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 CDC continued to hear of sporadic, unconfirmed cases in the months after MoistureLoc was withdrawn, Park said.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.
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.
AP alleged that Bausch and Lomb kept the cases out of public view by using a previously unknown (at least to me) strategy:
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.
With some fungal lawsuits still unresolved, the prospect of Bausch & Lomb's health care nightmare being aired in court has not entirely faded — which heartens some lawyers and doctors.
'The truth has been very carefully buried, and it appears to have been buried going back to the beginnings of the outbreak,' said Dr. Arthur Epstein, who was chairman of the American Optometric Association's contact lens and cornea section during the highly publicized crisis.
'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.'
When Bausch & Lomb was acquired by private equity firm Warburg Pincus for $3.67 billion in October 2007, Chief Executive Ronald Zarrella said the deal would allow the company 'to pursue the growth path we were on ... without a lot of outside distraction.'Zarrella retired last year.
'hey can do all this out of the public eye — guys like me aren't sitting there scrutinizing the financial impact of every single settlement,'said analyst Jeff Johnson of Robert W. Baird & Co. in Milwaukee. 'you can completely focus on your brand and on doing what's right by the patient.'
So, if I understand this correctly, after Warburg Pincus took the company private, it was no longer required to file certain reports with the US Securities and Exchange Commission (SEC), including reports that would have had to acknowledge the multiple settlements the company made of cases alleging adverse effects of its contact lens solution. What is striking is the allegation by the AP that "taking the company" private was a strategy meant to conceal the settlements of these cases, (rather than a strategy implemented to fulfill other aims, which had the side effect of diminishing reporting of these cases' results.)
Again, I am hardly an expert, but relatively opaque private equity firms like Warburg Pincus seem to have become increasingly influential in the US economy, and to have an increasing role in health care. In 2007, we had posted how private equity firms running nursing homes, including Warburg Pincus, seemed to contribute to the opacity of their operations. More recently, we posted about how leaders of private equity, and of other kinds of firms in the finance arena, seem to also increasingly be leaders to which medical schools report.
One final note... A quick tour through the Warburg Pincus website reveals how involved the firm is in health care. The firm claimed that as a "direct equity investor in healthcare for more than 30 years, Warburg Pincus has invested more than $4 billion in approximately 120 healthcare companies." Furthermore, the firm seems quite intertwined with the leadership of academic medicine. It has a Life Sciences Advisory Board, of which three of four members are current leaders in academic medicine. The most prominent, Dr Michael Rosenblatt, Dean of the Tufts University School of Medicine, did not disclose this relationship in several versions of his biography published on the university web-site. (See the Tufts administration version here, and the Tufts Medical Center version here.)
Oh, what a tangled web we have weaved in health care, a web that continually frustrates transparency and makes it hard to figure out who was responsible for what when things go wrong.