The U.S. pharmaceutical company Merck, Sharp & Dohme will pay $1 billion for endangering patients through mismarketing of the painkiller Vioxx
Many individuals in California and around the country are harmed by pharmaceuticals every year. A pharmaceutical can harm a person for a variety of reasons. Some defective pharmaceuticals are inadequately tested before they go to market and other drugs work well for their intended uses, but then create problems when they are marketed for off-label uses.
The drugmaker Merck, Sharp & Dohme was recently fined by a Boston judge in connection with the off-label marketing of the painkiller rofecoxib, also known as Vioxx, which was pulled from the market in 2004. The company must pay $321,636,000 for promoting the drug for rheumatoid arthritis during a three-year period before it was approved by the Food and Drug Administration. This hefty fine follows a November 2011 civil agreement in which the company must pay $628,364,000 regarding misstatements concerning the drug's cardiovascular safety.
The judge in the Merck criminal case said that off-label marketing was a rampant problem in the pharmaceutical industry and that the hefty fines should act as a deterrent for companies that are considering marketing drugs for unapproved uses. Many of the government agencies involved with the case also view the judgment as a strong warning to U.S. pharmaceutical companies.
"If all pharmaceutical manufacturers complied with the law, there would be no need for law enforcement actions," said Susan Waddell, special agent in charge for the Office of Inspector General of the U.S. Department of Health and Human Services. "But until they stop abusing the health care system and putting profits ahead of patient safety, OIG will continue to vigorously pursue corporations that flout the law."
Stuart F. Delery, acting assistant attorney general for the Justice Department's Civil Division, said that his department is pleased with the action against Merck and that the combined $1 billion in civil and criminal fines against the company are appropriate given the company's decision to endanger patient safety.
"The United States will not tolerate unlawful conduct by pharmaceutical companies," Delery said. "As the court's sentence makes clear, those who put profits before patient safety by promoting their products for unapproved uses will be prosecuted and held accountable."