Protocol for Preserving Removed Hernia Mesh Established in Ethicon Physiomesh MDL

The U.S. District Judge presiding over all federal Ethicon Physiomesh lawsuits has issued a practice and procedure order, outlining the protocol that must be followed for the preservation and testing of removed hernia mesh explants and tissue samples taken from plaintiffs who are pursuing product liability lawsuits against the manufacturer.

There are currently more than 900 product liability lawsuits pending in the federal court system over problems with Ethicon Physiomesh, which is a type of hernia patch that was removed from the market in 2016, amid reports of painful and debilitating complications, which typically result in the need for revision surgery within a few years.

Given similar questions of fact and law presented in the hernia mesh lawsuits, the federal court system has consolidated the cases before U.S. District Judge Richard Story in the Northern District of Georgia, to reduce duplicative discovery into common issues in the cases, avoid conflicting rulings from different courts on pretrial matters and to serve the convenience of the parties, witnesses and the judicial system.

In an order (PDF) issued on May 29, Judge Story explained the steps that must be taken to preserve, collect, store and divide any explants and tissue samples taken from plaintiffs with a case pending in the federal multidistrict litigation (MDL).

The protocol calls for patients to notify the health care facility holding the materials that they should be preserved and sent to Steelgate, Inc., a biomedical specimen storage and management company. Plaintiffs must provide a Past Surgery preservation notice to the facility, which also must be copied to Defendants’ lead counsel. Steelgate will send the materials to Florida and notify plaintiffs and defendants when the materials are requested and obtained.

The order details how the materials should be stored, and that the parties will split the expense of the monthly storage fees. It also explains how the materials can be examined, and what cannot be done with the samples as well.

Johnson & Johnson’s Ethicon unit introduced Physiomesh in March 2010, containing an absorbable film coating on each side of a polypropylene hernia mesh, which was designed to help the patch incorporate into the body and minimize inflammation. However, the hernia mesh was recalled in 2016, after a higher-than-expected number of individuals required revision surgery due to problems with the design.

As lawyers continue to review and file claims for individuals who have experienced complications following hernia repair surgery, the size and scope of the litigation is expected to continue to increase, and it is ultimately expected that several thousand lawsuits may be filed in the Ethicon Physiomesh MDL.

As part of the coordinated pretrial proceedings before Judge Story, it is expected that a small group of cases will be selected for early trial dates, to help gauge how juries may respond to certain evidence and testimony that is likely to be repeated throughout the litigation. Following the coordinated proceedings in the MDL, if Ethicon fails to reach hernia mesh settlements for individuals who had a Physiomesh patch fail, each individual complaint may be transferred back to the U.S. District Court where it originally would have been filed for a future trial date.