During the trial, Glaxo had Doctors, Stephen Hobbiger and Judith Jones, testify that the checked box was definitely a mistake because they don't do causality assessments in the US citing "almost certain," that they only do it that way in France.
During cross-examination, Tracey showed Jones a causality assessment from Canada that had "almost certain," and she said well, maybe they do it that way in Canada. He then showed her one from the US that also had "almost certain."
In the documents sent to the FDA, Glaxo did not include the words "almost certain," according to testimony by Dr Suzanne Parisian, a former FDA official.
Glaxo also never changed the Paxil label after receiving the report and the rules are that a drug company has to change or strengthen the warning on the label, if "they have reasonable evidence of an association with the report for their product and an adverse experience," Parisian explained.
Smoke and Mirrors
Throughout the trial, Glaxo attorneys focused on Lyam's IAA defect and harped on about "statistical significance," when as described above, the studies were designed to ensure that a "statistically significant" increased risk in rare defects would not be detected.
During closing arguments on October 8, 2009, Tracey told the jury he wanted to talk about Glaxo's "obsession" with ignoring the fact that Lyam had three cardiac defects. "All they want to talk about is this interrupted aortic arch," he pointed out.
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