Invokana Infection Led To Amputation, Lawsuit Alleges

A Kentucky man indicates that he developed diabetic ketoacidosis and an infection from Invokana side effects, which resulted in amputation of his left leg, according allegations raised in a product liability lawsuit filed against the manufacturers of the new-generation diabetes drug.

The complaint (PDF) was filed by Kevin Cobble and his wife, Lilly, against Johnson & Johnson and its Janssen subsidiary in the U.S. District Court for the District of New Jersey on August 18.

According to the lawsuit, Cobble was prescribed Invokana in 2015, for the treatment of diabetes. However, in August 2016, he was hospitalized for diabetic ketoacidosis and severe cellulitis of his left foot. As a result of the Invokana infection, amputation of his lower left leg below the knee was necessary, resulting in the need for a wheelchair or prosthesis for the rest of his life.

Invokana (canagliflozin) was introduced in March 2013, as the first member of a new class of diabetes drugs, known as sodium-glucose cotransporter 2 (SGLT2) inhibitors, which works in a unique way by impacting some normal kidney functions. Other members of this class include Invokamet, Jardiance, Farxiga, Xigduo and others, but Invokana has remained the biggest seller, amid aggressive marketing.

As more and more diabetics have switched to Invokana, a steady stream of serious health concerns have emerged from post-marketing adverse event reports, leading the FDA to require several warning label updates over the past few years.

In addition to the Invokana infection and amputation problems, the medication has also been linked to reports of diabetic ketoacidosis, kidney failure, heart attacks and other injuries.

In May 2017, the FDA required an Invokana warning update regarding the risk of leg and foot amputation, which manufacturers of other SGLT2 inhibitors claim is a unique risk with Invokana, not seen with their competing drugs.

In December 2015, the FDA required Johnson & Johnson to add new diabetic ketoacidosis warnings to Invokana, indicating that the medication increases the risk of this serious condition, which typically results in the need for emergency treatment to avoid life-threatening injury. Prior to the update, the Invokana warnings failed to alert consumers about the importance of seeking immediate medical attention if they experience symptoms like abdominal pain, fatigue, nausea, respiratory problems or vomiting.

In June 2016, the FDA required additional label warnings about the link between Invokana and kidney risks, indicating that the medication may increase the risk of acute kidney injury and other severe health problems.

Cobble’s complaint, and a growing number of other Invokana lawsuits, allege that the manufacturers knew or should have known of the risks of Invokana before it was placed on the market.

“Despite their knowledge of data indicating that Invokana use is causally related to the development of diabetic ketoacidosis, kidney failure and amputations, Defendants promoted and marketed Invokana as safe and effective for persons such as Kevin Cobble throughout the United States,” the lawsuit states. “Defendants failed to adequately warn consumers and physicians about the risks associated with Invokana and the monitoring required ensuring their patients’ safety.”

Given the similar questions of fact and law, Cobble’s complaint will be consolidated as part of an Invokana MDL, which is centralized before U.S. District Judge Brian Martinotti in the District of New Jersey for coordinated pretrial proceedings.

Following discovery and potential “bellwether” trials, which are designed to help the parties gauge how juries may respond to certain evidence and testimony that will be repeated throughout the litigation, if Invokana settlements or another resolution for the cases is not found, Cobble’s claim and hundreds of others may later be remanded to U.S. District Courts nationwide for separate trial dates.