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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Next, plaintiff argued the manufacturer should have withdrawn the device sooner.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.

A High‑Impact Program You’ll Feel in Your Practice

From May 20–22, at The Westin Copley Place, a AAA Four-Diamond hotel in the celebrated Back Bay neighborhood of Boston, you’ll dive into the issues shaping the future of drug and medical device litigation defense. Expect practical, immediately usable insights on Federal Rule of Evidence 702, expert challenges, global mass‑tort coordination, and emerging litigation trends like PFAS, ethylene oxide, and the rise of “clean pharma.” You’ll also hear directly from medical device General Counsel, in-house leaders, and regulatory voices offering the kind of candid perspective you simply can’t get anywhere else. You’ll even get to hear Bexis give a Ted talk.

Networking That Actually Moves You Forward

Let’s be honest: one of the biggest draws is the networking. This seminar consistently brings together the people who shape drug and device defense nationwide. You’ll connect with seasoned trial lawyers, corporate counsel, scientific experts, and peers who are tackling the same challenges you are. Whether you’re building new relationships or strengthening long-standing ones, the conversations you have here can genuinely shape your practice’s trajectory.

And with representatives from big companies like AbbVie, Becton Dickinson, GSK, Medtronic, Sanofi, and Stryker planning to attend, the opportunities to build meaningful professional connections are everywhere — from structured sessions to casual receptions.

Discount Ends in Just a Couple Weeks

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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.”

    Photo of Michelle Yeary

    Today’s case, Kouyate v. L. Perrigo Company, 2026 WL 591874 (W.D. Mich. Mar. 3, 2026), is the latest entry in the ever-growing pile of meritless benzene OTC class actions. This time, the target is acne treatments containing benzoyl peroxide (BPO), with the now-familiar allegation that BPO degrades into benzene during storage and shipping. If that sounds familiar, it should. Back in October, we covered dismissal of this very plaintiff’s nearly identical lawsuit against a different manufacturer. Then, we suggested that despite a steady stream of preemption dismissals, more of these cases were likely on the way. Not only were we right, but here we have the same plaintiff trying again in a different court against a different defendant. At some point, the definition of insanity starts to feel less like a cliché and more like a litigation strategy.

    In this new installment, defendant moved to dismiss on both preemption and standing grounds. Standing survived. Preemption did not. And, in a bit of poetic symmetry, plaintiff’s standing theory helped seal the fate of his claims.

    On standing, defendant argued that plaintiff’s alleged injury was hypothetical as opposed to “actual or imminent.” He never tested the products he purchased and instead relied on the presence of benzene found in generalized testing of BPO products. Normally, that sort of leap doesn’t clear the Article III hurdle. But here, the court accepted plaintiff’s allegation that defendant “always manufactured, stored and transported the Products in the same manner,” which was enough to infer “widespread or extensive contamination.” Id. at *3-4.

    That was enough—for standing purposes. But that same allegation created a preemption problem plaintiff could not escape.

    For OTC drugs, the FDCA expressly preempts all state court claims that impose requirements “different from or in addition to” federal requirements. 21 U.S.C. §379r(a). Here, those federal requirements are set out in the FDA’s monograph, dictating what goes on the label and what warnings are required. Therefore, claims that the product should have been designed differently or labeled with additional warnings would impose requirements “different from or in addition to” federal law and are expressly preempted. Plaintiff tried several familiar detours around that roadblock—all hinging on allegations that defendant’s labeling and sale of its products violated FDA regulations.

    First, he argued the product was “adulterated” because benzene is a “decomposed substance” prohibited by general FDCA regulations. Id. at *8. The court was not persuaded. In context, the statutory language—paired with terms like “filthy” and “putrid”—targets organic decomposition, not the sort of chemical breakdown alleged here. Benzene, in other words, is not that kind of “decomposed substance.”

