Department of Health and Human Services
DEPARTMENTAL APPEALS BOARD

Civil Remedies Division

Hanover Hill Health Care Center,
(CCN: 30-5009),

Petitioner,
v.
Centers for Medicare & Medicaid Services.
Docket No. C-11-420
Decision No. CR2617

Date: September 19, 2012

DECISION

Petitioner, Hanover Hill Health Care Center (Petitioner or facility), is a long-term care
facility located in Manchester, New Hampshire, that participates in the Medicare
program. Following a survey completed on February 11, 2011, the New Hampshire
Department of Health and Human Services (state agency) determined that the facility was
not in substantial compliance with Medicare participation requirements, and that the
facility’s noncompliance posed immediate jeopardy to the health and safety of at least
one of its residents, a demented man who died while eating peanut butter and crackers.
Based on the state agency’s findings, the Centers for Medicare and Medicaid Services
(CMS) imposed a per-instance civil money penalty (CMP) of $7,500. Petitioner now
appeals the noncompliance determination and enforcement remedy.

For the reasons set forth below, I find that Petitioner was not in substantial compliance
with Medicare participation requirements and that the penalty imposed is reasonable.
I. Background

The Social Security Act (Act) sets forth requirements for nursing facility participation in
the Medicare program, and authorizes the Secretary of Health and Human Services to
promulgate regulations implementing those statutory provisions. Act §1819. The
Secretary’s regulations are found at 42 C.F.R. Part 483. To participate in the Medicare
program, a nursing facility must maintain substantial compliance with program
requirements. To be in substantial compliance, a facility’s deficiencies may pose no
greater risk to resident health and safety than “the potential for causing minimal harm.”
42 CFR. § 488.301.

The Secretary contracts with state survey agencies to conduct periodic surveys to
determine whether skilled nursing facilities are in substantial compliance. Act § 1864(a);
42 C.F.R. § 488.20. The regulations require that each facility be surveyed once every
twelve months, and more often, if necessary, to ensure that identified deficiencies are
corrected. Act § 1819(g)(2)(A); 42 C.F.R. §§ 488.20(a); 488.308.

Here, the state agency surveyed the facility between February 9 and 11, 2011 and cited
deficiencies related to the care provided to one if its residents, referred to as “Resident
17” (R17). Among other deficiencies, the state agency cited two at the immediate
jeopardy level, concluding that the facility did not address sufficiently R17’s
demonstrated swallowing difficulties:

e 42C.F.R. § 483.13(c) (Tag F-224) (prohibit neglect), for failing to ensure that the
facility implemented policies and procedures to prohibit neglect of R17; and

e 42C.F.R. § 483.25 (Tag F-309) (quality of care), for failing to provide a
comprehensive assessment to determine the appropriate interventions for R17’s
swallowing difficulties.'

' The state agency cited the facility for five related deficiencies that did not cause actual
harm, with the potential for more than minimal harm: 42 C.F.R. §§ 483.13(c)(1)(ii)-(iii),
(c)(2)-(4) (failing to report the results of an allegation of neglect within five days);
483.13(c) (failing to report its investigation results within five days); 483.20(d)(3)
(failing to update R17’s comprehensive care plan); 483.75 (failing to administer the
facility in a manner that enabled it to provide residents with their highest practicable
well-being); and 483.75(i) (medical director’s failing to ensure adequate care and services
be provided to R17, who had a history of choking). CMS did not impose a remedy for
these deficiencies, however, expressly limiting the penalty to those deficiencies cited at
the immediate jeopardy level.
The state agency also determined that the immediate jeopardy had abated by the time of
the survey and that the facility achieved substantial compliance as of March 9, 2011.
CMS adopted the state agency’s findings and has imposed a $7,500 per-instance CMP.

Petitioner timely requested a hearing. CMS filed a pre-hearing brief and 13 proposed
exhibits (CMS Exs. 1-13). Petitioner filed a pre-hearing brief and 28 proposed exhibits
(P. Exs. 1-28). On December 5, 2011, I held a pre-hearing conference, during which I
admitted CMS Exs. 1-13 and P. Exs. 1-28. Following the pre-hearing conference, CMS
moved for summary judgment, which Petitioner opposed. With its motion for summary
judgment, CMS submitted one additional document, the facility’s application to
participate in the Medicare program, which it marked as CMS Ex. 14. In the absence of
any objection, I admit CMS Ex. 14.

I denied CMS’s motion for summary judgment and, on January 23, 2012, convened a
video hearing from the offices of the Departmental Appeals Board in Washington, D.C.
Counsel for the parties and the witness convened in Manchester, New Hampshire. Ms.
Jill Steinberg appeared on behalf of CMS, and Mr. Joseph L. Bianculli appeared on
behalf of Petitioner.

The parties have each submitted a post-hearing brief (Post-Hr’g Br.) and a post-hearing
reply brief (Post-Hr’g Reply Br.).

IL. Issues
This case presents the following issues:

1. Was the facility in substantial compliance with 42 C.F.R. § 483.13(c) (Tag
F-224 — staff treatment of residents: abuse/neglect policies) and 42 C.F.R.
§ 483.25 (Tag F-309 — quality of care);

2. Ifthe facility was not in substantial compliance, is the penalty imposed —
$7,500 per-instance — reasonable.

lam not authorized to review CMS’s immediate jeopardy determination. An
administrative law judge may review CMS’s scope and severity findings (which include a
finding of immediate jeopardy) only if a successful challenge would affect the range of
the CMP or if CMS has made a finding of substandard quality of care that results in the
loss of approval of a facility’s nurse aide training program. 42 C.F.R. § 498.3(b)(14); 42
C.F.R. §§ 498.3(b)(14), 498.3(d)(10); Cedar Lake Nursing Home, DAB No. 2344 at 9
(2010); Evergreen Commons, DAB No. 2175 (2008); Aase Haugen Homes, DAB No.
2013 (2006). For a per-instance penalty, the regulations provide only one range ($1,000
to $10,000), so the level of noncompliance here does not affect the range of the CMP. 42
C.F.R. § 488.438(a)(2).
The facility apparently does not operate a nurse aide training program. CMS Ex. 14 at 1.
Even if it did, CMS’s scope and severity finding would not affect approval of such a
program. By statute and regulation, if, as here, CMS imposes a penalty of $5,000 or
more, the state agency cannot approve the program, so the facility would lose its approval
without regard to the immediate jeopardy finding. Act § 1819(f)(2)(B); 42 C.F.R.

§ 483.151(b)(2)(iv).

Thus, because the immediate jeopardy finding here does not affect the range of the CMP
or cause the facility to lose approval of its nurse aide training program (if it has one), the
finding is not reviewable.

III. Discussion

A. Petitioner was not in substantial compliance with Medicare participation
requirements, because the facility did not implement its policy prohibiting
resident neglect and did not provide R17 with the assessment, care, and
services he needed after he showed signs of swallowing difficulties.”

Program Requirements. “Neglect” means failure to provide goods and services necessary
to avoid physical harm, mental anguish, or mental illness. 42 C.F.R. § 488.301.

Facilities must develop and implement written policies and procedures that prohibit
resident neglect. 42 C.F.R. § 483.13(c).

Section 483.13(c) “addresses a deficiency related to lack of an effective policy as
opposed to one directed at the occurrence of neglect itself.” Emerald Oaks, DAB No.
1800 at 12 (2001). However, the drafters of the regulation characterized as “inherent in
[section] 483.13(c)” the requirement that “each resident should be free from neglect as
well as other forms of mistreatment,” 59 Fed. Reg. 56,130 (Nov. 10, 1994). The drafters
also deliberately rejected the suggestion that the regulations require evidence of a
negative outcome to support the finding of neglect.

