When Takeda settled about 9,000 Actos-related lawsuits for $2.4 billion in 2015, it became one of the largest Big Pharma settlements in U.S. history.
According to thousands of lawsuits, Takeda failed to adequately warn patients of the risk of bladder cancer associated with the medication. Without admitting any guilt — and continuing to stand by the effectiveness of Actos — Takeda settled around 9,000 claims. At least 97 percent of cases opted to settle in September 2015.
Eligible claimants included those who alleged they had bladder cancer and first used Actos prior to December 1, 2011, which is when the FDA required Takeda to update the drug’s Warnings and Precautions section of the label. This included claimants with pending lawsuits and those who retained counsel to assert a claim within three days of the announcement of the settlement.
The settlement followed eight Actos jury verdicts, five of which were won by plaintiffs, although two were later overturned on appeal. More than 4,000 federal cases resided in the Multidistrict Litigation (MDL) group in the U.S. District Court for the Western District of Louisiana. Another 4,500 cases were filed in various state courts, including Illinois, Pennsylvania, California and West Virginia.
According to the Master Settlement Agreement, the amount awarded to claimants was calculated using a “points matrix.” Each claim was designated points based on certain criteria. The more points awarded, the more money a claimant could receive.
Some of the criteria included:
- Extent of injury and treatment
- Length of time a person took Actos
- Dosage of Actos
- Risk factors for bladder cancer, including smoking
Claimants also had the option to receive extra money from the Extraordinary Injury Fund if the injury or loss was severe enough.
Four Actos-related trials took place before the massive MDL settlement. The first, involving plaintiff Jack Cooper, was surrounded by controversy, with the award verdict overturned by a judge before being reinstated on appeal two years later.
Bellwether Trial Set Precedent for Actos MDL Lawsuits
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 fourth Actos case to go to trial but the first in the federal Actos multidistrict litigation (MDL), often referred to as a bellwether trial.
Bellwether trials are a small group of lawsuits, chosen from a larger group of similar cases, to be tried first. The outcomes of bellwether trials serve as a sort of litmus test for how future litigation might turn out.
Allen’s lawyers argued that Takeda and partner Eli Lilly & Co. were “more concerned with making money” than watching out for patient safety. 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 $38.6 million.
Losing a bellwether trial often provides incentive for a drugmaker to cut its losses and begin settling remaining cases. This was the case for the Allen trial, with Takeda resolving nearly 9,000 claims later in April 2015.
A fifth trial involving two plaintiffs settled in the Clark County District Court in Nevada in October 2015, just a few months after the monumental $2.4 billion MDL settlement.
Appeals Court Reinstates Verdict of First Actos Trial
Cooper’s case took many twists and turns. In April 2013, in this, the first Actos case in the country to go to trial, a Los Angeles jury awarded Cooper $6.5 million in damages after he claimed Actos caused his bladder cancer.
Takeda was found guilty of failure to warn but convinced the judge a witness was unreliable and so the verdict was overturned. The testimony of the plaintiff’s expert witness, Dr. Norm Smith, a urologic oncologist, was struck from the record, with Judge Kenneth R. Freeman ruling the testimony was speculative and lacking information.
But in 2015, a California appeals court panel reinstated the $6.5 million verdict, finding the trial court made a mistake in excluding Smith’s testimony.
“By requiring that the expert rule out all other possible causes for Jack Cooper’s bladder cancer, even where there was no substantial evidence that other such causes might be relevant, the court exceeded the proper boundaries of its gatekeeping function in determining the admissibility of the complex scientific testimony,” the panel wrote. “The evidence was clearly sufficient to support the jury’s finding that Actos was a substantial factor in causing Cooper’s bladder cancer.”
Two More Verdicts Granted to Takeda
In 2013, a Maryland jury awarded $1.7 million to the family of Diep An, a former Army translator who died from bladder cancer after taking Actos.
Takeda convinced the judge to throw out that verdict because the jury also found that Mr. An’s smoking history contributed to his death. Under Maryland’s contributory negligence law, product makers can avoid paying any damages if the plaintiff’s conduct may have contributed to his death.
Later that year, a jury in Nevada ruled in favor of Takeda, saying Actos was not responsible for causing plaintiff Alan Alsabagh’s bladder cancer. Alsabagh developed bladder cancer after taking Actos, but also purchased generic versions of the drug from online pharmacies outside of the U.S., before a generic version was approved by the FDA.
The defense also argued that the lack of medical records of Alsabagh, who emigrated from Lebanon in 1988, left uncertainties for the cause of his bladder cancer — which can take 10 to 15 years to develop.
Philadelphia Jury Awards $2 Million to Woman
In 2014, a Pennsylvania jury awarded more than $2 million to a woman who claimed Actos caused her bladder cancer. The verdict in favor of plaintiff Frances Wisniewski was reached after five hours of deliberations. Jurors in the Court of Common Pleas, Philadelphia County, Pennsylvania, found Takeda failed to warn Wisniewski and her doctors about the risk carried by Actos of causing bladder cancer. Jurors also agreed the company did not include enough information on medication labels.
Other Major Scandals and Controversies
In 2005, the PROspective pioglitAzone Clinical Trial In macroVascular Events (PROactive) clinical studies revealed a higher percentage of bladder cancer in people taking Actos as opposed to other drugs.
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 Ordered to Pay for Destroying Files
In November 2014, Takeda was ordered by a West Virginia jury to pay $155,000 over the destruction of documents about Actos’ link to bladder cancer.
Jurors concluded Takeda officials intentionally destroyed files about the development and marketing of Actos and that the missing files blocked plaintiff Richard Myers from proving his claims that the drug caused his cancer.
Whistleblower Accuses Takeda of Hiding Information
In 2012, former Takeda employee Dr. Helen Ge sued the drugmaker, accusing the company of hiding Actos side effects information from the FDA.
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 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, eventually leading to Allen’s landmark trial verdict two years later.