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According to allegations raised in a recent product liability lawsuit filed last week by a Kentucky woman, an Atrium C-Qur hernia mesh failed, resulting in recurrence of hernia and the need for additional surgery to remove the controversial patch, which has been linked to a number of similar cases.
The complaint (PDF) was filed by Jennifer Tipton in the U.S. District Court for the Eastern District of Kentucky on February 22, indicating that Atrium Medical Corporation sold a defective and unreasonably dangerous hernia mesh product.
Tipton underwent surgery for an open incisional hernia repair in December 2015, at which time an Atrium C-Qur patch was implanted in her body. According the lawsuit, she began to experience complications and pain, discovering that she was experience hernia recurrence in October 2016. Last month, Tipton required hernia revision surgery to have the Atrium CQur mesh removed.
Atrium C-Qur, which is pronounced “secure”, has been widely used during hernia repair since March 2006, containing a polypropylene mesh that has an Omega-3 fatty acid (O3FA) gel coating, which is designed to reduce scar tissue formation, while promoting fixation of the mesh to the abdominal wall. However, a number of individuals have experienced problems where the fish oil coating causes an inflammatory response that incites an inflammatory response that actually promotes bowel adhesion and causes other painful complications.
According the lawsuit filed by Tipton over her Atrium C-Qur hernia recurrence, the product packaging may have been a factor in the problems she experienced.
“Atrium failed to warn or instruct distributors and facilities of critical environmental guidelines, such as relative humidity or temperature during transportation and/or storage of the C-Qur Mesh,” the lawsuit states. “The environmental guidelines for the C-Qur Mesh are unique to the C-Qur Mesh and are not necessary for other similar or competing hernia mesh products. Excess temperature and/or humidity result in the C-Qur Mesh degrading and transforming into an even more dangerous product.”
The lawsuit indicates that Atrium used packaging that allowed humidity levels to fluctuate to unacceptably high levels, causing the O3FA coating to adhere to the packaging. Although Atrium allegedly assured doctors and consumers that the C-Qur mesh was still fit for human implantation, even if some or all of the gel coating had been pulled away, Tipton indicates that this actually poses a serious risk for consumers.
“Once the O3FA coating has started or shown propensity to detach from the polypropylene, it is much more likely that the O3FA coating will detach from the polypropylene once implanted,” according to the complaint filed by Tipton. “If the O3FA coating detaches once implanted, it can float in the body or ball up, causing an even more intense foreign body reaction, resulting in rejection and other complications [from] the C-Qur Mesh. Detachment of the O3FA coating also greatly increases the risk of the C-Qur mesh adhering to the patients underlying organs, resulting in significantly more difficult and complex surgeries to remove the mesh. Due to the C-Qur Mesh adhering to the underlying organs, patients experience significant, life-changing injuries, prolonged hospital stays and even death.”
The case joins a growing number of hernia mesh lawsuits filed in recent months of the Atrium C-Qur patch, each raising similar allegations that manufacturer knew or should have known about the risk of problems associated with their product. However, Tipton and other plaintiffs maintain that inadequate warnings were provided and the manufacturer failed to issue any official Atrium C-Qur hernia mesh recall, according to complaints filed in courts nationwide, instead choosing to withhold information from consumers and quietly remove certain products from the market.
Given the similar questions of fact and law raised in dozens of cases filed throughout the federal court system, the U.S. Judicial Panel on Multidistrict Litigation (JPML) decided to consolidate all Atrium C-Qur lawsuits last month, centralizing claims before U.S. District Judge Landya McCafferty in the District of New Hampshire, for coordinated pretrial proceedings.
As part of the coordinated pretrial proceedings, it is expected that Judge McCafferty will eventually schedule a series of early “bellwether” trials, which are designed to help the parties gauge how juries are likely to respond to certain evidence and testimony that may be repeated throughout the litigation.
Tipton’s case will be transferred to the MDL for discovery and pretrial proceedings. However, if Atrium CQur mesh settlements or another resolution is not reached following the MDL process, Tipton’s case and each individual lawsuit may be remanded back to the U.S. District Court where it was originally filed for a separate trial date in the future.