First Vioxx federal trial to focus on length of use

Merck lawyers declined to discuss the case, citing Fallon’s request that lawyers eschew public comments until a verdict is reached. The company’s court filings indicate Merck’s defense will center on whether Vioxx could be responsible for Irvin’s death when he took the painkiller for such a short time.

Ernst took Vioxx for eight months. Humeston took it intermittently for two months. Irvin took the drug for about a month, and Merck claims no studies show Vioxx can be lethal after such short-term use.

Plunkett counters that some of the 58 clinical trials involving 10,000 patients conducted before Vioxx went on the market in 1999 revealed it could trigger cardiovascular problems after a few weeks’ use.

Those studies were among several presented to jurors in the Ernst case. But Merck executives — several of whom are on Merck’s potential witness list for the Irvin case — testified that data from all the trials, evaluated in their entirety, showed the drug was safe and it won U.S. Food and Drug Administration approval.

Fallon ruled earlier this month that the six-member jury will slog through the scientific arguments.

Irvin’s health status will be a factor. His widow says he was in “very good health” when he began taking Vioxx, but Merck notes that he received a Vioxx prescription from his son-in-law — an emergency room physician — without a checkup.

Also, Irvin’s autopsy said he had moderate to severe clogged arteries, and a blood clot in a major coronary artery caused an irregular heartbeat and death.

Merck claims the clot formed when some of that plaque ruptured with no help from Vioxx. Plunkett alleges Vioxx — which inhibits an enzyme that promotes inflammation and thins the blood — led to the clot formation.

The trial will be the first of four overseen by Fallon. The next cases are slated for February, March and April, though the specific cases or trial dates have yet to be selected. Fallon told attorneys last month that when the fourth trial concludes, he will meet with them to explore a global settlement for all federal Vioxx litigation.

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