A Vermont man has filed a product liability lawsuit over a Fournier’s gangrene infection from Farxiga, indicating that makers of the diabetes drug failed to warn users about the risk of developing the painful and debilitating flesh-eating groin infection, which resulted in an extensive hospital stay and left him with permanent injuries.
David McDonald filed the complaint (PDF) in Delaware Superior Court on February 15, naming AstraZeneca and Bristol-Myers Squibb Co. as the defendants.
According to the lawsuit, McDonald was prescribed Farxiga in September 2018, for treatment of his type 2 diabetes and to aid in weight loss. However, in July 2019 he was developed a with Fournier’s gangrene infection, which attacked his genitals and led to the need for emergency debridement surgery and other procedures.
“After beginning treatment with Farxiga, and as a direct and proximate result thereof, Plaintiff required extensive medical treatment and suffered debilitating injuries, including, but not limited to, destruction of critical tissue and bodily structures, necrotizing fasciitis of the genital/perianal/gluteal regions and other injuries the full extent of which are not yet realized,” the lawsuit states. “These debilitating injuries required invasive procedures, surgical procedures and extensive hospitalization.”
McDonald was hospitalized for 25 days, after which he had to undergo a prolonged stay in a rehabilitation facility, according to the lawsuit, which indicates the groin infection was a direct result of Farxiga side effects, which were not adequately disclosed to users and the medical community.
Farxiga is part of a new generation of diabetes treatments from a class of medications known as sodium-glucose cotransporter-2 (SGLT2) inhibitors, which also includes Jardiance, Invokana, Invokamet, Xigduo XR and others.
In August 2018, the FDA required the makers of Farxiga and other SGLT2 inhibitors to add new warnings about the risk of flesh-eating groin infections from the diabetes drugs, after an analysis identified at least 12 cases for Fournier’s gangrene among users. The infections typically began within a few months after starting the treatment, and all 12 patients required hospitalization and surgical treatment, with at least one death.
McDonald’s lawsuit indicates the manufacturers released “inaccurate, false and misleading” information about the safety of the diabetes drug before the FDA warnings,
His claim joins a growing number of similar Farxiga lawsuits over Fournier’s gangrene infections filed in recent months by former users of the diabetes drug, each raising similar allegations that the severe groin infections may have been avoided, or been less severe, if users and the medical community had been warned earlier about the potential risks.