Bradley v. Sugarbaker , 809 F.3d 8 ( 2015 )

United States Court of Appeals
For the First Circuit
No. 15-1128
BARBARA J. BRADLEY and MICHAEL BRADLEY,
Plaintiffs, Appellants,
v.
DAVID J. SUGARBAKER, M.D.,
Defendant, Appellee.
APPEAL FROM THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF MASSACHUSETTS
[Hon. George A. O'Toole, U.S. District Judge]
Before
Torruella, Lynch, and Kayatta,
Circuit Judges.
Ilyas J. Rona, with whom Jin-Ho King and Milligan Rona Duran
& King LLP, were on brief, for appellants.
Carol Ann Kelly, with whom Philip E. Murray, Jr., James L.
Wilkinson, and Murray, Kelly & Bertrand, P.C., were on brief, for
appellee.
December 16, 2015
TORRUELLA, Circuit Judge. In this medical malpractice
action, Plaintiffs-Appellants Barbara and Michael Bradley appeal
the district court's decision to grant summary judgment as to their
medical battery claim. Following a jury trial as to their informed
consent claim, they also assert that the district court erred by
excluding expert testimony that a fine-needle aspiration ("FNA")
biopsy was a viable non-surgical alternative to a surgical biopsy.
After careful review of the record, we affirm the district court's
dismissal of the Bradleys' battery claim but vacate and remand
with respect to the excluded expert testimony.
I. Background
A. The Surgery
After experiencing shortness of breath and persistent
pain in her right arm and wrist following a 2002 car accident,
Mrs. Bradley underwent magnetic resonance imaging ("MRI") in
November 2004. The MRI revealed a mass at the top of Mrs.
Bradley's right lung that her physician feared was cancer. After
learning the results of the MRI, Mrs. Bradley was scheduled for a
positron emission tomography ("PET") scan and FNA biopsy.1 On
1 An FNA biopsy is an outpatient procedure in which a radiologist
inserts a long, hollow needle through the skin and into the mass
to extract cells. A pathologist then examines the specimen under
a microscope. The diagnostic yield -- or "the positive yield
rate" -- is between ninety to ninety-five percent.
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December 1, 2004, Mrs. Bradley received her PET scan results, which
suggested that the mass was benign, "although malignancy [could
not] be entirely ruled out."
Mrs. Bradley met with Dr. David Sugarbaker, the
Defendant-Appellee, a thoracic surgeon at Brigham & Women's
Hospital, in Boston on December 7, 2004. During the appointment,
Dr. Sugarbaker took Mrs. Bradley's medical history and learned
that she had scarring on her right lung from the 2002 car accident.
Dr. Sugarbaker stated that he was "more than 50 percent sure [Mrs.
Bradley had] cancer," and that Mrs. Bradley would need to undergo
a biopsy. Dr. Sugarbaker's notes from that day indicated that
"[a] malignancy needs to be ruled out. We will see whether an FNA
can be done to secure a diagnosis." Later that same day, Mrs.
Bradley met with Dr. Lambros Zellos, another thoracic surgeon at
Brigham & Women's, to review her MRI results. Mrs. Bradley
explained to Dr. Zellos that she had an FNA biopsy scheduled and
asked whether she should proceed with that procedure. Dr. Zellos
said it was necessary "to check with the radiologist first to see
if the biopsies could be done that way."
As recounted in more detail herein, Mrs. Bradley never
received an FNA biopsy. After a second PET scan, Dr. Sugarbaker
again met with the Bradleys on December 14, 2004. The scan
indicated that the mass was unlikely to be cancerous. After
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reviewing the scan, Dr. Sugarbaker advised the Bradleys that
"[t]his looks like it might not be cancer" and recommended
scheduling a surgical biopsy to remove and test tissue samples.
Dr. Sugarbaker did not discuss the next steps once he determined
whether the mass was benign or malignant.
Mrs. Bradley proceeded to surgery, which took place on
December 17, 2004. The informed consent form that she signed
indicated that she would undergo a bronchoscopy,2 mediastinoscopy,3
and minithoracotomy4 and described the risks associated with these
procedures. During the operation, Dr. Sugarbaker took six
samples, all of which tested negative for cancer. To obtain a
sixth sample, Dr. Sugarbaker performed a pulmonary wedge
resection, during which he excised a larger sample including
portions of healthy lung tissue. This section measured 8 x 3.5 x
3.5 centimeters, which was larger than each of the other samples.
Following surgery, Mrs. Bradley was dismayed to wake up
in the surgical intensive care unit. At that time, she discovered
2 During trial, Dr. Sugarbaker described a bronchoscopy as a
procedure in which a camera is used to "examine the airway passages
to look for signs of cancer."
3 One of Dr. Sugarbaker's colleagues, Dr. Christopher Ducko,
described a mediastinoscopy as a procedure to "sample and biopsy
the lymph nodes."
4 A minithoracotomy is a procedure whereby doctors biopsy a mass
to remove tissue samples.
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"that during the surgery they actually removed a piece of my lung
when they removed the mass." Her admission notes indicate that
the procedure had become "more extensive [secondary] to
significant scarring from prior trauma and surgery." The notes
also indicate that Mrs. Bradley suffered "multiple air leaks" as
a result of the wedge resection. She was not discharged until
approximately a week later, on December 25, due to the air leaks.
