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Today’s guest post is by Amy McVeigh and Jessica Farmer, who are partners at Holland & Knight. They comment on the demise of another purported class action against a manufacturer of hydrogen peroxide, which is an FDA-regulated over-the-counter (“OTC”) drug. As always our guest posters deserve 100% of the credit (and any blame)

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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

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One of 2022’s top-ten cases, In re Zantac (Ranitidine) Products Liability Litigation, ___ F. Supp.3d ___, 2022 WL 17480906 (S.D. Fla. Dec. 6, 2022), opened with a 4-page critique of the shortcomings of the product testing conducted by a purportedly “independent” laboratory that touched off that massively meritless MDL litigation.  Id. at *1-4.

More bogus product “testing” formed the basis for Sapienza v. Albertsons Companies, Inc., et al., 2022 WL 17404919 (D. Mass. Dec. 2, 2022), which was likewise dismissed four days earlier, only on preemption rather than Rule 702 grounds.  Sapienza was a putative nationwide class action based on allegations that “independent testing” showed the defendant’s over-the-counter (“OTC”) “rapid release” acetaminophen product “dissolve[d] more slowly than” similar products that were not labeled “rapid release.”  Id. at *1.  The rest of the complaint consisted of the usual boilerplate economic loss/“premium” pricing claims.  Id.Continue Reading OTC – One Terrible Class Action – Dismissed

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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