Ketoacidosis Lawsuit Filed Over Invokana Side Effects

According to allegations raised in a product liability lawsuit filed this week, side effects of Invokana caused an Arizona woman to develop ketoacidosis, a serious medical emergency that has left her with severe pain and permanent injuries.

The complaint (PDF) was filed by Gail Chafe in the U.S. District Court for the District of New Jersey on October 4, alleging that Johnson & Johnson, it’s Janssen Pharmaceuticals subsidiary and Mitsubishi Tanabe Pharma Corp. failed to adequately warn consumers or the medical community about the sever health risks associated with the diabetes drug.

Invokana (canagliflozin) is was introduced in March 2013, and has been aggressively marketed as a new type of diabetes treatment, which works in a unique way by impacting the normal function of the kidneys. However, as more individuals have been switched to the new drug, a steady stream of serious health risks have been uncovered, resulting in dozens of Invokana lawsuits alleging that the drug makers sold an unreasonably dangerous and defective product.

Chafe indicates that she began taking Invokana in May 2014, and continued to use the diabetes drug until about September 2015. According to the lawsuit, as a direct result of Invokana she developed diabetic ketoacidosis, which involves a dangerous build up of acid levels in the blood.

Ketoacidosis can cause swelling of the brain, low blood sugar, low potassium and other complications. It often requires emergency hospitalization and can be fatal in extreme cases. Most cases of diabetic ketoacidosis linked to Invokana have resulted in severe pain and on-going injuries, which Chafe and other plaintiffs allege could have been avoided if adequate warnings had been provided.

“Despite Defendants’ knowledge of the increased risk of severe injury among Invokana users, Defendants did not warn patients but instead continued to defend Invokana, mislead physicians and the public, and minimize unfavorable findings,” the lawsuit states. “Consumers, including Plaintiff, who have used Invokana for treatment of diabetes, have several alternative safer products available to treat the conditions.”

Chafe notes that Invokana was one of the Defendants’ top selling drugs, generating sales of $278 million in just the first quarter of 2015. However, the lawsuit points out that she never would have agreed to take Invokana if the ketoacidosis risks had been properly disclosed.

Invokana Lawsuits

Invokana was the first member of a new class of diabetes drugs introduced in recent years, known as sodium-glucose co-transporter 2 (SGLT2) inhibitors, which work in a unique way from other diabetes treatments. Other members of this class include Invokamet, Farxiga, Xigduo XR, Jardiance and Glyxambi.

Amid aggressive marketing and promotion by the drug makers, Invokana quickly became a popular and widely used medication. However, as more and more individuals began to use the drug, the FDA has required the drug maker to add a number of new warnings.

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.

In addition to concerns about ketacidosis, a number of lawsuits filed against the drug maker alleging that the drug makers knew or should have suspected that Invokana increases the risk of kidney failure.

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, the FDA released 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. A motion is currently pending with the U.S. Judicial Panel on Multidistrict Litigation (JPML) to consolidate and centralize the litigation before one judge for coordinated pretrial proceedings.

If an Invokana MDL is established, Chafe’s case, as well as other ketoacidosis lawsuits, kidney failure lawsuits and heart attack lawsuits filed against the makers of the diabetes drug would be handled in a coordinated manner to reduce duplicative discovery into common issues, avoid conflicting pretrial rulings from different courts and to serve the convenience of the parties, witnesses and the courts.