Ethicon Physiomesh is a flexible, composite, macroporous, and partially absorbable mesh made of non-absorbable polypropylene by Johnson & Johnson. FDA approved the use of Ethicon Physiomesh in March 2010 for repair of hernias and other fascial deficiencies that require the addition of a strengthening or bridging material to obtain the desired surgical result. A hernia is a condition which occurs when an organ, intestine, and/or tissue squeezes through a hole or weak point in the surrounding muscle or connective tissue. The number of hernia repair operations performed every year in the USA is remarkable.
Despite the already existing mesh implants in the market, the sale of Ethicon Physiomesh increased after the FDA approval as it was promoted as a physiologically well-designed device, offering strong and comfortable healing and giving an exceptional intraoperative handling benefit. But within a few years, Ethicon globally recalled the Physiomesh after thoroughly considering the data which was revealed out of Hernia registries.
More than 1000 lawsuits have been filed as Ethicon Physiomesh was found to cause too many issues, increasing the rate of a recurrent hernia and repeat surgeries.
Serious Alleged Injuries May Include:
- Pain
- Infection
- Hernia Recurrence
FDA Safety Warnings:
- Ethicon Physiomesh Flexible Composite Mesh was approved by FDA on the basis of 510k process, in which human testing is not a mandate if manufacturers of medical devices can validate that their products are substantially equivalent to another legally marketed device.
- Ethicon stated that their product, Physiomesh, was substantially equivalent to their own product, Proceed, a hernia mesh.
- Later, in 2006, Ethicon recalled Proceed as the layers separating and exposing the underlying polypropylene mesh during a hernia repair procedure were increasing the risk adhesions and bowel fistulas in the operated patients. Following this, Physiomesh was also ultimately recalled in 2016.
Legal Updates:
Defendants: Ethicon (a Johnson & Johnson Company), Atrium Medical, C. R. Bard, Inc. (Bard Davol)
Defense Law Firm:
J&J and Ethicon- Butler Snow LLP
Allegations: The mesh products named in the lawsuits contain polypropylene material, which can easily break, shrink or wear off. This often leads to device migration, organ perforation, infection, and several other complications. Lawsuits allege the defective design of the hernia mesh often required the patients to undergo additional correction surgeries.
Plaintiff Steering Committee -Ethicon Physiomesh Flexible Composite Hernia Mesh Products Liability Litigation
Henry G. Garrard, III - Blasingame, Burch, Garrard & Ashley, P.C.
Donald A. Migliori - Motley Rice LLC
Karen Beyea-Schroeder - Bumett Law Firm
Richard A. Freese - Freese & Goss, PLLC
Shelly A. Sanford - Watts Guerra LLP
Richard W. Schulte - Wright & Schulte, LLC
C. Andrew Childers - Childers, Schlueter & Smith, LLC
Douglass A. Kreis - Aylstock, Witkin, Kreis & Overholtz, PLLC
Aimee H. Wagstaff - Andrus Wagstaff, PC
Peter Samberg - Weitz & Luxenberg, LLC
Jayne Conroy - Simmons Hanly Conroy
Jon C. Conlin - Cory Watson, P.C.
Lawsuit Status:
There are more than 2,300 lawsuits involving complaints against three hernia mesh manufacturers. Ethicon's Physiomesh Flexible Composite mesh, Atrium C-QUR products, and different models of Bard Davol's line of polypropylene products.
MDL No. 2753; In Re: Atrium Medical Corp. C-Qur Mesh Products Liability Litigation) formed in December 2016 overlooked by Judge Landya McCafferty in New Hampshire District Court. There are 400 Atrium C-Qur hernia mesh lawsuits pending in the MDL as of 2018.
MDL No.2846; In Re: Davol, Inc./C.R. Bard, Inc., Polypropylene Hernia Mesh Products Liability Litigation in the Southern District of Ohio presided by Judge Edmund A. Sargus comprises over 180 lawsuits against the company.
MDL No.2782; In Re: Ethicon Physiomesh Flexible composite Hernia Mesh Products Liability Litigation was formed in June 2017 overlooked by Judge Richard W. Story in the Northern District of Georgia. There are about 1,450 pending lawsuits as of January 2018.
Important Verdicts & Settlements
C.R. Bard Inc.
2005: Between 2005 and 2007 Bard recalled several Kugel Patch mesh models
2007: Kugel Mesh Hernia Patch MDL was formed.
2012: In March 2012, Bard stopped selling CK Patch Mesh.
2010: In 2010, there were two bellwethers conducted against C.R. Bard for complications over their Kugel Patch mesh. The first one ended in defense verdict while in the second one the plaintiff was awarded $1.5 million in damages.
2014: Bard PerFix Light Plug was subject to a Class II Recall over chronic nerve damage and chronic pain, pelvic pain, and prolapse of organs
2017: The company spent almost $184 million to resolve about 2,600 Kugel Patch lawsuits and eventually the Kugel MDL which was closed on September 15, 2017. Unresolved cases were transferred to the Rhode Island State Courts. (In Re: Kugel Mesh Hernia Patch Products Liability Litigation (1:07-md-01842)) in the District Court of D. Rhode Island)
2018: All Polypropylene mesh lawsuits were centralized by the JPML in the Southern District of Ohio.
Atrium Medical
No settlement has been reached yet in Atrium C-Qur hernia mesh lawsuits.
May 2018: A Case management order issued on May 29, 2018, which stated first bellwether trial will begin on February 19, 2020, for Atrium C-Qur Hernia Mesh cases.
November 2018: Getinge AB, the Swiss parent company of Atrium Medical Corporation, announced setting aside an amount totaling to $200 million (SEK 1.8 billion) to cover the ongoing costs of litigation and future hernia mesh settlements involving around 900 lawsuits filed against Atrium Medical in the U.S and Canada.
January 2020: A settlement conference for the first lawsuit has been scheduled for January 6, 2020.
Ethicon Inc.
May 2017: A Cinnaminson woman was awarded $2.5 million in compensatory damages and $17.5 million in punitive damages in a trial against the company in Philadelphia.
May 2018: Judge Story issued an order allowing affected patients to preserve their Physiomesh implants for evidence at the trial.
August 2018: In a notice published on August 15, the New Jersey Supreme Court granted multicounty litigation (MCL) status to all the pending and future hernia mesh lawsuits against Johnson & Johnson and its subsidiary Ethicon Inc.
December 2019: First bellwether trial involving Ethicon Physiomesh Flexible Composite Mesh lawsuits will be held in Northern District of Georgia.
Evidence:
- Indication Of Usage In Medical Records
- Usage Of Hernia Mesh In Operative And Medical Records
- Identification Details For Hernia Mesh Implant
- Complications And Their Treatment After Hernia Mesh Implant
Medical Record Review and claim validation of Hernia Mesh case should take approximately 3 hours in most instances; however, this approximation may vary in cases based on the volume of records.
