Joint Actos Injury Lawsuit Filed Against Takeda

In an Actos injury lawsuit filed on July 15, 2013, ten plaintiffs contend that Takeda Pharmaceuticals failed to adequately warn about bladder cancer and heart failure risks. The bundled complaint is proceeding in the U.S. District Court, Western District of Louisiana – site of the Actos products liability MDL 2299.

Court documents submitted before Judge Doherty state that this action for personal injury is on behalf of plaintiffs, loss of consortium on behalf of plaintiffs’ spouses, and wrongful death on behalf of plaintiffs’ representatives against the defendants. The diabetes drugs Actos and/or Actosplus Met, Actosplus Met XR and Duetact (Actos), are alleged to have caused the claimants to incur serious bodily injuries, economic losses, pain and suffering.

Actos injury lawsuit allegations

Hailing from around the nation, all of the plaintiffs argue that Actos poses unreasonable health risks, including a heightened likelihood of developing bladder cancer and congestive heart failure – two complications that shortened their life expectancy. The lawsuit further alleges that Actos (pioglitazone hydrochloride) was in a defective condition and was unsafe, and that Takeda knew and had reason to know that the medication was inherently dangerous, especially when used as directed by the defendants.

The joint complaint against Takeda contains specific causes of action leveled by 10 claimants, two of whom are Robert and Patricia Wall, both New York residents. Robert took Actos to manage his Type 2 diabetes from September 2000 through November 2007. He was diagnosed with bladder cancer in July 2010. In addition, Wall alleges that he suffered congestive heart failure from Actos in November 2007. His wife Patricia is demanding damages for loss of spousal consortium.

Other plaintiffs in this lawsuit are Jorge Fernandes and his wife, Maria. Jorge used Actos from April 2008 until August 2010. In October 2010, Jorge developed bladder cancer, which he contends is a direct and proximate result of his Actos exposure. Edward Paniccia, individually and as the administrator of the estate of Theodore Paniccia alleges the decedent’s use of Actos between January 2005 and March 2011 led to his bladder cancer and untimely death in August of 2011.

Once again, Takeda is being held liable for designing, manufacturing and distributing a dangerous drug, while failing to warn of its risks. According to the complaint, had the plaintiffs and their doctors been adequately warned of the possible life-threatening side effects of Actos, the plaintiffs’ physicians would have changed the manner in which they prescribed the drug and passed on crucial safety information to their patients.

FDA warns of bladder cancer and Actos heart failure risk

In the wake of clinical research and post-marketing reports linking pioglitazone to heart problems, the FDA mandated a black box warning concerning Actos heart failure risk in 2007. Framed by an emphatic black line, the warning stated that TZD drugs such as Avandia and Actos can cause or worsen heart failure in patients. Federal regulators also recommend that all Actos patients are closely monitored for symptoms of heart failure.

On June 15, 2011, the FDA issued a safety notification alerting consumers and medical providers that the use of Actos for more than one year was associated with an increased risk of bladder cancer. This Actos bladder cancer warning was not framed by a black box, as the information was only updated in the warning and precautions section as well as the patient medication guide.

Takeda accused of negligence and fraudulent concealment

Pharmaceutical giant Takeda must defend nine causes of action in this recent Actos injury lawsuit, in which the plaintiffs are demanding both compensatory and punitive damages. These include:

• Negligence
• Strict products liability – failure to warn
• Strict products liability – defective design
• Breach of express warranty
• Breach of implied warranty
• Breach of implied warranty of merchantability
• Fraud and fraudulent concealment
• Loss of consortium
• Wrongful death

Takeda has consistently denied any wrongdoing and, despite negative press and Actos recalls in other countries outside the U.S., has made no mention of removing its blockbuster drug from the market.