Direct Filing of Invokana and Atrium C-Qur Lawsuits Now Permitted in Federal MDLs

In separate pretrial orders, the courts overseeing federal multidistrict litigation for Invokana and for Atrium C-Qur both ruled that plaintiffs may file their claims directly in the proceedings.

Direct filing eliminates delays involved in the transfer or removal of cases from other federal district courts.

Invokana MDL

The US Judicial Panel on Multidistrict Litigation (JPMDL) created the Invokana MDL on December 12, 2016. Plaintiffs charge that taking Invokana or Invokamet may result in patients suffering various injuries, including diabetic ketoacidosis and kidney damage. The actions thus implicate many common issues about the development, manufacture, testing, regulatory history, promotion, and labeling of the drugs.

Direct filing does not stop the running of any statute of limitation or determine the choice of law. It does not constitute a waiver of Lexecon v. Milberg Weiss, 523 U.S. 26 (1998), which holds that MDL transferee judges lack authority to try cases that originated outside of the transferee court. Upon completion of pretrial proceedings to a directly-filed case, the court will transfer that case to the district court based on the district designated in the complaint.

Any attorney in good standing in any federal court is admitted pro hac vice in the litigation.

Atrium C-Qur mesh MDL

The JPMDL created the Atrium Medical Corp. C-Qur Mesh Products Liability MDL on December 8, 2016. The plaintiffs allege that defects in defendants’ C-Qur mesh products incite an allergic or inflammatory response that causes severe complications. All the actions involve factual questions about whether C-Qur mesh was defectively designed or manufactured, whether defendants knew or should have known of the alleged propensity of C-Qur mesh to result in an allergic or inflammatory response, and whether defendants provided adequate instructions and warnings with the mesh.

Direct filing does not constitute a determination that venue is proper, has no impact on the choice of law including the statute of limitation.

Atrium is one of many hermia patch manufacturers facing lawsuits over making defective products. More hernia mesh MDLs may be created –  See MDL Motion Expected in Ethicon Physiomesh Hernia Repair Product Litigation.

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C-Qur Hernia Mesh Judge Pauses Discovery in New MDL

U.S. District Judge Landya B. McCafferty stayed all discovery proceedings in Pretrial Order No. 1, until an initial case management conference is held on February 24 in Atrium Medical Corp. C-Qur Mesh Products Liability Litigation.

At the conference, attorneys can express interest in the roles of lead counsel. The judge appointed Robert Bonsignore of Bonsignore Trial Lawyers PLLC of Las Vegas, NV, as temporary lead counsel.

Introductory briefs in the case, MDL Docket No. 16-md-2753-LM in the US District Court of New Hampshire, are due February 17 concerning the parties’ views on the appointment of a plaintiffs’ steering committee, the nature of the action and principal defenses, whether a consolidated complaint should be filed, and a list of all prior settlement discussions.

Inflammatory bowel response

Since the Judicial Panel on Multi-district Litigation created MDL 2753 on December 1, a total of 21 actions have been filed.

The litigation involves 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.

The company announced a worldwide market withdrawal of the product on May 25, 2016, after unpublished registry data indicated that Physiomesh was associated with higher recurrence and revision rates after laparoscopic ventral hernia repair compared to another set of mesh. A Physiomesh lawsuit pending in the U.S. District Court, Southern District of Illinois, will likely be the first case to go to trial, with jury selection scheduled to begin on January 22, 2018. (Case No. 3:16-cv-00368-JPG-PMF).

Atrium, which is headquartered in New Hampshire 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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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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JPMDL Creates New MDL 2753 for Atrium C-Qur Hernia Mesh

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

The Judicial Panel on Multidistrict Litigation (JPMDL) on Dec. 8, 2016 created the new MDL 2753 to consolidate lawsuits over Atrium Medical Corp. polypropylene surgical mesh patches.

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.

Causes complications

The plaintiffs charge that the C-Qur mesh incites an inflammatory response that promotes bowel adhesion formation, impedes proper abdominal wall fixation, and causes additional severe complications.

Atrium agreed in a brief filed on Nov. 1 that the MDL should be assigned to US District Judge Landya B. McCafferty in Concord, New Hamshire.

  • Atrium, based in Merrimack, NJ, had sales of $200 million in 2011, with the U.S. market accounting for 70% of sales and the remaining 30% sales through proprietary sale offices in the United Kingdom, Germany, France, the Netherlands, India, Australia and New Zealand.
  • Half of the pending cases are in the District of New Hampshire and no other district has more than one C-Qur Action.

A total of 15 cases are pending in seven different federal districts. Discovery has already begun in Zissa v. Atrium Medical Corporation, Civil Action No. 5:15-CV-00718 DAE, Western District of Texas, and in Fergerson v. Atrium Medical Corporation, Civil Action No. 2:16-cv-02058, District of Kansas.

Key plaintiff attorneys include Robert J. Bonsignore of Bonsignore, LLC in Belmont, NH, Aaron Broussard of Broussard & Hart in Lake Charles, LA, and Adam M. Evans of the Hollis Law Firm in Prairie Village, KS.

 

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