On April 25, 2012, one of the most recent lawsuits against the Japanese-based pharmaceutical giant Takeda Pharmaceuticals was filed in the Louisiana Western District Court (case no. 6:2012cv01001). The plaintiff Donald Shingleton of West Virginia claims that the anti-diabetic drug Actos is directly linked to his developing bladder cancer. Shingleton began taking Actos in 2005 to help manage his Type 2 diabetes and is seeking compensation for injury and emotional distress.  Once filed, this case became part of Multidistrict Litigation (MDL) No. 2299, a procedure in which all civil cases of a similar type are transferred to one federal judge in order to save time and money. U. S. District Judge Rebecca Doherty of the Western U. S. District Court of Louisiana presides over more than 150 Actos-related lawsuits.

Starting with the drug’s approval in July 1999, Takeda, along with its American business partner Eli Lilly & Co., marketed Actos as a safer alternative to other diabetes drugs even though studies proved a causal relationship between Actos use and bladder cancer, in addition to other serious side effects.

In June 2011, the U. S. Food and Drug Administration (FDA), based on the results of an independent French study, announced that the “use of the diabetes medication Actos (pioglitazone) for more than one year may be associated with an increased risk of bladder cancer” and required another label and Warnings and Precautions update. The French study following 1.5 million patients enrolled in the French National Health Insurance Plan for four years (2006-2009) and found a statistically significant increased risk of long-term use (more than one year) and bladder cancer and an increased risk of higher cumulative dosing (28,000 mg or greater) and bladder cancer.  The European community took this study seriously and acted immediately: use by new patients in both France and Germany was halted immediately.

Also in 2011, Dr. Helen Ge, a former Takeda employee who was hired to review “adverse events and to identify and evaluate potential safety signals for Actos, filed a whistleblower lawsuit under the False Claims Act. According to the lawsuit, Dr. Ge maintains the company knew about cancer risks as early as the 1990s after studies on rats and mice were completed, but executives insisted that these studies be classified as “unrelated” to Actos. During a period between late 2007 to early 2010, more than 100 cases of bladder cancer were reported to the company, but only 72 of these were forwarded to the FDA as related. Dr. Ge contends, “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.”

Actos has proven to be one of Takeda’s most profitable, and one of its most dangerous, drugs.  At its peak, Actos was responsible for more than half of the total revenue at Takeda Pharmaceuticals North America.  In 2008, it had $3.1 billion in sales, and in 2009, it had $3.4 billion in sales.  Unfortunately, though, Actos’ popularity and the company’s continued promotion of its safety and effectiveness has also caused it to adversely touch the lives of millions. In addition to bladder cancer, users have also developed heart failure, lactic acidosis, rhabdomyolysis, liver damage, and bone fractures.

Have you developed bladder cancer or any other severe, life-threatening side effects during or after Actos use? 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.