First Vioxx federal trial to focus on length of use

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But back pain relief was fleeting for the 53-year-old manager of a wholesale seafood distributor of St. Augustine, Fla. In May that year he went to work and told his boss he didn’t feel well. A little later his co-workers found him dead at his desk.
Whether Merck & Co.’s once-lucrative drug led to his death lies at the center of the third Vioxx-related case in the nation to face a jury, and the first to do so in federal court.
“It’s going to be interesting. Merck is pretty cocky, which is fine,” said Jere Beasley, former Alabama lieutenant governor who will lead his Montgomery, Ala. law firm’s team representing Irvin’s widow, Evelyn Irvin Plunkett.
Merck enters its third court battle with a split record in state courts — a loss in Texas and a win in its home turf of New Jersey. The federal face-off, to begin Tuesday with jury selection and opening statements, will be in Houston rather than its original venue of New Orleans because of damage wrought by Hurricane Katrina.
Whitehouse Station, N.J.-based Merck pulled Vioxx from the market in September 2004 after a long-term study showed the drug doubled risk of heart attack or stroke if taken for 18 months or longer. By then, more than 20 million Americans had used Vioxx.
The company faces about 7,000 state and federal lawsuits and billions in potential payouts for judgments, settlements and legal fees.
The Texas jury in August punched Merck with $253 million after finding the drug maker liable for the death of 59-year-old marathon runner Robert Ernst. The amount will fall to no more than $26.1 million under Texas caps on punitive damages, and Merck will appeal.
Earlier this month, the New Jersey jury absolved Merck of liability and left the plaintiff — 60-year-old Vietnam veteran Frederick “Mike” Humeston of Idaho who survived what he claimed was a Vioxx-induced heart attack — with nothing.
Any damages awarded if Plunkett wins will be governed by Florida law because the lawsuit was filed in Florida before it and all other federal Vioxx litigation came under the watch of U.S. District Judge Eldon Fallon of New Orleans to streamline trial preparations.
Merck said in court papers that under Florida law, jurors cannot award punitive damages if the company loses because such damages were already awarded in the Ernst case, which alleged similar misconduct.
That doesn’t mean the Texas punitive award precludes punitives in the Irvin case, said Jim Rossi, professor and associate dean for research at Florida State University College of Law.
He said Fallon can allow punitives if he determines those in the Ernst case insufficiently punished Merck. Texas caps require that jury’s punitive damage award of $229 million to be cut to $1.6 million.
“There will be an issue with the limitation in the Florida statute, but it is hardly an across-the-board barrier to the recovery of punitives in a later case,” Rossi said.
Florida law also caps punitive damages, Rossi added. If awarded, punitives are limited to $500,000 or three times the amount awarded for compensatory damages, whichever is greater. Compensatory damages are economic, such as lost income, and non-economic, such as pain and suffering.
However, if jurors find Vioxx to be “unreasonably dangerous” and that Merck was motivated by unreasonable financial gain, punitives can rise to $2 million or four times compensatory damages, Rossi said.ws concerning VIOXX
Merck lawyers declined to discuss the case, citing Fallon’s request that lawyers eschew public comments until a verdict is reached. The company’s court filings indicate Merck’s defense will center on whether Vioxx could be responsible for Irvin’s death when he took the painkiller for such a short time.
Ernst took Vioxx for eight months. Humeston took it intermittently for two months. Irvin took the drug for about a month, and Merck claims no studies show Vioxx can be lethal after such short-term use.
Plunkett counters that some of the 58 clinical trials involving 10,000 patients conducted before Vioxx went on the market in 1999 revealed it could trigger cardiovascular problems after a few weeks’ use.
Those studies were among several presented to jurors in the Ernst case. But Merck executives — several of whom are on Merck’s potential witness list for the Irvin case — testified that data from all the trials, evaluated in their entirety, showed the drug was safe and it won U.S. Food and Drug Administration approval.
Fallon ruled earlier this month that the six-member jury will slog through the scientific arguments.
Irvin’s health status will be a factor. His widow says he was in “very good health” when he began taking Vioxx, but Merck notes that he received a Vioxx prescription from his son-in-law — an emergency room physician — without a checkup.
Also, Irvin’s autopsy said he had moderate to severe clogged arteries, and a blood clot in a major coronary artery caused an irregular heartbeat and death.
Merck claims the clot formed when some of that plaque ruptured with no help from Vioxx. Plunkett alleges Vioxx — which inhibits an enzyme that promotes inflammation and thins the blood — led to the clot formation.
The trial will be the first of four overseen by Fallon. The next cases are slated for February, March and April, though the specific cases or trial dates have yet to be selected. Fallon told attorneys last month that when the fourth trial concludes, he will meet with them to explore a global settlement for all federal Vioxx litigation.