Invokana Lawsuits Consolidated into MDL in New Jersey

November 20, 2017, 1:30PM. By Anne Wallace

Trenton, NJThe FDA warns of fracture risk with Invokana and Invokamet and more recently of a higher risk for foot and leg amputation. The lawsuit chickens have now come home to roost.

As of November 7, 2017, 943 Invokana lawsuits had been filed in the US District Court for the District of New Jersey. These have now been consolidated into Invokana Multidistrict Litigation (MDL) 2750. Although the MDL is still in early stages, this may be the beginning of a just resolution for patients who have been injured because of the failure of Janssen Pharmaceuticals and its parent, Johnson & Johnson, Co., to disclose the dangers posed by the drug.

Since it was first approved by the FDA in 2013, Invokana (canagliflozin) has been prescribed more than 5 million times for the treatment of Type 2 diabetes in adults. Janssen and J&J have also marketed the drug for off-label purposes, including weight loss, blood pressure reduction, and improved glycemic control in type 1 diabetics. No surprise, it has been a big money maker -- $278 million in just the first quarter of 2015.

During the same period, however, evidence continued to mount linking the drug to an increased risk of various side-effects, including diabetic ketoacidosis, stroke, heart attack, severe kidney damage and gangrene resulting in the need for amputation of toes, feet and legs. As of May 2017, the drug label for Invokana must include an FDA ”Black Box Warning” to advise users about an increased risk of leg and foot amputations.

The lawsuits making up MDL 2750 allege, among other things, that the defendants:
• refused to conduct proper safety studies:
• failed to publicize alarming safety signals;
• suppressed information revealing serious risks; and
• willfully misrepresented the nature and safety of Invokana,
all while conducting an aggressive marketing campaign to make the drug a financial powerhouse. The Invokana product liability complaints are heavily laced with imprecations of corporate greed and dishonesty.

The MDL process can be slow and laborious, but there is a rough relationship between the number of lawsuits consolidated and the ultimate size of the settlement offer. At this early date, the situation looks fairly promising for plaintiffs. Even if settlements or other resolutions of the lawsuits are not reached during the MDL process, the claims involved in the litigation may later be remanded to U.S. District Courts nationwide for separate trials.