Thousands of Actos Injury Lawsuits Pending
The Hasbrook & Hasbrook law firm is investigating possible lawsuits on behalf of people in Oklahoma who have been diagnosed with bladder cancer after taking the prescription drug, Actos.
Actos is the brand name for pioglitazone, which is used to treat Type 2 diabetes, the most common form of the disease. Type 2 diabetes can often be treated with medications such as Actos, without the necessity of insulin shots.
Actos is manufactured by Takeda Pharmaceutical, based in Japan, which is the largest big pharma in Asia and one of the 15 largest in the world. It had $16.2 billion in revenue in 2012.
The FDA approved Actos for use in the U.S. in 1999. However, in the years since then, a steady stream of information has emerged indicating a link between Actos and bladder cancer. In addition, a former Takeda safety consultant has made the formal accusation that Takeda knew about the correlation between Actos and bladder cancer long before that information became public.
A two-year preclinical study in the 1990s, even before the FDA ever approved Actos, showed a link between pioglitazone and bladder tumors in laboratory rats. In 2002, three years after granting approval to Actos, the FDA ordered Takeda to launch a ten-year study of the drug and its link to various possible adverse effects, including bladder cancer.
On June 18, 2010, Dr. Helen Ge filed a “whistleblower lawsuit” against Takeda under the federal False Claim Acts, popularly known as the Lincoln Law. Dr. Ge is a medical doctor who had worked for Takeda as a safety consultant, reviewing adverse effects of the drug. In her lawsuit, Dr. Ge claimed that Takeda concealed information about risks caused by Actos.
Three months later, the FDA announced in September 2010 that it had begun a review of the data gathered in the ongoing ten-year study. The FDA said that it intended “to evaluate whether Actos (pioglitazone), is associated with an increased risk of bladder cancer. Findings from studies in animals and humans suggest this is a potential safety risk that needs further study.”
Prolonged Use Increases Risk
After its review of the data, in 2011 the FDA announced that “the use of pioglitazone for more than one year may be associated with an increased risk of bladder cancer.” The FDA ordered that pioglitazone’s labeling be updated accordingly.
The fact that the risk of bladder cancer increases with prolonged use of Actos is highly significant to almost all Actos users. Since there is no cure for Type 2 diabetes, if a diabetic is being treated with Actos, that treatment typically continues for years. Therefore, the discovery that the risk of bladder cancer increases when Actos is used for more than 12 months is pertinent to virtually every person who has used the drug.
The 2011 FDA announcement said:
“The risk of bladder cancer increased with increasing dose and duration of pioglitazone use. Compared to never being exposed to pioglitazone, a duration of pioglitazone therapy longer than 12 months was associated with a 40% increase in risk.”
Despite this discovery, the FDA has not removed the drug from the market. However, pioglitazone has been banned in France and Germany.
Thousands of Lawsuits
In the last two years, more than 3,000 lawsuits have been filed against Takeda in various states and at the federal level by Actos users and their loved one. Two cases have so far gone to trial.
In California in April 2013, a jury awarded $6.5 million in damages to a man who took Actos for five years and now has cancer which began in his bladder and has spread throughout his body. The Los Angeles jury found Takeda guilty of failing to warn the public or medical community that Actos caused an increased risk of cancer. However, a judge has thrown out the award and the case is being appealed.
In Baltimore in September 2013, the second Actos bladder cancer trial began. The plaintiffs are the family of a man who died from bladder cancer after taking Actos. Plaintiffs claim Takeda knew in 2005 that Actos increased the risk of cancer, but failed to make that knowledge public, which would have made it possible for doctors and patients to more accurately weigh the risks of taking the drug.
The first federal case went to trial in January 2014 in Louisiana.
If You Were Hurt After Using Actoa, Our Attorneys Can Help
If you or a loved one has been diagnosed with bladder cancer after prolonged use of Actos, contact our law office. You may contact us by telephone (866-416-4737), email ([email protected]) or use our website contact form.
Attorneys of the Hasbrook & Hasbrook law firm have a total of more than 75 years of experience representing Oklahoma citizens who have experienced harms or losses due to accidents, negligence, abuse, medical malpractice, product liability, wrongful termination, sexual harassment and discrimination.
All consultations are free of charge and completely confidential.