FECHO et al v. ELI LILLY AND COMPANY et al
Filing
357
Magistrate Judge Marianne B. Bowler: ORDER entered. MEMORANDUM AND ORDER. In accordance with the foregoing discussion, the motion to strike (Docket Entry 337 ) is ALLOWED in part and DENIED inpart. The motion for partial summary judgment (Docket Entry 324 ) is DENIED.(Garvin, Brendan)
UNITED STATES DISTRICT COURT
DISTRICT OF MASSACHUSETTS
MICHELE FECHO, et al,
Plaintiffs,
v.
CIVIL ACTION NO.
11-10152-MBB
ELI LILLY AND COMPANY, et al,
Defendants.
MEMORANDUM AND ORDER RE:
MOTION FOR PARTIAL SUMMARY JUDGMENT FOR FAILURE TO PROVE
PROXIMATE CAUSATION (DOCKET ENTRY # 324); MOTION TO
STRIKE EXHIBITS TO PLAINTIFFS’ OPPOSITION TO
MOTION FOR PARTIAL SUMMARY JUDGMENT FOR
FAILURE TO PROVE PROXIMATE CAUSATION
(DOCKET ENTRY # 337)
December 21, 2012
BOWLER, U.S.M.J.
Defendant Eli Lilly and Company (“Lilly”) moves for summary
judgment on a negligent failure to warn claim in the second
amended complaint (Count I).
(Docket Entry # 324).
Lilly
submits there is an absence of admissible evidence that the
breast cancer experienced by plaintiffs Andrea Andrews
(“Andrews”), Michele Fecho (“Fecho”), Donna McNeely (“McNeely”)
and Francine Melnick (collectively:
“plaintiffs”) was
proximately caused by Lilly’s failure to warn that maternal
ingestion of Diethylstilbestrol (“DES”) increases the risk of
breast cancer in the mother’s female offspring.
324).
(Docket Entry #
Lilly separately moves to strike three affidavits (Docket
Entry ## 331-4, 331-5 & 331-6) filed by plaintiffs to support
their opposition to the partial summary judgment motion (Docket
Entry # 337).
After conducting a hearing on November 19, 2012,
this court took the motions (Docket Entry ## 324 & 337) under
advisement.
Because the content of the summary judgment record
depends upon whether to include the three affidavits, this court
initially turns to the motion to strike.
I.
MOTION TO STRIKE
Lilly seeks to strike the affidavits of:
(1) Victor Greco,
M.D. (“Dr. Greco”), a board certified physician in the specialty
of general surgery; (2) Irene Makowiec (“Makowiec”), a former
patient of the late Richard Bonacci, M.D. (“Dr. Bonacci”); and
(3) Clare Ritz (“Ritz”), another former patient of Dr. Bonacci.
Dr. Bonacci was a general practitioner with an office located in
Tresckow, Pennsylvania.
Plaintiffs’ mother, the late Frances
Melnick (“Melnick” or “plaintiffs’ mother”), was under Dr.
Bonacci’s care during the pregnancies of her five children.
For
purposes of the partial summary judgment motion, Lilly
acknowledges that Melnick ingested Lilly’s DES.
(Docket Entry #
325, n.2).
Plaintiffs offer the affidavits to show that Dr. Bonacci’s
routine prescribing practice was to read and heed warnings from
drug manufacturers and to share the information with his
patients.
(Docket Entry ## 333 & 350).
2
Lilly maintains that Dr.
Greco’s testimony is hearsay because he lacks personal knowledge
of Dr. Bonacci’s practice and is not testifying as an expert.1
(Docket Entry # 325, n.9; Docket Entry # 338).
Lilly further
posits that the testimony is not admissible to show Dr. Bonacci’s
character or his “habit” of heeding drug manufacturers’ warnings
and advising his patients of such warnings.2
Lilly seeks to strike the remaining two affidavits as
inadmissible habit evidence for the same reasons.
As with Dr.
Greco’s testimony, Lilly argues that Ritz’s and Makowiec’s
testimony constitutes inadmissible character evidence under Rule
404, F.R.E. (“Rule 404”).
Lilly’s additional argument that the
1
Plaintiffs’ pretrial memorandum does not designate Dr.
Greco as an expert witness. (Docket Entry # 350, p. 31). At the
December 12 and 13, 2012 conferences, plaintiffs’ counsel
represented that Dr. Greco was a fact witness. This court stated
its agreement from the bench during the December 13, 2012
conference.
2
Lilly’s additional argument that the affidavit testimony
(Docket Entry # 331-4) contradicts Dr. Greco’s prior deposition
testimony is not well taken. It is true that where a party gives
“clear answers to unambiguous deposition questions, he or she
cannot raise an issue of fact by submitting a subsequent
affidavit that merely contradicts the deposition testimony.”
Lowery v. AIRCO, Inc., 725 F.Supp. 82, 85-86 (D.Mass. 1989);
accord Colantuoni v. Alfred Calcagni & Sons, Inc., 44 F.3d 1, 4-5
(1st Cir. 1994); Chapman Ex Rel. Estate of Chapman v. Bernard's,
Inc., 167 F.Supp.2d 406, 419 (D.Mass. 2001). “Variations in a
witness’s testimony and any failure of memory throughout the
course of discovery create an issue of credibility” which is
properly resolved by the finder of fact. Tippens v. Celotex
Corporation, 805 F.2d 949, 954 (11th Cir. 1986) (reversing
allowance of summary judgment and finding that affidavit was not
inherently inconsistent with deposition testimony and should have
been considered). Whereas certain portions of the deposition
testimony (Docket Entry # 327-8, pp. 50-51 & 100-102) vary from
the affidavit, other portions (Docket Entry # 327-8, pp. 103-108
& 131-133) coincide with the affidavit.
3
subject matter of the witnesses’ testimony (Dr. Bonacci’s
practices regarding warnings) constitutes a new statement is
unavailing.
The identity of these individuals is not a surprise.
Plaintiffs filed previous statements on July 6, 2012, identifying
them as former patients of Dr. Bonacci.3
The change in the
import of their testimony does not warrant striking it from the
summary judgment record.
BACKGROUND
As set forth in Dr. Greco’s deposition, he graduated from
Jefferson Medical College in Philadelphia, Pennsylvania in 1951.
After graduation, he remained in Philadelphia where he served his
surgical residency at the Jefferson Medical College Hospital.
After completing his residency, he moved to Drums, Pennsylvania
in 1956.
McNeely, Andrews, Fecho and Francine Melnick were born
in 1952, 1953, 1955 and 1958.
Dr. Greco therefore moved to the
area after the births of three of the four plaintiffs.
Drums, Tresckow and Hazleton, Pennsylvania are located in
the same general area.4
Dr. Greco began practicing surgery in
the Hazleton area in 1956.
The nature of his practice covered
3
Moreover, during a December 13, 2012 conference,
plaintiffs’ counsel represented that she first disclosed these
two individuals to Lilly in May or June 2012.
4
This court takes judicial notice of the locations of
Drums, Tresckow and Hazleton, Pennsylvania. See United States v.
