United States Court of Appeals
For the First Circuit
____________________
Nos. 00-2553, 00-2554, 00-2555
EVELYN HEINRICH, on behalf of her husband, GEORGE HEINRICH, and
HENRY M. SIENKEWICZ, on behalf of his mother, EILEEN ROSE
SIENKEWICZ JR.,
Plaintiffs, Appellants, Cross-Appellees,
ROSEMARY GUALTIERI, on behalf of her father, JOSEPH MAYNE, and
WALTER CARL VAN DYKE, Representative of the Estate of WALTER
CARMEN VAN DYKE,
Plaintiffs, Appellants,
v.
ELIZABETH DUTTON SWEET and FREDERICK H. GREIN JR.,
Representatives of the Estate of WILLIAM H. SWEET, M.D., and
MASSACHUSETTS GENERAL HOSPITAL,
Defendants, Appellees, Cross-Appellants,
UNITED STATES OF AMERICA,
Defendant, Appellee,
ESTATE OF LEE EDWARD FARR, ASSOCIATED UNIVERSITIES, INC., and
MASSACHUSETTS INSTITUTE OF TECHNOLOGY,
Defendants.
____________________
APPEALS FROM THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF MASSACHUSETTS
[Hon. William G. Young, U.S. District Judge]
____________________
Before
Lynch, Circuit Judge,
Coffin and Cyr, Senior Circuit Judges.
____________________
Anthony Z. Roisman with whom John K. McGuire Jr., McGuire
& McGuire, P.C., Martin H. Freeman, Freeman & Freeman, P.C., John
M. Clifford, Billie P. Garde, and Clifford, Lyons & Garde were on
brief for appellants, cross-appellees.
James B. Re with whom Karen W. Salon and Sally & Fitch
were on brief for appellees, cross-appellants Elizabeth Dutton
Sweet and Frederick H. Grein Jr., Representatives of the Estate of
William H. Sweet, M.D.
Joseph L. Doherty Jr. with whom Christopher J. Maley and
Martin, Magnuson, McCarthy & Kenney were on brief for appellee,
cross-appellant Massachusetts General Hospital.
Robert D. McCallum Jr., Assistant Attorney General Civil
Division, with whom J. Patrick Glynn, Director, Torts Branch, David
S. Fishback, Assistant Director, Torts Branch, and Burke M. Wong,
Trial Attorney, Torts Branch, were on brief for appellee United
States.
Pamela P. Heacock, Paul W. Johnson, and Smith & Duggan
LLP were on brief for amici curiae Professional Liability
Foundation, Ltd., Massachusetts Medical Society, American Medical
Association, and American College of Surgeons.
____________________
August 27, 2002
____________________
LYNCH, Circuit Judge. This is a medical malpractice
case, brought in 1995, for the deaths of two Massachusetts General
Hospital (MGH) patients in 1961. The plaintiffs sued the doctor
and institutions responsible for treating their decedents, Eileen
Sienkewicz and George Heinrich, who suffered from a terminal form
of brain cancer, with an experimental treatment known as boron
neutron capture therapy (BNCT). BNCT proved not to save the lives
of Sienkewicz or Heinrich.
The plaintiffs' complaint included eleven causes of
action. By the time the case reached trial, there were only three
causes of action left. The jury returned a verdict for the
plaintiffs on two claims -- negligence and wrongful death -- and
found for the defendants on the informed consent claim. The
defendants appeal from the negligence and wrongful death verdicts,
arguing that there was insufficient evidence.
The plaintiffs also sued the United States government
under the Federal Tort Claims Act (FTCA) for its involvement in the
experimental BNCT treatment through the Atomic Energy Commission
(AEC). The district court determined that the government "cannot
be held liable under the [FTCA] for the alleged negligence of the
private defendants" and allowed the government's motion for
judgment. Heinrich v. Sweet (Heinrich IV), 83 F. Supp. 2d 214, 224
(D. Mass. 2000). The plaintiffs appeal from that judgment and from
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the district court's subsequent reduction of the damages award to
the plaintiffs.
We affirm the district court's judgment for the United
States on the FTCA claim. We vacate the judgment for the
plaintiffs on the negligence and wrongful death claims because
there was insufficient evidence to meet the plaintiffs' burden of
proof, and we direct entry of judgment for the defendants, Dr.
Sweet and MGH.
I.
Because there is a challenge to the sufficiency of the
evidence, we describe the facts in this case in the light most
favorable to the verdicts. Rodowicz v. Mass. Mut. Life Ins. Co.,
279 F.3d 36, 39 (1st Cir. 2002).
The events surrounding this case happened over four
decades ago. George Heinrich and Eileen Sienkewicz, the
plaintiffs' decedents, both suffered from glioblastoma multiforme,
the most common, most malignant, and deadliest form of brain
cancer, and were both treated by Dr. Sweet at MGH in 1960-61. Both
Heinrich and Sienkewicz consented to and participated in medical
trials for Boron Neutron Capture Therapy (BNCT) performed by Dr.
Sweet at a nuclear reactor facility at the Massachusetts Institute
of Technology (MIT). It is these BNCT treatments that are the
subject of the malpractice case.
A. Eileen Sienkewicz
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Eileen Sienkewicz was admitted to MGH on June 10, 1960,
complaining of severe headaches, lethargy, lack of concentration,
and disorientation. At the time, she was thirty-nine years old.
Dr. Sweet observed her for a few days, and then performed a left
parietal-temporal craniotomy on June 13 during which he removed a
mass of brain tissue which proved to be a glioblastoma multiforme,
a cancerous tumor. Sienkewicz was then discharged from the
hospital on June 25.
Over the summer of 1960, she suffered from lethargy,
depression, insomnia, and general confusion. She was readmitted to
MGH on November 13, 1960, and on November 15 she underwent BNCT,
under Dr. Sweet's supervision, at the MIT reactor. At first, her
lethargy worsened, but a couple of days later, she began to improve
and "became more alert and began to talk again . . . and [was]
essentially as responsive as she had been preoperatively." She was
discharged again on December 3, 1960.
After her discharge, she continued to feel depressed.
She underwent electroshock therapy at a different hospital during
the first week of January 1961, her mood improved considerably, and
she was "up and about doing her housework at home."
On February 27, 1961, she experienced a headache on the
left side, weakness in her right limbs, and difficulty with speech.
She was again admitted to MGH and her condition improved
inexplicably. She was discharged on March 4, 1961.
-5-
Over the summer of 1961, she again became disoriented and
depressed. She could not sleep and she experienced nausea and
severe headaches. She was readmitted to MGH on August 13, 1961,
when a "[brain] scan showed a suspicious area" in the region of the
tumor. She was discharged on August 19. But on September 27, she
was again admitted to MGH because her condition worsened. She
experienced increased headaches, speech difficulties, insomnia, and
depression. At the hospital her condition only deteriorated. She
was very depressed and disoriented. She eventually lapsed into a
coma and died on October 31, 1961, sixteen and a half months after
she was first diagnosed with brain cancer.
B. George Heinrich
George Heinrich was admitted to MGH on October 22, 1960.
