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According to allegations raised in a product liability lawsuit filed against Johnson & Johnson and it’s Janssen Pharmaceuticals subsidiary, the amputation side effects of Invokana caused a Texas man to lose a toe and some of the bone in his foot after developing a severe diabetic ulcer following use of the controversial drug.
The complaint (PDF) was filed by Thomas Layton in the U.S. District Court for the District of New Jersey on September 29, indicating that the amputated toe has left him with limited mobility and permanently disabled.
Layton indicates that he was prescribed Invokana in May 2015, for the treatment of type 2 diabetes. However, in October 2015, he was hospitalized for a severe diabetic ulcer of the left foot. As a result, the fifth toe was amputated and he had to undergo further treatment in August 2016, resulting in additional bone removal from his left foot.
“Plaintiff is now limited to the use of crutches and/or a knee scooter in order to be mobile,” the lawsuit states. “He requires assistance from his spouse for many daily activities of living and has been unable to return to work as the Assistant Manager of a lumber company.”
Invokana (canagliflozin) is part 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 since it hit the market in March 2013.
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.
Manufacturers of other SGLT-2 inhibitors released statements around the same time, indicating that the Invokana leg and foot amputation problems were unique to that drug, maintaining that the same risks were not seen among users of their medications.
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.
Layton’s complaint, and a growing number of other Invokana lawsuits, allege that the manufacturers knew or should have known of the risks of Invokana before it was placed on the market.
Given the similar questions of fact and law, Layton’s complaint will be consolidated as part of an Invokana MDL, which is centralized before U.S. District Judge Brian Martinotti in the District of New Jersey for coordinated pretrial proceedings.
Following discovery and potential “bellwether” trials, which are designed to help the parties gauge how juries may respond to certain evidence and testimony that will be repeated throughout the litigation, if Invokana settlements or another resolution for the cases is not found, Layton’s claim and hundreds of others may later be remanded to U.S. District Courts nationwide for separate trial dates.