Bello, 194 F.3d 18, 23 (1st Cir. 1999) (“[g]eography has long
been peculiarly susceptible to judicial notice for the obvious
reason that geographic locations are facts which are not
generally controversial”).
4
“everything from remov[ing] toenails to operating on hearts.”
(Docket Entry # 327-8).
At the outset of his practice, he had
“free time” and, in an attempt to build his practice, he made one
or two social visits to Dr. Bonacci’s office in 1956 or 1957 to
introduce himself.
(Docket Entry # 327-8).
Dr. Greco did not
have the opportunity “to see” Dr. Bonacci during these social
visits because “he was always very busy.”
(Docket Entry # 327-
8).
Dr. Greco became more familiar with Dr. Bonacci during
monthly staff meetings at the two local hospitals, “St. Joseph’s
and Hazleton General.”
(Docket Entry # 327-8).
The discussion
at these educational staff meetings among the small community of
local doctors covered “anything and everything.”
327-8).
(Docket Entry #
Dr. Greco remembers discussing “mutual problems” as well
as advances in surgery, medical treatment for hypertension and
antibiotics with Dr. Bonacci.
(Docket Entry # 327-8).
In addition to seeing Dr. Bonacci twice a month at these
staff meetings, Dr. Greco saw him at the hospitals.
Dr. Greco
customarily did his rounds at 6:00 a.m. and 6:00 p.m.
A family
physician such as Dr. Bonacci would also conduct rounds when he
had patients at one of the hospitals.
In addition, Dr. Greco
estimated that he received “anywhere from one to four surgical
referrals” from Dr. Bonacci per month.
(Docket Entry # 327-8).
Dr. Greco usually consulted with Dr. Bonacci about all of the
5
patients he referred.
The two also discussed “advances in
surgery” and in antibiotics.
(Docket Entry # 327-8).
Dr. Greco did not treat patients in Dr. Bonacci’s office.
He never attended any of the house calls Dr. Bonacci made and he
never shared an office with Dr. Bonacci.
Dr. Greco, a general
surgeon, did not practice medicine with Dr. Bonacci, a family
practitioner.
The relevant portion of the deposition testimony
reads:
Q. . . . Dr. Bonacci made house calls did he not?
A.
Yes he did.
Q.
Did you ever go on any house calls with him?
A. No, I didn’t. If you’re going to ask me what is Dr.
Bonacci’s practice, I don’t know, I didn’t practice with
him. I know the type of physician he was, if you want to
ask me that.
(Docket Entry # 327-8, pp. 101-102).
familiar with Dr. Bonacci’s character.
Dr. Greco is, however,
He depicts:
Dr. Bonacci’s character as being conservative, very
compassionate and almost anal retentive as far as the care
of his patients was concerned. And his patients always came
first. And I am sure that if he read any warning on any
drug, if he thought it was bad enough, he certainly would
not dispense it, because that’s the type of individual he
was.
(Docket Entry # 327-8).
Dr. Greco does not recall talking to Dr. Bonacci about DES.
He does remember seeing “a prescription” for DES written by Dr.
6
Bonacci.5
In addition, he “would imagine” that Dr. Bonacci wrote
prescriptions for antibiotics because “very few doctors stocked
antibiotics in their office[s].”6
(Docket Entry # 327-8).
“[T]he common drugs that most doctors stocked” in their offices
included sedatives, sleeping capsules, aspirin and codeine
because they “treat[ed] the most common complaints that people
coming into a family doctor had.”
(Docket Entry # 331-7).
Like
Dr. Bonacci, Dr. Greco prescribed drugs from his office.
Consistent or, at a minimum, not inconsistent with Dr.
Greco’s clear answers at the deposition, he attests to the
following in the subsequent affidavit:
“[I]t was common for me
to discuss issues relating to the practice of medicine with Dr.
Bonacci half a dozen times a month, in either patient referrals,
5
The relevant portion of the deposition testimony reads:
Q. Do you know, as you sit here today, what specific
medicines [Dr. Bonacci] dispensed?
A. I know one of the medicines he dispensed was DES,
diethylstilbestrol, I know that as a matter of fact.
(Docket Entry # 331-7, p. 110).
At a later point during the deposition, Dr. Greco testified
as follows:
Q. Did you have the opportunity to ever actually see a
prescription written by Dr. Bonacci for DES?
A.
Yes, I testified to that.
(Docket Entry # 327-8, p. 130).
6
In the 1950s, Pennsylvania law allowed licensed
physicians to dispense medication. (Docket Entry # 327-8).
7
hospital rounds, or association meetings.”
4).
(Docket Entry # 331-
He describes his relationship with Dr. Bonacci as “both
personal and professional.”
(Docket Entry # 331-4).
The two
“often discuss[ed] treatment options” for the patients Dr.
Bonacci referred and whether “medication alone, or surgery, would
be most beneficial, and what were the side effects and risks of
the various modalities.”
(Docket Entry # 331-4).
It was
“impossible” for Dr. Greco to specify the number of conversations
he had with Dr. Bonacci about “drug side effects” but he believed
“it was enough” for him to know “the nature of [Dr. Bonacci’s]
practice.”
(Docket Entry # 331-4).
Dr. Greco does recall
discussing the risks and side effects of antibiotics with Dr.
Bonacci and the information in the manufacturer’s labeling.
Dr. Greco also averred that Dr. Bonacci’s “custom and habit”
was not to “prescribe any drug if it came with a warning similar
to” the warning attached to the affidavit.7
7
(Docket Entry # 331-
The attached hypothetical warning reads:
The safety and efficacy of DES is still under investigation.
Although there are reports that DES may be helpful in
maintaining a pregnancy, other reports question its
efficacy. Both human and animal studies report that natural
as well as synthetic estrogens (1) cross the placenta, (2)
cause anomalies in the sexual tissue of a developing fetus,
[and] (3) affect the breast of the newborn, presenting an
increased risk of vaginal or breast neoplasm. Synthetic and
natural estrogens are a known cause of cancer. Further
investigation is warranted. There are no controlled studies
which support either efficacy or safety.
(Docket Entry # 331-4).
8
4, ¶ 8).
In the affidavit, he further states:
that the standard medical practice in Hazleton was, and is,
to pass warnings on to our patients. In fact, to do any
less would amount to a departure from accepted practice.
Dr. Bonacci was regarded by myself, and other physicians, as
one of the best and most caring doctors in the area. That
he would prescribe DES, without discussing a warning like
this with his patients, would be a departure from his
routine and habitual practice. In the entire course of my
familiarity with Dr. Bonacci, for him to ignore a
manufacturer’s warning would be unthinkable.
(Docket Entry # 331-4, ¶ 9).
In sum, beginning in and around 1956 or 1957, Dr. Greco
became acquainted with Dr. Bonacci.
The two physicians developed
a personal and professional relationship.
of Dr. Bonacci’s practice.
Dr. Greco was not part
They did not discuss DES although Dr.
Greco does remember seeing a prescription for DES written by Dr.
Bonacci.
Dr. Greco never witnessed Dr. Bonacci warn a patient
about side effects of a medication let alone the side effects of
DES.
