The opinion of the court was delivered by: Shadur, District Judge.
Both Rachel Wetherill ("Wetherill") and Maureen Rogers
("Rogers") claim injury by exposure in utero to
diethylstilbestrol ("DES"), administered to their mothers as
part of a study (the "Study") conducted by Dr. William
Dieckmann ("Dieckmann") in the early 1950s at the University
of Chicago ("University") hospitals. Each Complaint contains
the same three counts:
Both actions have reached the final pre-trial order stage and
have been added to this Court's list of cases ready for trial.
Each plaintiff has now filed motions in limine:
1. to declare the relevance of the testimony of
Dr. Brian L. Strom ("Dr. Strom") to Counts I and
2. to exclude evidence concerning University's
asserted "routine practice" of obtaining the
consent of participants in the Study under
Fed.R.Evid. ("Rules") 403, 406 and 802.
For the reasons stated in this memorandum opinion and order
the first motion is granted but the second motion is denied.
Dr. Strom's Testimony
Dr. Strom's proposed testimony is described in the final
He will testify that at the time of plaintiff's
exposure to DES, the University of Chicago . . .
knew, or by the application of reasonable,
developed human skill and foresight should have
had knowledge of the dangers of DES use. Dr.
Strom will also testify that DES was inadequately
tested prior to its marketing for treatment of
accidents of pregnancy.
University concedes such testimony is relevant to Count III
but disputes its relevance to Counts I and II. This Court must
agree with plaintiffs' position on that score.
Dr. Strom's testimony is certainly pertinent at least to the
"informed consent" issue posed by one of the six acts of
negligence imputed to University by Count II: permitting "Dr.
Dieckmann and others to use patients of the HOSPITAL as
experimental subjects without the knowledge or consent of the
patients." Grounded in principles of negligence (rather than
the intentional tort of battery), the doctrine of informed
consent requires physicians to exercise reasonable care in
informing the patient of the risks of the treatment or
operation in question. See Mink v. University of Chicago,
460 F. Supp. 713, 716-17 (N.D.Ill. 1978). Dr. Strom's testimony that
University physicians who treated plaintiffs' mothers should
have known of DES's potential dangers during the early 1950s is
obviously probative of whether their conceded failure to
disclose such dangers breached that standard of due care.
As University correctly points out, Dr. Strom's testimony
has no bearing on plaintiffs' entitlement to compensatory
damages under Count I. That battery claim rests on the
total lack of consent by plaintiffs' mothers to the DES
treatment. Whether any consent given was uninformed (because of
the physician's inadequate disclosure) is simply irrelevant to
a battery action. See Mink, 460 F. Supp. at 717.
However, Dr. Strom's testimony is germane to the issue of
punitive damages raised by Count I (and Count II as well).
Under Illinois law punitive damages may be awarded "when the
defendant acts wilfully or with such gross negligence as to
indicate a wanton disregard of the rights of others."
Pendowski v. Patent Scaffolding Co., 89 Ill. App.3d 484, 487,
44 Ill.Dec. 544, 546, 411 N.E.2d 910, 912 (1st Dist. 1980). Dr.
Strom's anticipated testimony that numerous pre-1952 studies
had documented the harmful consequences of DES usage would
certainly support an inference of gross negligence on the part
of University physicians who treated plaintiffs' mothers.
Accordingly Dr. Strom's expected testimony is relevant to
both Counts I and II. Plaintiffs' motion for a ruling to that
effect is granted.*fn1
University's "Routine Practice" of Obtaining
As already stated, one critical element of a battery or
negligence claim is lack of consent on plaintiffs' mothers'
part. To prove that, plaintiffs will call their mothers
as witnesses to testify no University physician ever disclosed
the existence of, or sought their consent to, the Study.
University will indirectly counter such testimony*fn2 by
proving physicians who conducted the Study adhered to a
routine procedure of obtaining the consents of participants
after full disclosure.
According to University that "protocol" had three elements,
all noted by Dieckmann in his published report (the "Dieckmann
Report") of the results of his study:*fn3
1. Patients were apprised as to the beginning
and continuing amounts of DES to be taken and
were given charts to record the taking of each
2. They were told DES treatment would help
avert some pregnancy complications.
3. They were also assured DES would not harm
them or their fetuses.
To evidence that procedure University will rely on the
testimony of (a) several participants and (b) four of the
twenty-one physicians who carried out the Study — H. Close
Hesseltine ("Dr. Hesseltine"), Charles McCartney ("Dr.
McCartney"), Jorge Bustamante ("Dr. Bustamante") and Nicholas
Fugo ("Dr. Fugo"). Such testimony, University contends, is
admissible under Rule 406 to prove University physicians placed
plaintiffs' mothers on a DES regimen and acted in conformity
with that "routine practice" of securing consent.
Plaintiffs' motion advances three independent grounds for
excluding such evidence:
1. It fails to demonstrate a "routine practice"
under Rule 406.
2. Even if relevant under Rule 406, it must be
barred under Rule 403 because its probative value
is far outweighed by its potential for unfair
prejudice and confusion.
3. It constitutes inadmissible hearsay under
None of those objections withstands scrutiny.
1. Rule 406
Rule 406 provides:
Evidence of the habit of a person or of the
routine practice of an organization, whether
corroborated or not and regardless of the
presence of eyewitnesses, is relevant to prove
that the conduct of the person or organization on
a particular occasion was in conformity with the
habit or routine practice.
