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Not too long ago one of our bloggers (McConnell) critiqued a p-side law review article he had received from a lawyer on the other side with whom he was friendly.  Bexis isn’t as friendly with opposing counsel – Paul Rheingold being a rare exception.  But probably due to his activity in the American Law Institute, law professors on occasion have asked Bexis to review a law review article or two.  The articles are usually pro-plaintiff, as are most law professors.

Bexis can be a glutton for punishment – but knowing and being prepared to respond to what the other side might throw at us has some value.

Anyway, the article is by Luke Meier, a professor at Baylor Law School, who admittedly is at the plaintiffs’ end of the legal spectrum when it comes to prescription medical product liability litigation:

On one end of the spectrum is the notion that pharmaceutical defendants should be strictly liable (that is, liable even though the product was not defective) for injuries caused by their products.  I happen to fall into this camp. . . .

L. Meier, “Failure-to-Warn Suits Against Pharmaceutical Companies:  Physician Testimony, Causation, & Summary Judgment,” at p.46 (emphasis added).  It’s available here, although we caution that it doesn’t at all look like a finished product.  There are loads of citation-related typos and inconsistencies, a totally unattributed block quote (p.37), and a humorous “disinterred witness” typo that just happens to be in a hypothetical about shoveling (p. 42).  The article’s treatment of the law, however, is in no sense humorous.

Before it gets to its main thesis, however, the article makes some “background” points we can agree with.  Concerning manufacturing defects, “it is extremely rare for a pharmaceutical company to allow a product that has not been manufactured correctly to enter the market” (p.6 (footnote omitted)).  Concerning design defect claims, the article recognizes that “[p]ractically speaking, a plaintiff has very little chance of winning a design defect suit against a pharmaceutical manufacturer” (p.10 (footnote omitted)).  We agree, although with respect to design defect claims, our primary reason is not the common-law quirks that the article addresses, but rather preemption.  As the Supreme Court has recognized, “[o]nce a drug − whether generic or brand-name − is approved, the manufacturer is prohibited from making any major changes to the ‘qualitative or quantitative formulation of the drug product, including active ingredients, or in the specifications provided in the approved application.’” Mutual Pharmaceutical Co. v. Bartlett, 570 U.S. 472 (2013) (citation omitted).  The FDCA’s “major change” category extends to anything that could cause the type of injuries involved in product liability litigation – as we’ve discussed many times, such as here.

Thus the article pushes informationally based “warning” liability as a plaintiff’s last, best hope.  The learned intermediary rule (in addition to preemption in many cases) stands in the way of the author’s pro-liability point of view, so it must somehow be neutered.  How does the article propose to do that?  By ignoring the time-honored requirement that a tort plaintiff has the burden of proving causation, to start.  “Burden of proof” appears exactly once in this 47-page article, in a footnote quotation from one of Bexis’ favorite cases.  Meier Article p. 20 n.147.

The traditional tort burden of proof in a warning case requires the plaintiff to establish, with affirmative facts, that a different warning would have prevented his or her claimed injury.  In non-learned-intermediary situations, the person being warned is the plaintiff, so the plaintiff is his or her own primary witness to establish what we call “warning causation.”  Thus, extremely self-interested plaintiffs can be expected to testify to whatever is necessary to establish a prima facie warning causation case.  The article acknowledges that, in some jurisdictions, plaintiffs receive the benefit of a “heeding presumption” (something we have long detested) in warning cases, but dismisses the presumption as “weak” in learned intermediary rule cases because the same affirmative evidence that defeats causation under the learned intermediary rule also rebuts this presumption (p. 8).  See also Beck & Vale, Drug & Medical Liability Deskbook §2.05[4], at 2.05-92-97 (updated 2024) (discussing ways to rebut a heeding presumption).  That is also true.

What’s critically different in a learned intermediary situation is essentially the reason for this article.  Causation testimony does not come from an interested plaintiff. Ironically, the article spends significant ink attacking the “credibility” of medical professionals, Meier Article pp. 3-4, 38-39, whereas the plaintiffs themselves – who would have to testify to causation if the learned intermediary rule were somehow disabled – get a free pass despite their far worse credibility problems.

Under the learned intermediary rule, to prove causation, evidence must exist that, if believed by the finder of fact, an additional warning would have made some change (often defined as not prescribing the product) in the prescribing physician’s treatment of the patient that would have prevented the injury.  The plaintiff bears the burden of coming forward with such evidence.  But the physician is ordinarily independent and thus not beholden to the plaintiff.  So the plaintiff must obtain warning causation evidence to meet the burden of proof from a witness whose testimony may well be adverse.  If the plaintiff does not, then s/he fails to meet the applicable burden of proof.  If the plaintiff does, then usually disputed issues of fact exist, and the case goes to trial.  The article criticizes that as “asymmetrical risk” (pp.26-27) and “presum[ing] causation is lacking” (p. 30), but that is simply how summary judgment works in the adversary system – requiring the party bearing the burden of proof to meet that burden before a trial is warranted.  The party with the burden of proof must come forward with evidence, not allegations and not speculation.  It’s that simple.

Several types of physician testimony will leave the plaintiff without facts sufficient to meet the usual burden of establishing the possibility of materially different treatment, thus entitling the defendant to summary judgment.  These are compiled in Bexis’ book (and often on the blog as well).  Here are the most common warning causation roadblocks in learned intermediary rule causation cases:

  • The prescribing physician never read the allegedly inadequate warning.  Bexis’ book §2.05[2], at pp. 2.05-35 to -40; blogpost.
  • The prescribing physician testified that s/he already knew the information omitted from the allegedly inadequate warning.  Id. §2.05[2], at pp. 2.05-18 to -29; blogpost.
  • The prescribing physician testified that, even had s/he received the warning the plaintiff demands, s/he would have done nothing differently.  Id. §2.05[2], at pp. 2.05-43 to -48; blogpost.
  • The prescribing physician did not consider the risk severe enough to affect the prescription decision.  Id. §2.05[2], at pp. 2.05-41 to -42; blogpost.
  • The prescribing physician testified that, after the plaintiff was injured s/he did not change any relevant treatment protocols.  Id. §2.05[2], at pp. 2.05-1 to -3.
  • There is no evidence at all concerning the prescriber, either because s/he was never deposed or s/he had died, and there is no heeding presumption to flip the burden of proof.  Id. §2.05[2], at pp. 2.05-53 to -57; blogpost.
  • Further, it is hardly impossible for plaintiffs to establish warning causation under the learned intermediary rule, as the numerous citations to summary judgment denials in Bexis’ book demonstrate.  Id. §2.05[3], at pp. 2.05-69 to -78.

Thus, the law on learned intermediary causation is exactly as stated in Bexis’ book:

In a learned intermediary case, it is “well settled” that a manufacturer’s inadequate warning is causal only if a different warning would have changed the physician’s (or use) decision, or would have altered the physician’s conduct in some other that would have prevented the plaintiff’s injury.

