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 — injuries frequently mentioned in lawsuits.
Nearly 8,000 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 December 2019 statistics report. Each of the multidistrict litigations, or MDLs, involves a different hernia mesh manufacturer: Atrium Medical Corp., Ethicon and Bard.
There have been no verdicts and no major settlements in any of the cases, and the first trials are not expected until 2020. Other cases have been filed in state courts.
Bard Faces New Batch of Polypropylene Mesh Lawsuits
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. Products named in the litigation include: PerFix Mesh; 3DMax Mesh; Ventralex Patch; Ventralex ST Mesh; Sepramesh IP Composite Mesh; and Composix E/X Mesh.
As of December 2019, there were 3,559 pending 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.
Case Points to Evidence that Polypropylene Is Incompatible with Human Tissue
Gregory Rowe of Arkansas underwent hernia repair surgery in May 2014. According to the lawsuit he filed in January 2018, he received a PerFix Plug, a polypropylene hernia mesh product manufactured by Bard.
Rowe’s complaint said he developed inguinodynia, a condition characterized 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 it can cause an immune system response. Rowe’s complaint said he still suffers from chronic pain and other complications he blames on the mesh.
Kugel Patch Lawsuits End After $1.5M Verdict and $184M Settlement
While there have been no jury verdicts or major settlements in the current round of Bard hernia mesh litigation, the company did settle lawsuits over its Kugel Patch in 2011. Problems with the mesh patch led to more than 2,200 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
A judicial panel consolidated Kugel Patch lawsuits into a mass litigation in Rhode Island federal court
Bard won the first trial in the litigation
Jury awarded $1.5 million verdict to plaintiffs in second trial
Bard offered $184 million to settle majority of Kugel Patch lawsuits
Court closed the Kugel Patch litigation after 10 years and final settlement payments
Atrium C-QUR Lawsuits
Lawsuits claim that hernia mesh, including Atrium’s C-QUR mesh, led to serious complications that required surgery to fix. Some people even required multiple surgeries to remove and replace defective mesh.
According to court documents, some people who sued Atrium over its C-QUR mesh have claimed reactions to the mesh akin to allergic or immune system reactions. C-QUR’s fish oil-derived coating was added because omega-3 fatty acids are supposed to reduce inflammation.
The company claims they remove proteins that could cause reactions before the coating is applied, but lawsuits still blame the coating for triggering the reactions.
C-QUR Coating Safety Is Questioned, Linked to Recall
A 2009 study in the British Journal of Surgery raised questions about the fish oil-based coating. Researchers found that it prevented the mesh from sticking to organs or tissue in the short-term, but it became less effective as time passed. The study’s authors concluded that the coating might actually contribute to those kind of adhesions later on.
The coating played a role in Atrium’s decision to recall more than 112,000 C-QUR mesh devices in 2013. The company said that excess humidity could cause the coating to stick to packaging.
The U.S. Food and Drug Administration found repeated problems during four inspections at Atrium’s New Hampshire plant between 2009 and 2013. The agency became frustrated when the company failed to fix the problems. The FDA eventually asked a federal court for an injunction to force Atrium to close most of the factory until it fixed problems; the court granted the injunction in 2015.
1,700 C-QUR Lawsuits Filed to Date
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 pending lawsuits had grown to 1,719 as of December 2019, and the first trial is expected to begin in February 2020.
Man Sues Atrium over 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, so Hicks required yet another surgery to remove a section of bowel.
Claims Against Ethicon Physiomesh Flexible Composite Mesh
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 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.
Watring is one of more than 2,500 people who have filed Physiomesh lawsuits against Johnson & Johnson and its Ethicon unit in state and federal courts.
2,500 Cases Consolidated in Georgia Court, First Trial Expected in 2020
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 litigation. As of December 2019, there were 2,525 pending lawsuits — the first of which is expected to go to trial in February 2020.
Other cases have been filed in state courts, including 19 Physiomesh lawsuits that the New Jersey Supreme Court combined into a multicounty state litigation in August 2018. Lawyers who asked for the MCL said at the time they expected “several hundred more cases” to be filed.
Ethicon Discontinues Laparoscopic Version of Physiomesh After High Failure Rates
Physiomesh lawsuits ramped up after Ethicon pulled the version used in minimally invasive surgeries off the market in May 2016. The company sent out notices to customers and regulators around the world where it sold the mesh it was taking it off the market.
The market withdrawal was limited to Physiomesh Flexible Composite Mesh and did not affect other models in the Physiomesh line.
Ethicon made the decision after its Medical Safety Team reviewed unpublished data from a pair of hernia registries in Germany and Denmark. Medical device registries collect information — including the failure rates of devices.
The two European registries found that people who had ventral hernia repair with Physiomesh had their hernias come back or needed new surgeries at a higher rate than the average for competing hernia mesh from other companies. Ethicon didn’t come to any conclusion as to why its mesh failed at higher rates.
Preserving Hernia Mesh as Evidence: What You Need to Know
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 they take all the proper steps to preserve the mesh. This can be important if you decide 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 lawsuit later on.
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 Steelgate Inc., a medical specimen storage company in Florida, to preserve and store Physiomesh samples. And it set up rules for patients and lawyers on how the specimens are 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
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/