We do not accept this comment because neglect may be determined even if
no apparent negative outcome has occurred. The potential for negative
outcome must be considered.

59 Fed. Reg. at 56,130 (emphasis added).

The regulation requires that the facility “implement” its anti-neglect policies. 42 C.F.R.
§ 483.13(c). Implementing a policy requires more than drafting and maintaining

> My findings of fact and conclusions of law are set forth, in bold and italics, as captions
in the discussion section of this decision.
documents. Staff must carry out and follow the policy. The Board has recognized that
examples of neglect can demonstrate that the facility has not implemented its policies.
Barn Hill Care Ctr., DAB No. 1848 at 9-12 (2002); Emerald Oaks, DAB No. 1800 at 18;
59 Fed. Reg. 56,130; see also The Cottage Extended Care Ctr., DAB No. 2145 at 4n.4
(2008); Liberty Commons Nursing & Rehab. Ctr.-Johnston, DAB No. 2031 at 7-17
(2006), aff'd, Liberty Nursing & Rehab. Ctr.-Johnston v. Leavitt, 241 F. App’x 76 (4th
Cir. 2007).

In addition, under the Act and “quality of care” regulation, each resident must receive,
and the facility must provide, the necessary care and services to allow a resident to attain
or maintain the highest practicable physical, mental, and psychosocial well-being, in
accordance with the resident’s comprehensive assessment and plan of care. Act

§ 1819(b); 42 C.F.R. § 483.25. To this end, the facility must eliminate or reduce a known
or foreseeable risk of accident “to the greatest degree practicable.” De/ Rosa Villa, DAB
No. 2458 at 7 (2012) (quoting Clermont Nursing & Convalescent Ctr., DAB No. 1923 at
9-10 (2004), aff'd, Clermont Nursing & Convalescent Ctr., 142 F. App’x 900 (6" Cir.
2005).

The Facility’s Policies and Procedures. Here, consistent with the regulations, the
facility’s “Abuse Prohibition” policy states that the facility “will make every effort to
prevent patient/resident . . . neglect... by employing the seven components of
prevention: screening, training, prevention, identification, investigation, protection and
reporting/response.” CMS Ex. 5 at 19. As part of the “prevention” component, the
policy says that the facility will, among other requirements, “identify, correct, and
intervene in situations in which . . . neglect . . . is more likely to occur”; will “assure that
the staff assigned have knowledge of the individual residents’ care needs”; and will
“Ta]ssess, care plan for[,] and monitor residents with needs and behaviors which may lead
to... neglect... .” CMS Ex. 5 at 19-20.

Another policy, titled “Monitoring Residents/Patients as Having Significant or Health
Altering Nutritional Issues,” says that the facility will identify to the “Nutrition-at-Risk
Committee” residents with “significant, health altering nutritional issues.” CMS Ex. 5 at
2. The Nutrition-at-Risk Committee reviews residents “who meet at least on[e] of the
following criteria: .. . (5) Score of 10 or above on malnutrition risk assessment.” CMS
Ex. 5 at 2. The committee must discuss the resident’s nutritional issues, including
“current weight, variances in weight, current diet order and supplements, health status
review, changes in cognitive/behavior status, and identification of co-founding factors.”
CMS Ex. 5 at 2.
The facility’s “Aspiration Precautions” policy mandates that the facility promptly identify
“signs or symptoms of aspiration, changes in swallowing function, and sign[s] and
symptoms of aspiration pneumonia.” CMS Ex. 5 at 1. Staff must “[e]ncourage
resident[s] to eat in [a] supervised setting [and] [p]rovide supervision in [the resident’s]
preferred eating environment if [the] resident does not choose to attend supervised dining
areas.” CMS Ex. 5 at 1. Staff must also report changes in signs or symptoms of
dysphagia (difficulty swallowing) to the resident’s physician. CMS Ex. 5 at 1.

R17’s Swallowing Difficulties. R17 was a 69-year-old man who suffered from a
multitude of conditions, including chronic venous insufficiency, dementia, diabetes, and
heart disease. P. Ex. 2 at 3. Over a three-week period — from August 9, 2010 until his
death on August 29, 2010 — facility staff documented five instances of his choking or
having difficulty swallowing:

e On August 9, the facility’s nursing staff found R17 in his room, “red in face,”
choking on his lunch. CMS Ex. 6 at 41. A nurse performed “[two] pumps of the
[H]eimlich maneuver,” which dislodged the food and opened R17’s airway.
CMS Ex. 6 at 47; P. Ex. 18 at 3 (Bumford Decl.).

¢ On August 12, a nurse observed R17 “reddened in the face, attempting to cough
with difficulty” while eating apple slices, which he was “able to clear with thick
sputum and apple peels present in vomited remnants.” CMS Ex. 6 at 48.

¢ On August 14, R17 took his oral medication “with much difficulty.” CMS Ex. 6
at 50. The administering nurse reported that R17 “took a couple minutes to
swallow each individual pill,” and he “[r]Jefused to try taking pills with
applesauce or anything to aid with swallowing.” CMS Ex. 6 at 50.

¢ On August 15, R17 “took a significant time to swallow each individual pill with
difficulty.” CMS Ex. 6 at 50. The nurse wrote that R17 “tossed pills around in
his mouth and talk[ed] during swallowing.” She directed him to “focus on
swallowing during med[ication] administration to prevent choking, but [noted
that R17 is] forgetful.” CMS Ex. 6 at 50. He again “[rJefused to take pills
crushed or with applesauce to assist with swallowing.” CMS Ex. 6 at 50.

¢ On August 21, R17 had “difficulty swallowing pills,” and was “pocketing them
inside of [his] cheek.” CMS Ex. 6 at 52. The nurse “[a]dded applesauce to
whole pills,” which was “helpful in assisting with swallowing.” CMS Ex. 6 at
52.

August 9, 2010 Incident. Nursing staff reported the August 9 choking episode to the
facility’s speech and language pathologist, Heather Marttila, who assessed R17’s
swallowing functions and “observed [R17] consuming a regular texture with thin
liquids.” CMS Ex. 6 at 47. Speech Pathologist Marttila reported that R17 was
“tolerating [food] without overt signs [or] symptoms of aspiration [or] choking,” and
“{njo coughing, throat clearing or change in subsequent vocal quality.” CMS Ex. 6 at 47.
She concluded that the “‘[c]hoking episode appears to be an isolated event” but
recommended that nursing staff monitor him over the “next few shifts.” CMS Ex. 6 at
47.

Nursing staff notified Enieda Islamovic, the on-call physician’s assistant (covering for
R17’s primary care physician, Dr. Howard Suls), who issued no new orders. CMS Ex. 6
at 47. Staff also notified R17’s daughter of the incident, and “reviewed and updated”
R17’s plan of care. CMS Ex. 6 at 41.

The facility’s response to the August 9 choking incident presents no apparent problems.
Staff identified signs of “changes in swallowing function,” and, in accordance with the
facility’s aspiration precaution policy, timely notified the appropriate personnel (the
speech and language pathologist). See CMS Ex. 5 at 1. Speech Pathologist Marttila
assessed R17’s swallowing function, concluding that the incident was likely “isolated,”
although she recommended supervision for the “next few shifts.”> CMS Ex. 6 at 41, 47.
Staff also notified the physician’s assistant, as required by the facility’s written policy.
See CMS Ex. 5 at 1. Both the speech pathologist and the physician’s assistant directed
staff to monitor R17 for “a few shifts,” i.e., “for 72 hours.” CMS Ex. 6 at 42, 47.

