In our September 28, 2016 blog post, and subsequent Law360 Article, we reported that an internal Second-Circuit split had arisen regarding the deference owed to allegedly false and misleading pharmaceutical/medical device advertising where the FDA had considered and approved similar claims for labeling.
The earlier decision involved in the split, Apotex, Inc. v. Acorda Therapeutics, Inc. 823 F.3d 51 (2d Cir. May 16, 2016), suggested that substantial deference is owed to the FDA’s review. Id. at 64 (“A prior question is whether representations that are wholly consistent with an FDA label are subject to Lanham Act liability. This Court has yet to so hold, although a number of district courts in this Circuit have sensibly adhered to this principle. We agree with these courts and now hold that representations commensurate with information in an FDA label generally cannot form the basis for Lanham Act liability.”) (emphasis in original; footnotes omitted). The more recent case, Church & Dwight Co. Inc., v. SPD Swiss Precision Diagnostics, GMBH, Dkt. No. 15-241, 2016 WL 4708179 (2d Cir. Sept. 9, 2016), suggested that no such deference is due. Id. at *9 (“Notwithstanding that the FDA’s regulation of Defendant’s labeling addressed the same issue as raised by Plaintiff in its Lanham Act suit—the risk that consumers will misunderstand Defendant’s messages as implying that the Product utilizes the same metric for pregnancy duration as used by medical professionals—there is no reason to assume that Congress would see the FDCA’s precautions as undermined by a court’s decision, upon a competitor’s suit, that protection of the competitor against unfair competition through false advertising requires still greater protection against consumer miscomprehension than was mandated by the FDA.”)
In the Law360 article, we noted that the Apotex decision issued after briefing closed in the Church & Dwight case, that no supplemental briefing had been filed with the Church & Dwight court, and the Apotex decision was not referenced in the Church & Dwight opinion.
Apparently confirming that the parties in Church & Dwight had been unaware of the prior Second Circuit authority, on October 5, 2016, SPD lead counsel (and former U.S. Solicitor General) Seth Waxman forwarded the Apotex decision, along with a copy of the Law360 Article, to the Second Circuit. Waxman sent his letter pursuant to Fed. R. App. 28(j) as supplemental authority in further support of SPD’s pending Petition for Rehearing en banc, arguing that: “These two published decisions, issued within months of each other, take dramatically different views on the validity of Lanham Act claims that conflict with FDA requirements for highly regulated medical products, causing considerable confusion for companies.” A copy of the letter can be found here. On October 11, 2016, the Second Circuit directed Church & Dwight to respond to SPD’s petition for rehearing.
On October 28, Church & Dwight filed its response. Addressing the citation to Apotex, Church & Dwight criticized the late submission of this authority and sought to distinguish the Apotex decision on its facts (contending in part: “that decision was limited to the narrow context of advertising for pharmaceuticals”). Church & Dwight also noted that the Apotex panel held that “Lanham Act liability might arise if an advertisement uses information contained in an FDA-approved label that does not correspond to the label, or otherwise renders the advertisement literally or implicitly false.” Thus, Church & Dwight argued, “the ‘intra-circuit split’ SPD imagines in its 28(j) letter simply does not exist[.]”
A decision on the petition for rehearing remains pending.