Courthouses will explode with hernia mesh litigation in 2020 as several bellwether cases go to trial in federal and state courts in the sprawling litigation. Already 8,200 cases are filed in three MDLs against several companies, plus thousands of additional cases filed in state courts nationwide.
Millions of surgeries have relied upon the implant, and the failure rate is estimated as high as 12-30%. Many of the plaintiffs did not realize until years after the surgery.
The mesh can adhere through tissue ingrowth to vital organs and twist around the patient’s bowels and other internal organs, which can cause the patient to suffer bowel obstruction, and necrosis of the organ tissue. Moreover, it can be impossible for surgeons to remove the mesh without also removing large portions of the patient’s bowel, causing infection to develop, leading the patient to suffer peritonitis, sepsis, organ failure, or death.
There are four major makers of hernia mesh in the U.S:
- C.R. Bard
- Johnson & Johnson’s Ethicon subsidiary
- Atrium Medical Corp.
- Medtronic’s Covidien subsidiary.
There are 3 MDLs for the federal litigation.
Davol, Inc./C.R. Bard, Inc. polypropylene hernia mesh products liability litigation is consolidated before Chief District Court Judge Edmund A. Sargus, Jr. in Ohio. MDL 2846 currently has 3,569 cases.
Lawsuits over Bard Davol’s Kugel Patch formed an earlier MDL that ended in a $184 million settlement in 2011 for 2,600 Kugel Patch lawsuits. So far, this has been the largest settlement amount in any hernia mesh litigation.
Bard first recalled the patch in 2005 after the company said it could cause bowel perforations and fistulas. The first lawsuits followed soon after.
In 2007, a federal panel combined the first 150 Kugel Patch lawsuits into an MDL in a Rhode Island federal court. Eventually, plaintiffs filed more than 3,000 cases against C.R. Bard, Inc.
Two bellwether trials took place in 2010. Bard won the first, but a jury awarded $1.5 million to the plaintiffs in the second trial.
In the second trial, jurors heard the case of Christopher and Laure Thorpe of North Carolina. Christopher Thorpe underwent hernia repair with a Kugel Patch in 2005. Between 2007 and 2008, he underwent multiple surgeries to remove infection and a fistula resulting from the repair.
There are thousands of cases in state litigation in Rhode Island about Ventralex and Composix E/X.
Ethicon Physiomesh Flexible composite hernia mesh products are consolidated before Sr. District Judge Richard W. Story in Georgia. MDL 2782 has 2,664 cases. Johnson & Johnson subsidiary Ethicon, and it pulled a version of Physiomesh off the market in 2016 because high failure rates led to hernias recurring.
The FDA approved Physiomesh in 2010 through its 510(k) process, and it started receiving reports of Physiomesh failures shortly after the approval, including recurring hernias, adhesions, and infections.
The New Jersey Supreme Court consolidated 107 Physiomesh lawsuits into multicounty litigation in August 2018.
Atrium Medical Corp. C-Qur mesh products liability litigation is before U.S. District Judge Landya B. McCafferty in New Hampshire. MDL 2753 has 1,975 cases.
Atrium manufactures C-QUR, Vitamesh, Proloop, Prolite and Prolite Ultra brands of hernia mesh. Atrium recalled its C-QUR Edge mesh in 2013, 2015 and 2018.
There were also FDA injunctions against the manufacturer for failure to address complaints regarding the product as well as a Class II recall.
Covidien hernia mesh is manufactured by Medtronic, including three brands: Parietex Surgical Mesh, Parietex Composite Mesh, and Parietex ProGrip Mesh.
There is no MDL in the Covidien litigation so there is no readily available number of cases. Most cases are being filed in state court using state law claims. For example, there was a new lawsuit filed by a California man in state court in August 2019. There have been no recent settlements or verdicts to report.
Plaintiffs formulate cases
Plaintiff cases allege strict product liability-defective design, strict product liability – failure to warn, strict product liability – manufacturing defect, negligence, gross negligence and violations of state consumer protection laws.
There are more than 20 brands of hernia mesh:
- 3DMax Mesh
- 3DMax Light Mesh
- Bard (Marlex) Mesh Dart
- Bard Mesh
- Bard Soft Mesh
- Composix E/X
- Composix Kugel Hernia Patch
- Composix L/P
- Kugel Hernia Patch
- Modified Kugel Hernia Patch
- Perfix Light Plug
- PerFix Plug
- Sepramesh IP
- Ventralex Hernia Patch
- Ventralex ST Patch
- Ventralight ST
- Ventrio Patch
- Ventrio ST
Donna Jager’s Mesh Nightmare
In an illustrative case, Donna Jager of Apple Valley, CA, was left with a gaping hole in her abdomen from multiple surgeries to remove infected mesh. She sued Davol Inc. and C.R. Bard in federal court in 2016 in central California, Case No. 16-cv-01424-JGB-KK.
On October 4, 2004, Jager underwent a hernia repair procedure during which a Bard Composix Kugel hernia mesh was implanted. The company told doctors that the Patch was safe, cost effective and suitable for hernia repair.
But by April 3, 2015, Jager had a hernia mesh infection, requiring her to undergo an exploratory laparotomy, open ventral hernia repair, and an appendectomy.
The surgeon noted “[g]ross purulent drainage was present with [the] previous mesh involved.” Further, he observed, “[d]ense adhesions of the appendix was noted to the inferior edge of the mesh on the abdominal wall.”
Additionally, “[f]urther inspection revealed the tract of the fistula emanating from the tip of the appendix. In that area the ring from the Bard mesh had fractured and was poking into the tip of [her] appendix.” This required the surgeon to excise the fistula tract and detach Plaintiff’s appendix from her abdominal wall.
She spent more than a month in a hospital and was finally discharged on May 5, 2015. As a further result of her infected Kugel Patch, she was required to undergo a wound VAC as well as intensive home wound care for the gaping hole in her abdomen.
Jager alleges that Davol and Bard knew, prior to the recalls of the Kugel Patch, that it was not properly developed, manufactured, inspected, marketed, and sold; that the Patch was not suitable for the purpose it was intended; and it was unreasonably dangerous and likely to injure patients implanted with it.