Ward v. Schaefer ( 2024 )

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).
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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
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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.
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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
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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
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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
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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).
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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
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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
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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
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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 —
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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
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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.
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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
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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.
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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
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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
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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.
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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
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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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