The drug Actos (generic: pioglitazone) is predominantly prescribed to patients suffering from Type 2 diabetes, as it helps to control blood sugar levels in the body. However, recent research from the FDA suggests Actos use at a high dose and for over one year may lead to bladder cancer. The controversial ingredient in Actos, pioglitazone, is also found in Duetact, Actoplus Met, and Actoplus Met XR.
Do I Have a Actos Lawsuit? Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged. If you or a loved one have taken Actos and been diagnosed with bladder cancer, you should contact our lawyers immediately. You may be entitled to compensation by filing an Actos lawsuit.
UPDATE: Takeda Offers $2.4 Billion Settlement in Actos Litigation
April 29, 2015 — Takeda Pharmaceuticals Co. has agreed to pay $2.37 billion to settle the “vast majority” of lawsuits accusing the company of failing to warn about the risk of bladder cancer from Actos. Click here to read more.
February 12, 2015 — A man who used Actos for three years before being diagnosed with bladder cancer has been awarded $2.3 million in compensation by a jury in the Philadelphia Court of Common Pleas. Click here to read more.
January 23, 2015 — Takeda has been hit with a lawsuit by the family of a man who died from bladder cancer after taking Actos for four years. Click here to read more.
October 28, 2014 — A federal judge in Louisiana has slashed more than 99% off a record-setting $9 billion jury verdict against Takeda Pharmaceuticals and Eli Lilly & Co., allowing just $36.8 million in punitive damages to a plaintiff who developed bladder cancer after taking Actos. Click here to read more.
October 3, 2014 — A jury in Philadelphia has awarded $2 million to a woman who developed bladder cancer after taking Actos. Click here to read more.
October 2, 2014 — Bloomberg reports that trial attorneys have accused Takeda Pharmaceuticals of concealing information about bladder cancer to protect billions of dollars in profits on Actos. Click here to read more.
July 2, 2014 — A ruling issued June 30 by U.S. District Judge Rebecca Doherty has determined that Takeda Pharmaceuticals intentionally destroyed or deleted documents that were critical to 3,000 lawsuits involving Actos. Click here to read more.
June 2, 2014 — A jury in Las Vegas has awarded a defense verdict in favor of Takeda Pharmaceuticals, ruling against two women who developed bladder cancer after using Actos to treat type-2 diabetes. Attorneys for the women are planning to appeal. Click here to read more.
May 16, 2014 — Bloomberg reports that Takeda has won a trial after a jury found that the drug-maker was not responsible for the death of William Whitlatch, a man who died of bladder cancer in 2006. Click here to read more.
April 8, 2014 – In the seventh-largest jury verdict in U.S. history, Takeda and Eli Lilly have been ordered to pay $9 billion in punitive damages for failing to warn about the risk of bladder cancer. Judge Rebecca Doherty, who also oversees more than 2,700 Actos lawsuits, penalized the companies for destroying thousands of documents on over 40 employees involved in development and sales of Actos. Click here to read more.
October 2, 2013 – In the second Actos lawsuit to go to trial, a jury found Takeda liable for failing to warn about the risk of bladder cancer from Actos. Although the jury awarded plaintiff $1.7 million in damages, Takeda convinced Judge Brooke Murdock to throw out the verdict because An smoked cigarettes for 30 years. This is the second time Takeda has avoided paying damages after losing in court. Click here to read more.
September 10, 2013 – In the second Actos lawsuit to go before a jury, lawyers argue that Takeda Pharmaceuticals put profits above public safety by failing to warn about the side effects of Actos. Click here to read more.
October 16, 2012 – The Institute for Safe Medicine Practices (ISMP) has identified a “surge of reports” to the FDA’s adverse event reporting system — at least 1,025 reports of Actos bladder cancer since the beginning of 2011. Click here to read more.
October 4, 2012 – 1,000 Actos lawsuits have been filed in federal court in Louisiana. Click here to read more.
August 20, 2012 – The FDA has approved generic Actos (pioglitazone), to be manufactured by Mylan Pharmaceuticals.
August 16, 2012 –A new study has found that the entire thiazolidinedione (TZD) class of type-2 diabetes drugs (including Actos and Avandia) increase the risk of bladder cancer by 2-3 times. Click here to read more.
May 1, 2012 – Takeda has convinced a judge to throw out a $6.5 million award, arguing that plaintiffs’ lawyers did not present sufficient evidence to prove that Jack Cooper’s bladder cancer was caused by Actos. Click here to read more.
April 29, 2012 – The first Actos lawsuit to go to trial, plaintiff Jack Cooper and his wife, Nancy, were awarded $6.5 million. The jury found Takeda liable for failing to warn about the risk of bladder cancer. Click here to read more.
