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A Texas man indicates that he required a big toe amputation due to side effects of Invokana, according to a product liability lawsuit filed against the drug makers for failing to warn consumers and the medical community about the risks associated with the diabetes treatment.
The complaint (PDF) was filed this month in the U.S. District Court for the District of New Jersey, naming Janssen Pharmaceuticals and its parent company, Johnson & Johnson, as defendants.
Boren indicates that he began taking Invokana in January 2016, and continued to use the drug until April 2017. However, in October 2016, he experienced complications that resulted in the need to have his big toe amputated on his right foot.
A few months later, federal drug regulators required the addition of new Invokana amputation warnings to the medication, but Boren indicates he was unaware of the potential risk until that time.
Invokana (canagliflozin) was introduced in March 2013, as the first member of a new generation 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.
In May 2017, the FDA required an Invokana warning update regarding the risk of leg and foot amputation, which manufacturers of other similar diabetes drugs claim is a unique risk with Invokana.
The lawsuit claims that the manufacturers hid the risks for years, putting patients at unnecessary risk of amputations.
“Defendants were aware that the mechanism of action for Invokana places extraordinary strain on the kidneys and renal system,” the lawsuit states. “They were also aware that Invokana use causes volume depletion and that, as with thiazide diuretics, this could lead to increased risk of gangrene, diabetic foot ulcers, lower limb ischemia and eventually amputation of toes, feet and legs below the knee.”
Boren’s complaint will be consolidated with other Invokana lawsuits pending in the federal court system, which are currently consolidated for pretrial proceedings before one judge in New Jersey.
Following coordinated discovery and any bellwether trials held to help gauge how juries may respond to certain evidence and testimony that is likely to be repeated throughout the litigation, if Invokana settlements or another resolution for the claims is not reached, Boren’s case and hundreds of others may later be remanded back to U.S. District Courts nationwide for individual trial dates.