Lawsuit Over Invokana Alleges Acute Kidney Injury Caused by Diabetes Drug

A recently filed product liability lawsuit alleges that Johnson & Johnson downplayed the risk of kidney failure from Invokana, indicating that “kidney problems” were only a “possible side effect,” even though individuals nationwide have reported severe and potentially life-threatening complications after taking the new-generation diabetes drug.

The complaint (PDF) was filed by Loris Furlow in the U.S. District Court for the Central District of California on February 29, naming Johnson & Johnson and it’s Janssen Pharmaceuticals subsidiary as defendants.

Furlow indicates that she was began using Invokana for treatment of type 2 diabetes in April 2014, about one year after it was first introduced by the drug maker and heavily marketed to consumers and medical providers as a safe and effective treatment. However, Furlow indicates that Johnson & Johnson knew that side effects of Invokana may increase the kidney failure risk.

In March 2015, Furlow indicates that she was hospitalized due for acute kidney injury and kidney failure, which she blames on use of Invokana, indicating that she never would have used the new-generation treatment if the risks were adequately disclosed, as safer alternatives were available.

“Invokana is unreasonably dangerous and defective as formulated, putting consumers, including Plaintiff, at an unreasonable risk of suffering injury and death,” according to the complaint filed by Furlow. “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 extend of that risk associated with Invokana.”

The case joins a growing number of lawsuits over Invokana kidney failure injuries filed by individuals nationwide, each involving similar allegations.

Furlow seeks both compensatory and punitive damages under theories of strict liability, design defect, failure to warn, negligence, breach of warranty, fraud, misrepresentation, fraudulent concealment, negligent misrepresentation and violation of fair business practices.

Invokana Risks

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.

In addition to complaints filed by individuals diagnosed with kidney failure, Johnson & Johnson also faces a number of Invokana ketoacidosis lawsuits brought by individuals hospitalized due to this dangerous condition, which causes a build up of acid levels in the blood.