At Midpoint of Vioxx Trial, Merck Looks Battered

posted on:
August 6, 2005

author:
Staff

 Ernst v. Merck, the first Vioxx-related lawsuit to come to trial, is not over yet. But as the company begins to present its case after 14 days of testimony from plaintiffs, Merck appears to be in a deep hole. 

It is always risky to handicap the outcome of a trial, of course. But Merck’s expert witnesses may face a challenge in trying to turn the case – especially since W. Mark Lanier, the lead lawyer for the plaintiffs, is known for his skill at cross-examination. He has had the benefit of presenting the personal, painful stories of family members left to grieve for the man whose death is at the center of the lawsuit. He is also armed with many of Merck’s own documents that showed the company was concerned about Vioxx’s safety several years before pulling the drug from the market.

Merck, meanwhile, is relying mainly on the testimony of company scientists, who have had a hard time coming across sympathetically under Mr. Lanier’s questioning.

On Friday, for example, Mr. Lanier staged a withering examination of Dr. Alan S. Nies, a retired Merck scientist who led the Vioxx development program in the 1990’s. The lawyer presented documents that appeared to show that Merck tried to rush federal approval for Vioxx because it feared that Celebrex, a competing drug by Pfizer, would get approval first.

As Mr. Lanier repeatedly presented documents that contradicted statements Dr. Nies had made earlier in the day on direct examination by a Merck lawyer, Dr. Nies appeared defensive and seemed to lose his temper. “We’ve been over this before,” he said at one point, as Mr. Lanier read from a document.

“I’m just reading this into the record,” Mr. Lanier replied.

“O.K., so go ahead and read,” Dr. Nies said.

Mr. Lanier later asked Dr. Nies about a contract proposal in which Merck had offered to pay researchers at Harvard $200,000 to lead a study that would have directly examined Vioxx’s heart risks. Dr. Nies said the study would have been unethical, which is why the study was ultimately scrapped.

“Before you say it was unethical, look who signed the contract,” Mr. Lanier said, showing Dr. Nies the signature. “It was you.”

Mr. Lanier represents the family of Robert Ernst, who died in his bed in May 2001 after taking Vioxx, a painkiller and arthritis medicine, for eight months. Merck stopped selling Vioxx last September after a clinical trial showed that Vioxx increased the risk of heart attacks and strokes. Mr. Ernst’s family is suing Merck in state district court in Brazoria County, Tex., alleging that Vioxx caused his death. Testimony in the trial began July 18.

After appearing to make tactical errors early in the trial by presenting evidence in a scattershot way, Mr. Lanier seemed to gain momentum before resting his case Thursday. Mr. Lanier and other lawyers for Mr. Ernst’s family looked increasingly confident late this week, while lawyers for Merck seemed grim.

A turning point in the trial may have come on July 27. That day, Mr. Lanier asked Dr. Nancy Santanello, a senior Merck scientist, about a card that Merck sales representatives used as an aid in 2000 and 2001 when they visited doctors’ offices to talk about Vioxx’s heart risks.

Mr. Lanier pressed Dr. Santanello to admit that the card overestimated the risks faced by patients taking placebos, or sugar pills, in some Merck clinical trials of Vioxx. Merck intended to make Vioxx’s risks seem smaller compared with the placebo, Mr. Lanier said.

In fact, the information on the card appears to have been largely accurate. But on the stand, Dr. Santanello could not explain the card, and she appeared rattled, enabling Mr. Lanier to cast doubt on her understanding of the details of the clinical trials that Merck used to judge Vioxx’s safety.

On July 28, Mr. Lanier won another important victory. Over Merck’s objections, Judge Ben Hardin, who is overseeing the case, allowed the plaintiffs to present a videotaped deposition of Dr. Maria M. Araneta, the coroner who conducted Mr. Ernst’s autopsy.

In her autopsy, Dr. Araneta had found that Mr. Ernst had died of an arrhythmia, or irregular heartbeat, caused by hardening of the coronary arteries. Clinical trials have not linked Vioxx to arrhythmias, and lawyers for Merck say that fact proves that Vioxx could not have caused Mr. Ernst’s death. Indeed, in his opening statement, David Kiernan, a lawyer for Merck, encouraged the jury to rely heavily on Dr. Araneta’s written autopsy report, since she was an unbiased source.

But in her deposition, which was played before the jury this past Monday, Dr. Araneta said she believed that Vioxx was probably responsible for Mr. Ernst’s death. She said Vioxx caused a blood clot that interrupted the flow of blood to his heart, producing an arrhythmia that killed Mr. Ernst so quickly that it did not produce the muscle damage characteristic of heart attacks.

Three other medical experts presented by Mr. Lanier have agreed with that theory, enabling the plaintiffs to neutralize the autopsy report, which both sides had expected to be the defense’s strongest card.

With the help of Dr. David Egilman, another of his expert witnesses, Mr. Lanier also clarified the chronology of Merck’s evolving knowledge of Vioxx and its risks. By presenting company documents and e-mail messages among top Merck scientists, Mr. Lanier has shown that Merck was concerned about Vioxx’s possible heart risks even before a 2000 clinical trial – called Vigor – showed Vioxx caused five times as many heart attacks as naproxen, an older painkiller.

Mr. Lanier also presented marketing materials from Merck that showed the company repeatedly played down Vioxx’s potential heart risks to doctors after the Vigor study was published. To explain the difference between the drugs, Merck would say it believed that naproxen had potent protective effects on the heart – even though other clinical trials had not found such a powerful benefit from naproxen.

To help the jury understand the chronology, Mr. Lanier last week presented a detailed time-line, a visual aid absent from his presentation during the first week of trial. He and Dr. Egilman also offered the jury a “key” that they said could explain why some Vioxx studies showed increased heart risks and others did not.

Merck has said that after the Vigor trial, it examined earlier clinical trials and found that Vioxx did not increase heart risks compared with a placebo. But Mr. Lanier argues that the earlier trials were too short and did not include enough people to provide accurate estimates of Vioxx’s risks.

Mr. Lanier closed his case by presenting testimony from Carol Ernst, Mr. Ernst’s widow, and Shawna Sherrill, Ms. Ernst’s daughter, to show that Mr. Ernst’s death had deeply depressed Ms. Ernst. The jury can award only limited financial damages for Mr. Ernst’s death, since he was a relatively low-paid produce manager at Wal-Mart at the time he died. But it can award unlimited damages for Ms. Ernst’s pain and suffering.

While the Ernst's were married for only a year, both Ms. Ernst and her daughter said the marriage had been the happiest period of her life and that she has not recovered from Mr. Ernst’s death.

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