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A recent regulatory filing highlights the rapidly growing number of Invokana lawsuits Johnson & Johnson is facing, each raising similar allegations that the company’s Janssen Pharmaceuticals subsidiary failed to warn about serious risks associated with the new-generation diabetes drug, including kidney failure, diabetic ketoacidosis, heart attacks and even leg and foot amputations.
In a quarterly financial filing with the Securities and Exchange Commission (SEC), Johnson & Johnson reported that there were about 800 product liability cases pending over the side effects of Invokana, as of late last month.
The number represents a sharp increase since the beginning of the year. However, as Invokana injury lawyers continue to review and file additional cases over the coming months and years, the size of the litigation is expected to continue to increase dramatically.
Given similar questions of fact and law raised in the lawsuits filed throughout the federal court system, the U.S. Judicial Panel on Multidistrict Litigation (JPML) established consolidated pretrial proceedings in December 2016, at which time there were only about 55 Invokana cases pending in U.S. District Courts nationwide
The Invokana litigation is centralized before U.S. District Judge Brian Martinotti in the District of New Jersey to reduce duplicative discovery into common issues, avoid conflicting pretrial rulings and to serve the convenience of the parties, witnesses and the courts.
As part of the consolidated MDL proceedings, Judge Martinotti has indicated that a small group of Invokana “bellwether” cases will be prepared for early trial dates, which are expected to begin in September 2018. Representative claims will go to trial to help the parties gauge how juries may respond to certain evidence and testimony that is likely to be repeated throughout the litigation.
“The number of pending product liability lawsuits continues to increase, and the Company continues to receive information with respect to potential costs and the anticipated number of cases,” the Johnson & Johnson reported in the SEC filing.
In addition to the claims filed as part of the Invokana MDL, the filing notes that there are still separate federal cases pending in the Southern District of California and the Eastern District of Missouri, as well as state court cases pending in California, New Jersey and Pennsylvania. Johnson & Johnson also faces a number of Invokana class action lawsuits filed in Canada.
While most of the cases have involved kidney failure and diabetic ketoacidosis claims, a growing number of Invokana amputation lawsuits have also been filed, involving allegations that side effects of the diabetes drug also increase the risk that users may lose their leg or foot.
This new area of litigation emerged after the FDA required new Invokana warnings about the amputation risk in May 2017, which is a risk not associated with other diabetes drugs in the same new class of medication.
The warnings were supported by a study published a month later in the New England Journal of Medicine, which found that Invokana use increased the risk of amputations by 97%.
While the outcome of early bellwether cases that go to trial before Judge Martinotti will not be binding on other plaintiffs, they are likely to heavily influence eventual Invokana settlement negotiations that may be necessary to avoid the need for hundreds of separate trials to be held in U.S. District Courts nationwide.