Atrium Medical C-Qur Lawsuit

Atrium is facing lawsuits due to health complications that patients have experienced from its C-Qur hernia mesh. The FDA had inspected the Atrium manufacturing facilities and found violations of federal regulations. Eventually, the FDA issued a warning letter to Atrium, one of the strongest actions it can take against a company.

Following the warning, the FDA was able to seek an injunction against Atrium to prevent the company from manufacturing C-Qur hernia mesh for a period of time until it could prove that it had rectified the problems found by the FDA’s inspections. In 2016, Atrium was able to begin producing C-Qur hernia mesh again through the FDA’s 501(k) fast-track approval process.

Even though C-Qur hernia mesh was re-approved, that hasn’t stopped the complaints about negative side effects from the hernia mesh. Patients have claimed the fish oil coating on the hernia mesh has caused health complications. Many have sued Atrium over the complications they’ve experienced from the hernia mesh.

free case evaluation
Jump to topic
  • Why Are There C-Qur Hernia Mesh Lawsuits?
    • Was C-Qur Hernia Mesh Recalled?
    • Why Did the FDA Investigate Atrium?
    • Is C-Qur Hernia Mesh Approved by the FDA?
  • What C-Qur Hernia Mesh Lawsuits Are There?
    • What C-Qur Hernia Mesh Lawsuit Settlements Are There?
  • Should I Consider a C-Qur Hernia Mesh Lawsuit?
    • How Do I Find the RIght C-Qur Hernia Mesh Attorney?

Why Are There C-Qur Hernia Mesh Lawsuits?

Since 2016, patients who had C-Qur hernia mesh implanted to repair a hernia have sued Atrium, the manufacturer of C-Qur. C-Qur hernia mesh is manufactured with a fish oil coating which is intended to ensure that the tissue in the location of the repaired hernia didn’t start to adhere to the hernia mesh. However, many patients claimed that the fish oil coating caused negative impacts to their health. The symptoms they described included:

  • Infection
  • Sepsis
  • Mesh rejection
  • Mesh migration
  • Damage to organs
  • Fistula
  • Complex seroma
  • Formation of a sinus tract
  • Delays in the closure of the wound
  • Severe pain
  • Gastric ulcers
  • Organ perforation
  • Inflammation
  • Death

Was C-Qur Hernia Mesh Recalled?

C-Qur hernia mesh did undergo a recall in 2013 after the manufacturer announced that there had been an issue with the packaging that had allowed humidity to enter the packaging and cause the fish oil coating on the mesh to adhere to the packaging. More than a hundred thousand units of C-Qur hernia mesh were affected and recalled. However, that wasn’t the only problem that Atrium faced when it came to C-Qur hernia mesh.

Why Did the FDA Investigate Atrium?

The FDA had received reports of problems with C-Qur mesh as early as 2008. The organization conducted multiple investigations into Atrium’s manufacturing process for C-Qur hernia mesh and found numerous violations of federal regulations, from issues with monitoring and reporting to problems with the manufacturing process. Ultimately, the FDA sent a warning letter to Atrium, which is one of the strongest measures it can take.

Is C-Qur Hernia Mesh Approved by the FDA?

The FDA also sought an injunction against Atrium to prevent the company from manufacturing C-Qur hernia mesh until they could fix the problems with the manufacturing process. In 2016, Atrium applied for FDA approval, but did so using the FDA’s 501(k) fast track process. This means that the company would be exempt from normal research requirements because there were similar products already on the market.

What C-Qur Hernia Mesh Lawsuits Are There?

The earliest lawsuits against Atrium for health complications experienced by patients began in 2016. Numerous other lawsuits followed, enough that they were consolidated into multi-district litigation, also known as an MDL. An MDL differs from a class-action lawsuit in that all cases in multi-district litigation remain separate but are tried together in the same court under the same judge. In a class action lawsuit, all of the cases are combined into one case. By 2020, the multi-district litigation included more than a thousand lawsuits. 

What C-Qur Hernia Mesh Lawsuit Settlements Are There?

Although many of these lawsuits were filed as early as 2016, many of them have been delayed due to the pandemic. In 2021, Getinge Group, which is the parent company of Atrium, which manufactures C-Qur hernia mesh, announced that it would be paying $66 million as a settlement for thousands of cases in which plaintiffs claimed that they had been injured or had otherwise had negative health impacts from Atrium’s C-Qur hernia mesh.

 Not all C-Qur hernia mesh cases have had a favorable result, however. A lawsuit filed in 2016 by a man named Randy Africano, who claimed that the C-Qur hernia mesh that was used in his hernia repair surgery hadn’t been sterile and he developed an infection as a result, filed a lawsuit in 2017 against Atrium. Africano also claimed that he developed a seroma due to faulty C-Qur hernia mesh and in 2016 had to have corrective surgery to repair the damage. According to his lawsuit, he claimed that the particular unit of C-Qur hernia mesh used was one of the units that had been manufactured in 2013, which was when the FDA had warned Atrium about its manufacturing process, in particular in its sanitation process. However, after a six-day trial, a jury found that Atrium wasn’t liable in this particular case.

Should I Consider a C-Qur Hernia Mesh Lawsuit?

If you had a hernia that was repaired with C-Qur hernia mesh and experienced health complications or negative side effects as a result, then you should consider a C-Qur hernia mesh lawsuit. Atrium’s manufacturing process for producing C-Qur hernia mesh was investigated numerous times by the FDA and was even halted for a while until the company could address the problems found by the FDA. Plaintiffs suing Atrium claimed that the C-Qur hernia mesh they received came from contaminated batches that caused their health problems. Atrium even had to recall more than a hundred thousand C-Qur hernia mesh units due to faulty packaging.

How Do I Find the RIght C-Qur Hernia Mesh Attorney?

If you were harmed by using C-Qur hernia mesh in a hernia repair, then you may have a case against Atrium. The FDA found enough problems with the company’s manufacturing process for C-Qur hernia mesh to not only issue a warning to the company but to also seek an injunction from the courts to prevent the company from producing C-Qur hernia mesh until they could address the violations of federal regulations. Contact Seeger Weiss for a free consultation to discuss your case against Atrium.

View Sources

  1. Class 2 device recall CQUR VPatch Mesh. accessdata.fda.gov. (n.d.). Retrieved May 5, 2022, from https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=119925 
  2. Grzincic, B. (2021, October 20). Atrium Medical defeats Contaminated-mesh claim. Reuters. Retrieved May 5, 2022, from https://www.reuters.com/legal/litigation/atrium-medical-defeats-contaminated-mesh-claim-2021-10-20/

Have you been affected by a drug or device listed?