The federal court overseeing hernia mesh lawsuits involving Ethicon, Inc.’s Physiomesh Flexible Composite Mesh is moving forward with plans to convene a series of bellwether trials beginning early next year.
Just over 2,000 Ethicon Physiomesh lawsuits are pending in the U.S. District Court, Northern District of Georgia, where all such federally filed claims have been centralized for coordinated discovery and other pretrial proceedings. The litigation’s bellwether trials are tentatively set to begin in February 2020, and verdicts in those cases could provide insight into how other juries might decide similar claims.
An Initial Discovery Pool consisting of 37 representative Physiomesh lawsuits was established last November, and all underwent case-specific discovery in preparation for those trials. According to a Notice dated May 10th, the group of 37 was recently reduced to a 10-case Trial Pool, with Plaintiffs’ Counsel making the following 5 selections:
The remaining five Trial Pool cases were chosen by Defense Counsel:
Physiomesh Flexible Composite Mesh is indicated for use in abdominal hernia repair. The implants are constructed of a non-absorbable polypropylene netting that’s laminated between two layers of a material called Monocryl (poliglecaprone). This unique, multilayer design supposedly facilitates incorporation of the mesh into the body, minimizes inflammation and adhesions, and facilitates faster healing.
Because Ethicon was able to bring Physiomesh to market via the U.S. Food & Drug Administration’s (510(k) clearance program, the implants were never subjected to human clinical trials. Instead, the company merely had to demonstrate that the devices were “substantially equivalent” to an older product that had already been cleared through the agency’s much more stringent premarket approval program.
The 510(k) program is somewhat controversial, as the lack of human testing can allow major design flaws and other issues to go undetected before a device comes to market. In fact, serious safety problems that previously plagued transvaginal mesh, certain types of hip implants, and many other 510(k)-approved devices did not become apparent until they had actually harmed thousands of patients.
Ethicon announced a worldwide market withdrawal of Physiomesh Flexible Composite Mesh in March 2016, after unpublished data from two European hernia databases suggested the implants were associated with higher rates of complications than competitor meshes. The company was unable to determine the cause of the problems and indicated it would not be returning the affected products to market.
Ethicon did not characterize the action as a Physiomesh recall in the United States, although it did so in many other countries.
Plaintiffs pursuing Ethicon Physiomesh lawsuits claim that the polypropylene used in the devices is biologically incompatible with human tissue. This subsequently prevents the mesh from being absorbed by the body and triggers an inflammatory reaction that may ultimately cause:
Plaintiffs further allege that Ethicon failed to conduct adequate testing to ensure Physiomesh was safe and effective for its intended use, and neglected to provide doctors and patients with appropriate warnings regarding its potential risks.