Court Opinion

ID: 9927752
Source: CourtListenerOpinion
Date Created: 2024-01-29 22:00:26.119651+00
Date Added: 2024-06-11T09:24:46.023695
License: Public Domain

United States Court of Appeals
                      For the First Circuit

No. 22-1547

   VIRGINIA CORA WARD, as the administratrix of the estate of
                       EDMUND EDWARD WARD,

                      Plaintiff, Appellant,

                                v.

                      ERNST J. SCHAEFER, MD,

                       Defendant, Appellee.

          APPEAL FROM THE UNITED STATES DISTRICT COURT
               FOR THE DISTRICT OF MASSACHUSETTS

        [Hon. F. Dennis Saylor, IV, U.S. District Judge]

                              Before

                   Rikelman, Selya, and Howard,
                         Circuit Judges.

     Timothy Cornell, with whom Cornell Dolan, P.C. was on brief,
for appellant.
     Tory A. Weigand, with whom Morrison Mahoney, LLP was on brief,
for appellee.

                         January 29, 2024
           SELYA, Circuit Judge.           Although this appeal arises out

of an experimental protocol undertaken at a site famed for the

development of new cures and treatments, the appeal itself hinges

on familiar fare:      the persuasiveness vel non of the appellant's

claims of trial error.        After careful consideration of a scumbled

record, we conclude that the appellant's claims of error lack

force.    Accordingly, we affirm the judgment below as to the

remaining appellee.1

                                       I

           We briefly rehearse the relevant facts and travel of the

case. We take the facts in the light most congenial to the verdict,

consistent with record support.            See United States v. Kilmartin,

944 F.3d 315, 323 (1st Cir. 2019).

           Edmund    Edward    Ward    was    born   with   a   rare   genetic

deficiency that caused his body to refrain from producing a blood

enzyme called lecithin-cholesterol acyltransferase (LCAT), which

is   critical   to   cholesterol   production.        The   disease    process

      1 Because the appellant's claims of error against this
appellee (Ernst J. Schaefer, MD) raise a set of issues that are
distinct from his claims of error regarding certain other
appellees, we elected to resolve this appeal in two separate
opinions. See, e.g., Alston v. Town of Brookline, 997 F.3d 23, 29
n.1 (1st Cir. 2021); United States v. Santiago-Rivera, 744 F.3d
229, 231 n.1 (1st Cir. 2014). The first of these opinions has
already been issued. See Ward v. AlphaCore Pharma, LLC, 89 F.4th
203 (1st Cir. 2023). That opinion is based upon review of a prima
facie record and, thus, does not contain many of the factual
details that populate this opinion (which deals with claims of
error arising in the context of a full trial record).

                                      - 2 -
resulting from this enzyme deficiency — familial LCAT deficiency

(FLD) — may cause kidney failure, which requires either regular

dialysis or kidney transplantation.                  The doctor who initially

treated Ward for his kidney damage believed that he had LCAT

deficiency and referred him to a specialist practice.                             After

consulting several physicians about his condition, Ward met Dr.

Ernst J. Schaefer (who is the appellee here).                         Dr. Schaefer

confirmed a diagnosis of FLD and developed a creative approach to

Ward's medical care.

           Bereft     of    any   good     treatment    options,      Dr.   Schaefer

enlisted the National Institutes of Health (NIH) and AlphaCore

Pharma,   LLC   (ACP)      to   see   if    Ward    might   be   a   candidate     for

experimental enzyme therapy.               Ward's condition at the time was

deteriorating, and the prospect of dialysis loomed.                  Although Ward

alleges that he was promised a potential cure, Dr. Schaefer insists

that Ward was warned about the "unchart[ed] territory" that they

would be exploring.         If successful, the upshot would be delaying

dialysis, not a cure.

           An   NIH     researcher,        Dr.     Robert   Shamburek,      and    ACP

employees proceeded to write an expanded access protocol for ACP's

recombinant enzyme known as ACP-501.2               Dr. Schaefer testified that

     2 Expanded access, often referred to as "compassionate use,"
allows a person with a "serious or immediately life-threatening
disease or condition" to access an investigational medical product
(drug, biologic, or medical device) outside of the normal clinical

                                       - 3 -
he was not involved in drafting the ACP-501 protocol, but he did

lobby for approval of the protocol's expanded access use (which

the   United   States   Food     and   Drug   Administration   ultimately

granted).

