Vioxx Trial Could Set Precedent for Merck
Carol Ernst says Merck & Co. knew its pain reliever Vioxx was potentially deadly when it sold the drug to her husband, and today she is expected to become the first in a long line of plaintiffs to take the giant pharmaceutical company to trial.
Robert Ernst, an exercise fanatic who took Vioxx daily for chronic hand pain, died suddenly in his sleep four years ago. He was 59.
“I see a company that knew they had a problem with this medication long before they took it off the market,” said Carol Ernst, 60. “They were more concerned with being able to have a new blockbuster medication and weren’t concerned about patient safety at the time.”
Merck pulled Vioxx off the market in September after a clinical trial noted that patients who had been taking daily doses of the drug for more than 18 months had a greater chance of heart attack or stroke than those who hadn’t.
Vioxx was an enormous moneymaker for the company, which is based in Whitehouse Station, N.J. Worldwide sales in 2003 totaled $2.5 billion, with about 20 million patients taking it by the time sales of the drug were halted.
Merck, which has $16 billion in cash and equivalents, says it intends to fight every Vioxx case, including more than 3,800 individual plaintiffs and 118 potential class-action lawsuits pending in state and federal courts. On June 30, Texas Atty. Gen. Greg Abbott joined the line of litigants, alleging that Merck misrepresented Vioxx in a fraudulent scheme that cost the Texas Medicaid program $56 million in pharmacist reimbursements.
But Ernst -- barring a last-minute delay -- will be the first to go to trial.
A loss for Merck could encourage other plaintiffs. A win could put a damper on other suits.
“One case doesn’t mean that much, but because Ernst is the first case ... it will have significance,” said Barbara A. Ryan, an analyst at Deutsche Bank who follows the pharmaceutical industry. “And the market will also be able to judge Merck’s defense in this litigation.”
Early court battles are especially meaningful because defendants in medical product-liability cases are moving away from so-called global settlements that cover many plaintiffs, choosing to battle cases individually, said Deborah R. Hensler, a law professor at Stanford University.
So, from the start, Merck needs to discourage plaintiffs from pursuing their cases.
“They need to make the mass litigation go away,” Hensler said.
Merck’s legal team is headed by Gerry Lowry, a partner at Houston-based Fulbright & Jaworski. Lowry is familiar with the high stakes, high drama of pharmaceutical litigation. In 2003, she successfully defended Bayer in the first of thousands of cases the company faced from plaintiffs who alleged the cholesterol-lowering drug Baycol had harmed them.
Representing Ernst is Mark Lanier, an ordained Southern Baptist minister and plaintiff’s attorney best known for negotiating one of the largest asbestos settlements in U.S. history.
One key issue in the trial, observers say, is how soon Merck discovered risks of the drug.
At a May hearing before Congress, documents were released that showed the company did not include in sales packages any evidence from a 2000 study that showed Vioxx might increase a patient’s risk of heart problems. And Associated Press has reported that an internal document that surfaced in early stages of another Vioxx trial shows Merck researchers privately sought to reformulate the drug that same year to reduce its cardiovascular side effects.
“In my view, Merck made a conscious decision to kill a certain number of people for money,” Lanier said.
The plaintiff’s lawyer said he would focus on convincing jurors that Merck tried to hide problems with the drug -- arguing, for example, that a Merck executive traveled around the country threatening financial harm to doctors who asked questions about Vioxx.
But Merck lawyers say the company went public with evidence of a health problem as soon as possible.
“We’re going to present evidence that Merck acted responsibly,” said Jonathan Skidmore, a member of the defense team. “That they conducted clinical trials on almost 10,000 patients, that they monitored the drug once it was on the market and they then made a responsible decision to withdraw it.”
Another key issue in the case is Ernst’s cause of death. An autopsy concluded it was neither stroke nor cardiac arrest, the two events linked to Vioxx use. Instead, he was felled by cardiac arrhythmia.
“In short,” Lowry wrote in a motion filed June 27, “notwithstanding the volume of other Vioxx litigation and the publicity litigation has received, the facts of this case, no matter what angle one views them from, do not and cannot support a claim that Vioxx played a causative role.”
The cause of death is a problem for the plaintiff, said Mark Gergen, a law professor at the University of Texas in Austin. “Merck should not be liable, unless the plaintiff’s attorney could establish by credible evidence that there was some link between Vioxx and heart arrhythmia,” he said.
Lanier said he planned to do just that.
In addition to heart attack and stroke, “Vioxx causes arrhythmia,” he said. “I have documents to prove it -- memos and studies -- that I’m not allowed to release until I show them to the jury.”
Even that might not be enough, however. Beyond establishing that Vioxx created a risk, Lanier will have to convince a jury that it probably was a factor in one specific death: that of Robert Ernst.
“A real issue in these cases for the plaintiff’s attorney is that while there is significant evidence of a link between Vioxx and heightened risk of heart attack and strokes, at trial you have to demonstrate that this particular person’s injury was caused by taking this drug,” Hensler said.
Operating in favor of the plaintiffs is the site of the trial: Angleton, Texas, the seat of Brazoria County about 40 miles south of Houston.
Lanier was able to file the case in Brazoria County -- nearly 300 miles from the Ernst home near Dallas, where Merck’s Texas offices are based -- because he named a former Merck researcher as a co-defendant. Although the researcher later was dropped from the case, the move allowed Lanier to bring the case before jurors who are known nationally as “very sympathetic to victims,” Gergen said.
Lanier’s biggest win, the asbestos case, occurred in Brazoria County in 1998.
To further sharpen his edge, Lanier has retained jury consultant Robert Hirschhorn, who is best known for his work with defense teams in the 2003 Galveston, Texas, murder trial of real estate heir and millionaire Robert Durst, who was acquitted. He also helped the defense select jurors in the 1994 Branch Davidian trial in San Antonio, in which all of the defendants were acquitted of murder charges.
“The Brazoria County people are good, honest people,” Lanier said. Unlike counties “where the prevailing attitude seems to be to protect business at all costs ... they will not mind holding a company accountable.”