Id. at 2.05-6.  The accompanying footnote extends for nearly six pages of small (10 point) type and cites literally scores of cases.  That is the magnitude of what the Meier article proposes to do away with.

To replace all this law – hundreds, if not thousands, of decisions throughout the country – the Meier article offers the concept of “counterfacts” (pp. 41-45).  We’d never heard of that before, and this section of the article is notably lacking in supporting precedent, so we did what we usually do.  We researched it.  On Westlaw, allcases, the term appears exactly eleven times, and none of those cases use it the way the Meier article does, which is:

For purposes of failure-to-warn claims against pharmaceutical defendants, the “material” inquiry is whether the plaintiff would have avoided injury if the defendant had given the warning proposed by the plaintiff.  But this “material” point is not a “fact” − it is a “counterfact.”  As discussed above, the causation inquiry necessarily requires speculation about a world that never existed:  “Hypothesis and speculation are essential for determining causal connection, since every statement of causal connection asserts what would have happened if the facts had been different.

*          *          *          *

The pertinent question . . . is whether this testimony justifies summary judgment for the defendant.  On this point, the difference between “facts” and “counterfacts” matters. The complicated body of law regarding when the evidentiary record justifies summary judgment on a material fact simply cannot be applied the same with regard to counterfacts.  It is one thing to require a certain amount of evidence regarding a disputed event that actually happened, but it is nonsensical to apply this same standard to a hypothetical event that must be imagined.

Id. at 43-44 (footnote omitted).  For these propositions – including calling the opposite proposition “nonsense” – the Meier article cites no precedent and only the most general sort of tort treatises.

Thus, the Meier article would replace the plaintiff’s burden of proof with respect to “counterfacts” – defined as facts bearing on the likelihood of a possible alternative result – with nothing, that is to say “hypothesis and speculation.”  It proposes to overturn precedent nationwide (see Bexis’ book if you doubt us), and not just decisions having to do with the learned intermediary rule.  Most tort cases involve proof of what would qualify as “counterfacts” as the Meier article defines them.  All warning cases involve “what if” questions predicated on different warnings; only the recipients differ.  Crashworthiness, for another example, involves determining what a plaintiff’s injuries in a vehicular accident would have been with a differently designed vehicle.  Plaintiffs in other product liability litigation often claim that, had an additional safety feature been available, they would have used it.  Damages, particularly in commercial torts, are generally intended to place the plaintiff in the position s/he would have been in had the tortious conduct not occurred.

The article’s “counterfact” concept, in short, is not only unprecedented, but proves far too much.  That rationale – allowing “hypothesis and speculation” to substitute for facts in any case where an element of a claim involves an alternative set of facts – would push the law firmly towards the sort of absolute liability regime that Prof. Meier states that he favors.  Needless to say, we do not agree.

The article also advocates (pp. 32-33) relaxing the causation burden by inserting the plaintiff into the causation matrix with allegations that, while the recommended treatment might stay the same, the accompanying informed consent discussion might have mentioned the alleged risk.  We’ve addressed both of the two cases the article cites (as does Bexis’ book (pp 2.05-14 to -15).  We continue to think that they are directly contrary to one of the primary policy bases for the learned intermediary rule:  to prevent the law from interfering with or disrupting existing physician-patient relationships (Bexis’ book pp 2.03-6 to -9).  The only way that a plaintiff establishes causation in this informed consent variant is to claim that, had s/he received the additional informed consent information, s/he would have disregarded the prescriber’s medical advice and refused the recommended drug.  The article does not even address that inherent feature of letting plaintiffs testify (as they invariably will) that they would have rejected the medical treatment that their prescribers recommended.

Finally, we feel obliged to point out another way in which the Meier article diverges from the great weight of precedent, without acknowledging that it does so.  On several occasions, it suggests that FDA-approved drug warnings are somehow superior to, or more impactful than, other sources of medical information that doctors and other health professionals rely on.  Meier article at 3 (“a physician who is aware of academic literature discussing a particular risk might view that risk differently − and act differently − if a manufacturer deems the risk important enough to provide a warning”); 34 (“It is one thing for a doctor to be aware of information or risks because of the doctor’s own professional reading or conversations.  It is quite another thing, however, for a doctor to receive an explicit warning accompanying the drug”); p. 35 (“a doctor who was already aware of the risk might nevertheless refrain from prescribing the drug if explicit warnings are given by the manufacturer”); p. 35 n.2 (“manufacturer warnings . . . facilitate a potential medical malpractice claim”).  None of these statements is supported by any authority at all.

In this aspect, as well, the article (perhaps unintentionally) is contrary to established law.  Most medical malpractice cases hold that manufacturer warnings do not establish the medical standard of care, and in many jurisdictions FDA-approved drug warnings are not even admissible.

[D]rug manufacturers do not design package inserts and PDR entries to establish a standard of medical care.  Manufacturers write drug package inserts and PDR warnings for many reasons including compliance with FDA requirements, advertisement, the provision of useful information to physicians, and an attempt to limit the manufacturer’s liability. . . . Those considerations highlight the reasons expert testimony must accompany the introduction of PDR warnings to establish the applicable standard of care in prescribing a drug.

Morlino v. Medical Center, 706 A.2d 721, 729 (N.J. 1998).  For a complete discussion of the law on this subject, see our post here.  Far from being somehow superior to other sources of medical knowledge, a prescription medical product’s FDA-approved warnings are at best only a piece of the informational mix in medical malpractice/informed consent litigation, and they are in no way controlling or entitled to greater weight as the Meier article seems to suggest.

The author sought our views on his proposal.  You asked for it; you got it.

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Sometimes we feel as though we have gone back in time.  The Super Bowl is in San Francisco this week, as it was 10 years ago, although this time around, the atrium lobby of our building has been converted into an ESPN studio.  We are the temporary home of the Rich Eisen Show, with the likes of Hall of Famer Kurt Warner and performer O’Shea Jackson, Jr. gracing our presence.  It is quite the spectacle.  A Tech Boom accelerated about 10 years ago in San Francisco with companies like Salesforce and Twitter rapidly expanding, and now it’s happening again with AI and self-driving cars.  Justin Bieber was at his peak 10 years ago, and we are told that he totally nailed it just last week with a killer performance at the Grammys.  Good times.

The catalyst for this nostalgic romp is the district court’s order in Bynum v. Red River Talc, LLC, No. 24-7065, 2026 WL 242063 (D.N.J. Jan. 29, 2026), where a New Jersey federal judge put the kibosh on a medical monitoring class action.  Some of our earliest work in the product liability space was pushing back on class actions seeking future medical surveillance for individuals who have suffered no alleged injury.  Way back in 2006, we wrote an article for the Washington Legal Foundation (with our colleague and frequent guest blogger Kevin Hara) entitled Medical Monitoring: Innovative New Remedy or Money for Nothing?  You can guess which side of the debate we came out on. 

