The New Jersey Supreme Court has agreed to create a Multicounty Litigation for hernia mesh lawsuits involving injuries and complications allegedly associated with Ethicon, Inc.’s Physiomesh Flexible Composite mesh implants.
According to a Notice issued on August 15th, all such claims currently pending in the state’s courts, as well as any filed in the future, will be transferred to Superior Court Judge Nelson C. Johnson of the Atlantic County Superior Court.
Plaintiffs had filed a motion in March seeking Multicounty Litigation designation for all product liability lawsuits involving several Ethicon hernia mesh products, including Physiomesh Flexible Composite, Proceed Surgical Mesh, Proceed Ventral Patch, Prolene 3D, and the Prolene Hernia System.
In arguing for centralization, plaintiffs asserted that the cases shared many common, recurrent issues of law and fact, as well as common defendants, corporate witnesses, designs, materials, manufacturing and production methods, and underlying science. However, the New Jersey Supreme Court has opted to limit the newly-established Multicounty Litigation to those that involve Physiomesh.
Physiomesh Flexible Composite Mesh features a unique multi-layer design that incorporates 5 distinct layers: two layers of poliglecaprone-25 (“Monocryl”) film covering two underlying layers of polydioxanone film which are coated with a polypropylene mesh. Physiomesh is the only hernia mesh product sold in the United States that features this design.
Ethicon promised that this unique configuration would prevent or minimize adhesion and inflammation and facilitate incorporation of the mesh into the body, However, plaintiffs who have filed Physiomesh lawsuits dispute these claims and allege that the design actually prevents incorporation and increases the risk that patients will experience “intense inflammatory and chronic foreign body response, resulting in an adverse tissue reaction including migration and damage to surrounding tissue in the form of sclerotic, granulomatous and/or fibrotic tissue, and improper healing.”
Ethicon announced a worldwide market withdrawal of Physiomesh Flexible Composite Mesh in May 2016, after unpublished data from two European hernia registries suggested that the product was associated with higher average recurrence and revision rates compared to other meshes used in laparoscopic ventral hernia repair. The company was unable to determine the cause of this issue but noted that it could be due to product characteristics, as well as operative and patient factors.
Ethicon’s action was never officially declared a recall in the U.S. However, hospitals were asked to return any unused Physiomesh patches listed in its notification. The company indicated that it would not seek to return the affected products to the market.