In a lawsuit to be filed this week, the Physicians Committee for Responsible Medicine charges Merck wrongfully relied on animal tests showing Vioxx is safe, while setting aside evidence the painkiller increased the risk of heart attacks in humans.
Previously undisclosed Merck data are at the heart of the lawsuit, according to a statement by the nonprofit doctors group based in Washington, D.C. A Minneapolis woman who claims she developed congestive heart failure after taking Vioxx is also part of the lawsuit.
The physicians group, which has scheduled a news conference Thursday in Washington to discuss the complaint, declined to provide additional details yesterday.
The testing data cited by the Physicians Committee for Responsible Medicine are the latest in a series of company studies that have surfaced in recent weeks as part of an avalanche of lawsuits against Merck. The litigation accelerated last fall after the Whitehouse Station-based drug maker yanked Vioxx from the market over links to heart attacks and strokes.
The first case to go to trial got under way yesterday in Angleton, Texas, where about 120 potential jurors filled out questionnaires as part of the jury selection process.
The 19-page questionnaire includes more than 100 questions about health habits, favorite television shows and political leanings, among other topics.
The lawsuit is the first of more than 3,800 state and federal cases pending against Merck. Estimates of the drug maker’s potential liability range from $4 billion to $30 billion.
Merck claims the company acted responsibly, researching Vioxx’s safety in extensive clinical trials before it was approved by the Food and Drug Administration and monitoring the medicine after it went on the market in 1999. But thousands of plaintiffs allege otherwise.
The questionnaire in the Texas case asked jurors how much they agree with such statements as: “Corporate executives may lie under oath to protect the company’s profits and to increase salaries and bonuses,” and “I am sometimes outraged at the conduct of companies that make prescription medicines.”
The questionnaire also asked if potential jurors belonged to groups that support reducing, limiting or eliminating jury verdicts.
The case centers on the 2001 death of personal trainer and marathon runner R. Charles Ernst, 59. His widow, Carol Ernst, alleges her husband took Vioxx for about six months to ease pain and stiffness in his hip, and the drug caused him to die in his sleep of an arrhythmia, or irregular heartbeat.
Her lawyer, Mark Lanier, plans to argue Merck knew Vioxx could be lethal years before the company pulled the lucrative drug from the market.
Merck claims no studies link Vioxx to arrhythmia, and therefore Vioxx couldn’t have caused Robert Ernst’s death.
The jury pool is to return tomorrow for lawyers to question them, and opening statements were planned for Thursday, according to state District Judge Ben Hardin.
Lawyers are scheduled to spend today hashing out what expert testimony jurors will hear.
About 20 million people took the anti-inflammatory drug prescribed for arthritis and acute pain since it came on the market with great fanfare in 1999. In 2000, a study found some Vioxx users suffered five times as many heart attacks as users of the older painkiller naproxen, sold under the brand name Aleve.
In 2002, the FDA added warnings to Vioxx’s label. Follow-up research showed Vioxx doubled the risk of heart attack or stroke if taken for 18 months or longer, which prompted Merck to pull the drug.