Invokana medication manufacturers face three new legal actions over allegations that they failed to warn the users of the severe risk for lower extremity amputations.

The new Invokana medication lawsuits take aim against Johnson & Johnson for their failure to warn users of severe complications associated with the type-2 diabetes medication. The Invokana medication lawsuit alleges that the medicine put them at risk for amputations as a result of taking Invokana.

The individuals filing the Invokana medication lawsuits include Kimberly J. of Ashcamp, Ky., Steven L. of Pleasant Prairie, Wis., and Ronnie M. of Savannah, Ga.

According to her Invokana medication lawsuit, Kimberly “was prescribed and supplied with, received and has taken the prescription drug Invokana. This action seeks, among other relief, general and special damages and equitable relief due to plaintiff suffering severe and life-threatening injury, amputation of her left leg.”

The Invokana medication lawsuits raise similar claims for the other plaintiffs, with Steven losing his left foot and Ronnie losing a right toe after taking the diabetes drug.

In annual sales, Invokana accounts for more than $1 billion in revenue. It is an important medicine among patients with type-2 diabetes, along with exercise and diet control, to lower blood sugar levels. Invokana is a part of a class of medications known as sodium-glucose co transporter 2 (SGLT2) inhibitors. Among the class of medication, Invokana has the highest selectivity in the U.S. Currently, the medication is only approved for treatment and glycemic control of individuals with type-2 diabetes.

“Final results from two clinical trials- the CANVAS (Canagliflozin Cardiovascular Assessment Study) and CANVAS-R (A Study of the Effects of Canagliflozin on Rendal Endpoints in Adult Participants With Type 2 Diabetes Mellitus) – showed that leg and foot amputations occurred about twice as often in patients treated with canagliflozin compared to patients treated with placebo, which is an inactive treatment,” alleges the Invokana medication lawsuit.

The lawsuits allege that the manufacturers failed to notify users of Invokana that the medication could lead to risk of amputation. Instead, say the plaintiffs, manufacturers continued to defend Invokana, minimize unfavorable results of Invokana, and mislead the public and physicians of its side effects.

“Defendants failed to adequately warn consumers and physicians about the risks associated with Invokana and the monitoring required to ensure their patients’ safety,” contends the complaint. “Despite defendants’ knowledge of the increased risk of amputation among Invokana users, defendants did not conduct the necessary additional studies to properly evaluate this risk prior to marketing the drug to the general public.”