Atrium Medical Corp. faces trial for a plaintiff’s claims that a hernia mesh repair product resulted in severe infection and that the company didn’t warn doctors about the possibility of contamination during manufacture.
The case began in October 2017 with a complaint from Randy J. Africano. The patient alleged that a non-sterile patch of ProLite mesh, which was used during a hernia repair surgery, caused an infection and serious injuries.
The Food and Drug Administration (FDA) has warned Atrium about sterility and safety issues at some of its manufacturing facilities since 2012. In October 2021, the agency sent a warning to the company after facility inspections, noting a number of violations. In February 2015, a federal court in New Hampshire went as far as blocking the company from the distribution of several products made at its manufacturing buildings in New Hampshire, including the ProLite Mesh.
During pretrial proceedings, Atrium filed a motion of summary judgment and asked to have the case dismissed. However, in early June, U.S. District Judge Mary M. Rowland issued a memorandum opinion and order. She threw out Africano’s claims about defective design but allowed the lawsuit to move forward with his charges of manufacturing defect and failure to warn.
Atrium Hernia Mesh Litigation
Atrium currently faces thousands of product liability lawsuits related to its C-Qur hernia mesh products, which are currently pending as a federal multidistrict litigation (MDL). Allegations include issues with an omega-3 fatty acid gel coating used on the products. While it was intended to reduce scar tissue build-up and encourage attachment of the mesh to the abdominal wall, plaintiffs argue that it actually led to an increased risk of inflammatory response, bowel adhesions, and other serious complications that often required additional surgery.
Early trials begin this month, which will help parties better understand how juries may respond to testimonies and evidence throughout the upcoming thousands of individual cases.
For more information about Atrium’s defective hernia mesh repair products, contact us today.
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Tracy Everhart
Tracy Everhart is the Editor for Drug Law Journal. A highly-trained and certified medical professional, Tracy is also an accomplished medical writer. After spending years on the front lines of the medical profession, Tracy now devotes her expertise and skills to researching and reporting on new drugs and devices that enter the market, as well as their side-effects and the real-life stories involved. Prior to joining Drug Law Journal, Tracy wrote for benchmark online healthcare resources focused on families and, in particular, women’s health issues. Tracy holds post-graduate degrees from both the American College of Healthcare Sciences and the Yale School of Nursing. She is also a graduate of both Hampshire College, where she studied microbiology and the University of South Carolina school of nursing.