He complained of intermittent severe headaches, nausea, vomiting,
drowsiness, and decreased vision. After Heinrich was observed for
a few days, Dr. James C. White performed a left temporoparietal
craniotomy on October 25 and partially removed a tumor which proved
to be a glioblastoma multiforme. Heinrich was given twenty
conventional radiation treatments, and his recovery seemed to be
going well, but the tumor regrew and he had a second operation on
December 15, 1960. Again, Heinrich's condition improved
temporarily, but on January 2, 1961, he was readmitted to the
hospital because his wound was infected. The infection was treated
and subsided.
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On January 18, 1961, Heinrich was taken to the MIT
nuclear reactor and underwent BNCT. Despite the fact that Heinrich
experienced some problems with his surgical wound, "[f]or a short
time he again continued to do well." But around February 10, he
began to feel very lethargic and disoriented. His condition
continued to deteriorate, and a brain scan performed on April 11,
1961, showed "a definite abnormality" in the region of his tumor.
By May 15, his condition had so deteriorated that he was
transferred to a nursing home, where he died on May 27, 1961, about
seven months after he was diagnosed with brain cancer.
C. BNCT
Boron Neutron Capture Therapy was an experimental
treatment in the early 1960s for the deadliest form of brain cancer
-- glioblastoma multiforme. The various estimates of the expected
survival time for a patient with this type of brain cancer in 1960-
61 are all measured in months.
BNCT combines chemotherapy with radiation. The theory
behind BNCT at that time was that combining "boron-10 and thermal
neutrons, each innocuous by itself in the doses used," would
produce "a high energy nuclear reaction" that would deliver highly
localized radiation to tumor cells to destroy them while largely
sparing normal brain tissue. According to the theory, a compound
containing boron-10 would be injected into the bloodstream
supplying the brain. This compound would be taken up by tumor
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tissue but not by normal tissue. The tumor would then be exposed
to a neutron beam produced by a nuclear reactor. When the neutron
beam interacted with the boron-10, a fission reaction would occur
and destroy the surrounding tumor tissue.
BNCT was first attempted at the Brookhaven National
Laboratories in 1951 by a team that included Dr. Lee Edward Farr
and Dr. Sweet, both neurosurgeons. BNCT was performed on ten
patients from 1951-53. The experiments with BNCT at that time
proved unsuccessful, and all the patients died of the brain cancer
shortly after the therapy, although there was some short-lived
improvement in two of the patients. Dr. Sweet and his fellow
researchers stopped the experiments and tried to learn from the
failure. Three reasons for the failure of the treatment were
identified: (1) the radiation dose delivered was too low; (2) the
neutrons used had too low penetration; and (3) an optimal boron
compound had not yet been found.
Over the next decade, Dr. Sweet and others continued to
work on developing BNCT. In 1960-61 clinical trials of BNCT were
again performed, this time at MIT's nuclear reactor facility. The
AEC supported these trials with funding under a contract with Dr.
Sweet, as well as with supplies of boron necessary to conduct the
BNCT treatments. Consistent with its general policy of setting out
broad objectives and leaving most decisions in the hands of the
scientists and institutions who received funding for medical
-8-
research, the AEC monitored the trials through written reports and
occasional site visits.1
The team of doctors and scientists who worked with Dr.
Sweet on the BNCT trials at MIT included Dr. Soloway, the principal
chemist, Dr. Brownell, the principal physicist, and Dr. Ojemann, a
senior resident in neurosurgery at the time. Before Dr. Sweet
could proceed with the 1960-61 BNCT trials, he had to get approval
from three different medical and administrative committees at MGH.
In addition, he had to get the approval of the Biomedical Advisory
Committee at MIT, which was comprised of representatives from MIT
and three medical schools in the Boston area.
Improvements to BNCT had been made between the trials at
Brookhaven and those at MIT. MIT's reactor facility was considered
superior to Brookhaven's for three reasons. First, it could
deliver a therapeutic dose of neutrons in less time, which was
thought to be advantageous because it optimized the level of boron
compound in the tumor. Second, a more optimal boron-10 compound
was found and used. Finally, at MIT the doctors were able to
expose the tumor more directly to the neutron beam because of the
placement of the equipment and the operating room.
1
While a copy of the particular contract for the MIT
trials is not a part of the record, there is no indication that it
differed in these respects from other AEC contracts in operation at
the time.
-9-
A number of patients, all with terminal brain cancer,
consented to the BNCT treatments. Sienkewicz was the first patient
in this 1960-61 series of BNCT trials, while Heinrich was the sixth
patient. Between their two treatments there were four other
patients. The second patient was not irradiated because the tumor
was too far advanced. The third patient was given the therapy and
made a satisfactory recovery, but died of meningitis six weeks
later. The fourth patient had recurrences of cancer in other parts
of the body and died five months later. The fifth patient showed
no improvement and died two months later. All in all, there were
nineteen patients in this series of trials.
The doctors were very optimistic about the treatment
after seeing its effect on the first patient, Sienkewicz, "who was
strikingly improved" after BNCT "to the point that she could manage
her own home and children until the last 2½ months of her life."
This improvement was known as of December 3, 1960, before Heinrich
had his BNCT treatment on January 19, 1961. However, the doctors'
"cheerful optimism . . . waned" when they collected the results of
the entire study after its conclusion.
After the trials ended in August 1961, Dr. Sweet and
other members of his team studied the results. Dr. Sweet, Dr.
Ojemann, and two other doctors presented a paper at the 40th annual
meeting of the American Association of Neuropathologists in 1964,
summarizing the BNCT trials at MIT and analyzing the results. A
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revised version of the paper was later published in the Journal of
Neuropathology and Experimental Neurology in 1972. In addition,
Drs. Soloway, Brownell, Ojemann, and Sweet published an article in
1964 entitled "Boron-Slow Neutron Capture Therapy: Present Status."
Sweet and his coauthors concluded that the BNCT trials at MIT
failed due to four main "deficiencies," including:
1) [Their] lack of appreciation of the full complexity
and requirements of our biological systems with regard to
the boron compound, specifically to the need to clear it
from the cerebral blood stream.
2) The inadequacy of the current status of knowledge
regarding boron chemistry.
3) Insufficient information as to the methods of
optimizing the shape of neutron beam for capture therapy.
4) The lack of the requisite dosimetric [measuring]
equipment.
They also stated that "the theoretical aspects which prompted
[their] initial attempts" remained "attractive," and expressed
optimism that, after further study in a variety of scientific
fields, "[their] therapeutic goal may be within reach."
Since the 1960-61 BNCT trials at MIT, there have been
further BNCT trials in other places by other doctors. Most
notably, Dr. Hiroshi Hatanaka performed clinical trials in Japan
between 1968 and 1989 and achieved a survival rate of up to five
years in some of his patients.2
The medical doctors most closely involved with the BNCT
trials could not, by reason of age and infirmity or death, testify
2
The defendants offered additional evidence of ongoing
work with BNCT, but the district court excluded that evidence.
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at the belated trial. Dr. Farr, who supervised the BNCT trials at
Brookhaven, died in 1997. Dr. Sweet died after the trial in
January 2001. He did not testify at trial because his age and
medical condition had by then rendered him incompetent.
II.
The procedural history of this case is complicated. The
plaintiffs first brought the case in the Eastern District of New
York on September 21, 1995, as a putative class action on behalf of
their decedents. The case was transferred to the District of
Massachusetts on August 20, 1997. The complaint, filed on behalf
of decedents from the BNCT trials both at Brookhaven in 1951-53 and
MIT in 1960-61, included eleven causes of action against all of the
parties involved in the BNCT trials: Dr. Sweet; MGH; MIT;
Associated Universities, Inc., which operated Brookhaven National
Laboratories; the Estate of Dr. Lee Edward Farr, who supervised the
BNCT trials at Brookhaven; and the United States government, which
was responsible for the AEC.
