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Lawsuits over the Kugel mesh hernia patch are moving forward, with the first suits in the multi-district litigation set for trial this fall.

The suits claim that the patch is defectively designed, because it includes a plastic ring that can break off inside patients and cause the mesh to ball up or migrate, leading to perforation, infections and bowel injuries like fistulization and peritonitis.

There are currently about 3,000 cases filed in federal and state court, said Jon Conlin, an attorney with Cory Watson Crowder & DeGaris in Birmingham, Ala., and co-lead plaintiffs’ counsel.

Plaintiffs’ attorneys continue to field calls in these cases, since an estimated 100,000 patches have been sold and many patients do not experience problems until years after surgery, said Rhett Klok, co-lead plaintiffs’ counsel with Motley Rice in Mt. Pleasant, S.C.

In addition to the individual cases, the attorneys are seeking class certification for medical monitoring of patients who have the device and may yet experience problems.

“For those people, it’s a time bomb ready to explode,” said Conlin.

The product was recalled in three batches in 2005, 2006 and 2007. 

According to Conlin, manufacturer Davol Bard now uses a bio-absorbable ring instead of a plastic one.

Holly Glass, a spokesperson for the manufacturer, said that it is the company’s policy not to comment on ongoing litigation.

‘Memory recoil ring’

The mesh patches are used for the repair of ventral hernias.

These are often experienced by women who have had cesarean sections, individuals who have had surgery in the abdominal area or people with weak abdominal muscles, Klok said.

According to Klok, the design of the patch evolved from a patch invented by Dr. Robert Kugel, a surgeon in Washington.

The current patch has a sticky side to adhere to the abdominal wall and a slick side to allow fecal matter to go through the bowel.

The manufacturer “supersized the patch and made it bigger and bigger, and then put a hard plastic ring on the outside,” said Klok.

The plaintiffs claim that the ring, called a “memory recoil ring,” should never have been used.

“The ring is supposed to make it easier for a doctor to keep [the patch] flat to sew it in,” said Conlin.

“The patch folds like a taco, and it unfurls after inserted. But after deployment, the ring serves no other purpose,” Klok claims.

The legal cases are divided into “ring break” cases and “non ring-break” cases.

The plaintiffs claim that the ring either breaks and pierces the bowel wall or causes the patch to ball up or flip over so the sticky side adheres to the bowel or other organs.

Injuries include ruptures or blockage of the bowel, infection and in some cases death, the suits allege.

The suits also allege that the company failed to instruct doctors on how to fold the patch to minimize breakage of the oval-shaped ring, which is welded together at the ends.

“The company didn’t give surgeons instructions. If you fold [the patch] over the weld, it puts more stress on it; if you fold it with the weld, you’re not putting as much stress on it,” charged Klok.

‘Grey area’

The cases are “potentially very, very high damage cases, with large amounts of medical bills,” said Conlin.

He said that although the recalls only covered the largest sized patches, which have two rings, “we’ve seen ring failures in virtually every size.”

However, “the failures in design become more apparent the larger the patch gets, because of the general physics of the ring,” Conlin added.

Injury claims could be complicated by the fact that many hernia patients already have poor abdominal muscles.

But Conlin argues that “the company made the patch for people with compromised abdominal walls to begin with. They didn’t make the patch to put into an 18-year old marathon runner.”

He acknowledged that the cases can fall into a “grey area,” because any hernia surgery comes with risks, such as post-surgical infection or failure to heal at the site.

He has reviewed hundreds of cases involving infections that did not give rise to a claim for defective design.

“Every case has an infection element, but not every infection case is a claim.”

Questions or comments can be directed to the writer at: sylvia.hsieh@lawyersusaonline.com

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