Autopsy central in Vioxx-Related Civil Trial

posted on:
July 26, 2005

author:
Staff

 Lawyers for Merck & Co. in the nation’s first Vioxx-related civil trial have repeatedly pointed to a Texas man’s autopsy as proof that he died of an irregular heartbeat rather than a heart attack and therefore the painkiller couldn’t be responsible. 

Mark Lanier, the lead attorney for the man’s widow, had planned to spring the physician who performed the autopsy as a surprise witness today to testify that a heart attack more than likely killed Robert Ernst, but he died too quickly for his heart to show damage.

Merck’s legal team managed to block her testimony at least temporarily with state District Judge Ben Hardin’s approval to depose Dr. Maria Araneta before she testifies.

The judge ruled late Monday that jurors would be released around midday Tuesday so lawyers could conduct the deposition, which Lanier said would be videotaped to show to the jury in case Araneta’s schedule prevents her from staying at the trial long enough to testify.

“She’ll tell the truth,” Lanier said late Monday. “They said they built (the) case around her not coming.”

Jonathan Skidmore, one of Merck’s lawyers, said the company’s legal team believes “the autopsy was conducted in a professional manner, and the reported results are scientifically correct. We are not worried about the testimony, but rules are rules, and the identification of expert or fact witnesses are required to be listed well before trial starts.”

The case centers on whether Robert Ernst died of an arrhythmia alone or one brought on by a heart attack that could have been caused by Vioxx. It is the first of more than 4,200 Vioxx-related lawsuits across the country to go before a jury.

Araneta’s testimony, Lanier said, would corroborate the plaintiff attorney’s contention that Ernst’s sudden death didn’t leave enough time for his heart to show evidence of a heart attack even though her autopsy report attributed his death to arrhythmia secondary to blocked arteries.

Lanier also points to Merck’s medical manual, which says arrhythmia in some form occurs in more than 90 percent of heart attack patients.

Merck pulled Vioxx from the market last year when a study showed the painkiller doubled risk of heart attack or stroke if taken for 18 months or longer. The company contends that no studies link Vioxx to arrhythmia, so the drug couldn’t have caused Ernst’s death.

Earlier Monday, a UCLA Medical Center cardiologist told jurors that he believed Vioxx contributed to Ernst’s death.

Asked by Lanier if he believed Vioxx was a significant contributing factor in Ernst’s heart attack or sudden cardiac death, Dr. Isaac Wiener replied, “I would call it sudden cardiac death, and I would answer yes.”

But under questioning by Merck lawyer David Kiernan, the doctor admitted he couldn’t be medically certain that Ernst had a genuine heart attack.

“I think the traditional ways of diagnosing myocardial infarction (heart attacks) do not apply in sudden cardiac death,” Wiener said. “If you have chest pain and die 10 minutes later, the autopsy will not show myocardial infarction.”

Ernst, 59, a marathon runner and part-time personal trainer who worked as a produce manager at a Wal-Mart, died in May 2001 after taking Vioxx for eight months to relieve pain in his hands. His widow, Carol, is the plaintiff in the case on trial in Angleton, about 40 miles south of Houston.

About 20 million people took Vioxx after its launch in 1999. Controversy emerged when a 2000 study found that some Vioxx users suffered five times as many heart attacks as people who used the older pain reliever naproxen.

At the time, Merck attributed the difference to Naproxen’s heart-friendly qualities rather than a defect in Vioxx. That claim garnered a rebuke from the U.S. Food and Drug Administration for making that assertion without scientific proof.

Dr. Nancy Santanello, head of Merck’s epidemiology department and the company’s representative at the trial, testified Monday that Merck responded to the rebuke by saying Vioxx could increase heart attacks or naproxen could decrease them, but clinical trials hadn’t established which view was right.

After two years of wrangling with the FDA, Merck added warnings about cardiovascular risks to Vioxx’s label in 2002.

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