Foot Amputated Due to Use of Invokana, Lawsuit Alleges

A Texas man alleges that his right foot was removed due to the side effects of Invokana, joining a growing number of individuals nationwide who claim that the controversial diabetes drug increased their amputation risk. 

In a complaint (PDF) filed in the U.S. District Court of New Jersey, Celso Carillo indicates that Johnson & Johnson and it’s Janssen Pharmaceuticals subsidiary introduced and sold a diabetes treatment that is unfit for human use.

Carillo was prescribed Invokana in September 2015, for the treatment of type 2 diabetes. However, a year later, in September 2016, he was hospitalized with symptoms of necrotizing fasciitis, diabetic foot infection, severe sepsis and gas gangrene in his foot. He also suffered acute kidney injury, bandemia and had a partial right foot amputation.

The lawsuit alleges that the use of Invokana resulted in having his right foot amputated in December 2016, leaving him with permanent and disfiguring injuries.

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.

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.

“Defendants failed to adequately warn consumers and physicians about the risks associated with Invokana and the monitoring required ensuring their patients’ safety,” the lawsuit states. “Consumers of Invokana and their physicians relied on the Defendants’ false representations and were misled as to the drug’s safety, and as a result have suffered injuries including diabetic ketoacidosis, kidney failure, sepsis, cardiovascular problems, and the life threatening complications thereof.”

Carillo’s complaint 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.