Newspaper article St Louis Post-Dispatch (MO)

Ignoring Truth on Implants in Court $4.25 Billion Settlement Wasn't Based on Evidence

Newspaper article St Louis Post-Dispatch (MO)

Ignoring Truth on Implants in Court $4.25 Billion Settlement Wasn't Based on Evidence

Article excerpt

SCIENCE ON TRIAL

The Clash of Medical Evidence and the Law in the Breast Implant Case

By Marcia Angell 256 pages, W.W. Norton, $27.50 ***** `SCIENCE ON TRIAL" provides an illuminating, fascinating and chilling account of the subordination of scientific truth and the public good to the greed and avarice of plaintiff attorneys in the breast-implant case. Silicone gel breast implants came into usage in 1962. During the next 30 years, one million to two million women underwent the procedure - approximately 80 percent for cosmetic purposes and about 20 percent for reconstruction following breast cancer surgery. In 1985, concern began to rise that silicone-gel breast implants might produce connective tissue diseases, a group of systemic illnesses such as rheumatoid arthritis and scleroderma. In 1992, the Food and Drug Administration banned the device because the manufacturers had not demonstr ated its safety. This ban triggered a torrent of lawsuits and huge jury verdicts, which in 1994 resulted in a $4.25 billion class-action settlement against the largest supplier, Dow Corning, and several other manufacturers. The settlement quickly unraveled, and in May 1995 Dow Corning declared bankruptcy. The most astonishing aspect of the legal proceedings surrounding this case, according to Marcia Angell, executive editor of the New England Journal of Medicine and a physician known for her integrity and commitment to the public welfare, was the absence of scientific information suggesting a link between silicone gel breast implants and connective tissue diseases. At the time the FDA banned the implants, there was no concrete evidence implicating the implants in connective tissue disease, nor was there any experimental evidence to suggest why implants should have such an effect. A number of rigorous epidemiological studies initiated after the ban failed to demonstrate a connection between the implants and any systemic illness. …

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