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Mass Tort Update
First Vioxx Trial Verdict and Cases Challenge 18-Month Damage Claim
In May 2000, top research and marketing executives at pharmaceutical giant, Merck & Co., Inc., met to review ominous results from a clinical trial involving its blockbuster painkiller drug, Vioxx. They evaluated the credibility of the information that Merck received months earlier that signaled that Vioxx might pose a heart risk to its users. Its multi-billion dollar drug had only been on the market for two years, and the executives had to consider whether to conduct further studies to validate the troubling information.
Abdicating their responsibility to Vioxx consumers, the Merck executives rejected pursuing a study focused on Vioxx’s risks of cardiovascular events and strokes. Merck's marketers apparently feared such a study could send the wrong signal about the company's confidence in Vioxx, which already faced fierce competition from a rival drug, Celebrex. As reported in the national media, a slide prepared for the meeting read: "At present, there is no compelling marketing need for such a study. . . . The implied message is not favorable.
Over the next few years, Merck deflected scientific criticism of Vioxx’s safety profile by repeating the same mantra: that Vioxx was safe unless proven otherwise. But Merck's handling of Vioxx reveals that its neglect, soon after the drug's safety was questioned, forseeably resulted in one of the Nation’s worst public health disasters.
Despite knowing that its warnings were ineffective, and despite knowing that Vioxx may cause serious side effects, Merck concealed or downplayed the dangers associated with Vioxx. The company’s denial continued until, under pressure from the FDA and faced with the reality of a public health crisis of its own creation, Merck withdrew Vioxx from the market on September 30, 2004. Having let profits trump patient safety, Merck created a medical catastrophe that left an estimated 88,000 to 139,000 people dead or maimed from heart attacks, strokes and clotting disorders, according to FDA scientist David Graham. As a major editorial in Britain’s leading medical journal, concluded: “With Vioxx, Merck . . . acted out of a ruthless, short-sighted and irresponsible self-interest.”
On August 19, 2005, a jury in Angleton, Texas found that Merck’s conduct with respect to Vioxx was deceptive, fraudulent and punishable. The jury awarded $253.4 million in damages in the case of Ernst vs. Merck & Co. The final award, however, will not exceed $26.1 million due to Texas caps on punitive damages.
Robert Ernst, a marathon runner who died in his sleep at age 59, had taken Vioxx for fewer than seven months prior his death. In the precedent-setting trial, Mr. Ernst’s family lawyers claimed that Merck knew that patients suffered increased heart problems after taking Vioxx, yet deliberately withheld the information. Before the trial, drug giant Merck & Co. had maintained that Vioxx had nothing to do with Ernst’s death. It is believed that this verdict will make it more difficult for Merck to prove that heart damage in Vioxx users only occurs in patients who have taken the drug for more than 18 months.
During the trial, the Ernst family attorney presented internal Merck documents that indicated its own scientists were worried about the increased risk of heart attacks long before Merck withdrew Vioxx from the market in September 2004. A March 2000 communication between Merck & Co. scientists and the company’s patent department privately sought to have Vioxx reformulated with an anti-clotting agent to reduce the risk of heart problems and strokes. In 2001, Merck filed an application with the U.S. Patent Office for a new version of Vioxx that combined it with a Thromboxane inhibitor. Unfortunately, Merck eventually dropped the project and the patent.
In late August, lawyers met with hundreds of Vioxx patients to plan more cases against Merck & Co. Before the trial, more than 4,000 cases were pending. That number is expected to increase significantly as cases are filed on behalf of patients who used the drug for fewer than 18 months.
A Boise, Idaho postal worker’s case is scheduled for trial in September 2005. The postal worker had taken Vioxx for only two months prior to suffering a heart attack. Although he survived, he suffered permanent heart damage. The plaintiff blames Merck for the heart attack, but the drug giant contends that the man had blocked arteries. Merck had tried unsuccessfully to obtain a 45-day trial delay in this case, claiming that potential jurors would be biased as a result of the Texas trial.
In November, the first federal Vioxx case is slated to be heard. In that case, plaintiff Richard Irvin had only taken Vioxx for about a month before he died of a heart attack at age 53.
On August 26, 2005, Merck officials said that they will consider settling some Vioxx cases, specifically those where plaintiffs took the drug for at least 18 months and had low risks of cardiac problems.
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