Mistrial Declared in Federal Vioxx Trial

Monday, December 12th 2005, 10:10 am
By: News On 6

HOUSTON (AP) _ A judge declared a mistrial Monday in the first federal lawsuit over the once-popular painkiller Vioxx.

Merck & Co. emerged from its third Vioxx trial Monday with a hung jury when the panel failed, in about 18 hours of deliberations over three days, to side with the drug maker or the widow of a 53-year-old Florida man who died after taking Vioxx for about a month.

The jury resumed what was to be its fourth day of deliberations Monday, but within about 20 minutes, U.S. District Judge Eldon Fallon called the jurors in and reminded them they had agreed 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. Federal litigation requires a unanimous verdict.

The panel was at odds over whether Merck was liable in Richard ``Dicky'' Irvin's 2001 death and whether the company failed to issue safety warnings that the drug could have serious cardiovascular repercussions.

The unexpected outcome leaves Merck with a 1-and-1 record in state trials and an undecided in the first of four federal trials overseen by Fallon. The company faces about 7,000 pending state and federal lawsuits and its liability has been estimated at up to $50 billion.

Merck was expected to have an edge because federal courts are often viewed as business-friendly and disciplined, and less tolerant of attorney theatrics and flimsy evidence than state courts.

In the first case, a Texas state jury slapped Merck with a $253 million verdict for negligence and for failing to warn of Vioxx dangers in the 2001 death of a Texas man who took the drug for eight months. In November jurors in Merck's home state of New Jersey absolved Merck of liability, leaving nothing for an Idaho man who survived a heart attack after taking the drug intermittently for two months.

The crux of the federal case was whether Vioxx could be dangerous with short-term use.

Merck pulled the painkiller from the market in September 2004 after a long-term study showed it could double the risk of a heart attack or stroke if taken for 18 months or longer.

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

Irvin got a prescription for Vioxx from his son-in-law, an emergency-room physician, without a medical checkup.

His widow, Evelyn Irvin Plunkett, testified that her husband, a former college football player who managed a wholesale seafood company in St. Augustine, Fla., was ``a big, strong, healthy guy'' when he died at his desk a few hours after kissing her goodbye on his way to work. She alleged that Vioxx _ which inhibits an enzyme that promotes inflammation and thins the blood _ led to the clot formation.

Of the 21 witnesses who testified in the case, four testified on Merck's behalf, and none of those were cardiologists. 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.

On Thursday, the New England Journal of Medicine said authors of a report about a 2000 Merck-funded clinical study failed to disclose heart attacks suffered by three patients. The publication also alleges the study's authors deleted other relevant data before submitting their article.

In a statement, Whitehouse Station, N.J.-based Merck said it ``promptly and appropriately'' disclosed the study results.

Testimony in the federal case ended in less than two weeks and was heavily abbreviated in comparison to the Texas and New Jersey state trials, which lasted six and eight weeks, respectively. Fallon, who oversees all federal Vioxx litigation, limited evidence _ though much of it mirrored what had been presented in the state cases _ and required both sides to hammer out what will be presented long before a jury was chosen.

Texas caps on punitive damages will cut the Texas state case's award to no more than $26.1 million, and Merck is expected appeal.

Fallon has told attorneys that once the fourth trial ends, he intends to meet with lawyers on both sides to gauge the possibility of crafting a global settlement of all pending federal Vioxx litigation.

The next federal trials are slated for next year, but no specific dates have been set, nor have cases been selected to be tried.

The next state Vioxx trial is slated for Feb. 27 in New Jersey _ home to more than half the pending state lawsuits. Mark Lanier, the Houston litigator who represented the widow in the Texas state case that Merck lost, will face off with Merck again in that trial, which will likely consolidate two plaintiffs' cases involving use of Vioxx that surpassed two years.

About 20 million people took Vioxx after its launch in 1999. A study in 2000 found that Vioxx users suffered five times as many heart attacks as people who used the older pain reliever naproxen.

Merck has attributed the difference to naproxen's heart-friendly qualities rather than a defect in Vioxx, earning a rebuke from the U.S. Food and Drug Administration for making that assertion without scientific proof.

Merck added warnings about cardiovascular risks to Vioxx's label in 2002 after two years of wrangling with the FDA.