Baldonado, et al v. Wyeth, et al

Filing 382

MEMORANDUM Opinion and Order Signed by the Honorable Amy J. St. Eve on 8/31/2012:Mailed notice(kef, )

IN THE UNITED STATES DISTRICT COURT
FOR THE NORTHERN DISTRICT OF ILLINOIS
EASTERN DIVISION
JO BELLE BALDONADO,
Plaintiff.
v.
WYETH and its division,
WYETH PHARMACEUTICALS, INC.,
Defendant.

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Case No. 04 C 4312

MEMORANDUM OPINION AND ORDER
AMY J. ST. EVE, District Court Judge:
On July 30, 2012, Defendant Wyeth filed a “Renewed Motion in Limine No. 4 to Bar
Evidence, Argument, and Expert Opinions Concerning the Number of Women Whose Breast
Cancer was Purportedly Caused by Hormone Therapy.”1 (R. 340, Def.’s Mot.) Despite the
breadth of its caption, the motion is relatively narrow: Defendant seeks to exclude the expert
opinions of Dr. Graham Colditz “regarding the number of women in which HT allegedly caused
breast cancer.” (R. 344, Def.’s Mem. at 1.) The motion is denied as described below.

1

Defendant filed its original motion on June 15, 2012 (R. 249), but the Court denied that
motion without prejudice because, among other reasons, Defendant challenged the anticipated
testimony of a witness that Plaintiff had already withdrawn. (R. 334.)
1

BACKGROUND2
I.

Dr. Graham Colditz
Defendant does not challenge Dr. Colditz’s expert qualifications. For purposes of

background, Dr. Colditz is an expert epidemiologist who “stud[ies] the causes and prevention of
disease at the level of population.” (Colditz Dep. at 16.) His “primary focus is on cancer.” (Id.)
Dr. Colditz holds a medical degree from the University of Queensland in Brisbane, Australia,
which he earned in 1979. (Id. at 16-17.) Additionally, as Dr. Colditz explained at his deposition
I have a Master of Public Health from the Harvard School of Public Health. I
have a Doctorate in Public Health from the Harvard School of Public Health. I
have an M.D./Ph.D. equivalent from the University of Queensland on top of the
medical degree, and I’ve been admitted to the Australian Faculty of Public Health
Medicine, which in some circles, is also considered equivalent to a higher degree.
(Id. at 17-18.) Dr. Colditz’s educational background has involved “broad training in statistics,
epidemiology, health policy, [and] behavior,” and has provided him with a “grounding in
research skills” to work “in the public health sector.” (Id. at 18.)
Dr. Colditz currently serves as the Associate Director for Prevention and Control at the
Alvin J. Siteman Cancer Center, and the Niess-Gain Professor in the School of Medicine,
Department of Surgery, at the Washington University School of Medicine in St. Louis. (Id. at
18-19.) He has previously held academic and medical appointments at Harvard University, the
University of Michigan, and the University of Queensland. Dr. Colditz has authored and
published more than 700 articles in peer-reviewed journals. (Id.) He has written or co-authored

2

The Court presumes familiarity with the factual and procedural background of this
litigation. For a more detailed discussion of this case, see, for example, the Court’s
Memorandum Opinion and Order dated May 31, 2012 that denied Defendant’s motion to
exclude the expert testimony of Dr. Elizabeth Naftalis. (R. 228.)
2

six books, in addition to over 100 “reviews, editorials [or] commentaries.” (Id. at 21.) Dr.
Colditz has served in a leadership capacity in numerous professional associations, including
from 2000-2004 as the Director of the New England Division of the American Cancer Society
and from 2003-2006 as the Director of the Harvard Center for Cancer Prevention. Dr. Colditz
has received professional recognition for his work and, in addition to myriad other experiences,
has served as the Editor-in-Chief of the journal Cancer Causes and Control and as a principal
investigator on the Nurses Health Study, a decades-long study of chronic diseases in women,
including the relationship between hormone therapy and cancer. (Id. at 25-30.)

