Invokana Amputation Resulted in Loss of Leg Below-Knee, Lawsuit Alleges

An Iowa man indicates that the side effects of Invokana resulted in the amputation of one of his legs below the knee, according to a product liability lawsuit filed this week, which alleges that the makers of the controversial diabetes drug failed to adequately warn consumers and the medical community about the potential risks. 

The complaint (PDF) was filed by Michael R. Wilkinson in the Superior Court of New Jersey on December 13, naming Johnson & Johnson and it’s Janssen Pharmaceuticals subsidiary as defendants.

In addition to alleging that Invokana resulted in a partial leg amputation, the lawsuit also indicates that the drug makers withheld information about the risk of heart attacks, strokes and diabetic ketoacidosis.

Wilkinson indicates that he was prescribed Invokana in April 2015, and used the popular diabetes drug through May 2017. However, in December 2015, Wilkinson had to undergo a below-knee, right leg amputation, which he directly relates to the use of Invokana.

The lawsuit claims that because the manufacturers withheld known information about the link between Invokana and amputations, and that Wilkinson was unaware that the drug may be responsible for his injuries until recent warnings about Invokana amputation rates came to light.

“Defendants knew or should have known the risks associated with the use of Invokana, including the risk of amputation,” Wilkinson’s lawsuit states. “Plaintiff Michael R. Wilkinson’s injuries were a reasonably foreseeable consequence of Defendant’s conduct and Invokana’s defects.”

While Wilkinson’s lawsuit was filed in state court, nearly 1,000 other similar Invokana lawsuits have been filed at the federal level in the U.S. District Court for the District of New Jersey, where they are currently centralized for coordinated pretrial proceedings, as part of a federal multidistrict litigation (MDL) before U.S. District Judge Brian R. Martinotti.

Given common questions of fact and law raised in the Invokana litigation, the federal cases are centralized to reduce duplicative discovery into common issues, avoid conflicting pretrial rulings and to serve the convenience of the parties, witnesses and the judicial system.

Invokana Litigation

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 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.

As part of the coordinated pretrial proceedings in the federal court system, 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, Pitts’ claim and hundreds of others may later be remanded to U.S. District Courts nationwide for separate trial dates.