The federal court overseeing hundreds of hernia mesh lawsuits involving Ethicon, Inc.’s Physiomesh Flexible Composite Mesh implants has begun setting the stage for the litigation’s first bellwether trials.
According to a Practice and Procedure Order issued in the U.S. District Court, District of Georgia, on January 19th, the first Physiomesh trial will be convened on September 16, 2019.
By May 15, 2018, the parties are to each select 12 cases for inclusion in an Initial Discovery Pool. Physiomesh lawsuits eligible for the pool include all of those currently pending in the litigation that were filed as of January 11, 2018.
Plaintiff Fact Sheet for the selected cases must be submitted to the Court by June 15th. Defendant Fact Sheets are due by July 31st.
Ten additional cases will be selected for the Initial Discovery Pool on June 22nd, with the parties each selecting 5 lawsuits from all claims pending in the litigation. Completed Plaintiff Fact Sheets are due on those cases by July 13th, while Defendant Fact Sheets must be submitted by August 21st.
Following fact discovery, Plaintiffs and Defendants will each select 5 cases from the Initial Discovery Pool for inclusion in the Trial Pool. Those selections are to be made on or before December 1st.
By May 1st, each side is to submit a memorandum in support of their proposed manner of trial, order of selection of plaintiffs for trial, and timing of trials. The parties may submit a response to the opposing party’s memorandum regarding by May 8th. The Court will rule on these matters by May 15th.
Ethicon brought the first Physiomesh products to market in 2010, via the U.S. Food & Drug Administration’s 510(k) clearance process. This program allows a new medical device to come to market without undergoing human clinical trials if a manufacturer can show that it is “substantially equivalent” to a device that had previously undergone the FDA’s more stringent premarket approval process.
Ethicon withdrew Physiomesh Flexible Composite Mesh from the worldwide market in May 2016, after unpublished data from two European hernia databases suggested that the product was associated with higher average recurrence and revision rates compared to other meshes used in laparoscopic ventral hernia repair.
While Physiomesh recalls were announced in several countries, no such action has been taken in the U.S.
The federal litigation currently includes more than 460 hernia mesh lawsuits, all of which were filed on behalf of individuals who suffered serious and debilitating complications, including infection, adhesions, chronic pain, and hernia recurrence, due to an allegedly defective Physiomesh Flexible Composite Mesh patch.
The Physiomesh bellwether trials will serve as test cases, and could provide some insight into how juries might decide similar hernia mesh claims.