Mesh Medical Device News Desk, February 6, 2017~ The latest hernia mesh complications product to be placed in multidistrict litigation is C-QUR made by Atrium Medical. It is coated with fish oil, which creates problems for integration into the body says the first case to be filed.
Multidistrict litigation involving C-Qur hernia mesh has formed in New Hampshire. An initial case management meeting will be held before Judge Landya McCafferty, US District Court Judge on February 24. Until then, she has issued a stay on all discovery.
The Action was transferred to this court from the Middle District of Georgia on December 8, 2016 by the Judicial Panel on Multidistrict Litigation (JPML).
As of January 13, 2017 there were cases in Arizona, the Northern District of Florida, Middle District of Georgia, Northern District of Georgia, Southern District of Indiana, Kansas, Eastern District of Louisiana, Southern District of Mississippi,, Eastern District of Missouri, 8 cases from New Hampshire, Northern District of Ohio, Eastern District of Tennessee, Western District of Texas, at least 21 cases so far.
Temporary Lead Counsel is Robert J. Bonsignore of Las Vegas. Aylstock, Kreis and Overholtz along with Blasingame Burch Garrard, filed cases last September, 2016 in the District Court for the Middle District of Georgia (Athens) but those cases were closed December 19, 2016.
The Initial Complaint for Plaintiff J. A. Bryant, and her husband, (3:16-cv-00123-CDL), names Atrium Medical Corporation, Maquet Cardiovascular, LLC and Getinge AB, all are defendants.
Atrium Medical is incorporated under the laws of Delaware. At one time its manufacturing and support facilities were located in Hudson, NH. Maquet Cardiovascular, LLC is an LLC organized under the laws of New Jersey, with principal place of business in Wayne, NJ. Atrium has operated within, and as a business unit of Maquet.
Getinge AB is a Swedish corporation and is located there. At times Maquet was a wholly-owned subsidiary of Getinge AB, which is a holding company to coordinate the administration, finances and activities of its subsidiary companies. In 2011, Getinge acquired Atrium through a merger. It also acquired Atrium’s assets and assumed liabilities. Maquet has direct control over Atrium’s activities.
Getinge and Maquet manufacture and sell C-Qur product line. It is listed as one of the product lines of Maquet Getting Group’s biosurgery products. www.maquet.com http://www.maquet.com/us/productsw/C-QUR-mesh/?ccid=231.
“Because Atrium’s assets and capital are subject to the ownership and control of Maquet and Getinge, Atrium is undercapitalized and the failure to disregard Atrium’s corporate form would result in the inequitable and unjust result that Plaintiffs may be unable to satisfy any judgment ultimately obtained against Atrium.”
So Defendants are “vicariously liable” for the acts and or omissions of its employees and/or agents, says the Complaint.
The company makes:
- C-Qur: The original Omega 3 fatty acid hernia mesh for open and laparoscopic hernia repair.
- C-Qur Edge: The only C-Qur hernia mesh to be recalled.
- C-Qur V-Patch: Mesh for the repair of small hernias such as umbilical, epigastric and trocar site defects.
- C-Qur Tacshield: Mesh for the surgical repair of medium to large size open ventral hernia repairs.
- C-Qur FX: Mesh for open and laparoscopic hernia repair.
- C-Qur CentriFX: See-thru clarity mesh designed for lateral and medial hernia defects.
- C-Qur Mosaic: See-thru clarity mesh for open and laparoscopic hernia repair.
- C-Qur Film: Intended as an adjunct in abdominal and pelvic surgery to reduce the incidence, extent and severity of postoperative adhesions.
The Atrium C-Qur hernia mesh lawsuits includes all types of C-Qur mesh.
Ms. Bryant was implanted May 23, 2014. According to her Complaint, she suffered severe injury caused by the C-QUR mesh which spontaneously drained to the abdomen and nerve damage to the abdomen. Her surgeon removed the defective C-QUR September 9, 2014 and found a sclerotic area of tissue, and inflamed tissue, but not infected. Due to the mesh failure, she was forced to undergo another surgery for abdominal hernia expansion March 19, 2015 at Emory University Hospital. She was out of work for six weeks and experienced pain from scar tissue buildup and nerve damage to the abdomen.
THE MESH PRODUCT
According to the Bryant complaint – the C-QUR has an Omega 3 gel coating derived from fish oil over polypropylene. It is sold as promoting incorporation into the body. Instead the Omega 3 coating prevented incorporation and cause an intense inflammatory and chronic foreign body response resulting in an adverse tissue reaction including damage to surrounding tissue in the form of sclerotic, granulomatous and/or fibrotic, unhealthy, tissue and improper healing. Additionally the fish oil coating was not uniformly applied causing it to roll, curl and deform upon insertion in the body. It also fails to conform to the manufacturer’s specification in terms of shelf-life, thickness, durability and quality.
She nor her implanting physician were adequately warned. It failed to perform as intended. It was the direct and proximal cause of her removal necessity. The product is defective in its manufacture and in its warranty, says the complaint.
Because defendants have acted in bad faith, Plaintiffs are entitled to an award of their expenses of litigation and attorneys’ fees against Defendants.
ATRIUM AND ITS HISTORY
When Ethicon pulled its Physiomesh from the market in May 2016, it sent a letter to doctors alerting them to the recall. A few weeks later, Getinge and Maquet sent additional letters to doctors to capture the Physiomesh market. Here is that letter.
Prior to that in October 2012, the FDA issued warning letter to Atrium Medical Corporation complaining the company7 had not addressed multiple complaints related to infections with C-QUR hernia mesh. There were problems with sterility of the product with human hair found in some devices purported to be sterile. thee were problems with hearing during the manufacturing process that had led to some mesh being burned.
By August 9, 2013 the FDA announced a class 2 recall of C-QUR Edge mesh because some of the coating was adhering to the inner packaging liner. 1,501 meshes were recalled. The FDA has issued a permanent injunction stopping the manufacture and distribution of C-QUR at the Hudson facility. Production will be halted until the FDA finds the manufacturing, processing, packing holding and distribution are in compliance.
C-Qur MDL formed in New Hampshire
January 13, 2017
Official docket of the MDL is: 16-md-2753-LM
For the US District Court for the District of New Hampshire, Atrium Medical Corp. C-Qur Mesh
Products Liability Litigation MDL No. 2753
Initial case management will be held Feb. 24, 2017. Until then, discovery is stayed per Judge.
Hollis Law here: