Invokana Treatment Resulted in Partial Second Ray Amputation, Lawsuit Alleges

Less than a year after a Florida man was first prescribed Invokana for treatment of type 2 diabetes, a product liability lawsuit indicates that he had to undergo toe amputations, which was allegedly caused by side effects of Invokana. 

The complaint (PDF) was filed by Richard Greenhut in the U.S. District Court for the District of New Jersey on February 14, indicating that Johnson & Johnson and its Janssen subsidiary failed to adequately warn consumers and the medical community about the amputation risks associated with Invokana.

Greenhut was prescribed the new generation diabetes treatment in 2016, and states that he was subsequently hospitalized for a swollen, ulcerated toe and kidney failure. In January 2017, he underwent two surgeries that resulted in the amputation of his second right toe, due to ongoing ulceration and osteomyelitis. The procedure, a second ray amputation, required removing the corresponding metacarpal bones in the foot.

The lawsuit indicates that the Invokana toe amputation has left Greenhut permanently disfigured. It also notes that his injury could have been avoided if the medical community had been properly warned of the risks of Invokana.

“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, amputations, and the life-threatening complications thereof,” the lawsuit notes. “Consumers, including Richard A. Greenhut, have several alternatives safer methods for treating diabetes, including diet and exercise and other antidiabetic agents.”

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.

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 amputations, which manufacturers of other SGLT2 inhibitors claim is a unique risk with Invokana, not seen with their competing drugs.

The case filed by Greenhut will be centralized with about 1,000 other Invokana lawsuits pending in the federal court system, which are consolidated before U.S. District Judge Brian R. Martinotti in New Jersey to reduce duplicative discovery into common issues, avoid conflicting pretrial rulings and to serve the convenience of the parties, witnesses and the judicial system.

As part of the coordinated pretrial proceedings in the federal multidistrict litigation (MDL), it is expected that a small group of “bellwether” cases will be prepared for early trial dates to help the parties gauge how juries may respond to certain evidence and testimony that will be repeated throughout the litigation.

Following any bellwether trials, if Invokana settlements or another resolution for the cases is not found, Greenhut’s claim and hundreds of others may later be remanded to U.S. District Courts nationwide for separate trial dates.