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).
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
We begin with the news that the Drug and Device Law Rock Climber has a new puppy. He is six months old and already over 60 pounds – a rescued Australian Shepherd mix. He is also white with blue eyes, a color pattern linked to deafness in dogs and cats. And he is totally deaf,
The defense response to so many plaintiff allegations amounts to: so what? What difference did the complained of conduct make? Think of medical causation. Or think of warning causation in the context of a learned intermediary. In securities cases or, closer to our DDL hearts, False Claims Act cases, the ‘so what’ arrives dressed in
We’ve already provided two “reports from the front” about how the federal government is faring in False Claims Act cases where it has moved to dismiss actions over the objections of the relators supposedly pursuing recovery in the government’s name. Here’s a third one, about Polansky v. Executive Health Resources, Inc., ___ F.4th ___,
To bring suit in federal court, a plaintiff must have “Article III standing.” That is to say, the plaintiff must have a personal stake in the suit’s outcome. This is true whether a plaintiff is suing individually or as a member of a class.
Late last week, in TransUnion v. Ramirez, — S. Ct.
The recent appellate False Claims Act (“FCA”) decision in Dan Abrams Co. LLC v. Medtronic Inc., ___ F. Appx. ___, 2021 WL 1235845 (9th Cir. April 2, 2021), has us scratching our heads. It’s like riding a legal roller coaster. Some parts are really high, and others are really low.
Bexis first ran across