Sunday, January 11, 2015

Quite Unsurprisingly, Federal Law Preempts State (California) Claims -- On FDA Approved Sunscreen Labels

Although from time to time I have covered the competing SPF intellectual property claims battles (see archive image at right), and various claims between manufacturers -- last year, I did not cover this Merck case at all, because I was pretty darn certain as to how it would turn out. And it turned out exactly as expected. [It also turned out that Merck sold the entire line to Bayer mid-2014, along with lots of other legacy consumer health assets it has acquired from Schering-Plough.]

So. . . I just note it to complete the record here -- because Merck was the named putative class defendant in California, and because Merck. . . won. From Lexology, then (repeating a fine Reed Smith note to clients) -- a bit:

. . . .In Gisvold v. Merck & Co. Inc., No. 3:14-cv-01371, 2014WL6765718, at *1 (S.D. Cal. Nov. 25, 2014), the putative plaintiff class alleged that consumers have learned to associate higher SPF values with greater sun protection, but that high SPF labels were misleading because sunscreens with SPF values of greater than 50 allegedly do not provide any increased clinical benefit over sunscreens with an SPF equal to 50.

. . .[P]laintiff asserted that SPF 55, SPF 70+, SPF 80 and SPF 100+ labeling was false, misleading, and reasonably likely to deceive the public. . . . The putative class sought. . . an order requiring a label disclaimer about the supposed lack of clinical benefit from high SPF sunscreens. . . .

The court found that the plaintiff’s claims were preempted by the Food, Drug, and Cosmetic Act. . . [and also held] that the FDCA included an express preemption statute that was "unambiguous and broad in scope. [N]o State. . . may establish or continue in effect any requirement that relates to regulation of [OTC drugs]; and that is different from or in addition to, or that is otherwise not identical with a requirement under [the FDCA]. . . ."

Under the FDCA, over-the-counter sunscreens are governed by federal regulations that provide for SPF testing procedures and SPF labeling requirements. 76 Fed. Reg. 35620-21 (Jun. 17, 2011) (Labeling and Effectiveness Testing: Sunscreen Drug Products for Over-the-Counter Human Use). Significantly, these regulations mandate that over-the-counter sunscreen labels state the SPF value resulting from the detailed testing procedure described in the regulation. 21 C.F.R. § 201.327(a)(1) & (I) (describing testing procedure to arrive at appropriate SPF values and providing that labels “shall” state the SPF value). . . .

So it goes -- enjoy your easy Sunday(s) one and all. . . I'm out of pocket for the rest of day. . . will check back in tonight.

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