The Second Circuit affirmed dismissal of an FCA qui tam based on allegedly faulty medical devices, an area marked for particular FCA scrutiny by the DOJ-HHS FCA Working Group, as discussed here. The Second Circuit held the relator failed to plead either a claim or materiality with the requisite specificity and affirmed the dismissal pursuant to Rule 9(b). Wood v. Siemens Med. Sols. USA, Inc., No. 25-864, 2026 WL 504530 (2d Cir. Feb. 24, 2026).
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. Jones2026-03-04 10:22:032026-03-04 10:22:03Strictly Enforcing Rule 9(b), Second Circuit Affirms Dismissal of FCA Claim Based on Allegedly Defective Medical Devices
Recently a court took the rare step of granting a motion to dismiss a qui tam suit because the relator’s vague and conclusory scienter allegations failed to satisfy Rules 8 and 9(b). U.S. ex rel. Dietz v. Philips Respironics, No. 2:21-CV-00272 (W.D. Pa. Feb. 23, 2026).
In just the last week, the Texas Attorney General’s Office (“TX AG’s Office”) filed three actions against healthcare providers and entities, continuing an increasingly robust and aggressive enforcement regime that dates back to at least the beginning of 2025.
During her keynote speech at the Federal Bar Association’s Qui Tam Conference, Brenna Jenny, Deputy Assistant Attorney General for the Commercial Litigation Branch, stated that robust FCA enforcement is “the new normal.” Key statistics, including those we discussed here, back her up: she revealed that DOJ has issued more than 1,000 Civil Investigative Demands (“CIDs”) in each of the last four years, noted that qui tam actions increased by 33% last year, and that 480 qui tam actions have already been filed so far in fiscal year 2026. She attributed this dramatic increase at least in part to enhanced data mining being conducted by DOJ and whistleblowers. Describing the FCA as a “flexible tool,” Jenny left no doubt that FCA enforcement will remain high even as she acknowledged that it is not “an all-purpose anti-fraud statute.”
At the Federal Bar Association’s Qui Tam Conference, Brenna Jenny, the Deputy Assistant Attorney General of DOJ’s Commercial Litigation Branch, offered the most detailed description yet of the Trump Administration’s effort to employ the FCA to combat practices that violate federal antidiscrimination laws, as we have previously reported here, here, and here. Jenny noted that while promoting diversity is not itself unlawful, it is also “not a protective talisman.” She stated that she believed some companies had “lost their way” in the pursuit of DEI and engaged in unlawful discrimination by pressuring their employees to make hiring and promotion decisions based on race or sex.
Speaking as part of a panel at the Federal Bar Association’s annual Qui Tam Conference today, a Senior Trial Counsel at the Department of Justice (DOJ), Christelle Klovers, emphasized the government’s focus on pursuing trade and customs-based False Claims Act (FCA) cases. This area was also identified as a focus during the keynote address by DOJ’s Deputy Assistant Attorney General for the Commercial Litigation Branch, Brenna Jenny. In a separate speech last month, Jenny also highlighted a 50% increase in trade and customs-based FCA cases in 2025 compared to the prior five-year average, in what today’s panel called an “explosion” of trade and customs-related FCA cases.
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. Jones2026-02-19 17:50:082026-02-19 17:56:06DOJ Attorneys Underscore Heightened Focus on Trade Fraud During the Annual Qui Tam Conference
Last week, DOJ released its annual report detailing FCA recoveries and new cases, which can be found here. In the press release, accessible here, DOJ touts two records in fiscal year 2025 (“FY 2025”): (1) $6.89 billion in settlements and judgments (a 120% increase from FY 2024); and (2) 1,297 qui tam cases filed (a 32% increase from FY 2024). FCA cases against the healthcare industry once again accounted for a significant portion (83%) of total recoveries.
Earlier this week, the First Circuit in OMNI Healthcare held that “in FCA cases alleging Medicare fraud based on laboratory testing, generally a laboratory can rely on a doctor’s order to show that the test is ‘reasonable and necessary’” under the Medicare statute. U.S. ex rel. OMNI Healthcare Inc. v. MD Spine Solutions LLC, No. 25-1110 (1st Cir. Dec. 1, 2025).
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. Stein2025-12-08 11:34:442025-12-08 11:34:44First Circuit Clarifies Application of Medicare’s “Reasonable and Necessary” Standard in FCA Cases Against Clinical Labs
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Strictly Enforcing Rule 9(b), Second Circuit Affirms Dismissal of FCA Claim Based on Allegedly Defective Medical Devices
The Second Circuit affirmed dismissal of an FCA qui tam based on allegedly faulty medical devices, an area marked for particular FCA scrutiny by the DOJ-HHS FCA Working Group, as discussed here. The Second Circuit held the relator failed to plead either a claim or materiality with the requisite specificity and affirmed the dismissal pursuant to Rule 9(b). Wood v. Siemens Med. Sols. USA, Inc., No. 25-864, 2026 WL 504530 (2d Cir. Feb. 24, 2026).
(more…)
Jaime L.M. Jones
Chicago
jaime.jones@sidley.com
Scott D. Stein
Chicago
sstein@sidley.com
Joseph R. LoCascio
Chicago
joseph.locascio@sidley.com
Anna M. Schmitt
Chicago
anna.schmitt@sidley.com
Court Grants Motion to Dismiss FCA Claim for Failure Adequately to Plead Scienter
Recently a court took the rare step of granting a motion to dismiss a qui tam suit because the relator’s vague and conclusory scienter allegations failed to satisfy Rules 8 and 9(b). U.S. ex rel. Dietz v. Philips Respironics, No. 2:21-CV-00272 (W.D. Pa. Feb. 23, 2026).
