New treatments for chronic and incurable diseases—such as type 2 diabetes—are often met with great excitement and hope. When Actos was approved by the U.S. Food and Drug Administration (FDA) in 1999, many people suffering from diabetes hoped that this would be the medication that would help them improve their blood sugar control.
Unfortunately, it soon became clear that for some patients the disadvantages of Actos outweighed the benefits. Some of those who used heavier doses of Actos for an extended period began to receive frightening diagnoses from their doctors, such as bladder cancer, heart problems, chronic kidney disease, liver failure, and macular edema.
In some European countries, Actos has been banned because of its link to bladder cancer. In 2011, health regulators in France forced the drug manufacturer to pull Actos off the market, and a government order removed Actos from the list of reimbursed drugs in Germany.
However, in the United States, doctors continue to prescribe it for some of their type 2 diabetes patients. Thus, if you have Type 2 diabetes or if you love someone living with diabetes, then it is important to know more about the risks associated with Actos, about the FDA warnings regarding Actos, and about Atos lawsuits and settlements. We invite you to learn more on this page and in our free report, A Prescription for Harm: The Dangers of Actos.
Bladder Cancer Risk and Serious Side Effects
Patients who are currently taking or have taken Actos may have an increased risk of developing:
- Bladder cancer. The risk of bladder cancer appears to be highest for those who have taken Actos for a year or longer and those who exceeded a cumulative dosage of 28,000 mg. However, it is important for everyone who has taken Actos to be aware of this serious and potentially deadly risk.
- Chronic kidney disease. A 2014 study found that diabetes patients who take Actos may be four times as likely to develop chronic kidney disease when compared to diabetes patients who do not take Actos.
- Heart attack and heart failure. The FDA has issued a black box warning—its strongest warning—to Actos patients about the risk of heart attack or heart failure from this medication.
- Liver failure. Liver failure and hepatitis may be associated with Actos. There have been reports of Actos patients developing liver conditions.
- Macular edema. Patients with this eye condition develop swelling in the back of their eyes that can result in significant visual problems, including blindness.
Any patient who experiences symptoms of any of these conditions should promptly call his doctor for treatment and advice…and then call his attorney to find out more about his legal right to a possible financial recovery.
What the FDA Says About Actos
The FDA originally approved Actos for use in the United States in 1999. Even as early as 1999, the drug’s label referenced a pre-approval study that found rats that had been given Actos had an increased occurrence of tumors. However, the label described the relationship between the tumors in rats and potential tumors in humans as unclear.
Since 2009 the FDA has taken the following actions:
- In 2006, a label change was made to add findings from a study that showed that bladder tumors were more likely in rats that were given higher doses of Actos.
- In 2007, the FDA issued a black box warning about the potential for heart failure related to Actos. The use of Actos was discouraged for some patients and regular heart monitoring was encouraged for all patients.
- In 2011, the FDA issued a warning about Actos and bladder cancer. According to the FDA warning, taking Actos for more than one year could raise an individual’s risk of developing bladder cancer. The Warnings and Precautions portions of the drug’s label and the drug’s medication guide were revised to include this updated safety information.
- As of 2015, the FDA has not recalled Actos. However, the agency maintains that people with active bladder cancer and those who have had bladder cancer should not take this medication. Regardless of whether you have or have had bladder cancer or whether you take Actos or are considering the drug, you should talk to your doctor about the potential risks.
Takeda Pharmaceutical Company, the manufacturer of Actos, and Eli Lilly and Company, the marketer of Actos, are being accused of several wrongs, including:
- Failure to properly warn about potential side effects, including bladder cancer.
- Failing to properly test Actos before putting it on the market.
- Providing the public with misleading data.
- Failing to provide relevant safety information to the public from completed tests and research.
- Selling the drug when they knew about the potential dangers, including bladder cancer.
- Manufacturing a defective or unsafe product
- Breach of warranty for selling an unsafe drug.
Many people who have suffered serious Actos side effects or lost loved ones because of Actos have filed lawsuits against these companies for one or more of the reasons described above.
Generally, there are three important reasons to consider an Actos lawsuit. Filing a case may allow you to:
- Protect your own recovery. If you are successful in your Actos bladder cancer lawsuit, then you may be able to recover compensation for your past and future medical expenses, lost income, out-of-pocket costs, pain, suffering, and other damages. You may be able to help protect your family financially from the harm that has been done to you.
- Hold Takeda Pharmaceuticals accountable. Takeda Pharmaceuticals may have failed to warn you of the danger and may be liable for your injuries.
- Encourage better testing and warnings from other pharmaceutical companies. Other drug manufacturers may want to avoid the expense and bad press of dangerous drug lawsuits. They may be encouraged to provide better premarket testing for their medications and to provide better warnings to doctors and patients.
