U.S. District Judge Landya McCafferty, who presides over all Atrium C-Qur hernia mesh lawsuits, is considering rescheduling the first bellwether trial to the beginning of 2021. Initially scheduled for May 2020, the trial date is being reconsidered in lieu of the ongoing coronavirus pandemic. Atrium C-Qur victims have developed infections requiring extensive antibiotic treatment, infections, bleeding, seromas and revision surgeries.
Atrium Medical Corporation, a medical device manufacturer based in the U.S., is primarily noted for its soft tissue and hernia repair products, in addition to its coronary and peripheral stents and catheters.
C-QUR mesh products, utilized for hernia and other 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.
However, several studies suggest exactly otherwise: 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 in the near future.[i]
In December 2016, the U.S. Judicial Panel on Multidistrict Litigation (JPML) established combined pretrial proceedings for Atrium C-QUR hernia mesh cases, centralizing the cases under Judge Landya McCafferty. This litigation is set to take place in the court of the District of New Hampshire.[ii]
While the first trial had been scheduled to commence on May 20, discussions of disruptions in regard to COVID-19, in addition to a motion filed on April 8 by Atrium asking for a six month delay, has postponed the case to January 2021.
With Atrium facing nearly 2000 product liability lawsuits, the hernia mesh litigation continues to grow under the claim that C-QUR products trigger an allergic or inflammatory risk in users.