Janssen Pharmaceuticals Inc. faces an Invokana amputation lawsuit from a man who faults the diabetes medication for his toe and leg amputations.

The Invokana amputation lawsuit joins the growing number of lawsuits filed in New Jersey federal court. The claim was filed on May 11, 2018.

According to the Invokana amputation lawsuit, plaintiff Michael T. is a resident and citizen of Pensacola, Fla.

He says that due to taking Invokana he suffered “various injuries, physical pain and suffering, medical, hospital and surgical expenses…”

He says that he was prescribed and began taking Invokana in May 2014, although he had “several alternative and safer methods to treat his diabetes, including diet, exercise and other diabetes medications.” Although he agreed to take Invokana in an effort to reduce his blood sugar levels, he also relied on the drugmaker’s claims about the safety and effectiveness of Invokana to treat diabetes, the lawsuit states.

Michael says he underwent a toe amputation on June 23, 2014 and a leg amputation on Jan. 6, 2015. Both amputations were the result of his use of Invokana, he claims.

According to the lawsuit, his “injuries was preventable and resulted directly from … [Janssen’s] 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.”

Michael says he suffered damages including severe and permanent emotional and physical injuries. He says he suffered pain and suffering, loss of enjoyment of life, emotional distress, economic loss, and significant medical expenses. Michael says that he has also suffered mental anguish from the knowledge that he may suffer “life-long complications as a result of injuries caused by Invokana.”

The Invokana amputation lawsuit 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: Invokana & Lower Extremity Amputation

Adverse event reports are continuously being received by the U.S. Food and Drug Administration (FDA) over adverse side effects and complications associated with Invokana, including lower extremity amputation.

Invokana (canagliflozin) became approved by the FDA on March 29, 2013 and is part of a class of medications known as sodium-glucose transport inhibitors. Severe adverse side effects have been continuously reported that have included bone fractures, kidney injuries, and more recently lower extremity amputation.

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,” the agency said.

The FDA says it is “requiring new warnings, including our most prominent Boxed Warning, to be added to the canagliflozin drug labels to describe this risk,” they added.

The Invokana Amputation Lawsuit is Case No. 3:18-cv-09137-BRM-LHG, in the U.S. District Court for the District of New Jersey. The Invokana Lawsuit is MDL No. 2750 is in re: Invokana (Canagliflozin) Products Liability Litigation, in the U.S. District Court for the District of New Jersey.