The morning sickness drug Diclegis may have only been approved by the Food and Drug Administration recently, but Betty Mekdeci has known it well for nearly 40 years.

Diclegis is a combination of pyridoxine (vitamin B6) and doxylamine being offered by Canada’s Duchesnay Inc. This drug combination was once sold under the name Bendectin before its manufacturer pulled it from the market in 1983.

Bendectin is what Mekdeci believes caused her son David to be born with a heart defect and a deformed left arm in 1975. She wasn’t the only mother who gave birth to a child with a serious birth defect after taking Bendectin. Far from it.

After the birth of their son, Mekdeci and her husband Mike began an uphill battle against a giant pharmaceutical company to illustrate the dangers of the drug and get it off the market.

‘It Was Like a Bad TV Movie’

The Mekdecis didn’t know where to start looking for answers on behalf of their infant son. They sent a number of letters to the FDA, finally getting a response when they sent along a photo of David in a cowboy suit. Someone at the FDA hinted that they might be on to something.

So they filed requests under the Freedom of Information Act seeking government documents on Bendectin. But the cost for the government to copy the documents was more than the couple – she a freelance writer, he a teacher, both raising a growing family – could afford. They had hit a wall.

“It was like a bad TV movie,” Betty Mekdeci said.

But they found allies in an unlikely place: the same government agency that approved Bendectin. Mekdeci said “five or six” people at the FDA would point her in the right direction in her search. Some generous soul made microfiche copies of the slew of documents and studies the Mekdecis couldn’t afford and sent them over.

Without this help, Mekdeci said she never would have made it as far as she did. It also reinforced her belief that what she was seeking was very real.

“It was like a riddle. I would not have had the confidence that I knew what I was doing without help,” Mekdeci recalled. “How could I take on Bendectin if I didn’t have people telling me what to do and how to do it?”

Taking on a Giant

Fast forward to 1980. With a team of attorneys at their side, the Mekdeci’s case against manufacturer Merrell Dow eventually found its way to a courtroom. The Mekdeci’s case rested largely on animal studies of Bendectin. The jury awarded the case to the Mekdecis, but their verdict gave the family only $20,000 to cover past and future medical expenses.

“I was fine with that. We won,” Mekdeci said.

But it didn’t last. A judge tossed the verdict and ordered a new trial. This time, the jury sided with Merrell Dow. The Mekdecis appealed to the 11^th Circuit Court of Appeals.

In their 1983 decision, circuit court justices detailed the “extraordinary tale” of the Mekdeci’s litigation and its history, including the Mekdecis’ struggles with their own attorneys. The justices wrote that the evidence revealed “disturbing questions” regarding the ethics of the couple’s attorneys and suggested they did not fulfill their obligations to the Mekdecis.

While the Mekdecis had entered uncharted territory when their case began, by the time of the second trial, Bendectin was subject to a growing number of lawsuits that were potentially more profitable than the Mekdecis’ case. The appellate decision suggests the attorneys “abandoned” the Mekdecis to pursue more profitable Bendectin cases, and even touted the first Mekdeci trial as a selling point to get more cases.

The court ruled, however, that this was not sufficient to overturn the verdict.

Many cases against the company were handled by the high-profile attorney Melvin Belli, who initially took the Mekdeci’s case and was involved behind the scenes throughout the litigation. One of the Bendectin cases, Daubert v. Merrell Dow Pharmaceuticals, went all the way to the U.S. Supreme Court and became a landmark decision in the legal community for its effect of the admissibility of expert testimony.

In the midst of this bad publicity, Merrell Dow took Bendectin off the market in 1983, citing financial — not safety — concerns. The New York Times reported that some 300 lawsuits were pending against the company at the time.

A Question of Money, Not Safety

Even after pulling Bendectin, Merrell Dow maintained that the drug was safe. The company said the lawsuits raised the company’s insurance premiums to the point that Bendectin was less profitable than desired. The decision to take it off the market came because the company wasn’t making enough money.

Even when the dangers had been made public and Bendectin was on the verge of being pulled from the market, 1 in 10 pregnant women were taking the drug, the Times reported. Bendectin was the only drug approved for the treatment of morning sickness at the time, and, in the years that followed, no drug came along to take its place.

For this reason, Diclegis will likely be a hit on the pharmaceutical market.

The Good Fight

Betty Mekdeci’s fight didn’t end in 1983. During the Bendectin battle, the Mekdecis formed Birth Defect Research for Children to serve as a resource for parents whose children face birth defects. The organization is as active as ever today and currently maintains a thorough registry of birth defects in an attempt to spot patterns in their occurrence.

In a 1982 letter to then Surgeon General C. Everett Koop, Mekdeci wrote: “We feel that if our group can prevent the birth of a single defective baby, we have performed a valuable service to our country and its families.”

For more on the organization, see this The Oshman Firm blog post.

Ending the Sale of Dangerous Drugs

Mekdeci never received a dollar of compensation from Merrell Dow for David’s birth defect, but she’s OK with that. For her, it was more about the goal in the end: getting Bendectin off the market.

Ultimately, she said, the pharmaceutical business is just that – a business. She doesn’t put it past companies to market ineffective or dangerous drugs if they can make a dime from it. Even Bendectin, she said, didn’t do a great job of curbing her morning sickness.

“It’s not a life-saving drug. Its not even a particularly effective drug,” she said. “The only thing it has going for it is it’s a big moneymaker.”

The FDA says Diclegis is safe, and they have many doctors on their side. The link between pyridoxine/doxylamine and birth defects is not as well documented as that of selective serotonin reuptake inhibitor anti-depressants. When Bendectin was pulled, the Times called the research on Bendectin “inconclusive and contradictory.”

But Mekdeci is convinced. For her, her son David is proof of the drug’s potential for harm.

She worries mothers-to-be will start taking Diclegis without knowledge of its history. Mekdeci — who has almost four decades of experience with birth defects under her belt — offered a warning.

“If I had known what I knew today, you think I just wouldn’t have been sick for nine months?” she said. “That’s a lot better than being sick at heart for 38 years knowing what your son’s been through and will go through.”

Sales of Diclegis will begin in June. Will history repeat itself? Will litigation from devastated parents follow?