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.
"GSK's experts, on the other hand, are anti-lumping," she said. "They say that you can't lump all heart defects together because they form for different reasons at different times by different processes and that you can't use evidence as to one kind of defect to imply that it also applies to another kind of cardiac defect."
"And GSK's experts will tell you that statistical significance matters," she stated, "that without applying the tool of statistical significance, you have no idea whether the difference between the two groups is real and meaningful or whether it is simply the operation of chance or coincidence."
Studies Designed to Fail
During his September 15, 2009 opening statement, the family's lead attorney, Sean Tracey, told the jury: "You are going to hear from experts in this case that there are ways to design studies to fail."
"If you truly don't want to know the truth," he said, "very smart people can design studies that won't show you the truth."
Dr Shira Kramer, an epidemiologist, testified as an expert for the plaintiffs. Kramer was asked to explain what is meant by "inclusive by design." It's "a very, very serious problem that has been written about quite a bit," she told the jury.
The reason for "the tremendous amount of concern and literature on this topic," she said, "is many of these studies look like they have been designed to fail."
It's the "deliberate design of epidemiological studies in such a way as to make it, if not impossible, extraordinarily difficult to detect relationship between an exposure and an outcome or a disease," Kramer explained.