Jurors in the first federal trial over Vioxx were to resume deliberating about whether Merck & Co. was negligent in designing and marketing the once-popular painkiller and if it failed to warn about the drug’s risks.
The nine jurors, whose decisions must be unanimous, also must decide whether the drug was defective. If jurors answer yes, they then must decide whether any of those factors contributed to the 2001 death of Richard “Dicky” Irvin, 53, of St. Augustine, Fla., whose widow is suing Merck.
After deliberating about two hours Thursday, jurors were to resume Friday morning.
On Thursday, the New England Journal of Medicine said authors of a report about a 2000 Merck-funded clinical study failed to disclose heart attacks suffered by three patients. The publication also alleges the studies authors deleted other relevant data before submitting their article, which ran in the Journal.
In a statement issued Thursday afternoon, Whitehouse Station, N.J.-based Merck said it “promptly and appropriately” disclosed the study results.
The plaintiff’s lawyers declined to comment on whether they would seek a mistrial based on the report.
In the federal trial, both Merck and the plaintiff cited the study, which showed that Vioxx users suffered five times as many heart attacks as users of the older painkiller, naproxen. Merck said the results show that naproxen has a protective effect on the heart, much like aspirin – not that Vioxx leads to heart attacks.
During closing arguments Thursday, plaintiff’s attorneys said Merck knew Vioxx increased heart attack risks but misled doctors and the public because the company, facing the loss of patents on several profitable drugs, needed a blockbuster replacement.
“They could take the high road to patient safety, or they could take the low road to sales,” lawyer Andy Birchfield told jurors. “What did they do? They pushed forward.”
But Merck’s lead attorney, Phil Beck, said the pharmaceutical giant issued adequate warnings based on studies showing Vioxx was safe. He said Merck scientists put patient safety first and were not sales-driven, or “evil.”
Beck said evidence showed that Irvin died not from Vioxx but from ruptured plaque in an artery that caused a blood clot. Beck said studies show Vioxx can lead to cardiovascular problems after 18 months but isn’t considered a real risk until after three years; Irvin had been on Vioxx only a month when he died.
Although Merck voluntarily took Vioxx off the market last year, jurors cannot consider that as evidence that the product was defective or the company negligent, Beck said.
This is the first federal trial over Vioxx; Merck has already lost one state trial over the drug and won another, but it still faces about 7,000 lawsuits. The Irvin case was moved to Houston from its original venue of New Orleans because of damage from Hurricane Katrina.
Birchfield urged jurors to award about $350,000 to the widow, Evelyn Irvin Plunkett, and $53,000 to Irvin’s youngest daughter for loss of support and services. Birchfield said he did not know an appropriate amount for Plunkett’s loss of companionship – “a million, $5 million, $10 million?” – or the parenting lost by the couple’s two youngest children, who were minors when Irvin died.
If the jury finds Merck liable, the punitive damages will be determined in a later hearing in which attorneys can make arguments or call witnesses. Then the panel will deliberate and consider awarding punitive damages.