Plaintiffs in Vioxx Case File Motion for Mistrial

posted on:
December 9, 2005

author:
Staff

Attorneys for the plaintiff in a federal trial over Vioxx filed for a mistrial Friday, citing data that was withheld from a Merck & Co. clinical study about the painkiller when it was submitted to the New England Journal of Medicine.

Judge Eldon E. Fallon said he would take the motion under advisement, as jurors were in their second day of deliberations.

Shares of Merck were down 60 cents, or 2%, to $29.08 in afternoon trading on the New York Stock Exchange.

On Thursday, the NEJM 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. It also said including the three additional heart attacks “did not materially change” the conclusions of the study, dubbed Vigor, for Vioxx Gastrointestinal Outcomes Research study.

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.

Evelyn Irvin Plunkett alleges that Vioxx caused the 2001 fatal heart attack of her husband, Richard “Dicky” Irvin who took the drug for less than a month to treat back pain. In considering the case, the jury of five men and four women will have to answer 12 questions about the roles of Merck, the doctor who prescribed Vioxx to Mr. Irvin, Mr. Irvin himself and the dangers posed by Vioxx. If Merck is found liable, jurors will have to consider what would be fair compensation to Mr. Irvin’s children and widow for suffering and the loss of his income and companionship.

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.”

Mr. Beck said evidence showed that Mr. Irvin died not from Vioxx but from ruptured plaque in an artery that caused a blood clot. Mr. Beck said studies show Vioxx can lead to cardiovascular problems after 18 months but isn’t considered a real risk until after three years.

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, Mr. Beck said.

Merck lost the first Vioxx trial earlier this year when a Texas jury awarded $253.4 million to the widow of a man who died while taking Vioxx. Under state damage caps, that award will likely be reduced to $26 million. The Whitehouse Station, N.J., drug company came back to win a case tried in New Jersey Superior Court last month. All three cases have involved people who took the drugs for less than 18 months.

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