Claim against contact lens solution preempted by FDCA

Degelmann v. Advanced Medical Optics Inc., --- F.3d ----, 2011 WL 4470641 (9th Cir.)

Degelmann represents a putative class of purchasers of contact lens solution, alleging violations of the UCL and FAL because AMO advertised Complete MoisturePlus as a product that cleans and disinfects lenses. In 2007, the CDC reported an increase in a serious eye infection associated with the use of MoisturePlus; AMO recalled it and established a refund program for unused product. The putative class did not include people who’d contracted an eye infection. The court of appeals affirmed denial of certification on different grounds than the trial court used.

Plaintiffs alleged that AMO knew that MoisturePlus was a poor disinfectant compared to other similar products, and that the company misled consumers into believing MoisturePlus was as effective as other solutions. But for the inaccuracy of AMO's labeling practices, they alleged, they would not have purchased MoisturePlus. The district court ruled that the class suffered no injury because (1) they never contracted AK, so they suffered no harm from use of MoisturePlus, (2) they were not forced by the product recall to discard unused product, and (3) they did not lose money because if they had not bought MoisturePlus, they would have bought another lens solution.

The court of appeals disagreed. Class representatives properly averred that they bought MoisturePlus in reliance on the disinfectant representation, which means they suffered injury in fact: economic harm. It’s probably true that they would have bought other contact lens solution had they not bought MoisturePlus, but that doesn’t mean they didn’t suffer economic harm. They presented evidence that they were deceived into purchasing a product that did not disinfect as well as it represented. With accurate labeling, they would not have been willing to pay as much for, or would have refused to buy it. The district court read “injury in fact” too narrowly.

However, the court of appeals found that the case was preempted, because the FDA provides criteria for a contact lens solution to be labeled as a “disinfecting solution,” preempting claims that use of the term “disinfects” was false or misleading. The Medical Device Amendments of 1976 to the FDCA include a provision that states can’t establish any requirement “(1) which is different from, or in addition to, any requirement applicable under [the FDCA] to the device, and (2) which relates to the safety or effectiveness of the device or to any other matter included in a requirement applicable to the device under this chapter.”

First, the court had to decide whether the FDA had promulgated a specific requirement that applies to contact lens solution. Lens care products are Class II devices, involving some risk of injury but not subject to the intensive pre-market approval process. Class II devices need only § 510(k) clearance, designed to ensure only that a product is substantially equivalent to a product that is already on the market. AMO argued that MoisturePlus was subject to special controls on the testing, manufacture, and labeling of multipurpose contact lens solutions, as laid out in an FDA Guidance Document for Contact Lens Care Products. It sets out requirements for a contact lens care solution to be labeled a “disinfecting solution.” One path to such labeling is to “meet the primary performance criteria of the standalone procedure for contact lens disinfecting products.” This AMO’s product undisputedly did, and the court found that these were specific requirements for preemption purposes.

Then the question was whether the lawsuit would impose a different or additional requirement on AMO. The court held that, in order for the class to recover, a court would have to hold that the UCL and FAL required something different than what the FDA required to label MoisturePlus a disinfectant: that AMO test for a specific pathogen and show that MoisturePlus kills it in sufficient quantities. This was preempted.