Invokana Ketoacidosis Lawsuit Alleges Diabetes Drug is Unreasonably Dangerous

A Georgia woman has filed a product liability lawsuit against Johnson & Johnson and it’s Janssen subsidiary, alleging that she developed ketoacidosis from Invokana side effects, and claiming that she was sold an unreasonably dangerous diabetes drug.

The complaint (PDF) was filed by Paula Brazil in the U.S. District Court for the Northern District of Georgia on October 29, indicating that the drug manufacturers failed to adequately warn the public and the medical community that Invokana may result in users experiencing abnormally high and potentially dangerous blood acid levels.

Invokana (canagliflozin) was just introduced in March 2013, as the first member of a new class of diabetes drugs known as sodium-glucose co-transporter 2 (SGLT2) inhibitors. However, as more patients have been switched to the new diabetes treatment, a number of serious health concerns have emerged, leading to questions about whether the drug makers adequately warned about potential Invokana injury risks.

Brazil indicates that she was first prescribed Invokana by her physician on October 21, 2013, for treatment of type 2 diabetes. However, she immediately began losing significant weight and suffered nausea and repeated vomiting, the complaint indicates. She was admitted to a hospital just two weeks later, on November 3, 2013, where she was diagnosed with diabetic ketoacidosis.

Although diabetic ketoacidosis is commonly seen among type 1 diabetics, it is not often diagnosed among individuals with type 2 diabetes, which Invokana is designed to treat. The condition involves symptoms like difficulty breathing, nausea, vomiting, abdominal pain, confusion, fatigue or sleepiness, which are caused by excessive levels of acid in the blood. Ketoacidosis often requires urgent medical treatment or hospitalization.

“Invokana is unreasonably dangerous and defective as formulated, putting consumers, including Plaintiff, at an unreasonable risk of suffering injury and death,” the lawsuit states. “As the developers, manufacturers and distributors of Invokana, Defendants knew or should have known that it was associated with serious complications, including diabetic ketoacidosis.”

Brazil alleges that she almost died as a result of the Invokana ketoacidosis complications, and states that she has been left with long-term injuries.

Litigation Over Invokana

The case is the latest in a growing number of Invokana ketoacidosis lawsuits filed in recent weeks by users of the diabetes drug throughout the U.S. Similar claims have also been filed by individuals who allege they developed kidney failure from Invokana.

The momentum for the Invokana litigation has emerged since the FDA issued a drug safety warning in May 2015, indicating that it was investigating reports of high blood acid levels among users of the the SGLT2 inhibitor drugs diagnosed with diabetic ketoacidosis, ketosis or acidosis.

That same month, the Institute of Safe Medication Practices (ISMP) released a report that independently evaluated adverse event reports submitted to the FDA, identifying potential safety signals involving kidney problems with Invokana and other SGLT2 inhibitors.

The group raised questions about whether the potential risks associated with the medication may outweigh the benefits, leading some questions to be raised about whether an Invokana recall should be issued, or limitations should be placed on who receives the medication.

During the first year Invokana was on the market, ISMP highlighted 457 serious adverse event reports submitted to the FDA involving complications from Invokana. These adverse event reports typically only account for a small portion of the total problems associated with prescription medications on the market.

Many of the reported Invokana problems involved kidney failure, kidney impairment or problems with kidney stones, urinary tract infections, dehydration, hypersensitivity and abnormal weight loss. Looking at reports to the FDA’s adverse event reporting system, the ISMP found that Invokana received more serious adverse event reports than 92% of the other drugs regularly monitored by the group.

In addition to lawsuits over Invokana, product liability lawyers are also investigating similar claims involving injuries associated with other diabetes drugs that are part of the same new class of medications, known as SGLT2 inhibitors, such as Invokamet lawsuits, Farxiga lawsuits, Jardiance lawsuits, Xigduo XR lawsuits and Glyxambi lawsuits. All of the medications have been aggressively marketed since they hit the market over the past two years, but Invokana remains the most widely used of the class.