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TRENTON, N.J. (AP) – Soon after her heart attack in January 2004, longtime Vioxx user Elaine Doherty, 68, underwent a double heart bypass. The arthritic grandmother of seven still manages to baby-sit her daughter’s two school-age children, whose father was killed in the World Trade Center attacks.

But Doherty is suing drug maker Merck & Co., alleging its now-withdrawn painkiller caused her heart attack, leaving her with permanent heart muscle damage that makes her short of breath and fatigued.

Her case, which starts with jury selection today, is the seventh to come to trial out of more than 13,000 lawsuits filed so far. The trial will be the first since new Vioxx research results, recently disclosed by Merck, raised questions about how quickly the drug could cause harm, potentially undermining the credibility of Merck, which has vowed to fight every lawsuit individually.

The trial also is the first involving a female Vioxx user, and legal experts say she arguably is the most sympathetic plaintiff Whitehouse Station, N.J.-based Merck has had to battle.

“Of all the cases that have been tried, it’s by far the most compelling,” said plaintiff’s attorney David Berg, author of “The Trial Lawyer: What It Takes to Win.” “This has the potential to be the game breaker for Merck’s strategy (of fighting each suit), along with the latest data.”

In the past three weeks, Merck has twice released follow-up data from the clinical study that led it to pull Vioxx off the market on Sept. 30, 2004. This week, the company said its first published report on that study, called APPROVe, mislabeled a statistical method used to determine whether the cardiac risks to Vioxx users changed over time.

Merck officials insist that error didn’t affect any results and that all the data support its stand – the heart of its legal strategy – that Vioxx didn’t increase any risks until patients had taken it for at least 18 months.

However, numerous independent doctors say the new data appears to indicate that risk of heart attack and stroke began rising with just four months of Vioxx use and persisted for at least a year after patients stopped taking the popular arthritis pill. The number of heart attacks and strokes suffered by patients in the study was small enough that chance could have caused more of those complications in the Vioxx users than in those taking dummy pills.

But some doctors say it doesn’t make sense that risk would suddenly begin at 18 months.

Juries haven’t bought that argument, either, in two of the three trials Merck lost. Those cases, in plaintiff-friendly Texas courts, involved men who died of heart attacks after taking Vioxx briefly, one for a month and one for eight months, but brought jury awards totaling $285 million. Both will be slashed dramatically because of Texas caps on punitive damages.

“That 18-month defense failed in those cases and theoretically might be tougher now,” with plaintiff lawyers latching onto the new APPROVe data, said pharmaceuticals analyst Barbara Ryan of Deutsche Bank North America, which owns some Merck stock.

Ryan and other experts said the new data on how quickly Vioxx raised risk might have a big impact on cases of short-term Vioxx users but doesn’t apply directly to the Doherty trial.

That’s because the Lawrenceville homemaker had been taking Vioxx daily for arthritis in her hands and knees for 2½ years before her heart attack. She kept taking it for another eight months, until Merck halted sales.

Doherty attorney Michael Galpern said he’ll bring in the new data anyway.

“It debases Merck’s stock defense that you needed to be on the drug 18 months before you had increased risk,” he said, and the “high-school level statistical error” Merck just disclosed undercuts its credibility.

Merck’s legal team includes Baltimore lawyer Paul Strain and will be led by Diane Sullivan, who helped the company win its first Vioxx trial in New Jersey last November, despite several high-volume confrontations with State Superior Court Judge Carol E. Higbee. Higbee, a former medical malpractice attorney, is handling all the Vioxx lawsuits filed in New Jersey, about 6,435 as of Wednesday.

Most of the scientific data and testimony will echo what’s been hashed out in the previous six trials. Likewise, Merck again plans to argue the plaintiff’s risk factors – mainly high blood pressure, high cholesterol and mild diabetes – caused her heart attack, not Vioxx, according to Jim Fitzpatrick, a spokesman and lawyer for Merck.

Galpern said he and colleagues Jim Pettit and Steven Knowlton plan to argue that elderly people with those risk factors are exactly the group that Merck targeted in advertising for Vioxx, which had been a $2.5 billion-a-year blockbuster. He describes Doherty, who now is dependent on blood thinners and other drugs, as a sort of “everywoman” victim.

That could play well with the jury, as the other case Merck lost involved John McDarby, a 77-year-old man with so many cardiac risks that his lawyers argued a doctor would never have put him on Vioxx, had they known the risks.

“It’s a wonderful aikido move, taking the strength of Merck’s defense and then turning it against Merck,” said Seton Hall Law School professor Howard Erichson, referring to a Japanese self-defense martial art.

McDarby, who survived his heart attack, was the first plaintiff with documented Vioxx use for over 18 months; a jury in April awarded him $13.5 million.

Merck plans to appeal all three losses.



On the Net:

Merck: http://www.merck.com

AP-ES-06-01-06 1557EDT


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