II.

Evidence at Issue

In advance of trial, Plaintiff has designated certain portions of Dr. Colditz’s deposition
testimony for trial. Defendant presently moves to exclude the following deposition testimony:3
COUNSEL:

Have you done an estimate of the number of women per year who
have gotten breast cancer that was caused by their use of E plus P,
estrogen plus progestin?

COLDITZ:

Yes, I have made that calculation, just as other epidemiologists
have in their publications.

COUNSEL:

Now, you mentioned that this calculation that you did to come up
with this estimate was similar to calculations you’ve seen in the
literature; is that right?

COLDITZ:

I am using the same standard methods as we have in our discipline,
epidemiology, to estimate the number of cases in the population.
The same methods have been used to estimate the number of cases
in Norway, the number of cases in the United Kingdom, and so I
say I am using the standard methods consistent with the approach
that others have used, yes.

3

The Court limits its consideration to the specific testimony that Defendant challenges
and expresses no view on the admissibility of Dr. Colditz’s designated testimony that Defendant
has not challenged.
3

COUNSEL:

And what is your estimate of the number of women per year who
have gotten breast cancer because of their use of estrogen plus
progestin?

COLDITZ:

I estimate that between 8 and 15,000 women per year in the United
States develop breast cancer because of the use of estrogen plus
progestin therapy.

....
COUNSEL:

And the number of fewer cases, the 14,000 fewer cases seen per
year since the WHI, how does that match up with your calculation
of estimating that 8,000 to 15,000 breast cancers were being
caused in women by the use of E plus P?

COLDITZ:

Well, this falls exactly within the range that I had previously
estimated for the number of cases caused each year by the use of E
plus P.

....
COUNSEL:

Your opinion that E plus P caused an estimated 8,000 to 15,000
breast cancers in women per year, is that an opinion you hold to a
reasonable degree of medical probability?

COLDITZ:

Yes.

....
(R. 375, Def.’s Reply at 2 (quoting and citing R. 365, Pl.’s Resp., Ex. 7, Colditz Dep. Desig. at 6,
24).)
For purposes of its motion, Defendant proffers the following background information:
To measure breast cancer incidence rates, Dr. Colditz relies upon information
reported by the Surveillance, Epidemiology, and End Results (“SEER”) cancer
registry, a database that attempts to count the number of cancers in the United
States (but draws from registries covering only approximately 26% of the United
States population). He theorizes that because the SEER data shows fewer
estrogen-receptor positive breast cancers in post-menopausal women during the
period that HT usage was declining, he can attribute the decline in breast cancer
rates primarily to the contemporaneous decline in HT usage.
(R. 344, Def.’s Mem. at 6.)
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ANALYSIS
Defendant seeks to exclude Dr. Colditz’s foregoing testimony on the basis that it is
“irrelevant” under Rules 401 and 402; “unreliable and speculative” under Rule 702 and Daubert;
and “inflammatory and unfairly prejudicial” under Rule 403. (R. 344, Def.’s Mem. at 7, 10, 13.)
Defendant additionally argues that “admitting Dr. Colditz’s opinions would violate Wyeth’s due
process rights.” (Id. at 14.)
I.

Relevance – Rules 401 and 402
The Court begins with the threshold issue of relevance. Rule 401 provides that

“[e]vidence is relevant if: (a) it has any tendency to make a fact more or less probable than it
would be without the evidence; and (b) the fact is of consequence in determining the action.”
Fed. R. Evid. 401; see also Whitehead v. Bond, 680 F.3d 919, 930 (7th Cir. 2012). Relevant
evidence is generally admissible, but “irrelevant evidence is not admissible.” Fed. R. Evid. 402.
“The Federal Rules of Evidence do not limit [a party] to the ‘most’ probative evidence; all
relevant evidence is admissible and the Rules define relevance broadly.” United States v.
McKibbins, 656 F.3d 707, 711 (7th Cir. 2011). The Seventh Circuit recently reminded district
courts that “[a] party faces a significant obstacle in arguing that evidence should be barred
because it is not relevant, given that the Supreme Court has stated that there is a ‘low threshold’
for establishing that evidence is relevant.” United States v. Boros, 668 F.3d 901, 907 (7th Cir.
2012) (citing Tennard v. Dretke, 542 U.S. 274, 285, 124 S. Ct. 2562, 159 L. Ed. 2d 384 (2004)).
Here, in response to Defendant’s relevance challenge, Plaintiff represents that she will
seek to introduce the testimony for purposes of proving (1) general causation (i.e. that Prempro
is capable of causing breast cancer) and (2) the nature of the actual risks of Prempro for purposes