Just because other people have already filed their Actos bladder cancer cases does not mean that you are too late. Instead, the determination of whether you still have a possible case for the serious injuries that you have suffered will depend on the unique facts of your case.
If you think your illness was caused by taking Actos, you are not alone. Many people who have been injured, or their survivors, have formed a mass tort case. This means that a person or company did something wrong that resulted in injury to many different victims, and all are suing the same person or company. One major benefit to being part of a mass tort is that much of the preparation that goes into the case can be transferred from one plaintiff to another, making the entire process more efficient.
If you’ve decided to file a lawsuit due to the injuries you or a loved one has suffered from taking Actos, you’ll need to prove a few things. Specifically, you’ll need to prove:
- You’re suffering from a serious Actos side effect, such as bladder cancer. You’ll need adequate medical evidence and possibly expert medical testimony to prove that your condition was caused by Actos.
- The extent and severity of your injuries. Specifically, you will need to prove how your injury is impacting your life now, could impact your life in the future, or how it ended your loved one’s life.
- Liability. You will need to prove that the drug manufacturer or marketer is responsible for your injuries.
The thought of filing a lawsuit against a large company may be intimidating, but others have gone before you and have been successful.
Actos Lawsuit History and Settlements
To date, thousands of lawsuits have been filed against Takeda Pharmaceutical Company and Eli Lilly and Company. Some of the cases and settlements include:
- A 2013 Maryland case that found Takeda Pharmaceutical Co. directly responsible for causing the bladder cancer and resulting death of Diep An, a former U.S. Army translator. Mr. An began taking Actos to treat his diabetes in 2007 and was diagnosed with “high-grade bladder cancer” in September 2011. He died from the disease in January 2012. After more than six hours of deliberation, the jury agreed found that both Mr. An and his doctor were not properly warned about the risks of taking Actos. They ordered the company to pay over $1.7 million in damages. However, according to Maryland law, the judge had to set the verdict aside because of the jury’s finding that Mr. An’s smoking contributed to his own death.
- In 2014, a federal judge found that a jury in an Actos bladder cancer could hear evidence that Takeda Pharmaceutical Co., the manufacturer of Actos, intentionally destroyed files that may have been relevant to the litigation. More specifically, Takeda admitted that it could not find the files from 46 employees who were involved in the development, marketing, or sale of Actos. Some files were reportedly deleted from computers after employees had been warned not to get rid of any Actos-related documents. It will now be up to a jury to determine what weight to attribute to the evidence that Takeda may have intentionally destroyed these files.
- In April 2014, a federal jury in Louisiana returned a verdict for the plaintiff in an Actos bladder cancer case. The verdict included $6 billion in punitive damages against Takeda Pharmaceuticals and $3 billion in punitive damages against Eli Lilly. Almost $1.5 million in compensatory damages had previously been awarded to the plaintiff for the harm done by the diabetes medication. This verdict was reported to be the seventh largest in United States history, according to Bloomberg News.
- In the spring of 2015, Takeda reportedly offered to pay more than $2.2 billion to settle more than 8,000 lawsuits in the United States that alleged that the pharmaceutical company hid the cancer risk associated with Actos. While $2.2 billion is a big number, it may not be enough to fairly compensate Actos victims for the harm they suffered.
Further litigation and settlement talks may be necessary in order to help Actos victims get the recoveries that they deserve.
Gray and White’s Experience with Kentucky Actos Cases
Our firm is committed to helping those who have been hurt by Actos in Kentucky recover fair damages for the harm that they’ve suffered. Currently, we are representing a young man who died from bladder cancer after taking Actos. He had been prescribed Actos to control his type 2 diabetes, but he was otherwise a healthy individual who was not on other prescription medication. Our client began noticing symptoms of bladder cancer after several months on Actos and went to the doctor for a diagnosis. Once his bladder cancer was found, he was scheduled for surgery and underwent chemotherapy and radiation. However, he died from bladder cancer just a few months after his diagnosis. As of May 2015, the case is currently in litigation and we are actively engaged in key discovery to help resolve this case.
We are a local Louisville firm with a national presence—we have represented clients in complex litigation in at least 16 states. Our team of experienced lawyers will conduct a thorough investigation into what happened to you and work together to fight for your fair and just recovery if you have been hurt by Actos.
Contact Gray and White Today
We want to hear about what Actos has done to you or your loved one and we want to help you get the recovery that you deserve. We encourage you to schedule a free consultation with us so that we can discuss your legal options and help you get a fair recovery after an Actos injury. Please start a free chat with us now, contact us via the confidential form on this website, or call us at 888-450-4456 to schedule an appointment with a Louisville Actos attorney.