Invokana Ketoacidosis and Renal Failure Lawsuit Filed Over Failure To Warn

Johnson & Johnson’s Janssen Pharmaceuticals subsidiary failed to adequately warn that the side effects of Invokana may result in ketoacidosis and kidney failure, making it unreasonably dangerous, defective and unfit for use, according to allegations raised in a recently filed product liability lawsuit.

The complaint (PDF) was filed late last week by Michael Anderson in the U.S. District Court for the District of New Jersey, indicating that he began to suffer symptoms of ketoacidosis just days after he began using the new-generation diabetes drug, due to a dangerous increase in acid levels in his blood.

Anderson was prescribed Invokana in February 2015 for glycemic control to help treat his type 2 diabetes. However, he soon began to experience severe chest pain, shortness of breath, nausea, vomiting and abdominal pain, which led to his eventual diagnosis with diabetic ketoacidosis, acute renal failure, and lactic acidosis.

“Michael Anderson’s injuries were 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. “The conduct and the product defects were substantial factor in bringing about Plaintiffs’ injuries.”

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

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.