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Unsealed Actos Trial Documents Reveal Takeda Plan
to Deceive Physicians and Consumers

The first Actos bladder cancer case to go to trial resulted in a $6.5 judgment against the maker of Actos, Takeda Pharmaceuticals, due largely to its negligence in failing to warn the plaintiff of the link between Actos and bladder cancer. Though that verdict was later nullified by the trial judge, who found the testimony of one expert inadmissible (the case is currently on appeal), there can be little doubt that the jury was convinced Takeda willfully concealed evidence of an association between Actos and bladder cancer from consumers and physicians, including the plaintiff and his doctor. The evidenced proved it.

Documents presented at trial revealed that Takeda, from the top levels of management on down, had pursued a carefully orchestrated plan to battle the U.S. Food and Drug Administration (FDA) and keep scientific evidence of the Actos-bladder cancer link from public view.

Now that the trial has concluded, some of those trial documents have been unsealed and they are presented here. Each link below will take you to a page that briefly describes that document and its significance, with a link to the actual document itself. Though these are just a few of the documents presented at trial, they provide a revealing look into Takeda’s long-term practice of concealment.

Takeda protects Actos, not patients
Cooper MSJ Opp-Exh-20

Exhibit 20 is a 2005 email exchange between Takeda Japan executives and Takeda U.S. executives regarding how to deal with the bladder cancer issue. The document suggests that Takeda’s principal goal was to protect the “product” (instead of people) and that providing a bladder cancer warning would be a worst case scenario for the drug maker.

Takeda to Actos Reps: Don’t tell – sell, sell, sell
Cooper MSJ Opp-exh-26 (2)

Exhibit 26 is a sales team power point for Takeda sales reps attending an American Diabetic Association conference for health care professionals (HCPs).The 9th page of the attachment, “Sales Force Verbatim,” shows a middle bullet point regarding what to tell physicians attending the conference about the Actos bladder cancer issue: Don’t tell - sell, sell, sell. 

Takeda surveys doctors. Bladder cancer: what if they found out?
Cooper Plaintiff’s Opp to MSJ Exh 1

This exhibit contains the 2003 results of a survey Takeda did on physicians after Takeda was approached by the FDA to make a labeling change to reflect the risk of bladder cancer shown in drugs very similar to Actos. Doctors said if a bladder cancer risk was added to the label, they would not prescribe it to their diabetic patients. (See pages 75-77 of the document.)

FDA tells Takeda public not adequately informed about bladder cancer risks
El-Hage TPNA Conference Call Notes, July 2002

These conference call notes summarize a July 31, 2002 conversation FDA Toxicology Team Leader Jeri El-Hage had with Takeda (TPNA = Takeda Pharmaceuticals of North America) explaining the bladder cancer link to Actos shown in non-clinical trials of similar compounds. In those trials, 85% of the animals exposed to Actos had tumor formation. Dr. El Hage told Takeda representatives that the FDA believed the public was not being adequately informed about the bladder cancer risk associated with drugs like Actos.

Takeda battles European regulatory authorities’ push for clinical testing of Actos
MAA EU Bladder Issue

This document is the 2002 battle plan from Takeda international on how Takeda European division successfully fended off a bladder cancer warning—see last slide re: assert the Cohen hypothesis and “don’t turn over any stones.”


Actos Whistleblower states the case against Takeda
U.S. Court of Appeals, Opening Brief

Dr. Helen Ge is a medical doctor and former safety consultant to Takeda. Baum Hedlund Aristei & Goldman filed Dr. Ge’s qui tam action (a lawsuit brought by a private party on behalf of the government) in 2010 under the federal False Claims Act. The lawsuit alleges that Takeda intentionally made false statements to, and withheld facts from, the Food and Drug Administration in an effort to maximize profits from its diabetes drug, Actos. This opening brief lays out the basis of Dr. Ge’s lawsuit.