(more…)
Jaime L.M. Jones
Chicago
jaime.jones@sidley.com
Scott D. Stein
Chicago
sstein@sidley.com
Joseph R. LoCascio
Chicago
joseph.locascio@sidley.com
Hannah Zobair
Chicago
hannah.zobair@sidley.com
TX AG’s Office Continues Aggressive Enforcement Against Healthcare Entities Operating in Texas
In just the last week, the Texas Attorney General’s Office (“TX AG’s Office”) filed three actions against healthcare providers and entities, continuing an increasingly robust and aggressive enforcement regime that dates back to at least the beginning of 2025.
(more…)
Jaime L.M. Jones
Chicago
jaime.jones@sidley.com
Kenneth G. Coffin
Dallas
kenneth.coffin@sidley.com
DAAG Brenna Jenny Warns Heightened FCA Enforcement Is “The New Normal,” Addresses Enforcement Priorities and Policies
During her keynote speech at the Federal Bar Association’s Qui Tam Conference, Brenna Jenny, Deputy Assistant Attorney General for the Commercial Litigation Branch, stated that robust FCA enforcement is “the new normal.” Key statistics, including those we discussed here, back her up: she revealed that DOJ has issued more than 1,000 Civil Investigative Demands (“CIDs”) in each of the last four years, noted that qui tam actions increased by 33% last year, and that 480 qui tam actions have already been filed so far in fiscal year 2026. She attributed this dramatic increase at least in part to enhanced data mining being conducted by DOJ and whistleblowers. Describing the FCA as a “flexible tool,” Jenny left no doubt that FCA enforcement will remain high even as she acknowledged that it is not “an all-purpose anti-fraud statute.”
(more…)
Jaime L.M. Jones
Chicago
jaime.jones@sidley.com
Kristin Graham Koehler
Washington, D.C.
kkoehler@sidley.com
Hannah Zobair
Chicago
hannah.zobair@sidley.com
Anna M. Schmitt
Chicago
anna.schmitt@sidley.com
DAAG Jenny Reinforces Commitment to FCA Enforcement Premised on Discrimination
At the Federal Bar Association’s Qui Tam Conference, Brenna Jenny, the Deputy Assistant Attorney General of DOJ’s Commercial Litigation Branch, offered the most detailed description yet of the Trump Administration’s effort to employ the FCA to combat practices that violate federal antidiscrimination laws, as we have previously reported here, here, and here. Jenny noted that while promoting diversity is not itself unlawful, it is also “not a protective talisman.” She stated that she believed some companies had “lost their way” in the pursuit of DEI and engaged in unlawful discrimination by pressuring their employees to make hiring and promotion decisions based on race or sex.
(more…)
Jaime L.M. Jones
Chicago
jaime.jones@sidley.com
Kristin Graham Koehler
Washington, D.C.
kkoehler@sidley.com
Joseph R. LoCascio
Chicago
joseph.locascio@sidley.com
DOJ Attorneys Underscore Heightened Focus on Trade Fraud During the Annual Qui Tam Conference
Speaking as part of a panel at the Federal Bar Association’s annual Qui Tam Conference today, a Senior Trial Counsel at the Department of Justice (DOJ), Christelle Klovers, emphasized the government’s focus on pursuing trade and customs-based False Claims Act (FCA) cases. This area was also identified as a focus during the keynote address by DOJ’s Deputy Assistant Attorney General for the Commercial Litigation Branch, Brenna Jenny. In a separate speech last month, Jenny also highlighted a 50% increase in trade and customs-based FCA cases in 2025 compared to the prior five-year average, in what today’s panel called an “explosion” of trade and customs-related FCA cases.
(more…)
Jaime L.M. Jones
Chicago
jaime.jones@sidley.com
Kristin Graham Koehler
Washington, D.C.
kkoehler@sidley.com
Craig Francis Dukin
Washington, D.C.
cdukin@sidley.com
Ted Murphy
Washington, D.C.
ted.murphy@sidley.com
Justin R. Becker
Washington, D.C.
justin.becker@sidley.com
Kenneth G. Coffin
Dallas
kenneth.coffin@sidley.com
FY 2025 FCA Settlements and Judgments Statistics Show Highest Recoveries Ever
Last week, DOJ released its annual report detailing FCA recoveries and new cases, which can be found here. In the press release, accessible here, DOJ touts two records in fiscal year 2025 (“FY 2025”): (1) $6.89 billion in settlements and judgments (a 120% increase from FY 2024); and (2) 1,297 qui tam cases filed (a 32% increase from FY 2024). FCA cases against the healthcare industry once again accounted for a significant portion (83%) of total recoveries.
(more…)
Jaime L.M. Jones
Chicago
jaime.jones@sidley.com
Matt Bergs
Chicago
mbergs@sidley.com
Anna M. Schmitt
Chicago
anna.schmitt@sidley.com
First Circuit Clarifies Application of Medicare’s “Reasonable and Necessary” Standard in FCA Cases Against Clinical Labs
Earlier this week, the First Circuit in OMNI Healthcare held that “in FCA cases alleging Medicare fraud based on laboratory testing, generally a laboratory can rely on a doctor’s order to show that the test is ‘reasonable and necessary’” under the Medicare statute. U.S. ex rel. OMNI Healthcare Inc. v. MD Spine Solutions LLC, No. 25-1110 (1st Cir. Dec. 1, 2025).
(more…)
Scott D. Stein
Chicago
sstein@sidley.com
Joseph R. LoCascio
Chicago
joseph.locascio@sidley.com
Anna M. Schmitt
Chicago
anna.schmitt@sidley.com
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