In 2007, the drug maker Merck agreed to a $4.85 billion settlement with the individuals who suffered heart attacks, strokes or other injuries associated with the use of Vioxx, as well as with the families of those who died as a result of using the drug. The makers of this defective drug have now settled their case with the U.S. Justice Department for their illegal marketing of an off-label use for the medication. Despite the heavy financial toll, the company was quick to point out that the settlements do not indicate an admission of liability or wrongdoing.
The civil and criminal penalties Merck was facing came from their marketing efforts with regards to Vioxx. Despite the fact that the FDA had not yet approved Vioxx for the treatment of rheumatoid arthritis, Merck actively marketed the drug for such use. The company ignored a warning letter from the FDA regarding their marketing efforts. This settlement comes at a critical time. Several large drug manufacturing companies are suing the FDA over the ban on marketing off-label uses for drugs.
The U.S. Food and Drug Administration approval process is meant to protect consumers from exposure to dangerous products. Drug makers are looking to take a shortcut to expand the markets for their products. The two issues are at odds and the public stands to lose if the drug companies have their way.
Dangerous drugs are still occasionally approved by the FDA. Any reduction in the level of scrutiny received by these drugs before approval is a threat to public safety. Consumers should watch carefully to ensure that their interests are protected going forward.
Source: The Wall Street Journal, “Merck to Pay $950 Million in Vioxx Settlement,” Peter Loftus and Brent Kendall, 23 November 2011