Merck awaits verdict in first Vioxx trial

By Christopher Bowe
Tue Aug 16, 1:55 PM ET

It is now up to a Texas jury to weigh the evidence in the first trial considering whether Merck's withdrawn pain drug Vioxx caused the death of a patient. In closing arguments, attorneys for the US drugmaker and plaintiff Carol Ernst, a widow blaming Vioxx for the death of her husband, will make their final efforts to convince the jury.

Mrs Ernst and her attorney Mark Lanier claim Vioxx caused a heart attack that triggered an irregular heartbeat, or arrhythmia, and Robert Ernst's death in his sleep in 2001.

But Merck maintains Vioxx could not have caused Mr Ernst's arrhythmia, which, combined with clotting arteries, caused his heart to stop.

The verdict in the Brazoria County Courthouse, in the small town of Angleton, south of Houston, could help set the tone for further cases exploring Merck's liability over Vioxx. Merck potentially faces billions of dollars in claims from 4,000 lawsuits in the wake of the drug's withdrawal in September after finding increased risk of heart attacks and strokes after 18 months' use.

The plaintiff's case has crystallised around testimony from the coroner who examined Mr Ernst's body. Dr Maria Araneta testified she thought Mr Ernst's death from arrhythmia came after a heart attack.

However, Merck points out that Dr Araneta's report in 2001 cites Mr Ernst's cause of death as arrhythmia due to long-term hardening of the arteries. Merck's lawyers fought to keep her testimony out, and later tried to rebut her new theory. Dr Araneta said she was merely explaining her report further than she could at the time.

Legal experts watching the case say the weak part of the Ernst case is the nebulous link between Vioxx and Mr Ernst's arrhythmia. Moreover, Merck has used the coroner's written report as a foundation for its argument that the science does not back up the plaintiff's claim.

Forest Horne, trial attorney at Martin & Jones in Raleigh, North Carolina, says the issue of causation has not been neatly tied up, but the coroner's testimony has helped.

"One of the most important developments was the testimony of the coroner coming in," says Mr Horne, who has some Vioxx lawsuits that could go to trial in New Jersey early next year. "With the coroner testifying, I'm feeling better and better about it. But causation is still an issue."

Merck has repeatedly said science is on its side - that Vioxx could not be credibly shown as the cause of Mr Ernst's death.

In addition, it argues that Texas law requires the judge to instruct the jury that it must find Vioxx was a "substantial factor" in causing the death.

It argues that, contrary to Mr Lanier's statements to the jury, he must prove that Vioxx was more than just "a cause".

The trial, which has lasted five weeks, has featured Merck executives testifying live and via videotaped depositions, along with tearful testimony from Ms Ernst and her family.

In live testimony, Merck executives have attempted to show the company pursued rigorous science, and only pulled the drug when research conclusively showed new risks.

Using internal documents, emails and consumer advertising, Mr Lanier has challenged Merck executives over whether profit motives overruled the results of Vioxx clinical trial data - some of which showed a heart risk in 2001.

On the stand, Ms Ernst, 60, blamed herself for suggesting Vioxx for her athletic husband's joint pain after seeing television advertisements.

Timothy Anderson, analyst at Prudential Securities, estimates Merck faces an uphill battle, and shares might move by almost 10 per cent up or down depending on the outcome. "Our guess is that Merck has a greater chance than not of losing this case."

Mass tort litigation experts, such as Arvin Maskin, attorney at Weil, Gotshal & Manges, say one case will not make or break Merck's litigation liability. They say it must continue to fight to establish its scientific argument that Vioxx could not cause injuries purported in lawsuits.

But the verdict in Angleton is certain to be a milestone.