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On June 1, 2009 an Associated Press article reveals how during  the past year, Bausch & Lomb has quietly settled almost 600 fungal-infection lawsuits. To date plaintiffs’ have received approximately $250 million. More than 700 lens wearers in the United States and Asia say they were exposed to a potentially blinding infection known as Fusarium keratitis while using ReNu with MoistureLoc, a new-formula multipurpose solution for cleaning, storing and moistening soft contact lenses.

Quite often, the damage was permanent. Seven people in Florida, Maryland, New York, Oregon, Tennessee and West Virginia had to have an eye removed. At least 60 more Americans needed vision-saving corneal transplants.

The U.S. Centers for Disease Control and Prevention confirmed 180 cases in 35 states from June 2005 through September 2006, when the agency’s dedicated surveillance stopped, according to Dr. Benjamin Park, a CDC epidemiologist. CDC continued to hear of sporadic, unconfirmed cases in the months after MoistureLoc was withdrawn, Park said.

“Surveillance usually captures the tip of the iceberg and sometimes it captures a larger tip than other times,” Park said in an interview.

The culprit, an infection so rare that most eye doctors had never seen a case, somehow eluded MoistureLoc’s disinfecting defenses. The outbreak appeared first in Hong Kong in spring 2005 and reached its peak in the United States just days after MoistureLoc was removed from domestic markets in April 2006.

Victims typically complained of eye irritation that progressed to a sudden onset of searing pain. Many were mistakenly treated with antibiotics and steroids a delayed diagnosis that worsened the condition.

Leading eye doctors and government scientists concluded that MoistureLoc, launched in 2004 with novel disinfectant and moisturizing ingredients, was the only lens solution that contributed to the outbreak. Yet the mechanics of how it caused the problem are still not fully clear.

Some researchers theorize that the disinfectant, alexidine, absorbed into lenses at unusually high rates and the moisturizing agents created a biofilm in some circumstances that shielded and even fostered growth of the fungus to infectious levels.

In 2007, another popular formula made by Santa Ana, California based Advanced Medical Optics, the No. 3 manufacturer behind Alcon Inc. and Bausch & Lomb, was linked to a flurry of hard-to-treat Acanthamoeba keratitis infections caused by a parasite. More than 170 people have sued the company, which was acquired this year by Abbott Laboratories.

While Bausch says it has settled “the vast majority of fungal infection cases,” it is challenging another 500-plus lawsuits linking MoistureLoc to assorted bacterial, viral and parasitic afflictions. A pretrial hearing set for June 3-5 in New York will decide if there’s a reliable scientific basis for arguing such a link.

Based upon data from a study published in the November 2008 issue of Archives of Ophthalmology, Renu with Moistureloc, manufactured by Bausch & Lomb, a contact lens solution that was implicated in an epidemic of the eye infection Fusarium keratitis between 2004 and 2006 was likely due to a reduction in the solution’s antifungal activity because of exposure to prolonged temperature increase.

In August 2004, Bausch & Lomb introduced ReNu with MoistureLoc, a contact lens solution that contains a unique antimicrobial agent. The solution was associated with cases of Fusarium keratitis, according to U.S. government reports, since March 2006. Eventually there were 154 confirmed cases identified in the United States of this condition characterized by inflammation of the cornea (keratitis). Bausch & Lomb investigators acknowledged that all original cases appear to be related to ReNu with MoistureLoc produced in their Greenville, South Carolina plant.

In 2006, the FDA inspected the Greenville facility and cited Bausch & Lomb for poorly controlling temperature in the production, storage and transport of products from this plant. Researchers further studied the effects of temperature on the growth of the Fusarium fungus by analyzing five contact solutions in addition to ReNu with MoistureLoc. The researchers explain that, Two bottles of each solution were separately stored at room temperature and 60 degrees Celsius [140 degrees Fahrenheit] for four weeks, serially diluted and then tested for their ability to inhibit growth of 11 Fusarium isolates (seven of which were associated with the keratitis epidemic).

