Vioxx is a nonsteroidal anti-inflammatory drug (NSAID) developed by Merck & Co. to treat osteoarthritis, acute pain conditions, and dysmenorrhoea. Vioxx was approved by the FDA in 1999 and prescribed to more than 80 million people worldwide before it was recalled in 2004 due to health concerns.
Merck withdrew Vioxx from the market in 2004 after a clinical trial proved that Vioxx increases the risks of heart attacks and strokes. However, the fact that Vioxx was not withdrawn sooner is troubling. According to Merck’s internal company documents, Merck’s scientists were concerned about the risks of Vioxx several years before the recall. In fact, a large clinical trial that ended in 2000 showed that Vioxx was much riskier than naproxen, an older painkiller sold under the name Aleve.
In 2007, three years after withdrawing Vioxx from the market, Merck agreed to pay $4.85 billion to settle 27,000 lawsuits by people who claim they or their family members suffered injuries or died after taking the drug. The settlement, which is one of the largest ever in civil litigation history, came after nearly 20 Vioxx personal injury trials took place. In the first trial, a jury ordered Merck to pay $253 million to the plaintiff, Carol Ernst, whose husband was taking Vioxx when he died of a heart attack in 2001.
In May 2008, Merck also agreed to pay $58 million as part of a multistate settlement of allegations that its ads for Vioxx deceptively played down the drug’s health risks. The deceptive advertising lawsuits were brought by several state attorney generals and accused Merck of failing to disclose to consumers that Vioxx posed an increased risk of heart attack. The settlement money, which will be distributed to 29 states and the District of Columbia, will most likely be put into state funds and be given to consumers. As a condition of the settlement, Merck must submit all new TV commercials for its drugs to the FDA for review before they can be aired.
In addition to litigation on behalf of individuals, self-funded health and welfare funds, including Bernstein, Liebhard LLP clients, are suing Merck under the New Jersey Consumer Fraud Act, alleging that Merck failed to disclose Vioxx’s safety, health risks and efficacy problems to the funds. Wall Street analysts estimate that Merck’s potential exposure to private insurance plans is upwards of $8 billion.