The second trial out of more than 3,000 lawsuits alleging the most grievous of Actos side effects - bladder cancer - heard opening arguments September 3 in state court in Baltimore. According to Bloomberg News (9/4/13), the Vietnamese immigrant was put on an Actos regimen in 2007 to treat his diabetes. In September 2011 - the same year the US Food and Drug Administration (FDA) concluded there was an increased risk for Actos bladder cancer for patients using Actos beyond one year - An was diagnosed with high-grade bladder cancer.
He died four months later, in January 2012. His family launched an Actos bladder cancer lawsuit.
According to court filings for the plaintiff, Actos knew in 2005 that studies had revealed links between Actos and bladder cancer, as well as Actos heart failure. In their opening remarks, lawyers for the plaintiff contend that in spite of this knowledge Actos manufacturer Takeda waited six years before issuing a warning about the possible cancer risk.
What’s more, according to Bloomberg, former Actos users contend that researchers for Takeda ignored or downplayed emerging concerns over the potential for Actos to trigger cancer even before the drug was issued FDA approval and appeared on the market in 1999.
2011 turned out to be a watershed year for Actos. That was the year that a Takeda-sponsored study identified the link between Actos and bladder cancer, and the FDA issued its warning - although the US regulator stopped short of pulling Actos from the market. However, that’s what happened in France, after French regulators formally requested that Takeda disappear in that country.
Germany mandated that Actos be removed from its reimbursed list of drugs.
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In the Baltimore trial, Takeda maintained that An’s bladder cancer was triggered by his 30-year smoking habit. Plaintiff lawyers countered that An was not a heavy smoker, and quit his half-pack-a-day habit in 1996, fifteen years prior to his diagnosis.
Earlier this year, the first plaintiff to bring an Actos bladder cancer lawsuit won a judgment for $6.5 million before the verdict was later vacated. That ruling, according to Bloomberg, is in the throes of appeal. Meanwhile, the first of more than 1,200 federal cases consolidated before a federal judge in Louisiana is expected to go to trial in January.
The case is An v. Nieberlein, 24-C12003565, Circuit Court for the City of Baltimore, State of Maryland.