Actos six billion dollar damages order

Takeda Pharmaceutical has been ordered to pay $6 billion in punitive damages by a Louisiana jury over claims it had deliberately concealed cancer risks linked to the long-term usage of its diabetes drug Actos. Co-defendant Eli Lilly has been hit with $3 billion punitive damages.

Takeda says it respectfully disagrees with the Louisiana verdict. The same jury earlier this week awarded Terrence Allen $1.475 million in compensatory damages. Mr. Allen had alleged that Japan’s largest drugmaker was aware of the cancer risk associated with Actos many years ago, but decided not to inform consumers or the healthcare industry.

Mr. Allen had been using Actos from 2004 to 2011 and developed bladder cancer in 2011.

According to the Louisiana verdict, the allocation of liability was 75% Takeda and 25% Eli Lilly. The trial began on February 3rd in the United States District Court, Western District Louisiana, before presiding Judge Rebecca Doherty.

Takeda to challenge Actos verdict

In a written statement issued on Monday, Takeda wrote:

“Takeda respectfully disagrees with the verdict and we intend to vigorously challenge this outcome through all available legal means, including possible post-trial motions and an appeal. We have empathy for the Allens, but we believe the evidence did not support a finding that ACTOS caused his bladder cancer. We also believe we demonstrated that Takeda acted responsibly with regard to ACTOS.”

Patients claim Takeda knew about the cancer risk but kept quiet about it.

Takeda points out that in all three previous Actos trials, judgements were entered in Takeda’s favor. “This is the first federal case to be tried and the first in the consolidated ACTOS multidistrict litigation (MDL).”

Kenneth D. Greisman, senior vice president, general counsel, Takeda Pharmaceuticals U.S.A., Inc., said “Patient safety is a critical priority for Takeda. We are confident in the therapeutic benefits of ACTOS and its importance as a treatment for type 2 diabetes.”

Lawyer unsure Actos verdict will be upheld

Mark Lanier, Mr. Allen’s attorney, says he is not certain whether the damages will be upheld “No one has gone out and bought a new home. We’re not under any grand illusion,” Lanier said.

There are over 2,500 pending Actos lawsuits in the US federal court system, all alleging that Takeda concealed data on cancer risk from consumers and the healthcare industry. Mr. Allen’s case is the first.

A jury in California awarded $6.5 million in damages, but the verdict was later thrown out by a judge.

About Actos (pioglitazone)

Actos (pioglitazone) is a TZD (thiazolidinedione) drug with hypoglycemic (antihyperglycemic, antidiabetic) action for the treatment of diabetes. It was the 10th best-selling medication in the United States in 2008, with sales exceeding $2.4 billion.

After linking Actos usage with a higher bladder cancer risk, the drug was withdrawn in Canada, Japan, France, Australia, New Zealand and India.

When Actos was approved by the US Food and Drug Administration, a 10-year study to assess its association with bladder cancer was ordered.

In June, 2011, the French Agency for the Safety of Health Products (Agence française de sécurité sanitaire des produits de santé) withdrew the drug from the market after a study done by the French National Health Insurance showed that long-term Actos usage raised bladder cancer risk.

In the same month (June 2011) the German Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte – BfArM) advised doctors not to prescribe the drug until further investigations had been carried out.

In June, 2011, the US FDA informed US healthcare professionals and patients that long-term Actos (pioglitazone) usage can raise the risk of bladder cancer, and that the data about this risk would be added to the Warnings and Precautions section of the drug’s label.

In July, 2011, EMA (European Medicines Agency) warned about the “small risk of increased bladder cancer” associated with Actos usage, but concluded that for a limited population of type 2 diabetes patients the benefits of the medication outweighed the harms.

A meta analysis of Actos carried out in 2012 detected a 22% higher risk of bladder cancer in three cohort studies.