A Louisiana federal judge last month upheld an Actos bladder cancer verdict that resulted in $3 billion in punitive damages assessed to pharmaceutical giant Eli Lilly & Co.

This landmark Actos personal injury lawsuit demonstrated that both companies involved in co-promotion can be held responsible if they fail to warn of all possible drug risks, even if one of the co-promoters is not responsible for the re-labeling of the product.

This Actos bladder cancer lawsuit was the first of several bellwether trials approved earlier this year to help focus the direction of  thousands of Actos bladder cancer personal injury lawsuits consolidated in the Actos bladder cancer multidistrict litigation. The various lawsuits brought against drug manufacturer Takeda Pharmaceutical Co. and its partner in marketing, Eli Lilly, allege that both companies knew about serious side effects, like bladder cancer, associated with use of the diabetes drug and yet neglected to inform their Actos consumers about this risk.

In the bellwether trial with lead plaintiffs Terrence and Susan Allen, the jury handed down a verdict of $3 billion and $6 billion in punitive damages to Eli Lilly and Takeda, respectively. While Eli Lilly only marketed the product and did not design or manufacture Actos, the court still found that Eli Lilly’s alleged knowledge of the bladder cancer side effects while marketing the diabetes drug made the company liable.

During the trial, Eli Lilly argued that its role in Actos was limited only to marketing and sales of the diabetes product and that according to the U.S. Supreme Court’s ruling in Pliva Inc. v. Mensing were not liable for a mass tort claim.

However, Judge Rebecca Doherty disagreed. In her ruling, she said: “Defendants seek to use [Pliva] for the proposition that Lilly was forbidden from issuing any warning whatsoever about bladder cancer as if it were a generic drug company, when it is not. This is a misreading about the applicability of Pliva, generally.” Therefore the jury’s verdict and damages awards against Actos’ drug marketer were upheld.

The Actos Bladder Cancer MDL is In re: Actos (Pioglitazone) Products Liability Litigation, MDL No. 2299, in the U.S. District Court for the Western District of Louisiana.

Background on Actos

Actos is a type-2 diabetes medication designed and manufactured by Takeda and marketed by Eli Lilly. Since the late 1990s, Takeda has actively and aggressively promoted Actos through North America and with the help of Eli Lilly. Over the last 20 years, Takeda and Lilly have gained billions of dollars in annual revenue from Actos consumers.

During the ongoing Actos bladder cancer MDL court proceedings, it was discovered that Takeda and Lilly knew about the possibility of bladder cancer from taking the diabetic product since 2001, but failed to warn their consumers.

Aside from the increased risk of bladder cancer, many Actos consumers have reported additional side effects from short and long term use of the diabetic medications. These Actos side effects include:

• Chronic kidney disease
• Congestive heart failure
• Liver failure
• Lactic acidosis
• Bone fracture
• Rapid and excessive weight gain
• Difficulty breathing
• Edema (or fluid retention)