On September 2, 2022, the Department of Justice (DOJ) announced Bayer Corporation, and its related entities, Bayer HealthCare Pharmaceuticals Inc., Bayer HealthCare LLC and Bayer AG (collectively “Bayer”) agreed to pay $40 million to resolve alleged violations of the False Claims Act in connection with the drugs Trasylol, Avelox and Baycol.
The Settlement Agreement can be found here. According to the DOJ, the settlement arose from two whistleblower lawsuits. The cases are captioned United States ex rel. Simpson v. Bayer Corp. Civ. No. 05-cv-3895 (D.N.J.), and United States ex rel. Simpson v. Bayer Corp., Civ. No. 08-5758 (D.Minn).
The New Jersey lawsuit alleged Bayer paid kickbacks to hospitals and physicians to induce them to utilize Trasylol and Avelox, marketed these drugs for off-label uses that were not reasonable and necessary, and downplayed the safety risks of Trasylol. As of result of the alleged forgoing conduct, Bayer caused the submission of false claims to Medicare and Medicaid Programs.
The Minnesota lawsuit alleged Bayer knew about, but downplayed Baycol’s risks, misrepresented the efficacy of Baycol when compared to other statins, and fraudulently induced the Defense Logistics Agency to review certain contracts relating to Baycol.
The claims settled are allegations only, and there has been no admission of liability.