September 6, 2013

162017_132140396847214_292624_nOn September 3, 2013, a Baltimore City jury trial began in which the plaintiff alleges that the diabetes drug Actos was the cause of the bladder cancer that led to the death of a former U.S. Army translator in 2012. Actos is manufactured by Asia’s largest pharmaceutical manufacturer, Takeda Pharmaceutical Company Limited (“Takeda”).

The Maryland case is the second of over 3,000 cases filed throughout the United States to go to trial that blames Actos in causing bladder cancer in patients who used the drug: an earlier Actos trial in state court in California led to a $6.5 million verdict in favor of a diabetic who claimed that Actos led to his bladder cancer. A judge tossed the verdict, however, and the case is presently on appeal in California.

The Maryland Actos case alleges that Takeda knew by 2005, at the latest, that studies had indicated a link between Actos and bladder cancer yet Takeda failed to warn about the link until six years later in order to protect its profits at the expense of the lives of the people who took Actos. Sales of Actos represented 27% of Takeda’s profits in 2011, when the sale of Actos peaked at $4.5 billion. Actos was approved by the FDA in 1999 for sale in the U.S. and remains on the market. Actos critics claim that the FDA was misled about the risks of Actos during the approval process.

A review by the FDA in 2011 of a Takeda-sponsored study found that some users of Actos had an increased risk of developing bladder cancer and heart problems. The study is continuing and the results from the study are expected to be made available in 2014. Takeda removed Actos from the market in France in 2011 and Germany removed Actos from its list of drugs that are reimbursed that same year.

The Maryland man whose case is presently being tried before a Baltimore jury began taking Actos in 2007. In September 2011, the man was diagnosed with high-grade bladder cancer that resulted in his death in January 2012. The Maryland plaintiff claims a direct link between the man’s use of Actos and his bladder cancer. Takeda suggests that the man’s 30-year history of smoking (he stopped smoking in 1996) may have led to his bladder cancer.

There are presently more than 1,200 federal lawsuits involving Actos that have been consolidated before a Louisiana federal judge for the pretrial exchange of information. The first federal case involving Actos is presently scheduled to begin trial in January 2014.

Source: The Daily Record, September 5, 2013. An v. Nieberlein, Circuit Court for Baltimore City, Case No.: 24C12003565.

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