United States Court of Appeals For the First Circuit

No. 21-1574

UNITED STATES OF AMERICA,

Appellee,

v.

GLENN A. CHIN,

Defendant, Appellant.

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

[Hon. Richard G. Stearns, U.S. District Judge]

Before

Barron, Chief Judge, Lipez and Howard, Circuit Judges.

James L. Sultan, with whom Rankin & Sultan was on brief, for appellant. Christopher R. Looney, Assistant United States Attorney, with whom Rachael S. Rollins, United States Attorney, was on brief, for appellee.

July 15, 2022 BARRON, Chief Judge. This appeal requires us to revisit

the sentence that Glenn Chin, a former supervising pharmacist at

the New England Compounding Center ("NECC"), received for his

convictions in connection with the criminal investigation into the

deadly nationwide outbreak of fungal meningitis in 2012 that was

traced to the company's shipments of contaminated drugs. When we

last considered Chin's sentence, we vacated and remanded it. See

United States v. Chin,

(1st Cir. 2020) ("Chin I").

The United States District Court for the District of Massachusetts

resentenced Chin while applying two sentencing enhancements under

the United States Sentencing Guidelines ("Guidelines"). U.S.

Sent'g Guidelines Manual §§ 2B1.1(b)(16)(A), 3A1.1(b)(1)

[hereinafter U.S.S.G]. Chin contends that neither enhancement

applies and thus that his sentence must be vacated once again. We

affirm.

I.

The events at NECC have already been the subject of

several reported decisions by this Court. We thus will rehearse

only the facts relevant to Chin's current challenge to certain

aspects of his resentencing. We refer the reader to Chin's first

appeal, Chin I,

, and to the appeal of Barry

Cadden, Chin's boss at NECC, United States v. Cadden,

(1st Cir. 2020), for a more detailed discussion of the

underlying facts.

- 2 - NECC was a pharmacy based in Framingham, Massachusetts,

that specialized in high-risk drug compounding, which refers to a

process in which non-sterile ingredients are combined to create

sterile drugs that are prepared at the request of hospitals and

other healthcare providers. Chin worked as a licensed pharmacist

at NECC from April 2004 to October 2012.

In January 2010, Chin was promoted to the role of

supervising pharmacist at NECC, in which he oversaw all drug

production in NECC's two "clean rooms." In the fall of 2012, a

number of patients who had received epidural injections of

methylprednisolone acetate ("MPA") -- a steroid for pain

relief -- contracted rare fungal infections that were ultimately

traced back to contaminated drugs produced at NECC under Chin's

supervision. A number of those patients died.

A federal criminal investigation into NECC's practices

ensued, and in connection with it Chin was charged in December of

2014 with "racketeering in violation of

(c);

racketeering conspiracy in violation of

(d);

forty-three counts of federal mail fraud in violation of

; and thirty-two counts of violating the Federal Food, Drug,

and Cosmetic Act ('FDCA'), see

(a), 333(a)." Chin

I, 965 F.3d at 45. After a jury trial, Chin was found guilty on

all counts. Id. at 46.

- 3 - Evidence was introduced at trial that showed that Chin

was familiar with Chapter 797 of the United States Pharmacopeia

("USP-797"), which sets forth standards governing sterile

compounding that pharmacists licensed in Massachusetts must

follow. Evidence introduced at trial also supportably showed that,

despite NECC claiming to be USP-797 compliant, Chin knew that NECC

was selling MPA that had not been properly sterilized or tested

for sterility in accordance with USP-797. And, evidence was

introduced at trial that showed that NECC's clean room became

grossly contaminated with mold and bacteria after Chin instructed

clean room staff to ignore cleaning protocols, and that Chin knew

of this contamination.

At Chin's sentencing in January 2018, the government,

among other things, requested that the District Court apply the

two Guidelines that set forth the enhancements that are the subject

of Chin's present appeal. The first enhancement is U.S.S.G.

§ 2B1.1(b)(16)(A), which imposes a two-level increase in the base

offense level of those convicted of certain crimes "[i]f the

offense involved . . . the conscious or reckless risk of death or

serious bodily injury." The second enhancement is U.S.S.G.

§ 3A1.1(b), which imposes a two-level increase in the base offense

level "[i]f the defendant knew or should have known that a victim

of the offense was a vulnerable victim" and an additional two-

- 4 - level increase if that enhancement applies and "the offense

involved a large number of vulnerable victims."

