Actos pharmaceutical lawsuits resulted in some of the highest-paying settlements in U.S. history.

In 2015, Takeda, the manufacturer of the drug Actos, agreed to pay almost $2.4 billion in Actos case settlements. This substantial settlement resolved more than 9,000 state and federal Actos cases in which plaintiffs claimed injuries, including bladder cancer, after taking the Takeda-produced drug.

This guide will discuss the events that led to the massive Actos mass tort lawsuits and how Takeda eventually settled for such a large sum. It will also detail the steps you can take if you believe Actos contributed to your injuries or bladder cancer.

What Is Actos?

Actos, also known by the generic name pioglitazone, is a pharmaceutical drug used to treat diabetes. Doctors sometimes prescribe this drug to help people with Type 2 diabetes control their blood sugar levels. The drug increases the body’s insulin sensitivity and reduces glucose levels.

Takeda Pharmaceuticals America Inc. is the primary manufacturer of Actos. This company also makes two other versions of this drug: Actoplus Met and Actoplus Met XR. The manufacturer works with Eli Lilly, another pharmaceutical company, to market its Actos drug products.

The FDA initially approved Actos in 1999 and later approved the company’s other two versions of the medication. Actos quickly became one of the most successful diabetes medications, outranking its competitor Avandia after Avandia became linked to an increased risk of a heart attack.

However, Actos’ reputation declined just as quickly when numerous studies began to link higher dosages and prolonged use of the drug to an elevated risk of bladder cancer.

Side Effects of Actos

Like many pharmaceuticals, Actos can produce adverse effects on users. The most common side effects include cold-like symptoms, such as:

  • Sore throat
  • Headache
  • Sinus infection
  • Muscle pain
  • Shortness of breath

However, the drug can also produce more severe side effects, including:

  • Liver failure
  • Eye problems
  • Congestive heart failure
  • Low blood sugar
  • Bladder cancer

Takeda did not initially warn users about the potential risk of bladder cancer when taking this drug long-term.

FDA Warnings About Actos

In September 2010, the FDA alerted the public about a possible risk of bladder cancer associated with Actos usage. This alert came after a 10-year epidemiological study. At this time, the FDA changed the labels of Actos and other medications containing pioglitazone to include warnings about the risk of bladder cancer development.

The FDA updated this review on December 12, 2016. At this time, the FDA concluded that the use of medications containing pioglitazone may be linked to an elevated risk of bladder cancer. In some cases, the drug may increase the risk of bladder cancer by 40%. The FDA-approved label updates to warn consumers of these potential risks.

Despite these warnings, the FDA still approves pioglitazone for individuals with Type 2 diabetes. However, the organization warns that healthcare professionals should not prescribe this medication to individuals with active bladder cancer. They should also carefully examine the advantages and disadvantages of this medication before prescribing it.

Accusations Against Actos Manufacturer

After FDA studies began linking Actos to bladder cancer, law firms initiated legal action against Takeda and Eli Lilly, the drug’s manufacturer and marketer.

The primary accusation behind these lawsuits was that Takeda and Eli Lilly were aware of the elevated risk of bladder cancer from prolonged Actos use yet failed to warn the public about these risks.

However, Takeda was also accused of destroying and hiding evidence pointing to the potential risks of taking Actos long-term. Dr. Helen Ge, a former employee of Takeda, sued Takeda in 2012 over these allegations. Dr. Ge accused Takeda of hiding potential side effects of Actos from the Food and Drug Administration.

Dr. Ge was a safety consultant in Takeda’s pharmacovigilance department and stated that the organization knew of at least twelve varieties of cancer linked to Actos yet refused to acknowledge these risks. While the judge dismissed this case in 2012, in November 2014, jurors concluded that Takeda destroyed files containing documents linking Actos to bladder cancer.

Takeda Mass Tort and Settlement

In 2011, numerous plaintiffs in Louisiana began filing lawsuits against Takeda and Eli Lilly. These lawsuits were eventually transferred into multidistrict litigation (MDL). Four years later, more than 10,000 cases against Takeda had been launched in Louisiana and other states.

One of the most significant cases in the MDL was that of plaintiff Terrence Allen. Allen alleged that taking Actos caused him to develop bladder cancer.

This case was the first of the federal MDL cases to go to trial–a so-called bellwether or “test” trial.

The jury awarded Allen $1.5 million in compensatory damages and $9 billion in punitive damages, finding Takeda 75% liable and Lilly 25% responsible for these damages. Later, a judge decreased this verdict to $36.8 million total.

The following year, Takeda announced that it would settle all Actos lawsuits for $2.4 billion. This settlement would cover over 96% of the claimants. Each claimant received varying amounts of this settlement fund, depending on the following criteria:

  • Extent of injury
  • Dosage of Actos
  • Length of time taking Actos
  • Age
  • Additional bladder cancer risk factors

Ongoing Actos Litigation

Even though Takeda settled over 9,000 bladder cancer claims in 2015 for a total settlement of $2.4 billion, claimants continue to come forward regarding bladder cancer diagnoses after long-term Actos use.

Because Takeda has since updated its labels to include warnings about bladder cancers, not everyone who experiences a bladder cancer diagnosis can seek damages from the company. However, individuals who first used Actos before December 1, 2011, and later developed bladder cancer may have grounds to receive settlement payouts from the company.

If you’re interested in filing an Actos claim or would like to learn more about this closed Actos mass tort, we can help. Contact our team at Mass Tort Resource today at 844-636-7459, or fill out our online form for a free consultation.