This month, the Department of Justice (“DOJ”) announced that Shire Pharmaceuticals will pay $350 million to settle False Claims Act (“FCA”) allegations that Shire and the company it acquired in 2011, Advanced BioHealing (“ABH”), used kickbacks and other prohibited sales methods to compel hospitals, Doctors, and their firms to overuse its product “Dermagraft.”…
AstraZeneca and Cephalon have both reached settlements with the US Department of Justice (DOJ), totaling $54 million. AstraZeneca has agreed to pay the United States and participating states a total of $46.5 million with interest. Cephalon, which is now owned by Teva, has agreed to pay the United States and…
Inspire Pharmaceuticals, a specialty pharmaceutical company with its principal place of business in Lake Forest, Illinois, has reached a settlement agreement of $5.9 million with the US Department of Justice (DOJ). The settlement money will go to the United States and various state governments. According to the US District Attorney’s…
This week, Bristol-Myers Squibb Co. (“BMS”) and Otsuka America Pharmaceutical Inc. (“Otsuka”) asked a federal court judge in Ohio to dismiss a complaint filed against them by two relators that alleges that the pharmaceutical companies offered illegal kickbacks to physicians in order to induce them to promote off-label uses of…
The U.S. Department of Justice announced last week that Shire Pharmaceuticals LLC (“Shire”) has agreed to pay $56.5 million to settle allegations brought by several whistleblowers that it violated the False Claims Act. At issue was the Pennsylvania-based company’s improper marketing, promotion, and distribution of Adderall XR, Vyvanse, and Daytrana…
Pharmaceutical manufacturer Mallinckrodt LLC has agreed to pay $3.5 million to settle allegations that it made illegal payments to physicians to prescribe anti-depressants and sleep aids produced by the company. The improper payments allegedly created the submission of false claims to Medicare and Medicaid between January 2005 and June 2010…
The United States Department of Justice (“DOJ”) has intervened in two False Claims Act suits filed against the pharmaceutical giant Novartis, alleging the company paid unlawful kickbacks to physicians and pharmacies in violation of federal law. Novartis is the second-largest pharmaceutical company in the world by sales, the global headquarters…
Amgen, a California-based biotechnology company, has reached a settlement with the United States Department of Justice (DOJ), as a result of which the company will pay $24.9 million to resolve claims of Medicare and Medicaid fraud brought under the False Claims Act. The United States alleges that Amgen paid unlawful kickbacks…
A recent opinion handed down by a panel of the United States Court of Appeals for the Second Circuit in U.S. v. Caronia has raised serious questions about the constitutionality of criminal prosecutions for illegal promotion of drugs under the Federal Food, Drug, and Cosmetic Act (“FDCA”), a statute which many proponents…
Faced with allegations brought by the South Carolina Attorney General claiming that its drug Seroquel causes harmful side-effects and was promoted for off-label uses, AstraZeneca has abandoned a lawsuit against the South Carolina AG, agreeing instead to pay $26 million to resolve all of the state’s claims related to Seroquel.…