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A product liability lawsuit brought by a Tennessee man indicates that the side effects of Farxiga caused him to be hospitalized in an intensive care unit (ICU) due to diabetic ketoacidosis, joining a growing number of similar complaints filed in recent weeks over problems with the new-generation diabetes drug.
The complaint (PDF) was fled in the U.S. District Court for the Southern District of New York on December 30, indicating that Bristol-Myers Squibb and AstraZeneca failed to adequately warn consumers and the medical community about the injury risk associated with Farxiga, which was just introduced a few years ago as a unique diabetes treatment.
Cormier indicates that he was prescribed Farxiga in December 2015, and a little more than a month later he began to experience symptoms of diabetic ketoacidosis, which typically includes severe abdominal pain, nausea vomiting and other complications caused by a build up of acid levels in the blood. As a result of the Farxiga injury, Cormier indicates he was hospitalized and required several days of ICU treatment.
Farxiga (dapagliflozin) was the second member of a new class of medications approved in the U.S., known as s sodium glucose cotransporter-2 (SGLT-2) inhibitors, which work differently than most diabetes treatments, impacting the normal function of the kidney. However, as more diabetics have been switched to Farxiga and other SGLT-2 inhibitors, such as Invokana and Jardiance, a number of serious side effects and health risks have emerged, including diabetic ketoacidosis injuries, kidney failure and heart attacks.
“The development of Plaintiff’s injuries was 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 Farxiga,” the lawsuit states. “Both Defendants’ conduct and the marketing and promotional defects complained of herein were substantial factors in bringing about and exacerbating Plaintiff’s injuries.”
In December 2015, the FDA required new diabetic ketoacidosis warnings for Farxiga and other SGLT-2 inhibitors, which also include the new generation diabetes treatments Invokana, Jardiance and others. The new warning information, added about a year after Collins experienced problems from Farxiga, indicates that users should stop taking the drug and seek immediate medical attention if they develop symptoms of ketoacidosis.
The FDA issued another safety communication about the potential side effects of Farxiga in June 2016, announcing that label warnings were being added about the risk of kidney damage. The warning came after more than 100 adverse event reports involving individuals who suffered acute kidney injury while taking an SGLT-2 inhibitor.
Cormier’s complaint joins a growing number of similar Farxiga lawsuits filed in courts nationwide, as well as Invokana lawsuits filed over problems associated with that leading SGLT-2 inhibitor, which was the first member of the class introduced in the United States.
Given common questions of fact and law raised in complaints filed against Johnson & Johnson’s Janssen Pharmaceuticals unit over failure to warn about the side effects of Invokana, those cases have been consolidated as part of a federal MDL, or multidistrict litigation, centralizing cases pending nationwide before U.S. District Judge Brian Martinotti in the District of New Jersey for coordinated discovery and pretrial proceedings. However, Cormier’s lawsuit and other Farxiga cases are not currently included in the MDL.