[Drug and Device Law] Fun Fun Fun: Cal Court Dismisses Sunscreen Cases on Preemption
During a recent Surfin’ Safari we must have told the DDL Son at least five times to slather on more sunscreen. Naturally, he engaged in the usual noncompliance-defiance and, naturally, now has a face adorned with a scarlet nose. Years ago there was a famous commencement address built on the advice that everyone should wear sunscreen. Sunscreen sometimes makes a cameo appearance in the news of the weird. We learned that American Army World War II tins of sunscreen and bacon recently turned up on the Salisbury Plain (not so far from Stonehenge). And we were brought up short when we read that some sunscreen products were recalled because they might ignite.
In this season of Summer Fun and marathon photosynthesis sessions, God Only Knows how ignorant and indifferent so many of us are about the need for sunscreen. Do you use sunscreen? (You should – and not just when you are reading the latest Lisa Scottoline thriller at the Jersey Shore.) Do you know what the SPF (sun protection factor) numbers mean? (SPF 15 means that only 1/15th of the burning radiation will reach the skin, SPF 30 means only 1/30th will, SPF 50 means only 1/50th will, etc.) How often should you reapply sunscreen? (At least every two hours. Then Do it Again.) How much should you use? (Way more than you think.)
In this season of Summer Fun and marathon photosynthesis sessions, God Only Knows how ignorant and indifferent so many of us are about the need for sunscreen. Do you use sunscreen? (You should – and not just when you are reading the latest Lisa Scottoline thriller at the Jersey Shore.) Do you know what the SPF (sun protection factor) numbers mean? (SPF 15 means that only 1/15th of the burning radiation will reach the skin, SPF 30 means only 1/30th will, SPF 50 means only 1/50th will, etc.) How often should you reapply sunscreen? (At least every two hours. Then Do it Again.) How much should you use? (Way more than you think.)
Who regulates sunscreen? (The FDA. Sunscreen is considered an over-the-counter drug.)
And therein hangs the tale of today’s case, Eckler and Engel v. Neutrogena Corp., -- Cal. Rptr. 3d --, 2015 Cal. App. LEXIS 584 (Cal. App. 2d Dist. June 9, 2015). Two plaintiffs brought slightly different claims that sunscreen labeling was misleading, and those claims were Shut Down by the California appellate court (one that really knows about sunscreen) on grounds of preemption. Up front in the opinion, the court sums up the issue nicely: “This case concerns congressional intent with respect to label information on sunscreen products: is it to be determined solely by the federal agency it charged with ensuring uniform labeling for those products, or, in addition, by each state through private civil suits.” That formulation captures the need for preemption to ensure uniformity and to apply agency expertise.
What exactly were the claims? Engel focused on the terms “sunblock,” “waterproof,” and “sweatproof”, which the FDA prohibited in a regulation published on June 17, 2011, on the theory that such terms said a bit too much. No sunscreen can completely block the sun, or be impenetrable to the effects of water, or fully resist sweat. But the FDA made the compliance date December 17, 2012. Engle claimed that the defendant should have gotten rid of those terms even before the FDA’s compliance date. Eckler raised an additional product labeling issue with respect to sunscreen with SPF values greater than 50 (SPF 50+), contending that those higher numbers mislead consumers into thinking they were buying benefits that in facts did not exist. The plaintiffs alleged that the sunscreen labels were deceptive advertising and unlawful business practices under California’s Unfair Competition Law (Bus. & Prof. Code § 17200), False Advertising Law (Bus. & Prof. Code § 17500), and Consumer Legal Remedies Act (Civ. Code § 1750 et seq). The relief sought was the usual consumer protection litany: injunction, restitution, etc. There was no claim of personal injury.
The Superior Court had concluded that Engel’s claims were entirely preempted, and that the 18 months between publication of the Final Rule and its effective date represented a “safe harbor” reflecting the FDA’s cost-benefit analysis: a delay fashioned to “minimize transactions costs based on a global analysis of social welfare.” The preemption analysis was straightforward. The FDA Modernization Act of 1997 included a provision expressly preempting state law requirements regarding nonprescription drugs, including sunscreen products. Section 379r(a) specifically prohibits state requirements that are not identical with federal requirements. There is a clause that exempts from preemption product liability suits(§ 379r(e)), but these cases did not “arise from claims for personal injury or damage to property and thus the section 379r(e) savings clause does not apply.”
In enacting the Modernization Act, the Senate stated that “[a]n essential element of a nationwide marketplace is a national uniform system of regulation. It is intended that the FDA provide national leadership in assuring the safety, effectiveness and proper labeling and packaging for nonprescription drugs and cosmetics marketed throughout the country.” Interestingly, that Modernization Act, while reforming all food, drug and cosmetic regulation, singled out sunscreen products for future FDA regulatory action. In fact throughout all those years when we went through many (but apparently not enough) bottles of Coppertone and Banana Boat, when we made the switch to the higher priced, more convenient, aerosol spray bottles of sunscreen (which we now hear are much less effective and might even be banned – Help Me, Rhonda!), sunscreen products have been the subject of exhaustive federal regulatory action for many years: “During over three decades of proposed rules, comments, new data, and reconsideration, the agency’s view has evolved with medical and chemical advances, and in response to the data and comments it has received in the rulemaking process.” In other words, the FDA did what it was supposed to do. It listened to scientific evidence. It engaged in policy and data based rulemaking. It did not behave like a jury entranced by contingent fee invectives.