He never saw Dr. Bonacci inform a patient of risks or side
effects contained in a manufacturer’s label for a drug.
He
therefore did not have first hand knowledge of Dr. Bonacci’s
prescribing practices of heeding a manufacturer’s negative
warnings and not prescribing a medication or informing a patient
of side effects, if any, of a medication he was prescribing.
Dr. Greco has, however, spoken with Dr. Bonacci numerous
times about patients that they shared.
They saw each other
frequently including at monthly staff meetings and during
9
hospital rounds.
From 1956 until at least 1980,8 they both
practiced medicine in the Hazleton community.
They discussed
inter alia advances in medicine and mutual problems.
They also
had conferences about a particular patient’s concerns about drug
side effects and that such side effects should be discussed with
the patient.
Dr. Greco is also familiar with the standard medical
practice in the Hazleton area.
He moved to Drums in or around
July 1956 and established a surgical practice covering a wide
range of medical conditions.
He retired in 1986.
Monthly staff
meetings at the two hospitals allowed Dr. Greco to “get[] the
feel of what the practice was in the area.”
8).
(Docket Entry # 327-
The community of doctors in the area was small.9
DISCUSSION
Lilly maintains that Dr. Greco’s testimony is hearsay, does
not constitute a “habit” under Rule 406, F.R.E. (“Rule 406”), and
is inadmissible character evidence under Rule 404.
# 338).
(Docket Entry
Plaintiffs submit that Dr. Greco may testify about Dr.
Bonacci’s custom and prescribing practices under Rule 406.
According to plaintiffs, Dr. Greco’s familiarity with Dr.
8
Dr. Bonacci died in the 1980s.
Dr. Greco retired in
1986.
9
As discussed infra, such first hand knowledge about the
practice of medicine in the Hazleton area provides an adequate
foundation from which to provide a lay opinion about the standard
medical practice in Hazleton in and around the mid to late 1950s.
10
Bonacci’s practices allows him to testify about the latter’s
habit of passing manufacturer’s warnings about the drugs he
prescribed to his patients as well as his practice not to
prescribe drugs that carry a warning such as the one attached to
his affidavit.
(Docket Entry ## 333 & 331-4).
Dr. Greco’s
affidavit also opines about the standard medical practice in
Hazleton.
The standard practice encompassed passing warnings to
patients.
The Federal Rules of Evidence distinguish between character
evidence in Rule 404 and Rule 405, F.R.E., and habit evidence in
Rule 406.
Because different rules apply to each category, it is
important to clarify the distinctions as applied to Dr. Greco’s
statements.
A habit “describes one’s regular response to a repeated
specific situation.”
Rule 406, F.R.E., Advisory Committee Notes;
Weissenberger’s Federal Evidence Courtroom Manual, § 406 (7th ed.
2011) (“concept” of a habit “is best understood as a person’s
regular practice of meeting a particular kind of situation with a
specific type of responsive conduct”).
Habit evidence “may be
probative of ‘“the regular practice of meeting a particular kind
of situation with a specific type of conduct, such as the habit
of going down a particular stairway two stairs at a time, or of
giving the hand-signal for a left turn.”’”
United States v.
Newman, 982 F.2d 665, 668 (1st Cir. 1992) (quoting Advisory
11
Committee Notes of Rule 406, quoting McCormick, Evidence § 195 at
826).
In contrast, “Character is a generalized description of
one’s disposition, or of one’s disposition in respect to a
general trait, such as honesty, temperance, or peacefulness.”
Rule 406, F.R.E., Advisory Committee Notes.
Dr. Greco’s statement that, “Dr. Bonacci was regarded by
myself, and other physicians, as one of the best and most caring
doctors in the area” (Docket Entry # 331-4, ¶ 9, sent. 3-5) is a
statement about his character.
Likewise, Dr. Greco’s deposition
testimony describing “Dr. Bonacci’s character as being
conservative, very compassionate and almost anal retentive” or
his dedication to his patients (Docket Entry # 327-8, pp. 132-133
& 135-136) constitutes character evidence.
Insofar as plaintiffs
seek to rely on this evidence to establish Dr. Bonacci’s conduct
on the particular occasions that he prescribed DES to plaintiffs’
mother, Rule 404(a) does not permit it.
Subject to certain
exceptions that do not apply to Dr. Greco’s statements, Rule
404(a) prohibits the admission into evidence “of a person’s
character or character trait . . . to prove that on a particular
occasion the person acted in accordance with the character or
trait.”10
Rule 404(a), F.R.E.
10
Dr. Greco’s averment that “one of Dr. Bonacci’s greatest
concerns was ensuring that his patients and [Dr. Greco’s]
patients were well informed of the risks and benefits of their
medications” (Docket Entry # 331-4, ¶ 5) falls into a grey area
between character and habit evidence. If construed as character
evidence, it is not admissible under Rule 404. It is likewise
12
Turning to the proposed habit evidence, Dr. Greco’s
statements fall into the following categories:
(1) statements of
specific conduct that Dr. Bonacci dispensed DES and that he saw a
prescription for DES written by Dr. Bonacci (Docket Entry # 3317, pp. 110 & 131); (2) statements about his discussions with Dr.
Bonacci about the risks and side effects of antibiotics or
advances in antibiotics (Docket Entry # 331-4, ¶ 7; Docket Entry
# 327-8, p. 107, ln. 2-15); (3) statements about his discussions
with Dr. Bonacci regarding unidentified patients’ concerns about
the risks and side effects of medication (Docket Entry # 331-4,
¶¶ 4 & 6); (4) statements about his discussions with Dr. Bonacci
concerning advances in medicine, “mutual problems,” an
unidentified shared patient or the practice of medicine in
general (Docket Entry # 331-4, ¶ 3, sent. 1) (Docket Entry # 3278, p. 104, ln. 3-7; p. 105, ln. 20-24; p. 106, ln. 20-24; p. 107,
ln. 1 & 16-24; p. 108, ln. 1-18); and (5) opinions about Dr.
Bonacci’s prescribing practices (Docket Entry # 331-4, ¶¶ 2 & 8;
Docket Entry # 327-8, pp. 133-135) and the standard medical
practice in Hazleton (Docket Entry # 331-4, ¶ 9, sent. 1-2).
These statements either attempt to provide evidence of Dr.
Bonacci’s prescribing habits, opinions about the practice of
medicine in Hazleton or Dr. Bonacci’s practices in particular
and/or background or foundational evidence to support admission
of such evidence.
Plaintiffs also seek admission of the
inadmissible as habit evidence for reasons discussed infra.
13
aforementioned testimony by two of Dr. Bonacci’s patients.
Plaintiffs, as the parties offering the Rule 406 evidence,
bear the burden of establishing the habitual nature of the
practice.
See United States v. Newman, 982 F.2d at 668; Weil v.
Seltzer, 873 F.2d 1453, 1461 (D.C.Cir. 1989).
The two factors
considered controlling in determining whether an individual’s
behavior pattern “has matured into a habit” are the “‘adequacy of
sampling and uniformity of response.’”
