Merck (MRK) will pay $950 million to settle criminal and civil charges related to the improper promotion and marketing of the painkiller Vioxx. The U.S. Department of Justice say Merck will pay $321.6 million in criminal fines and $628.4 as part of a civil settlement. The company also pleaded guilty to a misdemeanor charge that it marketed Vioxx for off-label use. The Justice Department said the settlement resolves allegations that Merck made false, unproven, or misleading statements about Vioxx’s safety to increase sales and made false statements to Medicaid agencies about its safety. Merck said that the settlement clear its executive management from any implications that they were involved in the violations.
A federal judge thwarted Novartis’ (NVS) bid to overturn a verdict in which a jury decided the company failed to adequately warn patients that its Zometa and Aredia bone-strengthening drugs may cause severe bone damage. The ruling, made by U.S. District Court Judge James Beaty, was in regards to a 2010 lawsuit that awarded $12.8 million to Rita Fussman, who suffered jawbone damage while she had breast cancer. The punitive charges were later reduced to $1.3 million under North Carolina law. Novartis had hoped a new trial would find that the punitive damages were rewarded incorrectly, but Beaty noted that under North Carolina law, for a plaintiff to win punitive damages, a jury must be presented with clear and convincing evidence at trial. Beaty ruled that such evidence was, indeed, presented. “We are disappointed and disagree with the court’s decision,” Novartis told Pharmalot. “We are reviewing our appellate options.”
Three Synthes executives have been sentenced to serve jail time for their part in the unapproved testing of bone cement that left three people dead. In their haste to beat competitors to market Synthes executives circumvented the U.S. Food and Drug Administration by training selected surgeons in the off-label use of the bone cement. U.S. District Judge Legrome Davis called the officer’s conduct “egregious” and said they showed disregard for the sanctity of human life. He sentenced the former president and a former senior vice president to nine months in prison, while sentencing the director of regulatory and clinical affairs to five months in jail.
Bayer (BAYZF.PK) may be facing charges for seeking to market its Yasmin family of birth-control pills for unapproved uses, Bloomberg reported. As part of on-going lawsuits claiming that the drug caused injuries, e-mail messages and other internal company files were obtained by lawyers that suggested some Bayer officials discussed promoting its contraceptive drug, Yaz, for treatment of all types of premenstrual syndrome. Yaz had only been approved by the U.S. Food and Drug Administration for the most severe form of PMS. Attorneys for the women suing Bayer also allege that the company files show Berlex and Schering (Berlex is a subsidiary of Shering, which Bayer acquired in 2006) officials withheld some information from patients, doctors and regulators about the contraceptive drugs’ risk for blood-clots. Cases in which Yaz and Yasmin are alleged to have caused blood clots, heart attacks, and strokes will be heard starting in January 2012.
Boehringer Ingelheim received a precautionary recall order from the European Medicines Agency for three of its cancer drugs that were manufactured at its Ben Venue Laboratories facility. The recall of Busilvex, Velcade, and Vidaza comes just four days after Boehringer Ingelheim disclosed plans to “voluntarily and temporarily” suspend production and distribution at its Bedford, Ohio facility. The EMA recalled the drugs after a joint inspection by regulators from the EU and France, as well as the FDA. The inspection found several shortcomings in the quality-management system.
German drugmaker Merck KGaA has asked a New York judge to force Facebook. to produce information about an alleged takeover of its Facebook page by U.S.-based competitor Merck & Co. According to a filing in state court in New York, Merck KGaA has requested the information from Facebook so to consider a possible lawsuit for breach of contract or interference with business. According to the Germany based company, it had made an agreement with Facebook last year for exclusive use of the Web address www.facebook.com/merck but last month found that the page’s content was related to the U.S. based Merck & Co. An attorney for Merck KGaA attempted to resolve the matter with Facebook, but says the company didn’t receive a sufficient a response so it decided to file a lawsuit seeking to force Facebook to disclose the information.