Actos, when initially launched, proved to be a very promising drug for treating patients suffering from Type II diabetes who are not insulin dependent. Yet, 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, the release of muscle fibers into the blood stream which often leads to liver damage.
The many disturbing reports of unfavorable side effects presented to Takeda Pharmaceuticals, the manufacturer of Actos, and the FDA’s monitoring agency, the Adverse Events Reporting System (AERS), required the FDA to publish its first set of warnings to the public in 2007. This first statement concluded “that the drug may cause or worsen heart failure in certain patients.” Additionally, the FDA required Actos to carry a new label including a black-box warning, the FDA most severe warning, and an updated warning in the medication’s Warnings and Precautions guide. Over the next five years, numerous other notifications were published by the FDA in regards to Actos’ link to bladder cancer, bone fracture, and rhabdomyolysis. In July 2010, Actos was even recalled from France and Germany because of its link to an increased risk of developing bladder cancer after long-term use (more than one year).
The manufacturer of Actos, Takeda Pharmaceuticals, a subsidiary of the Japan’s largest drug company Takeda Pharmaceutical Company Limited, in conjunction with the U. S. based Eli Lilly & Co., began marketing Actos in 1999 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 used Actos since its appearance on the market, and in 2011, Actos alone brought in $8 billion of the company’s $17 billion in net profits.
However, Dr. Helen Ge, a former Takeda employee who prepared FDA-mandated safety reports for Actos, filed a whistleblower lawsuit under the False Claims Act in 2011 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. 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.”
By September 2011, Takeda acknowledged 54 lawsuits had been filed against the company; all claiming the drug’s association with serious, often life-threatening health ailments, most particularly with bladder cancer. These suits alleged Takeda inadequately warned patients of side effects, concealed dangers, and improperly and/or inadequately conducted research.
One such lawsuit was filed by Terrance Allen of Attica, New York. Allen took Actos for five years and then, in January 2011, learned he had developed bladder cancer. He had two surgeries to remove cancerous tissue and stated in a telephone interview with Bloomberg reporter Jef Feely, “If somebody had told me I could get cancer from Actos, I never would have taken it. There were other products out there that could have helped treat my diabetes without putting me through all of this.”
Thousands of complainants followed suit; so many, in fact, that the cases were consolidated into a Multi-district 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. It was determined on December 29, 2011, that all Actos cases would be part of an MDL No. 2299 presided over U. S. District Judge Rebecca Doherty of the Western U. S. District Court of Louisiana.
Even though the FDA has not recalled Actos from the market, anybody who has suffered taking Actos may be eligible for compensation, especially those who have been diagnosed with bladder cancer. As with any other legal claim, the Actos injury claim must be filed within the applicable statute of limitations, which may vary from one state to another and may vary depending on other case-specific variables as well. If you or a family member took Actos and suffered an Actos-related side effect, please contact us.
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.