Federal Court Overseeing Ethicon Physiomesh Lawsuits Convenes Initial Conference

Published on August 9, 2017 by Sandy Liebhard

The multidistrict litigation established earlier this year for federally-filed product liability lawsuits involving Ethicon, Inc.’s Physiomesh line of hernia patches is now underway, after an Initial Case Management Conference was convened in the U.S. District Court, Northern District of Georgia, on August 1st.

According to an Order filed just days after the Conference, the Court has directed the parties to meet and confer on the preparation of an order that would allow future Physiomesh lawsuits to be filed directly in the Northern District of Georgia.  The August 3rd Order also directs the parties to meet and confer regarding the procedural, case management, and discovery issues discussed during initial conference and prepare proposals governing case management. The Court will take up those proposals at the next scheduled status conference.

Finally, the Order sets forth a schedule of regular, monthly status conferences through the remainder of the year as follows:

  • September 12, 2017 at 2:00 p.m. EDT
  • October 10, 2017 at 2:00 p.m. EDT
  • November 16, 2017 at 2:00 p.m. EST
  • December 7, 2017 at 2:00 p.m. EST

Ethicon Physiomesh: What’s the Problem?

Ethicon obtained regulatory clearance for its first Physiomesh products in 2010, via the U.S. Food & Drug Administration’s (FDA) 510(K) program. This faster route to clearance allows 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 approved by the agency.

All of the hernia mesh patches included in the Physiomesh line are made 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. However, plaintiffs pursuing Physiomesh lawsuits claim that this multilayer construction actually hinders incorporation and increases the risk that patients will develop serious complications, including adhesions, perforations, infections, mesh erosion, hernia recurrence, and the need for Physiomesh revision surgery.

Ethicon announced it was withdrawing Physiomesh Flexible Composite Mesh from the worldwide market in May 2016, after unpublished data from two European hernia registries suggested that the product was associated with higher average recurrence and revision rates compared to other meshes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.

“Based on the currently available data, Ethicon believes the higher rates to be a multifactorial issue (including possible product characteristics, operative and patient factors), but has not been able to fully characterize these factors,” the company’s notification stated.

Ethicon has indicated that the Physiomesh products listed in the notification will not be returning to the market.

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