Subsequent X-rays revealed a pneumothorax, otherwise
known as a collapsed lung, where the mass was removed. In the
intervening months, Mrs. Bradley developed a cough and worsening
arm pain. A PET scan revealed what resembled an empyema -- a
collection of pus -- near her lung. Samples from Mrs. Bradley's
right upper chest area tested positive for a fungus known as
aspergillus fumigatus, and Mrs. Bradley was diagnosed with a
bronchopleural fistula, a leak which allowed the space where her
right upper lobe was removed to be infected with aspergillus.
Persistent infections have led to years of complications and pain.
In March 2006, Mrs. Bradley stopped working in her
position as a law librarian because she was "too sick to go to
work." During the summer of 2006, she received intravenous
treatments containing antifungals and antibiotics to treat the
infection. When these remedies proved unsuccessful, Mrs. Bradley
underwent additional surgeries in 2006 and 2009 to treat her
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ongoing infections. Mrs. Bradley still takes pain medications and
an expensive antifungal medication to prevent further aspergillus
infections.
B. District Court Proceedings and Jury Trial
On December 17, 2007, the Bradleys filed a complaint
against Dr. Sugarbaker in the United States District Court for the
District of Massachusetts. A second amended complaint was filed
on June 27, 2011, alleging claims based on medical negligence, Dr.
Sugarbaker's failure to obtain informed consent, and battery. The
second amended complaint asserted, among other things, that Dr.
Sugarbaker "negligently performed a major surgery to acquire
tissue to submit to pathology when . . . obtaining tissue should
and could have been done by less intrusive means, including a fine
needle aspirated biopsy." The Bradleys alleged that Mrs. Bradley
did not have enough information to "ma[k]e an informed choice [as
to] whether to undergo less intrusive methods for obtaining biopsy
tissue than an open surgical biopsy." The Bradleys also claimed
that Mrs. Bradley neither consented to nor was informed "that [Dr.
Sugarbaker] intended to take tissue of any significant size" and,
as a result, the wedge resection constituted battery.
Following discovery, Dr. Sugarbaker filed a motion for
summary judgment as to all of the Bradleys' claims. The district
court denied the motion as to the informed consent claims,
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explaining that "there are material facts in dispute about what
Dr. Sugarbaker told Barbara Bradley about her alternatives and the
associated risks." Summary judgment was granted as to the medical
battery claim because, according to the district court, "the
common-law tort of battery is based on the absence of consent to
a particular treatment rather than the lack of informed consent."
So long as Mrs. Bradley consented to surgery, "whatever the dispute
about its parameters," the district court reasoned, her battery
claim must fail.
The case proceeded to trial in February 2014. As
described in more detail below, Dr. Sugarbaker filed a motion in
limine seeking to exclude testimony from the Bradleys' expert
witness, Dr. Joe Putnam, which the district court judge allowed in
part. At the end of the trial, the jury returned a verdict for
Dr. Sugarbaker. The jury found that Mrs. Bradley was not provided
sufficient information to make an informed judgment as to whether
to consent to the procedure, but that she failed to prove "that
neither she nor a reasonable person in her situation would have
consented to the surgery had the material information been
provided."
II. Discussion
On appeal, the Bradleys assert two arguments. First,
they claim that the district court erred in granting the motion
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for summary judgment as to the battery claim. Second, they fault
the district court for excluding portions of Dr. Putnam's
testimony. We address each argument in turn.
A. Battery Claim
1. Standard of Review
Orders granting or denying summary judgment are subject
to de novo review. Loubriel v. Fondo del Seguro del Estado, 694
F.3d 139, 142 (1st Cir. 2012). We view "the facts in the light
most favorable to the non-moving party," Román v. Potter, 604 F.3d
34, 38 (1st Cir. 2010), and "affirm only if the record reveals
'that there is no genuine dispute as to any material fact and the
movant is entitled to judgment as a matter of law.'" Avery v.
Hughes, 661 F.3d 690, 693 (1st Cir. 2011) (quoting Fed. R. Civ. P.
56(a)).
2. Battery Under Massachusetts Law
A diversity suit such as this is governed by
Massachusetts substantive law. See Nett v. Bellucci, 269 F.3d 1,
5 (1st Cir. 2001). In Massachusetts, battery is defined as "an
intentional offensive touching of a person done without consent."
Moore v. Eli Lilly & Co., 626 F. Supp. 365, 368 (D. Mass. 1986)
(citing Belger v. Arnot, 183 N.E.2d 866, 869 (Mass. 1962)). In
the medical context, battery qualifies as "medical treatment of a
competent patient without his consent." In re Spring, 405 N.E.2d
-8-
115, 121 (Mass. 1980). The Bradleys contend that Dr. Sugarbaker
committed battery by failing to obtain consent to remove a large
section of Mrs. Bradley's lung before performing the wedge
resection procedure.
For medical battery claims, Massachusetts courts
distinguish "lack of consent" from "a lack of informed consent."
