A giant biotechnology company pleaded guilty in December 2012 to a single charge of illegally marketing a drug for uses expressly denied by the U.S. Food and Drug Administration (FDA), thus increasing the risk to patients of medication errors. A years-long investigation by the federal government, reportedly assisted by some company employees, led to a single misdemeanor charge. The guilty plea includes a sizeable criminal fine and civil settlement. The judge presiding over the case has delayed his decision on approving the settlement agreement, although he denied a whistleblower’s challenge to the settlement.
The FDA approved the drug in question, Aranesp, in 2001 to treat anemia in patients undergoing kidney dialysis and for cancer patients undergoing chemotherapy. The drug’s manufacturer, Amgen, is reportedly the world’s largest biotechnology company. Sales representatives employed by Amgen began reporting concerns about the company’s marketing of Aranesp and other drugs to the Department of Health and Human Services, which launched an investigation as early as 2004. Employees wore recording devices during meetings with Amgen managers, which provided evidence that the company was offering doctors financial incentives to prescribe Aranesp over other drugs, and promoting the drug for off-label uses.
Amgen allegedly promoted the use of Aranesp in cancer patients who were not undergoing chemotherapy. At least one study, reportedly sponsored by Amgen, showed an increased risk of mortality for non-chemo cancer patients. The company also allegedly promoted administering Aranesp less frequently but in larger doses, after the FDA refused to approve the drug for such a use. This was supposedly to encourage doctors to use Aranesp over a competing drug. The company allegedly profited $85 million from the misbranded drug.
Federal prosecutors charged Amgen in the U.S. District Court for the Eastern District of New York with one misdemeanor count of introducing a misbranded drug into interstate commerce. By intending off-label uses for the drug, and encouraging doctors to do so, the company violated federal law and put patients at risk, according to the government. Amgen was also the subject of multiple civil lawsuits alleging false statements about Aranesp and other drugs.
The Department of Justice announced a guilty plea and settlement in the case on December 19, 2012. In addition to pleading guilty to the misdemeanor charge, Amgen agreed to pay a total of $762 million, the largest such settlement by a biotech company in American history. This amount includes $136 million in criminal fines, forfeiture of $14 million, and civil settlements of $612 million. The judge delayed a decision on whether to approve the settlement.
At least one whistleblower, a New Jersey doctor who assisted in the undercover investigation, declined to sign on to the settlement and tried to challenge it in court. Under the federal False Claims Act, whistleblowers are entitled to a portion of settlement proceeds, and the doctor was reportedly concerned that he did not receive information as to his allocation. Prosecutors called his request “wholly improper.” The judge denied the request without stating a reason.
The Maryland attorneys at Lebowitz & Mzhen can assist victims of medication errors, who have been injured by drugs prescribed, dispensed, or administered incorrectly. Contact us today online or at (800) 654-1949 for a free and confidential consultation to discuss your case.
Drug Details: Aranesp (PDF file), Drugs@FDA, U.S. Food and Drug Administration
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