Invokana Kidney Failure Lawsuit Alleges Diabetes Drug is “Unreasonably Dangerous”

Johnson & Johnson and it’s Janssen Pharmaceuticals subsidiary failed to adequately warn consumers and the medical community about the potential link between Invokana and kidney failure, according to allegations raised in a recently filed product liability lawsuit, which describes the new-generation diabetes drug as “unreasonably dangerous.”

The complaint (PDF) was filed by Rose Ann Adye on February 19, in the U.S. District Court for the Western District of Kentucky, joining a growing number of lawsuits filed nationwide by individuals who indicate that they suffered kidney failure, ketoacidosis or other injuries following use of Invokana, which has become a blockbuster drug since it hit the market in March 2013.

Adye indicates that she was prescribed Invokana for treatment of type 2 diabetes in November 2014, less than two years after Johnson & Johnson’s Janssen unit introduced the medication as a new generation drug, which works in a unique way by inhibiting some normal kidney functions to increase the amount of sugar excreted in the urine.

By February 2015, Adye indicates that she was hospitalized for acute kidney injury and acute kidney failure, indicating that the conditions were caused by the side effects of Invokana.

“Due to the defective nature of Invokana, persons who were prescribed and ingested it, for even a brief period of time, including the Plaintiff, were at increased risk for developing serious, and sometimes life-threatening, complications, including kidney failure,” the lawsuit states. “The Defendants did not adequately warn of increased risk of kidney failure and other serious complications associated with Invokana, merely indicating that there was a risk for kidney problems, without addressing the specific increased risk of kidney failure or the extent of that risk associated with Invokana.”

Invokana (canagliflozin) was the first member of a new class of diabetes drugs that have been introduced in recent years, 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 the safety of Invokana.

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), which 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 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.

Adye’s case joins dozens of other Invokana lawsuits filed in recent months, and it is widely expected that hundreds, if not thousands, of other complaints will be filed in courts nationwide over the next year.