DEAR DOCTOR LETTERS
While the court’s reasoning is cursory (apparently because an MDL
transferee court had already denied a similar summary judgment motion and
the court was “hesitant to disturb the MDL court’s ruling”), it provides
some support to plaintiffs seeking to validate Dear Doctor—or other non-
label-based—causation arguments on a scarce evidentiary record.147
In Winter, Ruth Baldwin148 was prescribed cancer drugs Aredia and
Zometa after being diagnosed with breast cancer with metastases to her
spine and liver.149 The prescribing oncologist testified that he could not
recall a patient with metastases to whom he did not prescribe one of these
drugs prior to when he stopped using them on Ms. Baldwin.150 Beginning
in September 2003, Novartis made a series of changes in its package insert
to alert physicians to the potential side effect of osteonecrosis of the jaw
(ONJ)151—a serious bone disease that exposes the jaw bones through
lesions in the gums. Novartis also “highlighted” the latest label changes
regarding ONJ in a September 24, 2004 Dear Doctor letter.152
There was no dispute that plaintiff’s oncologist “never read the package
inserts for Aredia and Zometa,” apparently because he believed “Novartis
produced them in a way that made them useless to a practitioner.”153 The
parties disputed whether the oncologist received the September 24, 2004
Dear Doctor letter.154 The parties did not dispute, however, that
Ms. Baldwin’s dentist (who had not prescribed the subject drugs) had
received no warnings about the risks of ONJ in patients on Aredia and
Zometa, including the warning that tooth extractions—like those done on
plaintiff on November 6, 2003 and September 9, 2004 (twenty days before
the date of the Dear Doctor letter)—may exacerbate ONJ.155
Novartis argued that the fact that Ms. Baldwin’s oncologist testified that
he did not read the relevant package inserts— i.e. “made himself ignorant”
of their content—precluded a finding of causation on her failure-to-warn
claim.156 The district court disagreed on two grounds.
First, the court found a triable issue of fact in the oncologist’s
unsupported allegation that the package insert was “useless”157—even
5008008 (W.D. Mo. Oct. 20, 2011).
147. Id. at *2.
148. Plaintiff Christine Winter was suing on behalf of Ms. Baldwin’s estate. Id. at *1.
155. Id. at *1-*3.
156. Id. at *2.