The Risks of ACTOS and the Litigation That Followed

by Jay Pate

ACTOS (pioglitazone hydrochloride) is an oral medication used to treat Type 2 Diabetes. It is manufactured by pharmaceutical giant, Takeda Pharmaceuticals. It was first approved in 1999 to help lower blood sugar. Actos sales began to soar in 2007 – after competing diabetes drug Avandia was shown to increase the risk of heart attack – and reached an astounding 4.3 billion in 2010. In the summer of 2011, however, the FDA announced that use of Actos can lead to a 40% increased risk of developing bladder cancer. This revelation, based on a review of an interim analysis of an epidemiological study involving over 200,000 patients, was the first sign that Actos’ rise to fame was in danger of crumbling.

Actos Banned in European Countries

Even more alarming, Actos sales were suspended altogether in June, 2011 by medical regulators in France and Germany. The French and German decisions to ban the drug came after a study commissioned by the French Medicines Agency (FMA) determined that people taking Actos were more likely to develop aggressive forms of bladder cancer. This study examined cancer rates in approximately 155,000 people taking Actos in France from 2006 to 2009 and another 1.3 million other diabetics who were not taking the drug. Researchers found about a 22 percent higher risk of bladder cancer in those taking Actos compared with diabetics relying on other treatments.

Warning Labels Updated Too Late

Furthermore, in May 2011, another study looking at Adverse Event reports submitted to the FDA between 2004-2009 suggested that Actos patients faced a disproportionate risk of bladder cancer. The study reviewed a half million side effect reports associated with various diabetes medications and found that one-fifth of those involving bladder cancer occurred in patients using the drug.

As a consequence of these continuing developments, the FDA announced the approval of revised warning labels for Actos informing the public that use of the drug may be associated with increased risk of bladder cancer. This may minimize future cases of Actos-induced bladder cancer, but the warning label updates come too late for those who have already developed the devastating illness after taking Actos.

Additionally, new research has added to the growing body of evidence linking anti-diabetic drugs like Avandia and Actos to other adverse health risks. Avandia has long been associated with cardiovascular risks while Actos was believed a safer alternative. Yet, emerging research suggests that similar heart risks are being seen in both drugs. Other studies have linked Avandia and Actos to an increased risk of fractures, macular edema and liver problems.

Actos Victims Stand Up for their Rights

As a consequence of these previously undisclosed risks, lawsuits have been filed in the United States against Takeda Pharmaceuticals. These lawsuits allege that Takeda failed to adequately warn patients of the risk of bladder cancer associated with the medication, allowing millions of patients to be put at risk of developing cancer while they received treatment for diabetes. The mounting 2011 legal actions against Takeda include steps toward class action lawsuits and multidistrict litigation. Since August 2011, class-action claims have been filed in the U.S. District Courts in Illinois, New York, Louisiana, Ohio, New York, California and other states.

Millions of patients filled prescriptions for Actos over the years, and based on the increased risk, the number of people who may have developed bladder cancer since the drug’s approval in 1999 could easily number in the thousands. In addition to the Actos bladder cancer litigation, it is highly likely that there will be legal action based on claims that Actos causes heart attacks and strokes.

Anyone who has taken Actos and developed bladder cancer is legally entitled to compensation for their associated financial, emotional and physical costs. Takeda Pharmaceuticals has a legal responsibility, indeed a moral responsibility, to all of the consumers who helped make it a multi-billion dollar company. This responsibility includes adequate research into all possible harmful side effects of their drugs and notifying patients, physicians and the FDA of any risks. Unfortunately, until the FDA’s mandated label change, Tadeka failed to warn its consumers of the increased risk of bladder cancer.

In fact, there is some evidence to suggest that Takeda deliberately turned a blind eye to the accumulating evidence of health risks associated with Actos. After the unsealing of a federal whistleblower lawsuit in February of this year, it has been learned that a doctor hired by Tadeka claimed that she was fired in retaliation for reporting the risks of bladder cancer and heart failure associated with the drug.  If such claims prove accurate, this amounts to a classic instance of a drug company putting profits ahead of people.

Time is Limited to Seek Compensation

When a person discovers they have been injured by a drug like Actos they need to act immediately to ensure they preserve their legal rights. First and foremost, it is important to hire attorneys who have the knowledge and resources to pursue these often complex and expensive cases. This is a challenging and complex area of the law, and if you try to go it alone, you will almost certainly leave the courtroom with nothing. The lawyers at Heygood, Orr & Pearson have vast experience in drug litigation, and we work diligently with our clients to obtain the full and fair restitution to which they are entitled. We will listen to the details of your case, give you an honest assessment of its strengths and weaknesses and tell you how we may be able to help. Contact us today for a complimentary consultation.

by Jay Pate

John “Jay” Pate is a licensed attorney who focuses his practice on complex tort litigation involving catastrophic personal injury, wrongful death, medical malpractice, and product liability cases.