Jurors in U.S. district court returned a verdict last month that cleared Abbott Laboratories of responsibility for a child’s birth defects.
Danny Kaleta, born with spina bifida in 1999, sought $30 million in compensation.
The verdict provides leverage to Abbott in 84 other suits at district court, all alleging birth defects from epilepsy drug Depakote.
Abbott did not deny that Depakote caused Danny’s injuries, but argued that mother Mary Kaleta understood the risks of taking it or not taking it.
Abbott claimed Depakote controlled seizures that might have caused other birth defects.
Mary Kaleta testified that she continues taking Depakote.
District Judge Nancy Rosenstengel conducted the proceedings as a bellwether trial.
Judges who preside over many suits involving similar claims often hold bellwether trials to guide settlement negotiations.
Rosenstengel has scheduled two more Depakote bellwether trials.
In opening argument for Danny, attorney John Williams of Houston said Abbott decided to include women of child bearing potential in the market for Depakote.
“This company made decisions based on marketing,” Williams said.
He said Mary Kaleta’s doctor fell for an inadequate label.
“A label cannot be adequate unless it tells the whole truth, and we are going to show you the missing information that should have been in there.”
Kenneth Fibich of Houston, also representing Danny, told jurors, “If there is one thing I could change about this case, it would be that I would hope Mary Kaleta had a better memory.”
“She is going to say a lot of 'I don’t knows,'” Fibich said.
Defense counsel Paul Strain of Baltimore said Abbott warned about spina bifida and other birth defects exactly as the Food and Drug Administration told it to warn.
“She couldn’t risk having seizures because it would hurt her baby,” Strain said.
As testimony began for Danny, pediatrician Godfrey Oakley of Winston Salem, N.C. called Depakote a bigger deal than Thalidomide.
Rosenstengel had ruled prior to trial that no one could mention Thalidomide, a drug notorious for birth defects in the 1950s.
At a sidebar, Abbott counsel Strain moved for a mistrial.
Williams said, “I didn’t know that he (Oakley) was going to say Thalidomide.”
Rosenstengel said, “I was shocked when that came out as well.”
She denied a mistrial, but Oakley soon said it again.
Williams cried, “No, no. Wait.”
Oakley said, “Can’t say that?”
Rosenstengel told jurors that Thalidomide had nothing to do with the case, and that she had stricken it from the record.
Plaintiff counsel John Boundas of Houston then called witness Cheryl Blume of Tampa, Fla., an expert on drug labels.
Blume described a label as a living organism, always changing.
Boundas asked if labeling is an honor system at the Food and Drug Administration.
“It is very much an honor system,” Blume said.
Boundas asked if Abbott should have changed the label.
She said they should have included significant information so prescribers could share it with mothers.
Boundas asked if Abbott’s label was a living organism.
“No," she said, "because there was multiple information that had become available that would contradict this.”
On cross examination, Strain asked Blume if she read the medical records in the case.
“No," she said. "I’m not a neurologist. I don’t read medical records.”
Strain asked if 10 persons on a committee at the Food and Drug Administration disagreed with her.
“It would not change my opinion one bit,” she said.
He asked if the label was identical to what FDA said it must be.
“That is the sad part of this case," she said. "That is true.”
He asked if it was fair that she showed jurors a sentence from an Abbott document without showing the next sentence.
"It is quoted correctly on that slide,” she said.
Strain said that wasn’t his question. He asked again if it was fair.
"It's not fair to the jury also to be citing information that is not from peer reviewed sites,” she said.
Plaintiff counsel Fibich called Mary Kaleta of Summit, Ill. to the stand.
Fibich asked if she remembered what her neurologist said about Depakote.
She said no.
He read from the neurologist’s report, “Full risks discussed with patient.”
Fibich said, “Do you know if he did?”
“No, I do not,” Kaleta said.
On cross examination, Strain read from the neurologist’s report that she told him she would rather take the risk.
Strain read from the report, “She seems to very much understand.”
He asked if she remembered telling the neurologist she didn’t want to make changes.
“I do not remember, no," Kaleta said.
He asked if she remembered going to genetic counseling.
She said she did not.
He asked if she remembered the neurologist telling her not to get pregnant without talking to him.
She said she did not.
Other witnesses for Danny testified about his injuries and costs he would incur throughout his life.
Abbott built its defense on testimony from Stanford University neurology professor Martha Morrell.
Strain asked her if she prescribed Depakote for women of childbearing years in 1999.
She said yes.
He asked about Mary Kaleta’s condition before Depakote.
“She was having uncontrolled seizures,” Morrell said.
Strain asked how seizures affect a pregnant mother.
Morrell said blood goes to muscles and is shunted away from the placenta.
She said blood oxygen level goes down, and blood becomes very acidic.
Strain asked why Kaleta needed Depakote.
Morrell said, “Her seizure control is falling apart. She is getting worse and worse and worse.”
He asked if Kaleta’s physician continued her on Depakote in 1999.
Morrell said that was correct.
“Good decision? Bad decision?" Strain said. "What would you have done?”
Morrell said, “I would have done the same.”
Strain asked if Kaleta had grand mal seizures while carrying the baby.
Morrell said that according to medical records, she did not.
He asked her if she saw a list of studies that Blume reviewed.
“I did not consider that list of studies to be a fair representation,” Morrell said“Wrong information is worse than no information.”
Strain asked if she knew Blume.
Morrell said she never heard of her.
He asked if the label was accurate.
“I believe that it presented what we knew at that time, fairly and completely,” Morrell said.
On cross examination, Fibich read an Abbott email describing Morrell as “ML.”
He said, “Now that is a marketing leader.”
Morrell said, “I actually believe ML is medical liaison.”
Fibich read an Abbott email describing her as a key opinion leader.
“I am not privy to what Abbott was saying to each other,” she said.
Fibich said, “Now you are making me laugh.”
Morrell said, “Good.”
Fibich said, “You are still being a key opinion leader today, aren’t you?”
She said, “I don’t know what you mean by that.”
In closing argument, Fibich said Abbott didn’t test the drug.
“They did not want to know the answer because they feared that the answer would be bad,” Fibich said. “If that answer was as bad as we now know it is, they wouldn’t have made the nearly four billion dollars they made."
Abbott counsel Dan Ball of St. Louis objected. He asked Rosenstengel to instruct the jury to disregard the comment.
She sustained the objection and said, “I think that is going too far, Mr. Fibich.”
Fibich asked jurors to award damages in the neighborhood of $30 million.
Strain told jurors, “There could not be a clearer case of warnings given and warnings received.”
Jurors agreed. On March 20, they returned a verdict for Abbott.