Federal Vioxx Case. The nation’s first federal Vioxx trial ended Monday with a hung jury, but the case involving the 2001 death of a Florida man who took the once-popular painkiller for a month will be retried, a judge said.
The mistrial leaves Vioxx’s maker Merck & Co. with the prospect of 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.
About 20 million people took Vioxx before Merck withdrew what had become a $2.5 billion seller from the market last year when a separate, longer-term study showed it could double risk of heart attack or stroke if taken for 18 months or longer.
“You can’t lie to people like the New England Journal of Medicine and get away with it,” said a plaintiff’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 jury’s inability to reach a unanimous verdict apparently was unrelated to the journal revelations that came late last week, after deliberations began. The journal reported 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.
The 2000 study, called VIGOR, has figured heavily in the first three Vioxx trials to reach juries
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 disclosed the full amount of heart attacks to the FDA that year.
“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.
The mistrial means Merck gained no momentum in its battle against about 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 U.S. District Judge Eldon Fallon called the jurors 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. Federal litigation requires a unanimous verdict. Merck attorney Beck said Fallon gave the jury enough time.
“At some point if you are a judge you have to make a tough call and you say, you know what? they have been at it long enough and if I make them stay any longer, then people are going to be questioning whether the verdict … really reflects the consent of nine people or not.”
The jury couldn’t decide 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 side effects.
Merck argued that Vioxx was not a factor in Irvin’s death because he took the drug for about a month, and the long-term study that led to the drug’s withdrawal last year showed dangers only after 18 months’ use. The company blamed his death on clogged arteries and a blood clot that led to the heart attack.
Irvin, a former college football player who managed a wholesale seafood company in St. Augustine, Fla., got a prescription for Vioxx from his son-in-law, an emergency-room physician, without a medical checkup.
His wife, Evelyn Irvin Plunkett, alleged that Vioxx – which inhibits an enzyme that promotes inflammation and thins the blood – led to the clot formation. She said Monday she believed she had to convince a jury that Vioxx was the culprit.
“I knew in my heart my husband had died because of Vioxx and I had to push forward (with a lawsuit) because of that,” Plunkett said outside the courtroom. “A lot of people have been injured, hurt, died because of that drug.”
Beck and Beasley both said Fallon instructed jurors not to talk to the attorneys or the media
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 in a retrial than the Houston jury heard.
“We are not going to quit,” Beasley said. Beck said Merck was confident in its defense, even though the company rested its case without calling a cardiologist to testify.
“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.
In the first case, a Texas state jury slapped Merck with a $253 million verdict, which will be reduced to $26.1 million at most because of state caps on punitive damages. Merck is expected to appeal.
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.
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.
Testimony in the federal case ended in less than two weeks, while the state trials lasted three and four times as long. Fallon has said he intends to meet with lawyers about the possibility of a global settlement after the fourth federal trial wraps up.
The judge said he would confer with attorneys next week to set a retrial date. Beck said the retrial would likely be in February in its original venue of New Orleans. The trial was moved to Houston because of hurricane damage. The next state trial is scheduled for Feb. 27 in New Jersey.