The federal judge overseeing hundreds of hernia mesh lawsuits involving Atrium Medical, Inc.’s C-Qur implants has refused to dismiss claims asserted by a potential bellwether plaintiff.
Felicia Blackwood received an Atrium C-Qur V hernia patch in 2012 to repair an umbilical hernia. Less than a year later, she was rushed to the emergency room after complaining of abdominal pain, diarrhea, constipation, and reflux. An upper gastrointestinal endoscopy and CT scan revealed “tiny recurrent fat-containing periumbilical hernia.”
Nearly a year after the initial hernia surgery, Blackwood underwent an exploratory procedure that included removal of the C-Qur V mesh. However, she continues to suffer chronic infections, peritonitis, abdominal deformity, and nerve damage.
According to Blackwood’s hernia mesh lawsuit, Atrium and other defendants failed to properly research and test C-Qur V mesh. She further alleges that Atrium knew the product was causing widespread catastrophic complications, yet marketed and sold the device as a safe and effective product.
Blackwood’s case is among 1,400 Atrium C-Qur hernia mesh lawsuits centralized before a single judge in the U.S. District Court, District of New Hampshire, and one of 16 selected as potential bellwether trial candidates. Those trials are scheduled to begin in February 2020 and could provide insight into how other juries will decide similar lawsuits involving the C-Qur patch.
Atrium motioned to have Blackwood’s claims of strict liability, negligence, and consumer protection law violations dismissed, arguing that they were time-barred by the governing statute of limitations. But judge Landya McCafferty disagreed, finding that it’s unclear whether Blackwood should have known of the cause of her injuries within the three-year limitations period.
Judge McCafferty also found that Blackwood’s consumer protection claims were plead with the required specificity.
Atrium C-Qur mesh is indicated for permanent abdominal wall reinforcement in hernia surgeries. Like many other polypropylene hernia mesh products, the C-Qur patch was approved via the U.S. Food & Drug Administration 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 Atrium C-Qur was the first surgical mesh to ever utilize an Omega-3 barrier coating.
The Omega-3 coating ostensibly reduces the risk of adhesions and allows for better fixation to the abdominal wall. However, plaintiffs pursuing Atrium C-Qur hernia mesh lawsuits claim that this 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.