Morning Sickness, Legal Miscarriage

Editorial from The New York Times: July 30, 1984

Merrell Dow, the maker of the morning sickness drug Bendectin, has agreed to pay $120 million to settle claims that the drug causes birth defects. For that money - more than was paid even in the case of thalidomide - you'd think Bendectin had been proved some kind of a hazard. But it hasn't.

The company has so far won both the cases that have come to trial, and the Food and Drug Administration believes Bendectin is safe. From more than 20 epidemiological studies the agency concludes there's no evidence that the drug increases the natural rate of birth defects.

So why did the company choose to settle? Juries' hearts go out to deformed children and their parents. In one Bendectin case the jury decided the child's injuries were not caused by the drug but awarded $20,000 for medical expenses anyway. The company won on retrial. In the other case a jury awarded $750,000 and was reversed by the judge, whose decision is now under appeal.

These two wins by Merrell Dow did not discourage new claims, as the company had hoped. In fact, each trial stimulated a flood of new claims. Since even wins were only adding to the costs of defense, the company says, it decided to settle. It, or its insurers, may also have anticipated some costly losses; animal tests indicate a possible link with some kinds of birth defect, although these are not confirmed by epidemiology.

So there's now no drug on the market that's recommended for morning sickness. That may be all to the good: No drug should be lightly taken in pregnancy, and morning sickness can be treated through control of diet. But something is badly wrong with the route to the Bendectin settlement. If the drug is unsafe or ineffective, the Food and Drug Administration should have been the first to act against it. If Bendectin indeed increases the rate of birth defects, courts should so determine and the company should pay. That's not what's happened. The courts have so far determined the opposite but the company has paid anyway. Judgment of the issue has been usurped by the parties' considerations of legal cost and risk. Like the Vietnam veterans in the $180 million Agent Orange settlement, the Bendectin claimants will now receive administratively determined payments from the trust fund created by the defendant. With Agent Orange, too, there's been no proof, only quite flimsy suspicions that the herbicide has caused more than a skin disease. In both cases the central issue of causation has been left unresolved. The court administrators of these grand payouts will have little rational basis for excluding any veteran exposed to a drop of Agent Orange or anyone with a birth defect whose mother took Bendectin. Satisfying the F.D.A.'s safety requirements should not absolve a company of liability for unexpected damage caused by its drug. But Federal safety review, if properly conducted, ought to count for something. Courts are a necessary forum for second-guessing the F.D.A. and resolving scientific uncertainties. But in the case of Bendectin, they did neither. With Bendectin and Agent Orange, the law has made a devastation and called it a settlement.