    Next came misbranding. Plaintiff claimed the label failed to disclose that the product might be dangerous due to the presence of benzene. But monograph compliance forecloses that argument. A product that satisfies the FDA’s labeling requirements is not misbranded simply because a plaintiff disagrees with the agency’s safety determination. Id. Recasting the argument as one about manufacturing, storage, and shipping conditions did not help. Plaintiff never identified any specific practices that supposedly caused degradation. Instead, he alleged that degradation occurs under “normal conditions”—the very conditions the FDA presumably considered when approving BPO for OTC use. That theory runs headlong into the FDA’s conclusion that these products are safe and effective. Id.

    Which brings us to the most interesting twist–plaintiff’s standing theory comes back to haunt him. To establish standing, plaintiff needed to allege that benzene formation is widespread—essentially inevitable under ordinary conditions—so the court could infer it was present in the products he bought. But to avoid preemption, plaintiff needed to argue the opposite: that benzene formation depends on atypical, manufacturer-specific conditions and doesn’t undermine the FDA’s safety determination. The court wasn’t persuaded that plaintiff could have it both ways. If degradation is universal, then the claims challenge the FDA’s conclusion that BPO is safe. If it’s not universal, then plaintiff’s standing theory falls apart. Id. at *9. Pick your poison. Either way, the claims don’t survive.

    Plaintiff’s remaining arguments fared no better. Plaintiff’s claim that the products were mislabeled for failing to list benzene as an inactive ingredient failed because benzene is not an “inactive ingredient” under FDA definitions. It is, at most, an unintended byproduct. Id. at*9-10. And the attempt to recast the case as one about CGMP violations went nowhere, because those allegations still rested on the same core theory that conflicts with the FDA’s monograph determination. Id. at *10. CGMPs are not a back door around preemption when the front door is firmly shut.

    So, despite clearing the low bar the court set for standing, the case ultimately met the same fate as its predecessors–dismissal on preemption grounds. So where does that leave us? Right where we were in October. Watching these benzene OTC class actions pile up—and pile out. The theory has not changed. The result has not changed. And yet the filings keep coming. For now, at least, the preemption wall is holding—but we are not betting that we have seen the last attempt to run straight into it.

    Photo of Bexis

    Scott v. Amazon.com, Inc., ___ P.3d ___, 2026 WL 468578 (Wash. Feb. 19, 2026), is one of those decisions that makes us go hmmm.  Here’s why.

    Scott involves very unfortunate facts, four people who, in separate incidents, committed suicide using the same chemical, which they all allegedly purchased using the defendant’s online sales platform.  Id. at *1.  So far, so bad.  But it’s the other alleged facts – which had to be taken as true on a pleadings-based motion to dismiss – that make the Scott decision so palpably wrong (at least to us; it was a unanimous decision).  Those facts – alleged by the plaintiffs themselves –leave us scratching our heads about how there could conceivably be liability.

    • The chemical at issue, while a deadly poison at high concentrations, has legitimate uses, being “used in laboratories for research and medical purposes” and “in meat preservation.”  2026 WL 468578, at *1.
    • All of the decedents were determined to use it to commit suicide and did so within a few days or at most weeks of receiving it.  Id.
    • At least some, maybe all, of the decedents visited online “suicide forums.”  Id. at *2.  There were no allegations that the defendant had anything to do with those forums.
    • At least some, maybe all, of the decedents, consulted “a suicide instruction book that devotes a chapter to lethal inorganic salts, which contains instructions on how to use [the chemical] to die by suicide.”  Id.
    • The “suicide instruction book” told the decedents that the chemical was “readily available online and provide[d] a hyperlink to the [chemical]  products on the [defendant’s] webpage.”  Id.
    • One of the decedents also bought a “small scale” to make ensure he used enough.  Another also bought a prescription drug “that suicide forums recommend purchasing to prevent life-saving vomiting that occurs when [the chemical] is ingested.”  Id.

    Note:  unlike the Scott opinion, we neither identify the chemical nor provide the title of suicide manual.

    In sum, the pleadings in Scott established that these decedents, for whatever unfortunate reasons, were bound and determined to kill themselves.  They researched and planned how to do it, carried out their plans, and succeeded.  If that isn’t superseding cause (and maybe in pari delicto) as a matter of law, we don’t know what would be.

