Getinge AB announced last month that it had set aside $200 million (SEK 1.8 billion) to cover costs associated with hernia mesh lawsuits filed against its Atrium Medical, Inc. subsidiary.
According to a statement issued on October 14th, plaintiffs in the United States and Canada have filed at least 900 product liability claims over hernia mesh complications allegedly caused by Atrium’s C-Qur surgical mesh.
During an October 15th conference call, Getinge’s Chief Executive Officer Mattias Perjos and Chief Financial Officer Lars Sandstrom maintained that the provision should cover all current and future costs related to the Atrium hernia mesh litigation.
Atrium C-Qur mesh is constructed from polypropylene that has been coated with an Omega-3 barrier. The coating is intended to reduce risk of adhesions (scar tissue) and facilitate fixation of the hernia patch to the abdominal wall.
Atrium brought C-Qur mesh to market via the U.S. Food & Drug Administration’s (FDA) 510K program. This process allows manufacturers to forgo human clinical trials if they can demonstrate that a new medical device is “substantially equivalent” to another product previously approved via the agency’s far more stringent pre-market approval program.
It’s notable that Atrium was able to utilize the 510(k) program, as C-Qur was the first surgical mesh to ever utilize an Omega-3 barrier coating.
Atrium Medical received an FDA warning letter in 2012 for failing to adequately address multiple complaints related C-Qur hernia mesh infections. The letter also cited the company for ignoring sterility complaints, noting that it 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.
Atrium recalled C-Qur Edge mesh in August 2013, following reports that the Omega-3 barrier coating was adhering to the packaging materials when exposed to high-humidity conditions. However, rather than remove its recalled hernia mesh from the market, Atrium merely directed physicians to inspect the packaging before using the implants.
The Atrium C-Qur hernia mesh recall was designated a Class II medical device recall by the FDA, which indicates that use of the affected products could result in temporary or medically reversable adverse events and complications.
The FDA filed a lawsuit against Atrium in February 2015, alleging that its Hudson, New Hampshire manufacturing facility was not in conformity with current good manufacturing practice requirements for medical devices. A day later, the U.S. District Court, District of New Hampshire, issued a permanent injunction against Atrium preventing the company from manufacturing or distributing Atrium C-Qur mesh and certain other products until the procedures at the Hudson plant were brought into compliance with federal regulations.
The majority of Atrium C-Qur hernia mesh lawsuits have been centralized in a federal multidistrict litigation now underway in the U.S. District Court, District of New Hampshire.
Among other things, plaintiffs claim that the C-Qur mesh design can trigger 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.
Despite setting aside millions to cover the litigation, Getinge indicated that it would vigorously defend the claims.
Trials involving Atrium hernia mesh lawsuits are expected to begin in late 2019 and early 2020.