On April 20, 1999, the district court denied the
government's motion to dismiss the FTCA claims on the basis of the
statute of limitations. Heinrich v. Sweet (Heinrich I), 44
F. Supp. 2d 408 (D. Mass. 1999).
On April 30, 1999, the district court dismissed
plaintiffs' battery, intentional infliction of emotional distress,
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strict liability, toxic substances, and crimes against humanity
claims. Heinrich v. Sweet (Heinrich II), 49 F. Supp. 2d 27
(D. Mass. 1999).
On August 16, 1999, the district court dismissed the
state law claims of plaintiffs whose decedents underwent BNCT at
the Brookhaven National Laboratories in New York (Joseph Mayne and
Walter Carmen Van Dyke) as untimely under New York law. Heinrich
v. Sweet (Heinrich III), 62 F. Supp. 2d 282 (D. Mass. 1999). At
the same time, the district court held that the FTCA's independent
contractor exception and discretionary function exception did not
apply to the case and declined to dismiss plaintiffs' FTCA claims
against the United States on either basis. Id. at 321-26. On
September 9, 1999, the district court granted summary judgment on
the plaintiffs' Bivens claim against all the private defendants.3
The jury heard evidence over fifteen days between
September 10 and October 7, 1999. At the end of the trial, the
court dismissed the fraud and negligent misrepresentation claims on
a motion for judgment as a matter of law.
Finally, the jury returned a verdict for defendant MIT on
all counts. The jury's verdict form had verdicts for Dr. Sweet and
MGH on the same line, as if they were one party, because the
3
The district court made other rulings permitting
plaintiffs' claims to survive the statute of limitations and
retroactivity defenses, and ruled for plaintiffs on issues of which
statutory scheme applied. Heinrich III, 62 F. Supp. 2d at 304. We
have no occasion to pass on whether these rulings were correct.
-13-
plaintiffs' theory of liability as to MGH was based exclusively on
vicarious liability for Dr. Sweet's actions. The jury returned a
verdict for defendants Dr. Sweet and MGH on the informed consent
count, and for plaintiffs Heinrich and Sienkewicz on the negligence
and wrongful death counts. The jury assessed a total of $3 million
in compensatory damages against MGH and Dr. Sweet jointly and
severally. The jury also assessed $1.75 million in punitive
damages against Dr. Sweet, and $3.25 million against MGH.4
Because FTCA claims are heard by a judge rather than a
jury, see 28 U.S.C. § 2402, the district court ruled separately on
the remaining claims against the federal government on February 9,
2000. Heinrich v. Sweet (Heinrich IV), 83 F. Supp. 2d 214 (D.
Mass. 2000). Based on further evidence made available in post-
trial proceedings about the AEC's involvement in the BNCT
treatments, the court reversed its previous determination, found
that the independent contractor exception applied, and ordered
judgment for the United States. Id. at 221-24. Because its
finding on the independent contractor exception disposed of the
FTCA claims, the district court deemed it unnecessary to reach the
issue of the discretionary function exception.
Dr. Sweet and MGH filed a motion for a new trial, a
renewed motion for judgment as a matter of law, and a motion for
4
After the trial, on January 5, 2000, the district court
denied class certification.
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reduction of the jury award. Among the grounds asserted in their
motion for judgment as a matter of law was that the evidence did
not meet the plaintiffs' burden of proof. The district court
rejected the motion for a new trial and the motion for judgment as
a matter of law. The district court ruled from the bench that
"[t]he evidence is sufficient to support each of the causes of
action which were submitted to the jury" but gave no reasons for
its ruling. In a written opinion, the district court reduced the
jury award because it determined that the jury had been instructed
to apply the incorrect Massachusetts wrongful death statute (the
1995 statute instead of the one in effect when the treatments took
place). Thus, the award was reduced to $750,000 (joint and
several) for the negligence count, and $20,000 from each defendant
to each plaintiff for the wrongful death count. Heinrich v.
Sweet (Heinrich V), 118 F. Supp. 2d 73, 77-83 (D. Mass. 2000).
III.
The plaintiffs and the defendants appeal from the
judgments of the district court. Plaintiffs argue that the jury
award for the wrongful death claims should not have been reduced,
that they should be awarded prejudgment interest, and that the
judgment for the United States on the FTCA claim should be
reversed.
Defendants MGH and Dr. Sweet argue that judgment should
have been entered in their favor as a matter of law because the
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statute of limitations on the plaintiffs' claims had run. In
addition, they argue that there was insufficient evidence to
support the negligence and wrongful death claims. They argue that
the plaintiffs did not show that Dr. Sweet departed from the
applicable standard of care or that his actions hastened the
decedents' deaths. MGH also argues that it cannot be held liable
in light of the state charitable immunity doctrine. The government
argues that it cannot be held liable under the FTCA since both the
independent contractor exception and the discretionary function
exception under that Act apply. The government also asserts that
the FTCA's statute of limitations bars plaintiffs' claims against
the United States.
Because we agree with the defendants that there was
insufficient evidence to support the negligence and wrongful death
claims, we do not reach the plaintiffs' arguments about the
reduction of the jury award and prejudgment interest. We also do
not reach the statute of limitations issues or MGH's charitable
immunity argument.
IV.
A. Federal Tort Claims Act
Before proceeding to the underlying negligence and
wrongful death claims, we consider whether the FTCA, 28 U.S.C.
§§ 1346(b), 2671-80 (2000), waives sovereign immunity so that the
United States is susceptible to liability for these causes of
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action, whatever their merits. We affirm the district court's
judgment for the United States.
The district court concluded that the relationship that
the AEC had with Dr. Sweet and MGH was an independent contractor
relationship, because the AEC did not exercise "detailed
supervision or day-to-day control" over the BNCT treatments.
Heinrich IV, 83 F. Supp. 2d at 221-24. This finding required
dismissal of the claims under the independent contractor exception
to the FTCA, 28 U.S.C. § 2671. See United States v. Orleans, 425
U.S. 807, 816-17 (1976). Rather than directly disputing the
district court's characterization of the relationship, plaintiffs
object that "the U.S. should be liable for the AEC's failure to
follow its policy on human radiation experiments." As plaintiffs
summarize it, this policy required a "reasonable basis to believe
the experiment would provide therapeutic benefit to the patient."
This argument is unavailing. Plaintiffs derive the
purported "policy" from four letters written by AEC officials in
1947 and 1951, none of them about BNCT itself. There is, however,
no clear evidence that these letters represented any specific or
binding AEC policy. They are individual communications, not
necessarily disseminated to anyone but their individual addressees.
They contain only broadly-worded statements to the effect that a
doctor should not conduct experimental treatments without a
"reasonable hope" or an "expectation" of therapeutic benefit. One
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of the 1947 letters also emphasized the AEC's "understand[ing]"
that "the decision as to the advisability of the treatment will be
made by the doctor concerned." The final report of the
presidentially-appointed Advisory Committee on Human Radiation
Experiments, introduced into evidence by plaintiffs, analyzed the
same correspondence and concluded that it did not clearly represent
formal policy, with the possible exception of informed consent
requirements not at issue here.
