U.S. District Court Judge Eldon Fallon on Tuesday ruled that plaintiff attorneys can present as evidence a videotaped deposition from a Cleveland Clinic Cardiologist who has criticized how Merck handled the market withdrawal of the COX-2 inhibitor Vioxx in the first federal lawsuit related to the medication, the Wall Street Journal reports (Won Tesoriero, Wall Street Journal, 11/30). Merck withdrew Vioxx from the market in September 2004 over safety concerns and faces more than 7,000 lawsuits related to the medication in state and federal courts (American Health Line, 11/29). In the federal trial, plaintiff Everlyn Irvan Plunkett alleges that Vioxx caused the death of her husband, Richard Irvin, who experienced a fatal heart attack in 2001 after he took the medication for one month.
According a transcript of the videotaped deposition obtained by the Journal, Eric Topol, chair of cardiovascular medicine at the Cleveland Clinic, testified that short-term use of Vioxx increases the risk for cardiovascular events. Merck maintains that the use of Vioxx for less than 18 months does not increase risk for cardiovascular events. Topol testified that the results of four randomized studies indicate, “at four to six weeks after the start of (Vioxx) compared to naproxen, there is an over two-fold risk of serious events.” In previous trials, Merck has argued that naproxen, an older pain medication, has cardioprotective properties that explain the higher rate of cardiovascular events among study participants who took Vioxx compared with those who took naproxen. In his testimony, Topol said, “There are no data that I am aware of “that indicates naproxen has cardioprotective properties. Topol in 2001 co-wrote a study in the Journal of the American Medical Association that found Vioxx could cause cardiovascular events and later criticized how Merck handled the market withdrawal of Vioxx in the New York Times and the New England Journal of Medicine. Topol said he that he could not comment on his deposition, which currently is sealed. Kent Jarrell, a spokesman for Merck’s attorneys, said, “We’ve been asked by the judge to refrain from talking about specifics of the trial as it unfolds, and we are going to comply with that.” Plaintiff attorney Thomas Kline said that the “deposition speaks for itself and speaks volumes” (Wall Street Journal, 11/30/2005)
Jury Selection, Opening Statements
Meanwhile, a jury was selected in the federal trial on Tuesday, and attorneys for both sides presented opening statements (Agovino, AP/Washington Post, 11/30/2005). The jury included four women and two men, as well as three male alternates (Belli, Houston Chronicle, 11/29). In his opening statement, plaintiff attorney Andy Birchfield said, “There was nothing that would have triggered a fatal heart attack” in Irvin other than Vioxx. Birchfield said that Merck was aware of safety concerns related to Vioxx before the launch of the medication and that the company made a “premeditated, financial decision” not to issue a warning to expedite FDA approval of the treatment (AP/Washington Post, 11/30). Merck attorney Phillip Beck said that Irvin was in his 50s and was a “little overweight” and the he “did not get enough cardiac exercise.” Beck added, “Mr. Irvin’s problem was not that he took Vioxx, but that he had coronary artery disease” (Freeley/Brubaker Calkins, Bloomberg/Philadelphia Inquirer, 11/30/2005). Later on Tuesday, Benedict Lucchesi – a professor of pharmacology at the University of Michigan who testified in the first two Vioxx lawsuits that reached trial – was called as the first witness (Wall Street Journal, 11/30/2005). “I believe that Vioxx can produce blood clots,” Lucchesi testified, adding, “I believe that Merck either was aware or should have been aware that this potential existed” (Houston Chronicle, 11/29/2005). NPR’s “Morning Edition” on Wednesday reported the “starkly different pictures” of Vioxx presented at the federal trial (Prakash, “Morning Edition,” NPR, 11/30).