In 1982, San Francisco lawyer Nancy Hersh took on the case of Maria Stern, who was suffering from debilitating fatigue and arthritis that her doctor suspected were caused by her silicone gel breast implants.
With experience handling medical malpractice cases relating to women’s health care, including lawsuits involving the cancer-linked drug DES, Hersh says she figured that “if we did a little background research (on implants), we’d probably find that little or no testing was done by the implant manufacturers. . . and they (implants) were nevertheless sold to women.”
So Hersh sent an associate, Dan Bolton, to the Midland, Mich. headquarters of Dow Corning Corp., the maker of Stern’s implants, with a standard request known legally as discovery to review the company’s files.
Bolton now says he suspects the company did not know what was in its own files. He found documents detailing scores of complaints from women about medical problems and warnings from the company’s own researchers, who suspected dangers and wanted to conduct more safety studies.
The papers, the first installment of what Stern’s attorneys refer to as Dow Corning’s “smoking gun” documents, would help Hersh win the Stern case in 1984, the nation’s first successful lawsuit against an implant manufacturer alleging autoimmune disease related to defective implants. The jury awarded Stern $1.7 million; Dow Corning appealed and later settled with Stern for an undisclosed sum.
After such a landmark ruling, Stern’s lawyers might have expected scores of women to follow Stern to court. But that didn’t happen.
The Dow documents remained sealed as part of the settlement. With little news coverage of the Stern case and other breast-implant lawsuits settled out of court, hundreds of thousands of women continued to be fitted with implants, unaware of potential dangers, the lawyers say.
Now, almost a decade later, an avalanche of litigation has begun.
Attorneys report that in the last year or so, at least 3,000 lawsuits have been filed against implant manufacturers and the plastic surgeons who inserted them. Thousands of other suits are expected, lawyers say, because of recent events that have raised public awareness about possible dangers of implants. These include four multimillion-dollar jury verdicts against implant manufacturers, including a record $25 million award against Bristol-Myers Squibb Co. last month by a jury in Houston; a federal Food and Drug Administration moratorium announced in January 1992 on silicone gel implants, except in controlled studies; and the release in February 1992 by Dow Corning of the “smoking gun” documents.
The current lawsuits charge that breast implants have caused problems such as painful hardening of breast tissue and chronic, debilitating autoimmune diseases including scleroderma, lupus and cancer.
The companies and many of the doctors who implanted the devices maintain that there is no evidence linking implants to serious disorders.
“We don’t believe implants present an unreasonable risk,” says Christy Meter, a spokeswoman for Dow Corning, which was the leading implant manufacturer before it pulled out of the business in March. The American Society of Plastic and Reconstructive Surgeons in Arlington Heights, Ill., in June released a six-page statement attributing fear about implants largely to “sensational media coverage” and “exaggerated” concerns of the FDA.
An estimated 1 to 2 million American women have received breast implants to enlarge their breasts or to reconstruct them, most often after mastectomies. An unknown number of foreign women also received American-made implants, and some are suing the companies in U.S. courts, according to attorney Sybil Shainwald in New York, who represents plaintiffs from the Netherlands, Australia and Germany.
Many women who are satisfied with their implants have defended them. Hundreds of women wrote and called the FDA in support of implants during its 1991 hearings.
Even before the explosion in litigation, women such as Hersh were among the first lawyers in the country to question the implant manufacturers.
Now, with more than 700 attorneys preparing for what one calls “a race to the courthouse” over breast implant cases, these women are among the most prominent lawyers in this field of litigation.
In recent interviews, six women lawyers, among them handling hundreds of breast implant cases, said they believe this litigation represents another shameful example of a poor U.S. record on women’s health.
Now these lawyers stand to gain a lot of money. Generally in product liability cases, they get no fees upfront, but earn a one-third portion of any verdict or settlement, though the arrangements may vary, according to Shainwald.
But the lawyers interviewed say that the steady stream of chronically fatigued and often terrified women who come to their offices represent a lot more than a potentially big payoff in a few years. These clients have hammered home the message, as lawyer Margaret Moses Branch of Albuquerque, puts it, “That we have absolutely got to do something about our health care for women in this country.”
The following contacts may be of help to women with implants: Command Trust Network, a national self-help group, 310-556-1738; Public Citizen, a Washington consumer group, 202-833-3000; FDA’s breast implant information line, 800-532-4440. (To report a problem with implants to the FDA, 800-638-6725.
International Breast Implant Registry, run through the Medic Alert Foundation, a non-profit organization in Turlock, Calif.: Women can register for a $25 fee to receive implant information updates; telephone 800-892-9211.
