As many of the Blog’s authors and readers wake up today, they will be in New York for the ACI Drug and Medical Device Litigation Conference. Clearly, the choice of venue matters when it comes to a conference. It also matters to plaintiff lawyers and the medical product manufacturers that they sue. The infamous
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Epic Expert Tales: The Scope of Regulatory Testimony
Lawyers like to grouse about their lot in life. We complain about stress and the things that most contribute to such stress: hard work and unpleasant people. But if you labor long enough in this profession, you end up running into many excellent folks. By “excellent,” we mean brilliant and generous. We’ve long deployed a…
N.D. Indiana Dismisses Off-label False Claims Act Case
This is the second time in the last couple of weeks that we’ve written on a case brought under the False Claims Act (FCA). That is no accident. We are about to start a FCA trial, and have been studying all things FCA. Guess what we learned? Most FCA claims are even more bogus than…
Discovery is a Two-Way Street; Even for Governmental Plaintiffs
So learned plaintiff in United States ex rel. Plaintiff v. Novo Nordisk, Inc., 2024 U.S. Dist. LEXIS 174825 (W.D. Wash. Sept. 26, 2024), when the court granted defendant’s two motions to compel obviously relevant documents and information.
Plaintiff relator and intervening plaintiff, the State of Washington, assert False Claims Act (“FCA”) claims against the…
SDNY Dismisses Glucose Monitoring Device False Claims Act Case
United States ex rel. Powell v. Medtronic, Inc., 2024 U.S. Dist. LEXIS 165116 (S.D.N.Y. Sept. 12, 2024), is an interesting defense win in a False Claims Act (FCA) case involving alleged off-label use – reuse of single use devices (actually a component of a device – and that ends up mattering). Much of…
Wasting Time Looking For A Dime
We are unabashedly pro-science. In our cases, we are usually on the side of good science against bad or no science. In discussing large-scale product liability litigation, we have said many times how bad science and the risk of attendant litigation can negatively impact the development of new products. Even if we were so naïve…
The Non-Existent Tort of “Failure To Recall”
It seems like once every couple of weeks, we see a story about some plaintiff (such as this one) suing, or threatening to sue, a defendant product manufacturer over some product that, according to the plaintiff, “the company should have recalled sooner.”
That’s garbage.
There is no such claim. Rather failure-to-recall theories are…
E.D. Texas Dismisses Off-Label Promotion False Claims Act Case
It has been some time since we have discussed False Claims Act (“FCA”) litigation over alleged promotion of a prescription drug for off-label uses. And when we read United States ex rel. Hearrell v. Allergan, Inc., 2024 U.S. Dist. LEXIS 70888 (E.D. Tex. Apr. 18, 2024) we were reminded why. Off-label promotion is not…
D.N.J Dismisses Fluoroquinolone False Claims Act Case
Few things in the law are as subject to abuse as the False Claims Act, 31 USC section 3729 et seq. (the FCA). It was originally enacted to stop massive frauds perpetrated by large contractors during the Civil War. Now it is a litigation cottage industry.
In United States ex rel. Bennett v. Bayer Corp…
Guest Post – Michigan Product Liability Law: Retroactivity of New Law and Primer
Today’s guest post is by Sherry Knutson and Brenda Sweet of Tucker Ellis, and concerns the recently passed legislative repeal of a Michigan statute that, for several decades had effectively immunized prescription drugs from ordinary product liability actions under Michigan law. For background, here’s a prior blogpost that focused on the now-repealed statute. As…