Invokana Hand Amputation Results in Lawsuit Against Drug Makers For Failure to Warn

After using the new-generation diabetes drug Invokana, a Texas woman indicates that she developed a number of serious side effects, which ultimately led to the amputation of her left hand.

In a complaint (PDF) filed earlier this month in the U.S District Court for the District of New Jersey, Charlotte Nerio indicates that Janssen Pharmaceuticals and its parent company, Johnson & Johnson, failed to adequately warn users and the medical community about the known risks associated with Invokana.

Neiro indicates that she was first prescribed the diabetes treatment in 2015, and suffered severe tissue necrosis, dry gangrene and blackening of the fingers, which resulted in the amputation of her left hand. She also indicates that she was diagnosed with chronic kidney disease following use of the drug.

Invokana (canagliflozin) was introduced in March 2013, as the first member of a new generation 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.

Nerio’s lawsuit points to a number of serious safety concerns linked to Invokana, maintaining that she would have used another diabetes drug if she had been informed about the risks.

“Despite Defendants’ knowledge of the increased risk of severe injury among Invokana users, Defendants did not warn patients but instead continued to defend Invokana, mislead physicians and the public, and minimize unfavorable findings,” the lawsuit states. “Consumers, including Plaintiff, who have used INVOKANA for treatment of diabetes, have several alternative safer products available to treat the conditions.”

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 May 2017, the FDA required an Invokana warning update regarding the risk of leg and foot amputation, which manufacturers of other similar diabetes drugs claim is a unique risk with Invokana.

The hand amputation case filed by Nerio will be consolidated with other Invokana lawsuits pending in the federal court system, which are currently consolidated for pretrial proceedings before one judge in New Jersey.

Following coordinated discovery and any bellwether trials held to help gauge how juries may respond to certain evidence and testimony that is likely to be repeated throughout the litigation, if Invokana settlements or another resolution for the claims is not reached, Bottner’s case and hundreds of others may later be remanded back to U.S. District Courts nationwide for individual trial dates.