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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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This post is from the non-Reed Smith side of the blog.

They say it’s better to be lucky than good. But in Luckey v. Abbott Laboratories, Inc., 2026 WL 836122 (E.D. Ky. Mar. 26, 2026), plaintiff was neither.

This is a straightforward—and satisfying—PMA preemption decision involving a heart valve allegedly marketed to last at least 15 years. The device received PMA approval in 2016 and was implanted in plaintiff in 2018. In 2023, after published literature suggested higher-than-expected rates of early structural valve deterioration (“SVD”)—sometimes in five years or less—the manufacturer sent letters to physicians and patients and voluntarily withdrew the product from the market. Plaintiff had his valve explanted in 2024, at which point it showed signs of early SVD. Id. at *1. Suit followed, asserting the usual state law claims: strict liability, negligence, failure to warn, and breach of express and implied warranties. Id. at *2.

Defendant moved to dismiss on preemption grounds. And here’s where things get interesting.

Normally, we would not linger on a court’s recitation of PMA preemption standards as our readers know them well. But this court used a turn of phrase that we think is worth keeping. Instead of just the usual “narrow gap,” the court described the test for stating a non-preempted parallel claim as requiring the state-law claim to “mirror” federal requirements without breaking the “ceiling” of federal law by imposing additional requirements. Id. at *3. We like it. “Gaps” invite creativity; suggest loopholes. “Mirror and ceiling” slam the door.

And slam it the court did.

Plaintiff’s theories boiled down to three alleged violations: (1) failure to report adverse events to the FDA, (2) failure to withdraw the product sooner, and (3) failure to comply with CGMPs. Id. at *5. None survived.

Start with failure to report. Kentucky does not recognize a state-law duty to report adverse events to the FDA. That makes this theory nothing more than a disguised fraud-on-the-FDA claim—squarely impliedly preempted under Buckman. Id. No mirror there.

Next, plaintiff argued the manufacturer should have withdrawn the device sooner. But the withdrawal here was voluntary—not required by the FDA. That distinction matters. If plaintiff’s theory is that the device should have been pulled earlier because adverse events were not properly reported, we are right back in Buckman territory. And if plaintiff is trying to impose a free-standing state-law duty to withdraw, that runs headfirst into express preemption by adding requirements in addition to federal law. Id. The claim crashes right into the ceiling.

The CGMP allegations fared no better. Plaintiff did not allege that his particular valve suffered from a manufacturing defect or quality-control deviation. Instead, he claimed the entire line of valves was defective due to premature SVD. More fundamentally, the court recognized what several courts have before it–CGMPs are high-level, procedural requirements. They “outline procedures,” not specific mandates. They are therefore too vague to support a parallel claim. They also cannot be privately enforced under Buckman. Id. Once again–no mirror, no claim.

Finally, the court addressed the warranty claims. Plaintiff tried to argue that defendant represented the valve would last at least 15 years. But for PMA devices, that argument runs into a hard stop. The FDA controls the labeling. “[E]xpress representations’ relating to a device are limited to the labeling approved by the FDA.” Id. at *7. To the extent plaintiff claims the manufacturer said something more, that necessarily imposes obligations in addition to federal requirements—again breaking the ceiling. Id. at *5, 7. And if the representations are limited to the FDA-approved labeling, then the claim is simply an attack on the adequacy of that labeling, which is also preempted.

In the end, every claim failed the same way: it either did not “mirror” federal requirements or it attempted to push beyond them. Allowing the case to proceed would have required a court or jury to second-guess the FDA’s determinations about safety, reporting, and labeling—precisely what preemption forbids. As the court put it, such claims would “meddle” with or “usurp” the FDA’s role. Id. at *7.

And so, despite his name, plaintiff came up empty. No gap. No mirror. No luck.

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In a pair of decisions, Express Scripts, Inc. v. Anne Arundel County, ___ A.3d ___, 2026 WL 797872 (Md. March 23, 2026), an opioid case, and Mayor & City Council of Baltimore v. B.P. P.L.C., ___ A.3d ___, 2026 WL 809501 (Md. March 24, 2025), a climate change case, the Supreme Court of Maryland had definitively shut the door to public nuisance tort litigation as a basis for having courts make what are fundamentally political decisions about the risks and benefits of legally distributed products.  In both, the answer was an emphatic NO!!

