Johnson & Johnson is facing a new product liability claim regarding one of their popular type-2 diabetes drugs, alleging complications as serious as diabetes toe amputation.

According to the Invokana lawsuit, plaintiff Dwayne S. alleges he underwent an Invokana amputation that he could have avoided given a better warning from defendant Johnson & Johnson about the risk of diabetic amputation associated with Invokana.

Dwayne says he had been prescribed Invokana to treat his type-2 diabetes symptoms on Feb. 24, 2015, and had taken the medication according to prescription instructions and physician advice.

Dwayne had stayed on the medication until Oct. 31, 2016, during which time he allegedly had to undergo an Invokana amputation. Dwayne had to undergo diabetes toe amputation on his right great toe on Sept. 17, 2015, and a second amputation on his right second toe on Jan. 07, 2016.

Dwayne reportedly continued to suffer from severe diabetes symptoms, undergoing another diabetes toe amputation on his left great toe on Jan. 11, 2016 and a full amputation of his right foot on Aug. 25, 2016.

Overview of Invokana Amputation Risk

Amputation is one of the primary concerns of patients with type-2 diabetes, as the imbalance of hormones and blood sugar may cause swelling in nerve damages in the feet or legs.

The FDA recently warned that taking Invokana and other medications with canagliflozin may increase the risk of lower limb amputation in type-2 diabetes patients.

The FDA released the warning on May 16, 2017, after reviewing several studies showing that patients using canagliflozin medications were twice as likely to undergo lower limb amputations compared to patients taking other medications.

Diabetes toe amputation was reported the most common. Reports of upper and lower leg amputations were also reviewed. In the most severe cases, patients had to undergo multiple lower limb amputations, with some involving both legs.

The FDA further stated patients who suffer from nerve damage or diabetic foot ulcers may be the most at risk for potential Invokana amputation. The FDA ultimately stated that it will require new warnings to be added to the medication labels of Invokana, Invokamet, and Invokamet XR so that they mention reports of leg and foot amputations.

Invokana is a popular medication that is meant to help patients lower blood sugar levels when combined with diet and exercise. It is part of a class of medications called SGLT2 inhibitors, which mange blood sugar levels by signaling the kidneys to expel excess sugar through urination, reducing excess blood sugar levels.

The FDA advised patients on canagliflozin medications to regularly check in with their physicians, and to not stop the medication without the supervision of their physician.

Johnson & Johnson allegedly knew that Invokana amputation may have been a risk to patients, but failed to warn the public, according to plaintiffs like Dwayne. Dwayne stated that if he had known about the risk of potential Invokana amputation, he never would have agreed to take the medication.

This Invokana Amputation Lawsuit is Case No. 3:17-cv-07081-BRM-LHG, in the U.S. District Court for the District of New Jersey, Trenton Division.