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Advanced Medical Optics Failed to Report Eye Infections to the FDA


WASHINGTON (AP) — Complaints about a contact lens solution linked to a 2007 outbreak of eye infections that blinded several people went unreported by the manufacturer for more than a year, government documents show.

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 Food and Drug Administration, through a Freedom of Information Act request. The papers were obtained by The Associated Press.

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.

Of roughly 70 plaintiffs suing AMO and represented by the law firm Schmidt LLP (The Schmidt Firm, PLLC), three had eyes removed, three others suffered blindness and about two dozen had at least one corneal transplant. The others suffered permanent vision damage.

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.

“It confirms our suspicion that AMO knew, or should have known, that there was a significant increase in Acanthamoeba keratitis cases associated with Complete MoisturePlus,” said attorney Michael Schmidt of Dallas.

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.”

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