We’ll take Express Scripts first, since it’s squarely in the Blog’s sweet spot.

The plaintiffs in Express Scripts sued a bunch of defendants, alleging they were pharmacy benefit managers, mail-order pharmacies and retail pharmacies, and because they were part of the distribution chain for FDA-approved and legally sold opioid pain medicine, they supposedly caused a public nuisance by spurring opioid abuse.  In this litigation, the Maryland federal district court did the right thing and certified the public nuisance question to the MD Supreme Court:

Under Maryland’s common law, can the licensed dispensing of, or administration of benefit plans for, a controlled substance constitute an actionable public nuisance?

Express Scripts, 2026 WL 797872, at *1.  A second question was certified, but the court’s negative answer to #1 mooted it.

Here’s Express Scripts’ short answer to that question:

We answer “no” to the first question.  We hold that the licensed dispensing of, or administration of benefit plans for, a controlled substance does not constitute an actionable public nuisance.  As discussed herein, Maryland’s public nuisance common law has not been expanded beyond the traditional historical principles − namely, that an action for public nuisance brought by a governmental entity on behalf of the public was not regarded as a tort, but instead as a basis for public officials to pursue criminal prosecutions or seek injunctive relief to abate harmful conduct.  Although damages may be available in a private nuisance action (as they were under the common law), this Court has never recognized a government actor’s ability to recover damages in a public nuisance action.

Id. (emphasis added).

The longer answer in Express Scripts is, if anything, even better because – well – it’s longer (43 Westlaw pages), and it comprehensively rejects every argument the plaintiffs made in favor of using public nuisance against manufacturers of legal products.  First off (after spending well over a dozen WL pages describing the statutory and regulatory framework), Express Scripts turned to common-law nuisance.  One interesting tidbit that we didn’t realize is that the Second Restatement formulation of nuisance was an early example of what we have called American Law Institute transforming into “Always Liability Increases.”  The Institute as a whole insisted that the draft not restate the law, as Dean Prosser had attempted to do, but instead put a pro-liability thumb on the scale in favor of “its [public nuisance] use in emerging environmental cases.”  2026 WL 797872, at *20.  In order to “go on record in support of the emergent environmental movement,” a replacement reporter (after Dean Prosser resigned in disgust):

redrafted the definition of public nuisance and substituted the word “unreasonable” for the word “criminal”. . . .  The new definition was adopted in 1972.  With the substitution of a single word, the definition of “public nuisance” underwent a drastic expansion in the Second Restatement.

Id.  Thus, it appears that the ALI has been engaging in its conception of social policy – rather than faithfully restating the law – as a basis for the Torts restatement, for a lot longer than we realized.  The result was “very amorphous, open-ended language” in Restatement (Second) §821B.  2026 WL 797872, at *21.  Even so, “there is nothing in the Second Restatement about public officials recovering damages for a harm to the public generally.”  Id.

Express Scripts discussed Maryland public nuisance precedents − both common-law and statutory − at length, id. at *22-30.  From this extensive discussion Express Scripts drew several “conclusions”:

  • Public nuisance requires “an injury to the public at large” and is not strictly limited to “interfere[nce] with real property.”
  • “[P]rivate nuisance is a tort involving a nontrespassory invasion of another’s interest in the private use and enjoyment of land.”
  • “[W]e have declined invitations to expand the private nuisance action beyond its traditional common law formulation.”
  • Governmental nuisance actions are “invalid[]” when “(1) the alleged conduct was not a nuisance per se” or “defined as a nuisance by statute or a code; or (2) the enforcement action was . . . arbitrary or unreasonable.”
  • “[N]othing in our case law . . . adopt[s] an expansive tort of public nuisance based upon the [Second Restatement] definition contained in §821B.”
  • It was unprecedented for a “government” to seek “damages for an injury to the public based upon a common public right” – only “injunctive relief” was allowed.

Id. at *33-34.