We like the order in Bynum, which strikes the plaintiffs’ class allegations and dismisses medical monitoring claims under New Jersey and Washington law.  The plaintiffs in Bynum allegedly used talcum powder and are part of the long-running In re J&J Talcum Powder MDL.  Of the five named plaintiffs on the class action complaint, some alleged illness caused by the products, and others alleged no injury at all. 

That difference was the downfall of their putative class action.  As a group, the plaintiffs sought certification of five classes: Three classes seeking medical monitoring on behalf of exposure-only consumers who experienced no injury, and two classes seeking compensatory and punitive damages on behalf of both injured and uninjured individuals.

We have known since the Supreme Court’s opinions in Amchem Products, Inc. v. Windsor and Ortiz v. Fibreboard that putative class actions on behalf of both injured and uninjured individuals present intractable conflicts of interest.  That is because injured claimants want to maximize their recovery and do so as soon as possible, while uninjured claimants favor preservation of resources to pay their claims later or over time. 

That conflict alone led the district court in Bynum to rule that the class representatives were not adequate, which doomed all the class allegations.  The court explained it this way:

Plaintiffs seek to litigate a class action on behalf of individuals who allege a present cancer diagnosis, as well as individuals who allege no present injury at all. As the Supreme Court recognized in Amchem and Ortiz, these groups have materially divergent interests.  Those already diagnosed with cancer may reasonably prioritize immediate compensatory and punitive damages, while those without a cancer diagnosis may reasonably prioritize a fund for medical monitoring, long-term preservation of resources, and protections against premature valuation of their claims.

Bynum, at *5 (citations omitted).  The plaintiffs could not overcome these conflicts.  They did not identify separate counsel for the different classes, nor any other safeguard to protect one class against another.  And, their principal authority in support was the train wreck class certification order from the Valsartan MDL, which was our number one worst case of 2023 and which the district judge here wisely distinguished.  In the end, “the proposed class suffers from a fundamental adequacy defect that cannot be cured through discovery . . . and Plaintiffs’ class allegations will be stricken from the Amended Complaint.”  Id. at *6. 

There is more.  After striking the class allegations, the court still had plaintiffs from New Jersey and Washington pressing individual claims for medical monitoring.  Those claims went nowhere either because neither plaintiff alleged a present, existing injury, which both New Jersey and Washington require for a medical monitoring claim.  The plaintiffs pivoted to assert that monitoring costs constitute a present economic injury, but the court found the 189-page amended complaint lacked nonconclusory factual allegations establishing any economic loss.  More fundamentally, even if the plaintiffs had plausibly pled an economic loss, the court held that economic harm alone cannot sustain a medical monitoring claim in either jurisdiction.  The court dismissed the medical monitoring claims without prejudice.

We have a few closing observations about this order.  First, nothing has changed since Amchem and Ortiz.  Mixing present-injury and exposure-only claimants is inherently fraught with conflicts, rendering class representatives inadequate under Rule 23(a)(4).  Second, courts remain willing to strike class allegations pre-discovery where the complaint discloses legal barriers.  A motion to strike was once considered innovative, but not anymore.  A motion to strike can be productive, especially in mass tort contexts with entrenched conflicts and anticipated predominance/superiority issues. 

Third, medical monitoring remains jurisdictionally constrained.  The requirement of a present, physical injury under New Jersey and Washington law was dispositive here, and other states’ laws would have predicted that same result.  Many states, however, still have not clearly addressed medical monitoring, making outcomes under some states’ laws uncertain. (See our 50-state survey on medical monitoring here.)  Fourth, this court did not reach predominance and superiority to reject this putative class action, but it could have.  This class action presented all the usual minefields for medical monitoring classes—individualized medical histories, individual issues on causation, state-law variability, etc.  All these factors weigh against class certification, and correctly. 

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We are writing about another tenofovir case.  But this is not a product liability case or a foray into how far California law can be expanded to discourage innovation.  See here, here, and here for some of the bad ones.  Instead, this is a class certification ruling on a proposed class of purchaser suing for alleged violations of the Missouri Merchandising Practices Act and common law unjust enrichment.

Two things we have pointed out that seem to recur in decisions where courts favor drug and device plaintiffs are that they omit meaningful discussion of the benefit of product and/or the burdens on the plaintiffs.  The decision in Searcy v. Gilead Sciences, Inc., No. 4:20-cv-1523-MTS, 2026 U.S. Dist. LEXIS 11787 (E.D. Mo. Jan. 22, 2026), does not have these failings.  It starts with an affirmative statement of the important role that tenofovir has played in reducing the mortality of HIV in general and in treating the purported class representatives in particular.  It also makes clear that plaintiffs bore the burden to establish every requirement of Fed. R. Civ. P. 23.  It also displays the sort of common sense we sometimes find missing in decisions where complicated cognitive contortions are necessary to reach a pro-plaintiff result in a bogus case.  Plaintiffs’ basic contention was that each purchase of prescription drugs containing tenofovir disoproxil fumarate for twelve years before tenofovir alafenamide came to market was automatically an overpayment because an alternative world allegedly existed where drugs containing the later version of tenofovir were approved and came to market much sooner.  This being a proposed class, the plaintiffs defined the class to exclude anyone who claimed to have suffered a personal injury of any sort.  Instead, purchasing any of the tenofovir-containing drugs for any price during the twelve years was supposedly an economic injury for each class member.

Even before getting to the requirements of Rule 23, the Searcy court was wise to look at standing.  Perhaps because cases involving medical products are getting more tenuous, it seems that we have been seeing quite a few over the last two years dismissed for lack of standing, often because the plaintiffs cannot plausibly allege an injury in fact.  See, e.g., here and here.  In the class context, it is not enough for a proposed class rep to have standing, but the entire proposed class must have standing.  That makes sense, because “a named plaintiff cannot represent a class of persons who lack the ability to bring a suit themselves.”  2026 U.S. Dist. LEXIS 11787, *6-7 (quoting Avritt v. Reliastar Life Ins. Co., 615 F.3d 1023, 1034 (8th Cir. 2010)).  While one of the plaintiffs alleged an injury in fact by overpaying for his prescriptions of tenofovir-containing medications, the class included people—potentially a majority of the class—who paid nothing themselves for their prescriptions.  Id. at *9-10.  You cannot overpay when you do not pay.  This is particularly so when the medications were acknowledged to have value in treating HIV, even if they were allegedly suboptimal compared to drugs containing a later version of tenofovir.  Id. at *11.  The court also rejected the argument—applicable to the statutory claim not the common law claim—that people who “paid nothing or miniscule amounts still suffered an Article III injury because Missouri law entitles them to benefit of the bargain damages,” distinguishing between the required injury in fact and the legal fiction of an injury created by a legislative act.  Id. at *11-12.

