The federal multidistrict litigation recently established for hernia mesh lawsuits involving Ethicon, Inc.’s Physiomesh products will soon get underway. According to an Order issued in the U.S. District Court, Northern District of Georgia on June 21st, the proceeding’s Initial Conference will be convened on Tuesday, August 1st at 2:00 p.m. ET.
Counsel are to provide the Court with suggested agenda items within 10 days of the date of the Order. Preliminary statements are to be submitted by July 25, 2017. Finally, the Order stays all outstanding disclosure and discovery proceedings pending the August 1st conference.
Ethicon’s Physiomesh hernia patch products are constructed from non-absorbable polypropylene (plastic) filaments that are woven into fabric. Each side of the polypropylene mesh is covered with an absorbable film coating, which is intended to help the patch incorporate into the body and reduce inflammation. Ethicon obtained regulatory clearance for Physiomesh via the U.S. Food & Drug Administration’s (FDA) 510(K) program, which allows a device to come to market without human clinical if a manufacturer can demonstrate that it is “substantially equivalent” to another product previously approved by the agency.
Ethicon announced a worldwide market withdrawal of Physiomesh Flexible Composite Mesh in May 2016, after unpublished data from two European hernia registries suggested that the product was associated with higher average recurrence and revision rates compared to other meshes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.
“Based on the currently available data, Ethicon believes the higher rates to be a multifactorial issue (including possible product characteristics, operative and patient factors), but has not been able to fully characterize these factors,” the company stated in a notice issued to customers on May 26th. “Consequently, Ethicon have not been able at this time to issue further instructions to surgeons that might lead to a reduction in the recurrence rate and have decided to recall ETHICON PHYSIOMESH™ Composite Mesh from the global market.
Ethicon has indicated that will not be returning the affected Physiomesh products to the market.
In June, the U.S. Judicial Panel on Multidistrict Litigation (JPML) centralized all federally-filed Physiomesh lawsuits in the Northern District of Georgia, assigning the docket to U.S. District Judge Richard W. Story. All currently pending claims, as well as those filed in the future, will now undergo coordinated pretrial proceedings, including motion practice and discovery.
Court records indicate that 66 Physiomesh lawsuits were pending in the Northern District of Georgia as of June 15th. All of the cases were brought on behalf of individuals who allegedly suffered adhesions, perforations, infections, mesh erosion and other debilitating complications due to the product’s purportedly defective design. Among other things, plaintiffs assert that the that the Physiomesh multi-layer design actually prevents incorporation of the mesh and increases the likelihood of serious complications.