Kugel Mesh patches, used to repair ventral and incisional hernias, were approved by the FDA in 1996. By 2002, Davol Inc. began receiving complaints, but blamed injuries on the doctors who were installing the patches. However, they issued a recall in December of 2005.
The patch has a “memory recoil ring” that tends to break as it is placed into the body. Once broken, a patch-wearer risks bowel perforation, chronic intestinal fistulae, and abnormal connections between intestines and other organs. Sometimes, this can be fatal.
The best part of any litigation against a large corporation (in my opinion), is the documents. There is nothing better than requesting documents in discovery, receiving tens of thousands (or even hundreds of thousands, or sometimes millions) of pages of documents. Defendant corporations probably laugh as they hand over so many documents, thinking that we can’t possibly inspect them all. However, somehow, we manage to do just that. And that’s where you find out what the case is really about. Kugel Mesh lawsuits, now thickly embroiled in litigation, are no different.
Davol knew or should have known about a significant number of problems with the patch well before the recall. However, in the interests of the profit margin, or because the company was incompetent, the manufacturer decided that the reports did not justify warning the public or doctors of the potential problems. (See New York Times article).
In fact, an FDA inspection of the facility uncovered serious problems with the company’s manufacturing process as well as the methods it used to handle product complaints. The FDA believes that these problems hindered Davol’s ability to timely and effectively deal with the problems. A company that negligently (or intentionally) fails to monitor complaints, all the while making money on every product used will not recall a product as early as possible. These are considerations of safety, and it is astounding how many companies end up placing profit over safety.
2013 Update: Most of these Kugel cases have been resolved. C.R. Bard’s settlement offer was about $184 million for 2,600 lawsuits. People were left very disappointed. Here’s an article that discusses the plight of some.