Express Preemption

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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

Photo of Michelle Yeary

It’s the start of cold and flu season, so why not talk about cough syrup.  Most cough medicines come in two versions – daytime and nighttime.  The nighttime version typically contains an antihistamine which are known to cause drowsiness.  Daytime versions often contain an expectorant (to thin and loosen mucus) and a cough suppressant.  A common cough suppressant is dextromethorphan hydrobromide (DXM).  That is the ingredient at issue in Goldstein v. Walmart, Inc., 2022 U.S. Dist LEXIS 196743 (S.D.N.Y. Oct. 28, 2022). 

Walmart sells its own brand of OTC cough medicine containing DXM and the label says “Non-Drowsy.”  Plaintiff alleges she relied on that statement in selecting the medicine and she became unexpectedly drowsy after taking it.  She filed a putative class action alleging breach of express warranty, breach of the Magnuson-Moss Warranty Act, and violations of various state consumer protection laws.  Defendants moved to dismiss all claims as preempted.

The federal regulations governing OTC medicines are found in monographs which are promulgated by the FDA and set the approved active ingredients for a class of drugs as well as any conditions under which they are considered safe and effective.  Id. at *7-8.  There is a monograph for Cold, Cough, Allergy, Bronchodilator and Antiasthmatic drugs.  It requires certain products in this class to carry a warning that the drug may cause drowsiness.  DXM is not one of them.  Id. at *8. 

The FDCA has an express preemption clause for OTC drugs – requirements that are “different from or in addition to” or “not otherwise identical with” the FDCA are preempted.  Product liability claims have an exception, but this is not a products case.  The opinion does a thorough walk through of the relevant case law.  Id. at *21-31.  Plaintiff tried to squeeze her claims through a small gap in the preemption window: “preemption does not preclude a state-law claim if the state requirement is outside the scope of the relevant federal requirements.”  Id. at *23.  Courts within the Southern District of New York have approached the scope question and reached slightly different conclusions. …

Continue Reading Southern District of New York Puts Non-Drowsy Labeling Claims To Bed

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We are not the only ones who have pointed out that every new contraceptive for the last fifty years or so has been the subject of litigation and that it is not hard to see how the burden associated with such litigation, even if the manufacturer does well, discourages the development of new options.  This…

Photo of Steven Boranian

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…

Photo of Stephen McConnell

Happy Star Wars Day. May the Fourth be with you.

If all FDA approved medicines enjoyed the preemption protection that vaccines do, the DDL product liability litigation landscape would be leaner and less nonsensical. Flores v. Merck & Co., 2022 U.S. Dist. LEXIS 46442 (D. Nev. March 16, 2022), shows why that is so.…

Photo of Bexis

We had occasion recently to reread Riegel v. Medtronic, Inc., 552 U.S. 312 (2008), and here’s what the Court said about why the “reasonable assurance of safety and effectiveness” standard is preemptive of personal injury claims:

[The FDA] may thus approve devices that present great risks if they nonetheless offer great benefits in light

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Photo of Andrew Tauber

Today we report on Thornton v. Tyson Foods, Inc., — F.4th —-, 2022 WL 727628 (10th Cir. 2022)—a favorable express-preemption decision under the Federal Meat Inspection Act (FMIA), 21 U.S.C. §§ 601–695, that is directly applicable to medical-device cases. Although decided under a different statute, Thornton makes clear that the FDCA bars state-law claims…

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