The federal court overseeing hundreds of product liability lawsuits involving alleged Invokana side effects is moving forward with plans for the proceeding’s first bellwether trials.
According to a July 27th Case Management Order issued in the U.S. District Court, District of New Jersey, the parties have each been directed to identify three Invokana plaintiffs who allegedly developed diabetic ketoacidosis, as well as three who allegedly suffered kidney injuries, for inclusion in Core Bellwether Discovery Group A. Cases eligible for selection include only those lawsuits:
The list of 12 Invokana lawsuits is to be submitted to the Court no later than August 31, 2017.
By March 30, 2018, each party is to select three Invokana lawsuits alleging cardiovascular injury (heart attack, stroke, etc.) for Group B Bellwether Core Discovery. Eligible cases include those:
Bellwether Core Discovery for Group A will take place between September 1, 2017 and December 15, 2017, while Group B will undergo Bellwether Core Discovery between April 2, 2018 and August 25, 2018. Each side will be able to take four depositions per case.
Once Bellwether Core Discovery is complete for Group A, the parties are to submit separate proposals to the Court recommending four of their 12 cases for further discovery and bellwether trials. Two cases must be chosen from the ketoacidosis category and two from the kidney injury category. The selections must be submitted by January 5, 2018. The Court will make its Final Bellwether Selections by January 19th.
Once Bellwether Core Discovery is complete for Group B, the parties are to submit separate proposals to the Court recommending one of their 3 cases for further discovery and bellwether trials. Deadline for submissions is September 15, 2018. The Court will make its Final Bellwether Selection by September 29, 2018.
Invokana belongs to a class of Type 2 diabetes medications known as SGLT2 inhibitors, which lower blood sugar levels by inhibiting absorption via the kidneys. The medication was brought to market in March 2013, and was the first SGLT2 inhibitor to be approved for sale in this country.
Since coming to market, side effects potentially associated with Invokana and other SGLT2 inhibitors have prompted several U.S. Food & Drug Administration (FDA) safety alerts. In May 2015, the agency ordered the drugs’ manufacturers to update their product labels to note a potential risk of diabetic ketoacidosis. This condition occurs when toxic acids called ketones accumulate in the blood, and may lead to diabetic coma or death when not recognized and treated appropriately. At the same time, the labels were updated with new information regarding serious urinary tract infections that could result in hospitalization.
Last June, the FDA ordered the manufacturers of several SGLT2 inhibitors, including Invokana, Invokamet, Farxiga and Xigduo XR, to strengthen warnings on potential kidney side effects, after the drugs were implicated in more than 100 reports of acute renal injury.
This past May, the prescribing information for Invokana and Invokamet was modified with a new black box warning regarding a risk of leg and foot amputations. A black box is the FDA’s most urgent safety notice, and is reserved for the very serious or life-threatening side effects.