What is Vioxx? It is a non-steroidal anti-inflammatory drug and a prescription painkiller that was first approved by the FDA for official use in 1999. Merck & Co. was the manufacturer of the drug but the drug was said to be mired in scandal. 80 million patients initially used the drug and had no idea that it was jeopardizing their health at all.
The Food and Drug Administration (FDA) has a duty to protect patients from defective drugs that make it onto the market. On September 30, 2004, the FDA issued a public health advisory on Vioxx and Merck finally withdrew the drug from the market after complications that had been arising for years. The risks? The data safety monitoring board that oversaw a long-term study of the drug came to the conclusion that there was an increased risk of serious cardiovascular events, which included heart attacks and strokes. FDA Commissioner Dr. Lester M. Crawford stated on the matter, “Although the risk that an individual patient would have a heart attack or stroke related to Vioxx is very small, the study that was halted suggests that, overall, patients taking the drug chronically face twice the risk of a heart attack compared to patients receiving a placebo.”
So much damage was caused to patients because of Vioxx that it was deemed one of the worst drug disasters in history. In 2004 by the time the drug was pulled from the markets, more than 38,000 deaths were related to its usage, and up to 25 million Americans had taken the drug. In the wake of the recall, many people believed that a scandal was afoot – they believed that New-Jersey based Merck and the FDA had actually worked together to keep the drug on the market and quiet the health concerns attached to it.
Merck And The FDA
Initially, it was said that Merck tried to convince the FDA that Vioxx was better than other NSAIDs because it caused few digestive tract problems. A study known as the Vioxx Gastrointestinal Outcomes Research study (VIGOR) determined digestive risks and was released by Merck even before the FDA approved the drug. However, though it showed that Vioxx was easier on the digestive system than other NSAIDs, it also revealed that it increased the risks of heart issues. Merck pestered the FDA to allow the drug to drop digestive warnings on its label; and, in February 2001, the FDA approved the request to change the drug’s label to say that it was safer on the stomach than other NSAIDs. However, during this time, the FDA ordered Merck to send doctors a letter explaining the drug’s immense heart risks.
Within a year of the drug being pulled off the shelves, lawsuits started to arise in America and overseas. Overall, more than 60,000 claims ended up being filed with a multidistrict litigation. Merck set up a $4.85 billion settlement fund and paid out nearly 35,000 of the claims taken against them. Again in 2011, Merck agreed to pay $950 million and pleaded guilty to a federal misdemeanor charge in relation to its shady marketing and sales tactics.
If you believe you are victim to a defective drug as a patient, you may have a case. Call Welebir Law today to see where you stand and get your questions answered in a timely manner.