It is not uncommon that terms are used without knowledge of their origin and that the origin is instructive about the meaning or proper application of the term. We offer two examples. Many lawyers who at least dabble in product liability litigation have heard the term “Bradford Hill criteria.” Was it named after two different
Like having a first child, when you assume new responsibilities in caring for elderly parents, you get a crash-course education in topics you otherwise never would have thought about. Have your first child, and you likely will develop a new-found interest—if not firmly-held opinions—on concepts like sleep training and breast feeding. Take on a role…
Over-the-counter (“OTC”) drugs are protected from civil liability by an express preemption provision that is even stronger than the medical device preemption clause interpreted in Riegel v. Medtronic, Inc., 552 U.S. 312 (2008). That provision is:
Except as provided in subsection . . . (e) . . ., no State or political subdivision of a State may establish
Long, long ago, when we clerked for a federal district judge, we handled more than a few prisoner cases. We have to confess that many of the ones we saw were humorous to us, because they alleged a range of perceived slights and personal affronts as violations of their constitutional rights. (As readers know, we…
Last November, we offered well-deserved criticisms of a really bad MDL-wide preemption decision in In re Acetaminophen − ASD-ADHD Products Liability Litigation, MDL No. 3043, 2022 WL 17348351 (S.D.N.Y. Nov. 14, 2022) (“ASD-ADHD I”). One of its huge gaffes was not citing the Supreme Court’s decision in Merck Sharp & Dohme Corp.
The flimsy decision in In re Acetaminophen − ASD-ADHD Products Liability Litigation, 2022 WL 17348351 (S.D.N.Y. Nov. 14, 2022), leaves us scratching our heads. First, it claims to find “helpful guidance,” id. at *7, in Wyeth v. Levine, 555 U.S. 555 (2009), a prescription drug preemption case, despite the relevant drug(s) being over-the-counter (“OTC”), and thus approved under an entirely different FDA regulatory process. Since Levine is probably the worst prescription medical product liability decision to occur during the now 15-year lifespan of this Blog, when a citation like that appears, the result is not likely to be any good. Then, the decision makes a hash of the relevant administrative record, ignoring what the preemptive FDA regulations said in favor of material from the Federal Register that never actually made it into the regulations themselves.Continue Reading A Painful Preemption Decision
In preparation for our OTC panel next week at ACI-NY, we have kept our eyes open for any OTC cases that raise interesting issues. Today’s case, Rooney v. Procter & Gamble Co., 2022 U.S. Dist. LEXIS 210218 (E.D. La. Nov. 21, 2022), involves a claim by the plaintiffs that a woman developed triple negative breast cancer as a result of using an antiperspirant that she asserts contained benzene.
The assertion that benzene was in the antiperspirant rested on testing by Valisure, an analytical pharmacy. Some of you have heard of a Valisure before, as its testing, and results allegedly showing contamination, have been relied upon by plaintiffs in other mass torts. Valisure calls itself “the pharmacy that checks.” Perhaps we are cynical, but we think of a different sort of checks when we see a purported independent outfit that seems to cooperate closely with plaintiff lawyers. Here, Valisure ran tests on batches of the antiperspirant and came up with concentrations of benzene significantly higher than levels recommended by OSHA. Valisure filed a Citizen’s Petition with the FDA seeking a recall of antiperspirant batches containing too much benzene. (Sound familiar?) The FDA had not responded to the Citizen’s Petition. The defendant voluntarily implemented a recall of certain batches of the antiperspirant.
Before the court was the defendant’s motion to dismiss the plaintiffs’ second amended complaint. The plaintiffs alleged that the defendant violated the Louisiana Products Liability Act by selling antiperspirants without issuing adequate warnings. The plaintiffs also alleged that the defendant was liable under theories of negligence, gross negligence, strict liability, and “fault,” and that the defendant violated the FDCA. Some of those claims seem weird (some of what’s missing also seems weird, but it’s not our job to help plaintiffs author complaints – our criticisms are strictly destructive), but remember, we’re in Louisiana. Not that we’re complaining. The people are fun, the food is great, and did we mention that the Judge in this case dismissed the second amended complaint? Continue Reading E.D. Louisiana Dismisses Antiperspirant/Benzene Claims
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
It is Groundhog Day. So we will write about a fact pattern we’ve written about before. Multiple times.
We cringe whenever we see a case involving over-the-counter (OTC) drugs and children. It brings back memories of lawsuits with sympathetic plaintiffs and difficult facts. We remember one case in which a three year old gobbled half…