Bendectin may be back

The March of Dimes announced recently that Bendectin was making a comeback.

You may remember Bendectin, a morning sickness drug widely administered to pregnant women from 1956 to 1983.

Bendectin treats the most common unpleasant pregnancy complication, nausea, affecting up to 80% of pregnant women. By 1980, between 10 and 25% of pregnant women were taking Bendectin.  In 1983, Merrill Dow Pharmaceuticals withdrew the drug from the market due to an overwhelming number of lawsuits claiming Bendectin caused birth defects. The most famous of these is unquestionably Daubert v. Merrell Dow Pharmaceuticals, Inc. (1993) 509 U.S. 579, 113 S.Ct. 2786, 125 L.Ed.2d 469.  In Daubert, plaintiffs alleged Bendectin caused birth defects. Merrell Dow moved for summary judgment, submitting an affidavit from an expert epidemiologist, Dr. Lamm, who stated that none of the 30 pertinent published studies had ever found Bendectin capable of causing malformations in fetuses. Rather than directly contest Dr. Lamm's factual statements, plaintiffs responded with their own experts' declarations to the effect that their unpublished studies, and reanalyses of published studies, indicated a link between Bendectin and fetal malformation.

Plaintiffs, in short, practiced Junk Science.

The motion was granted, and on appeal, the Ninth Circuit Court of Appeals ruled that expert opinion based on methodology diverging "significantly from the procedures accepted by recognized authorities in the field ... cannot be shown to be 'generally accepted as a reliable technique,' ..." (Id. at p. 1130.) The Court of Appeals rejected plaintiffs' reanalyses as "unpublished, not subjected to the normal peer review process and generated solely for use in litigation." (Id. at p. 1131, fn. omitted.) Emphasis added. I cannot imagine how an attorney could ethically prepare a “study” solely for use in litigation. Ultimately, the Supreme Court issued its landmark ruling, cited above, making federal judges "the gatekeepers" with aresponibility of keeping "junk sciecne' out of the courtroom.

Now, a Canadian Company plans to market a drug with the same ingredients as Bendectin, to be called Diclectin. By now, there is a large body of research showing that there is no connection between Bendectin and birth defects. Unfortunately, doctors are reluctant to invite lawsuits by prescribing a drug that even ahs the underserved reputation of causing birth defects. I don’t blame them, but, in the meantime we lose an important tool in improving our quality of life. Certainly, in this case, more harm than good was done.  I object to junk science because its use has harmful consequences that should have been avoided.

Comments

[Nancy Wagner]

How do I know if my taking Bendectin in 1980 for the whole nine months caused my daughter's birth defects? She is now 25 and has cervical cancer and a divided uterus along with other gyn anamolies. They say that she will never be able to have children even with extensive reconstructive surgery.

[Angel MOM]

I will always believe that taking this drug cost me my daughter. She was born in 1975 with a serious heart defect, clubed fingers and toes. She was a wonderful (most of the time :p) daughter and I charish the 24 years she was with me. This drug didn't just cause her heart defect, it broke my heart too. It cost me a daughter, my son a sister, a grandgaugher, great grandaugher, niece cousin etc her loss ripples through our family.
How could they ever think of putting this drug back on the market. The COST in heart ache is way more then any profit they could ever make

[Marie LaRochelle]

Does bendectin cause obesity?