            Dr. Shamburek testified that — before commencing the

ACP-501 protocol — he twice reviewed with Ward (himself a lawyer)

the detailed consent form that had been written specifically for

this protocol.    He also testified that he advised Ward to discuss

the consent form with family and other doctors before signing it.

The signed consent form was admitted into evidence at the trial.

Ward testified, though, that he did not recognize the form, did

not recall discussing it with Dr. Shamburek, and did not remember

signing it.

            Nevertheless,   it    is   undisputed   that   Ward   traveled

periodically from his home in Massachusetts to the NIH facility in

Bethesda, Maryland, so that he could receive infusions of the

recombinant enzyme.     And Dr. Schaefer continued to monitor Ward in

Massachusetts.

            The experiment produced underwhelming results:        the drug

failed to ameliorate Ward's condition, and his suffering allegedly

worsened because he was compelled to delay more effective dialysis

trial constraints when "no comparable or satisfactory alternative
therapy to diagnose, monitor, or treat the disease or condition"
is available. 21 C.F.R. § 312.305; see id. § 812.36.

                                   - 4 -
treatments.    Thus, Ward began regular dialysis, departed from the

ACP-501 protocol, and concluded that the only conceivable outcome

was prolonged pain and suffering.       With the protocol consigned to

the scrap heap, Ward repaired to the courts.       He sued Dr. Schaefer;

Dr. Shamburek; Dr. Alan Remaley (an NIH physician who had worked

closely with Dr. Shamburek); ACP and one of its principals, Dr.

Bruce Auerbach; MedImmune, LLC (MedImmune), which had acquired

ACP;   and   AstraZeneca   Biopharmaceuticals,     Inc.      (AstraZeneca),

MedImmune's parent, in a Massachusetts state court. Drs. Shamburek

and Remaley removed the suit to the United States District Court

for the District of Massachusetts.          See 28 U.S.C. § 2679(d)(2).

The United States later was substituted for Drs. Shamburek and

Remaley as to certain claims.        See id.    The district court, in

separate orders, dismissed the claims against ACP and Dr. Auerbach;

the United States; and MedImmune and AstraZeneca.              See Ward v.

Schaefer, No. 16-12543, 2018 WL 1096829 (D. Mass. Feb. 27, 2018)

(dismissing claims against Drs. Remaley and Shamburek and United

States); Ward v. Auerbach, No. 16-12543, 2017 WL 2724938 (D. Mass.

June   23,   2017)   (dismissing   claims    against   Dr.    Auerbach   and

pharmaceutical companies).

             The claims of fraud and failure to obtain informed

consent against Dr. Schaefer went to trial.            Ward's theory was

that Dr. Schaefer fraudulently induced him to participate in the

ACP-501 protocol and otherwise failed to obtain informed consent

                                   - 5 -
for his participation in the protocol.          The jury disagreed and

returned a take-nothing verdict in favor of Dr. Schaefer on all

claims.   The district court denied Ward's motion for a new trial

in a text order.

           This   timely   appeal    ensued.     Ward   died    during   its

pendency, and Virginia Cora Ward, his sister and the administratrix

of his estate, was substituted in his place and stead.            See Fed.

R. App. P. 43(a).      We refer to her throughout as the appellant.

                                     II

           Before us, the appellant argues that Drs. Remaley and

Shamburek represented that Ward's kidney function was improving

materially while he was taking the drug, even though the data were

ambiguous at best and he had switched to a lower dose of the drug

due to a supply shortage. She also argues that Ward's nephrologist

advised   him   that   proceeding    without   dialysis   was   no   longer

medically acceptable.

           The appellant's assignments of error, though, do not

hinge on the substance of these arguments.        Instead, her flagship

contention as to the evidence is that the district court erred in

excluding the ACP-501 patent.

