Merck Faces First Hearing On Vioxx As Lawsuits MountNov 18, 2004 | USA TODAY
John Corran went to his doctor in April 2001 to get back pain checked. Just over two months later, the 64-year-old California man was found dead of a heart attack.
Keith Stubblefield, 37, complained to a Texas doctor about severe headaches and back pain in February 2001. One month later, he died of a heart attack.
Richard Irvin told his physician he had strained his back working as manager of a Florida seafood wholesaler in April 2001. One month later, Irvin, 53, collapsed from a fatal heart attack.
Three strikingly similar deaths, thousands of miles apart, linked by one common prescription. Each man died after taking doctor-prescribed Vioxx, the pain medication manufactured by Merck. The deaths are also among at least 300 personal-injury lawsuits that Merck said have been filed over Vioxx, which the firm withdrew Sept. 30 after company-sponsored testing showed it increased the risk of heart attack and stroke.
The growing volume of lawsuits prompted by the withdrawal along with multiple investigations that escalate with the first congressional hearing set for Thursday - by one estimate could pose as much as an $18 billion threat to the New Jersey-headquartered pharmaceutical giant.
The lawsuits are far from sure winners, say both Merck and lawyers who specialize in product-liability cases. Still, cases such as those filed by relatives of Corran, Stubblefield and Irvin, among the first moving toward trial, could help determine whether Merck knew about Vioxx health risks and failed to act decisively.
Lawyers for the families argue that company records obtained in pretrial proceedings show Merck knew of some signs of Vioxx danger well before the recall. But Merck general counsel Kenneth Frazier said Wednesday that it was only a week before the recall that the firm first learned about controlled clinical data documenting heightened risk of heart attack and stroke.
Before that, Frazier said, there was no conclusive evidence "that Vioxx was any different from placebos" with regard to questions of increased risk. To the contrary, he added, "There was a lot of data out there that showed Vioxx was similar to placebos."
Settling the conflicting arguments will be up to courts to decide, said Nancy Corran, who broke into tears last week as she recounted details of her husband's death.
"When you have a man who was perfectly fine one day, and dead the next, you've got to wonder whether it had something to do with any changes," Corran said. "The only thing different was that he was taking Vioxx."
The lawsuits target a much-prescribed controversial drug. Since its 1999 debut as a pain reliever without the gastrointestinal-related problems of some other drugs, Vioxx has been taken by an estimated 20 million Americans. The drug rang up $2.5 billion in sales for Merck last year, or 11% of its revenue. But it has also run up repeated safety questions.
A study published in the Journal of the American Medical Association in August 2001 warned that COX-2 inhibitors, the drug category that includes Vioxx, "raise a cautionary flag about the risk of cardiovascular events." Other studies subsequently sounded similar alarms.
Merck added a precaution about possible cardiovascular risks to the Vioxx label in 2002. Merck withdrew the drug from shelves after a clinical trial showed that someone taking a low, 25-milligram dosage of Vioxx for more than 18 months would be twice as likely to have a heart attack or stroke as someone taking a placebo.
Not typical victims
John Corran didn't seem like a typical heart attack candidate. His widow says Corran, a former insurance salesman, quit smoking 25 years ago, played basketball daily, built the couple's Piercy, Calif., dream home himself and ran a silk-screening business.
Although he'd never taken prescription medication on a continuing basis, Nancy Corran said her husband didn't seem to suffer any side effects after his doctor prescribed Vioxx for back pain.
"There was no heart disease in his family," said Corran, who added that her husband "was in a lot better shape than any of his friends."
She said the couple easily completed a five-hour canoe trip together on the Eel River in Northern California in May 2001. She was stunned when she returned home from a weekend camping trip with friends several weeks later and found her husband dead.
"I was hysterical," she said. "It just made no sense."
During the ensuing months, Corran said she noticed accounts about medical studies that raised concerns about Vioxx-related heart danger.
In all, 285 similar lawsuits against Merck had been consolidated in that court before the Vioxx withdrawal. Similarly, scores of other Vioxx cases have been consolidated in New Jersey Superior Court in Atlantic City. Merck recently asked a judicial panel to order all Vioxx cases filed in the nation's federal courts assigned to one judge.
