The federal court overseeing dozens of hernia mesh lawsuits involving Ethicon, Inc.’s Physiomesh products has approved the use of a Short Form Complaint, which will greatly streamline the process of filing new cases in the multidistrict litigation now underway in the U.S. District Court, Northern District of Georgia.
More than 80 Physiomesh lawsuits are now pending in the Northern District of Georgia, all of which were filed on behalf of patients who claim to have suffered serious complications due to Ethicon’s allegedly defective hernia patches. The multidistrict litigation was established earlier in June to allow all federally-filed hernia mesh lawsuits involving Ethicon Physiomesh to undergo coordinated pretrial proceedings.
The Court directed all future plaintiffs to file via the Short Form Complaint in an Order dated September 22nd. Plaintiffs who already have hernia mesh lawsuits pending in the litigation are also required to file a Short Form Complaint with the Court.
In addition to streamlining the filing process, the Short Form Complaint provides a standardized method of collecting information from all plaintiffs. It will allow each individual plaintiff to outline the specific allegations they are adopting from the litigation’s Master Complaint and provide information as to when and where their hernia mesh was implanted.
Ethicon brought its Physiomesh products to market in 2010. Like other hernia mesh patches, Physiomesh devices are constructed from non-absorbable polypropylene (plastic) filaments that are woven into fabric. Each side of the mesh is then covered with an absorbable film coating, which is intended to help the patch incorporate into the body and reduce inflammation.
However, plaintiffs pursuing Physiomesh lawsuits claim that this multilayer construction actually hinders incorporation and increases the risk that patients will develop serious complications, including adhesions, perforations, infections, mesh erosion, hernia recurrence, and the need for hernia mesh revision surgery.
Ethicon announced it was withdrawing Physiomesh Flexible Composite Mesh from the worldwide market in May 2016, after unpublished data from two hernia databases in Europe suggested that the product was associated with higher average recurrence and revision rates compared to other meshes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’s notification stated.
Ethicon has indicated that the Physiomesh products listed in the notification will not be returning to the market.