U.S. lawsuits targeting hernia mesh manufacturers have been ongoing for nearly two decades now, but it wasn't until 2016 the first lawsuits against Atrium Medical Corp. were filed. The first lawsuits were directed at the company's C-QUR product line and came after patients began to experience serious complications and attributed those complications to the C-QUR implant.
Getting answers to some of your most basic concerns is the first step to realizing if filing a lawsuit is right and appropriate for you. Here, we answer some of those questions to help you make better, informed decisions about your health and your future.
- 1. Why are hernia repair patients filing lawsuits against Atrium?
- 1.1 What is considered defective about Atrium's hernia mesh products?
- 1.2 How did Atrium market its product improperly?
- 1.3 What safety standards did Atrium not comply with?
- 1.4 How did Atrium communicate side effects to the medical profession and consumers?
- 2. What is the status of current lawsuits against Atrium?
- 2.1 What is Atrium's C-QUR multidistrict litigation?
- 2.2 Must you join the multidistrict litigation?
- 3. What is the timeline of Atrium's hernia mesh product line?
- 4. How do I know if I qualify to file a lawsuit against Atrium for the defective hernia mesh product used in my hernia repair surgery?
Every year nearly a million people experience hernias that require reparative surgery. Hernia repair patients have been filing lawsuits for more than two decades against manufacturers for defective mesh products that cause injuries -- some more severe than others but all requiring compensation. Atrium experienced its first lawsuits in 2016, and reasons for these lawsuits are summarized below.
- Injured consumers assert Atrium created a defective product.
- Injured consumers assert Atrium marketed its defective product improperly.
- Injured consumers assert Atrium files to comply with safety standards in the design and manufacture of its C-QUR products.
- Injured consumers assert Atrium failed to properly warn medical professionals and patients of the complications associated with its mesh implants.
Hernia mesh products can cause side effects, and these side effects are not always a reason for a lawsuit and do not always indicate a defective product. That said, there is reason to believe that Atrium's mesh products are defectively designed.
These products all use two materials known to cause complications: (1) polypropylene; and (2) omega 3 fatty acids from fish.
Polypropylene is a cheap plastic, and studies have shown patients who have had hernias repaired using uncoated polypropylene mesh can experience adhesion and/or bowel obstruction and subsequent complications emanating from these two injuries. 1
To counter the problem with polypropylene but to continue to take advantage of this cheap product, Atrium coats its hernia implants with omega 3 fatty acids derived from fish. Patients, however, can have mild to serious allergic reactions to the omega 3 fatty acids. This allergic reaction can cause additional complications, like infection. 2 Worse yet, the coating can wear off, and when that happens, patients can experience the same complications other patients experience with uncoated polypropylene implants.
Knowing these complications are associated with the design of the product, Atrium -- arguably -- unreasonably chose and still continues to choose to use these substances in its products.
These devices were marketed as sterile, but for awhile Atrium failed to address complaints that hair was found in its devices. By the time the FDA issued a warning letter regarding the same, there had been 35 formal complaints of the same. 3 And it wasn't until the FDA warning letter that Atrium addressed the concerns.
The FDA has certain safety standards for medical devices, and in 2015, a federal judge from the U.S. District Court for the District of New Hampshire entered a Consent Decree of permanent injunction against Maquet Holding B.V. & Co. KG. 4 This injunction included Atrium Medical Corp. a subsidiary of Maquet Holding. 5
According to the FDA, it conducted ten inspections combined at three Maquet facilities, one of which was Atrium Medical Corporation in Hudson, New Hampshire. 6 These inspections revealed serious violations of regulations, including regulations of
- Quality System
- Medical Device Reporting, and
- Correction and Removal. 7
During this time and while Atrium made specific corrections, the following hernia mesh devices were removed from the market temporarily:
- C-QUR (V-Patch, Tacshield, FX, Mosaic, and Film). 8
This injunction, unfortunately, did not prevent hospitals who already purchased Atrium mesh devices from using those devices in patients hernia repair surgeries.
