United States Court of Appeals
For the First Circuit
No. 01-1373
MELVIN D. HARRISON, PPA KENYEDA TAFT,
Plaintiff, Appellant,
v.
UNITED STATES OF AMERICA,
Defendant, Appellee.
APPEAL FROM THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF MASSACHUSETTS
[Hon. William G. Young, U.S. District Judge]
Before
Torruella, Lynch and Lipez,
Circuit Judges.
Adam R. Satin, with whom Andrew C. Meyer, Jr., William J.
Thompson, and Lubin & Meyer, P.C., were on brief, for appellant.
Mary Elizabeth Carmody, Assistant U.S. Attorney, with whom
James B. Farmer, United States Attorney, were on brief, for
appellee.
April 1, 2002
TORRUELLA, Circuit Judge. This is an appeal from a bench
trial in a medical malpractice case brought under the Federal Tort
Claims Act, 28 U.S.C. § 1346(b). Kenyeda Taft, on behalf of her
minor son, Melvin Harrison, sued Dr. Louis Laz, her obstetrician
and a federal employee, for injuries allegedly sustained by Melvin
during his birth. The complaint set forth two grounds for finding
negligence: failure to meet the standard of care and lack of
informed consent. The district court, after a five-day trial,
concluded that Dr. Laz was not negligent under either theory and
concomitantly entered judgment for the defendant of record, the
United States. Plaintiff-appellant, Melvin Harrison, appeals the
judgment on the informed consent claim. For the reasons discussed
below, we vacate the judgment and remand to the district court
judge.
I.
In 1996, Kenyeda Taft ("Ms. Taft") was pregnant with
Melvin Harrison, her second child. In March of that year,
Ms. Taft, almost four months pregnant, began her prenatal care at
the Lynn Community Health Center ("Lynn CHC") with an initial
screening visit conducted by a nurse practitioner. During this
visit, Ms. Taft provided a medical history, including the fact that
her first child, due to her large size of 9 pounds and 3 ounces,
suffered an injury during vaginal birth that resulted in Erb's
Palsy.1
1
Erb's Palsy is a brachial plexus injury, which results in
decreased mobility and functionality of the affected upper
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Ms. Taft first met with Dr. Louis Laz ("Dr. Laz"), a
Board-certified obstetrician and gynecologist, at the Lynn CHC on
April 29, 1996. Ms. Taft informed Dr. Laz that her first child
suffers from Erb's Palsy as a result of a shoulder dystocia,2 due
to the baby's large size. At the time, Dr. Laz's general practice
with patients who had had a prior large baby was to determine the
estimated fetal weight by ultrasound at about 37 weeks' gestation.
If the estimated weight was 4500 grams or more, Dr. Laz would offer
the patient an elective Cesarean section ("C-section"). If the
estimated weight was under this threshold, Dr. Laz would recommend
inducing labor at 37 or 38 weeks' gestation.
In addition to her previous large child, Ms. Taft
presented with other risk factors that increased the likelihood
that her second baby would also be large, and therefore more likely
to suffer complications, such as a shoulder dystocia or brachial
plexus injury, during a vaginal birth: she was pregnant with her
second child, and second children are usually larger than first;
the fetus was male, and males are generally larger; Ms. Taft was an
obese woman at the time of her pregnancy; Ms. Taft experienced
excessive weight gain during the pregnancy; and her prior delivery
resulted in an Erb's Palsy injury. While Dr. Laz recognized these
extremity.
2
Shoulder dystocia is a complication that can occur during a
vaginal birth where the fetus' shoulders impede the fetus' passage
through the birth canal after the head has been delivered.
Shoulder dystocia can cause Erb's Palsy, although Erb's Palsy can
also occur spontaneously.
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risk factors, he considered them to be normal birth risks and
therefore did not discuss them with Ms. Taft.