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of Plaintiff’s failure to warn and failure to test claims, as well as showing the “reprehensibility of
Wyeth’s actions” as a factor justifying punitive damages. (R. 365, Pl.’s Resp. at 1.) The Court
will consider reprehensibility in the context of Defendant’s due process argument below.
With regard to the first two bases, Plaintiff reasons that she has the burden at trial to
show that Prempro has the capacity to cause breast cancer, and also to show that Defendant
failed to adequacy warn or test Prempro “in the context of the actual risk of the drug.” (R. 365,
Pl.’s Resp. at 8.) For these reasons, she argues, the evidence is relevant under Rules 401 and
402. The Court agrees. See Boros, 668 F.3d at 903 (“the threshold for relevance under Rule 401
is quite low”); accord Okuda v. Wyeth, No. 04-CV-80 (D. Utah July 24, 2012) (holding that
evidence of “the number of women whose breast cancers were purportedly caused by hormone
therapy” is “ relevant to the issue of general causation, as well as the need for further testing, the
adequacy of the warnings given, and the risk/benefit analysis.”); Fraser v. Wyeth, No. 04-CV1373, Tr. of Pretrial Conf. (D. Conn. Mar. 14, 2012) (statement of the Court: “[Dr. Colditz’s
calculations are] some evidence that you can use that’s tested to the rigors of public health and
epidemiological principles that tells you by those standards there is some evidence of general
causation with efforts to weed out what else might be causing it.”); Schutter v. Wyeth, Inc., No.
05 C 955 (N.D. Ill. Feb. 24, 2012) (“the studies appear to be relevant to reprehensibility and the
risks and benefits of the drugs”).
The testimony at issue – that a certain number of women “develop breast cancer because
of the use of [E+P] therapy”– tends to show that Prempro, a leading E+P therapy, can cause
breast cancer generally, and tends to inform the nature of the actual risk of the drug. See Kuhn v.
Wyeth, 686 F.3d 618, 633 (8th Cir. 2012) (stating with approval that expert relied on

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“epidemiological evidence to support his opinion that short-term use of Prempro increases the
risk of breast cancer”); Kilpatrick v. Breg, Inc., 613 F.3d 1329, 1337 (11th Cir. 2010) (stating
that the absence of epidemiological studies makes it “more difficult” to prove general causation);
Needham v. White Labs., Inc., 847 F.3d 355, 359 (7th Cir. 1988) (observing in a pharmaceutical
liability case arising under Illinois law that, “[i]nvestigation of the dangers of a product is a form
of (or step toward) precaution against those dangers; so the greater the potential dangers, the
greater the duty of inquiry”); In re Yasmin and YAZ (Drospirenone) Mktg., Sales Practices &
Prods. Liab. Litig., 09-MD-2100, 2011 WL 6302287, at *12 (S.D. Ill. Dec. 16, 2011) (holding
that expert epidemiologist’s testimony “supports the general causation question grounded in
epidemiology”); accord Nat’l Enviorn. Dev. Ass’n’s Clean Air Proj. v. E.P.A., 686 F.3d 803, 812
(D.C. Cir. 2012) (stating with approval that a government agency considered epidemiologic
studies “to inform its view of the population-level risk”). Defendant’s arguments to the contrary
(for example, that Dr. Colditz’s calculations are over-inclusive) go the weight of the evidence,
not its admissibility under Rules 401 and 402. See Okuda v. Wyeth, 04-CV-80 (D. Utah July 24,
2012) (holding that alleged “[w]eaknesses in the studies giving rise to” excess breast cancer
calculations go to the weight of the evidence, not its relevance). Cf. United States v. Hawkins,
499 F.3d 703, 711 (7th Cir. 2007) (holding that issues of weight did not destroy the relevance of
the evidence at issue).
II.

