Partial Leg Amputation Caused by Failure to Warn About Side Effects of Invokana, Lawsuit Alleges

A New York man indicates that Johnson & Johnson should have provided better warnings to diabetes patients about the potential side effects of Invokana, which allegedly caused him to require a partial leg amputation after taking the medication. 

The complaint (PDF) was filed by John D. Krause in the U.S. District Court for the District of New Jersey on March 16, claiming that the drug makers knew or should have known about the risk that Invokana may cause sepsis and the need for amputation, yet withheld this safety information from consumers and doctors.

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, including a recent warning update about a risk of Invokana leg and foot amputations, which is not seen among users of other SGLT2 inhibitors.

Krause indicates that he was prescribed Invokana in January 2014, for treatment of type 2 diabetes. Following use of the drug for about two years, he was diagnosed with severe sepsis and required a left guillotine amputation on February 5, 2017, followed by a left femoral below knee amputation on February 7, 2017.

The lawsuit indicates that this partial leg amputation would not have been needed if Johnson & Johnson and its Janssen Pharmaceuticals subsidiary had adequately warned about the potential Invokana risks, which would have led him to take another drug.

“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, stroke, amputations and the life-threatening complications thereof, “Krause’s lawsuit states. “Plaintiff had several alternative and safer methods to treat his diabetes, including diet, exercise and other diabetes medications.”

The lawsuit notes that a number of studies in recent years have led to a growing laundry list of Invokana side effects which should have been known before the drug was placed on the market.

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.

More recently, 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.

The lawsuit filed by Krause 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, Krause’s case and hundreds of others may later be remanded back to U.S. District Courts nationwide for individual trial dates.