With that background, Express Scripts refused to expand public nuisance to include Second Restatement-based claims based on allegations of social externalities from legal products.  The court agreed with criticism of that Restatement “for going far beyond the common law.”  Id. at *35 (footnote omitted).  The Second Restatement failed to state what “public nuisance” required beyond “non-exhaustive, open-ended factors” that litigants could use to pursue political objectives.  Id. at *26.  Rather, Express Scripts (like other state high courts) agreed with the Third Restatement:

[W]ith the adoption of the Third Restatement − 48 years after the adoption of the expanded “public nuisance” definition in the Second Restatement − the American Law Institute acknowledges that an expansive common law public nuisance tort is an “inapt vehicle” for a government entity to seek recovery in the form of economic damages arising from products that may create widespread societal concerns. . . .  Comment b to §8 notes that “[a]n action by a public official will commonly lie to abate the nuisance by injunction but may not involve monetary recovery for harm done.”  Notably, the drafters of the Third Restatement address the attempts by government actors to bring tort suits based on public nuisance to recover economic damages for products such as tobacco, firearms, and lead paint.  The comment recognizes that liability based on public nuisance “has been rejected by most courts, and is excluded by this section, because the common law of public nuisance is an inapt vehicle for addressing the conduct at issue.”  Id. §8 cmt. g (emphasis added). The comment explains that “[m]ass harms caused by dangerous products are better addressed through the law of products liability, which has been developed and refined with sensitivity to the various policies at stake.”  Id.  The drafters explain that, if another body of law does “not supply adequate remedies or deterrence,” then “the best response is to address the problems at issue through legislation that can account for all the affected interests.”  Id.

2026 WL 797872, at *36 (emphasis original) (other citations omitted).  Express Scripts agreed that “[t]he Third Restatement reflects a national trend of courts refusing to allow products-based public nuisance claims for economic damages.”  Id. (citing a half-dozen appellate decisions).  Thus, from a public nuisance perspective, the Court stated that it would not loosen the tort of public nuisance pursuant to the expansive provisions in the Second Restatement, and, accordingly, added several important delineations for how the new cases seek to improperly expand the tort:

(1) Harms to individuals, even lots of them, do not involve a public right:

[T]he County’s complaint fails to satisfy a primary requirement of a public nuisance action − namely, that the Defendants’ dispensing of opioids, and administration of benefit plans for opioids, affects a common public right. . . .  No case of this Court has recognized a broad public right to be free from all potential harms associated with the prescribing and dispensing of opioids.

Id. at *37.  The defendants engaged in “lawful” – and, indeed “medically necessary” activities under both federal and Maryland law.  Id. at 39.  They distributed products that were “not unfit for human consumption” and that “d[id] not cause harm to everyone who consumes them.“  Id.

(2) Public nuisance does not apply to the sale of legal products:

[W]e decline to recognize a public right to be free from the adverse effects associated with a lawful product being diverted, misused, or abused.  To recognize a general common law “public right” would permit nuisance liability to be imposed on an endless list of manufacturers, distributors, and retailers of manufactured products that are intended to be used lawfully.

Id. at *40.  The sort of public nuisance liability being proposed would improperly create “a public right so broad and undefined that the presence of any potentially dangerous instrumentality in the community could be deemed to threaten it.”  Id. (quoting one of Bexis’ gun cases).

(3) Public nuisance should defer to regulatory regimes.  Even if all other elements of the tort were met:

[W]e would nonetheless decline to recognize an expanded tort here given the extensive statutory and regulatory framework that governs the conduct. . . .  [C]onduct that is fully authorized by statute, ordinance or administrative regulation does not subject the actor to tort liability. . . .  [A] court should be reluctant to use its equitable powers to impose an injunctive remedy on an activity that is highly regulated by statute. . . .  [T]he distribution of prescription opioids involves a complex subject matter that is a highly regulated activity under both federal and state law.

2026 WL 797872, at *40-41 (citation and quotation marks omitted) (emphasis original).  “[L]itigation should not be used to achieve legislative goals.”  Id. at *41 (again quoting the same gun case).  Thus:

To the extent that the County seeks to impose tort liability for the Defendants’ lawful conduct undertaken pursuant to the federal and state regulatory schemes that authorize the lawful dispensing of opioids and the administration of benefit plans for licensed opioids, Congress and the General Assembly have determined that the social utility of the licensed dispensing of opioids outweighs the gravity of the harm in permitting their lawful dispensing.  We decline to extend tort liability upon the basis of public nuisance where the Legislature has sanctioned the conduct by declaring it to be lawful.