Reliability – Rule 702 and Daubert
Next, Defendant argues that the “Court should exclude Dr. Colditz’s estimates” pursuant

to Rule 702 and Daubert v. Merrell Dow Pharm., Inc., 509 U.S. 579, 113 S. Ct. 2786, 125 L. Ed.
2d 469 (1993), because the estimates “rest on unsupported, speculative assumptions and

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fundamentally unsound methodology.” (R. 344, Def.’s Mem. at 10.)
Under Rule 702, “[a] witness who is qualified as an expert by knowledge, skill,
experience, training, or education may testify in the form of an opinion or otherwise if: (a) the
expert’s scientific, technical, or other specialized knowledge will help the trier of fact to
understand the evidence or to determine a fact in issue; (b) the testimony is based on sufficient
facts or data; (c) the testimony is the product of reliable principles and methods; and (d) the
expert has reliably applied the principles and methods to the facts of the case.” Fed. R. Evid.
702. “The district court functions as a gatekeeper with respect to testimony proffered under Rule
702 to ensure that the testimony is sufficiently reliable to qualify for admission.” Mihailovich v.
Laatsch, 359 F.3d 892, 918 (7th Cir. 2004) (citing Kumho Tire Co. v. Carmichael, 526 U.S. 137,
147, 119 S. Ct. 1167, 143 L. Ed. 2d 238 (1999)). Whether to admit expert testimony rests within
the discretion of the district court. See Gen. Elec. Co. v. Joiner, 522 U.S. 136, 118 S. Ct. 512,
139 L. Ed. 2d 508 (1997). “The goal of Daubert is to assure that experts employ the same
‘intellectual rigor’ in their courtroom testimony as would be employed by an expert in the
relevant field.” Jenkins v. Bartlett, 487 F.3d 482, 489 (7th Cir. 2007) (quoting Kumho Tire Co.,
526 U.S. at 152).
In support of its motion, Defendant argues that Dr. Colditz “bases his conclusion that HT
caused breast cancer in thousands of other women on a simplistic comparison of two trends:
breast cancer incidence and HT use.” (R. 344, Def.’s Mem. at 11.) Defendant contends that “the
two tends do not reliability support” his opinions because Dr. Colditz (1) assumes causation, but
does not prove it; (2) ignores individual risk factors; (3) does not isolate women who took
Prempro rather than another drug; (4) does not account for different durations of use or

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“compliance with the prescribed regimen”; (5) fails to account for alternative explanations for
the decline in breast cancer during 2002 and 2003, such as a decline in mammography; and (6)
does not point to any “reliable scientific studies that support his estimates.” (Id. at 11-13.)
Defendant advances these six broad-based arguments – in the span of just over two doublespaced pages – but largely fails to develop the arguments or support them with relevant citations
to the record.4 Additionally, Defendant does not meaningfully discuss the specific methodology
that Dr. Colditz employed or even general principles of epidemiology.
In any event, based on the Court’s review of the parties’ briefs and its independent
review of the record, it is clear that Dr. Colditz’s opinions are reliable for purposes of Rule 702
and Daubert. Dr. Colditz, as an epidemiologist, “focuses on populations and not on individual
causation.” (Colditz Dep. at 172-73 (quoting counsel’s question to which the witness ascribed).)
As he testified, “[w]e will measure exposures in individuals, but we’re focusing on the diseases
that are important at the population level, that are coming from both aggregate population data
and individual data[.]” (Id. (“Other disciplines focus on describing the individual and the
singular level of activity.”).) In approaching the calculations at issue, Dr. Colditz testified that
he applied generally accepted and standard principles and methods of epidemiology. In his

