What we've lost to frivolous lawsuits

OB/GYN News, Dec 15, 2003 by Elizabeth B. Connell

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 gel-filled silicone breast implants. I chaired the FDA hearings on this topic in November 1991 and in February 1992, and then testified before Congress in August 1995.

People began to pull all sorts of theories together to seek financial damage awards. There were obvious problems with the implants. They were known to get hard and to leak, but these imperfections were not really what the lawsuits were about. The lawsuits were claiming that the implants caused various autoimmune disorders, yet there was no scientific proof for this.

Our current litigious landscape has serious implications for health care, particularly for ob.gyns. For example, a nationwide survey of ob.gyns. and other primary care physicians found that 67% do not provide childbirth services because of sky-rocketing malpractice insurance costs. Even some of our country's major medical centers are discontinuing or limiting their obstetrical services.

There are some glimmers of hope at the federal and state levels for progress against frivolous litigation, such as caps on damages. In addition, more medical societies are devising ways to ensure that their members who serve as so-called "experts" in medical litigation trials are properly qualified to do so. But the tort liability lawyers are extremely powerful when it comes to politics.

Fortunately, there are a number of moves afoot to try to change the current landscape. I am now working with an initiative called the Sick of Lawsuits Campaign, which aims to educate the public about how frivolous lawsuits threaten our health care system (www.sickoflawsuits.org).

People need to become aware of what's happening to their health care. Our medical-legal system is broken, and our patients are paying the price.

DR. ELIZABETH B. CONNELL is professor emeritus of gynecology and obstetrics at Emory University School of Medicine, Atlanta. She is also a senior counselor with the Sick of Lawsuits Campaign, an initiative of the nonprofit Citizens Against Lawsuit Abuse.