NOVEMBER 22, 2011-When a defective product has harmed so many people and cost so many lives, the settlement numbers are huge too. Now the U.S. Justice Department says it has settled its civil case with Merck, the pharmaceutical giant that aggressively marketed Vioxx (Rofecoxib) making it a blockbuster drug.
In a settlement announced Tuesday, November 22, by the U.S. Justice Department (here), Merck & Co. of Whitehouse Station, N.J., will plead guilty to charges it illegally promoted the drug and will pay $950 million to settle criminal and civil charges, reports the Wall Street Journal (here).
The criminal charge of illegal promotion, a misdemeanor, will go away under the $321.6 million portion of the settlement. The civil settlement will be resolved with a payment of $628.4 million to the U.S. and 43 states as well as the District of Columbia to settle off-label marketing and false statements downplaying the drug’s cardiovascular dangers. Litigation still remains to be heard in seven states.
Merck is alleged to have made false statements in marketing Vioxx off-label for rheumatoid arthritis before it had been approved for such use. Vioxx was approved in 1999 as a pain medication to treat arthritis but was not approved for rheumatoid arthritis until April 2002.
This $950 million is among the top five settlements in history.
Merck insists the settlement is not an admission of liability, however, Merck has also agreed to enter into an expansive corporate integrity agreement that requires top company officials to file compliance certificates annually and Merck to post payouts to physicians on its website.
In November 2007, Merck & Co. agreed to pay $4.85 billion to settle about 95% of the 27,000 outstanding personal product liability claims to avoid years of protracted litigation.
Merck did not admit fault and vowed to fight all claims filed after that date.
The bulk of the settlement, $4 billion, went to plaintiffs suffering from myocardial infarction or MI (heart attack), claims with $850 million to go toward the ischemic stroke patients. An estimated 20,000 patients took the pain reliever, also known as a Cox-2 inhibitor. Despite reports of devastating side effects including evidence Vioxx doubled the risk of heart attack and stroke, the blockbuster drug made Merck $2.5 billion annually before Merck stopped selling it on September 30, 2004.
The Death Toll
Shortly after Vioxx was pulled from the market during a hearing on Vioxx before the Senate Finance Committee, Dr. David Graham of the FDA’s Office of Drug Safety warned that Vioxx has been a disaster that’s contributed to more than 27,000 deaths from heart attack and sudden cardiac death between1999-2003. Dr. Graham, an outspoken critic of the FDA, told lawmakers the drug represents an unprecedented failure of our national drug approval system.
FDA Cannot Assure Safety
According to a New York Times article from November 2, 2007 here, the FDA cannot assure the safety of the drugs it approves because it inspects so few foreign drug and raw materials manufacturing plants which provide up to 80 percent of all ingredients used domestically. Drug manufacturing standards are so lax there is nothing to stop adulterated and counterfeit ingredients from making their way to the U.S., the newspaper reports.
In June 2010, the FDA issued a Safety Alert that certain lots of C.R. Bard/Davol surgical mesh, that may have been made overseas, were counterfeit (here) and the counterfeit samples were not sterile and did not have finished selvage edges which may allow the mesh to unravel.