DEAR DOCTOR LETTERS
letter in litigation. When a Dear Doctor letter was not sent, plaintiffs fold
this into their failure-to-warn claim, arguing that had their doctor only
received such a letter, their injuries would have been avoided. This Dear
Doctor letter argument presents interesting issues of proximate causation on
summary judgment motions. And when a Dear Doctor letter has been sent
after the alleged injury, plaintiffs have tried to admit the letter as evidence
of the drug label’s inadequacy at the time the drug was prescribed. This
Dear Doctor letter argument raises admissibility issues for subsequent
But first, we discuss the role that Dear Doctor letters have played in
federal preemption cases laying out the warning duties of generic and brand
A. Preemption and Dear Doctor Letters, Pre- and Post-Mensing
1. Pre-Mensing: Using “Dear Doctor” Letters to Fight
Preemption Defense by Generic and Brand Name Manufacturers
For years, plaintiffs successfully argued that federal law did not preempt
failure-to-warn claims, in part because of the ability of manufacturers to
send out Dear Doctor letters.56 In Perry v. Novartis Pharma. Corp., for
example, the court noted that a plaintiff could maintain an action against a
brand-name manufacturer if the plaintiff “claimed that a manufacturer was
negligent in not sending a letter to prescribing physicians or other
healthcare professionals[.]”57 Similarly, in Weiss v. Fujisawa
Pharmaceutical Co., the court found “the regulations encourage [brand
name] drug manufacturers to periodically send important information,
including information regarding risks, to healthcare providers. Therefore,
there are a number of ways a drug company can warn users of its product’s
Even in cases involving generic drugs, courts routinely found that
manufacturers could “ask the FDA to send ‘Dear Doctor’ warning letters to
healthcare professionals,” thus precluding a finding of preemption.59 Just as
56. See, e.g., Weiss v. Fujisawa Pharm. Co., 464 F. Supp. 2d 666 (E.D. Ky. 2006),
Perry v. Novartis Pharma. Corp., 456 F. Supp. 2d 678 (E.D. Pa. 2006); Gaeta v. Perrigo
Pharms. Co., 630 F.3d 1225, 1231 (9th Cir. 2011); see also Demahy v. Actavis, Inc., 593
F.3d 428 (5th Cir. 2010); Vitatoe v. Mylan Pharms., Inc., 696 F.Supp. 2d 599 (N.D.W. Va.
2010); Schedin v. Ortho-McNeil-Janssen Pharms., Inc., 776 F.Supp. 2d 907, 911 (D. Minn.
2011) (“Ortho-McNeil still had various other options at its disposal to warn consumers, such
as ‘Dear Doctor’ letters, or training by sales representatives with individual doctors. It could
also have proposed an alteration to the label.”).
57. Perry, 456 F. Supp. 2d at 686.
58. Weiss, 464 F. Supp. 2d at 675.