Attorney Daily - Your source for the most important legal news

On May 6, 2008 information was released announcing that a total of seven patients at two Virginia hospitals were implanted with the defective, and recalled Davol Bard Kugel Mesh Hernia Patches. Four patients were at Sentara Virginia Beach General, and the other three were at Sentara Leigh in Norfolk.

FDA records show that as far back as 2002, Davol Bard began to receive complaints about broken rings in the extra large versions of the patch. Davol initially blamed the broken devices on doctors improperly folding the patches for placement during hernia repair.

It was not until December 2005 that Davol ran tests and realized that the broken rings were not due to doctor error, but rather failure at the ring weld. In 2006, the FDA found that Davol was tracking complaints about the hernia patch improperly and that adverse reports were understated, which resulted in a major recall. Then again in 2007, a third recall occurred.

Sentara’s Vice President Of Medical Affairs Dr. Tom Thames says, “It happened as a result of human error. It’s one no one intended to make and it’s one we’re conducting an in-depth, thorough analysis of.”

Dr. Thames says as soon as the hospital realized the recalled product was on its shelves, staff removed it sometime in mid 2007.

MyFox Hampton Roads asked if at that time it didn’t occur to anyone that patients might have been implanted with the recalled patch. Thames said, “that appears to be the case.”

Sentara has offered to help the patients, but Dr. Thames says it’s not likely this mesh is causing pain, because he says there have been no reports of breakage in these particular patches.

Patients with questions or concerns about a procedure done at a Sentara hospital can call 1-800-SENTARA.

A Kanawha County woman has filed a suit against the manufacturers of a recalled product that was used during her hernia operation.

Frances Landers of Sissonville with her husband Kenneth D. Landers, filed the suit Dec. 21 in Kanawha Circuit Court against Davol Inc. and Thomas Memorial Hospital.

Landers claims she has suffered more than $250,000 in medical expenses due to the complications from a Kugel Mesh that was used during her hernia operation.

According to the suit, the U.S. Food and Drug Administration recalled Kugel Mesh, manufactured by Davol, Inc., on Dec. 22, 2005, due to disastrous life and health threatening results.

Landers had an operation May 5, 2005, at Thomas Memorial Hospital. She claims she suffered a severe infection from the use of the Kugel Mesh, which required several operations and other related injuries. She claims she has incurred $250,000 in medical, hospital and doctor bills.

Kenneth Landers claims he suffered a loss of consortium from his wife, and has become obligated for the payment of her medical bills.

The Landers seek compensatory damages for their losses.

After having several surgeries to repair hernias, Marion Teague began to experience abdominal pain and inflammation. Teague claims the mesh patch used to repair the hernias had become infected, requiring additional surgery to remove the patch.

The Arkansas resident filed a product liability suit against the hernia repair patches manufacturer, C. R. Bard Inc. and Davol Inc. on Dec. 28 in the Texarkana Division of the Eastern District of Texas. Although Teague is an Arkansas resident, he argues the Texas court should retain jurisdiction because the surgeries at issue occurred in Bowie County, Texas.

Within the original complaint, the plaintiff argues his injuries are caused by the defective design, manufacture and marketing of the hernia repair mesh patches.

The suit claims the defendants, Bard and Davol, are negligent for designing an unreasonably dangerous product, failing to reduce patch malfunction in the product design, failing to provide adequate warnings or instructions and failing to monitor its manufacturing process to prevent the defective patch from reaching consumers.

Teague states the defendant breached implied warranties by distributing a hernia repair patch that “was unsafe for its intended use, and not merchantable quality, as warranted by defendants, in that it had dangerous propensities when used as intended and implanted into a patient’s body where it could cause serious injury of harm or death to the patient.”

Teague is seeking more than $75,000 in damages for past and future physical pain, mental anguish, disfigurement, physical impairment, medical expenses, lost wages, lost earning capacity, and loss of household services.

The U.S. Food and Drug Administration issued a recall in Dec. 22, 2005, for Bard’s Composix Kugel Mesh Patch. The recall states the mesh patch can break under the stress of placement, leading to bowel perforations and/or recurring abnormal connections between the intestines and other organs. The recall was recently updated on Jan. 24, 2007, with an expanded list of product codes and lot numbers.

Teague’s claims do not state if the patches at issue are involved in the recall.

Currently, the defendants have not responded to the allegations.