A Medical Device Daily

Ten contact lens solution users have filed a personal injury lawsuit against Advanced Medical Optics (AMO; Santa Ana, California), according to Lieff Cabraser Heimann & Bernstein.

AMO has already been slapped with a number of lawsuits both from company shareholders and consumers.

In November 2006 the company reported a voluntary recall of certain eye care product lots and the related manufacturing capacity constraints caused by a production-line issue at its manufacturing plant in China. By Jan. 4 the company had reported that problems with Complete were in the past. Then, on May 25, after the market closed, AMO reported the voluntary recall of Complete 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 (MDD, May 30, 2007). Following this news, AMO stock collapsed, dropping $5.51 a share on volume of 16.2 million shares.

AK 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.

"Almost six months have passed since AMO purportedly withdrew its defective contact lens solution from the market, yet it is still being used by consumers," said Wendy Fleishman, a partner at Lieff Cabraser. "AMO has failed to adequately notify consumers and retailers of the recall. We hope today's lawsuit will lead AMO to make its recall notice loud and clear, so that the product is completely off the market and no future injuries occur."

According to Lieff Cabraser, each plaintiff alleges he or she suffered vision loss due to AK from using AMO's Complete MoisturePlus solution. The plaintiffs are residents of Los Angeles and Mission Viejo, California; Cheshire, Connecticut; Asheville and Greensboro, North Carolina; Derry, New Hampshire; and Azle, Houston and Lubbock, Texas.

"AMO has not yet acknowledged its responsibilities to injured consumers," Fleishman said. "AMO must compensate all users of its contact lens solution who developed serious eye infections, including reimbursing patients for the cost of their surgeries and other expenses, and agree to pay for necessary future medical care."

The complaint brings claims of negligence, strict liability, breach of warranty, fraud, unjust enrichment, and violations of California statutory law, according to Lieff Cabraser. Plaintiffs seek compensatory and punitive damages against AMO for the injuries they suffered.