The District Court declined to apply either enhancement

in sentencing Chin to a term of imprisonment of 96 months, to be

followed by two years of supervised release. The District Court

determined at Chin's first sentencing that the "conscious or

reckless risk" enhancement did not apply because "the evidence did

not establish a reckless and knowing disregard of a reasonable

certainty of causing death or great bodily harm." The District

Court determined that the "vulnerable victim" enhancement did not

apply because "here the victims that were identified were the

clinics and the hospitals who purchased the drugs," and "because

we construe 'victim' differently for purposes of sentencing, the

enhancements do not apply on a proximate cause theory to persons

who were not recipients of NECC's representations" -- that is, the

individuals who were ultimately harmed by injections of tainted

pharmaceuticals from NECC.

The government appealed the sentence that the District

Court had imposed. It did so, in part, on the ground that the

District Court erred in not applying either enhancement.

On appeal, this Court rejected the District Court's

basis for determining that the "conscious or reckless risk"

enhancement did not apply. Chin I, 965 F.3d at 53. We first

explained that the District Court failed to consider whether Chin's

- 5 - "relevant conduct," rather than the nature of his "offense" alone,

carried with it the risk of death or serious bodily injury. Id.

at 52–53. We further explained that the District Court erred

because it

found that Chin did not act with a "reckless and knowing" state of mind in disregarding a "reasonable certainty of . . . death or great bodily harm." The sentencing enhancement, however, describes the requisite mental state using disjunctive language: the enhancement applies so long as the defendant acted in spite of either a "conscious or reckless risk." U.S.S.G. § 2B1.1(b)(16)(A) (emphasis added). Thus, the District Court's finding does not foreclose the possibility that Chin's offense involved the mental state necessary for the enhancement's application. We therefore vacate and remand the sentence for the District Court to assess whether any of Chin's relevant conduct, as defined under U.S.S.G. § 1B1.3(a), "involved . . . the conscious or reckless risk of death or serious bodily injury." Id. § 2B1.1(b)(16).

Id. at 53 (omissions in original).

Chin I was published on the same day as Cadden, and it

referenced the Cadden opinion in its analysis of the "conscious or

reckless risk" issue. See Chin I, 965 F.3d at 52. Cadden similarly

vacated the District Court's refusal to apply this enhancement to

Cadden and remanded for the court to consider the proper mens rea

for the § 2B1.1(b)(16)(A) enhancement. We explained that

the District Court . . . at no point directly addressed in sentencing whether a

- 6 - preponderance of the evidence . . . established that Cadden's relevant conduct associated with the mail fraud involved a "conscious or reckless risk of death or serious bodily injury." U.S.S.G. § 2B1.1(b)(16); Cf. United States v. Lucien,

(2d Cir. 2003) (concluding that a conscious risk is one "known to the defendant" while a reckless risk is "the type of risk that is obvious to a reasonable person and for which disregard of said risk represents a gross deviation from what a reasonable person would do").

, 34–35.

In Chin I, this Court also rejected the District Court's

basis for determining that the "vulnerable victim" enhancement did

not apply. We explained in doing so that, "'[t]o come within the

guidelines' definition' of 'victim,' 'one need not be a victim of

the charged offense so long as one is a victim of the defendant's

other relevant conduct.'" 965 F.3d at 54 (alteration in original)

(quoting Cadden,

). Moreover, in Chin I, with

respect to whether Chin's particular conduct warranted the

enhancement, we framed the question on remand with reference to

commentary in the Guidelines. Specifically, we stated, "[w]e

. . . leave it to the District Court in the first instance to

address, among other things, whether [Chin's] actions were

analogous to those of a fraudster who 'market[s] an

ineffective cancer cure,' who the Guidelines indicate would merit

- 7 - the enhancement, U.S.S.G. § 3A1.1 cmt. n.2." Chin I, 965 F.3d at

54.

Following this Court's decisions in Cadden and Chin I,

Cadden was resentenced on July 7, 2021. Chin was resentenced the

next day by the same judge who had resentenced Cadden and who had

previously sentenced both men.

At Cadden's resentencing, the District Court observed

that, at the first sentencing, it had treated the applicable mens

rea standard as "not recklessness in the tort law sense but in the

appreciably stricter criminal law sense, requiring actual

knowledge of an impending harm easily preventable." But, the

District Court noted in resentencing Cadden, "[i]t's clear rather

from the decision in Mr. Cadden's case that the First Circuit has

adopted the Second Circuit's definition [in Lucien,

], which is a quite different definition of recklessness."

The District Court then quoted the definition of recklessness from

Lucien: "the type of risk that is obvious to a reasonable person

and for which disregard of said risk represents a gross deviation

from what a reasonable person would do," Lucien,

-

57.