Moore, 626 F. Supp. 2d at 368. Accordingly, while an allegation
that there was no consent may be brought as a battery claim, where
the question of consent touches on the appropriate standard of
care -- for example, whether a patient was informed of the risks
accompanying a procedure -- the action is better understood as
sounding in negligence. See, e.g., id. ("While early cases
treated lack of informed consent as vitiating the consent to
treatment so there was liability for battery, the modern view is
that the action is in reality one for negligence in failing to
conform to the proper standard." (quoting Mink v. Univ. of Chi.,
460 F. Supp. 713, 716 (N.D. Ill. 1978))); Feeley v. Baer, 679
N.E.2d 180, 182 n.4 (Mass. 1997) ("Most authorities prefer to treat
informed consent liability solely as an aspect of malpractice or
negligence." (internal citation omitted)). The reasoning in
Heinrich v. Sweet sheds light on the difference between battery
claims and medical malpractice claims premised on a lack of
informed consent. Dismissing a medical battery claim, the
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district court explained, "[t]he Plaintiffs do not contend that
[they] gave no consent at all"; rather, the district court noted,
they claimed that relevant risks had not been disclosed. Heinrich
v. Sweet, 49 F. Supp. 2d 27, 38 (D. Mass. 1999) (emphasis added).
As a result, the claim "should be treated as a claim for medical
malpractice." Id.The Bradleys identify documents leading up to the
surgery as evidence that she never consented to a wedge resection
procedure. For example, while Mrs. Bradley's consent form
explicitly refers to a bronchoscopy, mediastinoscopy, and
minithoracotomy, it contains no mention of a wedge resection.
Similarly, while bronchoscopy, mediastinoscopy, minithoracotomy,
and biopsy are marked on Mrs. Bradley's surgical booking form, the
box for wedge resection is not marked. Mrs. Bradley essentially
argues that she consented to certain enumerated procedures, and
that the lack of references to a wedge resection before surgery
indicates that there was no consent for that procedure. But Mrs.
Bradley's focus on nomenclature is unavailing.
To be sure, Mrs. Bradley identifies critical differences
between the first five samples and the final sample. She asserts
that the timing of the test results for the first five samples
suggests that Dr. Sugarbaker confirmed that the mass was not
malignant before he performed the wedge resection, and that --
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whereas the other samples were tested in their entirety -- only a
small portion of the wedge resection was tested. As a result,
Mrs. Bradley's argument appears to be that she only consented to
diagnostic procedures, whereas the removal of scar tissue (the
wedge resection) was a treatment to which she did not consent.
While the record is "viewed in the light most favorable to the
nonmovant" on summary judgment, Casas Office Machs., Inc. v. Mita
Copystar Am., Inc., 42 F.3d 668, 679 (1st Cir. 1994), the evidence
here simply does not support the contention that the wedge
resection had no diagnostic purpose. To the contrary, the mass
was tested for malignancies and those results were incorporated
into Dr. Sugarbaker's conclusion that Mrs. Bradley did not have
cancer.
Mrs. Bradley consented to surgery for the purpose of
diagnosing an irregular mass on her lung. And there is no genuine
dispute that Dr. Sugarbaker's surgery furthered that purpose. The
dispute concerns, instead, whether Dr. Sugarbaker adequately
described the extent of the cutting and the tissue removal that
would be involved depending on the results of initial biopsies
during the surgery. Massachusetts law distinguishes between
"touching without consent which all concede is a battery," and "a
consented touching for which consent was induced by inadequate
information," which is addressed under the malpractice rubric.
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Erikson v. Garber, No. 1511, 2003 WL 21956025, at *3 (Mass. App.
Div. Aug. 13, 2003). The circumstances here do not quite fall
into either category because the inadequacy of the information
included a failure to describe the extent of the cutting.
Nevertheless, where a surgery and its purpose were agreed to, and
where the actual extent of the surgery was in keeping with the
purpose, we would expect Massachusetts courts to treat the
inadequacy under a theory of malpractice. See Feeley, 679 N.E.2d
at 183 (quoting approvingly from a treatise discussing the policy
reasons for funneling claims of this type into the malpractice
rubric).
We do not foreclose the possibility that a question as
to the scope of consent may sustain a medical battery claim in
some instances. See Reddington v. Clayman, 134 N.E.2d 920, 922
(Mass. 1956) (recognizing a battery claim where a doctor removed
the uvula after only receiving consent to remove the adenoids and
tonsils); 14C Mass. Prac., Summary of Basic Law § 17.151 ("[I]f
the patient has consented to one type of treatment and the
physician performs another, a case of battery is also
established."). But there was a logical nexus between the wedge
resection and the other five samples: the wedge resection came
from the general area for which Mrs. Bradley had consented to
surgery, and samples from the wedge resection were tested for
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cancer. As Mrs. Bradley contends, questions remain as to whether
she was adequately apprised of the potential scope of the surgery
beforehand. But, because this claim ultimately centers on the
standard of care used by Dr. Sugarbaker, it should be treated as
an action in negligence, not battery. Feeley, 679 N.E.2d at 183
(stating that "the problem of informed consent is essentially one
of professional responsibility, not intentional wrongdoing, and
can be handled more coherently within the framework of negligence
law than as an aspect of battery" (internal quotation marks
omitted)).
