False Claims Act (FCA) enforcement and litigation has increased rapidly in recent years. The U.S. Department of Justice routinely obtains billions of dollars in settlements and judgments in FCA enforcement actions and whistleblowers are increasingly litigating qui tam suits. Sidley’s FCA team has defended hundreds of FCA enforcement actions initiated by federal, state, and local government authorities across a wide range of industries and has litigated qui tam suits in federal and state courts across the country. The Chambers Band 1-FCA team draws on specialists across disciplines, including healthcare, FDA regulatory & enforcement, privacy and cybersecurity, labor and employment, trade and export control, antitrust, SEC regulatory & enforcement, and white collar defense, to efficiently and effectively guide clients through these complex matters.

“Sidley Austin offers a strong FCA team which includes a number of former government officials. It is particularly noted for its ability to expertly defend high-profile matters brought against pharmaceutical and medical device manufacturers, biotechnology companies and healthcare providers, while also demonstrating strong capability in defending financial institutions facing FCA allegations.”
Chambers USA 2025

We bring value to our clients in the following ways:

• A multidisciplinary approach with a deep national regulatory and investigatory bench. Our clients entrust us with their most complex FCA matters, relying on our multidisciplinary approach. We provide solutions across all key areas of law, including white collar, healthcare, life sciences, FDA, government contracts, banking and financial services, labor and employment, tax, international trade, and appellate. We have FCA practitioners in offices throughout the United States who partner with our subject matter, regulatory, and industry experts to establish formidable teams. Our lawyers have been consistently recognized for their FCA work by leading legal directories and publications, including Chambers USA, LMG Life Sciences, The Legal 500 US and Benchmark Litigation.
• A full-service, lifecycle FCA practice. Our lawyers advise clients throughout the lifecycle of potential FCA claims. On the front end, we help companies with compliance and risk management issues, including developing robust ethics and compliance programs designed to minimize FCA risk. We have extensive experience handling sensitive internal investigations regarding compliance issues and advising regarding self-reporting, including providing advice on related employment issues. We also have considerable experience assisting companies in their interactions with whistleblowers and potential whistleblowers. We assist during government investigations of qui tam matters, before an intervention decision is made, and during which, quite frequently, parallel civil and criminal investigations are proceeding. We understand what factors play into the government’s decision whether to intervene, and have succeeded in convincing the government not to intervene in FCA cases on many occasions.
• In those cases where the government has decided to intervene and the client has determined that settlement is the best option, we employ numerous strategies to resolve those cases on terms favorable to our clients. To that end, we have a vast amount of experience with damages modeling to reduce the amount of such resolution, as much as possible, based on principled arguments grounded in both the facts and the case law. Our lawyers also advise on issues related to those resolutions such as tax treatment, negotiation of CIAs, compliance program implementation and monitoring, and employment issues.
• Understanding of all aspects of FCA-related litigation. Where matters cannot be resolved through settlement, we bring to bear our formidable litigation skills. In FCA matters, we engage in cutting-edge and complex motions practice, regarding issues such as public disclosure, original source, and 9(b), with many cases successfully dismissed at the pleading stage. Where matters are not dismissed at the outset, we are well equipped to engage in affirmative and defensive discovery in the most complicated of regulatory areas. Thereafter, we have prevailed on numerous occasions at the summary judgment stage. We also have the expertise necessary to successfully try FCA cases.  
  
  We also have extensive experience litigating FCA matters brought by State and local authorities, which is increasingly important as state and municipal FCAs proliferate and there is increased coordination between the DOJ and State AGs, and a growing alliance between State AGs and plaintiffs’ contingency fee lawyers.
  
  We also have significant experience litigating ancillary matters related to core FCA claims, including retaliation claims, securities and product liability litigation, and suspension, debarment and exclusion proceedings.
• Sophisticated thought leadership. We bring our depth of experience and breadth of resources from the firm’s myriad legal disciplines to analyze emerging issues within this dynamic area of law on our industry-leading blog, Original Source: The Sidley Austin False Claims Act Blog. We also are frequent authors and presenters on cutting-edge FCA topics. We apply knowledge management techniques to take advantage of our prior FCA work, including by maintaining databases of settlements and prior motions, analyses of state False Claims Acts, and a robust database of FCA cases, and other resources, which enables us to leverage our previous engagements to provide cost-effective representation to our clients.

Our team has assisted clients from numerous industries, including:

