Bellwether Actos Bladder Cancer Lawsuit Long on Complexity

Lafayette, LAAn Actos bladder cancer lawsuit underway in Louisiana appears to be taking various detours around the primary allegation that pioglitazone (Actos) causes bladder cancer. To that end, the plaintiffs allege that a former marketing executive with the co-accused, Eli Lilly (Lilly), committed perjury in association with previous testimony concerning another drug within the context of a different lawsuit.

However, it all makes sense to Terrence and Susan Allen, who are the plaintiffs in the Actos bellwether trial currently underway in Louisiana Western District Court. Presiding Judge Rebecca F. Doherty is tasked with stickhandling through a myriad of complex evidence and accusations, while attempting to keep all the players on task.

According to court documents, the Allens are suing both Takeda Pharmaceuticals Co. Inc. and Eli Lilly. While Takeda, the Japanese pharma giant, serves as the current manufacturer and marketer of record for Actos, the Allen Actos lawsuit holds that Takeda and Eli Lilly co-marketed Actos from 1999 through 2006.

The Allens are claiming that Actos carries a risk for bladder cancer, one of the more serious Actos side effects associated with the drug designed to help patients manage their Type 2 diabetes. The risk is sufficient to prompt an FDA warning about the potentiality for Actos bladder cancer, amongst other side effects. The US Food and Drug Administration, the government agency tasked with overseeing and regulating the nation’s pharmaceutical drug supply, has chosen to leave Actos on the market, as, in its view, the benefits of Actos outweigh the risks for the constituency of patients for whom Actos was designed.

Drug regulators in Germany and France, however, pulled Actos from their respective markets altogether.

According to observers conversant with the Actos lawsuit, the plaintiffs sought a judgment against defendant Eli Lilly related to testimony given by a former Lilly executive at a 2012 state proceeding.

Perjury or misrepresentation?

Related to the aforementioned proceeding is testimony given by a former senior director for global marketing at Eli Lilly. According to the plaintiffs in their petition for judgment against Eli Lilly, during the Actos bladder cancer lawsuit proceedings, former marketing executive Ronald Hoven “expressed a stunning lack of knowledge” surrounding the marketing of Actos [at the time Lilly was involved with Takeda in marketing efforts].

However, according to the plaintiff petition, Hoven is said to have stated in the 2012 proceedings that he was, indeed, “readily familiar” with Lilly’s research and marketing of the drug, according to the plaintiff petition.

The Actos and bladder cancer lawsuit brought by the Allens was filed in 2012. The allegedly conflicting testimony of the former Lilly marketing man was given while Hoven remained employed at Eli Lilly in 2012.

The plaintiffs hoped to make a case that the former executive perjured himself, based upon testimony given by Hoven in 2012 that he was “readily familiar with the research, development, manufacturing, marketing and sales operation” of Actos in the US. In contrast, during the current trial, Hoven testified that his familiarity with Actos was only general in nature. “Familiar with the fact that those are activities that occur within a very big company does not mean that I am involved in every single aspect of the company,” Hoven said. “That’s - I’m familiar with the fact that we made - we manufacture and sell medications.”

Eli Lilly responded that in its view the comments of its former marketing executive had been misrepresented in the earlier proceeding.

Thus far, in excess of 6,000 lawsuits have been brought against Takeda with regard to Actos pioglitazone in multidistrict litigation (In re: Actos (Pioglitazone) Products Liability Litigation, Case No. 6:11-md-02299, in the US District Court for the Western District of Louisiana).

The specific Actos bladder cancer lawsuit is Allen et al. v. Takeda Pharmaceutical Co. Ltd. et al., Case No. 6:12-cv-00064, US District Court for the Western District of Louisiana.

Once a savior, now a villain

For the longest time, Actos was the Number Two medication, behind market leader Avandia [GlaxoSmithKline] for the treatment and management for Type 2 diabetes. When Avandia’s fortunes took a major downward turn when it was revealed, in 2008, that Avandia carried a serious risk for cardiovascular issues, doctors switched their Type 2 diabetes patients to Actos in droves. While Actos heart failure is also part of the Actos basket of side effects, it is generally held that cardiovascular risks inherent with Actos are less severe than those associated with Avandia. At the time, there was no mention of Actos bladder cancer.

It is alleged in many an Actos bladder cancer lawsuit that Takeda knew about the risks associated with bladder cancer and pioglitazone, but failed to inform consumers and health care professionals. In January, before the current Actos bladder cancer trial got underway, Judge Doherty discovered that Takeda had breached a duty to preserve evidence. To that end, it was determined that e-mails and other electronic documents and data related to Actos were destroyed across much of a 10-year period beginning in 2002, in spite of a litigation hold on documents and data related to Actos beginning in 2002.