Corporate recidivist C.R. Bard, the company behind vaginal meshes, IVC filters, and the Kugel Hernia Mesh is once again a named defendant in a lawsuit over one of its medical devices. This time it is the Ventralex Hernia Patch, a mesh developed by Bard subsidiary Davol.
Bard was sued at the end of November by a Florida woman who was implanted with a Ventralex mesh in July, 2014. She developed serious complications and was forced to have the device removed only four months later.
The Ventralex mesh is made from a number of different plastic products that were intended (according to Bard) to prevent many of the complications associated with other types of hernia mesh. These materials include polypropylene and expanded polytetrafluoroethylene (PTFE), which is essentially Teflon. According to the Bard website, the materials allow for an “intraabdominal, tension-free repair.” Unfortunately, the materials have proven toxic and prone to shrinkage. Because of the construction of the Ventralex, the device is also an ideal breeding ground for infectious bacteria.
Only five years ago, Bard was forced to shell out $200 million in order to settle some 3000 lawsuits citing complications and injuries due to the Kugel Hernia Patch. Approved in 1996, the Kugel consisted of two layers of polypropylene plastic and a “memory recoil” ring that allowed the device to be folded, inserted into the injury site, then spring back into its original shape, thus repairing the injury. Six years later, the FDA began receiving adverse event reports about injuries that included bowel obstruction, organ perforation, and fistulas. Eventually, the Kugel Hernia Patch was taken off the market in 2006.
When Bard filed its application with the FDA for the approval of the Ventralex hernia patch, it went through the now-infamous 510(k) Pre-Market Notification process. Because of this, Bard was not required to do any clinical tests. Instead, all that was necessary was to demonstrate that the new product was “substantially similar” to a product that already had FDA approval and was currently on the market. Ironically, the “predicate device” that Bard cited in its application was the Kugel Hernia Patch.
Given Bard’s history, it seems that the company’s main focus is to create defective products. Several years ago, Bard received a warning from one its suppliers that the polypropylene material it was using in the Avaulta pelvic mesh was toxic and should not be used in a product intended to be placed inside a human body. Instead of going back to the drawing board, a high-level executive at Bard issued a directive to his colleagues, instructing them to keep quiet about the use of polypropylene.
Today, Bard’s liability over the Avaulta Mesh stands at $68 million.
It is not yet known how much liability Bard will incur in connection with the Ventralex, but with total assets of nearly $5.6 billion (as of December 2017), whatever judgments and/or fines the company will wind up paying is not likely to affect their bottom line – and certainly won’t be enough to change their behavior.