Furthermore, even if the letters stated the AEC's policy,
that policy would not restrict the AEC's discretion concerning BNCT
treatments. The FTCA shields from liability a federal agency's
exercise of a "discretionary function." 28 U.S.C. § 2680(a). The
plaintiffs' asserted policy requiring a "reasonable basis" to
expect "therapeutic benefit" would hardly constrain the AEC's
judgment at all. It would be quite different from the narrow,
discretion-limiting rule in the case on which plaintiffs rely so
heavily, Berkovitz v. United States, 486 U.S. 531 (1988), which
concerned the detailed regulatory scheme for licensing and testing
of polio vaccines. Rather, these broad parameters leave a host of
case-by-case judgments for agency officials to make, each requiring
the exercise of discretion and the consideration of the agency's
overarching policy goals. This is a classic discretionary
function. See United States v. Gaubert, 499 U.S. 315, 327-34
(1991) (regulators' choices in oversight of savings and loan
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qualify as discretionary function); Shansky v. United States, 164
F.3d 688, 691 (1st Cir. 1999) (general statement in agency
operating manual leaves discretion to individual managers); Irving
v. United States, 162 F.3d 154, 162-63 (1st Cir. 1998) (en banc)
(guidelines in OSHA inspection manual leave discretion to
individual inspectors).
We affirm the district court's holding that the FTCA does
not permit suit against the federal government.
B. Sufficiency of the Evidence Against Dr. Sweet and MGH
Defendants Dr. Sweet and MGH challenge the sufficiency of
the evidence against them on the negligence and wrongful death
claims and argue that the district court should have entered
judgment as a matter of law in their favor. The district court,
ruling from the bench, denied the motion for judgment as a matter
of law based on insufficiency of the evidence without stating its
reasons for doing so. We review de novo a district court's denial
of a Rule 50 motion for judgment as a matter of law. But "[o]ur
review is weighted toward preservation of the jury verdict,"
Rodowicz, 279 F.3d at 41, and "[w]e must affirm unless the evidence
was 'so strongly and overwhelmingly' inconsistent with the verdicts
that no reasonable jury could have returned them," Walton v. Nalco
Chem. Co., 272 F.3d 13, 23 (1st Cir. 2001) (quoting Negron v. Caleb
Brett U.S.A., Inc., 212 F.3d 666, 668 (1st Cir. 2000)).
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Massachusetts law governs both the wrongful death and
negligence claims.
1. Wrongful Death
Dr. Sweet and MGH argue that because there was no
evidence that BNCT hastened the death of either decedent, the
district court should have entered judgment as a matter of law in
the defendants' favor on the wrongful death claim, and the jury
verdict against them on this claim should be vacated.
The district court instructed the jury that in order for
the plaintiffs to receive compensatory damages for a wrongful death
claim, the defendant had "to shorten the life" of the decedent.5
The court explained that "if, had there been no . . . procedure,
the person would have gone downhill, and would eventually then have
died of the disease, but because of the procedure they died
earlier, then you can award damages." The plaintiffs did not
object to this instruction specifically at the time it was given,
and so they have forfeited any potential objection to it on appeal,
absent plain error. See Fed. R. Civ. P. 51; Gray v. Genlyte Group,
289 F.3d 128, 133-34 (1st Cir. 2002).
5
Plaintiffs based their wrongful death claim on both
negligence and intentional misconduct. Cf. Necktas v. Gen. Motors
Corp., 357 Mass. 546, 259 N.E.2d 234, 236 (1970) ("The right of
recovery for death . . . is based either upon negligence or upon a
wilful, wanton or reckless act causing death."). The instructions
to the jury about wrongful death focused solely on wrongful death
as a negligence claim, and we do not understand plaintiffs to
pursue an intentional misconduct claim on appeal.
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This instruction was not inconsistent with Massachusetts
case law.6 To make out a claim for wrongful death on a negligence
theory, a plaintiff must show that the defendant's negligence
caused the plaintiff to die prematurely. Harlow v. Chin, 405 Mass.
697, 545 N.E.2d 602, 605 (1989) ("A plaintiff in a medical
malpractice action has the burden of proving that the physician's
negligence was the proximate cause of the plaintiff's injuries.").
Defendants dispute their liability for wrongful death by focusing
on this causation element. Under these jury instructions, where
the plaintiffs were terminally ill and death was imminent,
plaintiffs must show that the defendant's actions hastened death
"even though it would have occurred at no very remote date from
other causes." Edwards v. Warwick, 317 Mass. 573, 59 N.E.2d 194,
196 (1945); see also Coburn v. Moore, 320 Mass. 116, 68 N.E.2d 5,
10 (1946) (holding that there was "enough to show a causal relation
between the negligence of the defendant and the death of the
intestate" where the defendant's actions "accelerated [intestate's]
death"); Walker v. Gage, 223 Mass. 179, 111 N.E. 766, 767 (1916)
(holding that evidence that the accident hastened intestate's death
was "enough legally to constitute the accident the proximate cause
of his death"). There was not plain error in the instruction that
6
Because of this jury instruction, issued without
objection, we need not reach the issue of whether there are other
methods to win compensatory damages for wrongful death under
Massachusetts law.
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plaintiffs must show that the defendants "shorten[ed] the life" of
the decedent.
The necessary "causal connection between the negligence
of the defendant, if found, and the plaintiff's injuries . . . is
a question that a jury could determine only with the aid of expert
opinion." Berardi v. Menicks, 340 Mass. 396, 164 N.E.2d 544, 547
(1960); see also Mitchell v. United States, 141 F.3d 8, 13 (1st
Cir. 1998); Harlow, 545 N.E.2d at 605. Plaintiffs argue that the
jury's finding that death was hastened by defendant's negligence
need not be based on expert testimony if there is any probative
evidence at all. Plaintiffs rely on Edwards, 59 N.E.2d at 195-96,
where the court permitted consideration of the issue of whether an
automobile accident had hastened death. Edwards is inapposite.
Contrary to plaintiffs' argument, there was expert medical
testimony in Edwards tying the death to the auto accident.
Furthermore, in a medical malpractice case in which plaintiff
argues that the treatment, not the terminal disease, hastened the
death, and all of the expert testimony is that it cannot be said
that the treatment hastened the death, a jury is not free to reach
a contrary conclusion. Whether such a treatment ultimately
hastened a patient's death is not a topic of common experience; it
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requires expert testimony.7 There is no evidence at all in the
record that BNCT hastened decedents' deaths.
Plaintiffs' own medical expert, Dr. Larry Junck, a
professor of neurology and neuro-oncology, plainly stated that he
could not say that BNCT hastened the decedents' deaths:
I think it would be very difficult for me to say what
would have happened had they not received that treatment.
That would be just hypothetical and it's just the kind of
thing that I would have no basis for saying what would
have happened had they not received BNCT and perhaps
received some other treatment.
In addition, Dr. Junck responded on cross-examination as follows:
Q. But you certainly cannot say that the
administration of BNCT in any way hastened
[Sienkewicz's] death?
A. That's correct.
Q. And as to George Heinrich you cannot say that the
administration of the BNCT in any way hastened
George Heinrich's death; is that correct?
