Sitting by designation in D. Del., Circuit Judge Bibas recently issued an interesting 12(b)(6) opinion on false-advertising claims in the pharma context. These opinions tend to fly under the radar, but they often contain helpful practice tips.
The parties "both sell a medical cream, each with the same active ingredients in the same strength." Although the defendant's cream "is not an FDA-approved generic and has not been tested for bioequivalence[,]" it was listed in a database of pharmaceutical products "as an 'Equivalent Drug[.]'"
Judge Bibas found that this statement was neither false nor misleading:
Yet Sebela insists that “equivalent” implies more: bioequivalence and FDA approval. . . . The FDA has not approved TruPharma’s cream. But …