Actos News

Trial Exhibit Provides Insight into Jury Verdict
Monday, April 29, 2013

In its complaint against Actos manufacturer Takeda Pharmaceuticals, counsel for plaintiff Jack Cooper alleged that Takeda acted negligently in the selling, advertising, marketing and promotion of its diabetes drug by failing to warn physicians and consumers of the risk that Actos could cause bladder cancer. Jurors in the trial that concluded Friday agreed, awarding $6.5 million dollars to Cooper and his wife.

One exhibit that may well have influenced the jury’s decision was a document prepared by Takeda to instruct their sales representatives during a 2011 meeting of the American Diabetes Association. Takeda was one of the corporate sponsors of the event.

The document laid out exactly how Takeda wanted its sales force to handle questions dealing with Actos and bladder cancer. Particularly revealing was the “Sales Force Verbatim” that Takeda had prepared for its sales reps. The Verbatim was part of a “Bladder Cancer Protocol” Takeda had created and contained specific language to use if the bladder cancer issue was raised. 

The first bulleted item in the Verbatim suggested this opening response: “Dr., [thank you for asking.] As you may be aware, in an update to its ongoing safety review the FDA has informed the public that '…use of Actos for more than one year may be associated with an increased risk of bladder cancer.'”

This was critical information, an essential update for physicians or prospective patients, and it concerned an issue about which any drug maker, it is hoped, would want doctors fully informed.

But apparently not Takeda Pharmaceuticals, which added the following caveat to its instruction manual:

Please wait for HCP’s [Health Care Professionals] to ask the question before using the verbatim.
If no questions/concerns, do not discuss bladder cancer and sell, sell, sell.

In short, Takeda sales reps were only to discuss the risk with doctors who already knew of it; and whether or not those doctors were fully informed of the bladder cancer risk was up to them – not Takeda.

Another document used by the trial team showed that Takeda had surveyed doctors about bladder cancer as far back as 2003, and knew that its mere mention would severely impact sales. The full weight of evidence, much of it contained in internal Takeda documents, demonstrated a clear pattern of behavior on the part of Takeda – a modus operandi that put profits above patient safety. It was enough to convince jurors that Takeda had acted negligently.