The FCA Insider

The FCA Insider

Insights and updates on False Claims Act Litigation

Category Archives: FCA Litigation

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FCA Litigation, Settlements

Canadian Steel Companies and Owner to Pay $19M to Settle False Claims Act Allegations Relating to Evaded Customs Duties

On May 20, 2026, the DOJ announced a settlement under the False Claims Act (FCA) with two Canada-based steel companies, Farjess Inc. and Royal Canadian Steel Inc., and their part-owner and president, Feroz Jessani. They agreed to pay $19 million to resolve allegations that they knowingly and improperly misrepresented the country of origin and failed… Continue Reading
Defense Arguments, FCA Litigation

Ninth Circuit Ruling in FCA Case Predicated on 340B Pricing Violations Has Significant Implications for Pharma Manufacturers 

On March 17, 2026, the United States Court of Appeals for the Ninth Circuit issued a significant opinion in United States ex rel. Adventist Health System of West v. AbbVie Inc., [1] reversing the district court’s dismissal of a qui tam complaint brought under the False Claims Act (“FCA”) against four major drug manufacturers. The… Continue Reading
DOJ, FCA Litigation, Uncategorized

New Executive Order Targets DEI Practices by Federal Contractors, Imposes Mandatory Contract Clause and FCA Liability

Continuing his administration’s efforts to eliminate diversity, equity and inclusion (DEI) activities, President Donald Trump signed an executive order, “Addressing DEI Discrimination by Federal Contractors,” on March 26, 2026, that directs all executive departments and agencies to include a new clause in all federal contracts and subcontracts prohibiting what the order defines as “racially discriminatory… Continue Reading
DOJ, FCA Litigation

Defense Contractor, Private Equity Firm to Pay $1.75M to Settle FCA Allegations Regarding Cybersecurity Violations

On July 31, 2025, the U.S. Department of Justice announced a $1.75 million False Claims Act (FCA) settlement with Aero Turbine, a California-based defense contractor, and private equity firm Gallant Capital Partners. The settlement arises out of allegations that Aero Turbine failed to comply with cybersecurity requirements under a U.S. Air Force contract and provided… Continue Reading
Defense Arguments, FCA Defenses, FCA Litigation

Fifth Circuit Concurrence Adds Voice to FCA Constitutionality Questions

A first appellate circuit judge has questioned the False Claim Act’s constitutionality.  In the Fifth Circuit’s decision last month in United States ex rel Montcrief v. Peripheral Vascular Assocs., P.A., No. 24-50176, — F. 4th –, 2025 WL 939890 (5th Cir. Mar. 28, 2025), Judge Stuart Kyle Duncan separately wrote a concurring opinion to express… Continue Reading
FCA Litigation, OIG, Regulatory

Fourth Circuit Upholds OIG Advisory Opinion Process

On January 23, 2025, the United States Court of Appeals for the Fourth Circuit rejected a challenge to Advisory Opinion 22-19 (the “Advisory Opinion”) issued by the United States Department of Health and Human Services, Office of Inspector General (“OIG”). The case, Pharmaceutical Coalition for Patient Access v. United States, centered on whether the Advisory… Continue Reading
FCA Litigation, Regulatory

Department of Justice Suggests “Aggressive” Enforcement of False Claims Act

On February 20, 2025, during a speech to the Federal Bar Association’s annual qui tam conference, Michael Granston, Deputy Assistant Attorney General for the Commercial Litigation Branch at the U.S. Department of Justice (DOJ), said that the Trump Administration will seek to “aggressively” enforce the False Claims Act (FCA). In particular, Granston stated that active… Continue Reading
CMS Guidance, FCA Litigation, Stark Law

Stark Law Regulations Under the Microscope in a Post-Chevron World

Recently, in United States ex rel. Kyer v. Thomas Health Systems, the judge overseeinga whistleblower’s False Claims Act (FCA) suit against Thomas Health Systems Inc. stalled further decisions until both parties could file supplemental briefs addressing the U.S. Supreme Court’s decision in Loper Bright Enterprises v. Raimondo. The judge’s order requires the parties to articulate… Continue Reading
DOJ, FCA Litigation

Key Takeaways From McGuireWoods’ Webinar on Enforcement Against PE Funds in Healthcare

On July 9, 2024, McGuireWoods partners Brett Barnett, Mindy Sauter, Mike Elliott, and Michael Podberesky conducted a solution-oriented discussion of key enforcement and compliance developments that impact private equity (“PE”) funds in healthcare. They also highlighted relevant cases regarding the government’s increased interest in compliance diligence in the PE space.… Continue Reading
FCA Litigation

Federal District Court Finds Private-Insurer Relator Can Proceed with False Claims Action

Last month, the U.S. District Court for the District of New Jersey held that a private company, Allstate Insurance Company, could proceed with its whistleblower action against a clinical laboratory, Phoenix Toxicology and Lab Services, LLC, which allegedly submitted false claims to the federal government for medically unnecessary urine drug tests (“UDT”). See generally United… Continue Reading
Anti-Kickback Statute, FCA Litigation

A Failed Constitutional Challenge to the AKS Safe Harbor Provision – More to come?

