Photo of Bexis

The recent defense win in Dains v. Bayer HealthCare LLC, 2022 WL 16572021 (N.D.N.Y. Nov. 1, 2022), demonstrates why many plaintiff-side counsel are well-advised to steer away from cases involving PMA medical devices.  Between federal preemption and TwIqbal, not one of the plaintiff’s “seventeen separately enumerated causes of action” escaped the defendant’s motion to dismiss.  Id. at *3.

Continue Reading Preemption and Pleading Send Plaintiff Packing

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

Photo of Stephen McConnell

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

Photo of Michelle Yeary

“That which we call a rose by any other name would smell just as sweet.” William Shakespeare uses this line in his play Romeo and Juliet to convey that the naming of things is irrelevant. We may not always agree with that (for instance, this blogger is Washington Football Fan – enough said). But when