Thereafter, however, facility staff did not respond appropriately to growing evidence that
R17’s swallowing difficulties went beyond an isolated choking incident.

August 12, 2010 Incident. As noted above, on August 12, R17 coughed up the remnants
of apple slices. Petitioner denies that the resident choked on or had any difficulty
swallowing the food but argues that he experienced a benign coughing episode, which did
not merit further attention. P. Post-Hr’g Br. at 13. I note first that Petitioner offers no
testimony from anyone who witnessed the episode and that the contemporaneous nursing

> CMS questions the adequacy of Speech Pathologist Marttila’s assessment, suggesting
that it was a “screen” and did not meet the assessment standards described in the medical
literature. CMS Post-Hr’g Br. at 5 n.4. I do not find that the speech pathologist’s initial
assessment contributed in any significant way, if at all, to the facility’s substantial
noncompliance. Even assuming that the assessment falls short of ideal (which I do not
find), those purported short comings pale when compared to the staff’s responses (or the
absence of responses) when R17 again had problems swallowing.
note, entered by Melissa O’Donnell, seems to describe a swallowing problem that
escalated into a choking incident. Moreover, coughing while eating, including before
swallowing, is a sign of dysphagia. See CMS Ex. 9 at 2 (Jeanie Kayser-Jones and
Kathryn Pengilly, Dysphagia Among Nursing Home Residents, 20 Geriatric Nursing 77,
78 (No. 2 1999)); CMS Ex. 10 at 5-7 (American College of Chest Physicians, Cough and
Aspiration of Food and Liquids Due to Oral-Pharyngeal Dysphagia: ACCP Evidence-
Based Clinical Practice Guidelines (2006)) (in which Speech Pathologist Marttila lists
coughing as a symptom of aspiration or choking).

Obviously, Nurse O’ Donnell, who witnessed the incident, thought that R17 was again
having difficulty swallowing his food, because she wrote that she left a message with
Physician Assistant Islamovic “regarding recent med[ication] change of oxycontin and
any relation to swallowing issues.” CMS Ex. 6 at 48 (emphasis added). In response,
Physician Assistant Islamovic reduced R17’s oxycontin dosage, although she did no
assessment. See CMS Ex. 6 at 49. Inexplicably, no one mentioned the incident to
Speech Pathologist Marttila.

The facility’s registered dietician, Amy Goulas, who was in the facility at the time, also
considered this a choking incident. She ordered kitchen staff to stop providing apple
slices to R17, and wrote that staff supervised R17 at meals due to “recent choking
episodes on apples.” (emphasis added) CMS Ex. 6 at 38, 48. As Speech Pathologist
Marttila acknowledges, apple slices “can be a difficult food for some people to chew and
swallow.” P. Ex. 25, at 1. From this, I can reasonably infer that facility staff suspected
that R17 was again having difficulty swallowing certain foods, particularly since the
facility suggests no other credible reason for discontinuing the apple slices.

Notwithstanding her contemporaneous notes and her actions, Dietician Goulas now
claims that R17 was not choking. She says “I should have been clearer in my note, and
written that the resident had started coughing while eating apple slices, and that in an
exercise of caution that I had recommended replacement of that snack on his meal tray
ticket.” P. Ex. 19 at 3 (Goulas Decl.). I think it far more likely that Dietician Goulas
wrote “choking episodes” because she thought that R17 had choked on his food. See
Jennifer Matthew Nursing & Rehab. Ctr., DAB No. 2192 at 52 (2008) (finding that the
ALJ may reasonably give more weight to contemporaneous notes than to witness
testimony). Moreover, other nurses also described the August 12 incident as a choking
incident. See P. Ex. 20 at 2 (in which Licensed Practical Nurse (LPN) Judy Ballentine
says that she was aware of two choking episodes: August 9 and “a few days later, when
he began coughing on apple slices”); P. Ex. 18 at 4 (Unit Manager Shauna Bumford,
R.N., conceding that the oxycontin “might have been . . . slowing his swallow reflex.”).
In any event, whether Dietician Goulas and the others accurately characterized the
incident, its occurrence should have alerted them that the August 9 choking episode
might not have been isolated after all and that R17’s situation needed further
investigation in order to ensure the resident’s safety. That staff failed in this regard
violated federal regulations as well as the facility’s own policies requiring staff to
“identify, correct, and intervene,” as well as “‘assess, care plan for, and monitor” residents
with needs and behaviors that might lead to neglect. CMS Ex. 5 at 19-20.*

Finally, Petitioner claims that Dietician Goulas and Physician’s Assistant Islamovic
simply exercised their “professional judgment” by not asking that R17 be re-assessed. P.
Post-Hr’g Br. at 14. But the facility had an independent obligation to assess R17’s
swallowing difficulties, without regard to any obligations from the dietician or
physician’s assistant. So, even if I accepted that these medical professionals explicitly
determined that no further action was needed (which I do not), I would still have to
consider whether the facility met its obligation.°

Difficulty Swallowing Medication. As listed above, on August 14, August 15, and
August 21, nurses documented that R17 had difficulty swallowing his medication. P. Ex.
7 at 31-33; CMS Ex. 6 at 50, 52. Petitioner dismisses these incidents as attributable to
R17’s behavior problems. P. Post-Hr’g Br. at 9; P. Ex. 18 at 2 (Bumford Decl.)
(describing R17 as “manipulative,” and claiming that “sometimes” he refused
medications from certain nurses); accord P. Ex. 20 at 2 (Ballentine Decl.); P. Ex. 21 at 2
(Ouellette Decl.); P. Ex. 23 at 1 (Turgeon Decl.); P. Ex. 24 at 3 (Foster Decl.).

* Speech Pathologist Marttila also testified that “elaborate swallowing studies” are not
done after the “occasional occurrence” of swallowing problems. P. Ex. 25 at 2. This
may be so, but here the evidence of swallowing problems — at least five documented
incidents in three weeks — far exceeded an “occasional occurrence.” Moreover, the
problem was not that the facility failed to conduct an “elaborate swallowing study.” The
problem is that facility staff did not take these incidents seriously and, after August 9, no
one assessed, in any meaningful way, R17’s ability to swallow, and, aside from removing
apple slices from his diet, no one considered how to protect him from harm caused by his
difficulties swallowing.

> Ata minimum, I would expect to see the type of documentation provided by Speech
Pathologist Marttila on August 9, when she noted that, based on her clinical observations
of R17, the choking incident that day “appears to be an isolated event.” CMS Ex. 6 at 47.
But I see no contemporaneous evidence suggesting that Dietician Goulas, Physician’s
Assistant Islamovic, or anyone else associated with R17’s care even considered whether
further assessment of R17’s swallowing function was needed. I find wholly unpersuasive
Petitioner’s attempt to justify its inaction by now characterizing it as an undocumented
exercise of professional judgment. See CMS Ex. 6 at 38, 47, 48; Western Care Mgmt.
Corp., DAB No. 1921 at 48 (2004) (holding that a fact-finder may “assume, absent
contrary evidence, that a resident’s medical records accurately reflect the care and
services provided (or not provided).”

10

I have no doubt that R17, who suffered from dementia likely caused by organic brain
syndrome® (see CMS Ex. 6 at 1, 2), was often sarcastic, rude, and socially inappropriate.
CMS Ex. 6 at 11. That R17 exhibited these behaviors, however, does not preclude the
very real possibility that he was developing a problem swallowing and that he had
difficulty swallowing his medications. Indeed, refusing to swallow may itself signal
swallowing problems; and it is not uncommon for staff to mistake genuine swallowing
problems as the resident’s “deliberately being difficult.” See CMS Ex. 9 at 3 (Kayser-
Jones and Pengilly, 20 Geriatric Nursing at 79). In fact, according to R17’s care plan, he
may have resisted taking oral medications because of his problems with swallowing. A
care plan entry dated August 9, says “Resident often takes a long time to swallow pills
secondary to possible swallowing difficulties.’ CMS Ex. 6 at 24 (emphasis added).

