According to the Justice Department. Merck has agreed to pay $950 million and has pled guilty to a criminal charge over the marketing and sales of the painkiller Vioxx.
The negotiated settlement, was the result of a series of fraud cases brought by government prosecutors against major pharmaceutical companies.
Experts estimate that 25 million Americans had taken the Vioxx drug, from 1999 when it was approved by the Food and Drug Administration, to recall in 2004, because evidence showed that it increased cardiovascular risk.
According to the Justice Department, Merck agreed to pay a $321 million criminal fine and plead guilty to one misdemeanor count of illegally introducing a drug into interstate commerce. The charge was brought because Merck’s promotion of Vioxx to treat rheumatoid arthritis before the FDA approved it for that purpose in 2002.
Merck also agreed to pay $426 million fine to the federal government and $202 million fine to state Medicaid agencies. Those payments will settle civil claims that its illegal marketing caused doctors to prescribe and bill the government for Vioxx.
Generally physicians are allowed to prescribe drugs for any purpose they see fit, (off label prescribing), but drug companies are prohibited from marketing them for any uses except those that the FDA has determined are safe and beneficial.
Merck, recalled Vioxx from the market in more than 80 countries in 2004 after a clinical trial showed it doubled the risk of heart attack, stroke and death.
In 2007, Merck agreed to pay $4.85 billion to settle 27,000 lawsuits by people who had claimed they or their relatives had suffered injury or death after taking the drug.
No person was held liable for Merck’s conduct. According to pharmaceutical experts, this bad corporate behaviour is just a cost of doing business until a pharmaceutical executive does a perp walk.
Now fast forward to 2011. We have been locked in a battle with Bayer, over its YAZ, Yasmin and Ocella oral contraceptive pills. Similar allegations are being levelled against Bayer for its over marketing and promotion for the all types of pre-menstrual tension, when it was only approved for the worst type, pre-menstrual dysphoric disorder.
It was never approved for that by the FDA. Bayer had to spend $20 million in a fine for false and misleading advertising and re-do its ads. Now many plaintiffs are alleging and medical studies are revealing that Bayer's drugs have a higher risk profile for venous thromboembolism. Bayer hotly contestes this allegation. The first of many bellwether trials are scheduled to take place in January 2012.