           We review a preserved objection to the district court's

admission or exclusion of evidence for abuse of discretion.              See

Kilmartin, 944 F.3d at 335.         A discretionary decision, however,

"cannot be set aside by a reviewing court unless it has a definite

                                    - 6 -
and firm conviction that the court below committed a clear error

of judgment in the conclusion it reached upon a weighing of the

relevant factors."     Schubert v. Nissan Motor Corp., 148 F.3d 25,

30 (1st Cir. 1998) (quoting In re Josephson, 218 F.2d 174, 182

(1st Cir. 1954)).     We add, moreover, that abuse of discretion is

not a monolithic standard.     See United States v. Padilla-Galarza,

990 F.3d 60, 73 (1st Cir. 2021).     It "encompasses 'de novo review

of abstract questions of law, clear error review of findings of

fact, and deferential review of judgment calls.'"         Id. (quoting

United States v. Lewis, 517 F.3d 20, 24 (1st Cir. 2008)).

             The district court refused to allow the introduction of

the ACP-501 patent, concluding that the patent was inadmissible

because it had been offered without any foundation and, in all

events, had "nothing . . . to do with the medical issues" before

the jury.    The appellant contends that this ruling constituted an

abuse   of   discretion   because   "the   development,   effects,   and

properties of [ACP-501] were the central issues in the trial."

Inasmuch as claim one of the patent describes "a method for

decreasing the amount of cholesterol in arteries of a human subject

not suffering from [LCAT deficiency]," the appellant urges that

the patent makes pellucid that the drug was not formulated to treat

Ward's condition or the resulting kidney damage. She further urges

that administering the drug to Ward was especially inappropriate

                                 - 7 -
considering that none of his doctors had bothered to review the

patent.

            Dr. Schaefer offers a number of responses.                  First, he

submits that Ward neither made an offer of proof nor provided any

evidentiary basis for introducing the patent at trial.                  Second, he

submits that the patent is of no relevance to claims of fraud and

failure to obtain informed consent.

            We    start    with   the   patent's      relevance   and    with   the

application of Federal Rule of Evidence 403. Dr. Schaefer contends

that the appellant's arguments for admissibility are meritless

because the patent was offered without foundation and "any possible

tangential relevancy was minimal and substantially outweighed by

the . . . risk of confusion [due to] technical complexity."                      In

our view, an analysis under Rule 403 disposes of the matter.3

Accordingly, it would be superfluous to consider Dr. Schaefer's

other arguments regarding the admission of this evidence.

            Under Rule 403, a "court may exclude relevant evidence

if its probative value is substantially outweighed by a danger

of . . . unfair prejudice, confusing the issues, misleading the

jury,     undue   delay,    wasting      time,   or     needlessly      presenting

     3 Below, the district court did not articulate its exclusion
of the patent as the product of a Rule 403 balancing. Even so, we
"need not accept [the] district court's reasoning, but may affirm
[a] judgment on any independently sufficient ground supported by
the record." United States v. Nivica, 887 F.2d 1110, 1127 (1st
Cir. 1989).

                                        - 8 -
cumulative evidence."            Fed. R. Evid. 403; see United States v.

Leoner-Aguirre, 939 F.3d 310, 321 (1st Cir. 2019) ("A district

court     may     exclude      evidence      when    its   probative       value   is

substantially outweighed by the danger of unfair prejudice.").

Applying this standard, we agree with the district court that the

probative       value   of    the   patent    is    difficult    to    fathom.     The

requirements for obtaining patent protection are demanding, see 35

U.S.C.    §§ 101-103         (requiring,     inter    alia,     that   invention   be

useful,    novel,       and    non-obvious     for    patent     protection),      but

completely different from the medical issues here, such as the

efficacy and risks of a drug.             What was distinct about ACP-501 for

patent purposes is of absolutely no relevance to Dr. Schaefer's

alleged failure to apprise Ward of the potential risks and rewards

of taking the drug through expanded access.                     One sentence in a

twenty-five-page patent noting that the patent does not cover LCAT

deficiency reveals little about what risks the drug otherwise might

carry.    What is more, this limitation means only that the drug's

efficacy was not shown sufficiently for patent purposes; it does

not reveal what effect, if any, the drug might have when used

experimentally for LCAT deficiency.

            To be sure, Federal Rule of Evidence 401's standard for

relevancy is low, and it permits the introduction of evidence that

"has any tendency to make a fact more or less probable."                     Fed. R.

