The Sixth Circuit recently confirmed that there is no per se bar on relators releasing previously filed FCA claims as part of a settlement agreement, although the government must still subsequently consent to the dismissal of such claims. See State Farm Mut. Auto. Ins. Co. v. Angelo, 95 F.4th 419 (6th Cir. 2024).
https://fcablog.sidley.com/wp-content/uploads/sites/5/2022/08/sidleyLogo-e1643922598198.png00Jaime L.M. Joneshttps://fcablog.sidley.com/wp-content/uploads/sites/5/2022/08/sidleyLogo-e1643922598198.pngJaime L.M. Jones2024-04-15 10:18:032024-04-15 10:26:51Sixth Circuit Affirms Orders Compelling Relator to Seek Government Consent to Dismiss Qui Tam Pursuant to Settlement Agreement
A recent decision from the Central District of California held that a qui tam relator cannot bring a False Claims Act (FCA) case against pharmaceutical manufacturers to enforce the 340B Drug Pricing Program’s (“340B Program”) statutory requirements. See United States ex rel. Adventist Health System/West v. AbbVie, No. 21-cv-04249 (C.D. Cal. Mar. 18, 2024). The 340B Program is a federal program that requires pharmaceutical manufacturers to offer discounted prices, called a “ceiling price,” on applicable drugs to certain hospitals and clinics, referred to as 340B “covered entities.” The relator, Adventist Health System/West, a covered entity under the 340B Program, alleged that the defendant pharmaceutical manufacturers failed to comply with the 340B Program’s requirements related to the “penny pricing” policy, which requires manufacturers to offer drugs at a penny if the ceiling price calculation results in a number at or less than a penny.
https://fcablog.sidley.com/wp-content/uploads/sites/5/2022/08/sidleyLogo-e1643922598198.png00Jaime L.M. Joneshttps://fcablog.sidley.com/wp-content/uploads/sites/5/2022/08/sidleyLogo-e1643922598198.pngJaime L.M. Jones2024-03-22 14:32:022024-03-22 16:03:01Court Finds That Qui Tam Relator Cannot Enforce 340B Program Statute
A recent opinion from the Northern District of Georgia reminds False Claims Act defendants about a potentially powerful tool at their disposal—counterclaims. In United States ex rel. Cooley v. ERMI, LLC, the court permitted several counterclaims to proceed over the relator’s argument that they were against public policy, demonstrating how defendants can go on offense to hold relators accountable for their own misconduct. (more…)
https://fcablog.sidley.com/wp-content/uploads/sites/5/2022/08/sidleyLogo-e1643922598198.png00Kristin Graham Koehlerhttps://fcablog.sidley.com/wp-content/uploads/sites/5/2022/08/sidleyLogo-e1643922598198.pngKristin Graham Koehler2024-03-18 12:38:142024-03-18 13:10:01When the Best Defense May Be a Good Offense: False Claims Act Counterclaims
On February 22, 2024, Acting Associate Attorney General Benjamin C. Mizer and Civil Division Principal Deputy Assistant Attorney General Brian M. Boynton announced that settlements and judgments under the FCA exceeded $2.68 billion in fiscal year (“FY”) 2023. DOJ and whistleblowers, further, were party to 543 FCA settlements and judgments, the most ever in a single year. Detailed statistics on FCA recoveries from 1986 through FY 2023 are available here.
https://fcablog.sidley.com/wp-content/uploads/sites/5/2022/08/sidleyLogo-e1643922598198.png00Jaime L.M. Joneshttps://fcablog.sidley.com/wp-content/uploads/sites/5/2022/08/sidleyLogo-e1643922598198.pngJaime L.M. Jones2024-02-23 08:28:292024-02-23 08:31:33FY 2023 Saw the Most FCA Settlements and Judgments Ever in a Single Year, with the Majority of Recovered Funds Paid by the Healthcare Industry
The Department of Justice has published the inflationary adjustments to the civil monetary penalties associated with False Claims Act violations that will go into effect on February 12, 2024. The new penalties will align with the penalties announced by the Department of Commerce last month (discussed here). For any violations that occurred after November 2, 2015, but that are assessed after February 12, 2024, the adjusted penalties will be applied. The minimum False Claims Act penalty will increase from $13,508 to $13,946 per claim, and the maximum penalty will increase from $27,018 to $27,894 per claim.
