"The unacceptable cardiovascular risks of Vioxx were evident as early as 2000," Lancet editor Dr. Richard Horton wrote in a commentary. He faulted Merck for "astonishing failures" in monitoring the safety of its drugs and the U.S. Food and Drug Administration for "lethal weaknesses" in oversight.
A federal judge in Alabama has ruled that Merck needed to be ready for trial after Dec. 13 in a case brought by William Cook, a retired miner who had been taking Vioxx for about a year when he suffered a heart attack in 2000. The case was filed before Merck pulled Vioxx from the market. However, Merck filed a motion with the Judicial Panel on Multidistrict Litigation in Washington, D.C., to consolidate all the federal cases in one jurisdiction, which could delay Cook's trial, according to his lawyer, Andy Birchfield.
Cook declined to be interviewed.
The case that goes to trial first will be closely watched by other plaintiffs and their lawyers, who are hoping for a precedent that could set a pattern for future lawsuits. Fordham University law professor Benjamin Zipursky suggested the perfect patient for plaintiff lawyers would be a young person who took Vioxx for 18 months and had no other conditions that might trigger a heart attack or stroke. That would make it easier to prove Vioxx caused the plaintiff's illness and a big settlement might push Merck to settle more cases.
However, many patients taking Vioxx for arthritis were older people who are generally more prone to heart attacks and strokes, so establishing the connection between their illnesses and the drug could be difficult.
"The more common the adverse effect, the more difficult the case could be to win," said Frank McClellan, a law professor at the Beasley School of Law at Temple University in Philadelphia.
It's not clear how helpful Cook's case will be to either side. Cook, who is 50, had a sedentary lifestyle before his heart attack due to a back injury. Doctors consider a sedentary lifestyle to be a contributor to heart disease.
Other drugs that were taken off the market and the subject of numerous lawsuits such as Bayer AG's cholesterol drug Baycol and Wyeth's diet drugs Pondimin and Redux caused uncommon injuries that made proving liability easier.
Wyeth took its drugs off the market in 1997 and has paid out $13.6 billion in legal fees and settlements of its $16.6 billion reserve -- believed to be the biggest amount ever paid by a pharmaceutical company over a problem drug.
Baycol was withdrawn in 2001 and Bayer has paid out $1.09 billion so far.
