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Back in the bad old days of the Bone Screw litigation, we had to fight our way through a thicket of scurrilous allegations about how our clients supposedly promoted off-label use through continuing medical education seminars that the Bone Screw plaintiffs claimed were used to reward surgeons who regularly used our clients’ products with excessive speaker fees.  Back then – in the mid 1990s – the plaintiffs’ preferred avenues for asserting such allegations were state-law based:  negligence per se, fraud on the FDA, and conspiracy.  By the time that the infamous Franklin False Claims Act (“FCA”) decisions came down (United States ex rel. Franklin v. Parke-Davis,147 F. Supp.2d 39 (D. Mass. 2001), and United States  ex rel. Franklin v. Parke-Davis, 2003 WL 22048255 (D. Mass. Aug. 22, 2003)), we had won Buckman (and a lot of other things), so Bone Screw-related promotion allegations were never the subject of FCA litigation.

But the Bone Screw promotional allegations were close enough to what has been subsequently alleged ad nauseum in FCA litigation that we’ve followed similar FCA litigation ever since.  Today’s case, United States v. Gilead Sciences, Inc., 2025 WL 2627686 (E.D. Pa. Sept. 11, 2025), does not involve off-label use, but does involve allegations of kickbacks – through speaker programs and donations to charitable organizations.  We’re happy to say that the entire action was dismissed – on both sets of facts.  We’re even happier to recommend the discussion in Gilead as providing useful guidance for how pharmaceutical companies can manage both types of programs in compliance with applicable law.Continue Reading FCA Dismissal Illustrates Pharmaceutical Promotion Done Right

The billion-dollar-plus verdict in United States ex rel. Penelow v. Janssen Products, LP, 2025 WL 937504 (D.N.J. March 28, 2025), epitomizes everything that is wrong about the False Claims Act – and that’s just about everything.  A private plaintiff (“relator”), purporting to act as a self-appointed agent of the United States government, claimed that…

In a series of what we entitled “reports from the front,” we discussed how the federal government asserted, and eventually won, the right to intervene in ongoing False Claims Act suits to seek their dismissal notwithstanding the objections of the “relators” who were ostensibly pursuing these actions in the government’s name.  Basically, the relators claimed that, unless the government exercised its initial right to take over an FCA suit early on, the government lost all control over the relators, and they could essentially run wild using the government’s name.  The Supreme Court rightfully rejected that view.  United States ex rel. Polansky v. Executive Health Resources, Inc., 599 U.S. 419, 437-38 (2023) (government entitled to intervene and obtain dismissal of FCA action at any time on the basis of any “reasonable argument” regardless of the relator’s position).

However, three justices had more to add – they challenged that entire FCA private-attorney-general system as unconstitutional.  Justice Thomas stated in dissent:

The FCA’s qui tam provisions have long inhabited something of a constitutional twilight zone.  There are substantial arguments that the qui tam device is inconsistent with Article II and that private relators may not represent the interests of the United States in litigation. . . .  [T]he Court has held that conducting civil litigation for vindicating public rights of the United States is an executive function that may be discharged only by persons who are Officers of the United States under the Appointments Clause.  A private relator under the FCA, however, is not appointed as an officer of the United States under Article II.  It thus appears to follow that Congress cannot authorize a private relator to wield executive authority to represent the United States’ interests in civil litigation.  The potential inconsistency of qui tam suits with Article II has been noticed for decades.

Polansky, 599 U.S. at 449-50 (Thomas, J., dissenting) (citations and quotation marks omitted).  Concurring Justices Kavanaugh and Barrett agreed.  “I add only that I agree with Justice Thomas that “[t]here are substantial arguments that the qui tam device is inconsistent with Article II and that private relators may not represent the interests of the United States in litigation.”  Id. at 442 (concurring opinion).

Thus, we commented that “another front opens.”Continue Reading FCA Frontal Assault in Eleventh Circuit

Sometime last year, one of our esteemed bloggers wrote: “The qui tam provision of the FCA, which permits private plaintiffs – sorry, relators – to steer FCA claims presents marvelous opportunities for mischief.” We couldn’t have said it any better, so we won’t try.  Moreover, mischief makes us think of the Marauder’s Map (Harry…

Do kids still do connect-the-dots?  Back before tablets, smart phones, laptops, and even computers, when you went on a long car trip you passed the time playing license plate bingo, punch buggy, annoying your parents, and maybe you had an “activity book.”  An actual paperback book filled with coloring pages, mazes, word scrambles, seek-a-word, and…

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

We’ve long believed that False Claims Act (“FCA”) cases – particularly in the health sciences area – are out of control.  Twenty-first century lawyers, and their solicitation techniques, have turned Abraham Lincoln’s Nineteenth Century law aimed at corrupt government contractors into its own form of corruption.  Today’s FCA racket is complete with professional relators, deceit…

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FDA-regulated products now account for an estimated one-fifth of overall economic activity in the U.S. They have also been the focus of a litigation explosion. This timely guide covers all aspects of litigation involving drugs, medical devices, vaccines and other FDA-regulated prescription products.
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