Emerging Hernia Mesh Litigation – Strattice
Multi-County litigation is heating up in New Jersey state court over allegedly defective Strattice hernia mesh.
As of January of 2022, a New Jersey judge was selected to oversee the lawsuits. Five plaintiffs’ attorneys and two defense attorneys are in a leadership position in the state court multi-county litigation (MCL).
New Jersey Superior Court Judge John C. Porto from Atlantic County will head the MCL. Consolidating the growing number of cases filed so far is intended to avoid conflicting lower court rulings and discovery issues, so the cases move through the court system.
The Strattice hernia mesh products are designed, manufactured, marketed, and sold by LifeCell Corporation, Allergan Inc., and Allergan USA, Inc., based in New Jersey. The plaintiffs are from several states, including Arizona, Ohio, California, Wisconsin, Texas, as well as New Jersey.
In June 2021, lawyers for the growing number of plaintiffs requested that all Strattice hernia mesh lawsuits be consolidated under one judge. All alleged the hernia mesh was defective and failed, resulting in serious injuries and additional medical intervention.
Judge Porto will be in charge of pretrial proceedings and a series of bellwether trials, selected by both sides to determine the relative value of the cases and how they should be tried in the court.
The plaintiff attorneys predicted hundreds of additional cases would be filed against the defendants.
Hernias and Mesh
With more than one million hernia operations in the U.S. performed every year, the vast majority of them, more than 90%, used mesh to reinforce a tear in the abdominal wall.
The wall can tear for several reasons. Obesity is a condition that puts additional pressure on the abdominal wall. Some of us have inherited weaker tissue than others. Smoking and poor health can weaken the strength of the abdominal wall allowing intestines and abdominal organs to push past the wall, thus creating the hernia.
Unlike polypropylene mesh, Strattice mesh is considered a biologic hernia mesh product. In this case, it is created from porcine or a pig tissue graft. Also called a xenographic graft, Strattice was specifically made to repair a hernia because they allegedly reinforce or bridge body wall defects.
First introduced to the market in 2008, the pigskin is intended to produce a “cross-linked graft,” allowing the implant and the tissue to grow together, strengthening and reinforcing the area of the abdominal wall torn, which allows the intestines to push through.
The graft is preserved in a phosphate-buffered aqueous solution and was intended to be an alternative to polypropylene and its associated problems such as the body’s rejection of a foreign substance, the hosting of infections, and mesh erosion.
Instead, plaintiffs contend that Strattice causes a risk of foreign body response and incites infections.
Most of the plaintiffs contend that the promises did not come to fruition. Instead, they experienced mesh infections, and, in some cases, the infected Strattice hernia mesh had to be removed. In removing a medical device intended to be a permanent implant, more damage is done to healthy tissue.
Plaintiffs contend they suffered pain, disfigurement, loss of enjoyment of life, physical injuries, and financial losses.
Ethicon, Bard, Atrium have all faced similar lawsuits over their thermoplastic polymer meshes made of polypropylene. This MCL is the first-time similar problems have been linked to a biologic mesh.
Biologic Meshes
While the vast number of surgical mesh is made from the polymer polypropylene, CollaMend, FortaGen, Permacol, Strattice, Surgisis, and XenMatriX come from porcine or pig dermis and submucosa. SurgiMend, Veritas Collagen Matrix contains bovine or cow-derived parts.
Traditionally, the biologic mesh is not believed to be as strong and resistant to recurrence as polypropylene mesh.
A researcher at Washington University in St. Louis surveyed opinions about how religious preferences might affect different mesh choices.
He found out that Catholics and Methodists are opposed to any medical product if aborted fetal tissue or embryonic stem cells are used but they consider porcine and bovine acceptable.
Under Jewish law, pork consumption is prohibited, but there are no laws regarding the use of non-kosher products. And there is no restriction on any products for Muslims even though they have restrictions on consuming beef and pork, as do Islamic principles.
Doctors should tell patients the source of their mesh under legal and ethical obligations, concluding the survey.
Other biologic meshes include AlloDerm, Flex HD, AlloMax Surgical Graft, which all contain cadaver-harvested dermis.
Other meshes, such as composite Parietex Composite and C-Qur, are made with fatty acids from fish.
Strattice Litigation
The lawsuits contend that cross-linked grafts can cause painful, ongoing infections and rejection of the implanted hernia mesh. According to the U.S. Food and Drug Administration, from September 1990 through September 2020, there were at least 450 adverse event reports connected to problems with Strattice hernia mesh, including six reports of patient deaths, 340 injury reports, and more than 100 reports of mesh malfunctioning.
The plaintiffs contend that aside from foreign body rejection, mesh erosion, migration, infection, and pain, some Strattice hernia mesh complications include:
- Fever
- Obstructions
- Internal Bleeding
- Rejection of the mesh
- Organ punctures
- Migration of the mesh away from the implant site
- Gastrointestinal distress
- Sexual difficulties
- Abscesses
- Abdominal swelling
- Nerve damage
- Death
Among the plaintiff all allege:
- Design defect
- A failure to warn the end-user doctors and patients about the risks
- Negligence
- A breach of warranties
- The defendants engaged in fraud by misrepresenting the safety of Strattice
- Manufacturers knew of problems with Strattice and marketed it anyway
- Defendants failed to conduct proper pre and post-market testing
New Jersey MCL
Ethicon’s family of multilayered hernia mesh, made by Johnson & Johnson, is pending in Superior Court in New Jersey. They include polypropylene-based mesh properties such as Proceed, Proceed Ventral, Physiomesh Flexible, Prolene 3D, and Prolene Hernia system, alleged to contribute to adhesion formation.
Late last year, Judge Porto appointed the leadership roles to oversee pretrial proceedings, arguing motions, taking depositions, and reviewing discovery.
Each plaintiff will retain their own lawyer for their mesh lawsuit. They will coordinate with the lead and co-lead counsel for the MCL litigation.
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Sources:
New Jersey Courts
https://www.njcourts.gov/notices/2018/n180815a.pdf
MCL Notice to the Bar
https://www.njcourts.gov/notices/2021/n211014b.pdf
FDA and Strattice hernia mesh Maude report
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2422320\
Strattice tissue matrix
https://hcp.stratticetissuematrix.com/
Hernia facts
https://abouthernia.com/hernia-facts
N.J. Courts
Strattice Hernia Mesh Multicounty Litigation (MCL) Application
https://www.njcourts.gov › strattice › stratticeapp
Mesh News Desk, Feb 7, 2012, Hernia from Hell Treated with Biologic Mesh
https://www.meshmedicaldevicenewsdesk.com/articles/hernia-from-hell-treated-with-biologic-mesh
Mesh News Desk, November 2012, Religious Preferences and the Makeup of your Mesh
https://www.meshmedicaldevicenewsdesk.com/articles/religious-preferences-and-the-makeup-of-your-mesh