Bausch & Lomb, the maker of ReNu with MoistureLoc, has settled around 600 lawsuits involving the recalled contact lens solution. According to a report in the Associated Press, the settled ReNu with MoistureLoc claims have so far cost the company around $250 million.

Bausch & Lomb pulled ReNu with MoistureLoc from Asian markets in February 2006, and did the same in the U.S. in April of that year, after it was linked to an outbreak of Fusarium Keratitis, a potentially blinding eye infection. The company would ultimately issue a worldwide recall of ReNu with MoistureLoc on May 15, 2006.

A Centers for Disease Control (CDC) report on the outbreak found that those infected with Fusarium Keratitis were 20 time more likely to have used the ReNu with MoistureLoc solution. The CDC report determined that bad hygiene habits among users were not to blame for the infections, but that the contact lens solution appeared to have poor disinfectant qualities. The CDC ultimately confirmed 180 cases of Fusarium Keratitis in the U.S. According to the Associated Press, at least 60 more Americans needed vision-saving corneal transplants.

No one is exactly sure why ReNu with MoistureLoc turned out to be defective. As we reported last November, a study conducted by researchers at Wright State University Boonshoft School of Medicine in Dayton, Ohio found that ReNu with MoistureLoc loses much of its ability to fight fungal contamination when exposed to high temperatures for a long period of time.

As we reported previously, ReNu with MoistureLoc contained a microbial agent not found in other contact lens solutions. According to the Associated Press, it also contained some novel moisturizing agents. Some researchers have theorized that the disinfectant absorbed into lenses at unusually high rates and the moisturizing agents created a biofilm (a cluster of microbes held together by a glue-like matrix) that shielded and even fostered growth of the fungus to infectious levels, the Associated Press said.

Other multipurpose contact lens solutions have also been linked to eye infection outbreaks. For example, we’ve previously reported that in 2007 at least 21 cases of infections involving the water-borne acanthamoeba parasite were linked to Advanced Medical Optics (AMO) Complete MoisturePlus solution, prompting the Santa Ana, California-based company to recall the product. According to the Associated Press, 170 lawsuits are pending against AMO as a result of that outbreak.

Such incidents have raised concerns about the overall safety of multipurpose contact lens solution, which according to the Associated Press, have virtually replaced older lens cleansing systems since coming on the market over a decade ago. As we reported last June, a Food & Drug Administration (FDA) advisory panel recommended that contact lens solutions be subjected to more stringent testing protocols, and the agency has been working on such standards.

But there are worries that enough still isn’t being done to protect contact lens wearers from defective solutions like ReNu with MoistureLoc. At least one expert interviewed by the Associated Press expressed concerns that the confidential nature of the ReNu with MoistureLoc settlements is preventing facts about the catastrophe – including questions of blame and clinical findings about the Fusarium Keratitis outbreak – from seeing the light of day. But the doctor was hopeful that some of the other lawsuits still to be settled will end up at trial, thus making such facts part of the public record.

According to the Associated Press, while Bausch & Lomb has settled most Fusarium Keratitis cases, it still has several dozen pending. And the company says it plans to defend at least 500 filed by people who claim to have suffered a variety of other eye infections because of ReNu. A pretrial hearing is scheduled this week in New York to decide if there’s a reliable scientific basis for arguing that a link between ReNu and these other infections exists, the Associated Press said.

This entry was posted on Monday, June 1st, 2009 at 5:57 am and is filed under Renu.