Healthcare and Life Sciences Companies

• A major dialysis provider in connection with a government investigation of criminal and civil FCA claims arising from a qui tam suit filed by a former senior executive. Despite the sweeping nature of the allegations, the matter was resolved on favorable terms and without Corporate Integrity Agreement.
• HealthcarePartners Inc. in defense of a Department of Justice, Civil Frauds investigation and resolution of claims related to alleged Medicare Advantage “upcoding.”
• Novo Nordisk Inc. in qui tam litigation against the relator and State of Washington asserting FCA claims based on alleged off-label promotion and violations of the Anti-Kickback Statute in connection with physician arrangements and a patient support program. Sidley has obtained a dismissal of the nationwide claims and the parties continue to litigate the claims arising from conduct in the state of Washington.
• A national emergency medicine provider in qui tam litigation asserting claims based on alleged upcoding, use of medical scribes, and billing for midlevel practitioners.
• A skilled nursing facility provider in defense of qui tam litigation based on allegedly fraudulently inflated RUG scores.
• A large private equity firm in defense of a Department of Justice, Civil Frauds investigation of FCA liability arising from alleged conduct by a healthcare portfolio company.
• Jazz Pharmaceuticals in defense of qui tam litigation against the relator in the District of Massachusetts based on alleged fraud on the Patent & Trademark Office and FDA in connection with a particular method of use patent.
• Multiple molecular testing laboratories, in defense of FCA enforcement actions related to alleged violations of the “Medicare 14-Day Rule.”
• One of the largest clinical laboratory services companies in connection with qui tam suits brought in federal and state courts alleging payment of improper kickbacks and violation of state “usual and customary charge” requirements for Medicaid.
• A healthcare provider management services organization in a False Claims Act investigation related to the medical necessity of certain procedures for which the client provided oversight and billing services.
• Numerous pharmaceutical companies in DOJ False Claims Act investigations focused on promotional speaker programs.
• Incyte Corporation in a civil qui tam action, United States of America ex rel. Dillon v. Incyte Corporation, involving its charitable donations to patient assistance foundations. After an intensive DOJ investigation, the government declined to intervene in the qui tam action. The matter was resolved very favorably for the company without any admission of liability or a Corporate Integrity Agreement.Janssen Biotech in defending against False Claim Act claims based on allegations of fraud on the Patent Office in United States ex rel. Silbersher v. Janssen Biotech, Inc.
• Bayer Corporation in joint criminal and civil investigation by the U.S. Attorney’s Office for the Eastern District of New York and Main Justice’s Consumer Protection Branch and Civil Fraud Section regarding the alleged off-label promotion of pharmaceutical products. Government declined to proceed with enforcement action and persuaded relator to dismiss the qui tam complaint.
• A pharmacy provider in connection with a DOJ False Claims Act investigation related to alleged violations of the AKS in connection with the provision of patient financial hardship waivers and other billing issues and in connection with the pharmacy’s adherence programs funded by pharmaceutical manufacturers.
• United States ex rel. Proctor v. Safeway, Inc. and U.S. ex rel. Schutte v. SuperValu, Inc., Nos. 21-1326, 22-111 (S. Ct.) – representation of pharmacy respondents in the Supreme Court to resolve the question whether and when a defendant’s contemporaneous subjective understanding or beliefs about the lawfulness of its conduct are relevant to whether it ‘knowingly’ violated the False Claims Act.
• Kimberly-Clark in civil qui tam actions filed in California, Texas, and Georgia in which the relator alleges that Kimberly-Clark’s surgical gowns and other healthcare products did not meet industry standards. The DOJ has declined to intervene.
• Walgreens in two qui tam false claims act cases. One in the Central District of California alleges that Walgreens improperly delayed dispensing “time-sensitive” medications. The matter in the Eastern District of Pennsylvania involves allegations that Walgreens dispensed drugs that did not comply with certain package safety requirements.
• Bayer Corporation in a qui tam lawsuit in which the court dismissed the relator’s second amended complaint with prejudice for failure to plead fraud with particularity.
• Ista Pharmaceuticals, Inc. in criminal and civil qui tam investigations involving off-label promotion and kickbacks brought by DOJ’s Consumer Protection Branch and Civil Fraud Section and the U.S. Attorney’s Office for the Western District of New York.
• Bayer Corporation in a qui tam lawsuit in which the court dismissed the relator’s complaint under the False Claims Act with prejudice, agreeing with Sidley that the complaint was based upon publicly disclosed information and relator — a corporation formed for the sole purpose of filing this lawsuit — was not an original source of the information.

Government Contractors

• Laureate Education, Inc., one of the world’s largest higher education institutions, in connection with a qui tam action, United States of America ex rel. Sawyer and Kosicek v. Walden University LLC and Laureate Education, Inc. After an extensive internal investigation and considerable engagement with the DOJ, successfully convinced DOJ to decline to intervene in the qui tam action, and the relators subsequently dismissed the case.
• A major defense contractor in a FCA case involving allegations of fraud related to a weather satellite program. Following the government’s declination, the court dismissed the case with prejudice based on the public disclosure bar.
• A professional services firm, KPMG, in a qui tam action alleging that several government contractors presented claims for payment for travel expenses, which did not reflect volume-based vendor commissions, rebates and incentive payments.
• A government contractor in a Department of Justice investigation stemming from a qui tam case alleging that a GSA schedule contractor intentionally violated the price reductions clause.
• An aluminum manufacturing company in a civil qui tam investigation involving alleged non-conforming aluminum supplied for NASA’s and the Department of Defense’s rocket programs.

Sidley’s False Claims Act practice features lawyers who previously served in senior government posts, including an Acting Attorney General (and head of the Civil Division); a former Deputy Attorney General; a former Acting Chief Counsel of the FDA; a former Head of the FDA’s Special Prosecution Task Force; two former U.S. Attorneys and eight former Assistant U.S. Attorneys; a Special Assistant United States Attorney; a former Special Assistant to the Chief Counsel of the FDA Health Policy Advisor to the Senate Committee of Health, Education, Labor and Pensions; and four former Associate White House counsels.

We have worked with Main Justice and U.S. Attorneys’ Offices around the country and have extensive experience in historically active jurisdictions such as the Eastern District of Pennsylvania and the District of Massachusetts, as well as jurisdictions that have more recently become active in the FCA space, such as the Eastern District of New York, the District of New Jersey, the Central District of California, the Middle District of Florida, the Northern District of California, and scores of federal and state jurisdictions in between.