June 1, 2009
Bausch & Lomb Embroiled In Eye Fungus Suits
When contact lens maker Bausch & Lomb Inc. went private in 2007, it was not without good cause.
Company leaders have explained that the company wanted to handle a disastrous recall of its popular lens cleaner "without a lot of outside distraction."
In the past year, the optical products company has managed to quietly settle almost 600 lawsuits involving claims of fungal-infections, while dozens of individual claims are still waiting to be heard. In all, Bausch & Lomb Inc. has doled out a whopping $250 million "” and the number is still growing.
Upwards of 700 wearers of contact lenses in the U.S. and Asia claimed that they were exposed to a potentially blinding fungal infection known as Fusarium keratitis while using ReNu with MoistureLoc, a multipurpose cleaning solution for storing and moistening contact lenses.
In several cases, the damage was permanent. Seven people in Tennessee, Florida, Maryland, New York, Oregon and West Virginia had to have an eye removed, while at least 60 more have had to undergo corneal transplant surgery.
Between June 2005 and September 2006, officials from the U.S. Centers for Disease Control and Prevention confirmed 180 cases of infection in 35 states before the federal organization stopped its surveillance, explained Dr. Benjamin Park, an epidemiologist with the CDC. The organization continued to hear rumors of unconfirmed cases popping up in the months following the product MoistureLoc's removal from the market.
"Surveillance usually captures the tip of the iceberg and sometimes it captures a larger tip than other times," added Park in an interview.
One of the dozens of out-of-court settlements made in May was a case brought by Broadway actress and comedienne, Andrea Martin, whose cornea was scarred by a fungal infection. In another case in Colorado, a professional race-car driver's career came to an abrupt and early end after he had to undergo a corneal transplant.
The fungus responsible for the infections is so rare that the majority of American opthamoligists have never even encountered a case. Bausch & Lomb says they still don't know how the microbe managed to sneak in through their tight screening procedures.
The outbreak first popped up in Hong Kong in spring 2005 and later climaxed in the U.S. just days after the product was removed from shelves in April 2006.
Most victims complained of eye irritation that was later followed by intense, searing pain. A number of patients were improperly diagnosed and thus suffered from delayed or incorrect treatment. One woman in New York was first affected some three months after Bausch & Lomb announced a worldwide recall of the product.
"She didn't know about the recall, and the infection was so aggressive; she lost her eye within two months," explained her attorney.
Government health experts have concluded that MoistureLoc was the only contact lens solution that contributed to the outbreak, though the details remain largely a mystery.
A number of scientists have hypothesized that alexidine, the novel disinfectant used in MoistureLoc, was absorbed too quickly by the contact lenses and that the moisturizing ingredients in the solution formed a biofilm that promoted the growth of the fungus to levels capable of causing infection.
With several lawsuits still being contested, the possibility that Bausch & Lomb's health care disaster might be publicly aired in court is still very real "” a contingency that some lawyers and doctors would be pleased to see.
"The truth has been very carefully buried, and it appears to have been buried going back to the beginnings of the outbreak," said chairman of the American Optometric Association, Dr. Arthur Epstein.
"All settlements were predicated on silence about the clinical findings and blame and so forth. My hope was that what actually happened would become part of public record in a courtroom. That way, we'd be able to learn from it and move on and make sure it never happened again."
In the wake of the infections, the Food and Drug Administration has said that it intends to lay out more rigorous testing standards for lens solutions.
"We did take the two epidemics as very much of a wake-up call, because contact lens safety is an essential public health issue," said Dr. Malvina Eydelman, director of the federal agency's ophthalmic division.
Financial analysts predict that the MoistureLoc imbroglio could end up costing the company over $500 million in settlement and attorney payouts. Yet even more damaging for Bausch & Lomb has been the loss of hegemony in the highly profitable lens care market.
When the private equity firm Warburg Pincus purchased Bausch & Lomb for $3.67 billion in October 2007, Chief Executive Ronald Zarrella said that the buyout would let the company "pursue the growth path we were on [...] without a lot of outside distraction."
The 156-year-old Rochester-based company has over 13,000 employees and reported some $2.5 billion in sales for the 2007 fiscal year. Company leaders say they hope to return the firm to public ownership at some point in the next six years.
In an attempt to spruce up their rapidly retreating lens care sales, Bausch & Lomb has been forced to fall back on an older product, ReNu MultiPlus. But sales of the product have dropped by $72 million, from $522 million in 2005 to about $450 million in 2008. During the same period, one of the company's competitors, Alcon, has seen a rise in sales from $297 million to $469 million, according to analyst Peter Bye of Jefferies & Co. in New York.
Alcon's multipurpose solution still has a clean image, and "that's why they're cleaning up" in the market right now, explained Bye.
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