DEAR DOCTOR LETTERS
Zometa and Aredia to the jury.161 Based on FDA guidance issued after
Ms. Baldwin suffered her injuries, the answer is almost certainly yes.162
Indeed, in April 2012 a jury awarded Ms. Baldwin $225,000 in
compensatory damages for her injuries.
b. Tucker v. SmithKline Beecham, Corp.,
701 F.Supp. 2d 1040 (S.D. Ind. 2010)
Tucker, like Winter, does not provide direct support for the Dear Doctor
letter causation argument, but provides some helpful language for plaintiffs
trying to use that argument to avoid summary judgment. Tucker also raises
additional considerations that drug manufacturers should keep in mind
before issuing Dear Doctor letters. These considerations will be discussed
at the end of this section.
Tucker is distinguishable from Winter from the get go. In Tucker, the
treating doctor actually read the package insert for the drug at issue, but
complained it did not warn clearly enough about the attendant risk of
suicide.163 The causation argument balanced on whether an additional
“adequate” warning—be it in the label or through other means (such as a
Dear Doctor letter)—would have changed the doctor’s treatment decisions.
Tucker concerned the warnings associated with the drug Paxil, an
antidepressant classified as a selective serotonin re-uptake inhibitor or
“SSRI.”164 In 2002, the year Father Tucker (yes, the plaintiff was a priest)
was prescribed Paxil, the label warned that the “possibility of a suicide
attempt is inherent in major depressive disorder and may persist until
significant remission occurs.”165 Father Tucker committed suicide a few
weeks after he began taking Paxil.166
Before prescribing Paxil to Father Tucker, Dr. Bright reviewed the
package insert.167 He did not recall any “specific warnings in 2002
regarding an association between Paxil and suicide in adults,” nor did he
have any “independent knowledge” of such an association at that time.168
Dr. Bright testified that “[ i]f he had been provided with a warning that Paxil
was associated with suicide, he would have considered that warning in
161. Id. at *3.
162. See supra Section II( A)(4).
163. Tucker v. Smithkline Beecham, Corp., 701 F.Supp. 2d 1040, 1067 (S.D. Ind.
164. Id. at 1043.
165. Id. at 1044.
166. Id. at 1042.
167. Id. at 1044.