Id. at *42.  As for allegations of “unlawful” conduct, Express Scripts rejected a tort remedy because the “administrative enforcement remedies that are specifically enumerated within the statutory and regulatory scheme” belonged to “agencies entrusted by the Legislature,” not self-appointed plaintiffs, and those agencies “are better suited than judges or juries to determine in the first instance whether highly regulated and complex activity complies with the overlapping federal and state regulations.” Id.

In sum, in Maryland after Express Scripts, product related public nuisance is a bad idea whose time has passed.  “Complex societal problems are best suited for the Legislature, and judicial restraint is the appropriate principle to apply.”  Id.

Overall, the Express Scripts opinion is 43 Westlaw pages long with one concurrence and one concurrence/dissent.  While the concurrence would define public right differently, it still concluded:

[Plaintiff] offers no principle for distinguishing a harm to the public at large from a widespread aggregation of individual injuries.  In other words, [plaintiff’s] conception of a “public right” does not distinguish between a harm that affects everyone at large or everyone that interacts with the nuisance (contaminated drinking water) and harm that is widespread but ultimately affects a subset of the public that encounters the alleged nuisance (opioid consumption).  Without such a distinction, any product that causes sufficient individual harm would give rise to a public nuisance claim − effectively collapsing the boundary between public nuisance and mass tort as well as providing state and local governments boundless enforcement power.

2026 WL 797872, at *44.  The concurrence/dissent would not define ”public right” at all, leaving that to solely the General Assembly.  Id. at *48.

Interestingly, neither the majority nor either of the other two opinions in Express Scripts even so much as mentioned the recent Fourth Circuit opinion in City of Huntington v. AmerisourceBergen Drug Corp., 157 F.4th 547 (4th Cir. 2025) (criticized here).  As Blog readers well know, Huntington “predicted” (based on a couple of trial court opinions) that West Virginia would allow public nuisance in an opioid case.  Well, Maryland is within the Fourth Circuit, and its complete omission of any mention of Huntington – while citing other public nuisance precedent from around the country – looks like a judicial nose-thumb at the Fourth Circuit.  Evidently, no judge in Express Scripts considered Huntington worthy even of being distinguished or criticized.

Finally, while it’s not in our sandbox, we further note that later the same day, the Maryland Supreme Court reached the same conclusion – rejecting a public nuisance cause of action in a case involving legal products (so-called “fossil fuels”) – in the Baltimore v. B.P. climate change case.  Much of the Baltimore v. B.P. decision involved issues (existence of federal common law and preemption) peculiar to federal statutes (the Clean Water and Air Acts) with no applicability to prescription medical product liability litigation.  2026 WL 809501, at *6-25.  Baltimore v. B.P. reiterated that tort liability is not to be used to decide questions best left for the “political branches of government.  Id. at *26.

Baltimore v. B.P. then turned to state-law claims, particularly public nuisance, and reiterated its holdings in Express Scripts:

The [plaintiffs] do not state a claim under Maryland common law for public nuisance. As we discussed in Express Scripts, “Maryland has not expanded the public nuisance doctrine beyond the traditional historical principles embodied in the common law − namely, that a public nuisance action was not regarded as a tort but was instead a public action by a government entity to pursue criminal prosecutions or seek injunctive relief to abate harmful conduct.”  “This Court has never recognized a government entity’s ability to recover damages for public nuisance.”  To the extent that the [plaintiffs] are seeking damages for public nuisance, such recovery exceeds the bounds of Maryland’s public nuisance doctrine.  Moreover, . . . we . . . decline to expand Maryland’s common law of public nuisance to govern the conduct alleged . . . “given the extensive federal . . . statutory and regulatory framework that governs [this subject]. . . .  Where the legislature has, through the enactment of comprehensive legislation, entrusted such highly complex matters to an agency having expertise of the same, we decline to expand common law nuisance to address the same conduct.

2026 WL 809501, at *28 (Express Scripts citations omitted).  Further, climate change public nuisance litigation was simply absurd – the apotheosis of judicial triumphalism (the notion that litigation can solve everything):

[T]he notion that a local government . . . may pursue state law nuisance claims against the Defendants − seeking . . . to abate injuries arising from global greenhouse effects arising from worldwide conduct − is so far afield from any area of traditional state or local responsibility that it cannot be seriously contemplated.

