As of summer 2016, we are accepting Actos cases.
This page, written by an Actos lawyer, answers frequently asked questions about Actos and bladder cancer, including:
- What happened?
- Who can file an Actos lawsuit?
- Is there an Actos class action?
- What should I do if I am still taking Actos?
- Which Actos lawyers run this website?
- What steps has the Food and Drug Administration taken?
- What is the scientific evidence linking Actos with bladder cancer?
- What do the Actos lawsuits allege?
What Happened With Actos?
Actos (pioglitazone) was previously the best-selling Type 2 Diabetes drug in the world but has since come under scrutiny following several scientific studies which revealed that patients on Actos have a far higher rate of bladder cancer than patients on other diabetic glucose control medications.
Many Actos patients who developed bladder cancer filed lawsuits alleging that the manufacturer of Actos, Takeda Pharmaceuticals, was negligent in testing and designing the medication, and that the drug company failed to warn of the increased risk of bladder cancer, and the company agreed to a $2.3 billion settlement.
After the lawsuits were filed, the prescribing information for Actos was changed to include a reference to bladder cancer. In our opinion, however, this warning is inadequate and inaccurate. Doctors and patients are often still unaware of the true risks of Actos.
Who Can File An Actos Lawsuit?
There are a variety of claims all Actos patients could in theory raise, even if they did not develop a disease, including claims for consumer fraud, misrepresentation, and negligence. Our law firm focuses on serious injury and wrongful death cases, and so we have limited our Actos litigation practice to patients diagnosed with bladder cancer after taking Actos for three months or more.
Is There An Actos Class Action?
We don’t file our Actos lawsuits as a class action. Each client’s case is filed as an individual case, with individual representation. At the moment, there are no certified Actos class actions. Due to recent court rulings over the past few years in other pharmaceutical negligence cases, it is unlikely that there will be any class actions.
There is, however, a federal “multi-district litigation” panel, so that all Actos lawsuits in the federal courts are consolidated for pre-trial proceedings in the Western District of Louisiana. Most state courts with a significant number of Actos lawsuits, including Illinois, Missouri, and California, where Takeda subsidies are based, have also consolidated lawsuits filed within their state courts.
What Should I Do If Am Still Taking Actos?
Talk to your doctor about the new FDA warnings on Actos and discuss the possibility of using other treatment options. If you have already been diagnosed with bladder cancer, some research suggests Actos might increase the risk of recurrence and the rate at which the malignancy spreads, so please act soon.
Actos is sometimes sold in combination with metformin (Actoplus Met, Actoplus Met XR) and or in combination with glimepiride (Duetact). Diabetic patients who have been diagnosed with bladder cancer should review their medications and speak with their physicians to determine if their control medication included pioglitazone.
What Steps Has The Food and Drug Administration Taken?
The FDA has not recalled Actos or ordered that it be pulled from the market, but it has issued several new warnings about the drug.
On September 17, 2010, the FDA issued a Drug Safety Communication noting that, five years into a ten-year study of any association between Actos and bladder cancer, a link had been found for patients who took Actos for more than 24 months, with a higher dose correlated with a higher risk of bladder cancer.
On June 15, 2011, the FDA issued an updated warning that even just one year of pioglitazone use raises the risk of bladder cancer by more than 40%, or an extra 28 cases a year for every 100,000 people taking it. The FDA also recommended doctors not prescribe Actos for patients who have or have had bladder cancer.
On August 4, 2011, the FDA published new warning labels for Actos, which recommends doctors should not prescribe pioglitazone to patients with active bladder cancer, and exercise caution prescribing pioglitazone to patients with a prior history of bladder cancer. The drug labels recommend that patients should report to their doctor if they “experience any sign of blood in the urine or a red color in the urine or other symptoms such as new or worsening urinary urgency or pain on urination since starting pioglitazone, as these may be due to bladder cancer.”
What is the Scientific Evidence Linking Actos with Bladder Cancer?
Many of the Actos lawsuits filed have alleged that Takeda Pharmaceuticals declined to publish data from the PROactive (PROspective PioglitAzone Clinical Trial In MacroVascular Events) study in 2005 that showed a correlation between Actos use and bladder cancer. See, Dormandy J.A., et al. Secondary Prevention of Macrovascular Events in Patients with Type 2 Diabetes in the PROactive Study, Lancet, 266:1279-1286 (2005).
In April of 2011, the American Diabetes Association published Piccinni, et al. Assessing the Association of Pioglitazone Use and Bladder Cancer Through Drug Adverse Event Reporting, Diabetes Care, 34:1369-1371 (formally published June 2011). Using adverse events reports made to the FDA between 2004 and 2009, the study concluded that data was “consistent with an association between pioglitazone and bladder cancer. This issue needs constant epidemiologic surveillance and urgent definition by more specific studies.”
In February 2012, the French medical journal Diabetologia published a study, Pioglitazone and risk of bladder cancer among diabetic patients in France: a population-based cohort study, that followed nearly 1.5 million diabetic patients, including 155,535 of which took Actos, and found that “Pioglitazone exposure was significantly associated with bladder cancer incidence.” The more Actos a person took, and the longer they took it, the higher their risk of bladder cancer.
Other data, such as animal studies involving mice, has indicated a connection between pioglitazone and bladder cancer, particularly in males. In 2015, researchers published an article detailing the way in which evidence of the drug’s dangers had been concealed.
What do the Actos Lawsuits allege?
Ironically, Actos became the top-selling diabetes control medication — despite a prior link to heart failure, stroke, and blindness — after Avandia, the primary competitor to Actos, was found in 2007 to dramatically increase risk of heart attacks. Avandia was banned in Europe and tightly restricted in the United States. GlaxoSmithKline, the makr of Avandia, has as of this date settled about 12,000 of Avandia lawsuits for around $700 million.
The Actos lawsuits allege that, when Takeda Pharmaceuticals saw an opportunity to market Actos more aggressively and overtake sales of Avandia, the company negligently, recklessly or intentionally didn’t reveal data showing an increased risk of bladder cancer.
Like GlaxoSmithKline, the maker of Actos, Takeda Pharmaceuticals, may be legally responsible for damages arising from the increased risk of bladder cancer. Bladder cancer is typically treatable if caught early, but many of our clients’ oncologists have described the bladder cancer associated with Actos as unusually aggressive and quick to reoccur — likely because the patients continued using Actos even after the cancer was diagnosed, because they and their physicians were unaware of the risks. Unfortunately, even if the chemotherapy treatments and surgeries are performed properly, they can lead to infertility, impotence, and other reproductive problems. Takeda Pharmaceuticals may be responsible to pay compensation for those damages.
As I have discussed on this website before, many courts have sharply restricted defective drug design lawsuits, but many patents’ legal claims remain viable if they are handled appropriately by experienced attorneys.
Contact Our Actos Bladder Cancer Lawyers
If you were diagnosed with bladder cancer after using Actos, contact our dangerous drug lawyers for a free, confidential consultation by using the form at the bottom or by calling my office at (215) 931-2634. See also my pages about How Do I File An Actos Claim Or Find A Good Actos Lawyer?, and News and Information page, and my article (written for other lawyers) about the lawyer advertising for lawsuits.