WASHINGTON, DC, Dec. 19, 2012 -- Amgen Inc. has agreed to pay the federal government and numerous states a total of $762 million to settle a criminal fine and 10 whistleblower lawsuits, including one brought by Phillips & Cohen LLP.
The "qui tam" (whistleblower) lawsuits, which the government joined, alleged Amgen defrauded Medicare, Medicaid and other government healthcare programs by promoting "off-label" uses of Aranesp and other prescription drugs and paying kickbacks to doctors and other healthcare providers.
Phillips & Cohen LLP represents Tom Cantor, a San Diego businessman who alleged in his qui tam lawsuit that Amgen was giving financial inducements to doctors and other healthcare providers to convince them to prescribe Aranesp and Sensipar, two of Amgen's best-selling prescription drugs at the time.
Cantor's qui tam lawsuit against Amgen was filed "under seal" in 2004 in federal eastern district court in New York City. Today the court unsealed all of the whistleblower lawsuits, and the government announced the settlement.
Amgen's settlement covers allegations that the pharma giant engaged in off-label marketing and offered kickbacks to boost sales of six Amgen drugs: Aranesp, Enbrel, Epogen, Neulasta, Neupogen and Sensipar. The company also pleaded guilty to illegally introducing a misbranded drug, Aranesp, into interstate commerce -- a misdemeanor.
Kickbacks to those who make or influence healthcare decisions are illegal. The anti-kickback laws help ensure that treatment decisions are based solely on medical reasons, not financial benefits to prescribers.
"Off-label marketing" occurs when pharmaceutical companies market prescription drugs for uses that the U.S. Food and Drug Administration hasn't approved. Doctors, however, are free to prescribe to their patients whatever drugs they believe will help them.
Cantor also was responsible for exposing serious problems with a certain medical test kit manufactured by a subsidiary of Quest Diagnostics that was used to help determine treatment for dialysis patients. As a result of his qui tam lawsuit against Quest, the company stopped the manufacture and sale of the faulty test kits and paid the federal government $302 million in 2009 to settle the case.
Citation for the qui tam lawsuit filed by Phillips & Cohen: United States ex rel. Cantor v. Amgen, Inc., Civil Action No. CV-04-2511 (E.D.N.Y.)