According to court documents Wayne Smith received the Composix Kugel Hernia patch abdominal mesh for repair of a ventral hernia. Not long after surgery, according to documents, the plaintiff began experiencing severe abdominal pain, together with tenderness at the surgical site.
As it turned out, the manufacturer of the abdominal mesh product, Davol Inc. (a subsidiary of C.R. Bard), triggered a series of recalls for its Composix Kugel mesh due to problems with the so-called ‘memory ring’ used to deploy the patch inside the body by way of minimally-invasive surgery. Following several reports of the memory ring, which was made of plastic, splintering and migrating away from the surgical site – along with reports of intestinal fistulae, bowel perforation and in some cases, death – Davol recalled the mesh.
The recall was classified, in December 2005 as a Class 1 recall, the highest level of recall observed by the US Food and Drug Administration (FDA), given the risk of serious surgical mesh complications.
Plaintiff Wayne Smith consulted his surgeon, who recommended the abdominal patch be removed. The explantation would have involved a second surgical procedure, within close proximity to the first.
Smith subsequently filed a surgical mesh lawsuit against defendants Davol and C.R. Bard in Providence Superior Court citing violation of the Rhode Island Deceptive Trade Practices Act, strict product liability, negligent and intentional infliction of emotional distress, breach of warranty and failure to warn.
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Davol and C.R. Bard attempted to have the abdominal mesh lawsuit dismissed, asserting that Smith’s claims failed to satisfy Rhode Island law. The judge in the case, Alice B. Gibney disagreed with the defendants, noting that in her view the plaintiff’s claims satisfied Rhode Island law, and that there were sufficient grounds to support an allegation that a defect was the proximate cause of the man’s injury.
Judge Gibney issued her surgical mesh complications ruling November 28.
The lawsuit is Wayne Smith, et al. v. Davol Inc., et al., Case No. PC-08-8307, in Rhode Island Superior Court, Providence.