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Systematic Fraud Alleged in Defective Product Lawsuit

On Behalf of | Sep 7, 2012 | Wrongful Death

A new defective product lawsuit is alleging that a U.S. unit of Takeda Pharmaceutical Co. purposefully distorted reports to regulators about hundreds of cases of congestive heart failure caused by Actos, a diabetes drug. Helen Ge, a former Takeda medical reviewer, filed the complaint in federal court in Boston in 2010, and it has recently been unsealed. She is claiming that Takeda hid cases of “non-hospitalized or non- fatal” congestive heart failure by failing to classify them as serious in the U.S. Food and Drug Administration’s Adverse Event Reporting System. If her allegations are true, it would mean that Takeda is responsible for many personal injuries and wrongful deaths.

In the complaint, Ge claimed that, “These events were not properly identified or reported in the FDA’s safety database.” Ge’s complaint claims that Takeda routinely coerced its medical reviewers to, “change their professional opinion regarding adverse event classifications and assessments.” This is especially serious considering that in 2007, the FDA ordered Takeda to place its strongest warning on the labeling of their drugs about the risk of congestive heart failure. Ge is also claiming the company covered up data that tied Actos to bladder cancer.

Our New York personal injury attorneys are experts at winning personal injury and wrongful death cases that result from defective products and drugs. Personal injury victims who have suffered as the result of defective products have the right to file product liability cases against corporations such as Takeda. If you are entitled to a personal injury settlement, contact us today.