Invokana Amputation Risk Withheld by Drug Makers, Lawsuit By Woman Who Lost Right Leg Alleges

Following treatment with the controversial diabetes drug Invokana, a Tennessee woman indicates that she developed an infection that led to the amputation of her right leg, alleging in a recently filed product liability lawsuit that the drug maker knew about the amputation risk with Invokana, yet failed to warn her or her doctors.

The complaint (PDF) was filed by Audrey Phillips in the U.S. District Court for the District of New Jersey on May 16, indicating that Johnson & Johnson and it’s Janssen Pharmaceuticals subsidiary intentionally misrepresented the side effects of Invokana, failing to warn about the risk of diabetic ketoacidosis, kidney failure, sepsis, amputation and other injuries.

Phillips began taking Invokana in 2014, for the treatment of type 2 diabetes. However, by the fall of 2015, she developed several infections in her right leg and foot and began wound treatment for the infections and diabetic ulcers. In December 2015, her right leg was amputated, leaving her with constant pain and limited mobility.

The lawsuit alleges that the manufacturers oversold Invokana’s benefits and downplayed its potential health risks.

“In an effort to increase sales and market share, Defendants have aggressively marketed and continue to aggressively market Invokana to doctors and directly to patients for off-label purposes, including, but not limited to weight loss, reduced blood pressure, kidney benefits, cardiovascular benefits, and for use in type 1 diabetics,” the lawsuit states. “Defendants also, through their marketing materials, misrepresented and exaggerated the effectiveness of Invokana, both as to its ability to lower glucose, and its benefit for non-surrogate measures of health, such as reducing adverse cardiovascular outcomes.”

Invokana Health 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 Phillips 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, Phillip’s case and hundreds of others may later be remanded back to U.S. District Courts nationwide for individual trial dates.