Bard Kugel Hernia Mesh

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The Bard Composix Kugel Mesh hernia repair patch, manufactured by Davol Inc. (a subsidiary of C.R. Bard, Inc.) is a medical device approved for use in ventral hernia repair surgeries.

The device gained FDA approval in 1996, but when the company began introducing larger versions of the patch in 2002, reports of problems with the mesh material and memory recoil ring began to pour in. These problems have led to a number of FDA warnings, alerts, and recall notices as well as hundreds of lawsuits over patient injuries and fatalities. Complications associated with the hernia mesh include bowel perforation and obstruction, severe abdominal pain, infection, and even death.

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History of Kugel Mesh FDA Recalls

Thousands of actions were filed under a multidistrict litigation (MDL) against Bard and Davol for the defective medical device. In 2011, the manufacturers came to a settlement agreement with many plaintiffs for $184 million. Only six cases remain pending as of March 2017.

2005 – The FDA issues a Class 1 recall of the Bard Composix Kugel Mesh hernia patch (X-Large Patch Oval with ePTFE).

2006 – The FDA recall is expanded to include Oval, Large Oval, and Large Circle Kugel mesh hernia patches.

2007 – The hernia patch recall is further updated to include additional product codes and lot numbers recalled by Davol/Bard since the first recall was issued.


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A tort is a civil wrongful act committed by a person or company that results in harm to another person. A mass tort is when multiple victims are injured by the same single tort.
A court will consider if a mass tort lawsuit is permissible by determining:
  • whether a large number of plaintiffs are involved
  • whether the plaintiffs are located near or far from each other;
  • whether the injuries sustained are similar among the plaintiffs;
  • whether the claims arose from the same cause (defective toy, car part, oil spill, etc.)
  • Defective products, such as car parts, toys, or other consumer goods.
  • Pharmaceutical drugs, such as those that are later linked to severe or fatal health consequences
  • Environmental hazards, such as polluted water sources contaminated by nearby industrial sites or an oil leak.
Thousands of lawsuits across the country may be filed with a mass tort. These lawsuits are filed in numerous federal district courts. In a mass tort, federal judges will consolidate the thousands of lawsuits into a single proceeding. One judge in a single federal district court will oversee litigation, allowing for consistent rulings and a more expeditious process for the plaintiffs.
In a mass tort, each plaintiff (injured person) has an individual claim resulting from their unique damages. In a class action, many plaintiffs are considered collectively. Similarly, in a mass tort, each individual's claim "value" is unique to the severity of their injuries. In a class action, plaintiffs generally suffer injuries of similar severity, resulting in the same amount of compensation value.
If you have been injured or suffered illness due to a recalled drug, having an expert witnesses can be essential to proving your claim. Thomas J. Henry has spent decades building professional relationships with leading experts including:
  • Pharmacologists
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  • Regulatory Compliance Consultants
  • Forensic toxicologists
  • Drug Injury Causation Experts
  • Biomechanics

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No matter the injury or the accident, if you or a loved one were harmed due to the negligence of an individual or company, Thomas J. Henry is here to assist you.

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