It is a whole lot harder to file documents under seal than it used to be. We recall an MDL in the early 2000s where the parties filed everything under seal over the course of multiple years—litigating for the viewing pleasure of our “friends and family,” as the district judge often chided us. Times have
First Amendment
A Difference of Opinion is Not a Misrepresentation
So says the Fifth Circuit in Torrey v. Infectious Diseases Society of America, — F.4th –, 2023 WL 7890067 (5th Cir. Nov. 16, 2023). Which joins the Second and Third Circuits in protecting scientific free speech. Cases we discussed here and here and which support our firm belief that scientific articles are “core”…
FDA and Off-Label Communication – Getting Closer to Truth
In addition to its recent revamp of its “§510(k)” substantial equivalence clearance process for medical devices, (see our post here), the FDA has also been active with respect to off-label communications – another regulatory area of continuing interest to this Blog. Our position has been clear, and the same from the Blog’s beginning…
Litigation Over COVID-19 Policies Continues
If we had forgotten that there continue to be abundant U.S. cases of COVID-19, then there was plenty around us to remind us. Public mask usage seems to have increased. We heard how the “tripledemic” of viruses had made hospital beds scarce. We have had colleagues out of commission instead of completing our assignments. The…
Science Articles Marked by Possible Flaws but not Fraud Cannot Constitute Trade Libel
Pacira Biosciences, Inc. v. American Society of Anesthesiologists, Inc., 2022 WL 336585 (D. N.J. Feb. 4, 2022), is not a product liability opinion. Instead, it occurs in the context of a motion to dismiss a trade libel case brought by a pharmaceutical company. The Pacira court decided that the truth/falsity of scientific ideas published…
Supreme Court Declines To Enjoin Maine’s Vaccine Mandate, But Check Out The Dissent
We told you that if anti-vaxxers found a sympathetic court in their quest to declare government vaccine mandates unconstitutional, we would let you know. Well, we did not think it would be so soon. And we surely did not think that the sympathetic court would be the United States Supreme Court.
Don’t get the wrong…
Where Has This Been Hiding? – First Amendment-Based Dismissal of FCA Action
This post is about a hidden gem. That brings to mind a hiking trail that’s one of the two best in Pennsylvania (along with Ricketts Glen), but isn’t found in any of the “Fifty Hikes in [fill in the blank]” books that one finds in outdoorsy stores. The hike is part of the Appalachian…
Both Sides Equal Under the First Amendment
There’s a problem with attorney advertising in the prescription medical product space – but it’s not the one you normally hear us defense-side litigators kvetching about. Quite apart from its litigation-generating effects, attorney advertising can have adverse public health consequences when all the anti-pharma hyperbole causes patients to cease taking targeted products in violation of…
Law Review Article on Off-label is On Target
More than once we’ve said that we read law review articles so you don’t have to. We separate the wheat from the chaff. The wheat is scarce. That is because law review articles usually drown the little bits of objective description of what the cases DO say with enormous chunks of pie-in-the-sky suggestions of what…
Ninth Circuit En Banc Panel Holds that Central Hudson Survives Sorrell
Last week we bashed a Ninth Circuit Daubert decision. We feel a little bit bad about that, not because the decision wasn’t bashworthy – no, Wendell really is a rotten precedent – but because we hate contributing to the chorus of defense hacks who bemoan the Ninth Circuit’s supposedly liberal, pro-plaintiff bias. You see, we…