A plaintiff recently filed a products liability lawsuit against the manufacturers of Invokana, alleging he suffered adverse effects and complications due to ingesting the medication.

The plaintiff, Robert M.,  filed the Invokana problems lawsuit against Janssen Pharmaceuticals, Inc., and Johnson & Johnson Co. after having to undergo a foot amputation due to diabetes. The Invokana problems lawsuit alleges that the plaintiff, Robert, may “have suffered and may continue to suffer severe and permanent personal injuries, including amputation, diabetic ketoacidosis, acute kidney failure, stroke, and heart attack”.

Robert filed the following counts against the defendants: 1) Product Liability Act- Manufacturing Defect; 2) Product Liability Act- Defective Design; 3) Product Liability Act- Failure to Warn; 4) Breach of Express Warranty; 5) Breach of Warranty of Fitness for Ordinary Use; 6) Negligence; 7) Breach of Implied Warranty; 8) Fraudulent Misrepresentation; 9) Negligent Misrepresentation; 10) Fraudulent Concealment; 11) Fraud; and 12) Punitive Damages Allegations.

Invokana Problems

The U.S. Food and Drug Administration (FDA) warns that taking type-2 diabetes medication may increase the risks of suffering from a foot amputation due to diabetes, general lower limb amputation, and diabetic ketoacidosis. The specific class of medications the FDA is warning about are a class of drugs known as sodium-glucose cotransporter-2 (SGLT2) inhibitors. This class of SGLT-2 inhibitor includes Invokana (canaglioflozin), Invokamet (canagliflozin metformin), and Invokamet XR (canagliflozin and metformin hydrochloride extended-release).

Clinical studies have also illustrated that those taking a SGLT-2 Inhibitor medication are twice as likely to undergo lower limb amputations or suffer from a foot amputation due to diabetes. One such clinical study was conducted by comparing patients who took SGLT-2 inhibitors to those taking a placebo. Lower limb amputation due to diabetes includes amputations of the knee, foot, leg, or toe.

Loss and amputation of the toe and middle portion of the foot were the most common areas of amputation reported. In addition to a foot amputation due to diabetes, diabetic amputations from the leg, both above and below the knee, and at times amputations involving both limbs have also been reported. The likelihood of needing a foot amputation due to diabetes increases for people who suffer from vascular disease, nerve damage, also known as neuropathy, or foot sores, also known as diabetic foot ulcers.

In May 2017, the FDA announced that “based on new data from two large clinical trials, the U.S. Food and Drug Administration (FDA) has concluded that the type 2 diabetes medicine canagliflozin (Invokana, Invokamet, Invokamet XR) causes an increased risk of leg and foot amputations. We are requiring new warnings, including our most prominent Boxed Warning, to be added to the canagliflozin drug labels to describe this risk.”

The Invokana Problems Lawsuit is Case No. 3:17-cv-07500-BRM-LHG, in the U.S. District Court for the District of New Jersey. The Invokana MDL is In re: Invokana (Canagliflozin) Products Liability Litigation, MDL NO 2750., in the U.S. District Court, District of New Jersey.