United States v. Newman,
982 F.2d at 668 (quoting Rule 406 Advisory Committee Notes).
Both “factors focus on whether the behavior at issue ‘occurred
with sufficient regularity making it more probable than not that
it would be carried out in every instance or in most instances.’”
Id. (quoting Weil v. Seltzer, 873 F.2d at 1460).
“The requisite
regularity is tested by the ‘“ratio of reaction to situations.”’”
Id. (quoting Wilson v. Volkswagen of America, Inc., 561 F.2d 494,
512 (4th Cir. 1977), and citing Weil v. Seltzer, 873 F.2d at
1461).
Plaintiffs must therefore provide a sufficient foundation
to assess the adequacy of the sampling.
See id. (“[a]ppellant’s
proffer failed to demonstrate the admissibility of the MacDonald
testimony under Rule 406” and “provided no foundation for
assessing the adequacy of the sampling”).
“[T]he regularity of
the conduct alleged to be habitual” or routine, here, Dr.
Bonacci’s prescribing practices or the standard medical practices
in Hazleton of sharing warnings with patients, must “rest on an
14
analysis of instances numerous enough to support an inference of
systematic conduct and to establish one’s regular response to a
repeated specific situation.”
Id. (internal quotation marks and
brackets omitted).
The testimony of two of Dr. Bonacci’s former patients
(Docket Entry ## 331-5 & 331-6) falls significantly short of the
requisite number of instances and uniformity of response from
which to establish Dr. Bonacci’s prescribing practices.
Ritz and
Makowiec were Dr. Bonacci’s patients for a lengthy period of
time.
Dr. Bonacci, who was too busy to see Dr. Greco during the
latter’s social visit[s] to his office, had significantly more
than two patients to whom he prescribed medication.
The
instances of prescribing medications to Ritz and Makowiec are
therefore not numerous enough to support a finding of habitual
conduct.
See id. at 669 (quoting G.M. Brod & Co. v. U.S. Home
Corporation, 759 F.2d 1526, 1533 (11th Cir. 1985), rejecting Rule
406 evidence because the “specific instances within experience of
witness, when considered in light of thousands of unobserved
similar instances, ‘falls far short of the adequacy of sampling
and uniformity of response which are the controlling
considerations governing admissibility’”).
Turning to Dr. Greco’s testimony, plaintiffs wish to use his
testimony to show that Dr. Bonacci would have heeded a
manufacturer’s warning and not prescribed DES if the drug carried
15
a warning similar to the one attached to Dr. Greco’s affidavit.
According to plaintiffs, when faced with the situation of
prescribing medication to his patients, Dr. Bonacci had a regular
practice or habit of heeding a manufacturer’s warnings and either
not prescribing the medication or sharing the negative warnings
with his patients.
Dr. Greco, however, has never seen or
observed Dr. Bonacci prescribe medication.
He lacks personal
knowledge of Dr. Bonacci’s particular prescribing behavior of
heeding a manufacturer’s negative warning.
Dr. Greco never saw
or witnessed Dr. Bonacci prescribe medication to a patient let
alone see him prescribe DES.
Dr. Greco is not a member of Dr.
Bonacci’s staff and was not in a position to observe Dr. Bonacci
prescribe medication.
The statements in categories two through four do not
adequately or sufficiently show similar instances of the behavior
or practice at issue.
Discussions about medical advances or the
side effects of antibiotics between two physicians (as opposed to
a physician and a patient) or about a shared patient are not
evidence of similar instances let alone instances numerous enough
to warrant the inference of Dr. Bonacci’s habitual conduct of not
prescribing medications that carried negative warnings.
See also
G.M. Brod & Co., Inc. v. U.S. Home Corporation, 759 F.2d at 1533
(“Sierra’s testimony of specific instances of Home’s operation
within his personal experience, when considered in the light of .
16
. . the significant differences between the types of contracts
involved” and course of dealing “falls short of the adequacy of
sampling and uniformity of response”); accord United States v.
Newman, 982 F.2d at 669 (quoting G.M. Brod & Co., Inc. v. U.S.
Home Corporation, 759 F.2d at 1533).
As direct instances of
habit evidence, the testimony in categories two through four does
not constitute part of the summary judgment record.
The statements in category one that Dr. Greco saw “a
prescription written by Dr. Bonacci for DES” and his professed
knowledge that Dr. Bonacci dispensed DES (Docket Entry # 331-7,
pp. 110 & 131) also fail to establish that the behavior occurred
with sufficient regularity.
As specific instances of conduct,
these instances are not numerous enough, even including the two
affidavits from Dr. Bonacci’s former patients, to support an
inference of systemic conduct on the part of Dr. Bonacci in not
prescribing medication with negative warnings.
See United States
v. Newman, 982 F.2d at 668.
Lilly also argues that Dr. Greco’s testimony amounts to
hearsay.
The argument is well taken insofar as it applies to Dr.
Greco’s testimony about Dr. Bonacci’s prescribing practices.
Dr.
Greco’s recitations of what Dr. Bonacci said to him are hearsay.
Dr. Bonacci is not a party and, accordingly, his statements to
Dr. Greco do not constitute party admissions.
Dr. Greco has no
firsthand knowledge of the prescribing practices of Dr. Bonacci.
See, e.g., Weil v. Seltzer, 873 F.2d at 1461.
17
Categories one and
four, however, provide a foundational basis to support admissible
evidence in the form of Dr. Greco’s lay opinion on the standard
medical practice in Hazleton.
Rule 406 is silent with respect to the method of proof to
establish habit.
The rule simply states that:
Evidence of a person’s habit or an organization’s routine
practice may be admitted to prove that on a particular
occasion the person or organization acted in accordance with
the habit or routine practice. The court may admit this
evidence regardless of whether it is corroborated or whether
there was an eyewitness.11
Rule 406, F.R.E.
Here, the proponents of the evidence do not rely on expert
testimony as a means to prove habit.
They do, however, proffer
Dr. Greco’s lay opinions subdivided as:
(1) statements of his
opinion that Dr. Bonacci would not have prescribed DES or any
medication if it contained certain negative warnings (Docket
Entry # 331-4, ¶¶ 2 & 8) (Docket Entry # 327-8, pp. 133-135); and
(2) statements of Dr. Greco’s opinion about “the standard medical
practice” in Hazleton (Docket Entry # 331-4, ¶ 9, sent. 1-2).12
11
The latter sentence specifies that admissibility does
not require corroborating evidence or an eyewitness. Rule 406
therefore “abrogated older authority that habit evidence was not
admissible in certain cases if there was an eyewitness to the
event.” 2 J. Weinstein & M. Berger, Weinstein’s Federal Evidence
§ 406.05 (2nd ed. 2012).
12
Dr. Greco provides additional descriptions of the
medical practice in the Hazleton area (Docket Entry # 327-8, pp.
103 & 106) which, together with other evidence in the record,
provides sufficient foundation for the aforementioned lay opinion
regarding standard medical practice of local doctors practising
in the Hazleton area.
18
Rule 406 case law exemplifies a preference for proof of
specific instances of conduct based on the witnesses direct
observations.13
See Hall v. Arthur, 141 F.3d 844, 849 (8th Cir.
