Bitter Battles Over a Drug

Pennsylvania - New Jersey - New York - Nationwide

Millions took Bendectin, once prescribed for nausea during pregnancy, is the subject of many lawsuits alleging it caused birth defects

By Inquirer Staff Writer
SEPTEMBER 27, 1987

"Something's wrong with the feet." Joan Blum got the news right away, from the doctor who delivered her boy. Fred Blum saw for himself that something was wrong. He had brought his cameras to the delivery room at Pennsylvania Hospital - "overwhelmed with having a child," he later recalled - and wound up photographing a newborn boy with clubfeet.

Life hasn't been the same for the Blums since that day, Sept. 15, 1980. Despite three operations, Jeffrey Blum can't walk like a normal child - he moves only with the aid of braces - and there is no guarantee that further surgery will correct the problem. "It's been a very gut-wrenching experience," his father recently said. "It's terrible to see your child suffer so much."

A year earlier, on May 26, 1979, a State Department clerk named Sandra Ealy gave birth in Washington, D.C., to a son without thumbs - and elbows he cannot bend. In 1983, Ealy filed a civil suit against the maker of a drug she had been taken during pregnancy, alleging that the company had been negligent in not warning of the drug's dangers. Sekou Ealy, now 8 and a second-grader, testified in court this summer that he cannot raise his arms high enough to button his collar button, even though he has undergone two operations. "They [are] making fun of my hands," he said, referring to his schoolmates. "They [are] calling me three fingers and four." Birth defects strike 2 percent of all newborns, according to the federal Centers for Disease Control in Atlanta, but the Blum and Ealy cases share a common trait. Both mothers, suffering from morning sickness during their pregnancies, were users of Bendectin, an anti-nausea prescription pill that was manufactured and marketed by Merrell Dow Pharmaceuticals.

Thirty million women worldwide took the drug between 1957 and 1983, when the company pulled Bendectin off the market. The reason for its removal: Costs of defending Bendectin in court were threatening to exceed revenue from the drug. But the pullout may have come too late - lawyers for the Blums and Ealys believe the worst is still ahead for Merrell Dow.

Thomas R. Kline, who represented the Blums in a landmark court battle this year, said of Merrell Dow,"...there's a hurricane coming that they don't want to see. At some point, they'll have to pay the piper."

But Merrell Dow believes that the drug was safe and cites numerous studies supporting that position. On paper, it would appear the company has done well in defending itself in the birth-defect controversy. Seventeen cases have been tried thus far, and Merrell Dow has won favorable judgments or verdicts 13 times.

But as many as 500 cases are still pending in American courts. And two of the company's losses came this year in precedent-setting decisions. On Jan. 20, the Blums, from Huntingdon Valley, a Philadelphia suburb, became the first in the nation to successfully sue the company for both compensatory and punitive damages.

A Philadelphia Common Pleas Court jury linked Bendectin to Jeffrey Blum's birth defects and ruled that the company sold the drug with reckless disregard for its consequences. The Blums were awarded $1 million, and the company was assessed another $1 million as punishment for its behavior. It was the first punitive award in a Bendectin case. This summer, in the Sekou Ealy case, a Washington jury slapped the company with a $75 million punitive penalty. An additional $20 million was awarded to the family, to compensate the child.

The makers of Bendectin were stunned. As their own lawyers put it, "Never before has a pharmaceutical company been subjected to a punitive damage award . . . in an amount of this magnitude." No money has changed hands, however, because Merrell Dow has vowed never to surrender. The Blum and Ealy verdicts are on appeal. The company, as well as some medical experts, believe that Bendectin, the sole anti-nausea drug for pregnant women, has gotten a bum rap.

At the very least, the furor has focused attention on the use of drugs during pregnancy. "Doctors are increasingly recognizing that you just don't give anything [to pregnant women]during the first eight weeks unless it's absolutely necessary," said Kline. "If alcohol hurts fetuses, and caffeine presumably can do it, is it hard to believe Bendectin can do it? You're talking about a small creature living in the bloodstream of the mom. People now recognize that anything not natural carries a potential risk."