In assessing whether the enhancement applied to Cadden,

the District Court found that Cadden "preside[d] over" a "high-

risk enterprise" at NECC and did so

- 8 - despite warnings, signals, . . . incomplete testing, falsification of drug lab cleaning reports, . . . the appearance of mold and other contaminants in the clean room, and his superior knowledge of the risk involved[.] I have to conclude that [Cadden's] conduct did and does fit within the definition of "recklessness."

The District Court then applied the enhancement to Cadden.

Chin was resentenced by the District Court the day after

Cadden was. The District Court declared in resentencing Chin, "I

do not want to retread ground that I covered yesterday. . . . . I

assume [the First Circuit's quotation of Lucien in Cadden] meant

they were adopting or at least embracing the Second Circuit's view

of how 'recklessness' would be defined in this case." The District

Court then held the "conscious or reckless risk" enhancement

applicable to Chin.

In addition, at Cadden's resentencing, the District

Court noted that, in light of the First Circuit's ruling in

Cadden's first appeal, "'victims' [are] defined . . . by the larger

picture of [an offender's] conduct as a whole," and that "any

person who entrusts medical personnel to inject a foreign substance

into their spine by definition fits what I would think, and

ordinary people would think, is a definition of being in a

vulnerable position." The District Court then applied the

"vulnerable victim" enhancement to Cadden.

- 9 - At Chin's resentencing, the District Court observed that

the "First Circuit['s] . . . expansive view of what constitutes a

'victim' under the Guidelines was pretty clear to me," and that

"vulnerability can . . . refer to one's . . . inability to protect

one's self under the circumstances." The District Court then held

the "vulnerable victim" enhancement applicable to Chin as well.

After applying both the "conscious or reckless risk" and

"vulnerable victim" enhancements to Chin, the District Court

determined that Chin's total offense level was 34. Given that the

District Court determined that Chin's Criminal History Category

was I, the District Court calculated his Guidelines Sentencing

Range to be a term of imprisonment of 151–188 months. The District

Court thereafter imposed a 126-month term of imprisonment and two

years of supervised release. Chin timely appeals. "[W]e review

the District Court's 'factfinding for clear error and afford de

novo consideration to its interpretation and application of the

sentencing guidelines.'" Chin I, 965 F.3d at 50 (quoting United

States v. Benítez-Beltrán,

(1st Cir. 2018)).

II.

We start with Chin's challenge to the District Court's

application of the two-level enhancement set forth in U.S.S.G.

§ 2B1.1(b)(16)(A). We are not persuaded by it.

- 10 - A.

Chin first argues that the District Court erred in

interpreting § 2B1.1(b)(16)(A). He contends that is so because

the District Court held the enhancement to apply so long as there

is proof that the offense, including the defendant's relevant

conduct, involved a risk of death or serious bodily injury of which

the defendant should have been aware and thus to apply even in the

absence of proof by a preponderance of the evidence that the

defendant in fact knew of that risk.

Chin contends in support of that argument that the

District Court based its "should have known" interpretation of the

enhancement solely on our invocation in the course of construing

that same provision of the Guidelines in Cadden of the Second

Circuit's decision in Lucien. He goes on to contend, however,

that "it is not at all clear from this Court's 'Cf.' citation to

Lucien that it was adopting that particular definition of 'reckless

risk.'"

Chin further argues that, given that we did not hold in

Cadden that Lucien controls, we must construe the enhancement

afresh. And, he contends, by virtue of the use of the word

"reckless" in § 2B1.1(b)(16)(A), the enhancement is properly

construed to require proof that a defendant was aware that his

relevant conduct in committing his offense created a risk of death

or serious bodily injury and not merely that he should have known

- 11 - of that risk. He then contends that, in consequence, the

enhancement cannot be applied to him, because the government did

not prove by a preponderance of the evidence that Chin was aware

of any such risk in engaging in the conduct relevant to his

offense.

We agree with Chin that the "Cf." citation to Lucien in

our Cadden decision, 965 F.3d at 34–35, does not resolve how this

enhancement must be construed. We did not have occasion in Cadden

to address the meaning of the word "reckless" in the enhancement.

