Takeda Faces Another Actos Wrongful Death Lawsuit

An Actos wrongful death lawsuit has been brought against the makers and marketers of the Type 2 diabetes drug by the surviving wife of a Tennessee man. The case was filed in U.S. District Court, Western District of Tennessee (Memphis) on August 13, 2013 after having been removed from the Circuit Court of Tipton County, Tennessee. The plaintiff seeks compensatory damages, expenses, fees, and costs in the personal injury, product liability case.

The following were named as defendants:

• Takeda Pharmaceuticals America, Inc.
• Takeda Pharmaceuticals North America, Inc.
• Takeda Pharmaceutical Company Limited
• Takeda Global Research & Development Center, Inc.
• Eli Lilly and Company

The complaint alleges that the woman’s husband, who is now deceased, took Actos for the treatment of his Type 2 diabetes and “was injured and killed as a direct result of his use” of the drug and that his wife is entitled to recover damages individually, and as the surviving spouse, next of kin, and administrator of his estate.

Actos bladder cancer litigation

This is just one of a number of cases filed in federal and state courts nationwide over Actos. On December 29, 2011, the Judicial Panel on Multidistrict Litigation (JPML) established the MDL In re Actos (Pioglitazone) Products Liability Litigation in the Western District of Louisiana to coordinate all federal products liability cases involving the medication.

This Actos wrongful death lawsuit was removed to the United States District Court for the Western District of Tennessee, Western Division and is now part of the larger MDL where it is pending in pre-trial processing. 

Actos wrongful death lawsuit allegations

This Actos wrongful death lawsuit argues that the makers of Actos should have known that using Actos for more than 12 months is associated with bladder cancer, yet promoted Actos as a safe and efficacious treatment for Type II diabetes. And, that despite that they were aware of this dangerous Actos side effect, they never warned patients, physicians, and the medical community about Actos and bladder cancer risks.

This lawsuit alleges that the plaintiff’s husband was prescribed Actos by his physicians and later suffered a large right cortical infarction, the result of hypertension due to his Actos use. He never regained consciousness and died on May 14, 2012. He had been examined by his physician a few weeks prior with no incident. The Actos wrongful death lawsuit also alleges that because of the defendants’ actions and inactions, the deceased man was injured due to his ingestion of Actos, which caused him and his surviving wife injuries and damages. The lawsuit also alleges that, for Actos patients, there are safer alternatives for the treatment of Type 2 diabetes and that the defendants knew, had reason to know, or should have known that Actos is defective, unsafe, and/or unreasonably, dangerous, especially when used as instructed.

The lawsuit levels charges of failure to warn; negligence; product liability: defect in design, negligent misrepresentation, breach of express warranty, and breach of implied warranty; and  violations of the Tennessee Consumer Protection Act. The complaint also seeks past and future compensatory damages, including: medical expenses; lost income; loss of earning capacity; loss of consortium; and physical, mental and emotional pain and suffering.

Timeline: Actos tied to serious injury

Actos received U.S. Food and Drug Administration approval (FDA) July 1999 for the treatment of Type 2 diabetes and is in a class of diabetes medications known as thiazolidinediones (TZDs), which are also known for their links to serious cardiac events. Actos and bladder cancer risks have also been established by several medical studies.

Actos use is associated with edema, the accumulation of fluids in the body; heart failure involves the body becoming congested with fluids, resulting in major organ shutdown. Edema can intensify heart problems and may lead to a new diagnosis of heart failure. A number of studies have made links to Actos and serious adverse reactions to the heart and bladder.

• A 2007 study published in the Journal of the American Medical Association (JAMA) revealed an association to congestive heart failure with Actos use. The FDA added a black box warning, its most serious, over heart failure, stating that TZDs can cause or exacerbate heart failure.

• Within two years of Actos’ release there, Canadian health officials issued an advisory regarding an increasing number of heart failure, pulmonary edema, and pleural effusion (fluid in the lungs) cases connected to Actos.

• In a complaint filed in the U.S. District Court in Massachusetts, a former medical reviewer alleged that Takeda hid heart risks tied with Actos use and failed to properly report hundreds of congestive heart failure cases to the FDA’s adverse event reporting system (AERS).

• The PROactive Study (PROspective PioglitAzone Clinical Trial In Macro Vascular Events), in place to review cardiovascular events and outcomes associated with Actos, found an increased number of bladder cancer cases in people taking Actos.

• On September 17, 2010, the FDA issued a Safety Announcement stating it was reviewing data from an ongoing, 10-year epidemiological study conducted by Kaiser Permanente to evaluate Actos and bladder cancer. At the five-year interim analysis, data revealed that bladder cancer risks increase with increasing Actos dose and duration of, reaching statistical significance after 24 months.

• On June, 10, 2011, Germany suspended the use of Actos, according to Reuters.

• On June 15,2011, the FDA issued another Safety Announcement stating that “use of the diabetes medication Actos (pioglitazone) for more than one year may be associated with an increased risk of bladder cancer.” The FDA ordered information about this risk be added to the Warnings and Precautions section of the Actos label and also reported that bladder cancer risks increased with increased dosing and duration and that Actos patients experienced a 40 percent increased risk for developing bladder cancer after one year and a 27.5 percent increased risk of the disease after 12 months.

• On July 12, 2011, Takeda Limited issued an Actos recall in France.

Despite mounting litigation, including this Actos wrongful death lawsuit; adverse event reports with the FDA; and other suspensions of Actos sales in other countries, Takeda has yet to issue an Actos recall in the United States.