    But Scott in its infinite judicial wisdom, held that these allegations stated a claim − the plaintiffs’ decedents’ deliberate and sustained intent to kill themselves notwithstanding.  First, Scott held that intentional suicide was no longer ipso facto a superseding cause:

    Plaintiffs alleged . . . that the decedents’ suicide risk was known to [defendant] prior to the negligent act complained of . . . which creates a duty to safeguard the four decedents from the foreseeable consequence of its existence. . . .  Taking the facts Plaintiffs have alleged as true, we are unable to say, as a matter of law, beyond a reasonable doubt, that the decedents’ deaths were not proximately caused by [defendant’s] alleged tortious sales practices of the [chemical].  The rule . . . that the act of suicide is a superseding cause as a matter of law does not control here. We hold that the act of suicide, as a matter of law, is not a superseding cause.

    Id. at *5 (citations and quotation marks omitted) (emphasis added).  “Beyond a reasonable doubt”?  Since when do defendants have to meet a criminal standard of proof to establish superseding cause?

    Okay, we grant that jurisprudential arguments exist that cut both ways on suicide in the abstract.  But Scott was anything but abstract.  Consider the pleaded facts.  If this isn’t superseding cause as a matter of law, what could be?  (1) The decedents frequented suicide-related internet forums.  (2) They consulted a book that told them specifically what to use and where to buy it.  (3) The defendant did not run the forums nor write the book.  (4) The decedents were directed by the sites and the book to use this chemical, and how much of it was necessary.  (5) The book told the decedents where they could buy it.  (6) The book told the decedents they could buy a prescription drug to suppress the body’s ability to resist the poison through vomiting.  (7) Tragically, the decedents followed these instructions and achieved the result they were seeking – to kill themselves.

    Perhaps some suicides might not be superseding causes.  See Id. at *5 (relying on a case about a hospital that “actually” knew of a “foreseeable” risk by a specific individual”).  These people, however, were internet purchasers, not individually known individuals.  So the upshot of Scott appears to be an indiscriminate duty owed to the entire world (“every individual has a duty to exercise reasonable care to avoid the foreseeable consequences and harm from their acts,” including “ exposing another to harm from the foreseeable conduct of a third party”).  Id. at *5 (citations and quotation marks omitted).  We can see no way, short of banning sale of this chemical – again one with legitimate uses – to have prevented its use by these determined decedents.  Indeed, Scott hints that this may be the opening salvo for judicially imposed product bans.  Id. at *6 (rejecting argument against “allow[ing] juries to legislate whether a well-made product should not be sold because of potential misuse”) (internal quotation marks omitted); cf. id. at *10, 13 (concurring opinion stating that the defendant “never restricted . . . sales to adults or to commercial buyers” and indicating that sale for “household use” should be banned).  We have always believed that banning products should be a legislative, not judicial, act.

    Even more concerning (if possible) is that Scott waved through a warning-based claim.  See Id. at *2 (describing plaintiffs’ allegations that the defendant’s website had “no warnings or descriptions of the product . . . visible to customers” and “no warnings to consumers about how deadly the product is or how to reverse its effects”).  Okay, we’ll take all those facts as true.  Then what?

    The decedents here were deliberately trying to kill themselves.  They already knew from suicide websites and a suicide manual that the product would kill them if they used X amount of it.  What warning would have stopped them?  Putting a skull and crossbones symbol or a “deadly poison” label on the product would only have encouraged them further.  Moreover, the decedents didn’t want to “reverse its effects” (except maybe when it was too late) – they bought a separate drug to prevent that.  Nor was there any indication that any emergency responder didn’t know how to respond (assuming success was ever possible).

    Our blog is directed, first and foremost, to the defense of prescription medical product liability litigation.  Scott is concerning because, while it involved a chemical, many prescription and OTC drugs can be deadly in the event of an overdose – whether accidental or intentional.  Will plaintiffs mount the same over-the-top absolute liability allegations in prescription medical product liability litigation?  Probably, but we doubt they will succeed, any more than with the SSRI suicide cases being litigated when we first started blogging.  First, prescription medical products are just that; they require a physician’s prescription, whether bought in a store or over the internet.  Scott did not have to address the learned intermediary rule.  Second, Scott involved a direct seller, not a product manufacturer.  That’s another layer of protection.  Third, and perhaps most important, both prescription medical products and OTC drugs (and their labeling) must be FDA approved.  States cannot ban, through litigation or otherwise, products that have been federally approved for marketing nationwide.  E.g., Mutual Pharmaceutical Co. v. Bartlett, 570 U.S. 472, 488-49 (2013) (see our post here, collecting stop selling preemption cases).

