By KJ McElrath  |  April 23, 2019

Category: Diabetes

The family of a man who died of a rare flesh-eating bacteria from taking Invokana says drugmaker Johnson & Johnson misled the public about dangerous side effects.

Ray Lo Re of Wayne County, New York, says his father, Giacomo, began taking the medication for the treatment of type-2 diabetes in September 2016, according to the Democrat & Chronicle. Four months later, Ray’s otherwise healthy 68-year-old father was dead from sepsis, resulting from a condition known as Fournier’s Gangrene.

Giocomo’s widow, Venera, is now pursuing a lawsuit against the New Jersey drugmaker, which the defendant has requested be joined with over 1,100 other cases in multidistrict litigation citing Invokana as a cause of action.

The Victim

Lo Re, a naturalized U.S. citizen who immigrated from Sicily in the 1960s, was a non-insulin dependent type-2 diabetic who, according to his son, was active and “took real good care of himself.”

According to the complaint, Lo Re began taking Invokana after reading Johnson & Johnson’s marketing materials, which described the medication as a “simpler alternative” to other treatments.

Plaintiffs say the drugmaker’s promotions also included glowing testimonials from patients who claimed the medication helped them to lose weight and gave them more energy. The Lo Re family’s counsel notes that Invokana is considered to be the first-line treatment, not a “last chance medication.”

Lo Re’s widow reports that he had been taking Invokana for only 4 weeks before he began experiencing symptoms that included “mild discomfort” urinating and genital skin irritation. Venera says that at that time, his physician dismissed it as a minor skin condition. He prescribed topical skin cream, then scheduled a follow-up visit 3 months later.

Venera said that by that time, however, her late husband was experiencing fever, along with diarrhea, vomiting and serious urinary pain.

On Jan. 27, Venera states, an urgent care physician prescribed a painkiller and a diuretic medication, instructing Lo Re to go to an emergency room if his symptoms failed to improve. The next day, however, Lo Re was dead. The complaint states that the cause of death was sepsis, a complication from Fournier’s Gangrene as determined by the post-mortem examination.

About Invokana

At the time Invokana was introduced, it was hailed as a “miracle drug,” that allowed excess blood sugar to be excreted through the urine. However, at a meeting with an FDA advisory committee in January 2013, in which representatives of J&J subsidiary Janssen Pharmaceuticals presented and promoted the new medication, prominent physicians raised serious concerns about safety issues related to cardiovascular health.

According to one of the doctors in attendance, Janssen’s request for FDA approval was based on only one aspect of Invokana’s efficacy, the lowering of a patient’s HbA1c levels – and there was no evidence that outcomes were any better than those of metformin, an older, established treatment.

Nonetheless, the FDA decided that the benefits outweighed the risks, and gave the drug the green light on the condition that the drugmaker conducts post-marketing studies within 4 years.

Since then, Invokana and similar medications of its class of SGLT-2 inhibitors have been linked to a variety of serious side effects, including kidney damage, ketoacidosis, and lower limb amputation. The risk of Fournier’s Gangrene was announced over a year after Giacomo Lo Re’s death – but his family and other plaintiffs in Invokana lawsuits say Janssen and J&J were aware of those risks long before that.

It should be noted that during the 5-year period following Invokana’s approval, the FDA received 12 reports of Fournier’s Gangrene attributed to SGLT-2 inhibitors – twice as many as had been received in the previous three decades.

Join a Free Diabetes Medications & Flesh-Eating Infection Lawsuit Investigation

The type-2 diabetes medications linked to the flesh-eating infection include:

  • Invokana
  • Invokamet/Invokamet XR
  • Farxiga
  • Xigduo XR
  • Qtern
  • Jardiance
  • Glyxambi
  • Synjardy/Synjardy XR
  • Steglato
  • Segluromet
  • Steglujan

If you or a loved one took one of the type-2 diabetes medications listed above and suffered from a flesh-eating genital infection, you may qualify to join this diabetes medication lawsuit investigation. Fill out the FREE form on this page for more information.

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