https://fcablog.sidley.com/wp-content/uploads/sites/5/2022/08/sidleyLogo-e1643922598198.png00Scott D. Steinhttps://fcablog.sidley.com/wp-content/uploads/sites/5/2022/08/sidleyLogo-e1643922598198.pngScott D. Stein2024-02-13 14:24:382024-02-13 14:24:38DOJ Announces 2024 Inflationary Adjustments to FCA Penalties
On Thursday, a Minnesota district court judge more than halved a $490 million False Claims Act jury verdict against an ophthalmology distributor and its founder for Anti-Kickback Statute (“AKS”) violations, to $217 million, holding the damages were “notably severe” and “grossly disproportional” to the offense, and thus improper under the Excessive Fines Clause.
We previously wrote here regarding the Ninth Circuit’s decision in United States ex rel. Silbersher v. Valeant Pharmaceuticals Int’l Inc., 76 F.4th 843 (9th Cir. Aug. 3, 2023) (Valeant). Earlier this month, the same panel denied Valeant Pharmaceuticals’ petition for a rehearing en banc, but also issued a revised decision, significantly curtailing its original opinion.
https://fcablog.sidley.com/wp-content/uploads/sites/5/2022/08/sidleyLogo-e1643922598198.png00Gordon D. Toddhttps://fcablog.sidley.com/wp-content/uploads/sites/5/2022/08/sidleyLogo-e1643922598198.pngGordon D. Todd2024-02-01 16:31:342024-02-02 10:32:53Ninth Circuit Panel Subtly Back-Pedals Prior Ruling on the Application of the Public Disclosure Bar in the False Claims Act Context
A recent False Claims Act settlement between the Department of Justice, a New Jersey hospital, and the hospital’s investors also included a novel Federal Debt Collection Practices Act (“FDCPA”) settlement with the investors, highlighting the government’s continued efforts to pursue investors in the healthcare industry.
https://fcablog.sidley.com/wp-content/uploads/sites/5/2022/08/sidleyLogo-e1643922598198.png00Jaime L.M. Joneshttps://fcablog.sidley.com/wp-content/uploads/sites/5/2022/08/sidleyLogo-e1643922598198.pngJaime L.M. Jones2024-01-24 10:30:032024-01-24 10:43:42Potential Liability of Investors in the Healthcare Industry Heightens as Hospital Investors Enter into Novel Settlement
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Sixth Circuit Affirms Orders Compelling Relator to Seek Government Consent to Dismiss Qui Tam Pursuant to Settlement Agreement
The Sixth Circuit recently confirmed that there is no per se bar on relators releasing previously filed FCA claims as part of a settlement agreement, although the government must still subsequently consent to the dismissal of such claims. See State Farm Mut. Auto. Ins. Co. v. Angelo, 95 F.4th 419 (6th Cir. 2024).
(more…)
Jaime L.M. Jones
Chicago
jaimejones@sidley.com
Brenna E. Jenny
Washington, D.C.
bjenny@sidley.com
Jane E. Fisher
Chicago
jane.fisher@sidley.com
Court Finds That Qui Tam Relator Cannot Enforce 340B Program Statute
A recent decision from the Central District of California held that a qui tam relator cannot bring a False Claims Act (FCA) case against pharmaceutical manufacturers to enforce the 340B Drug Pricing Program’s (“340B Program”) statutory requirements. See United States ex rel. Adventist Health System/West v. AbbVie, No. 21-cv-04249 (C.D. Cal. Mar. 18, 2024). The 340B Program is a federal program that requires pharmaceutical manufacturers to offer discounted prices, called a “ceiling price,” on applicable drugs to certain hospitals and clinics, referred to as 340B “covered entities.” The relator, Adventist Health System/West, a covered entity under the 340B Program, alleged that the defendant pharmaceutical manufacturers failed to comply with the 340B Program’s requirements related to the “penny pricing” policy, which requires manufacturers to offer drugs at a penny if the ceiling price calculation results in a number at or less than a penny.
