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A June 21, 2009, Associated Press article highlighting government documents show complaints about a contact lens solution linked to a 2007 outbreak of eye infections that blinded several people went unreported by the manufacturer for in excess of a year.

The documents show Advanced Medical Optics received complaints about the solution more than a year before it was recalled, and failed to promptly report nine complaints as required by law. The company pulled its Complete MoisturePlus off the market in May 2007 after the Centers for Disease Control and Prevention linked the fluid to dozens of cases of a serious infection called Acanthamoeba keratitis.

Lawyers for customers suing AMO obtained the documents, which stem from a previously undisclosed inspection by the FDA through a Freedom of Information Act request.

It’s impossible to know whether the reports would have triggered an earlier recall had they been submitted to the FDA. But medical experts say they certainly should have sounded an alarm.

When questioned by FDA inspectors, company officials said they were not obligated to report the complaints because the product’s labeling does not say it protects against Acanthamoeba, according to the FDA documents.

But consumer advocates criticize that reasoning.

“It’s a little bit like saying, ‘Our cars are not claimed to prevent crashes, and therefore we’re under no obligation to make our cars as crash-proof as possible,” said Dr. Peter Lurie of Public Citizen, a consumer advocacy group.

Kelly Morrison, a spokeswoman for Abbott Laboratories, which acquired AMO in February, said the company “believed it was reporting customer complaints in compliance with FDA regulations. She declined to elaborate. Abbott Laboratories is based in North Chicago.

The FDA documents illustrate just how much the government relies on manufacturers to report problems. They also raise questions about how aggressively regulators have gone after companies that don’t report critical information.

Beginning in February 2006 and continuing through November, AMO received a series of complaints about users who were diagnosed with the Acanthamoeba infections. But those reports were not disclosed until June 2007, when FDA inspectors came to investigate the company’s headquarters following its product recall.

Despite that violation and a half-dozen other documentation problems involving consumer complaints and quality control, the FDA never pursued legal action against AMO.

The FDA routinely issues warning letters to companies that don’t follow regulations. The letters are not legally binding and the agency rarely takes companies to court over the violations. Even that step was not taken with AMO.

Instead, after the recall, the FDA met with the company and discussed the problems outlined by the inspectors’ report, known as a Form 483.

“FDA felt that the company’s response to the 483, in conjunction with the face-to-face meeting, were adequate,” said agency spokesman Christopher Kelly.

The company agreed to comply with regulations and outlined plans for doing so, FDA said. The plant is subject to a follow-up inspection.

The Acanthamoeba is a microscopic organism typically found in water or soil that can cause devastating harm when it enters the eye, usually by attaching to a contact lens. It is notoriously difficult to kill because it can seal itself in a protective coating when confronted with antibacterial drugs, and emerge unharmed weeks or months later.

If left untreated, the amoeba can damage the eye, cause blindness and, in rare cases, result in a deadly infection of the brain and spinal cord.

The FDA and CDC pressured the company to pull its formula off the market after concluding that contact lens wearers who had the infection were at least seven times more likely to have used Complete MoisturePlus than those who didn’t get the infection.

It’s still unclear what caused the link, but the company blamed improper handling and shipping of the product.

By June 2007, the CDC had confirmed nearly 160 cases of the infection in patients across the U.S.

One of those patients was Paige Reichardt of Valparaiso, Ind., a lifelong contact lens user who became infected in 2005. Over the next year she underwent a series of surgeries to remove her cataract lens, iris and cornea. Ultimately surgeons had to remove her entire eye and replace it with a glass prosthetic.

“I describe the pain as a feeling that someone has thrown hydrochloric acid in your eye and then stabbed it with knives,” Reichardt wrote in a 2007 editorial on the Prevent Blindness America Web site. She declined to be interviewed for this article, citing instructions from her lawyers.

Reichardt settled her case against the company out of court last month, but 220 other plaintiffs are pushing ahead with litigation in California against AMO, now part of Abbott. The next case is scheduled to begin go to trial in August in California Superior Court in Orange County.

At the center of the litigation is the FDA report.

Medical manufacturers are supposed to report product complaints tied to serious injury within 30 days of the end of each quarter. But FDA inspectors uncovered nine reports of Acanthamoeba dating from 2006 that went unreported until they arrived to inspect the company’s plant following the recall.

A swifter response could have even helped the government head off some infections, said Lurie, of Public Citizen.

“A relatively small number of cases of something as serious as this could tip the balance between something that seems like background noise, and something that’s a legitimate outbreak,” he said.

Acanthamoeba infections generally occur in one to two contact lens wearers per million. With 30 million contact lens wearers in the U.S., the expected national rate of infections would be 30 and 60. Yet that figure exploded to more than 100 in 2007.

The recall of AMO’s solution was one of two high-profile product recalls in the middle of the decade in products linked to eye infections. The other a Bausch & Lomb product tied to an eye fungus.

Product recalls are expensive, as AMO had already learned the hard way. In November 2006, it slashed sales estimates by more than $40 million after voluntarily recalling 18 batches of contact solution at risk of bacterial contamination. The issue was unrelated to Acanthamoeba. AMO would lose tens of millions more in sales after the May recall, before ultimately being bought out by Abbott.

Hauling companies into court for reporting violations takes significant money and manpower, two things consumer advocates say the FDA has long lacked. But Public Citizen’s Dr. Sidney Wolfe argues that not disciplining companies endangers the public health by encouraging reckless corporate behavior.

“Enforcing the criminal statutes is so important because these inspection reports are a matter of public record,” said Wolfe, who is the group’s acting president. “If other companies notice that violations don’t lead to any criminal investigation, that’s a big problem.”

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.

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.”