A Richmond woman is among more than 100 plaintiffs who are awaiting the outcome of a federal trial, set to start Tuesday in Boston, that was initiated by women who have had breast cancer and whose mothers used the synthetic hormone DES while pregnant.
The lawsuit claims that Eli Lilly and Co. was negligent in its failure to test for and warn against problems related to DES, diethylstilbestrol, which has been found to increase fertility problems and cancer risks in daughters of women who used the drug.
The landmark court case involves four sisters from Pennsylvania, but the outcome is expected to affect all other claims related to a class-action lawsuit filed two years ago, including a complaint by Patricia Royall of Richmond.
Royall’s mother, the late Virginia Inness-Brown Conn, was one of millions of pregnant women in the United States who were prescribed DES from 1938 to 1971 to prevent miscarriages and premature births.
Royall was 28 when she learned that she’s a so-called DES daughter. A sudden bout of profuse vaginal bleeding sent her to the emergency room.
The doctor noticed reproductive abnormalities and asked if her mother had taken DES. She had no idea.
“I asked my mother and she was a little bit defensive at first,” said Royall. “Then she told me she took DES the whole time she was pregnant with me because she had a miscarriage.”
In the years since then, Royall, now 59, has had a host of health problems, including breast and cervical cancer, an autoimmune disease and a pre-cancerous growth in her colon.
Her reproductive abnormalities included a hooded cervix and a tilted uterus, both of which contributed to a miscarriage and the premature birth of her son.
Her mother, who was 84 when she died in 2011, also had breast cancer.
Royall, one of five children, said her mother didn’t take DES while she was pregnant with her three sisters and a brother. She said none of them has had cancer or any other serious illness.
Royall and the other DES plaintiffs are represented by Aaron Levine & Associates, a Washington, D.C., law firm, in claims against Eli Lilly and 13 other drug companies.
The firm claims that Eli Lilly and other drug makers never did controlled testing and ignored studies published as early as the 1930s that found DES increased the risk of cancer and developmental problems, according to a news release.
The drug companies have argued that no firm link has been established between DES and breast cancer, The Associated Press reported.
Eli Lilly issued a statement Monday, saying: “We believe these claims are without merit and are prepared to defend against them vigorously.”
The case is considered a “bellwether” trial, scheduled because judge-ordered mediation failed to produce settlements, the AP reported.
The outcome of the trial is expected to influence actions of the DES daughters and the drug companies, and could lead to settlements for all of the plaintiffs.
The first case involves the four Melnick sisters, who have had reproductive problems and breast cancer and whose mother took DES while she was pregnant with them, the AP reported.
Their mother didn’t take DES while pregnant with their older sister, who has been free of cancer and reproductive problems.
The Melnick sisters are seeking unspecified damages.
Between 5 million and 10 million people in the United States were exposed to DES, including pregnant women who were prescribed the drug and their children, according to the U.S. Centers for Disease Control and Prevention.
By 1950, clinical studies showed that DES was ineffective in preventing miscarriages and other pregnancy complications, the National Institutes of Health reported. In 1971, the U.S. Food and Drug Administration advised physicians to stop prescribing DES because it was linked to a rare vaginal cancer.
A study by the National Cancer Institute, published in 2011, said that DES daughters have nearly twice the risk of getting breast cancer after age 40 and nearly five times the risk of delivering a baby prematurely, among other elevated risk factors.
Royall, who works for a book publisher, will be in the courtroom in Boston on Tuesday to hear opening arguments in the Melnick case.
The case reminds her of all the health problems she has had and raises concern about problems that may crop up in the future.
She hopes the legal outcome will force drug companies to acknowledge their responsibility and raise public awareness about the health risks associated with DES.
“There are many people in Maine who were exposed to DES and they don’t know it because we haven’t done a good job of getting the word out,” Royall said. “Physicians need to be educated, too, so they can alert their patients to the increased risks.”
Staff Writer Kelley Bouchard can be contacted at 791-6328 or at: