United States District Court, S.D. California
MARIA FLORES, by and through her guardian, Josie Clark, Plaintiff,
THE UNITED STATES OF AMERICA, Defendant.
FINDINGS OF FACT AND CONCLUSIONS OF LAW FOLLOWING
Gonzalo P. Curiel United States District Judge
Flores, by and through her guardian Josie Clark
(“Plaintiff”), brings this action against
Defendant United States of America (“Defendant”
or “the Government”) for injuries sustained due
to an “overdose” of rivastigmine, (also known as
the “Exelon Patch, ” “the Patch, ” or
“Exelon”) a transdermal medication, that occurred
at the San Ysidro Health Center (“SYHC” or
“the Center”) located in San Diego County.
Pl.'s Trial Brief, Dkt. No. 36 at 1-2. Plaintiff asserts
that the nursing staff at SYHC committed medical negligence
when they applied an Exelon Patch to Flores without removing
a prior patch, thereby causing the “overdose.”
Id. The Court held a bench trial on June 5- 7,
2017. Alvin M. Gomez appeared on behalf of
Plaintiff and Steve B. Chu and Glen Dorgan appeared on behalf
of Defendant. Having carefully reviewed the evidence and the
arguments of the parties, as presented at trial, and in their
written submissions, the Court makes the following findings
of fact and conclusions of law pursuant to Rule 52 of the
Federal Rules of Civil Procedure.
Ysidro Health Center is an adult daycare center for patients
who require assistance with basic activities of daily living.
The Center takes care of participants Monday through Friday
from approximately 8:00 am to 5:00 pm and, depending on
enrollment, can have up to one hundred individuals in
attendance on a weekly basis. SYHC employs a number of
registered nurses, social workers, and other individuals who
together form a care team to watch over the Center's
Flores, born January 8, 1934, was living with her daughters,
Josie Clark and Leticia Reynoso (“daughters”),
prior to her enrollment at San Ysidro Health Center.
Plaintiff moved in with her daughters, who alternated
handling her care, in 2012 because she could no longer take
care of herself. She was experiencing memory problems and
would get confused easily. It was difficult for her to follow
a conversation. While living with her daughters, Flores began
wandering out of the house, into the street. To prevent any
harm resulting from such behavior, the daughters placed
deadbolts on their homes to ensure their mother would not
leave when she was not being watched over.
between the late summer and fall of 2013, the daughters
decided to enroll their mother in a caregiver program. They
looked at three different centers before deciding on SYHC.
They settled on SYHC because it had Spanish-speaking staff,
as Plaintiff only spoke Spanish, had activities for the
enrollees, and was close to Reynoso's place of work. Soon
thereafter, Flores was accepted into the SYHC program. Flores
attended the program Monday through Friday for at least four
hours per day. A bus went to the homes of the daughters to
retrieve Flores in the morning and afternoon, as she was no
longer driving in 2013.
Flores' Medical Background
Michael Lobatz, an expert in neurology, testified that the
first mention of Alzheimer's in Flores' medical
records appeared on April 29, 2011. Flores had visited her
primary care physician, Dr. Sharna Shachar, with her son who
told the doctor that his mother had short-term memory loss,
was sleeping more, was getting frustrated and forgetful, and
had become slightly paranoid and accusatory. Dr. Shachar
diagnosed Flores with dementia and prescribed her donepezil
to ameliorate the symptoms.
two years later, Flores saw Dr. Roberto Gratianne, a
neurologist, on February 18, 2013. Joint Exhibit 17-024. Dr.
Gratianne's medical records indicate that Flores
presented herself to him for an evaluation of her memory
loss. At that time, she had a history of progressive dementia
that had started back in 2008 and that had been diagnosed in
2010. She required constant supervision and help with
self-care. Dr. Gratianne's contemporaneous records also
indicate that Flores was exhibiting behavioral problems as
she thought her son was her husband. In fact and according to
Dr. Lobatz, Flores' primary care physician, Dr. Shachar,
had prescribed Flores an antipsychiatric tranquilizer, called
risperdal, at around the time she began to see Dr. Gratianne.
Lobatz testified that Dr. Gratianne performed a standard
cognitive evaluation of Flores called the Mini Mental Status
Examination (“MMSE”). The MMSE has a total score
of 30 points. Achieving 26 points or greater would be
expected for a normally educated individual. Twenty to 26
points would be indicative of mild cognitive changes and 10
to 20 points would be indicative of moderate changes. Below
10 points indicates a severe condition. The MMSE, however,
does not test behavioral symptoms. Dr. Lobatz testified that
in individual with mild memory loss, but very bad behavior
associated with cognitive degeneration, would have a severe,
not a mild case.
scored a 13 out of 30 on the MMSE administered by Dr.
Gratianne on February 18, 2013. She scored a 12 out of 30 on
the MMSE administered by Dr. Gratianne on April 24, 2013. Dr.
