COVID-19 Might Delay First Atrium C-Qur Hernia Mesh Trial

COVID-19 Might Delay First Atrium C-Qur Hernia Mesh Trial

Introduction

The U.S. District Judge Landya McCafferty is considering postponing the start of the first bellwether trial over lawsuits involving Atrium C-Qur hernia mesh, due to the current outbreak of coronavirus.

According to a motion filed on April 8, the defendant asked the court to delay the start of the trial to more than six months and extend all pretrial deadlines by about 90 days.

The original trial was scheduled to begin on May 20, which might be pushed back to January 2021. The defendant requested expedited consideration of the motion, following the fast-approaching deadlines associated with the original trial date.

The Court had set continued deadlines for selecting the final trial cases that were supposed to be done this week, and the plaintiffs have been ordered to file a response on or before April 16.

C-QUR mesh products, utilized for hernia and another soft tissue repair, act as permanent implants. Atrium’s C-QUR hernia mesh products incorporate a fish-oil-derived coating, a component the company claimed would prevent adhesions and inflammations, therefore reducing potential hernia mesh complications.

Several studies suggest C-QUR products may have a higher rate of infection and adhesion compared to other types of mesh. Multiple reports of patient complications such as bowel obstructions, hematoma, seroma, and fistula formation, have been received by the U.S. Food and Drug Administration. 

The company’s history of legal scrutinization started years ago when the FDA sent Atrium a warning in 2012 following an inspection that revealed critical problems with sterilization and manufacturing procedures. The FDA noted complications as early as 2008 and held four inspections on the C-QUR manufacturing plant between 2009 and 2013.

Subsequently, in 2013, the FDA solicited an order to stop the manufacturing of C-QUR until these issues were properly addressed. More than 145,000 C-QUR units were recalled during this year. Atrium paid 6 million dollars for the issues outlined in the injunction and agreed to pay another $6 million if the problems were not corrected shortly.

Ethicon Physiomesh is a flexible, composite, macroporous, and partially absorbable mesh made of non-absorbable polypropylene by Johnson & Johnson. FDA approved the use of Ethicon Physiomesh in March 2010 for the repair of hernias and other fascial deficiencies that require the addition of strengthening or bridging material to obtain the desired surgical result. A hernia is a condition that occurs when an organ, intestine, and/or tissue squeezes through a hole or weak point in the surrounding muscle or connective tissue. The number of hernia repair operations performed every year in the USA is remarkable.

Despite the already existing mesh implants in the market, the sale of Ethicon Physiomesh increased after the FDA approval as it was promoted as a physiologically well-designed device, offering strong and comfortable healing and giving an exceptional intraoperative handling benefit. But within a few years, Ethicon globally recalled the Physiomesh after thoroughly considering the data which was revealed out of Hernia registries.

Currently, Atrium Medical Corp. faces nearly 2000 product liability lawsuits throughout the federal court with the allegations that the C- Qur hernia mesh system increases the risk of an inflammatory response, bowel adhesions, and other painful complications, often resulting in additional surgery.