Much of Merck & Co.'s success in fighting lawsuits related to Vioxx has centered around the argument that the drug posed cardiovascular risks only to those who took it for 18 months or longer. Now plaintiffs' lawyers are salivating over evidence they hope could support their argument that even patients who used the painkiller for short periods were in danger.
In coming weeks The New England Journal of Medicine is expected to publish data from a study looking at Vioxx as a potential treatment for colon cancer. The clinical trial, which was halted when Vioxx came off the market in 2004, is expected to show that some patients suffered heart attacks within a year of starting the drug. "It has become clear from a variety of studies that there is increased risk with short-term use of the drug," says Thomas R. Kline, a member of the plaintiffs' steering committee for federal Vioxx litigation.
While Merck declined to comment on the study until it is published, its outside counsel, Ted Mayer, points out that some data from it already were presented at a medical meeting and had been used as fodder in courtroom debates. With 10 of 15 liability rulings having gone in Merck's favor, the company's lawyers remain confident of their ability to argue that it properly warned patients of the risk. "Looking at the totality of the data, you don't see support for a short-term effect," says Mayer. "We hope juries will put [the new study] in context."
As the debate continues, another potential source of pain may be lying in wait. On July 3 a U.S. district court judge in Louisiana paved the way for the release of Vioxx-related e-mails and other material that Merck had tried to keep out of the hands of plaintiffs' lawyers. "We're anxious to get ahold of these documents," says Kline. Merck plans to file objections to the ruling.