Merck Rests Defense in Vioxx Retrial

posted on:
February 16, 2006

author:
Staff

 NEW ORLEANS (AP)—Merck & Co. rested its defense Thursday in the first federal Vioxx case. Attorneys will give closing arguments Friday morning, U.S. District Judge Eldon Fallon told jurors. 

They will have to decide whether the once popular painkiller caused the heart attack that killed Richard “Dickie” Irvin in May 2001, whether it was defective or unreasonably dangerous, and whether the drug company concealed its dangers.

The final witness was Dr. Thomas M. Wheeler, head of Baylor College of Medicine’s pathology department, who also testified in the first trial, which ended with a hung jury in Houston.

He said Vioxx had nothing to do with the blood clot that caused Irvin’s heart attack. The clot formed after plaque ruptured in an artery, Wheeler said.

Before his testimony, Merck played a brief videotape of Irvin’s daughter, Alesha Schirmer, saying she found Vioxx samples in her father’s desk drawer after his funeral.

Her mother, Evelyn Irvin Plunkett, contends that her husband was active and healthy, and that taking the drug for a month caused the heart attack which killed Irvin.

Before Wheeler testified, plaintiff’s attorney Andy Birchfield used a big black, red and yellow chart labeled “Merck Knew But No Warning” to emphasize his points as he cross-examined Dr. Alise Reicin, the company’s vice president of clinical research.

He asked her about two studies in which patients taking Vioxx had more heart attacks than those in comparison groups, and about related events.

The New England Journal of Medicine criticized VIGOR’s authors in an editorial published online the day that the first jury began deliberations, saying they failed to mention three heart attacks among patients who were taking Vioxx.

Reicin said the company did report them to the FDA, but didn’t feel it had to tell the journal because they didn’t significantly change the results. With either set of figures, she said, rounding would have made the “relative risk” figure the same.

The figures reported to the journal were 17 heart attacks among patients on Vioxx and four among those taking another drug, called naproxen, or 4 1/4 times as many. The additional three changed that to 20, or five times as many.

Merck, saying that the difference was probably because naproxen kept blood clots from forming, framed it as a reduction in the likely risk. Rounding off made that the same in either case, Reicin said: “a fivefold difference.”

“And we highlighted those results in that paper,” she said.

In earlier videotaped testimony, the journal’s executive editor, Dr. Gregory Curfman, said the numeric difference was of great interest to the journal and its readers, and should have been reported to keep the article up to date.

“You withheld these three myocardial infarctions from the New England Journal of Medicine,” Birchfield said.

That was “mischaracterization,” Reicin said.

“You never gave it to them,” Birchfield said.

That was because the earlier analysis already showed a significant difference, Reicin said. “Had these changed the conclusions, I think we would have thought differently about it. But it didn’t change the conclusions.”

She also repeated Merck’s contention that it asked the FDA that year to approve a new label, but the approval process took two years.

A plaintiff’s expert testified earlier that a label’s warning can be strengthened without getting approval first from the FDA. Reicin said she wasn’t aware of that.

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