A spokesperson of Merck Sharp & Dohme announced that the company agreed to plead guilty to one count of misbranding Vioxx. The unit of Merck & Co., the second-largest U.S. drug maker, plead guilty to a criminal misdemeanor charge as part of a $950 million settlement of a U.S. government probe of its illegal marketing of the painkiller Vioxx.
To resolve civil claims, stating that Merck Sharp & Dohme sold Vioxx for unapproved uses and made false statements about its cardiovascular safety, the company agreed to pay $628.3 million towards those claims, as well as a $321.6 million criminal fine. U.S. District Judge Patti Saris accepted the plea.
The company already settled thousands of lawsuits claiming injuries that totaled $4.85 billion and legal expenses worth $1.9 billion. In October 2010, it put aside $950 million for the criminal settlement that resulted in the claim.
As part of the plea, the company admitted to selling Vioxx for a period of three years to treat rheumatoid arthritis prior to approval from the FDA. The drug maker did not get permission to sell Vioxx for that ailment until April 2002. The FDA sent a warning letter on Sept. 17, 2001 in response to the company’s salespeople pushing Vioxx to physicians for rheumatoid arthritis.
Grand Jury Investigation
In March 2009, Federal prosecutors had recognized the company as a target of a grand jury investigation. The prosecutors inspected the company’s handling of internal research of Vioxx’s health risks and their marketing strategy in selling the drug starting in 2004, Merck stated.
Preceding to the agreement to create a $4.85 billion settlement fund in 2007, the company had 16 Vioxx lawsuits and won 11 of them. Court filings said the company settled to pay about $4 billion to resolve heart-attack claims and about $850 million for stroke suits.
The criminal case is U.S. v. Merck, Sharp & Dohme Corp., 11-CR-10384-PBS, U.S. District Court, District of Massachusetts.