This hernia mesh post about Atrium C-QUR™ mesh was written to provide hernia mesh victims information about hernia mesh litigation and lawsuits. If you have further questions about Atrium C-Qur hernia mesh, please contact a hernia mesh attorney at the number on this site.
WHO is pursuing Atrium C- QUR™ lawsuits in Federal Court?
We are reviewing Atrium C-QUR™ claims (Lap – no FX) for potential individual lawsuits in United States Federal Courts. These Atrium C-QUR™ cases are pending before the UNITED STATES DISTRICT COURT FOR THE DISTRICT OF NEW HAMPSHIRE.
The Honorable United States District Judge Landya McCafferty is presiding over these medical device product liability claims. The Court is located at the U.S. District Court District of New Hampshire. The Court is located at 55 Pleasant Street Room 110 Concord, NH 03301, 603.225.1423.
The official case caption for the MDL is: In Re: Atrium Medical Corp. C-QUR™ Mesh Products Liability Litigation (MDL No. 2753) MDL Docket No. 16-md-2753-LM
The Atrium C-QUR™ causes of action have been consolidated “for pretrial purposes” as multi-district litigation. (otherwise known as an “MDL”)
What orders have issued from the courts deciding the individual Atrium C-QUR lawsuits?
According to the Case Management Order #1, The Court ordered that: “The actions listed in Attachment A are consolidated for pretrial purposes. Any “tag-along” actions later removed to or transferred to this court, or directly filed in this court, will automatically be consolidated with this action without the necessity of future motions or orders. This consolidation, however, does not constitute a determination that the actions should be consolidated for trial, nor does it have the effect of making any entity a party to any action in which he, she, or it has not been named, served, or added in accordance with the Federal Rules of Civil Procedure.” CASE MANAGEMENT ORDER NUMBER 1, January 13, 2017
The 2nd Case Management order declares that, “In order to eliminate delay and to promote judicial efficiency, any plaintiff whose case would qualify for transfer to MDL No. 2753 under the Judicial Panel on Multidistrict Litigation’s December 8, 2016 transfer order (doc. no. 1) may file his or her complaint directly in MDL No. 2753 in this court. Defendants reserve the right to object to the inclusion of any such action in this MDL.” CASE MANAGEMENT ORDER NO. 2 (Direct Filing and Waiver of Service)
What is multi-district litigation (MDL)?
“Multi-district Litigation is litigation comprised of multiple civil cases involving one or more common questions of fact which have been transferred by the Judicial Panel on Multidistrict Litigation from multiple federal district courts across the country to a single federal district court for coordinated or consolidated pretrial proceedings under 28 U.S.C. Section 1407.” United States District Court District of New Hampshire, MDL
WHAT are the Atruim C-QUR™ lawsuits about?
The C-QUR™ hernia mesh victims who have filed lawsuits in Federal Court are asserting that the Atrium C-QUR™ device is defectively designed. They also alleged that they were not properly warned of the device’s dangers. These litigants allege that such medical devices caused them certain complications including:
- Pain and suffering
- Mesh migration
- Bacterial infections
- Hernia recurrence
- Additional surgeries to treat hernia recurrence
WHEN can I file a lawsuit?
You can file a hernia mesh claim after you retain a top hernia mesh attorney
WHERE are the Atrium C-QUR™ lawsuits filed?
UNITED STATES DISTRICT COURT FOR THE DISTRICT OF NEW HAMPSHIRE
Are these C-QUR™ hernia mesh cases a Class action?
No the Atruim C-QUR™ claims are individual lawsuits with each victim represented by their own hernia mesh attorney. It is important that you retain one of the best hernia mesh lawyers in the United States.
WHY did this occur?
Atrium utilized the controversial 510(k) Premarket Notification process to get C-QUR™ approved. On 03/31/2006 the FDA determined that ATRIUM MEDICAL CORPORATION C-QUR MESH aka “C-QUR™ Mesh” is “Substantially Equivalent (SESE)” to another type of mesh marketed years prior. By using the 510 (k) process Atrium avoided the strenuous testing protocol usually required by the FDA.
On March 31, 2007 the FDA wrote a letter to Atrium stating, “We have reviewed your Section 5 10(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act.” https://www.accessdata.fda.gov/cdrh_docs/pdf5/K050311.pdf
What is a 510 (k) pre-market notification process?
“Section 510(k) of the Food, Drug and Cosmetic Act requires device manufacturers who must register, to notify FDA of their intent to market a medical device at least 90 days in advance. This is known as Premarket Notification – also called PMN or 510(k). This allows FDA to determine whether the device is equivalent to a device already placed into one of the three classification categories. Thus, “new” devices (not in commercial distribution prior to May 28, 1976) that have not been classified can be properly identified. Specifically, medical device manufacturers are required to submit a premarket notification if they intend to introduce a device into commercial distribution for the first time or reintroduce a device that will be significantly changed or modified to the extent that its safety or effectiveness could be affected. Such change or modification could relate to the design, material, chemical composition, energy source, manufacturing process, or intended use.” FDA, https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/510kClearances/default.htm
What is C-QUR™ Mesh?
“C-QUR™ Mesh is indicated for use in hernia repair, chest wall reconstruction, traumatic or surgical wounds, and other fascial surgical intervention procedures requiring reinforcement with a non-absorbable supportive material.” More information
Atrium C-QUR is a mesh material that is used mainly in the surgical repair of hernias. It has also been used in chest wall reconstruction and in the repair of traumatic or surgical wounds. It is manufactured by Atrium Medical Corporation. The use of Atrium C-QUR has been found to cause serious injuries to some patients. As a result, legal action has been taken against the manufacturer in some instances. Patients may encounter adverse reactions to the product immediately or, more typically, after the product has been in use for some time.
