Effects of morning sickness drug are debated in trial

Philadelphia, Pennsylvania, New Jersey and New York

By Staff Reporter
WEDNESDAY, JANUARY 21, 1987

For 27 years, doctors routinely prescribed it to women who complained that pregnancy was making them sick. An estimated 33 million women around the world took Bendectin - a mixture of a B vitamin and an antihistamine called doxylamine - before it was withdrawn from the market in 1983.

Last week, a Philadelphia jury found that by manufacturing this commonly used drug, Merrell Dow Pharmaceutical Co., Inc. of Cincinnati had acted not only negligently but with reckless disregard of the consequences to the unborn children of the women who took it. The jury then punished the company by ordering it to pay $1 million in damages - the first punitive award in the nation in a Bendectin case - to a Huntingdon Valley boy born with club feet. The jury awarded the child, Jeffrey Blum, 6, and his parents, Fred and Joan Blum, another $1 million to compensate them for the pain, suffering and medical expenses resulting from Jeffrey's birth defects.

During the 8 week trial before Judge Nicholas D'Allessandro in Common Pleas Court, testimony showed that Joan Blum took two Bendectin pills daily from the 30th day of her pregnancy until she delivered Jeffrey. After the verdict, Merrell Dow, which has continued to maintain that no scientifically acceptable evidence exists to support claims that Bendectin causes birth defects, announced that it would appeal the jury's decision. "We still maintain the drug is safe," said company spokesman William R. Donaldson. Despite the verdict last week, that is a view echoed by the Public Citizen Health Research Group, a Washington- based consumer health organization that often has been critical of the nation's pharmaceutical industry.

The drug was marketed for relief of the "morning sickness" that often accompanies early pregnancy and that plagues some pregnant women morning, noon and night for nine months. At one time, Bendectin, the only morning-sickness remedy approved by the federal Food and Drug Administration (FDA), was ingested by one out of every four pregnant women in the United States. When the company stopped making Bendectin in 1983, the decision was attributed to "compelling non-medical reasons," particularly the costs of defending about 300 lawsuits, as well as rising insurance premiums and adverse publicity.

The company's decision to stop production of Bendectin came 13 days after a Washington, D.C., jury awarded $750,000 in compensatory damages to the family of a girl who was born with a deformed hand. The decision also closely followed a decision by the FDA to require Merrell Dow to alert doctors to an association between Bendectin and a birth defect called pyloric stenosis - a malformation of the digestive tract that can be corrected by a relatively simple surgical procedure.

The FDA did not then, nor did it ever, seek the removal of the drug from the market. In defending itself against the lawsuits that have gone to trial, Merrell Dow has repeatedly cited 35 independent studies concluding that Bendectin does not cause birth defects. "None of these studies establish a statistically significant association between Bendectin and birth defects in general, or limb defects specifically," said the company in a pretrial statement laying out its defense in the Blum case. "The studies reveal that one finds virtually the same number of children born with birth defects whether or not their mothers took Bendectin," the statement says. "Approximately 2 to 5 percent of all children are born with birth defects. The cause of these birth defects is unknown in the vast majority of cases."

During the trial, Thomas R. Kline, the Blums' attorney, disputed the results of several defense studies, and presented evidence he said showed that the company had withheld all laboratory findings from the FDA. "Evidence from laboratory notebooks showed an association with all sorts of defects - cleft lip and palate, gastrointestinal defects, club feet, heart defects and limb defects," Kline said in an interview after the trial.

During the trial, Kline presented as evidence original laboratory notes showing that some rabbits had aborted offspring with club limbs after ingesting Bendectin - a fact never reported to the FDA. Witnesses for the company testified that its researchers were under no obligation to report the aborted fetuses, witnesses for the Blums said the FDA should have been alerted, and Kline took to reminding the jury that the animals were "not only deformed, but dead and deformed." In the end, one side's expert witnesses - such as physicians, epidemiologists and geneticists - were pitted against the other's, and the jury apparently believed the plaintiffs'. "I think the jury sent a message that the drug was not tested properly and tests were not reported properly," said Kline, who called Merrell Dow's testing methods "outrageous." "It was a real tough fight," said Jeffrey's father, Fred Blum, who filed the suit on behalf of his son more than four years ago.