Our focus there was solely on the District Court's failure to

address Cadden's "relevant conduct" in applying the enhancement

as § 1B1.1 cmt. n.1(I) of the Guidelines requires, given that the

District Court appeared to focus in assessing whether the

enhancement applied on the nature of the offenses of which Cadden

had been convicted. See Cadden,

; U.S.S.G. § 1B1.1

cmt. n.1(I) (defining "offense"); id. § 1B1.3(a)(1)(A) (setting

forth "relevant conduct" for purposes of computing base offense

level, offense characteristics, and adjustments). But, even

though Cadden's invocation of Lucien is not controlling of the

question presented here, we nonetheless conclude that the

enhancement is best construed as Lucien construed it.

The Guideline refers to a "conscious or reckless

risk." U.S.S.G. § 2B1.1(b)(16)(A) (emphasis added). If we were

to read "reckless" in this Guideline itself to require a defendant

- 12 - to be aware of the risk of death or substantial bodily injury, as

Chin contends we must, the use of the words "conscious or" in that

same Guideline would be superfluous. See United States v. DeLuca,

(1st Cir. 1994) ("'[A]ll words and provisions of

statutes are intended to have meaning and are to be given effect,

and no construction should be adopted which would render statutory

words or phrases meaningless, redundant or superfluous.' We think

that this principle is fully applicable to the

sentencing guidelines . . . ." (internal citations omitted)

(quoting Lamore v. Ives,

, 716–17 (1st Cir. 1992))).

Nor can this redundancy be avoided, as Chin suggests, by

"requiring the government to prove, at the very least, what amounts

to willful blindness" to prove recklessness. "Willful blindness

serves as an alternate theory on which the government may prove

knowledge." United States v. Pérez-Meléndez,

(1st

Cir. 2010).

In construing the Guideline to require proof only that

the risk would have been obvious to a reasonable person in Chin's

position, we align ourselves not only with the Second Circuit

decision in Lucien, but with the Ninth and Tenth Circuits too.

See United States v. Maestas,

(10th Cir. 2011)

("[A] defendant’s conduct involves a conscious risk if the

defendant was subjectively aware that his or her conduct created

a risk of serious bodily injury, and a defendant’s conduct involves

- 13 - a reckless risk if the risk of bodily injury would have been

obvious to a reasonable person."); United States v. Johansson,

(9th Cir. 2001) ("We do not believe that a defendant

can escape the application of the serious risk of injury

enhancement by claiming that he was not aware that his conduct

created a serious risk, that is, a defendant does not have to

subjectively know that his conduct created the risk."). And while

Chin is right that two courts of appeals have ruled to the contrary

and interpreted § 2B1.1(b)(16)(A) to require actual, subjective

awareness of a risk, see United States v. Mohsin,

(7th Cir. 2018); United States v. McCord, Inc.,

(8th Cir. 1998), neither of those courts explains how that

interpretation accords with the enhancement's use of the words

"conscious or" before "reckless." See Johansson,

("Our concern with the Eighth Circuit's interpretation of

'reckless' [in McCord] . . . is that there is no meaningful

distinction between an offense that involves the 'conscious' risk

of injury, and an offense that involves the 'reckless' risk of

injury, if under either prong the defendant must have been aware

of the risk in the first place."); accord Maestas,

.1

1Chin does also point to the Eleventh Circuit's decision in United States v. Mateos,

(11th Cir. 2010), which applied the enhancement on the ground that the sentencing court had "f[ound] that a trained nurse, such as [the defendant] . . .,

- 14 - Chin does point out that, although neither

§ 2B1.1(b)(16)(A) nor its application notes define the term

"reckless," a definition of that word does appear elsewhere in the

Guidelines. He then argues that we thus must apply that definition

of "reckless" here.

Chin has in mind the definition of "reckless" that

appears in the application notes to the Guideline that concerns

involuntary manslaughter. See U.S.S.G. § 2A1.4. That Guideline

sets different base offense levels for involuntary manslaughter

depending on whether "the offense involved criminally negligent

conduct; or . . . the offense involved reckless conduct; or . . .

the offense involved the reckless operation of a means of

transportation." Id. The application note to that Guideline, in

turn, defines "reckless" as follows:

"Reckless" means a situation in which the defendant was aware of the risk created by his conduct and the risk was of such a nature and degree that to disregard that risk constituted a gross deviation from the standard of care that a reasonable person would exercise in such a situation.

would be well aware" of the risks associated with her criminal activity, id. at 1371. But, as the government observes, this standard more closely resembles a should-have-known standard than an actual awareness standard. Moreover, insofar as the Eleventh Circuit meant to embrace an actual-awareness-of-risk requirement in Mateos, see id. ("the Guidelines provision focuses on the defendant's disregard of risk"), it, too, made no attempt to explain how such a requirement could be reconciled with the Guideline's text.

