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Hernia Mesh Lawsuits: Physiomesh, C-QUR

Federal courts have taken up more than 3,000 hernia mesh lawsuits in recent years after patients reported serious complications ranging from infections to organ damage. Hernia mesh lawsuits have already resulted in at least one verdict of $1.5 million and a settlement worth $184 million.

Injured by complications related to Hernia Mesh?

If you or a loved one suffered complications or injury after hernia mesh surgery, you may have legal options.

Hernia Mesh Lawsuit Facts
  1. Plaintiff Injuries Wrongful death; infections; organ damage; autoimmune problems; adhesions; bowel obstructions
  2. Defendants Atrium Medical Corp.; Ethicon; Johnson & Johnson; C.R. Bard, Davol Inc.
  3. Settlement Bard settled about 2,000 Kugel hernia patch cases for $184 million
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Hundreds of hernia mesh lawsuits from across the U.S. have been combined into two new multidistrict litigations (MDLs) in federal court. MDLs allow cases to move more quickly and efficiently through the legal system. Lawyers expect hundreds more could be added before the cases go to trial.

People filing lawsuits claim Ethicon’s Physiomesh Flexible Composite products and Atrium C-QUR hernia mesh were not properly designed and caused serious internal injuries, allowed hernias to recur or other complications.

Status of Current Hernia Mesh Lawsuits

As of March 2018, more than 700 lawsuits were pending in federal MDLs against two hernia mesh manufacturers.

Atrium C-QUR Mesh MDL
A total of 30 Atrium C-QUR mesh lawsuits were pending in New Hampshire District Court as of March 2018. The Judicial Panel on Multidistrict Litigation established the MDL in December 2016.
Ethicon Physiomesh Flexible Composite Mesh MDL
As of March 2018, there were 680 lawsuits over Ethicon’s Physiomesh Flexible Composite Hernia Mesh pending in Georgia Northern District Court. The MDL panel established the MDL in June 2017.
Injured by complications related to Hernia Mesh? Free Case Review

Why People File Hernia Mesh Lawsuits

People who developed serious complications following hernia mesh surgery filed lawsuits claiming the mesh was responsible for their injuries.

Injuries listed in Hernia Mesh lawsuits include:
  • Adherence (becoming stuck to internal tissue)
  • Bowel obstruction
  • Infection
  • Mesh failure
  • Migration (moving from where it was implanted)
  • Perforation of organs or tissues
  • Seromas (pockets of fluid) that require surgery

People filing C-QUR hernia mesh lawsuits also claim the products’ fish oil-derived coating led to “allergic or inflammatory” responses that caused further complications.

How to File a Hernia Mesh Lawsuit

The first step to filing a hernia mesh lawsuit is often consulting with a lawyer. A products liability lawyer, particularly one who specializes in medical device cases, can help explain to people injured by hernia mesh whether they may be entitled to compensation.

People considering a lawsuit should look at several factors and gather as much information as possible about their complications.

Hernia Mesh lawsuit checklist
  • Recognize Your Injury
    You or a loved one must have been injured by hernia mesh to file a lawsuit.
  • Know Your Deadline
    Be aware that you may have a deadline to file a lawsuit; this may be as little as one year after your injury.
  • Gather Medical Records
    Try to gather as many medical records about your injuries and your original hernia mesh surgery.
  • Find Manufacturer and Brand Names
    Try to find the names of the manufacturer and brand of your hernia mesh (This may be in your medical records.).
  • Consult with an Experienced Lawyer
    Consider talking to a lawyer about your legal options.

Lawyers who specialize in products liability and medical device cases usually offer free consultations. These can help determine if a person has a case.

Accusations Against Hernia Mesh Manufacturers

People filing C-QUR and Physiomesh lawsuits claim hernia mesh manufacturers knew or should have known their products were defective, but failed to warn people of the complications.

Hernia mesh lawsuits accuse device makers of several counts of negligence, including:
  1. Manufacturing a defective product
  2. Failing to adequately test hernia mesh
  3. Failing to warn the public about the risks of mesh
  4. Intentionally, knowingly and recklessly concealing information about the defective mesh
  5. Intentionally misrepresenting the quality and safety of hernia mesh
  6. Negligently designing and marketing unsafe hernia mesh

Hernia Mesh Manufacturers Being Sued

At least four manufacturers and 19 different products are embroiled in the latest wave of hernia mesh lawsuits. While Atrium and Ethicon products have been combined into MDLs, patients receiving Bard or Covidien mesh products have also brought individual lawsuits against those companies alleging complications.