Plaintiffs argue unpersuasively that University's physician
and patient testimony falls short of establishing a "routine
practice" of obtaining consents in three respects:
1. Rule 406 allows proof only that University
physicians who treated plaintiffs' mothers
— not the other physicians who conducted the Study
— adhered to such a routine practice.
2. University's physician and patient witnesses
are too small a sample to imply the existence of
a routine practice.
3. Testimony of those witnesses is too
inconclusive to substantiate that routine
Plaintiffs' first contention would have merit only if the
organizers of the Study had failed to promulgate and apprise
collaborating physicians of the uniform protocol to secure
patient consent. But it appears at least a preponderance of
the evidence is to the contrary (or at least a jury could so
1. At the 1983 trial in Mink v. University of
Chicago, 77 C 1432 (N.D.Ill.) Dr. Hesseltine — one
of the three division heads in University's
obstetrics department who were in charge of the
Study — testified a special departmental meeting
had been called to notify participating physicians
and staff members of the protocol to be followed in
the Study (Tr. 967). Dr. Hesseltine also said each
division head monitored his subordinates' adherence
to those disclosure rules.
2. At the same trial Dr. McCartney testified
University's customary procedure in conducting
experiments similar to the Study was to announce
the protocol at a departmental meeting and then
to post it on the bulletin boards (id. at
3. In his deposition in Tsurutani v. University
of Chicago, 77 C 4098 (N.D.Ill.) Dr. Bustamante
testified he was told by one of the physicians who
helped design the Study (a) only those patients who
agreed to participate would be used and (b) a
protocol to insure the voluntariness of their
decision to cooperate was in the drafting stage.
4. According to Dr. Fugo's deposition
testimony, he learned of the protocol through
conversations with his department head and other
physicians in charge of the Study. That testimony
not only implicitly confirms the existence of a
uniform policy of obtaining consent but also
substantiates Dr. Hesseltine's assertion the
department heads took steps to insure their staff
observed that policy. To be sure, Dr. Fugo's
testimony arguably (but not necessarily) suggests
informal rather than formal channels were used to
inform participating doctors of the protocol. But
that implication certainly does not mean
participating physicians were apprised of the
protocol in a fortuitous and haphazard fashion,
as plaintiffs so vigorously insist.
In short it could reasonably be found that University
physicians who treated plaintiffs' mothers became part of an
"organization" with a policy of seeking patients' consent
after fully disclosing the experimental nature of the Study.
Consequently evidence that other University physicians
routinely followed that practice is admissible under Rule 406
to prove the two treating physicians acted in conformity with
that "routine practice" before exposing plaintiffs' mothers to
Nor is the number of physician and patient witnesses
insufficient to document the existence of the "routine
practice" under Rule 406. As plaintiffs correctly point out,
the "routine practice" concept contemplates a certain
threshold "ratio of the proved instances to the total conduct
claimed to be habitual [or routine]." 23 Wright and Graham,
Federal Practice and Procedure § 5276, at 64. That ratio in
turn depends on the nature of the routine practice at issue.
Id. In this case the anticipated testimony of the physician
witnesses alone*fn5 will embrace more than enough specific
1. Unless the doctor witnesses' testimony were
confined to their own disclosure practices,
plaintiffs could not use the ratio of the number of
doctor witnesses to the total number of
participating doctors to estimate the ratio of
specific instances to the total universe of the
conduct at issue.*fn6 But Rule 406 does not
limit proof of specific instances to testimony by
witnesses with personal knowledge. It also
permits resort to circumstantial evidence,
documents or even opinion testimony (id. at 67).
At least Dr. Hesseltine will offer opinion
testimony (if not testimony based on personal
knowledge) as to all other participating doctors'
regular observance of the protocol. Moreover
University can also substantiate the doctors'
routine adherence to the protocol through
documentary evidence — the dosage charts
assertedly given to their participating patients.
In sum, University's proof covers a sufficient number of
specific instances to imply a "routine practice." It remains
only to resolve whether those specific instances in fact
exemplify the claimed practice — the issue posed by
plaintiffs' third argument.
Unless marred by internal contradictions, University's
showing would support a finding of "routine practice," for
plaintiffs have not proffered any countervailing
evidence.*fn8 Careful review of the proposed testimony of
University's physician and patient witnesses reveals no such
Despite the passage of almost 30 years, the witnesses'
recollections of the specific content of the disclosures made
are surprisingly similar. Nevertheless, plaintiffs seize on
partial variations in those witnesses' accounts:
But those testimonial gaps concern aspects of the protocol
that have no bearing on the issue of informed consent (and a
fortiori the issue of actual consent) and hence are not
Accordingly University has demonstrated admissibility of its
evidence that its physicians adhered to the "routine practice"
of asking patients to participate in the Study after
disclosing its experimental nature. If believed, that practice
was tantamount to a policy of securing patients' informed
consent so long as those physicians did not know or have
reason to know of the harmful consequences of DES.
2. Rule 403
Rule 403 permits exclusion of relevant evidence when "its
probative value is substantially outweighed by the danger of
unfair prejudice, confusion of the issues or misleading the
jury, or by consideration of undue delay, waste of time, or
needless presentation of cumulative evidence." Here Rule 403's
balancing test plainly weighs in favor of admissibility:
Accordingly University's "routine practice" testimony cannot
be barred under Rule 403.
3. Rule 802