Vioxx® Recall And Injuries Lead To Thousands Of Patient Lawsuits
Many people depend on pain relief drugs to ease inflammation and discomfort. For patients suffering from arthritis, the chronic pain can be unbearable, making everyday tasks impossible—and they depend on medications stronger than over-the-counter remedies. However, one pain reliever that was found to do more harm than good put all of its users at risk—and research now shows that the company who made it was aware of the dangers.
Merck Denies Vioxx Heart Risks for Years, Increasing Patient Injuries
Vioxx is a non-steroidal anti-inflammatory drug (NSAID) that was approved by the U.S. Food and Drug Administration in 1999. While the medication is in the same class of drugs as ibuprofen and naproxen, it was intended for the relief of acute and chronic pain, such as arthritis symptoms and intense menstrual cramping.
Vioxx differs from other NSAIDs because it directly targets and suppresses COX-2, the enzyme in the body that is responsible for inflammation and pain. Doctors would often prescribe COX-2 inhibitors like Vioxx because they provided longer relief from symptoms than traditional NSAIDs. However, patients taking Vioxx and other COX-2 inhibitors soon found that the risks outweighed the benefits.
Evidence of the dangers of Vioxx was discovered almost immediately after its release. Just weeks after FDA approval, clinical trials uncovered a steep increase in the incidence of heart attacks in patients taking Vioxx compared to other NSAIDs. Research conducted by the drug’s creator, Merck, found that people on Vioxx® suffered four times the risk of heart problems as other patients.
Merck responded to criticism by refuting the data in the trial, claiming that the results were unreliable. When the FDA ruled to label Vioxx to warn patients of heart risks, Merck fought the decision, lobbying the FDA to remove the label. Merck and the FDA reached an agreement in 2002, and the label about the cardiovascular risks stood.
In the years that followed, independent studies reinforced the link between Vioxx and cardiovascular events, claiming that many patients suffered strokes, heart attacks, and blood clots within the first two weeks of taking the drug. In 2003, Merck performed a second study to test Vioxx’s effect on colon polyps and confirmed what other researchers has been saying for years: Vioxx was found to raise the risk of a heart attack in patients who had been taking it for under 12 months. Merck finally withdrew Vioxx from the market in 2004.
Merck Agrees to Pay Victims in Vioxx Recall Lawsuits
Lawsuits against Merck began soon after the official recall, with patients claiming they suffered serious cardiac events while Merck continued to profit. Over 60,000 separate U.S. claims were combined into a multi-district litigation (MDL) in New Orleans in 2005, with many more patients filing individual lawsuits against Merck. Estimates suggest that the company had made $200 million off of Vioxx alone in the U.S., and over $2 billion worldwide.
The lawsuits have made a number of claims against Merck, including failure to warn of known drug dangers and actively suppressing research results. At least one scientist has testified that that FDA officials repeatedly tried to block his findings against Vioxx, suggesting that both Merck and the FDA knew of and ignored the drug’s tendency to cause heart attacks.
In 2007, Merck agreed to settle 35,000 existing Vioxx claims without claiming liability for injuries or admitting any wrongdoing, paying $4.85 billion in damages. When the company was charged with a federal misdemeanor for its illegal and negligent marketing and sales of Vioxx, Merck plead guilty. In 2011, Merck was ordered to pay the federal government and state Medicaid agencies $950 million, including a $320 million criminal fine.