Atrium did not provide specific warnings regarding its hernia mesh medical devices. It did not communicate with medical professionals and consumers, including those who complained to the company about the products and their side effects. In addition to noting Atrium's failure to sterilize the implants, the FDA sent letters warning the company of its failure to communicate with and address the complaints and incident reports. 9
Atrium Medical Corp. is being sued by persons (patients and healthcare professionals) throughout the United States. Most common among these lawsuits are lawsuits related to Atrium's C-QUR hernia mesh products, but other hernia mesh products, like the ProLite, are also the subject of lawsuits. From California to Texas to Maryland to New Hampshire, the latter of which is the home state of a multidistrict litigation (MDL) related to Atrium's C-QUR line.
In December 2016, the Judicial Panel established a multidistrict litigation in New Hampshire District Court for lawsuits against Atrium Medical Corp. 10 As of June 2018, there are nearly close to 500 Atrium C-QUR mesh lawsuits pending. The first trial is set for February 19, 2020.
MDLs are legal procedures designed to combine lawsuits with similar questions of fact for economical and efficiency purposes. Each plaintiff has his or her own attorney representing him or her for damages. In this way, MDLs are not like lawsuits where one plaintiff or a small group of plaintiffs bring a claim on behalf of an entire class of consumers.
You do not have much of a choice if an MDL is set up. For instance
- if your attorney files a claim in state court, the case will likely be removed to federal court on diversity and then transferred to the MDL by the Judicial Panel of Multidistrict Litigation.
- If your attorney files your case in any U.S. District Court, it will be removed to the MDL court by the Judicial Panel of Multidistrict Litigation.
C-QUR approved by FDA via 510(k) application process.
FDA cites Atrium for numerous manufacturing and quality violations after on-site inspections.
Atrium notifies customers by letter warning them of certain defects but does not remove C-QUR from the market.
FDA issued Class II Recall of C-QUR due to packaging -- no devices were pulled from the market though devices on the market were affected & no one asked if the coating could easily adhere to the packaging, could it not easily wear off or adhere once implanted?
U.S. filed a lawsuit on behalf of the FDA and a federal judge ordered a Consent Decree of Permanent Injunction against Maquet and Atrium for safety violations.
Lawsuits start adding up against Atrium for injuries caused by C-QUR and a motion is filed to consolidate into a MDL.
|MDL established in New Hampshire.|
If the following conditions apply in your case, you may be entitled to file a lawsuit against Atrium:
- You have had hernia repair surgery.
- Your surgery included hernia mesh manufactured by Atrium.
- You suffered injuries directly as a result of the mesh.
- The mesh was defective either by design, manufacture, or marketing.
- You injuries are monetarily quantifiable.
You may or may not know if any or all of these conditions apply. It is always in your best interests to seek a free initial consultation with experienced personal injury and/or product liability attorneys. At Shouse Law Group, our attorneys can review your case and identify your legal options.
We are currently taking hernia mesh cases now. We have offices locally throughout California but accept these types of cases throughout the United States. Call our office today at (855) 396-0370 or complete our online form. We will review your case and your options with you.
- Elango, S., Perumalsamy, S., Ramachandran, K., Vadodaria, K. Mesh materials and hernia repair. Biomedicine (Taipei). 2017 Sep; 7(3): 16. Doi: 10.1051/bmdcn/2017070316. See also, Vaz, M., Krebs, R.K., Trindade, E.N., Trindade, M.R.M. Fibroplasia after polypropylene mesh implantation for abdominal wall hernia repair in rats. Acta Cir. Bras. 2009 Jan/Feb; 24(1).
- Kong, Lai, Khoo, Rahman, Chin. Inflammatory reaction to fish oil coated polypropylene mesh used for laparoscopic incisional hernia repair: a case report. BMC Surg. 2016; 16: 8. doi: 10.1186/s12893-016-0123-8.
- FDA. Atrium Recalls.
- FDA Consent Decree Suspends Some Operations of Getinge Group's Atrium and Maquet Facilities. Endovascular Today. February 4, 2015. See also, Complaint for Permanent Injunction, Case 1:15-cv-00041. Filed February 3, 2015.
- FDA. Class 2 Device Recall. Recall Event ID 65698.
- United States Judicial Panel on Multidistrict Litigation, In Re: Atrium Medical Corp. C-QUR Mesh Products Liability Litigation. Transfer Order. MDL No. 2753. Doc. 53. Filed December, 8, 2016.