A. That's correct.
Dr. Junck testified that in the early 1960s the median
life expectancy for glioblastoma multiforme patients such as
Sienkewicz and Heinrich, from diagnosis to death, without any
treatment, was four to six months. He also testified that the life
expectancy for a glioblastoma multiforme patient who underwent
conventional therapy including conventional radiation was eight to
twelve months. Sienkewicz well exceeded this life expectancy as
she lived for sixteen and a half months after she was first
7
Plaintiffs also argue that such proof may come in
documentary form; but the documents they cite do not support their
proposition.
-23-
diagnosed, and eleven months after she underwent BNCT. Heinrich
survived for seven months after he was first diagnosed. Although
this is slightly below the median life expectancy for glioblastoma
multiforme patients who received conventional therapy, as
identified by Dr. Junck, it is not sufficiently below the median to
show that Heinrich would have lived longer had he not received
BNCT.
In addition, two of defendants' experts also clearly
testified that they could not determine that BNCT hastened the
decedents' deaths. Dr. Raymond Laws, a professor of neurosurgery
and a practicing neurosurgeon, stated that he "found no evidence
that the BNCT hastened [Sienkewicz's] demise" or that "[it]
hastened [Heinrich's] demise." Dr. Edward G. Koski, an
anesthesiologist and Director of Human Research Affairs for
Partners Health Care Systems, which includes MGH, stated that "Ms.
Sienkewicz appeared to have lived somewhat longer than would have
been expected given the nature of her tumor and the usual course of
the disease and people in her age group."
In response, plaintiffs attempt to rely on an article
entitled "The Longevity of Patients with Glioblastoma Multiforme,"
published in 1950 in the Journal of Neurosurgery. The article
stated that "[t]he average duration from the first symptom to
exitus was 17 months." The plaintiffs depend on this assertion to
say that both Sienkewicz and Heinrich lived below the life
-24-
expectancy and that BNCT hastened their deaths. The very next two
sentences in this article read: "However, this average was
distorted by the unusual cases to be discussed. The median
survival was 8.3 months, a figure that is more indicative of the
usual case." Moreover, when Dr. Junck, plaintiffs' expert, himself
commented on this portion of the article, he said "the average
really isn't telling us as much about what the typical patient did
because it's so heavily influenced by two particular people. The
median is a figure that describes the patient in the exact middle
of the group."
The plaintiffs also rely on the fact that "Dr[]. Sweet
. . . as well as other writers . . . concluded that there is no
evidence that the BNCT experiments at the MIT reactor in 1960 and
1961 prolonged anyone's life." In an article written by Dr. Sweet
and others, published in the Journal of Neuropathology and
Experimental Neurology in 1972, the authors stated that BNCT, as
utilized in 1961, "offered no advantage over standard methods of
therapy already available." Similarly, in an article by Dr. Sweet
and others about the "present status" of BNCT, published in 1964,
the authors wrote that there was "[o]nly one instance of prolonged
improvement," apparently referring to Sienkewicz. There is no
doubt that these articles, written by the doctors most closely
involved with BNCT, stated that BNCT as performed in 1961 was not
a more successful way to treat glioblastoma multiforme than the
-25-
conventional treatment available at the time. However, the
articles also say nothing about BNCT causing the death of the
patients earlier than would otherwise be expected. In fact, in the
article published in 1972, the authors say that "[t]he average
survival time from the time of diagnosis . . . was roughly the same
[as the] average survival for a similar large series treated [in
the conventional manner.]"
Taking the evidence in the light most favorable to the
verdict, there was no evidence that BNCT hastened the death of
Heinrich or Sienkewicz. The evidence was overwhelmingly
inconsistent with the verdicts for plaintiffs on their wrongful
death claims and is therefore insufficient to uphold those
verdicts. Independently, our conclusion that the evidence was not
sufficient to support a verdict of negligence, described below,
also means that the wrongful death verdict cannot stand.
2. Negligence
Dr. Sweet and MGH challenge the jury's verdict in favor
of plaintiffs on the negligence claims. They argue that there was
insufficient evidence to show that Dr. Sweet deviated from the
applicable standard of care.
To prevail on a negligence claim, a plaintiff must show
by a preponderance of the evidence "(1) a legal duty owed by
defendant to plaintiff; (2) a breach of that duty; (3) proximate or
legal cause; and (4) actual damage or injury." Jorgensen v. Mass.
-26-
Port Auth., 905 F.2d 515, 522 (1st Cir. 1990); see also Harlow, 545
N.E.2d at 604-05 ("'To entitle the plaintiff to go to the jury [on
a negligence claim] there must be sufficient evidence to warrant a
finding (1) of negligence on the defendant's part, and (2) of a
causal relationship between the negligence and the plaintiff's
injuries.'" (quoting Civitarese v. Gorney, 358 Mass. 652, 266
N.E.2d 668, 671 (1971))).
The defendants argue that there was insufficient evidence
at trial to show that Dr. Sweet violated his duty of care to the
plaintiffs' decedents by failing to comply with the applicable
standard of care.
The Massachusetts Supreme Judicial Court articulated the
standard of care for physicians in Brune v. Belinkoff:
The proper standard is whether the physician,
if a general practitioner, has exercised the degree of
care and skill of the average qualified practitioner,
taking into account the advances in the profession. In
applying this standard it is permissible to consider the
medical resources available to the physician as one
circumstance in determining the skill and care required.
Under this standard some allowance is thus made for the
type of community in which the physician carries on his
practice.
One holding himself out as a specialist should
be held to the standard of care and skill of the average
member of the profession practising the specialty, taking
into account the advances in the profession. And, as in
the case of the general practitioner, it is permissible
to consider the medical resources available to him.
354 Mass. 102, 235 N.E.2d 793, 798 (1968) (emphasis added)
(citations omitted); see also Stepakoff v. Kantar, 393 Mass. 836,
473 N.E.2d 1131, 1135 (1985). The standard of care for medical
-27-
doctors is not static or rigid. It is a standard that changes
depending on many factors, including a doctor's specialty, the
resources available, and the advances of the medical profession at
the time of the alleged negligent act. The duty to be measured is
the one as of the time of the act. Here, that means November 1960
as to Sienkewicz, and January 1961 as to Heinrich.
In this case, the determination of the standard of care
owed by Dr. Sweet to the decedents must be influenced by his
specialty, the state of medical practice and advances as of
November 1960 and January 1961, and the fact that in treating the
decedents he was also conducting medical research for a new
treatment. Under the circumstances of this case, where the jury
was asked to evaluate the doctor's conduct many years after the
events took place, it is especially important that the correct
standard of care in place at the time of the treatments be clearly
established and used.
Massachusetts law requires that unless "'the negligence
and harmful results are sufficiently obvious as to lie within
common knowledge,'" such as "a case where there is certainty of a
foreign object or dangerous physical organ left in a patient during
an operation," the plaintiff must present expert testimony as to
the standard of care and its breach. Haggerty v. McCarthy, 344
Mass. 136, 181 N.E.2d 562, 565-66 (1962) (quoting Cyr v. Giesen,
150 Me. 248, 108 A.2d 316, 318 (1954)); see also Collins v. Baron,
-28-
392 Mass. 565, 467 N.E.2d 171, 173-74 (1984). This case required
such expert testimony. As an alternative or an addition to expert
testimony, the plaintiff may also present admissions from the
defendant about his fault. Collins, 467 N.E.2d at 173-74.
