Actos Lawsuits

Drugmaker Takeda Pharmaceuticals agreed to pay $2.4 billion to settle about 9,000 lawsuits over life-threatening injuries caused by its Type 2 diabetes drug Actos. The 2015 settlement was one of the largest Big Pharma settlements in U.S. history.

Actos Pills
Actos Lawsuit Facts
  1. Number of Lawsuits: More than 10,000
  2. Plaintiff Injuries: Bladder cancer and heart failure
  3. Defendants: Takeda Pharmaceuticals; Eli Lilly & Co.
  4. MDL Location: Western District of Louisiana (Closed)
  5. Litigation Status: Mostly inactive
  6. Top Settlement: $2.4 billion

More than 10,000 lawsuits accused Takeda Pharmaceuticals of failing to adequately warn patients of the risk of bladder cancer and other side effects associated with its Type 2 diabetes drug Actos.

Without admitting guilt — and continuing to stand by the effectiveness of Actos — Takeda settled around 9,000 claims for $2.4 billion in 2015.

Today, Actos litigation is mostly inactive. A federal court that once coordinated thousands of Actos lawsuits stopped accepting Actos cases in April 2018. Drugwatch’s legal partners are no longer taking Actos cases.

Actos Litigation History

At one point, more than 5,000 federal cases were part of the Actos multidistrict litigation (MDL) in the U.S. District Court for the Western District of Louisiana. MDLs are how federal courts manage large numbers of lawsuits that involve the same or similar issues.

Actos Trials
Juries ordered Takeda to pay $22 million to injured Actos users before the drugmaker announced a $2.4 billion settlement.

Another 4,500 Actos lawsuits were filed in various state courts, including Illinois, Pennsylvania, California and West Virginia.

Nine cases went to trial before Takeda announced its plan to pay up to $2.4 billion to settle Actos lawsuits. Trial juries had ordered Takeda to pay more than $22 million to injured Actos users. Judges threw out at least two of the verdicts, but an appeals court reinstated one of them.

When announcing its settlement plans, Takeda said the company would resolve seven of the nine previously tried Actos cases, which had been in various stages of the appeals process. The Actos MDL closed in April 2018 because the majority of the cases in the MDL were resolved by the settlement.

Bladder Cancer, Other Side Effects in Actos Lawsuits

Actos users blamed the drug for several life-threatening side effects.

In lawsuits, patients and family members sought compensation for conditions including congestive heart failure, bladder cancer, liver failure, chronic kidney disease, bone fractures and lactic acidosis.

Accusations Against Takeda and Eli Lilly

The majority of Actos-related lawsuits claimed Takeda, the drug’s manufacturer, and Eli Lilly, the drug’s marketer, knew about the risk of bladder cancer and other side effects but did not warn the public.

In 2011, drug regulators in France and Germany ordered doctors to stop prescribing Actos following a French study linking the drug to an increased bladder cancer risk.

Although the FDA has not implemented an Actos recall, the agency required Takeda to update the drug’s warning section to include that it “may be associated with a 40% increased risk of bladder cancer.”

Takeda Accused of Hiding, Destroying Evidence

In 2012, former Takeda employee Dr. Helen Ge sued the drugmaker, accusing the company of hiding Actos side effects information from the FDA.

Takeda Pharmaceutical Building
Head office of Takeda Pharmaceutical in Osaka, Japan

Ge, who worked for Takeda as a safety consultant in the pharmacovigilance division, said the company knew about the drug’s link to at least a dozen types of cancer but refused to recognize it.

The lawsuit was dismissed later in 2012 after a judge’s order allowed patients to join the MDL by filing their lawsuit directly with the Louisiana court.

Jurors in November 2014 concluded Takeda officials intentionally destroyed files about the development and marketing of Actos. The West Virginia jury ordered Takeda to pay $155,000 over the destruction of documents about Actos’ link to bladder cancer.

$9 Billion Actos Verdict

In April 2014, a Louisiana jury awarded $9 billion in punitive damages and $1.5 million in compensatory damages to Terrence Allen, a former shopkeeper from New York who said Actos caused his bladder cancer. It was the fifth Actos case to go to trial but the first in the federal Actos MDL.

The Allen case was designated a bellwether trial. This is the name given to the first trials in MDLs. Bellwether cases are intended to help the parties determine whether to settle.

The jury found Takeda 75 percent liable and Lilly 25 percent liable, awarding Allen $6 billion in punitive damages against Takeda and $3 billion against Lilly. A judge later reduced the total to $36.8 million.

$2.4 Billion Actos Settlement

Takeda announced in April 2015 that it would pay up to $2.4 billion to settle Actos lawsuits.

By September 2015, more than 96 percent of people suing the company had signed up to participate in the settlement, Takeda said.

The amount awarded to claimants was calculated using a “points matrix,” according to the Master Settlement Agreement. Each claim was designated points based on certain criteria. The more points awarded, the more money a claimant could receive.

Criteria for Settlement Payouts

People eligible for the settlement payouts included those who alleged they had bladder cancer and first used Actos prior to Dec. 1, 2011, which is when the FDA required Takeda to update the drug’s label.

FDA Required Actos Label to Mention 40% Increased Risk of Bladder Cancer

This included people with pending lawsuits and those who hired a lawyer to assert a claim within three days of the announcement of the settlement.

Criteria considered in determining the amount awarded to each claimant included:
  • Extent of injury or treatment
  • Age
  • Length of time on Actos
  • Dosage of Actos
  • Additional risk factors for bladder cancer, including smoking.

For patients with particularly severe injuries, extra money was available in an “Extraordinary Injury Fund.”

Please seek the advice of a medical professional before making health care decisions.

Related Pages
Elaine Silvestrini
Written By Elaine Silvestrini Writer

Elaine Silvestrini is an award-winning journalist with 30 years of experience covering state and federal court systems. She joined Drugwatch in 2017. Her coverage for Drugwatch has been cited in the CDC’s Public Health Law News and the USA Today Network. Some of her qualifications include:

  • Centers for Disease Control and Prevention certificates in Health Literacy
  • Experience as an assistant investigator for the Federal Public Defender
  • Loyola Law School Journalist Law School Fellowship
Edited By

12 Cited Research Articles

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  6. Moylan, T. (2014, April 8). Jury Awards $9B In 1st MDL Actos Bladder Cancer Trial Against Takeda, Eli Lilly. Retrieved from
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