By: Helen Lucaitis
Chicago Daily Law Bulletin
January 15, 1992
Lawyers already are calling silicone breast implants the Dalkon Shield of the 1990s.
Spurred by last week's Food and Drug Administration request that doctors stop using the implants until safety data can be reviewed, lawyers are laying the groundwork for potential lawsuits. The FDA's concern is over the health dangers of silicone leaking from the implant into a woman's body.
A small number of lawyers who for the last few years have handled these cases are getting flooded with calls. And other lawyers are trying to drum up business.
Less than 48 hours after the FDA's action, billboards of lawyers advertising, "Do you have breast implants? If so, call ...We can help you," started popping up in California and in the Southwest.
There's also the Breast Information Clearing House that potential plaintiffs can call. Started in 1988 by Ralph Nader's Public Citizen Health Research Group, the clearinghouse sends callers a list of about 70 plaintiffs' lawyers who might represent them. Lawyers pay the clearing-house $750 for a spot on the list.
"There's a lot of effort on the part of the plaintiffs' bar in stimulating women to start litigation," according to Michael E. Reed, general counsel for the American Society of Plastic and Reconstructive Surgeons, based in Arlington Heights.
In September, the society assessed its members $1,000 each, collecting $4 million used to lobby the FDA to keep implants on the market.
But some of the nearly 2 million women who have silicone implants want the implants off the market.
Attorneys say the women have complained of problems for some time but were discouraged from filing suits.
"A lot of attorneys were skeptical. They were waiting for the FDA decision before filing suit," according to Kenneth B. Moll, a lawyer with McDowell & Colantoni in Chicago.
Before Monday, there were about 500 claims nationwide brought by women who blame leaky silicone implants for their illnesses, according to Moll.
Moll, who himself represented about 50 women with claims as of Sunday, said he is now weeding through a stack of phone messages from women wanting to file suit.
Dow Corning Corp., the biggest producer of silicone-gel, is the target of almost every lawsuit filed so far. The California-based corporation has seen a increase in lawsuits, but Dow Corning spokesman Scott Seyberger declined to say by how many.
"Considering the number of implants are in the public there have been very few lawsuits," Seyberger said.
"We have seen an increase in lawsuits during this public controversy. We are confident of our 30 years of research," he said.
The plastic surgeons' association saw a significant increase in lawsuits after a television show last year that focused on women claiming they got sick following implant surgery, said Reed.
In two recent implant suits against manufacturers, a California woman won a $7.3 million verdict, and a Alabama woman won $5.4 million, both mostly in punitive damages.
While not life threatening, implant leaks have deposited silicone in women's brains, lungs and uteruses, Moll said. Leaked silicone typically lodges in connective tissue, which produces arthritic-like joint pain. The body's "scavenger cells," which normally breakdown foreign substances, cannot digest silicone.
"In one Illinois woman, it's coming out of her skin because it has hardened," according to Moll.
Moll belongs to the 40-member Breast Implant Litigation Group, sponsored by the American Trial Lawyers Association. The group, made up of lawyers who have been handling implant cases, helps them network. They are meeting in Boca Raton, Fla., this week to swap stories and plot strategies.
"We are forced to be a close-knit group," Moll said. Only a handful of rheumatologists have diagnosed illnesses resulting from implants, and only a few plastic surgeons remove leaking implants, he said.
Most of the lawsuits filed so far name the manufacturers of the implant envelope and the silicone gel as defendants. Fewer than 10 companies manufacture the implant itself.
Lawsuits appear to being (sic) going after mostly manufacturers. But Connecticut attorney Karen Koskoff, who has filed six suits so far and has a growing list of clients, plans to name plastic surgeons as defendants in almost every case she files.
"If you look at package inserts that accompany implants, it's sort of a disclaimer. None of the physicians ever told [their patients] about the inserts," Koskoff said.
Koskoff, 37, was diagnosed with breast cancer two years ago and had implant surgery after having a mastectomy. She recently had the implants removed. Koskoff, also a member of the Breast Implant Litigation Group, testified at the FDA hearings about the perceived dangers.
The plastic surgeon association's Reed said he knows of only one case where the plastic surgeon was named as a defendant in a suit. There is no evidence yet that plastic surgeons failed to communicate information to patients, Reed said.
Moll has already received phone calls from out-of-state attorneys wanting to start a class-action suit against the manufacturers of implants and silicone gel, he said. For now, Moll is filing individual suits for his clients.
"Each product is different, each manufacturer is different. But one thing is the same: Dow Corning manufactured the gel, and they are the big culprit," he said.
In addition, Moll said he is considering filing a class-action suit against the FDA for failing to inform women of the dangers of the implants.
While many of manufacturers' documents are under protective order, what appears to be damaging evidence to manufacturers is an office memorandum written by a manufacturer's employees acknowledging leaks could occur and could be harmful, according to Moll and Koskoff.
Claims seem to fall into two categories, "low-bleeders" and "high-bleeders," according to Moll. The less serious cases, alleging little injury, are settling as low as $20,000. The more serious cases involve claims of one of three resulting illnesses: Human adjuvant disease, connective tissue disorder or autoimmune deficiencies, Moll said.
"If you have a diagnosis of any one of the three by a rheumatologist, you can get $400,000 to $900,000," he said.
Federal regulation of breast implants began in the 1970s under the Medical Devices Act, which required manufacturers of certain medical devices to first obtain a pre-market approval of the device's safety, unless another method could be shown to prove safety. However, devices that were already on the market, like breast implants, were exempt.
Last year, the FDA ruled implants were no longer exempt, and gave manufacturers until July 1991 to seek safety approval. Last week's action gives the FDA an indefinite time to evaluate the safety of the implants.