Lawsuit Alleges Invokana Caused Toe Amputation, Acute Kidney Injury

A Georgia man indicates that he developed severe kidney problems and required a toe amputation due to side effects of Invokana, a controversial new-generation diabetes drug that is the subject of a growing number of product liability lawsuits filed by individuals nationwide.

In a complaint (PDF) filed against Johnson & Johnson and it’s Janssen Pharmaceuticals subsidiary on December 7, William H. Pitts alleges that the drug makers knew about the risks associated with Invokana, but failed to inform him or his doctors,

Pitts indicates that he was prescribed Invokana in 2015, and by December of that year, he was diagnosed with an acute kidney injury, which involves a sudden loss of kidney function that has been reported among a number of users of Invokana. Pitts also indicates that he developed an infection from Invokana, which led to the need for surgery to amputate one of the toes on his right foot in September 2016.

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“William H. Pitts’ injuries were preventable and resulted directly from Defendants’ failure and refusal to conduct proper safety studies, failure to properly assess and publicize alarming safety signals, suppression of information revealing serious and life threatening and debilitating risks, willful and wanton failure to provide adequate instructions, and willful misrepresentations concerning the nature and safety of Invokana,” the lawsuit states. “The conduct and the product defects were a substantial factor in bringing about Plaintiff’s injuries.”

The case was filed in the U.S. District Court for the District of New Jersey, where more than nearly 1,000 other Invokana lawsuits are currently centralized for coordinated pretrial proceedings, as part of a federal multidistrict litigation (MDL) before U.S. District Judge Brian R. Martinotti.

Given similar questions of fact and law raised in the Invokana litigation, the 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.


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