Articles Posted in Dangerous Drugs and Medical Devices

On April 7th, a jury in the first federal court Actos bladder cancer trial returned a verdict for almost $9.15 billion dollars against co-defendants, Takeda Pharmaceuticals USA Inc. and Eli Lilly & Co. Inc. (In Re: Actos [Pioglitazone] Products Liability Litigation, MDL Docket No. 2299, No. 6:11-md-2299, Allen v. Takeda Pharmaceuticals North America Inc., et al., No. 12-62, E.D. La.), the seventh largest verdict in U.S. history.

The plaintiffs in the case, Terrence and Susan Allen, were awarded $1,475,000 in compensatory damages (i.e., damages for medical bills, lost wages, pain and suffering, emotional distress, and/or mental anguish), and $9 billion in punitive damages.  The jury found that Takeda was 75% liable and Eli Lilly was 25% liable, and split the punitive award accordingly – $6 billion against Takeda and $3 billion against Lilly.  The plaintiffs’ case was premised on the theory that the drug manufacturers had marketed Actos knowing it could cause cancer, but failed to disclose this information to doctors and failed to warn consumers about the risks associated with taking the drug.  The plaintiffs alleged that the pharmaceutical companies failed to disclose this information in order to reap the substantial profits Actos supplied.  For example, in 2011, Actos sales revenue was $4.5 billion and accounted for nearly 27% of Takeda’s total revenue for that fiscal year.  Since its release in 1999, Actos has generated more than $16 billion in sales for Lilly and Takeda, who partnered together to produce and market the drug in the United States.

Actos was originally approved by the FDA in 1999 as an oral medication for type 2 diabetes blood sugar control.  According to the original drug applications and approval literature, it was recommended for patients who have been unsuccessful at regulating blood sugar levels through diet and exercise alone.  However, at the heart of this litigation was an FDA mandated 10-year safety study which was required at the time of approval, to assess whether Actos had any link to bladder cancer.  That study was concluded in 2011, and found that the use of the drug for more than one year continuously might be associated with an increased risk of bladder cancer.