- 15 - Id. § 2A1.4 cmt. n.1. The application note also explains that

"'[c]riminally negligent' means conduct that involves a gross

deviation from the standard of care that a reasonable person would

exercise under the circumstances, but which is not reckless." Id.

But, the application note that sets forth this

definition of "reckless" in connection with the Guideline that

concerns involuntary manslaughter does not purport to apply

throughout the Guidelines. Nor does it even purport to apply to

the Guideline at issue here in particular, which applies to fraud

and certain related offenses. Thus, the application note does

not, by its terms, require us to apply the definition of "reckless"

that it sets forth here.

Moreover, it is problematic to apply that definition

here as a textual matter. The definition of "reckless" in the

involuntary manslaughter Guideline refers to a "risk." See

U.S.S.G. § 2A1.4 cmt. n.1. It is thus hard to see how that

definition could have been intended to apply to this Guideline,

because this Guideline itself uses the word "reckless" to modify

the word "risk." No such awkwardness arises under the involuntary

manslaughter Guideline; it uses the adjective "reckless" to

describe a defendant's conduct -- either "reckless conduct" or

"reckless operation of a means of transportation," U.S.S.G.

§ 2A1.4. See Maestas,

(observing the distinction

- 16 - between the two Guidelines' respective uses of "reckless conduct"

and "reckless risk"); Johansson,

("The Guideline

describes a 'reckless risk,' not a reckless disregard of a known

risk.").2

Chin separately argues that -- the definition of

"reckless" elsewhere in the Guidelines aside -- the term as it

appears in the enhancement at issue here is best construed to

require the defendant to be aware of the risk of death or serious

bodily injury. He relies for this contention in part on other

instances in which recklessness has been defined to require a

2 Chin draws our attention to a case in which this Court relied on the definition of "reckless" from the involuntary manslaughter Guideline when interpreting a third Guideline's use of that word. See United States v. Carrero-Hernández,

, 348–50 (1st Cir. 2011). There, this Court was tasked with interpreting a Guideline that provided for an increased offense level "if the defendant recklessly created a substantial risk of death or serious bodily injury to another person in the course of fleeing from a law enforcement officer," U.S.S.G. § 3C1.2, whose application note expressly imported the definition of "reckless" from the Guideline on involuntary manslaughter, id. cmt. n.2; see also Carrero-Hernández,

. But, even setting aside the fact that in that case -- unlike this one -- the Guideline in question expressly incorporated the definition of "reckless" set out in the application note to § 2A1.4, Carrero-Hernández illustrates why the text of Chin's enhancement compels a different construction of the word "reckless." The provision at issue in Carrero-Hernández, like the involuntary manslaughter Guideline, used "reckless[]" to describe how an offender engaged in risky conduct. See U.S.S.G. § 3C1.2 ("If the defendant recklessly created a substantial risk . . ."); id. § 2A1.4 ("if the offense involved reckless conduct . . ."). By contrast, as we have explained, "reckless" in § 2B1.1(b)(16)(A) describes expressly a "risk," not the way an offender conducted himself with respect to that risk. See id. § 2B1.1(b)(16)(A).

- 17 - defendant's subjective awareness of a risk. See Voisine v. United

States,

(2016) (describing reckless conduct

as "acts undertaken with awareness of their substantial risk of

causing injury" and "with conscious disregard of a substantial

risk of harm"); Farmer v. Brennan,

, 836–37 (1994)

("The criminal law . . . generally permits a finding of

recklessness only when a person disregards a risk of harm of which

he is aware.").

But, in those instances, the term defines the mens rea

element of a criminal offense, see Voisine,

;

Farmer, 511 U.S. at 836–37, which must be proved beyond a

reasonable doubt.3 Here, however, the term appears in a sentencing

enhancement, which is subject only to the lower preponderance of

the evidence standard that also applies in the civil context. See

United States v. Hernández-Negrón,

(1st Cir.

2021). Thus, the examples of "reckless" being given the stricter

meaning on which Chin relies fail to show that this Guideline is

best construed to incorporate a meaning of "reckless" that is used

to define an element of a crime, rather than a meaning of

3Farmer was a civil Bivens action in which the Court held that "deliberate indifference," for the purposes of defining a violation of the Eighth Amendment, see Helling v. McKinney,

(1993), required actual knowledge and disregard of a risk, rather than merely an objective risk.

, 839– 40. The Court explained in so holding, however, that it was "adopt[ing]" what it called "subjective recklessness as used in the criminal law."

at 839–40.

