Adverse Event Reports Go Unreported While Consumers Loose Eye Sight.

In a report by the Associate Press (June 20, 2009) the company – Advanced Medical Optics - chose to not report at least 9 Adverse Events cause by it’s product Complete MoisturePlus that showed a connection between its product and a serious eye infection caused by Acanthamoeba.

“Of roughly 70 plaintiffs suing AMO and represented by the law firm Schmidt LLP,three had eyes removed, three others suffered blindness and about two dozen had at least one corneal transplant. The others suffered permanent vision damage. By June 2007, the CDC had confirmed nearly 160 cases of the infection in patients across the U.S.

Currently there are 257 Adverse Events listed in the Medical Device database (MAUDE).

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.”

Apparently AMO chooses to not understand the requirements or purpose of Adverse Event Reporting. Suggesting that they are not required to report a problem that their label does not specifically address seems to indicate that the company feels that they are not obligated to be at all concerned about the consumer after they have taken payment for their product.

It is a given that AMO will play the FDA Preemption card in their liability defense. It is also likely that the case will be thrown out of court on those grounds.