Gray & White is no longer accepting Actos injury cases.
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.
Bladder Cancer Risk and Other Serious Side Effects
Patients who take or who have taken Actos may have an increased risk of developing:
- Bladder cancer. The FDA has said that patients taking Actos for more than one year have a 40 percent increased risk for bladder cancer. In May 2012, a study published in the British Medical Journal (BMJ) put that risk much higher—at 83 percent.
- 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. Macular edema is swelling or thickening of the eye’s macula, the part of the eye responsible for detailed, central vision. Persons living with diabetes are already at risk of developing macular edema, but it is believed that taking Actos increases that risk.
Any patient who experiences symptoms of any of these conditions should promptly call his doctor for treatment and advice.
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 2016, 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.
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.
Gray and White’s Experience With Kentucky Actos Cases
Our firm helped people who had been hurt by Actos in Kentucky recover fair damages for the harm that they suffered. We are proud of the work that we did on behalf of people who suffered serious Actos side effects and we will continue to work on behalf of patients who suffer serious injuries from other prescription drugs or medical devices.