October
October

2, 2017
201 7

2,

Les Weisbrod
Weisbrod
Miller Weisbrod
Weisbrod LLP
Miller
11551
Dr. Ste.
300
11551 Forest
Forest Central
Ste. 300
Central Dr.
Dallas, TX 75243
75243
Dallas,
Dear
Dear Mr.
Weisbrod:
Mr. Weisbrod:
Thank you
you for
opportunity to
to review
review the
for giving
giving me the
the opportunity
the records
records of
of Jesus
Jesus Guzman regarding
regarding
his
care and
to his
surgery in
his care.
and treatment
treatment related
related to
his cataract
cataract surgery
in February
2017.
Febmary 2017.
is Wesley K.
as an
K. Herman,
physician practicing
practicing in
an
Dallas, Texas as
a physician
in Dallas,
Herman, M.D. II am a
My name is
ophthalmic
since 1981.
comeal and
fellowship-trained corneal
ophthalmic microsurgeon
microsurgeon since
1981. II am a
a fellowship-trained
and anterior
anterior segment
segment
refractive surgeon
certified as
vision correction
correction specialist
and cataract
cataract surgery.
refractive
surgeon certified
as a
a laser
laser vision
in comeal
corneal and
specialist in
surgery.

Science thesis
in Biochemistry
Bachelor of
of Science
thesis was in
undergraduate Honors Program Bachelor
with
Biochemistry with
My undergraduate

a double
Bachelor of
of North
Dakota.
a
double major
in Humanities
Humanities with
with a
a Bachelor
from the
the University
major in
Arts from
North Dakota.
0f Arts
University of
at the
While obtaining
obtaining my Doctor
While
Medicine Degree at
School
Doctor of
of Medicine
the University
University ofNorth Dakota School
in Grand
ofMedicine
Grand Forks,
Nmih Dakota,
I
also
studied
as
a
special
third
year
student
in
Clinical
student
also
studied
Medicine in
0f
as
Special
third
Clinical
Forks, North
I
a
in
Dakota,
year
Medicine at
University of
Medicine
at the
the University
of Minnesota
Minnesota School
School of
of Medicine.
Medicine. During
During my fomih
fourth year
studied
year II studied
and General
Plastic Surgery
at Stanford
Ophthalmology and
and Ophthalmic
Ophthalmic Plastic
Plastic surgery
General Plastic
Stanford University
University
Ophthalmology
Surgery at
surgery and
Medical
Center as
student. Thereafter,
Thereafter, II completed
completed an
Medicine Residency
special student.
Medical Center
as a
a special
an Emergency Medicine
Residency
Intemship
at Hennepin County
County Medical
Minnesota before
before completing
completing aa
Iniemship at
Medical Center
Center in
in Minneapolis,
Minneapolis, Minnesota
three
year Ophthalmology
& Ophthalmic
Ophthalmic
three year
and a
a Fellowship
Fellowship in
in Comea,
External Disease
Disease &
Ophthalmology Residency
Cornea, Extemal
Residency and
Microsurgery
at the
the University
Minnesota Graduate
of Minnesota
Graduate Medical
Medical School.
School. Il am a
a Member of
of the
the
Microsurgery at
University of
of Ophthalmology
and
the
American
Society
of
Cataract
and
Refractive
American Academy of
the
Cataract
Refractive
Ophthalmology
Society of
Surgery.
Surgery.
Since
the founding
practice, Vision
Quest, II have
inception of
founding and
limited my services
Since the
0f my practice:
services
Vision Quast,
have limited
and inception
to
and refractive
consultation for
anterior
cataract and
and to
restorative anterior
refractive surgery,
t0 comeal,
to consultation
for visually
corneal, cataract
visually restorative
surgery, and
segment surgery
surgery with
with specific
attention to
potential. This
This has
has
specific attention
t0 structural
structural and
and functional
functional macular
macular potential.
been
been my career
career interest
interest and
and passion.
passion.
In
extensive experience
as an
ophthalmic microsurgeon,
microsurgeon, and specifically
in January
In my extensive
experience as
an ophthalmic
specifically in
January
and Febuary
2017,
I
have
treated
and
managed
patients
suffering
from
the
same
signs
treated
patients suffering
the
signs and
February 2017, I
symptoms
at my first
in July
July 2017.
Mr. Jesus
Jesus Guzman presented
presented with
with at
first consultation
consultation in
201 7. Not only
symptoms which Mr.
only
corneal
I
care
for
other
censultation
perform
provide
do
I
perform
comeal
and
cataract
surgeries
but
I
also
provide
care
and
consultation
for
other
also
but
and
Surgeries
cataract
and
d0 I
surgeons and
and/or revision
cataract and
and their
their patients
patients requiring
requiring reconstructive
after complicated
complicated cataract
and
reconstructive and/or
revision after
surgeons
other comeal
other
corneal procedures.
procedures.
I regularly
regularly examine
with environmentally
environmentally toxic
toxic and
and chemical
as well
chemical issues,
well
patients with
examine patients
issues, as
apatients
prescribed medications
ocular tissues.
a regular
apalients on
0n prescribed
medications potentially
toxic to
t0 several
several ocular
tissues. I
I am a
regular
potentially toxic
consulting
for patients
consulting physician
patients of
0f the
the Environmental
Environmental Health
Health Center
Center in
in Dallas.
Dallas. Specifically,
in
physician for
Specifically, in
I

