Testimony may Hurt Merck in Vioxx Trial

posted on:
July 28, 2005

author:
Staff

 The pathologist who performed the 2001 autopsy of a Texas man at the center of the nation’s first Vioxx-related civil trial may give testimony that could pose a challenge for the drug’s maker, Merck & Co. 

According to a transcript of a deposition obtained by The Associated Press, Dr. Maria Araneta told attorneys on both sides of the lawsuit that the arrhythmia or irregular heart beat that caused Robert Ernst’s death was probably brought on by a heart attack.

“Arrhythmia does not spontaneously occur. Something must trigger it,” Araneta said.

Merck has said Vioxx couldn’t have caused Ernst’s death because there is no evidence linking the drug to arrhythmias. Merck pulled Vioxx off the market last year after a study showed it doubled patients’ risk of heart attacks and strokes if taken longer than 18 months.

Araneta’s opinion supports plaintiff’s lawyer Mark Lanier’s contention that Ernst suffered a heart attack that killed him too fast to leave evidence of heart damage. He also has drawn jurors’ attention to Merck’s medical manual used by doctors across the country, which says arrhythmia in some form occurs in more than 90 percent of heart attack patients.

However, Araneta was not identified by name as a witness by the pretrial deadline, so Merck’s team balked at what they called her surprise appearance. State District Judge Ben Hardin allowed both sides to question Araneta privately on Tuesday, and scheduled a hearing later Thursday to address whether she will testify.

If the judge rules Araneta can testify, Lanier will decide whether to put her on the stand or have jurors watch her videotaped deposition.

Lanier’s legal team flew Araneta to Texas from Abu Dhabi, United Arab Emirates, over the weekend to testify in the first of more than 4,200 lawsuits across the country to go before a jury.

At the time of Ernst’s death, Araneta was an assistant coroner for the Johnson County Medical Examiner’s office who performed autopsies at Walls Regional Hospital in Cleburne near Fort Worth. Araneta said Ernst, whose widow, Carol, is the plaintiff in the case, probably had a heart attack because a blood clot blocked blood flow in an artery already clogged with plaque.

Araneta said that vigorous CPR conducted on Ernst _ including pounding on his chest that fractured some of his ribs _ probably dislodged the clot and his sudden death left no time for his heart to show damage, she said.

“Vigorous CPR could dislodge a clot. Also, the clot may be small. It doesn’t have to be a big clot to cause a myocardial infarction,” she said, using the medical term for heart attack.

However, Araneta also conceded that sudden cardiac death with clogged arteries can occur without a heart attack.

Araneta told Merck lawyer Joseph Piorkowski she didn’t see evidence of a heart attack, which isn’t unusual in sudden deaths.

She also told Piorkowski she didn’t get his e-mail sent before she traveled to Texas asking whether she had spoken to Lanier and if she would be a witness.

“My only conclusion is that it must have gone into my spam box,” she said.

Testimony Thursday came from Dr. David Egilman, a physician and professor at Brown University, who said Merck’s multiple Vioxx studies conducted before the drug was approved in 1999 were unreliable because they were too short and involved too few patients to produce solid data. Merck’s lawyers had yet to question him.

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