A federal jury began considering a plaintiff’s claim that Merck & Co. ignored evidence that its blockbuster drug Vioxx caused heart attacks and that the medicine probably caused the death of a 53-year old Florida man.
The trial is the first federal case, but the second trial for Irvin’s widow, Evelyn Irvin Plunkett, and her youngest children who contend that Vioxx contributed to Richard “Dickie” Irvin’s fatal heart attack in 2001. The first trial, held in Houston because of damage from Hurricane Katrina, ended in December when jurors were unable to reach a verdict.
To reach a verdict, jurors must all agree on at least one of the three complex questions: whether Merck was negligent, sold a defective drug or failed to warn doctors about its dangers and, in each case, whether Merck’s actions contributed to the death of Richard “Dickie” Irvin.
If the answer to any of those three questions is yes, they then decide whether Irvin or his son-in-law, an emergency room physician who prescribed Vioxx over the phone, is partly to blame. Then they would consider damages.
They don’t have to agree that Vioxx definitely caused the heart attack in May 2001, or that it was the only possible cause, only that it is “more likely true than not true” that it was among the causes, U.S. District Judge Eldon Fallon told jurors.
“Our burden of proof is to show more likely than not. Fifty-one percent. More likely than not to show his heart attack was caused by Vioxx,” Andy Birchfield, who represents Evelyn Irvin Plunkett and two of her children, told the jury during his closing argument.
He noted epidemiologist Wayne Ray’s testimony that the drug probably was to blame for 54 percent of all heart attacks among people who suffered them while taking Vioxx. Ray made the assertion after examining results from numerous Vioxx trials. He said there was a 54 percent chance that Vioxx was among reasons for Irvin’s heart attack.
Merck attorney Phil Beck countered that no physician testified that Vioxx caused Irvin’s death. “In fact, no doctor testified that Vioxx was even a small factor in Mr. Irvin’s heart attack and death.”
Birchfield said Merck ignored early signs of danger, such as a study called VIGOR in which patients taking Vioxx had five times the rate of heart attacks as those taking a drug called naproxen. Merck explained the results by saying that naproxen helps prevent heart attacks.
Merck learned of those results in 2000. Had it stopped selling Vioxx or put a warning label on the drug then, Birchfield said, Irvin’s son-in-law would not have prescribed Vioxx for Irvin in April 2001.
“Did they rein in their massive marketing campaign? … No. They pushed on wide open,” he said. And he quoted the comment of Dr. Eric Topol, a cardiologist subpoenaed for videotaped testimony while at the Cleveland Clinic. “He said that was human experimentation,” Birchfield continued. “Merck was playing Russian roulette for money with Dickie Irvin.”
When VIGOR results were submitted to the New England Journal of Medicine three additional heart attacks were left out of the data even though the events were reported to the U.S. Food and Drug Administration.
In a videotaped deposition, The New England Journal of Medicine executive editor Dr. Gregory Curfman claimed that the disparity was because “the company wanted to keep the journal article pristine for the purposes of marketing. And it worked – for a while.”
Merck said the data reported to the journal occurred before a cutoff date set when a safety monitoring board for the study asked for analysis of cardiovascular side effects. Curfman said the journal should have been updated.
As of the end of December, Merck faced more than 9,600 cases.
Merck’s state court record is 1-1. It lost a $253 million judgment in Texas, where another trial is under way, and won a case in its home state, New Jersey, where another is to begin later this month.