In 2011 the FDA issued a Final Rule on labeling and effectiveness testing for sunscreen products, along with a Proposed Rule that invited comments concerning limiting the labeling of sunscreen products to SPF 50. The Final Rule mandated that sunscreen labels state the SPF value resulting from the detailed testing procedure described in the regulation. Sunscreen products cannot include on labels the descriptions “sunblock,” “sweatproof,” and “waterproof.” The Final Rule initially had a compliance date of June 18, 2012. That date was later extended to December 17, 2012. In extending the compliance date, the FDA stated that “granting manufacturers additional time to complete testing and relabeling is in the public interest.” Nevertheless, Engel wanted manufacturers to be on the hook during that interim time period, FDA policy considerations be damned. The Proposed Rule would limit the maximum labeled SPF value for over-the-counter sunscreen drug products to “50+”. The Proposed Rule declared no final FDA position on the safety and effectiveness of products with SPF values over 50. While the agency expressed concerns about the efficacy of such products, it lacked scientific evidence to issue a rule. Accordingly, the FDA’s Proposed Rule invited relevant data. But Eckler argued that the FDA could do data navel-gazing on its own time, while lawsuits should go full speed ahead either lacking such data or conjuring up the sort of ‘data’ that comes from soundbites and jukebox experts and that incites runaway juries.
The Eckler/Engle state court examined a couple of California federal cases that addressed similar issues. In Corra v. Energizer Holdings, Inc., 962 F. Supp. 2d 1207 (E.D. Cal. 2013), a consumer alleged that the defendant distributed sunscreen products that had SPF values over 85 that commanded a premium price but did not really confer any more protection than lower SPF products. The district court denied defendant’s motion to dismiss based on preemption. Bad result. One might even say it burns. The claim was nearly identical in Gisvold v. Merck & Co., Inc., 2014 WL 6765718 (S.D. Cal. Nov. 25, 2014) , but in that case the court concluded that the plaintiff’s claims were preempted. Why the difference? The Gisvold court seemed to pay more attention to the express preemption language in the federal statute. The Gisvold court had the benefit of the Corra decision, and observed that the Corra court had not considered whether a disclaimer regarding clinical benefits would “add to or be identical with FDA’s labeling requirements.” That opinion is soothing. (We blogged about the Gisvold decision here.) Neither federal decision was binding on the Eckler/Engel court, but it had no difficulty siding with Gisvold. Further, Corra could be distinguished because one could read the plaintiff as not necessarily seeking a change in product labeling and advertising. At least the Corra court assumed as much. We’re not sure how that could work, but we are happy to discard the Corra decision. (Just like you should throw out any sunscreen that is more than three years old.)
The heart of Engel’s claim was that product descriptions on sunscreen labels that were, until the FDA’s Final Rule, in compliance with federal law, nevertheless violated California law. If that isn’t an effort to enforce a state requirement “that is different from or in addition to, or that is otherwise not identical with” federal law, then we’ll drink a bottle of Bain de Soleil. The complication is that the FDA had kind of agreed with Engel’s position that the terms “sunblock,” “waterproof,” and “sweatproof” should no longer be used. The issue was whether the manufacturer should be liable for products marketed during the 18-month period after publication of the Final Rule and before the December 17, 2012 compliance date. But properly understood, this 18-month period was “a safe harbor reflecting a utilitarian cost-benefit analysis.” The FDA had assured manufacturers that they would have the time to comply with the new testing and labeling regime and that non-compliant products could remain on the market. Engel’s claim, in other words urged “that states may compel compliance with a federal requirement before the federal agency requires.” When the issue is put that way, it is clear that the claim must be preempted.
Meanwhile, Eckler claimed that while the manufacturer accurately stated the SPF value on its products, consumers would likely to be misled about the efficacy of SPF 50+ products. The FDA had not yet embraced that position, nor had it rejected it. The FDA wanted more information. The court concluded that Eckler’s “SPF 50+ claim is based on a distorted reading of FDA regulations and on speculation about what consumers believe.” Moreover, “Eckler’s suit would involve the state court in precisely the type of scientific inquiry and policy balancing that is within the expert agency’s proper purview.” For that reason, the court reasoned that Eckler’s suit was just as preempted as Engel’s was. Engel seemed to be the easier case; the FDA had explicitly set forth the 18 month safe harbor. By contrast, the FDA had not issued a final determination on the issue of products with SPF values above 50. It wanted more time, more information, and more thought. According to the court – and here is a line of reasoning that we DDL defense hacks should do our best to import into our cases – the FDA’s decision to think some more before deciding was “not a reason to permit suits like Eckler’s. It is a reason to allow the federal agency to complete its Congressionally mandated objections without states imposing a premature patchwork of disparate requirements.”
The Eckler/Engel case might not exactly be beach reading, but it’s worth remembering the next time someone asks Wouldn’t it Be Nice if there was a good California preemption decision. Enjoy the Good Vibrations.
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Posted By Steve McConnell to Drug and Device Law at 7/08/2015 07:30:00 AM --
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