ACTOS: $9 Billion Awarded in First MDL Bladder Cancer Trial against Manufacturers Takeda & Eli Lily

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.

Due to this finding, the drug’s warning label was subsequently changed nearly 12 years after it had already been on the market and had seen widespread use.  In addition to the links to bladder cancer, Actos also has other serious potential side effects, including heart failure, hypoglycemia, weight gain, and even liver toxicity.

Takeda and Lilly still face an additional 2,923 cases in the MDL pending in the Western District of Louisiana, but plan to pursue all legal avenues following the verdict, including post-trial motions and appeals, according to its senior vice president and general counsel, Kenneth D. Greisman.

The following symptoms are potentially associated with bladder cancer: bloody urine, pain with urinating, increased urge to urinate, and unusual back pain.  Complex litigation against large pharmaceutical companies demands specialized legal experience.  If you or a loved one believe you have been harmed by taking Actos, contact the firm of Hollis Wright for more information.