Dompé Settles Anti-Kickback Allegations for $32 Million

Dompé Settles Anti-Kickback Allegations for $32 Million

On September 10, the US Department of Justice (DOJ) announced that Dompé U.S. Inc., the US subsidiary of Italian pharmaceutical company Dompé farmaceutici S.p.A., agreed to pay $32 million to resolve allegations that, between 2018 and 2021, it violated the Anti-Kickback Statute (AKS) and the False Claims Act (FCA) by paying Medicare beneficiary co-pays through patient assistance foundations to induce the purchase of its drug, Oxervate.

As part of the settlement, Dompé U.S. admitted that prior to the launch of Oxervate, employees expressed reservations about launching the drug in the United States paying a patient assistance foundation that would cover patients’ co-pays for the drug. After the launch, Dompé U.S. made contributions to two foundations that paid co-pays for Oxervate. 

The Dompé settlement is the latest in a long line of enforcement actions reflecting the government’s sustained focus on the relationship between pharmaceutical manufacturers and co-pay assistance charities. For example, as we previously reported, in 2024, Teva Pharmaceuticals agreed to pay $450 million to, in part, resolve allegations it conspired with a specialty pharmacy and two co-pay assistance foundations to cover Medicare patients’ co-pays for its multiple sclerosis drug, Copaxone. As we have also reported previously, the DOJ’s ongoing lawsuit against Regeneron — which alleges that it paid money to a charitable foundation to subsidize patient copays for its drug Eylea — remains pending in the District of Massachusetts. In addition to the co-pay violations, Dompé U.S. also admitted that it solicited data directly from the foundations and from the specialty pharmacy that provided hub services to patients and then provided it directly or indirectly to the company’s Market Access team and certain individuals involved in the patient assistance foundation budgeting process.

Notably, Dompé farmaceutici self-disclosed this conduct by Dompé U.S., and according to the settlement agreement, “this was among the first voluntary disclosures made by a pharmaceutical company to the U.S. Attorney’s Office for the District of Massachusetts pursuant to Justice Manual § 4-4.112, Guidelines for Taking Disclosure, Cooperation, and Remediation into Account in False Claims Act Matters, which had become effective on May 6, 2019. Dompé’s disclosure was proactive and timely and identified individuals substantially involved in the relevant activity in accordance with Justice Manual § 44-112.”

Read the DOJ’s press release here.

Abbott Laboratories Settles Contaminated Infant Formula Claims for $384 Million

On September 14, the DOJ announced that Abbott Laboratories agreed to pay $384,999,040 to resolve allegations that it caused false claims to be submitted to state and federal programs arising from its failure to manufacture certain powder infant formula and nutritional therapy products in compliance with federal and state requirements. 

In November 2025, the government filed a Complaint in Intervention alleging that Abbott knowingly manufactured infant formula in an environment that placed the products at unacceptable risk of contamination. For example, it alleged that roof leaks were “a common occurrence” at the facility in Sturgis, Michigan, that water leaks had dripped all over the equipment and solutions, and that rather than permanently addressing the causes of the leaks or structural issues, Abbott used temporary solutions. Further, the complaint alleged that Abbott intentionally did not test for bacterial growth to avoid results showing contamination and that Abbott failed to disclose the results demonstrating “micro” contamination when responding to US Food and Drug Administration inspection requests in 2019 and 2022. 

Under the settlement, Abbott will pay $348,700,868, plus interest, to the United States and $35,491,288.40, plus interest, to certain states to resolve the allegations. The relators will receive $69 million as their share of the federal settlement. 

The claims resolved by the settlement are allegations only and there has been no determination of liability.

The case caption is U.S. v. Abbott Laboratories, No. 22-cv-994 (W.D. Mich.).

Read the DOJ’s press release here.

Accenture Agrees to Pay $25 Million to Resolve Alleged Employment Discrimination in Federal Contracting

On September 14, the DOJ announced that Accenture Federal Services, Accenture plc, and Accenture LLP agreed to pay $25 million to resolve alleged violations of the FCA stemming from Accenture’s alleged failure to comply with anti-discrimination requirements in federal contracts and for discriminating against employees and applicants based on race or sex.

The government alleged that, from 2017 to the present, Accenture took race or sex into account when making hiring and promotion decisions, and offered certain training, partnerships, programs, resources, and other opportunities to only certain employees based on race or sex. Leaders at Accenture allegedly received monthly summaries of racial and gender demographics within their units, with representation figures highlighted green, yellow, or red to indicate whether the unit met, neared, or fell below its targets.

The government contended that, during the promotion process, Accenture conducted separate discussions of candidates who furthered the company’s race or sex demographic goals and ranked these candidates separately from others who did not further the company’s demographic goals. 

The claims resolved by the settlement are allegations only and there has been no determination of liability.

Read the DOJ’s press release here.

Global Wound Care Medical Group Agrees to Pay Up to $525 Million to Resolve $1.5 Billion in Alleged FCA Claims

On September 11, bankrupt medical practice Global Wound Care Medical Group asked a Houston, Texas, bankruptcy court to approve a settlement with the United States under which it will pay up to $525 million to resolve alleged FCA claims originally valued at over $1.5 billion. 

Global Wound Care, which operated under the name Wound Pros, was licensed in more than 20 states and provided wound care services primarily to elderly patients who received Medicare. The government alleged that Global Wound Care sought and obtained enrollment in the Medicare program based on false statements and omissions, including the ownership interest of a person who had a 2013 felony conviction for bank fraud. The government also alleged that Global Wound Care provided illegal remuneration, in the form of $25 to $100 “incentive” payments, to independent contractor clinicians for each biologic skin substitute ordered, applied, and billed to Medicare, TRICARE, and the Veterans Affairs, in violation of the AKS. The government further alleged that false claims were submitted to Medicare, TRICARE, and the Veterans Affairs that falsely represented that a physician or other clinician had rendered certain services to obtain reimbursement, or a higher amount of reimbursement, to which Global Wound Care was not entitled. 

Global Wound Care filed for Chapter 11 bankruptcy in October 2024 after the Centers for Medicare & Medicaid Services (CMS) suspended payments based on a determination that credible allegations of fraud existed. In December 2025, following reduced CMS reimbursement rates, the company suspended operations. 

Under the settlement, Global Wound Care will pay the United States up to $525 million. Part of this settlement amount will originate from roughly $316.7 million of suspended payments from CMS. As part of the settlement, CMS agreed to rescind extrapolated overpayments totaling $1,130,283,438.89. Global Wound Care will be excluded from Medicare, Medicaid, and all other federal health care programs for 50 years. 

The case caption is In re: Global Wound Care Medical Group, No. 24-34908 (Bankr. S.D. Tex.).