Plaintiffs who allegedly suffered serious injuries and complications due to Ethicon Inc.’s Physiomesh Flexible Composite Mesh product are seeking to have their hernia mesh lawsuits centralized in the U.S. District Court, Middle District of Florida. In a brief filed with the U.S. Judicial Panel on Multidistrict Litigation on March 9th, plaintiffs assert that consolidation of all federally-filed Physiomesh lawsuits will allow the cases to proceed more efficiently through the court system.
According to the document, there are currently 18 Physiomesh lawsuits pending in nine U.S. District Courts: six in the Middle District of Florida; two each in the Northern District of Florida and District of Colorado; and 1 each in the Southern District of Illinois, Middle District of Georgia, District of Massachusetts, District of South Carolina, Northern District of Oklahoma and District of New Jersey.
“Upon information and belief, there were more than 330,000 Physiomesh devices sold worldwide, and Plaintiffs believe approximately 50%of those products were sold in the United States,” the brief states. “It is the expectation of the undersigned that there will be hundreds of additional cases filed in the near future involving these products.”
The creation of the centralized docket would allow federally-filed Physiomesh claims, as well as any filed in the future, to undergo coordinated pretrial proceedings, thereby avoiding duplicative discovery and inconsistent rulings from various courts. The creation of a multidistrict litigation is intended to conserve the resources of the parties, witnesses, and courts involved in the litigation.
Ethicon brought Physiomesh Flexible Composite Mesh to market in 2010. It features a unique five-layer design that incorporates two layers of polyglecaprone-25 (‘Monocryl’) film covering two underlying layers of polydioxanone film, which in turn covers a fifth layer of polypropylene mesh. The design of the Phyisomesh product was supposed to prevent or minimize adhesion and inflammation and facilitate incorporation and fixation of the device into the abdomen. However, plaintiffs allege that the multi-layer configuration actually prevented incorporation and contributed to a number of serious complications.
Ethicon announced a worldwide market withdrawal of Physiomesh Flexible Composite Mesh in May 2016, after unpublished data from two European hernia registries suggested that the product was associated with higher average recurrence and revision rates compared to other meshes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. Ethicon 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.
Ethicon asked hospitals to return all unused Physiomesh patches included in the market withdrawal. The company indicated that it would not seek to return the affected products to the market.