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Pioglitazone is an oral diabetes medicine of the class thiazolidinedione (TZD), marketed by Takeda Pharmaceuticals under the trade name, Actos and approved by FDA in 1999, in tablet form (15 and 30 mg) for oral administration and is taken once a day. Actos is a drug that helps control blood sugar levels for people with Type 2 Diabetes.

Actos Litigation

In a Safety Announcement published in June 2011, the FDA warned that patients using Actos were at an increased risk of bladder cancer. Long-term use of Actos is linked to a number of serious health complications, including bladder cancer that led to lawsuits against Takeda.

Since then till date, Takeda has been hit with over 9,000 lawsuits involving bladder cancer; individual lawsuits were centralized in a federal court. Takeda continues to believe the benefits of Actos outweigh the risk of cancer and agreed to pay $2.37 billion to settle approximately 8,000 federal and state lawsuits over its drug Actos. The 8K cases include 3,500 lawsuits in Lafayette, Louisiana before U.S. District Judge Rebecca Doherty (In Re: Actos (Pioglitazone) Products Liability Litigation, 11-md-02299, U.S. District Court, Western District of Louisiana), and about 4,500 suits in California, Pennsylvania, Illinois, and West Virginia.

On April 28, 2015, the U.S. District Court, overseeing the Actos injury cases in federal court nationwide issued an order recognizing that Takeda has agreed to settle all bladder cancer claims brought against the company from Actos users provided three conditions are met:

  1. 1. they took Actos at some time prior to December 1, 2011,
  2. 2. they were diagnosed with bladder cancer on or before April 28, 2015, and
  3. 3. they are represented by counsel, or retained counsel by May 1, 2015.

The settlement amount was increased from $2.37 to $2.4 billion, because the percentage of claimants who decided to participate exceeded 97% before the opt-in deadline of September 11, 2015. Average payments per person will be increased for more severe injuries, and reductions will occur where an individual had other likely causes of bladder cancer, such as smoking.

Scoring Actos Cases

  • A meticulous review of plaintiff's medical and pharmacy records of entire treatment duration; and
  • A thorough comparative analysis in light of risk and adjustment factors is needed to achieve the desirable and most appropriate compensation.

Medical Record Review and claim validation of Actos case should take approximately 5 hours in most instances; however, this approximation may vary in cases based on the volume of records.

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