Evid. 401.        The patent's specific exclusion of LCAT deficiency

                                        - 9 -
arguably offers some commentary — if minimal — on the biological

nuances of the drug and, thus, what effects Ward reasonably could

have expected.     Yet, as the record plainly reflects, that tiny bit

of   relevant   information    would       be   grossly     outweighed    by   the

confusion created and time wasted by including the stockpile of

other   information   that    this    dense      document    encompasses.       In

describing its relevance, Ward singles out a sentence from claim

one of the patent while trying to introduce the entire twenty-

five-page document, which is rife with irrelevant technicalities.

Perhaps most strikingly, the document contains seven full pages

that are filled with lines of letters that represent biologically

important DNA sequences.         We could not fault any reasonable

factfinder for plunging into utter confusion as to what this

alphabet soup adds to a fraud trial.            An additional five full pages

contain black-and-white figures that might seem like a Rorschach

test to a lay jury.           The remaining pages are littered with

scientific jargon.     Any relevance of the patent is sure to be lost

in this sea of unrelated information.

           Given    the   breadth     of   the    patent    and   its    marginal

relevance, we cannot fault the district court for excluding it.

After all, "[o]nly rarely — and in extraordinarily compelling

circumstances — will we, from the vista of a cold appellate record,

reverse a district court's on-the-spot judgment concerning the

relative weighing of probative value and unfair effect."                  Freeman

                                     - 10 -
v. Package Mach. Co., 865 F.2d 1331, 1340 (1st Cir. 1988).                The

district court reasonably concluded that the patent lacked any

significant probative value, and the record reveals an ample

potential for prejudice should the patent have been introduced.

We hold, therefore, that the district court did not abuse its

discretion in excluding the patent.

                                     III

            The appellant stakes out two claims of instructional

error.     First, she argues that the district court erred in not

adopting    Ward's   proposed   language      for   the    jury   instruction

describing    his    professional    relationship     with    Dr.   Schaefer.

Second, she argues that the district court erred in not instructing

the jury on res ipsa loquitur.             We start with the standard of

review for jury instructions and then discuss each claim.

                                      A

            The standard of review for instructional error turns on

the particular claim of error.       See Shervin v. Partners Healthcare

Sys., Inc., 804 F.3d 23, 47 (1st Cir. 2015).              "We review de novo

questions about whether a given instruction is, in substance,

legally correct."     Id.   In doing so, we must remember that "[j]ury

instructions are intended to furnish a set of directions composing,

in the aggregate, the proper legal standards to be applied by lay

jurors in determining the issues that they must resolve in a

particular case."      United States v. DeStefano, 59 F.3d 1, 2 (1st

                                    - 11 -
Cir. 1995).        "We review for abuse of discretion the particular

wording chosen to convey a concept to the jury."                            Shervin, 804

F.3d at 47.         The wording of the instruction must "adequately

illuminate the law applicable to the controverted issues in the

case without unduly complicating matters or misleading the jury."

Testa v. Wal-Mart Stores, Inc., 144 F.3d 173, 175 (1st Cir. 1998).

              If, however, the asserted error is failure to give a

requested instruction, "the omitted instruction [must be] integral

to an important part of the case and its content [must be legally

correct    and]      not     otherwise       substantially          covered        by     the

instructions as given."              Shervin, 804 F.3d at 47.                    "Like the

district      court,   [w]e        examine       the     evidence      on    the       record

and . . . draw       those    inferences          as    can    reasonably         be    drawn

therefrom, determining whether the proof, taken in the light most

favorable to the [requesting party,] can plausibly support the

theory of the [party]."            United States v. Baird, 712 F.3d 623, 627

(1st   Cir.    2013)   (first       and    second        alterations        in    original)

(internal quotations omitted).                   In all events, "we examine the

court's instructions as a whole, rather than reviewing fragments

in isolation."       Shervin, 804 F.3d at 47.

