Actos News

Takeda Employs “Just Following Orders” Defense in Actos Bladder Cancer Trial,
Places Blame on Federal Regulators
Thursday, March 14, 2013

A central question at issue in the current trial pitting Takeda Pharmaceuticals against a man who claims Takeda’s diabetes drug Actos caused his terminal bladder cancer, is whether Takeda adequately informed physicians and consumers about the potential bladder cancer risk associated with its drug.

This is the first of thousands of Actos bladder cancer case to go to trial. Plaintiff Jack Cooper claims that Takeda’s blockbuster drug Actos led to his terminal bladder cancer. The trial has been underway since February 19, 2013, and is being held in the Central Civil West Courthouse, Superior Court of California in Los Angeles.

Depositions taken by Takeda of two key plaintiff’s witnesses suggest that the drug maker may employ a “just following orders” strategy in its defense, arguing it did everything the Food and Drug Administration (FDA) required in terms of the Actos label, and therefore, if the label did not fully convey the bladder cancer risk associated with Actos, the FDA, not Takeda, should be held liable.

Take, for example, the following exchange between witness for the plaintiff James Morrison (an expert on drug regulation and FDA policies and procedure) and a Takeda defense attorney. After Morrison expressed the opinion that Takeda should have followed up on early studies that showed problems with bladder tumors in rats, defense counsel asked: “Are you aware of any information that as of August of ’06 was known to Takeda or known to the FDA that should have been in the label … as it relates to the safety of Actos?”

The defense pursued this line of questioning, trying to get Mr. Morrison to answer what they characterized as a “specific” question.  Again they asked, “… are you aware of any other information actually known to Takeda that it's going to be your position should have been in the label as of August of 2006?  That's my only question.”

In his reply, Mr. Morrison took the liberty of zeroing in on an issue defense counsel appeared to be skirting. “My point is that a drug company has a responsibility not to avoid doing studies on any issue that has been brought to their attention as a potential toxicity and then claim that information was not available because, in fact , they didn't do any follow-up to the information that they were given,” said Morrison.

At that point the defense moved to strike Morrison’s testimony, saying, “It’s not responsive.”

In the deposition of plaintiff’s expert Dr. Howard Greenburg, defense counsel again focused heavily on the Actos label, appearing to suggest that the label was fully the FDA’s responsibility, not Takeda’s. Defense attorneys went into a line of questioning that appeared to be premised upon the notion that the FDA was in charge and Takeda was just following their directions.

However, in documents filed with the court, plaintiff’s counsel stated that the law is clear regarding a drug maker’s responsibility – and that responsibility is not limited to the label. Citing previous legal decisions, they argued that warnings required by the FDA “may be only minimal in nature and when the manufacturer knows of, or has reason to know of greater dangers not included in the warning, its duty to warn may not be fulfilled.”



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