Takeda Pharmaceutical Co., Asia's biggest drugmaker, with North American headquaters in Deerfield, is facing its first trial of lawsuits alleging that its Actos diabetes drug caused cancer in some patients.
Jack Cooper, a former cable splicer for Pacific Bell who took Actos for more than two years, contends officials of Takeda's U.S. unit didn't properly warn consumers that Actos could cause bladder cancer. Jury selection in Cooper's case is slated to begin to today in state court in Los Angeles.
Cooper, 69, was diagnosed with bladder cancer in November 2011 and "is gravely ill," Judge Kenneth Freeman said in an October ruling ordering an expedited trial of his claims.
The trial comes a month after Osaka, Japan-based Takeda won U.S. regulatory approval for Nesina, a new diabetes drug to replace Actos, which lost patent protection last year. Actos was once the world's biggest-selling diabetes drug.
Sales of Actos peaked in the year ended March 2011 at $4.5 billion for Takeda and accounted for 27 percent of the company's revenue at the time, according to data compiled by Bloomberg.
Takeda is facing more than 3,000 suits alleging Actos caused bladder cancer or other ailments among patients, according to court records. Cooper's suit is among the cases that have been gathered before Freeman in California. There are other cases in state court in Illinois, according to court dockets.
More than 1,200 suits have been consolidated before a federal judge in Louisiana for pretrial information exchanges. The first federal case is set for trial in November 2014, according to court filings.
Takeda officials defended the company's handling of Actos by noting the U.S. Food and Drug Administration found it to be a safe and effective drug and arguing there's no proof that it causes bladder cancer.
"We empathize with the plaintiffs but believe that Takeda acted responsibly with regard to Actos," D'Lesli Davis, one of Takeda's lawyers, said in an e-mailed statement. "Studies do not establish a causal link between Actos and bladder cancer."
FDA officials found in 2011 that an analysis of a company- sponsored study showed some Actos users faced an increased risk of developing bladder cancer or heart problems. The company pulled the drug off the market in Germany and France that same year at the request of those countries' regulators.
Takeda officials said in an e-mailed statement that the study FDA officials reviewed about Actos's risk is continuing and results are scheduled to be available next year. They said other information generated by the study showed that over time, patients' risks of developing bladder cancer from the medicine decreased.
Lawyers for former Actos users contend in court filings that Takeda researchers ignored or downplayed concerns about the drug's cancer-causing potential before it went on the U.S. market in 1999 and misled U.S. regulators about the medicine's risks.
Helen Ge, a former Takeda medical reviewer, accused the company in a whistleblower lawsuit of failing to forward reports of congestive heart-failure cases associated with Actos to the FDA. She said Takeda's actions led to the filing of false reimbursement claims for the drug.
The company failed to classify "non-hospitalized or non- fatal" congestive heart failure cases as serious from late 2007 to January 2010, Ge said in the complaint, filed in federal court in Boston. Takeda, like other drugmakers, is required to update the FDA on side-effect reports.
"These events were not properly identified or reported in the FDA's safety database," Ge said in the suit. "Takeda's motivation to fraudulently report and under-report the serious adverse events was driven by an economic desire to falsely enhance Actos's safety profile and to increase sales."
U.S. District Judge F. Dennis Saylor in Massachusetts dismissed Ge's whistleblower suit in November, finding she couldn't meet the requirements for a valid false-claims suit based on her evidence that Takeda failed to hand over side- effect reports to regulators.
Cooper contends that Takeda researchers knew about Actos's links to bladder cancer before the company won approval for its use in the U.S. in 1999.
To protect the drug's profits, Takeda executives resisted the FDA's requests that the drugmaker add bladder-cancer warnings to Actos's label for years, the Cooper claims in court filings.
"Takeda clearly knew of greater risks than were included in the product labeling for Actos, but chose not to warn physicians, including Jack Cooper's prescribing physicians," according to the Jan. 25 filing.
Takeda countered that their communications with the FDA about Actos's warning label were handled properly and the plaintiffs can't prove the drug caused cancer.
The plaintiffs have "no admissible evidence that Actos was the cause of Cooper's bladder cancer," the company's lawyers said in a Jan. 18 filing seeking to have the case thrown out. The judge hadn't ruled on that request as of Feb. 14.
The company may argue that Cooper developed bladder cancer as a result of factors other taking Actos. The disease is the fourth most-common cancer among men after prostate lung and colon cancer, according to the Bladder Cancer Advocacy Network.
Plaintiffs' lawyers said thousands of ex-Actos users joined Cooper in suing Takeda over the drug given its rise in popularity after GlaxoSmithKline Plc's Avandia diabetes drug was found to pose an increased heart-attack risk.
Glaxo officials pulled Avandia from European markets and curtailed sales in the U.S. in 2007 after studies found the drug posed greater risk of heart attacks and strokes than Actos.
The London-based drugmaker has paid more than $8 billion in settlements and legal costs tied to Avandia and other medicines. In the wake of Avandia's problems, Actos's sales rose to almost $5 billion in 2010 from about $3 billion in 2006.