"Testimony concerning conclusory admissions by a malpractice
defendant may suffice to sustain a jury's finding of negligence if,
from the admission, the jury 'could infer an acknowledgment of all
the necessary elements of legal liability.'" Id. (quoting
Zimmerman v. Litvich, 297 Mass. 91, 7 N.E.2d 437, 438 (1937)).
Plaintiffs' theory of the case, presented in their
closing argument, was that Dr. Sweet knew all along that BNCT had
no therapeutic value and that it would harm his patients, but that
he nonetheless proceeded with the BNCT trials in the name of the
progress of medical research and concealed what he knew about the
danger of BNCT from his patients.
Plaintiffs make a several-pronged argument. The first is
that before Dr. Sweet used BNCT in treating Heinrich and
Sienkewicz, Dr. Sweet had no basis to believe that BNCT would be
therapeutic. More specifically, they maintain that Dr. Sweet did
not know how much radiation he would give and whether it would help
his patients or lead to their deaths. Plaintiffs' theory was that
in 1960-61 the defendants should not have proceeded with BNCT when
they had not found a boron compound of acceptable toxicity and had
not established a way of determining the level of radiation that
-29-
was going to the tumor as opposed to normal brain tissue.8
Plaintiffs also assert that Dr. Sweet knew after he used BNCT on
the two patients and before their deaths that BNCT caused
substantial loss of function and brain necrosis; the record
contains no evidence to show these final assertions.
Plaintiffs presented two medical expert witnesses to
support their theory of the case: Dr. Junck, a professor of
neurology and neuro-oncology, and Dr. Grodin, an expert on medical
ethics. For purposes of this appeal, we assume that the district
court did not abuse its discretion in qualifying any of the medical
experts to testify, including Dr. Junck and Dr. Grodin.
Plaintiffs' lead expert, Dr. Junck, was not asked to
relate his opinion as to whether Dr. Sweet had violated the
relevant standard of care. Instead, he was asked, over objection,
whether Dr. Sweet, MGH, and MIT had acted "appropriately or
inappropriately, responsibly or irresponsibly, in performing human
experiments on George Heinrich and Eileen Sienkewicz." In
response, Dr. Junck said: "I believe that the evidence indicated
that Massachusetts General Hospital and MIT acted inappropriately
in relation to performing human experiments on the two persons
8
No evidence was ever submitted that there was any way of
achieving greater clarity about these points other than through
human subjects. The evidence in the record is that animal studies
were not sufficiently similar.
-30-
named." In response to a follow-up question, again allowed over
objection, Dr. Junck extended this statement to include Dr. Sweet.
There are several problems with the expert testimony
presented by Dr. Junck, plaintiffs' lead expert. The first two
concerns are related. First, we think the question put to Dr.
Junck was wrong. Its highly suggestive emphasis on acting
"responsibly" and its prejudicial reference to "human
experimentation" did not concern a standard of care for medical
treatment. Second, the form of the question was incorrect and did
not lead to the required information. While the standard of care
question need not be formulaic and some leeway is allowed, see
Bradford v. Baystate Med. Ctr., 415 Mass. 202, 613 N.E.2d 82, 86-87
& n.6 (1993); Nickerson v. Lee, 42 Mass. App. Ct. 106, 674 N.E.2d
1111, 1115 (1997); Rahilly v. North Adams Reg'l Hosp., 36 Mass.
App. Ct. 714, 636 N.E.2d 280, 283 n.6 (1994), we think this
question was inadequate to tie Dr. Junck's opinion to the standard
of care for a specialist like Dr. Sweet in 1960-61. To say that
Dr. Sweet was in breach of the standard of care, the jury must know
what the standard of care was, see 37 J.R. Nolan & L.J. Sartorio,
Massachusetts Practice § 279, at 452 (2d ed. 1989), and neither the
question presented to Dr. Junck nor his answer provide this
information.
Apart from the incorrect form of the question presented
to Dr. Junck, there is a fundamental problem with his opinion: it
-31-
was based in an undifferentiated fashion on information, analyses,
and publications which became available only after the BNCT
treatments had been undertaken and not on the information that was
available to Dr. Sweet when he conducted the trials. Dr. Junck
relied on articles written about the BNCT trials conducted at MIT
after the trials ended (and after Heinrich and Sienkewicz had
died). Such articles may sometimes contain probative information
about the doctors' state of knowledge before they begin a set a
medical trials. This is not the case here. Instead, the articles'
pertinent information was learned after the trials, once the
doctors had an opportunity to study and analyze them. For example,
in March 1962, Dr. Sweet wrote a report to the AEC in which he
stated that BNCT destroyed too much normal brain tissue along with
the tumor. This report was written with the benefit of hindsight,
and does not show what Dr. Sweet and his team knew when they were
conducting the trials in 1960-61. Much less does it support the
conclusion that Dr. Sweet violated any standard of care in 1960-61.
The report is not an admission of negligence. That medical
research at times produces results less than hoped for is to be
expected. This does not logically lead to the conclusion that the
research should not be undertaken. To the extent that Dr. Junck
described this report as evidence on which he relied in forming his
opinion, it was not evidence about what Dr. Sweet knew at the time
of the trials, but about what he learned as a result of the trials.
-32-
Furthermore, some of Dr. Junck's opinions rested on
particular data or publications that do not support his conclusions
and have been mischaracterized by plaintiffs in their briefs to us.
We give some examples. In testifying that no acceptable boron
compound had been found by the time of the BNCT trials at MIT, Dr.
Junck relied on a document in which an AEC representative
memorialized his March 30, 1959, meeting with Drs. Sweet, Brownell,
and Soloway. The memorandum includes a paragraph about the
doctors' discussion of the "brain tumor therapy" research and notes
that one of "the major issues at stake" was "the finding of a
suitable boron compound which has a low toxicity." However, the
document goes on to note that "Dr. Soloway, the biochemist . . .
[said] he had received a very promising compound from [another
doctor]. . . ." This document is insufficient to show that Dr.
Sweet's team's research was so inadequate as to violate the
standard of care by the time the BNCT trials took place.9
To support his view that Dr. Sweet knew nothing about
determining the level of radiation which was going to the tumor as
opposed to normal brain tissue, Dr. Junck relied on a letter dated
January 31, 1952, written from the Brookhaven National Laboratories
to Dr. Sweet's office. The letter stated that the levels of
9
Plaintiffs also point to a portion of Dr. Junck's
testimony in which he said "[t]hey hadn't . . . found a boron
compound . . . that was free of a lot of substantial side effects."
But this testimony was struck from the record and its citation to
us is improper.
-33-
radiation that patients had received were not actually known
because of the difficulties of measuring them during the treatment.
This letter was written while the earlier BNCT trials were taking
place at Brookhaven in the early 1950s and seems to relate
information about those trials. The letter was relevant, but
insufficient to establish that Dr. Sweet knew so little at the time
he conducted the BNCT trials at MIT in 1960-61 as to violate the
standard of care.
In turn, the testimony of Dr. Grodin, the plaintiffs'
medical ethics expert, about BNCT was that
there was no evidence that there was any benefit,
potential benefit to the individual terminally ill
subjects and there was significant evidence of harm, cell
death due to necrosis, and therefore it was [his] opinion
that in weighing the risks against the benefits that the
risks outweighed the benefits and therefore . . . the
research should not be conducted.
Dr. Grodin's conclusion suffers from the same problems as Dr.
