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WETHERILL v. UNIVERSITY OF CHICAGO

United States District Court, Northern District of Illinois, E.D


August 23, 1983

RACHEL WETHERILL, PLAINTIFF,
v.
UNIVERSITY OF CHICAGO, DEFENDANT. MAUREEN ROGERS, PLAINTIFF, V. UNIVERSITY OF CHICAGO, DEFENDANT.

The opinion of the court was delivered by: Shadur, District Judge.

MEMORANDUM OPINION AND ORDER

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:

    1. Count I charges University committed a
  battery by subjecting plaintiff's mother to the
  Study without her prior knowledge or consent.

    2. Count II sounds in malpractice, asserting
  various acts of negligence by University and its
  hospital employees.

    3. Count III seeks recovery on strict liability
  grounds.

  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
  II, 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 pretrial order:

  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 Consents

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
  daily dose.

    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
  Rule 802.

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
  practice.

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 find):

    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
  1081).*fn4

    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 DES.

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 instances:

    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
  assertedly proved

  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.

    2. Rule 406's foundational requirements for
  admissibility of evidence of "routine practice"
  are appropriately less stringent than those
  demonstrating the "habit of a person"
  (id. § 5274, at 44-45). In accord with their
  greater receptiveness to such evidence, courts have
  frequently been willing to find a "routine
  practice" on the basis of testimony from one or two
  witnesses. See e.g., United States v. Oddo,
  314 F.2d 115, 117 (2d Cir. 1963); Bean v. United
  States, 533 F. Supp. 567, 572-74 (D.Colo.
  1980).*fn7

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 inconsistencies:

    1. All four doctors will uniformly testify they
  scrupulously followed the practice of (a)
  explaining to their maternity patients the
  experimental nature of the Study and (b) then
  seeking their patients' voluntary participation.

    2. All the mother witnesses will similarly
  testify they knowingly consented to the Study
  after discussing the matter with their
  physicians.

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:

    1. Two of the four physicians cannot recall
  whether they told their patients DES had no
  harmful potential — one of the three elements of
  protocol as described in the Dieckmann Report.

    2. One of the six mother witnesses cannot
  remember whether her treating physician told her
  DES reportedly prevented the complications of
  pregnancy.

    3. Several of the doctors and mothers cannot
  recollect whether the use of placebos had been
  mentioned.

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 part of the "routine practice" that University seeks to establish:*fn9

    1. Resolution of the informed consent issue
  would be the same regardless of whether each
  University physician told his patients DES had no
  harmful properties. In either event a patient's
  consent would be uninformed only if the physician
  knew or had reason to know of DES's deleterious
  effects. Because University strenuously denies
  its physicians were ever on notice as to DES's
  harmful consequences, it has never defined its
  physicians' routine practice of eliciting their
  patients' consent to include disclosure of such
  side effects.

    2, 3. University physicians' failure to
  acknowledge DES's beneficial qualities or the use
  of placebos in the Study arguably rendered their
  patients' consent less "informed." But such
  nondisclosure could not possibly have proximately
  caused any injuries sustained by those mothers or
  their fetuses, for revelation of the withheld
  information would have enhanced their willingness
  to participate in the Study.*fn10

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:

    1. If believed, the probative value of
  University's physician and patient testimony is
  considerable, for it is apparently the only
  evidence marshalled by University to rebut the
  testimony of plaintiffs' mothers on the critical
  consent issues posed by Counts I and II.

    2. According to the Advisory Committee, "unfair
  prejudice" connotes "an undue tendency to suggest
  decision on an improper basis, commonly, though
  not necessarily, an emotional one." But
  plaintiffs have failed to identify (and this
  Court fails to perceive) any "improper basis" for
  decision conveyed by the testimony. If believed,
  the evidence will by definition be proper. If
  disbelieved, it will simply fail to establish a
  "routine practice" of disclosure and will hence
  be irrelevant to whether University physicians
  who treated plaintiffs' mothers sought their
  consent. That latter prospect — the lack of basis
  for a factfinder's decision — is not what is meant
  by the Advisory Committee's reference to "improper
  basis."

    3. Any possibility of confusion (that may occur
  if the evidence fails to disclose a "routine
  practice") can be averted through appropriate
  cautionary instructions.

Accordingly University's "routine practice" testimony cannot be barred under Rule 403.

3. Rule 802

Plaintiffs' hearsay objection is plainly frivolous. University's "routine practice" testimony, which largely concerns out-of-court statements by those physicians who participated in the Study, is tendered to prove the making of those declarations, not "the truth of the matters asserted" in those declarations. And all the physician and mother witnesses have personal knowledge on that subject. Only the opinion testimony that may be offered by physician witnesses involves hearsay. But such hearsay is independently admissible under Rule 406 and thus cannot be excluded under Rule 802.

Conclusion

Dr. Strom's anticipated testimony is relevant to all three counts. University's "routine practice" testimony is admissible under Rule 406. Plaintiffs are ordered to file on or before September 2, 1983 a revised form of cautionary jury instruction conforming to this opinion, and University is ordered to file its comments on that instruction on or before September 12, 1983.


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