Takeda Pharmaceuticals and Eli Lilly and Co., the companies behind the diabetes drug Actos, are still seeking to reverse the $9 billion punitive damages charges in the ongoing Actos bladder cancer lawsuits.

The damages award was ordered in April by the jury in the first of the Actos bellwether trials, Allen v. Takeda Pharmaceuticals North America Inc.

In addition to $1.5 million compensatory damages to be paid to Terrance Allen and his wife, Takeda and Lilly were also ordered to pay an additional $9 billion in punitive damages, the seventh largest punitive damages charge in U.S. history. The big penalty was for allegedly withholding information linking use of Actos with an increased risk of bladder cancer. Takeda and Lilly claim the punitive damages in the Actos bladder cancer lawsuit was based on prejudice of the jurors and not on the facts of Allen’s case.

In Takeda and Lilly’s petition for new trial, submitted June 27, the companies state, “Defendants are entitled to a new trial because the jury’s multi-billion dollar punitive damages awards are unconstitutional and so excessive as to per se demonstrate passion and prejudice[.]” The judge has yet to rule on the petition.

The Allen bellwether case is just the first of 3,000 pending Actos bladder cancer lawsuits filed in federal court.

What is Actos?

Actos is a prescription drug used to treat type-2 diabetes. The drug is produced and sold by Takeda Pharmaceuticals and marketed by Eli Lilly and Co. Since its introduction into the American drug market, Takeda has made billions of dollars in profits from thousands of consumers. However, during the Actos trial, evidence was presented that Takeda possessed pre-clinical scientific studies linking Actos with patient development of bladder cancer as early as 2001.

On June 15, 2011, the U.S. Food and Drug Administration (FDA) released a public warning to Actos consumers of the increased risk of bladder cancer due to long term use of the diabetes medication. The FDA’s report also strongly advised doctors to cease prescription of Actos to patients who had previously been diagnosed with bladder cancer. In light of this evidence and the FDA mandate, Takeda and Lilly have altered labeling and marketing of Actos to reflect the increased risk of bladder cancer to long-term Actos users.

Actos Side Effects

Bladder cancer is not the only adverse side effect reported by Actos consumers. Many individuals have also reported other Actos side effects from short and long term use of the diabetes medication, including:

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