The number of hernia mesh lawsuits filed in the United States has been increasing since the mid-2010s following recalls and reports of patient injuries.
The U.S. Food and Drug Administration tracks hernia mesh complications, and its database shows recalled hernia mesh is responsible for many of the injury reports it receives. The FDA says the most serious complications from recalled hernia mesh include perforated or obstructed bowels. These injuries are frequently mentioned in lawsuits.
First Hernia Mesh Trials Expected in 2020
Roughly 4,780 hernia mesh lawsuits from across the United States have been combined in three different mass litigations, according to the Judicial Panel for Multidistrict Litigation’s April 2019 statistics report.
Each of the multidistrict litigations, or MDLs, involves a different hernia mesh manufacturer: Atrium Medical Corp., Ethicon and Bard. The number of lawsuits in the litigations has grown steadily since the federal panel created them.
There have been no verdicts and no major settlements in any of the cases. The first trials are not expected until 2020.
Other cases have been filed in state courts, including 62 Physiomesh lawsuits that the New Jersey Supreme Court combined into a multicounty state litigation in August 2018. At the time, attorneys expected “dozens, if not hundreds of additional cases” in that state litigation.
Atrium C-QUR Lawsuits
The Judicial Panel on Multidistrict Litigation created MDL-2753 IN RE: Atrium Medical Corp. C-QUR Mesh Products Liability Litigation in December 2016. At the time, 13 cases were pending in seven districts.
The panel chose United States District Judge Landya B. McCafferty to oversee the litigation in New Hampshire. The number of lawsuits grew to 1,217 in April 2019. The first trial is expected to begin in February 2020.
Lawsuits Against Ethicon Over Physiomesh Flexible Composite Mesh
Physiomesh Flexible Composite Mesh lawsuits were combined in Georgia’s Northern District federal court in June 2017. Johnson & Johnson and its Ethicon unit are named as defendants in the litigation, which is formally called MDL -2782 IN RE: Ethicon Physiomesh Flexible Composite Hernia Mesh Products Liability Litigation.
United States District Judge Richard W. Story is overseeing the 1,900 lawsuits — the first of which is expected to go to trial in February 2020. A separate litigation involving more than 60 cases is also underway in New Jersey.
Bard Faces New Polypropylene Mesh Cases
The Bard mesh litigation involves virtually all Bard hernia mesh product lines made from polypropylene, a type of plastic used in most hernia mesh products in the United States.
- PerFix Mesh
- 3DMax Mesh
- Ventralex Patch
- Ventralex ST Mesh
- Sepramesh IP Composite Mesh
- Composix E/X Mesh
As of April 2019, there were 1,576 lawsuits in the Bard litigation. The cases were combined in federal court in Ohio’s Southern District in August 2018. No date has been set for the first trial.
Revision Surgery and Other Injuries Mentioned in Lawsuits
Lawsuits claim that hernia mesh led to serious complications that required surgery to fix. Some people required multiple surgeries to remove and replace defective mesh.
- Adhesions — scar-like tissue that causes organs to stick together
- Bowel obstructions — blockages in the small or large intestine
- Fistulas — abnormal connections between different organs
- Perforations — holes in nearby tissue or organs
Some people who sued Atrium over its C-QUR mesh have also claimed reactions to the mesh akin to allergic or immune system reactions. Lawsuits blame a coating on the mesh derived from fish oil for triggering the unwanted responses.
Ethicon never recalled Physiomesh Flexible Composite Mesh. But the company did remove the device for laparoscopic use from the global market after European hernia registries found it was failing at an unusually high rate. The failures allowed hernias to come back in patients, a condition called recurrence. Physiomesh lawsuits claim people had to go through multiple repairs in some cases when the mesh failed them.
C-QUR Claims: Blocked Intestine and Bowel Removal Surgeries
Daniel Hicks of Florida underwent hernia repair with Atrium’s C-QUR mesh on Jan. 25, 2012. In early 2015, he told his doctor he’d been experiencing severe pain, according to his complaint.
A CT scan showed an abnormal connection of the tissues inside his body near the location of the mesh. In the following months, doctors found the mesh was sticking to his small intestine.
A surgeon had to remove the mesh and part of the bowel. Hicks also underwent an additional hernia repair with C-QUR mesh at that time.
But just a month later, he was in pain again. The new mesh had blocked his small intestine, and Hicks needed another surgery to remove a different section of bowel.
