DEAR DOCTOR LETTERS
name manufacturers should issue Dear Doctor letters.68
Despite Mensing’s apparently clear ruling regarding generic
manufacturers’ lack of any duty to send Dear Doctor letters, some lower
courts have already criticized the holding.69 Others have found that there
are still situations in which generic manufacturers are required to send Dear
Doctor letters.70 In Fisher v. Pelstring, for example, the Superior Court of
Washington D. C. defied Mensing’s holding and ruled that the generic
manufacturer should have “issue[d] a ‘Dear Doctor’ letter” alerting
physicians of changes made in the branded drug’s label.”71 Similarly, in
Brasley-Thrash v. Teva Pharmaceuticals, the District Court for the
Southern District of Alabama held that the plaintiff’s effort to amend her
complaint was not futile where she planned to allege that the defendant
generic drug manufacturers were liable for failing to send a Dear Doctor
letter advising her treating physician of a change in the label for a brand
name drug.72 Thus, despite Mensing’s seeming preemption protection,
generic manufacturers still have to consider whether a Dear Doctor mailer
should be sent, and if so, work with the FDA to encourage either the FDA
or the brand name manufacturer to send them out.
Also looming over Mensing’s preemption holding is proposed legislation
to overturn it. Introduced by Senator Patrick Leahy (D-Vt.) in April 2012,
the bill would permit generic drug manufacturers to change their labels
independent of the brand name drug.73 Although the legislation has not yet
passed in its current form, it is unlikely to be Congress’s last word in
response to Mensing. Other alternative bills may surface, which could
69. See e.g., In re Budeprion Marketing & Sales Litig., Case Nos. 2107,09-md-2107,
2012 U.S. Dist. LEXIS 91176 at *46 (E.D. Pa. July 2, 2012) (“An individual’s ability to sue
for damages caused by prescription medication should not depend on whether the drug was
name brand or generic. If drug manufacturers are legally responsible for their products (like
every other maker of a good), generic drug makers should not be immune from liability. The
Supreme Court decision renders generic drug makers parrots, free from liability provided
they do a competent job copying the label of the name brand drug maker’s label.”)
70. See, e.g., Bartlett v. Mut. Pharm. Co., 678 F.3d 30 (1st Cir. 2012); Couick v. Wyeth,
Inc., Civ. A. No. 09-210, 2012 WL 79670 (W.D.N. C. Feb. 16, 2012); Brasley-Thrash v.
Teva Pharms. USA, Inc., Civ. A. No. 10-31, 2011 U.S. Dist. LEXIS 102858, 2012 WL
4025734 (S.D. Ala. Sept. 12, 2011); Hassett v. Dafoe, No. 1551, 1997, 2012 WL 1512551
( C. C.P. Phila. Mar. 22, 2012).
71. Fisher v. Pelstring, 817 F. Supp. 2d 791, 834-35 (D. C.S. C. 2012).
72. Brasley-Thrash v. Teva Pharms. USA, Inc., 2011 WL 4025734, at 4 (S.D. Ala. Sept.
73. Patient Safety and Generic Labeling Improvement Act, S. 2295, 112th Cong.
(2012); see generally James W. Huston, Erin M. Bosman & Julie Y. Park, Client Alert: Bill
to Undo Mensing Decision and Allow Patients to Sue Generic Drug Makers for Failure to
Warn, MORRISON & FOERSTER LLP (Apr. 19, 2012), available at http://www.mofo.com/files/