AstraZeneca faces a product liability lawsuit over the failure to warn about the risk of painful and debilitating groin infections from Farxiga, indicating a Missouri man would have avoided the new-generation diabetes treatment if the drug maker had disclosed the risk of Fournier’s gangrene associated with Farxiga.
The complaint (PDF) was filed by Micheal Tuschhoff and his wife, Rona, in Delaware Superior Court on March 10, alleging the rare groin infection experienced following use of Farxiga left him with a necrotic scrotal abscess and other painful injuries.
Tuschhoff was first prescribed Farxiga in 2014, which is part of a new class of diabetes treatments known as sodium-glucose cotransporter-2 (SGLT2) inhibitors. After developing an infection, he was required to undergo genital gangrene surgery in June 2017, with extensive hospitalization and wound care. He then had to be hospitalized again in September 2018, for an incision and drainage of a scrotal wall abscess.
The lawsuit alleges AstraZeneca knew or should have known about the risk of necrotizing fasciitis of the genitals which may result from Farxiga, based on basic principals of infections disease science and data available to the drug maker. However, warnings were not provided to users or the medical community at the time Tuschhoff was prescribed the medication.
“Plaintiff’s injuries were preventable and resulted directly from Defendants’ failure and refusal to conduct proper safety studies, failure to properly test Farxiga, and failure to properly assess and publicize alarming safety signals,” the lawsuit states. “Defendants actively suppressed information revealing serious and life-threatening risks with Farxiga, promoted Farxiga for weight loss, and willfully and wantonly failed to provide adequate instructions and warnings and made misrepresentations concerning the nature and safety of Farxiga. This conduct and the product defects complained of brought about and/or were substantial factors in bringing about and exacerbating Plaintiff’s injuries.”
About a year after Tuschhoff’s devastating injuries surfaced, the FDA required the makers of Farxiga and other SGLT2 inhibitors to add new warnings about the risk of flesh-eating groin infections in August 2018, after an analysis identified cases of Fournier’s gangrene among users.
Consumers were advised to seek immediate medical attention if they experienced any symptoms of tenderness, redness or swelling of the genitals, and doctors were urged to discontinue use of the drug if problems were identified and start immediate antibiotic treatments.
The case filed by Tuschhoff 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 users would have avoided the diabetes drug if earlier warnings and information had been provided about the potential risks.