Over The Counter Drugs

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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

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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

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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

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It has been a while since we saw a movie in a theater.  That is one aspect of the oft-discussed return to normality that appeals to us.  When we saw a trailer recently for The Many Saints of Newark, a prequel to old HBO mainstay The Sopranos, it piqued our interest.  It even made us

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Did you remember that there can be express preemption for over-the-counter drugs?  We sometimes forget too, but there are really good reasons for that.  The Food Drug and Cosmetic Act includes the following provision:

[N]o State or political subdivision of a State may establish or continue in effect any requirement – (1) that relates to

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We’re serious – we’re not planning to give a flip answer like “an extortion racket.”  No, it’s more like law school, where a first-year contracts professor began with the question “What is Chicken?”  (Hint – that’s discussed in Frigaliment Importing Co., Ltd. v. BNS International Sales Corp., 190 F. Supp. 116 (S.D.N.Y. 1960)).  The

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The Reed Smith blogging team has just returned from this year’s annual ACI Drug & Medical Device Litigation conference.  In addition to excessive amounts of eating, drinking, and socializing (now called “networking”), we kept our eyes open for new and interesting topics to blog about.  We were not disappointed.  We learned a lot more regarding preemption of claims involving non-prescription, over-the-counter (“OTC”) drugs, particularly those governed by parts of the FDA’s monograph system that we haven’t considered much before.

We knew, of course, that OTC drug preemption is governed by 21 U.S.C. §379r, which contains not only an express preemption clause, but also a savings clause. Under the preemption clause, tort claims demanding warnings or other information that is “different from,” “addition[al] to,” or “otherwise not identical with” federal labeling requirements are preempted.  However – and it’s a great big however – the savings clause exempts “product liability” claims from preemption. Id. §379r(e).  That doesn’t mean that preemption covers nothing of interest to us.  We’ve discussed at some length how many courts have considered non-personal injury claims to be outside the scope of the “product liability” saving language, and therefore precluded by express preemption.  Most recently, we described a 2014 New Jersey case involving mouthwash that refused to apply a presumption against preemption to the express preemption clause, finding the presumption precedent “confused” and inapplicable.  Bowling v. Johnson & Johnson, 65 F. Supp. 3d 371, 374 & n.17 (S.D.N.Y. 2014).

But what about implied preemption by reason of conflict – specifically the impossibility preemption rationale adopted in PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011), and Mutual Pharmaceutical Co. v. Bartlett, 133 S.Ct. 2468, (2013)?  What we heard at the ACI conference sounded good enough to us that we thought we’d investigate it pass along what we found.

Continue Reading Implied Preemption and Monograph Drugs

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What follows is a guest post from Reed Smith’s Andrew Stillufsen, an associate in our Princeton office.  He discusses a new FDCA preemption case involving a cosmetic, rather than a drug or device.  As always, Andrew is entitled to all the credit (and any blame) for the contents of this post.

Take it away Andrew, and beware Sir Nose D’voidoffunk.

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The ingenuity of our friends in the plaintiffs’ bar is never-ending and always fascinating, like Cyrano deBergerac’s prodigious proboscis.  For example, this post is about a case brought by some resourceful lawyers who did  not turn up their nose at the possibility of a contingent fee based on the weight of a stick of deodorant.  Perhaps they were inspired by television ads showing average-looking twenty-somethings apply a certain deodorant and instantly becoming the best-looking  (and best-smelling) people in the room.  Perhaps not.  In any case, one thing is certain:  the court did not like what it sniffed after plaintiffs’ claims were unwrapped, and so applied the sweet smell of preemption.  Another thing is also certain:  an overload of olfactory references appear in this post.

Before we nosedive into the court’s preemption analysis, let’s take a look at plaintiffs’ claims.  This putative consumer fraud class action was brought in the Southern District of New York and alleged the usual potpourri  of violations of consumer protection laws, as well as common law claims for breach of warranty, negligent misrepresentation and unjust enrichment. Plaintiffs alleged that the defendant deceived them by (a) misstating the actual weight of usable product in each stick of its deodorant, (b) misstating the total net weight of each stick, and (c) not stating the amount of non-functional slack fill in each stick.  Bimont v. Unilever United States, Inc.,  2015 US Dist. Lexis 119908, at *2 ( S.D.N.Y. Sept. 9, 2015).

Defendant’s motion to dismiss was likely inspired by the fragrance of preemption, since the deodorants at issue were both cosmetics and OTC drugs, and thus subject to the FDCA and FDA regulations.  This blog has posted before on preemption, cosmetics and OTC drugs, including sunscreen twice, and mouthwash.

Continue Reading Guest Post – The Sweet Smell of Preemption Overcomes Plaintiffs’ Stinky Consumer Fraud Claims