Misrepresentation of Active Ingredients Can Be Actionable Under the Lanham Act

July 22, 2010

By Nisha P. Shah

A U.S. District Court recently held that misrepresentation and false description of active ingredients by a manufacturer of generic prescription vitamins can be actionable under the Lanham Act.  Sciele Pharma, Inc. v. Brookstone Pharmaceuticals, LLC.  
Plaintiff, Sciele Pharma, Inc., develops and sells branded prescription products, including the prenatal vitamins PRENATE ELETE and PRENATE DHA.  An alleged unique feature of PRENATE is that it contains a 1 mg combination of 400 mcg of folic acid and 600 mcg of L-Methylfolate (“L-MTHF”), a bioactive form of folate that does not require additional metabolism by the body. Defendant, Brookstone Pharmaceuticals, LLC, a/k/a Acella Pharmaceuticals, LLC, develops and sells generic prescription prenatal vitamins called PNV and PNV-DHA.  Defendant’s labels and package inserts represent that PNV vitamins contains the same combination of folate as the PRENATE vitamins. 

However, plaintiff asserts in this litigation that defendant’s vitamins do not contain L-MTHF, but rather a different dietary ingredient known as D,L-MTHF.  This ingredient allegedly contains an equal mixture of the L-isomer and D-isomer of MTHF.  According to plaintiff, D,L-MTHF and L-MTHF are recognized as distinct dietary ingredients.  Plaintiff also claims that the presence of the D-isomer may be harmful to women taking the PNV vitamins. 
Plaintiff argues that defendant’s labels and package inserts for PNV vitamins are false and likely to deceive consumers, pharmacists, and others in the pharmaceutical distribution chain as to the content of the vitamins.  Since PNV vitamins are cheaper than PRENATE vitamins, plaintiff contends that pharmacists could decide to substitute PNV for PRENATE, despite having different active ingredients.  Plaintiff asserts claims under (1) the Lanham Act for false advertising and unfair competition, and (2) the Georgia Uniform Deceptive Practices Act.  Defendant filed a motion to dismiss on the grounds that the Federal Food, Drug, and Cosmetic Act (“FDCA”) precludes plaintiff from bringing Lanham Act claims.

The Court initially recognizes that the FDCA does not allow for a private right of action and that a tension exists between the FDCA and the Lanham Act in cases involving products regulated by FDA.  Further, the Court remarks that plaintiffs cannot use the Lanham Act as a vehicle to enforce the FDCA. 

Nevertheless, the Court looks at “the extent to which the plaintiff relies on the FDCA as the basis for its claim, or alternatively the extent to which the claim would require the Court to interpret or apply the FDCA or FDA regulations.”  Id. at *10.  According to the Court, “plaintiff credibly argues” its claim that defendant is misrepresenting the content of the PNV vitamins “can, and will, be proven without reference to the FCDA.”  Id. at *12.  In rejecting defendant’s motion, the Court concludes that “the simple fact that a Lanham Act claim touches upon an area that is within the purview of the FDCA is not a bar to proceeding,” and that “the Lanham Act prohibits exactly the type of misconduct that plaintiff alleges in its complaint: the misrepresentation and false description of the nature of the product.”  Id. at *12-13.

The Court similarly dismisses Brookstone’s second motion to dismiss on the merits of the Lanham Act claims.  Defendant argues that plaintiff’s claims cannot success because defendant complied with Georgia law on pharmaceutical substitution and that the disclaimers used with the vitamins insulate defendant from Lanham Act liability.  According to the Court, at the motion to dismiss stage, it must accept as true plaintiff’s allegations that the L-MTHF in PRENATE vitamins and the D,L-MTHF in the PNV vitamins are distinct dietary ingredients, and therefore, the two vitamins are not legally substitutable.  If plaintiff’s claims are accurate, the Court concludes that defendant’s misrepresentation is “unquestionably actionable under the Lanham Act.”  Id. at *14-15.  Moreover, the Court agrees with plaintiff’s argument that the disclaimer issue is better resolved on a motion for summary judgment or at trial. 

The Court also addresses several other motions, including the Court’s grant of plaintiff’s motion to remove the confidentiality designation to documents that (1) identify defendant’s manufacturers and suppliers, and (2) state the current formulation and/or ingredients of PNV vitamins, as both types of documents are not considered trade secrets. 


Categories: Drug Development