Mere Weeks after AMO Recall, Lawsuits Start Coming

Chicago, ILIt didn't take long for lawyer's phones to start ringing after Advanced Medical Optics of Santa Ana, California pulled their stock of AMO Complete MoisturePlus Multi-Purpose Solution from store shelves last month. On June 8th a resident of Santa Clara County, Nicole Lazar, was named as the lead plaintiff on behalf of California consumers who may have purchased Complete MoisturePlus.

The lawsuit, which aims for class-action status, also seeks re-imbursement for funds spent by consumers on the recalled lens solution, and the costs borne by consumers to replace it after the voluntary recall.

In late May, consumers were advised to dispose of all containers of AMO MoisturePlus, over concerns about a potentially serious eye infection. The Centre for Disease Control and Prevention in Atlanta (CDC) has been investigating 138 confirmed cases of Acanthamoeba keratitis, a rare inflammation of the cornea. If left untreated, the infection has the potential to cause blindness.

The CDC has linked this emergence of the rare eye disease to AMO MoisturePlus Multi-Purpose Solution, and has stated that the risk of developing Acanthamoeba keratitis amongst users of AMO MoisturePlus is statistically seven-fold.

Earlier in the week a California man launched a lawsuit against Advanced Medical Optics, alleging that he developed the painful eye infection in August of last year, while using AMO Complete MoisturePlus. Michael Connolly, an engineering systems analyst based in San Diego, alleges that AMO has made a defective product and failed to warn consumers. The 37-year-old professional has not recovered from the infection and may require surgery. Connolly is almost blind in one eye. He is suing for unspecified damages.

The escalating emergence of Acanthamoeba keratitis (remember that the Centre for Disease Control used the term 'outbreak' in reference to the product recall), and its cause remain a mystery, and the investigation continues. According to Dr. Clark Springs, an assistant professor of ophthalmology, and a cornea specialist at the Indiana University School of Medicine, the normal incidence rate is extremely rare - one, or two cases per million.

That's why the number of cases linked to AMO MoisturePlus - 138 so far - has provided for so much concern. And while the Acanthamoeba parasite itself is commonly found in tap water and recreational bodies of water such as pools and hot tubs - it can have the greatest negative impact when it associates with the eyes. In the most severe cases, it can lead to blindness.

Early diagnosis is key, due to the capacity of the parasite to lie dormant, only to re-surface at a later date. That is why, states Dr. Springs, treatment lasts at least four months and can sometimes take up to a year.

When the recall was announced last month, Advanced Medical Optics (a publicly traded company) recommended disposing of not only the solution, but also the lenses and lens case - anything that may have come in contact with the parasite, and potentially tainted solution.

Symptoms can include eye pain, redness, blurred vision, sensitivity to light, sensation of something in the eye, and excessive tearing. Any individual with signs of these symptoms should seek medical attention.

The first trouble signs of Acanthamoeba keratitis appeared in 2004, when Dr. Elmer Tu, a Chicago-based ophthalmologist, noted about a dozen cases of the infection. Normally, in a year, he might only see one or two.

Digging back into records at the University of Chicago-Illinois (UCI), Dr. Tu found that of 35 patients exhibiting symptoms of Acanthamoeba keratitis between May 2003 and September 2006, fifty-five per cent had used the AMO product exclusively.

Dr. Tu, who is affiliated with UCI, theorizes that the fault may not lie with the manufacturing process, but rather with the product's potential inability to protect the eyes during activities such as swimming, or showering.

AMO MoisturePlus is not expressly marketed to protect against such parasites or amoeba, according to a spokesperson with the U.S. Food and Drug Administration. That said, the product is not supposed to contain any microorganisms, which could serve as a catalyst to infection.

The 35 cases seen at the UCI were referred to the Illinois state health department, which in turn notified the CDC in Atlanta. The latter conducted investigations and collected data in 35 States, before sounding the alarm bells in late May.

Later next week we will report first-hand accounts from AMO victims—stay tuned.