Atrium C-Qur V-Patch Lawsuit Alleges Infections, Hernia Mesh Failures Due to Design Problems

According to allegations raised in a recently filed product liability lawsuit, Atrium C-Qur mesh failures that have caused hernia repair patients to experience complications and the need for revision surgery in recent years are the result of design problems with the hernia patch, which the manufacturer has allegedly ignored for years. 

The complaint (PDF), was filed last week by Lynn Mizell in the U.S. District Court for the District of New Jersey, naming Atrium Medical Corporation, Getinge AB, and Maquet Cardiovascular US Sales, LLC as defendants.

Mitzell indicates that her surgeon’s implanted a 10 by 14-inch Atrium C-Qur V-Patch in September 2012, during a procedure to repair an incarcerated ventral hernia. However, only a few months later, she developed signs of infection and underwent additional hernia repair surgery, where doctors found that a large portion of the mesh was incorporated, and needed to be removed from her body. The hernia repair wound was found to be severely contaminated.

Atrium C-Qur, which is pronounced “secure”, has been widely used during hernia repair since March 2006, containing a polypropylene mesh that has an Omega-3 fatty acid (O3FA) gel coating, which is designed to reduce scar tissue formation, while promoting fixation of the mesh to the abdominal wall. However, a growing number of individuals nationwide have filed similar lawsuits alleging that they experienced problems due to a fish oil that coating causes an inflammatory response</a, promoting bowel adhesion and causes other painful complications.

“For years the Defendants have been notified and warned about the widespread catastrophic complications associated with the C-Qur Mesh by leading hernia repair specialists, surgeons, hospitals, patients, internal consultants, and employees,” the lawsuit states. “However, not a single C-Qur Mesh has been formally recalled from the market. Defendants have misrepresented the efficacy and safety of the C-Qur Mesh, through various means and media, actively and intentionally misleading the medical community, patients, and the public at large.”

Mizell and other plaintiffs pursuing hernia patch lawsuits allege that Atrium knew or should have known about problems with the C-Qur V-Patch, but withheld information from consumers and the medical community. Rather than issuing an Atrium C-Qur mesh recall, plaintiffs allege that the manufacturer decided to quietly remove certain products from the market.

Given the similar questions of fact and law raised in dozens of cases filed throughout the federal court system, the U.S. Judicial Panel on Multidistrict Litigation (JPML) decided to consolidate all Atrium C-Qur lawsuits in December 2016, centralizing claims before U.S. District Judge Landya McCafferty in the District of New Hampshire, for coordinated pretrial proceedings.

As part of the coordinated pretrial proceedings, it is expected that Judge McCafferty is expected to schedule a series of early “bellwether” trials, which are designed to help the parties gauge how juries are likely to respond to certain evidence and testimony that may be repeated throughout the litigation.

Mizell’s case will be transferred to the MDL for discovery and pretrial proceedings. However, if Atrium CQur mesh settlements or another resolution is not reached following the MDL process, Mizell’s case and each individual lawsuit may be remanded back to the U.S. District Court where it was originally filed for a separate trial date in the future.