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U.S. District Judge Eldon Fallon of the Eastern District of Louisiana recently declared a mistrial in the first federal Vioxx trial, the retrial of which will begin on Feb. 6. The jury had deliberated for 18 hours over whether Merck & Co.’s drug caused the death of Richard Irvin, a 53-year-old Florida man. This case was closely watched because it was the initial federal court trial of the approximately 3,000 federal suits filed and because Merck had lost the first, and won the second, state court trials among several thousand state suits. Many observers-including reporters and lawyers who watched the first trials and Wall Street analysts-believed that the large New Jersey pharmaceutical company would easily win the Irvin case. First, institutional defendants generally fare better in federal court. Daubert v. Merrell-Dow, the major U.S. Supreme Court case, requires federal district judges to operate as “gatekeepers,” deciding whether evidence has scientific validity and is appropriate for the particular case. Therefore, most federal judges admit evidence less readily than state judges. Federal juries may also be more solicitous of institutional defendants than state juries. Second, numerous observers thought that the plaintiff’s case in the first federal trial was relatively weak. Irvin, who died of a heart attack, had taken Vioxx for less than a month. Short-term usage cases are more difficult to win because Merck has maintained that Vioxx only poses risks of heart attacks after someone has taken the drug for 18 months. Merck also alleged that Irvin suffered risk factors, such as clogged arteries, relatively older age and higher weight, which contributed to his heart attack. Too soon for winners and losers Some observers considered the initial federal trial a “showdown” because the plaintiff won the first lawsuit tried in state court and Merck won the second state case. However, it was premature to declare winners and losers based on the initial three lawsuits when 6,000 additional cases remain to be decided. Because the Irvin verdict had to be unanimous and the jurors were deadlocked after 18 hours, the case ended in a mistrial. Certain members of the press and Merck have characterized the mistrial as a tie. Most reports now state that jurors opposed liability, 8-1, when Fallon declared a mistrial. Phil Beck, Merck’s lead trial counsel, simultaneously remarked that death cases are generally difficult for defendants like Merck to win. On Dec. 8, the day the Irvin jury began deliberations, the New England Journal of Medicine editors issued an “Expression of Concern” related to an article that it published on a major Vioxx study in 2000. The editors voiced concern that the study authors had deleted crucial data that suggested that three additional Vioxx users had experienced heart attacks. Plaintiffs’ counsel filed a motion for mistrial the next day; however, Fallon did not rule on that motion. The Vioxx study and the allegations respecting the data’s possible omission will be critical to the Irvin retrial, and to future trials, a number of which are scheduled for this spring. Merck relied heavily on the study and its co-author, Alise Reicin, as a major witness, in the first three trials. The Journal statement could also erode Merck’s reputation as a pharmaceutical company that would never jeopardize patient safety and the credibility of its lead witness. Plaintiffs’ counsel have already stated that they intend to exploit these perceived weaknesses strategically in future trials. Thus, the initial federal trial might seem to be a draw. However, closer scrutiny reveals that Merck’s situation is less favorable, given those credibility issues and the fact that Irvin and the first two cases involved short-term Vioxx users, who have greater difficulty proving Vioxx caused their harm. Fallon’s next several trials after the Irvin retrial, which are scheduled each month this spring, will involve longer-term usage. The next two New Jersey state trials, scheduled for late February, will concomitantly involve plaintiffs who took Vioxx for 18 months or longer and are before Judge Carol Higbee, who tried the second state case and is responsible for 2,000 Vioxx lawsuits. Fallon and Higbee are apparently sequencing longer-term usage trials next in an effort to ascertain whether this will yield verdict patterns that might encourage the parties to settle cases. In the final analysis, the mistrial of the initial federal Vioxx trial might be inconclusive. However, the future Vioxx litigation landscape is somewhat clearer. Merck must now persuasively respond to the Journal allegations regarding data omission if it hopes to defend successfully the more difficult long-term usage cases. The stakes continue to be high and the ultimate outcome remains uncertain. Carl Tobias is the Williams Professor at the University of Richmond School of Law.

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