Hernia mesh lawsuits involving Ethicon, Inc.’s Physiomesh Flexible Composite mesh products continue to move forward in the U.S. District Court, Northern District of Georgia, where all such federal claims are undergoing coordinated pretrial proceedings before a single judge.
The Court issued its 8th Practice and Procedure Order on March 3rd, establishing procedures by which Plaintiffs can access records collected by Defendants from certain third parties.
“Practice and Procedure Order No. 6 provided, in part, for the Plaintiffs’ submission to the Defendants of Plaintiff Profile Forms and certain blank, signed authorizations allowing the Defendants’ counsel to obtain from third parties certain Plaintiffs’ records,” the document states. “This Order establishes the procedures for the Plaintiffs to access the records the Defendants collect. This Order is not intended to and does not create any obligation for any Plaintiff to access any of the records collected by Defendants.”
Physiomesh hernia patches are constructed from non-absorbable polypropylene (plastic) filaments that are woven into fabric and laminated with an absorbable film coating. According to Ethicon, the coating helps the hernia mesh incorporate into the body and reduces inflammation.
Like other hernia mesh manufacturers, Ethicon obtained regulatory clearance to sell Physiomesh via the U.S. Food & Drug Administration’s (FDA) 510(K) program. These clearance protocols allow a medical device to come to market without human clinical trials, as long as a manufacturer can demonstrate that it is “substantially equivalent” to another product previously brought to market through the agency’s stricter pre-market approval process.
Ethicon announced it was withdrawing Physiomesh Flexible Composite Mesh from the worldwide market in May 2016, after unpublished data from two European hernia registries suggested that the product was associated with higher average recurrence and revision rates compared to other meshes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 market withdrawal affected 10 different sizes and configurations of Physiomesh Flexible Composite Mesh.
More than 600 Physiomesh lawsuits are now pending in the Northern District of Georgia.
Plaintiffs involved in this litigation claim that the hernia mesh’s unique, multilayer design is defective and prevents Physiomesh from incorporating into the body, thus increasing the risk that patients will develop serious complications, including adhesions, perforations, infections, mesh erosion, hernia recurrence, and the need for hernia revision surgery.
The complaints further allege that Ethicon failed to provide doctors and patients with adequate safety warnings, though it had long been aware of the risks posed by Physiomesh. Plaintiffs assert that they could have avoided painful and debilitating hernia complications had proper warnings been made available.