Even more compelling, the nurses’ notes that document his difficulties taking oral
medication describe swallowing difficulties, not behavioral issues.’ He did not refuse to
take his medication on August 14, for example. According to the note written by
Kimberly Jacobson, R.N., he took his pills “with much difficulty,” but refused to take the
pills with applesauce or anything else “to aid with swallowing.” CMS Ex. 6 at 50
(emphasis added). From this, I can draw only one inference: that he was having trouble
swallowing his pills.

On August 15, Nurse Jacobson again reported that R17 “took a significant time to
swallow each individual pill with difficulty.” She directed him to “focus on swallowing”
but noted that he was “forgetful” and, again, would not allow the pills to be crushed or
taken with applesauce “to assist with swallowing.” CMS Ex. 6 at 50.

Less than one week later, on August 21, Nurse O’Donnell reported that R17 was having
“difficulty swallowing pills, pocketing them inside of cheek.” This time he allowed her
to add applesauce to the whole pills, which she described as “helpful in assisting with
swallowing.” CMS Ex. 6 at 52; P. Ex. 7 at 33 (emphasis added). Again, nothing in the
progress note suggests that he was refusing to take the pills or exhibiting any other
behavioral problem.

Malnutrition Risk Assessment. The facility periodically assessed R17’s nutrition status,
concluding each time that he was at high risk for malnutrition. See, e.g. CMS Ex. 6 at 65,
66. On August 24, Nurse O’Donnell completed a new assessment, again finding that he
was at high risk for malnutrition. This assessment reflected two notable changes,

° Organic brain syndrome describes decreased mental function caused by a medical
disease that is not a psychiatric disorder.

’ For this reason I find unconvincing, at best, and deeply disturbing, at worst, Director of
Nursing (DON) Heather Foster’s claim that not one of her staff members ever reported
that R17 had a physical problem swallowing medication. P. Ex. 24 at 3 (Foster Decl.).
11

however: 1) R17’s mental status deteriorated from “alert-oriented x 3” (i.e. oriented to
person, place and time) to “lethargic-disoriented x 2” and 2) R17 had an additional risk
factor “difficulty swallowing/frequent choking.” CMS Ex. 6 at 43.

I find this persuasive evidence that facility staff recognized R17’s growing problem with
swallowing. Under the facility’s nutrition policy, the nurse or dietician should have
conveyed this new information to the Nutrition-at-Risk Committee so that the committee
could reconsider the resident’s treatment in light of the changes. CMS Ex. 5 at 2 § 1, 2.
Because they failed to do so, they neither implemented the facility’s written policy to
prevent neglect nor provided R17 with the care and services he needed to maintain his
highest practicable physical well-being.

Petitioner justifies its failure to follow its own policy by attacking the validity of the
assessment. In remarkable testimony, the facility’s administrator, Lori McIntire, and its
DON, Heather Foster, R.N., claim that R17’s “malnutrition risk assessment” inaccurately
describes R17’s “difficulty swallowing/frequent choking.” P. Ex. 24 at 3 (Foster Decl.);
CMS Ex. 6 at 43. According to DON Foster, “the software that generates this form
automatically enters that language when the nurse completing the assessment enters any
episode of choking. ...” P. Ex. 24 at 3 (Foster Decl.). These claims are belied by the
medical record, with its documented incidents of swallowing problems and choking.
Moreover, a resident’s assessment is supposed to be individualized and, it should go
without saying, must accurately reflect the resident’s actual condition. 42 C.F .R.

§ 483.20(b)(2)(ii). An inaccurate assessment compromises the integrity of the resident’s
care plan, because the care plan — which is supposed to describe the “services to be
furnished to attain or maintain the resident’s highest practicable physical, mental, and
psychosocial well-being as required under [section] 483.25” — is based on the assessment.
Basing a care plan on an inaccurate assessment obviously puts the facility out of
substantial compliance with the quality of care regulation, 42 C.F.R. § 483.25, and would
evidence a very serious deficiency. Conversely, disregarding the assessment would also
put the facility out of substantial compliance and would evidence a very serious
deficiency.

R17’s Death on August 29, 2010. On August 29, R17 died while eating crackers covered
in peanut butter. CMS Ex. 6 at 57. The contemporaneous nursing notes, reports from the
emergency responders, as well as the resident’s death certificate all describe his choking
to death on peanut butter and crackers. LPN Judith Ballentine writes that he called as she
was passing his room. He was coughing, had difficulty speaking, and “appeared to be
choking.” She attempted the Heimlich maneuver, removing a piece of peanut butter, and
he started coughing again. He spoke but “appeared to have difficulty catching his
breath.” She attempted the Heimlich a second time, “with no effect.” He became
unresponsive, “no breath noted.” CMS Ex. 6 at 57.

The responding paramedics reported that the resident “started choking” while eating

peanut butter, noting that he had a history o
airway was obstructed by peanut butter and

“shoveling peanut butter in his mouth.” His
they removed a large amount of it, but were

unable to suction successfully because of the “thickness of the peanut butter.” CMS Ex.

6 at 122. According to the death certificate,

airway obstruction by food.” CMS Ex. 8 at 1.

Citing the testimony of Howard Suls, M.D.,
medical director, the facility maintains that

R17 died from “asphyxia” and “upper

who was R17’s physician and the facility’s
R17 died, not from choking on peanut butter,

but from a cardiac event that just happened to coincide with his eating (but not
swallowing) a lot of peanut butter on crackers. P. Ex. 28 at 3-4. I find this highly
unlikely based on all of the contemporaneous evidence. Nevertheless, this case does not
rest on whether R17 choked to death on peanut butter and crackers. The facility was not
in substantial compliance because, contrary to the requirements of the regulations and its
own policies, it failed to assess properly and care-plan appropriately for R17 after he
demonstrated repeatedly that he was experiencing difficulties swallowing.

August 17 Review by Dr. Suls. Petitioner argues that Dr. Suls assessed R17 on August
17 and determined that the resident did not have swallowing issues that called for further
assessment or intervention. I found Dr. Suls’ testimony on this issue equivocal and
generally not credible. He testified that he decided no intervention was necessary, based
on the information he had, but he could not recall what information he had. Transcript
(Tr.) 23.

e When asked, on cross-examination, whether he reviewed the progress note about
the August 14 instance of difficulty swallowing medication, Dr. Suls stated that “I
don’t recall if I did, but I won’t say that I didn’t either.” Tr. 17.

e When asked whether he was aware of either the August 15 or August 21 instance
of swallowing problems, Dr. Suls testified that “I can’t say that I was, but I can’t
say that I wasn’t.” Tr. 18.

e When asked whether he reviewed the relevant medical records pertaining to R17’s
swallowing difficulty, he replied “I cannot specifically recall.” Tr. 23.

On redirect examination, he testified that he made his decision based on Speech
Pathologist Marttila’s August 9 assessment.

Q DjJo you have a recollection that you, in fact, did
make a professional judgment at some point that no
intervention for that [the August 9 choking incident] was
necessary?
13

A I—I made the decision, as you said, that no
intervention was necessary, based on the information I had.

Q All right. And what caused you to draw that
conclusion or make that professional judgment?

A The fact that [R17] had been seen essentially
immediately by the speech therapist in the building and felt it
had no clinical evidence of any kind of swallowing disorder.

