Vioxx Recall May Bring Flood of Suits to Merck

Published: October 5, 2004

Last week's decision by Merck to halt sales of Vioxx, its blockbuster painkiller, could lead to an onslaught of new lawsuits against the company.

Hundreds and perhaps thousands of new Vioxx lawsuits are likely to be filed, lawyers said, with many of them class actions that aim to represent large groups of Vioxx users who have taken the drug for extended periods. Indeed, radio advertisements seeking plaintiffs are being broadcast and some suits were filed almost immediately after Merck's recall announcement on Thursday.

"Our lawsuit was in the works but the filing was accelerated by the recall," said Don S. Strong, a lawyer who filed a suit against Merck on Thursday in the United States District Court in Oklahoma City.

"The recall makes our burden of proof easier," Mr. Strong said, "because it validates what our experts have been telling us for several months." The lawsuit says that Mr. Strong's client suffered ministrokes and a number of heart problems from taking Vioxx.

But some experienced product liability lawyers say a new wave of litigation may not necessarily be more distracting for Merck than the suits that are already working their way through the courts.

Assuming the Vioxx cases follow the pattern of other major product liability battles, a surge in lawsuits could well encourage court-ordered consolidation of the litigation, hastening its resolution.

Whether the decision to recall the product ends up undermining Merck's legal defenses or improving its image to juries is less predictable, according to legal experts.

"Both sides will try to spin this in their favor," said Vincent S. Walkowiak, a Dallas lawyer who has worked for Merck in other cases but is not involved in the Vioxx litigation. "The plaintiffs will say this is confirmation of Vioxx's dangers and Merck will use it to establish that it is behaving responsibly."

While declining to comment directly on the legal impact of Vioxx's withdrawal, Theodore V. H. Mayer, a lawyer at Hughes Hubbard & Reed, a firm retained by Merck, said the company "continues to believe it has strong and meritorious defenses to the lawsuits brought against it."

Hundreds of lawsuits had been filed against Merck, which is based in Whitehouse Station, N.J., long before last week's recall decision. The lawsuits blame Vioxx - currently used by about 1.3 million Americans and 700,000 arthritis sufferers in other countries - for heart attacks, strokes and other health problems.

They also charge that Merck's aggressive marketing of Vioxx failed to disclose adequately the information the company had about those risks and that Merck did not diligently pursue research into the hazards of Vioxx. Some of the lawsuits include drug distributors and doctors as co-defendants.

The decision to recall Vioxx could have an impact on whether the drug is found to be defective, according to Mr. Walkowiak.

Some states have statutes that create a presumption that there is no defect in drugs and drug labels that have been approved by the Food and Drug Administration; Vioxx had such approval. It is unclear, though, whether courts will rule that the Vioxx recall eliminates such presumptions.

If Vioxx is found to be defective under certain state laws, the timing and the circumstances of the recall could become a factor in determining whether Merck behaved so negligently or recklessly that it should pay punitive damages. State laws will be used to determine liability, regardless of whether a case is in state or federal court.

"It frames the issue for a jury," Mr. Walkowiak said.

Merck announced that it would withdraw Vioxx from the market after it learned on Sept. 23 that the drug's users were twice as likely to suffer heart attacks or strokes as test subjects receiving a placebo. The data came to light in a major clinical trial that Merck had hoped would show that Vioxx could help prevent colon polyps, which can become cancerous.

Merck had contested all previous reports that Vioxx was dangerous, contending they were based on faulty or inconclusive research.

Several lawsuits have been filed since Thursday, including a class action against Merck Frosst, the Canadian subsidiary of Merck, brought by a consumers' group in Quebec. Some lawyers, including those who had filed suits against Merck before the Vioxx withdrawal, said that they already had plenty of evidence of the drug's dangers before last week's announcement.

"The evidence is no better," said Robert E. Cartwright Jr., a San Francisco lawyer whose lawsuits against Merck are among approximately 285 similar cases that have been consolidated before a single California state judge in Los Angeles.

"It was just a matter of time before the recall occurred," said Mr. Cartwright, whose first case was filed in March 2002.

One Vioxx case brought by a plaintiff in Alabama is scheduled for trial in December.

The withdrawal of Vioxx leaves numerous unanswered questions about the extent of the risks it poses. Some plaintiffs could ask Merck to finance more research into the effects of the drug.

The most serious health risks associated with Vioxx seem to appear after consumers have been taking the drug for 18 months or longer. Merck said yesterday that it was still looking into how many Vioxx users fell into that group. More than 105 million Vioxx prescriptions have been filled for about 20 million consumers since the drug was first sold in August 1999, according to the company.

Vioxx's $2.5 billion in sales accounted for about 11 percent of Merck's revenue last year and, according to analysts' estimates, about $1.2 billion, or 18 percent, of its earnings. The crucial role Vioxx plays in Merck's portfolio was apparent last week when Merck's shares plunged 27 percent to $33 after the withdrawal announcement.

Since then, shares of Merck have rebounded modestly. They rose 92 cents yesterday, to $34.23.

Copyright 2004 The New York Times Company