At the end of this past year, the Department of Justice announced a huge settlement it reached with Amgen Inc., one of the largest biotechnology companies in the United States. The settlement resolved accusations against Amgen regarding its sale and promotion of certain drugs.
The ten qui tam lawsuits against Amgen were filed in New York, Massachusetts, and Washington. The settlement resolves allegations that Amgen improperly promoted the sale and use of a drug called Aranesp. Aranesp is approved by the FDA for specific dosages and to treat very specific groups of patients suffering from anemia. Amgen allegedly promoted Aranesp for unapproved doses and unapproved anemia patient groups such as individuals suffering anemia caused by cancer, chronic disease, and myelodysplastic syndrome. The civil suits also accused Amgen of similarly promoting its drugs Enbrel and Neulasta. The suits further allege that Amgen reported inaccurate pricing information for many of its drugs.
In addition to the civil settlement, Amgen accepted a guilty plea for its criminal liability resulting from its promotion of Aranesp. The company will also pay $150 million in criminal penalties, bringing the total settlement to $762 million.
The overall settlement with Amgen is the single largest criminal and civil False Claims Act settlement involving a US biotech company. The investigation and settlement was a massive undertaking that involved numerous state and federal agencies. The attorneys at Tycko & Zavareei are proud of the collaborative effort the federal and state governments made in order to reach this settlement. Additionally, we commend the numerous whistleblowers in these cases for taking active steps to stop Amgen’s fraudulent activities.
For more information on this settlement, visit out website at www.fraudfighters.net.