1. Industries & Practices

False Claims Act Investigations & Litigation

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In an environment of heightened False Claims Act enforcement, ArentFox Schiff provides coordinated compliance, investigations, and litigation counsel to help clients mitigate risk while avoiding business disruption and reputational harm.

Overview

False Claims Act (FCA) enforcement affects organizations across health care, life sciences, and government contracting. Companies in these highly regulated sectors that receive, or even indirectly benefit from, government funds are subject to intense scrutiny by multiple agencies. Investigations may involve parallel civil and criminal exposure, alongside significant financial and operational consequences. With decades of experience, a deep understanding of government enforcement strategies, and a proven track record of success, ArentFox Schiff works with clients navigating these environments through every phase of an FCA matter – from the earliest compliance counseling and internal investigation to litigation in federal district courts across the country, parallel criminal proceedings, appeals, and resolutions.

Our Focus

ArentFox Schiff’s FCA team of veteran lawyers includes former federal and state prosecutors, regulators, government enforcement officials, and civil and criminal litigators. We represent 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 (OIG), state attorneys general, and qui tam whistleblowers. 

We understand the unique business risks our clients face and deliver practical, results-oriented solutions in sensitive matters. Our integrated, multi-disciplinary 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. Drawing on our longstanding relationships and credibility with government attorneys and regulators, we guide clients through high-stakes enforcement matters and develop defense strategies tailored to our clients’ financial, operational, and reputational interests.

Focus Areas

In False Claims Act Investigations & Litigation, we support clients with:

What Do We Do?

  • Perform compliance audits and develop compliance programs to mitigate FCA exposure risk
  • Advise on allegations involving the Anti-Kickback Statute, Stark Law, off-label marketing, government pricing manipulation, and procurement fraud
  • Respond to subpoenas, civil investigative demands, search warrants, outside audits, grand jury proceedings, and other government inquiries
  • Represent organizations 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
  • Coordinate parallel civil and criminal investigations where applicable
  • Defend companies and individuals in all stages of FCA litigation, including trial and appellate proceedings
  • Engage with government investigators and prosecutors during investigative stages
  • Negotiate the closure of government investigations
  • Negotiate and implement corporate integrity agreements or monitorships
  • Help strengthen compliance programs to prevent future FCA issues and demonstrate good faith to regulators
  • Protect clients’ reputations through strategic communications and media management

Who Do We Help?

  • Pharmaceutical and medical device manufacturers
  • Hospitals, health systems, and clinical providers
  • Medical suppliers
  • Digital health companies and emerging health technology companies
  • Defense contractors and other government contractors
  • Any organizations that receive federal funding

How Can We Help?

Our veteran litigators and regulatory professionals are poised to help organizations facing government audits, subpoenas, whistleblower allegations, or broader enforcement inquiries. We also assist with FCA-related matters arising during compliance reviews, internal reporting, transactional diligence, or in response to regulatory changes that affect reimbursement, pricing, or procurement practices.

Our Experience

  • Represented a pharmaceutical manufacturer in a $46 million resolution of a four-year 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 in United States ex rel. Toulsor 1, Inc. v. Veloxis Pharmaceuticals A/S, et al. (DOJ; USDC D. Mass.).
  • Representation of a 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).
  • Served as lead counsel representing 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 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 declination on behalf of a former executive of a health care company in a wide-ranging investigation focusing on allegations related to violations of California’s Unfair Competition Law and False Advertising Law through the corporate practice of medicine (the company entered into a multimillion-dollar settlement) in California v. Carbon Heath Technologies, et al. (Superior Court CA).
  • 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.).
  • Represented a large pharmaceutical manufacturer in a False Claims Act investigation brought by DOJ involving alleged violations of the Federal Food, Drug, and Cosmetic Act.
  • Represented a multi-national generic pharmaceutical manufacturer in a False Claims Act investigation brought by DOJ involving alleged violations of the Federal Food, Drug, and Cosmetic Act.
  • 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).
  • Served as lead counsel representing 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.).
  • Representation of a major hospital in connection with a proposed government audit and complex administrative subpoena (USDC ED Pa.; 3rd Cir.).
  • Representation of a 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).
  • Representation of a major pharmaceutical company in connection with patent and unfair competition litigation (USDC MD).

Key Contacts

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FAQs

What typically triggers a False Claims Act investigation?

The most common trigger is a whistleblower — known as a qui tam relator — often a current or former employee with inside knowledge, who files a complaint under seal in federal court for the Department of Justice to investigate. Because qui tam complaints are filed under seal, a company may not know an investigation is underway until it receives a subpoena or civil investigative demand. Investigations can also begin through government enforcement priorities, government audits, referrals from agencies such as the Office of Inspector General, or self-disclosures during internal compliance reviews.

How are civil and criminal FCA proceedings related?

DOJ frequently runs parallel civil and criminal investigations because conduct that gives rise to civil FCA liability may also support criminal charges, including health care fraud, wire fraud, or making false statements. A coordinated defense strategy is critical because statements or disclosures in one proceeding can directly affect the other.

What role do internal investigations play in FCA matters?

A properly structured, privileged internal investigation allows a company to determine the facts before the government does, assess the scope of potential liability, develop legal and factual defenses, and make informed decisions about whether to self-disclose or present findings to the government. It also helps preserve key documents and positions the legal team to engage credibly with investigators early in the process.

When should a company consider engaging counsel for FCA risk?

The earlier, the better. The highest-leverage moment in an FCA matter is during the investigation stage, before the government has committed to a theory of the case. Engaging experienced counsel early allows you to respond to subpoenas or civil investigative demands strategically, present exculpatory evidence to the government, and shape the direction of the inquiry before it escalates to litigation.