Because the case is being appealed, the Blums declined to comment further. Doxylamine, the main ingredient in Bendectin, is still found in many over-the-counter medications, including the sleeping aid Unisom and Vicks cough medicines Nyquil and Formula 44. These medicines carry labels warning pregnant women to consult a health professional before taking them - but so do most other over-the-counter remedies today.

The removal of Bendectin from the market was part of "a dramatic decrease in the prescribing of all drugs to pregnant women," said Dr. Sidney Wolfe, director of the Public Citizen Health Research Group. Wolfe's group petitioned the FDA to have Bendectin removed from the market in 1982 - not on the ground that it was harmful, but because it was "only marginally effective" in treating nausea, Wolfe said. "We have reviewed all the studies, and we happen to agree with the company that scientific evidence does not support a link between Bendectin and birth defects," Wolfe said. Wolfe said his group's argument against Bendectin was simply that it was unnecessary. Since Bendectin was removed from sale, doctors have learned that "there are a lot of things they can do to treat nausea in pregnant women, such as recommending that they eat a lot of small meals and take soda crackers in the morning," Wolfe said. "Doctors like to prescribe drugs. It's the only thing they know most about. They don't know much about nutrition," Wolfe said. "But now that Bendectin is off the market, they've learned they can do other things for pregnant women besides feed them a drug."

Dow Chemical Unit and Rite-Aid Told To Pay $2 Million

A state jury in Philadelphia awarded $2 million in damages to a six-year-old Pennsylvania boy after deciding that his deformed feet were caused by his mother's use of Bendectin, an anti-nausea pregnancy medicine. It was the largest amount awarded to a plaintiff alleging birth defects from the drug, which is manufactured by Merrell Dow Pharmaceuticals Inc., a unit of Midland, Mich.-based Dow Chemical Co. The jury decided that Merrell Dow and Rite-Aid Pharmacy Co., which sold the drug, should split the cost of $1 million in compensatory damages, and that the manufacturer should pay $1 million in punitive damages. In a prepared statement, Merrell Dow "strongly expressed its belief that the verdict is not consistent with the strong and continually growing scientific evidence that Bendectin doesn't increase the risk of birth defects." It added that it will "take all necessary steps to reverse this verdict and obtain a ruling in its favor." A Rite-Aid spokeswoman said the drugstore chain was indemnified by the manufacturer, and wouldn't be responsible for any possible damages. Merrell Dow sold the widely used drug from 1956 to 1983, when it discontinued the product because of growing litigation alleging birth defects. A total of 10 lawsuits - including this case - have gone to trial in the U.S. Merrell Dow said juries have sided with the company in five of those cases and couldn't reach a verdict in another. One case ended in a mistrial. The company said it won two cases that went to trial in Europe. Juries have sided with the plaintiffs against the company three times, including the Philadelphia verdict Monday. In one of those cases, an appeals court last March reversed a lower court ruling and upheld a $750,000 award against the company for a Maryland girl. Merrell Dow is appealing that decision. In another case, a federal judge last month overturned a $1,160,000 verdict against Merrell Dow. A company spokesman said he didn't know whether the plaintiff was appealing. There are two more trials "that are most likely to go forward within the next month," the spokesman said. He said he was aware of three more that were moving toward trial, but said he didn't know the timing. About 300 lawsuits are outstanding, the spokesman said, down from a high of 1,700. The Philadelphia trial, which lasted more than two months, involved Jeffrey Blum, who was "born with severely deformed feet, on which he's never been able to walk, despite four operations," according to his attorney, Thomas R. Kline. Mr. Kline said he is handling several other Bendectin cases.