Multiple medical studies link the Type 2 diabetes medication Actos to the onset of bladder cancer. That life-threatening side effect, as well as heart failure, led thousands of people to seek compensation for damages caused by the drug. Drug maker Takeda Pharmaceuticals in April 2015 settled about 9,000 Actos-related lawsuits for $2.37 billion.
Why People File Actos Lawsuits
Lawsuits filed by people injured by Actos list a number of counts against Takeda and Eli Lilly, including failure to warn about side effects and willfully concealing the safety concerns with the drug.
- Failed to warn the public and health care providers that taking Actos for longer than 12 months may increase the risk of bladder cancer
- Manufactured a defective product
- Failed to properly test Actos
- Concealed testing and research data from the public
- Provided misleading data to the public
- Manufactured an unsafe product
- Knew the dangers of the product, but sold it anyway to maximize profits
- Breached warranty by selling a drug that was not fit for use
Compensation for Actos Injuries
Filing a lawsuit can compensate people injured by the drug for emotional, physical and financial damages – a lawsuit can also send the company a message. There are several types of compensation that may be awarded if Takeda and Eli Lilly are found at fault.
Some people who file lawsuits do so to punish companies for misleading them and failing to warn the public. These damages are awarded to discourage drugmakers from similar conduct.
Medical Bills and Funeral Expenses
The cost of treatment can add up – including bills for checkups, surgery, medications, hospital bills, caregiving and funeral expenses. Lawsuits can help families cover these costs.
The inability to go to work because of medical problems – especially Actos bladder cancer – leads to lost income. Caregivers may also lose time from work as they care for a loved one.
Pain and Suffering
Dealing with Actos health problems, especially those that cause long-term damage, can also cause emotional suffering. Verdicts or settlements can help families to cope with these losses.
Loss of Consortium
Actos-related medical issues – specifically bladder cancer and the necessary surgeries and treatments – can also damage intimate relationships. Spouses of Actos patients may be eligible to file this type of claim.
Serious Actos Complications
Actos can cause a number of serious side effects. One of the main reasons people file Actos lawsuits is to obtain compensation for medical expenses and other losses related to injuries caused by the drug. Two of the most serious potential side effects are bladder cancer and congestive heart failure.
Each year in the United States, about 70,000 people are diagnosed with bladder cancer. If caught before it spreads, the cancer can usually be treated. However, it has a high recurrence rate. Takeda does not acknowledge any links between Actos and bladder cancer.
The FDA considers the risk of congestive heart failure from Actos to be significant enough to require a black-box warning on the drug's label. Avandia, another drug in the same class, is also known to cause severe heart problems.
Timeline of Actos Bladder Cancer Studies & Litigation
Actos lawsuits claim Takeda Pharmaceuticals, the drug's manufacturer, and Eli Lilly, the drug's marketer, knew about the risk of bladder cancer and other side effects but did not warn the public. Since the drug was introduced in the 1990s, there has been a history of controversy surrounding the drug's link to bladder cancer and other side effects.
Takeda and Eli Lilly launched Actos, a thiazolidinedione (TZD). Pre-approval studies showed tumors in rats given the drug. Its label said the relationship between the tumors in rats and possible tumors in humans is "unclear."
Actos is found to increase the risk of congestive heart failure.
Two clinical studies that were a part of Takeda's PROactive study revealed a higher percentage of bladder cancer in people taking Actos as opposed to another drug.
The FDA upgrades Actos label to its most extreme black-box warning to highlight risk of heart failure.
A study finds that Actos doubles the risk of fractures in post-menopausal women.
A study finds Actos more than doubles the risk of an eye disorder (macular edema) that can cause reduced vision and blindness.
FDA begins reviewing data from 10 year Actos study.
French study finds increased bladder cancer risk in patients taking Actos. The drug is pulled off market in France, and Germany recommended not starting Actos in new patients.
FDA releases safety announcement warning that using Actos for over a year "may be associated with a 40% increased risk of bladder cancer." First Actos bladder cancer suits are filed.
Federal lawsuits are combined into multidistrict litigation (MDL) in Louisiana. The number is expected to reach 10,000.
Former employee Dr. Helen Ge sues Takeda, accusing the company of hiding Actos side effects information from the FDA.
Judge’s order allows patients to join the MDL by filing their lawsuit directly with the Louisiana court. Dr. Helen Ge’s whistle-blower lawsuit is dismissed.
Jury awards $9 billion to Terrence Allen. The award is cut to $37 million in October. First test trial in federal MDL.
Takeda settles about 9,000 claims filed about Actos for at least $2.37 billion, one of the largest Big Pharma settlements in U.S. history. As part of the agreement, the drug maker does not admit any wrongdoing.
Actos Lawsuits, Settlements and Jury Verdicts
According to thousands of lawsuits, Takeda failed to adequately warn patients of the risk of bladder cancer associated with the medication. Without admitting any guilt -- and continuing to stand by the effectiveness of Actos -- Takeda in April 2015 settled about 9,000 claims related to the medication. The settlement price was between $2.37 billion and $2.7 billion, depending on the number of plaintiffs who signed onto the agreement. The settlement followed eight Actos jury verdicts, five of which were won by plaintiffs, although two later were overturned on appeal. Many of the settled cases resided in MDL No. 2299 in the U.S. District Court for the Western District of Louisiana. There are an unknown number of outstanding claims. One man who sued Takeda told Bloomberg, "If somebody had told me I could get cancer from Actos, I never would have taken it. There were other products out there that could have helped treat my diabetes without putting me through all of this.” Other patients share a similar story.
In 2013, a jury awarded Jack Cooper $6.5M in damages after he took Actos and was diagnosed with bladder cancer. Takeda was found guilty of failure to warn but convinced the judge a witness was unreliable and the verdict was overturned. Cooper's attorneys are appealing.
Louisiana resident Darin Andrews filed a lawsuit against Takeda in 2012 after being diagnosed with bladder cancer several months after he started taking Actos. His lawsuit states the drug was "inadequately tested, dangerous to human health and lacked proper warnings."
Edwene Person's husband, James, was diagnosed with and died from bladder cancer after taking Actos. Her lawsuit states that James' injuries were a result of the defendants' "wrongful conduct, acts, omissions, [and] fraudulent misrepresentations."
New York resident Jose Vega claims that Takeda purposely withheld information in the United States. Vega, 58, began taking Actos in September 2006 to treat his type 2 diabetes. He was diagnosed with bladder cancer in July 2007. Vega continued to take Actos after being diagnosed and treated for bladder cancer.
Finding a Qualified Actos Lawyer
With mounting evidence that the type 2 diabetes drug Actos has a direct link to bladder cancer, heart failure and bone fractures, and with growing suspicion that the drugmaker hid those problems, injured patients nationwide are turning to qualified attorneys for help in navigating the legal system.
People seek legal assistance because they need money to cover substantial damages that can result from Actos use. If you have suffered complications from Actos, the physical, emotional and financial costs will likely be high. You may be eligible for financial compensation for substantial losses and expenses related to your injuries. But first, you have to prove that the companies behind Actos are liable for your injuries.
It helps to have someone who is familiar with the pharmaceutical industry on your side. Actos attorneys are experienced in investigating dangerous drug claims and understand how prescription drugs are marketed. They know what’s needed to prove liability in drug cases.