A federal judge in Houston will meet next week with lawyers in the first federal Vioxx trial to set a date for a retrial of the lawsuit against Merck, the painkiller's maker. As jurors began their fourth day of deliberations Monday, the judge found them to be deadlocked and declared a mistrial.
The jury failed to side with the drugmaker or the widow of a 53-year-old Florida man who died after taking Vioxx for about a month. The outcome wasn't a complete surprise. Jurors had told the judge on Saturday that they were deadlocked. He asked them to keep deliberating for "a reasonable time." That period ended this morning.
Both sides said they were disappointed.
Jere Beesley represented the plaintiff. He told reporters, "It's hard on the family to wait from Thursday afternoon until today to find it's a mistrial. They feel very strongly about going forward, and we're going to go forward. They're not going to quit."
Two previous Vioxx cases have gone to trial in state courts. Merck lost the first one, and won the second.
Philip Beck, who represented Merck in this case, was philosophical about the mistrial. He said, "Merck is in it for the long haul. There are going to be wins and losses. Now we know there are going to be ties. We just dust ourselves off and keep going."
Merck faces some 7,000 Vioxx cases around the country. The company has vowed to fight each one in court.
Merck Faces Tougher Time Next Time
The next time Merck goes to court, it will likely face new evidence about a large scientific study called Vigor, completed in the year 2000. Last week, after the two sides had completed their closing arguments, the editors of the New England Journal of Medicine wrote an editorial saying that Merck had withheld data about heart attacks when it submitted a paper on the study for publication. The jury in this case never heard about the editorial.
The Vigor study was meant to prove that Vioxx was safer for the stomach than an older painkiller, Naproxen. It did show that, but it also showed a five-fold increase in heart attacks compared to Naproxen. In a paper published in the New England Journal of Medicine, Merck's scientists argued the study showed that Naproxen protected the heart.
Many prominent scientists have long argued that that Merck's reasoning was scientifically unsound, and that the Vigor study provided a clear, early warning that Vioxx was risky for the heart. Now their position — and that of Vioxx plaintiffs — appears to have been bolstered by the most prestigious medical journal in the world.
The New England Journal's editors said that had they been provided all the data about heart attacks in the Vigor study, they wouldn't have published a paper that argued Vioxx was benign for the heart.
On Monday, Merck lawyer, Philip Beck, said he "looked forward to responding" in future trials to the issues raised by the editorial.
Merck's Side of the Story
According to Merck lawyer Beck, in May 2000, when the authors of the scientific paper turned in their manuscript to the New England Journal, they submitted data about all the cardiovascular events that occurred before a pre-specified date. He said such dates are set to avoid data manipulation.
Beck said Merck told the Food and Drug Administration about all heart attacks and other cardiovascular events, including those that occurred after that preset date. He said the company submitted information to the FDA about additional heart attacks that occurred after the preset date in October 2000, one month before the journal article was published.
"The idea that we are withholding data is an absurd one," he said.
Moreover, he said, all regulatory decisions, including the change in the Vioxx label in 2002, were based on the data sent to the FDA, not what was published in the New England Journal.
In an interview with NPR last week, the journal's executive editor, Gregory Curfman, said his publication hadn't been told there was a cut-off date for cardiovascular events.
"You can't let incomplete data stand in a New England Journal article when you know you have other data, especially when it has to do with heart attacks," Curfman said. "It's inappropriate, unacceptable and their explanation borders on being ludicrous."
Lawyer Andy Birchfield, who represented the plaintiff in this case, said he plans to introduce the New England Journal editorial into evidence when this case is retried. He said that Merck had thousands of copies of the New England Journal article reprinted, and distributed to doctors as part of its marketing efforts.
"They used that New England Journal of Medicine publication as a marketing tool to explain away the five- fold increase risk of heart attacks," Birchfield said.. "Doctors rely on what they read in the New England Journal of Medicine and other medical literature, they rely on that to get accurate and truthful results of studies, and that was not the case" with this article.
Judge Fallon will hold a meeting with the lawyers next week to decide when this case will be retried. About a third of the Vioxx cases are filed in federal court, and Fallon has charge of all of them.
He's hoping that a verdict in this case, and a handful of others, will give the two sides the information they need to negotiate a broad settlement of all the federal cases.