Rufe ruled the plaintiffs had presented a sufficient outline of a scheme whereby GSK suppressed the adverse events evidence associated with Avandia in order to increase the number of prescriptions written and justify its cost.
“Plaintiffs have put forth factual allegations which, if proved, would support a finding that GSK deliberately concealed Avandia’s cardiovascular risk, as well as issuing affirmatively misleading statements,” the judge said. “Therefore, plaintiffs have adequately alleged that GSK misrepresented the safety of Avandia, and that these misrepresentations influenced the inclusion of Avandia on the formularies.”
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According to the opinion, GSK allegedly paid for ghost-written scientific papers extolling Avandia, pressured a scientist into retracting reservations about the drug, and used questionable marketing tactics to dispute investigations into evidence of heart-related adverse events.
The plaintiffs cite data from a 2010 investigative report by the US Senate Finance Committee which found that GSK knew that Avandia could increase the risk of cardiac events, and they knew this years prior to it becoming public knowledge, yet failed to inform the US Food and Drug Administration.