That was enough to end the class—the real reason for bringing a case like this—but the Searcy court went ahead and made it clear that plaintiffs did not carry their burden as to multiple Rule 23 requirements.  On the big requirement, “individual issues predominate [over common issues] because prescribing decisions are patient-specific and give rise to individual issues that are central to questions of causation and loss.”  Id. at *14.  It could not be assumed that all class members had certain expectations about the risks and benefits of the medications they were prescribed to make a further assumption that they would not have purchased the medications if the defendant had behaved differently.  Similarly, individual proof would be required to address the knowledge and decision making of both prescribing physicians and purchasing patients.  Id. at *16.  Even the named plaintiff who the court said had alleged an injury in fact had a record of prescription, purchase, and use of medications containing both versions of tenofovir that emphasized the importance of individualized proof (and undercut his core contentions).  This discussion of the record on Rule 23, which we have presented briefly, makes it clear that plaintiffs cannot find another route to class certification by tweaking their proposed class definition or offering some other late amendment.

While refraining from ruling on the admissibility of plaintiffs’ economics expert at trial, the Searcy court took pains to call out his “damages model for calculating class-wide benefit of the bargain damages.”  We have long found the use of economics/pharmacoeconomics/econometrics to establish injury or causation under the guise of opinions on damages to be a stretch, albeit one that occasionally gets some traction when courts struggle with the class action requirements.  See, e.g., here, here, and here.  A calculation of “the difference between the ‘as represented’ value of the product and the ‘as is’ or ‘actual’ value of the product” will inevitably be used to prove that there was a misrepresentation of value and that it caused an overpayment, issues the court had already rightly determined to require consideration of individualized evidence for prescription medications used to treat a potentially fatal condition.  Only with very firm limiting instructions should such flimflam be presented to try to establish damages only.  But, even when offered solely on damages, this model was flawed.  For one thing, because the model failed to account for out-of-pocket payments by the patient-purchasers versus payments by third-party payors, calculated losses could greatly exceed what the plaintiff actually paid.  Id. at *23-24.  It also determined the value of branded medications by looking to the price of much cheaper generic medications.  In addition to looking like a shameless attempt to inflate damages, it is ironic because plaintiffs claimed the alleged delay in bringing the later version of tenofovir to market was because the manufacturer wanted to use its patent exclusivity to delay the entry of generics.  In terms of class damages, though, this model was not designed to “measure only damages attributable to [plaintiffs’] theory,” so it could not be used to support class certification.  Id. at *26 (internal citation omitted).

Another irony here is that these massive failings do not end the case.  They just end any chance at certification of the class as alleged.  Searcy has been pending since 2020.  Surely, the amount of time and effort spent on a fundamentally flawed case, simply because it includes a class allegation, is out of whack.  After all, as the court asked up front,

Plaintiffs, two HIV-positive men, were prescribed and took medications, as directed by their healthcare providers, that Gilead manufactured. The medications they took worked exactly as prescribed, effectively managing their HIV. What is more, the medications did so safely; neither Plaintiff alleges that he suffered any personal injury from taking them. So why have they sued Gilead after taking its lifesaving medications without adverse effect?

Id. at *3.  We have not seen an answer that would justify the longevity of this case.

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We do not quite fit the stereotype of the fat cat – at least (we hope), not anymore.  But there was a time when at least one evening per week would be marked by scotch and cigars. Our antiquity and iffy physical constitution have now reduced such festivities to two or three times per annum. (We missed last week’s Bobby Burns Night Dinner; missed the poetry, missed the peaty firewater, and missed the conviviality of old friends, some of whom, sadly, have passed on.) Still, as the most interesting man in the world might say, while we do not always smoke cigars, when we do, we like Rocky Patel cigars. So imagine our curiosity when Bexis sent us a case with Rocky Patel in the caption. The case is Rocky Patel Premium Cigars, Inc., et al. v. Bonta, 2025 WL 3903972 (S.D. Cal. Dec. 23, 2025).  That “et al.” on the plaintiff side includes some other fine cigar makers, such as A. Fuente, as well as distributors and trade associations. Fuente cigars, such as the Hemingway Short Story, are splendid. We had a rooting interest in this case. The defendant, Bonta, is the California Attorney General. So we really had a rooting interest. On the theory of smoke’em if you’ve got’em, we could not resist scribbling about the Rocky Patel case this week, even if its application to our daily practice is even more iffy than our geezerish health.

We previously blogged about a tobacco decision that applied Buckman preemption against an Iowa consumer fraud law clamping down on vape tobacco products. The Iowa law created a registration regime that explicitly incorporated federal premarket standards as a determinative factor for market access. That is, Iowa was asserting enforcement authority that belonged exclusively to the Food and Drug Administration (FDA). Hello, Buckman preemption. Iowa’s law would have had a better chance of surviving if it was a flat-out ban.

Now we come to today’s case, a decision from the Southern District of California that goes the other way, but still offers backhanded support for Buckman preemption in the drug/device area.  The Rocky Patel case concerns California’s ban of flavored tobacco products.  The statute at issue is Cal. Health & Safety Code section 104559.5. The California AG established and maintained a list of unflavored tobacco products (“UTL”).  Any tobacco product not appearing on the UTL after it is published shall be deemed a flavored product banned by the statute. There is an out “if the FDA has indicated that the product does not require such approval.”

The cigar sellers argued that “premium cigars, as defined by federal regulations, are exempt from the federal premarket tobacco product application process” and, therefore, they cannot be flavored products within the meaning of the California statute. Just a little thought should lead one to the conclusion that premium cigars are not the sort of flavored tobacco products that the California solons had in mind. It is not as if kids are looking to puff on $30 cigars because they have the flavor of .. of what?  Not fruit or vanilla or treacle; rather, it is the flavor of tobacco. Really good tobacco. It is a grown-up flavor. It is an acquired taste. And, just possibly, it is a flavor preference that is none of the government’s business. People gripe about Big Tobacco. What about Big Nanny? What would Winston Churchill and Sigmund Freud say about California’s silly law? (Or have they both been canceled?)

In any event, the cigar sellers challenged the California statute.  They asserted five causes of action: (1) violation of the First and Fourteenth Amendments; (2) violation of the dormant Commerce Clause; (3) violation of the Supremacy Clause (implied preemption); and (5) violation of the Due Process Clause.  The complaint sought injunctive relief. The first test for a preliminary injunction is likelihood of success. In assessing that likelihood, the court focused on express preemption, implied preemption, and the First Amendment.