Hernias Came Back After Repairs with Physiomesh, Lawsuit Says
David Watring of Massachusetts underwent hernia repair surgery using Physiomesh in April 2013. His hernia came back, a condition called recurrence, by November. Several loops of his small intestine were caught in the reopened hernia.
After another repair, the hernia recurred yet again in March 2016. Again, there were several loops of the small intestine protruding through the hernia with “dense adhesions between the loops of bowel,” according to his complaint.
After the surgery, Watring experienced yet another recurrence. At the time of his complaint, Watring was awaiting a doctor’s decision on what to do next. Until that point, his complaint said, all repairs were done with Physiomesh.
Bard’s Polypropylene Mesh Blamed for Chronic Pain and Other Complications
Gregory Rowe of Arkansas underwent hernia repair surgery in May 2018. He received a PerFix Plug, a polypropylene hernia mesh product manufactured by Bard.
Rowe’s complaint said he developed inguinodynia, a condition categorized by chronic pain around the hernia site that lasts for more than three months. The pain was enough to cause a surgeon to remove the mesh in December 2016.
The doctor noted that the plug was “contracted in nature” after removing it. Rowe’s complaint refers to “a substantial body of scientific evidence” that polypropylene is incompatible with human tissue.
It also claimed research has found polypropylene can cause an immune system response. Rowe’s complaint said he still suffers chronic pain and other complications he blames on the mesh.
Preserving Hernia Mesh as Evidence
Before you have defective hernia mesh removed, make arrangements with your surgeon and hospital to preserve the mesh. It also may be a good idea to talk to a lawyer before having the mesh removed to make sure the surgeon and hospital take all the proper steps to preserve the mesh. This can be important if the patient decides to file a lawsuit against the mesh manufacturer later on.
The American Bar Association calls preserving evidence “crucial” in a product liability case like a hernia mesh lawsuit. Courts sometimes set specific rules on how a medical device is handled after it’s removed in case there is a subsequent lawsuit.
The court in the Physiomesh litigation, for example, set out very specific rules for how the mesh should be preserved and handled after it is surgically removed. It selected a medical specimen storage company in Florida, Steelgate Inc., to preserve and store Physiomesh samples. And it set up rules for patients and lawyers for how the specimens should be shipped and handled.
Court Rules for Preserving Physiomesh for Lawsuits
- Patient must notify surgeon to preserve both mesh and any tissue removed
- Patient must notify hospital to ship the evidence to Steelgate’s facility
- Patient’s lawyer must coordinate shipping
- Steelgate stores all samples
- Both sides in lawsuits share storage costs
- Attorneys for patient and for Ethicon examine tissue and mesh samples
- Lawyers for the opposing side can be present during all examinations
- Any tests that may destroy a sample are not allowed
Bard Kugel Patch: $1.5M Verdict and $184M Settlement
While there have been no jury verdicts or major settlements in the current round of hernia mesh litigation, Bard did settle lawsuits over its Kugel Patch in 2011. Problems with the mesh patch led to more than 2,300 lawsuits and a $1.5 million verdict against Bard before the company agreed to settle.
Bard recalled more than 137,000 Kugel Patches after reports of patient injuries.
- June 2007A judicial panel consolidated Kugel Patch lawsuits into a mass litigation in Rhode Island federal court.
- April 2010Bard won the first trial in the litigation.
- August 2010A jury awarded $1.5 million to the plaintiff in the second trial.
- June 2011Bard offered $184 million settle the majority of Kugel Patch lawsuits.