The Cincinnati-based Merrell Dow can trace its roots to 19th-century North Carolina, to a product called Vicks VapoRub. By 1953, the company, by then a major drug manufacturer, was seeking ways to market a drug for pregnant women. That year, the company president read a memo from the medical research division about a new compound "to be promoted primarily for nausea and vomiting of pregnancy." Bendectin was submitted for approval to the federal Food and Drug Administration in 1956. The FDA endorsed it in 28 days. The drug's impact on laboratory animals was not studied; in those days, such studies were crude, and the government didn't require them. But Bendectin has been scrutinized repeatedly since the 1960s, said company spokesman William Donaldson, "and the scientific facts, found in 35 separate reports, indicate that Bendectin does not increase the risk of birth defects."

But this view has been challenged by the District of Columbia Court of Appeals, which earlier this month refused a company request that it reconsider its 1986 decision linking Bendectin to a Maryland girl's defects. "Like the pieces of a mosaic," the court said last year, "the individual studies showed little or nothing when viewed separately . . . but they combined to produce a whole greater than the sum of its parts." Donaldson said that "where you get into a courtroom, it's a tough rent situation [for the company]. There is an overriding human concern for any child born with a defect. I don't care what walk of life you come from, you have a basic compassion for such a child. Sympathy in a courtroom is a real issue for us to deal with. "The problem is, you can't 'prove' the safety of anything. A lawyer can play on that nicely. It's like we're guilty until proven innocent - a reverse of the usual rules. You'll never reach the point of absolute safety, no matter how many studies you do. From that standpoint, we're at a disadvantage." There is still support in the medical world for Bendectin. "We were sorry they pulled it off the market, because the scientific evidence shows no connection," said Mort Lebow, spokesman for the American College of Obstetricians and Gynecologists. "It left physicians without a very good weapon to counteract severe nausea and vomiting. Today, you just make sure they [women] get to the hospital if they're dehydrated - and pay a hell of a lot more money for treatment. That's the tradeoff. It ain't a perfect world." And in government circles, the FDA has always defended the drug, though noting in 1980 that there was "residual uncertainty" about its safety.

But both Kline and John Sellinger, a lawyer who helped represent the Ealys, argue that he company never tried to adequately test Bendectin and de-emphasized the adverse evidence it did receive. They allege, in Kline's words, that "a credible case of company misconduct" helped sway those two juries. In 1963, six days after pregnant women began using the drug in large numbers, the company conducted its first animal tests. According to the lab technician's notebooks, which became part of the court record in the Blum and Ealy cases, 18 of 112 rabbit offspring were deformed. When the test data were given to the FDA - three years later, when a reporting requirement was enacted - only seven deformed offspring were reported. For example, in the lab notes on one rabbit, "seven live and normal" offspring were recorded - plus a dead sibling with a clubfoot. Yet the FDA was told only about the live babies, according to court records. "Their own test results should have raised red flags for them," said Sellinger. Donaldson, the company spokesman, called this evidence "unfortunate. The lab technician did some initial assessments, and the supervisor had a different opinion, different interpretation. That goes on in every lab. The supervisor just didn't agree with the technician; he wasn't trying to change or hide anything. In retrospect, it looks bad, but it wasn't intended to be that way."

In 1978, a British doctor, R.W. Smithells, published the results of his won study, which concluded that there was "no evidence to suggest" that Bendectin caused birth defects. The company later cited the Smithells study in defense of its product, and submitted it to the FDA two years later, when the agency was conducting a review of Bendectin. According to court records, however, Smithells had close ties to the drug company - which Kline alleges is proof of the firm's "corrupted state of mind." In September 1975, the court records show, Smithells wrote to Mark Hoekenga, a company vice-president, and asked for financial assistance, saying, "I imagine that if we are to give [Bendectin] a clean bill of health with regards to [birth defects], this [prospective study] would be of substantial help in the courtrooms." Hoenkenga replied in writing, suggested a payment of $1,500, and talked to "an ongoing relationship with Merrell" after the study was completed, according to court records. In an Internal memorandum in 1976, Hoekenga wrote that Smithells had invited the company "to make any observations we wish" prior to publication. In 1977, Smithells wrote again, the court records show, asking for $15,000 in research money, reminding the company that his study could help the firm save "large sums" in court, "which is rather what I thought when we undertook this study." The following year, Hoekenga informed Smithells by mail that two Merrell divisions would each pay him $13,000 over a three-year period. When asked about this episode, Donaldson called it "irrelevant. A side issue. A lot of it was said not seriously. Unfortunately, it doesn't look good in the record. But none of that detracts from the Smithells study itself," which, he said, exonerates the drug. (Kline, nevertheless, argued that recalculations of Smithells' numbers did reveal an increased risk.)

