May 5, 2006

A newly published study that suggests an increased adverse event risk with the short-term use of Merck's arthritis drug Vioxx (rofecoxib) could cause a resurgence in lawsuits related to the medication, according to an attorney representing Vioxx users.

Lawyer Chris Placitella, a partner at Red Bank, N.J.-based firm Cohen, Placitella & Roth, noted that the Canadian Medical Association Journal study, which found that senior citizens taking the drug faced the highest risk of heart attack during their first two weeks of treatment, could lead to the reconsideration of lawsuits that were previously rejected.

"Prior to this research, we were fairly stringent about our cutoff-time for cases," he told FDAnews, noting that the firm generally handled the cases of patients who had taken Vioxx for two months or more. "But now, in light of this study, we want to go back and meet with our panel of experts. We've already spoken with several epidemiologists, toxicologists and cardiologists, who will be reviewing the specific protocols and results of several cases."

Placitella is currently handling approximately 1,000 Vioxx cases.

Led by researchers at McGill University in Montreal, the Canadian study suggested that Vioxx may have triggered early-onset cardiac events in particularly at-risk patients -- such as those with heart disease -- who would be more immediately sensitive to the medication. The observed decrease in the risk of heart attack over time, noted the study, "is presumably owing to the depletion of susceptible people." Further investigation of the drug was warranted, the study concluded.

The research, said Placitella, could prompt a widespread reexamination of Vioxx claims. "Just based on discussions with my colleagues and others who have handled Vioxx issues, this could open up the potential for new cases," he said. "It seems like everyone is in the process of reevaluating.

Vioxx was withdrawn in late 2004 amid concerns of increased stroke and heart attack risk. Merck currently has more than 9,600 Vioxx-related product liability lawsuits filed against it. To date, it has lost three of the cases and won three. (http://www.fdanews.com/did/5_89/)