We don’t spend much time on this blog on over-the-counter (“OTC”) drugs, but when OTC crosses paths with preemption in our own backyard, we can’t help but be interested.  And as this case also had a few other interesting bits, we thought we’d share it. 
The case is Crozier v. Johnson & Johnson Consumer Cos., Inc., 2012 U.S. Dist. LEXIS 140320 (D.N.J. Sep. 28, 2012).  The product at issue is one of many in J&J’s Neosporin brand line.  Neosporin is well known as a topical antibiotic cream, but in fact there are many products in the line, including “Neosporin NEO TO GO! first aid antiseptic/pain relieving spray.”  Note the difference in our description of the cream and the spray.  The former contains an antibiotic, the latter an antiseptic.  Plaintiff claims this is confusing.  Specifically, plaintiff alleges that J&J’s labeling and marketing of the antiseptic spray under the Neosporin brand misleads consumers to believe that the spray contains antibiotics.  Id. at *3-5.  So plaintiff in Crozier (and its companion case McNamee v. J&J), brought a putative class action against J&J alleging violations of the New Jersey Consumer Fraud Act and breach of implied warranty.  J&J moved to dismiss. 
First, we recommend the court’s nice discussion of the Twiqbal standard for motions to dismiss which includes a rejection of plaintiff’s attempts to rely on either pre-Twiqbal law (“Plaintiffs seem unaware that pleading standards in federal court have changed in the past five years”), id. at *11, or state law (“The Federal Rules of Civil Procedure govern the procedure in all civil actions and proceedings in the United States district courts.”).  Id. at *12.  Although, it ends with an equally well-stated justification for allowing plaintiffs in diversity cases an opportunity to amend when their complaints don’t come up to Twiqbal snuff.  If the case was, as Crozier was, originally filed in a state court with more liberal pleading standards “it is important for the Court to exercise its discretion in favor of permitting Plaintiffs to attempt an amended pleading” that meets the “enhanced” federal standard.  Id. at *13.  We are long familiar with second bites at the apple and also well aware that they often fail to satisfy as well.  So, while we prefer a dismissal with prejudice, we’ll take what we can get.
Next, in response to the motion to dismiss, plaintiff cited, referenced, and quote materials obtained in discovery in other proceedings and described television ads she alleged supported her claims.  But, as the court reminds, this is a motion to dismiss:

To the extent that Plaintiffs reference exhibits in their Opposition to establish facts beyond those pled in the Complaint, the Court must disregard them. Plaintiffs cannot add factual allegations in Opposition; the mechanism for curing pleading deficiencies is to file an amended complaint . . .  It is axiomatic that the complaint may not be amended by the briefs in opposition to a motion to dismiss.

Id. at *16.
            Then the court turned to the substance and rather quickly ruled that plaintiff’s labeling-based claims were expressly preempted.    21 U.S.C. §379r provides that express preemption for OTC drugs:

Except as provided in subsection . . . (e) . . . of this section, no State or political subdivision of a State may establish or continue in effect any requirement – that relates to the regulation of a drug that is not subject to the requirements of section 353(b)(1) or 353(f)(1)(A) of this title [that means an OTC drug]; and that is different from or in addition to, or that is otherwise not identical with, a requirement under this chapter . . . .

21 U.S.C. §379r(a).  For a more fulsome discussion of OTC preemption (and the exception thereto) see our post here.  So New Jersey becomes yet another state to recognize OTC preemption:

Federal regulations . . . specify the required content on over-the-counter medication labels and, with 21 U.S.C. § 379r, Congress preempted state law claims regarding such labels. Any of Plaintiffs’ claims that pertain to the spray’s label are preempted.

Id. at *24-25.  Plaintiff tried to argue that preemption didn’t apply because she wasn’t alleging that the product’s label was inaccurate but rather that it was misleading – that consumers would be confused by the antiseptic spray carrying the Neosporin brand name.  The court didn’t see the distinction:

FDA regulations cover the entire label, including indications of a product’s brand name, and thus preempt challenges to a label, even if the challenge is not based on inaccuracy  or incompleteness. . . . . [Since] the FDA specifically considered brand name confusion in drafting its regulations; Plaintiffs’ present claims pertaining to the spray’s label are preempted.

Id. at *26-27. 
            The court, however, was unwilling to extend its preemption decision to all of plaintiff’s marketing claims.  While the court agreed that “claims based upon FDA-approved statements in product labeling and advertising are preempted,” id. at *29 (emphasis added; citing Carter v. Novartis Consumer Health, Inc., 582 F. Supp. 2d 1271 (C.D. Cal. 2008)), it turned to Rule 9(b) to dismiss plaintiff’s consumer fraud claims.  And as we’ve seen time and time again, plaintiff failed to plead any, let alone sufficient, facts to establish causation:

The Complaint[] contains no information about when Plaintiffs saw J&J’s advertising, when or where they bought the spray, why they bought the spray, whether they bought the spray because they thought it contained antibiotics, or whether Plaintiffs even noticed the Signature Gold Mark and trade dress. In short, [the] Complaint [does not] allege[] with particularity the gravamen of Plaintiffs’ claims, i.e., that Plaintiffs bought the spray specifically because its advertising contained the Neosporin trade dress and signature gold mark, thus leading them to believe that the product contained antibiotics. Plaintiffs’ failure to plead that they were misled is fatal, particularly given the specificity that Rule 9(b) requires for NJCFA claims.

Id. at *32-33.  But, as we indicated earlier, the court was inclined to let the plaintiff try it again – at least as to consumer fraud claims based on marketing activities.  The court tossed out plaintiff’s breach of warranty claims due to no allegation of a product defect.  Id. at *39-40.  Those claims are gone and aren’t coming back. 

            Not a complete victory, but plaintiff has her work cut out for her.

  • Since you've opened the OTC/preemption door, any thoughts on SCOTUS' denial of cert in McNeil v. Christina Hoyt Hutto (Infant Tylenol labeling issue)?