First Federal Actos Bladder Cancer Bellwether Trial Underway

Lafayette, LAThe latest Actos bladder cancer bellwether case commenced January 27, in US District Court, Western District of Louisiana with the process of jury selection, or so it was expected by pundits and experts conversant with the case. Opening statements are likely to begin next week before US District Judge Rebecca Doherty, with trial expected to last about six weeks.

The case is Terrence Allen et ux. v. Takeda Pharmaceuticals North America Inc. et al (Civil No. 12-0064) and is part of the group of consolidated cases known as In re: Actos (Pioglitazone) products Liability Litigation (MDL No. 2299). The latest tally stands at about 2,800 cases in the MDL pipeline, consolidated and pending in the US District Court, Western District of Illinois. There are more than 3,000 cases in total peppered across the country.

According to the complaint, plaintiff Terrence Allen was prescribed Actos and used the product for about seven years, from 2004 until 2011, when Allen was diagnosed with bladder cancer. One of the Actos side effects that has been emerging with increasing frequency is Actos bladder cancer.

In his Actos lawsuit, Allen maintains that had he and his doctor known about the potential for Actos and bladder cancer, he would have pursued a different treatment option. The plaintiffs allege that Takeda was aware of the link between Actos and bladder cancer early in the decade, but chose to withhold the information from consumers and the healthcare industry.

Earlier in January, Judge Doherty issued an Order denying Takeda’s motion for Partial Summary Judgment, finding that the defense had failed to provide sufficient evidence to support their preemption defense to the Plaintiff’s failure-to-warn claims.

Previous bellwether cases have found for the plaintiffs, but were vacated due to various legal technicalities - thus all eyes will be on this trial, plus one other that was originally scheduled to start April 14. However, a recent judicial order with regard to John Chiody et ux. v. Takeda Pharmaceuticals North America Inc. et al (Civil No. 12-2319) has the case in a state of continuance until further notice, with all previous deadlines for the case suspended for the time being.

Meanwhile, Takeda announced in December that it is abandoning development of a new drug that was intended to replace Actos, given that patent protection for Actos expired in 2012. Up to that time, Actos was by far the biggest moneymaker for Takeda until generics began taking a bite out of the Asian manufacturer’s market share.

It was on Boxing day, December 26, that Takeda quietly let it be known that it had terminated development of fasiglifam over concerns with liver safety. According to Bloomberg News (12/27/13), Takeda had previously presented various findings to the Japan Diabetes Society. However, Bloomberg reported that following a consultation with three independent panels with regard to TAK-875, it was determined that the benefits of fasiglifam failed to outweigh the risks.

“The company has reached the conclusion that, on balance, the benefits of treating patients with fasiglifam do not outweigh the potential risks,” Takeda said, referring to TAK-875 by its generic name in a statement published by Bloomberg. “Takeda is working with trial investigators and local regulatory authorities to ensure that patients who participated in the fasiglifam trials are transitioned to appropriate therapies.”

Bladder cancer is not the only concern over Actos. Actos heart failure is also a concern for those patients prone to heart disease, although the heart risk is said to be less than that of rival Type 2 diabetes drug Avandia, manufactured by GlaxoSmithKline. The US Food and Drug Administration (FDA) placed severe restrictions on Avandia about three years ago in response to serious concerns about the safety of the drug. Those restrictions were only recently relaxed.

Takeda continues to actively search for a successor to Actos. In the meantime, the Allen Actos bladder cancer lawsuit continues...