Lawsuit Over Invokana Ketoacidosis Side Effects That Occurred After Just One Month of Use

The diabetes drug Invokana allegedly caused a Kentucky man to suffer ketoacidosis side effects just one month after he was switched to the new-generation treatment, according to a recently filed lawsuit.

The complaint (PDF) was filed earlier this month by Ricky Bowling and his wife, Brittany, in the U.S. District Court for the District of New Jersey, naming Johnson & Johnson, it’s Janssen subsidiary, and Mitsubishi Tanabe Pharma Corp. as defendants.

Bowling indicates that he was prescribed Invokana in May 2015, only a few years after it was introduced as the a new generation diabetes treatment that works by inhibiting some kidney functions to increase the amount of sugar excreted in the urine. After suffering severe complications caused by a build up of acid in the blood, known as diabetic ketoacidosis, Bowling stopped using the drug only a month later, in June 2015.

According to allegations raised in the lawsuit, the drug makers failed to adequately research the side effects of Invokana or warn consumers and the medical community about the risk of diabetic ketoacidosis, which often results in the need for hospitalization.

Although Johnson & Johnson just introduced the medication in March 2013, the FDA has already required a number of warning label updates and a growing number of consumers are now pursuing similar Invokana ketoacidosis lawsuits after experiencing severe problems with the drug.

Invokana (canagliflozin) is the first member of a new class of diabetes drugs, known as sodium-glucose co-transporter 2 (SGLT2) inhibitors. Amid aggressive marketing by the drug maker following approval, the medication was quickly adopted by the medical community. However, it now appears the drug makers failed to adequately research the medication or warn about potential side effects.

“The development of Plaintiff Ricky Bowling’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 Invokana,” the lawsuit states. “This conduct and the product defects complained of herein were substantial factors in bringing about and exacerbating Plaintiff Ricky Bowling’s injuries.”

Invokana Risks

As  Invokana use increased, the FDA began to receive a large number of adverse event reports involving health risks that were not initially indicated on the warning label for the diabetes drug.

In May 2015, the FDA launched an investigation into the link between Invokana and ketoacidosis after identifying at least 20 reports of individuals being hospitalized due to acid problems with the drug or other members of the SGLT2 inhibitor class of diabetes medications, which also include Invokamet, Farxiga, Xigduo XR, Jardiance and Glyxambi.

The agency ultimately required Johnson & Johnson to add new Invokana warnings about ketoacidosis in December 2015, 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 September 2015, the FDA required new Invokana bone fracture warnings, indicating that the drug may lead to decreased bone density.

Over the first year the drug was on the market, the FDA also received a surprisingly large number of adverse event reports involving kidney problems with Invokana, including kidney failure, kidney impairment and other issues that may be linked to the unique mechanism of action for the new class of diabetes drugs.

According to a report issued by the Institute for Safe Medication Practices released in May 2015, Invokana received more serious adverse event reports than 92% of the other drugs regularly monitored by the group. As a result, 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.

Bowling and his wife present claims of defective manufacturing, defective design, failure to warn, breach of warranty, negligence, fraudulent misrepresentation, negligent misrepresentation, fraudulent concealment, and fraud. They seek both compensatory and punitive damages.