Bendectin is Back

Thirty years after Merrell Dow Pharmaceuticals pulled the morning sickness drug Bendectin off the American market in response to a waive of junk science-inspired claims that it caused limb reduction birth defects, the product is returning to the market under a new name with a new manufacturer.  Contrary to what one might reasonably surmise from the linked report, the FDA never pulled Bendectin from the market; rather, no one was willing to market the drug given the litigation climate in the United States.  American women who wanted the drug, which still has no substitute, have had to either make a homemade concoction from its ingredients, as some doctors recommended, or get it from Canada.  This has meant, in practice, that few American women have used it.  The result has been much needless suffering, including a hospitalization rate for morning sickness double in the U.S. compared to Canada. Ironically, the absence of Bendectin may have even led to an increase in the rate of birth defects because some women with morning sickness are unable to keep food down and give their babies proper nutrition.  I discuss the Bendectin litigation and the negative health ramifications it caused in some detail in an article in the Michigan Law Review.

The only positive aspect of the Bendectin litigation is that the contrast between jury verdicts for plaintiffs and the overwhelming contrary scientific evidence was such that it led several federal courts to issue decisions radically (for the time) limiting plaintiffs” ability to proffer dubious causation evidence, which in turn led to the Supreme Court’s “Daubert Trilogy” and amended Federal Rule of Evidence 702.  By tightening the rules for the admissibility of expert testimony, these changes have made a recurrence of the tragedy of the Bendectin litigation unlikely.

In related news, I was just reading that a product that David Kessler’s FDA did pull off the market for political reasons with no scientific basis for doing so, silicone breast implants, have made a huge comeback, and are now used in hundreds of thousands of surgeries in the United States annually.  Unfortunately, the judiciary’s crackdown on dubious science didn’t come quickly enough to save the manufacturers from paying out billions of dollars in jury verdicts and settlements.