The federal law at issue is the Family Smoking Prevention and Tobacco Control Act (the TCA), which amended the Food, Drug, and Cosmetic Act (FDCA) to give the FDA regulatory authority over aspects of tobacco. The structure of the TCA makes preemption something of an adventure. The TCA contains a broad “preservation” clause allowing states to regulate more stringently (including outright bans) than federal law, followed by multiple preemptive carveouts, in turn followed by a savings clause allowing state regulation of tobacco “sales.” This byzantine preemption/savings structure renders the express preemption aspect of the Rocky Patel opinion not perfectly analogous to our drug/device sandbox. 

First, the court held that the plaintiff’s express preemption argument was unlikely to succeed. The issue was whether the state’s UTL statute and implementing regulations “establish requirements relating to premarket review that are different from or in addition to those established by the TCA … or whether the UTL regime establishes requirements relating to a permissible sales ban on flavored products, such that it falls within the Preservation and Savings Clauses.” This issue turned on an interpretation of what “premarket review” means. The court ultimately decided that the preservation of “premarket review” as a basis for express preemption would cover a fraud on the FDA claim or a state redefinition of categories subject to PMA, but not this flat sales ban. 

As for implied preemption, the court agreed that a state enforcement system “parasitic” on the FDCA (like the Iowa vaping statute in our earlier blogpost) would be preempted.  But the court deemed California’s flavored tobacco ban as being non-parasitic.  The court distinguished (and somewhat demeaned) the Iowa decision. According to the Rocky Patel court, California’s ban on flavored tobacco was a public health measure, and thus the dreaded presumption against implied preemption applied.  As the court saw it, the federal tobacco regulation generally constituted a mere floor that state laws could exceed.  A state ban does not rely on FDA regulatory standards as an enforcement mechanism.  Since the federal tobacco statute intended to preserve a large role for the states, nothing in drug (Nexus Pharmaceuticals) or device (Buckman) cases prohibited state reliance on FDA determinations to enforce its ban.  The ban does not rely on the FDCA; rather, it relies on historic state power to govern tobacco sales and the statutorily established federal regulatory floor for regulation of tobacco products.  In the context of tobacco sales regulation, incorporating federal standards into a state sales’ requirement is not “enforcement” of federal law. 

The plaintiffs argued that the California statute “restricts the manner in which premium cigar manufacturers and importers may describe their products and thus their commercial speech.” The court rejected this First Amendment argument, but at least did acknowledge that the ban triggered First Amendment scrutiny under the Central Hudson test for evaluating restrictions on commercial speech. In applying that test, the Rocky Patel court held that that statute’s “creation of a rebuttable presumption where a manufacturer describes its product as having a characterizing flavor is narrowly tailored to serve the State’s interest in banning flavored tobacco products.” Moreover, the UTL “does not prohibit manufacturers from using any descriptions but merely seeks to further the goal of ferreting out flavored products by drawing special attention to these products that the manufacturer itself describes as being flavored.” 

That “merely” is doing a lot of work.  But we think the “ferreting” word is appropriate. Maybe Big Nanny is also Big Ferret. Maybe the California UTL law is constitutional, but it is also, as Justice Stewart said in his Griswold dissent, an “uncommonly silly” law.   

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Some cases feel brand new. Others feel like a remake you didn’t ask for—but somehow know all the lines to already. This one is firmly in the latter category. For those of us who have been around long enough to remember dial-up internet and the original pedicle screw litigation, this case reads like a throwback. In fact, one of this blogger’s very first cases (working with Bexis) was the Bone Screw MDL—the one that gave us Buckman Co. v. Plaintiffs’ Legal Committee. So, Elowson v. Alphatec Spine Inc., 2026 U.S. Dist. LEXIS 13591 (D. Ariz. Jan. 26, 2026), a negligence per se claim based entirely on alleged FDCA violations, involving pedicle screws, gave us a distinct sense of déjà vu. Spoiler alert: Buckman still wins.

The plaintiff underwent spinal surgery in 2019 to remove a tumor on her lumbar spine. Part of the procedure required spinal fusion using a plate-and-screw system. Things went along just fine—no complaints, no complications, no litigation—for half a decade. Then, in 2024, plaintiff began experiencing pain. An x-ray revealed that one screw had broken at some point before the bone fully fused. Id. at *1.

Cue the lawsuit. Never mind that the device lasted five years. Never mind that the product warnings expressly state that screws may fail if fusion does not occur. Never mind that pedicle screws are subject to the immutable laws of physics. Plaintiff sued anyway, alleging among other things negligence per se based entirely on supposed violations of the FDCA and FDA regulations.

That claim did not survive defendant’s motion to dismiss. And for good reason. Plaintiff’s negligence per se theory was simple in concept and fatal in execution. According to plaintiff, the manufacturer had a duty to update the device design because it was based on an allegedly “outdated” “European style of design” and because U.S. manufacturers supposedly use a design that reduces the risk of fracture. Id. at *4-5. Plaintiff alleged that the “source” of that duty was the FDCA and its regulations, id. at *5-6, rather than any traditional state-law tort principle. That is a problem.  A Buckman-sized problem.

As the court correctly held, negligence per se claims premised exclusively on alleged FDCA or FDA regulatory violations are preempted. Full stop. The Supreme Court settled this decades ago. Id. at *7. If Buckman had a walk-on song, this would be its moment.

The negligence per se claim here would not exist without the FDCA. Plaintiff did not identify any independent state-law duty requiring manufacturers to update designs based on evolving regulatory expectations or comparative international practices. Instead, plaintiff attempted to bootstrap FDA regulations into a state tort claim. That is exactly what Buckman forbids: private litigants bringing private enforcement actions of the FDCA under the guise of state law.

Negligence per se is not a free-floating cause of action. It applies only where a defendant violates a “specific legal requirement, not a general standard of care.” The plaintiff’s problem was that the only “specificity” she could point to came from FDA regulations. Without those regulations, there was no duty, no breach, and no claim.

Courts have consistently recognized that claims not tied to traditional state tort duties—but instead dependent on federal regulatory schemes—are preempted. Allowing them to proceed would invite juries to second-guess FDA regulatory decisions and enforcement priorities. That, again, is Buckman territory. The court declined that invitation.

The court did, however, allow plaintiff’s strict liability design defect claim to survive the pleadings stage. Defendant argued that Arizona follows either the Second or Third Restatement of Torts and that under either it would reject strict liability design defect for a medical device. On the former, the court concluded that whether comment k applies—whether defendant’s screws are unavoidably unsafe—is a question of fact that can’t be resolved on the pleadings. Id. at *11-12. On the latter, the court disagreed with defendant that Restatement Third §6c was Arizona law. Under §6c, a strict liability design defect claim would require plaintiff to plead that a reasonable health-care provider, knowing the risks and benefits of the medical device, would not prescribe the device to any class of patients. Id. at *12. The Arizona Supreme Court, however, in a case that pre-dates the Restatement Third, adopted the standard risk/utility test for strict liability design. As a federal court sitting in diversity, the Elowson court was bound to apply that standard. Id. at *13. Plaintiff’s allegations sufficiently alleged a design defect (the “outdated” European style); an alternative design (the “smooth” U.S. style), and that defendant’s “failure to design screws that remain intact and do not break caused her injuries.” Id. at *15. That was enough to survive a TwIqbal challenge.

