Hernia mesh lawsuits involving Atrium Medical Corp.’s C-Qur devices continue to move forward in the U.S. District Court, District of New Hampshire, where all such federally-filed claims have been consolidated for the purpose of coordinated pretrial proceedings.
According to a notice posted on the Court’s docket on October 5th, the proceeding is scheduled to convene a “Science Day” at 8:30 a.m. on October 27, 2017.
The upcoming Science Day will allow the parties involved in Atrium C-Qur hernia mesh lawsuits an opportunity to apprise the Court of the medical and scientific issues applicable to these cases in an off-the-record and non-adversarial manner.
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 (scar tissue) between the hernia mesh and the intestines. The company also promises that that the Omega-3 barrier allows for better fixation of the hernia patch 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.
The U.S. Judicial Panel on Multidistrict Litigation (JPML) consolidated around a dozen federally-filed Atrium C-Qur mesh lawsuits earlier this year, and transferred the docket to single judge in the District of New Hampshire. All pending hernia mesh lawsuit involving C-Qur products, as well as any filed in or transferred to New Hampshire in the future, will undergo coordinated pretrial proceedings, including discovery and motions practice.
Since the litigation was established, additional lawsuits have joined the proceeding, bringing the total number of pending claims to 30 as of October 15th.
Atrium obtained regulatory approval for C-Qur hernia mesh devices via the U.S. Food & Drug Administration’s (FDA) 510 (K) program, which does not require new medical devices to undergo human clinical trials if it is demonstrated that it is substantially equivalent to a product previously approved by the agency.
Atrium Medical received an FDA Warning Letter in October 2012 for failing to report problems associated with C-Qur hernia mesh. Among other things, the letter asserted that the company had failed to properly investigate several reports of hernia mesh. The letter also noted that Atrium had received 35 complaints of human hair in medical devices that were supposed to be sterile, and suggested that the company was ignoring those complaints.
A Class II recall was announced by the FDA for Atrium C-Qur Edge mesh in August 2013, because of concerns that high humidity could cause the barrier coating to adhere to the inner packaging sleeve.