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Long before the Supreme Court decided Dobbs v. Jackson Women’s Health Org., 142 S. Ct. 2228 (2022), Bexis was concerned that FDCA preemption would be dragged into the country’s culture wars by the abortion issue.  He hoped the Supreme Court would adhere to long-established precedent and thus keep FDCA preemption out of politics and in product liability litigation where it belonged.  Dobbs extinguished that hope (and many others), so Bexis decided that he might as well embrace the inevitable.

He proposed writing his own law review article on this subject – about which he knows as much as anyone – to the Food & Drug Law Institute.  FDLI accepted the proposal, and now, over a year later, the article is now published:  Beck, Danziger, Johansen & Hayes, “Federal Preemption & the Post-Dobbs Reproductive Freedom Frontier,” 78(2) Food & Drug L.J. 109 (2023).  The article is available to the public at the journal’s website, here.  Bexis hardly did this alone, being ably assisted by three (then) Reed Smith colleagues, Philip W. Danziger, Sarah B. Johansen, and Andrew R. Hayes.Continue Reading Bexis Publishes Article Applying FDCA Preemption to Medication Abortions

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Every once in a while in this space we summarize law review articles.  In the course of doing so, we typically pat ourselves on the back by announcing that we read such articles so that you don’t have to.  That is not true with the article we are discussing today, Goldberg, Gramling, & O’Rourke, “A…

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Back in 1998, Bexis published the first major law review article about off-label use of drugs and medical devices and tort liability, James Beck & Elizabeth Azari, “FDA, Off-Label Use, & Informed Consent:  Debunking Myths & Misconceptions,” 53 Food & Drug L.J. 71 (1998).  This article came to be cited twice by the United States…

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We recently came across the law review article, E. Lindenfeld, “Clear Evidence Clarified,” 75 Food & Drug L.J. 346 (2020).  Since it cited and critiqued a number of our blogposts, we thought it was appropriate to reply.

Our initial impression is that the Lindenfeld article is comparatively reasonable – that is, compared to some prior…

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For the better part of a decade, Bexis has participated in the Food & Drug Law Institute’s (“FDLI”) annual Top Food and Drug Cases project.  For 2019, he wrote about (surprise!) Merck Sharp & Dohme Corp. v. Albrecht, 139 S. Ct. 1668 (U.S. 2019).  These haven’t been discussed previously on the Blog because, due…

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How many of us entered law school dreaming of following the paths of Brandeis, Marshall, etc. in the field of constitutional law? How many of us now can go weeks, or even months, without reading a Supreme Court case? Paying off student loans led many of us to work for law firms where there was…

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We recently read an interesting new empirical study that confirms what we’ve long suspected − that so-called “no-injury” class actions, those that allege that a product was “worth less” than it should have been due to some inchoate, unmanifested defect, are a litigation boondoggle, benefiting nobody but the lawyers who bring them.

The study is Joanna M. Shepherd, “An Empirical Survey of No-Injury Class Actions,” available through the Social Science Research Network, here. Ms. Shepherd, a professor at the Emory University School of Law, started with all class action settlements between 2005 and 2015 that could be located on Lexis or Westlaw – 2158 cases. She applied four criteria for identifying “no-injury” classes:

  1. the plaintiffs suffered no actual or imminent concrete harm giving rise to an injury in fact;
  2. the only harm alleged was a technical statutory violation (primarily of the Fair Debt Collection Practices Act, the Telephone Consumer Protection Act, the Fair Credit Reporting Act, and the Electronic Funds Transfer Act);
  3. if any out-of-pocket economic loss was negligible or infinitesimal; or
  4. the recovery sought was unrelated to compensating plaintiffs for economic or other harm.

Shepherd Empirical Study at 1. After applying those criteria, Professor Shepherd included only cases about which information existed on both attorneys’ fees and settlement funds. Id. This culling produced 432 class actions that could be studied.Continue Reading Empirical Study Confirms That No-Injury Class Actions only Benefit Lawyers

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FDA-regulated products now account for an estimated one-fifth of overall economic activity in the U.S. They have also been the focus of a litigation explosion. This timely guide covers all aspects of litigation involving drugs, medical devices, vaccines and other FDA-regulated prescription products.
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