Frazier said the company has a strong defense against the lawsuits, "and we intend to defend them vigorously." He stressed that the only definitive study documenting a Vioxx risk showed the danger occurred only after a person took a daily dosage for 18 months or more on a continual basis. If that standard is accepted by courts, relatives of Corran, Stubblefield and Irvin could find it difficult to win their cases.
Lawsuits face serious challenges
Such a move could raise legal hurdles for Kimberly Stubblefield. She was left to raise four children in Houston after her husband, Keith, the high school sweetheart she met while the two worked at a Jack in the Box eatery, collapsed and died in March 2001 while cleaning his SUV.
As his widow tells it, Stubblefield, an area manager for Captain D's Seafood, a restaurant franchise, "never really got sick" before he went to a doctor complaining of back pain. For the month before he died, Kimberly Stubblefield said her husband took a relatively high, doctor-prescribed dosage of Vioxx, 50 milligrams a day. Convinced that the drug caused his death, she filed a lawsuit.
"To go from being healthy and hardly ever being sick, to basically collapsing at the car wash, something had to be wrong," she said.
Some personal-injury lawyers, flooded with thousands of potential new Vioxx cases since the Vioxx withdrawal, have begun screening claims to select those most likely to withstand corporate defense challenges.
"The challenge will be distinguishing the good cases from the bad," said Scott Haworth, vice chairman of the New York State Bar Association's product-liability committee. "Both sides will delve into each plaintiff's medical history as they try to establish causation."
For Merck, the legal stakes are high. The company's stock has lost nearly 40% of its value since it closed at $45.07 a share the day before the Vioxx withdrawal. It closed Wednesday at $27.34. Earlier this month, the Food and Drug Administration released details from an agency memorandum that said Vioxx might have played a role in more than 27,785 heart attacks and deaths from 1999 to 2003. In a Nov. 3 report, Merrill Lynch estimated the company's potential legal liability could run as high as $18 billion. That estimate included up to $15.3 billion for serious cardiovascular payments, $1 billion to $2 billion for "nuisance" case payments and $1 billion in litigation-related expenses.
A subsequent Merrill report, written after Merck disclosed that it was the subject of new inquiries by the Department of Justice and the Securities and Exchange Commission, concluded that the firm "can continue to pay its dividend." Some plaintiff lawyers handling Vioxx cases are less optimistic.
"I think there are questions about future solvency here," Cartwright said.
Others under scrutiny
Merck isn't alone in the investigation spotlight. Today's scheduled hearing by the Senate Finance Committee also focuses on the company's federal regulator, the Food and Drug Administration. The panel wants answers to two questions: What did Merck and the FDA (news - web sites) know about Vioxx risks, and when did they know it?
In seeking answers, the committee has obtained some of the internal records and communications Merck provided as pre-trial discovery material to lawyers suing the firm. The committee plans to discuss them at today's hearing, with the aim of avoiding any violation of legal protective orders courts placed on the material.
Sen. Chuck Grassley, R-Iowa, the committee chairman, said, "Consumers should not have to second guess the safety of what's in their medicine cabinets. The public should feel confident that when the FDA approves a drug, you can bank on it, and if a drug isn't safe, the FDA will take it off the market."
Evelyn Irvin Plunkett says she wishes someone anyone had alerted her husband, Richard, to the concerns before he began taking Vioxx. The St. Augustine, Fla., man, a former University of Richmond football player, was "very physically active" unloading trucks and doing other work at his seafood business, she said.
The father of four, known as Dicky to family, friends and associates, didn't smoke, his widow said. He was constantly at Menendez High School, helping stage fundraisers and helping out at interscholastic sports. Both his parents are in their 70s, undercutting any attempt to argue he might have inherited heart disease, said Andrew Birchfield, the Alabama attorney representing Irvin's widow in a case filed in Palm Beach County Circuit Court.
Plunkett said she became convinced Vioxx killed her husband after reading a Newsweek magazine story that mentioned the 2001 study about Vioxx and potential health risks. During the years since, she said she's seethed over TV commercials that featured celebrities touting Vioxx.
When she heard Merck had withdrawn the drug from the market, Plunkett said she felt some measure of relief.
"Why did they wait so long? " she asked. "I just want the truth to come out, so that at some point Merck will admit they were wrong."