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A product liability lawsuit filed against Johnson & Johnson and it’s Janssen subsidiary alleges that side effects of Invokana caused a Kentucky woman to undergo multiple amputations and suffer multiple heart attacks and hospitalization, indicating that the drug makers failed to adequately warn about the risks associated with their popular diabetes medication.
The complaint (PDF) was filed by Whitney Bridgford in the U.S. District Court for the District of New Jersey on January 15, indicating that her permanent injuries and disability could have been avoided if warnings had been provided for patients and the medical community about the link between Invokana and amputations, as well as other adverse health risks.
Bridgford indicates that started taking Invokana in May 2013, to reduce her blood sugar. Due to the drug’s side effects, Bridgford indicates she suffered heart attacks in July and December of 2014, as well as in April 2015 and April 2017. In addition, she had to undergo amputation surgeries in March and September of 2015, November 2016, and in January, March, July and August of 2017.
“Despite Defendants’ knowledge of the increased risk of severe injury among Invokana users, Defendants did not warn patients but instead continued to defend Invokana, mislead physicians and the public, and minimize unfavorable findings,” the lawsuit states. “Consumers, including Plaintiff, Whitney Bridgford, who have used Invokana for treatment of diabetes, have several alternative safer products available to treat the conditions.”
The case was filed in the U.S. District Court for the District of New Jersey, where more than 1,000 other Invokana lawsuits are currently centralized for coordinated pretrial proceedings, as part of a federal multidistrict litigation (MDL) before U.S. District Judge Brian R. Martinotti.
Given similar questions of fact and law raised in the Invokana litigation, the cases are centralized to reduce duplicative discovery into common issues, avoid conflicting pretrial rulings and to serve the convenience of the parties, witnesses and the judicial system.
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, Bridgford’s claim and hundreds of others may later be remanded to U.S. District Courts nationwide for separate trial dates.