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In re Kugel Mesh Hernia Patch Products Liability Litigation

Court: United States District Court for the District of Rhode Island
Case No.:
MDL No. 1842

Wexler Wallace represents individuals who have had defective Composix Kugel Mesh hernia repair patches implanted in their bodies.  The firm is a member of both the State and Federal Plaintiffs’ Steering Committees, chair of the Plaintiffs’ Law Committee and a member of the trial team.  The Plaintiffs who Wexler Wallace represent all suffered serious injuries from the failure of their patches, whether resulting injuries have required the patch to be surgically removed or the patch remains implanted in the patient, but will require continual medical monitoring in the future.

If you or a loved one had a Composix Kugel Mesh Patch surgically implanted, you may be eligible to file a claim. Please contact us or complete our Online Form. Your information will be reviewed by counsel and by Wexler Wallace nursing staff to determine your eligibility to pursue a claim.

Wexler Wallace also welcomes inquiries from other counsel considering referring a case with respect to Composix Kugel Mesh Patch injuries.  We maintain significant relationships with other firms and counsel of the highest quality throughout the United States. 

Overview
In December of 2005, at the direction of the FDA, C.R. Bard and Davol announced a recall of the large and extra large varieties of their surgically implanted hernia repair patches, known as the Composix Kugel Mesh Patch. Despite having knowledge of the patches’ defective design and manufacture, C.R. Bard and Davol failed to alert physicians about potential problems.  Approximately 75,000 patches were sold. The patches’ defects have led to serious and permanent injuries to implant patients and can result in death.

After initially denying that the injuries were caused by product defects, Davol subsequently did tests revealing product failures were to blame.  Davol issued a hernia patch recall for the extra-large model of the Kugel mesh hernia patch in December 2005.  Subsequently, Davol issued two more Kugel mesh hernia patch recalls (March 2006 and January 2007) at the prompting of the FDA, after reports linked the hernia patch to several fatalities and more than 80 injuries or other problems.

Hernia Patch Purpose
A hernia occurs when the stomach muscles are too weak to contain the intestines and a rupture occurs in the muscle wall, causing the intestines to protrude.

The Composix Kugel Mesh Patch was designed to treat hernias caused by the thinning or stretching of scar tissue that forms after surgery. The patch is inserted behind the hernia defect in the abdomen through a small incision. In order to fit through the small incision the mesh is folded in half. Once inside the abdomen the mesh re-deploys as a result of a hard “memory recoil ring” (also called a “PET coil ring”) that surrounds the mesh.

Due to defects in the design and manufacturing of the Composix Kugel Mesh Patch, the “memory recoil ring” that opens the patch can break under the stress of placement of the product in the intra-abdominal space. Once the memory recoil ring has broken, it can later come loose and cause serious injuries as it travels through the body. These injuries include: intestinal perforations; ring migration through the abdominal wall; abscesses; bowel obstruction and sepsis; bowel perforations and chronic enteric fistulae (abnormal connections or passageways between the intestines and other organs).

Bowel obstructions
A bowel obstruction is a partial or complete blockage in the intestines. The obstruction prevents the intestinal contents from passing through in a normal manner. Blockages of this kind can be caused by several conditions, including hernias, medication, scar tissue, tumors, twisted intestines, gallstones, or foreign objects such as the Kugel Mesh Hernia Patch.

Patients suffering bowel obstruction may have abdominal pain, constipation, bloating, vomiting, or diarrhea. If it is not treated, a bowel obstruction can lead to infection, gangrene, or bowel perforation.

Bowel perforations
When an opening forms in the intestinal wall, its contents may flow into the abdominal cavity. This condition is known as a bowel perforation. Injury, illness and bowel obstruction have been known to cause bowel perforations.

Some of the early symptoms of bowel perforations include high fever, abdominal pain, nausea, and vomiting. If left untreated, a bowel perforation can lead to sepsis, a potentially fatal blood infection.

Chronic enteric fistulas
A chronic enteric fistula is an abnormal connection that forms between two parts of the intestine. Some patients with enteric fistulas may have few serious symptoms; in others, the condition causes major abdominal pain.

Sometimes, one fistula opening closes while the other remains open. This results in an accumulation of bowel contents in this cavity. An abscess or infection may develop that, in some cases, can spread to the bloodstream.

Several Kugel Mesh Patch patients have suffered chronic enteric fistulas after receiving the patch. At least one of them died of septic shock and heart attack after an operation to repair the intestinal fistulas.

FDA Hernia Patch Recall
Soon after the hernia patch was released in 2002, Davol began receiving a disproportionately high number of reports of broken patches from doctors. The breakages were occurring in the memory coil rings. However, the company continued selling the hernia patch without informing the FDA of the increase in complaints. Davol initially attributed the broken rings to mistakes made by doctors while performing hernia-repair surgery. However, company tests revealed that the failures nearly always occurred at the spot where the ring was welded together. It was discovered that the memory recoil rings can break under the stress of placement in the intra-abdominal space.

