The recent litigation over Takeda Pharmaceuticals diabetes drug Actos (pioglitazone) has taken a significant turn recently, after a federal judge ruled the company breached its duty to preserve evidence in the Actos multi-district litigation (MDL). The MDL, based in Louisiana, focuses on claims that the medication caused bladder cancer in diabetic patients. Actos attorneys at Pintas & Mullins take a closer look at this breach of duty and what it means for our Actos clients.
At issue is the destruction and disappearance of critical Takeda documents, including internal executive emails, which are critical pieces of evidence in the MDL. There has been a hold on the documents and electronic data since 2002, when the FDA first issued a warning letter concerning Actos and its potential health problems.
Congestive Heart Failure and Bladder Cancer
Initially, the FDA was concerned that Actos patients were experiencing severe fluid retention leading to congestive heart failure, and changed its labels to reflect this risk. Patients with type 2 diabetes are already at risk of heart failure, and Takeda's failure to warn patients of this additional risk is not only negligent but malicious as well.
Less than ten years after the heart failure warnings, the FDA acknowledged reports of bladder cancer associated with Actos. This finding was based on a decade-long study which concluded that patients taking Actos for longer than one year had a 40% increased risk of developing bladder cancer. Another study published two years later in the esteemed British Medical Journal found the increased bladder risk to be closer to 83%.
In 2013, about 15,200 American patients died of bladder cancer, and it is estimated that 1 out of every 26 men will develop bladder cancer in their lifetime. This is already a high statistic; that Takeda is manufacturing, selling, and promoting a drug it knows to increase the risk of cancer is unconscionable.
Even more unconscionable is Takeda's most recent actions in blatant disregard for the law. The pharmaceutical company has repeatedly destroyed documents critical to the MDL, which currently involved about 3,000 injured Actos plaintiffs, clearly in effort to evade responsibility in causing bladder cancer in thousands of patients. The documents were valuable pieces of evidence, and their destruction will deeply impact the ability for plaintiffs to prove their case.
The judge involved in the MDL, Judge Doherty, will soon determine the strength and nature of how the jury will be informed of Takeda's misdeeds. Opening statements in the first Actos trial are scheduled to begin on Monday, February 3, 2014. The judge will decide how to properly punish Takeda during the trial's final conference. The judge did go so far to agree with plaintiffs that Takeda acted in bad faith, which is supported by evidence now on the record.
Health agencies in Germany, France and other European counties have recalled Actos in light of its severe health injuries; however, the FDA continues to allow it to be prescribed in the U.S. Other health conditions associated with Actos include lactic acidosis, a potentially fatal stomach conditions, and bone fractures, particularly in women.
Symptoms of bladder cancer include:
• Lower back or abdominal pain
• Pain during urination
• Blood or red color in urine
• Urgent need to urinate
If you have taken Actos and demonstrate any of these symptoms, contact your prescribing physician immediately. If you or a loved one was diagnosed with bladder cancer after taking Actos for longer than one year, you should seriously consider consulting with an Actos attorney involved in the MDL. Our firm is currently accepting and investigating Actos cases, and provides free case reviews to potential clients nationwide. If you chose to take part in the Actos MDL, you could receive considerable compensation for your medical bills, lost wages, or loss of a loved one.