Johnson & Johnson and its subsidiary Janssen Pharmaceuticals is facing a new Invokana problems lawsuit by a Maryland man joining a growing multidistrict litigation (MDL) filed against the company.

Plaintiff David H. has filed an Invokana problems lawsuit in New Jersey federal court. The lawsuit was filed on June 6, 2018.

According to the Invokana problems lawsuit, David says that he began taking Invokana primarily to treat his diabetes. However, he says that the medication caused him to suffer a number of severe adverse side effects including suffering from an amputated toe on his right foot.

As a result of these injuries, David began to require substantial medical treatment and was hospitalized, the Invokana lawsuit states.

David claims that due to improper disclosure of Invokana’s associated risks and due to improper omissions and misrepresentations of Invokana, he was caused to suffer this significant injury and amputated toe.

According to the lawsuit, “The development of Plaintiff’s injuries was 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.”

Overview: Invokana Problems

Invokana (canagliflozin) is a type-2 diabetes medication prescribed to help lower patients’ blood sugar levels. It was approved by the U.S. Food and Drug Administration (FDA) on March 29, 2013, to be prescribed to patients in combination with proper diet and exercise. Invokana belongs to a class of sodium-glucose contransporter-2 (SGLT2) inhibitors.

However, several adverse side effects and complications have been associated with Invokana, such as David’s toe amputation. Due to these side effects, however, the FDA made an announcement regarding the drug’s serious complications.

According to the FDA, “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.”

The FDA has urged medical practitioners to evaluate a patients’ overall risk of amputation before prescribing Invokana.

Patients taking Invokana should also be closely monitored for adverse side effects such as foot ulcers and potentials for an amputated toe and other infections that may lead a patient to undergo an amputation procedure.

Though the FDA has not stated that other SGLT-2 inhibitors may have the same effects thus causing potential and risks for amputation, a February announcement made by the European Agency indicated that this this may be a class effect. Other class inhibitors also include empagliflozin (Jardiance) and dapagliflozin (Farxiga).

The Invokana Problems Lawsuit is Case No. 3:18-cv-10218-BRM-LHG, in the U.S. District Court for the District of New Jersey. The Invokana Lawsuit is MDL No. 2750 in re: Invokana (Canagliflozin) Products Liability Litigation, in the U.S. District Court for the District of New Jersey.