This past summer, in United States v. Booker, a North Carolina district court ruled against a challenge to the constitutionality of Congress’s delegation of authority to promulgate safe harbors to the Anti-Kickback Statute (AKS). In filing a motion for acquittal, Defendant Donald Booker argued the AKS “Safe Harbor Provision,” which grants the Secretary of Health… Continue Reading
Anti-Kickback Statute, FCA Litigation

The Growing Causal Divide: But-For Causation in AKS/FCA Actions

In United States v. Regeneron, the District of Massachusetts Court recently joined the Sixth and Eighth Circuits in requiring the government to show a direct tie between kickbacks and referrals that proximately caused claims to federal healthcare programs to prevail in Anti-Kickback Statute (AKS) and False Claims Act (FCA) actions. The District Court’s ruling contributes… Continue Reading
Anti-Kickback Statute, FCA Litigation, OIG, Regulatory

Lessons for Providers and Practice Entities: Ophthalmology Groups Pay Millions to Settle Co-Management, Optometrist Relationship Allegations

Two ophthalmology practice groups recently reached settlements with the U.S. government totaling nearly $20 million to resolve allegations that their third-party cataract arrangements violated several healthcare laws. Read on to discover how the settlements offer guidance to vision providers with respect to the government’s focus on ophthalmology-optometry relationships, and whether the settlements’ lessons have broader… Continue Reading
DOJ, FCA Litigation, Settlements

DOJ Settles Self-Reported Referral Incentives With Dermatology Practice Manager

On Sept. 13, the U.S. Attorney’s Office for the Northern District of Texas announced a settlement with Oliver Street Dermatology Management LLC to resolve self-reported allegations that its acquisition of several dermatology practices violated the Stark Law, the Anti-Kickback Statute and the False Claims Act. Read on for details about this matter, plus helpful guidance… Continue Reading
DOJ, FCA Litigation

U.S. Supreme Court Clarifies DOJ’s Authority to Dismiss Whistleblowers’ False Claims Act Suits, Questions Constitutionality of Qui Tam Provisions

In United States ex rel. Polansky v. Executive Health Resources, Inc., the U.S. Supreme Court recently resolved a circuit split[1] by holding that in a False Claims Act (“FCA”) action (1) the Government may seek dismissal of a qui tam case in which it initially declined to intervene over the relator’s objection as long as… Continue Reading
Anti-Kickback Statute, DOJ, FCA Litigation, Settlements, Stark Law

Regional Hospital System and Two Physicians Pay More Than $69 Million to Settle False Claims Act, Involving Allegations of Improper Financial Relationships With Referring Physicians

On March 29, 2023, the U.S. District Court for the Eastern District of Michigan granted the parties’ joint stipulation for dismissal in U.S. ex. rel. Godsholl v. Covenant Healthcare, following three settlements of the relator’s claims pursuant to the False Claims Act, 31 U.S.C. § 3729 (“FCA”), the Michigan Medicaid False Claim Act, MCL 400.601,… Continue Reading
FCA Litigation

Home Cooking: Washington Transfers Venue to Court in State

Earlier this year, the U.S. District Court for the Western District of Oklahoma granted Washington state’s motion to intervene to transfer venue to the Western District of Washington in James Siegel, M.D. v. Novo Nordisk, Inc. Relator Dr. Siegel originally filed suit in Oklahoma on February 2, 2015, alleging violations of the Federal False Claims… Continue Reading
FCA Litigation

Supreme Court Clarifies the False Claims Act’s Knowledge Requirement, Eliminating a Potential Defense for Government Contractors and Healthcare Providers Accused of Fraud

On June 1, the Supreme Court unanimously ruled in favor of whistleblower plaintiffs in consolidated False Claims Act cases in a decision that clarified the application of the FCA’s knowledge requirement. In United States ex rel. Schutte v. SuperValu Inc., the court held that the FCA reaches defendants who knew the claims they submitted were fraudulent,… Continue Reading
FCA Litigation

Pharmaceutical Suppliers Beware: Expect Increased Scrutiny of Average Wholesale Pricing Methodology and Marketing “The Spread”

A Texas federal court recently denied a pharmaceutical supplier’s motion to dismiss claims brought by a whistleblower under the federal False Claims Act (FCA) alleging violations of the Anti-Kickback Statute (AKS) and manipulation of Average Wholesale Pricing (AWP) rules. The complaint was filed by a pharmacist (the Relator) who previously worked for the defendant, Professional… Continue Reading
Anti-Kickback Statute, FCA Litigation

Distributor of Ophthalmic Surgical Products Found Guilty of Paying Kickbacks and Violating the False Claims Act: May Be Liable For Up To $848 Million in Civil Damages and Penalties

On February 28, 2023, a federal jury in the District of Minnesota found the Cameron-Ehlen Group, d/b/a Precision Lens, and its founder and owner Paul Ehlen (the “Defendants”) guilty of paying kickbacks to ophthalmic surgeons in violation of the False Claims Act, 31 U.S.C. 3729 (“FCA”) and Federal Anti-Kickback Statute, 42 U.S.C. 1320a-7b(b) (“AKS”) between… Continue Reading

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