Actos Lawsuit Documents Claim Takeda “Put Countless Lives at Risk”


. By Heidi Turner

More documents have been filed in the Actos lawsuit that saw the plaintiffs awarded $9 billion in punitive damages. Takeda Pharmaceuticals has filed a motion for a new trial, alleging the punitive damages in the Actos side effects lawsuit were too high given the compensatory damages awarded.
Now, the plaintiffs have filed their opposition to the new trial, arguing Takeda “put countless lives at risk” to improve profits.


The filing (by Terrence and Susan Allen, MDL No 6:11-md-2299, case number 6:12-cv-00064-RFD-PJH, US District Court, Western District of Louisiana) argues that Takeda has requested the new trial because not asking for a new trial would be admitting that its conduct was reprehensible. Takeda came under fire from the judge for failing to preserve documents that the judge found could have helped the plaintiffs in their lawsuit.

Among the alleged actions that the Allens argue show Takeda’s reckless disregard for its patients was Takeda reportedly hiding data from a clinical trial showing a link between Actos and bladder cancer; submitting to the FDA all disproportionality analyses and results except one study that found a significant disproportion of reported bladder cancer cases linked to Actos; backpedaling on the results of their own study that suggested an increased risk of bladder cancer; hiding or failing to properly study the risk of bladder cancer, including allegedly preventing a researcher from using Takeda’s own data to examine the potential link between Actos and bladder cancer; and destroying documents related to Actos.

The document also cites Takeda’s practice of ghostwriting, in which Takeda employees allegedly ghostwrote scientific articles regarding Actos to give it a more favorable profile.

“The Ghostwriting was equivalent to publishing fake science in the context of the health and safety of millions of Americans,” the Allens allege. They further argue that Dr. Helen Ge, a consultant for Takeda, testified that Takeda attempted to downgrade serious adverse event reports and further tried to keep information from the FDA.

The Allens argue that Takeda showed indifference to and reckless disregard for the health and safety of the general public. “The conduct in question here was not isolated to a single incident, but rather involved numerous and repeated actions occurring over a significant length of time,” the filing states. “The actions were constantly engaged in by numerous superior officers over a period of 12 years.” The plaintiffs further claim that the harm was the result of intentional malice and deceit, and not the result of an accident.

As such, they feel the court should deny Takeda’s motion for a new trial.


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