Heinrich Ex Rel. Heinrich v. Sweet

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

-3-
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

-4-
 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.

-6-
 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

-7-
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

-10-
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.

-11-
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,

-12-
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.

-14-
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

-15-
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

-16-
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

-17-
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

-18-
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)).

-19-
 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.

-20-
 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.

-21-
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

-22-
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

-44-
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.

-45-