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.
The SCOTUS Mensing case controlled the result. In Mensing, the High Court held that state tort law requiring generic drug manufacturers to change a drug label was preempted because it was incompatible with the federal requirement that generic labels must be the same as the branded label. It would be impossible for the manufacturer to comply with both federal and state law. Hello, Supremacy Clause, hello duty of sameness, and good bye strict liability failure to warn claim. Because the federal definition of drug labeling is quite broad (including, not only the label, but other communications/advertisements, etc. regarding the drug), the Mensing decision shuts down claims of failure to warn and breach of express warranty. The defendant did not have the power independently to alter its label or other safety communications regarding the drug.
Similarly, the defendant had no power “to unilaterally alter the design of their generic Amlodipine Besylate.” The Adamson court cited another W.D. Kentucky case, Mitchell, to support its dismissal of the design defect/strict liability claims. The Adamson court could also have cited the SCOTUS Bartlett case, but it didn’t. That’s neither here nor there, we suppose, except that Bartlett was also a SJS case. Plaintiffs have claimed that just about everything causes SJS, which means they have no idea.
The plaintiff’s negligence claim was a menagerie of allegations, including negligence in manufacturing, designing, etc., failure to conduct studies, failure to warn (again), failure to provide adequate instructions, and advertising that seemed to suggest that using amlodipine might be good (what other kind of advertising could there be?). According to the Adamson court, “[a]ll of these claims are preempted by the FDCA because they relate back to FDCA prohibitions against changing the marketing materials, or altering the labels or the design of the drug.” Just so. The negligent misrepresentation is also preempted under a theory of impossibility — obviously.
Finally, the plaintiff’s remaining claims for breach of warranty (including merchantability and fitness for a particular purpose) are also preempted. The plaintiff criticized the warranties to the extent they suggested the drug was safe and effective. Apparently, any warranty would be defective unless it said the product was unsafe and that consumers should run in terror from the bottles. But, per Mensing, a generic manufacturer is not allowed to add such a curious gloss to drug labeling, so the claims are barred.
We warned you that the Adamson case was an exercise in the obvious. But isn’t a dose of the obvious occasionally a welcome thing?
Now sign up for our CLE on warning causation. We warn you: you’ll hate yourself if you miss it.