Actos, or pioglitazone, belongs in a class of medications called thiazolidinediones (TZDs). Taken orally and prescribed to treat Type 2 diabetic patients who are not insulin dependent, Actos is manufactured by Takeda Pharmaceuticals, a subsidiary of the Japan’s largest drug company Takeda Pharmaceutical Company Limited.

When first launched, Actos proved to be a very promising treatment: patients illustrated statistically significant reductions in blood glucose levels.  Additionally, Takeda, in conjunction with the U. S. based Eli Lilly & Co. (Lilly), marketed Actos as a safer alternative to its predecessor, Avandia, know for its link to congestive heart failure.  Based upon these claims, patients felt confident in the safety of consuming Actos.  As a result, more than ten million patients have taken Actos, and in 2011, Actos alone brought in $8 billion of the company’s $17 billion in net profits.

Yet, the good news was not to last. Since its approval in 1999, numerous severe and life-threatening side effects have been attributed to Actos: bladder cancer, heart disease and heart failure, bone fractures, and rhabdomyolysis, which often leads to liver damage.

In August 2011, the FDA required the manufacturer to update the drug’s label and to disclose the link between Actos and bladder in the medications Warnings and Precautions guide.  The FDA’s decision came on the heels of a report submitted by Takeda at the half-way mark of an on-going, ten year epidemioloical study, running from January 1, 1997 through April 30, 2008.  The manufacturer reported no statistically significant association between Actos and bladder cancer, yet the FDA determined the study did indicate an increased risk in those using Actos long term (for more than one year) and that further study was needed.

Also in 2011, Dr. Helen Ge, a former Takeda employee who prepared FDA-mandated safety reports for Actos, filed a whistleblower lawsuit under the False Claims Act claiming Takeda executives, during a period between late 2007 to early 2010, asked her to ignore some reports or under-report links to heart conditions and bladder cancer to the FDA, even though it is required by law to reveal this information. Ge alleged, “Takeda’s motivation to fraudulently report and under report the serious adverse events were driven by an economic desire to falsely enhance Actos’ safety profile and to increase sales.”

The interim study and Dr. Ge’s lawsuit convinced many Actos-users who had developed bladder cancer or suffered heart failure that there was enough evidence to file lawsuits against Takeda for allegedly failing to adequately warn patients of side effects, concealing dangers, and improperly and/or inadequately conducting research.  In addition to suits against Takeda, many of the lawsuits also name Lilly, as a defendant, based on its joint venture with Takeda in the early stages of the marketing of Actos.

Thousands of lawsuits have been filed against Takeda since 2011.  Fearing a log-jam in the judicial system, the cases were consolidated into a Multidistrict Litigation, or MDL.  An MDL is a procedure in which all civil cases of a similar type are transferred to one federal judge.  This allows plaintiffs to save time, money, and resources and still retain their own attorney and negotiate their own terms.  A panel of seven federal judges appointed by the U.S. Supreme Court meets periodically to determine who will oversee each MDL.  The panel determined on December 29, 2011 that all Actos cases would be part of an MDL No. 2299 presided over by U. S. District Judge Rebecca Doherty of the Western U. S. District Court of Louisiana.

Any individual or the relative of an individual who has suffered due to Actos’ side effects is permitted to file a lawsuit. The lawyers can help you determine whether you are qualified to seek compensation.  You may be eligible to seek reimbursement for medical expenses, compensation for pain and suffering, and punitive damages (compensation granted for losses suffered). If you need further information about the harmful side effects of Actos or legal advice concerning personal injury matters, we invite you to contact us or to fill out our form on this website for a free case evaluation.