After meeting with Ms. Taft, Dr. Laz obtained the
delivery record for Ms. Taft's first child, Keneisha Taft, from
Salem Hospital. At trial, Dr. Laz testified that it was his
general practice to request the hospital delivery notes for any
patient who had a history of delivery complications. The delivery
record of Dr. Orkin, the treating obstetrician, indicated that
Keneisha's birth occurred "without any complications." Dr. Laz,
considering the obstetrician's delivery notes to be the "gold
standard of what happened at that delivery," concluded that Ms.
Taft did not experience a shoulder dystocia during her first birth.
Therefore, Dr. Laz believed that the Erb's Palsy developed
spontaneously, rather than as a result of a shoulder dystocia.
Although Dr. Laz testified that he would have discussed an elective
C-section with a patient where there was documented evidence of a
prior shoulder dystocia resulting in an injury, he did not do so in
this case, since the delivery notes did not document such
complication.
On September 12, 1996, at approximately 37 weeks'
gestation, in accordance with Dr. Laz's general practice, Ms. Taft
had an ultrasound at Union Hospital to estimate the fetal weight.
The ultrasound report estimated the fetal weight to be 3676 grams
(a little over 8 pounds). Because the estimated weight was under
the 4500 grams threshold, Dr. Laz determined that a vaginal
delivery, as opposed to a C-section, was the appropriate mode of
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childbirth. Dr. Laz recommended to Ms. Taft that labor be induced,
but he did not discuss with her either the risks of vaginal birth
or the possibility of a C-section.
On September 17, 1996, Ms. Taft, at 37.5 weeks'
gestation, was admitted to Beverly Hospital for induction of labor.
During labor, the baby's head crowned, but the shoulders did not
deliver. Dr. Laz and the delivery team followed standard steps to
attempt to resolve the shoulder dystocia. After these steps were
unsuccessful, Dr. Laz delivered the posterior (right) arm, which
then allowed delivery of the baby at 12:46 a.m. on September 18.
The baby, Melvin Harrison, weighed 4508 grams (9 pounds and 15
ounces) at birth and had a weakness of the right arm and hand,
which was subsequently diagnosed as Erb's Palsy.
The plaintiff filed suit against Dr. Laz for medical
malpractice in Essex County Superior Court. However, since Dr. Laz
was a federal employee at the time he treated Ms. Taft, the action
was removed to the United States District Court for the District of
Massachusetts, and the United States was substituted as the
defendant. The plaintiff's suit was premised on two grounds of
negligence: (1) Dr. Laz's failure to meet the standard of care by
not originally offering an elective C-section and by not performing
a C-section during labor based on fetal heart monitorings; and (2)
Dr. Laz's failure to obtain Ms. Taft's informed consent by not
discussing the risks of vaginal birth and disclosing the
alternative of a C-section. A bench trial began on December 18,
2000. At the close of the plaintiff's case, the district court
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granted the United States' motion for judgment as a matter of law
on the question of Dr. Laz's compliance with the standard of care
during labor.
At the conclusion of the trial, the district court
determined that Dr. Laz did not fail to obtain the patient's
informed consent and entered judgment for the defendant. The court
found that, although the risks of vaginal birth for the baby were
"something more than negligible," when these risks were balanced
against the risks to the mother from a C-section, "a cesarean
section to avoid brachial plexus injury was not a reasonable
medical judgment." Therefore, even though the court found that
Ms. Taft would have opted for a C-section if informed of the
possibility, the court concluded that "Dr. Laz was under no duty
to afford [Ms. Taft] the opportunity to have a cesarean section .
. . ."
The plaintiff appeals the court's judgment only on the
informed consent claim, arguing that Dr. Laz, because such
information was material to her decision to deliver vaginally, did
have a duty to inform Ms. Taft of both the risks of vaginal birth
and the availability of a C-section as an alternative method of
childbirth.
II.
We review a district court's factual findings for clear
error. See Fed. R. Civ. P. 52(a); La Esperanza de P.R., Inc. v.
