Actos Lawsuit Settlements | Actos Bladder Cancer

Actos Bladder Cancer Victim Claims Takeda Knew of Risk

Shay Morrigan | October 10th, 2011

Paul McMahan, a resident of Andover, Minnesota, used Actos to help treat his Type 2 diabetes. In his recently filed Actos bladder cancer lawsuit, he claims the medication caused his bladder cancer, and he’s going to trial in the hopes of winning compensation for his medical expenses.

Actos side effects initially didn’t warn of bladder cancer

According to Mr. McMahan’s case, even before Actos (pioglitazone) was approved by the FDA in July of 1999, defendants Takeda and Eli Lilly and Company—who jointly launched the product—were aware that it could potentially increase risk of cancer. A two-year animal study had shown tumors in male rats receiving doses of Actos that produced blood drug levels equivalent to those resulting from a clinical dose in humans.

The drug was approved anyway and launched with no warnings about Actos bladder cancer. Mr. McMahan’s case states, “Defendants possessed pre-clinical scientific studies including animal evidence, which evidence said Defendants knew or should have known was a signal that bladder cancer risk needed to be further tested and studied before placing Actos on the market.”

Study of Actos side effects raised questions

In 2005, results of the PROactive three-year study on Actos were published in the journal Lancet. Researchers had planned to look only at potential cardiovascular events and outcomes, but during the course of the study became aware of a statistically significant number of Actos bladder cancer results in patients receiving the drug. According to the McMahan case, neither the researchers nor the defendants (Takeda and Eli Lilly) brought awareness to those bladder cancer cases.

It wasn’t until September 2010 that the FDA issued a safety announcement stating it was looking into a possible connection between the diabetes drug and Actos bladder cancer.

American Diabetes Association urges study on Actos bladder cancer

In early 2011, the American Diabetes Association published a study in Diabetes Care that looked at the Actos side effects adverse event reports sent to the FDA between 2004 and 2009. They concluded that they also found an association between the drug and bladder cancer, and urged more specific studies.

Still, Takeda made no move to suspend sales of its drug to conduct further studies. (The company took over all marketing and sales in 2006, leaving Eli Lilly to sell in Canada, Mexico and parts of Europe and Asia.)

In June 2011, the French Medicines Agency announced its decision to suspend the use of all pioglitazone-containing drugs because of a retrospective study in the country that demonstrated a statistically significant increase in the risk of Actos bladder cancer in those who took it for more than a year. Shortly after, Germany recommended doctors no longer prescribe it. Finally, on June 15, 2011, the FDA released a warning alerting the public and healthcare professionals that using Actos for more than a year may be associated with an increased risk of Actos bladder cancer. Simultaneously, they ordered that the Actos label be changed to reflect this information.

Possibility of Actos lawsuit settlements

When an Actos lawyer speculates about the potential for future Actos lawsuit settlements, one can see that these events would seem to show negligence on the part of Takeda. McMahan claims that for over 10 years the company failed to completely disclose its knowledge that Actos was associated with Actos bladder cancer, and that as a result, many alleged victims like him have had to suffer.

McMahan took Actos from January 2010 until about August 2011—over a year, which puts him in the “increased risk” group described in studies.