Junck's conclusion -- it was not tied to the time period in
question,10 and it depended heavily on information about BNCT that
became available to Dr. Sweet and his team only after the
completion and analysis of the trials. In addition, the evidence
does not support Dr. Grodin's conclusion that the BNCT trials
should not have been approved.
10
Dr. Grodin's opinion about the boron injection, by
contrast, was tied to the 1960-61 time period when the BNCT trials
were conducted at MIT.
-34-
Dr. Grodin's opinion was based, in part, on a paper
presented by Dr. Sweet and others to the American Association of
Neuropathologists in 1964, after the events in question and
learning from those events. The paper stated that "the cause of
death at post mortem examination was cerebral in nature,
specifically extensive radiation necrosis to the brain in nine [of
fourteen subjects]." Of course, after-the-fact autopsy evidence
does not establish what the state of knowledge was at the time of
treatment. To the extent that Dr. Grodin relied on this evidence
in forming his opinion, his reliance was misplaced. Again, this
was not evidence about what Dr. Sweet knew at the time of the
trials, but about what he learned as a result of the trials.
In addition, Dr. Grodin's opinion in essence was that the
research project should not have been approved. However, he was
unaware of the scope of the duties of the various medical
committees which reviewed and approved the BNCT research in 1960-
61, he was unaware of what materials were before the MIT committee
which approved the BNCT trials, and he had no basis to say the
committee did not act in good faith. There was not an adequate
foundation established for Dr. Grodin to express an opinion that
the treatments, approved at the time by numerous relevant
committees, violated the standard of care in 1960-61.
Besides the expert testimony, plaintiffs also rely on
several documents admitted into evidence to support that testimony
-35-
and their theory that Dr. Sweet knew before he conducted the BNCT
trials at MIT that they would have no therapeutic value. This
claim by plaintiffs is undercut by the fact that Sienkewicz's
condition improved dramatically after BNCT, and that this instilled
confidence and optimism in Dr. Sweet and his team in the treatment.
There were only a few pieces of documentary evidence that contained
information on the knowledge about BNCT before 1960-61. None of
them show that Dr. Sweet knew before he conducted the BNCT trials
that they would have no therapeutic value.
First, there was a 1951 letter from the AEC to Dr. Sweet
asking him for more information about BNCT before supplying him
with boron 10. The letter asked Dr. Sweet whether BNCT trials had
been conducted on animals, and what the dosage of radiation would
be. Dr. Sweet responded with his own letter stating that no
experiments had been performed on animals because these would not
be useful "since the conditions are so different," and that there
were no "useful answers" to any of the questions. On its face this
is not evidence of negligence. It is also evidence from a decade
before the trials in question took place.11
11
There was also the 1952 letter from Brookhaven to Dr.
Sweet's office at MGH, discussed previously with regard to Dr.
Junck's testimony. Again, this letter, discussing the lack of
knowledge about the amount of radiation that patients received
during BNCT, pertained to the BNCT studies at Brookhaven and does
not say much about the knowledge accumulated by Dr. Sweet and his
team almost a decade later.
-36-
Second, there was a 1955 article by Dr. Sweet and others
published in Cancer that analyzed the results of autopsies of eight
BNCT patients at Brookhaven in 1951-52. The article noted that the
patients' brains were adversely affected by radiation which may
have been caused by BNCT. However, the article was written about
the BNCT trials at Brookhaven, which occurred nearly a decade
before the BNCT studies in question here. In addition, the
evidence at trial was that the MIT facility was superior to the
Brookhaven facility and was designed in ways that were meant to
address these concerns.
Third, there were two 1959 memoranda by an AEC
representative which memorialized his meetings with Dr. Sweet and
some members of Dr. Sweet's team. Although the first memorandum,
discussed earlier, stated a remaining problem with BNCT, it was
also optimistic that a solution to the problem was near.
Similarly, the second memorandum of a June 19, 1959, meeting stated
that Dr. Sweet had "some rough going" with the BNCT research, but
again expressed optimism about the contacts made by Dr. Soloway and
how these would help him find a suitable boron compound.
Lastly, there were two articles written in 1954 by Dr.
Sweet and others in which the BNCT trials at Brookhaven were
analyzed. These articles pointed to the problems with BNCT at the
time, but also expressed hope about the further use of BNCT after
more exploration and research. They do not support the conclusion
-37-
that there was no evidence of any potential benefit to the patients
from BNCT in 1960-61.
The plaintiffs also rely on articles and documents
written by Dr. Sweet and others on his team after the BNCT trials
conducted at MIT, to support the contention that the doctors
themselves admitted to wrongdoing, and that these alleged
admissions are sufficient to show that Dr. Sweet violated his duty
of care to the plaintiffs. For example, in 1964 Dr. Sweet co-
authored an article entitled "Boron-Slow Neutron Capture Therapy:
Present Status," in which the authors concluded that there were
four main "deficiencies" that rendered BNCT not "practicable," and
went on to outline those deficiencies. No reasonable reader could
view the articles, written after the BNCT trials at MIT ended,
based on hindsight, and presented to colleagues in science and
medicine for consideration, as admissions of wrongdoing. The
articles, rather, are objective academic appraisals of the BNCT
trials and their failures. The purpose of medical research and
trials is to learn from them and improve medical treatments for
diseases, including treatment for the subjects of the trials.
There would surely be a chilling effect on research in the medical
field and deterrence of important progress in medical treatments if
doctors and scientists could not frankly assess the successes and
failures of their studies in published academic articles so that
others can build on their work and learn from it.
-38-
The only correct articulation at trial of the standard of
care applicable to Dr. Sweet came from one of the defense experts,
Dr. Charles Fager, a neurosurgeon. In response to questions asking
him to "tak[e] into consideration the advances in the profession at
the time and the resources available to Dr. Sweet at that time . .
. for a person practicing within the specialty of neurosurgery at
that time," he testified that he had an opinion, given those
factors. Within those criteria, which were not the criteria used
by plaintiffs' experts, Dr. Fager stated that "Dr. Sweet certainly
maintained the acceptable methods of practice of neurosurgery at
that time."
Dr. Fager formed his opinion by considering what was
known about glioblastoma multiforme and BNCT and its effects in
1960-61, when Dr. Sweet conducted the trials in question. More
specifically, he took into account the circumstances surrounding
the plaintiffs' BNCT treatments. He stated that Sienkewicz was
suffering from a "malignant brain tumor," and that there was a
"recurrence of tumor" after Dr. Sweet operated on her. He also
said that Heinrich was suffering from "a malignant invasive tumor"
and that "[h]e had no hope of survival."
Dr. Koski, the Director of Human Research Affairs for
Partners Health Care System (which includes MGH) also provided
expert testimony for the defendants. As Director of Human Research
Affairs, Dr. Koski has "broad responsibility for oversight of all
-39-
human investigation that is conducted within the Partners Health
Care System, particularly with respect to protection of human
subjects who are participating in research . . . ." Dr. Koski
testified that various committees at MGH had reviewed and approved
Dr. Sweet's application to conduct the BNCT trials at MIT,
including the surgical executive committee, which "consider[ed]
issues of treatments and therapies that came up before the
[surgery] department"; the general executive committee of the
staff, which "is the principal governing committee of the
Massachusetts General Hospital"; and the Board of Trustees, which
has "the overall responsibility for governance of the hospital."