Hernia Mesh makers and products in current lawsuits
Atrium
C-QUR Mesh, C-QUR Edge Mesh V-Patch, C-QUR Lite Mesh V-Patch, C-QUR OVT Mesh, C-QUR RPM Mesh, C-QUR TacShield, C-QUR V-Patch, C-QUR Mosaic
Bard
PerFix Mesh, 3DMax Mesh, Ventralex Patch, Ventralex ST Mesh, Sepramesh IP Composite Mesh, Composix E/X Mesh
Covidien
Parietex Surgical Mesh, Parietex Composite Mesh, Parietex ProGrip Mesh
Ethicon
Physiomesh Flexible Composite Mesh
Were you or a loved one injured by hernia mesh? Get a Free Case Review

Previous Hernia Mesh Verdicts & Settlement Amounts

Various models of Bard Davol’s Kugel Patch were among of the first hernia-mesh devices involved in multidistrict litigation. Bard first recalled the patch in 2005 because it could cause bowel perforations and fistulas. The first lawsuits followed soon after. Eventually, plaintiffs filed over 3,000 cases against C.R. Bard, Inc., and its subsidiaries for the design, manufacture, and use of specific hernia mesh devices.

  • June 2007
    First 150 cases consolidated into MDL in Rhode Island federal court
  • April 2010
    Defense verdict for Bard in first bellwether trial of MDL
  • August 2010
    $1.5 million verdict for plaintiffs in second trial
  • June 2011
    Bard offers $184 million in settlements to 2,600 Kugel patch lawsuits
  • September 2017
    Kugel Hernia Mesh Patch MDL closed after 10 years

Hernia Mesh Class Action Lawsuit

The latest series of hernia mesh lawsuits in the U.S. involve multidistrict litigations (MDLs). These differ from class action lawsuits in a few important ways.

Class Action Lawsuits

These involve a few people filing a single lawsuit over a common injury or injuries. Only people who suffered those injuries are eligible to collect any portion of the verdict or settlement. Usually, everyone in the class receives a proportionate share of awards or settlements.

Multidistrict Litigations (MDLs)

These start as multiple lawsuits filed by several – even hundreds or thousands – of people in federal courts. These are combined to speed them through much of the pre-trial portions of the case more quickly and less expensively. They tend to be more flexible on the range of injuries allowed and settlement payments may be based on each type of injury.

Canadian law is somewhat different, and at least two brands of hernia mesh have been entangled in that country’s version of class action litigation in recent years.

Clinical Studies, FDA Actions on Hernia Mesh

Scientific studies have questioned the effectiveness of some hernia mesh and companies have pulled products off the market after high failure rates were reported. The FDA has even sent a warning to at least one company over its manufacturing and quality control process at a hernia mesh manufacturing plant. “Many complications related to hernia repair with surgical mesh that have been reported to the FDA have been associated with recalled mesh products that are no longer on the market” the FDA said.

Timeline of hernia mesh studies and FDA actions
  • 2006
    FDA approves Atrium’s first C-QUR mesh products
  • 2009
    Researchers find every C-QUR mesh in their study had increased rate of adhesions and immune system responses
  • 2010
    FDA approves Ethicon’s Physiomesh Flexible Composite Mesh
  • 2012
    FDA issues a warning letter to Atrium Medical noting that there were complaints of infections from the mesh that were not properly addressed or documented and Atrium’s sterilization process may have been inadequate.
  • 2015
    Federal court grants FDA an injunction against Atrium to stop distribution and manufacturing of medical devices from the company’s Hudson, New Hampshire plant until it complied with certain provisions of the Federal Food, Drug, and Cosmetic Act.
  • 2016
    Study published in JAMA finds that while mesh reduces chances of hernia recurrences within 5 years of surgery, benefits are often offset by mesh complications.
  • 2016
    Two, large European hernia registries report higher than average failure rates for Physiomesh Flexible Composite Mesh.
  • 2016
    Ethicon issues a “market withdrawal” of Physiomesh Flexible Composite Mesh products.
  • 2016
    Study finds recalled mesh is responsible for some of the most serious complications.

The FDA has different definitions for recalls and market withdrawals. The FDA considers a market withdrawal as cases where there were no grounds for the agency to take legal action against a manufacturer. In those cases, the company simply removes the product from the market or corrects the violation.

Please seek the advice of a medical professional before making health care decisions.

