December 13, 2016 — The U.S. Judicial Panel on Multidistrict Litigation (JPML) has centralized 21 lawsuits involving allergic or inflammatory reactions to Atrium C-QUR hernia mesh coated in fish oil (Omega-3).
Federal judges issued an order (PDF) transferring all C-QUR Mesh lawsuits into the U.S. District Court for New Hampshire under Judge Landya B. McCafferty — In Re: Atrium Medical Corp. C-QUR Mesh Products Liability Litigation — Multi-District Litigation (MDL No. 2753).
All of the lawsuits allege that defects in C-QUR Mesh cause an allergic or inflammatory response that can lead to severe complications. In many cases, patients require surgery to remove it.
C-QUR Mesh is the only type of hernia mesh on the market that is coated in fish oil (Omega-3) gel. This coating is advertised as an “anti-adhesion barrier,” but some people develop severe adhesions.
In July 2013, Atrium issued Class II recalls for over 100,000 units of C-QUR V-Patch Mesh, C-QUR Edge Mesh, and C-QUR TacShield Mesh. The recall was issued because the fish oil gel coating could peel off and stick to the inside of its package when exposed to high humidity.
Over the next few years, many lawsuits were filed by people who were severely injured when the gel coating peeled off inside their body. Atrium blamed the problem on the package, which is why the recalled C-QUR Mesh products were never actually removed from the market.
According to one lawsuit (PDF) filed in Georgia, lawyers said Atrium “stealth recalled” C-QUR Mesh that was linked to high rates of side effects by simply halting production, never notifying doctors or patients.
Lawyers also say the fish oil gel coating requires a “dry” sterilization process that does not effectively prevent certain types of infections. In 2012, the FDA sent Atrium a warning letter for poor manufacturing practices, noting 35 confirmed cases of hair being found in “sterile” devices.
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