DEAR DOCTOR LETTERS
April 2010.193 Votzmeyer admitted, however, that providing full
information concerning Humira’s risks was ultimately Abbott’s
responsibility—not the FDA’s.194
In closing, Tietz argued that Abbott’s delay in sending the Dear Doctor
letter was unreasonable and contributed to his wife’s injuries. He asked for
$5.8 million in damages; the jury returned a verdict in his favor for $2.2
million.195
That Tietz was able to argue that Abbott should have sent the Dear
Doctor letter sooner despite FDA-imposed guidelines serves as a reminder
that not all courts view Dear Doctor letters as inadmissible subsequent
remedial measures.196 Additionally, it indicates that manufacturers are not
permitted to sit on information that may affect physician prescribing
decisions, and that compliance with FDA-imposed deadlines is not
sufficient to avoid liability, even when such compliance is arguably the
industry standard.197
Despite Schedin and Tietz, manufacturers should continue to try to
exclude post-event Dear Doctor letters and label changes in limine under
Rule 407 or the parallel state rule of evidence. Not all jurisdictions
recognize the superior governmental authority exception. Moreover, even
in those jurisdictions that do, there are strong policy arguments to be made
that Rule 407 encourages cooperation with government agencies, such as
the FDA. By admitting evidence of post-event Dear Doctor letters and
label changes, the courts are discouraging manufacturers from being
proactive and working with the FDA to make drugs safer by providing
physicians with additional warnings and information. Nonetheless,
manufacturers should take care in crafting and sending Dear Doctor letters
because they may very well be seen—and relied upon—by a jury in the
future.
IV. CONCLUSION
The decision whether to send a Dear Doctor letter is multifaceted.
Pharmaceutical manufacturers and their counsel must consider the form,
193. Id.
194. Id.
195. Id.
196. The Illinois law on subsequent remedial measures is not clear. The authors of the
Illinois Rules of Evidence “reserved” on the issue of whether to adopt the federal Rule 407
standard due to a conflict among the Illinois courts of appeal.
197. Compliance with an industry standard, although evidence of non-negligence, is not
alone sufficient to avoid liability. The T.J. Hooper, 60 F.2d 737 (2d Cir. 1932) (“Courts
must in the end say what is required; there are precautions so imperative that even their
universal disregard will not excuse their omission.”).
