Between 1938 and the early 1970’s, up to six million women worldwide were prescribed Diethylstilbestrol (DES), a synthetic hormone meant to prevent a miscarriage. On January 19, 2012, fifty three woman were given the green light in a Boston based Federal Court to move forward with a lawsuit against 14 pharmaceutical manufacturers who made DES, claiming that their exposure to DES in utero has caused cancer.
After a two-hour final hearing, Magistrate Judge Marianne B. Bowler denied the motion to dismiss made by the drug companies. The drug companies argued that the opinions of the women’s experts were not based on reliable science; the judge did not agree, and is allowing the case to move forward. If Judge Bowler granted the drug companies’ Motion to Dismiss, the case would not have been allowed to go to trial.
In the early 1970s, studies published in the New England Journal of Medicine connected DES to vaginal cancer in the daughters of women who took it. Following the studies, the U.S. Food and Drug Administration told doctors to stop prescribing it. In subsequent trials, DES was connected to fertility problems and breast cancer in the daughters of women who took it, as well as breast cancer in women who took it.
As far as what the ensuing case will look like, Dr. Michael Grodin, a professor of medical ethics at Boston University’s School of Public Health, has identified two of the issues bound to come up at trial; causation, and negligence. Causation requires that the woman prove a link (in legal terms, “causation”) between DES and the plaintiffs’ cancer.
With regard to negligence, Dr. Gordin explained that proving it may be difficult because, “DES was prescribed at a time when medical advice was rarely questioned and drugs were not subjected to the kinds of rigorous clinical trials they are today. Dr. Gordin continued that, “the question of negligence is what did they know, when did they know it and what did they do about it? Those are all in contention.”
Jackie White, a 48 year old plaintiff from Ohio, is hoping that the court sees things her way. When Ms. White was 13 years old, her mother told her that she had taken DES while pregnant with her. Despite no family history of breast cancer, in 2010 test showed 20 tumors in one breast, two pre-cancerous lumps in the other, and cancer in her lymph nodes. Ms. White subsequently underwent a double mastectomy, six months of chemotherapy and seven weeks of radiation.
Ms. White stated that since discovering that her mother took DES, “I exercise daily. I ate healthy, low-fat, did all of the maintenance screenings that a person needs, self-exams, mammograms, OB-GYN appointments, eliminated the exposure to birth control or things like that, just like doctors recommended.” Now that there is enough evidence to allow the case to move forward, both sides will present their arguments. It is up to the court whether the plaintiffs’ illnesses were caused by negligent drug companies, or not.