Finally, in December 2005, Davol recalled some of its hernia patches, with subsequent recalls in March 2006 and January 2007. In March 2006, the FDA sent a recall letter to physicians and patients advising patients implanted with one of the recalled lots to seek immediate medical attention if they experience persistent or unexplained abdominal pain, fever, tenderness at the implant site, or other related symptoms.

The recall is still in effect. Patients should contact their physician, if they have not done so, for further evaluation.

This recall is product code- and lot-specific and applies to the large-sized patches. The specific products, codes and lots recalled are:

  1. Recalled December 2005 http://www.fda.gov/cdrh/recalls/recall-122205-previous2.html
    Date Recall
    Initiated:
    December 22, 2005
    Product: Bard® Composix® Kugel® Mesh X-Large Patch Oval with ePTFE with the following lot numbers:
    41XMXXXX – M = 2002
    41XNXXXX – N = 2003
    43XMXXXX – M = 2002
    43XNXXXX – N = 2003
    43XOXXXX – O = 2004
    43XPXXXX – P = 2005
    (If the lot number does not contain either M, N, O, or P as the 4th character, then the lot is not affected by this recall.)
  2. Recalled March 2006 http://www.fda.gov/cdrh/recalls/recall-122205-previous.html
    Product Code Description Lot Numbers Recalled Date Recalled
    0010206 Bard® Composix® Kugel® Extra Large Oval, 8.7” x 10.7” All Lot Numbers December 2005 and January 2006
    0010207 Bard® Composix® Kugel® Extra Large Oval, 10.8” x 13.7” All Lot Numbers December 2005 and January 2006
    0010208 Bard® Composix® Kugel® Extra Large Oval, 7.7” x 9.7” All Lot Numbers December 2005 and January 2006
    0010209 Bard® Composix® Kugel® Oval, 6.3” x 12.3” All Lot Numbers March, 24, 2006
    0010202 Bard® Composix® Kugel® Large Oval, 5.4” x 7.0” 41*L****, 41*M****, 41*N****, 43*L****, 43*M****, 43*N**** March 24, 2006
    0010204 Bard® Composix® Kugel® Large Circle, 4.5” 41*L****, 41*M****, 41*N****, 43*L****, 43*M****, 43*N**** March 24, 2006
  3. Recall notice update January 2007 http://www.fda.gov/cdrh/recalls/recall-122205.html
    Product Code Description Lot Numbers Recalled Date Recalled
    0010206 Bard® Composix® Kugel® Extra Large Oval, 8.7” x 10.7” All Lot Numbers manufactured before January 2006 December 2005 and January 2006
    0010207 Bard® Composix® Kugel® Extra Large Oval, 10.8” x 13.7” All Lot Numbers manufactured before January 2006 December 2005 and January 2006
    0010208 Bard® Composix® Kugel® Extra Large Oval, 7.7” x 9.7” All Lot Numbers manufactured before January 2006 December 2005 and January 2006
    0010209 Bard® Composix® Kugel® Oval, 6.3” x 12.3” All Lot Numbers manufactured before March 2006 March, 24, 2006
    0010202 Bard® Composix® Kugel® Large Oval, 5.4” x 7.0” Lot Numbers manufactured before October 2005 (see below) January 10, 2007
    0010204 Bard® Composix® Kugel® Large Circle, 4.5” Lot Numbers manufactured before October 2005 (see below) January 10, 2007

Hernia Patch Lawsuits
Many patients who were injured after using the Kugel patch have filed hernia patch lawsuits against Davol and its parent company, C.R. Bard Inc. These lawsuits allege that Davol and C.R. Bard were aware of manufacturing and design problems with the Kugel hernia patch, but failed to inform patients, doctors or health officials of the health risks posed by the patch. They further allege that Davol failed to accurately report to the FDA a number of complaints it received about injuries or deaths related to the Kugel Mesh Patch. Plaintiffs charge the Defendants with products liability, negligence, deceptive trade practices, fraud and wrongful death. Had Davol acted faster to issue the hernia patch recall, Plaintiffs might have been saved from serious hernia patch side effects.

There have been two bellwether trials thus far in federal court. In the first, Whitefield v. Davol, the jury found for the defendants’ deciding that Bard’s patches were neither defectively designed nor inadequately labeled. The second trial occurred in August 2010 and resulted in a $1.5 million verdict for Christopher and Laure Thorpe, who had claimed that the surgical mesh patches were unreasonably designed and carried an inadequate warning of risk.

Judge Mary M. Lisi of the U.S. District Court for the District of Rhode Island denied Bard’s motions for summary judgment not withstanding the verdict and for summary judgment on the inadequate design claim.

 










0010204

Bard® Composix® Kugel® Large Circle, 4.5”

41*L****, 41*M****, 41*N****, 43*L****, 43*M****, 43*N****

March 24, 2006