Lawsuits about breast implants tell a fascinating story about how false perception of side effects became courtroom reality. Co-author Dr. James Watson.
The 22-year history of breast implant litigation provides us with a most important lesson. Specifically,
scientific study must preceed commerce and marketing.
Even if the scientific data is provided “after the fact”, it does not stop a legal disaster from unfolding. The lack of this data in the 1990s led to a 14-year ban on silicone gel implants, billions spent in two class action suits, over 20,000 individual lawsuits, and the temporary collapse of an entire industry. The following attempts to summarize this story:
1977: A Houston attorney won the first breast implant lawsuit for a Cleveland woman who claimed her implants had caused pain and suffering. She received a $170,000 settlement from Dow Corning and the case received little publicity.
1980s: Raph Nader’s Public Citizen Research Group sent out warnings that silicone breast implants cause cancer.
1984: A California attorney won a case for Maria Stern who claimed that her autoimmune disease was caused by her breast implants. Evidence was introduced from Dow Corning’s own internal documents that they had been aware of high rupture rates and gel bleed with the 2nd generation implants. “Expert witnesses” theorized the silicone–immune link for the first time. The San Francisco court awarded $211,000 in compensatory damages and $1.5 million in punitive damages.
1990: A television program, “Face to Face with Connie Chung” aired, discussing the dangers of silicone gel filled breast implants. Public concern mounted, and a Congressional hearing was held on the safety of breast implants.
July, 1991: Dow Corning released 329 studies to the FDA. In a separate lawsuit against Baxter/Heyer-Schulte, an Alabama court awarded a $5.4 million settlement to Brenda Toole, who showed only preliminary symptoms of systemic autoimmune disease, but had silicone in her lymph nodes. “Expert witnesses” stated that she was thus at increased risk of developing autoimmune disease.
December, 1991: Attorney Dan Bolton, who won the case for Maria Stern, won another case for Mariann Hopkins who claimed that her mixed connective tissue disease was linked to her ruptured silicone breast implants.
February, 1992: A class action lawsuit was filed in Cincinnati by Stan Chesley. The hope was to compensate women at a faster rate than filing individual lawsuits. The FDA Panel recommended that the further use of silicone implants be limited for reconstruction only. The panel also concluded that no causal link has yet been established between autoimmune disease and silicone breast implants.
March, 1992: Dow Corning, Bristol-Myers Squibb and Bioplasty all left the breast implant business. Dow Corning set up a fund for further research into the safety of breast implants.
April, 1992: The FDA placed a ban on the use of silicone breast implants outside of an FDA-approved research study. The only women allowed to receive implants were those undergoing breast reconstruction. All of the implant recipients must become part of a scientific protocol.
March, 1994: A class action lawsuit was finalized by the manufacturers, including Dow Corning, Baxter, Bristol-Meyers Squibb/MEC, and 3M. At $3.4 billion, it was then the largest class action lawsuit in history. Women would be allowed to drop out of the settlement if they choose. Companies could also “opt out” if too few women register claims.
June, 1994: Mayo Clinic epidemiologists published a report in the New England Journal of Medicine which finds no increased risk of connective tissue disease in women with silicone breast implants.
1995: The American College of Rheumatology issued a statement that the evidence is “compelling” that implants do not cause systemic disease.
May, 1995: Dow Corning filed for Chapter 11 Bankruptcy, with over 20,000 individual lawsuits pending. Over 410,000 have filed claims in the class action settlement. The bankruptcy essentially halted all litigation.
November, 1995: A new global settlement was developed without Dow Corning.
December, 1995: More than 20 scientific studies and abstracts have been published showing no causal relationship between silicone implants and a variety of auto-immune diseases.
September, 1996: The California Court of Appeals upheld a decision dismissing Dow Corning from 1,800 lawsuits.
December, 1996: An Oregon Federal Judge ruled that plaintiff’s lawyers cannot present evidence that silicone implants caused disease because it is scientifically invalid. Seventy claims were dismissed.
January, 1997: The American Academy of Neurology reviewed existing studies and reported that there is no link between silicone breast implants and neurological disease.
March, 1997: A Michigan Judge ruled that Dow Corning is not liable for hundreds of women in the state.
September, 1997: The Journal of the National Cancer Institute published a review of scores of medical studies that concludes breast implants do not cause breast cancer. The researchers described the evidence for linking implants to any other disease as "borderline."
April, 1998: Two large scientific studies failed to show that silicone implants are linked to neurological disease.
December, 1998: After two years and $800,000, a panel of four independent experts appointed by Judge Sam C. Pointer, overseer of implant lawsuits in the Federal courts, concluded that scientific evidence so far has failed to show that silicone breast implants cause disease.
June, 1999: The Institute of Medicine released a 400-page report prepared by an independent committee of 13 scientists. They concluded that although silicone breast implants may be responsible for localized problems such as hardening or scarring of breast tissue, implants do not cause any major diseases such as lupus or rheumatoid arthritis. The Institute of Medicine is part of the National Academy of Sciences, the nation's most prestigious scientific organization. Congress had asked the Institute to set up the committee.
August, 2004: August of 2004 was the deadline for registering for the re-negotiated global settlement with Dow Corning, which they established after coming out of chapter 13 bankruptcy. By this time, most all individual lawsuits against Dow Corning had been thrown out or dropped. The breast implant litigation era ended with little media fanfare.
November, 2006: The FDA lifted the ban on silicone gel filled implants, 14½ years later. By now, silicone implants sold are “4th generation” implants which are much improved over the “2nd generation” implants with the thin walls and high “gel bleed” that led to all the media attention. The further improved “5th generation” implants are still not FDA approved, but are available in other countries.
