The federal court overseeing hundreds of hernia mesh lawsuits involving Ethicon, Inc.’s Physiomesh Flexible Composite Mesh implants continues to prepare for upcoming bellwether trials.
According to a Notice filed in the U.S. District Court, Northern District of Georgia, on November 5th, the parties have chosen 37 Physiomesh lawsuits for inclusion in an Initial Discovery Pool. As previously reported, the Initial Discovery Pool will be reduced to a 10-member Trial Pool following completion of case-specific discovery.
There are currently more than 1,450 hernia mesh lawsuits pending in the multidistrict litigation underway in the Northern District of Georgia. All of the claims were filed on behalf individuals who suffered allegedly serious injuries and complications following implantation of Ethicon’s Physiomesh Flexible Composite Mesh implants during ventral hernia repair surgery.
The first Phyisomesh lawsuit will go to trial on December 2, 2019. Verdicts in the litigation’s bellwether cases could provide insight into how other juries might decide similar hernia mesh claims.
The U.S. Food & Drug Administration first approved Physiomesh Flexible Composite Mesh via the 510(k) clearance program. This program allows medical device manufacturers to bypass human clinical trials if they can show that a new product is “substantially equivalent” to a device that has already undergone the agency’s far more stringent premarket approval process.
Physiomesh Flexible Composite Mesh is indicated for use in ventral (abdominal) hernia repair. The implants consist of a netting made from non-absorbable polypropylene filaments that have been laminated between two layers of called Monocryl (poliglecaprone). This multilayer design is supposed to facilitate incorporation of the mesh into the body, minimize inflammation and adhesions, and facilitate faster healing.
Ethicon withdrew Physiomesh Flexible Composite Mesh from the worldwide market in March 2016, after unpublished data from two European hernia databases suggested that the implants were associated with higher rates of complications than similar meshes when used in laparoscopic ventral hernia repair surgeries.
Ethicon never officially announced a Phyisomesh recall in the United States, even though the market withdrawal was characterized as a recall overseas.
Plaintiffs allege that the polypropylene used in Physiomesh Flexible Composite Mesh is incompatible with human tissue and actually prevents the device from being absorbed into the abdominal wall. The failure of the mesh to incorporate in the body can trigger an inflammatory reaction that may result in:
Plaintiffs further claim that Ethicon had long been aware of these risks, but failed to provide doctors and patients with adequate safety warnings.