Litigation Concerns Rise as FDA Proposes Reclassification of Tanning Beds
The Food and Drug Administration (FDA) issued a press release regarding its proposed order to reclassify sunlamp products from a Class I medical device (low risk) to a Class II medical device (moderate risk). Additionally, the FDA is now recommending that persons under the age of 18 be warned to not use these products at all. The FDA press release notes that “[a]ccording to the American Academy of Dermatology, there is a 75 percent increase in the risk of melanoma, the deadliest type of skin cancer, in those who have been exposed to ultraviolet radiation from indoor tanning, and the risk increases with each use.” If the proposed order is finalized, manufactures of tanning beds “would have to submit to pre-market notification (510(k)) to the FDA for these devises, which are currently exempt from any pre-market review.” The proposed order also seeks additional labeling to include a warning that “frequent users of sunlamp products should be regularly screened for skin cancer.”
In the last two years, awareness of the dangers of tanning beds and similar products has become more pronounced, which has given rise to litigation and related question of federal preemption. For example, in Pennsylvania one claim has been allowed to proceed to trial and was held to not be preempted by federal law. In Powell v. Instant Replay Video, Inc. the Common Pleas Court of Allegheny County, Pennsylvania, Civil Division, held that the plaintiff’s claims that she contracted skin cancer from using tanning beds based on a failure to warn were not outright preempted. The defendants in Powell moved to dismiss the failure to warn portion of her claim as preempted by the FDA regulations specifying the exact warnings to be given to users of tanning beds.
In analyzing the applicable case law, specifically, Medtronic, Inc. v. Lohr and Green v. Dolsky, the court in Powell noted that the certain design claims were not preempted when “the device had been approved for sale under the §510(k) provision, which meant that the FDA had not examined the merits or safety of this particular device, but had decided only that it was substantially equivalent to devices already on the market.” Powell v. Instant Replay Video, Inc. Furthermore, it was noted that in order to determine whether manufacturing and labeling claims are preempted requires, “a careful comparison between the allegedly pre-empting federal requirement and the allegedly pre-empted state requirement.” Powell v. Instant Replay Video, Inc. In line with this reasoning, and noting that determination on a preemption argument was premature, the court denied the defendants motion to dismiss.
The Powell case subsequently went to trial and the verdict was rendered in the defendant’s favor. However, the Powell case is troubling precedent in light of the FDA’s newly proposed order, especially since the FDA exempts tanning beds from pre-market review. It remains to be seen whether tanning beds become the latest trend in medical device litigation, but the science and the law seems to be creating the right atmosphere for it.
Click here for a copy of the FDA’s press release.