It is possible that individuals diagnosed with bladder cancer after using Actos may face a deadline for filing their lawsuit later this week, if the medication was prescribed or used in a state with a one-year statute of limitations.
Attorneys for Takeda Pharmaceuticals are expected to argue that the Actos statute of limitations started running in many cases on June 15, 2011, when the FDA issued a warning about the possible link between Actos and bladder cancer.
Although no court has suggested that such arguments are likely to be successful, many lawyers are planning to make sure all cases are filed on behalf of individuals who may be subject to a one-year statute of limitations, which would require that they file a complaint within one year from the date they knew or reasonably should have known that their diagnosis of bladder cancer may have been caused by use of Actos.
The exact calculation of the statute of limitations period in each legal claim varies based on the laws of that state and the circumstances surrounding the case. While most states have a statute of limitations period that requires individuals to file their claim within two or three years, several states have only a one year limits period.
Actos (pioglitazone) was developed by Takeda Pharmaceuticals and approved in the United States for treatment of type 2 diabetes in July 1999.
The FDA began reviewing the potential risk of bladder cancer from Actos side effects in September 2010, after interim data from an on-going 10 year study found an increased incidence of tumors among users of the medication. Data suggested that the rate of exposure and increased risk of bladder cancer reached statistical significance after 24 months of use.
In June 2011, information about the risk of bladder cancer from Actos was widely reported in the media when regulators in France issued an Actos recall after a review of public insurance data identified an increased incidence of cancer among users of the medication.
On June 15, the FDA issued a drug safety communication that indicated new information would be added to the warning label for Actos, which states that use of the medication for more than one year may increase the risk of developing bladder cancer. Takeda Pharmaceuticals may argue that this notification would reasonably be expected to cause individuals to know that their may be a connection between their use of Actos and bladder cancer diagnosis.
Hundreds of individuals throughout the United States have already filed an Actos lawsuit against Takeda Pharmaceuticals, alleging that the drug maker failed to properly research the medication or warn about the risk of developing bladder cancer.
All federal cases involving bladder cancer with Actos use have been consolidated for pretrial proceedings as part of an MDL, or multidistrict litigation, which is centralized in the U.S. District Court for the Western District of Louisiana.
In recent weeks, the number of Actos cases filed in the MDL has increased dramatically. However, most of the filings are not related to the possible approaching statute of limitations for Actos cases, but rather due to new procedures recently put in place by the Court, which allow for direct filing of lawsuits in the MDL.
An evaluation of the applicable statute of limitations for each Actos lawsuit is made on a case-by-case basis by attorneys investigating potential cases. Although sound arguments may exist against Takeda’s likely position, many attorneys are treating June 15 as a possible deadline for filing cases from one-year discovery states.