Takeda Pharmaceuticals has been found liable by a California jury for failing to warn of the risks of Bladder Cancer posed by its blockbuster Type 2 Diabetes Drug, Actos.   The $6.5 million verdict came after a lengthy trial and several days of jury deliberation.  Suit was filed by Jack Cooper against Takeda after he was diagnosed with bladder cancer after years of taking Actos.

The entire time, Takeda neglected to inform consumers, like him, that their diabetes drug, Actos, was linked to bladder cancer. Attorneys across the country have been building a case against Takeda on behalf of Bladder Cancer victims since the summer of 2011, when the FDA finally ordered Takeda to issue warnings related to the cancer risk.  Cooper’s case was set for an early trial, under a California procedure that allows early trial settings for people who have been given a prognosis that they have little time to live.  In Mr. Cooper’s case, and in many others, the warnings of cancer came far too late.

Actos has been Takeda’s veritable cash-cow, raking in around $4.5 billion in 2011 which was 27 percent of its revenue, Bloomberg reports.  During trial, Internal documents from the early 2000’s showed that Takeda participated in a methodical, concerted effort to keep cancer warnings off the drug’s label, for fear that increased warnings would damage the drug’s sales.

The British Medical Journal released a study last May indicating that Actos (pioglitazone) increased the risk of bladder cancer in patients suffering from Type-2 diabetes.  Takeda has been trying shrug off accountability for the drug’s dangers and accountability for its complete disregard for properly informing Actos consumers.  Takeda executive Kiyoshi Kitazama exemplified the company’s disregard to consumer well-being in an email conversation from 2005 stating that “Takeda officials were worried that regulators would demand that the company add warnings about the illness (cancer) to Actos’s label.”

Documents and statements from Takeda, now made public during trial, show that Takeda has been aware of Actos’s health risks since before the drug hit the market, and had human clinical evidence of the risk of cancer since 2004, but kept it quiet from drug regulators for nearly a decade.  Not only did Takeda know about the dangers of Actos, many of Takeda’s executives tried to manipulate the U.S. Food and Drug Administration to downplay cancer warnings.  

Over the next year, there are several trial settings that may ultimately lead to more verdicts against the company.  A major trial event is scheduled in January, 2014, when the Federal Multidistrict Litigation centered in the Western District of Louisiana (Lafayette) is set to begin federal bellwether trials, which will have an impact on some 1,500 cases currently filed in federal court.  Leadership firms, such as the Levin, Papantonio firm, are gearing up for waves of discovery, depositions, and pre-trial proceedings.

Actos was approved for marketing in 1999, and the labeling remained free from bladder cancer warnings until 2011.  

“Mounting evidence such as what was seen in California is proving that Takeda placed profits over safety and aggressively marketed their drug without regard for giving doctors and patients a complete picture of the true risks of the drug,”” said Robert Price, attorney at Levin, Papantonio, Thomas, Mitchell, Rafferty & Proctor, P.A.  “This verdict and the evidence shown at trial is only the tip of the iceberg.  This company reaped profits while keeping doctors and patients in the dark.  It is time for them to pay the price. ”

There are now approximately 3,500 lawsuits filed against Takeda in federal and state court for its lack of concern for Actos consumers and since more than 2.3 million prescriptions were issued, there’s no definite answer on how many more this drug is likely to have harmed.

Joshua de Leon is a writer and researcher with Ring of Fire.