We’ve discussed decisions applying preemption under the Public Readiness & Emergency Preparedness Act (hereafter “PREP Act”), 42 U.S.C. §247d-6d, on several occasions since the COVID-19 pandemic began. At this point, some four years after the COVID-19 pandemic declaration, we believe that sufficient PREP Act preemption precedent has accumulated, and that the caselaw is sufficiently
Before we dive into today’s case, Avrin v. Mentor Worldwide LLC, 2024 WL 115672 (C.D. Cal. March 15, 2024), we offer two preliminary observations:
1. We love to hear from our readers. Sometimes we get emails commenting on a post. Often, those comments arrive in the form of gushing reviews. That’s nice. Less often
Today’s guest post is by Amy McVeigh and Jessica Farmer, who are partners at Holland & Knight. They comment on the demise of another purported class action against a manufacturer of hydrogen peroxide, which is an FDA-regulated over-the-counter (“OTC”) drug. As always our guest posters deserve 100% of the credit (and any blame)
We all know that getting it right isn’t as easy as it sounds. Straightforward application of established law ought to be simple. If only it were so. Today’s decision gets it right, and we’re happy to report on Wilhite v. Medtronic, Inc., 2024 WL 968867 (N.D. Ala., Mar. 6, 2024).
Wilhite involved allegations that
In Puerto Rico v. Franklin-California Tax-Free Trust, 579 U.S. 115 (2016) (initially discussed here), the Supreme Court drove a stake through the heart of the misbegotten “presumption against preemption” in express preemption cases.
[B]ecause the statute contains an express pre-emption clause, we do not invoke any presumption against pre-emption but instead focus on
Happy Valentine’s Day. To celebrate, we will discuss a court decision that we love.
Preemption and the Ohio Product Liability Act (OPLA) are two of the best friends a drug/device defense lawyer has. Both show up in Groeschen v. Alcon Laboratories, Inc., 2024 Ohio Misc. LEXIS 2 (Ohio Ct. Comm. Pleas Feb. 2, 2024). As
We’ve pointed out several times recently (and will be pointing out in an ACI presentation today) that cases against over the counter (OTC) drugs are on the uptick. Why? Here’s our theory: there are lots of OTC consumers, hence lots of potential plaintiffs, and there are no pesky learned intermediaries, which means that plaintiffs can
We have no inclination to mess with Texas. Heck, a state ornery enough to secede from two different countries in order to preserve slavery isn’t likely to care, anyway. So if Texas wants to run its own power grid, not connect to the rest of us, and freeze in the dark when that system fails, we’re certainly not going to stand in the way. Conversely, when Texas emphatically adopted the learned intermediary rule in Centocor, Inc. v. Hamilton, 372 S.W.3d 140 (Tex. 2012), we hailed it as the best decision of 2012.
But when Texas decides to mess with the rest of us…. Well, that’s different.
So we do have comments on the bizarre complaint that the Texas attorney general recently filed over COVID-19. The complaint, brought under the Texas consumer protection statute, sued a major manufacturer of COVID-19 vaccine that was used to control the recent pandemic. That Complaint alleges various antivax conspiracy theories concerning COVID-19 vaccines, the FDA, emergency use authorizations, and the media that have circulated since these vaccines first became available. The Texas Complaint also claims that, in various ways, the vaccine manufacturer violated certain mandatory FDCA provisions and FDA regulations (¶22), did not follow voluntary FDA guidance (¶¶25-31), supposedly committed fraud on the FDA by submitting misleading data (¶¶47, 117, 120-21), and mostly that it purportedly misled the public and/or the press (¶¶50, 55-91, 154-55, 157-59, 161-63, 165-66, 168-69).Continue Reading A Texas Mess
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
Kulkarni v. Generics, 2023 U.S.Dist.LEXIS 160730 (S.D.N.Y. Sept. 8, 2023), is an interesting generic preemption (mostly) dismissal involving an “old” (pre-1962) drug. A pro se plaintiff sued five affiliated pharmaceutical companies alleging that a course of generic prednisone caused her to develop functional myoclonus. The plaintiff’s theory of the case was that the drug label failed