    Photo of Steven Boranian

    Cannabis is big business, so it was only a matter of time before someone filed a consumer class action claiming that his cannabis was schwag.  It happened in Illinois, where a judge in the Northern District promptly shot it down—not because the plaintiff’s theory was necessarily wrong, but because his theory of deception was a theory of law, not of fact.  The order also provides useful guidance on Article III standing and privity requirements in the context of state-regulated industries.

    In McKenzie v. Progressive Treatment Solutions, LLC, No. 25-cv-1768, 2026 WL 636741 (N.D. Ill. Mar. 6, 2026), the plaintiff purchased a cannabis vape cartridge—a cannabis product containing upwards of 74% THC.  That concentration of THC was significant because the Illinois CRTA divides cannabis products into two categories: smokeable products and cannabis-infused products (“CIPs”).  The distinction matters because Illinois limits CIP possession to 500 milligrams of THC and single-package sales to 100 milligrams, while smokeable concentrates face no equivalent cap.  The product at issue—sold in a one-gram quantity at 74% THC potency—far exceeded the CIP thresholds.

    So where is the fraud?  Well, the vape cartridge that this plaintiff purchased was labeled as though it was a smokable product—to which no THC cap applies.  The plaintiff argued, however, that the CRTA defines “smoking” as the “inhalation of smoke caused by the combustion of cannabis.”  And, because vaping involves heating rather than burning, the cartridge allegedly was not a smokeable product at all—it was a CIP, unlawfully sold with THC concentration well over the statutory limit. 

    The plaintiff therefore demanded his money back on behalf of himself and a class of purchasers.  He did not allege any harm resulting from his use of the cartridge, or even that he ever used the cartridge.  His alleged injury was the purchase price of an allegedly unsafe product. 

    The district court dismissed the action.  To start, the court ruled that the plaintiff had suffered an injury in fact by virtue of paying for the product, but he had standing to sue only in connection with the product that he purchased.  His complaint purported to encompass all of the defendants’ “vapable oils” exceeding 100 milligrams of THC, but the court held that a plaintiff cannot acquire standing for unpurchased products “through the back door of a class action.”  Id. at *2-*3.

    The most significant portion of the order addresses why the plaintiff’s fraud claims failed on the merits.  The court applied the longstanding Illinois rule that “misrepresentations or mistakes of law cannot form the basis of a claim for fraud.”  Id. at *6.  Because all people are presumed to know the law, “erroneous conclusion[s] of the legal effect of known facts constitute[ ] a mistake of law,” not a misrepresentation of fact.  Id.  Here, the plaintiff did not allege that the defendants misrepresented the contents of the cartridge, its potency, or its efficacy.  He alleged only that the defendants’ products were CIPs and that the defendants concealed that fact by packaging their products as though they were not.  That alleged delineation is legal in nature, depending on the interpretation of such statutory terms as “smoking” and “combustion.” 

    In other words, the plaintiffs alleged that the defendants misrepresented the product’s regulatory classification.  That alleged conduct is not an actionable representation of fact.  As the court concluded, “if the CRTA does consider vaping to be smoking, or if it does regard the underlying process as involving combustion—which, by [the plaintiff’s] own admission, requires one to parse both statutory and dictionary definitions—then Defendants neither misrepresented nor concealed anything, period.”  Id. at *7.

    The plaintiff’s contract-based claims fared no better.  On the breach of express warranty claim, the court held that no actionable warranty had been identified:  The plaintiff did not allege that the product’s labeling was false, only that it was inconsistent with what CIP regulations would require.  Breach of express warranty requires that goods deviate from the label, not merely from a legal standard.

