Actos® Bladder Cancer Attorneys

Actos Bladder Cancer Litigation Update

April 28, 2015: Takeda Pharmaceutical Co. Agrees to Pay $2.4 Billion Settlement Over Actos Cancer Risks

June 27, 2013: Actos® (pioglitazone), which has been linked to increasing the risk of bladder cancer, has been banned in India, as have two other drugs. In the wake of a strong push by government that drugs prohibited for sale in other countries should be prohibited in India, Actos, pain-killer Analgin, and anti-depressant Deanxit, are being removed from market. Though Actos remains on sale in the U.S. and U.K., it is banned in Germany and France and carries serious health risks.

The Ministry of Health and Family Welfare in India has banned the sale and manufacture of these drugs under Section 26A of the Drugs and Cosmetics Act, 1940. The decision to ban pioglitazone and its combinations not only affects Takeda Pharmaceuticals, but various Indian pharmaceutical companies, including Abbott, USV, Lupin, Sun Pharma, Wockhardt and Ranbaxy Laboratories.

April 26, 2013: A jury awarded Jack Cooper and his wife, Nancy Cooper, $6.5 million in damages in his lawsuit against Takeda Pharmaceuticals, Inc., a Japanese-based pharmaceutical company and the maker of the oral anti-diabetic drug, Actos. Mr. Cooper claimed that he developed bladder cancer as a result of taking Actos for five years and that Takeda failed to warn his prescribing physician of the increased risk of bladder cancer from taking the drug.

Mr. Cooper is a 79-year-old retiree currently living in Chula Vista with his wife of 56 years, Nancy. Mr. Cooper was diagnosed with Type-2 diabetes mellitus in the summer of 2006, and was initially prescribed a different oral anti-diabetic drug, metformin. Due to the unpleasant side effects Mr. Cooper experienced while taking metformin, his doctor switched him to Actos. For five years, Mr. Cooper took the drug in order to control his diabetes, until late 2011, when Mr. Cooper was diagnosed with stage IV transitional-cell cancer in his urinary bladder. Mr. Cooper’s life expectancy is estimated at less than six months.

Mr. Cooper claims that Actos caused his bladder cancer and that he would not have taken it, nor would his doctor have prescribed it to him, if Takeda had properly and timely warned that Actos would increase his risk of developing bladder cancer. The jury in his case, Cooper v. Takeda, agreed and awarded Mr. Cooper $5 million for his pain and suffering and Ms. Cooper $1.5 million for the impending loss of her husband.

Mr. Cooper claims that Takeda knew about the increased risk of bladder cancer during the time that he was taking Actos, but Takeda did not warn his doctor of that increased risk. In a March 2000 email from Takeda’s Phillip Collett to Dr. Samuel Cohen, Takeda thanked Dr. Cohen for his help as “the bladder issue has almost gone away.” Mr. Cooper also claims that only after Takeda changed Actos’ label in August 2011 to include a warning about bladder cancer were doctors fully informed by Takeda sales representatives of the increased cancer risk.

Takeda believes that Actos did not cause Mr. Cooper’s bladder cancer. Mr. Cooper was already at high risk for bladder cancer given his personal circumstances. Takeda argued that because Mr. Cooper is an older diabetic, Caucasian male, who is a former smoker and worked for decades at a telephone company, his chances of developing bladder cancer were very great already and that Actos was not a factor in causing his bladder cancer.

April 13, 2012: Since the publication of several studies linking the diabetes drug Actos (pioglitazone) to an increased incidence of bladder cancer, and the suspension of the drug from France and Germany in July 2011, hundreds of cases have been filed in federal and state courts throughout the U.S.

In December 2011, a seven-judge federal Judicial Panel on MultiDistrict Litigation (MDL) granted a motion to transfer and coordinate federal Actos cases nationwide. The Panel sent the lawsuits to the Western District of Louisiana, in Lafayette, to be overseen by U.S. District Judge Rebecca Doherty who will coordinate pretrial proceedings, including evidence-gathering. The purpose of consolidating the cases and assigning them to a single judge is to avoid contradictory rulings by multiple judges and prevent overlapping on the discovered facts and legal issues during the pretrial proceedings. MDL consolidation of the cases is a very positive development in that it effectively streamlines the litigation process and makes it more efficient for all the parties.

