Lawsuit Over Infected Strattice Hernia Mesh Alleges Biologic Graft Was Defectively Designed

Allergan and its LifeCell subsidiary face a product liability lawsuit brought by a Maryland woman, who indicates that infected Strattice hernia mesh had to be removed only a few months after it was placed in her body, alleging that the pig skin biologic graft was defectively designed and unreasonably dangerous.

The complaint (PDF) was filed by Ledda Sellars on February 10 in the U.S. District Court for the District of New Jersey, indicating that LifeCell Strattice mesh was used during a hernia repair in March 2015, which is a biologic graft made using material from pigs, which was introduced as an alternative to synthetic hernia mesh.

Only a month after the Strattice mesh was placed in her body, Sellars returned to the hospital suffering from pain and an abdominal wall abscess, discovering that the Strattice mesh was infected. As a result, Sellars required additional surgery in July 2015, to remove the Strattice mesh, which also involved primary closure of the abdominal wall and dissection of adhesions which had formed since the mesh was implanted.

LifeCell’s Strattice mesh was first introduced to the market in 2008, constructed from pig skin and preserved in a phosphate buffered aqueous solution. It is known as a cross-linked graft device, which is intended 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 lawsuits over infected Strattice mesh now being filed by individuals who received the product.

Sellars indicates the manufacturers failed to properly design and test the biologic mesh, and ignored signs of problems with Strattice mesh infections that were submitted by doctors and patients.

“Defendants failed to design, manufacture, market, promote, and manage the product post-market in a reasonable, safe manner,” the lawsuit states. “Defendants knew or should have known the product was dangerous and would injure patients, including in the ways Plaintiff was injured.”

The lawsuit is one of a growing number involving injuries linked to the Strattice mesh, which have been filed in courts nationwide, but have primarily been in the state of New Jersey, where the manufacturers’ U.S. headquarters are located.

Given common questions raised in complaints brought throughout the state, the Strattice mesh litigation was centralized and consolidated before New Jersey Superior Court Judge John C. Porto in Atlantic County in October, as part of a multicounty litigation (MCL), which is intended to reduce duplicative discovery and avoid conflicting pretrial rulings from different judges.

Similar to multidistrict litigations (MDLs) used at the federal level, consolidating the cases as part of a New Jersey MCL transferred claims pending throughout the state to Judge Porto 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.

The allegations presented in the litigation are different than those raised in other lawsuits over hernia mesh filed in recent years over products made with polypropylene; a thermoplastic polymer. There are tens of thousands of Ethicon Physiomesh lawsuits, Atrium C-Qur mesh lawsuits, Bard hernia patch lawsuits and similar claims alleging that design defects with the polypropylene products resulted in painful and complications. However, the Strattice mesh lawsuits allege that similar problems have been linked to this biologic product.