Farxiga Lawsuit Filed Over Diabetic Ketoacidosis Side Effects

Bristol-Myers Squibb and AstraZeneca face a product liability lawsuit over side effects of Farxiga, claiming that the controversial new-generation diabetes drug caused a Texas woman to suffer diabetic ketoacidosis, which is a serious medical complications caused by a build up of acid levels in the blood. 

The complaint (PDF) was filed last month by Adelina Quintanilla, in the U.S. District Court for the Southern District of Texas, claiming that the drug manufacturer failed to warn users and the medical community that Farxiga may increase the risk of diabetic ketoacidosis, heart attacks, strokes and other health problems.

Quintanilla indicates that she was prescribed Farxiga for treatment of diabetes in May 2014, shortly after the new diabetes drug was approved by the FDA. Although the drug makers promoted their product as safe and effective, Quintanilla indicates that she subsequently developed elevated acid levels in the blood, alleging that the drug makers knew or should have known about the risk of diabetic ketoacidosis from Farxiga.

Farxiga was introduced in 2014, as the second member of a new class of diabetes drugs, known as sodium glucose cotransporter-2 (SGLT-2) inhibitors. These drugs work in a unique way, impacting the normal function of the kidneys, and have been linked to a number of serious side effects during the few short years they have been on the market, including incidence of diabetic ketoacidosis, often resulting in the need for hospitalization. Other members of this class include Invokana, Invokamet, Xigduo XR, Jardiance and Glyxambi, which have all been aggressively marketed to diabetics during the short time they have been on the market.

“Defendants knew of the significant risk of diabetic ketoacidosis and kidney damage caused by ingestion of Farxiga. However, Defendants did not adequately and sufficiently warn consumers, including Plaintiff, or the medical community of the severity of such risks,” according to the complaint filed by Quintanilla. “To the contrary, Defendants conducted nationwide sales and marketing campaigns to promote Farxiga, and they willfully deceived Plaintiff, Plaintiff’s health care professionals, the medical community, and the general public as to the health risks and consequences of the use of Farxiga.”

Quintanilla’s case is one of a growing number of Farxiga lawsuits and Invokana lawsuits filed in recent months, each raising similar allegations that the makers of these new diabetes drugs placed their desire for profits before consumer safety by pushing doctors and patients to use these new drugs without disclosing potential side effects.

As more and more individuals switch to Farxiga, Invokana or other SGLT-2 inhibitors, a steady stream of serious safety signals have emerged in post-marketing adverse event reports, leading the FDA to issue several warnings for consumers and the medical community over the past year.

On June 14, the FDA issued a drug safety communication ordering the makers of Invokana, Invokamet, Farxiga and Xigduo XR to add stronger label warnings about the risk of kidney damage. The warning comes after more than 100 adverse event reports involving patients who suffered acute kidney injury, which may cause hospitalization or potentially lead to kidney failure and death.

The order came about a month after an investigation by federal health officials that also required new warnings about problems with diabetic ketoacidosis with Farxiga, Invokana and other members of the class.

“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 complaint filed by Quintanilla states. “Both Defendants’ conduct and the product defects complained of herein were substantial factors in bringing about and exacerbating Plaintiff’s injuries.”

Quintanilla presents claims of defective design, failure to warn, willful or wanton misconduct and negligence. The lawsuit seeks both compensatory and punitive damages.

As Farxiga and Invokana injury attorneys continue to review cases, they expect that the number of claims will continue to grow, with potentially hundreds or thousands of Farxiga and Invokana lawsuits filed in the coming months and years.