Vioxx Lawsuit Help

Vioxx Victims

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 wondering 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’s safety appears to never have been fully established, and Vioxx victims wonder how the drug was able to remain on the market for as long as it did. Launched in May 1999, Vioxx is part of a relatively new class of NSAID drugs (like aspirin and ibuprofen) called COX-2 inhibitors. The lure to allowing Vioxx onto the market was not because they were more effective than classic NSAIDs, but because they were less likely to cause bleeding and other digestive tract complications. Now Vioxx victims are wondering if an older NSAID drug would have been just as effective and a much safer treatment option than Vioxx.

The FDA initially required Merck to include the same digestive warning as NSAIDs. When Merck launched a trial comparing Vioxx to a traditional NSAID naproxen in hopes of proving its drug was safer on the digestive tract and should not have to carry the same warning, the trial backfired. The study to prove that Vioxx was associated to fewer digestive tract problems than naproxen was successful, but the study had an unexpected result. It showed that patients taking Vioxx had double the risk of cardiovascular problems compared to those taking naproxen. The Vioxx victims that are alleging cardiovascular events suffered were the result of Vioxx are now questioning Merck’s four and a half year delay from the study results to finally pulling the drug from the market.

Merck announced in its March 27, 2000 press release that “significantly fewer thromboembolic events (or heart attacks and strokes) were observed in patients taking naproxen,” trying to put a positive spin on the events. Peter Kim, president of Merck Research Laboratories, responded to allegations that Vioxx could have been pulled from the market several years earlier following these clinical trial results by saying he was not able to make a conclusion without including a placebo as a comparison. Even though Merck has emphatically defended its handling of Vioxx, Vioxx victims think the way Merck continued to argue until a month prior to the recall announcement that Vioxx did not cause cardiovascular problems but naproxen protected against them was side-stepping serious safety concerns for the sake of its lucrative blockbuster drug.

Merck’s claim that naproxen was protecting against cardiovascular problems was an argument never based on clinical studies, and the FDA , in September 2001 , ordered the company to send doctors a letter in order to clear up the misleading impressions and information. There are many questions why Merck, if dedicated to assuring patient safety, did not launch a study involving a placebo earlier to better determine safety concerns, especially since researchers continued to recommend against the use of Vioxx as more studies were performed. In addition, regulators and Vioxx victims are questioning why the FDA did not take a stronger stance when potentially deadly reports of Vioxx effects emerged and only sent a letter to Merck citing “misleading impressions and information” the agency believed the company was giving doctors.

The latest study leading up to Merck’s decision to pull Vioxx was intended to be a three-year study involving a 2,600-patient randomized trial to see whether Vioxx, like rival Celebrex, could claim it protects against the recurrence of colon polyps, which can become cancerous. Its second study to backfire, after 18 months Merck had to stop the trial early when researchers observed a higher heart attack and stroke risk in patients compared to a placebo. No longer able to divert blame, Merck’s announcement came as a shock to many Vioxx victims now wondering if the drug was to blame for their health maladies.

For more information on Vioxx, please contact us to confer with an attorney.

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