Jurors deliberated about eight hours today without reaching a verdict on whether Merck & Co.’s Vioxx contributed to the 2001 death of a Florida man who had been taking the once-popular painkiller for about a month.
The nine-member federal jury, which has deliberated nearly 10 hours over two days, was to return Saturday. The panel is considering whether the drug was defective, if the company failed to warn about its risks and was negligent in designing and marketing Vioxx.
I f jurors answer yes, they then must decide whether any of those factors contributed to the fatal heart attack of Richard "Dicky" Irvin, 53, of St. Augustine, Fla., whose widow is suing Merck. A verdict must be unanimous.
Lawyers on both sides declined to comment today on whether the plaintiff plans to ask for a mistrial based on revelations Thursday from the New England Journal of Medicine, which said authors of a report about a 2000 Merck-funded clinical study failed to disclose three patients’ heart attacks.
The jury federal panel met for about two hours Thursday after hearing closing arguments from both sides in the first federal trial of the once-popular painkiller.
Telling jurors their decision will have "far-reaching consequences for how drug companies conduct their business," the attorney for Irvin’s wife asked the panel to send Merck a message.
"If Merck simply warned of the dangers, we wouldn’t be here," Andy Birchfield told the jury during closing arguments. "’you have the power to make a difference."
Irvin’s widow, Evelyn Irvin Plunkett, sued the company, which yanked the painkiller 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.
Irvin, who took the drug for back pain, died in May 2001.
In his instructions to the jury, U.S. District Judge Eldon Fallon told the panel not to consider Merck’s voluntary withdrawal of the drug in its deliberations.
Merck attorney Phil Beck told the jury in his closing arguments that Merck believes Irvin’s short-term use of Vioxx played no role in his death.
Instead, plaque in his arteries ruptured and formed a blood clot, which happens to 300,000 to 400,000 people every year, Beck said.
"Not one witness said Vioxx could cause plaque rupture," he said.
Beck said that Merck exceeded the Food and Drug Administration requirements by doing more than the required number of drug trials, which involved more people and were longer than required. He said there were 128 clinical trials in all.
Testimony in the trial has revolved around when Merck learned that its drug had unintended cardiovascular consequences. Birchfield told the jury that by February 2001, Merck should have pulled Vioxx off the market or at least issued a big warning because company officials knew then there was a problem.
Birchfield asked the jurors to strongly consider the testimony of Dr. Eric Topol, chairman of the department of cardiovascular medicine at the Cleveland Clinic Foundation, who testified that his research showed the immediate cardiovascular risks of taking Vioxx.
Birchfield told jurors that Merck tried to weaken the impact of a critical article Topol and his colleagues published in the Journal of the American Medical Association based on his research with a news release and letters shipped overnight to all doctors in the United-States.
The company tried "to drown out the warning signals," Birchfield said.
Topol also testified that before the article was published, Merck officials tried to pressure him into not publishing.
To that, Beck said the company never tried to "intimidate" Topol, describing Dr. Alise Reicin -the Merck executive who visited with the cardiologist about the article – as "98 pounds sopping wet."
Beck described Topol as a doctor with a Dr. Jekyll & Mr. Hyde personality who doesn’t like to be contradicted.
"I’m sure Dr. Topol is a great heart doctor, but he doesn’t like it when people disagree with him," Beck said.
In August, a Brazoria County jury awarded $253 million to the widow of a former marathon runner who died of a heart attack after taking the drug. But last month, a New Jersey jury found no wrongdoing in the case of an Idaho postal worker who suffered a nonfatal heart attack.
Merck faces an estimated 7,000 lawsuits by former Vioxx users or their families.