NEW YORK — In a major step toward resolving health claims against the diet drug combination fen-phen, drugmaker American Home Products said just 1 percent of the drug's users have opted out of a multibillion dollar settlement.
Nearly 6 million people took fen-phen before it was pulled from the market in 1997 due to links with serious heart problems, but just 45,000 of them have elected to refuse the $3.75 billion settlement, American Home said Thursday, adding it has decided to go ahead with the deal.
March 30 was the deadline for fen-phen users to opt out. Those who did so retain the right to sue American Home for punitive damages. If too many people had opted out, American Home could have scrapped the settlement.
The deal, reached last October, would pay individual fen-phen users up to $1.5 million. Most, however, would get far less, depending on their level of injury and how long they took the drugs. It includes money to pay patients who say they were injured by the drugs and for future medical monitoring for those who are still healthy.
So far more than 9,000 suits have been filed against American Home by fen-phen users, imposing a major obstacle for the company as it tries to win back trust of investors who have seen its stock drop because of the litigation and problems with other medicines.
The litigation has also hurt the company's efforts to find a merger partner. American Home lost its bid to buy rival Warner-Lambert Co. in part because of uncertainty surrounding the diet drug litigation.
The national settlement still must be approved by a judge. A hearing is scheduled in federal court in Philadelphia on May 2.
Madison, N.J.-based American Home made fenfluramine, the "fen" in the fen-phen combination, and gave the drug a brand name of Pondimin. It also made Redux, a chemical cousin. In September 1997, the drugs were removed from the market after a Mayo Clinic study linked fen-phen to potentially fatal heart valve damage. The second drug in the combination, phentermine, is still on the market.
The settlement is open to anyone who used fen-phen and Redux in the United States, whether or not they filed suit.
"The number of opt outs is well within the expected range for a nationwide settlement of this magnitude and the company is confident that it can continue to manage this level of opt outs," said Louis Hoynes Jr., American Home's senior vice president. The company said most of those who opted out of the deal aren't sick.
Most of the opt-outs have yet to sue American Home, raising the prospect of thousands of new suits.
However, the company showed little concern about this.
"Experience with litigation of these types suggests that such opt outs have generally weaker claims and also may be subject to statute of limitations defenses," American Home said in a statement.
About 200,000 drug users registered to participate in the settlement and many more are expected since a deadline for registration hasn't yet been set.
"We believe the response to this settlement represents an overwhelming endorsement of the settlement as a fair and appropriate way to remedy the health problems caused by AHP's diet drugs," said Arnold Levin, a plaintiff attorney who helped negotiate the settlement.