Actos Diabetes Drug Lawsuits (2010s): Understanding Settlements for Pharmaceutical Injuries
In the 2010s, a significant number of lawsuits emerged concerning Actos, a medication prescribed for type 2 diabetes. These lawsuits primarily revolved around allegations of an increased risk of bladder cancer associated with the drug’s use. The legal battles and subsequent settlements have had a profound impact on pharmaceutical litigation and patient safety. According to the FDA, Actos, when used for over a year, may be associated with an increased risk of bladder cancer.
What is Actos?
Pioglitazone, sold under the brand name Actos, is an oral anti-diabetic drug that helps control blood sugar levels in patients with type 2 diabetes. It works by increasing the body’s sensitivity to insulin. Actos was first approved for use in the United States in 1999. While effective in managing diabetes, concerns about its potential side effects, particularly bladder cancer, have led to numerous legal challenges.
The Link Between Actos and Bladder Cancer
The primary concern that fueled Actos diabetes drug lawsuits in the 2010s was the alleged link between the medication and an increased risk of bladder cancer. Studies, including a 10-year study requested by the FDA, suggested that prolonged use of Actos (over 12 months) might elevate the risk of developing bladder cancer. A 2011 study by researchers in France found an increased risk of bladder cancer in patients taking Actos, causing the drug to be removed from the market in that country.
In June 2011, the FDA issued a safety communication, advising the public about the potential increased risk of bladder cancer with Actos. The FDA discovered that the longer people took Actos, the greater their risk of developing bladder cancer. They also found that higher doses of the drug increased this risk.
Symptoms of bladder cancer that may be indicative of problems related to Actos include:
- Abnormal urine testing with blood in the urine
- Urinary urgency
- Pain during urination
- Associated abdominal or back pain
If you have had these symptoms but do not have a diagnosis of bladder cancer, it is recommended that you discuss this with your treating doctor.
Actos Lawsuits: A Timeline of Events
The timeline of Actos lawsuits is marked by key events:
- 2010: The FDA began reviewing data from a 10-year study on Actos and its complications.
- 2011: The FDA issued a safety statement warning that Actos may be associated with an increased risk of bladder cancer. France suspended the use and sale of Actos, and Germany recommended not starting Actos therapy in new patients.
- 2013: Actos was banned in India. A jury awarded Jack Cooper and his wife $6.5 million in damages in a lawsuit against Takeda Pharmaceuticals.
- 2015: Takeda Pharmaceuticals agreed to settle approximately 9,000 claims for at least $2.37 billion.
Settlements in Actos Lawsuits
The Actos litigation culminated in a significant settlement in 2015, when Takeda Pharmaceuticals, the manufacturer of Actos, agreed to pay $2.4 billion to settle thousands of lawsuits. This settlement resolved claims from individuals who alleged that they developed bladder cancer as a result of taking Actos. While Takeda did not admit any wrongdoing, the settlement provided compensation to those who had suffered harm.
The settlement terms generally covered individuals who:
- Took Actos at some time prior to December 1, 2011
- Were diagnosed with bladder cancer on or before April 28, 2015
- Retained counsel before May 1, 2015
Under the terms of the settlement, approximately $2.4 billion in aggregate funds were distributed to thousands of qualifying Actos users according to their level of injury, degree of Actos use, and other relevant factors.
Statute of Limitations in Actos Lawsuits
A critical aspect of pharmaceutical injury lawsuits is the statute of limitations, which sets a deadline for filing a claim. The statute of limitations for Actos lawsuits varies by state. Most states require that a case be filed within two or three years after the cause of action arose or when the individual knew or should have known that their diagnosis of bladder cancer may have been caused by the use of Actos.
For example, if you started taking Actos in 2019 and were diagnosed with bladder cancer or kidney failure in 2022, you would have two years from your diagnosis or until 2024 to file a claim.
Legal and Medical Advice
If you believe you have been harmed by Actos, consulting with an attorney experienced in pharmaceutical litigation is essential. A lawyer can evaluate your case, explain your legal rights and options, and help you navigate the complexities of the legal process. It is also crucial to seek medical advice from a healthcare professional for any health concerns or symptoms you may be experiencing.
Current Status of Actos
Actos remains on the market in the United States, but it carries a warning about the increased risk of bladder cancer. Patients taking Actos should be aware of the potential risks and discuss any concerns with their healthcare providers.
Seeking Legal Assistance
If you or a loved one has been harmed or has developed bladder cancer after taking Actos, seeking legal assistance is crucial. A law firm familiar with Actos cases can evaluate your situation, explain your rights, and help you pursue compensation for medical expenses, lost income, and pain and suffering.
Navigating the complexities of pharmaceutical litigation requires the expertise of an Actos lawyer familiar with the drug’s history and associated legal challenges. Statutes of limitations can restrict the timeframe for filing a lawsuit, making prompt consultation essential.
Conclusion
The Actos diabetes drug lawsuits of the 2010s highlight the importance of pharmaceutical safety and the legal recourse available to individuals harmed by dangerous drugs. The settlements reached in these cases provided compensation to many affected individuals and underscored the need for ongoing vigilance in monitoring the safety and efficacy of pharmaceutical products. If you have concerns about Actos or believe you have been injured by the drug, seeking legal and medical advice is highly recommended.