Life Sciences and Health Care FCA: Investigations and Litigation

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FCA Litigation Victories

• Argued the seminal Executive Health Resources case in the Supreme Court concerning the scope of DOJ’s dismissal authority under the FCA after obtaining a DOJ dismissal and summary judgment in Eastern District of Pennsylvania, and Third Circuit affirmation. U.S. ex rel. Polansky v. Executive Health Resources, Inc. (SCOTUS No. 21-1052) (June 16, 2023).
• Represented McKesson in an FCA investigation and follow-on litigation premised on alleged AKS violations. After obtaining a declination from SDNY, obtained Second Circuit affirmance of relator’s failure to adequately plead scienter, and successfully opposed relator's cert petition. U.S. ex rel. Hart v. McKesson Corp. (2nd Circuit No. 23-726) (March 12, 2024).
• Represented Johnson & Johnson in obtaining Third Circuit affirmance of dismissal of FCA claims. U.S. ex rel. Bennett v. Bayer Corp., et al. (3^rd Circuit No. 24-1807) (April 10, 2025).
• Represented Roche in a multi-year DOJ investigation of FCA allegations premised on a fraudulent inducement theory of liability. After DOJ declined to intervene, the relator continued to litigate. DOJ ultimately filed a motion to dismiss, resulting in a voluntary dismissal. U.S. ex rel. Jefferson v. Roche Holding AG, et al. (D. Md. No. 14-cv-03665) (July 13, 2023).
• Represented Bayer in litigation alleging violations of the AKS related to nurse education and reimbursement support activities. After dismissal of federal claims, relator pursued claims pursuant to the New Jersey False Claims Act. We obtained dismissal, affirmed by the NJ Appellate Division. New Jersey ex rel. Health Choice Group LLC v. Bayer Corp. (NJ App. Div. No. A-2731-20) (March 1, 2024).
• Won motion to dismiss and Third Circuit affirmance for Genentech in False Claims Act lawsuit related to alleged FDA reporting issues. U.S. ex rel. Petratos v. Genentech, Inc., et al. (D.N.J. Oct. 29, 2015) (Third Circuit May 1, 2017).
• Represented Novartis Pharmaceutical Corporation in obtaining a declination of FCA allegations concerning alleged offer of discounts to influence formulary position; subsequently won a motion to dismiss federal and state false claims act action. U.S. ex rel. Perri v. Novartis Pharmaceuticals Corp. et al., No. 15-06547, 2019 U.S. Dist. LEXIS 28594 (D.N.J. Feb. 21, 2019).
• Related follow-on litigation examples: Represented Biogen (D. Mass.) and Avanir Pharmaceuticals (C.D. Cal.) in civil RICO litigation after DOJ resolutions, winning motions to dismiss in both cases; Represented Avanir Pharmaceuticals (N.D. Ohio) in litigation of False Claims Act retaliation claims, winning motion to dismiss; Won summary judgment for medical device manufacturer in qui tam action brought under California Insurance Frauds Prevention Act.

FCA Declinations

• Obtained a declination for a pharmaceutical manufacturer in an FCA case concerning alleged off-label promotion and kickback violations relating to speaker programs.
• Obtained a declination for a pharmaceutical manufacturer in an FCA case concerning alleged underfill of multi-dose vials.
• Obtained a declination for a pharmaceutical manufacturer in an FCA case concerning allegedly misleading statements to the FDA and related safety issues.
• Represented biopharmaceutical manufacturer in obtaining criminal and civil declination of investigation concerning alleged cGMP violations.
• Obtained a declination in an investigation of a leading national healthcare company concerning the company's discount practices and potential violations of the Anti-Kickback Statute and related violations of the FCA.
• Obtained a declination for a pharmaceutical manufacturer of an FCA investigation concerning alleged improper price reporting.
• Obtained a declination for a pharmaceutical manufacturer of an FCA investigation concerning alleged Anti-Kickback Statute violations.
• Obtained a declination for a leading national healthcare company in an investigation concerning alleged violations of the Anti-Kickback Statute relating to product overfill.
• Represented four pharmaceutical manufacturers in industry-wide FCA investigation concerning donations to independent charitable patient assistance foundations; none resulted in settlements or litigation.
• Represented pharmaceutical manufacturer in obtaining declination of FCA investigation premised on alleged Anti-Kickback Statute violations associated with reimbursement support services.

FCA Resolutions

• Represented a major pharmaceutical company in FCA settlement relating to alleged safety issues and FDA reporting (2025).
• Represented a major medical device company in FCA settlement relating to alleged regulatory violations with respect to certain devices (2025).
• Represented a Covid testing provider in resolving an FCA investigation related to the alleged submission of improper claims to the Covid 19 Uninsured Program (2025).
• Represented a compound ingredient supplier in FCA settlement concerning price reporting for its products (2024).
• Represented a specialty pharmaceutical company in resolving a civil and criminal investigation regarding free product provided to HCPs with a $100,000 civil-only settlement and no CIA (2023).
• Many other FCA resolutions for manufacturers and health care companies over the last 20 years, including some of the most complex and consequential matters.
• Represented pharmaceutical manufacturer in criminal and civil resolution of federal and state investigation of allegations of improper conduct with respect to speaker programs, off-label promotion, prior authorizations and protected health information.
• Represented pharmaceutical manufacturer in criminal resolution and FCA settlement in investigation concerning alleged AKS violations (speaker programs) and off-label promotion.
• Represented pharmaceutical manufacturer in FCA settlement relating to alleged AKS violations (speaker programs).