DEAR DOCTOR LETTERS
argument that the 2002 Paxil label was adequate as a matter of law.179
While the court in Tucker held that a reasonable jury could find the 2002
label inadequate “[e]ven without comparing Paxil’s 2002 label with
[SmithKline’s] revisions,” it is difficult to imagine that the court did not
consider such a comparison, or that the jury would not consider it either, if
presented with the juxtaposition. This leads into the discussion of whether
post-injury Dear Doctor letters constitute subsequent remedial measures
and are therefore inadmissible under Federal Rule of Evidence 407.
C. Dear Doctor Letters as Post-Remedial Measures: Courts Divided
The Dear Doctor letter causation argument shows how not sending a
Dear Doctor letter may subject a manufacturer to a failure-to-warn claim.
When a Dear Doctor letter has been sent out after a plaintiff’s alleged injury
from the drug or medical device at issue, a plaintiff may want to offer it as
evidence of the package insert’s inadequacy or the manufacturer’s
negligence, as we saw in Tucker.
The question then becomes, can a manufacturer exclude an issued Dear
Doctor letter from evidence at trial? It all depends on the jurisdiction.
Some courts have held that post-event label changes constitute subsequent
remedial measures and are thus inadmissible under Federal Rule of
Evidence 407.180 For example, in Chlopek v. Federal Insurance Co.,181 the
Seventh Circuit held that the defendant’s “motive for making the [label]
change is irrelevant. All the rule requires is that the measure ‘would have
made the injury or harm less likely to occur.’”182 Several other courts have
agreed, at least with respect to “true” label changes (these decisions do not
necessarily discuss Dear Doctor letters specifically).183
At least one recent decision has come out the other way, however,
finding that Rule 407 does not apply. In 2011, Schedin v. Ortho-McNeil-Nanssen Pharmaceuticals,184 the District Court of Minnesota held, over the
manufacturer’s Rule 407 objection, that evidence of labeling and label
changes (including Dear Doctor letters) that occurred after the plaintiff
ingested the drug at issue—Levaquin—were admissible.185 The court held
179. Id. at 1067.
180. Fed. R. Evid. 407.
181. Chlopek v. Fed. Ins. Co., 499 F.3d 692, 700 (7th Cir. 2007).
183. Janssen Pharm., Inc. v. Armond, 866 So. 2d 1092, 1100-01 (Miss. 2004); Stahl v.
Novartis Pharm. Corp., 283 F.3d 254, 270 n.10 (5th Cir. 2002); Martinkovic v. Bangash, No.
84 C 9568, 1987 WL 28400, at *1 (N.D. Ill. Dec. 18, 1987); DeLuryea v. Winthrop
Laboratories, 697 F.2d 222, 227-29 (8th Cir. 1983).
184. 808 F. Supp.2d 1125 (D. Minn. 2011).