The Shadow of DES: Understanding the 1970s Litigation and Settlements for Pharmaceutical Injuries
In the 1970s, a storm of litigation broke over the pharmaceutical industry, exposing the devastating consequences of a drug once hailed as a breakthrough: Diethylstilbestrol, or DES. Millions of pregnant women were prescribed DES between 1938 and 1971, with the promise of preventing miscarriages and ensuring healthy pregnancies. However, this promise turned into a nightmare, leaving a legacy of health problems for both the women who took the drug and their children, particularly their daughters. This blog post delves into the history of DES, the resulting litigation, and the settlements for pharmaceutical injuries that followed, shedding light on a landmark case that continues to impact lives today.
What was DES and Why Was It Prescribed?
Diethylstilbestrol (DES) was a synthetic estrogen, a man-made form of the female sex hormone. It was first synthesized in 1938 and quickly gained popularity as a supposed remedy for pregnancy complications. Doctors prescribed DES to women who had a history of miscarriages, premature births, or other pregnancy-related issues. The belief was that DES would help maintain the pregnancy and prevent complications. It is estimated that between 5 and 10 million women in the United States, and many more worldwide, were prescribed DES.
However, by the 1950s, studies began to question the effectiveness of DES in preventing miscarriages. Despite the lack of evidence supporting its benefits, doctors continued to prescribe it, and it wasn’t until 1971 that the FDA issued an advisory against its use during pregnancy. This decision came after a groundbreaking study revealed a link between DES exposure in utero and a rare form of vaginal cancer in young women, known as clear cell adenocarcinoma (CCA).
The Devastating Effects of DES Exposure
The 1971 study in The New England Journal of Medicine marked a turning point in the understanding of DES. It revealed that seven out of eight young women diagnosed with CCA had been exposed to DES prenatally. This discovery exposed DES as one of the first known transplacental carcinogens, meaning it could cross the placenta and harm the developing fetus.
The consequences of DES exposure extended far beyond CCA. “DES daughters,” women exposed to DES in utero, faced a range of health problems, including:
- Clear Cell Adenocarcinoma (CCA): A rare cancer of the vagina and cervix, with DES daughters having a 40 times higher risk than unexposed women.
- Reproductive Tract Abnormalities: Including vaginal adenosis, cervical abnormalities, and a T-shaped uterus, which can lead to fertility problems and pregnancy complications.
- Pregnancy Complications: Increased risk of ectopic pregnancy, miscarriage, premature labor, and delivery problems.
- Increased Risk of Breast Cancer: Studies suggest that DES daughters have almost twice the risk of developing breast cancer compared to women who were not exposed to DES in utero.
- Cervical Pre-cancers: DES daughters are about twice as likely to develop high-grade cell changes in the cervix than females not exposed to DES in utero.
“DES sons,” men exposed to DES in utero, also faced health risks, including:
- Genital Abnormalities: Such as undescended testicles and cysts in the epididymis.
- Possible Increased Risk of Testicular Cancer: Although the evidence is mixed.
- Increased risks of inflammation or infection of the testicles
Even “DES grandchildren,” the children of DES daughters and sons, are being studied for potential health issues, including a higher risk of premature birth, low birth weight, irregular menstrual cycles, and possibly ADHD.
The DES Litigation: A Fight for Justice
The revelation of DES’s harmful effects sparked a wave of lawsuits against the drug manufacturers. DES daughters, mothers who took DES, and even some DES sons sought compensation for their injuries. These lawsuits were complex and challenging, raising novel legal issues.
One of the major hurdles in DES litigation was the statute of limitations. Many years had passed between the time the drug was taken and the onset of health problems, exceeding the statutory period for filing a lawsuit in many jurisdictions. However, courts in some states adopted the discovery rule, which states that the statute of limitations does not begin to run until the plaintiff discovers, or reasonably should have discovered, the injury and its cause.
Another challenge was identifying the specific manufacturer of the DES taken by a particular woman. DES was a generic drug, and many companies produced it. To address this issue, some courts adopted the market share liability theory, which allows plaintiffs to sue manufacturers based on their share of the DES market at the time the drug was ingested.
Settlements and Compensation for Pharmaceutical Injuries
Despite the legal challenges, many DES cases resulted in settlements or verdicts in favor of the plaintiffs. These settlements provided compensation for medical expenses, lost wages, emotional distress, and other damages. In some cases, punitive damages were also awarded to punish the drug companies for their negligence and deter similar conduct in the future.
Some notable examples of DES litigation and settlements include:
- The Bichler v. Eli Lilly case (1978): Joyce Bichler, a 25-year-old cancer survivor, was awarded half a million dollars in her case against Eli Lilly, marking the first successful legal trial over DES injuries.
- The Melnick sisters’ case (2013): Four sisters who developed breast cancer after their mother took DES reached a settlement with Eli Lilly on the second day of trial. The amount was undisclosed, but it set a precedent for future DES breast cancer cases.
- The Netherlands compensation fund: Lawsuits against several laboratories producing DES led to the creation of a compensation fund of €35 million for DES victims in the Netherlands.
The Ongoing Legacy of DES
The DES story serves as a stark reminder of the potential dangers of pharmaceutical drugs and the importance of rigorous testing and regulation. While DES is no longer prescribed, its legacy continues to affect millions of people worldwide.
DES daughters, sons, and even grandchildren still face increased risks of various health problems and require ongoing medical screening and monitoring. Support groups and advocacy organizations like DES Action USA provide valuable resources and support for those affected by DES exposure.
If you believe you or a family member may have been affected by DES, it is crucial to:
- Inform your healthcare provider: Discuss your DES exposure and the potential health risks.
- Undergo regular screenings: Follow recommended screening guidelines for DES-related health problems.
- Seek legal advice: Consult with an attorney experienced in pharmaceutical litigation to understand your legal rights and options.
The DES litigation paved the way for greater accountability in the pharmaceutical industry and helped establish legal principles that protect individuals harmed by dangerous drugs. It is a story of perseverance, resilience, and the pursuit of justice for those whose lives were forever altered by a drug that promised health but delivered harm.