In the first Paxil birth defect trial that resulted in a $2.5 million verdict against GlaxoSmithKline in October 2009, the infant, Lyam Kilker, was born with three heart defects; an atrial septal defect, a ventricular septal defect, and an interrupted aortic arch, after his mother took Paxil while pregnant.
Pregnant women cannot participate in clinical trials on drugs due to the risk of harm to the fetus. But after a drug has been on the market for a while, epidemiology studies can review the medical records of women who have taken a new drug while pregnant and the records of women who were not exposed to the drug while pregnant and compare the outcomes of the infants.
The plaintiff's experts, Doctors Ra-id Abdulla, David Healy, Shira Kramer and Suzanne Parisian, all testified that they believed Paxil (paroxetine) caused Lyam's defects, based in part, on the scientific literature on studies available on Paxil to date.
Battle of the Experts
During her September 15, 2009 opening statement, Glaxo's lead attorney, Chilton Varner, told the jury, the "experts in the case diverge sharply on how they interpret that body of scientific literature."
The "plaintiffs' experts say that these scientific studies prove causation, they prove that Paxil causes cardiac defects and IAA," she noted.
"They get there by ... lumping all cardiac defects together and looking at the numbers for cardiac defects as a group," she said, "They also get there by rejecting any application of the tool of statistical significance."
"The plaintiffs' experts will tell you they believe that as long as there is a difference between the two groups, and the Paxil group is higher than the control group, that's enough," Varner told the jury.