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At ACI’s December session in New York we will be part of a panel discussion on product liability actions against over the counter (OTC) medicines.  Such lawsuits are certainly not new, but some aspects of them are.  For example, so called “independent” laboratories have played an outsized, perhaps inappropriate, role in driving such lawsuits.  In addition, proof of use problems abound with OTC products.  Without prescription records, can the mere say-so of a plaintiff carry the day on usage, or should there be corroboration in the form of bottles, photographs, receipts, loyalty program records, etc.?  Scientific issues of medical causation can be very different with OTC drugs as compared with rX versions. There are usually different doses and durations. Warning causation can also take a very different shape in OTC world.  The absence of a learned intermediary (though, to be sure, sometimes there is a learned intermediary advising the patient to take an OTC medicine – what to do about that?) makes it easier for patients to engage in misuse.  At the same time, alleged injuries from OTC medicines can be every bit as profound as from prescription drugs.  Think of all those terrible SJS/TEN cases.  

And then there is the defense of preemption.  As we’ve written about several times before (here, for example), there is pretty broad express preemption of non-product liability actions against OTC medicines.  Now after all that wind-up, we come to today’s case, Truss v. Bayer Healthcare Pharmaceuticals Inc., et al., 2022 WL 16951538 (S.D.N.Y. Nov. 15, 2022), which is a defense favorable OTC drug preemption case involving a purported economic loss class action against a sunscreen manufacturer. The plaintiffs filed a putative class action claiming that the sunscreen manufacturers falsely marketed the sunscreen as being hypoallergenic and gentle for skin even though the sunscreen actually contained benzophenone, which they allege to be hazardous degradation product.  (Yes, this is yet another case in which the plaintiff alleges harm from chemical breakdown/degradation substances in a product.  Perhaps a new chapter in the plaintiff drug and device playbook is being written.) The plaintiffs asserted claims under California and New York consumer protection laws, as well as common law theories of unjust enrichment and breach of warranty.  The defendant filed a motion to dismiss.  …

Continue Reading SDNY Dismisses Sunscreen Case Based on Preemption

Once again this week we turn to the aridities of personal jurisdiction.  Or is that perhaps a bit … harsh?  After all, last week personal jurisdiction had a rare moment in the public spotlight as a result of SCOTUS oral arguments in a case involving the law of Pennsylvania — our usually-fair-but-not-so-much-in-this-case Commonwealth.  The issue was whether Pennsylvania could condition a corporation’s right to do business in the Keystone State on that corporation’s consent to personal jurisdiction in our overly exciting court system. We’ve written about this consent theory before, and we previewed the SCOTUS case here. If Pennsylvania and other jurisdictions can get away with it, then the Bauman and BMS SCOTUS personal jurisdiction decisions become something very near to dead letters.  It seems that several of the Justices last week thought as much, as their questions evinced deep skepticism about this bogus jurisdiction-via-consent  scheme.  You’ve heard of long-arm jurisdiction statutes, right?  These are strong-arm jurisdiction statutes.  

But predicting SCOTUS rulings is a sucker’s game. 

Meanwhile, press coverage of the SCOTUS arguments was predictably daft. Some commentators bemoaned how rejection by SCOTUS of jurisdictional consent via coercive business registration statutes might make it harder to sue corporations. That is utterly wrong. One can sue the corporation where it is incorporated or headquartered, or where the the events at issue happened. What is unfair about that?  The only real losers would be plaintiff lawyers who apparently think there is a need and a right to sue companies where the plaintiff lawyers are located.  Nothing propinks like propinquity. But no one should shed any tears for lazy and/or cynical forum shopping.

Today’s case, Armstrong v. Atrium Med. Corp., 2022 U.S. Dist. LEXIS 195231 (E.D. Wash. Oct. 26, 2022), involves a more quotidian personal jurisdiction issue: can a product liability plaintiff drag a foreign parent company into court?  We’ve written about this issue before (here, for example).  Including a corporate parent in a lawsuit can be a nice bit of leverage for a plaintiff.  It is an annoyance. It is unnecessary. Fortunately, courts usually do not smile upon it. 

