Last month, Judge Rebecca F. Doherty of the U.S. District Court for the Western District of Louisiana ruled that Takeda destroyed evidence that would have been both relevant and beneficial to the plaintiffs’ lawsuits. In her order, Judge Doherty described how Takeda Pharmaceuticals, the maker of Actos, destroyed documents showing that another drug company refused to partner with Takeda to bring Actos to market because of concerns regarding toxicology studies and the drug’s “margin of safety.”
The breadth of Takeda leadership whose files have been lost, deleted or destroyed is, in and of itself, troubling.
According to the judge’s order, Takeda destroyed the documents in question even though in July of 2002 the drug company put in place a “litigation hold,” instructing all of the company’s employees, directors, and officers to keep any files, documents, or emails regarding Actos. Specifically, the litigation hold stated:
“Until further notice, you are instructed to preserve any and all documents and electronic data which discuss, mention, or relate to Actos. This means do not destroy, delete, throw away or otherwise discard any such documents or electronic data.”
Despite the broad and sweeping language in the litigation hold, a number of files that should have been kept by the company were deleted, destroyed, or simply thrown away, the order said.
Judge Doherty found that Takeda destroyed the files of 46 of its employees, including company presidents, key officers, and Takeda executives and employees who had critical information regarding the development and marketing of Actos.
Attorneys for Takeda attempted to argue that the company did not have a duty until 2011 to preserve documents regarding whether Actos could cause bladder cancer, because, prior to that date, the personal injury and wrongful death lawsuits filed against the company had only alleged that Actos could cause liver cancer. Judge Doherty ruled that the company’s litigation hold was broad and “sweeping in nature,” and therefore applied to any documents regarding the company’s knowledge of the risks associated with Actos, including the risk of bladder cancer.
Judge Doherty found the arguments offered by Takeda’s attorneys to be “wholly unpersuasive” and ruled that “the breadth of Takeda leadership whose files have been lost, deleted or destroyed is, in and of itself, troubling.”
Of particular concern, Takeda conceded that it destroyed the files belonging to Dr. Kiyoshi Kitazawa, a Managing Director and Board Member of the company who was intimately involved with clinical trials for Actos. Documents obtained through third-party discovery showed that Dr. Kitazawa had been working with another pharmaceutical company, Upjohn, to develop a partnership for the clinical development of Actos.
As described in the documents, in September of 1993 the president of Upjohn declined Takeda’s offer to form a partnership to market Actos because, “Upjohn’s highest scientific decision-making body, carefully reviewed the results of the toxicology and clinical studies” and determined that further clinical development of Actos could not be justified based on Upjohn’s concern with the drug’s “margin of safety.”
In response to Upjohn’s letter describing its safety concerns regarding Actos, Dr. Kitazawa requested that Upjohn “revise” its statement to instead note that Upjohn declined partnering with Takeda because of “efficacy concerns” rather than safety concerns. The documents reveal that Dr. Kitazawa asked an executive at Upjohn to revise its Actos statement to say that Actos “did not show the reduction of blood glucose enough to satisfy Upjohn’s in-house requirement.”
Attorneys representing the Actos plaintiffs argued that, “Takeda’s blatant attempt to eliminate language referencing Upjohn’s safety concerns from not only the language used, but the stated reason Upjohn expressed for withdrawing from the collaboration, is clear evidence of Takeda’s culpable intent to conceal the expressed safety concerns Upjohn associated with Actos.”
Judge Doherty ruled that Takeda breached its duty to preserve documents relevant to the Actos lawsuits and concluded her legal analysis by stating, “the fact remains this court finds itself on the eve of the first bellwether trial without persuasive, credible, and informed explanation as to why the destruction of files actually occurred.”
Takeda didn’t have much to say about the ruling. As reported by Bloomberg, an attorney for Takeda released an email statement proclaiming that the company “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.”
Actos has been a blockbuster drug for the Japanese pharmaceutical giant. Sales of the drug peaked in 2011 at $4.5 billion a year and accounted for 27 percent of the company’s total revenue. Since its release in 1999, Actos has generated more than $16 billion in total, worldwide sales. Takeda Pharmaceutical Company is the largest pharmaceutical company in Japan and Asia.
Judge Doherty reserved ruling on whether the company should be assessed financial sanctions for its destruction of evidence. The judge also deferred ruling on whether attorneys for plaintiffs will be allowed to present testimony to the jury regarding Takeda’s destruction of documents.
There are currently nearly 3,000 Actos lawsuits pending in the multidistrict litigation. If you or a loved one have suffered injuries after taking Actos, please complete our free case evaluation form to learn if you may be eligible to participate in the litigation.