A Medical Device Daily

What is believed to be the first class action lawsuit brought in the U.S. against the maker of Complete MoisturePlus contact lens solution was filed today in Orange County Superior Court in Santa Ana, California.

The product was voluntarily recalled late last month as a precaution because of reports linking it to a rare, and serious, eye infection, acanthamoeba keratitis (AK), caused by a parasite. The link between the solution and the infection was identified as a result of an investigation by the Centers for Disease Control and Prevention (CDC; Atlanta) (Medical Device Daily, May 30, 2007).

The lawsuit, naming ocular products manufacturer Advanced Medical Optics (AMO; Santa Ana, California) and others as defendants, was brought by Nicole Lazar on behalf of California consumers who bought the product but have not alleged physical injuries. The lawsuit seeks reimbursement of money consumers spent to buy the contact lens solution. In addition, the action seeks reimbursement for the cost of replacing potentially contaminated contact lenses and lens cases as a result of the FDA’s recommendation that these products also be discarded by anyone who has used them in conjunction with Complete MoisturePlus.

The lawsuit alleges that AMO falsely marketed the solution as an effective contact lens disinfectant against infection-causing microbes. The complaint cites CDC data showing that consumers who disinfected their lenses with Complete MoisturePlus had a seven-fold increased risk of developing AK as compared with consumers who used other lens disinfectant products.

Acanthamoeba is a microorganism commonly found in water, soil, sewage systems, cooling towers, and heating/ventilation/air conditioning systems. AK is usually found among individuals who improperly store/handle/disinfect their lenses (e.g., use tap water or homemade solutions for cleaning), swim/use hot tubs/shower while wearing lenses, come in contact with contaminated water, have minor damage to their corneas, or have previous corneal trauma.

Complete MoisturePlus is one of a number of “all-in-one” or “multipurpose” contact lens solutions designed to be convenient alternatives to hydrogen peroxide disinfectant systems. According to the class action complaint, studies published well before the product was recalled showed that the disinfectant in Complete MoisturePlus was vastly inferior to hydrogen peroxide as well as other solutions on the market in eradicating acanthamoeba. The class action alleges that AMO was aware of the ineffectiveness of their product but concealed that information from consumers who were led to believe that the solution was at least as effective as others on the market.

AMO said in a conference call last week that it would shift its focus to “rub” formulations of lens cleaners and hydrogen peroxide products (MDD, June 6, 2007).

“Rubbing promotes the most thorough level of lens cleaning and disinfection and is therefore in the best interest of all contact lens wearers,” James Mazzo, president/CEO of AMO said during the call. “The industry has grappled for years to balance efficacy, comfort and convenience.”

“Injured consumers will be able to bring their own individual cases, but there also needs to be a remedy for those who escaped infection, but were nevertheless persuaded by AMO’s marketing campaign to purchase an inferior product,” said Newport Beach attorney Mark Robinson, whose firm Robinson, Calcagnie & Robinson is acting as co-lead counsel on the case with Thomas Moore of Moore Labriola, also based in Newport Beach. Moore’s firm, along with Schmidt & Clark in Dallas, represent the plaintiff in the first personal injury case against AMO filed on behalf of a San Diego man who developed AK and suffered sight loss after using the now-recalled solution. Robinson, Moore, and Schmidt say they are reviewing a number of potential claims and expect additional personal injury cases to be filed in the near future.