Trial Magazine

E.R.G. v. Abbott Labs., No. 3:15-cv-00702 (S.D. Ill. June 9, 2017).

Stevie Gonzalez was born with spina bifida and other physical and cognitive challenges after his mother took Depakote while she was pregnant to treat her bipolar disorder. Now 10, he requires a wheelchair and has undergone 12 surgeries.

Acting on Gonzalez’s behalf, his mother sued Depakote’s manufacturer, Abbott Laboratories, Inc., alleging that the company failed to warn of the drug’s total risk of birth defects. Although Depakote’s label stated that using the drug during pregnancy could lead to birth defects, the label did not warn ­doctors of Depakote’s true level of risk.

Representing Gonzalez were attorneys Brian Abramson, John Boundas, Sejal Brahmbhatt, Margot Trevino, and John Eddie Williams Jr., all of Houston. “Depakote’s warning label stated that it had a 1 to 2 percent risk of causing spina bifida, but the drug’s overall risk of birth defects was 10.7 percent, which Abbott knew. This is extremely high, and one of our experts described Depakote as one of the three most dangerous drugs he’s ever seen with regard to birth defects,” said Williams.

Williams explained that “Abbott also concealed that Depakote’s birth defect risks were four times greater than those of its competitors. By not disclosing this information—as was its duty—Abbott prevented the doctors treating our
client’s mother from making informed decisions about her medical care, and this directly injured Stevie.”

Since Depakote was developed in the 1980s, a growing body of scientific research has shown the serious danger the drug poses to unborn children. Abbott’s internal documents and testimony from employees showed that the company was aware of this data. Dating back to at least the early 2000s, Depakote was described within Abbott as a “dirty drug” with known hazards. Instead of disclosing these risks, the company continued to push the drug, which was one of its most profitable products.

“We were able to show at trial that, even knowing the magnitude of the drug’s birth defect risks, Abbott continued to market Depakote to women of childbearing age,” said Trevino. “We introduced into evidence a great deal of their marketing materials targeting these women and their doctors, which helped show how Abbott consistently put its bottom line before patient safety.” Abramson also noted that Abbott spent tens of millions of dollars each year marketing the drug but did not conduct any independent studies evaluating the drug’s risks to pregnant women.

Abbott countered that the warning label was sufficient because it clearly stated that taking Depakote during pregnancy posed a risk of birth defects. Gonzalez’s attorneys knew it would be challenging to explain to jurors why a doctor would prescribe—and a pregnant woman would take—a drug that had any known birth defect risk.

“We knew that the defense would try to convince jurors that Stevie’s mother was to blame,” observed Boundas. “We explained that she did not have a choice about taking medication. Her serious mental illness required treatment at all times—and that’s why it was so crucial for her physicians to be informed of how dangerous Depakote really is.”

Brahmbhatt added, “[A]t trial, one of her doctors testified that if he had been made aware of the drug’s overall rate of total malformation, he would not have prescribed Depakote during her pregnancy. That was very important for the jury to know.”

Gonzalez’s attorneys also had to prove to jurors that Abbott’s failure to warn was a deliberate, repeated corporate calculation—not a mistake. “We called one of the company’s vice presidents as an adverse witness. Going beyond what she had said in her deposition, she eventually admitted that the company knew that Depakote’s overall risk of birth defects was 10.7 percent but did not feel this was essential information to tell physicians,” Williams said.

“Another key moment,” Trevino noted, “was at the end of this same executive’s testimony: When she was asked whether knowing everything she knew about Depakote and the harm it had caused if she would do anything differently, she answered no. She said that the company had acted reasonably.”

The jury found the drugmaker liable for failing to warn of Depakote’s risks and awarded Gonzalez $15 million in compensatory damages. The district court later rejected Abbott’s motions for judgment as a matter of law or for a new trial, finding that the jury had sufficient evidence to support its decision, including that Depakote’s “label, including the spina bifida warning, was inadequate.” Abbott has appealed to the Seventh Circuit.

“One of the things we hope this decision helps establish is that jurors understand degrees of danger,” Boundas said. “Abbott and other companies try to defend themselves in these cases by arguing that a product with a label warning of some risks is sufficient as a matter of law. But verdicts like these show manufacturers that jurors can appreciate that the information these companies provide makes a difference in how people behave. The strength of these warnings matters.”

Mandy Brown is an associate editor of Trial.