Dozens of hernia mesh lawsuits involving Atrium Medical Corp.’s C-Qur Mesh implants continue to move forward in the U.S. District Court, District of New Hampshire, where all such federally-filed claims have been centralized before a single judge for coordinated pretrial proceeding.
According to a Case Management Order dated April 20th, the Court convened its most recent status conference on April 19th, at which time depositions, plans for bellwether trials, and a number of other matters were addressed.
Among other things, the Order notes that the parties exchanged drafts of a Proposed Bellwether Case Management Order, which among other things, would set forth guidelines for selecting individual hernia mesh lawsuits for the litigation’s early trials. The parties indicated that they would finalize their proposal and submit it to the court within two weeks.
Bellwether trials are standard in centralized proceedings, such as the multidistrict litigation established in New Hampshire for C-Qur hernia mesh lawsuits. Verdicts in these cases could provide insight into how other juries might rule in similar product liability claims involving Atrium C-Qur Mesh.
The Order further notes that Plaintiffs have noticed or requested the depositions of several individuals. While Defendants object to two of these requests, the parties are addressing the objections and indicated that they do not require court intervention at this time.
The parties also suggested procedures to follow when they object to a deposition request or notice in its entirety, which the Court agreed to adopt.
Atrium’s C-Qur Mesh implants are indicated for use in hernia repair and other surgical procedures.
The devices are made from polypropylene mesh that has been coated with an all-natural Omega-3 gel “derived from highly purified pharmaceutical grade fish oil consisting of a unique blend of triglycerides and Omega 3 fatty acids.” Use of the coating is intended to reduce the risk of adhesion (scar tissue) formation and allow for better incorporation of the hernia patch with the abdominal wall.
Plaintiffs with cases pending in the District of New Hampshire claim that the polypropylene used in C-Qur Mesh is “biologically incompatible with human tissue and promotes an immune response” in some patients, resulting in degradation of the mesh and severe adverse reactions, resulting in the need for hernia revision surgery. They further charge that the Omega-3 coating can also trigger an immune response, resulting in pain, graft rejection, graft migration, organ damage, complex seroma, fistula, sinus tract formation, delayed wound closure, infection, sepsis, and death.
Atrium obtained regulatory approval for C-Qur Mesh in 2006, via the U.S. Food & Drug Administration’s (FDA) 510(k) clearance protocols, thus avoiding the agency’s much more stringent premarket approval process. The 510(k) program does not require that manufacturers test a new device on human beings when they are able to show that it is substantially equivalent to another product that was previously approved by the agency.
Atrium received an FDA warning letter in 2012 for, among other things, failing to address complaints regarding C-Qur Mesh infections. The letter also noted that Atrium had ignored multiple sterility complaints, including at least 35 separate instances where human hair found was found in supposedly sterile medical devices.
In August 2013, concerns that high humidity could cause the Omega-3 coating to adhere to the device packaging prompted Atrium to recall more than 1,500 C-Qur Mesh implants. The FDA designated the C-Qur Mesh recall a Class II medical device recall, which indicates that use of the affected implants could lead to temporary or medically reversible health consequences.