New Mass Tort Dockets Created for Invokana and C-Qur mesh

invokana-warning kidney-damageThe Judicial Panel for Multidistrict Litigation (JPMDL) has created new:

Invokana Diabetes Drug

The Invokana litigation consists of 55 actions involving allegations that Invokana causes diabetic ketoacidosis and kidney damage, and that defendant Janssen Pharmaceuticals, Inc. (Janssen), which developed and manufactured the drug, failed to adequately test the drug and warn of its risks.

As requested by the plaintiffs, Judge Brian R. Martinotti of the District of New Jersey will supervise the MDL. Janssen is headquartered there, and many witnesses and relevant documents are likely to be found there. In addition, 37 of the constituent actions are pending in that district, as are multiple tag-along actions.

The JPMDL declined to include other SLGT2 inhibitors in the litigation, such as Farxiga (dapagliflozin) and Jardiance (empagliflozin). Farxiga is marketed and distributed by AstraZeneca Pharmaceuticals LP, AstraZeneca LP, AstraZeneca AB, AstraZeneca PLC, and Bristol-Myers Squibb Co., and Jardiance is marketed and distributed by Boehringer Ingelheim Pharmaceuticals, Inc., Eli Lilly and Company, and Lilly USA, LLC.

Invokana went on sale in 2013 to treat type 2 diabetes by inhibiting renal glucose reabsorption with the goal of lowering blood glucose. Canagliflozin is a member of the gliflozin class of pharmaceuticals, also known as sodiumglucose cotransporter 2 (“SGLT2”) inhibitors.

Off label marketing

The defendants marketed and continue to market Invokana for off label purposes, including weight loss, reduced blood pressure, and improved glycemic control in type 1 diabetics.

In June 2016, the FDA released a safety announcement concerning canagliflozin and dapagliflozin, strengthening the existing warning about the risk of acute kidney injury for the type 2 diabetes medicines canagliflozin (Invokana, Invokamet) and dapagliflozin (Farxiga, Xigduo XR).

The FDA added a further warning for ketoacidosis, including “Reports of ketoacidosis, a serious life-threatening condition requiring urgent hospitalization have been identified in postmarketing surveillance in patients with type 1 and type 2 diabetes mellitus receiving sodium glucose cotransporter-2 (SGLT2) inhibitors, including INVOKANA.”

The FDA added even more warnings in August 2016. Also see: Health Canada Warns of Diabetic Ketoacidosis from Invokana Diabetes Drug

Atrium Medical c-qur surgical mesh
Atrium Medical C-Qur surgical mesh

C-Qur Hernia Mesh

Creation of the C-Qur mesh MDL was expected, see Parties Agree on New MDL for Atrium C-Qur Hernia Mesh. Judge Landya B. McCafferty in federal court in New Hampshire will oversee MDL 2753. Seven of the actions on the motion, as well as a number of state court cases, are pending in this district, and Atrium is headquartered there.

This litigation consists of thirteen actions pending in seven federal court districts, involving allegations that defects in defendants’ C-Qur mesh products incite an inflammatory response that promotes bowel adhesion formation, impedes proper abdominal wall fixation, and causes additional severe complications.

Judge Landya B. McCafferty in federal court in New Hampshire will oversee MDL 2753. Seven of the actions on the motion, as well as a number of state court cases, are pending in this district, and Atrium is headquartered there.

Atrium promotes the C-Qur line of surgical mesh products for permanent abdominal wall reinforcement in hernia surgeries, claiming that the C-Qur Mesh’s proprietary Omega-3 barrier coating reduces scar tissue formation between the mesh and the patient’s intestines (clinically known as “adhesions”) while promoting permanent fixation of the mesh to the abdominal wall.

 


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