Amidst recent U.S. Food and Drug Administration (FDA) warnings regarding flesh-eating infections due to Invokana and similar diabetes drugs, a product liability lawsuit has been filed on September 6, by a Connecticut man who had to undergo a partial scrotum amputation, as he developed Fournier’s gangrene after taking Invokamet.
The lawsuit, filed by plaintiff Lee Letourneau in the U.S. District Court for the District of New Jersey, states that Letourneau was under the diabetes medication since February 2017 and experienced flesh-eating infection as a severe side-effect, which prompted him to undergo surgical removal of 60% of his scrotum. Until FDA's warning issued last month, Letourneau indicates he was unaware of the drug's gangrene effect and blames Johnson & Johnson and its Janssen Pharmaceuticals subsidiary for failing to warn about the potential hazards of taking Invokamet. Invokamet combines Invokana with the older diabetes drug metformin. The FDA found that though diabetes can increase the risk of the infections, the side-effects are still rare among patients not under Invokana & similar drug's treatment. The regulators have ordered for a new warning label for several drugs belonging to the SGLT-2 class which includes Invokamet also.
Lawsuits filed in several state courts allege Invokana use has led to amputations of legs, feet and toes, Diabetic ketoacidosis, Kidney failure, Cardiac arrest, and Urinary tract infections. As of August 2018, the multidistrict litigation (MDL No. 2750; In Re: Invokana (Canagliflozin) Products Liability Litigation) holds more than 1,036 cases over Invokana complications, which are centralized before Honorable Brian R. Martinotti in District of New Jersey for coordinated pretrial proceedings.