Actos: An Overview
Actos (pioglitazone) is a diabetes medication that is manufactured by Takeda Pharmaceuticals and marketed in the U.S. by Eli Lilly & Co. The FDA approved Actos in July 1999 to help control blood sugar and insulin in adults with type-2 diabetes. Actos works by stabilizing the body’s response to insulin, a naturally-occurring hormone that helps control blood-sugar.
Actos belongs to a class of drugs known as thiazolidinedione (TZD). This group only has two other members, Avandia (rosiglitazone) and Rezulin (troglitazone). Avandia was pulled from American markets in May 2011 because of an increased risk of heart attack. Rezulin was pulled from shelves in March 2000 because it was linked to severe liver damage, resulting in death or transplant.
Actos Lawsuit Information
Takeda Pharmaceuticals and Eli Lilly & Co. are facing about 2,700 Actos lawsuits involving bladder cancer in federal court in Louisiana. These lawsuits are not part of an Actos class action — they are individual lawsuits that have been centralized in a Multi-District Litigation (MDL). Individual lawsuits have also been filed in state courts around the country.
In April 2014, a jury ordered Takeda and Eli Lilly to pay a combined $9 billion in punitive damages for failing to warn about the risk of bladder cancer. The plaintiff, Terrance Allen, was also awarded $1.5 million in compensation. According to data compiled by Bloomberg, it is the seventh-largest jury award in U.S. history, though it will likely be appealed. A major factor in the award was Takeada’s destruction of vital documents on 46 employees who were involved in developing and marketing Actos.
FDA Safety Warning for Actos
Currently, Takeda Pharmaceuticals is conducting a ten-year epidemiological study on Actos and the potential of bladder cancer. After the first five years of research, the FDA completed a review of the study, which is following 193,099 patients with diabetes.
The results of the study found that although there was not an overall increased risk of bladder cancer associated with Actos or pioglitazone use, there was an increased risk noted among patients with the longest exposure and highest doses.
As the FDA explained in a Safety Communication published on June 15, 2011:
“Compared to never being exposed to pioglitazone, a duration of pioglitazone therapy longer than 12 months was associated with a 40% increase in risk . . . Based upon these data, FDA calculated that duration of therapy longer than 12 months was associated with 27.5 excess cases of bladder cancer per 100,000 person-years follow-up, compared to never use of pioglitazone.”
The FDA’s findings mirrored the conclusions of another study, conducted by the French National Health Insurance Plan study that followed 1.5 million diabetes patients over a 4-year span. The study’s results suggested there were significant increases in the risk of bladder cancer in patients exposed to pioglitazone, compared to patients exposed to other anti-diabetic drugs. The risk of bladder cancer increased with stronger doses and longer exposure lengths. The study found men were at a particularly high risk.
French and German Health Authorities Pull Actos
The results of the studies have prompted the French government to pull Actos from store shelves and Germany is recommending no new prescriptions be made. Meanwhile, the FDA is asking American doctors not to prescribe Actos to current bladder cancer patients and to prescribe it with caution to any patients with a history of bladder cancer.
Symptoms of Bladder Cancer
- Blood in the urine
- Red coloring in the ruine
- Increased urinary urgency or frequency
- Urinary pain
- Urine leakage
- Abdominal pain
- Bone pain or tenderness
- Weight loss
On May 18, 2011, the FDA recalled Avandia (rosiglitazone) from general US markets because of evidence suggesting it was linked to an elevated risk of heart failure, which includes stroke and heart attack. Manufactured by GlaxoSmithKline, Avandia only became available to patients who could not be treated with any other similar medication — and even these patients and doctors had to enroll in a special program in order to receive the drugs.
This restriction follows a previous warning by the FDA on September 23, 2010, which notified doctors and patients that it was going to significantly restrict access of Avandia. The restrictions came in response to data that suggest an elevated risk of cardiovascular events. At the time, the FDA only recommended a change to the drug’s label.
Rezulin is the third member of the TZD family. It was pulled from US markets in 2000. After it was proven to be toxic to the liver, the FDA announced Rezulin manufacturer Parke-Davis/Warner-Lamber had agreed to discontinue the drug. Rezulin-induced liver toxicity could lead to death or the need for a liver transplant. At the time, Dr. Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research said: “Use of Rezulin now poses an unacceptable risk to patients.”
Do I Have a Actos Lawsuit?
Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged.
Collen’s amazing success in the courtroom and well known dedication to his clients has earned him the recognition of his peers as one of The Top Trial Lawyers in Texas.”
The Clark Firm has assembled a team of trial lawyers with more than 100 years experience, participation in over 600 jury trials and $60 million in verdicts and/or settlements. Please use the form below to contact us for a free Actos lawsuit review or you may also call us directly by dialing (866) 879-3040.