We’ve gleefully detailed the plaintiffs’ utter failure in the Zostavax MDL to establish causation. Now, the Gardasil MDL likewise seems well on the way to a place on the list (along with Bone Screw, Aredia/Zometa, Taxotere, and Zantac) of MDLs that plaintiffs’ counsel wish they’d given a miss. Maybe plaintiffs will
Search results for: gardasil
Gardasil MDL Sets Guardrails For Implied Preemption, And Gets It Right
Taking pot shots at “Big Pharma” is easy. Crack a joke about Big Pharma and you are sure to get a laugh. Amirite?
That is not to say there is never a fair point or two to be made about pharmaceutical development or marketing, or health care and the delivery of same in this country. …
Gardasil MDL Court Dismisses Plaintiffs Who Had Not Timely Filed in Vaccine Court
We are not speaking for anyone else (clients, colleagues, our firm, etc.) when we say that drug and device product liability cases should be patterned after the Vaccine Act (42 U.S.C. Section 300aa-1 et seq.). It is faster, fairer, more predictable, and cheaper for everyone. From the defense side, we like that actions under the…
D. Nevada Dismisses Gardasil Vaccine Lawsuit
Happy Star Wars Day. May the Fourth be with you.
If all FDA approved medicines enjoyed the preemption protection that vaccines do, the DDL product liability litigation landscape would be leaner and less nonsensical. Flores v. Merck & Co., 2022 U.S. Dist. LEXIS 46442 (D. Nev. March 16, 2022), shows why that is so.…
Running the Table – The Ten Best Prescription Drug/Medical Device Decisions of 2025
A year ago, Bexis thought this would be the last blogpost he would ever write, and that he would retire along with 2025. Not gonna happen – at least not yet, thanks to Reed Smith making him an offer he couldn’t refuse. Bexis will be stepping back from some things, but not from the Blog. …
Getting Noticed – Receiving FDA-Related Judicial Notice
This post sort of got away from us. We started with the proposition that our prescription medical product clients frequently move to dismiss cases, and thus seek to get courts to take judicial notice of FDA-related documents in product liability litigation involving their products. Judicial notice in cases involving FDA regulated products can be of great assistance on pleadings-based motions (Rule 12(b)(6) and judgment on the pleadings) because judicial notice is an exception to the usual limitation of such motions to what plaintiffs plead – or, equally importantly, fail to plead – in their complaints. Not only do judicially noticeable documents fill in facts that plaintiffs deliberately omit, but they can also defeat contrary factual allegations that the documents establish are untrue. This is an important exception to the Rule 12 mantra that challenged allegations are to be taken as true. Instead, allegations in a complaint are not credited where contradicted by judicially noticeable documents. E.g., Fuqua v. Santa Fe County Sheriff’s Office, ___ F.4th ___, 2025 WL 3072794, at *4 (10th Cir. Nov. 4, 2025); Jeffery v. City of New York, 113 F.4th 176, 179 (2d Cir. 2024); Clark v. Stone, 998 F.3d 287, 298 (6th Cir. 2021); Massey v. Ojaniit, 759 F.3d 343, 353 (4th Cir. 2014); Kaempe v. Myers, 367 F.3d 958, 963 (D.C. Cir. 2004); Sprewell v. Golden State Warriors, 266 F.3d 979, 988 (9th Cir. 2001). So judicial notice can overcome contrary pleadings.Continue Reading Getting Noticed – Receiving FDA-Related Judicial Notice
Presenting the Presentment Clause
Have you ever heard of the “Presentment Clause” to the United States Constitution? U.S. Const. Art. I §, cl. 2. While we can’t say that we had never heard of it – we are aware of presidential vetoes, pocket vetoes, and such – we had never had occasion to consider it in the context of the legal work we do defending prescription medical product liability litigation. That changed with In re Gardasil Products Liability Litigation, ___ F.4th ___, 2025 WL 2535105 (4th Cir. Sept. 4, 2025), which we recently discussed, here.Continue Reading Presenting the Presentment Clause
The Fourth Circuit Rejects Attempts To Avoid And Invalidate The Vaccine Act
As we have riffed on before, staying apolitical when discussing the science and law implicated by our posts can be harder than one might expect. That has become increasingly true with regard to litigation over alleged injuries from vaccines, to say nothing of vaccine mandates for public health. It was not terribly…
How Not To Create “Newly Acquired Information”
Bexis is updating (probably for the last time) the preemption chapter of his drug and device product liability treatise, so expect blogposts like this on preemption-related topics.
Briefly, preemption in the prescription drug context is limited to implied preemption because, unlike medical devices, the FDCA lacks any preemption language applicable to those products. The…
Arbitrary and Capricious Action as a Management Style
When a federal agency reverses course, the Supreme Court has a test to determine whether that agency action is impermissibly “arbitrary and capricious.” FCC v. Fox Television Stations, Inc., 556 U.S. 502 (2009), set the current APA standard for review of federal agency flipflops. While no “heightened standard” exists under the APA for reversals…