The Bradleys also focus on the relative size of the
samples, contending that Mrs. Bradley understood that Dr.
Sugarbaker would only be extracting much smaller samples of tissue.
The Bradleys explain, "if [Mrs. Bradley] had asked Dr. Sugarbaker
to . . . avoid major surgery, her battery claim would succeed
because the wedge resection, which was major surgery, would have
fallen outside the scope of her narrow consent." But even were
we to accept Mrs. Bradley's contention that a wedge resection
qualified as a "major surgery," there is no evidence in the record
that Mrs. Bradley ever asked Dr. Sugarbaker to remove only small
samples. During her deposition, Mrs. Bradley stated that Dr.
Sugarbaker did not indicate how many samples he would take or how
large those samples would be. Rather, Mrs. Bradley assumed that
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the surgery would only consist of "little snippets of the mass."
Viewed in the light most favorable to Mrs. Bradley, such testimony
does not support the inference that Dr. Sugarbaker ever
affirmatively represented that he would take only small samples;
at worst, it suggests that Dr. Sugarbaker failed to provide
adequate information as to the size of the samples that would be
removed.
B. Negligence and Informed Consent Claims
1. Informed Consent Under Massachusetts Law
Massachusetts law recognizes the right of a competent
adult to forgo treatment, and the "[k]nowing exercise of this right
requires knowledge of the available options and the risks attendant
on each." Harnish v. Children's Hosp. Med. Ctr., 439 N.E.2d 240,
242 (Mass. 1982). For a plaintiff to prevail on a theory of
informed consent, "(1) the physician must have a duty to disclose
the information at issue to the patient, and (2) the breach of
that duty must be causally related to the patient's injury."
Halley v. Birbiglia, 458 N.E.2d 710, 715 (Mass. 1983). Under the
duty inquiry,
(a) a sufficiently close doctor-patient relationship
must exist; (b) the information subject to disclosure
must be that which the doctor knows or reasonably should
know; (c) the information must be of such a nature that
the doctor should reasonably recognize that it is
material to the patient's decision; and (d) the doctor
must fail to disclose the subject information to the
patient.
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Id. In turn, for the causation inquiry, the plaintiff must
demonstrate "that had the proper information been provided neither
he nor a reasonable person in similar circumstances would have
undergone the procedure." Harnish, 439 N.E.2d at 244.
A physician need only disclose information "that is
material to an intelligent decision by the patient whether to
undergo a proposed procedure." Id. at 243. Materiality is
defined as "the significance a reasonable person, in what the
physician knows or should know is his patient's position, would
attach to the disclosed risk or risks in deciding whether to submit
or not to submit to surgery or treatment." Id. (internal citation
omitted); accord Precourt v. Frederick, 481 N.E.2d 1144, 1146
(Mass. 1985). In addition to encompassing the risks associated
with a particular procedure, material information also includes
"the available alternatives, including their risks and benefits."
Harnish, 439 N.E.2d at 243.
2. Medical Negligence Under Massachusetts Law
The Bradleys also assert claims of medical negligence.
To show medical negligence, the "plaintiff must show (1) the
existence of a doctor or nurse-patient relationship, (2) that the
performance of the doctor or nurse did not conform to good medical
practice, and (3) that damage resulted therefrom." St. Germain
v. Pfeifer, 637 N.E.2d 848, 851 (Mass. 1994). To establish the
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appropriate standard of care, a plaintiff typically must present
expert testimony to that effect. Pagés-Ramírez v. Ramírez-
González, 605 F.3d 109, 113 (1st Cir. 2010) ("In order to determine
the applicable standard of care in a medical malpractice action
and to make a judgment on causation, a trier of fact will generally
need the assistance of expert testimony.").
3. Admissibility of Expert Testimony
Rule 702 of the Federal Rules of Evidence governs the
admission of expert testimony. Fed. R. Evid. 702. Rule 702
requires that the "testimony be (1) 'based upon sufficient facts
or data,' (2) 'the product of reliable principles and methods,'
and (3) that the witness apply 'the principles and methods reliably
to the facts of the case.'" Pagés-Ramírez, 605 F.3d at 113(quoting Fed. R. Evid. 702). When determining whether such
evidence is admissible, "the judge must determine: 'whether the
expert is proposing to testify to (1) scientific knowledge that
(2) will assist the trier of fact to understand or determine a
fact in issue.'" Mitchell v. United States, 141 F.3d 8, 14 (1st
Cir. 1998) (quoting Daubert v. Merrell Dow Pharm., Inc., 509 U.S.
579, 592–93 (1993)). A district court enjoys broad discretion
when making such evidentiary determinations, id. at 15, and its
decision to admit or exclude testimony is reviewed for an abuse of
discretion, Pagés-Ramírez, 605 F.3d at 115. But "[t]he standard
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is not monolithic: within it, embedded findings of fact are
reviewed for clear error, [and] questions of law are reviewed de
novo." Milward v. Acuity Specialty Prods. Grp., Inc., 639 F.3d
11, 13–14 (1st Cir. 2011) (quoting Ungar v. Palestine Liberation
Org., 599 F.3d 79, 83 (1st Cir. 2010)). We affirm where the lower
court's "error [does] not affect the parties' substantial rights
and likely [does] not affect the outcome of the case." Martínez
v. Cui, 608 F.3d 54, 59 (1st Cir. 2010).
