Actos Lawsuits

In 2015, Takeda Pharmaceuticals agreed to pay over $2.4 billion to settle almost 9,000 Actos lawsuits. In addition to lawsuits filed by Actos users who developed bladder cancer, the anti-diabetic drug has been the subject to lawsuits for congestive heart failure and other serious injuries.

Quick Summary
Actos Lawsuits

Actos (pioglitazone) is a medication used for Type 2 diabetes which has been prescribed over 100 million times in the U.S. Since its 1999 approval, Actos has been the subject of numerous FDA warnings and restrictions in the U.S. including a black box waring issued in 2011 and has been recalled in a number of other countries.

Concerns have been raised about a doubling in the risks for bladder cancer, blindness and bone fractures, four-fold increased risk of lactic acidosis and kidney disease, and a high risk of congestive heart failure associated with Actos use. Thousands of lawsuits have been filed and settled for serious injuries and deaths caused by Actos, including nearly 9,000 lawsuits settled in 2015 for $2.4 billion.

Takeda Wrongdoing

In addition to injury claims by patients, in 2012, Takeda was accused of wrongdoing by one of its safety consultants who claimed that the company knew about cancer links but failed to act.

During a 2014 trial, evidence showed that Takeda had destroyed documents related to the case after a judge ruled that the jury must hear claims of wrongdoing. Even though employees had been warned to save all pertinent information, the company admitted they were unable to find files compiled by 46 current and former employees involved with the development, marketing, and sale of the drug, including information from two of the company’s directors.

This disclosure resulted in one of the biggest damages verdicts ever awarded when a Louisiana jury ruled Takeda Pharmaceuticals and co-marketer Eli Lilly to pay $9 billion in punitive damages. The damages were later reduced to a total of $38.5 million, still one of the largest settlements in drug liability to date and Takeda quickly settled about 9,000 drug injury cases shortly afterwards.

Actos (pioglitazone) is an antidiabetic medication used to treat Type 2 diabetes which was approved in 1999. It is manufactured by Takeda Pharmaceuticals, a Japanese company and co-marketed by U.S. pharma giant, Eli Lilly.

Actos has been the subject of numerous FDA warnings, restrictions and recalls in other countries. Concerns have been raised over a possible two-fold increase in bladder cancer, bone fracture and blindness, a high risk for congestive heart failure, a four-fold increase in risk for lactic acidosis and kidney disease and other serious side effects which may be life threatening.

From 2007 to 2011, Actos was a “Top 10 Drug” based on U.S. sales which averaged $3 to 4 billion per year and accounted for 25% of Takeda’s revenue. Over 10,000 lawsuits have been filed by plaintiffs injured by Actos and in 2015, the company agreed to settle over many of those claims for a total of $2.4 billion. By the time of the 2015 settlement, sales of the drug had exceeded $25 billion with over 100 million prescriptions filled in the U.S.

Actos Serious Adverse Events

Actos has been linked to a number of serious adverse events which may be harmful, cause permanent damage or be life threatening.

  • Bladder Cancer – Actos was linked to an increased risk of bladder cancer and Takeda was ordered to conduct additional 10-year safety studies. Final results of the cancer study showed that the risk of bladder cancer may be double in Actos users. In 2014, court disclosures revealed that Takeda may have known about the increased cancer risk.
  • Bone Fracture Risk – Actos may increase the risk of bone fracture by two or more times. The risk appears to be greater in women but may include men and occurs mostly in the lower legs, arms or hips and is likely related to Actos’ effect on bone tissue growth.
  • Congestive Heart Failure – Actos may double the chance of heart failure. In 2007, the FDA required the addition of a “black-box warning” to be included on information for Actos regarding the risk of Congestive Heart Failure.
  • Chronic Kidney Disease – Taking Actos may increase the risk of kidney disease by as much as 400 percent. Kidney disease may cause high blood pressure, worsen cardiac problems and may result in a need for kidney replacement or end stage renal disease (ESRD) which may cause death.
  • Macular Edema – Macular edema may result in damage to the retina and permanent blindness. The risk of macular edema is increased in diabetic patients, but a 2009 study showed that the medication doubles the risk of developing macular edema and blindness.
  • Congestive Heart FailureActos may double the chance of heart failure. In 2007, the FDA required the addition of a “black-box warning” to be included on information for Actos regarding the risk of Congestive Heart Failure.

Takeda Wrongdoing

In addition to injury claims by patients, in 2012, Takeda was accused of wrongdoing by one of its safety consultants. The pharmacovigilance employee claimed that the company knew about Actos link to several types of cancer but failed to act.

Court documents state that Takeda conducted a survey of doctors asking if a bladder cancer warning would affect their likelihood of prescribing a diabetes drug. The results suggested that Actos sales would plummet. It is speculated that Takeda knowingly postponed adequate warnings to continue making high profit.

In a 2014 trial, evidence arose that Takeda destroyed documents related to the case. Shortly before the trial began, a judge, believing the company acted in bad faith, ruled the jury must hear claims that files and documents were destroyed after employees were warned to save all pertinent information. The company admitted they were unable to find files compiled by 46 current and former employees involved with the development, marketing, and sale of the drug, including information from two of the company’s directors.

Actos Settlements

In one of the first cases to go to court, the 2014 federal Actos lawsuit, filed in Louisiana, resulted in one of the biggest damages verdicts to date of $9 billion, when a Louisiana jury ruled Takeda Pharmaceuticals to pay a $6 billion in punitive damages and required Eli Lilly to pay $3 billion of the total damages. The damages were later reduced to a total of $38.5 million, still one of the largest settlements in drug liability to date.

Facing thousands of lawsuits in federal, state and local courts, and having already paid millions of dollars to a handful of plaintiffs in trial cases, Takeda opted to settle nearly 9,000 cases for $2.4 billion. About 5,000 federal multi-district litigation (MDL) cases and an estimated 4,000 state and local Actos lawsuit cases were eligible for an Actos settlement.

Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA.