A recent published opinion from the Ninth Circuit covers two issues near and dear to our hearts—federal preemption and claims based on outside laboratory testing. We care about federal preemption because . . . well, because we are the Drug and Device Law Blog, where there are some weeks when we write on preemption every
A new published opinion from the Ninth Circuit covers two issues near and dear to our hearts—federal preemption and claims based on outside laboratory testing. We care about federal preemption because . . . well, because we are the Drug and Device Law Blog, where there are some weeks when we write on preemption every
He didn’t win, but he sure looked beautiful. Luca, that is. Faithful readers know that our beautiful standard poodle puppy made his show debut last weekend in Massachusetts. He is learning the ropes and settling down – winning will come in time. We can’t express how thrilled we were to be ringside for these first
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
If we advertised our blog as being non-drowsy, would that be false advertising? We hope not.
In Amara v. Publix Supermarkets, Inc., 2022 WL 3357575(M. D. Fla. August 15, 2022), the plaintiff claimed that a cough syrup was falsely advertised as non-drowsy. According to the plaintiff, the cough syrup contained an ingredient called
We scratched our heads last year when the Third Circuit misconstrued the federal PREP Act to allow a state-law negligence claim arising from an alleged COVID-related death, in direct contravention of the Act’s express preemption. See Maglioli v. Alliance HC Holdings LLC, 16 F. 4th 393 (3d Cir. 2021). The other shoe dropped the
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
There has been a veritable pandemic of posts about Covid-19 regulations (vaccine mandates, restrictions on indoor gatherings, etc.) on the DDL blog as of late, so we thought we’d take a break from the craziness and report on a good, old-fashioned medical device preemption case. And yet we still found ourselves encountering a loathsome disease
The plaintiff in Vesoulis v. Reshape Lifesciences, 2021 WL 1909725 (E.D. Louisiana May 12, 2021), was a dentist. So if he was complaining about pain and suffering, we’d step back and take notice. (Think of the Steve Martin song from the Little Shop of Horrors musical film.) The plaintiff certainly did have something
This post is from the non-Reed Smith side of the blog.
This blog has repeatedly lamented the tendency of MDL courts to flout federal pleading standards when assessing the sufficiency of master complaints. All too often MDL courts disregard Rule 8(a), which—as authoritatively interpreted by the Supreme Court in Twombly and Iqbal—requires plaintiffs to