Drug Recall Lawyer Blog

Kugel hernia mesh lawsuits are beginning to settle, thanks in part to a change in defense counsel. The products, manufactured by Davol, are defective because they the plastic ring can break off, causing perforation and infections. Left untreated, these injuries can be fatal. Davol has since eliminated use of the plastic rings, in favor of a bio-absorbable ring.

Now represented by the New York firm Reed Smith, Davol has signaled a change in thinking to a more reasonable approach—these can be very meritorious cases worthy of settlement, and the expense of litigation is unnecessary. There are about 1,000 cases in the Rhode Island United States District Court MDL, and about 1,200 cases in Providence state court (the manufacturer, Davol, is a Rhode Island company). Right now, 4 federal suits have been settled, and one state claim has been settled. This looks to be the tip of the iceberg, as the parties move toward the first scheduled federal court trial in March, 2010. That will be followed shortly thereafter by the first state court case in June 2010. The settlements will probably come in rapid numbers, now that discovery is coming to a close and the trials quickly approach.

For more on Kugel Mesh lawsuits and settlements, see our website and prior blog post.

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.