Retrying Merck: The Once and Future Federal Vioxx Suits

JURIST Guest Columnist Carl Tobias of the University of Richmond School of Law says Merck faces new legal difficulties as a retrial of the first federal Vioxx case begins...



The retrial of the first federal Vioxx case begins Monday with jury selection. In December a jury deadlocked after deliberating for two days over whether Vioxx caused the death of Richard Irvin, a 53 year-old Florida man. This suit was closely watched, as it was the initial trial of some 4000 federal cases filed, which U.S. District Judge Eldon Fallon is handling, while Merck had lost the first, and won the second, trials among 5000 state court lawsuits.

Numerous observers - including media and counsel who attended the three trials and stock analysts - thought Merck would handily win the Irvin suit. First, drug companies, like other institutional defendants, enjoy greater success in federal court. Most federal judges are stricter than state judges about rejecting marginal evidence. Federal juries can also evince more solicitude for institutional defendants than state juries. Second, many observers believed the plaintiff had a rather weak case. Irvin took Vioxx for less than a month before his heart attack. Short-term usage suits are challenging because Merck argues that Vioxx can lead to heart attacks only after 18 months' use. The company also contended that Irvin experienced risk factors, namely somewhat older age and greater weight, which caused his heart attack.

Certain observers apparently saw the first federal trial as critical because the plaintiff won the initial, and Merck the second, state trials. However, ultimate winners and losers cannot be identified when 9000 more suits remain. Some reporters and Merck have described the federal mistrial as a draw. Because the verdict had to be unanimous and the jurors disagreed, a mistrial resulted. Early reports indicated the jurors were sharply divided on Merck's liability, but most later stated that jurors opposed liability 8-1, when a mistrial was declared.

On the day jury deliberations began, the New England Journal of Medicine (NEJM) editors published an "Expression of Concern" regarding a 2000 article which they printed on a major Vioxx study. The editors were concerned that the study authors had omitted crucial data showing three more Vioxx users had heart attacks. These assertions will be central to Irvin's retrial, and to later federal and state trials, many of which will proceed this spring. Merck has heavily relied on the study and its co-author as a lead witness in the three early trials. The "Expression of Concern" might also erode Merck's reputation and its witness's credibility. Plaintiffs' lawyers have vowed to exploit those apparent weaknesses in upcoming trials.

The Irvin trial, accordingly, seemed to be a tie. However, closer analysis suggests Merck is more vulnerable, given these credibility issues and the fact that the first three suits implicated short-term users, who have more difficulty proving Vioxx caused their harm. This spring, Judge Fallon's next few trials will involve longer-term usage, as will the next two New Jersey state trials before Judge Carol Higbee, who tried the second case and is managing 4000 Vioxx suits. The judges may be sequencing longer-term usage trials next to determine whether this will foster verdict patterns which prompt settlements. The jurists might think, and experience with analogous mass tort cases indicates, that this spring's trials could result in patterns which lead plaintiffs and Merck to settle.

In the end, the first federal Vioxx case's mistrial has yielded no definitive conclusions, but the future appears clearer. Merck must address the NEJM concerns, if it hopes to win the more difficult long-term usage suits. The stakes remain high and the outcome inconclusive.


Carl Tobias is the Williams Professor of Law at the University of Richmond
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