Bausch & Lomb permanently removed its contact lens solution Renu with MoistureLoc from the market on May 15, 2006 due to an outbreak of extremely serious fungal eye infections called fungal keratitis, caused by the fusarium fungus. Bausch & Lomb had suspended shipments in April and asked retailers to stop selling the product. In February 2006, the company stopped selling ReNu with MoistureLoc in several Asian countries.  The outbreak affected hundreds of contact lens wearers worldwide. Many victims of ReNu with MoistureLoc suffered partial or complete loss of vision in the affected eye(s) and were forced to undergo cornea transplantation surgery, with some requiring multiple cornea surgeries.

ReNu with MoistureLoc showed the greatest decline in anti-fungal activity after the 60-degree storage period, while Clear Care and ReNu MultiPlus demonstrated the smallest decline. The authors also specifically analyzed the strains of Fusarium that were linked to the keratitis epidemic. In addition, the authors of the study found that when stored at room temperature, ReNu with MoistureLoc allowed fungal growth in 27 of 84 different blends of isolates grown in different solutions and at different levels of dilution. When stored at 140 degrees Farenheit, the solution allowed fungal growth in 67 of 84 of these combinations.

After Bausch & Lomb and Advanced Medical Optics contact lens solutions were linked to hundreds of eye infections the past two years, federal regulators are considering stricter testing requirements for the solutions. On June 6, 2008, the FDA outlined numerous proposals aimed at improving the safety of solutions used by as many as 34 million Americans who wear contact lenses.

Specifically, the FDA is considering new testing standards for contact solutions and updated labeling, including recommending that users gently rub their lenses during the cleaning process. On June 10, 2008 the agency will ask a panel of outside experts to weigh in on the ideas.

Multipurpose solutions have been on the market for a decade, all but replacing older systems that use several formulas to rinse and clean contacts. But the effectiveness of newer solutions has been questioned since Bausch & Lomb and Advanced Medical Optics separately pulled their products off the market in 2006 and 2007 after eye infection outbreaks.

The Centers for Disease Control and Prevention concluded in summer 2006 that Bausch & Lomb’s MoistureLoc solution played a key role in an outbreak of 180 Fusarium keratitis fungal infections, which can cause blindness.

A Bausch and Lomb spokesman said the company has been in discussions with FDA for over a year to ensure its remaining solution, Renu Multiplus, is used safely.

Like most other products on the market, Renu’s labeling does not advise patients to rub their contacts, an instruction which some eye doctors say helps keep lenses clean. FDA will ask its panel of eye care experts whether the recommendation should be a requirement. If the government favors that action, Bausch and Lomb said it would comply.

“We felt that if the solution was effective enough to pass FDA’s stringent requirements without rubbing then consumers should get that benefit,” said company spokesman Michael McDougall. “But should FDA decide a rub requirement is necessitated, we would have no problem with that.”

Advanced Medical Optics added a “rinse and rub” instruction to its latest solution, which it reformulated after last year’s withdrawal. Competing products from Alcon Inc. and other companies carry a “no rub” instruction.

Panelists also will debate whether contact solutions should be tested against a wider range of bacteria. That issue came to a head last year after CDC linked Advanced Medical Optics’ Complete Moistureplus solution to rare eye-infecting bacteria called Acanthamoeba keratitis. It is not among the bacteria and fungi FDA currently requires products be tested against.

Dr. Elmer Tu, professor of clinical ophthalmology at the University of Illinois at Chicago, said reports of the infection have continued despite AMO pulling its product off the market, suggesting competing products are susceptible to the same type of infection.

“Our hypothesis was that AMO happened to be the weakest solution of the group, but that doesn’t mean all the others are OK,” said Tu, who will present recommendations to FDA on June 10, 2008 on behalf of the American Academy of Ophthalmology. “If the outbreak is continuing and the current solutions are not working then there needs to be more research into how to reduce that risk.”