1998) (affirming Rule 406 admission of testimony from dentist’s
other patients who had personal knowledge of what the dentist
told or did not tell them about risks for the same procedure the
dentist performed on the plaintiff); Meyer v. United States, 638
F.2d 155, 156 (10th Cir. 1980) (affirming Rule 406 admission of
dentist’s own testimony of what he did to advise patients of
risk); Weil v. Seltzer, 873 F.2d at 1460-1461 (unsuccessful
attempt to introduce testimony of five former patients who had
personal knowledge of how the defendant treated their allergies
but no personal knowledge of how the defendant treated other
patients).
Rule 406 does not, however, exclude lay opinion evidence.
As explained by one commentator:
Rules 602 and 701 in combination provide that an opinion of
a nonexpert witness is admissible if based upon personal
knowledge and helpful to the trier of fact in determining a
fact of consequence. Opinions of witnesses as to the
routine practice of an organization or habit of an
individual based upon personal knowledge of the witness
should normally be permitted on such grounds. If
undisputed, opinion testimony would avoid wasting time.
Where in controversy, specific instances of conduct may in
the discretion of the court be required to be disclosed as
part of development of the witness’ basis for his opinion.
13
Although the testimony of the habit bearer would also
suffice, see, e.g., United States v. Arredondo, 349 F.3d 310, 315
(6th Cir. 2003), Dr. Bonacci died in the mid-1980s.
19
Specific instances forming the basis of the witness’ opinion
may of course be developed on cross-examination.
Michael H. Graham, Handbook of Federal Evidence § 406:4 (6th ed.
2006).
Exercising this court’s discretion, see generally 2 J.
Weinstein & M. Berger, Weinstein’s Federal Evidence § 406.06[2]
(2nd ed. 2012), Dr. Greco’s lay opinions may provide a proper
means to establish habit or routine practice if they satisfy the
requirements of Rule 701.14
Rule 701 governs the admission into evidence of a lay
opinion.
The lay opinion witness remains a fact witness as
14
With respect to the lay opinion of the standard medical
practice in Hazleton (Docket Entry # 331-4, ¶ 9), the Hazleton
community of doctors must constitute an organization or group
within the meaning of Rule 406. See 2 J. Weinstein & M. Berger,
Weinstein’s Federal Evidence § 406.03[2] (2nd ed. 2012) (entity
must be cohesive organization to admit routine practice under
Rule 406); Rule 406, F.R.E., Advisory Committee Notes
(“[e]quivalent behavior on the part of a group is designated
‘routine practice of an organization’ in the rule”); see also
United States v. Rangel-Arreola, 991 F.2d 1519, 1523 (10th Cir.
1993) (“loose-knit group” of truck drivers “with no apparent
structure or routine” was not an organization or group within the
meaning of Rule 406). More specifically, the entity in question
“must be a cohesive organization marked by structure and
routine.” 2 J. Weinstein & M. Berger, Weinstein’s Federal
Evidence § 406.03[2] (2nd ed. 2012) (citing United States v.
Rangel-Arreola, 991 F.2d at 1523); see generally Elias v. Suran,
616 N.E.2d 134, 137 (Mass.App.Ct. 1993) (applying Massachusetts
law). Here, the practice in the Hazleton community of local
doctors differed from the practice in “big cities.” (Docket
Entry # 327-8, p. 103). Doctors followed their patients in the
hospital. It was a rule in the two local hospitals to attend
monthly staff meetings. (Docket Entry # 327-8, p. 105). Dr.
Greco and Dr. Bonacci were members of that group inasmuch as they
saw each other at these meetings. “It was a small community.”
(Docket Entry # 327-8, pp. 106-107). For purposes of summary
judgment only, this court finds that the group qualifies as an
organization.
20
opposed to an expert witness.
See Weissenberger’s Federal
Evidence Courtroom Manual, § 701 (7th ed. 2011) (“Rule 701
governs the admissibility of opinion testimony by lay witnesses,
more commonly referred to as ‘fact’ witnesses”).
Unlike an
expert’s opinion, a layman’s opinion must be “rationally based on
the witness’s perception.”
Rule 701(a), F.R.E.; see Rule 602,
F.R.E.; 23 Charles Alan Wright & Kenneth W. Graham, Jr. Federal
Practice and Procedure § 5276 (1980) (noting need to “show that
his opinion or generalization is based on his personal
knowledge”).
The rule imposes additional conditions that the
opinion testimony is helpful to determine a fact or clearly
understand the witness’s testimony and is not based on
scientific, technical or other specialized knowledge under Rule
702.15
Under the rule, courts allow “lay witnesses to express
opinions about a business ‘based on the witness’s own perceptions
and “knowledge and participation in the day-to-day affairs of the
15
The rule reads as follows:
Opinion Testimony by Lay Witnesses
If a witness is not testifying as an expert, testimony in
the form of an opinion is limited to one that is:
(a) rationally based on the witness’s perception;
(b) helpful to clearly understanding the witness’s testimony
or to determining a fact in issue; and
(c) not based on scientific, technical, or other specialized
knowledge within the scope of Rule 702.
Rule 701, F.R.E.
21
business.”’”
United States v. Munoz-Franco, 487 F.3d 25, 35-36
(1st Cir. 2007) (quoting United States v. Polishan, 336 F.3d 234,
242 (3rd Cir. 2003), with internal brackets omitted); see United
States v. Valdivia, 680 F.3d 33, 50-51 (1st Cir. 2012) (drug
enforcement agent allowed to give lay opinion about telephone
account at issue based on his prior drug investigations and
experience “that traffickers often list unrelated third parties
as their telephones’ subscribers”).
For previously stated reasons, Dr. Greco lacks firsthand
knowledge of Dr. Bonacci’s prescribing practices.
Accordingly,
there is an inadequate foundation under Rule 701(a) to consider
Dr. Greco’s opinion that Dr. Bonacci would not have prescribed
DES if it contained a warning similar to the one attached to Dr.
Greco’s affidavit.
(Docket Entry # 331-4, ¶ 2).
Turning to the existence of the requisite knowledge under
Rule 701(a) as a basis to consider Dr. Greco’s opinion about
standard medical practice in the Hazleton area, he practiced
medicine as a surgeon in the area from 1956 to 1986.
He is
intimately familiar with the small community of doctors having
attended monthly staff meetings and conducted rounds at the two
hospitals.
He therefore has the requisite knowledge within the
meaning of Rule 701(a).
The opinion is helpful to determine the
proximate cause issue in Count I.
Routine medical practice in
the mid to late 1950s in Hazleton is decidedly less complex than
22
it is today.
(Docket Entry # 327-8, p. 103).
As such, it is not
based on knowledge within the scope of Rule 702.
As evidence of habit, although a patient’s medical history
is not routine, a manufacturer’s warnings about a medication are
established by product literature disclosed and communicated by
the manufacturer or contained in established authorities such as
the Physicians’ Desk Reference to Pharmaceutical Specialities and
Biologicals (1952) (Docket Entry # 331-3) or the American
Druggist Blue Book (1952) (Docket Entry # 327-4).
