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Jury Rules Takeda Didn't Properly Warn About Its Diabetes Drug Actos's Cancer-related Risks

Sep 27, 2013

A Baltimore, Maryland-based jury yesterday ruled that Takeda Pharmaceutical Co. failed to properly warn the plaintiff and his doctor about the risks associated with the company’s Actos diabetes drug. Jurors spent about six hours across two days before deciding to hold Asia’s largest drug maker liable for the plaintiff’s cancer death, ordering Takeda to pay more than $1.7 million in damages, BloombergBusinessweek reported.

This is the second case out of some 3,000 lawsuits filed against Actos to reach trial. Most of the lawsuits include allegations that Takeda researchers either ignored or downplayed the drug’s cancer-causing potential before it even launched in the U.S. in 1999, and that they also misled U.S. regulators about Actos’s dangers. In the first lawsuit to reach trial, a California jury ordered Takeda to pay $6.5 million in damages to man who alleged that Actos caused his bladder cancer, BloombergBusinessweek reported. In that case, the judge overturned the verdict; the family appealed. In the recent Maryland case, since the jurors also found that the Plaintiff was a longtime smoker and may have contributed to his own death, the judge had to set the verdict aside.

Takeda’s primary defense is that it has appropriately warned consumers and physicians about Actos’s risks. However, it’s been widely reported that, by the year 2005, Takeda officials more than likely had to have known that clinical studies were linking Actos and cancer, despite their allegations to the contrary; still, the company didn’t go issue a warning, and the drug’s risks remained mostly veiled for about six years.

The U.S. Food and Drug Administration (FDA), which approved Actos, issued its first safety communication about the drug’s dangers in 2011, the year the regulator first learned of them courtesy of its review of a Takeda-sponsored study that revealed some Actos users faced an increased risk of developing bladder cancer or heart problems, BloombergBusinessweek reported. The safety communication detailed the fact that anyone who was taking Actos for more than a year faced a greater risk of developing bladder cancer. The FDA also then noted that Actos’s label had been revised to reflect the bladder cancer risk (specifically it warned about key bladder cancer symptoms, such as bloody urine, urinary urgency or pain on urination). The updated drug label also offered healthcare professionals two recommendations:

  • Don’t use Actos (pioglitazone) in patients with active bladder cancer.
  • Exercise caution when using Actos to treat patients with a history of bladder cancer.

Aside from the FDA, research studies from other groups provide additional support for the notion of a link between Actos and bladder cancer. The British Medical Journal published a study on May 31, 2012, that revealed Actos users were twice as likely to develop bladder cancer after two years. Then, on July 3, 2012, the Canadian Medical Association Journal reported that patients taking the medication were 22 percent more likely to get bladder cancer.

Takeda has since pulled the drug off the market in France and Germany, scarce consolation for the thousands of U.S. patients suffering from bladder cancer and waiting for their lawsuits to get before juries.

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