Product News and Recalls

Trouble for Diabetes Drug Makers?

invokana and farxiga mdls to move forwardKnown as SGLT2 inhibitors for short, sodium glucose co-transporter 2 inhibitors are a class of drugs intended for certain individuals with Type II diabetes. The drugs prevent glucose from being absorbed in the kidneys and reduce glucose in the blood by causing it to be expelled in the urine.

Unfortunately, this relatively new class of drugs has already allegedly caused enough harm to warrant FDA action and a slew of negative press. And, in the latest news, enough Invokana lawsuits and Farxiga lawsuits have accumulated to justify the formation of two MDLs, or multi-district litigations.

In September 2016, a motion was filed with the U.S. Judicial Panel on Multidistrict Litigation (JPML) to establish an Invokana MDL. In December, that request was granted and dozens of Invokana lawsuits were transferred to the District Court of New Jersey. In these cases, drug maker Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson, is facing claims that Invokana caused injuries like ketoacidosis and kidney failure in users.

Ketoacidosis may be life-threatening. The condition occurs when there is not enough insulin in the body and cells are unable to get the glucose they need for energy. Glucose that can’t get into the cells stays in the blood and is removed through urine; meanwhile, the body begins to break down fat and muscle for energy when the cells find themselves deprived of glucose. This results in ketones, or fatty acids, being produced and entering the bloodstream, causing a chemical imbalance known as diabetic ketoacidosis.

In forming the In Re: Invokana (Canaglifozin) Products Liability Litigation, MDL Docket No. 2750, the JPML noted the actions involve common questions of fact, and that centralization of these cases will serve “the convenience of the parties and witnesses and promote the just and efficient conduct of this litigation.” The panel, however, limited the MDL to cases involving only the SGLT2 inhibitor Invokana.

Now, the latest SGLT2 inhibitor to become the focus of lawsuits is Farxiga. This SGLT2 inhibitor was developed and is sold by AstraZeneca and Bristol-Myers Squibb. Federal Farxiga lawsuits recently received MDL status and were transferred to the Southern District of New York. The original 18 cases included in In Re: Farxiga (Dapagliflozin) Products Liability Litigation, MDL Docket No. 2776, allege, like Invokana lawsuits, that use of the medication causes patients to suffer from ketoacidosis and kidney damage.

The number of Farxiga lawsuits and Invokana lawsuits will likely continue to grow, as both products remain available by prescription. We will monitor the status of the MDLs, as well as any SGLT2 inhibitor litigation in general.