Lawsuit Alleges Leg Amputated Due to Invokana Side Effects

According to allegations raised in a product liability lawsuit filed against Johnson & Johnson and its Janssen Pharmaceuticals subsidiary, a Missippi man had to undergo surgery to have his leg amputated due to Invokana side effects, indicating that the new-generation diabetes drug also caused him to suffer kidney failure, diabetic ketoacidosis and sepsis.

In a complaint (PDF) filed in the U.S. District Court for the District of New Jersey on February 28, Jim Dedeaux indicates that the drug makers failed to adequately warn patients and the medical community about the risks associated with their diabetes treatment.

Dedeaux indicates that he was prescribed Invokana for treatment of type 2 diabetes. However, he experienced diabetic ketoacidosis, which involves a build up of acid levels in the blood, as well as kidney problems and infection. Ultimately, he had to undergo a right foot amputation, then his entire right leg was amputated below the knee.

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

“The development of Plaintiff Jim Dedeaux’s injuries was 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 risks, willful and wanton failure to provide adequate instructions, and willful misrepresentations concerning the nature and safety of Invokana,” the lawsuit states. “This conduct and the product defects complained of herin were substantial factors in bringing about and exacerbating Plaintiff Jim Dedeaux’s injuries.”

Nearly 1,000 similar Invokana lawsuits have been filed against the drug makers in the federal court system, each raising similar allegations that the diabetes drug was not adequately researched and that inadequate warnings were provided. Given similar questions of fact and law, the claims are centralized for coordinated pretrial proceedings as part of a federal multidistrict litigation (MDL), before U.S. District Judge Brian R. Martinotti in the District of New Jersey.

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