Q And

is that a professional judgment that, in your

ordinary course of medical practice you would rely upon in
making your own conclusions and judgments?

A Yes,
experts and

Q And

it is. These are — this — these consultants are my
I rely on them.

did you do so in this case?

A I did so.

Tr. 23-24. I find two significant problems with Dr. Sul’s testimony. First, he
mischaracterizes Speech Pathologist Marttila’s assessment. As he later conceded, she
performed a quick evaluation, thought the choking was probably an isolated event, which
is what she reported, but also said that staff should keep an eye on him and (presumably)

let her know if additional
important, his testimony

problems arose. Tr. 28; CMS Ex. 6 at 47. Second, and more

establishes that he did not consider any of the post-August 9

swallowing incidents. At best, he based his decision on incomplete information.

Despite the instances of
no further action but just

R17’s swallowing difficulty after that incident, the facility took
relied on what was, by August 12, an outdated assessment.

See also P. Ex. 18 at 4 (in which Unit Manager Bumford explains that she “personally did

not consider another suc
pathologist had assessed

assessment necessary [on August 12] since the speech

[R17] only a few days earlier and found no swallowing

problem.”). It therefore failed to implement its policies that required staff to provide R17

with the services he need

led to avoid physical harm, in violation of 42 C.F.R. § 483.13(c),

and it failed to provide him the care and services he needed to maintain his highest
practicable physical well-being in accordance with his assessment and care plan, in

violation of 42 C.F.R.
§ 483.25.8

® Petitioner also complains that CMS did not offer expert testimony about R17’s
swallowing issues. P. Post-Hr’g Br. at 2-3; P. Post-Hr’g Reply Br. at 2-7. But CMS need
14

B. The penalty imposed is reasonable.

To determine whether a CMP is reasonable, I apply the factors listed in 42 C.F.R.

§ 488.438(f): 1) the facility’s history of noncompliance; 2) the facility’s financial
condition; 3) factors specified in 42 C.F.R. § 488.404; and 4) the facility’s degree of
culpability, which includes neglect, indifference, or disregard for resident care, comfort
or safety. The absence of culpability is not a mitigating factor. The factors in 42 C.F.R.
§ 488.404 include: 1) the scope and severity of the deficiency; 2) the relationship of the
deficiency to other deficiencies resulting in noncompliance; and 3) the facility’s prior
istory of noncompliance in general and specifically with reference to the cited
deficiencies.

I consider whether the evidence supports a finding that the amount of the CMP is at a
level reasonably related to an effort to produce corrective action by a provider with the
ind of deficiencies found, and in light of the section 488.438(f) factors. I am neither
bound to defer to CMS’s factual assertions nor free to make a wholly independent choice
of remedies without regard for CMS’s discretion. Barn Hill Care Ctr., DAB No. 1848, at
21 (2002); Comty. Nursing Home, DAB No. 1807 at 22 et seq. (2002); Emerald Oaks,
DAB No. 1800 at 9 (2001); CarePlex of Silver Spring, DAB No. 1638 at 8 (1999).

Here, CMS imposed a penalty of $7,500 per-instance, which is in the middle-to-higher
range for a per-instance CMP ($1,000-$10,000) and is modest considering what CMS
might have imposed. 42 C.F.R. § 488.408(e)(1)(iv); see Plum City Care Ctr., DAB No.
2272 at 18-19 (2009) (observing that even a $10,000 per-instance CMP can be “a modest
penalty when compared to what CMS might have imposed”).

not establish that R17 had a swallowing disorder or that his inability to swallow
ultimately caused his death. The facility’s own documents unequivocally describe R17’s
swallowing problems, which put the facility on notice that he needed further assessment
and, likely, additional care. Its failure to respond violated the facility’s policies and the
regulations.

Petitioner also questions whether difficulty swallowing pills bears any relationship to
difficulty swallowing food. First, at least one nurse suggested that R17 had problems
with his pills because he was forgetting how to swallow, which would evidence a very
serious problem and require further assessment. CMS Ex. 6 at 50. Second, an adequate
assessment could have shown whether his difficulties were as limited as Petitioner now
suggests. Finally, R17’s inability to swallow apple slices on August 12, by itself, should
immediately have alerted staff to his potentially serious swallowing problems and
triggered a reassessment, regardless of his subsequent difficulties with pills.
15

Petitioner does not claim that its financial condition affects its ability to pay this
relatively small CMP.

The facility has a significant history of substantial noncompliance. In 9 out of 10 surveys
since 2001, CMS has found substantial noncompliance. “Quality-of care” (42 C.F.R.
§ 483.25) deficiencies have been cited repeatedly. CMS Ex. 4. For example:

e In 2001, the facility was not in substantial compliance with “resident assessment”
(Tags F-282 and F-279) and “quality of care” requirements (Tag F-316); the
deficiencies were isolated but with a potential for more than minimal harm;

e In 2003, the facility was not in substantial compliance with “quality of care”
requirements (Tags F-309 and F-324), and its deficiencies caused actual harm; it
was not in substantial compliance with “resident assessment” requirements (Tag
F-281), and those deficiencies were widespread with a potential for more than
minimal harm;

e In 2004, the facility was not in substantial compliance with “quality of care”
requirements (Tag F-316); the deficiencies were isolated but with the potential for
more than minimal harm;

e In 2006, the facility was not in substantial compliance with requirements
governing “staff treatment of residents” (Tags F-225 and F-226); CMS found a
pattern of noncompliance with the potential for more than minimal harm; the
facility was not is substantial compliance with “quality of care” requirements (Tag
F-309); those deficiencies were isolated but caused actual harm;

e In 2007, the facility was not in substantial compliance with the requirements for
“comprehensive assessments” (Tag F-272), and those deficiencies were isolated
but with the potential for more than minimal harm;

e In 2008, the facility was not in substantial compliance with requirements
governing “staff treatment of residents” (Tag F-226); those deficiencies were
isolated with a potential for more than minimal harm. CMS Ex. 4, at 2-5.

The facility history alone justifies the relatively low penalty.

With respect to the remaining factors, multiple staff did not recognize or chose to ignore
symptoms of a potentially serious condition — the inability to swallow — which put the
resident in immediate jeopardy. Although they had many opportunities to intervene, they
effectively ignored the multiple warning signs that occurred after August 9, taking no
action to ensure the resident’s safety. The facility is culpable for their inaction.
16

For these reasons, | find that the $7,500 per-instance CMP is reasonable.
IV. Conclusion

Petitioner was not in substantial compliance with Medicare participation requirements, 42
C.F.R. §§ 483.13(c) and 483.25. The relatively small penalty imposed — $7,500 per-
instance — is reasonable.

/s/
Carolyn Cozad Hughes
Administrative Law Judge


Department of Health and Human Services
DEPARTMENTAL APPEALS BOARD

Civil Remedies Division

Center for Tobacco Products,
Complainant,
v.
Juan Martinez d/b/a Gratz Food Market,
Respondent.

Docket No. C-12-1036
FDA Docket No. FDA-2012-H-0791

Decision No. CR2616

Date: September 18, 2012

INITIAL DECISION AND DEFAULT JUDGMENT

I enter a default judgment against Respondent, Juan Martinez d/b/a Gratz Food
Market. The Center for Tobacco Products (CTP) filed an administrative complaint
against Respondent that alleges facts and legal authority that are sufficient to
justify the imposition of a civil money penalty of $500. Respondent did not timely
answer the complaint nor did Respondent request an extension of time within
which to file an answer.

