Search results for: hippocratic

Standing should not be a political issue.  Ensuring that someone who initiates a lawsuit has enough of a connection to the alleged harm for which they seek redress from a court is a key part of the broader constitutional concept of justiciability.  Because federal courts are courts of limited jurisdiction, they cannot decide just any…

We have been following – and commenting about − the unprecedented attacks on the FDA’s authority to approve drugs (and by extension all the products the agency regulates) in the Alliance for Hippocratic Medicine v. FDA litigation pretty much since the first bizarre district court rulings about a year ago in Alliance for Hippocratic Medicine v. FDA, 668 F. Supp.3d 507 (N.D. Tex. 2023), aff’d in part & vacated in part, 78 F.4th 210 (5th Cir. 2023), cert. granted in part and denied in part, 144 S. Ct. 537 (2023) (hereafter “AHM I” and AHM II”).Continue Reading A Couple of Thoughts about the Comstock Act

Back in 2008, the United States Supreme Court held, in Riegel v. Medtronic, Inc., 552 U.S. 312 (2008), that essentially all product liability claims against manufacturers of FDA pre-market approved (“PMA”) medical devices were preempted.  After all, PMA “is in no sense an exemption from federal safety review − it is federal safety review.”  Id. at 323.  Thus, by a 7-2 margin the Court held, per Justice Scalia, that all state-law liability claims before it – “strict liability; breach of implied warranty; and negligence in the [product’s] design, testing, inspection, distribution, labeling, marketing, and sale,” id. at 320 – were expressly preempted:Continue Reading PMA Preemption Decision Slides to the Bottom of the “Parallel Claim” Slippery Slope

We have posted a few times (here, here, and here) about the Alliance for Hippocratic Medicine v. FDA/Alliance for Hippocratic Medicine v. Danco Labs., LLC litigation, in which an anti-abortion group is seeking to invalidate regulatory actions taken by the FDA with regard to mifepristone, a pharmaceutical FDA-approved for use…

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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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Bexis’ Book

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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