Settlement Reached for Actos Bladder Cancer Victims

Takeda, the manufacturer of Actos, has agreed to pay $nearly $2.4 billion to settle bladder cancer claims brought by users: 

  1. who  took Actos at some time prior to December 1, 2011,
  2. who were diagnosed with bladder cancer on or before April 28, 2015, and
  3. who retained counsel before May 1, 2015. Under the terms of the settlement, approximately $2.4 billion will be distributed to approximately 10,600 Actos qualifying users, for average award of $225,000. 

The exact amount of any individual settlement award will be determined through an agreed-upon points matrix by which a number of points will be assigned to each individual claimant based on the level of injury.  The point total will then be adjusted up or down based on various factors, such as length of Actos use, smoking history, and prior history of bladder cancer. 

The five levels of injury include 1) a single occurrence of low grade bladder cancer; 2) recurrence of bladder cancer or occurrence of high grade or T1 bladder cancer; 3) occurrence of T2 bladder cancer or treatment for any bladder cancer by radiation or oral or intravenous chemotherapy; 4) occurrence of T3 bladder cancer or partial or radical cystectomy or nephrectomy to treat bladder cancer; and 5) occurrence of T4 bladder cancer or death from bladder cancer. 

If you meet the criteria above, you should be receiving more information from your attorney.  Please note that Individuals who wish to participate in the settlement must opt-in to the resolution program by July 13, 2015, and then submit a claim package (by a date to be determined) including documentation substantiating the injury and factors accounted for in the points matrix.  A Claims Administrator will then determine points each participant, and calculate the dollar value of each point to determine individual settlement awards. 

Deal or No Deal? Takeda offers $2.2 billion

 Takeda Pharmaceutical Co. the manufacture of Actos diabetes medicine has offered to pay more than $2.2 billion to resolve patients’ claims that the drug caused their cancer, according to Bloomberg News. More than 8,000 patients fighting bladder cancer have filed lawsuits in state and federal court. The settlement offer would pay each patient or his heirs approximately $275,000.  

Many people doubt that the $2.2 billion is sufficient to compensate all of the patients. It is speculated that Takeda may choose to settle cases with some lawyers and continue negotiations with others. Plaintiff lawyers who oversee the litigation in federal court for plaintiffs have stated that at this time, “There is no deal.”

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Takeda Ignored Bladder Cancer Warning Signs

More than 10 years ago during animal trials of the diabetes drug Actos, its manufacturer (Takeda International) learned that rats exposed to Actos developed more bladder tumors than rats exposed to a placebo. Takeda did not research the cause of increased rate of tumor formation, nor did it conduct further studies with human volunteers. Instead, Takeda minimized the risks, pushed through production and sought FDA approval. Takeda claimed “the evidence did not point to a risk in humans.”

Despite the results of the rat study and though Takeda never tested on human volunteers, the FDA approved Actos for sale in the U.S.

As a condition of its approval, the FDA required Takeda to conduct a 10-year observational safety study. In effect, the FDA gave its endorsement to use the entire global population of Actos users as “human lab rats”. When interim data was available in 2010 , it revealed that patients taking Actos for the longest period had an increased risk of developing bladder cancer -- a result consistent with the rat study.

Again, Takeda decided not to warn users. But this time, the FDA disagreed and advised the public that taking Actos for more than a year may indeed carry an increased risk of bladder cancer. The European regulators went even further, banning Actos altogether from the European market.

Takeda’s failure to properly investigate Actos' side effects and the FDA’s lackadaisical approach raises questions: What purpose do investigative studies serve? Why conduct animal studies if the correlation to humans is ultimately ignored? Can a drug manufacture use patients as “lab rats” and get away with it? If Actos had been properly tested before it hit the global market, how many victims might have been spared bladder cancer?

Actos victims are hopeful that their attorneys will find answers through the newly created multi-district litigation, In Re: Actos (Pioglitazone) Products Liability Litigation.

 

Who is Takeda International?

Takeda International is a global pharmaceutical company headquartered in Japan.  It’s top selling product, Actos,  improves the body's insulin use; while it also reduces blood sugar levels.  In 1998 Takeda entered into a marketing partnership with Eli Lilly and Co. to push Actos in the United States and obtain FDA approval.  Remarkably, one year later Actos was approved for release in the U.S. market and Takeda set up shop in Deerfield, Illinois, its U.S. corporate headquarters.  Actos has been a huge success for Takeda, as Both Takeda  and Eli Lilly marketed the drug in Japan, the United States, France and Germany.  In 2010, Takeda’s global sales revenue from Actos was an estimated $4.8 billion with an estimated 2.3 million prescriptions filled in the United States.  Recently Takeda has been on the defensive.  In 2011 researchers determined that users of Actos are at an increased risk of bladder cancer.  And , the top-selling drug is now the center of hundreds of lawsuits with Takeda as their target.  

Are U.S. Scientists in Actos Manufacturer's Pocket?

In April, U.S. scientists reported that short term use of the popular diabetes drug, Actos (pioglitazone), posed no risk of bladder cancer, while use for more than two years was only weakly associated with an increased risk.

But last month a French study found diabetics who used Actos for longer than 12 months were exposed to a 40 percent increase in risk for bladder cancer compared to diabetics who had never used Actos.

In a footnote to their study the U.S. scientists admit:

  • The study was funded by a grant from Takeda the manufacturer of the Actos. 
  • Takeda reviewed and commented on the study before it was submitted for publication.
  • The scientists are paid consultants of Takeda, as well as, other drug manufacturers GlaxoSmithKline and the Actos distributor Eli Lily. 

When the U.S. study was published the U.S. Food and Drug Administration did not take any action against Actos or its manufacturer Takeda.

But, when the French study was published, France and Germany pulled Actos from the market.  In response to the French study, the FDA issued a warning to consumers that Actos may increase the risk of bladder cancer when used for more than a year.

Did the funding from the drug manufacturers influence the results of the U.S. study?  It sure looks that way. How did the French study uncover such a strong association of risk of bladder cancer, when the U.S. researchers missed it?  

FDA Links Diabetes Drug Actos to Bladder Cancer

Actos has become one of the most popular treatments for type 2 diabetes melliActos linked to bladder cancertus.  Now the FDA is warning of a link between Actos and bladder cancer. A recent study showed that the risk increases by 40% after 12 months on the drug.  That risk is significant enough that the use of the drug has been suspended in France and no new patients are to be started on the drug in Germany. The FDA is suggesting that doctors limit the use of Actos while it continues to study the matter.

According to class action law firm Girard Gibbs, who is investigating the drug, early symptoms include blood in the urine, an urgent need to urinate or pain while urinating, and low back or lower abdomen pain.

The irony is why Actos is so popular:

Actos, despite links to heart failure risk and other serious side effects, became the No. 1 diabetes pill after Avandia, the only other drug in that class, was found in 2007 to sharply increase risk of heart attacks. Avandia’s use was banned in the EU and sharply restricted here. Actos sales jumped from about $2.9 billion in 2006 to more than $4.3 billion last year.

More at the Actos lawyers' website.