Pérez y Cía. de P.R., Inc., 124 F.3d 10, 15 (1st Cir. 1997). "We
deem a finding to be clearly erroneous only when, after reviewing
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the entire record, we are left with the definite and firm
conviction that a mistake has been committed." La Esperanza, 124
F.3d at 15 (internal quotation marks omitted). Questions of
negligence decided in a bench trial are treated as questions of
fact, or as mixed questions of fact and law, and are therefore
evaluated under this deferential standard. See id. at 15-16.
However, when the district court's factual findings are
premised on an incorrect interpretation of the relevant legal
principles, we do not owe the court the same level of deference.
See United States v. 15 Bosworth St., 236 F.3d 50, 54 (1st Cir.
2001); Vinick v. United States, 205 F.3d 1, 6-7 (1st Cir. 2000).
"Instead, we treat the trial court's conclusion as a question of
law," Vinick, 205 F.3d at 7, and review it de novo. 15 Bosworth
St., 236 F.3d at 53.
III.
Under the Federal Tort Claims Act, 28 U.S.C. § 1346(b),
state law is "the source of substantive liability." Fed. Deposit
Ins. Corp. v. Meyer, 510 U.S. 471, 477-78 (1994). To recover under
a theory of informed consent in Massachusetts, a patient must prove
that the physician has a duty to disclose certain information and
that a breach of that duty caused the patient's injury. See Halley
v. Birbiglia, 458 N.E.2d 710, 715 (Mass. 1983). To establish a
breach of the physician's duty of disclosure, the plaintiff must
establish that: (1) a sufficiently close doctor-patient
relationship exists; (2) the doctor knows or should know of the
information to be disclosed; (3) the information is such that the
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doctor should reasonably recognize that it is material to the
patient's decision; and (4) the doctor fails to disclose this
information. See id. In this case, only the materiality of the
information to the patient is contested.3
If a duty exists, a physician must disclose "sufficient
information to enable the patient to make an informed judgment
whether to give or withhold consent to a medical or surgical
procedure." Harnish v. Children's Hosp. Med. Ctr., 439 N.E.2d 240,
242 (Mass. 1982). Failure to do so constitutes medical
malpractice. See id.
There are two primary standards for determining the
requisite scope of the physician's disclosure in informed consent
cases: "customary practice" and "materiality." See id. at 243-44;
Canterbury v. Spence, 464 F.2d 772, 786-87 (D.C. Cir. 1972). Many
jurisdictions require a physician to disclose whatever information
a reasonable physician in similar circumstances would customarily
disclose. See Harnish, 439 N.E.2d at 243; Canterbury, 464 F.2d at
786 & n.70. The Commonwealth of Massachusetts, however, has
rejected the customary practice standard as providing insufficient
protection for the patient's autonomy, which is the very purpose of
disclosure.4 See Harnish, 439 N.E.2d at 243-44; Precourt v.
3
Appellee, in its brief, states that the doctor's knowledge of
the information is also disputed. However, the doctor's knowledge
is not at issue given his and defense counsel's admission at trial
that he was aware of Ms. Taft's risk factors for delivering a large
child.
4
The Supreme Judicial Court of Massachusetts has, in prior cases,
cited Canterbury with approval for its explanation rejecting the
customary practice standard:
-8-
Frederick, 481 N.E.2d 1144, 1149 (Mass. 1985) (balancing patient's
right to self-determination and desire to not unduly burden
practice of medicine). Instead, Massachusetts has adopted the
"materiality" standard, requiring the physician to disclose
"information he should reasonably recognize is material to the
[patient's] decision." Harnish, 439 N.E.2d at 243.
"'Materiality may be said to be 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. at 243 (quoting Wilkinson v. Vesey, 295 A.2d 676
(R.I. 1972)). Material information "may include the nature of the
patient's condition, the nature and probability of risks involved,
the benefits to be reasonably expected, . . . the likely result of
The decision to unveil the patient's condition
and the chances as to remediation, as we shall
see, is ofttimes a non-medical judgment and,
if so, is a decision outside the ambit of the
special [medical] standard. Where that is the
situation, professional custom hardly
furnishes the legal criterion for measuring
the physician's responsibility to reasonably
inform his patient of the options and the
hazards as to treatment.
