Takeda Pharmaceutical Co., the creator and manufacturer of the diabetes medication Actos, and its marketing partner Eli Lilly & Co. are moving to overturn the $9 billion punitive damages the companies were ordered to pay in the initial Actos personal injury bellwether trial.

In April, a jury assessed $9 billion in punitive damages to the two companies for various alleged illegal business activities, including destroying evidence. The court found in favor of plaintiffs Terrence and Susan Allen, who alleged in their Actos lawsuit that Takeda and Lilly actively concealed research linking consumption of Actos with higher rates of bladder cancer. This particular legal award is believed to be the seventh largest punitive damages ruling in U.S. court history.

Lawyers for Takeda and Lilly said even if the ruling is not completely overturned, they are hoping that the court will reduce the punitive damages award. If the court finds the jury made its decision based on prejudiced assumptions about Takeda and Lilly from other Actos lawsuits that do not directly relate to the Allen’s bellwether case, it could be possible for Takeda and Lilly to escape paying the punitive damages award.

If the Allen bellwather jury ruling is upheld, observers say this could mean a good outcome for other Actos lawsuits that have been consolidated in the Actos multidistrict litigation In re: Actos (Pioglitazone) Products Liability Litigation, MDL No. 2299, in the U.S. District Court for the Western District of  Louisiana.

What is Actos?

Actos is a prescription drug to treat for type-2 diabetes. The drug is produced and sold by Takeda Pharmaceuticals, but marketed by Eli Lilly Co. Nearly two decades after the U.S. Food & Drug Administration (FDA) approved Actos for public consumption in 1996, Takeda sold its diabetes treatment to thousands of consumers and made billions of dollars in profits. However, Actos lawsuits allege that in 2001 Takeda was in possession of pre-clinical scientific studies that showed a high medical correlation between consumption of Actos and a patient’s development of bladder cancer.

The FDA in 2011 published an official report warning all Actos consumers that using the diabetes medication could increase the risk of bladder cancer. In the same report, the FDA advised doctors to discontinue all Actos prescriptions and treatments for patients already diagnosed with bladder cancer. Since this FDA warning, Takeda has altered the labeling and marketing of the drug to incorporate the increased risk of Actos bladder cancer in long-term users.

Actos Side Effects

Aside from an increased risk of bladder cancer, Actos has also been reported to have other side effects, such as:

• Chronic kidney disease
• Congestive heart failure
• Liver failure
• Lactic acidosis
• Bone fracture
• Rapid and excessive weight gain
• Difficulty breathing
• Edema (or fluid retention)