(more…)
Jaime L.M. Jones
Chicago
jaimejones@sidley.com
Brenna E. Jenny
Washington, D.C.
bjenny@sidley.com
Elizabeth Hardcastle
Washington, D.C.
ehardcastle@sidley.com
Joseph T. McNally
Chicago
jmcnally@sidley.com
When the Best Defense May Be a Good Offense: False Claims Act Counterclaims
A recent opinion from the Northern District of Georgia reminds False Claims Act defendants about a potentially powerful tool at their disposal—counterclaims. In United States ex rel. Cooley v. ERMI, LLC, the court permitted several counterclaims to proceed over the relator’s argument that they were against public policy, demonstrating how defendants can go on offense to hold relators accountable for their own misconduct. (more…)
Kristin Graham Koehler
Washington, D.C.
kkoehler@sidley.com
Joshua J. Fougere
Washington, D.C.
jfougere@sidley.com
Tyler J. Domino
New York
tdomino@sidley.com
FY 2023 Saw the Most FCA Settlements and Judgments Ever in a Single Year, with the Majority of Recovered Funds Paid by the Healthcare Industry
On February 22, 2024, Acting Associate Attorney General Benjamin C. Mizer and Civil Division Principal Deputy Assistant Attorney General Brian M. Boynton announced that settlements and judgments under the FCA exceeded $2.68 billion in fiscal year (“FY”) 2023. DOJ and whistleblowers, further, were party to 543 FCA settlements and judgments, the most ever in a single year. Detailed statistics on FCA recoveries from 1986 through FY 2023 are available here.
(more…)
Jaime L.M. Jones
Chicago
jaimejones@sidley.com
Brenna E. Jenny
Washington, D.C.
bjenny@sidley.com
Joseph R. LoCascio
Chicago
joseph.locascio@sidley.com
DOJ Announces 2024 Inflationary Adjustments to FCA Penalties
The Department of Justice has published the inflationary adjustments to the civil monetary penalties associated with False Claims Act violations that will go into effect on February 12, 2024. The new penalties will align with the penalties announced by the Department of Commerce last month (discussed here). For any violations that occurred after November 2, 2015, but that are assessed after February 12, 2024, the adjusted penalties will be applied. The minimum False Claims Act penalty will increase from $13,508 to $13,946 per claim, and the maximum penalty will increase from $27,018 to $27,894 per claim.
(more…)
Scott D. Stein
Chicago
sstein@sidley.com
Catherine Stewart
Chicago
cstewart@sidley.com
Court Cuts False Claims Act Jury Verdict in Half in Rare Constitutional Decision
On Thursday, a Minnesota district court judge more than halved a $490 million False Claims Act jury verdict against an ophthalmology distributor and its founder for Anti-Kickback Statute (“AKS”) violations, to $217 million, holding the damages were “notably severe” and “grossly disproportional” to the offense, and thus improper under the Excessive Fines Clause.
(more…)
Jaime L.M. Jones
Chicago
jaimejones@sidley.com
Scott D. Stein
Chicago
sstein@sidley.com
Brenna E. Jenny
Washington, D.C.
bjenny@sidley.com
Lauren McBride
Chicago
lmcbride@sidley.com
Ninth Circuit Panel Subtly Back-Pedals Prior Ruling on the Application of the Public Disclosure Bar in the False Claims Act Context
We previously wrote here regarding the Ninth Circuit’s decision in United States ex rel. Silbersher v. Valeant Pharmaceuticals Int’l Inc., 76 F.4th 843 (9th Cir. Aug. 3, 2023) (Valeant). Earlier this month, the same panel denied Valeant Pharmaceuticals’ petition for a rehearing en banc, but also issued a revised decision, significantly curtailing its original opinion.
(more…)
Gordon D. Todd
Washington, D.C.
gtodd@sidley.com
Kamila Rivas
Washington, D.C.
krivas@sidley.com
Potential Liability of Investors in the Healthcare Industry Heightens as Hospital Investors Enter into Novel Settlement
A recent False Claims Act settlement between the Department of Justice, a New Jersey hospital, and the hospital’s investors also included a novel Federal Debt Collection Practices Act (“FDCPA”) settlement with the investors, highlighting the government’s continued efforts to pursue investors in the healthcare industry.
(more…)
Jaime L.M. Jones
Chicago
jaimejones@sidley.com
Jon S. Zucker
Washington D.C.
jzucker@sidley.com
Lauren McBride
Chicago
lmcbride@sidley.com
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