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Over the past few months, Bexis, with the substantial help of several Reed Smith associates, has prepared a law review article – “Federal Preemption and the Post- Dobbs Reproductive Freedom Frontier” – which will soon be published in the Food & Drug Law Journal.  A draft of this article is now available on SSRN.

The core premise of Bexis’ article is very simple:  Once the FDA has said “yes” and approved a particular drug for a particular indication (“intended use”) for sale in the United States, federal preemption precludes any state from saying “no” and trying to ban that same FDA-approved drug.  It doesn’t matter whether that drug is morphine, methadone, minoxidil – or mifepristone.

Continue Reading Mifepristone Manufacturer Wins First Round in West Virginia
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The plaintiffs in Acosta-Aguayo v. Walgreen Co., 2023 U.S. Dist. LEXIS 34836  (N.D. Ill. March 2, 2023), visited their friendly neighborhood drug store and bought a lawsuit.  Well, first they bought pain relief patches.  Those patches were over the counter (OTC) products.  No prescriptions were required.  Maybe those pain patches worked and maybe they

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Today’s case is not about drugs or medical devices.  It is about popcorn, a perfect prompt (or as good as ours ever get) for a rant about movies.  We are working our way through the Oscar nominees, in anticipation of the upcoming Academy Awards.  (Pre-apocalypse, we hosted an annual Oscar party, featuring good food, good

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We’ve written several posts about ridiculous absolute liability theories seeking to hold drug manufacturers liable simply for making an FDA approved prescription drug.  Wilkins v. Genzyme Corp., 2022 WL 4237528 (D. Mass. Sept. 14, 2022), is an even stranger claim, with the plaintiff seeking to hold the defendant liable for not manufacturing a prescription drug.  Fortunately, in Wilkins, those claims (several theories alleging essentially the same thing) did not state a claim.

Continue Reading No Liability for Not Manufacturing a Product
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Purported class actions on behalf of people who haven’t really suffered any injury are one of the banes of our existence.  While not limited to California or courts in the Ninth Circuit, some of the worst (most of which we haven’t covered because they are adverse non-drug/device cases) decisions certainly hail from there.

Recently, however

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Isn’t enough for standing that is.  And, likely not enough for plaintiff’s case to survive, but that question was left for another day.  We’ve done a few posts on “slack fill” which is defined by the FDA as the difference between the capacity of a container and the volume of product inside.  Slack fill lawsuits

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We continue to scratch our heads over consumer class actions seeking monetary compensation when the customers received exactly what they paid for.  We see them from time to time in the pharmaceutical space, where patients claim monetary compensation even though the prescription drugs they used worked like they were supposed to with no adverse reactions.