But perspective is important. Pleading survival is not victory—it is a timeout. The case now proceeds with discovery, expert scrutiny, and the inconvenient reality that spinal fixation devices, by their very nature, carry a risk of mechanical failure. To date, no bone screws—whether designed in the U.S., the U.K., or on Mars——are immune from breakage, especially in the absence of fusion. Gravity and biomechanics remain undefeated. Warnings here explicitly addressed the precise risk that materialized. The device functioned for five years. And the alternative design theory exists, for now, only on paper. In other words, this looks far more like a temporary setback than a turning point.

The more important takeaway is that this decision reinforces a familiar but critical principle: plaintiffs cannot manufacture negligence per se claims by repackaging alleged FDCA violations. Buckman remains the OG pedicle screw case—and it still has teeth. Sometimes, the old rules still work—much like those screws did, for half a decade.

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At the recent ACI Drug and Medical Device annual conference, Bexis created something of a stir by broaching the subject of litigation discovery into the “prompts” that are typically used to create output from generative artificial intelligence.  A fair number of the attendees apparently had not considered that possibility.  Well, it’s already being done, and counsel need to be prepared to address it.

What caselaw exists – so far exclusively from AI copyright litigation − treats prompts as one more form of ediscovery, discoverable (or not) under generally applicable discovery principles.  In Concord Music Group, Inc. v. Anthropic PBC, 2025 WL 1482734 (N.D. Cal. May 23, 2025), for example, the defendant was compelled to “produce a total of 5 million prompt-output pairs” to “be drawn equally from pre-suit and post-suit data” and “randomly selected.”  Id. at 4.  Non-lawyer AI prompts by a party’s employees have also been ordered produced, subject to usual proportionality constraints.  Concord Music Group, Inc. v. Anthropic PBC, 2025 WL 2267950, at *1-2 (N.D. Cal. Aug. 8, 2025) (ordering production of prompt/output generated by the defendant’s “founder, executive or managing agent” and any other “identif[ied]” employee).  Irrelevant AI prompts and their results are, by definition, non-discoverable.  In re OpenAI, Inc., Copyright Infringement Litigation, 800 F. Supp.3d 602, 611-12 (Mag. S.D.N.Y. 2025). Also in the Concord Music litigation, counsel was held to have waived the work product privilege to the extent that they had turned over AI prompts to an expert witness. Concord Music Group, Inc. v. Anthropic PBC, 2025 WL 3677935, at *3 (N.D. Cal. Dec. 18, 2025).

Application of general legal principles also means that, to the extent that counsel are using AI – and prompting it – in the conduct of litigation, the prompts and the resulting output (referred to as “prompt/output” or “prompt/output pairs”) can be protected by discovery by work-product principles.  Concord Music also addressed this issue and rejected an argument that attorney prompts were unprivileged as “unpersuasive.”

[Defendant’s] initial argument, that the information it seeks (undisclosed prompts and outputs, and the settings therefore) is not privileged is unpersuasive.  [Plaintiffs] cite cases where courts . . . have found precisely this information to constitute attorney work product.  [Defendant] distinguishes only [the] denial of waiver, . . . but does not distinguish the basic finding that the failed prompts and related settings are attorney work product.  This Court agrees. . . .

Id. at *2 (citations omitted).  See Tremblay v. OpenAI, Inc., 2024 WL 3748003, at *2 (N.D. Cal. Aug. 8, 2024) (“ChatGPT prompts were queries crafted by counsel and contain counsel’s mental impressions and opinions about how to interrogate ChatGPT, in an effort to vindicate Plaintiffs’ [case]”).

That’s all we’ve found, since this is a quite new area.  We do note, however that the Tenth Circuit recently ordered a litigant to identify AI prompts used in preparing a brief, citing its “inherent power,“ but that was in the context of sanctioning that party for hallucinated citations. Moore v. City of Del City, 2025 WL 3471341, at *2 (10th Cir. Dec. 3, 2025). Non-lawyers – particularly corporate employees, need to appreciate that their AI prompts and the resultant outputs can be discoverable to the same extent as other electronically stored information.  Counsel need to know that they can waive work product protection of prompt/output pairs if they do not treat litigation-related AI use as confidential.  Defense counsel, in particular, need to ensure that our clients are prepared for potential discovery into AI prompts and their results.

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We previously posted about plaintiffs’ shenanigans in attempting to defeat diversity in a medical device case removed to the Northern District of Illinois. Plaintiffs’ antics were unsuccessful, and the federal court denied plaintiff’s motion remand.  Today’s decision addresses the defendants’ motion to dismiss plaintiffs’ third amended complaint in the same case, and it is very favorable from a preemption standpoint. Miller v. Rush University Medical Center, 2026 WL 147413 (N.D. Ill. Jan. 20, 2026).

Miller involves a cervical disc replacement device (the “Mobi-C”). The device includes an accompanying inserter with a “depth stop” mechanism used to prevent the Mobi-C from going too far into the spinal cord during insertion. Plaintiff and his spouse sued the device manufacturer, the distributor, two sales representatives, the hospital, and the treating physician based on claims that he suffered spinal cord contusions during surgery. The defendants moved to dismiss, with the manufacturer and distributor arguing that all claims against them were preempted. The court agreed.  

Continue Reading PMA Preemption in the Northern District of Illinois
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December 9, 2026?  What is that about? 

Well, December 9, 2026 is the deadline for each member nation within the European Union to have incorporated the EU’s new Product Liability Directive (“PLD”) into their own national laws.  In key markets like Germany, that work is well underway.

Not every EU member state will meet the deadline, and we doubt that courts within the E.U. will instantaneously be overrun with rabid plaintiff-side product liability lawyers from the United States, but the date is significant nonetheless because the EU—for reasons that boggle us—has decided that Europe simply does not have enough product liability litigation, and the EU PLD is the solution they hit upon to address this “problem”.

We have raised the alarm about the new EU Product Liability Directive before, for good reason.  Formally known as Directive (EU) 2024/2853 of the European Parliament and of the Council of 23 October 2024 on liability for defective products and repealing Council Directive 85/374/EEC (Nov. 18, 2024), the EU PLD signifies a seismic shift in product liability exposure in Europe.

The EU PLD establishes a no-fault liability regime for “economic operators”—including manufacturers, importers, authorized representatives, fulfilment service providers, and, in certain cases, distributors and online platforms—for damage caused by defective products.

