In the Paxil studies, many of the "designed characteristics have been such that they would minimize or make it more difficult to detect an increased risk," she said. "And despite that, these studies have shown consistency in showing an increased risk of cardiac malformations associated with first trimester Paroxetine exposure."
"The pressure is always against the ability to detect increased risk in the way these studies are designed," Kramer said. "And, yet, despite that, we are seeing consistently elevated risks associated with Paxil, which is very, very important, very compelling, and very alarming actually."
Kramer described the difference between association and causation as meaning that a single study with a finding of an elevated risk of birth defects would only show an association. "When you have a body of literature which shows through multiple studies consistently elevated findings, then you move from association in one study to causation, that this factor causes the disease," she told the jury.
During closing arguments on October 8, 2009, Tracey told the jury that, "Defense lawyers can't stand the word 'causal.'"
"Causal" is the "kiss of death" for a defense lawyer, he said, because they know that is one of the questions the jury will be asked.
"The second question you are going to be asked," he told the jury, is "Do you find that Michelle David's ingestion of defendant's drug Paxil was a factual cause in bringing about the heart defects?"
Epidemiology 101
While testifying, Kramer explained what is meant by relative risks and confidence intervals. "Our real interest in epidemiology is to measure rates of disease and excess risk," she said. "But we also want to know really how precise is this measure."
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