Baylor pathologist corroborates Merck in Vioxx case

By KRISTEN HAYS AP Business Writer August 7, 2005 ANGLETON, Texas-
The head pathologist at Baylor College of Medicine told jurors Monday in the nation's first Vioxx-related civil trial the once-popular painkiller could not have caused a Texas man's death and that clogged arteries made him a 'walking time bomb.' 'No, and I say that respectfully,' Dr. Thomas Wheeler said when asked by a Merck attorney if the drug caused Robert Ernst's death. The answer was a direct challenge to the plaintiff's theory that a Vioxx-induced heart attack led to the 59-year-old's fatal arrhythmia. Wheeler said blocked arteries led to the arrhythmia that killed Ernst, and that neither a heart attack nor a blood clot that could cause a heart attack were involved. 'He was like a walking time bomb,' Wheeler said. However, Ernst, a produce manager at a Wal-Mart, also ran marathons and taught aerobics classes and enough blood flowed to his heart during those activities, plaintiff's lawyer Mark Lanier noted on cross-examination.

"Many of these things (heart attacks) happen with a variety of stimuli," some of which are never detected, Wheeler said.

Whether Vioxx caused Ernst's death in 2001 is the crux of the case, the first of more than 4,200 Vioxx-related state and federal lawsuits against the New Jersey pharmaceutical company to go before a jury.

Wheeler's testimony contradicted that of Dr. Maria Araneta, the pathologist who performed Ernst's autopsy. While she conceded that her report attributed Ernst's death to arrhythmia secondary to blocked arteries, she said he more than likely died of a heart attack brought on by a blood clot. She also said Ernst died too suddenly for his heart to show damage, and a clot was likely dislodged during vigorous CPR.

Araneta didn't say whether she thought Vioxx caused the clot or heart attack, noting that she knew little of the drug in 2001, just two years after it went on the market.

Wheeler called Araneta's opinion on CPR dislodging the clot "a preposterous notion" with no scientific evidence to back it up.

"Knowing how thoroughly she examined those arteries, the fact that she didn't find a clot essentially rules it out," he said.

"Do we know in this case what caused the fatal arrhythmia?" Merck attorney Gerry Lowry asked.

"Yes, the severe atherosclerosis," Wheeler replied, using the medical term for blocked arteries.

Merck pulled Vioxx from the market in September when a study showed the once-popular painkiller doubled risk of heart attack or stroke if taken for 18 months or longer. Plaintiff Carol Ernst, Robert Ernst's wife, contends Merck knew years ago that Vioxx could be dangerous but minimized those concerns for profit.

Merck contends the company acted responsibly and disclosed research. Merck also claims no studies link Vioxx to arrhythmia, so the drug couldn't have caused Ernst's death.

Under cross-examination, Wheeler conceded that Merck's own medical manuals say arrhythmia occurs in more than 90 percent of heart attack patients. He also conceded that Merck's manual says about half of arrhythmia victims show no sign of a heart attack even though it often comes first.

But Wheeler insisted that a blood clot could not have formed in Ernst's arteries because the severe blockage had hardened too much to rupture and cause a clot.

"If you have a thrombus (or blood clot), you have a rupture, in the vast majority of cases," Wheeler said.

Merck has relied heavily on Araneta's autopsy report to corroborate its contention that no heart attack was involved.

In opening statements nearly a month ago, Merck lawyer David Kiernan praised Araneta's unbiased view, saying, "No one can argue that she was tainted by the influence of one side or the other." However, that was before she testified, and Merck lost efforts to block her appearance.

Two other state Vioxx cases in South Texas and New Jersey are slated for trial next month, and the first federal case will go to trial in New Orleans in late November. Merck has said it will defend each.