The opinion
could therefore be admissible to show the practice of the small
group of doctors in the local community allowing the jury to
infer the practice of Dr. Bonacci.
Finally, this determination to include Dr. Greco’s lay
opinion on the standard medical practice in Hazleton as habit
evidence under Rule 406 as part of the summary judgment record or
that such a practice in the Hazleton community exists and
qualifies as Rule 406 habit evidence is not the law of this case
with respect to the proceedings at trial based on a different
record.
See Fisher v. Trainor, 242 F.3d 24, 29 n.4 (1st Cir.
2001) (“‘initial denial of summary judgment does not foreclose,
as the law of the case, a subsequent grant of summary judgment on
an amplified record’”).
The ruling also does not foreclose the
possibility of admitting Dr. Greco’s lay opinion testimony for
purposes other than to show the routine practice of medicine in
23
the Hazleton under Rule 406.
See generally United States v.
Valdivia, 680 F.3d at 50-51 (discussing lay opinion of drug
enforcement agent without referring to Rule 406).
As a final matter, at the November 2012 hearing, plaintiffs
opposed the motion to strike as outside the parameters of a
procedural order.
The order limited the number of pages of the
memorandum in support of summary judgment, the LR. 56.1 statement
and the “[s]upporting exhibits and affidavits.”
319).
(Docket Entry #
It did not limit Lilly’s ability to file a motion to
strike exhibits filed by plaintiffs to support their opposition.
See generally Iacobucci v. Boulter, 193 F.3d 14, 19 (1st Cir.
1999) (“[a] trial court ordinarily is the best expositor of its
own orders”).
II.
MOTION FOR PARTIAL SUMMARY JUDGMENT
Lilly seeks partial summary judgment on the duty to warn
negligence count due to the absence of evidence that Lilly’s
failure to warn that DES increases the risk of breast cancer in a
patient’s female offspring proximately caused plaintiffs’ breast
cancer.
Under the “learned intermediary” rule, plaintiffs must
show “that if Lilly had warned Dr. Bonacci that DES increased the
risk of breast cancer in a patient’s female offspring, then Dr.
Bonacci would not have prescribed the drug,” according to Lilly.
(Docket Entry # 325).
24
Plaintiffs assert that Pennsylvania law16 applies a
rebuttable “heeding presumption” because they were exposed to DES
without their consent, there is no evidence that Dr. Bonacci
ignored Lilly’s warnings and there is evidence that he deferred
to manufacturers’ warnings.
Plaintiffs submit it is a question
for the jury as to whether Dr. Bonacci had a habit, custom or
practice of reading and heeding warnings for drugs he prescribed
and whether Dr. Bonacci would not have prescribed DES to
plaintiffs’ mother if he was given a proper warning.
It is also
a jury question whether, if Dr. Bonacci shared an adequate
warning with plaintiffs’ mother, she would have refused to take
the drug, according to plaintiffs.
(Docket Entry # 333).
STANDARD OF REVIEW
Summary judgment is designed “‘to pierce the boilerplate of
the pleadings and assay the parties’ proof in order to determine
whether trial is actually required.’”
Davila v. Corporacion De
Puerto Rico Para La Difusion Publica, 498 F.3d 9, 12 (1st Cir.
2007).
It is appropriate when the summary judgment record shows
“there is no genuine issue of material fact, and the moving party
is entitled to judgment as a matter of law.”
Civ. P.
Rule 56(a), Fed. R.
“A dispute is genuine if the evidence about the fact is
such that a reasonable jury could resolve the point in the favor
of the non-moving party.”
American Steel Erectors, Inc. v. Local
16
The parties correctly agree that Pennsylvania law
applies to Count I.
25
Union No. 7, International Association of Bridge, Structural,
Ornamental & Reinforcing Iron Workers, 536 F.3d 68, 75 (1st Cir.
2008).
“‘A fact is material if it carries with it the potential
to affect the outcome of the suit under the applicable law.’”
OneBeacon America Insurance Co. v. Commercial Union Assurance Co.
of Canada, 684 F.3d 237, 241 (1st Cir. 2012).
Facts are viewed in favor of the non-movants, i.e.,
plaintiffs.
2009).
Noonan v. Staples, Inc., 556 F.3d 20, 23 (1st Cir.
“Where, as here, the nonmovant has the burden of proof
and the evidence on one or more of the critical issues in the
case is not significantly probative, summary judgment may be
granted.”
Davila v. Corporacion De Puerto Rico Para La Difusion
Publica, 498 F.3d at 12 (internal quotation marks, citation and
ellipses omitted); accord OneBeacon America Insurance Co. v.
Commercial Union Assurance Co. of Canada, 684 F.3d at 241 (on
issues where movant does not have burden of proof, movant can
obtain summary judgment by showing “‘an absence of evidence to
support the nonmoving party’s case’”); Clifford v. Barnhart, 449
F.3d 276, 280 (1st Cir. 2006) (if moving party makes preliminary
showing, nonmoving party must “produce specific facts, in
suitable evidentiary form, to establish the presence of a
trialworthy issue” with respect to each element on which he
“would bear the burden of proof at trial”) (internal quotation
marks and citations omitted).
26
Nonmovants such as plaintiffs “‘may defeat a summary
judgment motion by demonstrating, through submissions of
evidentiary quality, that a trialworthy issue persists.’”
Rockwood v. SKF USA Inc., 687 F.3d 1, 9 (1st Cir. 2012).
“[C]onclusory allegations, improbable inferences, and unsupported
speculation” however are “insufficient to discharge the
nonmovant’s burden.”
Id. (internal brackets supplied and
internal quotation marks omitted)); see Chiang v. Verizon New
England Inc., 595 F.3d 26, 30 (1st Cir. 2010) (noting requirement
to ignore “‘conclusory allegations, improbable inferences, and
unsupported speculation’” on summary judgment).
Finally,
uncontroverted statements of fact in a LR. 56.1 statement
comprise part of the summary judgment record.
See Cochran v.
Quest Software, Inc., 328 F.3d 1, 12 (1st Cir. 2003) (the
plaintiff’s failure to contest date in LR. 56.1 statement of
material facts caused date to be admitted on summary judgment).
FACTUAL BACKGROUND
In addition to Dr. Greco’s lay opinion, the summary judgment
record shows the following.
Plaintiffs’ mother suffered a
miscarriage in 1949.
She gave birth to Mary Ann Killian
(“Killian”) in 1950.
In 1951, she experienced a second
miscarriage.
Thereafter, she gave birth to McNeely, Andrews,
Fecho and Francine Melnick in 1952, 1953, 1955 and 1958.
Plaintiffs’ mother was a patient of Dr. Bonacci’s throughout this
time period.
Dr. Bonacci did not prescribe DES to plaintiffs’
27
mother during her first pregnancy.
For purposes of the present
motion, she did ingest Lilly’s DES during the pregnancies of each
of the four plaintiffs.
Dr. Bonacci is deceased and has not
provided any testimony or documentation relative to his treatment
of plaintiffs’ mother.
During the 1950s, Lilly recommended DES treatment for
threatened abortion as well as repeated or habitual abortion.
(Docket Entry # 327-6).