CTP began this case by serving a complaint on Respondent and by filing a copy of
the complaint with the Food and Drug Administration’s (FDA) Division of
Dockets Management. The complaint alleges that Respondent impermissibly sold
tobacco products to a minor and failed to verify the age of a person purchasing
tobacco products, violating the Federal Food, Drug, and Cosmetic Act (Act) and
its implementing regulations at 21 C.F.R. Part 1140. CTP seeks a civil money
penalty of $500.
On July 30, 2012, CTP served the complaint on Respondent by United Parcel

Service, as is provided for by 21 C.F.R. §§ 17.5 and 17.7. In the complaint and

accompanying cover letter, CTP explained that, within 30 days, Respondent

should pay the penalty, file an answer, or request an extension of time in whic’
file an answer. CTP warned Respondent that, if Respondent failed to take one
these actions within 30 days, the Administrative Law Judge could, pursuant to

to
of
21

C.F.

prop
regul

lam

penalty and the Respondent fails to answer timely or to request an extension. 21

C.F.

appropriate here, and I conclude that it is merited based on the allegations of the

R. § 17.11, issue an initial decision ordering it to pay the full amount of the
osed penalty. Respondent did not file an answer within the time provided by
ation.

required to issue a default judgment if the complaint is sufficient to justify a

R. § 17.11(a). For that reason, I decide whether a default judgment is

administrative complaint and Respondent’s failure to answer them.

For purposes of this decision, I assume that the following facts alleged in the

com]

plaint are true. Specifically:

Respondent owns a business that sells tobacco products under the name of
Gratz Food Market. The business is located at 4500 N. Gratz Street,
Philadelphia, PA 19140.

On August 17, 2011, an FDA-commissioned inspector made observations
at Respondent’s place of business that included: the sale of cigarettes or
smokeless tobacco to a minor under the age of 18 and failure to verify the
identification of the purchaser by means of photo identification containing
the bearer’s date of birth.

On November 10, 2011, CTP issued a Warning Letter to Respondent that
recited the August 17, 2011 observations. The letter informed Respondent
that the observed facts constituted violations of regulations at 21 CFR §
1140.14(a) and (b) that prohibited sales of tobacco products to individuals
under the age of 18 and that required sellers of tobacco products to verify
the age of purchasers by means of photo identification containing the
bearer’s date of birth. It advised Respondent that failure to correct the
violation could result in the imposition of a civil money penalty or other
regulatory action by FDA.

The Warning Letter was delivered to Respondent. On February 13, 2012,
Respondent replied to the Warning Letter. Respondent acknowledged that
he was the owner of Gratz Food Market. Respondent asserted that he had
reiterated the rules and regulations governing sale of tobacco products to all
of his employees. He asserted, additionally, that he and his employees
would in the future check purchasers for proper identification of age.

e¢ On March 30, 2012, at about 3:02 p.m., an inspector observed a minor
under the age of 18 buy a package Newport Non-Menthol cigarettes at
Respondent’s place of business. Additionally, the inspector observed that
the minor’s identification was not verified before the sale by means of
photo identification containing the bearer’s date of birth.

These facts establish that Respondent is liable under the Act. The Act prohibits
misbranding of a tobacco product. 21 U.S.C. § 331(k). A tobacco product is
misbranded if sold or distributed in violation of regulations issued under section
906(d) of the Act. 21 U.S.C. § 387c(a)(7)(B); 21 C.F.R § 1140(b). Under 21
C.F.R. § 1140.14(a), no retailer may sell cigarettes or smokeless tobacco to any
person younger than 18 years of age. Under 21 C.F.R. § 1140.14(b)(1), a retailer
must verify, by means of photo identification containing the bearer’s date of birth,
that no person purchasing the tobacco product is younger than 18 years of age.

Here, Respondent sold tobacco products to individuals younger than age 18 on
two occasions, on August 17, 2011 and March 30, 2012. On both occasions,
Respondent failed to verify the age of the purchaser. These actions and omissions
by Respondent constitute a violation of law for which a civil money penalty is
merited. Therefore, I find that a civil money penalty of $500 is permissible under
21 C.F.R. § 17.2

/s/
Steven T. Kessel
Administrative Law Judge


Department of Health and Human Services
DEPARTMENTAL APPEALS BOARD

Civil Remedies Division

Center for Tobacco Products,
Complainant,
v.
Jean Gervais d/b/a Papi’s Mini Market,
Respondent.

Docket No. C-12-973
FDA Docket No. FDA-2012-H-0718

Decision No. CR2605

Date: August 31, 2012

INITIAL DECISION AND DEFAULT JUDGMENT

I enter a default judgment against Respondent, Jean Gervais d/b/a Papi’s
Mini Market. The Center for Tobacco Products (CTP) filed an
administrative complaint against Respondent that alleges facts and legal
authority that are sufficient to justify the imposition of a civil money penalty
of $500. Respondent did not timely answer the complaint nor did he request
an extension of time within which to file an answer.

CTP began this case by serving a complaint on Respondent and by filing a
copy of the complaint with the Food and Drug Administration’s (FDA)

Division of Dockets Management. The complaint alleges that Respondent
impermissibly sold tobacco products to a minor and failed to verify the age
of a person purchasing tobacco products, violating the Federal Food, Drug,
and Cosmetic Act (Act) and its implementing regulations at 21 C.F.R. Part
1140. CTP seeks a civil money penalty of $500.

On June 29, 2012, CTP served the complaint on Respondent by United
Parcel Service, as is provided for by 21 C.F.R. §§ 17.5 and 17.7. In the
complaint and accompanying cover letter, CTP explained that, within 30
days, Respondent should pay the penalty, file an answer, or request an
extension of time in which to file answer. CTP warned Respondent that, if it
failed to take one of these actions within 30 days, the Administrative Law
Judge could, pursuant to 21 C.F.R. § 17.11, issue an initial decision ordering
it to pay the full amount of the proposed penalty. Respondent did not file an
answer within the time provided by regulation.

lam required to issue a default judgment if the complaint is sufficient to
justify a penalty and the Respondent fails to answer timely or to request an
extension. 21 C.F.R. § 17.11(a). For that reason, I decide whether a default
judgment is appropriate here, and I conclude that it is merited based on the
allegations of the administrative complaint and Respondent’s failure to
answer them.

For purposes of this decision, I assume that the following facts alleged in the
complaint are true. Specifically:

e Respondent owns an establishment that sells tobacco products and
which does business as Papi’s Mini Market. The business is located
at 4201 Germantown Avenue, Philadelphia, PA, 19140.

e On June 30, 2011, an FDA-commissioned inspector made
observations at Respondent’s place of business that included: sale of
cigarettes or smokeless tobacco to a minor under the age of 18; and
failure by him to identify by means of photographic identification,
containing the bearer’s date of birth, that no person purchasing
cigarettes or smokeless tobacco was younger than 18 years of age.

e On September 22, 2011, CTP issued a Warning Letter to Respondent
that recited the June 30, 2011, observations. The letter informed
Respondent that the observed facts constituted violations of
regulations at 21 C.F.R. §§ 1140.14(a) and (b)(1) that prohibited sales
of tobacco products to individuals under the age of 18 and that
required verification of age of purchasers of tobacco products. It
advised him that failure to correct the violations could result in the
imposition of a civil money penalty or other regulatory action by
FDA.

e The Warning Letter was delivered to Respondent. Respondent did not
reply to it.

e On February 23, 2012, at about 2:30 p.m., an inspector observed a
minor under the age of 18 buy a package of Newport Non-Menthol
Box Cigarettes at Respondent’s place of business.

e On February 29, 2012, an inspector observed Respondent or its
employee sell individual (unpackaged) cigarettes.

