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A small group of Invokana cases, involving claims that the controversial diabetes drug caused users to develop kidney failure or diabetic ketoacidosis, will be selected this month to serve as potential bellwether trials in the federal mutidistrict litigation (MDL).
There are currently at least 445 product liability lawsuits filed against Johnson & Johnson’s Janssen Pharmaceuticals in the federal court system, each presenting similar allegations that inadequate warnings were provided for users and the medical community about the potential side effects of Invokana.
Given similar questions of fact and law raised in the cases, the federal litigation has been centralized before U.S. District Judge Brian Martinotti in New Jersey since December 2016, 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.
In a case management order (PDF) issued on July 27, Judge Martinotti indicated that each side should select six cases as potential bellwether candidates by the end of this month.
To provide a group that is representative of other claims in the litigation, the order indicates that plaintiffs and defendants must each select three cases involving diabetic ketoacidosis from Invokana, with the other three involving Invokana kidney failure cases.
Each of the bellwether selections must have been filed before July 31, and must involve plaintiffs who had Type 2 diabetes and used Invokana. In addition, plaintiff selected for the bellwether trial pool must have a substantially complete Plaintiff Fact Sheet served on or before July 31.
The pool of 12 potential bellwether trials must be submitted to the Court by August 31.
“In selecting their respective six (6) cases, the parties are strongly encouraged to select cases that they have a good faith belief are representative cases that should be robustly discovered and then taken to trial,” Judge Martinotti ordered.
A second batch of bellwether cases, designated Group B, will involve a total of six claims involving cardiovascular injuries from Invokana, such as heart attacks and strokes. Each side has been ordered to submit three selections for that pool of potential bellwether cases by March 30, 2018. Those Invokana cases must be drawn from lawsuits filed and submitted with a substantially completed Plaintiff Fact Sheet by February 16, 2018.
In recent weeks, 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.