ANGLETON, Tex., July 27 - A scientist for Merck acknowledged under pointed questioning on Wednesday that the company did not change its warning label on the painkiller Vioxx for two years after a study showed that it sharply increased the risk of heart attacks compared with an older drug.
In the first wrongful death case involving Vioxx to reach trial, the scientist, Dr. Nancy Santanello, also testified that Merck had persuaded regulators to move language describing Vioxx's potential heart risks to a less prominent position on the drug's label.
"At that time we felt there was not data to provide a warning," Dr. Santanello said in response to a question by the lawyer for the plaintiffs.
Meanwhile, the two sides moved closer to a crucial fight over whether a coroner, Dr. Maria M. Araneta, should be allowed to testify. Dr. Araneta carried out the autopsy of Robert Ernst, who died in his bed in May 2001 after taking Vioxx for eight months. Mr. Ernst's family contends that Vioxx caused his death and is suing Merck in a state court in Angleton, about 30 miles south of Houston.
In her autopsy of Mr. Ernst, Dr. Araneta found that he had died from an arrhythmia, or irregular heartbeat. Vioxx has never been shown to cause arrhythmias, and Merck's lawyers have made Dr. Araneta's autopsy report an important part of their defense. In his opening statement, David Kiernan, a lawyer for Merck, said that the jury should pay close attention to Dr. Araneta's autopsy because she was an unbiased observer who completed her report long before any lawsuit was filed.
But in a deposition conducted before the judge on Tuesday, Dr. Araneta said that she thought it was more likely than not that a heart attack caused Mr. Ernst's arrhythmia, according to people on both sides who heard her deposition.
W. Mark Lanier, the lawyer for Mr. Ernst's family, has repeatedly offered that theory to the jury. Mr. Lanier now wants to call Dr. Araneta as a witness, or have her deposition played before the jury, to support his theory.
But Merck argues that Dr. Araneta should not be allowed to testify because Mr. Lanier did not list her as a potential witness and did properly give notice to Merck's lawyers of his plans to call her.
"Her appearance is surprising, considering that she was not on the witness list as required under Texas rules," Jonathan Skidmore, a lawyer for Merck, said Wednesday. Mr. Skidmore also said that Dr. Araneta had testified in her deposition that she could not remember the autopsy.
Mr. Lanier acknowledged Wednesday that he had not specifically listed Dr. Araneta by name as a potential witness. He said, however, that his witness list included the coroner of Johnson County, Tex., a description that only Dr. Araneta could meet.
"I listed her as 'the coroner,' " Mr. Lanier said. "There was only one."
Further complicating matters, Merck itself listed Dr. Araneta by name as a potential witness, meaning that Mr. Lanier might have the right to call her as an "adverse witness," even though he actually wants her to testify while Merck does not.
Judge Ben Hardin, who is overseeing the trial, has not yet ruled on whether Dr. Araneta can testify because Mr. Lanier has not formally attempted to call her and probably will not do so until early next week. If Judge Hardin does allow her to testify, Merck may immediately appeal the ruling to a higher state court, possibly forcing the trial to stop while the higher court considers the issue, lawyers for both sides said.
The issue of Dr. Araneta's testimony is another twist in a trial that is shaping up to be longer and more complex than either side predicted. Before the trial began, Mr. Lanier said he expected to present about eight days of testimony. It now appears that his case will take longer.
The slow pace may be to Merck's advantage. But on Wednesday, Mr. Lanier appeared for the first time to seriously rattle Dr. Santanello, an epidemiologist with Merck, as he questioned her about the details of data about Vioxx's risks of causing heart attacks and strokes.
During Dr. Santanello's testimony Wednesday morning, Mr. Lanier suggested that Merck had overstated the rate of heart attacks and strokes suffered by patients taking placebos in several clinical trials. Dr. Santanello disputed his analysis but was unable to offer a detailed rebuttal, and she appeared shaken the rest of the day. Dr. Santanello concluded her testimony in the afternoon, after five and a half days on the stand.
On Thursday, Dr. David Egilman, a witness for Mr. Ernst's family, will resume his testimony.
