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According to allegations raised in a product liability lawsuit filed against Boehringer Ingelheim, side effects of Jardiance caused a woman to suffer diabetic ketoacidosis, resulting in hospitalization and permanent injuries after using the new-generation diabetes drug.
In the complaint (PDF) filed earlier this month in the U.S. District Court for the District of Arizona, Kristi Ann Lane accuses drug manufacturer of failing to warn users and the medical community about the potential health risks linked to Jardiance.
Lane indicates that she was prescribed Jardiance in late January 2016. Less than two months later, in March 2016, she developed diabetic ketoacidosis, which is a serious medical emergency involving elevated levels of acid in the blood. As a result of the complications, Lane was admitted to an intensive care unit (ICU) at Northwest Medical Center in Tucscon, Arizona and claims that she continues to suffer damages as a result of the injury.
“Defendants knew or should have known the risks associated with the use of Jardiance, including the risk of developing diabetic ketoacidosis,” Lane’s lawsuit states. “The development of Plaintiff’s injuries was preventable and resulted directly from Defendants’ failure and refusal to conduct proper safety studies, failure to properly asses 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 Jardiance.”
Jardiance (empagliflozin) belongs to a new class of diabetes drugs, known as sodium glucose cotransporter-2 (SGLT-2) inhibitors, which also includes the controversial drugs Invokana, Invokamet, Farxiga and Xigduo.
The FDA approved Jardiance on August 1, 2014. However, the agency issued a safety alert linking Jardiance and similar drugs to an increased risk of diabetic ketoacidosis in May 2015, based on adverse event reports that were submitted from March 2013 to June 2014; before Jardiance was approved for sale.
Lane presents claims against Boehringer Ingelheim design defects, failure to warn, negligence, breach of express and implied warranty, misrepresentation, concealment and fraud, seeking both compensatory and punitive damages.
Jardiance Ketoacidosis Side Effects
Concerns about the potential link between Jardiance and ketoacidosis emerged in May 2015, when the FDA indicated that during the first 15 months the new class of diabetes drugs was on the market, more than 20 adverse event reports were received involving individuals using an SGLT2 inhibitor who required emergency room treatment or hospitalization due to diabetic ketoacidosis, ketosis, acidosis or other related conditions.
Ketoacidosis can result in symptoms like difficulty breathing, nausea, vomiting, abdominal pain, confusion, fatigue or sleepiness, often requiring urgent medical treatment and potentially resulting in severe health consequences.
Although diabetic ketoacidosis is commonly associated with type 1 diabetes, it is not normally seen among individuals diagnosed with type 2 diabetes, which is the type of diabetes Jardiance and Invokana are approved to treat. Type 2 diabetes is an acquired and curable condition, while type 1 diabetes is usually something someone is born with and persists for life.
In December 2015, diabetic ketoacidosis warnings were added to Jardiance, Invokana and other SGLT2 inhibitors, indicating for the first time that users may face of risk of developing this serious condition.
Prior warnings failed to alert consumers about the importance of seeking immediate medical attention if they experience symptoms like abdominal pain, fatigue, nausea, respiratory problems or vomiting, which is critical for avoiding serious complications from diabetic ketoacidosis.
Concerns about a potential link between SGLT-2 inhibitors and kidney failure have also emerged since the drug hit the market. In June 2016, the FDA required that new information be added to the drug label about the risk of acute kidney injury and other kidney issues.
In addition to cases for Jardiance, several hundred Invokana lawsuits are being pursued nationwide against the makers of this competing diabetes drug, which is the most widely used member of the class. A small group of Invokana “bellwether” cases are being prepared for early trial dates, which are expected to begin in September 2018, to help gauge how juries may respond to certain evidence and testimony that will be repeated throughout the litigation.