. . . .
. . . Any definition of scope [of
disclosure] in terms purely of a professional
standard is at odds with the patient's
prerogative to decide on projected therapy
himself. That prerogative, we have said, is
at the very foundation of the duty to
disclose, and both the patient's right to know
and the physician's correlative obligation to
tell him are diluted to the extent that its
compass is dictated by the medical profession.
464 F.2d 785-86.
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no treatment, and the available alternatives, including their risks
and benefits." Id.
Whether a risk of injury is material to a patient depends
upon the severity of the potential injury as well as the
probability of its occurrence. See Precourt, 481 N.E.2d at 1148.
If the likelihood of an injury occurring is negligible, then the
risk is not considered material, and the risk is insufficient to
trigger the physician's duty to disclose.5 See Feeley v. Baer, 679
N.E.2d 180, 182 (Mass. 1997) (holding that physician had no duty to
disclose risk of serious infection because plaintiffs failed to
prove that there was "more than a negligible risk"); Precourt, 481
N.E.2d at 1148 (noting that a risk of injury "cannot be considered
a material factor" if the probability of its occurrence "is so
small as to be practically nonexistent"). Similarly, if the
severity of the potential injury is "very minor," the risk is
immaterial and need not be disclosed. Precourt, 481 N.E.2d at 1149
(quoting LaCaze v. Collier, 434 So.2d 1039, 1046 (La. 1983))
(internal quotation marks omitted).
In the case at hand, the plaintiff, citing to Feeley,
argues that any risk that is more than negligible automatically
qualifies as a material factor that must be disclosed. See Feeley,
679 N.E.2d at 182 (stating that "[t]he risk that must exist in
order to invoke informed consent principles in this case is a more
5
We note, however, that there is no "magic number" for
determining whether a probability of injury is sufficient to make
the risk material. See Canterbury, 464 F.2d at 788 & n.86 (citing
cases, among which one percent chance of loss of hearing was
material but 1.5 percent chance of loss of eye was not material).
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than negligible risk . . . ."). The defendant, however, challenges
the plaintiff's understanding of the Commonwealth's informed
consent law. The defendant argues that Feeley and the other
Massachusetts informed consent cases indicate that materiality
requires more than just non-negligibility. The defendant contends
that Feeley stands for the proposition that if a plaintiff can show
evidence of only a negligible risk, then there is no duty to
disclose, because such a risk is, as a matter of law, not material.
See id., 679 N.E.2d at 182 (holding that there was no duty to
disclose because plaintiff failed to show "more than a negligible
risk").
The district court seemingly adopted the plaintiff's
interpretation of the law by stating that "the doctor must inform
the patient where there exists more than a negligible risk of one
or more serious consequences from the course of treatment that is
being undertaken by the doctor." After hearing the evidence, the
court found that Dr. Laz was aware of the risk factors for a birth
injury and that these risk factors were "something more than
negligible." However, the court then weighed the risks to the
mother of a C-section, which the court found to be "more than
normally associated with the birth of a child," against the risks
to the child of a vaginal birth and found "that Dr. Laz was under
no duty to afford [Ms. Taft] the opportunity to have a cesarean
section and on the particular circumstances of this case a cesarean
section to avoid brachial plexus injury was not a reasonable
medical judgment."
