Actos News

Actos Manufacturer Evaded Reporting Actos Bladder Cancers and Congestive Heart Failures, According to Former Takeda Medical Reviewer
Tuesday, March 20, 2012

Baum Hedlund is proud to represent the former Takeda medical doctor, Helen Ge, in her whistleblower lawsuit against the Actos maker for failing to properly report all Actos related bladder cancer and congestive heart failure adverse events to the FDA. Takeda hired Dr. Ge to work in the company’s pharmacovigilance department in the U.S. to review adverse events and to identify and evaluate potential safety signals for the diabetes drug Actos (amongst other drugs). When she tried to report bladder cancer and congestive heart failures as serious adverse events related to patients’ Actos use, she encountered resistance from her superiors. She claims in her qui tam lawsuit that she was ordered to falsely report adverse events that occurred between 2007 and 2010 so that Takeda could avoid its responsibility of accurately analyzing and reporting hundreds of serious adverse events to the FDA. When Dr. Ge complained to her superiors that her medical assessments were being downgraded from “serious” to “non-serious” and that adverse events were being under-reported to the FDA, her contract with Takeda was terminated. Her whistleblower lawsuit was unsealed in February 2012.