A magistrate judge ruled last week that expert testimony is to be allowed in a DES breast cancer lawsuit. The ruling is a significant blow to 14 drug makers fighting class action allegations concerning the controversial anti-miscarriage medication diethylstilbestrol.
According to the judge, the plaintiffs sufficiently supported expert testimony that found that DES exposure in the womb later increases breast cancer risks in women over the age of 40, said Law 360.
As we’ve explained, DES was prescribed heavily to pregnant women from the 1940s through the 1970s to prevent miscarriage, premature birth, or other problems during pregnancy. Thousands of women born to mothers prescribed these drugs allege adverse reactions as a result of their mothers being prescribed DES.
This lawsuit was sent to mediation when U.S. Magistrate Judge Marianne B. Bowler denied motions to exclude the testimony from Eli Lilly & Co. and Bristol-Myers Squibb Co., among others. The companies allege the testimony did not meet admissibility standards under a 1993 U.S. Supreme Court decision, said Law 360. The parties previously agreed to mediation if this motion was denied.
The multimillion-dollar lawsuit was filed by dozens of women alleging they developed breast cancer because they were exposed to DES when they were in the womb, said Law 360 and “asserts claims of negligent failure to warn, negligent failure to test, breach of warranty, and misrepresentation.” The lawsuit is also seeks to establish a class of women exposed to DES in utero, who were born 1948 – 1972, and who were diagnosed with breast cancer after they turned 40; women previously diagnosed with breast cancer or with a genetic predisposition to breast cancer are excluded.
DES was first prescribed in 1938 to women with a history of miscarriages or giving birth prematurely; the drug received U.S. Food and Drug Administration (FDA) approval in 1941 to treat some menopausal and postpartum conditions, later receiving approval for miscarriage prevention, said Law 360. In 1971, Massachusetts General Hospital physicians published a study in The New England Journal of Medicine that found a link between DES and rare vaginal cancer in the female children of DES mothers. The study results prompted the FDA to issue a drug bulletin to physicians recommending against prescribing DES to pregnant women. In 1975 the agency withdrew market approval for DES products containing 25 milligrams or more and mandated warning labels be included on lower doses.
Since, other adverse reactions have been linked to DES, said the FDA, including that women prescribed DES when pregnant suffer a 30 percent increased risk for developing breast cancer. A link was also found between noncancerous epididymal cysts in male children of DES mothers, said the FDA. The FDA continued to withdraw DES approval and, in 1997, the last U.S. manufacturers stopped making and selling the drug. In 1999, DES was added to the FDA’s list of drugs withdrawn or removed from the market over safety or efficacy reasons, said Law 360.
The Massachusetts class action is first-of-its-kind lawsuit that alleges DES caused breast cancer in women who were exposed to the drug in utero. Some 53 women, or DES daughters, are named as plaintiffs in the complaint.