    Both the express and implied warranty claims failed also for lack of privity.  Because the plaintiff purchased the product from a dispensary—and not from any defendant—he was not in privity with the manufacturers.  Nor could plaintiff bring himself within any exception.  First, the “direct dealing” exception did not apply because passive website advertising and general consumer-facing marketing do not constitute the kind of direct, individualized communication contemplated by the exception.  Second, the “third-party beneficiary” exception failed because the plaintiff did not allege that the defendants knew his individual identity—only that defendants had knowledge of consumers generally.

    Finally, the unjust enrichment claim was dismissed as a derivative claim that could not survive independently once the fraud claims were extinguished.

    We find the McKenzie order useful for a few reasons.  First, it clearly illustrates the mistake-of-law doctrine as applied in consumer fraud litigation in Illinois.  That doctrine is easy to overlook, but is potentially dispositive whenever a plaintiff’s theory of deception turns on the regulatory or statutory characterization of a product (an example being whether the product was being used on- or off-label), rather than on a factual misrepresentation about its physical attributes.  Second, the case reinforces an increasingly firm stance that class action plaintiffs must establish personal standing for each product they seek to challenge at the pleading stage, rather than deferring the question to certification.  Finally, the rulings on privity reinforce the governing rules and vigilantly limit the application of supposed exceptions.  At least in this court, there is no substitute for genuine direct dealing with individual buyers.

    The dismissal was without prejudice, leaving the door open for the plaintiff to replead.  Whether he can do so in a way that characterizes the defendants’ conduct as a misrepresentation of fact rather than of law—an inherently difficult task given the theory he has developed—remains to be seen.

    Photo of Eric Alexander

    Five months ago, we posted on a decision from an Ohio intermediate appellate court finding that a state AG action against sellers of vaping products was impliedly preempted under Buckman.  Part of what got our attention about the decision in State ex rel. Yost v. Cent. Tobacco & Stuff, Inc., No. 24 CAE 11 0103, 2025 WL 2828526 (Ohio Ct. App. Oct. 1, 2025) (“CTS”)—now published at 273 N.E.3d 714—was that implied preemption applied to a state AG action the same as it would have to a private action.  We also were taken aback by how the CTS dissent seemed confused about some preemption basics.  In State ex rel. Yost v. Elevate Smoke, LLC, No. C-250175, 2025 WL 3688747, — N.E.3d — (Oh. Ct. App. Dec. 19, 2025) (“Elevate”), we end up with the same result as to “identical” claims brought by the same state AG against a different vaping retailer.  Despite the overlap, we thought that Elevate was worth discussing.  For one thing, whereas the CTS decision by Ohio’s Court of Appeals for the Fifth District was split, the First District’s decision in Elevate was unanimous.  Ergo, it lacked a dissent that someone looking to avoid preemption could cite.  It also added that the plaintiff’s claims were preempted under an obstacle theory, something raised as stalking horse in the CTS dissent and not argued by the defendant in Elevate.  Seeing the same counsel representing the defendants in both CTS and Elevate and advancing the same preemption arguments also reveals the broader strategy of a self-described “preemption nerd” to advance the law that might also favor manufacturers of FDA-regulated medical products when they get sued by a state AG or a private litigant.  (James Fraser gets the much sought-after “shout out” from us.)

    As in CTS, in Elevate,Ohio’s AG went after a retailer for selling vaping products that FDA had not approved—making them “adulterated” in FDCA terms—and for not including labeling identifying them as such.  The asserted claims were framed under Ohio’s consumer protection laws but clearly emanated from FDA requirements.  The Elevate trial court found all the claims were impliedly preempted under Buckman.  In its ruling, the trial court took a motion to dismiss and converted it to a motion for summary judgment because extraneous materials attached to the complaint were considered.  The first part of the appellate decision involved determining that the trial court’s citation of Ohio’s version of 12(b)(6) was harmless error because the preemption decision rested solely on questions of law with no real dispute about whether any operative facts were disputed.  Although we are procedural sticklers, this error was clearly harmless; if the plaintiff lost under a 12(b)(6) standard, the plaintiff would have lost under a Rule 56 standard.

