A diabetes patient from Pennsylvania says SGLT2 inhibitors like Invokana are defective, dangerous and lacking in proper warnings.

Plaintiff Rebecca H. says she started taking Invokana in November 2014 at her doctor’s direction as a treatment for her type-2 diabetes. In March 2015, she says she was hospitalized with symptoms of nausea, vomiting and dehydration. Her physicians diagnosed her with diabetic ketoacidosis.

Rebecca now believes this episode of ketoacidosis can be attributed to the Invokana she had been taking. She says she could have avoided this dangerous condition had the drug’s manufacturers issued a proper warning about the associated risk.

In her Invokana lawsuit, Rebecca names as defendants Janssen Pharmaceuticals, Johnson & Johnson, Mitsubishi Tanabe, and their associated business entities, all of whom are allegedly involved in the manufacture and sale of Invokana.

SGLT2 Inhibitors and Ketoacidosis

Invokana is also known as canagliflozin, its generic name. First approved by the FDA in 2014, Invokana is one of the newer diabetes drugs on the market. It’s used to help reduce the high levels of blood sugar associated with type-2 diabetes.

Invokana is part of a class of diabetes drugs called SGLT2 inhibitors. These drugs reduce blood sugar by inhibiting glucose reabsorption in the kidneys.

Ketoacidosis is a condition in which the blood’s acidity rises to dangerous levels. It’s caused by the presence of an excess of ketones, acidic compounds that are produced by fat metabolism.

When cells can’t get enough glucose to meet their energy needs, they start using fat for energy instead. Cells that are severely starved for glucose may produce an abundance of ketones, putting the patient at risk for ketosis.

Ketoacidosis is considered a serious medical emergency. Patients with this condition are at risk for coma and possibly death.

In May 2015, the FDA issued a drug safety communication addressing the risk of ketoacidosis associated with SGLT2 inhibitors.

The agency said that between March 2013 and June 2014, it received reports of 20 cases of ketoacidosis suffered by patients taking these drugs. All patients reportedly required emergency room treatment or hospitalization.

The FDA followed up in December 2015, adding a new warning to the label for SGLT2 inhibitors about the risk of ketoacidosis. The agency now recommends patients stop taking their SGLT2 inhibitor immediately and seek medical attention if they experience any symptoms of ketoacidosis.

The Invokana MDL

Dozens of other patients who had an experience similar to Rebecca’s have brought Invokana lawsuits of their own. Many of these patients believe the makers of Invokana and similar drugs knew about the risk of ketoacidosis but kept that information to themselves to avoid harming sales of their drugs.

In anticipation of more such claims being filed, the federal court system has created a multidistrict litigation, or MDL, to handle them all. All relevant cases will be transferred to a federal court in New Jersey, where U.S. District Judge Brian R. Martinotti will oversee coordinated pretrial procedures.

Rebecca’s Invokana Lawsuit is Case no. 3:17-cv-01636. The Invokana MDL is In re: Invokana (Canagliflozin) Products Liability Litigation, MDL No. 2750, in the U.S. District Court for the District of New Jersey.