How much of a settlement can I expect?
No one can predict the amount of settlement or judgment a victim will receive as a result of bringing a hernia mesh claim. The amount of a settlement in 2017 depends on the severity of pain and suffering and symptoms as well as:
- Amount of medical bills, medication costs and medical device expenses
- Number of revision surgeries or other surgical procedures
- The skill, expertise and aggressiveness of the hernia mesh victim’s medical device attorney
- The financial resources of the manufacturer to pay thousands of claims, Does the defendant have deep enough pockets
- The nature, extent and longevity of the pain and suffering of the victim
- other factors not set forth above
- Hundreds of mesh victims are searching the internet seeking justice and accountability for their suffering. Many of these victims are searching for the following keywords: Hernia mesh settlement 206, Mesh settlement 2017, hernia mesh settlement amounts, hernia mesh lawsuit 2017, hernia mesh lawsuit settlement amounts 2017, “know before you file hernia mesh lawsuit” and “average settlement for hernia mesh.”
History of the Atrium C-QUR
Atrium C-QUR is a brand of mesh that is utilized for the treatment and repair of a hernia. Hernias occur a portion of the intestine or nearby tissues force through a weakened portion of the nearby muscle or connective tissue. Surgical mesh is typically used of synthetic materials that is woven together to form a non-absorbable barrier that can be used in surgical procedures.
Mesh patches are not necessarily designed to provide a long-term solution but instead offer a basis for the body to grow tissue that will strengthen the area. However, medical complications can occur that may be very serious. One such complication occurs when the loops of the intestines adhere to the mesh or to each other. This can create a serious medical emergency or obstruction which requires immediate surgery.
Symptoms of Adverse Reactions to Atrium C-QUR
Not everyone experiences problems with mesh implants. However, if a patient notices any adverse reactions, it is imperative to seek immediate medical attention. Your doctor will make a determination as to whether the mesh implant has failed or has caused or contributed to the complication.
- Pain or swelling
- Diarrhea or vomiting
- Recurrence of the hernia
- Mesh adherence to the intestines
- Bowel obstruction
- Damage to an organ, nerves or blood vessels
These complications may occur at any time after the original surgery has taken place. If the mesh material begins to break down before the body has naturally repaired the area, the individual will likely experience some complications. These may range from minor to severe, but often require additional surgery to repair the area. In some instances, complications can be life-threatening. The most common complications that occur with the use of Atrium C-QUR are migration and erosion.
Treatment for Mesh Implant Complications
There are various treatments that may be necessary for mesh implant complications. The University of Mississippi Medical Center, the treatment plan may include topical treatments, oral medications to treat pain or muscle spasms and injections to reduce inflammation and pain. Surgery is likely the most common method of treatment.
It is important to note that generally, mesh implants usually cannot be completely removed once they have been implanted. The body grows tissue in and around the mesh rendering it impossible to fully remove without causing major internal damage. Therefore, surgical repair methods must be used which may include partial removal and the further use of mesh if necessary.
The U.S. Food & Drug Administration, FDA, has provided communication regarding safety concerns for some types of mesh implants. Patients who experience complications from the use of surgical mesh should report the problem to the FDA through the MedWatch Adverse Event Reporting program. This may be done online or by mail or fax. Doctors are also encouraged to report complications. It is important that all those who experience medical problems report them to the FDA so that proper steps are taken to prevent further injuries from occurring. The FDA may require a company to recall products that are reported to be dangerous to patients.
Recall of hernia Mesh Implants
In 2013 Atrium Medical Corporation issued a recall of their C-QUR products with lot numbers 10405513 and higher. The recall was made due to humidity concerns with product packaging. When exposed to high levels of humidity the fish oil coating on the mesh can cause the product to adhere to the packaging. The recall applied to packaging concerns only and did not directly address medical problems associated with surgical use.
Defective product liability
Unfortunately, there have been complications reported that involve defects in the product after it is implanted in the body. Those who have suffered a complication due to a faulty Atrium C-QUR mesh implant should report the problem to the FDA. The physician should also report the injury. Legal action may be necessary against the manufacturer because of the failure to warn of possible injuries and complications and their lack of response in resolving the reported problems. The company should be responsible for any injuries that occurred because of a defect in their product or lack of warning to patients.
Litigation History and Current Status
Lawsuits have been filed against Atrium Medical Corporation for poor design of the product and for inadequate manufacture. The company has a duty to fully test their products before they are sold, and they must also warn consumers of the potential risks involved in using the products. A number of lawsuits have been filed against AMC for injuries that resulted from the use of C-QUR mesh products. These lawsuits have not yet been resolved. You may be able to file a lawsuit if you had hernia repair which utilized Atrium C-QUR after May 2006 and suffered complications that required additional surgery or other medical treatment.
How to Take Legal Action
Those who have suffered medical complications due to the use of Atrium C-QUR mesh may be entitled to compensation. Litigation may be needed in order to receive compensation for medical costs, lost wages, pain and suffering, and other expenses directly caused by faulty mesh implants. A diagnosis must show that the patient’s injury is due to the use of an Atrium C-QUR mesh implant. Patients should obtain medical records that provide information regarding the specific type of mesh implant that was utilized in their original hernia surgery. A patient should take action as soon as possible after learning about the injury because there are legal time limits to file a legal claim. Multiple cases may be combined in a class action lawsuit.