Third Actos Bladder Cancer Bellwether Lawsuit Concludes

Las Vegas, NVA third Actos bladder cancer bellwether lawsuit just recently concluded in Nevada was a victory for Actos manufacturer Takeda Pharmaceutical America Inc. (Takeda) after a jury cleared Takeda of any liability with regard to the plaintiff’s bladder cancer. However, as was the case with two previous Actos lawsuits, there were extenuating circumstances that served to cloud the issue. With no fewer than 2,750 lawsuits in the Actos multidistrict litigation (In re: Actos Product Liability Litigation, MDL No. 2299), the previous three bellwether cases serve to remind the Actos bladder cancer lawyer that there are a few curves in the road.

In the case just concluded in mid-December, the jury heard that plaintiff Allen Alsabagh developed terminal bladder cancer after taking name brand Actos to treat his Type 2 diabetes. Alsabagh was also a smoker, and a previous Actos lawsuit originally finding for the plaintiff proved to be a defeat in the end after the jury - finding that Actos did indeed lead to the plaintiff’s bladder cancer - also found that the plaintiff’s smoking was a contributing factor, thus vacating the award.

However, what appeared to complicate this most recent Actos bladder cancer lawsuit was the fact that plaintiff Alsabagh also purchased generic versions of Actos from online pharmacies located outside of the US. The US Food and Drug Administration (FDA) approved a generic version of Actos in 2012, but this was after Alsabagh was diagnosed with Actos bladder cancer.

Were this not the case, might the Actos bladder cancer lawsuit have concluded differently?

During closing arguments in the case, which concluded December 16, attorneys representing defendant Takeda noted that drugs ordered from online pharmacies introduce various unknown factors, such as handling and warehousing. Jurors heard also that such medications coming into the US are often seized by customs officials.

To that end, Takeda challenged, based on the plaintiff’s use of online pharmacies, the capacity to conclusively prove that Takeda actually manufactured the Actos that plaintiff Alsabagh used, as opposed to a generic or a series of generics that, prior to 2012, had not been approved by the FDA.

It should be noted that drugs and medications obtained from online pharmacies are often less expensive than purchasing them from traditional, mainstream sources. Patients without adequate health insurance or pharmaceutical benefits will often go that route in an attempt to make their medication acquisitions more affordable.

It was also noted that the plaintiff’s medical records were incomplete, given that the plaintiff immigrated to the US from Lebanon in 1988. The jury heard from Takeda that bladder cancer has a long latency period - upwards of 15 years - but that, due to incomplete medical records, the plaintiff, in Takeda’s view, could not conclusively prove that Actos caused his Actos bladder cancer, given that he could not rule out anything that might have contributed to the emergence of bladder cancer prior to starting on Actos.

Thus, the link between Actos and bladder cancer, in this case, could not be definitively confirmed, according to Takeda.

Alsabagh’s attorneys reminded the jury in closing arguments that Actos had been banned in France and Germany following studies that linked Actos and bladder cancer, and that the FDA had mandated a label change for Actos to highlight the risk for Actos bladder cancer - a label change that occurred a year after Alsabagh’s diagnosis of terminal bladder cancer.

Attorneys arguing for the plaintiff also accused Takeda of deliberately ignoring evidence of a link between Actos and bladder cancer in order to maintain revenues generated by a popular drug.

It should be noted that Actos, a competitor to GlaxoSmithKline’s Avandia, benefited from previous concern that Avandia contributed a high risk for heart attack and other cardiovascular issues. Doctors, while noting that Actos heart failure was also a risk, viewed the Actos risk as less significant than that of Avandia - at the time the most popular Type 2 diabetes drug on the market - and switched their patients to Actos in droves. Takeda’s market share soared.

After deliberating less than a day, the Nevada jury found in favor of Takeda and ruled that Actos could not be proven as causing Actos bladder cancer in plaintiff Alsabagh.

The first federal trial involving Actos litigation is slated to begin in January in Louisiana, the home of well over 1,000 individual cases consolidated before US District Court Judge Rebecca F. Doherty in US District Court, Western District of Louisiana. The previous two bellwether cases saw verdicts favoring the plaintiffs, with jury awards of $6.5 million and $1.7 million respectively. However, in both cases, the verdicts were subsequently vacated by the trial judge.

This most recent Actos bladder cancer lawsuit was Allen K. Alsabagh v. Takeda Pharmaceutical America Inc., et al., case number A-12-655741-C, Clark County District Court, Nevada, the Hon. Susan Johnson presiding. The next status conference for the Actos MDL is slated for January 23, 2014.