Contact2World.com

About 150 lawsuits are moving forward alleging that Complete MoisturePlus contact lens solution causes a nasty eye infection that can require corneal transplants and in some cases result in blindness. The majority of cases have been filed in a coordinated proceeding in state court in Orange County, Calif., where defendants Allergan and Advanced Medical Optics Inc. are headquartered.

In one of the first bellweather cases, scheduled for trial on May 4, 2009, 34 year-old plaintiff Kellie Bataglia is alleging that she contracted an acanthamoeba keratitis infection after using the all-in-one Complete MoisturePlus product.

Despite two corneal transplants, Bataglia has not completely regained her vision and has a persistent infection that still requires round-the-clock treatment, according to her attorney, Wendy Fleishman of Lieff Cabraser Heimann & Bernstein in New York. Her damages include medical expenses, lost wages, and pain and suffering. She is also seeking punitive damages, Fleishman added.
The product was recalled in May 2007.

“The cases were strong when the recall occurred and have only gotten stronger,” despite lingering discovery battles, said Thomas Moore of Moore & Labriola in Newport Beach, Calif.

Lawyers for both sides are currently locked in a discovery dispute over tens of thousands of documents that the defendants claim are subject to the attorney-client privilege.

Defense counsel Anthony Brazil of Morris Polich & Purdy in Los Angeles did not return a call to his office seeking comment.

Painful Infection

Acanthamoeba keratitis infection is a painful infection that can cause blindness or even death if it spreads to the optic nerve and brain.

To make things worse, acanthamoeba infections are often misdiagnosed, are highly-resistant to treatment and tend to go dormant and then return even stronger.

Many plaintiffs have lost their vision because the organism was not caught in time to save the eye, or have had multiple corneal transplants because the organism was not dead before a transplant was performed.

The lawsuits allege a number of defects in the design, marketing and testing of the contact lens product.

Specifically, they claim that in place of a three-step cleaning, disinfecting and rinsing process, MoisturePlus uses an all-in-one solution that reduces the amount of disinfectant, thereby making the solution more comfortable in the eye, but less effective at fighting infection.

The suits also allege that the addition of a lubricant to improve comfort created a fertile incubating environment for acanthamoeba, and that the “no rub” solution eliminated the step of rubbing the contact lens in the solution, which would have helped prevent infection.

The product was marketed as a more comfortable and convenient lens solution and targeted at younger contact lens wearers. This means many of the plaintiffs are teenagers and people in their 20’s, 30’s, and 40’s said Jason Ochs, an attorney with Lopez McHugh in Newport Beach, Calif., who is handling about 15 cases.

Jim Doyle, an attorney with Williams Kherkher in Houston, represents about 15 plaintiffs.

He said his cases will also include a misrepresentation claim, because advertisements for the product indicated that it was appropriate for use while swimming, an environment which would have exacerbated the growth of acanthamoeba.

The defendants are expected to argue that the FDA does not require testing for acanthamoeba, so they are not required to prove that their product is effective against the organism.

But plaintiffs’ attorneys claim that the companies did their own testing and knew of the risks.

“We are confident we can prove they knew the product was causing acanthamoeba infection at rates above and beyond [other similar products]. We allege they had early notice of the problem and the high rates based on their own research and review of internal documents,” said Ochs.

Although the product was recalled in 2007, there are cases occurring after the recall which will allege inadequate notification.

“They did not do the kind of recall notification that was adequate,” said Moore, noting that although the company notified optometrists’ offices to tell their patients, there was little direct consumer notification.

“Many consumers purchased the solution in bulk stores or online. Lots of folks had unexpired solution that they continued to use [after the recall],” said Moore.

Discovery Battle

The defendants have claimed that thousands of documents are covered by the attorney-client privilege.

According to Moore, this includes all documents relating to scientific information on the product or correspondence with regulatory agencies about the product, including a post-recall root-cause investigation that is customarily required by the FDA.

“It really goes to the heart of the case,” he said.

Moore claims that the defendants intermingled the post-recall investigation with the legal investigation.

“Instead of running their litigation testing separately, they intermingled them and now they are trying to claim all the documents are privileged,” he said.

A ruling on a subset of the documents sent to the defendants by the FDA is expected soon, he added.