The phrase “habitual abortion” denotes
three or more consecutive abortions.
Lilly also recommended DES
therapy “to prevent accidents of pregnancy.”
331-3).
(Docket Entry #
Lilly’s literature supplied to physicians did not
include any warning about the risk that DES could cross the
placenta and affect a baby in utero.
327-5 & 327-6).
(Docket Entry ## 331-2,
Lilly’s literature provided to physicians also
noted that, “In the absence of hypothyroidism, probably the most
effective agent” for treating habitual abortion is DES.
(Docket
Entry # 331-2).
DISCUSSION
Count I raises a negligent duty to warn claim against Lilly
as the manufacturer of DES.
As a federal court sitting in
diversity and adjudicating a state law claim, this court is bound
by the state’s substantive law as pronounced by the state’s
highest court.
2011).
See Barton v. Clancy, 632 F.3d 9, 17 (1st Cir.
Turning to the pronouncements of the Pennsylvania Supreme
Court, section 388 of the Restatement (Second) of Torts (“the
Restatement”) provides the applicable standard of care in a
28
negligent failure to warn claim against the manufacturer of a
prescription drug.
Hahn v. Richter, 673 A.2d 888, 890 (Pa. 1996)
(product liability action against manufacturer of prescription
drug); accord Incollingo v. Ewing, 282 A.2d 206, 220 n.8 (Pa.
1971) (action against pediatrician and osteopath for negligently
prescribing drug and against manufacturer for negligent failure
to warn).
Under section 388, “the supplier has a duty to
exercise reasonable care to inform those for whose use the
article is supplied of the facts which make it likely to be
dangerous.”
Incollingo v. Ewing, 282 A.2d at 220 n.8.
Lilly seeks to apply the learned intermediary doctrine first
adopted in Incollingo v. Ewing, 282 A.2d at 206.
See Mazur v.
Merck & Co., Inc., 964 F.2d 1348, 1356 (3rd Cir. 1992) (“learned
intermediary rule was first adopted by the Pennsylvania Supreme
Court in Incollingo v. Ewing, 282 A.2d at 206”).
As set forth in
Incollingo, the rule instructs that when a drug is “available
only upon prescription of a duly licensed physician, the warning
required is not to the general public or to the patient, but to
the prescribing doctor.”
Incollingo v. Ewing, 282 A.2d at 220.
Two decades after Incollingo, the Pennsylvania Supreme Court
reiterated the rule that a manufacturer’s warning for a
prescription drug runs to the prescribing doctor as opposed to
the patient.
Coyle by Coyle v. Richardson-Merrell, Inc., 584
A.2d 1383, 1385-1386 (Pa. 1991) (citing Incollingo v. Ewing, 282
29
A.2d at 220).17
The Coyle court elaborated upon the rule in the
following manner:
“it is the duty of the prescribing physician to be fully
aware of (1) the characteristics of the drug he is
prescribing, (2) the amount of the drug which can be safely
administered, and (3) the different medications the patient
is taking. It is also the duty of the physician to advise
the patient of any dangers or side effects associated with
the use of the drug as well as how and when to take the
drug. The warnings which must accompany such drugs are
directed to the physician rather than to the
patient-consumer as ‘[i]t is for the prescribing physician
to use his independent medical judgment, taking into account
the data supplied to him by the manufacturer, other medical
literature, and any other source available to him, and
weighing that knowledge against the personal medical history
of his patient, whether to prescribe a given drug.’”
Id. at 1385-1386 (quoting with approval Makripodis v. Merrell Dow
Pharmaceuticals, Inc., 523 A.2d 374, 378 (Pa.Super. 1987),
quoting Leibowitz v. Ortho Pharmaceutical Corporation, 307 A.2d
449, 457 (Pa.Super. 1973)).
The learned intermediary doctrine undeniably poses an
obstacle to plaintiffs in establishing causation.
Plaintiffs do
not dispute that proximate cause is a required element in a
negligent failure to warn claim against a manufacturer.
See
Simon v. Wyeth Pharmaceuticals, Inc., 989 A.2d 356, 368
(Pa.Super. 2009) (“[p]roximate cause is an essential element in
failure-to-warn cases involving prescription medications”);
accord Cochran v. Wyeth, Inc., 3 A.3d 673, 676 (Pa.Super. 2010)
(same); Owens v. Wyeth, 2010 WL 2965014, at *2 (Pa.Super. July
26, 2010) (same) (unpublished); Lineberger v. Wyeth, 894 A.2d
17
The Coyle court refused to extend strict liability under
section 402A of the Restatement to pharmacists dispensing
prescription drugs. Id. at 1386 n.1 & 1387.
30
141, 150 (Pa.Super. 2006) (same).
Instead, they seek to impose
the rebuttable heeding presumption primarily based on a number of
asbestos cases.18
These cases do not involve a manufacturer’s
alleged failure to issue proper warnings for prescription drugs.
Rather, they involve strict liability causes of action under
section 402A of the Restatement against manufacturers based on an
inadequate warning.
The leading asbestos case plaintiffs cite that applies the
rebuttable heeding presumption, Coward, 729 A.2d at 621, holds
that:
[I]n cases where warnings or instructions are required to
make a product non-defective and a warning has not been
given, the plaintiff should be afforded the use of the
presumption that he or she would have followed an adequate
warning, and that the defendant, in order to rebut that
presumption, must produce evidence that such a warning would
not have been heeded.
Id.
Because the plaintiffs in Coward had little choice but to
confront the known risk of asbestos exposure in their places of
employment, the court imposed a rebuttable presumption that they
would have followed an adequate warning.
Id. at 620-621.
The
other asbestos cases plaintiffs cite, all decisions by lower
courts, adhere to Coward and apply the rebuttable heeding
preemption in strict liability failure to warn cases against the
manufacturer.
See Lonasco v. A-Best Products Co., 757 A.2d at
377 (quoting and applying holding in Coward, 729 A.2d at 621, in
18
Coward v. Owens-Corning Fiberglas Corporation, 729 A.2d
614 (Pa.Super. 1999); Lonasco v. A-Best Products Co., 757 A.2d
367 (Pa.Super. 2000); Chicano v. General Electric Co., 2004 WL
2250990 (E.D.Pa. Oct. 5, 2004).
31
strict liability asbestos failure to warn case against
manufacturer); Chicano v. General Electric Co., 2004 WL 2250990,
at *5-6 & *11 (quoting and applying holding in Coward, 729 A.2d
at 621, in asbestos strict liability case against manufacturer).
Plaintiffs reason that the lack of choice that applied to
the toxic, asbestos exposures to the plaintiffs in Coward,
Chicano and Lonasco applies to plaintiffs’ involuntary exposure
to DES in utero.
(Docket Entry # 333, pp. 5-8).
Plaintiffs also
rely on Viguers v. Philip Morris USA, Inc., 837 A.2d 534
(Pa.Super. 2003).
Viguers holds “that the heeding presumption
does not apply” where the plaintiff, a smoker, made “the
voluntary choice . . . to begin and continue smoking tobacco”
despite the existence of federally-mandated warnings on cigarette
packages.
Id. at 538 (emphasis added).
