Former Pfizer oncology director Delina Ferretti has been given permission by a federal judge to sue Pfizer under whistleblower laws regarding alleged bad clinical trial results hidden by the company from US Food and Drug Administration regulators, reports Pharmalot's Ed Silverman. Two years ago, Ferretti claimed she noticed a problem with a drug in Phase I testing, and that adverse events from that trial weren't being reported to FDA. "In effect, the data was dirty," Silverman says. She told her supervisor that the study needed to be redone, but was ignored. Eventually, she says she was fired because she kept investigating and reported the incident to Pfizer's compliance hotline.
She sued Pfizer, but her lawsuit was put in limbo when Pfizer argued she had no right to pursue it because she wasn't protected by a state labor law on retaliatory dismissals, and that she was fired for refusing to continue working on the faulty trial. Now, a US District Court Judge Lucy Koh has ruled that even taking Ferretti's actions in the light most favorable to Pfizer, "it is reasonable to infer that plaintiff refused to participate in defendant's PanHER program because defendant's PanHER program violated and would continue to violate several federal IND regulations."