Update
Late in April 2010, the US Supreme Court decided that a class action lawsuit against pharmaceutical giant Merck can, finally, go to trial.
The suit was filed back in 2003 by Merck shareholders and investors. They claim they lost millions of dollars because Merck didn't give the public proper warnings about Vioxx before the drug was taken off the market. For years, Merck argued the suit wasn't filed in time and should have been thrown out.
Merck claimed the suit should have been filed within two years after problems with Vioxx were made public late in 2001. The shareholders and investors claimed they had two years to file the suit starting from the time they discovered, or with reasonable efforts should've discovered, wrongdoing by Merck.
The Supreme Court ended the debate and sided with the shareholders. Their two-year clock began to tick only when they actually knew, or reasonably should have known, of Merck's efforts to deceive, manipulate, or defraud the public and investors about the safety of Vioxx.
Original Article
What is Vioxx?
Vioxx® (rofecoxib) is a type of prescription pain medication known as a COX-2 selective nonsteroidal anti-inflammatory drug (NSAID) or a COX-2 inhibitor. Considered a "miracle drug" when it was first offered by the pharmaceutical giant Merck & Co., Vioxx® provided millions of sufferers relief from arthritis pain and inflammation without the stomach upset or other risks associated with aspirin, naproxen, or ibuprofen. It also made billions of dollars for Merck between its introduction in May 1999 and September 30, 2004, when the company voluntarily withdrew Vioxx® from the worldwide market.
Why was Vioxx Taken off the Market?
Merck announced that it was withdrawing Vioxx® from the marketplace when its own research showed that the drug increased the risk of heart attack and stroke in patients who took the drug for at least 18 months. Merck's three-year study, which was designed to find out whether Vioxx® would prevent polyps from forming in the colon, was abruptly halted when clinical trials showed that subjects who took Vioxx® for more than 18 months were at risk of suffering a heart attack or stroke--1.5% for the Vioxx® users, compared to 0.75% for subjects who were given a placebo.
Because of the cardiovascular risk connected with the sustained use of Vioxx®, Merck made the decision to withdraw the drug from the market. It did so without input from the U.S. Food and Drug Administration (FDA); although, the FDA followed Merck's September 30, 2004, announcement with a public health advisory of its own concerning the possible risks associated with Vioxx® use.
Because of Merck's voluntary withdrawal of the drug, Vioxx® is no longer available for prescription in the United States.
What Risks are Associated with Taking Vioxx?
Patients taking Vioxx® have suffered:
- Chest pains
- Heart attack
- Heart failure
- Blood clots
- Serious bleeding
- Strokes
- Death
Although the risk that an individual patient taking Vioxx® will suffer a serious health effect is small, there is no way to predict which patients can take the drug safely and which ones cannot.
Why is Merck Being Sued?
In the five years Vioxx® was on the market, Merck spent hundreds of millions of dollars on commercials and other direct advertising to convince consumers, particularly arthritis sufferers, to ask their doctors for the drug. By the time it was withdrawn, more than 20 million Americans had taken Vioxx® at least once. Because it was so popular and widely known, the withdrawal of the painkiller represented the largest prescription drug recall in history.
The Vioxx® withdrawal spawned allegations concerning how long Merck had known about the drug's potentially life-threatening side effects, and raised doubts about the benefits of COX-2 inhibitors in general. These drugs, which included Vioxx®, Celebrex®, and Bextra®, were supposed to provide powerful pain relief without damaging the stomach lining. But they cost as much as $2 to $3 per day, and many doctors felt that they were hyped far beyond their medical value.