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
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
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
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 It was originally enacted to stop massive frauds perpetrated by large contractors during the Civil War.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
The result for the defendant (a “distributor of ophthalmologic supplies”) in the False Claims Act decision, United States ex rel. Fesenmaier v. Cameron-Ehlen Group, Inc., ___ F. Supp.3d ___, 2024 WL 489708 (D. Minn. Feb. 8, 2024), was so terrible that something good ended up happening.Continue Reading FCA Verdict Slashed as Unconstitutional Excessive Fine
Thirteen years litigating the same case is a looooong time. Absurdly long. Long enough for an attorney working on the case to go from an associate learning to coax a newborn to sleep, to a partner juggling teen school and soccer commitments. Long enough for lawyers to migrate from Blackberrys and voicemail, to smart phones
Since 2018, we have blogged several times about the federal government’s crackdown on abusive False Claims Act (“FCA”) litigation via motions for dismissal, and how the abusive relators have tried to resist those efforts. Last week the Supreme Court ruled that, yes, the government does have the power to shut down rogue litigation ostensibly being conducted in the name of the United States of America.
All the federal government has to do is intervene and give a coherent reason why.Continue Reading Final Report From One FCA Front – As Another Front Opens
We always thought that the decade-old Nargol v. DePuy False Claims Act litigation was a particularly abusive misapplication of the FCA for legal reasons. As discussed here, the primary allegations asserted the same sort of “fraud on the FDA” claim that, when brought as a common-law tort claim, were held preempted in Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001) – that the defendant purportedly misled the FDA to clear a §510(k) medical device, and that, as a result, every use of the device was ipso facto a false claim. No other causation needed. As the earlier post discussed, the First Circuit rightly put an end to that attack on FDA authority in United States ex rel. Nargol v. DePuy Orthopaedics, Inc., 865 F.3d 29 (1st Cir. 2017).
Then it turned out that a lot more was wrong with Nargol than just a bogus legal theory. The relators were p-side “experts,” Antoni Nargol and David Langton, who had access to documents from a couple of MDLs that targeted the defendant’s hip implant products. Critically:
Protective orders regarding confidential [defendant’s] product design information were issued in both of the multidistrict litigation cases (individually, the “ASR protective order” and the “Pinnacle protective order”; collectively, the “Protective Orders”).
United States ex rel. Nargol v. DePuy Orthopaedics, Inc., ___ F.4th ___, 2023 WL 3746534, at *1 (1st Cir. May 18, 2023).Continue Reading Dismissal of Experts-Turned-Plaintiffs’ FCA Case as Sanction Affirmed
Three times previously we have “reported from the front” on the federal government’s efforts to dismiss False Claims Act litigation – ostensibly (and often ostentatiously) filed in the government’s name – after the government has concluded that the particular case is more bother than it is worth. The most recent of those posts was late last year, and reported on Polansky v. Executive Health Resources, Inc., 17 F.4th 376 (3d Cir. 2021).Continue Reading The FCA Front Moves To The Supreme Court
The Orthopedic Bone Screw litigation would never have occurred – and Bexis might never have found his way to prescription medical product liability litigation – if not for the Kessler-era FDA’s ill-considered salami slicing of the “intended use” of that product. In that instance, the FDA had limited its cleared “intended use” to disc spaces