A married couple have filed an Invokana amputation lawsuit in a federal court in New Jersey. The couple, plaintiffs Kim P. and James P., allege in the Invokana amputation lawsuit that because of treatment for with the diabetes drug Invokana, Kim needed diabetic leg amputation.

The plaintiffs are bringing this Invokana amputation lawsuit against Janssen Pharmaceuticals, the developers and manufacturers of Invokana, and its parent company Johnson & Johnson. Kim and her husband James are citizens and residents of the state of Michigan, but her product liability case and those of other Invokana patients have been filed in New Jersey to be handled as part of the Invokana multidistrict litigation.

The Plaintiff’s Story

Kim says she took Invokana for about a year from May 28, 2014 until April 23, 2015. In late February of 2015, she was admitted to Munson Medical Center and underwent a diabetic leg amputation just below the left knee.

This diabetic leg amputation occurred on March 5, she claims. By March 25, she says she was admitted back into this medical facility for a left knee infection because of the amputation below it. Treatment with antibiotics was initiated at that time.

Eight months later, Kim was evaluated at the University of Michigan Medical Center again for left knee infection. Although a decision was made to avoid this drastic of intervention, there was a recommendation for diabetic leg amputation above the knee to stem further infection.

Kim and her spouse allege in her Invokana amputation lawsuit that she has suffered severe and permanent injuries such as diabetic leg amputation with infection and may suffer other injuries in the future because of ingesting Invokana such as diabetic ketoacidosis, kidney failure, stroke, and cardiac arrest.

Invokana’s History

According to the narrative in the Invokana amputation lawsuit, Invokana—known generically as canagliflozin—was approved by the U.S. Food and Drug Administration (FDA) for the treatment of type-2 diabetes in March 2013.

Canagliflozin is of the SGLT2 inhibitor class of drugs which lower blood glucose levels by deterring the kidneys from reabsorbing excess sugars and encouraging excretion through urine output.

There is a known high-risk factor for kidney disease among diabetics, and the stress of this process quadruples this risk, according to the Invokana amputation lawsuit. Since the drug’s commercial release five years ago, the FDA Adverse Event Reporting System (FAERS) has had a significant number of negative medical events with Invokana reported such as the need for amputations, and development of diabetic ketoacidosis.

Despite these reports, Janssen Pharmaceuticals and Johnson & Johnson Inc. have supposedly continued to promote the drug’s safety and seek its ‘off-label’ use for everything from control of hypertension or high-blood pressure to weight loss. The defendants advertise Invokana as safe and effective, plaintiffs claim.

Kim and James are bringing 12 causes of action against the defendants, including but not limited to failure to warn, defective design, breach of implied warranty, fraud, loss of consortium, negligence, and manufacturer defect.

The couple seek compensatory damages that include medical expenses, interest on judgment, attorney and court fees. They also hope for punitive damages to be assessed.

The Invokana Amputation Lawsuit is Case No. 3:18-cv-03066-BRM-LHG in U.S. District Court, District of New Jersey.