The final bill for Merck’s Vioxx fiasco is just beginning to be toted up and it’s sure to be a whopper. Before it pulled Vioxx off the market on September 30 because of the cardiac risks the painkiller could pose to long-term users, Merck faced hundreds of individual lawsuits and at least one class action filed on behalf of Vioxx users who allegedly suffered serious and sometimes fatal side effects from taking the drug.
Since then the legal soup has only gotten deeper and hotter for the Whitehouse Station company. Dozens more individual suits have been filed in state courts, as well as new class actions in federal court in Oklahoma City and Newark on behalf of all those who suffered serious health effects while taking the drug.
“The key liability issue is obviously to demonstrate whatever injury they had was caused solely by Vioxx,” says Fred Gerson, a Florham Park attorney who is co-counsel for the plaintiffs in 30 individual cases pending against Merck in state court in Atlantic City. While Merck declined to comment on the suits against it, a spokesman says the company believes it has “strong and meritorious defenses” to assert.
New Jersey is certain to be a key legal battleground. Last year all cases in state court claiming injuries from the drug were consolidated before Superior Court Judge Carol Higbee in Atlantic City. Her roster of cases had grown to 175 as of last month and lawyers say they expect it to swell rapidly. Because New Jersey is Merck’s home state, the company can’t shift cases filed against it in state court here to federal court. Sol Weiss, whose Cherry Hill law firm is handling 86 of the 175 cases before Higbee, says state court can offer plaintiffs quicker hearings for their claims and friendlier juries than federal venues.
With an estimated 84 million people having taken Vioxx worldwide, the pool of potential plaintiffs is vast. Local law firms have been trying to pull in business with newspaper and radio ads urging people who may have suffered cardiac problems while taking the drug to contact them to discuss their rights.
Lawyers involved in the cases say they expect the final cost to Merck to fall somewhere between the roughly $1 billion Bayer had agreed to pay 2,825 people who claimed adverse effects from the anti-cholesterol drug Baycol, as of August, and the more than $16.6 billion that Madison-based Wyeth had reserved, as of June 30, to cover claims from people who say they were harmed by its fen-phen diet drugs.
In explaining the decision to recall Vioxx, which had been generating annual sales of $2.5 billion, Merck executives said they acted promptly after receiving clear statistical proof from a rigorous clinical study that the drug posed a higher risk of heart attack and stroke for long-term users.
However, Merck had consistently challenged the results of three previous studies dating back to 2000 that had pointed to possible cardiac risks associated with Vioxx. Merck called those studies ambiguous or inconclusive. But in 2001 the FDA required the company to add a new warning of possible cardiac risks to its Vioxx labeling.
The question of how Merck handled the information it had on Vioxx will be critical to juries, says Andy Birchfield, a Montgomery, Alabama, lawyer whose firm is co-counsel to plaintiffs in 37 of the New Jersey cases. Birchfield says the big questions will be, “What did Merck know, when did it know it,” and whether “there has been a big cover up.”