Invokana Lawsuit Filed Over Big Toe Amputation

An Illinois man indicates that side effects of Invokana resulted in the amputation of his big toe, filing product liability against the manufacturers of the diabetes drug for failing to adequately warn users and the medical community about the risk.

The complaint (PDF) was filed last week by Stephen Wiley, in the U.S. District Court for the District of New Jersey, where hundreds of similar cases are being pursued against Johnson & Johnson and it’s Janssen Pharmaceuticals subsidiary.

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.

According to Wiley’s lawsuit, the Invokana amputation risk makes the drug defective, indicating that it should not have been sold without stronger warnings.

“When placed in the stream of commerce, Invokana contained unreasonably dangerous design defects and was not reasonably safe as intended to be used, subjecting Plaintiff Stephen Wiley to risks that exceeded the benefits of the subject product, including, but not limited to, permanent personal injuries including, but not limited to, amputation and other serious injuries and side effects,” the lawsuit states.

The case 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, Wiley’s claim and hundreds of others may later be remanded to U.S. District Courts nationwide for separate trial dates.