We recently reported about a DES Daughter that was suing drug manufacturers for their role in her sickness. Now, this first of it’s kind lawsuit is going a step further. The judge in the case has recently ordered the parties to go to mediation, and is also allowing expert testimony for the women who believe there is a link between DES, or diethylstilbestrol, and breast cancer.
The ruling is a significant blow to 14 drug makers fighting class action allegations concerning the controversial synthetic estrogen 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 previously reported, 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. Thus the term DES Daughter.
DES was first prescribed in 1938 to women with a history of miscarriages or giving birth prematurely; the drug received FDA approval in 1941 to treat some menopausal and postpartum conditions, later receiving approval for miscarriage prevention.
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.
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 In 1999, DES was added to the FDA’s list of drugs withdrawn or removed from the market over safety or efficacy reasons.
This Massachusetts class action is a 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.
The 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 drug companies had claimed that the testimony did not meet admissibility standards established under the U.S. Supreme Court in the 1993 Daubert v. Merrell Dow Pharmaceuticals Inc., decision. However, Judge Bowler ruled that plaintiffs adequately supported the expert testimony.
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.
The drug companies have not said whether they will appeal the ruling.