Actos® Settlements: Among the Highest Pharmaceutical Payouts in History

Claimants continue to pursue compensation for losses suffered due to complications from Actos® diabetes medication, including bladder cancer and congestive heart failure. If you or a loved one suffered an adverse complication while taking Actos®, you may be entitled to significant compensation. Our legal team is currently offering free case evaluations to victims of pharmaceutical negligence. Schedule your consultation today.

About Actos® and Liability  

Actos® (pioglitazone) has been a popular insulin sensitizer medication for type 2 diabetics since it was introduced to the U.S. market in 1999. Total sales for Actos® are reported to be over $16 billion. Takeda Pharmaceuticals partnered with Eli Lilly and Company to promote the drug, which has been widely prescribed in the U.S. and around the world. In 2011 alone, Actos® sales were calculated at $3.85 billion in the U.S. and $4.5 billion worldwide.

The Actos® payout is one of the highest settlement amounts in the history of pharmaceutical litigation.

Belonging to the same class of drugs as Avandia, Actos® is designed to increase the body’s receptivity to insulin and maintain blood glucose levels within a healthy range. Avandia had been associated with a higher risk of heart attacks, and unfortunately, reports of serious Actos® complications began to arise shortly after the drug’s release.

The initial claims in the Actos® lawsuit were primarily related to bladder cancer. Thousands of plaintiffs accused Takeda of failing to warn doctors and patients that taking the drug for an extended period of time may increase the risk of developing the condition. Lawsuit claimants sought to hold Takeda and Eli Lilly liable for manufacturing and promoting an unsafe drug, as well as::

• Failure to properly test Actos®
• Fraudulent concealment of research and test data
• Negligence
• Breach of Warranty

Mass Tort Settlement

In 2011, numerous federal lawsuits filed by plaintiffs were transferred to multidistrict litigation (MDL) in Louisiana. By 2015, there were more than 10,000 cases, including thousands in the MDL and many more individual state cases. Claimants who reside in a state other than where the defendants conduct business must file in federal court. When there are multiple similar cases involving a common defendant or defendants, they are often transferred to MDL under a single federal judge.

Takeda Pharmaceuticals agreed to offer a settlement to 9,000 plaintiffs in April 2015. The company offered $2.37 billion as compensation for medical bills, wage losses, pain and suffering, and loss of consortium. The terms of the settlement agreement allowed Takeda to pay restitution without actually admitting wrongdoing in the development or marketing of Actos®.

The settlement offer was spurred by the outcomes of the initial bellwether trials, the first cases to be heard in the MDL. Takeda lost five of the eight initial trials, and most jurors agreed that the corporation was liable and there was a link between Actos® and bladder cancer.

The first bellwether case, tried in 2014, saw a $9 billion punitive damages jury award, which was among the top ten punitive awards in U.S. history. Plaintiff Terrence Allen of New York was prescribed Actos® beginning in 2006 and was diagnosed with bladder cancer in 2011. The jury split liability between Takeda ($6 billion) and Eli Lilly ($3 billion). When defendants appealed the verdict, the judge decreased the amount, but the plaintiff’s $36.8 million award was certainly still significant.

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The judge overseeing the MDL made a favorable ruling, allowing jurors to hear evidence that alleged Takeda had destroyed documents and emails pertaining to the case. This supported the prosecution’s assertions that the company was actively concealing evidence of known health risks related to Actos®.

Takeda’s $2.37 settlement offer stipulated that 95 percent of claimants must opt in before the funds would be dispersed. By August 2015, only 75 percent of claimants had agreed, and there were concerns that the deal would not go through. However, the next month, Takeda said that 97 percent of claimants had accepted their offer, which was then increased to $2.4 billion with this additional level of participation.

The amount of money awarded to each claimant was to be determined individually, calculated with a points matrix. There were many factors considered, including:

• Patient’s age.
• Actos® dosage
• Extent of injury and treatment received
• Length of time taking the drug
• Other bladder cancer risk factors, such as smoking.

For the most severe losses, an Extraordinary Injury Fund was made available to provide additional compensation. Qualifying plaintiffs would have economic damages of $200,000 or more, minor children at the time of injury, or other circumstances that were not addressed by the point matrix.

Other Actos® Case Settlements and Verdicts

The Allen case was the fourth Actos® trial in the United States. In two of the three previous state cases tried, juries returned verdicts in favor of the plaintiffs, including a $6.5 million award in California and a $1.7 million Maryland verdict in a wrongful death case. In both cases, the judge was convinced by Takeda to throw out the verdicts, but the California verdict was eventually reinstated.

The fifth bladder cancer case also included $1.3 billion in punitive damages, in addition to $2.3 million in compensatory damages awarded to the Pennsylvania plaintiff. The claimant developed bladder cancer after taking Actos®, and the jury declared that Takeda had shown “reckless indifference” to his health.

Company executives have bribed doctors to promote and prescribe Actos® for off-label purposes.

Additional Actos® cases have been resolved after Takeda’s mass tort settlement terms were drawn. In October 2015, Takeda moved to settle two claims. A confidential settlement was reached in a Nevada case concerning a man who died of bladder cancer, and $2 million was awarded to a female cancer patient in a Pennsylvania court.

Evidence of Wrongdoing

Recently, a whistleblower case was filed that accuses Takeda of a new level of wrongdoing related to Actos®. The case was brought by a former Director at a prominent British pharmaceutical corporation, GlaxoSmithKline. Peter Lawton alleges that he interviewed at Takeda in 2009, and in a series of three meetings, learned that company executives have bribed doctors to promote and prescribe Actos® for off-label purposes. He said Takeda knew the U.S. Food and Drug Administration (FDA) would not approve Actos® for pre-diabetes treatment, and were pursuing this illegal avenue to get around the problem.

Actos® is not FDA approved to treat pre-diabetic symptoms, but doctors have prescribed the drug to patients who show the associated signs. While it is not uncommon for doctors to prescribe a medication for off-label uses, it is illegal for a manufacturer to promote medication for an unapproved use.

Ongoing Litigation

New claims continue to be filed by former Actos® patients and families as they discover the drug’s potential role in their injuries. In addition to the increased risk of bladder cancer, a recently released medical study has found a potential link between Actos® and tumors in the pancreas and prostate.

Speak with an Experienced Attorney

If you or your loved one have suffered a serious health complication after taking Actos®, you may benefit from the counsel of a pharmaceutical liability lawyer. Unfortunately, Actos® is not the only diabetes medication that has caused patients serious harm. Invokana® and Onglyza® have both been implicated in adverse health events, including kidney failure and heart attacks.

Our network of attorneys has helped many victims recover compensation for their injuries. Please contact our legal team to schedule a complimentary case evaluation with an experienced professional.