    The meat of Elevate started with a detailed discussion of the Family Smoking Prevention and Tobacco Control Act (“TCA,” as used in Elevate), how it affects vaping products, how plaintiff’s asserted claims relate to it, and some of the basics of express and implied preemption.  By and large, the discussion of preemption was strong and included a number of the drug decisions we discuss on a regular basis.  Compared to the typical express preemption language applicable to Class III devices, OTC drugs, or vaccines, the carve-out in the TCA is broader, consistent with an “explicit decision to preserve for the states a robust role in regulating, and even banning, sales of tobacco products.”  2025 WL 3688747, *7 (quoting U.S. Smokeless Tobacco Mfg. Co. v. City of New York, 708 F.3d 428, 436 (2d Cir. 2013)).  Relevant here, “more stringent” state requirements “relating to . . . the sale . . . advertising and promotion of . . . tobacco products” are not expressly preempted, meaning additional point-of-sale restrictions by states are not expressly preempted.  Id. at *8-9.  At least some of plaintiff’s claims survived express preemption,

    Unlike the dissent in CTS, the court in Elevate understood that claims can be impliedly preempted even if a statutory carve-out saves them from being expressly preempted.  After citing the right law and noting that the trial court and CTS found these claims impliedly preempted under Buckman, the Elevate appellate court found the claims impliedly preempted under Buckman.  With two minor gripes, we find the analysis in Elevate thorough and correct.  Plaintiff’s counts—whether tied to the sale of the unapproved products, allegedly misleading consumers that the products were approved by not saying they were unapproved, or failing to explain what the “Origin Label” required by the TCA means—all sought to enforce the TCA.  Id. at *11-12.  Only FDA can do that, just as Buckman found with the FDCA and medical devices.  “In substance, by seeking to create civil liability for Elevate Smoke’s sale of unauthorized e-cigarettes, the State seeks to enforce the TCA.”  Id. at *11.  The analysis of the “Origin Label” theories of liability noted that the defendant could not have simultaneously complied with the federal requirements and the proposed state obligation.  Quoting Bartlett, the Elevate court noted, “The preemption doctrine does not force an actor faced with competing state and federal laws ‘to cease acting altogether in order to avoid liability.’”  Id. at *12.  The court also rejected the plaintiff’s argument that the proposed application of Ohio’s consumer protection law was like the directory requirements in Wisconsin and North Carolina statutes that other courts had found not preempted.  It clearly was not.

    Lastly, in a footnote to the impossibility discussion, the Elevate court included a brief discussion of why the claims based on the “Origin Label” would also be impliedly preempted under an obstacle theory.  Id. at *12 n.2.  “The TCA imposes strict labeling requirements to limit consumer confusion and to combat illicit trade of tobacco products . . . . [and c]ompliance with [the proposed state requirements] would weaken Congress’s attempt to prevent illicit trade and frustrate the stated purpose of the TCA.”  Id.  This may be a bit too sui generis to be used in drug or device preemption arguments, but, where an obstacle argument (even if made by the court itself) has won, we like to point it out.

    Us being us, we also like to air our gripes.  First, the court said there was a presumption against implied preemption because state regulation of tobacco predated federal law.  That would make sense for field preemption, where a presumption against preemption still exists, but there is no such presumption for implied preemption regardless of the product at issue.  We have explained this more than a few times.  Second, the court noted that plaintiff had raised the Tenth Amendment in suggesting its claims were less vulnerable to implied preemption than those of a private litigant.  It would have been good for the court to reject that argument expressly.  It did so impliedly by noting that only the federal government can enforce the FDCA/TCA.  Neither the state AG nor private litigants are the federal government.  However, the Tenth Amendment should not help the plaintiff anyway because the TCA fits within a few powers delegated to the federal government in the Constitution.  Also, the Supremacy Clause is the ultimate source for all federal preemption, so the Tenth Amendment is a red herring.  Elevate may have had other reasons to reject the argument, which could have been cited when other State AG plaintiffs try to get creative in arguing against implied preemption.  They will surely keep bringing preempted claims and arguing that their status protects them from implied preemption that would bar similar claims brought by private plaintiffs.

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