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With its “decline in sales revenue,” Actos (pioglitazone) had done little for the bottom line of its manufacturer, Takeda, in the corporation’s previous fiscal year. Moreover, the type-2 diabetes drug faces generic competition in 2013 that will chomp some of its competitiveness.

Nevertheless, the corporate prognosis is rosy in comparison to that of patients who developed bladder cancer, many of whom, seeking to recover their medical expenses and other damages, have filed Actos lawsuits.

Litigation emerging from the drug’s apparent increased bladder cancer risk is on the minds of Takeda brass, in addition to the uphill climb against incipient generic pioglitazone production.

Actos had been approved in 1999, but the U.S. Food and Drug Administration, consistent with prevailing scientific findings that plaintiffs have claimed the manufacturer should have known, could not sound the Actos bladder cancer alarm until 2011. That warning applied specifically to those who would take the drug for more than a year.

So, Takeda has planned to offset a projected roughly 40 percent operating-income decline for the fiscal year ending March 31, which was triggered by, as Takeda CEO Yasuchika Hasegawa explained Feb. 4 for the corporation’s 2012 Annual Report, “the impact on profits of lower sales revenue from Actos, increased amortization of intangibles and goodwill, higher [research and development] expenses, and our aggressive investment program, mainly focused on emerging markets.”

At the same time, Takeda reported to its investors that while the leadership has remained “confident” in the benefits of Actos, international regulators, reacting to the harm linked to the drug, have been unimpressed.

“[Takeda] and Eli Lilly & Co. have been named as defendants in lawsuits pending in U.S. federal and state courts in which plaintiffs allege they have developed bladder cancer as a result of taking pioglitazone-containing products,” according to Takeda’s 2012 recap. “A proposed class action has also been filed in the Ontario Superior Court in Canada. The Company is vigorously defending the aforementioned lawsuits.”

Addressing labeling changes, which included those imposed in Takeda’s native Japan, Takeda reported, “In July 2011, Laboratoires Takeda (Takeda’s wholly owned subsidiary in France) withdrew pioglitazone-containing products in France based on a decision by the French authorities. In the United States and Japan, the description related to bladder cancer in the product label for pioglitazone-containing products was revised through consultations with each authority. In Europe, the European Commission also approved label changes and clarifications on the product indications in January 2012.”

Even before generic drug competition sprouted — after a brand-name patent fell — Actos had generated a global regulatory and tort impact based not on avarice but on the harm linked to an arguably unreasonably dangerous drug, the increased risks of which the manufacturer should have known and disclosed, ideally pre-market.

From 1999 to 2011, the time in which a class of U.S. first graders became high school graduates, thousands of unaware diabetics gambled with their health and drew bladder cancer in their losing cards. But it was the manufacturer, not the diabetics, who had a seat at the game and chips on the regulatory table, the wager representing Takeda’s investment in the drug. The patients were in the dark as to the risks of Actos side effects. Medical professionals also were unaware.

As Paul Harvey would say, if he were still with us, “Now you know the rest of the story.” Although Actos has been a drain on corporate revenue, it has been the bane of bladder cancer sufferers who took the drug for a prolonged period. Every victim deserves justice.

The experienced Actos attorneys at Reich & Binstock have represented their fair share of Actos victims. Anyone else whose bladder cancer may have stemmed from taking the diabetes treatment medication may contact Reich & Binstock for a free consultation. Such a patient may be entitled to compensation.

The pharmaceutical injury attorneys at Reich & Binstock may be reached by an electronic request for free legal advice through its Web site,, or toll-free at 1-866-LAW-2400.

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