4. Analysis
The Bradleys contend that the district court erred in
excluding Dr. Putnam's testimony related to the availability of an
FNA biopsy, explaining that such testimony was relevant to the
standard of care for both their informed consent and medical
negligence claims.5 The expert disclosure report identified three
opinions that subsequently were excluded:
1. The surgeon departed from the standard of care
by failing to perform a less invasive
procedure (such as needle biopsy or
bronchoscopy), rather than thoracotomy as the
first diagnostic procedure.
2. If the surgeon dissuaded the patient from
consideration of needle biopsy, an alternative
to diagnosis of the superior sulcus tumor and
which would modify the patient's treatment
options, the surgeon departed from the
standard of care.
5 The parties do not dispute Dr. Putnam's professional
qualifications on appeal. Rather, their dispute is limited to the
relevance of his testimony.
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3. If the surgeon did not do so, the surgeon
departed from the standard of care by failing
to discuss with the patient and family the
alternative diagnostic options to wedge
resection (such as needle biopsy or
bronchoscopy) as part of informed consent.6
The Bradleys contend that Dr. Putnam's testimony
regarding Dr. Sugarbaker's failure to discuss the availability of
the FNA biopsy was relevant to the available alternatives and the
standard of care for the informed consent claims. During the
trial, the Bradleys expanded upon Dr. Putnam's expected testimony,
which would touch on the "general approach of getting informed
consent which involves a general discussion of what you're going
to do, the risks, the benefits, the reasonable alternatives and
the risks and benefits of those." The Bradleys acknowledged that
this was not a situation where an FNA biopsy had never been offered
-- indeed, one had been scheduled, with another hospital, prior to
the PET scan. Nevertheless, the Bradleys contend that Dr.
Sugarbaker did not satisfy the standard of care articulated in
Harnish by failing to engage in a discussion of "the alternate
routes of obtaining a biopsy" after her PET scan: "[Mrs. Bradley]
can't possibly have understood that something she was told was not
6 The district court did admit portions of Dr. Putnam's testimony
pertaining to Dr. Sugarbaker's failure to discuss Mrs. Bradley's
increased risk of complications in light of her previous chest
trauma.
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going to be pursued anymore would have given her the alternate
means of obtaining the information she wanted on December 14th
[the date of the PET scan]."
As to Dr. Sugarbaker's failure to perform a less invasive
procedure, Dr. Putnam would have testified that performing an FNA
biopsy was relevant to the standard of care for purposes of the
medical negligence claim.7 In this respect, the Bradleys intended
to have Dr. Putnam testify that an FNA biopsy "is less invasive
and . . . safer than doing surgery." Dr. Putnam would explain
that an FNA biopsy "is a standard initial diagnostic procedure"
that would provide "crucial" information "before an operation
would be performed."
As to causation, the Bradleys also intended for Dr.
Putnam to testify that "what happened to Barbara Bradley would not
have happened had the standard of care been followed." Dr. Putnam
would have explained that, where an FNA biopsy returns negative
results, the doctor should discuss with the patient the likelihood
that the mass is nevertheless cancerous. In the case of Mrs.
7 During trial, the Bradleys' counsel referred to this testimony
as Dr. Putnam's "second specific opinion." As listed on the
disclosure report, the "second" opinion concerns whether Dr.
Sugarbaker, having allegedly dissuaded Mrs. Bradley from
undergoing an FNA biopsy, deviated from the standard of care. The
discussion that follows, however, touches on the failure to perform
the procedure, which is in fact the first opinion listed on the
disclosure report.
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Bradley, who had suffered previous chest trauma, the doctor would
then explain the "greater than average risk" posed by surgery and
query whether other therapy options are available.
a. Federal Rule of Evidence 103(a)(2)
Dr. Sugarbaker first contends that the Bradleys did not
preserve their evidentiary issue as they failed to comply with
Rule 103(a)(2) of the Federal Rules of Evidence, which requires
one "claim[ing] error in a ruling to admit or exclude evidence" to
"inform[] the court of its substance by an offer of proof, unless
the substance was apparent from context." Dr. Sugarbaker contends
that "the Bradleys did not make an offer of proof with respect to
the specifics of the relevant opinion testimony that they sought
to elicit from Dr. Putnam."
This assertion is unsupported by the record. The
Bradleys' proffer included a detailed Disclosure Report from Dr.
Putnam as well as a deposition. Indeed, when determining which
sections of Dr. Putnam's disclosure report were admissible, the
district court methodically analyzed each paragraph of the
disclosures. Such specificity is a strong indication that the
Bradleys' proffer satisfied Rule 103's requirements.
Turning to the merits, we address each of Dr. Putnam's
three opinions in turn.
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b. Opinion 3: Dr. Sugarbaker Failed to Discuss the
Alternative Diagnostic Options
The district court excluded Dr. Putnam's testimony
regarding Dr. Sugarbaker's failure to discuss alternatives. It
reasoned that, while the FNA biopsy theoretically was an
alternative, it was not an alternative in this instance: "[the
FNA biopsy] was . . . considered an alternative until it stopped
being one." The district court noted that this decision was based
on "the facts of the case," which indicate that an FNA biopsy "was
not a practical alternative."
