Since Merck withdrew its blockbuster painkilling drug Vioxx from the market last September, saying it increased the risk of heart attacks and strokes, the company has been deluged by lawsuits. One law firm alone, alone, among hundreds across the nation handling Vioxx cases, has received more than 10,000 inquiries from the drug.
The Vioxx Fiasco-including a surprise recommendation by a Food and Drug Administration panel to return the drug to the market-has put a spotlight on drugmakers’ practices and the government’s role in monitoring them. But the stakes for Americans who have taken the drug over the years, oblivious to its risks, are purely personal. Were those chest pains-or worse-due to Vioxx or other factors?
In the coming months, the lawsuits- 850 were already filed by Jan/ 31-will put Merck’s actions under intense scrutiny. The company says it will mount a “vigorous” defense. “Merck acted responsibly ever step of the way,” the company said in a statement, “from researching [Vioxx] prior to approval-to monitoring the drug while it was on the market- and the voluntarily withdrawing the drug when it did.”
Attorneys who have filed suits contend that studies showing an increased cardiovascular risk in Vioxx go back as for as March 2000, less than a year after the drug was launched. So a key issue in court will be the classis one, “what did Merck know and when did they know it?” says Arthur LaFrance, an expert on health law and visiting professor at the University of Houston law school.
For individual claimants, the question will be, “Did Mr. Smith have his heart attack as a result of Vioxx or because genetic or lifestyle or other issues?” says James O’ Reilly, an authority on drug safety law and a professor at the University of Cincinnati College of Law.
“We certainly expect this to be defense that Merck poses,” says Andy D. Birchfield Jr., an attorney with Beasley Allen, a law firm in Birmingham, Ala. that has filed many Vioxx suits. “But in most jurisdictions, you don’t have to prove that Vioxx was the sole cause-just a contributing case. From the clinical studies, we know that Vioxx [increases risk of] heart attacks and strokes.” Still, he adds, if someone developed such problems several months or years after stopping use of the drug, “it was probably not Vioxx-related.”
O’ Reilly and LaFrance say that people thinking of claiming damages against Merck need to consult their doctor before hiring a lawyer. Because of the legal difficulties in establishing “causation,” they should join a lawsuit “only if their physician is clearly going to support the view that Vioxx caused the injury,” Lafrance says.
Hundreds of individual and class action Vioxx lawsuits filed across the country have recently been consolidated into one huge federal case in New Orleans. The whole process, experts say, could take several years.
The outcry against Merck- which spent an estimated $500 million advertising Vioxx during the past five years-has raised some important questions. Did the FDA fail to protect public health by not closely scrutinizing medicines already on the market? (The agency now plans a new drug safety board to remedy that.) And to what extent does television advertising cause powerful drugs to be overprescribed?
In an unexpected twist in February, an FDA advisory panel of 32 doctors narrowly voted, 17 to 15, to recommend Vioxx’s return to the market. However, they said, Vioxx and its competitors, Pfizer’s Celebrex and Bextra, should be sold only with the strongest possible “black box” warning labels, and should not be advertized directly to consumers. Such advice, if accepted would limit prescriptions to the relatively small number of people with gastric problems who actually need this type pain killer.
Birchfield says that even if the FDA does not allow Vioxx to return, it will not have much effect on the lawsuits. “An argument we’ve been making for a long, long time is that the [Vioxx] labels warning to doctors and patients was inadequate,” he says. “So in that sense it bolsters our claim.”