Lobatz testified that the results of the April examination
alone, and not including any behavioral symptoms, indicated
that Flores had significant moderate dementia approaching
severe. A third MMSE was administered to Flores by Dr.
Gratianne in July 2013. She scored an 11 out of 30 on that
test. According to Dr. Lobatz, that the July score was
similar to the April score validated the abnormalities
recorded by the April MMSE.
Gratianne diagnosed Flores with Alzheimer's at her
February 2013 appointment. He subsequently examined her in
April 2013, June 2013, July 2013, August 2013, November 2013,
and on January 4, 2014. According to Dr. Gratianne's
November 2013 records, Flores was not doing well. She had
worsening balance, gait and mental status. She was also
having occasional hallucinations. According to Dr.
Gratinanne's January 4, 2014 records, Flores arrived in a
wheelchair and needed total care and constant supervision at
also assessed Flores at the time of her enrollment. Dr.
Lobatz testified that SYHC performed a somewhat similar test
called the SLUMS (St. Louis University Mental Status
Examination). Dr. Lobatz testified that the SLUMS is more
sensitive to milder forms of early dementia, but that once an
individual has more severe symptoms, the SLUMS and MMSE start
approaching one another in terms of their sensitivity. On
average, Dr. Lobatz testified, a SLUMS score is about 4.5
points less than a MMSE score. Staff at SYHC performed a
SLUMS on Flores on September 25, 2013. Joint Exhibit 15-140.
She scored 4 out of 30 points on the examination, which, Dr.
Lobatz testified, is roughly equivalent to a score of 8.5 on
her MMSE and SLUMS scores, Dr. Lobatz testified that as of
September 2013, Flores was at the 8-to-10 level of the MMSE.
Dr. Lobatz testified that in September 2013 Flores'
Alzheimer's disease was very severe.
The Exelon Patch
November 21, 2013, Dr. Roberto Gratianne prescribed Flores
Exelon, or rivastigmine, at a dosage of 4.6 mg/24 hours to
aid with her Alzheimer's symptoms. Joint Exhibit
7-001. According to SYHC's records, Flores
began taking Exelon on December 5, 2013. Joint Exhibit 4-002.
Lobatz testified that Exelon ameliorates Alzheimer's
symptoms by enhancing short term memory. Acetylcholine is a
neurotransmitter that is correlated with short term memory.
The more acetylcholine present in the brain, the better
one's memory. Dr. Lobatz testified that as acetylcholine
levels drop in Alzheimer's disease, memory worsens
gradually. Accordingly, Dr. Lobatz testified, one strategy
for treating Alzheimer's disease is to prescribe a
medication that increases the acetylcholine level within the
brain. Acetylcholine is broken down by an enzyme that
naturally occurs in the brain called cholinesterase. As such,
to increase acetylcholine levels to help memory, doctors
prescribe cholinesterase inhibitors, which prevent the acetyl
cholinesterase enzyme from breaking down acetylcholine.
Rivastigmine is a cholinesterase inhibitor. The drug was
first developed as an oral medication and later developed as
a transdermal patch.
Lobatz testified that the Exelon Patch is dosed initially at
4.6 mg per 24 hours. When an Alzheimer patient begins
therapy, he or she starts at the lowest possible dose, which
is 4.6 mg per 24 hours. If the individual is tolerating the
medication, the effective dose is increased to 9.5 mg per 24
hours. Dr. Lobatz testified that there was nothing in
Flores' medical records prior to January 7, 2014 to
indicate that Flores was not tolerating the medication.
Richard Clark, an expert in toxicology, testified that the
Exelon Patch is similar to a small Band-Aid that has a
reservoir of the drug impregnated within it. The drug
diffuses into the skin surface and then into the fat level
right below the skin. As the drug diffuses into the fat, it
is slowly absorbed by the blood vessels travelling through
the skin, which then distribute the drug throughout the body.
The Patch dispenses the drug throughout the 24 hours that it
Date of Incident
medical records indicate that, as of January 7, 2014, Flores
was taking two oral medications per day: Namenda for her
dementia and Citalopram, an antidepressant. Those records
also indicate that Flores was contemporaneously receiving
rivastigmine through the Exelon Patch once per day. SYHC was
responsible for applying the Patch and administering her
other medications, Monday through Friday. Over the weekends,
the daughters would administer their mother's medication,
including the transdermal Exelon Patch.
Tuesday, January 7, 2014, Flores arrived at the Center.
