A federal court has sanctioned Merck & Co. Inc. with a $321.6 million fine for its improper off-label marketing of its drug Vioxx. This fine settles criminal charges and will be shared by the federal government and 44 states, including North Carolina. The pharmaceutical giant recently settled a civil case about Vioxx that resulted in sizeable damage awards. The total bill may reach as much as $1 billion.
The company agreed to the deal on April 19, just four months after entering a guilty plea to charges of violating the Food, Drug and Cosmetic Act. For such a complicated case, the basic charges were fairly straightforward: The government accused Merck of selling Vioxx as a misbranded drug in interstate commerce.
The Food and Drug Administration’s initial approval of the drug was based on its use as a pain killer. According to the court, Merck violated federal law when it promoted Vioxx as a treatment for rheumatoid arthritis before the FDA approved the drug for that purpose.
The off-label use was not the only issue with Vioxx, though. After its release, Vioxx was linked to an increased risk of heart attack and stroke. Merck pulled the drug from shelves in 2004.
In November 2011, a civil court ordered the company to pay $628.4 million in damages. Plaintiffs in that case accused Merck of making false statements about the drug’s safety as well as engaging in other off-label marketing activities.
Vioxx is just one high-profile case in the federal government’s efforts to stop drug companies from marketing their products for off-label uses. As in this case, companies face both criminal charges and civil actions.
Source: The National Law Journal, “Judge imposes $321.6M criminal fine against Merck over Vioxx off-label marketing,” Sheri Qualters, April 20, 2012