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According to recent court records, more than 1,000 Invokana lawsuits are currently pending the federal multidistrict litigation (MDL) established for cases filed on behalf of individuals who have suffered amputations, diabetic ketoacidosis, kidney failure and other injuries after use of the controversial diabetes drug.
Each of the complaints raise similar allegations that Johnson & Johnson and its Janssen Pharmaceuticals subsidiary failed to adequately research the potential side effects of Invokana, and withheld important safety warnings from consumers and the medical community in recent years.
Given common questions of fact and law raised, all Invokana cases pending in the federal court system have been consolidated before U.S. District Judge Brian Martinotti in the District of New Jersey. The litigation was centralized as part of an MDL in December 2016, to reduce duplicative discovery, avoid conflicting pretrial rulings and to serve the convenience of the parties, witnesses and the judicial system.
According to a case management order (PDF) issued on January 11, there were 1,001 claims were pending in the District of New Jersey at the start of this month. The cases generally consist of three different injury categories: claims that Invokana caused kidney failure, lawsuits over cases of the development of diabetic ketoacidosis, and claims that Invokana increases the risk of amputations.
As part of the consolidated MDL proceedings, Judge Martinotti has previously established a “bellwether” program, where a small group of Invokana cases are being prepared for early trial dates, which are designed to help the parties gauge how juries may respond to certain evidence and testimony that is likely to be repeated throughout the litigation.
The case management order confirms that the litigation is still on schedule for trials to start in September 2018. It also announces that the next status conference is scheduled for February 8, and notes that the Court intends to appoint a special master, which will be discussed at the next status conference.
Invokana Side Effects
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.
Following any bellwether trials, if Invokana settlements or another resolution for the cases is not found, each individual claim pending in the MDL ultimately be remanded back to U.S. District Courts nationwide for separate trial dates.