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
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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 twentyfive-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
- 11 -

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 
- 16 -

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 subinvestigator 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 
- 19 -

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 

5 Because 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 
- 21 -

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 
- 22 -

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.