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It’s not the Supreme Court (there are no preemption cases left to be decided this term), but still this is welcome.  Thanks to Jay Lefkowitz at Kirkland for letting us know of his win in Guarino v. Wyeth, ___ F.3d ___, No. 12-13263, slip op. (11th Cir. June 25, 2013).  Guarino is a one-two punch affirmance:  Preemption (and in this case, state law as well) bars the generic claims, and Florida would not recognize innovator liability where the plaintiff only took the generic product.


Plaintiff’s “failure to communicate” claim, based on “Dear Doctor” letters, is merely a warning claim “in disguise,” and is preempted under Mensing:

[Plaintiff’s] attempt to elude Mensing by clothing her allegations as “failure-to-communicate” claims rather than failure-to-warn claims does not alter our analysis.  No matter the garb in which she attempts to present them, [plaintiff’s] claims are at bottom allegations regarding [defendant’s] failure to warn her of the dangers of long-term metoclopramide use, and they therefore cannot escape Mensing’s grasp. . . .  Were we to accept the failure-to-communicate theory, generic manufacturers such as [defendant] would need to take affirmative action to notify consumers, doctors, or pharmacists of FDA-approved changes to the drug label in order to avoid liability. . . .  If generic drug manufacturers, but not the brand-name manufacturer, sent additional communications such as ‘Dear Doctor’ letters, that would inaccurately imply a therapeutic difference between the brand and generic drugs and thus could be impermissibly misleading.  That fact is determinative here.

Guarino, slip op. at 7-8 (citation and quotation marks omitted).  Alternatively Guarino also held the warning adequate as a matter of law.  Id. at 9-11.


Florida law would not approve any sort of warning-based theory that would impose liability on a non-manufacturer whose products the plaintiff never used:

Every court in Florida to consider the question has concluded that the brand manufacturer of a prescription drug cannot be held liable for injuries suffered by consumers who ingested only the generic form of a drug.  As one court explained, “[i]t is well-settled under Florida law that a plaintiff may only recover from the defendant who manufactured or sold the product that caused the injuries in question.”  We see no reason to doubt this interpretation of the law.

Slip op. at 11-12 (numerous citations omitted).  Guarino refused to make an adventurous Erie prediction.  Id. at 12-13 (“considerations of comity and federalism counsel that we proceed gingerly when venturing into uncharted waters of state substantive law”).  Prior Florida market share liability precedent did not support innovator liability where, as here, the identity of the actual manufacturer was know, since market share liability allowed exculpation.  Id. at 13.  Moreover, a “mountain of authority” across the country “steels us in our determination that Florida law does not recognize a claim against the brand manufacturer of a prescription drug when the plaintiff is known to have consumed only the generic form.”  Id. at 15-16.