Id. at *29 (emphasis added).

We have been fighting to prevent public nuisance from intruding on product liability ever since the theory (in its modern formulation) first reared its ugly head in firearms litigation nearly thirty years ago.  To us, the claim that purported state law could ever declare that the manufacturing and marketing of FDA-approved products for their FDA-approved uses is a “public nuisance” is ridiculous.  We are thrilled that yet another state high court has agreed with us.

We wish to acknowledge that parts of this blogpost were adapted (or plagiarized) from an excellent summary of the Express Scripts decision that we received from Phil Goldberg of Shook Hardy, who filed an amicus brief in that case.

Finally, the title of this post comes from a line in “Maryland My Maryland,” a borderline treasonous Civil War era song that was once the Maryland state anthem.

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If you do the kind of law that we on the Blog do, you don’t want to miss this. Registration for the 2026 DRI Drug and Medical Device Seminar is officially open, and Early Bird pricing disappears on April 6. Waiting means paying more, up to $700 more, for the exact same experience. If this seminar is on your radar, now is the moment to lock in your spot.

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We’re not bashful about our affinity for real science. It underpins our clients’ ability to develop life-saving drugs and devices, supports Rule 702’s role in keeping junk science out of courtrooms, and reflects the skeptical habits of mind that should matter to everyone. Shortly before his death in 1996, Carl Sagan discussed with Charlie Rose the dangers of a society where fundamental understandings of science and technology continue to diminish:

There [are] two kinds of dangers. One is . . . [t]hat we’ve arranged a society based on science and technology in which nobody understands anything about science and technology, and this combustible mixture of ignorance and power, sooner or later, is going to blow up in our faces. I mean, who is running the science and technology in a democracy if the people don’t know anything about it? And the second reason that I’m worried about this is that science is more than a body of knowledge. It’s a way of thinking. A way of skeptically interrogating the universe with a fine understanding of human fallibility. If we are not able to ask skeptical questions, to interrogate those who tell us that something is true, to be skeptical of those in authority, then we’re up for grabs for the next charlatan political or religious who comes ambling along. It’s a thing that Jefferson laid great stress on. It wasn’t enough, he said, to enshrine some rights in a Constitution or a Bill of Rights. The people had to be educated, and they had to practice their skepticism and their education.

Carl Sagan’s Last Interview. Fast forward, and today we’re discussing a case where the court quotes Carl Sagan and notes that, in the context of vaccines, science is “the best we have.”  Am. Acad. of Pediatrics v. Kennedy, __ F. Supp. 3d __, 2026 WL 733828 (D. Mass. Mar. 16, 2026).  Through a combination of good science and government oversight, the United States’ vaccination program has been a beacon for public health: 

Congress and the Executive have built—over decades—an apparatus that marries the rigors of science with the execution and force of the United States government. One extraordinary product of that apparatus has been the eradication and reduction of certain communicable diseases through the development and use of vaccines.  In the words of the Centers for Disease Control and Prevention (CDC), vaccines are one of the greatest achievements of biomedical science and public health.

Id. at *1 (cleaned up).  That success in the eradication of certain diseases is based on a rigorous method by which decisions about vaccine policy are made—“a method scientific in nature and codified into law through procedural requirements.” Id.  In this case, that rigorous and well-established method (both scientific and legal) was ignored.

Continue Reading Injunction Granted against Revised Childhood Vaccination Schedule and Wholesale Reconstitution of Vaccine Advisory Committee
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Navigating the FDA’s website can pose challenges.  Search functionality is iffy, data can be buried on unexpected sub-pages, and there just is a lot of material there.

Adverse event report information historically has been spread across six systems:

  • FAERS (FDA Adverse Event Reporting System) — containing reports for drugs, biologics, cosmetic products, and color additives. 
  • VAERS (Vaccine Adverse Event Reporting System) — containing reports for vaccines (co-managed by FDA and Centers for Disease Control and Prevention). 
  • AERS (Adverse Event Reporting System) — two databases containing reports for animal drugs and animal foods. 
  • MAUDE (Manufacturer and User Facility Device Experience) — containing reports for medical devices.
  • HFCS (Human Foods Complaint System) — containing reports for human foods and dietary supplements. 
  • CTPAE (Center for Tobacco Products Adverse Event Reporting System) — containing reports for Electronic Nicotine Delivery Systems (ENDS) and other tobacco products.

