Tort Law

Breast Implant Lawsuits

When a company produces a dangerous or defective product that injures an individual, the injured person may sue the company in a products-liability tort action, demanding compensation for the injuries. To prevail in a products-liability action, the plaintiff must demonstrate that the injury-causing product was defective, that the defect existed at the time the product left the control of the defendant, and that such defect was the proximate cause of the plaintiff's injury. If many individuals have been injured by the same product, the court may permit the filing of a CLASS ACTION lawsuit, in which a small number of plaintiffs represent the entire group of injured victims.

One of the more controversial class actions involved the silicone breast-implant litigation. Notwithstanding a class totaling more than 400,000 plaintiffs, a settlement that offered more than $3 billion in compensation for their alleged injuries, and a federal government ban on the product, no evidence was ever provided that conclusively linked silicone breast implants with any form of serious disease. In fact, following the settlement at least two scientific studies affirmatively concluded that no such link exists. In the wake of those studies, manufacturers have sought government approval to resume selling silicone breast implants to the public.

In 1962 Dow Corning became the first company to manufacture and market silicone breast implants. The implants consisted of a rubbery silicone envelope containing silicone gel. Plastic surgeons soon discovered that a certain (and as yet undetermined) percentage of implants rupture on their own, either because of trauma to the breast or because the implant simply tears. In many cases, the gel stays either in the implants or in the immediate vicinity. In rare cases, the gel may migrate through the body. Moreover, the implants themselves are permeable, and minute amounts of silicone gel can seep through the implants and remain in nearby tissue or migrate throughout the body.

For many years, breast implants were essentially unregulated by the government. The FOOD AND DRUG ADMINISTRATION (FDA) did not have jurisdiction over medical devices, including breast implants, until the 1976 Medical Devices Amendment to the Food, Drug and Cosmetic Act (MDA) became law. The MDA "grandfathered-in" existing devices, such as breast implants, allowing them to remain on the market until the FDA could classify and regulate them. In 1982 the FDA proposed classifying silicone-gel breast implants as Class III devices, the most stringently regulated category. The FDA expressed concern about the scar tissue that forms around the implant, about potential long-term toxic effects of silicone that might leak from the implants, and about possible health effects from the silicone polymers from which the implant shells were made.

That same year Maria Stern filed the first silicone-breast-implant-related PRODUCT LIABILITY suit against Dow Corning, Inc., after her implants ruptured. Testifying before a jury sitting in the U.S. District Court for the Northern District of California, Stern said that she suffered from chronic fatigue and joint pains before and after the implants were removed. Although her doctors speculated that Stern's problems had been caused by the silicone migrating throughout her body, they offered no valid scientific proof of causation. However, Stern did demonstrate that the company had acted irresponsibly by failing to conduct any research into the possible ill effects of silicone on the human body despite evidence that Dow Corning knew that implants could leak and rupture. A jury found for the plaintiff and awarded Stern $200,000 in damages. The jury also awarded her $1.2 million in PUNITIVE DAMAGES. After the trial judge upheld the awards, the case was settled before appeal for an undisclosed sum, and the record was sealed.

The media did not immediately pick up on the Stern settlement or the smattering of similar lawsuits that were pending in state and federal courts around the country. After several relatively uneventful years following a series FDA hearings in the late 1980s, however, NBC aired an episode of Face to Face with Connie Chung which focused on the dangers of breast implants. The December 1990 show frightened and outraged thousands of implant recipients. Chung referred to silicone gel as "an ooze of slimy gelatin that could be poisoning women." She interviewed several women who blamed implants for causing their auto-immune diseases, but Chung never questioned the presumed link. Chung concluded the segment by showing viewers pictures of Sybil Goldrich, whose chest had been disfigured by operations to remove her implants.

On July 9, 1991, a deadline expired for implant manufacturers to prove the safety of their product to the FDA, and no manufacturer offered any convincing proof on the matter. A year later the FDA ordered that silicone breast implants be removed from the market. Thereafter, the number of breast-implant lawsuits filed against manufacturers rose dramatically. By 1992 plaintiffs had filed 3,558 individual lawsuits against Dow Corning alone. In June 1992, the federal Judicial Panel on Multidistrict Litigation certified a multi-district class-action lawsuit against the major implant manufacturers, including Dow Corning, Bristol-Myers Squibb, Baxter International, and Minnesota Mining & Manufacturing Co.

In September 1993 the parties tentatively agreed to settle the class-action products liability lawsuit for $4.75 billion. But settlement ultimately collapsed after 440,000 women registered for the settlement, forcing Dow Corning, the largest contributor to the settlement, to file for BANKRUPTCY in 1995. On November 30, 1998, U.S. Bankruptcy Judge Arthur Spector approved Dow Corning's $4.5 billion plan to emerge from bankruptcy, which included $3.2 billion to settle implant claims with more than 170,000 women. Eventually, the other implant manufacturers entered similar settlement agreements with most of the remaining plaintiffs. More than 90 percent of the eligible class-action plaintiffs accepted the defendants' settlement offers. The remaining plaintiffs opted-out of the class settlement, which allowed them to sue the defendants individually.

A little more than a year after the class action was settled, a scientific panel appointed by the court overseeing the settlement released the results of its breast-implant study, finding that there was no sufficient scientific basis to link silicone implants to cancer, connective tissue diseases, immune system dysfunctions, or any other disease. On June 21, 1999, the Institute of Medicine of the National Academy of Sciences issued a congressionally funded report that reached the same conclusion.

In March of 2003 two California-based companies announced their desire to re-introduce silicone breast implants into the stream of commerce, and the FDA agreed to hold safety hearings and reconsider its ban on the product. The potential return of silicone gel-filled implants came at a time when more women were looking to increase their breast size: the American Society of Plastic Surgeons reported more than 206,300 breast augmentations in 2001, up from about 32,600 in 1992.