                                             B

              To   begin,    the    appellant          takes   issue    with      the    jury

instruction about Dr. Schaefer's status and duties.                              She posits

that Dr. Schaefer — who only monitored Ward from Massachusetts —

                                          - 12 -
still had a "sufficiently close doctor-patient relationship" with

Ward such that Dr. Schaefer had to obtain informed consent for

Ward to participate in the ACP-501 protocol.              At the charge

conference, Ward lobbied for language to include the possibility

that Dr. Schaefer, despite not administering the ACP-501 protocol

himself, was acting as a principal investigator, co-investigator,

or sub-investigator.        And the appellant now explicitly asserts

that   a   doctor-patient   relationship   can   exist   "without   direct

treatment of the patient."

            The district court, though, considered that level of

detail unnecessary, and Dr. Schaefer defends that decision on

appeal.    He suggests that any asserted difference between Ward's

requested instruction and the district court's instruction is

legally meaningless and that the court's instruction was legally

correct.

            We turn first to the legal standard for a claim of

failure to obtain informed consent under Massachusetts law and

then assess the jury instructions against the discerned standard.

                                    1

            In order to state a claim of failure to obtain informed

consent under Massachusetts law, a doctor must have had a duty to

disclose the relevant information to the patient, and the doctor's

                                  - 13 -
breach of that duty must have caused the patient's injury.4                   See

Halley v. Birbiglia, 458 N.E.2d 710, 715 (Mass. 1983).                A doctor

has a duty to disclose information if there was "a sufficiently

close doctor-patient relationship"; the doctor knew, or reasonably

should have known, the information; and the doctor reasonably

should    have    recognized   that    the     information   would   have   been

material to the patient's decision.             Id.

            The     Massachusetts       Supreme       Judicial   Court      (SJC)

considered this issue in two seminal cases. We take their measure.

            In Harnish v. Children's Hospital Medical Center, the

plaintiff alleged that surgeons failed to inform her of the

potential for lost tongue function after a cosmetic procedure to

remove a neck tumor.      See 439 N.E.2d 240, 241 (Mass. 1982).               The

SJC held that a sufficient doctor-patient relationship existed not

only between the plaintiff and the surgeon in charge but also

between the plaintiff and one of two assistant surgeons.                 See id.

at 245.     That assistant surgeon had assured the plaintiff of the

operation's success and mentioned potential consequences of the

operation but omitted any mention of the risk of lost tongue

function.    See id.    The second assistant surgeon — as far as the

SJC could discern — had helped only with the performance of the

     4 The consent form that bears Ward's signature was introduced
at trial, but for purposes of this appeal, we need not reach the
question of whether that informed consent shelved any need for Dr.
Schaefer to obtain his own informed consent.

                                      - 14 -
surgery.    See id.     On these facts, the SJC held that the first

assistant    surgeon,     along    with      the   surgeon       in    charge,   had

established a doctor-patient relationship.                See id.         Given the

absence of any comparable patient interaction, though, the second

assistant    surgeon      had     not       established      a        doctor-patient

relationship.    See id.

            In Halley v. Birbiglia, parents alleged that doctors

failed to inform them of the risks associated with an imaging

technique performed on their one-year-old son, which caused blood

clots that ultimately necessitated amputation of the child's foot.

See 458 N.E.2d at 712.          The SJC held that one of the physicians

involved in the child's care had not established a doctor-patient

relationship    because    he     had   served     only   as     "a     neurological

consultant" who was not the admitting or attending doctor, "saw

[the child] intermittently," did not order or perform the imaging,

and did not assure the parents of the procedure's safety.                     Id. at

715-16.     The SJC held that another doctor had established a

doctor-patient relationship because he had performed the imaging

and spoken to the parents right after the procedure's completion.

See id. at 716.

                                        2

            Against this backdrop, the appellant first complains

that the district court refused to instruct the jury consistent

                                    - 15 -
with its framing of the same issue in the summary judgment order.

This plaint lacks force.

              The summary judgment order reasoned:               "If [Dr. Schaefer]

did not have [a sufficiently close doctor-patient] relationship,

he stands in the position of the assistant surgeon in Harnish, or

the consulting neurologist in Halley, and had no duty to obtain

. . . consent.        If he did have such a relationship, he had such a

duty."    Ward v. Schaefer, No. 16-12543, 2021 WL 1178291, at *13

(D.   Mass.    Mar.    29,   2021)     (emphases       in   original).       The      jury

instructions     contained       the   "sufficiently          close   doctor-patient

relationship" language that formed the centerpiece of the summary

judgment order.        And as our ensuing analysis reveals, the jury

instructions otherwise fit seamlessly within the framework of the

summary judgment order.

