Johnson & Johnson and its subsidiary Janssen Pharmaceutical face a man’s recent Invokana lawsuit over allegations that the drug led to his diabetic toe amputation, among other severe adverse side effects and complications.

Plaintiff David B. has filed the diabetic toe amputationlawsuit in New Jersey federal court joining a growing multidistrict litigation (MDL) against the companies.

According to the diabetic toe amputation lawsuit, David is a resident and citizen of Philadelphia. He says that he was prescribed and began taking Invokana in May 2016 to primarily treat diabetes. In deciding to begin treatment and reduce his blood sugar with Invokana, he says that he relied on Janssen’s claims that the drug was safe and effective for treatment.

However, allegedly as a direct result of taking Invokana, he says that he suffered from “an amputation of the fifth toe, including the metatarsal head, of the left foot …” He also says that on Feb. 20, 2018, he “suffered from an amputation of the remaining portion of the fifth metatarsal of the left foot.”

Due to these injuries, he was hospitalized and required substantial medical treatment, the diabetic toe amputation lawsuit states.

According to the lawsuit, Invokana manufacturers knew or should have known that Invokana included risks of lower extremity amputations. David’s injuries were allegedly “preventable and resulted directly from Defendants’ failure and refusal to conduct proper safety studies, failure to properly assess and publicize alarming safety signals, suppression of information revealing serious and life-threatening risks, willful and wanton failure to provide adequate instructions, and willful misrepresentations concerning the nature and safety of Invokana,” the diabetic toe amputation lawsuit states.

The diabetic toe amputation lawsuit was filed on June 12, 2018. It was filed on multiple counts including strict liability, manufacturing defect, design defect, failure to warn, negligence, breach of express warranty, breach of implied warranty, negligent misrepresentation, fraudulent misrepresentation, unjust enrichment, fraud, violation of consumer protection laws and punitive damages.

Overview: Diabetic Toe Amputation

David’s diabetic toe amputation lawsuit is part of a large multidistrict litigation (MDL) centered on allegations that Invokana (canagliflozin) causes serious complications including lower extremity amputations.

According to a May 2017 announcement by the U.S. Food and Drug Administration (FDA), they said that “based on new data from two large clinical trials, the U.S. Food and Drug Administration (FDA) has concluded that the type 2 diabetes medicine canagliflozin (Invokana, Invokamet, Invokamet XR) causes an increased risk of leg and foot amputations.”

“We are requiring new warnings, including our most prominent Boxed Warning, to be added to the canagliflozin drug labels to describe this risk.”

Side effects that have been linked to the medication have include: amputation risks, lactic acidosis, kidney and blood infections, acute kidney injury warning and diabetic ketoacidosis (DKA).

The Diabetic Toe Amputation Lawsuit is Case No. 3:18-cv-10449-BRM-LHG, in the U.S. District Court for the District of New Jersey. The Invokana MDL is MDL No. 2750 is in re: Invokana (Canagliflozin) Products Liability Litigation, in the U.S. District Court for the District of New Jersey.