The federal court overseeing dozens of hernia mesh lawsuits involving Ethicon, Inc.’s allegedly defective Physiomesh Flexible Composite Mesh devices has given plaintiff’s leave to file their cases directly in the U.S. District Court, Northern District of Georgia.
Direct filing is intended to improve judicial efficiency, and will eliminate delays associated with the transfer of cases from other federal jurisdictions.
“The direct filing of any Complaint does not constitute a determination by this Court that jurisdiction or venue is proper in this Court. Upon the completion of pretrial proceedings applicable to a case filed directly in this MDL pursuant to this paragraph, and where appropriate, the Court shall transfer the case pursuant to 28 U.S.C. § 1404 to a court of appropriate jurisdiction and venue for trial,” U.S. District Judge Richard Story wrote in an Order dated August 22nd. “For any Complaint, no matter how filed, Defendants reserve all rights to challenge personal jurisdiction or the appropriate venue after the conclusion of pretrial proceedings in this Court, or at any other appropriate time.”
Judge Story’s order addressed several other matters, including the Court’s intention to require all plaintiffs to file a Short Form Complaint. Lead Counsel for the parties are to jointly submit a proposed Short Form Complaint to the Court by September 12, 2017.
The consolidated Physiomesh litigation was established in June, in order to allow all federally-filed injury claims involving the hernia mesh products to undergo coordinated discovery and other pretrial proceedings. Initially, just 18 Physiomesh lawsuits were transferred to the Northern District of Georgia. Dozens of new cases have since been added to the litigation, bringing the total number of pending cases to 92 as of August 15th.
Ethicon launched the Physiomesh product line in 2010. The multi-layer hernia patches 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. However, plaintiffs pursuing Physiomesh lawsuits claim that this design actually inhibits incorporation and places patients at risk for serious injuries and complications.
“When affixed to the body’s tissue, the impermeable multi-layer coating of the Physiomesh prevents fluid escape, which leads to seroma formation, and which in turn can cause infection, abscess formation and other complications,” the complaints state. “The multi-layer coating provides a breeding ground for bacteria in which the bacteria cannot be eliminated by the body’s immune response, which allows infection to proliferate.”
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.
According to Ethicon’s recall notice, the hernia patches included in the Physiomesh withdrawal will not be returning to the market.