The largest medical product liability settlement in history--a $4.25-billion deal for women with silicone breast implants--formally died Monday as a federal judge in Birmingham, Ala., announced that three corporate defendants were proposing a new agreement for a smaller group of women.
Although details of the agreement are still being hammered out under the supervision of U.S. District Judge Sam Pointer, attorneys for both plaintiffs and defendants said that women who participate in the deal would get substantially less money than they would have under the original pact, which has been imperiled for months. That settlement had a payment grid ranging from $100,000 to $1.4 million, depending on the extent of a woman's injuries.
"This deal is a debacle--it's shameful," said Sybil Goldrich, co-founder of the Command Trust Network, the largest support group for implant recipients. She said the new offer is not nearly as good as the original one and predicted that thousands of women would decline to participate and take their chances with lawsuits against the companies.
That could place a great strain on the court systems of several states, including California's, according to Roman Silberfeld, a Los Angeles attorney whose firm represents 750 women who say they were injured by their implants.
Under the new deal, Baxter Healthcare Corp., Bristol-Myers Squibb and Minnesota Mining & Manufacturing Co. would pay American women with implants from one of those companies fixed amounts ranging from $5,000 to $500,000, depending on the medical problems they can document, sources said. Final details are expected to be released by the judge by week's end, and the women would be given 30 to 90 days to decide whether to accept it.
This proposal has no immediate impact on women whose claims against Dow Corning Inc.--the largest producer of silicone implants--are in limbo because the company is in bankruptcy proceedings and therefore must work out a separate settlement under bankruptcy court supervision.
According to a statement released by Pointer's office, women who submitted claims by Sept. 16 that they have current injuries would have two options.
Under the first, they could accept a fixed amount based on disease criteria and severity levels in the original settlement. Under the second, women could elect to receive potentially higher benefits "based on having or developing during a 15-year period certain diseases that meet more restrictive criteria." Both groups of women would get an initial $5,000 as soon as administratively feasible, sources said.
Women who registered to be part of the original settlement but are not claiming current injuries "would receive compensation if, during the 15-year period, they develop any of the diseases defined under the more restrictive criteria," according to Pointer's announcement. The announcement is available to the women at (800) 887-6828. Those women also would receive an additional payment to defray the costs of removing implants during that 15-year period if they chose to do so.
The new proposal provides that if a woman with a current qualifying disease agrees to participate, she would get some money. Under the old proposal, the companies could opt out if too few or too many women decided to participate.
Thousands of women claim that their implants cause a variety of maladies, including lupus and auto-immune disorders. The manufacturers dispute these allegations, pointing to several studies that failed to show linkage between implants and diseases. However, the women and some scientists have said the studies were based on inadequate data and that the women developed diseases that did not fit into traditional criteria.
Details of the disease criteria in the companies' new proposal were not released Monday, nor were the amounts that women would receive if they got particular diseases. But plaintiffs' attorneys panned the deal.
"I think that this settlement will be rejected almost across the board," said Houston attorney Mike Gallagher, who represents about 1,000 implant recipients and is a member of the plaintiffs' steering committee that negotiated the original settlement.
"This proposal is designed to offer women a de minimis amount of money up front--$5,000--to get them into the settlement corral so that the companies don't have to deal with them on the open range," Gallagher said. "I'm going to tell virtually 100% of my clients to reject this deal and take their chances on the open range," meaning a lawsuit, Gallagher said.
Margaret Branch of Albuquerque, N.M., a member of the plaintiffs steering committee, predicted that a majority of women nationwide would participate in the deal in order to avoid lengthy and potentially wrenching litigation.
The original deal ran into serious trouble in mid-May when Dow Corning, the largest contributor to the settlement, filed for bankruptcy protection, jerking $2 billion out of the pact. During the summer, Pointer said the deal would have to be drastically changed because many more women than expected had registered for the settlement, causing the benefit levels to be driven down too far to keep the settlement intact unless the companies put in a lot more money.
Further negotiations in recent weeks did not produce enough additional funds to satisfy the plaintiffs, leading to the scaled-down offer, sources said.
A lawyer for one of the companies said "the dollar amounts being guaranteed are realistic for the first time." Spokesmen for the three companies declined detailed comment, pending approval by their boards of directors.