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What we've lost to frivolous lawsuits.(Guest Editorial)

OB GYN News

| December 15, 2003 | Connell, Elizabeth B. | COPYRIGHT 2003 International Medical News Group. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan.  All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)Copyright

Frivolous lawsuits have adversely affected the development and availability of reproductive medical technology in the United States. As a result, we have lost access to several safe and effective medications and devices, and others will never be realized.

When I started my work with the Food and Drug Administration as a member of the obstetrics and gynecology advisory committee in 1970, there were more than a dozen pharmaceutical companies doing work in the field of contraceptive technology. Now there are only a few. Frivolous litigation is a major reason for that.

The first drug we lost to this litigation was Bendectin. Approved in 1956, Bendectin was the only drug ever developed for nausea and vomiting related to pregnancy. But in 1983, Merrell Dow pulled it from the marketplace because an increasing number of lawsuits were filed claiming the drug caused birth defects. These claims were never backed by convincing scientific data.

In the mid-1980s, we lost two good intrauterine devices--the Copper-7 and Tatum-T--to lawsuits claiming use of the devices put women at high risk for the development of pelvic infections. Again, there were no convincing scientific data to back up the claims, yet the manufacturers pulled the products from the market due largely to mounting legal defense costs, even though they were winning lawsuits.

More recently, we lost the six-rod Norplant contraceptive, which was highly effective. Soon after its FDA approval in 1991, several lawsuits were filed against its manufacturer, American Home Products, claiming that because it contained silicone its use was linked to an increased risk of developing autoimmune disease. Because of this, the company never did introduce the two-rod Norplant system to the marketplace. It is important to note that Bendectin, the Copper-7, the TatumT, and the six-rod Norplant never lost their FDA approval status.

The most disheartening example of frivolous lawsuits took place more than a decade ago during the trials of ...

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