Invokana Diabetic Ketoacidosis Injury Preventable if Warnings Hadn’t Been Withheld: Lawsuit

If Johnson & Johnson’s Janssen Pharmaceuticals subsidiary had provided warnings about the risk of diabetic ketoacidosis from Invokana, a Louisiana man indicates that he may have avoided severe health complications associated with the build up of acid in his blood after he switched to the new generation diabetes drug.

In a complaint (PDF) filed last week in the U.S. District Court for the Eastern District of Louisiana, Niles Monnin indicates that he was diagnosed with diabetic ketoacidosis only two months after he began taking Invokana in September 2014, resulting in severe pain, hospitalization and ongoing health complications resulting from the medical emergency.

The case is one of the latest in a growing number of Invokana lawsuits filed in recent months, alleging that the drug maker failed to adequately research the potential side effects and withheld important safety warnings from consumers and the medical community.

“Defendants… misrepresented that Invokana is a safe and effective treatment for type 2 diabetes mellitus when in fact that drug causes serious medical problems, which require hospitalization and can lead to life threatening complications, including but not limited to diabetic ketoacidosis and its sequelae, kidney failure and its sequelae,” according to the case filed by Monnin.

Invokana (canagliflozin) was just introduced in March 2013, as the first member of new class of diabetes treatments, known as sodium glucose cotransporter 2 (SGLT-2) inhibitors. These drugs work in a unique way, by altering some normal kidney functions to increase the amount of sugar excreted in the urine. However, since Invokana has hit the market, a growing number of serious health risks have been reported, leading to concerns over the lack of research before introducing the drug and decisions by the drug maker to withhold certain warnings from the initial label.

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.

However, the problems were not just limited to ketoacidosis. 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 Invokana and other 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 a new Invokana safety warning, indicating that the medication may increase the risk of acute kidney injury and other severe health problems.

As Invokana 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.

Given similar questions of fact and law raised in cases filed by individuals throughout the U.S., centralized federal pretrial proceedings have been established for the Invokana litigation before U.S. District Judge Brian Martinotti in the District of New Jersey. However, if Invokana settlements or another resolution for the cases is not reached following discovery and a series of early bellwether trials, each case may later be remanded back to the U.S. District Court where it was originally filed for a separate trial date.