Dr. Sugarbaker contends that Dr. Putnam's testimony
improperly spoke to the materiality of the availability of the FNA
biopsy. Under Massachusetts law, "[t]he materiality determination
is one that lay persons are qualified to make without the aid of
an expert." Harnish, 439 N.E.2d at 243. As a threshold matter,
a judge will consider the "severity of the injury" as well as the
"likelihood that it will occur." Precourt, 481 N.E.2d at 1148.
The determination of whether that information is "material" is
then left to the factfinder. Id. at 1148–49. As a matter of law,
a negligible risk is not material and need not be submitted to the
jury. Id. at 1149.8 In Precourt, the Supreme Judicial Court
8 In Harrison v. United States, 284 F.3d 293 (1st Cir. 2002), we
expanded upon Precourt, noting that "the caselaw stands for the
proposition that there is no duty to disclose negligible risks,
not that all non-negligible risks are actionable if not revealed."
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("SJC") of Massachusetts cautioned, "[t]he development of our law
concerning risks that as a matter of law may be considered remote,
and those that may be left to the determination of a fact finder,
must await future cases." Id.As discussed herein, Opinion 3 would have included
testimony touching on the "general approach to getting informed
consent." Dr. Putnam would have explained that Dr. Sugarbaker
failed to inform Mrs. Bradley of an FNA biopsy, which would "be
the easiest, most straightforward, [and] carry the greatest
benefit of a diagnostic with the least risk, of any procedure."
Contrary to Dr. Sugarbaker's assertions, Dr. Putnam's testimony
does not infringe on the jury's materiality analysis. Rather, it
would explain the general category of risks and alternatives that
a physician must disclose to his patient and the factors relevant
to whether an FNA biopsy should have been disclosed as an
alternative in this instance. In this way, Dr. Putnam's testimony
was relevant to what the standard of care requires when a physician
engages in a discussion of alternatives with his patient. In
Harnish, the SJC explained, "[w]hat the physician should know
involves professional expertise and can ordinarily be proved only
through the testimony of experts." 439 N.E.2d at 243.9 Likewise,
Id. at 300.
9 The Bradleys contend that the district court improperly excluded
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the manner that a physician discusses a procedure with a patient
and the types of information he must include in that conversation
are areas where an expert may be necessary to aid the jury. The
fact that Harnish does not require expert testimony on what is
material does not mean that expert testimony on the available
choices that doctors in the exercise of standard care offer to
their patients is not relevant.
Further, the district court's determination that an FNA
biopsy was not available as an alternative is not supported by the
evidence adduced at trial.10 Mrs. Bradley recounted a call from
this evidence on the theory that it embraced an ultimate issue.
See Fed. R. Evid. 704(a) ("An opinion is not objectionable just
because it embraces an ultimate issue."). To the contrary, the
district court stated that "the ultimate question of evaluating
severity and likelihood is one for the jury," which is an accurate
restatement of the law that the issue of materiality is for the
jury. Harnish, 439 N.E.2d at 243.
10 The Bradleys contend that the district court improperly usurped
the jury's function by deciding this issue of fact. Under Daubert,
however, when determining the admissibility of expert testimony,
"the trial judge must determine at the outset, pursuant to [Federal
Rule of Evidence] 104(a), whether the expert is proposing to
testify to (1) scientific knowledge that (2) will assist the trier
of fact to understand or determine a fact in issue." Daubert, 509
U.S. at 592; cf. Fed. R. Evid. 104(b) ("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."). Dr.
Putnam's testimony as to whether dissuasion or non-discussion of
available alternatives (Opinions 2 and 3, respectively) satisfies
the standard of care is only relevant insofar as the Bradleys
demonstrated that non-discussion and dissuasion of available
alternatives are facts at issue here, and the district court did
not err in making this preliminary factual determination. See
Bogosian v. Mercedes-Benz of N. Am., Inc., 104 F.3d 472, 476 (1st
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Dr. Sugarbaker's physician assistant, William Hung, in which he
explained that an FNA biopsy was not possible as they would be
unable to access the mass using that procedure. In light of that
conversation, Mrs. Bradley cancelled her previously scheduled FNA
biopsy. Hung does not recall this conversation and his notes from
that day do not mention the FNA procedure. At trial, Hung
explained that he spoke with a radiologist, Dr. Francine Jacobsen,
and that Dr. Jacobsen had recommended against an FNA biopsy. But
Hung's notes contain no mention of Dr. Jacobsen's suggestions
regarding the procedure. In addition, Dr. Sugarbaker recalled
having a conversation with either Hung or Dr. Jacobsen in which
they agreed not to proceed with an FNA biopsy "given the location
of the mass." As Bradley's trial counsel noted, there were no
records of these conversations, and Dr. Sugarbaker's testimony
regarding his conversation with Dr. Jacobsen is inconsistent with
Cir. 1997) ("[T]he court performs a gatekeeping function to
ascertain whether the testimony is helpful to the trier of fact,
i.e., whether it . . . is relevant to the facts of the case.").
