Farxiga Wrongful Death Lawsuit Filed Over Kidney Injury from Diabetes Drug

Bristol-Myers Squibb and AstraZeneca face a wrongful death lawsuit filed by the family of a Tennessee woman, which indicates that side effects of Farxiga caused a fatal case of kidney failure. 

The complaint (PDF) was filed by Garret Scott in the U.S. District Court for the Southern District of New York on September 15, on behalf of himself and the estate of Linda Alexis White, who died in September 2016.

White began using Farxiga in January 2014, shortly after the diabetes drug was introduced as the second member of a new class of medications approved in the U.S., known as sodium glucose cotransporter-2 (SGLT-2) inhibitors. The new-generation treatment works differently than most diabetes drugs, 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.

According to allegations raised in the Farxiga wrongful death lawsuit, White suffered diabetic ketoacidosis in February 2016, which involves elevated levels of acid in the blood, which have been linked to side effects of SGLT-2 inhibitors. She was then diagnosed with acute renal failure in March 2016; acute kidney injury in April 2016; suffered another case of acute renal failure in June 2016, and end-stage renal disease in July 2016. She died of chronic kidney disease on September 17, 2016.

In December 2015, the FDA required new diabetic ketoacidosis warnings for Farxiga and other SGLT-2 inhibitors, indicating that users should stop taking the drug and seek immediate medical attention if they develop symptoms of the medical emergency, which causes a build up of acid levels in the blood.

The FDA issued another safety communication about the potential kidney 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.

“Farxiga, by its very mechanism of action, causes dehydration and osmotic diuresis. Osmotic diuresis is the increase of urination rate caused by the presence of certain substances in the small tubes of the kidneys. The excretion occurs when substances such as glucose enter the kidney tubules and cannot be reabsorbed,” the lawsuit states. “Because Farxiga blocks sugar from being reabsorbed by the kidneys, the kidneys expel the sugar in the patient’s urine. A buildup of sugar in the tubes leading from the kidneys leads to acute kidney (or ‘renal’) failure.”

Scott’s complaint will be consolidated with other Farxiga lawsuits in the MDL established before Judge Lorna G. Schofield, for coordinated discovery and bellwether trials. However, if settlements or another resolution for the litigation is not reached in the MDL, each case would be remanded for separate trials throughout the U.S.

Hundreds of similar Invokana lawsuits have been filed over this competing diabetes treatment, which has been linked to similar risks. Those cases are centralized as part of a separate MDL in the U.S> District Court for the District of New Jersey.