Hernia Patch Lawsuits
Davol Inc., maker of the Kugel mesh hernia patch, and its parent company, C.R. Bard Inc., have been hit with a lawsuit. This legal action alleges that the patch failed after it was implanted, causing severe pain to a hernia patient. He then had to undergo bowel dissection surgery to remove the patch.
From patient to plaintiff
Lawyers claim that Davol knew the Kugel mesh patch might fail but did not properly warn the public. The man’s Kugel mesh patch was implanted in 2004. The device used by his doctor was not covered by the initial Kugel hernia patch recall but was included in the second recall.
Given that in excess of 80 injuries and several deaths have occurred, it is quite likely that there will be more—perhaps many more—Kugel mesh hernia patch lawsuits in the future. Nearly 33,000 of the devices had been sold and put to use before Davol’s first recall.
Medical monitoring class certification sought
On February 14, 2007, attorneys in Rhode Island sought certification of a nationwide medical monitoring class for people who have had the Kugel mesh hernia patch implanted in their abdomens. They applied for this certification by citing Davol’s unfair and deceptive trade practices under Rhode Island law.
The plaintiffs in the suit underwent surgery in which Kugel patches were implanted. Although neither has yet gone bad—leading to such unfortunate results as intestinal perforations, abscesses, bowel obstructions, sepsis and chronic intestinal fistulas—they may in the future, so frequent CT scans and other forms of medical monitoring are needed.
If the nationwide medical monitoring class certification is granted, this could be a step toward one or several class action suits being filed against Davol and its parent company.
FDA finds problems with Davol
An investigation by the FDA in early 2006 found a number of “discrepancies” and “inconsistencies” in how Davol recorded and assessed complaints about the various Kugel mesh hernia patches. The FDA also discovered that Davol failed to accurately report the severity of some of the complaints by those who had experienced side effects from the Kugel patch.