We don’t get blood shield statute cases very often, but here is one involving a human tissue-based spinal bone graft. In Sherrill v. Spinalgraft Technologies, LLC, et al., 2024 WL 1979452 (W.D.N.C May 3, 2024), the plaintiff had undergone spinal surgery. That surgery included the use of processed bone graft material, which is “made
Last year Bexis was lead author on a law review article in the Food and Drug Law Journal titled Federal Preemption and the Post-Dobbs Reproductive Freedom Frontier. The article expands on themes previously raised in this blog, including here, here and here. It discusses the application of federal preemption under the Food Drug and Cosmetic Act (FDCA) to state-law medication abortion restrictions after Dobbs. The article recognized that, following Dobbs, it was inevitable that FDCA preemption would become embroiled in the abortion controversy. That prediction was accurate. Today’s decision addresses the impact of preemption on a North Carolina law that imposed significant restrictions on an FDA approved medication taken to terminate a pregnancy.Continue Reading North Carolina and Post-Dobbs Regulation of Mifepristone
When we last reported on Beaver v. Pfizer, the plaintiff’s complaint alleging that the FDA “suggested” that the defendant’s drug be removed from the market had been dismissed because it was a preempted “stop selling” claim. In any event, as we also pointed out, the plaintiff did not claim the condition that had purportedly
A plaintiff lawyer recently filed a case against our client in North Carolina. He has made a settlement demand that any rational observer would regard as ambitious to the point of outrageous. Despite that crazy number, we are on fairly friendly terms with the plaintiff lawyer. We jawbone at each other in a generally good
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
Last year we wrote a post about Froman v. Coopersurgical, Inc., 2022 US Dist LEXIS 120725, *2-3 (N.D.AL Jul. 8, 2022), calling it trifecta Tuesday because the case was dismissed on the grounds of personal jurisdiction, pleadings deficiencies, and preemption. Today’s case involves the same product, the same defendants, and the same conclusions on
Today is sort of a twofer Tuesday. We have two cases, but only one issue. So, maybe it’s more of a two-for-one deal. There is also one general takeaway – it pays to look at state-specific defenses to state-specific claims. For example, the privity requirements in North Carolina make it extremely difficult to bring a
It is beach weather, but which beach? The Jersey shore is close, has fun boardwalks and rides, and offers the comfort of the familiar. Then again, you must pay to get on sand covered with New Yorkers. The Outer Banks are lovely, with dunes, wild horses along the surf, splendid lighthouses, and the spot where
Here are some things you probably will not hear very often, if at all: 1) a fervent supporter of a defeated political candidate agreeing that the winning elected official has done a good job, regardless of economic growth, infrastructure projects, public health progress, or some other measure of good government; 2) a fervent supporter of
We have promised ourselves that we will stream this week’s “This Is Us” episode when we finish this blog post. We love this series beyond reason, and we dread its imminent demise, notwithstanding the title’s grammatical transgression. (We generally condition any sort of allegiance on correct use of predicate nominatives.) We are struck, over and