Vioxx trial is high stakes for Merck

If drug maker loses, analysts say, it may face $20 billion in liability

09:31 PM CDT on Tuesday, August 16, 2005

By BRUCE NICHOLS / The Dallas Morning News

ANGLETON, Texas – The first Vioxx case to go to trial started modestly. Carol Ernst just wanted someone to take responsibility for the sudden death of her seemingly healthy husband, Bob, who took the painkiller for eight months.

As it heads to a jury today , the case has become more than that.

The future of Vioxx's maker, Merck & Co., one of the oldest and largest U.S. drug makers, is at stake. More than 4,000 similar lawsuits have been filed nationwide. If Merck loses this case, analysts say, claims could climb to 100,000, with Merck's potential liability reaching $20 billion.

Both the U.S. Food & Drug Administration, which licensed Vioxx in 1999, and the industry as a whole have been affected. The agency appears to be taking more care as a result of controversy surrounding Vioxx and such drugs as Fen Phen for dieting, Prozac for depression and Viagra for impotence. The industry has set more cautious advertising standards for itself.

Vioxx and other drug scares have shaken public confidence, said Ken Kaitin, director of the Center for the Study of Drug Development at Tufts University in Massachusetts.

"It gives more fuel to activists that claim that the FDA is not doing its job," he said, "and that the industry is only concerned with profits, is pushing unsafe drugs onto the market."

The trial has included eyebrow-raising evidence of aggressive marketing tactics by Merck, including keeping track of prescriptions that doctors write, coaching salesmen to avoid answering questions and confronting opinion leaders who expressed doubts about Vioxx.

But Merck has maintained throughout that it acted responsibly and on the basis of good science.

The basic facts of the Ernst case are fairly straightforward.

Robert Ernst was an active, athletic 59-year-old Wal-Mart produce manager. But he suffered hip pain and tendonitis in his hands. He'd been taking as many as 16 Advil daily when his doctor prescribed once-a-day Vioxx in late 2000.

One evening in May 2001, he returned from a run feeling ill. His wife later found him unconscious in bed. Ambulance workers in his hometown of Keene, southwest of Dallas, couldn't revive him. He was declared dead of an apparent heart attack at a hospital in Cleburne.

New Jersey-based Merck rolled out Vioxx with great fanfare in 1999, saying it was easier on the stomach than other painkillers. Ulcers and gastronintestinal bleeding are big problems for some pain patients, and a study showed that Vioxx reduced such incidents by half.

Another study, however, showed that Vioxx nearly doubled the risk of heart attack and stroke, and Merck voluntarily pulled the drug off the market last September.

Beyond the basic facts, things get fuzzier.

Mrs. Ernst blamed Vioxx for her husband's death, testifying that her loss was particularly poignant because the couple had met late in life and married 11 months before he died.

But she had a problem: The coroner's report blamed an irregular heartbeat due to hardening of the arteries – not a heart attack. No study ever linked Vioxx to arrhythmia.

Mrs. Ernst's lawyer, prominent Houston plaintiffs attorney Mark Lanier, tried to overcome the finding with experts, including the coroner who autopsied Mr. Ernst. They testified that arrhythmia could be caused by a heart attack that escapes detection in sudden death.

Merck witnesses dismissed the theory as a stretch, noting that a key artery in Mr. Ernst's heart was 75 percent blocked and asserting that he could have died anytime, with or without Vioxx.

Mrs. Ernst seemed on firmer ground with her contention that Merck failed to fully disclose problems with Vioxx before her husband died.

Merck's embarrassment: Documents and e-mails suggesting that Merck fought FDA regulators over how Vioxx's risks were worded on the label. One executive even called FDA officials "bastards."

Company witnesses said that the risk wasn't clear until late 2004.

Merck's aggressive marketing was successful. By the time Vioxx was withdrawn after five years, 80 million prescriptions had been written, and sales had reached $2.5 billion a year.

Success exposed Merck to greater potential liability. Millions used Vioxx. Heart attack and stroke are common. And because it's hard to prove what caused them, juries have a lot of latitude in casting blame. In Texas and most other states, all a plaintiff has to do to win at least a partial victory is to get a jury to say the defendant was partly responsible.

Much of the trial involved statistical testimony about seemingly small differences in risk.

For example, the study that forced Vioxx off the market showed that 3.5 percent of subjects taking it had a heart attack or stroke, compared with 1.9 percent of those taking a sugar pill. Merck said studies also showed patients had to take Vioxx for 18 months or more – 10 months longer than Mr. Ernst – to experience extra risk.

Mr. Lanier tried to lighten the load for a panel sprinkled with blue-collar workers. He drew diagrams and defined terms on a big easel pad, and he used electronic equipment to project his case on a large screen.

He picked Angleton for this fight by naming a local Vioxx researcher as a defendant, then dropping him before trial.

"It's a conservative county for jurors, but by the same token, they're tough on crime. You show them a company's done something really wrong, and they'll speak out," Mr. Lanier said.

Merck's lawyers probably chose to fight the Ernst case because of the questionable cause of death, analysts said.

"The one you pick to go to court is the one you think you have the best chance of winning," said Sidney Wolfe of the consumer group Public Citizen.

Mrs. Ernst, 60, a small, soft-spoken social worker, has sat in the front row throughout the trial, looking weary and amazed.

When she started, she said in an interview that money didn't matter. But she has struggled with deep depression. And paying the bills – especially medical bills – has become a concern.

"When I first started, I never thought that I would be in this position," she said. "I initially struggled with should I do this or not. ... My kids encouraged me to do it. 'If Bob were here, he'd tell you ... to take this on,' " she quoted them as saying.

A couple of factors probably worsened Merck's legal exposure, analysts said.

FDA rules changes in 1997 allowing more direct-to-consumer television advertising spread the harm beyond the population that really needed the drug, those with gastrointestinal issues, Dr. Kaitin said.

And Merck "triggered far more litigation" by pulling Vioxx off the market without being pushed by the FDA, said John Calfee, an American Enterprise Institute scholar who has studied the issue. Merck faces shareholder suits and potential criminal investigations.

Lawsuits are part of the problem, Dr. Calfee said, arguing that juries have trouble evaluating scientific evidence and that damage awards are often out of proportion to real harm, increasing drug costs.

Others see courts as the safety net under a flawed regulatory system. "Industry has in very dangerous ways taken over the FDA," argued Dr. Wolfe, citing 1992 legislation allowing drug companies to fund FDA drug studies to get quicker review as a key example.

Ironically, Vioxx may return to pharmacy shelves "unless the litigation takes a really bad turn," said Dr. Calfee.

The FDA has begun to suspect that more common over-the-counter medications of the same type also may increase cardiovascular risks.