Bayer Corporation, an Indiana corporation and manufacturer of pharmaceutical products, and its related entities, Bayer HealthCare Pharmaceuticals Inc., Bayer HealthCare LLC and Bayer AG (collectively “Bayer”), have 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 arose from two “whistleblower” lawsuits filed and pursued by Laurie Simpson, a former employee of Bayer who worked in its marketing department.
In a lawsuit filed in the District of New Jersey, Simpson alleged that Bayer paid kickbacks to hospitals and physicians to induce them to utilize the drugs Trasylol and Avelox, and also marketed these drugs for off-label uses that were not reasonable and necessary. Simpson further alleged that Bayer downplayed the safety risks of Trasylol. The lawsuit alleged that as a result of this conduct, Bayer caused the submission of false claims to the Medicare and Medicaid Programs and violated the laws of 20 states and the District of Columbia. Trasylol is a drug used to control bleeding in certain heart surgeries. Avelox is an antibiotic approved to treat certain strains of bacteria.
Simpson filed a second lawsuit relating to Bayer’s statin drug, Baycol, which was later transferred to the District of Minnesota. That lawsuit alleged that Bayer knew about, but downplayed, Baycol’s risks of causing rhabdomyolysis. The lawsuit further alleged that Bayer misrepresented the efficacy of Baycol when compared to other statins and fraudulently induced the Defense Logistics Agency to renew certain contracts relating to Baycol. Subsequently, Trasylol and Baycol were withdrawn from the market for safety reasons.
Under the terms of the settlement, Bayer will pay $38,860,555 to the United States and $1,139,445 to the 20 states and the District of Columbia.
The two actions resolved by the settlement were brought under the qui tam or whistleblower provisions of the False Claims Act, which permit private citizens to bring suit on behalf of the government for false claims and share in any recovery. The United States may intervene in the action or, as in this case, the whistleblower may proceed with the matter. Simpson will receive approximately $11 million from the proceeds of the settlement.