              The essence of the appellant's complaint seems to focus

on the appropriateness of the language                      employed in      the jury

instruction, which asked the jury to determine whether the doctor

either "serve[d] a primary or lead role in treating the patient or

discusse[d] with the patient a course of treatment in detail."

This query was juxtaposed with language that asked, alternatively,

whether   "the    doctor     [was]     only    tangentially       involved       in   the

patient's treatment and care."            In the former instance, a duty to

obtain    informed     consent    would       arise,    but    not    in   the   latter

instance.

                                        - 16 -
            We discern no abuse of discretion in the phrasing of

these instructions. The language about a doctor serving a "primary

or lead role" in patient treatment and discussing "a course of

treatment in detail" is quite similar to the language employed by

the SJC discussions in Halley, 458 N.E.2d at 715-16, and Harnish,

439 N.E.2d at 244-45.       Whether a doctor leads the treatment or is

the   primary     treatment      provider     effectively      encompasses       the

distinction between positions such as an attending or admitting

physician (who must obtain informed consent) and a consultant (who

need not obtain informed consent).            So, too, a doctor who serves

a primary or lead role in treatment invariably will have more

extensive patient contact (and, thus, will be required to obtain

informed    consent)   in     contrast   to    one    who    only    assists     with

treatment (and, thus, will not be required to obtain informed

consent).    By the same token, a doctor who is "only tangentially

involved"    in   a   patient's    treatment     cannot      be     the   attending

physician and, by definition, would not have significant direct

patient contact. Indeed, this latter phrasing is the very language

that the SJC elected to use in Halley.                 See 458 N.E.2d at 716

(recognizing      absence   of   "support     [for]    the    extension     of   the

informed    consent    doctrine     to   an    individual      so    tangentially

involved in the performance of a medical procedure").

            Any remaining quibbles with the particular wording of

the court's instructions are inconsequential.                  A district court

                                     - 17 -
retains broad discretion in choosing the specific language used to

convey technical concepts to a lay jury.           See, e.g., Febres v.

Challenger Caribbean Corp., 214 F.3d 57, 62-63 (1st. Cir. 2000).

"So long as the charge sufficiently conveys the [party]'s theory,

it need not parrot the exact language that the [party] prefers."

United States v. McGill, 953 F.2d 10, 12 (1st Cir. 1992).           Here,

the court appropriately exercised this discretion because its

instructions explained the relevant Massachusetts law to the jury

in an accurate and understandable manner.         See Testa, 144 F.3d at

175 (constraining appellate review to whether jury instructions

"adequately illuminate[d] the law applicable to the controverted

issues   in    the   case   without   unduly   complicating   matters   or

misleading the jury").

              Contrary to the appellant's importunings, whether Dr.

Schaefer was a principal investigator, co-investigator, or sub-

investigator is not a meaningful legal distinction.           A clinical

investigator's duties may require direct patient interaction and

treatment such that the investigator would be obligated to obtain

informed consent under the SJC's analysis.        See Halley, 458 N.E.2d

at 715-16; Harnish, 439 N.E.2d at 244-45.         The relevant inquiry,

though, would focus on the doctor's interaction with patients, not

on his formal title or status in a clinical study.        And as we have

explained, the court was permitted to prefer its explanation of

                                  - 18 -
the law over Ward's         even if   both satisfactorily covered the

subject.

           To the extent that the appellant now argues for an

instruction that a doctor-patient relationship can exist "without

direct treatment of the patient," such a statement does not

accurately reflect Massachusetts law on informed consent.5             The

requested instruction would contradict the SJC's teachings that a

doctor who is only tangentially involved need not obtain informed

consent.   See Halley, 458 N.E.2d at 716.        By definition, a doctor

who is not directly treating the patient must be only tangentially

involved in the patient's care.           A doctor who does not directly

treat the patient is akin to the assistant surgeon in Harnish and

the consulting neurologist in Halley, both of whom the SJC absolved

of   responsibility   for    obtaining    informed   consent.   See   id.;

Harnish, 439 N.E.2d at 245.

