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. The blockbuster drug had been marketed in over 80 countries with worldwide sales in 2003 totaling $2.5 billion. Sold in the U.S. for more than five years, Merck was spending more than $100 million a year in direct-to-consumer advertising, while minimizing safety concerns up until a month before it decided to withdraw the drug.
Though many speculate the number of Vioxx lawsuits filed will not rival the more than 100,000 lawsuits that followed the massive fen phen diet drug recall in 1997, preliminary estimates issued by the Prudential Equity Group following the announcement of the Vioxx recall was that about 16,632 people may ultimately file a legitimate Vioxx lawsuit, though some have estimated this number to be significantly higher. More than 20 million people in the U.S. have taken Vioxx since its 1999 launch, and the clinical trial that was stopped short because of safety problems found people taking even the low dose of Vioxx, 25 milligrams, for more than 18 months were twice as likely to have a heart attack or stroke as patients taking a placebo.
Although lawsuits involving drugs in general can be difficult to prove, many people believe Vioxx lawsuits will involve a lot more internal evidence showing Merck was aware of the risks involved with the drug , but they continued to promote and put a spin on the events that did not give physicians or patients the whole picture. A September 17, 2001 warning letter the FDA sent to Merck Chief Executive Raymond Gilmartin is expected to be used to help win Vioxx lawsuits filed against the drug giant. The eight-page letter included the agency saying that Merck had engaged in “a promotional campaign for Vioxx that minimized the potentially serious cardiovascular findings that were observed” in a clinical trial comparing Vioxx to naproxen.
Despite finding Vioxx caused more cardiovascular problems when compared to naproxen in 2000, Merck continued to argue the results were actually that naproxen protected against cardiovascular events, which Vioxx lawsuits are expected to acknowledge. Considering previous clinical studies had never proven naproxen to protect the heart, the FDA letter scolded Merck for implying it had. The FDA letter, containing potentially damaging contents for Merck, has been seized and could become a major factor for the Vioxx lawsuits. The FDA chastis ed Merck for suggesting to physicians that the higher incidence of heart attack with Vioxx in the study was that naproxen has heart benefits and for failing “to disclose that your explanation is hypothetical, has not been demonstrated by substantial evidence.”
As of an October 1, 2004, Kaiser Daily Health Policy Report reported about 200 Vioxx lawsuits had already been filed, with more Vioxx lawsuits being filed everyday. The first Vioxx lawsuit set for trial is scheduled for December in a Birmingham, Alabama federal court. The Vioxx lawsuit is expected to receive a lot of media attention and scrutiny and could help determine the direction Vioxx lawsuits will unfold.