The Bradleys' reliance on Milward is unavailing. There, this
Court determined that, "[w]hen the factual underpinning of an
expert's opinion is weak, it is a matter affecting the weight and
credibility of the testimony -- a question to be resolved by the
jury." Milward, 639 F.3d at 22 (internal citation omitted). But
Milward concerned the district court's extensive evaluation of the
reliability of the scientific theories underscoring the expert's
testimony, and not the threshold issue of factual relevance.
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earlier statements that he did not recall discussing the
availability of the FNA biopsy with another medical professional.
Moreover, the district court's determination that an FNA
biopsy was not an available alternative is further undercut by its
decision to admit the testimony of expert Dr. Mark Edelman, Mrs.
Bradley's interventional radiologist, who testified to the
benefits of the FNA biopsy. At trial, he explained that an FNA
biopsy "could have been safely performed with respect to Barbara
Bradley" and opined that the location of the mass did not render
it inaccessible by FNA biopsy. He also remarked on the benefit
of this non-surgical alternative due to the "complications of
surgery and difficulty recovering from surgery." Contrary to the
district court's determination, such testimony suggests that the
FNA biopsy was a viable alternative here.11
Nor can it be said that the risks associated with a
surgical biopsy were so minimal that, as a matter of law, Dr.
Sugarbaker was not obligated to disclose less invasive
alternatives. At trial, Dr. Putnam testified that the risk of
complications arising from surgery were heightened due to Mrs.
Bradley having "sustained significant thoracic trauma just 18
11 In addition, during his deposition, Dr. Ralph Reichle, an
interventional radiologist and expert for Dr. Sugarbaker,
testified that he could have performed an FNA biopsy on Mrs.
Bradley without complication.
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months or so previously." Dr. Putnam explained that scarring from
a previous trauma may increase the risk of bleeding or otherwise
complicate the surgery -- potentially requiring a longer procedure
or adversely affecting the surgeon's "ability to do the operation
as efficiently as [he] could without it." Furthermore, Mrs.
Bradley's scarring from her chest trauma likely contributed to the
apical space12 that formed following surgery. While a physician
is not required to disclose all non-negligible risks, Harrison v.
United States, 284 F.3d 293, 300 (1st Cir. 2002), Dr. Putnam's
testimony demonstrated that the likelihood that complications
might arise was far from remote, see Harnish, 439 N.E.2d at 243
(suggesting that a surgeon need not disclose "remotely possible
risks") and, further, that these risks were not "inherent in any
operation," id. On the contrary, they were specific to Mrs.
Bradley's medical situation.
At trial, the jury heard testimony from Dr. Gary Strauss,
an oncology expert, that an FNA biopsy, even if negative, would
not rule out the possibility of cancer, especially where a patient
had a particularly high risk of cancer, and that Mrs. Bradley's
computed tomography ("CT") and PET scans indicated that she was at
12 An apical space refers to an area where there is no lung
immediately after surgery. It can also be described as a non-
expansion of the lung.
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a high risk. Dr. Strauss also testified that "it would not be
reasonable for Dr. Sugarbaker to rely upon a negative FNA in this
setting where everything else really points to it being cancer to
say she didn't have a cancer." This testimony indicated that,
under the appropriate standard of care, Dr. Sugarbaker was not
required to present an FNA biopsy as an alternative prior to the
surgical biopsy. By excluding Dr. Putnam's testimony, the
district court effectively prevented Mrs. Bradley from presenting
evidence that Dr. Sugarbaker's "duty to disclose in a reasonable
manner all significant medical information," Harnish, 439 N.E.2d
at 243, necessitated a discussion of non-surgical alternatives and
therefore from rebutting Dr. Strauss's testimony to the contrary,
see Pagés-Ramírez, 605 F.3d at 116 (finding that the district court
abused its discretion by refusing to allow an expert to testify in
a medical malpractice case where, "without [the expert]'s
testimony on causation and the standard of care, the plaintiffs
were unable to present evidence on two elements of their case").
Dr. Sugarbaker argues that the Bradleys cannot
demonstrate causation because Dr. Putnam conceded in his
deposition that, if the results of an FNA biopsy had been negative,
the mass would nevertheless have needed to be removed. But Dr.
Putnam made no such cut-and-dried statement. While he
acknowledged that removal of the mass was a possibility, he also
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stated that a discussion of next steps was necessary in light of
Mrs. Bradley's previous chest trauma. In particular, Dr. Putnam's
testimony would have supported the view that a non-surgical
alternative such as "watchful waiting" was a reasonable option
following a negative FNA biopsy. "It would make little sense to
expand the law of informed consent such that a plaintiff, in
addition to demonstrating that she would have chosen an alternate
course of treatment, must also delineate the precise plan of action
that she would have followed to obtain that treatment . . . ."
Harrison v. United States, 233 F. Supp. 2d 128, 135 (D. Mass.