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Continue Reading E.D. Wash. Finds No Personal Jurisdiction Over Swedish Parent Company

Bexis has already plugged the Reed Smith Life Sciences CLE programs this week, so we won’t replug  — except to remind you that Rachel Weil and the drudge/author of this post will tomorrow discuss the taxonomy and tactics of warning causation.  We talk in terms of taxonomy because there are so many interesting variations of the contents of the warning, the relevant audience, doctors who read, who didn’t read, who already know, and who would like to have known, as well as the rules and burdens of proof in jurisdictions around this great, over-warned country. 

It turns out that Kentucky offers some good pro-defense law on warning causation but, then again, there is some weird, unnerving stuff courtesy of the Sixth Circuit.  Tune in tomorrow for details.  In the meantime, we (obviously) have a preference for clear rules, even though the muddy areas are (obviously) where good lawyers can make a difference and earn their money.

There’s nothing wrong with being obvious.  In today’s case, Adamson v. Lupin Pharmaceuticals, Inc., 2022 WL 3448044 (W.D. Ky. Aug. 17, 2022), we get a blissfully clear and obvious ruling from a Kentucky court, and it is in our favorite legal area, preemption, to boot.  The plaintiff in Adamson alleged that he suffered from Stevens-Johnson Syndrome (SJS) — a serious disease that causes the top layer of the skin to die and shed — as a result of taking generic amlodipine besylate.  If you are one of those folks wrestling with hypertension, you might have some familiarity with amlodipine. 

The Adamson complaint included a messy mixture of claims for failure to warn, negligence, negligent misrepresentation, defective design, and breach of warranties.  The defendant moved to dismiss the complaint on the ground that all the claims were preempted by federal law.  The court agreed with the defendant, dismissed the complaint, and did not waste any time in doing so.…

Continue Reading W.D. Kentucky Dismisses Amlodipine Claims on Preemption Grounds

Like most judicial clerks (and, for that matter, judges) we found writing dissents more fun than writing majority opinions. Dissents free one from the need to articulate a consensus.  Moreover, since a dissent does not establish a precedent that others must at least pretend to follow, the dissent’s author can be less precise and can let the rhetorical fireworks fly.  To reverse the Spider Man rubric, with lack of responsibility comes great power to write colorfully.

We clerked on the Ninth Circuit.  The Ninth Circuit is often unjustly maligned. And yet the fact is that the Ninth Circuit more often than not gets things right.  Put another way, not every Ninth Circuit dissent hits the mark.  We certainly do not agree with the dissent to the denial of rehearing en banc in California Chamber of Commerce v. Council for Education and Research on Toxics, 2022 WL 14725243 (9th Cir. Oct. 26, 2022).  But it is a fun read. 

The underlying Ninth Circuit decision enjoined certain Proposition 65 litigation on first amendment grounds, and we discussed that decision last May.  Here is a brief refresher: Proposition 65 requires postings of warnings about substances “known to the state [of California] to cause cancer.” You see those warnings pretty much everywhere in California.  In truth, the warnings are so ubiquitous as to be useless.  …

Continue Reading Ninth Circuit Dissent from Denial of En Banc re Injunction against Prop 65 Lawsuit: Sturm und Drang und Wrong

More plaintiffs, more money. And we don’t mean a mere linear increase. If, as Hegel said, quantitative differences ultimately become qualitative differences, in litigation that happens when going from one plaintiff to two, and certainly to several or many.  When a jury sees multiple people bringing claims against a defendant, they think something’s up, where…

We listen to the This American Life show on National Public Radio most weeks, and it often reveals interesting things about, uh, this American life.   On Saturday, as we drove around the Main Line doing chores, we listened to a This American Life program that illustrated the Tolstoyan ditty about how unhappy families are each…

Fraud via omission of facts is a popular plaintiff lawsuit theory, but many of those lawsuits themselves suffer from the omission of plausibility and specificity.  In Womack v. Evol Nutrition Assocs., 2022 U.S. Dist. LEXIS 145754 (N.D.N.Y. Aug. 16, 2022), the plaintiff filed a purported class action alleging that a manufacturer of energy drinks failed…


From the defense perspective, the worst thing about a mass tort is that it is so … massive.  The more the merrier?  No way. The presence of multiple plaintiffs signals to the jury that something must be wrong with the product.  Don’t believe us?  We think there is research to support our dislike of consolidation…

Drug & Device Resources

Bexis’ Book

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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