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We believe that the district court erred in its
interpretation of Massachusetts law, thereby triggering de novo
review of its finding that Dr. Laz owed no duty to disclose the
risks and alternative methods of childbirth. See 15 Bosworth St.,
236 F.3d at 54; Vinick, 205 F.3d at 6-7. As discussed above,
Harnish and Precourt establish materiality as the standard for
determining whether a physician has an affirmative duty to
disclose. See Harnish, 439 N.E.2d at 243 (noting duty to disclose
material information, but that this does not require the disclosure
of all risks); Precourt, 481 N.E.2d at 1148-49 (recognizing duty to
disclose material information, which does not include "remote
risks"). However, Precourt reserved the issue of how to determine
when a risk need not be disclosed, except for indicating there is
no duty to disclose negligible risks:
The development of our law concerning the
distinction between 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. It is clear,
however, that when, as in this case, the
evidence does not permit the jury to draw an
inference that the physician knew or
reasonably should have known that the
probability that a particular risk would
materialize was other than negligible, the
evidence is insufficient to warrant a finding
that the physician violated his duty of
disclosure.
481 N.E.2d at 1149-50.
Feeley did not change this materiality approach to
informed consent. In Feeley, a mother sued for medical malpractice
when her child died from streptococcus pneumonia five days after
birth. See 679 N.E.2d at 181. The mother alleged that the
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treating physician, who opted for spontaneous labor (as opposed to
inducing labor) after her water broke, failed to disclose any risk
of infection from this procedure. See id. The Supreme Judicial
Court of Massachusetts, citing Harnish and Precourt, undertook a
materiality analysis and concluded that "[t]he evidence would not
permit a finding that the risk to the child of serious infection
was more than negligible." 679 N.E.2d at 181. Thus, because the
severity of the potential injury was minimal, the court concluded
that the information was not material, and the doctor, therefore,
had no duty to disclose. See id. at 181-82.
The plaintiffs in Feeley, similar to the plaintiff in
this case, argued that there was more than a negligible risk and,
as a result, that risk had to be disclosed. See id. On the
particular facts, however, the Feeley court determined that the
risk was not more than negligible. See id. at 182. Thus, the
court stated that "[t]he risk that must exist in order to invoke
informed consent principles in this case is a more than negligible
risk of one or more infections that will have serious
consequences." Id. This context clarifies that the court was
merely negating any duty to disclose negligible risks. The court
was not, as plaintiff argues, declaring an affirmative duty to
disclose any risk that is "more than negligible." Thus, 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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As a result, when the district court's analysis focused
on whether the risks were "more than negligible" rather than on
materiality, the district court applied the incorrect legal
standard. Thus, we vacate the district court's judgment and remand
the case to the district court judge to assess the materiality of
the risks of vaginal birth to a reasonable person in Ms. Taft's
position.6
Moreover, the court made a second legal error by
balancing the risks to the child from a vaginal birth against the
risks to the mother from a C-section and concluding that, because
the C-section presented a greater risk and was therefore not
medically recommended, the doctor had no duty to disclose the risks
of either procedure. The materiality standard for disclosure does
not incorporate a balancing test by which the court can weigh the
risks of alternate treatments in deciding what information is
material to the patient. An obstetrician in the delivery room is
in the unique situation of having to take into account the best
interests of two individuals, mother and child, in rendering
medical care. Cf. Thomas v. Ellis, 106 N.E.2d 687, 689-90 (Mass.
1952) (holding that evidence could support finding of negligence
where doctor's external turning of fetus' position, causing a
6
Materiality, since it is a factual determination, is properly
left for the district court to determine. See Kissinger v.
Lofgren, 836 F.2d 678, 681 (1st Cir. 1988) (finding that once jury
had heard evidence on likelihood and severity of injury, it was
jury's responsibility to determine materiality); Harnish, 439
N.E.2d at 243; Canterbury, 464 F.2d at 787, 788, 794; McMahon v.
Finlayson, 632 N.E.2d 410, 413 (Mass. App. Ct. 1994) (stating that
materiality is issue for the fact finder once there has been expert
testimony regarding the likelihood of the injury).
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separated placenta, endangered health of both mother and child).
As such, in recommending a course of treatment to his patients, the
standard of care may require the doctor to consider the risks to
the mother, the risks to the child, and the appropriate balance of
these risks.