2002). Accordingly, we conclude that the district court abused
its discretion by excluding Opinion 3.
c. Opinion 2: Dr. Sugarbaker Dissuaded Mrs. Bradley
from Considering an FNA Biopsy
The district court excluded Opinion 2, noting that, at
most, there was "evidence of nonperformance and perhaps . . . non-
discussion," but not evidence of "dissuasion." But there was
clear evidence of dissuasion: as described herein, Mrs. Bradley
testified that Dr. Sugarbaker's assistant, Hung, told her that
surgery likely would be necessary as the mass would be inaccessible
by an FNA biopsy. Moreover, Mrs. Bradley's conversation with Hung
in fact dissuaded her from undergoing an FNA biopsy. Following
the conversation, she cancelled her previously scheduled FNA
biopsy at Hartford Hospital because she did not "want to go to
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Hartford to have an FNA done only to find out they couldn't access
[the mass] with an FNA."
The fact that Dr. Sugarbaker did not personally dissuade
Mrs. Bradley does not change the result. Hung served as Dr.
Sugarbaker's assistant, and Dr. Sugarbaker's testimony at trial
suggested that he was aware of Hung's views that an FNA biopsy
would not be feasible for Mrs. Bradley. See Mass. Gen. Laws ch.
112, § 9E ("If a physician assistant is employed by a physician or
group of physicians, the assistant shall be supervised by and shall
be the legal responsibility of the employing physician or
physicians."). Nevertheless, Dr. Sugarbaker never recanted Hung's
initial recommendations regarding the FNA biopsy. In such an
instance, a jury reasonably could attribute the relevant
dissuasive statements to Dr. Sugarbaker. Cf. Santos v. Kim, 706
N.E.2d 658, 661–62 (Mass. 1999) (evaluating instances where a
physician may be liable for "his failure to institute practices
and procedures"). Accordingly, the district court's factual
finding that there was no evidence of dissuasion was clearly
erroneous, and the district court abused its discretion by
excluding Opinion 2.
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d. Opinion 1: Dr. Sugarbaker Failed to Perform an FNA
Biopsy
The district court excluded Dr. Putnam's testimony
regarding Dr. Sugarbaker's failure to perform an FNA biopsy because
it found that this testimony was not related to "an informing
obligation but a performing obligation." The district court
reasoned that, because Dr. Sugarbaker would not have been the
doctor to perform the procedure, "the failure [could] have . . .
no legal significance." Insofar as this ruling pertained to the
informed consent claim, the district court is correct: the
informed consent inquiry focuses on the physician's disclosure
obligations, rather than how a medical procedure was performed.
Harnish, 438 N.E.2d at 154 (describing the informed consent
doctrine as relating to "a physician's failure to divulge in a
reasonable manner to a competent adult patient sufficient
information to enable the patient to make an informed judgment").
The Bradleys contend that this Court has "emphasized that a duty
to disclose, if it exists . . . does not necessarily indicate any
duty to offer or to perform" the procedure at issue. Harrison,
284 F.3d at 301 n.8. But they misconstrue our precedents. It is
true that the fact that a physician would not perform a particular
procedure will not immunize him from an informed consent claim.
Harrison, 233 F. Supp. 2d at 134 ("[A] doctor cannot 'save' himself
from liability for breach of informed consent by merely arguing
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that . . . causation is lacking because he himself would have been
unwilling to perform that procedure upon the patient's request.").
But this legal analysis does not imply that the converse is true,
i.e., that the non-performance of a specific procedure will sustain
an informed consent claim. Again, informed consent is about
disclosure, not performance.
The Bradleys also contend that this testimony is
relevant to their medical negligence claim, which was brought
"independent of any of [Mrs. Bradley's] informed-consent claims."
Dr. Sugarbaker does not address this argument. The Bradleys
assert that the standard of care required that Dr. Sugarbaker
perform a less invasive procedure to obtain tissue for the surgical
biopsy. As the Bradleys contend, the fact that Dr. Sugarbaker
himself would not have performed the procedure will not foreclose
a claim in the medical negligence context. Santos, 706 N.E.2d at
663 (explaining that the fact that a doctor would not personally
treat a patient does not "automatically absolve him of liability").
Moreover, a physician's failure to perform a less invasive
procedure may speak to whether he deviated from the standard of
care. See Emerson v. Bentwood, 769 A.2d 403, 409 (N.H. 2001)
(reversing a trial court's directed verdict where "[t]he expert's
testimony was sufficient for a rational trier of fact to conclude
that the defendant should have employed less invasive measures
-31-
. . . and that said deviation from the standard of care resulted
in the plaintiff's injury"). Accordingly, the non-performance
testimony in Opinion 1 may be relevant to the Bradleys' medical
negligence claim.
That said, the negligence claim does not appear ever to
have reached the jury: the verdict form only references Mrs.
Bradley's informed consent claim, and the jury instructions were
limited to the elements of informed consent. Indeed, the jury was
told that "[t]his [case] is about whether there was an adequate
consent to the surgery that followed," and not about the manner in
which the surgery was performed. Neither party addresses whether
these facts support a finding of waiver as to the medical
negligence claim. In light of the poorly developed record on this
issue, we leave for the district court the question of Opinion 1's
relevance to the Bradleys' medical negligence claim.
III. Conclusion
For the foregoing reasons, the judgment is vacated, and
the case is remanded for further proceedings consistent with this
opinion.
Vacated and Remanded. No costs are awarded.
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