4

For example, Defendant’s first argument relies solely on Dr. Colditz’s testimony from an
unrelated 2007 state court case. (See R. 344, Def.’s Mem. at 11, Ex. 2.) Defendant’s second,
third, fourth, and fifth arguments are largely devoid of record citation (argument three contains
no citations whatsoever). (Id. at 11-13.) Defendant’s fifth and sixth arguments cite exclusively
to the expert declaration of one of Defendant’s own experts. (Id.) Cf. Morisch v. United States,
653 F.3d 522, 529 (7th Cir. 2011) (“In a case of dueling experts . . . ‘it is left to the trier of fact,
not the reviewing court, to decide how to weigh the competing expert testimony.’”) (quoting
Wipf v. Kowalski, 519 F.3d 380, 385 (7th Cir. 2008)). Defendant’s sixth argument – that Dr.
Colditz “points to no reliable published scientific studies that support his estimates” – is
conclusory and completely fails to address Dr. Colditz’s deposition testimony or otherwise. (Id.
at 13.)
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words:
I am using the same standard methods as we have in our discipline, epidemiology,
to estimate the number of cases in the population. The same methods have been
used to estimate the number of cases in Norway, the number of cases in the
United Kingdom, and so I say I am using the standard methods consistent with the
approach that others have used, yes.
....
We used a standard epidemiological approach to estimate th[e] number [of breast
cancers]. The factors that feed into the arithmetic that we do is the relative risk,
the increase in risk with the combination therapy, the proportion of women in the
age group who are using combination therapy, and the total number of cancers
diagnosed in the United States in women in the age range who are either taking or
choosing not to take combination therapy.
(Id. at 38, 82.) Dr. Colditz further testified that he employed the same methodology that is
described in most every textbook of epidemiology.” (Id. at 82; see also id. at 633 (“It is the body
of evidence that we put together to conclude causation, just as the International Agency For
Research on Cancer has done.”).)
Additionally, Dr. Colditz has published his calculations in a peer-reviewed journal,
Breast Cancer Research. (R. 287, Ex. 5, Colditz, “Decline in Breast Cancer Incidents Due to
Removal of Promoter: Combination Estrogen Plus Progestin,” 9 Breast Cancer Research (Vol. 9,
No. 108, 2007).) Others have offered similar calculations. (See R. 287, Ex. 2 (media report on a
New England Journal of Medicine article regarding 200,000 excess breast cancers from E+P);
id., Ex. 15 (article in leading medical journal, The Lancet, stating: “Use of HRT by UK women
aged 50-64 years in the past decade is estimated to have resulted in an extra 20,000 incident
beast cancers, combined oestrogen- HRT accounting for 15,000 of these additional cancers.”);
accord Colditz Dep. at 38-39.)

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For all of these reasons, the Court rejects Defendant’s challenge to the reliability of the
expert opinions at issue for purposes of admission under Rule 702 and Daubert. Accord Schutter
v. Wyeth, Inc., No. 05 C 0998 (N.D. Ill. Feb. 24, 2012) (holding that there is no “real argument”
that the studies on excess breast cancers “were not conducted with accepted epidemiological
methodologies”); Deutsch v. Wyeth, No. MID-L-0998-06-MT (N.J. Super. Ct. June 19, 2007)
(“The Court finds that Dr. Colditz is qualified to offer his opinions and that the methodology that
he used to determine excess breast cancers is generally accepted. . . . Dr. Colditz opinion about
excess breast cancers relating to combination hormone therapy is reliable and based on a
standard method used y epidemiologists.”). Cf. Hines v. Wyeth, No. 04-CV-0690, 2011 WL
2680718, at *4 (S.D. Va. July 8, 2011) (rejecting Daubert challenge to expert’s opinion on
general causation, and observing that the expert relies on “various peer-reviewed articles and
epidemiological studies” including research by Dr. Colditz).
III.

