Contact lens maker Bausch & Lomb Inc. had an overriding reason for going private in 2007: It wanted to handle a devastating recall of its flagship lens cleaner, its chief executive said, "without a lot of outside distraction."
Over the past year, away from the glare of public scrutiny, the optical products company has quietly settled nearly 600 fungal-infection lawsuits — with dozens more individual claims yet to be resolved. The cost so far: Upward of $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.
Sometimes, the damage was irreparable. 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 CDC continued to hear of sporadic, unconfirmed cases in the months after MoistureLoc was withdrawn, Park said.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.
Among out-of-court settlements reached in May was a potential bellwether case brought by Andrea Martin, a Broadway actress and comedienne whose eye was scarred. In Colorado, a corneal transplant ended a race-car driver's career. In Baltimore, a chimney-sweep business owner who lost an eye got hooked on painkillers.
"It left him with a chronic pain situation where at one point he had to go through drug rehab," said attorney Andy Alonso. "His business — handed down from generation to generation in his family — has fallen apart, his marriage has fallen apart and he now lives with his mother."
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. A woman in New York was afflicted three months after Bausch & Lomb announced a worldwide recall in May 2006.
"She didn't know about the recall, and the infection was so aggressive, she lost her eye within two months," said her attorney, Hunter Shkolnik.
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.