ReNu with MoistureLoc: Bausch & Lomb gets a Pass, but Hurdles Remain

Rochester, NYIn spite of its Greenville, South Carolina plant earning a pass after inspection by the FDA, Bausch & Lomb is still in the hot seat, facing more than 400 consumer lawsuits over its' recall last year of ReNu with MoistureLoc contact lens solution.

The issue stems from a suspected link to Fusarium keratitus infection, which first surfaced in Asia. Bausch & Lomb pulled MoistureLoc from the Asian market in February of last year and followed suit in the U.S. two months later.

A worldwide recall was implemented in May 2006 - which on the surface may have appeared as though the manufacturer was doing the right thing. However, it is reported that in October of last year the U.S. Food and Drug Administration had some harsh words for Bausch & Lomb over their reluctance to act after Asian reports of the Fusarium keratitis infection first came to light.

The FDA also slammed Bausch & Lomb for deficiencies at its Greenville manufacturing plant.
In a report issued by the Centres for Disease Control and Prevention (CDCP) in Atlanta, 164 cases of the rare eye infection had been confirmed as of June 30th, 2006. Their data suggests that those who had contracted the infection were to found to be twenty times more likely to have used the ReNu MoistureLoc solution, and that poor personal hygiene practises on the part of the users had little to do with their eye troubles.

In fact, the CDCP reported that the contact lens solution presented poor disinfectant qualities.

This finding relates to alleged deficiencies at the Bausch & Lomb manufacturing facility in Greenville, South Carolina uncovered by an inspection carried out by the FDA last year. While the agency found no problems with the manufacturing process, the FDA did identify deficiencies with production, including failure to check suppliers, and failure to properly test solutions.

After the company installed new, stainless steel surfaces in the mix room, put in new air conditioning equipment and added additional quality control staff, the plant was re-inspected and given a clean bill of health as of June 29 of this year.

The Greenville plant employs 500 people.

The issues surrounding ReNu with MoistureLoc could be based on several different criteria. First, the aforementioned deficiencies in the Greenville manufacturing facility, which have since been rectified but had yet to be addressed at the time of, and prior to the product recall. There is also the possibility, it is alleged, that a primary ingredient - sodium phosphate - depletes the eye of important enzymes and dries it out, leave the eye increasingly susceptible to infection.

Fusarium keratitus can have dire consequences if left untreated. Complete corneal transplants are not uncommon. The eye pain, blurred vision, redness and excessive discharge can have an adverse affect on employment, and enjoyment of life.

Unlike a similar recall by Advanced Medical Optics, which reacted swiftly at the first sign of trouble, Bausch & Lomb is accused of dragging its heels. The delay in dealing with the issue may have negatively impacted countless people who otherwise may not have been adversely affected had the manufacturer been more diligent in this regard.

In an ironic twist of fate, Bausch & Lomb is an acquisition target - and while lawsuits stemming from the ReNu with MoistureLoc product wind their way through the courts, Bausch & Lomb potentially finds itself at the receiving end of a class-action lawsuit of a different sort - brought on my its own shareholders not happy with the price-per-share being offered by its current suitor, a private equity firm.

A counter-offer was made recently by one of Bausch & Lomb's competitors: Advanced Medical Optics, of Santa Ana, California and the makers of AMO MoisturePlus - itself the subject of a massive recall.

Bausch & Lomb could be facing as much as $1 billion in settlements over the recall of ReNu with MoistureLoc, although some analysts expect that figure to be much higher.