By end of May, all of these adverse event reporting systems will be shut down, and adverse event information will be wrapped up into a single “Adverse Event Monitoring System” or “AEMS”.  The FDA’s press release is here.  The new public dashboard is here (but the device, food, and tobacco portions are not yet operational). 

According to the website, AEMS will cover more than adverse events, serving “as a centralized platform for managing consumer complaints, regulatory misconduct reports, and whistleblower submissions across all FDA centers.” 

For our drug and device litigation purposes, the new system contains useful express caveats about the use (or mis-use) of adverse event information.  The dashboard landing page starts it off by stating: 

AEMS Data Limitations

While the FDA AEMS Public Dashboard offers stakeholders many more ways of searching for and organizing data on adverse events reported to the FDA, there remain limitations to the data. For example, while AEMS contains reports on a particular drug or biologic, this does not mean that the drug or biologic caused the adverse event. Importantly, the AEMS data by themselves are not an indicator of the safety profile of a product. Some additional limitations to note include:

1. Duplicate and incomplete reports are in the system: There are many instances of duplicative reports and some reports do not contain all the necessary information.

2. Existence of a report does not establish causation: For any given report, there is no certainty that a suspected product caused the event. While consumers and healthcare professionals are encouraged to report adverse events, the event may have been related to the underlying disease being treated, or caused by some other drug being taken concurrently, or occurred for other reasons. The information in these reports reflects only the reporter’s observations and opinions.

3. Information in reports has not been verified: Submission of a report does not mean that the information included in it has been confirmed nor it is an admission from the reporter that the product caused or contributed the event.

4. Rates of occurrence cannot be established with reports: The information in these reports cannot be used to estimate the incidence (occurrence rates) of the events reported.

5. Patients should talk to their doctor before stopping or changing how they take their medications.

    Even better, to access AEMS, a user has to affirmatively accept the terms outlined in a pop-up disclaimer, which reads as follows (with some emphasis added):

    Disclaimer

    Each year, the FDA receives over two million adverse event and medication error reports associated with the use of drugs and biologic products. The FDA uses these reports to monitor the safety of drug and biologic products through the FDA Adverse Event Monitoring System (AEMS) database, which houses reports submitted by drug manufacturers (who are required to submit these reports) as well as healthcare professionals and consumers. It is important to note that submission of a safety report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.

    Although these reports provide valuable information, this surveillance system has inherent limitations. Reports may contain incomplete, inaccurate, untimely, and/or unverified information. Additionally, the true incidence or prevalence of an event cannot be determined from this reporting system alone due to potential under-reporting and lack of information about frequency of use. Because of these limitations, AEMS data comprise only one component of the FDA’s comprehensive post-market surveillance program, and the information does not confirm a causal relationship between the drug or biologic product and the reported adverse event(s).

    American public (or consumers) should be aware of several important considerations when interpreting AEMS data.

    – Consumers should not stop or change medication without first consulting with a health care professional.

    – AEMS data alone cannot be used to establish event rates, evaluate changes in event rates over time, or compare event rates between products.

    – The number of reports cannot be interpreted in isolation to reach conclusions about the existence, severity, or frequency of problems associated with drug products.

    – Confirming whether a drug product caused a specific event can be difficult based solely on information provided in each report.

    – Therefore, AEMS data should be interpreted in the context of other available information when making drug or biologic-related treatment decisions.

    The AEMS web search feature covers adverse event reports from 1968 to present, with data submitted to AEMS made available daily (near real-time) through the online querying tool. However, variations in trade, product, and company names affect search results, as searches only retrieve records containing the specific search terms provided. Safety reports submitted to FDA do not necessarily reflect a conclusion by FDA that the information constitutes an admission that the drug or biologic caused or contributed to an adverse event.

    Because AEMS users have to accept the disclaimer terms to access data, any plaintiff-side expert who attempts to rely on adverse event data to support causation opinions will be vulnerable to cross-examination about how they explicitly acknowledged that adverse event reports “may contain incomplete, inaccurate, untimely, and/or unverified information” and “[do] not confirm a causal relationship between the drug or biologic product and the reported adverse event(s).”