- 18 - "reckless" that is traditionally used in the civil context, which

is the one the Second Circuit attributes to it in Lucien,

. See Safeco Ins. Co. of Am. v. Burr,

(2007) ("While 'the term recklessness is not self-defining,' the

common law has generally understood it in the sphere of civil

liability as conduct violating an objective standard: action

entailing 'an unjustifiably high risk of harm that is either known

or so obvious that it should be known.'" (quoting Farmer,

)); see also

at 68 n.18 ("Unlike civil recklessness,

criminal recklessness also requires subjective knowledge on the

part of the offender.").

We do not mean to suggest that the word "reckless" in a

Guideline necessarily incorporates the traditional common-law

understanding of the term in the civil context. But, given the

use of the words "conscious or reckless" to modify risk in

§ 2B1.1(b)(16)(A), the text requires us to construe "reckless"

here to refer to that standard.

B.

Chin argues in the alternative that the record fails to

show by a preponderance of the evidence that his relevant conduct

satisfied the objective standard for recklessness, even if that

standard is the applicable one under this Guideline. Specifically,

he contends that "[w]hile [he] was aware that there were

deficiencies in testing and the condition of the compounding lab

- 19 - . . ., it would have required rank speculation to foresee that

those shortcomings would cause the vials of MPA to become

contaminated with fungus, leading to a scourge of serious illness

and death." We are not persuaded.

The District Court did not expressly set forth findings

about the nature of the risk of which Chin should have been aware

from his relevant conduct in committing his offense. However, we

may look to the record of the sentencing hearing to ascertain the

District Court's reasoning. Cf. United States v. Montero-Montero,

(1st Cir. 2016) ("To be sure, a sentencing court's

rationale sometimes may be inferred from the sentencing colloquy

and the parties' arguments (oral or written) in connection with

sentencing.").

Notably, before applying the § 2B1.1(b)(16)(A)

enhancement to Chin, the District Court explained that it "d[id]

not want to retread ground that [it] covered yesterday." It is

thus evident that the District Court was relying on the same

rationale for applying this enhancement to Chin that it had relied

on the day before in applying the enhancement to Cadden. And, at

Cadden's resentencing, it had explained that the enhancement

applied to Cadden because Cadden "preside[d] over" a "high-risk

enterprise" at NECC

despite warnings, signals, . . . incomplete testing, falsification of drug lab cleaning reports, . . . the appearance of mold and

- 20 - other contaminants in the clean room, and his superior knowledge of the risk involved.

Of course, the record in Chin's case must provide support

for the District Court's decision to apply the enhancement to him

based on this same rationale. But, reviewing the District Court’s

factfinding for clear error, Chin I, 965 F.3d at 50, we conclude

that the record here supportably shows that Chin knew in 2012 that

NECC's clean room was grossly contaminated after his staff's

failure to adhere to cleaning protocols, that he knew that NECC

was selling MPA that was not properly sterilized or tested for

sterility despite claiming that it was USP-797 compliant, and that

he instructed NECC technicians to mislabel untested drugs with the

lot numbers of older lots that NECC had tested. And, as the

government points out, the record also supportably shows that Chin

was required to follow USP-797 standards, the purpose of which "is

to describe conditions and practices to prevent harm, including

death, to patients that could result from . . . microbial

contamination." Thus, the District Court did not clearly err in

finding that Chin should have been aware of the risk of death or

serious bodily injury that his conduct in committing his offense

posed, given the evidence supportably showing that he breached

USP-797 standards that exist in part to "prevent

. . . death . . . to patients."

- 21 - III.

We next address Chin's contention that the District

Court erred in applying an enhancement to his sentence that

provides for a two-level increase "[i]f the defendant knew or

should have known that a victim of the offense was a vulnerable

victim." U.S.S.G. § 3A1.1(b)(1).4 The application note further

explains that the enhancement "applies to offenses involving an

unusually vulnerable victim." Id. § 3A1.1 cmt. n.2. To apply the

"vulnerable victim" enhancement, "the sentencing court must

determine that (1) 'the victim of the crime was vulnerable, that

is, . . . the victim had an "impaired capacity . . . to detect or

prevent crime;"' and (2) 'the defendant knew or should have known

of the victim's unusual vulnerability.'" United States v. Stella,

(1st Cir. 2009) (quoting United States v.

Donnelly,

(1st Cir. 2004)).

