DEAR DOCTOR LETTERS
these Dear Doctor letter preemption arguments seemed to be gaining
traction, the Supreme Court reversed course in the landmark generic
preemption case, Pliva v. Mensing.60
2. Post-Mensing: Generic Manufacturers Cannot
Independently Transmit “Dear Doctor” Letters
On June 23, 2011, after years of plaintiffs using Dear Doctor letters to
defeat manufacturing defendants’ preemption arguments, the Supreme
Court issued its decision in Pliva v. Mensing. That decision—for now—
forecloses the argument that a manufacturer of a generic drug could have
and should have sent a Dear Doctor letter to strengthen a drug’s warnings;
the Supreme Court held that “federal law d[oes] not permit [generic]
Manufacturers to issue additional warnings through Dear Doctor letters.”61
In Mensing, plaintiff respondents sued generic drug manufacturers
alleging failure to warn of risks of developing tardive dyskinesia from
taking metoclopramide (the generic form of Reglan®).62 They argued that
the generic manufacturers should have strengthened their label through
either the CBE process or through a Dear Doctor letter.63 Specifically, they
asserted that the generic manufacturers “could have used ‘Dear Doctor’
letters to send additional warnings to prescribing physicians and other
After a review of the FDA’s position and its labeling regulations, the
Supreme Court rejected plaintiffs’ position. The Court ruled “[a] Dear
Doctor letter that contained substantial new warning information would not
be consistent with the drug’s approved labeling.”65 Accordingly, the Court
found that “if generic drug manufacturers, but not the brand-name
manufacturer, sent such letters, that would inaccurately imply a therapeutic
difference between the brand and generic drugs and thus could be
impermissibly ‘misleading’.”66 The Court “conclude[d] that federal law did
not permit the manufacturers to issue additional warnings through Dear
Doctor letters.”67 Unfortunately, Mensing gave no guidance on when brand
FDA send a ‘Dear Doctor’ letter to health care professional, warning them of the risks
associated with using ibuprofen concurrently with other drugs known to be hepatotoxic); see
also, Demahy, 593 F.3d at 444-45 (5th Cir. 2010); Vitatoe, 696 F. Supp. 2d at 615-16.
60. Pliva v. Mensing, 131 S. Ct. 2567, 2576 (2011).
61. Id. at 2576.
62. Id. at 2573.
63. Id. at 2575-76.
64. Id. at 2576.