The Composix Kugel (CK) hernia patch manufactured by Rhode Island-based Davol (a subsidiary of C.R. Bard) was designed to be an alternative to laparoscopic hernia repair. Among other features, the patch boasted the need for only a small (3–4-cm) incision, the same mesh replacement as laparoscopic repair without the costs and complications, and “near-sutureless” repair.
North Carolina resident Christopher Thorpe underwent surgery with a CK patch in 2005, according to court documents.
Afterward, Thorpe complained of constant, sharp abdominal pain and spent the next five years undergoing surgical attempts to correct the problem. Doctors determined that the cause was a failure in the memory ring used to hold the device in place. In 2008, Thorpe and his wife, Laure, filed a complaint against Davol in Rhode Island District Court, alleging that the CK patch was inherently dangerous and that the company failed to implement a safe and effective memory ring.
The Thorpes’ case wasn’t the first brought against Davol, nor would it be the last. Missouri resident John Whitfield, who alleged that he suffered bowel obstructions, severe abdominal pain and swelling, nausea, sickness, permanent bowel disfigurement, and other problems after a CK patch broke inside his body following a hernia repair surgery in 2004. According to LexisNexus, a jury found that C.R. Bard’s design of the CK patch was negligent.
The Whitfield decision opened the door for the Thorpe case. In 2010, Christopher and Laure Thorpe were awarded $1.5 million and $200,000 for loss of consortium, respectively, after a jury found that Davol and C.R. Bard inadequately designed the CK patch and failed to warn Thorpe or his doctor that the device could fail.
For its part, Davol voluntarily recalled the CK patch in 2005. Daniel LaFever, former president of Davol, testified in the Thorpe case that in 2005 Davol management realized that “stresses to put the device in may cause ring breaks.” As a result of FDA observations following the recall, Davol also hired an outside consulting company that concluded that, prior to the recall,
“There were deficiencies in Davol’s quality control system and that investigations into complaints were inadequate.”
More than 3000 cases have been brought against Davol and C.R. Bard over the CK patch, and by 2011 C.R. Bard had extended an estimated $184 million in settlement offers.