The Bitterest Pill

Executive Summary

Women across the country have suffered tremendously as a result of defective and dangerous drugs and medical devices. History shows that many FDA-approved drugs and devices that have caused some of the most serious injuries and death have been marketed specifically for women. This is largely due to the number of products routinely prescribed to otherwise healthy women to control some aspect of their reproductive system. In addition, some drugs have had a disproportionate impact on pregnant women and their children.

Many drugs and devices were made safer only after women and their families filed lawsuits against those responsible. Sometimes, companies that have been hit with large verdicts or settlements act immediately to change their unsafe product or practice. Lawsuits also have had a tremendously beneficial role spurring medical research and alerting the public – and ultimately pressuring regulators – to act on larger health risks and problems. As a result, the lives of countless other women have been saved.

In addition, unlike the regulatory scheme, which provides no direct benefit to victims, civil cases hold companies directly accountable to those whom they have hurt, and provide their victims with compensation to help rebuild their lives. Drug company immunity would remove the most significant and effective financial consequence to a company for choosing to keep a dangerous drug or device on the market.

Lethal Hormones

The Bitterest Pill, How Drug Companies Fail to Protect Women and How Lawsuits Save Their Lives, Center for Justice & Democracy, 2008.

DES (diethylstilbestrol) was a synthetic estrogen created in 1938 and “marketed using hundreds of brand names in the mistaken belief it prevented miscarriages and premature deliveries. It was considered the standard of care for problem pregnancies from the late 1940s well into the 1960s in the U.S. and was widely prescribed during that time.” Estimates are that it was prescribed to at least five million pregnant women. The FDA eventually contraindicated DES use in pregnancy in 1971.

Not only did DES not work, it increased the risk for cancer, elevating the risk of vaginal and breast cancer and caused malformations of the reproductive tract, infertility and other serious health problems for not only the women who took it, but also the children they carried. The drug continued to be marketed for 18 years after it was determined to be ineffective. As University of Buffalo Law Professor Lucinda Finley has written:

After the drug DES was proven ineffective in preventing miscarriage in 1953, the drug companies continued to promote it for that purpose and expanded their efficacy claims to include the completely unproven assertion that DES would promote bigger healthier babies. Thus, for almost two decades after the drug was proven ineffective, the manufacturers continued to expose hundreds of thousands of women and their offspring to needless risk. In addition, after the connection between DES and cancer was established, the FDA took no remedial action for months and the manufacturers continued to promote the drug without warning physicians about the cancer risk until the FDA finally ordered it off the market.

It took much effort and persistence by DES mothers and children to sue successfully over DES. Eventually the perseverance paid off but it has been difficult for a few reasons. First, some DES claims were declared “time-barred” by a state’s statute of limitations, which in some states required that a case be brought within a short time after the actual injury, instead of the date the injury was discovered. In other words, some judges were deciding to penalize women – particularly DES children – for the latent nature of their injuries or because they had not learned earlier of health risks that the company had covered-up.

Indeed, in a 1984 New York case, two women –a young Queens woman with cervical cancer, whose mother had taken DES years before, and a Long Island woman, also with cancer – sued. However, their cases were dismissed because at the time, New York law required that such cases be brought within three years of the date the women would have been initially exposed to DES. At the time, New York was in the minority of states with such a restrictive rule and New York shortly thereafter changed the law to correct such an unfair result for DES victims.

Another problem some DES victims faced was the biased view of some judges at the time about the significance of the damage caused by DES. Specifically, some viewed harm to the reproductive system “as purely emotional in nature” and therefore not involving significant economic loss for women, or conversely, financial consequences for the company. As Professor Finley wrote;

For example, in the contemporary case of Payton v. Abbott Labs, in which a class of women sought compensation for a variety of injuries caused by the drug DES, the court held that the plaintiffs could not seek damages for their “purely emotional” harm because they had no accompanying physical injury. The court ruled in this manner despite the fact that many DES daughters have malformations of their cervixes and uteruses, as well as cellular changes to the vaginal and cervical lining. Moreover, gynecologists recommend as a practice that women exposed to DES undergo regular medical monitoring and far more extensive internal exams than non-exposed women.

Eventually, many lawsuits were successful, which were important for a number of reasons. Wrote Finley, “Until women started bringing and winning lawsuits, many DES exposed women did not know about the risks they faced.” Moreover, “until the first wave of successful lawsuits, little follow up research had been done to learn about the health effects of DES exposure. As such research has been done, more and more adverse health effects have come to light“.

Amanda Melpolder, Amy Widman and Joanne Doroshow, 2008.

Click to download the pull paper (PDF).

More DES DiEthylStilbestrol Resources

• Other papers on DES cases and lawsuits.
• Diethylstilbestrol DES studies by topics.