The federal litigation involving hundreds of hernia mesh lawsuits filed on behalf of individuals allegedly injured by Atrium Medical’s C-Qur devices continues to prepare for bellwether trials.
According to a Joint Notice filed in the U.S. District Court, District of New Hampshire on August 9th, counsel for plaintiffs and defendants have selected a group of 16 cases for an Initial Bellwether Trial Pool.
By March 1, 2019 – once initial discovery has been completed – the parties will each select 4 cases, for a total of 8, to undergo case specific discovery.
Case specific discovery is to be completed by September 20, 2010.
The Court has indicated that it intends to convene the first bellwether trial on February 19, 2020.
More than 470 hernia mesh lawsuits are currently pending in the District of New Hampshire, where all federal claims involving Atrium C-Qur implants have been centralized before a single judge for coordinated pretrial proceedings. The litigation’s bellwether trials involve cases representative of others in the proceeding. Verdicts in these trials could provide insight into how other juries might rule in similar claims.
Atrium C-Qur mesh is indicated for permanent abdominal wall reinforcement in hernia surgeries. The polypropylene mesh features an Omega-3 barrier coating, which Atrium claims reduces the risk of adhesions between the hernia patch and the intestines. The Omega-3 barrier is also supposed to provide for better fixation of the device to the abdominal wall.
However, plaintiffs charge that the C-Qur mesh design actually causes an inflammatory response that promotes the formation of bowel adhesions, impedes proper abdominal wall fixation, and causes additional severe complications that may result in the need for painful and risky hernia revision surgery.
Like many other polypropylene hernia mesh implants, C-Qur mesh was approved via the U.S. Food & Drug Administration (FDA) 510K program, which allows a medical device to come to market as long as a manufacturer can demonstrate that it is “substantially equivalent” to another product previously approved by the agency. This was permitted even though C-Qur was the first surgical mesh to ever utilize an Omega-3 barrier coating.
In October 2012, the FDA issued a warning letter to Atrium Medical for failing to adequately address multiple complaints related to infections associated with the C-Qur hernia mesh. The agency also faulted the company for ignoring sterility complaints, and noted that the company had added the C—Qur V Patch and other products to the sterilization load without adequately evaluating the additional challenges that could present to effective sterilization.
In August 2013, the FDA issued a Class II recall for C-Qur Edge mesh after receiving reports that the Omega-3 barrier coating was adhering to the packaging materials when exposed to high-humidity conditions. However, Atrium did not remove any of the affected devices from the market and merely directed physicians to inspect the packaging before implanting the device.
In February 2015, the FDA issued a permanent injunction against Atrium Medical to stop the manufacture and distribution of C-Qur hernia mesh at its Hudson, New Hampshire facility. The injunction was entered one day after the agency filed a lawsuit against Atrium alleging that its methods of manufacturing, packing, storing and installing were not in conformity with the current good manufacturing practice requirements for medical devices.