As Invokana Settlements Continue, Court Orders Disclosure of Info in Unresolved Claims

Following the success of recent efforts to settle Invokana lawsuits involving claims for diabetic ketoacidosis, kidney injuries and amputations, the U.S. District Judge presiding over the diabetes drug litigation has ordered new and existing plaintiffs with unresolved cases to submit certain documentation regarding their case.

Johnson & Johnson and it’s Janssen Pharmaceuticals subsidiary have faced hundreds of product liability lawsuits in recent years involving allegations that users and the medical community were not adequately warned about the potential side effects of Invokana.

Given similar questions of fact and law raised in the cases, the federal litigation has been centralized before U.S. District Judge Brian Martinotti in the District of New Jersey for coordinated discovery and pretrial proceedings.

While the court prepared a “bellwether” program, where a small group of Invokana cases were prepared for early trial dates to help gauge how juries would respond to certain evidence and testimony, the drug maker has reached settlement agreements with several law firms in recent months.

In an administrative order (PDF) issued on August 16, Judge Martinotti recognized the “tremendous efforts of the parties to achieve resolutions for various injuries claimed in this complicated multidistrict litigation,” indicating that plaintiffs who have not reached some form of resolution must produce specified information about their claim.

Plaintiffs are required to notify treating doctors and dispensing pharmacies to preserve evidence, as well as provide available medical records, pharmacy records, death records and fact sheets about their claim. The requirements go into effect immediately for new cases filed, but the order is stayed until October 30 for existing plaintiffs.

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.

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.

If the drug maker fails to reach Invokana settlements or another resolution for remaining cases, Judge Martinotti may set additional cases for trial or start remanding claims back to U.S. District Courts nationwide for separate trial dates.