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19 Cited Research Articles

  1. James and Kimberly Brown vs Atrium Medical Corporation. (2017, January 9.) U.S. District Court of New Hampshire. Retrieved from https://45ijagbx6du4albwj3e23cj1-wpengine.netdna-ssl.com/wp-content/uploads/https-ecf-nhd-uscourts-gov-doc1-11711835179.pdf
  2. Lexis Legal News. (2017, September 9). Kugel Hernia Mesh Patch MDL Closed Sept. 15 After 10 Years. Retrieved from https://www.lexislegalnews.com/articles/20550/kugel-hernia-mesh-patch-mdl-closed-sept-15-after-10-years
  3. Matthew Huff vs. Ethicon, Inc. (2016, April 1) U.S. District Court, Southern District of Illinois. Retrieved from https://18vtbxct6zl2lh5x8psdj8p7-wpengine.netdna-ssl.com/wp-content/uploads/2016-04-01-Complaint.pdf
  4. The Internet Archive. (2016, May 25). Ethicon Physimesh Flexible Composite Mesh. Retrieved from https://archive.org/stream/EthiconPhysiomeshRecall/ethicon%20physiomesh%20recall_djvu.txt
  5. U.S. Food and Drug Administration. (2017, April 4). Hernia Surgical Mesh Implants. Retrieved from https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/HerniaSurgicalMesh/default.htm
  6. Science Daily. (2016, October 18). Study finds mixed results for use of mesh for hernia repair. Retrieved from https://www.sciencedaily.com/releases/2016/10/161018094928.htm
  7. Kokotovic, D. et al. Long-term Recurrence and Complications Associated With Elective Incisional Hernia Repair. Retrieved from http://jamanetwork.com/journals/jama/fullarticle/2565771
  8. U.S. Food and Drug Administration. (2012, October 11). Warning Letter CMS # 363780. Retrieved from http://wayback.archive-it.org/7993/20161023095443/http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2012/ucm325084.htm
  9. U.S. Food and Drug Administration (2015, Feb. 4). Federal judge approves consent decree with Maquet Holding B.V. & Co [Press release]. Retrieved from https://wayback.archive-it.org/7993/20170112222807/http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm432925.htm
  10. IN RE: Atrium Medical Corp. C-QUR Mesh Products Liability Litigation. (2016, December 8). Transfer Order, MDL No. 2753. U.S. Panel on Multidistrict Litigation. Retrieved from http://www.jpml.uscourts.gov/sites/jpml/files/MDL-2753-Initial_Transfer-12-16.pdf
  11. IN RE: Ethicon Physiomesh Flexible Composite Hernia Mesh Products Liability Litigation. (2017, June 2). Transfer Order, MDL No. 2782. U.S. Panel on Multidistrict Litigation. Retrieved from http://www.jpml.uscourts.gov/sites/jpml/files/MDL-2782-Initial_Transfer-05-17.pdf
  12. Judicial Panel on Multidistrict Litigation. (2016, December 8). IN RE: Atrium Medical Corp. C-QUR Mesh Products Liability Litigation; MDL No. 2753. Retrieved from: http://www.jpml.uscourts.gov/sites/jpml/files/MDL-2753-Initial_Transfer-12-16.pdf
  13. U.S. Department of Justice. (2015, February 3). District Court Enters Permanent Injunction Against New Hampshire Company and Senior Executives to Stop Distribution of Adulterated and Misbranded Products. Retrieved from: https://www.justice.gov/opa/pr/district-court-enters-permanent-injunction-against-new-hampshire-company-and-senior
  14. Schreinemacher, M.H., et al. (2009, March). Degradation of Mesh Coatings and Intraperitoneal Adhesion Formation in an Experimental Model. Retrieved from: https://www.ncbi.nlm.nih.gov/pubmed/19224521
  15. FDA. (2010, April 9). 510(k) Premarket Notification; Physiomesh. Retrieved from: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K093932
  16. FDA. (2006, March 31). 510(k) Premarket Notification; Atrium C-QUR. Retrieved from: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K050311
  17. Perriello, B. (2016, June 20). J&J’s Ethicon recalls Physiomesh flexible composite hernia mesh. Retrieved from: http://www.massdevice.com/jjs-ethicon-recalls-physiomesh-flexible-composite-hernia-mesh/
  18. U.S. District Court, Northern District of Georgia. (2018, January 19). In re: Ethicon Physiomesh Flexible Composite Hernia Mesh Products Liability Litigation; Practice and Procedure Order No. 7. Retrieved from http://www.gand.uscourts.gov/sites/default/files/rws2782_doc297.pdf
  19. U.S. Judicial Panel on Multidistrict Litigation (2018, March 15). MDL Statistics Report – Distribution of Pending MDL Dockets by District. Retrieved from http://www.jpml.uscourts.gov/sites/jpml/files/Pending_MDL_Dockets_By_District-March-15-2018.pdf
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