[Drug and Device Law] When More Is Neither Better Nor a Lawsuit
I didn’t know that the SPF value for sunscreens can reach higher than 100. But they can. As someone of Irish descent, someone who can burst into flames at the hint of sunlight like a John Carpenter vampire, I should have known that. For instance, Coppertone markets a product called SPORT SPF 100+. I’m going to buy a case.
Now, some plaintiffs’ attorneys will tell me that I’m wasting my money. Or, they might tell me that I have a lawsuit.
Or maybe I don’t. Plaintiff Danika Gisvold brought a class action claiming that she paid an extra dollar for Coppertone SPORT SPF 100+ at Walmart, but it didn’t provide any more protection than Coppertone products with only an SPF value of 50 . Gisvold v. Merck & Co., Inc., 2014 WL 6765718 (S.D.Cal.) (S.D. Cal. Nov. 25, 2014). She thought she was getting double the protection, but she wasn’t. She sued to get her dollar back and an order that Merck should issue a corrected label and corrective advertising. Id. at *1.
Her complaint was dismissed. Why? Preemption. Sunscreen is an OTC drug, and the Food, Drug & Cosmetics Act (FDCA) has a strong preemption clause for OTC drugs. Any requirement that is different from FDA requirements is preempted:
[N]o State . . . may establish or continue in effect any requirement . . . that is different from or in addition to, or that is otherwise not identical with, a requirement under [FDCA].
21 U.S.C. § 379r. .
The FDA has extensive requirements for sunscreen and SPF values. It has published a guidance document: “Labeling and Effectiveness Testing: Sunscreen Drug Products for Over-the-Counter Human Use.” (http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm330694.htm) And, as the Gisvold court described, the FDA issued a rule – “Labeling and Effectiveness Testing: Sunscreen Drug Products for Over-the-Counter Human Use” ( 76 FR 35620) – that addresses sunscreen labeling and SPF values:
The current regulations establish labeling requirements, provide for effectiveness testing upon which the labeling relies, and identify false and misleading claims that render a product misbranded. . . . Significantly, the regulations promulgated by the Final Rule mandate that OTC sunscreen labels state the SPF value resulting from the detailed testing procedure described in the regulation.
Gisvold, 2014 WL 6765718 (S.D.Cal.), at *2.
The FDA’s rule establishes SPF testing procedures and requires manufacturers to place the SPF value on the label. Merck did that. In fact, plaintiff’s only factual allegation was that she read the sunscreen’s label and its SPF value. Id. at *1. Any claim that Merck should have labeled the product’s SPF value differently is preempted. And that’s exactly what she claimed:
Plaintiff argues she is not seeking “to disrupt existing federal regulations, but rather to provide greater consumer protections that are consistent with FDA regulations.” But in seeking to provide greater consumer protections, Plaintiff targets Merck's sunscreen label (which complies with current FDA regulations), and proposes a disclaimer regarding the level of sunscreen effectiveness beyond SPF 50. Because the proposed disclaimer plainly adds to and is not identical with the FDA's requirements, Plaintiff's action is expressly pre-empted under 21 U.S.C. § 379r.
Id. at *3.
Maybe plaintiff is right, and products with SPF values over 50 are no more beneficial than products with 50 SPF. And maybe she’s not. Regardless, more SPF does not equal a lawsuit.
It was encouraging to see that the court also relied upon primary jurisdiction to dismiss the complaint. Under the primary jurisdiction doctrine, courts defer to regulatory agencies, under appropriate circumstances, to address issues within their regulatory expertise, particularly issues of first impression. The FDA passed a regulation that explicitly addresses primary jurisdiction:
FDA has primary jurisdiction to make initial de-termination on issues within its statutory mandate, and will request a court to dismiss, or to hold in abeyance its determination of or refer to the agency for administrative determination, any issue which h as not previously been determined by the agency or which, if previously determined, the agency concluded should be reconsidered and subject to a new administrative determination.
21 C.F.R. § 10.25.
Since the FDA is in the midst of considering (admittedly, slowly) whether SPF values greater than 50 provide any additional benefit, the court saw the wisdom of abstaining. A ruling from the court or a verdict from a jury could easily conflict with the FDA’s ultimate determination. Accordingly, the court deferred to the FDA’s primary jurisdiction. Id. at *4-5.
Plaintiff’s double-50 SPF claim met a double whammy: preemption and primary jurisdiction. But she’ll get another chance. The dismissal was without prejudice. Here’s hoping the amended complaint is also unsuccessful. I need to buy this stuff come summer.
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Posted By John J. Sullivan to Drug and Device Law at 12/05/2014 09:00:00 AM --
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