DES (Diethylstilbestrol) Litigation in the 1970s: Understanding Settlements for Pharmaceutical Injuries
Between 1938 and 1971, an estimated 5 to 10 million women and children in the U.S. were exposed to diethylstilbestrol (DES). This synthetic estrogen was widely prescribed to pregnant women with the belief that it would prevent miscarriages and premature births. However, this “miracle drug” soon became a nightmare, leading to a surge of DES litigation in the 1970s and beyond, as the severe health consequences for both mothers and their children became apparent.
What is DES and Why Was It Prescribed?
Diethylstilbestrol (DES), also known as Stilboestrol, is a synthetic form of estrogen. From the 1940s to the early 1970s, it was commonly prescribed to pregnant women to prevent miscarriages and other pregnancy complications. Doctors at the time believed that low estrogen levels were a primary cause of pregnancy issues. However, a 1953 study revealed that DES was ineffective in preventing miscarriages, yet it remained on the market until 1971.
The Dark Side of DES: Health Consequences
In 1971, the link between prenatal DES exposure and a rare form of vaginal cancer, clear cell adenocarcinoma (CCA), in young women was discovered. This led the FDA to issue a drug bulletin advising doctors to stop prescribing DES to pregnant women. However, the damage was already done.
For DES Daughters (women exposed to DES in utero):
- Clear Cell Adenocarcinoma (CCA): A rare cancer of the vagina and cervix, with an estimated risk of 1 in 1,000.
- Reproductive System Abnormalities: Increased risk of structural anomalies of the cervix, uterus, and fallopian tubes.
- Pregnancy Complications: Higher likelihood of ectopic pregnancy, miscarriage, premature birth, and infertility. Studies show that DES daughters are 8.6 times more likely to have an ectopic pregnancy, 1.8 times more likely to have a miscarriage, and 4.7 times more likely to have a premature birth than unexposed women.
- Breast Cancer: Some studies suggest an increased risk of breast cancer, particularly estrogen-positive tumors, with some studies indicating a doubled risk of breast cancer.
- Early Menopause: DES daughters may experience menopause earlier than unexposed women.
- Vaginal Adenosis: Abnormal columnar epithelium of the cervix and upper vagina.
- Cervical Intraepithelial Neoplasia: Precancerous changes in the cervix.
For DES Sons (men exposed to DES in utero):
- Genital Abnormalities: Increased risk of non-cancerous epididymal cysts and cryptorchidism (undescended testicles), a risk factor for testicular cancer.
- Possible Increased Risk of Testicular Tumors: Although the association remains controversial.
- Sub/Infertility: Studies have shown that DES sons may experience subfertility issues.
For DES Mothers (women who took DES during pregnancy):
- Increased Risk of Breast Cancer: Studies suggest a modest association between DES exposure and breast cancer risk.
DES Litigation: Seeking Justice for Pharmaceutical Injuries
The discovery of these health consequences led to a wave of lawsuits against DES manufacturers. DES litigation presented unique legal challenges, including:
- Statute of Limitations: The long latency period between DES exposure and the manifestation of health problems meant that many potential lawsuits were at risk of being barred by statutes of limitations.
- Identification of the Manufacturer: DES was produced by over 200 different companies, making it difficult to identify the specific manufacturer responsible for a particular plaintiff’s exposure.
Legal Doctrines Applied in DES Cases
To address these challenges, courts developed and applied several legal doctrines:
- Discovery Rule: This rule 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.
- Market Share Liability: This doctrine, conceived in a DES daughters case, allows plaintiffs to sue multiple DES manufacturers if they cannot identify the specific manufacturer of the drug their mother took. Each defendant is held liable for a share of the damages based on its market share at the time the drug was sold.
- Concert of Action: This theory posits that if drug companies acted together in the development, testing, or marketing of DES, they could be held jointly liable.
Notable DES Lawsuits and Settlements
- Sindell v. Abbott Laboratories (1980): A landmark California Supreme Court case that established the market share liability doctrine.
- Melnick Sisters Case: Four sisters, all DES daughters, diagnosed with breast cancer, filed a lawsuit against Eli Lilly and Co. In January 2013, they reached a settlement with the drug company, setting a precedent for future DES breast cancer cases.
- French DES Litigation: In France, two women who developed cancer after their mothers took DES won their case against UCB Pharma in 2011. This was the first successful suit involving the drug in France.
Compensation and Support for DES Victims
Compensation for DES victims has varied widely depending on the severity of the health issues and the jurisdiction. In the Netherlands, a €38 million compensation fund was established for DES mothers, daughters, sons, and some grandchildren. Compensation payouts ranged from €750 to over €250,000, with the largest amounts awarded to those who developed CCA at a young age with life-long consequences.
The Legacy of DES: A Cautionary Tale
The DES tragedy serves as a stark reminder of the potential dangers of inadequately tested pharmaceuticals and the importance of rigorous safety standards. It also highlights the long-term consequences of prenatal drug exposure and the need for ongoing research and monitoring of exposed individuals.
Are You a DES Daughter or Son?
If you believe you may have been exposed to DES, it is crucial to:
- Inform your doctor: Discuss your DES exposure with your healthcare provider and undergo recommended screenings.
- Maintain detailed medical records: Keep track of your medical history and any health issues that may be related to DES exposure.
- Consider legal options: If you have suffered health consequences due to DES exposure, consult with an attorney experienced in pharmaceutical litigation to explore your legal options.
While the era of DES prescriptions has ended, the legacy of this drug continues to affect millions. Understanding the risks, legal options, and available support is essential for those impacted by this tragic chapter in medical history.