Plaintiffs’ reasoning is misplaced because in prescription
drug cases the manufacturer’s duty to warn goes to the learned
intermediary, the physician, not to the patient.
The physician
has the choice of whether to prescribe a drug after weighing the
data and warnings supplied by the manufacturer against his
patient’s medical history and taking into account other relevant
concerns.
See Simon v. Wyeth Pharmaceuticals, Inc., 989 A.2d at
368-369.
In asbestos failure to warn cases, there is no learned
intermediary exercising his independent medical judgment.
Furthermore, strict liability applies as opposed to negligence
under section 388.
See Anderson v. Wyeth, 2005 WL 1383174, at *4
(Pa.Com.Pl. June 7, 2005).
32
Plaintiffs also point out that the Third Circuit in Pavlik
v. Lane Ltd./Tobacco Exporters International, 135 F.3d 876 (3rd
Cir. 1998), “predict[s] that Pennsylvania would adopt a
rebuttable heeding presumption as a logical corollary to comment
j” to section 402A of the Restatement.
Id. at 883.
Comment j
states that, “Where warning is given, the seller may reasonably
assume that it will be read and heeded; and a product bearing
such a warning, which is safe for use if it is followed, is not
in defective condition, nor is it unreasonably dangerous.”
Restatement (Second) of Torts, § 402A, cmt. j.
The corollary to
this rule “presume[s] that, when no warning or an inadequate
warning is provided, the end-user would have read and heeded an
adequate warning had one been given by the manufacturer.”
Pavlik
v. Lane Ltd./Tobacco Exporters International, 135 F.3d at 883.
Pavlik does not require applying a heeding presumption in
the case at bar because the court made a prediction in a strict
liability case against a distributer and manufacturer of a brand
of butane fuel.
Here again, this case involves a negligent
failure to warn claim under section 388 against the manufacturer
of a prescription drug in which the learned intermediary
customarily exercises “‘independent medical judgment,’” Coyle by
Coyle v. Richardson-Merrell, Inc., 584 A.2d at 1386.
Plaintiffs additionally discount the reach of a series of
cases cited by Lilly.
See Gronniger v. American Home Products
Corporation, 2005 WL 3766685, at *5 (Pa.Com.Pl. Oct. 21, 2005)
(rejecting heeding presumption as applied to manufacturer of
33
prescription diet drugs in negligent failure to warn action);
Leffler v. American Home Products, 2005 WL 2999712, at *5
(Pa.Com.Pl. Oct. 20, 2005) (same); Adams v. Wyeth, 2005 WL
1528656, at *1 (Pa.Com.Pl. June 13, 2005) (rejecting heeding
preemption in negligent failure to warn claim against
manufacturer of prescription diet drug, Pondimin); Anderson v.
Wyeth, 2005 WL 1383174, at *6 (Pa.Com.Pl. June 7, 2005)
(rejecting application of heeding presumption to negligent
failure to warn claim against manufacturer of Redux and other
diet drugs).
Leffler as well as Gronniger accurately explain
that, “Pennsylvania courts have consistently declined to apply
any heeding presumption in pharmaceutical and most other product
liability cases, strictly limiting the application of any such
presumption to claims arising from involuntary workplace exposure
to asbestos.”
Leffler v. American Home Products, 2005 WL
2999712, at *5 (emphasis omitted); accord Gronniger v. American
Home Products Corporation, 2005 WL 3766685, at *5 (same).
Plaintiffs correctly point out that the same judge decided
all four cases in the course of a six month time period involving
the same or similar prescription diet drugs.
Accepting the
resulting limitation on the precedential reach of these
decisions, proximate cause remains “an essential element in
failure to warn cases involving prescription medications.”
Daniel v. Wyeth Pharmaceuticals, Inc., 15 A.3d 909, 923
34
(Pa.Super. 2011);19 Simon v. Wyeth Pharmaceuticals, Inc., 989
A.2d at 368.
As stated in both these Pennsylvania appellate
court cases adjudicating negligent failure to warn cases against
prescription drug manufacturers, “Pennsylvania law requires that
‘there must be some reasonable connection between the act or
omission of the defendant and the injury suffered by the
plaintiff.’”
Daniel v. Wyeth Pharmaceuticals, Inc., 15 A.3d at
924 (quoting Demmler v. SmithKline Beecham Corp., 671 A.2d 1151,
1155 (Pa.Super. 1996), which involved strict liability defective
warning claim against prescription drug manufacturer); Simon v.
Wyeth Pharmaceuticals, Inc., 989 A.2d at 368 (same).
More
specifically, in the context of a negligence duty to warn claim,
“‘plaintiffs must further establish proximate causation by
showing that had defendant issued a proper warning to the learned
intermediary, he would have altered his behavior and the injury
would have been avoided.’”
Simon v. Wyeth Pharmaceuticals, Inc.,
989 A.2d at 368 (quoting Demmler, 671 A.2d at 1155); accord
Daniel v. Wyeth Pharmaceuticals, Inc., 15 A.3d at 924 (“the
plaintiff must establish that if defendant ‘had issued a proper
warning to the learned intermediary, he would have altered his
behavior and the injury would have been avoided’”) (quoting
Demmler, 671 A.2d at 1155); Cochran v. Wyeth, Inc., 3 A.3d at
676-677.
19
The Pennsylvania Supreme Court granted an appeal in part
in Daniel limited to a separate issue. Daniel v. Wyeth
Pharmaceuticals, Inc., 32 A.3d 1260 (Pa. 2011) (Nos. 318 EAL
2011, 319 EAL 2011).
35
In the case at bar, plaintiffs must provide sufficient facts
in suitable evidentiary form with respect to proximate causation
to allow a jury to find in their favor.
Construing the record in
plaintiffs’ favor, including reasonable inferences, Dr. Greco, a
lay witness, opines that the standard medical practice in
Hazleton in and around the mid to late 1950s was for doctors to
pass warnings from manufacturers of prescription drugs to their
patients.
Drawing reasonable inferences, Dr. Bonacci, a busy and
therefore well known family physician in the area, adhered to
this standard medical practice in Hazleton.
Plaintiffs’ mother, having experienced two miscarriages,
sought therapeutic treatment from Dr. Bonacci.
Again drawing
reasonable inferences in plaintiffs’ favor, Dr. Bonacci
prescribed Lilly’s DES which plaintiffs’ mother ingested.
Lacking information about DES, Dr. Bonacci did not warn
plaintiffs’ mother of the risk.
In accordance with the standard
medical practice in Hazleton, the jury can reasonably infer that
Dr. Bonacci would have shared the warning with plaintiffs’
mother.
It is also reasonable to infer that plaintiffs’ mother
would have deferred to the warning Dr. Bonacci presented and,
having successfully conceived Killian, would not have ingested
the DES.
CONCLUSION
In accordance with the foregoing discussion, the motion to
strike (Docket Entry # 337) is ALLOWED in part and DENIED in
part.
The motion for partial summary judgment (Docket Entry #
36
324) is DENIED.
/s/ Marianne B. Bowler
MARIANNE B. BOWLER
United States Magistrate Judge
37
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