How FDA regulations and injury litigation cripple the medical device industry.

• Author: Homsy, Charles A.
• Position: Law & Justice

MEDICAL DEVICES and implants are among the modern marvels that alleviate pain and suffering, as well as prolong and add to the quality of life. However, manufacturers of medical devices face a triple threat in their efforts to develop such products. The U.S. Food.and Drug Administration can use its open-ended powers to drive manufacturers out of business, even when the FDA itself certifies their devices. The personal injury liability system makes it all too easy for predatory lawyers to extract billions of dollars from manufacturers of safe products, forcing them into bankruptcy. Sensationalist media accounts of allegedly dangerous devices, often stoked by the FDA, add to the problems faced by device manufacturers. Three examples illustrate these threats:

The $3,000,000,000 Dalkon Shield "mistake." In 1974, the media highlighted lawsuit allegations that the Dalkon Shield intra-uterine contraceptive device was causing more septic spontaneous abortions and deaths than were other IUDs. The FDA impulsively asked A.H. Robins to remove the Dalkon Shield from the market, even though, at that time, the agency had no statutory authority to ban medical devices. Yet, an FDA report later that year stated that the allegations concerning abortions and deaths were not in fact proven.

Unsubstantiated assertions in new lawsuits alleged that the Dalkon Shield was causing pelvic inflammatory disease (PID) more often than other IUDs were. Thus, the FDA action appeared to foster litigation and fanned the media tire. Congressional hearings followed, with calls for the extension of the FDA mandate to cover devices as well as drugs. This was enacted in 1976.

After the removal of the Dalkon Shield from the market, there followed a steep decline in the number of IUD users. It had been estimated that, because 2,300,000 American IUD users were forced to switch to other, less-effective methods, there were 160,000 additional unintended pregnancies per year. Was this a case of the government's acting wisely to protect the public from dangerous products? The full story leaves a different impression.

Two medical journal articles in 1981 and 1983 concluded that IUDs in general, and the Dalkon Shield especially, carried a high risk of PID. These studies generated still more lawsuits, and A.H. Robins declared bankruptcy in 1985. By that time, the company had defended itself in about 7,000 lawsuits. The Dalkon Shield Claimants Trust then distributed almost $3,000,000,000 in payments to about 200,000 women.

University of Washington/Oregon Health Sciences University and the Center for Research on Population and Security at Research Triangle Park in North Carolina reanalyzed the 1981 and 1983 papers. The results were published in 1991 and 1992 in the Journal of Clinical Epidemiology and Fertility and Sterility, respectively. They showed that, when nonusers of any contraceptives (as opposed to nonusers of IUDs) were compared to IUD users, there was no risk attached to IUD use among all women (including those with a history of PID who had been excluded from the earlier studies). That result reflected the substantial protective effect against PID provided by oral contraceptives and barrier methods such as IUDs. The earlier studies had not taken this into account in reaching their findings.

In 1996, R.J. Beerhuizen of the Department of Obstetrics and Gynecology, University of Ghent, Belgium, reported that PID among IUD users was strongly related both to the insertion process and to the background risk of sexually transmissible disease. In 1998, a report by S.L. Kimble-Haas of the Public Health Service Hospital at Pine Ridge, S.D., noted that the stigma against IUDs continued to limit their use sharply, whereas "rigid patient-selection guidelines and strict aseptic insertion techniques can provide safe, cost-effective, and highly efficacious contraception for monogamous women."

The FDA, predatory lawsuits, and media hysteria had brought down a $2,500,000,000 company, curtailed availability of IUDs to American women, disrupted research and development in contraception using barrier devices, and rewarded plaintiffs' attorneys for this mayhem with $1,000,000,000.

The silicone breast implant "$4,300,000,000 mistake." Silicone breast implants, largely produced by Dow Corning, became the subject of FDA accusations, liability suits, and media hysteria starting in 1988. Although no sound science has ever shown the devices to be dangerous, the manufacturer was driven out of business--again, by accusations and lawsuits.

Commercial marketing of those products in the U.S. began in 1964, but the FDA waited until 1982 before proposing to assign breast implants to Class III, meaning it required more data to show safety and effectiveness. It was not until 1988, though, that the FDA actually made that classification official, requiring sales be stopped and data submitted no later than July 9, 1991. The 1988 date coincided with a wave of lawsuits...