New California Lawsuit Filed Due to Actos Side Effects

On December 11, 2012, a new product liability lawsuits was filed in the Superior Court of the State of California, Los Angeles against the manufacturer of the diabetes medication Actos, Takeda Pharmaceuticals and subsidiary Eli Lilly.

The case was filed by an Actos lawyer representing seven plaintiffs. Of the seven plaintiffs, four allege that they were seriously injured by the medication. The remaining three are spouses who claim loss of consortium.

They bring counts of violation of civil codes, negligent misrepresentation, deceit by concealment, violation of business codes, breach of warranties, manufacturing defect, strict liability, and negligence. All seek punitive, special and general damages.

Takeda accused of failing to disclose Actos link to bladder cancer

In the filing, the attorney for the plaintiffs notes the history of Actos and states that the defendants became aware of evidence of a link between bladder cancer and the medication in human clinical trials in the early 2000s. However, the manufacturer failed to completely disclose their knowledge of the connection between the drug and the disease for over ten years.

The complaint states that four of the plaintiffs were taking Actos for maintenance of their type II diabetes and suffered from significant injuries including permanent bodily impairment, bladder failure, bladder surgery, bladder cancer and other problems. It was due to these side effects that the plaintiffs required hospitalization, medications, surgeries and other treatments.

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U.S., France, and Germany take action to protect public from Actos dangers

Two of the plaintiffs are residents of California; the others are from Iowa, Ohio and Maryland.

All claim that they were injured due to the use of Actos and because Takeda didn’t provide an adequate warning regarding the risk of cancer. They state that the warnings on the product were vague and incomplete and failed to alert doctors as to the dangers of the drug. The plaintiffs claim that if they had been aware of these risks, they would not have used it.

The plaintiffs also note several dates in 2011 that are deemed as important. Health agencies in the U.S., France, and Germany took action to protect patients from the risks of Actos. A published report in France, dated June 7, 2011, indicated a statistically significant connection between Actos and bladder cancer, and that those who were exposed to the drug for longer than year were subject to an increased risk.

Actos recalled in France

The European Medicine Agency suspended the use of the medication on June 9, 2011. On June 10, 2011, the Federal Institute for Drugs and Medical Devices in Germany suspended the use of Actos pending further investigation.

The FDA informed Americans on June 15, 2011, that the use of Actos for more than a year could be associated with bladder cancer.

The Warnings and Precautions section of the label of Actos was changed to reflect this new information.

A recall of the medication was implemented in France by Takeda in July of 2011. The Institute for Safe Medication Practices stated that since the beginning of 2011, a total of 1,025 complaints alleging cancer from Actos have been filed with the FDA.