I've always wondered why there is a pill for just about everything under the sun that ails you but no pharmaceutical companies marketing a pill for something as ubiquitous as morning sickness. Now I know why.
In 1975, Mekdeci gave birth to a son with limb reduction birth defects; the cause of most such birth defects is unknown. Not satisfied with that answer, she began a quest to determine what caused her child's suffering, and persuaded herself that the culprit was the morning sickness drug Bendectin, which she had ingested during pregnancy.
In 1977, when Mekdeci brought her lawsuit, fourteen epidemiological studies of varying strength and quality had examined the relationship between Bendectin and birth defects and found no association. While these studies were not powerful enough to rule out some connection between Bendectin and birth defects, they certainly provided no cause for alarm. Bendectin had been on the market since 1956 with no serious doubts raised regarding its safety in the scientific or medical community. Nor did Bendectin contain suspiciously toxic ingredients: one active ingredient of Bendectin was a simple B vitamin, and the other was an ingredient used in a popular over-the-counter sleeping pill.
Beyond the mere fact that she ingested Bendectin during pregnancy and later gave birth to a child with a limb reduction birth defect, Mekdeci's evidence of causation consisted primarily of eighty-six reports to the FDA of other women who had also given birth to children with limb reduction defects after taking Bendectin.
Despite FDA approval, Bendectin, the only drug proved safe and effective in combating nausea and vomiting in pregnancy, remains unavailable in the U.S. (but is available everywhere else), having been taken off the market at the height of the litigation to avoid further lawsuits. Studies have shown that the rate of limb birth defects in the U.S. has not been affected by the removal of Bendectin from the market, but hospitalizations for severe morning sickness have soared.
I made this comment on the post at The Volokh Conspiracy:
Full disclosure: I'm a woman of childbearing age who has had increasingly unpleasant episodes of morning sickness.
I've seen a few comments here to the effect that women weren't really harmed by the demise of Bendectin. I was born in 1976. I was all of 7 years old when this product was taken off the market. Until about an hour ago I had no idea that something like Bendectin had ever existed or that a simple combination of B6 and doxylamine had been proven effective in treating morning sickness. In my experience the most advice a pregnant woman can expect from anyone these days on how to deal with morning sickness is to eat something before you get out or bed. Just between you and me that's not all that effective.
If anyone chose to look you would find at least a generation of women who suffered from this litigation because we were either small children or not even born yet when this all went down and had no way of learning that B6 and doxylamine would help relieve morning sickness. Who was going to tell us about it after the product had been taken off the market because of the litigation?
Hat tip What if?