Skip to Content
Blog

Amgen to Pay $762 Million to Settle Whistleblower Suits

December 27, 2012

Last week, biotechnology giant Amgen agreed to pay some $762 million to resolve claims involving unlawful marketing of the anemia drug Aranesp. Federal prosecutors charged Amgen with illegally marketing Aranesp for unapproved uses even after the Food and Drug Administration (“FDA”) expressly ruled them out. The federal charges were made public as Amgen pleaded guilty to unlawful marketing of the drug. Physicians are permitted to use drugs for unapproved uses, but companies are not permitted to promote such uses. In recent years, the federal government has collected billions of dollars from drug companies for unlawful off-label marketing to physicians. Amgen agreed to pay $136 million in criminal fines, a forfeiture of $14 million, and to pay $612 million to resolve civil litigation stemming from a number of whistleblower suits.

Prosecutors asserted that Amgen had unlawfully promoted the use of Aranesp to treat anemia in cancer patients who were not undergoing chemotherapy, even though the drug’s approval was only for patients receiving chemotherapy. A study sponsored by Amgen showed that use of Aranesp by those non-chemotherapy cancer patients actually increased the risk of death. Amgen sought approval for use with non-chemotherapy patients, but the FDA rejected that request, reporting that Amgen’s studies were inadequate. Nonetheless, Amgen continued to promote the off-label use with physicians, relying on the same studies the FDA had deemed inadequate.

According to the federal investigation, Amgen sales representatives were trained to elicit questions from doctors about off-label uses as a way to initiate discussion and circumvent the prohibition on off-label use promotion. Those questions would provide the “necessary cover” for sales representatives to provide the doctor with studies supporting the off-label use, according to a document summarizing the charges against Amgen. The drug company also was able to list the unapproved uses in a reference called a compendium. The compendium system is intended to make drugs more easily available to cancer patients. Medicare is required to pay for off-label uses of cancer drugs listed in an approved compendium.

Aranesp was once Amgen’s biggest product, with sales of more than $4 billion per year. Sales have steadily declined since 2007 because studies have shown that high doses of the drug can lead to blood clots and the worsening of cancer.

Free Consultation
Martin & Jones, PLLC logo

“I would like to leave a testimonial thanking Steven and Allison for their care and understanding. Steven’s pursuit and success in getting some compensation for our loss. A final closure of our loss of brother Mike. Thanks to Martin & Jones for looking after Mike’s care since his injury in 2005. You have been there for Mike and his family for a long time. Mike passed in 2016 and you stood for the family up to the present (July 2017). Many thanks.”

Martin & Jones, PLLC. Badges
Martin & Jones, PLLC. Badges
Martin & Jones, PLLC. Badges
Martin & Jones, PLLC. Badges
Martin & Jones, PLLC. Badges
Martin & Jones, PLLC. Badges

Contact Our North Carolina Personal Injury Law Firm

for a Consultation for Your Accident or Medical Malpractice Claim

Call us at 800-662-1234
Free Consultation

The law firm you choose makes a difference. If you are the victim of an accident or an illness that someone else caused, the North Carolina personal injury law firm of Martin & Jones has the depth of experience, skills and sensitivity to make your road to recovery as smooth as possible. Whether you have experience with the legal system or have never hired a medical malpractice or personal injury lawyer before, our attorneys and staff will do our best to answer your questions, provide clear advice and prepare you and your family for what to expect. If you would like more information or to meet with one of our attorneys, please fill out the form below or call us at 800.662.1234.