Wrongful Death Lawsuit Filed Over SGLT-2 Inhibitor Diabetes Drug Risks

According to allegations raised in a wrongful death lawsuit filed by the family of a Kentucky man, side effects of Invokana or another similar diabetes drugs caused fatal kidney failure and respiratory failure injuries. 

The lawsuit was filed by Donna Royse, on behalf of her husband, Terry Royse, on November 28 .

The complaint (PDF) was filed late last month by the family of Terry Royse in the in the U.S. District Court for the Eastern District of Kentucky, indicating that Johnson & Johnson, it’s Janssen Pharmaceuticals subsidiary, Eli Lilly, Mitsubishi Tanabi Pharma, Boehringer Ingelheim, Bristol-Myers Squibb Co. and AstraZeneca each failed to disclose the risks associated with diabetes drugs that are part of a new class of medications, known as sodium-glucose co-transporter 2 (SGLT2) inhibitors.

SGLT-2 inhibitors are work in a different way from other diabetes treatments, impacting the normal kidney functions to increase the amount of sugar excreted in the urine. Invokana was the first member of this new class to hit the market, introduced in early 2013 and aggressively marketed to consumers and doctors as a superior new type of treatment. However, as more individuals have switched to the drug, and other SGLT2 inhibitors which followed, such as Farxiga, Jardiance, Invokamet, Glyxambi and Xigduo, a steady stream of serious side effects have emerged.

The lawsuit indicates that Royse was prescribed SGLT2 inhibitors to reduce his blood glucose levels. However, the family claims that the medications caused him to suffer respiratory failure, kidney damage, kidney failure and ultimately took his life. The lawsuit names the manufacturers of every SGLT2 inhibitor on the market and does not specify which drug or drugs Royse ingested. However, the complaint alleges that all of the defendants have failed to provide adequate warning to consumers and the medical community about the risk of serious health problems associated with the new class of drugs.

“Despite Defendants’ knowledge of the increased risk of severe injury among SGLT2 inhibitor users, Defendants did not warn patients, including Decedent, but instead continued to defend SGLT2 Inhibitor, mislead physicians and the public, and minimize unfavorable findings,” the lawsuit states.

The case joins a growing number of similar Invokana lawsuits, Farxiga lawsuits and other cases filed against other SGLT2 inhibitor manufacturers filed in recent months, including claims by other individuals who developed diabetic ketoacidosis, kidney failure, heart attacks and other injuries.

SGLT-2 inhibitor diabetic ketoacidosis problems can cause low blood sugar, low potassium levels that can interfere with the functioning of the heart, muscles and nervous system, and can also cause swelling of the brain. If left untreated, ketoacidosis can result in loss of consciousness and even death.

In December 2015, the FDA required Johnson & Johnson and the makers of other SGLT2 inhibitors to add new diabetic ketoacidosis warnings to their medications, urging users to stop taking the drug and seek immediate medical attention if they experience symptoms like abdominal pain, fatigue, nausea, respiratory problems or vomiting.

In May 2015, the Institute for Safe Medication Practices (ISMP) conducted a detailed review of adverse event reports submitted to the FDA during the first year Invokana was on the market, and identified a potential risk of kidney damage with SGLT2 inhibitors, raising questions about whether the benefits provided by the medication justify the risk.

In June 2016, the FDA required the drug makers to add new Invokana safety warning, indicating that the medication may increase the risk of acute kidney injury and other severe health problems.

As SGLT-2 inhibitor diabetes drug injury lawyers continue to review and file claims for individuals nationwide, it is widely expected that hundreds, if not thousands, of additional lawsuits may be filed in the coming months and years.