Invokana Foot Amputation Results in Lawsuit Over Failure to Disclose Risk

A Texas man has filed a product liability lawsuit, alleging that he needed a foot amputation due to the prescription of Invokana for treatment of his diabetes, indicating that the drug makers failed to adequately disclose the large number of amputation problems with Invokana reported by users nationwide.

The complaint (PDF) was filed late last month by Michael W. Mayfield, in the U.S. District Court for the District of New Jersey, indicating that Johnson & Johnson and its Janssen Pharmaceuticals subsidiary failed to adequately warn patients and the medical community about the increased risk of leg and foot amputations linked to Invokana.

“Defendants knew of the significant risk of severe injury caused by ingestion of Invokana. However, Defendants did not warn or did not adequately and sufficiently warn consumers, including Plaintiff, or the medical community of the severity of such risks,” Mayfield’s lawsuit states. “To the contrary, Defendants conducted nationwide sales and marketing campaigns to promote the sale of Invokana and willfully deceived Plaintiff, his/her health care professionals, the medical community, and the general public as to the health risks and consequences of the use of Invokana.”

Mayfield was prescribed Invokana in February 2015, for the treatment of type 2 diabetes. However, in June 2017, he had to undergo a transmetatarsal amputation of the right foot, and then two days later had to undergo a guillotine amputation of the right foot above the ankle.

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 similar diabetes drugs claim is a unique risk with Invokana.

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