These facts establish that Respondent is liable under the Act. The Act
prohibits misbranding of a tobacco product. 21 U.S.C. § 331(k). A tobacco
product is misbranded if sold or distributed in violation of regulations issued
under section 906(d) of the Act. 21 U.S.C. § 387c(a)(7)(B); 21 C.F.R

§ 1140(b). Under 21 C.F.R. § 1140.14(a), no retailer may sell cigarettes or
smokeless tobacco to any person younger than 18 years of age. Under 21
C.F.R. § 1140.14(b)(1), a retailer must verify, by means of photo
identification containing the bearer’s date of birth, that no person purchasing
the tobacco product is younger than 18 years of age. Under 21 C.F.R.

§ 1140.14(d), a retailer may not sell individual cigarettes.

Here, Respondent sold tobacco products to individuals younger than age 18
on two occasions, on June 30, 2011, and February 23, 2012. On June 30,
2011, Respondent failed to verify the age of the purchaser. On February 29,
2012, Respondent sold unpackaged cigarettes. These actions and omissions
by Respondent constitute a violation of law for which a civil money penalty
is merited. Therefore, I find that a civil money penalty of $500 is
permissible under 21 C.F.R. § 17.2.

/s/
Steven T. Kessel
Administrative Law Judge


Department of Health and Human Services
DEPARTMENTAL APPEALS BOARD

Civil Remedies Division

Center for Tobacco Products,
Complainant,
v.
Pamela Antonetty d/b/a Bodega 24,
Respondent.
Docket No. C-12-946
FDA Docket No. FDA-2012-H-0704
Decision No. CR2604

Date: August 31, 2012

INITIAL DECISION AND DEFAULT JUDGMENT

I enter a default judgment against Respondent, Pamela Antonetty d/b/a
Bodega 24. The Center for Tobacco Products (CTP) filed an administrative
complaint against Respondent that alleges facts and legal authority that are
sufficient to justify the imposition of a civil money penalty of $2,000.
Respondent did not timely answer the complaint nor did she request an
extension of time within which to file an answer.

CTP began this case by serving a complaint on Respondent and by filing a
copy of the complaint with the Food and Drug Administration’s (FDA)
Division of Dockets Management. The complaint alleges that Respondent
impermissibly sold tobacco products to a minor, violating the Federal Food,
Drug, and Cosmetic Act (Act) and its implementing regulations at 21 C.F.R.
Part 1140. CTP seeks a civil money penalty of $2,000.

On July 13, 2012, CTP served the complaint on Respondent by United
Parcel Service, as is provided for by 21 C.F.R. §§ 17.5 and 17.7. In the
complaint and accompanying cover letter, CTP explained that, within 30
days, Respondent should pay the penalty, file an answer, or request an
extension of time in which to file answer. CTP warned Respondent that, if it
failed to take one of these actions within 30 days, the Administrative Law
Judge could, pursuant to 21 C.F.R. § 17.11, issue an initial decision ordering
it to pay the full amount of the proposed penalty. Respondent did not file an
answer within the time provided by regulation.

lam required to issue a default judgment if the complaint is sufficient to
justify a penalty and the Respondent fails to answer timely or to request an
extension. 21 C.F.R. § 17.11(a). For that reason, I decide whether a default
judgment is appropriate here, and I conclude that it is merited based on the
allegations of the administrative complaint and Respondent’s failure to
answer them.

For purposes of this decision, I assume that the following facts alleged in the
complaint are true. Specifically:

e Respondent owns an establishment that sells tobacco products and
which does business as Bodega 24. The business is located at 154
High Street, Holyoke, MA 01040.

e On April 27, 2011, an FDA-commissioned inspector made
observations at Respondent’s place of business consisting of: sale of
cigarettes or smokeless tobacco to a minor under the age of 18; and
failure to identify the age of an individual through photographic
identification.

e On July 14, 2011, CTP issued a Warning Letter to Respondent that
recited the April 27, 2011, observations. The letter informed
Respondent that the observed facts constituted violations of
regulations at 21 C.F.R. §§ 1140.14(a) and 1140.14(b) that prohibited
sales of tobacco products to individuals under the age of 18 and that
required verification of age of purchasers of tobacco products. It
advised Respondent that failure to correct the violations could result
in the imposition of a civil money penalty or other regulatory action
by FDA.

e The Warning Letter was delivered to Respondent. On July 27, 2011,
Respondent replied to the warning letter. Respondent stated that she
would prevent future violations by training Respondent’s employees
regarding the sale of tobacco products

e On February 25, 2012, at about 12:45 p.m. ET, an inspector observed
a minor under the age of 18 buy a package of Marlboro 100’s
cigarettes at Respondent’s place of business. Respondent or her
employees failed to verify the purchaser’s age by photographic
identification. Furthermore, Respondent or her employees sold
individual (unpackaged) cigarettes.

These facts establish that Respondent is liable under the Act. The Act
prohibits misbranding of a tobacco product. 21 U.S.C. § 331(k). A tobacco
product is misbranded if sold or distributed in violation of regulations issued
under section 906(d) of the Act. 21 U.S.C. § 387c(a)(7)(B); 21 C.F.R §
1140(b). Under 21 C.F.R. § 1140.14(a), no retailer may sell cigarettes or
smokeless tobacco to any person younger than 18 years of age. Under 21
C.F.R. § 1140.14(b), a retailer must verify a purchaser’s age by means of
photographic identification. Under 21 C.F.R. § 1140.14(d), a retailer must
not sell individual cigarettes.

Here, Respondent sold tobacco products to individuals younger than age 18
on two occasions, on April 27, 2011, and February 25, 2012. On both of
these occasions Respondent failed to verify the age of the purchaser through
photographic identification. On February 25, 2012, Respondent sold
cigarettes individually. These actions and omissions by Respondent
constitute a violation of law for which a civil money penalty is merited.
Therefore, I find that a civil money penalty of $2,000 is permissible under
21 C.F.R. § 17.2.

/s/
Steven T. Kessel
Administrative Law Judge


Department of Health and Human Services
DEPARTMENTAL APPEALS BOARD

Civil Remedies Division

Center for Tobacco Products,
Complainant,
v.
Pastor Ledesma d/b/a El Ruvio Grocery and/or Antonia’s Groceries,
Respondent.

Docket No. C-12-990
FDA Docket No. FDA-2012-H-0740

Decision No. CR2603

Date: August 31, 2012

INITIAL DECISION AND DEFAULT JUDGMENT

I enter a default judgment against Respondent, Pastor Ledesma d/b/a El
Ruvio Grocery and/or Antonia’s Groceries. The Center for Tobacco
Products (CTP) filed an administrative complaint against Respondent that
alleges facts and legal authority that are sufficient to justify the imposition of
a civil money penalty of $250. Respondent did not timely answer the
complaint nor did he request an extension of time within which to file an
answer.

CTP began this case by serving a complaint on Respondent and by filing a
copy of the complaint with the Food and Drug Administration’s (FDA)
Division of Dockets Management. The complaint alleges that Respondent
impermissibly sold tobacco products to a minor, violating the Federal Food,
Drug, and Cosmetic Act (Act) and its implementing regulations at 21 C.F.R.
Part 1140. CTP seeks a civil money penalty of $250.

On July 13, 2012, CTP served the complaint on Respondent by United
Parcel Service, as is provided for by 21 C.F.R. §§ 17.5 and 17.7. In the
complaint and accompanying cover letter, CTP explained that, within 30
days, Respondent should pay the penalty, file an answer, or request an
extension of time in which to file answer. CTP warned Respondent that, if
he failed to take one of these actions within 30 days, the Administrative Law
Judge could, pursuant to 21 C.F.R. § 17.11, issue an initial decision ordering
him to pay the full amount of the proposed penalty. Respondent did not file
an answer within the time provided by regulation.

