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If we have said it once, we have said it a hundred times:  medical product manufacturers are not insurers of their products.  Almost as frequently uttered would be that strict liability is not the same thing as absolute liability.  In the show position might be that the temporal relationship between a new medical condition and

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At least try to do something different.

As we discussed before, because his prescription drug warning claims collided with federal preemption, the plaintiff in Roshkovan v. Bristol-Myers Squibb Co., 2022 WL 3012519 (C.D. Cal. Jun. 22, 2022), needed to plead what the FDA didn’t know, not what it did, to avoid dismissal.  His second try wasn’t any better than the first.

Continue Reading When at First You Don’t Succeed…

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When last we spoke, we were about to deliver our beautiful standard poodle puppy, Luca (registered name Tivin Dreamcatcher), to his show handler, who would trim him and train him and launch his dog show career.  The transfer was accomplished without incident, if you don’t count mommy’s predicable reaction to the separation.  It also included

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Second chances, sure.  Two bites at the apple, we see it all the time.  Three strikes before you are out, fairly common.  But a fourth amended complaint to cure basic pleading deficiencies?  That seems overly generous by any standards.  Well, almost any standards because that is what plaintiff got in Greenwood v. Arthrex, Inc.

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We have made no secret of our long-held views that “failure to withdraw” or “stop selling” theories of liability for FDA-authorized medical products are unwarranted perversions of state design defect law and preempted anyway.  When we say long-held, we mean it, because we had a few of the first cases where this theory was put

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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