Autopsy central in Vioxx trial

07/26/2005 -Associated Press
Lawyers on both sides of the nation's first Vioxx-related civil trial on Tuesday deposed the coroner who autopsied a man who died of an irregular heartbeat eight months after beginning a regimen of Vioxx to ease pain in his hands. Dr. Maria Araneta is a crucial witness to the question of whether the once-popular painkiller caused Robert Ernst's death. Plaintiff's attorney Mark Lanier had planned to spring Araneta as a surprise witness Tuesday to testify that a heart attack more than likely killed Ernst, but he died too quickly for his heart to show damage.

Merck's legal team persuaded state District Judge Ben Hardin to postpone her testimony to question Araneta privately and away from the jury. The deposition was completed Tuesday afternoon, but Hardin had yet to decide what if any testimony she would present to the jury. Araneta, now a pathologist in the United Arab Emirates, was an assistant coroner in the Johnson County Medical Examiner's office when Ernst died in May 2001. She attributed his death to arrhythmia, or an irregular heartbeat, secondary to clogged arteries. Vioxx maker Merck & Co. has repeatedly pointed to that autopsy as proof that Vioxx couldn't have caused Ernst's death. The company pulled the multibillion-dollar seller from the market last year when a study showed it could double the risk of heart attack or stroke if taken for 18 months or longer. Merck contends no studies link Vioxx to arrhythmia. But Lanier said Araneta intended to testify that Ernst died too quickly for his heart to show damage and that he likely died of a heart attack.

Repeatedly during the nearly two-week-old trial, Lanier has pointed to Merck's medical manual, which says arrhythmia occurs in more than 90 percent of heart attack patients. Lanier did not have Araneta on a witness list by the pretrial deadline, and Merck's legal team held Lanier to that rule against springing such surprises in arguing for the deposition. Before jurors were dismissed Tuesday, Lanier injected a bit of theater as he continued questioning Dr. Nancy Santanello, Merck's top epidemiologist.

To illustrate his contention that Merck buried the U.S. Food and Drug Administration under Vioxx-related documents before the agency approved the drug in 1999, members of Lanier's legal team wheeled 157 boxes of papers into court. Santanello had already testified about summaries of Vioxx safety and other issues submitted to the FDA with all the other information. Merck lawyer Gerry Lowry had to ask that Lanier move some of the boxes because they blocked her view of the jury. Santanello said Merck sent the FDA the documents electronically, on three DVDs and one CD. "Yes, there's a lot of data, we do a lot of studies," she said.

Ernst, 59, a marathon runner and part-time personal trainer who worked as a produce manager at a Wal-Mart, died in his sleep next to his widow, Carol, the plaintiff in the case on trial in Angleton, about 40 miles south of Houston. The case is the first of more than 4,200 state and federal Vioxx-related lawsuits across the country to go before a jury. About 20 million people took Vioxx after its launch in 1999.