Bendectin

FIRST MANUFACTURED by Merrell Dow Pharmaceuticals in 1956, Bendectin was a prescription drug used to alleviate nausea and morning sickness associated with pregnancy. Over 33 million pregnant women worldwide were taking the drug when Betty Mekdeci, a woman determined to find the cause of her son's severe birth defects, linked the defects to the Bendectin she took during pregnancy. The story broke in the National Enquirer in October 1979, implicating Bendectin as the cause of birth defects among thousands of newborns in the United States.

Women taking the drug panicked; some had unnecessary abortions, and thousands more sued Merrell Dow Pharmaceuticals. At one point, the company was faced with more than 1,800 lawsuits from women whose babies were born with defects. The cost of litigation exceeded the profit from the drug, and, in 1983, Merrell Dow stopped manufacturing Bendectin.

Merrell Dow's problem during litigation was a lack of scientific evidence. Specifically manufactured in 1956 for pregnant women, the three ingredients in Bendectin never underwent any reproductive toxicity tests. The only study to look at the teratogenic effects of the drug was performed by Merrell Dow researchers in the mid-1970s and it was of such poor quality that it did not hold up in court.

One of the Bendectin cases, Daubert v. Merrell Dow, actually lead the U.S. Supreme Court to set [Page 89]guidelines for the admissibility of scientific expert testimony. Another problem was that Merrell Dow also neglected to mention the possibility of birth defects on Bendectin's pharmaceutical packaging label until 1981.

However, Bendectin is a safe drug; over 30 studies have proven that it does not cause birth defects. In fact, the Food and Drug Administration (FDA) continues to call the drug safe and the Centers for Disease Control reports no change in the incidence of birth defects in the United States after Bendectin was taken off the market. On the other hand, the number of pregnant women hospitalized for severe nausea has doubled since the drug was discontinued.

Duchesnay Inc., a pharmaceutical company in Canada, has continued to manufacture and distribute Diclectin, a drug identical to Bendectin. Duchesnay was petitioning the FDA in 2003 to sell the drug in the United States. Until approval, two of the three ingredients that make up Bendectin are available without a prescription, vitamin B-6 and doxyalmine, an antihistamine found in Unisom. Many doctors have been instructing pregnant women suffering from nausea and its effects to find relief by combining specific amounts of these two ingredients.