Rule 403
Defendant alternatively seeks to exclude the evidence on the basis that it is

“inflammatory and unfairly prejudicial.” (R. 344, Def.’s Mem. at 13.) Rule 403 provides that
the trial court, in its discretion, “may exclude relevant evidence if its probative value is
substantially outweighed by a danger of one or more of the following: unfair prejudice,
confusing the issues, misleading the jury, undue delay, wasting time, or needlessly presenting
cumulative evidence.” Fed. R. Evid. 403; see also United States v. Khan, 508 F.3d 413, 417 (7th
Cir. 2007) (“Rule 403 codifies the district court’s broad discretion to control the admission of
evidence.”). According to Defendant, “[t]he obvious purpose” of the evidence “is to incite jury
passion and prejudice by suggesting that Wyeth grievously injured thousands of women each

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year.” (R. 344, Def.’s Mem. at 13.) Defendant continues that the underlying data “is far too
general to support causation, and therefore, such numbers are likely to confuse and mislead the
jury unfairly to Wyeth’s prejudice.” (Id. at 13-14 (further stating that “[t]o mitigate the
prejudice, Wyeth would need to present complicated testimony about the origins, statistical
validity, and significance of the calculations and data in question, thereby lengthening the trial
unnecessarily”).)
Defendant’s argument, however, relies on a misapplication of the legal standard under
Rule 403. As the Seventh Circuit has stated, “the probative value of the evidence must not
merely be outweighed, it must be substantially outweighed, by its negative consequences, to be
excludable.” .Mattenson v. Baxter Healthcare Corp., 438 F.3d 763, 771 (7th Cir. 2006); see also
United States v. Dennis, 497 F.3d 765, 769 (7th Cir. 2007) (“Rule 403 was never intended to
exclude relevant evidence simply because it is detrimental to one party’s case; rather, the
relevant inquiry is whether any unfair prejudice from the evidence substantially outweighs its
probative value.”) (internal citation and quotation marks omitted). In its opening brief,
Defendant makes no argument that the probative value of the evidence is “substantially”
outweighed by the Rule 403 considerations.5 The motion is therefore denied.
IV.

Due Process
Finally, Defendant argues that the evidence is inadmissible under the Due Process Clause

“as support for Plaintiff’s claim for punitive damages.” (R. 344, Def.’s Mem. at 14.) See Philip

5

After Plaintiff pointed out this defect, Defendant advanced a new argument in reply:
that the probative value of the evidence is “substantially outweighed by the danger of unfair
prejudice.” (R. 375, Def.’s Reply at 8.) The Court will not consider, for purposes of this motion,
arguments raised for the first time in reply.
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Morris USA v. Williams, 549 U.S. 346, 356-57, 127 S. Ct. 1057, 166 L. Ed. 2d 940 (2007)
(“Evidence of actual harm to nonparties can help to show that the conduct that harmed the
plaintiff also posed a substantial risk of harm to the general public, and so was particularly
reprehensible[, but ] . . . jury may not go further than this and use a punitive damages verdict to
punish a defendant directly on account of harms it is alleged to have visited on nonparties”);
State Farm Mut. Auto Ins. Co. v. Campbell, 538 U.S. 408, 416, 123 S. Ct. 408, 155 L. Ed. 2d 585
(2003) (identifying certain constitutional “guideposts” – including reprehensibility – that limit
the authority of courts to impose punitive damages). Plaintiff responds that the evidence is
“relevant to the issue of reprehensibility” under Phillip Morris. (R. 365, Pl.’s Resp. at 8-9.)
Defendant disagrees in its reply. (R. 375, Def.’s Reply at 10 (“Dr. Colditz’s calculations are not
relevant to the issue of reprehensibility.”).)
Neither party, however, addresses whether the evidence at issue has “any tendency to
make . . . more or less probable” any fact that is “of consequence” to the question of punitive
damages. Fed. R. Evid. 401. The constitutional limits stemming from the due process clause
cannot answer that question in the first instance; only the substantive law of Illinois can. See
Huddleston v. United States, 485 U.S. 681, 108 S. Ct. 1496, 99 L. Ed. 2d 771 (1988)
(“Relevancy is not an inherent characteristic of any item of evidence but exists only as a relation
between an item of evidence and a matter properly provable in the case.”) (internal citation and
quotation marks omitted). “In a diversity action such as this one, state law governs the factors a
jury may consider in determining the amount of punitive damages, while federal law governs the
district court’s review of the jury award and appellate review of the district court’s decision.”
Kempner Mobile Elecs., Inc. v. Southwestern Bell Mobile Sys., 428 F.3d 706, 714 (7th Cir.

