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According to allegations raised in a recently filed product liability lawsuit, the LifeCell Strattice biologic graft is defective and unreasonably dangerous, causing a painful and disfiguring hernia mesh complications when the implant failed and had to be surgically removed.
The complaint (PDF) was filed by Robert Sandoval in the Superior Court of New Jersey for Morris County on September 9, naming LifeCell Corporation and Allergan as defendants, for manufacturing and selling the Strattice mesh without disclosing problems with the biologic graft used for hernia repairs.
LifeCell Strattice mesh was first introduced to the market in 2008, as an alternative to synthetic mesh, since it is constructed from pig skin and preserved in a phosphate buffered aqueous solution. It is known as a cross-linked graft device, which is designed to chemically link the proteins in the tissue together. However, cross-linking has been linked to a risk of foreign body response and infections, according to allegations raised in a growing number of Strattice mesh lawsuits now being filed by individuals who received the product.
According to the lawsuit, Sandoval was implanted with Strattice Mesh during hernia repair surgery in December 2008. However, nearly 10 years later, he was hospitalized with infected mesh, after the biologic graft failed. As a result, doctors had to remove the hernia mesh, causing him to suffer severe physical injury, pain and suffering, as well as leaving him with permanent disfigurement.
A number of similar lawsuits have been filed over the past few years, which claim the manufacturer knew about problems with the Strattice mesh design since at least 2010, after receiving a number of reports of doctors having to remove failed and infected mesh from patients.
“Defendants failed to design, manufacture, market, promote, and manage the product post-market in a reasonable, safe manner, “Sandoval’s lawsuit states. “Defendants knew or should have known the product was dangerous and would injure patients, including in the ways Plaintiff was injured.”
From September 1990 through September 2020 the FDA received at least 450 Medical Device Reports (MDRs) linked to problems with the Strattice mesh. Six of those reports included patient deaths, more than 340 were injury reports, and at least 107 indicated malfunctions of the mesh.
In June 2021, several plaintiffs proposed that all Strattice Mesh lawsuits should be consolidated before one judge in New Jersey state court, for pretrial proceedings as part of a multi-county litigation (MCL).
Similar to multidistrict litigations (MDLs) used at the federal level, consolidating the cases as part of a New Jersey MCL would transfer claims pending throughout the state to one judge for all pretrial proceedings. While each lawsuit remains an individual case, the Court will coordinate discovery into common issues in the claims and likely schedule a series of early “bellwether” trials to help the parties gauge how juries are likely to respond to certain evidence and testimony that will be repeated throughout the litigation.