Bradley v. Sugarbaker

2015 | Cited 0 times | First Circuit | December 16, 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

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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

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. . . 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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