As we emerge from our fourth month-long trial in a little over two years, we are sure that we have missed some recent legal developments. As good as this Blog is as a source for what is going on in drug and device product liability litigation, you do actually need to read it to absorb
The FDA has taken recent steps that may, or may not, affect product liability litigation. We’re discussing the “may” aspect. For purely regulatory analysis, plenty of other commentary is available.
These actions occurred on September 7, 2023, and involve three “draft guidances” bearing on the “§510(k)” substantial equivalence clearance process for medical devices. Any litigator with even passing knowledge of medical device preemption knows that this − more properly, a prior (1982) version − is the process that the Supreme Court stated, was “focused on equivalence, not safety” in Medtronic, Inc. v. Lohr, 518 U.S. 470, 493 (1996) (emphasis original).Continue Reading Tort-Related Implications of Recent FDA Device Draft Guidances
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
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
We acquired our trial chops in the Central District of California, where we were an AUSA. We had a great time. We learned a lot. We have warm feelings for C.D. Cal. But we do not love all the decisions that come out of that jurisdiction.
Burton v. Abbvie, Inc., 2023 U.S. Dist. LEXIS
We say today’s case is about SIRVA (shoulder injury related to vaccine administration), but plaintiff tried her best to run from that allegation in her opposition to defendants’ motion to dismiss. That’s because a SIRVA case runs up against not only a preemption obstacle, but also serious duty and causation barriers. But since the court
Is what the court finally had to tell plaintiff in Roshkovan v. Bristol-Myers Squibb Co., 2023 U.S. Dist. LEXIS 166742 (C.D. Cal. Sep. 19, 2023) in dismissing his second amended complaint as both preempted and inadequately pleaded. We posted about the dismissals of the original and first amended complaints on the same grounds here
It is fair to say that Bexis co-founded this blog (in 2006!) in part to aid the cause of medical device and pharmaceutical manufacturers, targets in our lawsuit-obsessed country. Over the years, this blog has come to serve as an important resource for our drug and defense bar colleagues, and Bexis regularly identifies—if not
Since before the Dobbs decision reversed decades of precedent on reproductive rights, we have been looking at the implications for drug and device manufacturers. See here and here. Our posts have, of course, followed the ins and outs of the notorious AHM (or Hippo) litigation as it makes its way up to the
Plaintiff in Gurule v. Boston Scientific Corp., 2023 Cal. Super. LEXIS 49321 (Cal. Super. Jul. 18, 2023), tried to pull off a little magic through misdirection, but couldn’t fool the court. Plaintiff tried to distract the court from the complete lack of sufficient allegations to satisfy even notice pleading requirements by alleging an elaborate