Chin does not dispute that the patients who were

administered NECC drugs are "victims" in the relevant sense. See

United States v. Bradley,

(11th Cir. 2011)

(concluding that "recipients of recycled blood-derivatives are

4U.S.S.G. § 3A1.1(b)(2) provides, "[i]f (A) subdivision (1) applies; and (B) the offense involved a large number of vulnerable victims, increase the offense level determined under subdivision (1) by 2 additional levels." The District Court applied this enhancement at Chin's resentencing. Chin does not argue that the District Court erred in applying the additional enhancement in § 3A1.1(b)(2) if the District Court properly applied the enhancement in § 3A1.1(b)(1).

- 22 - 'vulnerable victims'" where owner of pharmaceutical wholesaler's

fraudulent billing scheme caused AIDS and hemophilia patients to

be treated with recycled blood derivatives); United States v.

Milstein,

(2d Cir. 2005) (affirming application of

"vulnerable victims" enhancement where defendant "distribute[d]

counterfeit and misbranded drugs to doctors, pharmacists, and

pharmaceutical wholesalers, knowing that those customers would

distribute the drugs to women with fertility problems and

to Parkinson's disease patients"); see also United States v.

Sidhu,

(5th Cir. 1997) ("[A] physician's patients

can be victimized by a fraudulent billing scheme directed at

insurers or other health care providers."). But, he still argues

that neither prong of the enhancement is satisfied here. Reviewing

the District Court's factfinding for clear error and its

interpretation of the Guidelines de novo, Chin I, 965 F.3d at 50,

we do not agree.

A.

Chin contends that the victims here -- i.e., the patients

harmed by contaminated NECC drugs -- "were not 'unusually

vulnerable'" merely because they were members of "a generic class

of all medical patients." He further contends that such a finding

would be inconsistent with the intent and purpose of the Guideline,

which he says is meant to punish "defendants who exploit the

particular weaknesses of society's most vulnerable members." To

- 23 - the extent Chin contends that the District Court erred in its

interpretation and application of the Guideline, we disagree under

de novo review. To the extent he challenges the District Court's

factual finding that the victims at issue were in fact "unusually

vulnerable," we discern no clear error.

The District Court did not find, as Chin suggests, that

these victims were unusually vulnerable merely because they

belonged to "a generic class of all medical patients." Rather,

the District Court supportably found that they were unusually

vulnerable because their pain led them to "entrust medical

personnel to inject a foreign substance into their spine[s],"

recognizing that "vulnerability can equally refer to one's . . .

inability to protect one's self under the circumstances." Applying

the enhancement based on particularized class characteristics such

as these is consistent with our precedent. Although we have said

that the sentencing court should focus "on the victim's individual

characteristics" in applying this enhancement, "above and beyond

mere membership in a large class," see United States v. Feldman,

(1st Cir. 1996), we have also made clear that "this

is in no way a fixed rule," United States v. Gill,

(1st Cir. 1996). Indeed, "[i]n some cases the inference to

be drawn from the class characteristics may be so powerful that

there can be little doubt about unusual vulnerability of class

members within the meaning of section 3A1.1."

at 487 (citing

- 24 - United States v. Echevarria,

(2d Cir. 1994)

(upholding enhancement as applied to unlicensed doctor based on

group determination of vulnerability of medical patients),

superseded by regulation on other grounds as stated in United

States v. Hussey,

, 433 n.3 (2d Cir. 2001), and United

States v. Bachynsky,

(5th Cir. 1991) (same, as

applied to physician making false diagnoses)). Thus, reviewing de

novo, we conclude that the District Court did not err in

interpreting the Guideline.

Nor do we find any clear error in the District Court's

application of the Guideline to Chin. Indeed, we have upheld the

application of the enhancement in similar circumstances: in

Stella, we held that victims' "illnesses" can distinguish them

from members of the "general public" for purposes of the

vulnerable-victim enhancement, insofar as their need for

medication vitiates their ability to "help themselves" or "to

detect or prevent against the [relevant harm]."

(quoting the sentencing court's findings). Cf. Bradley,

(concluding that victims "were vulnerable due to their

medical condition -- AIDS and hemophilia"); Milstein,

(concluding that "women with fertility problems and . . .

Parkinson's disease patients" constituted vulnerable victims).

Here, the patients receiving MPA injections into their spine were

in a similarly "unusually vulnerable" position, see U.S.S.G.

- 25 - § 3A1.1 cmt. n.2, by virtue of their physical condition and the

circumstances of the procedure. Thus, we discern no error in the

District Court's application of the enhancement.

B.

Chin also argues that the record fails to show that Chin

knew or should have known of the victims' unusual vulnerability.

