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A California jury in April awarded a combined $6.5 million in compensatory damages to a bladder cancer patient who had taken Actos for several years and to his wife. It was the first of more than 3,000 Actos lawsuits that have been filed nationally.

The relationship between an increased risk of bladder cancer and the use of the type-2 diabetes drug Actos (pioglitazone) is well-documented by numerous studies. Nevertheless, the plight of the unfortunate Actos patient, whose bladder cancer diagnosis bears out the increased risk, may not be as salient.

These complementary observations dovetail with some recent scientific literature that might deepen an understanding of that which the bladder cancer patient can experience.

As a matter of public policy, it should be pointed out from the top that the FDA released a statement in June 2011 based on prevailing science. A part of it read, “The U.S. Food and Drug Administration is informing the public that use of the diabetes medication Actos (pioglitazone) for more than one year may be associated with an increased risk of bladder cancer. Information about this risk will be added to the Warnings and Precautions section of the label for pioglitazone-containing medicines. The patient Medication Guide for these medicines will also be revised to include information on the risk of bladder cancer.”

Bladder cancer originates in the organ that stores urine, according to the National Cancer Institute of the U.S. National Institutes of Health. The NCI estimates that in the U.S. in 2013 there will be 72,570 new bladder cancer cases and 15,210 deaths attributable to the disease. The NCI explained that this cancer “forms in tissues of the bladder.”

If it gets bad enough, the NCI reported, “Bladder cancer cells can spread by breaking away from the original tumor. They can spread through the blood vessels to the liver, lungs, and bones. In addition, bladder cancer cells can spread through lymph vessels to nearby lymph nodes. After spreading, the cancer cells may attach to other tissues and grow to form new tumors that may damage those tissues.” Surgical options may include attachment of either a bag worn outside the body under the clothing or a new internal bladder pouch.

“Bladder substitution procedures, when they are oncologically safe, have the advantage of allowing patients to continue voiding through the urethra, which may have some impact on the quality of life,” according to an article written by two Belgium-based physicians and published in July 2012 in the journal Cancer Management and Research.

The down side, Belgian clinicians Dr. Hans Goethuys and Dr. Hein Van Poppel wrote, would include the possibility of “urinary stress incontinence,” in which, as the FDA put it, urine leaks “during moments of physical activity.”

The Leuven-based doctors continued, writing that “even more embarrassing, hypercontinence can occur, which is much more frequent in females than in males but can occur in both genders,” leading to catheterization. “Additionally,” they add, “enuresis nocturna [bedwetting] is a well-documented and frequently occurring consequence of bladder replacement.”

There is fresh information on this topic on physicians’ shelves and desks, right now. For instance, the May 2013 editions of medical journals described treatment options and delineated the damages for which, under our justice system, bladder cancer victims who were taking Actos may be entitled to compensation through an Actos lawsuit. The legal conclusions are drawn here, not by the researchers.

For the May 2013 edition of European Urology, numerous researchers with Massachusetts General Hospital and with the Harvard Radiation Oncology Program wrote about the “Use of Potentially Curative Therapies for Muscle-invasive Bladder Cancer in the United States.”

Some of the identified treatments included “radical or partial cystectomy with or without chemotherapy, chemoradiotherapy [simultaneous chemotherapy and radiation therapy], radiation therapy or chemotherapy alone, and observation following biopsy.”

Here’s something current from the Pacific Northwest. Dr. Andrew C. James and Dr. John L. Gore with the University of Washington’s Department of Urology covered “The Costs of Non-Muscle Invasive Bladder Cancer” for the May 2013 edition of The Urologic Clinics of North America.

The abstract, made available by the U.S. National Institutes of Health, explained some the losses that non-muscle invasive bladder cancer victims may suffer. Notice that health insurance can be drained in a heartbeat. That is one reason, a personal injury attorney might point out, that compensation is in order for Actos patients victimized by the unreasonable risk of bladder cancer which, in the absence of proper warnings, the diabetic Actos patient would not have known enough to avert.

Reportedly, an Actos lawsuit plaintiff in a California court claimed in April that executives for the manufacturer, Takeda, tried to conceal the bladder cancer risk several years before the FDA announced that the crucial health risk updates would be made to the product’s labeling and medication guide.

“Because the diagnosis, management, and long-term follow-up of non-muscle invasive bladder cancer require advanced imaging and invasive testing, economic evaluations have shown bladder cancer to be the costliest cancer to treat in the U.S. on a per capita basis,” James and Gore wrote. “Adjunctive tests for surveillance have not obviated the need for cystoscopy and cytology. Indirect costs to patients include loss of work, decreased productivity, and diminished quality of life associated with diagnosis, treatment, and surveillance.”

The Actos lawsuit is not centered on the manufacturer, Takeda. It’s about the clearly suffering client. So maybe the Actos victim’s painful and serious complications, embarrassment, oft-extensive treatment, and the economic losses that the latter siphons are not as salient as the latest scientific developments — and, for that matter, as the reported settlements.

They should be.

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A current or former Actos patient who has been diagnosed with bladder cancer may contact one of the pharmaceutical injury attorneys at Reich & Binstock, who operate in every state, to determine whether he or she is entitled to compensation. The law firm may be reached toll-free at 1-866-LAW-2400 for a free consultation. The law firm’s website is

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