The Department of Justice issued a press release on Friday, announcing that Bayer and related entities have agreed to pay $40 million to settle allegations that they violated the False Claims Act when they used kickbacks and made false statements regarding the drugs Trasylol, Avelox, and Baycol.
According to the press release, the lawsuit against the pharmaceutical giant was initially filed in New Jersey by Bayer’s former employee, Laurie Simpson. Simpson was reportedly employed by Bayer in their marketing department and 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.” Further, Bayer allegedly downplayed the risks of Trasylol.
Traysol is a drug that is intended to control bleeding throughout heart surgeries, while Avelox is an antibiotic with the intended use treating specific strains of bacteria, the press release said.
As a result of the defendant’s alleged misconduct, Simpson contends that false claims were submitted to both the Medicare and Medicaid Programs in violation of 20 state laws as well as District of Columbia law.
A second lawsuit, also filed by Simpson, alleged that Bayer was aware that their statin drug, Baycol, might cause rhabdomyolysis, but downplayed this risk to the general public. Simpson stated 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.”
Simpson brought the two suits under the whistleblower provision of the False Claims Act. The settlement, which was announced last Friday, details that Bayer will pay $38,860,555.00 to the United States and $1,139,445 to the 20 states and District of Columbia.
U.S. Attorney Philip R. Sellinger for the District of New Jersey explained that “this resolution should send a message to the pharmaceutical industry that such conduct undermines the integrity of federal health care programs and jeopardizes patient safety.”
