- 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
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.
Congestive Heart Failure
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.
- Heart Attacks
- Liver Damage
- Bone Fractures
- Kidney Damage
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.”
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.
Eli Lilly stops marketing Actos. The drug’s label is changed to add the findings from a two-year study that showed bladder tumors in rats given a high dose of Actos.
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 an increased risk of bladder cancer.”
First Actos bladder cancer suits are filed.
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.
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 D. Person
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.”
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.
Before contacting a lawyer, you should fully understand your legal rights and options. We can help you understand your legal rights and options, as well as the legal process.
- U.S. Food and Drug Administration (FDA). (2011, August 4). FDA Drug Safety Communication: Updated drug labels for pioglitazone-containing medicines. Retrieved from http://www.fda.gov/Drugs/DrugSafety/ucm266555.htm
- U.S. Food and Drug Administration (FDA). (2011, August 4). Letter to Jessie Y. Lee, Ph.D. Retrieved from http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021073Orig1s043s044-021842Orig1s014s015-022024Orig1s008s007-021925Orig1s010s011ltr.pdf
- Feeley, J. (2011, December 1). Takeda may face 10,000 U.S. suits over Actos cancer claims. Bloomberg. Retrieved from http://www.bloomberg.com/news/2011-12-01/takeda-may-face-10-000-u-s-suits-over-actos-cancer-claims.html
- Andrews v. Takeda Pharmaceuticals America et al.
- Person v. Takeda Pharmaceuticals America et al.
- Feeley, J. (2013, May 1). Takeda gets $6.5 Million Diabetes-Drug Verdict Thrown Out. Bloomberg. Retrieved from http://www.bloomberg.com/news/2013-05-01/takeda-gets-6-5-million-diabetes-drug-verdict-thrown-out.html
- Torsoli, Albertina. (2011, June 9). Takeda’s Actos drug suspended in France on cancer risk study. Bloomberg. Retrieved from http://www.bloomberg.com/news/2011-06-09/takeda-s-actos-drug-suspended-in-https://web.archive.org/web/20160330230512/france-on-cancer-risk-study-3-.html
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