A 53-year-old former college football player was "a big, strong, healthy guy" when he died unexpectedly of a heart attack after taking the painkiller Vioxx for a month, his widow testified Monday in the trial of her federal lawsuit against Merck & Co.
Evelyn Irvin Plunkett said her husband of nearly 31 years, Richard "Dicky” Irvin, was never sick and got lots of exercise lifting boxes at the St. Augustine, Fla., seafood distributor he managed. He had been taking Vioxx for about a month for back pain when he died in 2001, just a few hours after he kissed his wife goodbye and went to work.
"I felt like I lost my best friend, my husband, the person who gave everything to me, that loved me beyond—it was awful. I can’t even explain it,” Plunkett testified through tears.
Plunkett, who remarried last year, also testified that Irvin’s mother had heart bypass surgery several years ago but had fully recovered. Under cross-examination, Plunkett said Irvin’s sister died of lupus and not from a heart attack, as the widow previously stated in an affidavit.
Her attorneys rested their case after Plunkett testified. They also withdrew two of their five lawsuit claims: fraud and breach of warranty.
Merck began its defense Monday afternoon with an expert witness, Dr. David S. Silver, a Los Angeles physician who has done 100 clinical trials of drugs, including some of Cox-2 inhibitors such as Vioxx. He was to continue testifying Tuesday.
Merck argues that the drug wasn’t responsible for Irvin’s death, saying problems with Vioxx surface after 18 months of use, not one month, and alleging that plaque in Irvin’s artery ruptured and caused the heart attack.
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 wrought by Hurricane Katrina.
Earlier Monday, jurors watched several videotaped depositions of Dr. Edward Scolnick, who retired last year as president of Merck Research Laboratories. He said he initially was concerned about a 2000 study showing Vioxx users suffered five times as many heart attacks as users of the older painkiller naproxen, sold under the brand name Aleve.
Although he changed his mind several months later and still attributes the disparity to naproxen’s cardioprotective qualities rather than a defect in Vioxx, he said he wanted Merck to do other studies that were not done.
"I always worried about the safety of our drugs, and I continue to worry about it,” Scolnick told plaintiffs’ attorneys in the March deposition. In one e-mail to some of his employees several years ago, Scolnick wrote, "I actually am in minor agony.”
Under cross-examination by Merck attorneys, Scolnick said he took Vioxx himself for back problems, even after that study was done. He said patient safety was his priority at Merck because he considered himself a physician first.
Scolnick also testified that he was upset when the Food and Drug Administration wanted to put a warning label on Vioxx, which was approved in 1999. He acknowledged that such a label could hurt sales, but said he objected because ‘’it didn’t accurately reflect our data.”
"If we had been wrong, there would have been serious consequences,” Scolnick said in the deposition. "We did not believe we were wrong.”
In a 2001 e-mail to some employees encouraging them to keep fighting the FDA, Scolnick said the warning label was "ugly cubed” It wasn’t until February 2002 that the FDA changed the warning label on Vioxx to reflect those study results showing increased risk of heart attacks and strokes. Merck voluntarily withdrew Vioxx from the market last year.