Thursday, January 30, 2014

Takeda - Jury Can Hear Claims Over Destroyed Actos Files

Takeda Pharmaceutical Co. (4502) must let a jury hear claims that it intentionally destroyed files related its Actos diabetes drug, a judge ruled before the first federal trial over allegations the pills cause bladder cancer.

Officials of Osaka, Japan-based Takeda admitted they can’t find files compiled by 46 current and former employees involved with the development, marketing and sale of Actos, including those of two directors, U.S. District Judge Rebecca Doherty said. Some files were deleted from company computers after executives warned employees to retain Actos-related material, the judge said.

“The breadth of Takeda leadership whose files have been lost, deleted or destroyed is, in and of itself, disturbing,” Doherty wrote in a Jan. 27 filing.

Takeda, Asia’s largest drugmaker, is preparing for the federal-court trial in Lafayette,Louisiana, about a month after it scrapped development of another diabetes drug when research linked it to liver damage.

To punish the company, the judge will let lawyers for an ex-Actos user suing Takeda over his bladder cancer tell jurors about the document destruction at his trial next month. Mark Lanier, a lawyer for plaintiff Terrence Allen in the Lafayette trial, declined to comment on Doherty’s ruling.

Downplayed Concerns

Former Actos users contend 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 its risks.

“We will address and comment on this issue in the trial, but we believe it would be inappropriate to comment outside of that forum at this time,” Kenneth Greisman, general counsel of Takeda Pharmaceuticals U.S.A., said in an e-mailed statement.

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. The company now faces generic competition from Ranbaxy Laboratories Ltd. (RBXY)

The consolidated Actos cases in Louisiana are In Re Actos (Pioglitazone) Products Liability Litigation, 11-md-02299, U.S. District Court, Western District of Louisiana (Lafayette). Allen’s case is Allen v. Takeda Pharmaceuticals North America Inc., 12-cv-00064, U.S. District Court, Western District of Louisiana (Lafayette).

To contact the reporter on this story: Jef Feeley in Wilmington, Delaware,

To contact the editor responsible for this story: Michael Hytha

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