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Although plaintiffs claim Johnson & Johnson knew or should have known about the amputation risks from Invokana, a recently filed product liability lawsuit alleges that the drug maker withheld warnings from consumers and the medical community, causing a Louisiana woman to lose her right leg.
Josefa Sarmiento filed the complaint (PDF) late last month in the U.S. District Court of the District of New Jersey, naming Johnson & Johnson and it’s Janssen Pharmaceuticals subsidiary as defendants.
According to the lawsuit, Sarmiento began taking Invokana for the treatment of diabetes in 2015, However, in March 2017 she had her right leg amputated above the knee, which she indicates was caused by side effects of Invokana.
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, just two months after Sarmiento’s surgery to remove her right leg, 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.
“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,” the lawsuit states. “Their conduct and the product defects were substantial factors in bringing about the Plaintiff’s injuries.”
Sarmiento’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.