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Actos Diabetes Drug Did Not Warn of Bladder Cancer Risks California Class Action

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Actos became a worldwide, top-selling drug for treatment of Type II diabetes. But the complaint for this class action claims that it increases the risk of bladder cancer—and that the companies involved in developing and promoting the drug knew about this and concealed it.

The class for this action is all consumers in California who paid for or incurred costs for Actos, for purposes other than resale, between 1999 and the present.

Takeda Pharmaceuticals North America, Inc. originally developed Actos in partnership with Upjohn. In 1993, Upjohn pulled out of the project because of concerns about the drug’s safety, the complaint claims. Takeda proceeded, but the complaint claims that it persuaded Upjohn to say it had pulled our for business reasons.

In 1996, Takeda’s studies were showing bladder cancer or pre-cancerous signs in mice and rats. The company then developed a hypothesis (“the Cohen hypothesis”) to explain why rats might develop bladder cancer but humans would not. The drug was approved in 1999.

In the meantime, they developed a co-promotion agreement with Eli Lilly. The complaint quotes a fax between the company showing that rumors about Upjohn’s reasons for pulling out were raised but finally ignored. Eventually Lilly began promoting the drug in the US. According to the complaint, “Lilly also explicitly agreed not to use data from clinical studies that would negatively affect sales of Actos…”

However, in 2002, the FDA became concerned about bladder cancer and rejected the Cohen hypothesis. An FDA doctor cited a recent study involving Actos and recommended that the label warnings be changed and that Actos patients be monitored in long-term trials. Takeda and Lilly resisted this, in ways that the complaint describes as a cover-up.

In 2009, the FDA received a new report showing a statistically significant increase in the risk of bladder cancer in patients taking Actos long-term. In 2010, it announced it was investigating Actos. Meanwhile, a whistleblower who had worked at Takeda filed a complaint alleging that the company had systematically underreported instances of bladder cancer. France and Germany conducted studies which led to suspensions of Actos in those countries.

In 2011, the FDA issued a safety announcement linking long-term use of the drug to bladder cancer. Takeda finally added the warning to its label. Sales of the drug dropped by about 80%, showing that prescribers and patients would not have accepted the drug if they had known of the risks earlier.

In 2015, the International Agency for Research on Cancer deemed Actos a probable carcinogen.

According to the complaint, however, Takeda has destroyed records and files pertaining to Actos from at least forty-six witnesses.

The complaint claims that Takeda and Lilly have violated California laws, such as the False Advertising Law and Unfair Competition Act.

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