Invokana Lawsuit for Ketoacidosis Injury Filed Against J&J, Janssen

A product liability lawsuit filed last week against Johnson & Johnson and it’s Janssen subsidiary blames the side effects of Invokana for causing a Louisiana man to suffer severe and permanent injuries, including diabetic ketoacidosis. 

The complaint (PDF) was brought by David Lessard in the U.S. District Court Eastern District of Louisiana, indicating that the drug makers failed to adequately warn about that users may experience a dangerous build up of acid in the blood after using the new-generation diabetes medication.

Lessard indicates that he suffered diabetic ketoacidosis from Invokana after starting use of the medication in June 2015, resulting in economic and non-economic damages, including medical expenses, pain and suffering, mental anguish, and diminished enjoyment of life.

Diabetic ketoacidosis (DKA) is a medical emergency that results in the need for immediate medical treatment and may lead to long-term health complications if not promptly treated. Symptoms of DKA may include abdominal pain, nausea, vomiting, fatigue, shortness of breath or other complications.

“The development of Plaintiff’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.

The case joins a growing number of Invokana lawsuits filed in recent months, each raising similar allegations that Johnson & Johnson and it’s Janssen unit withheld important safety information from consumers and the medical community.

Invokana Side Effects

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. While the medication was quickly adopted by the medical community amid aggressive marketing by the drug maker, serious concerns have emerged about risk of Invokana side effects.

In December, the FDA announced that it is requiring new Invokana warnings about ketoacidosis, indicating that users should stop taking the drug and seek immediate medical attention if they develop symptoms. The new warnings also indicate that Invokana may cause urinary tract infections, kidney infections or blood infections, which could potentially lead to kidney infections and potentially to the development of kidney failure.

In May 2015, a report by the Institute of Safe Medication Practices (ISMP) raised concerns about the potential link between Invokana and kidney failure, noting that the new-generation diabetes drug works in a unique way by impacting the normal function of the kidneys.

ISMP analyzed adverse event reports submitted to the FDA during the first year Invokana was on the market, identified potential safety signals involving kidney damage linked to Invokana and other SGLT2 inhibitors that have hit the market, such as Farxiga, Jardiance, Invokamet, Xigduo XR and Glyxambi.

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 kidney problems involved renal 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.