Washington, DCUS District Judge Cynthia M. Rufe of the Eastern District of Pennsylvania has ruled that three plaintiffs' expert witnesses meet the Daubert standard for scientific validity in Avandia lawsuits currently before the court.
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"Although the conclusions differ from the conclusions reached by GSK's experts, generally speaking the epidemiological studies relied upon by plaintiffs' experts are the same studies consulted by GSK and the FDA [the federal Food and Drug Administration] in their evaluation of the risk profile of Avandia," Rufe wrote January 3, 2011. "Plaintiffs' experts arrived at their conclusions that sound scientific evidence supports a causal inference without any speculative leap."
Among 23 observational studies being cited by plaintiffs' experts, nine showed a statistically significant increase for heart attacks in people taking Avandia. No statistically significant correlation was evident in 13 of the studies, and one showed a "statistically significant protective effect," Rufe said.
Avandia lawsuits are numerous, with some 3,500 cases filed in California state courts, and 1,200 in Pennsylvania, with all but 250 of those having been settled with GlaxoSmithKline – the maker of the diabetes medication.