Invokana Complications Resulted in Left Foot and Right Foot Toe Amputations, Lawsuit Alleges

A Colorado man indicates he lost his left foot and a toe on his right foot due to the side effects of Invokana, a popular diabetes drug that has been linked to an increased risk of amputations. 

The complaint (PDF) was filed by Todd E. Baker in New Jersey federal court on June 1, naming Johnson & Johnson and it’s Janssen subsidiary as defendants.

According to the lawsuit, Baker was prescribed Invokana in August 2014 for the treatment of diabetes. However, in June 2015, he underwent a transmetatarsal amputation of his left foot. This was followed by an amputation of the first toe of his right foot in October 2015.

The lawsuit claims that the amputations were the direct result of Invokana complications, alleging that Baker and other patients were purposefully deceived about the safety of the drug, which has been linked to a steady stream of serious health risks since it hit the market a few years ago as a new-generation diabetes treatment.

“Plaintiff agreed to initiate treatment with Invokana in an effort to reduce his/her blood sugar. In doing so, Plaintiff relied on claims made by Defendants that Invokana was safe and effective for the treatment of diabetes,” the lawsuit states. “Instead, Invokana can cause severe injuries, including heart attack, stroke, renal failure, renal impairment, renal insufficiency, kidney injury, diabetic ketoacidosis and amputations.”

Invokana Amputations and Complication Risks

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 similar diabetes drugs claim is a unique risk with Invokana.

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