In 1978, as lawsuits filed by "Bendectin mothers" were beginning to make news, the company came up with a plan to sell more Bendectin. "There has been pressure within the medical profession, especially by pediatricians, to eliminate all medications during pregnancy," the sales memo stated. "If this type of activity should spread, the effect on Bendectin sales would be detrimental." The memo urged salesmen "to emphasize the importance of morning sickness as a serious medical problem, and to encourage physicians to become aware of 'morning sickness' and to use Bendectin as a routine measure." "The drug was marketed to death," said John Sellinger. At the time the sales campaign was being mapped, the company was sending the opposite message to doctors who read the Physicians Desk Reference, a product information manual. Bendectin was not depicted as a "routine measure" in the PDR. Instead, the company stated: "Like all drugs considered for use during pregnancy . . . Bendectin should be used only when clearly needed."

To the Blum and Ealy families, all this was evidence of reckless behavior by the company, and the juries apparently agreed. But Donaldson, the company spokesman, said that the memo flap "is just another distraction from the scientific facts." He said the company was confident at the time that Bendectin was safe, and thus it is wrong to argue that the sales crew was knowingly attempting to exploit pregnant women for profit. None of these explanations satisfies Joan Blum. "They have an answer for everything," she said. Fred Blum, talking at length recently for the first time since the trial, said, "Something happened this summer that was real upsetting, probably more upsetting to us as parents than to Jeffrey. He went to a Jewish day camp, and they had 'Israeli day.' They brought in people from a kibbutz, who explained to the kids about the Wailing Wall, and how if you stick a note in there, sometimes your wishes come true. Well, Jeffrey gave the people a note to take back over there. The note said he wished his feet were all better."

Merrell Dow will fight the Blum case, and hundreds of others, to the end. At present, the company is asking a Philadelphia Common Pleas Curt judge to throw out the guilty verdict in the Blum case and order a new trial. A ruling on this motion alone could take many months. Even now, there are health experts who feel that the courtroom is no place to get at the truth about Bendectin.

"If we had a better social welfare system for these kids, we wouldn't need to go that [legal] route," said Sidney Wolfe, the physician who heads the Health Research Group, a public interest organization with ties to Ralph Nader. "There's no national health insurance, so there's this tug of war for money in court. Juries know that if birth defects happened to their kids, they'd be up the same creek." In fact, Wolfe sides with Merrell Dow on the causation question. He doesn't believe the studies prove any link between Bendectin and the birth defects seen in Jeffrey Blum and Sekou Ealy.

Kline counters by saying, "I've looked at this stuff a lot more carefully than a lot of physicians have." One medical expert retained by Kline said that a woman who took Bendectin was twice as likely to have a baby with clubfeet as a woman who avoided the drug. But in the final analysis, said Wolfe, the ongoing legal quagmire only proves that Bendectin "is a ridiculous drug to have on the market, because you're guaranteed to have cases like this. When someone is pregnant, they should take drugs only when there's a life-threatening condition. Vomiting by the mother doesn't usually create a risk to the fetus. "We're talking about women between the ages of 18 and 40, very healthy people being treated with things that aren't necessary. Obviously, women who are nauseous and vomiting these days are managing to do without Bendectin. The message is getting out: Don't use drugs during pregnancy."

In Cincinnati, Merrell Dow has no plans to come up with a new antinausea drug for women. "We've discontinued research in the obstetrics area," said Donaldson. "One of the fallouts is, the consumer suffers in the end, and that's unfortunate. We've gotten letters from women, saying, 'We won't have another child, because we can't do without it.' But we can't afford anymore to be an innocent bystander when birth defects happen." In Washington, a child psychiatrist is helping Sekou Ealy deal with his problems at school. And in Huntingdon Valley, the Blums are reconciled to the fact that judgment day is a long way off. Indeed their lawsuit was filed five years ago. "It's interesting," said Fred Blum, "because I've never really felt anger. I hurt for Jeffrey. I hurt for what his future is going to be." "This has been real long and real hard for everybody in the family," said Joan Blum. "But we still feel we did the right thing, and we're prepared to do whatever we have to do. Whatever you can do for your kids you do.