BEN DOBBIN
AP Business Writer
ROCHESTER, N.Y. (AP) — Bausch & Lomb Inc., rocked by the worldwide recall of its flagship contact lens solution in 2006, has beaten back scientific claims blaming ReNu with MoistureLoc cleaner for a flurry of non-fungal eye infections.
The optical products maker has already paid out more than $250 million to settle roughly 600 lawsuits linking MoistureLoc to a potentially blinding fungal infection known as Fusarium keratitis.
But after a hearing in New York in June on the admissibility of expert evidence, a federal judge in South Carolina said there's no reliable scientific basis for arguing that MoistureLoc caused another 1,024 lens wearers across the United States to contract assorted bacterial, viral and parasitic infections.
Attorneys relying on the expert opinion of corneal specialist Dr. Elisabeth Cohen "did not submit any peer-reviewed studies, articles or case reports concluding that there is a causal relationship between MoistureLoc and non-Fusarium infections," Judge David Norton wrote in a ruling issued Friday.
"Dr. Cohen's theory as to general causation is built on an unsupported hypothesis, and is thus fundamentally flawed and must be excluded," added Norton, the chief U.S. District judge in Charleston, S.C.
Attorneys for the plaintiffs either declined to comment or did not return calls Monday. There was no immediate word on whether an appeal would be lodged.
In a statement, Bausch & Lomb said that in Fusarium-related cases "where people were directly affected, the company sought to compensate them fairly, and has done so through more than 600 settlements — the vast majority of these claims.
"At the same time, we have vowed to fight vigorously where there is no scientific basis for claims, and will continue to do so."
Financial analysts and lawyers estimate the MoistureLoc debacle could wind up costing Bausch & Lomb as much as $500 million. The 156-year-old company, which posted $2.5 billion in 2007 sales before going private, employs 13,000 people. It expects to return to public ownership within the next six years.
Seven Americans had to have an eye removed and at least 60 others needed vision-saving corneal transplants after contracting Fusarium keratitis while using MoistureLoc, a new-formula multipurpose solution for cleaning, storing and moistening soft contact lenses.
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. Bausch & Lomb announced a worldwide recall a month later.
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.
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, Calif.-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. Dozens of people have sued the company, which was acquired this year by Abbott Laboratories.