We are no longer accepting Actos cases.
Exhibit 20 is a 2005 email exchange between Takeda Japan executives and Takeda US executives regarding how to deal with the bladder cancer issue. The document shows that efforts to prevent the Actos-bladder cancer link from reaching the public were coordinated at the top levels of Takeda management and included executives with Takeda’s Research and Development Center (referenced as TGRD in the document).
Within the email chain, the executives refer to the U.S. Food and Drug Administration (FDA), the FDA’s Data Safety and Monitoring Board (DSMB), the EMEA (European Medicines Agency), which regulates Medicines for the European Union (EU), and two important research studies that had revealed a link between Actos and bladder cancer – the ProActive study and the Kaiser Permanente Northern California (KPNC) study.
In one of the emails, Takeda’s Vice President of Regulatory Affairs writes to Takeda’s President of Medical Research and Development and copies a number of other executives, including the Managing Director of Takeda Pharmaceutical Co. Ltd, Kiyoshi Kitazawa. The VP expresses the idea that any label change incorporating bladder cancer findings, and even a “Dear Healthcare Provider” letter, a standard means of alerting physicians and health care providers about new information regarding a drug, would be a “worst case scenario.”
Kitazawa responded by advising that “we need to manage this issue very carefully and successfully not to cause any damage for this product globally.”
Plaintiff’s expert Dr. Howard Greenburg, an expert in pharmacology and drug regulation, testified extensively regarding this email and other internal Takeda documents early on in the trial.
Return to Unsealed Actos Trial Documents Reveal Takeda Plan to Deceive Physicians and Consumers
|