Thus, Dr. Sweet's proposal to conduct BNCT trials in 1960-61
received three levels of administrative review at MGH, and was
approved at every level. Furthermore, other evidence indicated
that the BNCT trials were also reviewed and approved by the
Biomedical Advisory Committee at MIT, which was comprised of
representatives from MIT and three area medical schools and whose
function was "the review and approval of biomedical experiments
. . . at the reactor from the point of view of provision of maximum
safety to investigators, patients, or any human beings on whom
tracer experiments, diagnosis, or therapy is to be performed." The
ten members of the MIT committee -- seven from institutions other
than MIT -- had to be unanimous on their vote to approve a research
project. Approval by these various committees is very compelling
-40-
evidence to show that the BNCT trials complied with the prevalent
standard of care at the time. Indeed, Dr. Koski stated that "[i]n
[his] opinion, the initiation of the boron neutron capture therapy
studies [was] in accordance with the process that was prevailing at
the time."
Our discussion above is alone sufficient to vacate the
verdict. Nonetheless, we add this additional reasoning on an
independent ground. The fact that Dr. Sweet and MGH prevailed on
the informed consent claim also is pertinent to the insufficiency
of the evidence to show that Dr. Sweet was in breach of his duty of
care to his patients.12 Under the informed consent doctrine in
Massachusetts, "a physician owes to his patient the duty to
disclose in a reasonable manner all significant medical information
that the physician possesses or reasonably should possess that is
material to an intelligent decision by the patient whether to
undergo a proposed procedure." Harnish v. Children's Hosp. Med.
Ctr., 387 Mass. 152, 439 N.E.2d 240, 243 (1982). Thus, a doctor
who proposes an experimental course of treatment must not only tell
the patient about the treatment and its consequences, but must also
12
The plaintiffs argue that the trial court instructed that
the jury could find informed consent even if Dr. Sweet and MGH did
not provide them with material information as to risks and possible
benefits. The transcript does not support that reading. The
transcript shows that the trial judge was dealing with the
different problem of proximate causation -- whether the decedents
would have withheld consent but for lack of information -- which
the jury needed to consider. We reject the rest of the plaintiffs'
argument that Dr. Sweet failed to disclose material information.
-41-
inform the patient that he is conducting an experimental treatment
and that the patient is part of a study. The doctor must not only
tell the patient the known risks of the treatment, as he would in
a conventional setting, but must also inform the patient that there
may be unknown risks.13 Cf. Moore v. Regents of Univ. of Cal., 793
P.2d 479, 483 (Cal. 1990) (holding that in obtaining a patient's
consent to a procedure, "a physician must disclose personal
interests unrelated to the patient's health, whether research or
economic, that may affect the physician's professional judgment");
1 S.E. Pegalis & H.F. Wachsman, American Law of Medical Malpractice
2d §4:1, at 185-86, 189 (1992) ("When human research is being
conducted, standards governing disclosure are considerably
different from those in the therapeutic setting.").
Defendants argue that if Heinrich and Sienkewicz were
adequately informed about the treatment, its experimental nature,
and its known risks, and agreed to undergo the treatment
nonetheless, then Dr. Sweet and MGH cannot be liable for performing
13
There are now federal regulations in place which deal
specifically with what a doctor must tell a patient to obtain
informed consent before that patient can become part of a research
study. See 1 M.J. Zaremski & L.S. Goldstein, Medical and Hospital
Negligence § 15:10 (1995). In addition, some states also have laws
that deal with informed consent in the realm of "therapeutic
experimental procedures." See, e.g., Whitlock v. Duke Univ., 637
F. Supp. 1463, 1467-68 (M.D.N.C. 1986).
-42-
the very treatment to which the patients agreed.14 On the facts of
this case, we agree with the argument.
While there are surely fact patterns where the
defendants' argument would be invalid, this case does not fit
within them. This is not an instance in which the doctor fully
informs the patient about a certain treatment, but then does
something at variance with the described treatment; that would be
independently negligent and falls below the standard of care. An
example would be if a doctor were to fully inform a patient that he
will be performing a certain surgery, and then performs the
surgery, but leaves the scalpel in the patient's body. Nor is this
a situation where the doctor fully informs the patient about an
overtly negligent procedure with no possible benefits to the
patient, and then performs that procedure. For example, if a
doctor were to inform the patient that he would be performing a
certain surgery and that he would be leaving the scalpel in the
patient's body after the surgery, even if a patient may have
ignorantly agreed to this procedure, the doctor's actions would
still fall below the standard of care, constituting negligence.
14
Plaintiffs argue that because defendants did not bring to
the trial court's attention any alleged inconsistency in the
verdict, defendants have waived the claim that the verdicts cannot
stand because they are inconsistent. Masure v. Donnelly, 962 F.2d
128, 134 (1st Cir. 1992). However we do not understand defendants
to be making an inconsistency argument, per se, but rather to be
using the informed consent verdict in their favor as further
evidence that there was no evidentiary support for a finding of
negligence.
-43-
The district court, presumably, was alluding to these
situations when it said that informed consent does not "operate[]
as a defense to a claim of negligence in Massachusetts." Heinrich
V, 118 F. Supp. 2d at 91. These situations do not exist here.
There is no evidence to show that the procedure which Dr. Sweet
performed was any different from the procedure about which he
informed his patients, and there is no evidence to show that what
he proposed to his patients was blatantly negligent. The informed
consent verdict for the defendants also means that the jury
rejected plaintiffs' theory that Dr. Sweet concealed what he knew
about the danger of BNCT from the plaintiffs, thus narrowing the
plaintiffs' theory to the grounds discussed and rejected earlier.
In summary, the evidence presented at trial to show that
Dr. Sweet violated the standard of care had several fatal flaws.
The evidence from the plaintiffs' experts that Dr. Sweet did not
conform to the applicable standard of care in 1960-61 was wholly
inadequate. The evidence was not linked to the state of Dr. Sweet
and his team's knowledge at the time the trials took place, and was
largely based on articles written by Dr. Sweet and other members of
his team about the BNCT trials and their weaknesses after the
trials had ended and the authors had compiled and analyzed the data
obtained from the trials. In contrast, there was strong evidence
from the defendants' experts that Dr. Sweet did act within the
standard of care at that time. In addition, the documentary
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evidence, including the letters, memoranda, and articles from
before 1960, does not show that Dr. Sweet and his team knew that
BNCT had no therapeutic value. Furthermore, the BNCT treatments
were reviewed and approved by three different committees at MGH and
one committee at MIT before they were conducted. Lastly, the
defendants' argument is buttressed by the fact that the jury ruled
in favor of the defendants on the informed consent claim.
V.
This is a difficult case. What is at stake is the
medical treatment of two patients and the professional reputations
of individuals and institutions based on services performed over
four decades ago. The bar to be surmounted in litigation over
current charges of malpractice is a demanding one. That bar cannot
be lowered to compensate for absence of relevant experience, fading
memory, or lack of documentary evidence. Conclusory opinions,
unattached to predicate evidence of existing standards, cannot
fairly fill the void.
The district court's judgment for the United States is
affirmed. The jury verdict for the plaintiffs on the negligence
and wrongful death claims is vacated and we direct entry of
judgment for the defendants Dr. Sweet and MGH. No costs are
awarded.
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Heinrich Ex Rel. Heinrich v. Sweet
Court: Court of Appeals for the First Circuit
Date filed: 2002-08-27
Citations: 308 F.3d 48
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