However, the standard of care that governs a conventional
medical malpractice case differs from the materiality standard that
governs informed consent cases. See Steinhilber v. McCarthy, 26 F.
Supp. 2d 265, 272, 274-75 (D. Mass. 1998) (analyzing doctor's
negligence under the standard of care of an average member of his
profession but his duty to disclose under materiality of the
information). Under informed consent law, if a risk to the baby or
a risk to the mother is material to the patient-mother's decision,
the doctor has a duty to disclose that risk. See Harnish, 439
N.E.2d at 243 (asserting that physician has duty to disclose "all
significant information that the physician possesses" that is
material to the patient's decision). Once these risks and other
material information have been disclosed, it is the patient's
prerogative to balance these risks and choose the form of treatment
that best meets that patient's needs. See Harnish, 439 N.E.2d at
244 (declaring it is "the patient's right to decide for himself");
Canterbury, 464 F.2d at 781 ("To the physician, whose training
enables a self-satisfying evaluation, the answer may seem clear,
but it is the prerogative of the patient, not the physician, to
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determine for himself the direction in which his interests seem to
lie.").7
Thus, if, on remand, the district court finds that a risk
existed either as to the mother's health or as to the child's
health and that such information would have been material to a
reasonable patient in Ms. Taft's position, then Dr. Laz had a duty
to disclose that risk. Moreover, because there are only two
methods of childbirth, if the district court finds the risk of
vaginal birth to be material to the patient, then Dr. Laz also had
a duty to present the alternative option of a C-section that might
minimize such risk, regardless of his medical opinion on the proper
course of treatment.8
7
The patient's opportunity to perform this balancing may assume
particular importance when the patient is a mother giving birth.
In such a case, the mother may purposefully discount risks to
herself in order to choose a treatment or procedure that will
present the least risk to her newborn child. While the treating
physician will undoubtedly feel the need to balance the welfare of
mother and child, the mother may consider her baby's health as the
paramount concern. See Statement by American Medical Association
on Forced Cesarean Section Court Case in Chicago, U.S. Newswire,
December 15, 1993, available at 1993 WL 7132850 (opining that in
cases where there is a "trade-off" between the health of the mother
and the child, "pregnant women routinely choose" and "should"
choose a cesarean section "for the benefit of their fetuses," even
though the risk to the woman is higher than from a vaginal
delivery).
8
We emphasize that a duty to disclose, if it exists, does not
necessarily indicate any duty to offer or to perform a C-section if
the doctor does not consider one to be warranted in his medical
judgment. See Canterbury, 464 F.2d at 781 (separating physician's
duty "to treat [and diagnose] his patient skillfully" from his
"obligation to communicate specific information to the patient").
The duty to disclose is intended to be limited, so as not to unduly
burden the practice of medicine. See Harnish, 439 N.E.2d at 243.
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IV.
The plaintiff also challenges on appeal the district
court's analysis of his claim for damages arising out of the
alleged malpractice. The district court, in an effort to provide
a "complete record of factual findings," analyzed the case
backwards, starting with an assessment of damages, then proceeding
to causation, negligence, and duty, in that order. Although we
understand why the court engaged in this method of analysis, rather
than simply concluding its ruling after finding there was no duty
to disclose, such analysis resulted in extraneous factual findings.
Therefore, because the district court did not need to reach the
issue of damages, any findings regarding damages are dicta; the
district court did not actually award any damages. As a result,
plaintiff's claims of error in computing the damages are premature.
See United States v. Ottati & Goss, Inc., 900 F.2d 429, 443 (1st
Cir. 1990) (refusing to address appeal of district court's
liability finding since such finding was not necessary to the
judgment below). Rather, plaintiff should raise his claims if, on
remand, the district court finds Dr. Laz liable and awards damages.
V.
For the reasons discussed herein, we vacate the district
court's judgment and remand the case to the district court judge
for a determination of materiality.
Vacated and remanded for actions consistent with this
opinion.
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