- September 2017The judicial panel closed the Kugel Patch litigation after 10 years.Last Modified: October 4, 2019
20 Cited Research Articles
- Moylan, T. (2010, August 23). Plaintiff Awarded $1.5 Million in Second Bellwether Trial in Kugel Hernia Patch MDL. LexisNexis. Retrieved from https://www.lexisnexis.com/legalnewsroom/litigation/b/litigation-blog/posts/plaintiff-awarded-1-5-million-in-second-bellwether-trial-in-kugel-hernia-patch-mdl
- Supreme Court of New Jersey. (2018, August 15). Notice to the Bar; Multicounty Litigation – Physiomesh Flexible Composite Mesh Litigation. New Jersey Courts. Retrieved from https://www.njcourts.gov/notices/2018/n180815a.pdf
- Town of Merrimack New Hampshire. (n.d.). Merrimack Business Profiles. Retrieved from https://www.merrimacknh.gov/economic-development/pages/merrimack-business-profiles
- U.S. District Court, Dist. of Massachusetts. (2016, November 12). Watring v. Ethicon, Inc.; Complaint and Jury Demand; Case 1:17-cv-02300. Retrieved from http://www.pacer.gov
- U.S. District Court, Dist. of New Hampshire. (2018, May 29). In re: Atrium Medical Corp. C-QUR Mesh Products Liability Litigation (MDL No. 2753); Case Management Order 3H. Retrieved from http://www.nhd.uscourts.gov/pdf/Atrium_CMO3H.pdf
- U.S. District Court, District of New Hampshire. (2016, August 5). Hicks v. Atrium Medical Corporation, et al.; Complaint and Jury Demand; Case 1:16-cv-00357. Retrieved from http://www.pacer.gov
- U.S. District Court, Northern Dist. of Georgia. (2018, May 29). In re: Ethicon Physiomesh Flexible Composite Hernia Mesh Products Liability Litigation; Practice and Procedure Order No. 11. Retrieved from http://www.gand.uscourts.gov/sites/default/files/rws2782_Doc345.pdf
- U.S. District Court, Northern Dist. of Georgia. (2019, January 17). In re: Ethicon Physiomesh Flexible Composite Hernia Mesh Products Liability Litigation; MDL No. 2782; Practice and Procedure Order No. 15. Retrieved from http://www.gand.uscourts.gov/sites/default/files/rws2782_doc425.pdf
- U.S. District Court, Southern Dist., Ohio. (n.d.). Introduction – MDL 2846. Retrieved from https://www.ohsd.uscourts.gov/introduction-mdl-2846
- U.S. District Court, Western Dist. of Missouri. (2018, January 18). Rowe v. Davol, Inc., et al.; Jury Trial Demanded; Civil Action No.: 6:18-cv-3019. Retrieved from http://www.pacer.gov
- U.S. Food and Drug Administration. (2005, December 22). Class 1 Device Recall Bard. Retrieved from https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=43767
- U.S. Food and Drug Administration. (2007, January 10, 2007). Class 1 Device Recall Davol Composix Kugel Hernia Patch. Retrieved from https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=49722
- U.S. Food and Drug Administration. (2017, December 28). Hernia Surgical Mesh Implants: FDA Activities. Retrieved from https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/HerniaSurgicalMesh/ucm317440.htm
- U.S. Food and Drug Administration. (2017, December 28). Hernia Surgical Mesh Implants: Reporting Problems to the FDA. Retrieved from https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/HerniaSurgicalMesh/ucm317444.htm
- U.S. Food and Drug Administration. (2017, January 28). Hernia Surgical Mesh Implants: Information for Patients. Retrieved from https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/HerniaSurgicalMesh/ucm317438.htm
- U.S. Food and Drug Administration. (2018, February 4). Hernia Surgical Mesh Implants. Retrieved from https://www.fda.gov/medicaldevices/productsandmedicalprocedures/implantsandprosthetics/herniasurgicalmesh/default.htm
- U.S. Judicial Panel on Multidistrict Litigation. (2016, December 8). In re: Atrium Medical Corp. C-QUR Mesh Products Liability Litigation; MDL No. 2753; Transfer Order. Retrieved from https://www.jpml.uscourts.gov/sites/jpml/files/MDL-2753-Initial_Transfer-12-16.pdf
- U.S. Judicial Panel on Multidistrict Litigation. (2017, June 2). In re: Ethicon Physiomesh Flexible Composite Hernia Mesh Products Liability Litigation; MDL No. 2782; Transfer Order. Retrieved from https://www.jpml.uscourts.gov/sites/jpml/files/MDL-2782-Initial_Transfer-05-17.pdf
- U.S. Judicial Panel on Multidistrict Litigation. (2019, April 15). MDL Statistics Report. Retrieved from https://www.jpml.uscourts.gov/sites/jpml/files/Pending_MDL_Dockets_By_District-April-15-2019.pdf
- Villarraga, M.l. and Kane, W. (2017, February 21). Preserving Evidence in a Product Liability Case: Focus on Medical Devices. American Bar Association. Retrieved from https://www.americanbar.org/groups/litigation/committees/expert-witnesses/articles/2017/preserving-evidence-prod-liab-case-focus-on-medical-devices/
- June 2007
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