The definition of “product” also is expansive, and includes not only tangible goods but also software, digital manufacturing files, raw materials, and electricity.  So it is not just companies that are used to product liability exposure in the U.S. that need to pay attention, because the EU PLD treats software as a product for product liability purposes and digital services integrated into or inter-connected with products, such as software updates or health monitoring services, are potentially within the scope of liability if they affect product safety.  Free and open-source software supplied outside commercial activity is excluded, but if such software is integrated into a product in the course of commercial activity, the manufacturer of the final product may be held liable. 

The point being that in addition to manufacturers and sellers of what we think of as products, even tech companies, social media, suppliers of medical devices with software functionality or services, also might want to assess their risk, insurance, and contracts with the EU PLD in mind.

Other key points of the EU PLD include:

Types of Compensable Damage:

Compensation is available for death or personal injury (including medically recognized psychological harm), damage to or destruction of property (excluding the defective product itself and property used exclusively for professional purposes), and destruction or corruption of non-professional data. Pure economic loss, privacy infringements, and discrimination do not trigger liability under this Directive, though other liability regimes may apply.

Determining Defectiveness:

A product is considered defective if it fails to provide the safety that the public is entitled to expect, assessed objectively and taking into account factors such as intended use, foreseeable misuse, presentation, technical features, expected lifespan, and compliance with safety requirements—including cybersecurity.

The EU PLD specifically addresses products with high safety expectations, such as life-sustaining medical devices, and allows courts to find all devices defective just because they come from the same production series as another defective device.

Presumptions and Burden of Proof:

Claimants under the EU PLD technically must prove defectiveness, damage, and causation, but the Directive has several rebuttable presumptions that really lighten the claimants’ evidentiary burdens.

•           Defectiveness is presumed if the defendant fails to disclose relevant evidence, if the product does not comply with mandatory safety requirements, or in cases of “obvious malfunction”.

•           Causation is presumed where the type of damage is typically caused by the defect in question.

•           Courts may presume defectiveness or causation (or both) where technical or scientific complexity makes it hard for the claimant.  Seriously. 

Defendants retain the right to rebut these presumptions, and the first order of business under this new product liability regime will be for defendants to establish good law about how this is done.  Member States must publish final appellate judgments, and the EU Commission will maintain a public database of relevant case law, so good authorities potentially will help across all member states—and bad precedent potentially will hurt the same way.

Liability and Exemptions:

Liability is joint and several where multiple economic operators are involved. Economic operators may be exempted if they prove, among other things, that the defect did not exist when the product was placed on the market, that defectiveness resulted from compliance with legal requirements, or that the state of scientific and technical knowledge at the relevant time could not have revealed the defect (“development risk defence”). However, Member States may elect to forgo the development risk defence for specific product categories in the public interest.

Manufacturers remain liable for defectiveness arising after market placement if it results from software, related services, or lack of necessary updates within their control.

Liability cannot be contractually limited or excluded, and national laws may not set financial ceilings.

Circular Economy and Substantial Modifications:

The Directive addresses circular economy practices, holding those who substantially modify products outside the original manufacturer’s control liable as manufacturers of the modified product. Substantial modification includes changes to performance, purpose, or risk profile not foreseen in the initial risk assessment.

Statutes of Limitations and Repose:

The limitation period for claims is three years from the date the injured person became aware of the damage, defectiveness, and liable operator. An “expiry period” of ten years applies from market placement, extended to 25 years for latent personal injuries.

There is little to like in the EU PLD.  Add in the fact that many EU countries have markedly different approaches to attorney-client privilege and work product confidentiality, changes that make representative or group actions more available, and the interplay between other EU regulatory regimes and the EU PLD, and a storm is brewing. 

We are still only under a watch, not a warning which, in weather forecaster public messaging terms, means the tortillas, meat, salsa and other ingredients are ready, but the taco is not yet on the table. 

Use the time remaining ‘til December 9, 2026 to batten down the hatches.

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How many times have you seen a lawyer end the trial direct examination (or deposition redirect) of his/her expert by perfunctorily asking, “Do you hold all your opinions to a reasonable degree of certainty?” Then there is the obligatory “Yes.” The magic words have been uttered.  All is right with the world, right?

Maybe. 

If the expert has done a good job of describing the opinions and supporting analyses, those magic words might not be necessary. More interestingly, if the supporting analyses are frail, or the opinions are hedged with modifiers (less politely described as weasel-words)  the magic words might not be sufficient.  

For the second week in a row, we are discussing a Pennsylvania Supreme Court decision in a criminal matter.  Last week, it was an affirmance.  This week, in Commonwealth of Pennsylvania v. Fitzpatrick, 2026 WL 157732 (Pa. Jan. 21, 2026), it is a reversal of a murder conviction. The issue is whether an expert’s testimony about the manner (not scientific cause) of death, even though such expert testimony is not required by law to support the prosecution’s theory of manner of death, must satisfy the “reasonable certainty” requirement that applies to expert testimony. The answer is Yes. Thus, Fitzpatrick is yet another criminal case with significant civil implications. 

The defendant in Fitzpatrick was accused of murdering his wife.  She drowned in a tributary of the Susquehanna River after an accident involving an all-terrain vehicle (ATV). Husband and wife were supposedly riding together.  The husband claimed that the ATV flipped backwards, tossing them both into the creek.  The husband managed to climb out of the creek unscathed. The wife was not so lucky 

There was no doubt that drowning was the cause of the wife’s death.  The issue, according to the Supreme Court, was the manner of death – accident, homicide, suicide, etc.  At the beginning of the opinion, we are treated to a long discussion of the difference between cause and manner of death. It feels very scholarly in an old-timey way. And then we noticed that the author was Justice Wecht. He was one of the three Democratic Justices who won a retention election last November.  He is a double Yalie, and that shows in the intellectual heft in the Fitzpatrick opinion. The opinion is well written. Plus, the subject matter of the case is fascinating. It is a good read. Think of the Restatement as rewritten by Mick Herron. In any event, while the prosecution needs an expert to opine as to the cause of death (here, drowning), whether the drowning happened via accident or malevolence is an issue that a jury can decide without help from an expert. 

Nevertheless, the Commonwealth offered that help to the jury, via a prosecution expert witness (an expert on aquatic deaths) who testified using the “magic words” “reasonable degree of medical certainty” to certain opinions concerning the manner of death.  Based on the nature of the wife’s injuries and the husband’s complete absence of injuries, the prosecution expert opined that the wife did not die because the ATV accidentally flipped over but, rather, because the husband administered blunt force injuries and then deposited his wife into the creek. (There was other evidence against the defendant, such as his wife’s written statements that she feared her husband wanted to kill her, the husband’s affair with another woman, the existence of a life insurance policy, the husband’s internet searches on polygraphs and life insurance, and the husband’s lie about the existence of his wife’s cell phone. But that evidence was separate and apart from the expert’s opinions regarding manner of death.)

