less than three years since FDA approved a label that discussed the relevant risks extensively.  Id.  Instead, on briefing, he offered mere speculation that there could be additional information the defendant had that FDA did not, but that does not count.  Id. at *5 (quoting the Gibbons case we discussed at length here).  “Plaintiff was not met his burden to allege newly acquired information regarding the risk of suicidality secondary to akathisia that created a labeling deficiency correctable through the CBE regulation.”  Id.  Plaintiff was not afforded another chance to plead a non-preempted warnings claim.

Next up were express and implied warranty claims, which were governed by the WPLA and were so boilerplate as to be confused with an actual metal plate affixed to a boiler.  Predictably, these were not sufficiently pled and were dismissed.  Unfortunately, plaintiff will get to replead them.  The court “reject[ed] Defendant’s argument that Count IV is a common law breach of warranty claim subject to preemption by the WPLA, *6 n.4, but there is the larger issue of how the implied warranty claim will inevitably be based on the same impermissible reformulation of the drug that the court held preempted as the design defect claim.

Last was a vague WPLA claim for “misrepresentation or concealment,” which was unsupported by the basic required factual allegations.  Consistent with not applying the heightened pleading standard under Fed. R. Civ. P. 9(b) for “fraud or mistake,” the Stockwell court gave plaintiff another shot at pleading.  However, to the extent that the alleged misrepresentation or concealment relates to the content of FDA-approved labeling—and there is not much else it could relate to—it will be preempted under the same analysis the court already undertook on the warnings claim.

So, plaintiff will get another chance to plead some of his claims with factual bases and without running smack into implied preemption.  The court may never end up having to resolve whether plaintiff suffered a legally cognizable injury.  Our feeling is that plaintiff’s apparent inability to plead a non-preempted cause of action stems, at least in part, from his alleged injury being simultaneously intangible and fuzzy.  That is just our feeling, though.

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On February 11, we blogged about the New Jersey Appellate Court’s disqualification of a lead plaintiff firm (Beasley Allen) in the Johnson & Johnson New Jersey state court talc litigation because that firm had been canoodling with a lawyer who had formerly worked for J&J.  Okay, “canoodling” is not exactly a technical, legal term, but we will soon get to what that means and why it matters.  Recall that the New Jersey Appellate Court reversed the trial court’s ruling of no disqualification. Since that Appellate disqualification ruling, the plaintiff firm has been feverishly trying to stay and overturn that ruling. So far, the New Jersey Appellate Court and Supreme Court have done nothing to halt the disqualification.  

Now things have gotten worse for the plaintiff firm, because last week the New Jersey federal court that is overseeing the multidistrict litigation (MDL) regarding J&J talc arrived at the same result. The disqualification ruling in In re Johnson & Johnson Talcum Powder Prods. Marketing, Sales Practices, and Prods. Liab. Litigation, 2026 WL 837332 (D. N.J. March 26, 2026), means that the plaintiff firm has now been disqualified in both the New Jersey state coordinated proceedings and the MDL. That is a big deal, and is a very bad result for the plaintiff firm. But it is the right result, and the federal court does a good job of explaining why that is so. 

Just as with the state court qualification, the key issue is the status of a lawyer who had formerly worked for J&J and had been intimately involved with settlement strategy. That lawyer later set up Legacy Liability Solutions LLC, which purported to offer a solution to mass tort liabilities, such as those presented in the talc MDL. That lawyer remains active and authorized to practice law, but says that he does not practice law or act in the capacity of an attorney at Legacy. Does that matter?  We shall see.  [Spoiler alert: it does not matter.]

Legacy made a pitch to J&J to take ownership of talc liabilities and fund current and future talc claims. It would be a form of settlement. Now if Legacy had merely made such a proposal to J&J, there might not be much of a controversy. But the problem is that Legacy was walking on both sides of the street. Legacy engaged in discussions with the plaintiff talc firm regarding settlement proposals to present to J&J. The topics focused on such things as a term sheet and claims administration. That is the “canoodling,” and that canoodling went to the heart of settlement negotiations. That canoodling is part of a zero-sum game where one side’s benefit is the other side’s detriment. What’s the best evidence of that? The MDL Plaintiff Steering Committee (PSC) asserted the mediation privilege over its discussions with Legacy. That is, the PSC did not want J&J to know what Legacy and the PSC were discussing. Why do you suppose that is? As a plaintiff lawyer once told us during settlement negotiations long ago, “I was born at night, but it wasn’t last night.”

Nevertheless, the turncoat lawyer (at this point that does not seem like an unfair or overly dramatic characterization) denied that he had shared any J&J confidences with the plaintiff lawyers. But the evidence was clear that it would be “impossible” for  the turncoat lawyer to separate out what he learned from his prior representation of J&J. One thinks of the current Apple TV drama Severance, where people’s minds are wholly separated between their work and home lives, each half knowing nothing of the other. (Yes, there are days when that would seem to be a splendid relief.) That scenario, of course, is science fiction. In any event, the conflicted lawyer admitted that he would not have been able to do what he was doing if he was acting as a lawyer in his dealings with the plaintiff lawyers.  That admission was inescapable in light of Rule of Professional Conduct (RPC) 1.9(a)(“A lawyer who has represented a client in a matter shall not thereafter represent another client in the same or a substantially related matter in which that client’s interests are materially adverse to the interests of the former client unless the former client gives informed consent confirmed in writing.”). As with the state court disqualification decision, the issue turns on the application of RPC 5.3(c)(1), which calls for disqualification when a lawyer employs, retains, “or associates with a nonlawyer” who engages in conduct that, if he were a lawyer, would violate the RPC, and the lawyer ordered or “ratified” the nonlawyer’s conduct.

Beasley argued that the state appellate court went astray by overinterpreting the word “associates.” But the federal court had little difficulty consulting authorities such as Black’s Law Dictionary, the Oxford English Dictionary, and good old Merriam-Webster to determine that “associates” covered the relationship between the turncoat lawyer and the plaintiff lawyers to extract a settlement from J&J. RPC 5.3 applies to “associates” such as document vendors who are doing a good deal less substantive work than the turncoat lawyer was performing in this case. The plaintiff firm leaned hard on the fact that it never formally employed the turncoat lawyer, but that means precisely nothing under RPC 5.3. As the federal court reasoned, “By stating ‘or associates with,’ the plain language and context of the Rule lead to the unremarkable conclusion that RPC 5.3 does not require the lawyer to formally employ or retain the nonlawyer.” Moreover, Beasley unquestionably “ratified” the work of the turncoat lawyer by seeking to “use the fruits” of his efforts in this MDL. Legacy communicated with the mediators as intended by Beasley. They even coordinated to the point of authoring articles on mass tort strategy the same day and jointly appearing at a conference. As the court concluded, “Notably, this collaboration was to such an extent that Beasley Allen shared confidential privileged material with Mr. Conlan, deeming him sufficiently associated so as to maintain a privilege over their communications.”

The final issue for the federal court was the balancing of interests. Predictably, Beasley argued that its disqualification would harm its clients. There are, to be sure, many thousands of clients in the MDL. But not all were represented by Beasley, and the other plaintiff law firms appear to be managing just fine without associating with J&J’s former attorneys. In any event, the court did not buy Beasley’s implicit argument that it was too big to fail. Counterbalancing the risks of delay and disruption was “the risk of maintaining the integrity of these proceedings.” Public trust in judicial proceedings is important – more important than the fortunes of an overreaching plaintiff law firm.  “Serious ethical violations warrant serious consequences.” The disqualification here was appropriate.    

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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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