The federal court overseeing hundreds of hernia mesh lawsuits involving Ethicon, Inc.’s Physiomesh Flexible Composite mesh implants hit another milestone last week, with the adoption of Plaintiff and Defendant Fact Sheets.
Plaintiff and Defendant Fact Sheets are used in mass tort litigations to help streamline discovery by replacing general interrogatories. Among other things, the Plaintiff Fact Sheet requires claimants to identify:
The Defendant Fact Sheet requires Ethicon to identify sales reps who interacted with a specific plaintiff’s healthcare providers, as well as, sales data and information on adverse event reports related to Physiomesh.
Ethicon’s Physiomesh hernia patches are constructed from non-absorbable polypropylene (plastic) filaments that are woven into fabric and laminated with an absorbable film coating. The company claims that this unique, multilayer design helps the hernia mesh incorporate into the body and reduces inflammation.
Ethicon launched Physiomesh hernia product line 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 testing if a manufacturer can show that it is “substantially equivalent” to a product that has already gone through the FDA’s standard – and stricter – premarket approval process.
Ethicon withdrew Physiomesh Flexible Composite Mesh from the global market two years ago, after unpublished data from two European hernia registries suggested that the product was associated with higher average recurrence and revision rates when used in laparoscopic ventral hernia repair compared to other mesh products
While Ethicon announced hernia mesh recalls for Physiomesh in several countries, no such action has been taken in the U.S.
Nearly 900 hernia mesh lawsuits are pending in the Northern District of Georgia. All of the cases were filed on behalf of individuals who suffered serious injuries and complications due to the allegedly defective nature of Ethicon’s Physiomesh Flexible Composite mesh patches.
Among other things, the complaints allege that the polypropylene used to manufacture Physiomesh is biologically incompatible with human tissue and that the multi-layer design is a breeding ground for bacteria, which may lead to severe adverse reactions including, chronic pain, recurrence of hernia, infection, scaarring and adhesions, and tissue damage.