Actos Judge Allows Argument That Manufacturer Destroyed Files

On the first day of the first federal Actos trial, which is under way this week in Louisiana, the judge made a crucial ruling on behalf of the plaintiffs: the jury will be allowed to hear the plaintiffs’ contention that Takeda Pharmaceutical Co. intentionally destroyed files to conceal the adverse effects of Actos.

Actos (pioglitazone) is prescribed to treat Type 2 diabetes. Takeda placed the drug on the U.S. market in 1999. However, Actos has since been linked to an increased risk of bladder cancer. Plaintiffs in thousands of lawsuits against Takeda contend that the company knew about the bladder cancer risk years before the FDA made that information public in 2010, and possibly before the drug was ever placed on the market.

Plaintiffs have requested Takeda documents which might reveal what the company knew and when. However, Takeda executives told Judge Rebecca F. Doherty that some computer files have been deleted and other files have been lost. The missing files were created by 46 Takeda employees who worked on the development and marketing of Actos.

In Doherty’s ruling, she wrote,

“The breadth of Takeda leadership whose files have been lost, deleted or destroyed is, in and of itself, disturbing.”

The case, Allen v. Takeda Pharmaceuticals North America, began with jury selection on Monday, and opening arguments are set to start next Monday. Terrence and Susan Allen of New York claim that Takeda was negligent because of its failure to warn about the drug’s bladder cancer risk. Terrence Allen began taking the drug in 2006 and was diagnosed with cancer in 2011.

The case is the first “bellwether trial” for 2,692 federal Actos lawsuits which have been consolidated in a multidistrict litigation (MDL) in the Western District Court of Louisiana before Judge Doherty. In a bellwether trial, many issues are resolved by rulings which apply to the subsequent trials in the MDL. Also, the outcome of the first few bellwether cases in an MDL often set the context for settlement of the remaining cases. A second Actos bellwether is set for April 2014.

Takeda is based in Japan and is the largest pharmaceutical in Asia. Actos has generated more than $16 billion in sales revenue for Takeda. Eli Lilly and Co. is a co-defendant in the Allen trial because it jointly marketed Actos in the U.S.

Takeda released a statement by email in which it held its ground that Takeda does not cause bladder cancer. It said:

“We empathize with the patients, but believe that Takeda acted responsibly with regard to Actos. There is no credible scientific evidence that establishes a causal link between Actos and bladder cancer. Further, the FDA has confirmed Actos as safe and effective for the treatment of type 2 diabetes.”

However, in a 2011 FDA statement, the agency announced the findings of a multi-year study:

“The risk of bladder cancer increased with increasing dose and duration of pioglitazone use. Compared to never being exposed to pioglitazone, a duration of pioglitazone therapy longer than 12 months was associated with a 40% increase in risk.”

Three 2013 trials at the state level provided little guidance as to how plaintiffs will fare in the federal court. In a California trial in April, a jury made a $6.5 million award against Takeda, but the judge throw out the award and the case is on appeal. In a Baltimore trial in September, a jury returned a $1.7 million verdict, but the judge in that trial also negated the award. A Las Vegas trial in December ended with a verdict favoring Takeda.

If you or a loved one are an Oklahoma resident who has taken Actos and have subsequently been diagnosed with bladder cancer, you can learn more about Actos, its link to bladder cancer, and your legal rights on our web page: Actos Linked to Bladder Cancer.