In April 2015, a settlement agreement resolving thousands of lawsuits over the diabetes medication Actos was finally reached by its manufacturer Takeda Pharmaceutical Co. Ltd. The pharmaceutical company agreed to provide $2.4 billion of financial compensation to patients and families in the U.S. affected by the medication linked to bladder cancer. Current claimants and litigants who meet specific criteria are expected to receive financial payouts from the settlement fund.
The Actos diabetes prescription medication arrived in the medical marketplace in early 1999 after receiving approval from the FDA (Food and Drug Administration). Within a decade, Actos was one of the 10 most prescribed medications in the U.S. However, in information released at trial, internal studies by the pharmaceutical manufacturer as far back as 2004 linked the drug to an increased risk in bladder cancer.
Though the company has agreed to the settlement, they are not admitting liability and claim all allegations are without merit. While the agreement has been finalized, it only becomes effective when 95 percent of the claimants and litigants opt to accept the settlement. This agreement settles the charges that Takeda had failed to warn patients prescribed Actos of its increased potential risk for acquiring bladder cancer.
The Dangers of Actos
Doctors prescribe Actos (pioglitazone) medication to be used in conjunction with exercise and diet as an adjunct for improving glucose (blood sugar) control in patients suffering from type II diabetes. This is because its anti-hyperglycemic effects are only exerted in endogenous insulin. It is not effective for treating type I diabetes and has not been proven effective or safe for children 18 years or younger.
There are numerous well-known side effects to taking Actos that can occur when beginning the medication, increasing its dosage or stopping the drug altogether. Common dangerous side effects can be severe, requiring immediate medical attention. Other factors that cause problems with use could be related to overall health, gender, weight, age and ethnicity. Some of those serious and life-threatening side effects include:
- Upper respiratory infection
- Muscle pain
- Sinus irritation or infection
- Tooth pain
- Fevers, chills and sore throat
- Allergic reactions including swelling of the tongue, lips and face
- Skin reactions including itching and hives
- Hypoglycemia (low blood sugar)
- Bladder cancer
- Lactic acidosis
- Bone fractures
- Congestive heart failure
The prescription medication tends to worsen when used with many comorbidity problems or pre-existing medical conditions. The prescription medication should never be prescribed any patient suffering bladder problems, bladder tumors or cancer.
FDA Safety Communication
As far back as June 2011, the Food and Drug Administration released a drug safety communication informing Actos users of the link of pioglitazone and increased bladder cancer risks. At that time, the FDA revised its patient Medication Guide to include the increased risks of developing bladder cancer when taking the diabetes controlling drug.
Attorneys for the plaintiffs presented evidence at trial that Takeda had for years employed marketing strategies to increase their sales while withholding information from medical professionals of the associated risk of bladder cancer while taking the drug. In addition, the trial jury also heard evidence of how the pharmaceutical manufacturer failed to provide the same adequate warning to patients, some who have since lost their lives to terminal bladder cancer.
As a part of the terms of settlement, funds will be awarded to claimants at an amount based on a points matrix. The injured victim will receive an amount based on various criteria including:
- The extent of injuries the patient suffered and the treatment involved
- The age of the patient
- The dose of Actos taken
- The length of time the prescription medication was taken
- Any associated risk factor like smoking that could have increased the potential of developing bladder cancer
This settlement agreement should resolve more than 9000 pending bladder cancer claims against Takeda. More claims and lawsuits are expected to be filed against the company in the future. Because of the harmful effects and damages caused by Actos, future litigants will likely be eligible to receive financial compensation through a settlement or jury verdict. However, these types of cases are complex and often require the skills of an experienced personal injury attorney who specializes in bad drug cases.