Evelyn Irvin Plunkett said she remembers the day her husband starting taking Vioxx for back pain. It was April 15, 2001.
One month later, Richard Irvin Jr. died of a heart attack.
Plunkett said her 53-year-old husband, the manager of a wholesale seafood business in St. Augustine, Fla., was in “very good health.” She is convinced he died because he took Vioxx, the medicine drug maker Merck abruptly pulled from the market Sept. 30 after scientific studies years in the making showed Vioxx doubled the risk of heart attack or stroke.
Plunkett said she concluded Vioxx was to blame six weeks after her husband’s death, when her daughter noticed a magazine article linking the arthritis and pain medication to an increased risk of heart attack.
“I knew it in my heart that is what killed my husband. … I knew immediately,” said Plunkett, who filed a lawsuit against Merck in state court in Florida in May 2003.
Plunkett’s case is one of hundreds of lawsuits that have been filed against Merck. More are expected in the wake of the company’s surprising decision to immediately stop selling a medicine that accounted for $2.5 billion in sales last year.
The cases raise the specter of a massive and costly legal problem for Whitehouse Station-based Merck, long considered a model corporate citizen. But some experts said the details of cases also illustrate how difficult it may be to prove Vioxx was to blame, even as plaintiffs’ attorneys insist they expect to prevail.
“I don’t think it’s going to be fen-phen II,” said Stephen Sheller, an attorney, referring to the thousands of diet-pill lawsuits filed against Madison-based drug maker Wyeth.
For starters, many of those taking Vioxx are older and, therefore, tend to have other medical problems. Also, heart attacks are relatively common and can happen to people in seemingly good health, sometimes for no obvious reason.
Plus, Merck contends the study that prompted the withdrawal showed a safety problem only among those taking Vioxx continuously for 18 months or more, in marked contrast to earlier studies that showed no safety problems.
There also doesn’t yet appear to be an indisputable, tell-tale sign that something has gone wrong and can be linked to Vioxx—what some refer to as a signature—according to some experts.
In the case of the diet drugs, for example, that signature was heart- valve damage, an unusual condition in many patients that could be verified by medical testing. Wyeth has set aside $16 billion to settle thousands of lawsuits filed after the company withdrew its diet pills in 1997.
Similarly, Rezulin, a diabetes drug withdrawn in 2002 by Warner- Lambert, was linked to liver failure. Baycol, a cholesterol medicine taken off the market by Bayer in 2001, was linked to a rare muscle disorder.
Eric Weinberg, an attorney who was involved in the Baycol litigation, said deciding whether Vioxx is to blame for a person’s medical problems won’t be easy.
“It may be really clear in some and muddy in others,” he said. “It will depend how complicated a person’s medical history really is.”
With lawyers advertising for clients, Merck, the world’s fourth-biggest drug maker, is defending the steps it took and said it plans a vigorous defense. Twenty million consumers in the United States have taken Vioxx since it went on sale in 1999.
“We have a strong case in terms of the company monitoring studies and disclosing cardiovascular results of clinical studies,” said Ted Mayer, an attorney at Hughes Hubbard & Reed who is representing Merck.
He added, “Juries can understand that a particular patient’s condition is best explained by something other than the medicine they took.”
But Plunkett’s attorney, Andy Birchfield, said his expert cardiologists have isolated a signature among the 58 cases he has filed against Merck related to Vioxx.
In the case of Irvin, a former football lineman at the University of Richmond, Birchfield said the tell-tale sign is based on medical records showing he suffered a heart attack because of an “unattached” clot in an artery near the heart. That type of clot differs from the gradual build-up of deposits that cause atherosclerosis and hardening of the arteries that is a major cause of heart attacks.
“We know that is a signature of a Vioxx heart attack,” said Birchfield, of the firm Beasley, Allen, Crow, Methvin, Portis & Miles in Montgomery, Ala. “Doctors make those determinations every day.”
Birchfield said he is equally confident he can prove Vioxx was to blame for a heart attack suffered by William Cook, who survived. A trial is scheduled for December in Alabama, which could make it the first case to go before a judge, he said. Cook, 50, a retired mine worker who had smoked, took Vioxx for about a year.
In New Jersey, 175 lawsuits making claims about side effects caused by Vioxx are being handled as a mass tort case in state Superior Court, Atlantic County. Typically, cases are filed in New Jersey because Merck is based here.
“We’re confident we can show Vioxx was the cause of our clients’ injuries,” attorney Gregory Spizer said.
One of the New Jersey cases involves a 45-year-old Florida man who suffered congestive heart failure after taking Vioxx for six months. The father of two teenagers has been treated in emergency rooms eight times since August.
The man, whom lawyers wouldn’t identify, had no history of heart problems and will die without a heart transplant.
“When you consider there were no risk factors and no history of heart problems, experts relate it to the Vioxx,” said Frederick Gerson, one of his attorneys.