13

2005).
Under Illinois law, a jury may award punitive damages if “the defendant has acted
willfully, or with such gross negligence as to indicate a wanton disregard of the rights of others.”
Blount v. Stroud, 395 Ill. App. 3d 8, 20, 333 Ill. Dec. 845, 915 N.E.2d 925 (2009) (citing Kelsay
v. Motorola, Inc., 74 Ill.2d 172, 186, 23 Ill. Dec. 559, 384 N.E.2d 353 (1978)). Following State
Farm, the Illinois Supreme Court embraced reprehensibility as a relevant factor and further held,
relying on State Farm, that:
Courts are instructed to consider the following factors when determining
reprehensibility: (1) whether the harm caused was physical as opposed to
economic; (2) whether the tortious conduct evinced an indifference to or a
reckless disregard for the health and safety of others; (3) whether the target of the
conduct was financially vulnerable; (4) whether the conduct involved repeated
actions or was an isolated incident; and (5) whether the harm was the result of
intentional malice, trickery, or deceit, or mere accident.
Int’l. Union of Oper. Eng’rs, Local 150 v. Lowe Excavating Co., 225 Ill.2d 456, 470, 312 Ill.
Dec. 238, 870 N.E.2d 303 (2006).
The parties have not attempted to explain how the evidence at issue “has any tendency to
make” any of the these factors “more or less probable.” Fed. R. Evid. 401. Nor is it
immediately clear that the evidence has any such tendency, or that there is a sufficient
evidentiary basis for the jury to so find. See Fed. R. Evid. 104(b). Relevance may well depend
on the existence of other facts, including the extent of Defendant’s knowledge about the actual
risk of Prempro during the relevant time period. See id. (“When the relevance of evidence
depends on whether a fact exists, proof must be introduced sufficient to support a finding that the
fact does exist.”). For all of these reasons, the Court denies the motion without prejudice. The
Court need not reach the due process question unless the evidence is relevant under Rule 401 in

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the first instance. If Plaintiff can show that it is, then Defendant may renew its argument at trial
based on the purpose for which Plaintiff seeks to offer the evidence. Cf. Williams v. Pugh, No.
10-2700, 2012 WL 2899403, at *3 (7th Cir. July 17, 2012) (observing that whether admission of
certain evidence violates the constitution depends on the purpose for which it was offered);
Stephens v. Miller, 13 F.3d 998, 1009 (7th Cir. 1994) (“The analysis therefore depends entirely
on the purpose for which the testimony was offered.”) (Rover, J., concurring).
That said, as discussed above (see supra § II.A), the evidence at minimum is relevant to
issues other than punitive damages. The Court will appropriately instruct the jury on the legal
standard governing an award of punitive damages, including the permissible purposes for which
the jury may consider evidence. See Schutter v. Wyeth, No. 05-CV-998 (N.D. Ill. Feb. 24, 2012)
(stating in response to a due process challenge that “careful jury instructions would seem to
mitigate any risk to Wyeth”) (citing Philip Morris, 549 U.S. at 354-56 (“[I]t is constitutionally
important for a court to provide assurance that the jury will ask the right question, not the wrong
one.”). The parties should meet and confer and include appropriate jury instructions on the issue
of punitive damages in their joint proposed jury instructions.
CONCLUSION
The Court denies Defendant’s motion as described herein.
Dated: August 31, 2012
ENTERED

AMY J. ST. EVE
United States District Judge

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