                                      C

           The appellant strikes her hammer one more time to chip

away at the jury instructions.        The district court refused to let

      5Because Ward failed to request this instruction below, the
argument is forfeited and our review is for plain error.        See
DeCaro v. Hasbro, Inc., 580 F.3d 55, 60 (1st Cir. 2009) (explaining
that substantial failure to comply with Federal Rule of Civil
Procedure 51(d)(1)(B)'s requirement that objecting party present
desired instruction to the court "normally results in forfeiture
of the objection to which the failure relates"). We need not delve
into the plain error construct, though, because the appellant has
failed to persuade us that any error has occurred.

                                  - 19 -
Ward pursue damages for harm allegedly caused by a three-day atrial

fibrillation episode at the NIH without presenting an expert

witness to testify on causation.   This expert witness requirement,

the appellant says, creates an insurmountable hurdle because the

experimental nature of Ward's use of ACP-501 meant that no expert

could offer a credible opinion on whether ACP-501 caused any

subsequent medical condition.    In the absence of direct evidence

showing a causal connection, the appellant says that the jury

should have been allowed to consider a res ipsa loquitur theory.

That is, the jury should have been instructed that it could infer

negligence from the circumstances without identifying a specific

cause.   See Enrich v. Windmere Corp., 616 N.E.2d 1081, 1084-85

(Mass. 1993) (allowing "inference of negligence . . . [without

showing] specific cause of the occurrence when an accident is of

the kind that does not ordinarily happen unless the defendant was

negligent . . . and     other      responsible    causes . . . are

sufficiently eliminated").

          The appellant presents as supporting facts that Ward was

susceptible to atrial fibrillation, that atrial fibrillation was

a known risk of ACP-501, that the atrial fibrillation episode was

unusually severe given Ward's medical history, and that the NIH

directed all of Ward's medical care during the ACP-501 protocol.

From this nucleus of operative facts, the appellant suggests that

a jury should have been able to infer that — even without expert

                                - 20 -
testimony on causation — this is the kind of situation in which

Ward's atrial fibrillation episode could have been attributed only

to the ACP-501 protocol.

            We resist this suggestion.      The appellant's attempt to

invoke res ipsa loquitur is an exercise in futility.        To apply res

ipsa loquitur, "(1) the instrumentality causing the accident [must

be] in the sole and exclusive control and management of the

defendant; and (2) the accident [must be] of the type or kind that

would not happen in the ordinary course of things unless there was

negligence by the defendant."       Wilson v. Honeywell, Inc., 569

N.E.2d 1011, 1013 (Mass. 1991) (internal quotation marks omitted).

This doctrine is plainly inapplicable here.

            For a start,     the appellant fails to show         that Dr.

Schaefer was negligent in any respect, let alone show negligence

in any of Ward's medical care.            In a contrived effort, the

appellant   struggles   to   reimagine    this   situationally   specific

doctrine used to show causation in negligence cases to excuse the

paucity of evidence connecting Ward's maladies to Dr. Schaefer's

alleged misrepresentations.     The effort goes nowhere.

            Even in the absence of negligence, there was no proof

that atrial fibrillation episodes might not occur during the

administration of the protocol.          Critically, Ward presented no

evidence at trial from which the jury could determine that the

mere occurrence of an atrial fibrillation episode under these

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circumstances    implied   that   the    ACP-501   protocol   caused   the

episode.    Cf. Enrich, 616 N.E.2d at 1085 ("The jury must be able

to find . . . that the mere occurrence of the accident shows

negligence as a cause.").    What is more, the appellant's own facts

undermine her argument.      She admits that Ward had experienced

episodes of atrial fibrillation before the ACP-501 protocol was

implemented — and she provides no explanation as to why the very

same phenomenon, occurring during the ACP-501 protocol, must have

been   caused   by   the   protocol.       Thus,   the   district   court

appropriately rejected the appellant's attempt to smuggle res ipsa

loquitur into the case.

                                    IV

            We need go no further. For the reasons elucidated above,

the judgment of the district court, in so far as it concerns the

claims asserted against Dr. Schaefer, is

Affirmed.

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