Alabama plaintiff Anita Kulisek filed an Actos lawsuit against Japanese pharmaceutical giant, Takeda Pharmaceuticals, for the injuries she allegedly suffered from taking the type-2 diabetes drug.

Kulisek accuses the company of deliberately concealing information regarding the possible Actos side effect of bladder cancer.

Actos is a well-known diabetic medication, with a reputation of being an aggressive treatment method. Patients have reported that the drug has worked faster and more efficiently in encouraging the body to produce insulin compared with other treatments.

Additionally, Takeda boasted the drug’s effectiveness when it was first released into the United States in 1999, attracting many new patients to it.

Kulisek was one of the many patients who began taking Actos in 2000 after it was recommended to her by her physician.

According to the Actos lawsuit, for the past 14 years, Kulisek had followed all prescription and physician instructions regarding Actos, and did not deviate from her required diabetic schedule. Despite faithfully following instructions, she was diagnosed with bladder cancer on Dec. 18, 2013.

Kulisek continued her prescription into 2014 because she had not been informed that Actos was linked with causing bladder cancer in patients.

She is filing this Actos lawsuit against Takeda Pharmaceuticals for fraudulent marketing and concealing vital safety information, after learning about this association from a televised commercial.

Kulisek’s legal team argues that at the time of Actos prescription, she had not received full disclosure for the medication she was receiving including this dangerous Actos side effect, and could not make a reasonable decision.

Kulisek insists that she never would have used the medication if she had known about the possibility of bladder cancer. There were no warnings or indications on the product’s label to indicate bladder cancer, nor had the defendant provided any relevant scientific literature to her physicians. Kulisek insists in her Actos lawsuit that Takeda had the civil responsibility of warning her and other patients about Actos side effects, because they rely on the accuracy on the given information.

For being allegedly responsible for manufacturing, selling, distributing, and marketing a dangerous drug, Kulisek is filing this Actos lawsuit against Takeda Pharmaceuticals. The charges include: negligence, false advertising, concealing information, and misrepresenting a product.

Overview of Actos Complications

Since Actos was approved in 1999, it has quickly gained the reputation as one of the most aggressive diabetic treatment medications. Due to its aggressive nature, Actos is normally prescribed as an alternative treatment medication when others have been proven ineffective.

Actos is a part of a class of insulin-sensitizing diabetes agents known as thiazolidinediones (TZDs), which only reacts in the presence of insulin, making the drug useless for patients with type-1 diabetes.

Several scientific studies have found that patients, who use Actos for a year, often develop an aggressive form of bladder cancer, which is often in a latent stage at the time of diagnosis. Since the release of Actos, Takeda received more than 180 bladder cancer reports on average per year, but the company has never made any official confirmation of the bladder cancer side effect.

However, FDA investigations found that Takeda had conducted in-house pre-clinical trials for Actos on rats and mice. Reportedly, the mice had extreme adverse reactions to the drug, including significantly damaged bladders.

Despite the amount of findings the FDA and other respected institutions have found, Takeda has still not updated Actos’ label to include the possibility of bladder cancer. This has led to mass criticism from the public and FDA, as well as a large litigation movement against the company, in the form of individual class-actions and multidistrict litigation (MDL), or mass tort, movements.

The Actos Bladder Cancer Lawsuit has been added to the Actos Multidistrict Litigation currently underway, In Re: Actos Products Liability Litigation, MDL No.-2299, in the U.S. District Court for the Western District of Louisiana.