False Claims Act Investigations & Litigation

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Our Focus

Companies operating in highly regulated industries that receive, or even indirectly benefit from, government funds can face sprawling, multi-agency investigations, substantial exposure under the False Claims Act, (including treble damages, civil penalties, and even debarment), as well as business disruption and reputational harm. With decades of experience, a deep understanding of government enforcement strategies, and a proven track record of success, ArentFox Schiff is uniquely positioned to guide clients through the complexities of FCA matters.

ArentFox Schiff’s False Claims Act team of veteran lawyers including former federal and state prosecutors, regulators, government enforcement officials, and civil and criminal litigators, represents both individuals and companies in high-stakes civil and criminal fraud investigations and litigation initiated by the US Department of Justice, US Attorneys’ Offices, the Office of Inspector General, state attorneys general, and qui tam whistleblowers.

Our attorneys handle a wide range of fraud matters, including allegations involving the Anti-Kickback Statute, Stark Law, off-label marketing, government pricing manipulation, and procurement fraud. Our team manages every aspect of FCA matters – from responding to subpoenas, civil investigative demands, and internal investigations, to representing clients in jury, bench, and administrative trials in state and federal courts nationwide.

We serve clients across all branches of the health care and life science industries, including pharmaceutical and device manufacturers, medical suppliers, large hospitals and health systems, clinics, telehealth companies, and other emerging technology companies. Our experience also extends to the full range of defense contractors, as well as other companies that receive federal funding. We are recognized as industry leaders because we understand the unique business risks our clients face and deliver practical, results-oriented solutions in sensitive matters.

Our Approach

Our approach to False Claims Act investigations is comprehensive and strategic:

Integrated, Multi-Disciplinary Teams: We assemble teams that combine industry-leading regulatory knowledge with top-tier litigation skills, ensuring that every matter is addressed from all relevant angles.

Early Case Assessment: We conduct thorough, confidential internal investigations to assess exposure and develop a tailored defense strategy.

Proactive Engagement: We engage government investigators and prosecutors early to shape the narrative and often persuade the government to decline intervention and close their investigation. Our longstanding relationships with government attorneys and regulators and reputation for integrity enable us to advocate effectively for our clients.

Strategic Litigation: When litigation is unavoidable, we mount aggressive, creative defenses to challenge the government’s case at every turn.

Compliance Counseling: We help clients strengthen compliance programs to prevent future FCA issues and demonstrate good faith to regulators.

How We Can Help

• Respond to subpoenas, civil investigative demands (CIDs), search warrants, outside audits, grand jury proceedings, and other government inquiries
• Represent companies in audits and investigations by OIG or other regulatory agencies
• Conduct internal investigations to assess the validity and scope of FCA allegations
• Advise on self-disclosure obligations and voluntary disclosures to government agencies
• Perform compliance audits and develop and implement robust compliance programs to mitigate future risk
• Defend individuals and companies in all stages of FCA litigation, including trial and appeal
• Coordinate parallel criminal and civil investigations
• Negotiate the closure of government investigations
• Negotiate and implement corporate integrity agreements or corporate monitorships
• Protect clients’ reputations through strategic communications and media management

ArentFox Schiff’s FCA team is committed to protecting our clients’ interests, minimizing risk, and achieving favorable outcomes in even the most challenging government investigations and enforcement actions.

Representative Matters:

• Represented large public hospital in the resolution of a $70 million False Claims Act and Stark Law litigation in United States ex rel. Reilly v. North Broward Hospital District (USDC SD Fla.)
• For more than 17 years, served as lead litigation counsel representing a global pharmaceutical manufacturer in connection with the Average Wholesale Price MDL throughout the country in In re Pharmaceutical Industry Average Wholesale Litigation (MDL No. 1456)
• Represented a large, international pharmaceutical company in an investigation brought by the US Attorney for the District of Massachusetts and DOJ alleging violations of the False Claims Act and possible violations of the Federal Food, Drug, and Cosmetic Act in United States ex rel. Albermarle v. Cipla, et al. (DOJ; USDC D. Mass)
• Obtained dismissal on behalf of a global pharmaceutical company in two related litigations alleging violations of the False Claims Act, United States ex rel. John R. Borzilleri, M.D., et al v. Abbvie, Inc., et al. (USDC SDNY and DRI; 1st Cir. and 2nd Cir.)
• Obtained declination of two proton therapy centers in a False Claims Act, Stark Law, and Anti-Kickback Statute investigation in United States ex. rel. Ward v. ProCure Management (USDC WD Ok.)
• Obtained declination on behalf of the former president of a benefit management company in a False Claims Act investigation (the former company entered into a $54 million settlement) in United States ex. rel. Miller v. CareCore National (USDC SDNY)
• Represented pharmaceutical manufacturer in bet-the-company investigation brought by the US Attorney for the District of Massachusetts and DOJ alleging violations of the False Claims Act, the Anti-Kickback Statute, antitrust laws, and the Federal Food, Drug, and Cosmetic Act (DOJ; Mass. US Attorney’s Office)
• Represented large pharmaceutical manufacturer in False Claims Act investigation brought by DOJ involving alleged violations of the Federal Food, Drug, and Cosmetic Act (DOJ)
• Represented multi-national generic pharmaceutical manufacturer in False Claims Act investigation brought by DOJ involving alleged violations of the Federal Food, Drug, and Cosmetic Act (DOJ)
• Represented multiple entities in investigations brought by the US Attorney for the District of Massachusetts into whether pharmaceutical manufacturers and patient assistance programs violated the Anti-Kickback Statute and False Claims Act relating to the provision of co-pays, obtaining declination of one entity (DOJ; USDC D. Mass.)
• Obtained dismissal of a financial institution in a False Claims Act lawsuit asserting billions of dollars in claims in United States ex. rel. Brown and Stone v. BankUnited Trust (USDC SD Fla.)
• Obtained favorable settlements on behalf of multiple pharmaceutical companies in pricing disputes alleging fraudulent Medicaid reimbursements in State of Louisiana v. Abbott Laboratories, et al. (19th Judicial District; 1st Cir.; Supreme Court (LA))
• Obtained declination on behalf of an international medical device manufacturer in an investigation by the DOJ Consumer Protection Branch and the United States Attorney’s Office for the District of Massachusetts into False Claims Act allegations and possible criminal or civil violations of the Federal Food, Drug, and Cosmetic Act in United States v. Coloplast et al. (USDC D. Mass)
• Obtained dismissal of a major pharmaceutical company in a False Claims Act litigation in United States, ex rel. Conrad v. Actavis Mid-Atlantic, et al. (USDC D. Mass)
• Obtained dismissal of a public hospital in four False Claims Act Cases where its former General Counsel brought suit (Sup. Ct. Cal.; USDC ND Cal.)
• Represented major hospital in connection with a proposed Government audit and complex administrative subpoena (USDC ED Pa.; 3rd Cir.)
• Represented major urban hospital in connection with a False Claims Act case (USDC DDC)
• Obtained dismissal of a vaccine manufacturer in a False Claims Act litigation in Dingle v. BioPort Corp. (USDC WD Mich.; 6th Cir.; USSC)
• Obtained summary judgment in favor of a generic pharmaceutical company in a patent case in Glaxo v. Impax Laboratories (USDC ND Cal.)
• Obtained dismissal on behalf of a major vaccine producer in a challenge brought by military service members in Bates v. BioPort Corp. (USDC DDC)
• Represented major pharmaceutical company in connection with patent and unfair competition litigation (USDC MD)