Lawsuits against Atrium Medical Corp. for its C-QUR hernia mesh product alleging these devices were not safe for use by humans.
One of the most recent cases is one filed in Florida Middle District Court in Orlando just this past month. In his filing, which alleges negligent manufacturing and strict product liability, plaintiff alleges he underwent surgery in April 2013 to repair multiple hernias. His surgeon used the C-QUR product. Subsequently, plaintiff alleges, he suffered injury.
Although the recent Florida Record article reporting the filing does not offer specific details on the man’s injury, we can make the inference based on previous claims, the type of liability asserted here and also what we know about the company’s history.
Let’s start with the previous claims. Most people were implanted with C-QUR after undergoing surgery to repair a hernia. Hernias occur when underlying organs or layers of fatty tissue squeeze through weakened muscle walls and form a sac. Many of these occur at the abdominal site. After the hernia is repaired, surgeons often stitch in a “plug” to prevent the hernia from re-opening using a type of mesh. Meshes can be absorbed or they may be permanent, and there are many different companies that make them. Atrium is one of those, and Atrium’s C-QUR product is unique in that it uses Omega-3 in the gel coating that surrounds it.
However, those who have undergone this surgery with C-QUR have complained they later suffered:
- Organ perforation;
- Rejection;
- Chronic pain;
- Allergic reactions;
- Reactions to foreign bodies;
- Recurrence of hernia;
- Scar tissue adhesion;
- Mesh contraction;
- Blockage of large and small intestines.
Atrium isn’t the only hernia mesh manufacturer to come under fire for allegedly defective products. Ethicon too has faced such allegations regarding its Physiomesh. However, Atirum is the only one that issued a recall due to an apparent manufacturing issue. Specifically, the company conceded that the packaging of the C-QUR product was such that when exposed to high humidity, it caused the gel coating to become adhesive to the packaging.
This sheds some insight into the adhesive quality of the product inside the human body.
Many plaintiffs who have so far filed C-QUR mesh lawsuits say allege defective design, saying the product was rushed to market via the U.S. Food & Drug Administration’s 510(k) program and that the material used is not compatible with human biology.
Interestingly, the most recent plaintiff out of Florida is asserting defective manufacture. What this means is while a product may not be unsafe as designed, some error or flaw in the manufacturing process resulted in the product becoming unsafe.
Manufacturing defect is a specific type of product liability claim wherein the product may even depart from the intended design and is generally more dangerous than consumers reasonably expect.
Meanwhile, strict liability for manufacturing defect asserts that a person was injured by the product. In this claim, one need not prove manufacturer failed to use reasonable care. Instead, one only has to show the product was defective and that the defect caused his or her injuries.
If you are the victim of Massachusetts product liability, call Jeffrey Glassman Injury Lawyers for a free and confidential appointment — (617) 777-7777.
Additional Resources:
Godwin v. Atrium Medical Corporation, March 2, 2017, Florida Middle District Court Orlando Office
More Blog Entries:
Consumer Reports: Tesla Autopilot Systems Improperly Marketed, March 2, 2017, Defective Hernia Mesh Lawyer Blog