Judge Keeps Hammering Takeda in Actos Bladder Cancer Lawsuit

Shreveport, LAMonths after an Actos lawsuit ended in favor of the plaintiffs in a trial that included allegations of document destruction on the part of Takeda Pharmaceuticals, the federal judge presiding over the case has again addressed the underlying issue of evidence destruction in Allen et al. v. Takeda Pharmaceutical Co. Ltd. et al.

“There is no dispute in this case as to the intentional nature of the defendants’ document destruction,” said US District Judge Rebecca Doherty, in her June 20th ruling. “The absence of those files can be reasonably assumed to have prejudiced Mr. and Mrs. Allen from presenting a full and complete picture of Takeda’s actions and will prejudice the [plaintiffs steering committee] within this MDL, as those documents are forever lost and the electronically generated or stored information was deleted and cannot be fully reconstituted.”

The Actos bladder cancer lawsuit, brought by plaintiffs Terrence and Susan Allen, was a bellwether case that found in favor of the plaintiffs in April. Takeda Pharmaceuticals was hit with $6 billion in punitive damages while former marketing partner Eli Lilly & Co. was saddled with a $3 billion punitive bill. Lilly was said to be negotiating with Takeda over that charge due to a prior contractual agreement which Lilly claimed indemnified Eli Lilly & Co. from liability.

It was also reported that $1.5 million in actual damages awarded to Allen over his Actos bladder cancer, would be shared between Takeda and Lilly.

The Actos lawsuit, which was closely tracked by pundits, featured allegations of failure to preserve evidence, and alleged demonstrations of improper conduct on the part of attorneys for the defense, given their alleged articulations of subject matter deemed off limits by the judge in her pre-trial orders. In her June 20th ruling, Judge Doherty announced she would defer the subject of attorney misconduct to a later date. Judge Doherty also deferred a default judgment against Takeda, a ruling sought by the steering committee for the plaintiff.

However, Judge Doherty ordered Takeda to keep moving forward with the reconstruction of deleted files. Takeda, for its part, denied any malicious intent over the destruction of documents. “Takeda denies that any documents were destroyed with the intent of prohibiting their use in litigation,” Takeda said in a statement issued in concert with Judge Doherty’s ruling on June 20. “We also respectfully disagree with the jury instruction given during the Allen trial that Takeda had a duty to preserve Actos documents for use in bladder cancer cases beginning nine years before the first bladder cancer lawsuit was filed.”

The knight in shining armor has a dark side…

When Actos was seen as the beneficiary to the falling fortunes of Avandia several years ago due to health concerns, the Actos side effects such as Actos heart failure were deemed an acceptable risk for patients suffering from Type 2 diabetes. The potential for Actos congestive heart failure and other cardiovascular events, a risk with Actos, was deemed to be a lower risk than that of Avandia at the time.

There was no mention of any association between Actos and bladder cancer.

Allen’s Actos lawsuit accused Takeda of knowing the potential for Actos bladder cancer even before pioglitazone (Actos) was approved by the US Food and Drug Administration (FDA). Further, there were allegations that Takeda knew about Actos bladder cancer before the application for FDA approval was even submitted. The lawsuit went on to claim that clinical trials in the early 2000s revealed that pioglitazone could induce bladder cancer in humans.

The Actos lawsuit alleged that Takeda withheld that important information from consumers.

Allen, in his Actos bladder cancer lawsuit, alleged that he was not made aware of the potential for Actos and bladder cancer prior to his ongoing use of Actos to help rein in his Type 2 diabetes. He has since been made to deal with pain and emotional anguish over the possibility and potential of future cancers, together with the need for lifelong medical treatment.

In his Actos lawsuit, Allen said that Actos bladder cancer ruined his life.

Actos side effects can include Actos macular edema, which is an Actos vision problem. The liver can also be affected, with many lawsuits alleging Actos liver issues.

More than 6,000 lawsuits have been filed and consolidated in multidistrict litigation.

The cases are Allen et al. v. Takeda Pharmaceutical Co. Ltd. et al., Case No. 6:12-cv-00064 in the US District Court for the Western District of Louisiana. MDL is In re: Actos (Pioglitazone) Products Liability Litigation, Case No 6:11-md-02299, US District Court for the Western District of Louisiana.