Flores used a walker at the Center to assist her with
ambulating. Registered nurses Alejandro Florez, Shirley
Roman, and Claudia Gonzalez were all present at SYHC that
morning. Absent from the roster was Yessica Toscano, the
individual who dispenses medication to the Center's
participants on a daily basis. Because Toscano was not
working that day, the other floor nurses, Florez, Roman, and
Gonzalez, were responsible for performing Toscano's
duties. According to Flores' Medication Administration
Record, Flores received the Exelon Patch at 10:00 am each
morning. Joint Exhibit 15-074.
floor nurses had trouble locating the bottle containing
Flores' Citalopram medication on the morning of January
7, 2014. As a result, Gonzalez called Clark at 10:21 am to
report that staff could not find Flores' medication and
that the daughters needed to bring some. Joint Trial Exhibit
19-001. A few minutes afterwards, at 10:28 am, Clark called
Reynoso, her sister, about the missing medication.
the report about Flores' medication, Reynoso headed to
the Center and arrived late morning, before noon. Reynoso
recalls that she arrived at the Center before noon because
she was late to go on a lunch date with her husband, which
they had scheduled around noon. When she arrived at the
facility, the staff told her that they had already found
Flores' medication and already administered it to
While at the Center, Reynoso observed that her mom was
“restrained” in a seated position and that she
did not have her walker. Seeing her mother in this state
upset Reynoso. She found another walker somewhere in the
facility, unbuckled her mom, and watched her for a while.
Sometime thereafter she left to have lunch with her husband
had administered Flores' medication that day. Roman first
gave Flores her Namenda. Next, she turned to Flores'
transdermal medication. Roman consulted Flores' Medical
Administrative Record, Joint Exhibit 15-074, to determine
where Gonzalez had administered Flores' Exelon Patch the
previous day. As Roman tried to administer the medication to
Flores' back, Flores tried to hit Roman with her elbows.
She had become agitated after taking the Namenda. Roman did
not visualize Flores' skin before removing and placing
the new Exelon Patch. Instead, she used her hands to feel for
the previous day's patch. Roman testified that she
removed a patch from Flores' right upper back. She placed
the old patch on her glove and noticed that there was a long
white hair on it. She testified that she specifically recalls
removing a patch because she felt bad because she thought she
had pulled a hair from Flores' head.
testified at her deposition that she administered Flores her
medications soon after 11:00 am. At trial, however, Roman
testified that she gave Flores her medication closer to 1:00
pm than 12:00 pm. She stated that only fifteen or so minutes
had passed between the time that she administered Flores her
medication and the time that Flores began vomiting, which was
between 1:00 pm and 1:15 pm, approximately. Roman states that
she recalls that the vomiting began fifteen minutes after she
administered Flores' medication because she had
specifically thought that Flores must have been throwing up
the oral medication. The Court, however, finds that
Roman's deposition testimony is more credible than her
trial testimony given that it was taken closer in time to the
incident - that is, on February 19, 2016, more than fifteen
months prior to her trial testimony - and because it
coincides with the testimony provided by Reynoso, which
indicated that Flores had received her medication prior to
noon. Accordingly, the Court finds that Flores received her
prescribed dose of Exelon at approximately 11:00 am.
thereafter, at around 1:00 pm, Flores became nauseous and
began to vomit. Before 1:00 pm, Gonzalez had noticed that
Flores appeared pale, cold, and clammy. Around 1:00 pm,
Gonzalez realized that Flores was not well. Gonzalez observed
Flores sitting in a chair with vomit in her lap. Gonzalez
instructed a Certified Nursing Assistant (CNA) to get the
vital machine to check Flores. Once the CNA returned with the
vital machine, Gonzalez began to measure her signs. Gonzalez
observed that Flores was conscious but that she had begun to
slouch on the side of her chair. She noticed that Flores was
sweating and that she had stopped vomiting. When Gonzalez
could not pick up a pulse anymore, she asked the CNA to call
to the Comprehensive Report of the Paramedics, they received
a call at 1:20 pm for a patient in cardiac arrest and they
arrived at 1:23 pm. Joint Exhibit 9. Upon arrival at the
Center, the paramedics found Flores laying on the floor on
her back. The paramedics reported that Flores was
nonresponsive, cold, pale and dry. Flores was PEA, meaning
she had pulseless electrical activity. She was also suffering
from bradycardia, a slow heart rate, as her heart was beating
at 30 bpm (beats per minute). The paramedics proceeded to
perform CPR. Flores remained PEA until she was intubated. Dr.
Barnard testified that Flores had, indeed, experienced
cardiac arrest given that she required resuscitation to
regain her vital signs.
Flores was intubated, her heart rate increased from 30 bpm to
132 bpm. The patient remained intubated and unresponsive en
route to the hospital. Both of Flores' daughters, along
with Flores' granddaughter Yolanda Clark, were onsite
while the paramedics were present. They had arrived after
9-1-1 was called. Josie Clark testified that when she arrived
at the Center she observed vomit everywhere and that her
mother was on her back.
was taken to Sharp Chula Vista Hospital for treatment. Joint
Exhibit 13-259 - 13-511. While at the hospital and after
discussing Flores' DNR (Do Not Resuscitate) status, the
daughters decided to remove their mother's breathing
tube, believing that she would die. Joint Exhibit 13-260.
Flores' other children were present at her bedside
because the daughters had called to inform them of their
mother's state. Hospital staff removed Flores'
breathing tubes. Flores started gasping and made an
unexpected recovery. Dr. Robert Clark, the Government's
expert in toxicology, reviewed the ...