The federal court overseeing hernia mesh lawsuits involving Atrium Medical’s C-Qur products continues to prepare for upcoming bellwether trials.
According to a Case Management Order issued in the U.S. District Court, District of New Hampshire on December 17th, the parties are to select the final two bellwether trial candidates by the end of January 2020. The selections will be made from a bellwether trial pool consisting of eight Atrium hernia mesh lawsuits that was established by the Court last summer.
Before the final selections are made, each side will have an opportunity to strike one case from the pool. By January 31st, they will each select a single hernia mesh lawsuit from the remaining six cases. Their final two selections will be prepared for the litigation’s initial bellwether trials, with the first to begin in May 2020.
More 1,400 Atrium hernia mesh lawsuits are currently pending in the District of New Hampshire, where all federally filed claims alleging injury and complications from defectively designed C-Qur devices have been consolidated for coordinated discovery and other pretrial proceedings. The litigation’s bellwether trials are intended to act as test cases and could provide insight into how other juries might decide similar hernia mesh lawsuits.
Atrium C-Qur hernia mesh is constructed from polypropylene that has been coated with an Omega-3 barrier. While this configuration supposedly reduces the risk of adhesions and facilitates fixation to the abdominal wall, plaintiffs pursuing Atrium hernia mesh lawsuits claim the Omega-3 coating actually promotes an inflammatory response in certain individuals, potentially leading to graft rejection and migration, organ damage, complex seroma, fistula, sinus tract formation, delayed wound closure, infection, sepsis, and even death.
Atruim C-Qur hernia mesh came to market under the U.S. Food & Drug Administration’s (FDA) 510K program, which allows manufacturers to forego human testing as long as they can show a new device is “substantially equivalent” to another product that has already undergone the agency’s strict premarket approval process. The FDA allowed Atrium to utilize the 510K program, even though C-Qur was the first surgical mesh to ever utilize an Omega-3 barrier coating.
Atrium Medical received an FDA Warning Letter in October 2012, after the agency found that the company had not adequately addressed multiple complaints related to C-Qur hernia mesh infections. The letter also cited Atrium for ignoring sterility complaints.
Less than a year later, the FDA issued a Class II recall for C-Qur Edge mesh due to reports that the Omega-3 barrier coating was adhering to the packaging materials when exposed to high-humidity conditions. However, Atrium did not remove the recalled implants from the market and merely directed physicians to inspect the packaging prior to use.
In February 2015, the FDA filed a lawsuit against Atrium alleging that its methods of manufacturing, packing, storing and installing Atrium C-Qur mesh were not in conformity with the current good manufacturing practice requirements for medical devices. A day later, the agency issued a permanent injunction that forced Atrium to stop manufacturing and distributing C-Qur hernia mesh at its Hudson, New Hampshire facility.