Ketoacidosis Lawsuit Alleges Invokana Warnings Were Inadequate

A New Jersey man indicates that he was hospitalized with ketoacidosis caused by Invokana, indicating that he could have avoided the injury if Johnson & Johnson and it’s Janssen subsidiary had provided adequate warnings about the importance of monitoring for signs of a build up of acid levels in the blood while using the diabetes drug.

In a product liability complaint (PDF) filed last week, Mark Goldring indicates that he never would have taken Invokana if he were aware of the serious risks associated with the medication, alleging that the drug makers overstated the benefits of the treatment and withheld information about the potential side effects of Invokana.

Goldring began using Invokana in November 2015 for the treatment of type 2 diabetes, and developed diabetic ketoacidosis in October 2016, which is a serious medical emergency that can lead to kidney failure and other complications if not promptly treated. As a result of the injury, Goldring indicates that he required hospitalization and has been left with a continuing injury.

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. Other members of this class include Invokamet, Jardiance, Farxiga, Xigduo and others, but Invokana has remained the biggest seller since it hit the market in March 2013.

Amid aggressive marketing by Janssen, Invokana quickly grew to become a blockbuster treatment. However, as more users began to switch to the drug, a serious of serious safety problems have emerged, resulting in a number of warning label updates over the past few years.

In December 2015, after a number of adverse event reports were identified involving involving diabetic ketoacidosis from Invokana, the FDA required a warning label update. At that time, the drug makers were forced to provide information for the first time to consumers and the medical community about the importance of users seeking immediate medical attention if users experience abdominal pain, fatigue, nausea, vomiting, respiratory problems or other symptoms while taking Invokana.

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, FDA required a warning update about the Invokana amputation risks, placing information about the increased incidence of leg, foot and toe amputations in a prominent black box on the label, which is one of the strongest warnings the agency can require a prescription medication to carry.

“Defendants knew of the significant risk of severe injury caused by ingestion of Invokana. However, Defendants did not adequately and sufficiently warn consumers, including Plaintiffs, or the medical community of the severity of such risks,” Goldring’s lawsuit claims. “To the contrary, Defendants conducted nationwide sales and marketing campaigns to promote the sale of Invokana and willfully deceived Plaintiffs, their health care professionals, the medical community, and the general public as to the benefits, health risks and consequences of the use of Invokana.”

The complaint joins a growing number of other Invokana lawsuits filed by users nationwide, each raising similar allegations that the drug makers withheld critical safety information about their type 2 diabetes treatment.

As part of the coordinated pretrial proceedings in the federal court system, which are centralized before U.S. District Judge Brian Martinotti in the District of New Jersey, 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, Norris’s claim and hundreds of others may later be remanded to U.S. District Courts nationwide for separate trial dates.