Invokana Heart Attack Risks Not Disclosed by Drug Makers, Lawsuit Alleges

Although Johnson & Johnson and its Janssen Pharmaceuticals subsidiary allegedly knew about the link between Invokana and heart attacks, a lawsuit filed by a Texas woman indicates that the drug makers withheld information from consumers and the medical community about the risks associated with their new-generation diabetes treatment.

In a complaint (PDF) filed last week in the U.S. District Court for the District of New Jersey, Marthasue Neve indicates that she suffered a heart attack in February 2014, which was allegedly caused by the side effects of Invonaka.

Invokana (canagliflozin) is a controversial new diabetes treatment introduced in March 2013, which has been aggressively promoted by Johnson & Johnson and Janssen in an attempt to convince doctors and patients to switch their medications. However, it has been linked to a steady stream of serious safety risks, which have led the FDA to require several warning label updates during the first few years Invokana has been on the market.

Neve indicates that she began taking Invokana in October 2013, only a few months after the drug hit the market. Although the lawsuit indicates that there are several alternative and safer methods to treat her diabetes, Neve agreed to initiate treatment with Invokana based on claims made by the drug maker that it was safe and effective.

In February 2014, Neve indicates that she suffered a myocardial infarction, or heart attack, which the lawsuit alleges was caused by the use of Invokana.

“Defendants knew or should have known the risks associated with the use of Invokana, including the risk of Myocardial Infarction,” the according to the complaint. “The development of Plaintiff’s 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 risks, willful and wanton failure to provide adequate instructions, and willful misrepresentations concerning the nature and safety of Invokana.”

Neve’s complaint joins a growing number of Invokana lawsuits filed by individuals nationwide. In addition to heart attack lawsuits, the drug makers also face claims that Invokana caused users to suffer diabetic ketoacidosis, kidney failure and other injuries.

In December 2015, the FDA required Johnson & Johnson and the makers of other SGLT2 inhibitors to add new warnings about the diabetic ketoacidosis risk from Invokana, urging users to stop taking the drug and seek immediate medical attention if they experience symptoms like abdominal pain, fatigue, nausea, respiratory problems or vomiting. The condition involves a dangerous build of acid levels in the blood, which typically results in the need for emergency treatment to avoid life-threatening injury.

Less than a year later, in June 2016, the FDA required another warning label update to add information 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.

Given similar questions of fact and law raised in lawsuits filed throughout the federal court system, Neve’s case will be consolidated as part of an Invokana MDL (multidistrict litigation), which is centralized before U.S. District Judge Brian Martinotti in the District of New Jersey for coordinated discovery and pretrial proceedings. However, if Invokana settlements or another resolution for the cases is not reached during the MDL process, Neve’s case and others involved in the litigation may later be remanded to U.S. District Courts nationwide for separate trial dates.