The prescription drug Actos has been known for some time to increase a patient's risk of developing bladder cancer over the course of their diabetes treatment. Most of the Actos cases we handled on patients' behalf are long since resolved, but lately we have noticed an uptick in calls from people scrambling to file suit before the opportunity passes them by completely.
Is it too late to file an Actos lawsuit? The short answer is "no" followed by "but..." It may still be possible to file a claim, but it's a little more complicated than that.
A Quick Rundown on Actos
For those unfamiliar with this drug, here's some background on what it does and what the lawsuit is about.
Developed by Takeda Pharmaceutical Company (Takeda) in the late 1990's, pioglitazone (the main ingredient of Actos) was approved by the FDA in 1999 as a once-daily supplement to diet and exercise for the treatment and control of type 2 diabetes symptoms.
The drug is considered effective at suppressing some of the worst symptoms of type 2 diabetes. Without getting too lost in the weeds of medical terminology, pioglitazone has hypoglycemic properties, meaning it reduces both the concentration and rate of use of glucose in the blood. It selectively activates the peroxisome proliferator-activated receptor (PPAR) protein, which reduces insulin resistance in the liver (a troublesome issue for diabetics).
Actos was prescribed and used by millions of people for many years; in 2008 it was the tenth-best selling drug in the United States with sales over $2 billion. However, within a few years its reign at the top began to erode.
In 2011 a French research institution released the results of its multi-year epidemiological study of patients on pioglitazone. According to their findings, patients who took Actors for extended periods were more likely to develop bladder cancer. The U.S. Food and Drug Administration (FDA) analyzed five years' worth of pioglitazone patient records and found strong correlations between long-term Actos use and bladder cancer.
Takeda's internal safety research didn't reflect these problems, leading some to question their methods. A former Takeda employee later suggested the company fudged its safety reports to make the drug appear somewhat safer than it really is, in order to better compete with GlaxoSmithKline's similar drug Avandia. To avoid safety complications, Takeda allegedly misidentified known side effects in the FDA's Adverse Event Reporting System. Serious potential issues like congestive heart failure and bladder cancer, were not listed in the database as "serious," meaning they weren't subject to proper evaluation and oversight.
So that's where things stand: As more information came out about Actos' potential hazards and about Takeda's attempts to downplay or conceal them, lawsuits were filed across the country. Those have been going for years and many have been settled.
Some People May Still Be Able to File.
If this were a conventional single-person injury claim, it's likely that time would be up for filing a new case. However, the Actos litigation has far more than a single plaintiff.
Many prescription drug lawsuits are actually multi-district litigations (MDLs), which are a little more complicated than straightforward injury claims. In order to efficiently process cases that could involve hundreds (or thousands) of plaintiffs in dozens of different federal courts that all share common issues, MDLs are typically a consolidation of many individual claims to be tried in a single location. Most MDLs involve anywhere from dozens to hundreds of plaintiffs, with notable outliers like the asbestos MDL that has lasted for over 25 years and involved more than 100,000 plaintiffs.
MDLs are often complicated because the state where the injury occurred may not have the same laws as the state where the case is tried. There is a chance that each state's statute of limitations (SOL) may be different. Time limits vary by state from one to six years at either extreme, with most states ruling that a case must be filed within two years of the date of injury. Generally the laws of the state where the injury originally occurred govern the SOL to be applied; if a plaintiff is injured in Texas but the MDL is consolidated in Minnesota, Texas' 2-year SOL would be used rather than Minnesota's 4-year limitation.
But wait, there's more: Beyond standard SOL concerns lies the matter of discovery. Discovery describes the period of time in which people realize the association between use of the prescription drug and the onset of their related symptoms. It's often the case with MDL's that the court will allow many cases to be pursued even if their respective SOLs have run.
Looking at Actos' trial and resolution history over the last few years, that doesn't necessarily seem to be the case this time--the courts have adhere pretty strictly to each state's limitations. That means if a patient lives in a 2-year SOL state (like Texas) and found out about his bladder cancer's potential link to Actos on or before August 1, 2016, they may be out of luck. Those who reside in with a 3- or more-year statute of limitations may still have time to file, even though the information about the cancer risk has been available for several years.
Another group may also be eligible to file: People who have only recently learned they have bladder cancer. In many cases the diagnosis of a condition functionally begins the start of the SOL "clock." People with a long history of Actos use who are only just learning they have bladder cancer may still have the opportunity to file suit even though their state's SOL has run since the announcement of the Actos MDL.
So Can I Still Sue for My Actos Injury?
The answer to that is probably too complicated for a simple "yes" or "no." It depends on too many variables:
- If you have been conclusively diagnosed with bladder cancer
- When you were diagnosed
- Where you lived when you were diagnosed
- If you used/were prescribed Actos (and not its generic equivalent pioglitazone) prior to your diagnosis
Those are a few of the most prevalent concerns, but there may be other obstacles depending on one's answers to the above questions.
The law wants to help people that may have been hurt by Takeda's negligent misrepresentation of its drug. It does have certain restraints on how long it is able to offer such assistance, and in some instances that time may have run out. That's not true everywhere, though, and Actos users who have contracted this debilitating condition may want to investigate their options before any more time can pass.