Takeda Pharmaceutical Co. executives hid the risks of its Actos diabetes drug and should be held liable for a former shopkeeper’s cancer, a lawyer said at the start of the first federal trial over the medication.
Officials of Osaka, Japan-based Takeda failed until 2011 to provide any warning that research showed Actos was linked to bladder cancer, duping patients such as Terrence Allen into thinking the drug was safe, Mark Lanier, Allen’s lawyer, told a jury in Lafayette, Louisiana, during opening statements today.
“You’ll hear testimony from Terry’s doctors that if they’d been told the truth about this drug, they would not have given it” to him, Lanier told the seven-woman, two-man jury. Allen, a retired hardware-store manager, is seeking at least $15 million in damages from Takeda.
Takeda, Asia’s largest drugmaker, faces the claims over Actos about a month after it scrapped development of another diabetes drug when research linked it to liver damage. The Louisiana jury is the fourth panel to weigh allegations that Takeda executives sold Actos knowing it could cause cancer and failed to properly warn doctors and consumers about the medication’s risks.
Last year, state juries in California and Maryland ordered Takeda to pay a total $8.2 million in damages to former Actos users who sued over the drug. Judges in both states threw out the verdicts. Last month, jurors in state court in Las Vegas rejected claims the company failed to properly warn consumers about the health risks of Actos.
Takeda argues that Allen’s bladder cancer wasn’t caused by his Actos use and that it properly warned of the drug’s risks. Researchers haven’t conclusively linked Actos to bladder cancer, Bruce Parker, a company lawyer, said in his opening statement.
“There is no evidence from these studies that there is any connection or causal relationship between Actos and bladder cancer,” Parker said.
Sales of Actos peaked in the year ended March 2011 at $4.5 billion and accounted for 27 percent of Takeda’s revenue at the time, according to data compiled by Bloomberg. Actos has generated more than $16 billion in sales since its 1999 release, according to court filings. Takeda now faces generic competition from Ranbaxy Laboratories Ltd.
More than 2,700 suits have been consolidated before U.S. District Judge Rebecca Doherty for pretrial information exchanges, according to court dockets. Doherty is presiding over Allen’s trial.
Lanier said he will present evidence that Allen, of Attica, New York, developed bladder cancer after taking Actos for more than five years starting in 2006, according to court filings.
Allen argues in court filings that Takeda researchers ignored or downplayed concerns about the drug’s cancer-causing potential before it went on sale in the U.S. and misled regulators about risks to protect billions of dollars in sales.
In his opening, Lanier said the U.S. was a “multi-billion-dollar market” for diabetes drugs such as Actos and that the drug was one of Takeda’s main revenue sources when Allen started taking it.
Parker countered that the company shouldn’t be held liable for Allen’s cancer since medical records show he may have suffered from the disease before taking Actos.
Doherty ruled that jurors may hear claims that Takeda intentionally destroyed files of 46 former and current employees involved in the drug’s development, marketing and sales.
Lanier will argue that Takeda executives destroyed the files to cover up the company’s mishandling of the drug. In his opening argument, Parker said the company has all relevant material on the medication’s creation and safety.
“The whole truth is that all of the scientific and medical evidence on this drug was kept in centralized files and none of that has been lost,” Parker said.
The consolidated Actos cases in Louisiana are In Re Actos (Pioglitazone) Products Liability Litigation, 11-md-02299. Allen’s case is Allen v. Takeda Pharmaceuticals North America Inc., 12-cv-00064, both in U.S. District Court, Western District of Louisiana (Lafayette).