• Actos Medical Record Review & Outsourcing Services

Actos (Pioglitazone) is an oral diabetes medicine of the thiazolidinedione (TZD) class, manufactured by the Japanese pharmaceutical company Takeda and marketed by Eli Lilly (Eli Lilly stopped marketing Actos in 2006). It was approved by the U.S Food and Drug Administration (FDA) in 1999, in a 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.

Serious Alleged Injuries may include:

  • Increased risk of bladder cancer
  • Chronic kidney disease
  • Lactic acidosis
  • Bone fractures

FDA Safety Warnings:

In a Safety Announcement published in June 2011, the FDA warned that the 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.

The FDA also issued a black-box warning for congestive heart failure.

Legal Updates:

More than 10,000 lawsuits were filed against the drug maker Takeda Pharmaceuticals for their drug Actos, which caused life-threatening side effects. Takeda settled about 9,000 Actos-related lawsuits for $2.4 billion in 2015 without admitting any guilt and continue to believe the benefits of Actos outweigh the risk of cancer and became one of the largest Big Pharma settlements in U.S. history. The settlement followed eight Actos jury verdicts.

Nearly 4,000 federal cases were a part of the Multidistrict Litigation (MDL) group in the U.S. District Court for the Western District of Louisiana 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. About 4,500 cases were filed in various state courts, including Illinois, Pennsylvania, California and West Virginia. 

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

  1.  they took Actos at some time prior to December 1, 2011,
  2.  they were diagnosed with bladder cancer on or before April 28, 2015, and
  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 the 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 the 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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