False Claims Act Litigation

Our work in this dynamic space is shaped by the following attributes:

• A Multidisciplinary, Industry-Integrated Approach. Sidley is uniquely positioned to manage the complexity of FCA litigation in the healthcare and life sciences industry. Our lawyers collaborate seamlessly with our destination healthcare and FDA regulatory teams, enabling us to assess issues holistically and develop cohesive strategies grounded in deep subject-matter knowledge.
  
  We also rely on a deep government enforcement bench that includes several former high-level government officials, including a former Assistant Attorney General and Deputy Assistant Attorney General for the Criminal Division of DOJ; former U.S. Attorneys and former Assistant U.S. Attorneys; a former Acting Chief Counsel of the FDA; and a former Head of the FDA’s Special Prosecution Task Force. Our team has excellent working relationships with the senior lawyers at DOJ handling these matters, including Sidley alumni.
• Litigation Excellence. Sidley brings decades of experience handling complex FCA disputes in every federal circuit and in state courts across the country. In these cases, we have dealt with virtually every legal issue that can arise — from constitutional issues to jurisdictional issues to pleadings issues, and the full array of substantive issues. Our clients have prevailed on the vast majority of dispositive motions we have filed.
  
  We also have a strong record defending companies in FCA matters brought under state and local statutes, where collaboration between DOJ, state attorneys general, and private relators is increasingly common. In addition, we regularly handle related litigation, including retaliation claims, exclusion and debarment proceedings, and overlapping product liability and securities matters.
• 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.

Representative Matters

• A major dialysis provider in connection with a government investigation of 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 a 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, United States of America ex rel. Siegel v. Novo Nordisk Inc., 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.
• 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.
• Novo Nordisk Inc. in qui tam litigation, United States of America ex rel. Daniel v. Novo Nordisk Inc., asserting FCA claims based on alleged off-label promotion and violations of the Anti-Kickback Statute in connection with the promotion of the company’s GLP-1 products.
• Envision Healthcare, a national emergency medicine provider, in qui tam litigation, United States ex rel. Hernandez v. Envision Healthcare, asserting claims based on alleged upcoding, use of medical scribes, and billing for midlevel practitioners.
• Kindred, a skilled nursing facility provider, in defense of qui tam litigation based on allegedly fraudulently inflated RUG scores.
• 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.
• 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, United States ex rel. Sorghi v. Jazz Pharmaceuticals, 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.
• Novo Nordisk Inc., in defense of a Department of Justice, Civil Frauds investigation and resolution of claims related to False Claims Act concerns arising from alleged failure to comply with an FDA-mandated REMS program, off-label promotion, and kickbacks.
• Numerous pharmaceutical companies in DOJ False Claims Act investigations focused on promotional speaker programs.
• 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.
• Pharmacies in United States ex rel. Proctor v. Safeway, Inc. and U.S. ex rel. Schutte v. SuperValu, Inc., Nos. 21-1326, 22-111 (S. Ct.), before 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.
• Represented Bayer Corporation in a qui tam action, United States of America ex rel. Simpson v. Bayer Corporation, et al., involving U.S. Department of Defense contracts and Bayer’s cholesterol-lowering drug Baycol. After an extensive investigation by DOJ, successfully convinced DOJ to decline to intervene in the matter.
• DaVita in connection with a government investigation of criminal and civil FCA claims related to the Company’s physician joint venture practices. Also in connection with that matter Sidley negotiated DaVita’s Corporate Integrity Agreement.