Merck & Co. headed into the week having won five of the eight Vioxx® (rofecoxib) cases that have reached the courtroom. At week's end, the company was four-four following a federal jury's award of $51 million to a former FBI agent who suffered a heart attack after taking Vioxx for 33 months, and a New Jersey superior court decision tossing out Merck's win in the case of a man who had taken the drug for only a few weeks.

In the federal case, a New Orleans jury found in favor of a patient who is still relatively healthy and active but who had a heart attack after taking Vioxx for an extended period. The jury awarded Gerald Barnett $50 million in compensatory damages and $1 million in punitive damages. The jury concluded that Merck had failed to adequately warn Mr. Barnett's physician and to disclose the risks associated with Vioxx, and that the drug was a cause of the heart attack.¹

New Jersey superior court judge Carol E. Higbee cited the "Expression of Concern" published online December 8, 2005, by New England Journal of Medicine editors Gregory D. Curfman, MD, Stephen Morrissey, PhD, and Jeffrey M. Drazen, MD,² as part of her decision to vacate the state court decision of an Atlantic City jury who found in November of 2005 that the company was not liable in the case of Frederick "Mike" Humeston. That editorial focuses on data from the Vioxx Gastrointestinal Outcomes Research (VIGOR) study published in 2001 and information about three heart attacks in the VIGOR study subjects that occurred soon after the study closed and were not included in the first published report.²

Merck is expected to appeal both decisions. Vioxx litigation has become a major industry for tort lawyers who have filed an estimated 14,000 lawsuits against Merck. Although Merck attorneys stoutly maintain that the company will fight each case independently, outside observers expect that many will eventually be consolidated into settlement negotiations, and the monetary awards in these early cases will set the benchmark for settlement offers.

References

1. Tesoriero HW. Merck suffers Vioxx-case setbacks. Wall St Journal. Aug 18, 2006.
2. Curfman GD, Morrissey S, Drazen JM. Expression of Concern: Bombardier et al, "Comparison of Upper Gastrointestinal Toxicity of Rofecoxib and Naproxen in Patients with Rheumatoid Arthritis." N Engl J Med. 2000;343:1520-1528. Published at www.nejm.org on Dec 8, 2005 (10.1056/NEJMe058314).