Back in the early days of the blog, when it was a Bexis/Herrmann operation, we wrote about the California Supreme Court decision that opened the floodgates to all that food litigation that now plagues that state − Farm Raised Salmon Cases, 175 P.3d 1170 (Cal. 2008). We explained how the court In Farm Raised
Survival of the Vaxxest
All of us are long-time defenders of prescription medical product manufacturers, and some of us are veterans of the vaccine wars of the 1980s and 1990s involving DPT vaccine and thimerosal. We are big fans of vaccines and the tremendous health benefits they have bestowed on humanity, and are mystified by the alliance between anti-vaccine
Zantac Chronicles V – Medical Monitoring and the Wheels Coming Off
Still more Zantac MDL dismissal orders.
Today’s installment grants dismissal of the plaintiffs’ medical monitoring claims, and also sheds some light on the questionable factual basis of everything being asserted in this MDL. As we’ve pointed out in our prior posts (such as this one), plaintiffs allege that the active ingredient in this drug
FDA Reporting and Consumer Protection Issues Certified to Connecticut Supreme Court
As we discussed in our recent 50-state survey on failure-to-report claims, plaintiff-side allegations seeking to predicate “warning” liability on a defendant’s allegedly failing to comply with FDCA adverse event reporting claims are “relatively new.” That’s because, like so many other novel claims we’ve seen lately, it’s a transparent dodge to avoid preemption. We said
Banned on the Run
With apologies, this time, to Sir Paul − “The circuit judge, who held a grudge, has put the FDA’s banned on the run. . . .”
That’s just about what happened in Judge Rotenberg Educational Center, Inc. v. United States FDA, ___ F.4th ___, 2021 WL 2799891 (D.C. Cir. July 6, 2021) (note the
It’s Back! It’s Wayback! It’s Away, Wayback! It’s Admissible!
With apologies to Harry Kalas.
Bexis had a couple of encounters with the “Wayback Machine” (a/k/a/ the “Internet Archive”) recently. If you don’t know what that is, it’s digital library of Internet ephemera – web pages and the like − that have since been taken down, revised, or otherwise have become unavailable in
The 402A Plot Thickens in Pennsylvania
Recently, in the context of an IVC filter case, the Third Circuit Court of Appeals certified two questions to the Pennsylvania Supreme Court:
1. Under Pennsylvania law, must a plaintiff bringing a negligent design claim against a prescription medical device manufacturer prove that the device was too harmful to be used by anyone, or may
Testing, One, Two, Three….
The Ninth Circuit recently answered a preemption question that we had seen arise intermittently, mostly in food litigation, over the past couple of years. Because the relevant preemption clause closely resembles the language of the Medical Device Amendments, we thought it was worth a look.
In Webb v. Trader Joe’s Co., ___ F.3d ___,
More MDL Madness – Defeating Preemption with Made-Up “State Law” Claims
We’re not surprised by the preemption ruling in In re Smith & Nephew Birmingham Hip Resurfacing (BHR) Hip Implant Products Liability Litigation, 2021 U.S. Dist. Lexis 100041 (D. Md. May 17, 2021), but that doesn’t makes us any less appalled.
First, here’s what happened.
This latest Birmingham Hip ruling was in preparation for
Can – or Should – State Tort Law Force Defendants To Prevent Off-Label Use?
The United States Supreme Court in Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001), determined that “off-label usage” is “accepted and necessary” by both the FDA and the medical community. Id. at 350. Thus, “[p]hysicians may prescribe drugs and devices for off-label uses.” Id. at 351 n.5 (citation and quotation marks omitted).