Class action suit against Bausch & Lomb makes way to Kansas City

Daily Record and the Kansas City Daily News-Press, Jul 3, 2006 by Charles Emerick

The maker of a contact lens solution faces a class action suit filed in the U.S. District Court for the Western District of Missouri.

The complaint filed by Michael A. Schneider of Kansas City claims that Bausch & Lomb's ReNu with MoistureLoc Multi-Purpose Solution contained the fusarium fungus. Schneider's use of the infected solution caused fusarium keratitis in his right eye, he alleged.

Schneider's complaint is one of dozens of lawsuits filed against Bausch & Lomb in federal courts throughout the country.

There may be more in our area, said Karen Renwick, Schneider's attorney. This is becoming more widespread because it was distributed nationwide.

The Walters Bender Strohbehn & Vaughan attorney added that she was appalled by what her client suffered.

I get upset when I find out what Bausch & Lomb knew, especially overseas, Renwick said. They said nothing. There were a lot of red flags, and they wouldn't admit there was anything wrong with their product.

Reports of fungal keratitis began in Hong Kong last year shortly after the product was launched there. The infection can develop through the whole depth of the cornea. A corneal implant is often required to remove the fungus, and in some cases the complete removal of the eye may be necessary.

Renwick said the company failed to act promptly after numerous reports of fusarium by MoistureLoc users in Hong Kong and Singapore, where Bausch & Lomb suspended sales of the product in February. MoistureLoc was removed from shelves in the United States on April 13.

An inspection conducted earlier this year by the Food and Drug Administration reported that Bausch & Lomb did not file a medical device report within 30 days of receiving information that suggests that a marketed device may have caused or contributed to a death or serious injury, the reported stated.

Specifically, the FDA inspection noted that the company failed report 35 fusarium keratitis cases documented by Singapore's Minister of Health in February as of April 7.

Additional complaints reported to the company in July 2005 had not been reported as of May 9, 2006.

People have lost eyes and been blinded, Renwick said. It's amazing that they didn't tell anybody about this.

In a statement by Bausch & Lomb, the company said it followed guidelines adopted by the Contact Lens Institute in 1997.

Within days of receiving a report in February of an unusual spike in fusarium keratitis cases among contact lens wearers in Singapore, Bausch & Lomb discussed those initial case reports with FDA's Office of Compliance in the Center for Devices and Radiological Health, the statement said. As details of the Singapore cases were gathered, the company continued to provide updates to FDA.

In Schneider's case, he purchased a travel-sized bottle of MoistureLoc solution for a business trip to Las Vegas in February. It was the only brand of contact solution he used while on the trip, according to Renwick.

While in Las Vegas, the plaintiff began experiencing symptoms of fusarium keratitis, including eye redness, itching and light sensitivity. He was diagnosed with the infection on March 17, and his bottle tested positive for the fungus in April, according to the complaint.

Renwick said it might take more than one corneal transplant surgery to rid Schneider's right eye of the fungus. Schneider is required to place drops in his eye every 30 to 60 minutes, all day long.

In the complaint, Schneider and the class alleged damages of severe and permanent injuries that will continue to occur in the future, past and future medical and pharmaceutical expenses, past and future lost wages, severe and enduring pain and suffering, loss of earnings capacity, mental anguish and the costs of the product.

Other statements released by Bausch & Lomb say health and safety are the company's first priorities, and it suggests that hygiene may have played a role in the infections.

After thousands of tests, there is no evidence of MoistureLoc contamination, tampering or counterfeiting, a statement on the company's Web site states. That leads us to believe that there may be some aspect of the MoistureLoc formula, when combined with certain environmental factors, lens wear and care practices, and other factors, that might increase the risk of fusarium infection in rare circumstances.