In support of this contention, Chin appears to argue that the "knew

or should have known" requirement in § 3A1.1(b) per se precludes

the enhancement's application to him because he was merely a

supplier of medical products to health care facilities and thus

stood at a remove from the patients who were harmed by the

contaminated drugs that NECC compounded. But, insofar as Chin in

pressing this contention is making a legal argument about the

proper construction of the Guideline, such that our review is de

novo, see Chin I, 965 F.3d at 50, we must reject the contention.

Nothing in the text of the provision supports the per se

exclusion of medical suppliers. Thus, nothing in the text bars

the application of the enhancement to a medical supplier who knew

or should have known that he was distributing unsafe drugs that

would be used by vulnerable patients. See Bradley,

; Milstein,

; see also United States v. Moran,

, 952–53, 978–79 (11th Cir. 2015) (applying "vulnerable

victim" enhancement to defendant CEO of medical facility who was

not directly involved in patient care). Rather, the text merely

- 26 - provides that the enhancement applies to an offender who "knew or

should have known that a victim of the offense was a vulnerable

victim." U.S.S.G. § 3A1.1(b).

Chin next argues that the enhancement may not be applied

to him by referencing the application note to it. The application

note explains that "[t]he adjustment would apply, for example, in

a fraud case in which the defendant marketed an ineffective cancer

cure." U.S.S.G. § 3A1.1 cmt. n.2. Chin contends that, in addition

to the fact that he was not himself "a health care provider," he

also is not analogous to a fraudster who marketed an ineffective

cancer cure. And that is so, Chin contends, because NECC had

previously sold lots of MPA without incident, and the record fails

to show by a preponderance of the evidence that he "kn[e]w that

any of the drugs he compounded were contaminated." He thus appears

to be contending that, absent a showing by a preponderance of the

evidence of his intent to defraud the victims, there can be no

finding that Chin knew or should have known that the victims were

vulnerable.

But, even if we understand this argument to be a

contention about the proper way to construe the Guideline, such

that our review is de novo rather than for clear error, Chin I,

965 F.3d at 50, we reject it. The text of the Guideline provides

no basis for concluding that the "knew or should have known"

standard may be satisfied only by a finding that the defendant

- 27 - intended to defraud his victims. Nor does the application note,

in giving an example of how the Guideline could be satisfied,

purport to suggest that there is a requirement to prove an intent

to defraud. Instead, the Guideline merely requires that it be

shown by a preponderance of the evidence that, in engaging in the

conduct relevant to his offense, Chin knew or should have known

that vulnerable patients would be using the unsafe drugs he

produced at NECC.

Finally, Chin appears to be arguing that, even if the

Guideline may be applied to a medical supplier who was not

defrauding patients, the District Court clearly erred in finding

that he "knew or should have known" that the victims were

vulnerable. Here, his assertion is that there is an absence of

record evidence of his individualized knowledge of both who the

end users of NECC drugs would be and that the drugs that NECC

shipped were contaminated. But, we cannot agree.

The District Court supportably found that "[e]vidence

introduced at trial, including internal NECC emails, brought home

the certainty that Chin and other of the coconspirators were fully

aware of the risks involved in the distribution of defective

drugs." Chin's resume advertised his "[k]nowledge of USP[-]797,"

and the first sentence of the introduction to USP-797 reads, "[t]he

objective of this chapter is to describe conditions and practices

to prevent harm, including death, to patients that could result

- 28 - from . . . microbial contamination . . . ." And, Chin himself

concedes in his brief to us that he "was aware that there were

deficiencies in testing and the condition of the compounding lab

and that all the USP-797 protocols were not being strictly adhered

to." Indeed, evidence was presented at trial that tended to show

that Chin was aware of the particularly grave risks associated

with injecting contaminated medication into a patient's spinal

fluid, as opposed to other routes of drug administration.5 Thus,

the District Court did not clearly err in concluding that Chin

knew or should have known that downstream recipients of MPA from

NECC were particularly vulnerable.

IV.

For the foregoing reasons, we affirm Chin's sentence.

An NECC compounding technician testified that Chin, when 5

training him in clean-room sanitation practices, "stressed that with the injectable drugs [there] was even more a need to be vigilant in terms of cleanliness because you're bypassing the immune system, basically injecting it right into the cerebral spinal fluid, whatever it is, and it's going to go straight up into their brain." Additionally, the second sentence of the introduction to USP-797 explains that "[c]ontaminated [compounded sterile preparations] are potentially most hazardous to patients when administered into body cavities, central nervous and vascular systems, eyes, and joints and when used as baths for live organs and tissues."

- 29 -