While the number of Actos side effects lawsuits continues to climb and number in the thousands, the company noted a concern over the loss of Actos exclusivity, now that generics have found their way into the market.
Takeda spent some time talking about the outcomes of recent lawsuits against the backdrop of a business context, although the company did note that out of five Actos bellwether trials, Takeda has won four of them. The May 2014 case Whitlatch v. Takeda, representing the death of William Whitlatch from bladder cancer alleged to have been caused by pioglitazone (Actos), went to Takeda - as did three others.
The Actos side effects case that did not go to Takeda resulted in a jury award of $1.476 million to the plaintiff, together with $6 billion in punitive damages assessed to Takeda, and $3 billion to Eli Lilly, Takeda’s former marketing partner.
Takeda, in its Q3 forecast, noted to shareholders that it is “challenging the outcome of this case.”
Later in the Q3 report, filed with the US Securities & Exchange Commission (SEC), Takeda referenced the punitive damages assessed to itself and Eli Lilly following a successful jury outcome for plaintiff Terrence Allen, “who alleged that Takeda was aware of the link between the medicine and bladder cancer, and had withheld this information from consumers and the healthcare industry,” Takeda noted.
While the jury sided with the plaintiff and awarded punitive damages based on the allegation(s) by the plaintiff, Takeda is appealing - thus, the allegations of withholding information from consumers and doctors remain allegations until the appeals process has been exhausted. However, judges have previously censured Takeda for failing to ensure that important documents integral to court actions were preserved.
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Meanwhile, Eli Lilly in its Form 10-Q report filed with the SEC at the end of April noted that Lily is named with Takeda as a defendant in four Actos bladder cancer class-action lawsuits in Canada: two in Ontario (Casseres et al. v. Takeda Pharmaceutical North America, Inc., et al. and Carrier et al. v. Eli Lilly et al.), one in Quebec (Whyte et al. v. Eli Lilly et al.), and one in Alberta (Epp v. Takeda Canada et al.).
“We believe these lawsuits are without merit, and we and Takeda are prepared to defend against them vigorously,” the company said of the Actos and bladder cancer lawsuits.