    Hopefully, this pop-up disclaimer language will be updated soon to include more than just “drug or biologic” products as AEMS will cover medical devices and vaccines as well. 

    But we appreciate its inclusion, and that assent is required for access.  It won’t end plaintiffs’ experts from misusing adverse event data, but it does give us good fodder for cross and the Rule 702 motions that follow.

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    Kansas has given us many great people and institutions. We Philadelphians are particularly grateful for Darren Daulton, the late, great Phillies catcher. We have also enjoyed the work of Charlie Parker, Buster Keaton, and, of course, Dorothy Gale. Further, the Kansas college basketball team is perennially very good. (But that was a tough loss last Sunday to St. John’s. And someone surprised us with the fact that Bill Self’s team has not made it through the first weekend of the NCAA tournament in four years. Yikes.) We especially esteem Kansas because it has not shown up on any Hellhole list that we have seen. Its courts are almost always sane. 

    Minshew v. Krumme, 2026 WL 759033 (D. Kansas March 18, 2026), is a purported class action alleging non-sterile conditions in Kansas and Missouri operating rooms. The plaintiffs sued a series of doctors and medical institutions, alleging that the defendants performed surgeries with unsterile tools and thereby caused the plaintiffs to sustain infections. The complaint contained causes of action for negligence, negligence per se, breach of fiduciary duty, breach of express contract, breach of implied contract, unjust enrichment, violation of the Kansas Consumer Protection Act, medical malpractice, and fraud.  The plaintiffs filed the case in state court, but the defendants removed it to federal court. The defendants then filed motions to dismiss. Most of the causes of action were dismissed.  

    Why should you care? 

    One part of the decision is relevant to product liability claims.  That is the dismissal of the negligence per se claim under Kansas law.  In Kansas, as in many other states, negligence per se is limited “to violations of a statute for which the legislature intended to create a private cause of action.”  The cite is to the Brooks favorable Tenth Circuit FDA medical device preemption decision.  The FDCA was not at issue here, but analogous federal and Kansas regulations were.  The plaintiffs claimed that defendants violated federal Medicare regulations and state hospital licensing regulations.  

    Kansas courts deploy a two-part test to determine whether a private right of action is created: (1) the party must show that the statute was designed to protect a specific group of people rather than protect the general public; and (2) the court must review legislative history to see whether a private right of action was intended. (Justice Scalia would have frowned at the last bit.)

    The problem for the plaintiff in Minshew is that none of the regulations or underlying laws at issue reflected any intent to provide a private cause of action.  Because enacting bodies (Congress for Medicare and the Kansas legislature for the enabling statute for the state regs) did not intend a private right of action, the negligence per se claims failed.  The state statute had been amended several times and the legislature had never included any private action.  Moreover, Kansas appellate courts generally will not infer a private right of action where a statute provides criminal penalties but does not mention civil liability. That was the situation here. 

    The federal Medicare regulations at issue did not confer any private right of action. The plaintiff could not evade that obstacle by relying on the Medicare as Secondary Payor (MSP) statute. First, the MSP facially did not apply to the allegations of the complaint. Second, the MSP shows that Congress knew how to create a private action had it so desired — and it did not do so for the statutes that supposedly supported the plaintiff’s claims here. 

    This result fits into one of the “defenses to negligence per se” that Bexis blogged about way back in 2007. Plaintiffs in prescription medical product liability litigation frequently claim negligence per se as to purported FDCA violations.  Fight back. With Minshew and other cases, we defense hacks have plenty of ammunition. 

    The plaintiffs tried to save the negligence per se claim by pointing to Missouri regulations, as well as the Kansas regulations. But Kansas choice of law principles do not allow depecage (the application of the law of different states to different issues within the same claim), so the effort to drive the case over the state line did not work. 

    The rest of the opinion is not especially blogworthy because the dismissals, or non-dismissals, are mostly related to medical malpractice peculiarities. The court did clean things up considerably (appropriate when cleanliness was the main issue) by holding that the plaintiffs’ “negligence and medical-malpractice claims subsume their claims for fraud, breach of implied and express contract, unjust enrichment, and breach of fiduciary duty.”

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