I am required to issue a default judgment if the complaint is sufficient to
justify a penalty and the Respondent fails to answer timely or to request an
extension. 21 C.F.R. § 17.11(a). For that reason, I decide whether a default
judgment is appropriate here, and I conclude that it is merited based on the
allegations of the administrative complaint and Respondent’s failure to
answer them.

For purposes of this decision, I assume that the following facts alleged in the
complaint are true. Specifically:

e Respondent owns an establishment that sells tobacco products and
which does business as El Ruvio Grocery and/or Antonia’s Groceries.
The business is located at 2066 North 2™ Street, Philadelphia, PA,
19122.

e On August 17, 2011, an FDA-commissioned inspector made
observations at Respondent’s place of business that included: sale of
cigarettes or smokeless tobacco to a minor under the age of 18; and
failure by him to identify by means of photographic identification,
containing the bearer’s date of birth, that no person purchasing
cigarettes or smokeless tobacco was younger than 18 years of age.

e On November 17, 2011, CTP issued a Warning Letter to Respondent
that recited the August 17, 2011, observations. The letter informed
Respondent that the observed facts constituted violations of
regulations at 21 C.F.R. §§ 1140.14(a) and (b)(1) that prohibited sales
of tobacco products to individuals under the age of 18 and that
required verification of age of purchasers of tobacco products. It
advised him that failure to correct the violations could result in the
imposition of a civil money penalty or other regulatory action by
FDA.

e The Warning Letter was delivered to Respondent. Respondent did not
reply to it.

e On March 30, 2012, at about 5:01 p.m., an inspector observed a minor
under the age of 18 buy a package of Newport Box Cigarettes at
Respondent’s place of business.

These facts establish that Respondent is liable under the Act. The Act
prohibits misbranding of a tobacco product. 21 U.S.C. § 331(k). A tobacco
product is misbranded if sold or distributed in violation of regulations issued
under section 906(d) of the Act. 21 U.S.C. § 387c(a)(7)(B); 21 C.F.R. §
1140(b). Under 21 C.F.R. § 1140.14(a), no retailer may sell cigarettes or
smokeless tobacco to any person younger than 18 years of age. Under 21
C.F.R. § 1140.14(b)(1), a retailer must verify, by means of photo
identification containing the bearer’s date of birth, that no person purchasing
the tobacco product is younger than 18 years of age.

Here, Respondent sold tobacco products to individuals younger than age 18
on two occasions, on August 17, 2011, and March 30, 2012. On August 17,
2011, Respondent failed to verify the age of the purchaser. These actions
and omissions by Respondent constitute a violation of law for which a civil
money penalty is merited. Therefore, I find that a civil money penalty of
$250 is permissible under 21 C.F.R. § 17.2.

/s/
Steven T. Kessel
Administrative Law Judge


Department of Health and Human Services
DEPARTMENTAL APPEALS BOARD

Civil Remedies Division

Center for Tobacco Products,
Complainant,
v.
Jing Sheng Liu d/b/a New China,
Respondent.

Docket No. C-12-899
FDA Docket No. FDA-2012-H-0679

Decision No. CR2602

Date: August 24, 2012

INITIAL DECISION AND DEFAULT JUDGMENT

I enter a default judgment against Respondent, Jing Sheng Liu d/b/a New China.
The Center for Tobacco Products (CTP) filed an administrative complaint against
Respondent that alleges facts and legal authority that are sufficient to justify the
imposition of a civil money penalty of $500. Respondent did not timely answer
the complaint nor did he request an extension of time within which to file an
answer.

CTP began this case by serving a complaint on Respondent and by filing a copy of
the complaint with the Food and Drug Administration’s (FDA) Division of
Dockets Management. The complaint alleges that Respondent impermissibly sold
tobacco products to a minor and failed to verify the age of a person purchasing
tobacco products, violating the Federal Food, Drug, and Cosmetic Act (Act) and
its implementing regulations at 21 C.F.R. Part 1140. CTP seeks a civil money
penalty of $500.
On July 2, 2012, CTP served the complaint on Respondent by United Parcel
Service, as is provided for by 21 C.F.R. §§ 17.5 and 17.7. In the complaint and
accompanying cover letter, CTP explained that, within 30 days, Respondent
should pay the penalty, file an answer, or request an extension of time in which to
file answer. CTP warned Respondent that, if he failed to take one of these actions
within 30 days, the Administrative Law Judge could, pursuant to 21 C.F.R.
§ 17.11, issue an initial decision ordering him to pay the full amount of the
proposed penalty. Respondent did not file an answer within the time provided by
regulation.

I am required to issue a default judgment if the complaint is sufficient to justify a
penalty and the Respondent fails to answer timely or to request an extension. 21
C.F.R. § 17.11(a). For that reason I decide whether a default judgment is
appropriate here, and I conclude that it is merited based on the allegations of the
administrative complaint and Respondent’s failure to answer them.

For purposes of this decision, I assume that the following facts alleged in the
complaint are true. Specifically:

e Respondent owns an establishment that sells tobacco products and which
does business as New China. The business is located at 1620 West Olney
Avenue, Philadelphia, PA, 19141.

e¢ On July 23, 2011, an FDA-commissioned inspector made observations at
Respondent’s place of business that included: sale of cigarettes or
smokeless tobacco to a minor under the age of 18; and failure by him to
identify by means of photographic identification, containing the bearer’s
date of birth, that no person purchasing cigarettes or smokeless tobacco was
younger than 18 years of age.

¢ On October 6, 2011, CTP issued a Warning Letter to Respondent that
recited the July 23, 2011, observations. The letter informed Respondent
that the observed facts constituted violations of regulations at 21 C.F.R.
§§ 1140.14(a) and (b)(1) that prohibited sales of tobacco products to
individuals under the age of 18 and that required verification of age of
purchasers of tobacco products. It advised him that failure to correct the
violations could result in the imposition of a civil money penalty or other
regulatory action by FDA.

e The Warning Letter was delivered to Respondent. Respondent did not
reply to it directly. However, an individual who identified herself as
Angela Cheung responded by telephone on Respondent’s behalf on
November 17, 2011. Subsequently, on November 28, 2011, Respondent
sent a letter to CTP, and in that letter he stated that Respondent would
comply with the requirements of the law.

e¢ On March 26, 2012, at about 4:48 p.m., an inspector observed a minor
under the age of 18 buy a package of Newport Box 100s cigarettes at
Respondent’s place of business. Additionally, the inspector observed that
the minor’s identification was not verified before the sale.

These facts establish that Respondent is liable under the Act. The Act prohibits
misbranding of a tobacco product. 21 U.S.C. § 331(k). A tobacco product is
misbranded if sold or distributed in violation of regulations issued under section
906(d) of the Act. 21 U.S.C. § 387c(a)(7)(B); 21 C.F.R § 1140(b). Under 21
C.F.R. § 1140.14(a), no retailer may sell cigarettes or smokeless tobacco to any
person younger than 18 years of age. Under 21 C.F.R. § 1140.14(b)(1), a retailer
must verify, by means of photo identification containing the bearer’s date of birth,
that no person purchasing the tobacco product is younger than 18 years of age.

Here, Respondent sold tobacco products to individuals younger than age 18 on
two occasions, on July 23, 2011, and March 26, 2012. On both occasions
Respondent failed to verify the age of the purchaser. These actions and omissions
by Respondent constitute a violation of law for which a civil money penalty is
merited. Therefore, I find that a civil money penalty of $500 is permissible under
21 CFR. § 17.2.

/s/
Steven T. Kessel
Administrative Law Judge