The problem is that on cross examination, the prosecution expert admitted that his opinions were held to a “more likely than not” standard – a situation often seen in civil litigation.  The expert deployed some very unmagic words such as “possibility,” unlikely,” “I don’t think,” and “consistent with.” The trial court excluded the testimony, but the Superior Court, on appeal, reversed and invented a novel exception to the reasonable degree of medical certainty requirement for manner of death; because such expert testimony was not, strictly speaking, required to establish that element of the crime, the jury could hear such expert testimony if it was “sturdy.”

The Supreme Court reversed.  We get some history as to the origin of the “reasonable certainty” standard.  Those words are absent in Pa. R. Evid. 702. The concept originated in a Chicago personal injury case in 1916.  It did not appear in a Pennsylvania case until 1968.  The standard saw a “virtual explosion of usage” in the 1970’s, to the point where it became “unmistakably clear” that Pennsylvania “case law, evidentiary rules, and supporting secondary materials require that an expert hold his or her opinion to a reasonable degree of certainty in order to be admissible in legal proceedings.”  (It might be entertaining and useful for you to conduct a similar archeological expedition as to the origin of the “reasonable certainty” standard in your jurisdiction.) 

The Fitzpatrick court held that there are no exceptions to the requirement that all expert opinions must be held to a reasonable degree of professional certainty, which in the case of medical testimony means “medical certainty.”   The Supreme Court also definitively held that mere “more likely than not” or “could have” testimony does not rise to the level of reasonable certainty and thus must be excluded.  Further, the entirety of the relevant opinion evidence must be considered, and rote pronouncement of the “magic words” is not controlling.  

The Supreme Court rejected the Superior Court’s invention of the lesser “sturdy” standard in any area of expert testimony.  The term is incapable of being reliably and consistently applied. (That is an excellent and unanswerable point.) It is not enough that the opinion be reached using the generally applicable standards of the relevant profession, it must also be held to a reasonable degree of certainty.  

Therefore, the prosecution expert opinion in Fitzpatrick was inadmissible, even though the expert used the magic words, because of his admissions on cross-examination.  “[M]ore likely than not falls below the level of certainty required for the admission of expert testimony.” 

While few readers of this blog will work on murder cases, Fitzpatrick might be useful in any case where the other side’s expert plays the usual game of using the “magic words” of “reasonable certainty” as a fig leaf covering what is really a mere “more likely than not” opinion. If failure to satisfy the actual “reasonable certainty” standard can overturn a murder case, it should also prevent a private plaintiff from inflicting junk science on a jury. 

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If you ever needed proof that timing is everything, the Taxotere litigation has you covered.

Last month, a court denied summary judgment to the brand manufacturer, finding that it allegedly acquired “newly acquired information” post-dating Taxotere’s original FDA approval in 1996. This month, however, the very same court granted summary judgment to the manufacturers of docetaxel, the active ingredient in Taxotere, whose products were approved in 2011 via §505(b)(2) of the FDCA.   

The key distinction—the clock didn’t start running in 1996 for everyone. In re Taxotere (Docetexal) Eye Injury Products Liability Litigation, 2026 WL 123664 (E.D. La. Jan. 16, 2026).

To start, a §505(b)(2) approval is something of a hybrid between a New Drug Application (brands) and an Abbreviated New Drug Application (generics). It is available for drugs that differ from the RLD (reference listed drug) “in ways that are slight enough for the manufacturer to still rely on the RLD’s safety and efficacy data.” The manufacturer submits an NDA, but it “need contain only that information needed to support the modification(s) of the listed drug.  Unlike [generic] drugs, §505(b)(2) drugs are not required to use the exact same labeling as the RLD.” Id. at *2. So yes we are talking about generics. No, we are not talking about Mensing preemption.

The labels for both Taxotere and docetexal warned of “excessive tearing which may be attributable to lacrimal duct obstruction,” but plaintiffs argue it should have said more. Such claims are preempted, however, unless plaintiffs can point to newly acquired information that would have permitted a unilateral label change (i.e. without the FDA’s approval) under the FDA’s Changes Being Effected (“CBE”) regulation.  In the case of docetexal, plaintiffs argued that information that post-dated the original Taxotere approval but pre-dated the §505(b)(2) approvals should be considered newly acquired. Which if allowed would almost certainly have led the court to reach the same conclusion it did in December.

But here’s where we get a little help from the Fifth Circuit and the first Taxotere MDL. In Hickey v. Hospira, 102 F.4th 748 (5th Cir. 2024), which we talk about here, the appellate court found that “the newly acquired information inquiry centers on what happens after the FDA approves a §505(b)(2) drug.” In re Taxotere, 2026 WL 123664, *9 (emphasis in original). While the §505(b)(2) manufacturers can rely on the brand manufacturer’s safety and efficacy data, they don’t have a “right of reference” to it, meaning they don’t get to see all of it. You can’t say what is “new” if you don’t have a point of reference to compare it to. Id. at *8. That’s why their clock did not start in 1996. Instead, the Fifth Circuit said the proper “baseline comparator” for §505(b)(2) manufacturers is the “publicly available literature that existed prior to the §505(b)(2) manufacturers’ approval.” Id. at *10.

Once the right timing for the baseline was set, the rest of the decision is a standard CBE analysis—did the §505(b)(2) manufacturers have newly acquired information that post-dated the 2011 approval of their drugs that would have supported a unilateral label change. Id.  Without going into the details of the science, the answer was no. Id. at *10-14.

Under the CBE regulation, post-approval information qualifies as “newly acquired” only if it reveals “risks of a different type, or greater severity or frequency” than what was already known and disclosed at the time of approval. Id. at *10. That’s a high bar—and intentionally so. The FDA, not juries, decides what risks warrant warnings, and manufacturers can only change labels unilaterally when genuinely new safety information emerges.

Here, the science tells the same story it did before approval—just with more footnotes. And no, calling old data “new” doesn’t magically make it so. Relying on new articles that “summarize pre-approval literature” is simply repackaging existing knowledge. Id.at *13. If the post-approval literature confirms what was already known, that’s called confirmation, not innovation. And confirmation does not authorize a CBE label change. Because the manufacturers could not have changed their labels without prior FDA approval, plaintiffs’ state-law failure-to-warn claims collapse under impossibility preemption.

While different, the two Taxotere rulings are not contradictory. They’re chronological. And while we think the December ruling was strained on what constitutes newly acquired information, what may count for a product approved in 1996 does not automatically remain “new” forever. By 2011, the FDA had already seen it, digested it, and approved products with that knowledge in hand. When nothing new emerges after approval, manufacturers—brand or generic—cannot be faulted for failing to warn about risks the FDA already considered.

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FDA-regulated products now account for an estimated one-fifth of overall economic activity in the U.S. They have also been the focus of a litigation explosion. This timely guide covers all aspects of litigation involving drugs, medical devices, vaccines and other FDA-regulated prescription products.
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