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Mistrial declared as jury deadlocks in Merck's first federal Vioxx trial

Tuesday, December 13, 2005

HOUSTON -- Conventional wisdom said the first federal Vioxx trial was Merck & Co.'s to lose.

The Florida man whose 2001 death of a heart attack lay at the center of the case took the once-popular painkiller for just a month. Richard "Dicky" Irvin got the prescription from his son-in-law without a medical checkup. His arteries were clogged by more than half in some places.

Merck insisted no science showed that Vioxx could heighten the risk of heart attacks or strokes unless taken for 18 months or more. A long-term study showing that 18 months of constant use could increase the chances of a heart attack prompted the company to withdraw the painkiller from the market in September last year.

But jurors couldn't reach a unanimous verdict -- as required in federal court -- after more than 18 hours of deliberations, prompting U.S. District Judge Eldon Fallon to declare a mistrial Monday. He will confer with attorneys next week to set a date for a retrial.

For now, the result leaves Merck with a win and a loss in state trials and an undecided in its first battle in the federal forum widely considered to be more disciplined and corporate-friendly than many state courts.

Irvin's widow, though disappointed, matter-of-factly accepted the outcome and nodded as her attorneys vowed to retry the case.

"I know in my heart my husband had died because of Vioxx and I had to push forward because of that," said Evelyn Irvin Plunkett, 56, surrounded by the couple's apparently stunned children. "A lot of people have been injured, hurt, died because of that drug.

"I have never backed down from the feelings I had," she said.

The mistrial also leaves Merck facing a new jury that could hear allegations that the company withheld information from the New England Journal of Medicine about a 2000 Vioxx study so the drug would appear safer than it was. A separate, longer-term study disclosed last year led to the drug's withdrawal.

Merck shares closed down 72 cents, or nearly 2.5 percent, at $28.41 as the trial's outcome shook investors worried about the company's liability in the thousands of pending Vioxx cases.

About 20 million people took Vioxx before Merck withdrew the $2.5 billion seller.

"You can't lie to people like the New England Journal of Medicine and get away with it," said Plunkett's lawyer Jere Beasley. "We look forward to the next trial."

Merck lead attorney Phil Beck said last week's revelations from the medical journal would be a "non-issue" in a retrial and that Merck supplied all the updated safety data to the Food and Drug Administration before the journal article was published.

The journal reported after deliberations had begun Thursday that authors of a report about the Merck-funded study -- including Merck's head of clinical trials and a key witness for Merck, Dr. Alise Reicin -- omitted three patients' heart attacks in the data they submitted to the journal, making it appear that Vioxx caused four times, rather than five times, as many heart attacks as the painkiller naproxen.

Merck attributed the disparity to naproxen's heart-friendly qualities rather than to a defect in Vioxx. The FDA criticized Merck for making the assertion, for which they had no scientific evidence.

The 2000 study, called VIGOR, has figured heavily in the first three Vioxx trials to reach juries -- one in a Texas state court that Merck lost, another in its home state of New Jersey that the company won, and in the federal case held in Houston.

Merck later disclosed the full amount of heart attacks to the FDA.

"The FDA based all of its safety decisions and labeling and approval decisions ... on the full updated information," Beck said, meaning the data that said Vioxx caused five times as many heart attacks as naproxen.

Merck faces 7,000 pending state and federal Vioxx lawsuits and potentially billions of dollars in payouts.

The nine-member jury was about 20 minutes into its fourth day of deliberations when Fallon called the panel in and reminded them they had agreed Saturday to reach a verdict in a "reasonable time."

"It has now been a reasonable time. We cannot get a verdict," Fallon said, declaring a mistrial.

The jury couldn't decide whether Merck was liable for Irvin's 2001 death and whether the company failed to issue safety warnings that the drug could have serious cardiovascular side effects.

Merck argued that Vioxx was not a factor in Irvin's death because he took the drug for such a short time. The company blamed his death on clogged arteries and a blood clot that led to the heart attack.

Plunkett alleged that Vioxx, which inhibits an enzyme that promotes inflammation and thins the blood, led to the clot formation.

Jurors in the Texas state case gave the widow of a marathon runner who took Vioxx for eight months before he died a $253 million verdict against Merck. That award will drop to no more than $26.1 million under Texas caps on punitive damages, and Merck plans to appeal.

The New Jersey jury absolved Merck of liability in the illness of an Idaho man who survived a heart attack after taking Vioxx intermittently for two months.

Testimony in the federal case ended in less than two weeks under testimony and evidence limits set by Fallon, while the state trials lasted three and four times as long.

Beck and Beasley both said Fallon instructed jurors not to talk to the attorneys or the media, so neither attorney knew how the jury was split. Juror identities were not revealed, nor did Fallon make them available to discuss their difficulty in reaching a verdict.

Beasley said the plaintiff's team hopes to present the journal allegations and more evidence than the Houston jury heard in a retrial.

Beck said Merck was confident in its defense.

"It is neither a moral victory nor a moral defeat for either side. To me, we failed to get a verdict. That happens sometimes. We are going to try again and we are going to do our best to win next time," he said.

Of the 21 witnesses who testified in the federal trial, four testified on Merck's behalf. The plaintiff's witnesses included Dr. Eric Topol, chairman of the cardiovascular medicine department of the Cleveland Clinic and a vocal critic of Vioxx, who said the drug can cause heart attacks any time after a patient begins taking it.

Fallon has said he intends to meet with lawyers about the possibility of a global settlement after the fourth federal trial wraps up.

Beck said a retrial likely will be in February in its original venue of New Orleans, which could force Fallon to push trials now slated for February, March and April back a month. The trial was moved to Houston because of hurricane damage.

The next state trial is scheduled for Feb. 27 in New Jersey.


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