A nationally known pharmacology expert testified Tuesday that the prescription painkiller Vioxx can cause blood clots like the one that led to the death of a Florida seafood salesman four years ago.
Further, scientists and officials from drug maker Merck either intentionally ignored or were oblivious to that risk, said Benedict Lucchesi, a professor at the University of Michigan and an expert in drug management of heart disease.
Lucchesi was the first witness in the nation’s first federal Vioxx trial. Although U.S. District Judge Eldon Fallon of New Orleans is presiding over the case, it is being held in Houston because of damage Hurricane Katrina caused to the courthouse there.
“I believe that Vioxx can produce blood clots,” Lucchesi said. “I believe that Merck either was aware or should have been aware that this potential existed.”
He said that research indicating that potential had been available for decades and was well known in scientific communities.
Earlier Tuesday, Fallon impaneled four women and two men, as well as three male alternates, to serve on the jury. He has told the lawyers in the case that he intends to wrap up testimony within two weeks.
Jurors are trying to determine if Merck should be held liable in the death of 53-year-old Richard “Dicky” Irvin, who died at work in May 2001 after taking Vioxx for 22 days for back pain.
His widow, Evelyn Irvin Plunkett, is seeking unspecified damages against the drug giant, which pulled Vioxx from the market in September 2004 after a study showed that it doubled the risk of heart attacks and strokes in patients who took it for 18 months or longer.
During an hour long opening statement, Plunkett attorney Andy Birchfield told the jury that Merck downplayed years of studies that showed Vioxx was linked to heart attacks because it was in a hurry to get the drug on the market before competitor Pfizer won approval of its similar drug, Celebrex.
“Merck was in a race to beat Celebrex to the market,” Birchfield said in a courtroom full of attorneys and onlookers.
“They calculated how much more money they would make by being first to the market instead of second. And it was a lot of money.
“Merck pushed one of its drugs to market even though there were serious concerns about heart attacks.”
“We’re going to show you in Merck’s documents how they discussed this problem.”
Merck lawyer Phil Beck told the Houston panel during his opening statement that the company acted responsibly by pulling Vioxx from the market after learning of the serious heart risks.
Further, the U.S. Food and Drug Administration had been made fully aware of all of the Vioxx studies, Beck said, and not only approved sales of the drug but also continued to approve sales for additional uses up until it was withdrawn.
Beck, best known for representing President Bush in the famous hanging-chad ballot case in Florida in 2000, added that it was Irvin’s poor health that led to his death, not Vioxx.
“Vioxx is not what caused Mr. Irvin’s death,” Beck said. “He died from what is the leading cause of death, especially for men his age. He died from clogged arteries.”
The FDA approved Vioxx for sale in 1999. When it was pulled from the market five years later, it accounted for $2.5 billion in annual sales, the company has said.
Birchfield said that even though Irvin’s autopsy showed he had 60 percent blockage in an artery, the former professional Canadian football player was a healthy man who was often physically active as manager of a wholesale seafood store in St. Augustine, Fla.
And he tried to diffuse what likely will be one of Merck’s chief defenses: that Vioxx does not lead to cardiac events in cases of short-term use.
“All of these studies are big studies that show that Vioxx increased the risk of heart attacks,” Birchfield said after giving brief descriptions of several clinical trials conducted by Merck. “It didn’t matter how long you took it.”
He also said he would present evidence of the huge marketing effort employed by Merck to sell Vioxx, include a record 3,500-person sales force and widespread TV and print advertising campaigns.
Further, Birchfield said he would produce materials describing the company’s “dodgeball” training program in which salespeople were allegedly encouraged to avoid doctors’ questions about heart risks.
That testimony elicited some of the strongest reaction in jurors in a Brazoria County state district court, which returned a $253 million verdict against Merck in August. That verdict likely will be reduced to about $26 million under Texas punitive damage caps.
A New Jersey state court, however, cleared Merck in a trial that ended earlier this month.