In March 2012, Judge Doherty appointed 19 plaintiffs’ lawyers to manage the Actos litigation. Mark P. Robinson, Jr. of Robinson Calcagnie, Inc. was appointed to the Plaintiffs’ Executive Committee.

On March 22, the court held its first Case Management Conference and has since issued orders requiring the Defendant to produce certain documents including Defendants’ corporate organizational charts and documents submitted to the FDA as part of Actos’ New Drug Application (NDA).

The lawsuits are consolidated in In Re: Actos Products Liability Litigation, MDL 2299.

We are currently investigating claims involving the development of bladder cancer arising from the use of Actos. If you or a loved one have taken Actos and are now suffering from side effects related to Actos, including bladder cancer, please contact our attorneys immediately for a free case evaluation.

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3/12/12 – Actos MDL Judge Rebecca Doherty appoints Mark P. Robinson, Jr. to Plaintiffs’ Executive Committee

FDA Orders Bladder Cancer Warning on Actos Label

The use of the popular diabetes medication Actos (pioglitazone) for more than 12 months may be associated with a 40 percent increased risk of developing bladder cancer.

Actos was first approved for use in the United States in 1999. In 2003, the U.S. Food and Drug Administration (FDA) requested that the manufacturer of Actos, Takeda Pharmaceuticals, conduct a 10-year study to evaluate whether Actos is associated with an increased risk of bladder cancer. In June of 2011, following its review of data from the first five years of the study, the FDA issued a Safety Communication advising the public about the elevated risk of bladder cancer. The FDA discovered that the longer people took Actos, the greater their risk of developing bladder cancer. In addition, the FDA discovered that higher doses of the drug also increased the risk of developing bladder cancer. The FDA ordered Takeda to include information about this risk in the “Warnings and Precautions” section of the label for Actos and other medicines containing pioglitazone. The FDA also ordered that the updated label include a warning that patients who have a history of bladder cancer or who have bladder cancer should not use Actos. Actos has not been recalled by the FDA and is still on the market in the United States.

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Other Studies Link Actos with Increased Risk of Bladder Cancer – France and Germany Suspend Sales

A study based on the FDA’s Adverse Event Reporting System was published by the American Diabetes Association in April of 2011. This study indicated that there were significantly increased reports of bladder cancer in users of pioglitazone over a five-year period. The study’s authors concluded that the results were consistent with an association between pioglitazone and bladder cancer.

Another study conducted by France’s national health insurance agency resulted in the suspension of the sale of Actos in France and Germany in June of 2011. The French study examined the cancer rates in approximately 155,000 people between the ages of 40 and 79 who were treated with pioglitazone between the years 2006 and 2009, and compared those rates with cancer rates in 1.3 million diabetics who were not treated with pioglitazone. The study confirmed an increase in the risk of bladder cancer in patients who were treated with pioglitazone. Takeda withdrew the drug from France in July of 2011.

About Actos and Bladder Cancer

Actos, which is used along with diet and exercise to treat Type 2 diabetes, is available in several forms, including Actoplus Met, Actoplus Met XR and Duetact. Actos is one of Takeda’s top-selling drugs. In 2011, Actos had sales of over $4 billion and accounted for 27 percent of Takeda’s revenue. It has been estimated that over 2.3 million prescriptions for medications containing pioglitazone were filled in 2010. Actos became the top-selling diabetes medication after Avandia, another diabetes medication, was linked to a dramatically increased risk of heart attack.

Over 70,000 Americans develop bladder cancer each year, and over 14,000 bladder cancer deaths are reported each year. Symptoms of bladder cancer include blood or blood clots in the urine (hematuria); painful and/or frequent urination; frequent urinary tract infections; pain in the lower back; swelling in the lower leg; pelvic mass; anemia; weight loss; and pain in the rectal, anal or pelvic area. If you experience any of these symptoms, you should immediately consult with your physician.

We are currently investigating claims involving the development of bladder cancer arising from the use of Actos. If you or a loved one have taken Actos and are now suffering from side effects related to Actos, including bladder cancer, please contact our attorneys immediately for a free case evaluation.

Click Here for an Actos Lawsuit Evaluation.