The federal court overseeing hundreds of hernia mesh lawsuits involving Ethicon, Inc.’s Physiomesh devices has issued a new Order that governs communications with Plaintiffs’ treating physicians.
The December 12th Order in the U.S. District Court, Northern District of Georgia, addresses a Plaintiffs’ Motion that sought to preclude Defendants from engaging in ex parte communications with treating physicians for the purpose of retaining expert witnesses.
The Order indicates that the Court will allow Defendants to engage in such communications, subject to certain restrictions, including:
Just over 300 Physiomesh lawsuits are now pending in the Northern District of Georgia, all of which were filed on behalf of plaintiffs who developed serious complications, including hernia recurrence and the need for revision surgery, following hernia repair with a Physiomesh product. Among other things, plaintiffs claim that the multilayer design unique to Physiomesh prevents the implant from incorporating into the body, increasing the risk of adhesions, perforations, infections, mesh erosion, and other painful and debilitating injuries.
In May 2016, Ethicon announced it was withdrawing certain Physiomesh Flexible Composite Mesh patches from the worldwide market, after unpublished data from two European hernia registries indicated that the device was associated with higher average recurrence and revision rates compared to other hernia mesh products used in laparoscopic ventral hernia repair.
Ethicon was unable to determine the cause of these issues and has indicated that it will not be returning the withdrawn hernia mesh products from the market.