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 Sebela gives no reason to think that pharmacists are confused, let alone misled. All it claims is that pharmacists substitute one cream for the other and that some states’ laws forbid substituting drugs without FDA approval.
He ultimately concluded that the plaintiffs' allegations were "just possible, not plausible[,]" and dismissed the false-advertising claims with prejudice
I find it implausible that trained, licensed pharmacists are fooled. Far more likely, they are just heeding frugal patients, insurers, and pharmacy-benefits managers. That alone is not enough.
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