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The number of Vioxx lawsuits in response to the September 30, 2004 recall is not yet clear, but Merck & Co. has said it will create a reserve to cover potential legal costs related to Vioxx lawsuits filed by users with heart problems. When Vioxx was pulled off the market, two million Americans were taking the drug.
On September 30, 2004 the Vioxx recall was announced. The Vioxx recall decision was made after a new study found a higher rate of heart attacks and strokes in patients taking the drug than those on a placebo. The study was not the first indicator that Vioxx had major safety concerns.
Cases involving drugs causing side effects can be extremely difficult to prove. Up against powerful drug companies and having to prove without a doubt that the drug was responsible for the alleged health effect can be challenging. In the case of Vioxx, the drug was recalled because of the increased risk of heart attack and stroke, which can be suffered because of many various reasons.
Vioxx attorneys have seized an FDA warning letter dated September 17, 2001 that was sent to Merck Chief Executive Raymond Gilmartin.
Merck & Co. has estimated 20 million Americans have used its arthritis and pain-relief drug Vioxx during its stay on the market and is unsure how many people worldwide have used the popular drug. When Merck made the announcement September 30, 2004 that it was removing Vioxx from the shelves, a potentially high number of Vioxx victims were left wondering if adequate steps had been taken to ensure the safety of patients. In recent years, troubling events have left patients leery of the drug industry and if federal regulators are too passive in enforcing safety measures. The Vioxx recall is the latest event to bring focus and criticism on both the drug industry and the FDA, and Vioxx victims are determined to fight back.
Vioxx heart attack and stroke links have been made practically since Vioxx was first FDA approved, escalating especially in the recent years. The Vioxx safety concerns were evident in the lagging sales Merck & Co. experienced, though the blockbuster drug still reached sales of $2.5 billion in 2003 alone. For years, researchers have been warning about the Vioxx heart attack and stroke connection, but until the September 30, 2004 recall, Merck continued to argue they were unaware of significant risks.
FDA whistleblower creates more waves regarding Vioxx
Dr. David Graham, an FDA scientist and whistleblower, said he was firmly discouraged from publishing his data questioning the safety of Vioxx, which was recalled last September.
The paper suggested while Vioxx was on the market from 1999 to September 2004, it caused up to 140,000 serious injuries or deaths. A leading international medical journal, The Lancet, was supposed to publish Graham's paper on November 17, but has just released it online.