BOSTON - Eli Lilly and Co. failed to test a drug's effect on fetuses before promoting it as a way to prevent miscarriages, a lawyer charged Tuesday in opening statements in a trial over whether four sisters' breast cancer was caused by medication their mother took during pregnancy.
A lawyer for Eli Lilly told the jury there is no evidence the synthetic estrogen known as DES causes breast cancer in the daughters of women who took it. No medical records show the mother of the four women in the Boston case took DES, he said, or that if she did take it, that it was made by Eli Lilly.
The sisters' case is the first to go to trial out of scores of similar claims filed in Boston and around the country. A total of 51 women have DES lawsuits pending in Boston against more than a dozen companies that made or marketed the drug.
DES, or diethylstilbestrol, which was prescribed to millions of pregnant women between the late 1930s and early 1970s to prevent miscarriages, premature births and other problems. Studies later showed the drug did not prevent miscarriages.
The Melnick sisters, who grew up in Tresckow, Pa., say they all developed breast cancer in their 40s after their mother took DES while pregnant in the 1950s. They say their mother did not take DES while pregnant with a fifth sister, and that sister has not developed breast cancer.
The sisters allege Eli Lilly urged doctors to prescribe DES without proof that it prevented miscarriages and other reproductive problems. They are seeking unspecified damages.
The companies that make DES argue that no firm link has been established between breast cancer and the drug. It was eventually taken off the market after it was linked to a rare vaginal cancer in women whose mothers used DES.
Indianapolis-based Eli Lilly argues in court documents there is no evidence that the Melnick sisters' mother even took DES. She and her doctor are dead, and the drug company says there are no medical records documenting her treatment. A company spokesman said Eli Lilly believes the claims are without merit and is prepared to defend against them vigorously.
All four Melnick sisters had miscarriages, fertility problems or other reproductive tract problems long suspected of being caused by prenatal exposure to DES. They were diagnosed with breast cancer between 1997 and 2003 and had treatments ranging from lump-removal surgery to a full mastectomy, radiation and chemotherapy.
Then in 2008, one sister read about a study reporting an increased incidence of breast cancer in the daughters of women who took DES during pregnancy.
Lawyers for the Melnick sisters cite a study published in 2011 that suggests the risk of breast cancer is nearly double in DES daughters over 40. The study, led by a researcher at the National Cancer Institute, found that the chances that a DES daughter will develop breast cancer by age 55 are about 1 in 25. For the average woman, it is about 1 in 50.
Thousands of lawsuits have been filed alleging links between DES and vaginal and cervical cancer, as well as fertility problems. Many of those cases were settled.
The Boston trial is expected to last several weeks.