Actos Diabetes Drug Lawsuits (2010s): Understanding Pharmaceutical Injury Settlements
The diabetes drug Actos (pioglitazone), once a popular medication for managing type 2 diabetes, became the center of significant legal battles throughout the 2010s. These lawsuits, filed by thousands of individuals, alleged a link between Actos use and an increased risk of bladder cancer. This article delves into the Actos diabetes drug lawsuits of the 2010s, exploring the basis of the claims, the outcomes of the litigation, and the broader implications for pharmaceutical injury settlements.
The Allegations Against Actos
Actos, manufactured by Takeda Pharmaceuticals, was designed to improve glycemic control in adults with type 2 diabetes by increasing the body’s sensitivity to insulin. While initially hailed as a breakthrough, concerns about its safety emerged over time. The primary allegation in the Actos lawsuits was that Takeda failed to adequately warn patients and healthcare providers about the increased risk of bladder cancer associated with long-term use of the drug.
Specifically, plaintiffs claimed that Takeda knew or should have known about the potential cancer risk but downplayed the concerns and misled regulators. Some lawsuits even accused the company of manipulating study results and concealing unfavorable data. These allegations formed the basis for product liability claims, arguing that Actos was a defective drug due to its dangerous side effects and the manufacturer’s failure to provide adequate warnings.
FDA Warnings and International Actions
The U.S. Food and Drug Administration (FDA) first announced it was reviewing the potential risk of bladder cancer from Actos in September 2010. This announcement followed interim data from an ongoing 10-year study that showed an increased incidence of tumors among individuals using the medication.
In June 2011, the FDA issued a Drug Safety Communication, informing the public that using Actos for more than one year may be associated with an increased risk of bladder cancer. The agency mandated that information about this risk be added to the warnings and precautions section of the drug’s label and the patient medication guide. The FDA review of data from a planned five-year interim analysis of an ongoing, ten-year epidemiological study showed that while there was no overall increased risk of bladder cancer with pioglitazone use, an increased risk of bladder cancer was noted among patients with the longest exposure to pioglitazone, and in those exposed to the highest cumulative dose of pioglitazone.
Notably, other countries took more drastic action. In 2011, France suspended the use of pioglitazone, and Germany recommended against starting new patients on the drug due to concerns about bladder cancer risks.
The Multidistrict Litigation and Settlement
As lawsuits against Takeda mounted, thousands of federal cases were consolidated into multidistrict litigation (MDL) in the U.S. District Court for the Western District of Louisiana. MDLs are designed to streamline the handling of complex cases involving similar allegations against a common defendant.
After several bellwether trials (initial trials intended to gauge the strength of the plaintiffs’ claims) resulted in significant jury awards against Takeda, the company agreed to a settlement in April 2015. Takeda announced it would pay up to $2.4 billion to resolve the majority of Actos lawsuits. By September 2015, over 96% of people suing the company had signed up to participate in the settlement.
The settlement amount awarded to individual claimants was calculated using a “points matrix,” which assigned points based on specific criteria, such as the severity of the injury, the duration of Actos use, and other contributing factors. While Takeda did not admit guilt as part of the settlement agreement, the resolution provided compensation to thousands of individuals who alleged they developed bladder cancer due to Actos.
Individual Settlements and Verdicts
While the $2.4 billion settlement resolved a large number of cases, some lawsuits continued to proceed individually in state and local courts. Some notable individual case outcomes include:
- Allen v. Takeda and Eli Lilly (2014): In this bellwether trial, a jury ordered Takeda and Eli Lilly (who co-marketed Actos) to pay a combined $9 billion in punitive damages to a plaintiff who developed bladder cancer after taking Actos. While a judge later reduced the award to $36.8 million, the verdict sent a strong message to the pharmaceutical companies.
- Other Verdicts: Prior to the global settlement, juries in several state court cases also returned verdicts in favor of plaintiffs, including a $6.5 million award in California and a $1.7 million verdict in Maryland.
Statute of Limitations
It’s important to note that Actos injury lawsuits have a deadline for filing, known as the statute of limitations. This deadline varies by state and typically ranges from one to two years from the date of diagnosis or when the individual knew or should have known that their bladder cancer may have been caused by Actos.
Lessons Learned and Future Implications
The Actos litigation serves as a reminder of the potential risks associated with pharmaceutical drugs and the importance of adequate safety testing and transparent communication from manufacturers. The case also highlights the role of the FDA in monitoring drug safety and the legal system in providing recourse for individuals harmed by defective products.
While the major Actos settlements occurred in the 2010s, the legal implications continue to resonate. Pharmaceutical companies face increasing scrutiny regarding their marketing practices, safety protocols, and transparency with consumers. Furthermore, the Actos case may influence future pharmaceutical injury settlements by setting precedents for evaluating damages and determining liability in similar cases.
Seeking Legal Advice
If you or a loved one has been diagnosed with bladder cancer after taking Actos, it is essential to seek legal advice from an experienced attorney. A lawyer can evaluate your case, explain your legal options, and help you pursue compensation for your injuries.
Conclusion
The Actos diabetes drug lawsuits of the 2010s represent a significant chapter in pharmaceutical litigation history. The allegations of a link between Actos and bladder cancer, the massive MDL settlement, and the individual case outcomes have had a lasting impact on the legal landscape and the pharmaceutical industry. By understanding the details of these lawsuits, individuals can make informed decisions about their health and legal rights.