Cardiologist testifies Vioxx contributed to Texas man's death

By The Associated Press
(7/26/05 - ANGLETON, TX) — A UCLA Medical Center cardiologist told jurors in the nation's first Vioxx-related civil trial Monday that he believed the painkiller contributed to a Texas man's death from arrhythmia.

Asked by plaintiff's lawyer Mark Lanier if he believed Vioxx was a significant contributing factor in Robert Ernst's 2001 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 lawyers for Vioxx producer Merck & Co., the doctor admitted he couldn't be medically certain that the man had a genuine heart attack. Wiener, a cardiologist and co-director of the Cardiac Arrhythmia Center at UCLA Medical Center in Los Angeles, was testifying for the plaintiff, who claims that Merck's once-lucrative painkiller caused the death of Ernst, 59.

Ernst, a marathon runner and part-time personal trainer who worked as a produce manager at a Wal-Mart, died of an arrhythmia, or irregular heartbeat. He had been taking Vioxx for eight months to relieve pain in his hands. The lawsuit by Ernst's widow, Carol Ernst, is the first of more than 4,200 Vioxx-related state and federal lawsuits to go before a jury. The New Jersey pharmaceutical giant pulled the drug from the market last year after a study showed it doubled risk of heart attack or stroke if taken for 18 months or more, but the company claims no studies link Vioxx to arrhythmia.

Last week Merck's lawyers presented evidence that the company studied whether Vioxx caused arrhythmias in nine clinical trials before the drug went on the market in 1999. They said the company found "no clinically meaningful differences" in patients who took the painkiller compared to those who took sugar pills or other anti-inflammatory pain relievers. But Lanier and Carol Ernst contend Robert Ernst died too quickly for his heart to show evidence of a heart attack. Lanier also points to Merck's medical manual, which says arrhythmia in some form occurs in more than 90 percent of heart attack patients.

Under questioning from Merck lawyer David Kiernan, Wiener conceded that he can't say with reasonable medical probability that Ernst had a bona fide heart attack. "I think the traditional ways of diagnosing myocardial infarction (heart attacks) do not apply in sudden cardiac death," he said. "If you have chest pain and die 10 minutes later, the autopsy will not show myocardial infarction." Merck lawyers have repeatedly pointed to Ernst's autopsy, performed by Dr. Maria Araneta, that says Ernst died of cardiac arrhythmia secondary to blocked arteries. Lanier intended for her to testify Tuesday that more than likely a heart attack killed Ernst, but his death was too sudden for the heart to show damage. "She'll tell the truth," Lanier said late Monday. "They said they built her case around her not coming."

However, her appearance in court would have been a surprise, so state District Judge Ben Hardin decided to let jurors go after half a day Tuesday so Merck's lawyers could question her first outside the jury's presence in a deposition. "We believe that the autopsy was conducted in a professional manner and the reported results are scientifically correct," said Jonathan Skidmore, one of Merck's lawyers. "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." Lanier alleges Merck knew Vioxx could be dangerous years before the company pulled the drug but minimized those concerns in favor of aggressive marketing for a multibillion-dollar seller. Merck's lawyers say the company disclosed studies on Vioxx and believed it was safe until results from the long-term study last year prompted them to pull the drug.

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 yet 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.