Medical products such as drugs and surgical devices are supposed to make us better however, sometimes they have the opposite effect. At Montlick & Associates, our team of Georgia Product Liability Lawyers are firmly committed to helping those who were injured as a result of using dangerous medical products. We understand the devastation associated with learning that something you trusted to treat your medical condition ended up causing you harm. If you were injured after using a medical product, you may have legal recourse. To learn more about your legal options, call Montlick & Associates now to schedule your Free Consultation at 1-800-LAW-NEED (1-800-529-6333), or feel free to contact us online through our website using our 24/7 live online chat or email form. We will take the time answer all of your questions so that you can make informed decisions in your case. Contact us now to receive the compensation you deserve for your injuries!
Manufactured by Takeda Pharmaceuticals ("Takeda"), Actos, also known as Pioglitazone, is a drug that is used to treat Type 2 Diabetes - a condition where the pancreas does not sufficiently process or produce enough insulin required to regulate the body's blood sugar levels. Like all Pioglitazone-containing drugs, Actos is part of a larger family of medications known as "thiazolidinediones," which aids in regulating the body's insulin levels and normalizes one's blood sugar levels.
Despite the drug's popularity among those diagnosed with Type 2 diabetes, numerous medical studies have demonstrated a link between taking Actos and suffering life-threatening side effects, including heart failure, bladder cancer, bone fractures, liver damage, and eye/vision problems. In fact, according to the U.S. Food and Drug Administration, preliminary lab tests of the drug that were conducted by Takeda demonstrated a significant causal link between Actos and bladder cancer. Further studies have confirmed this finding, leading to an international recall of the drug. Notwithstanding, the United States continues to allow Actos to remain on the market.
Following reports of bladder cancer and other serious side effects associated with Actos, in 2003, the FDA asked Takeda to conduct a 10-year study of the potential risks of contracting bladder cancer after taking Actos. Following said request, there were nearly 900 newly reported cases of bladder cancer. In the meantime, a number of additional studies of the drug were conducted, which rendered surprising results. One of the most credible studies performed to date was conducted by Kaiser Permanente in Northern California ("Kaiser"). According to the results of its five-year interim analysis (their study is for a total of ten years), Actos users have a 40% percent greater chance of developing bladder cancer if taken for more than a year. The study further suggested that males are at a greater risk than females of receiving a bladder cancer diagnosis.
Additionally, the most widely known international study was performed by the French Medicines Agency, or AFSAAPS, which supported Kaiser’s findings. After examining the relationship between Actos and bladder cancer over a three year period, starting in 2006 and ending in 2009, it found that patients taking Actos are a much greater risk of receiving a bladder cancer diagnosis. Despite these alarming statistics, the FDA, despite issuing a safety warning about the use of Actos, has yet to recall the drug in the United States.
After several people around the globe began to report serious side effects associated with the usage of Actos, the French Medicines Agency, or AFSSAPS, (now known as the National Agency for the Safety of Medicines and Health Products (MSNA)), decided to conduct an international safety study of the drug. According to the study, it found that people who take Actos have a 22% greater chance of developing bladder cancer than those who have never taken Actos. As a result, in June 2011, the country decided to pull the drug from its shelves and issue a nation-wide recall.
Following France's swift Actos recall, German regulators immediately instructed physicians to stop prescribing the drug to its patients until further research was conducted. In essence, Germany agreed with France's concerns regarding the link between Actos and bladder cancer. Despite France and Germany's efforts to ban the drug, there has been no Actos recall in the United States. According to the U.S. FDA, in order to do so, the agency must have a "reasonable probability" that the drug will cause "serious adverse health consequences or death".
Given the FDA's acknowledgement of a link between taking Actos and developing bladder cancer, the FDA issued a warning advising that it should not be given to those with active cases of bladder cancer. It further urged physicians to exercise caution when prescribing the drug to individuals who have a history of the disease. The agency also advised Actos users to be on the alert for the following symptoms of bladder cancer, such as:
Due to the possible Actos bladder cancer link, the agency also announced that the risk will be reflected in the drug's label and patient medication guide.
In spite of the U.S. FDA's efforts, many people feel that they have not done enough to protect American consumers. In essence, they feel that the U.S. should follow in Europe's footsteps and issue a nationwide Actos recall. As a result, those who have filed lawsuits against Takeda are citing the proactive measures taken by France and Germany in support of their causes of action for the serious harm that they suffered from taking the drug. Moreover, Actos litigants believe that the U.S. FDA has not acted quickly enough to address the growing number of bladder cancer cases and other health complications associated with the use of the drug. Accordingly, more than ten thousand lawsuits have been filed against Takeda, who reportedly admitted in federal court that there is a significant connection between Actos and bladder cancer.
As a result of the high volume of lawsuits being filed against Actos' manufacturer, the United States Judicial Panel on Multidistrict Litigation transferred all federal claims to the United States District Court for the Western District of Louisiana. This court is centrally located to process and handle Actos litigation and is known as Multidistrict Litigation (MDL) No. 2299 and is currently being overseen by the Honorable Rebecca Doherty. Specifically, all of the actions involve claims arising from people's use of Actos and subsequent bladder cancer diagnosis. Plaintiffs further allege that Takeda concealed their knowledge of the risks associated with taking Actos and as such, failed to warn the public and health care professionals about said adverse health considerations. Takeda continues to deny liability in all of the suits, as reported in a recent Bloomberg News article. Notwithstanding, the number of federally consolidated lawsuits continues to increase, with about 2,675 currently pending in the Actos MDL litigation suit.
While the law does not require you to hire a lawyer, the answer is inevitably yes. Undoubtedly, product liability cases, especially those involving pharmaceutical drugs and devices are extremely complex, and also, highly nuanced. As such, a skilled Georgia Actos Injury Lawyer has the training and knowledge necessary to help maximize your chances of obtaining the compensation you deserve, including the costs you incurred for your medical costs, pain and suffering, emotional trauma, funeral expenses, and loss of income. Contact Montick & Associates now for your Free Consultation to learn more about your legal rights and options.
If you or a loved one was diagnosed with or died from bladder cancer after taking Actos, contact the Georgia Actos Injury Attorneys at Montlick & Associates. Our product liability lawyers have been representing victims of defective devices and medications and providing legal services throughout all the State of Georgia and the Southeast since 1984, including but not limited to all smaller cities and rural areas in the state. No matter where you are located, our attorneys are just a phone call away, and we will even come to you in the event that you cannot come to us. Call us 24 hours a day/7 days a week for your Free Consultation at 1-800-LAW-NEED (1-800-529-6333). You can also visit us online at www.montlick.com and use our Free Case Evaluation Form or 24-hour Live Online Chat.