Plaintiffs' Notice of Filing Expert Reports - Page 4 of 70

 July of2017
and treatment
retinal
experienced retinal
0f 20 l7 and
and currently,
provide care
care and
treatment for
for patients
patients who have experienced
currently, II provide
July
toxic
toxic events.
events.
full-time practice,
Currently,
and in
daily, full-time
in July
as part
part of
of my daily,
utilize injectable
injectable
practice, II utilize
Currently. and
2017, as
July 2017,
f01mulations
pcst-surgical patients.
formulations for
for my surgical
surgical and post-surgical
patients. These injectable
injectable f01mulations
formulations include
include
compounded Moxifloxacin
(Tri-Moxi). II interact
interact with
with compounding
Triamcinolone (Tri-Moxi).
and Triamcinolone
Moxifloxacin and
pha1macies
and II am familiar
related to
to the
the
familiar with
requirements of compounding phmmacies
pharmacies related
pharmacies and
the requirements
with the
of compounded ophthalmic
ophthalmic products
provision of
provision
products including
including Moxifloxacin
Moxifloxacin and Triamcinolone
Triamcinolone (Tri(TriMoxi).
with the
familiar With
the standard
0f care
care for
for a
a compounding phmmacist
pharmacist such
such as
as Jack
Jack
standard of
Moxi). Thus,
Thus, II am familiar
Munn and
as Guardian
of my
because of
Guardian Phmmacy.
and for
for the
the compounding pharmacy
such as
Likewise, because
Pharmacy. Likewise,
pharmacy such
extensive
experience utilizing
treating patients
patients with
with retinal
toxic events
events and
retinal toxic
extensive experience
utilizing such
such compounds, and treating
fi'om retinal
their
their sequalae,
familiar with
with the
cause of
0f injuries
to patients
patients who suffer
suffer from
retinal toxic
toxic
injuries to
the cause
sequalae, II am familiar
events,
familiar with
with how such injuries
injuries occur
occur and progress.
in this
this case,
progress. Further,
Further, in
events, and am familiar
case, II have
had
his condition,
candition,
had the
the opportunity
t0 personally
Mr. Guzman. II am specifically
familiar with
with his
specifically familiar
opportunity to
personally exam Mr.
the
the cause
the likely
cause of
medical probability,
future damages
reasonable medical
of his
his condition,
in reasonable
likely future
condition, and in
probability, the
suffered by
a result
his retinal
suffered
retinal toxicity.
result of his
as a
toxicity.
by him as

II can
can and
and am willing
willing to
t0 testify
conceming my qualifications,
training and
and
qualifications, education,
education, training
testify concerning
experience,
education, training,
experience into
opinions related
related
into my opinions
that education,
incorporate that
experience, and will
will incorporate
training, and experience
care that
have attached
my curriculum
to
to the
in this
curriculum
attached a copy
case. IIhave
that apply
this case.
the applicable
ofcare
applicable standards
standards of
apply in
copy of
nfmy
vitae
vitae as
as Exhibit
Exhibit A and incorporated
herein for
for all
a1] purposes.
opinions are
are based
based upon my
purposes. My opinions
incorporated herein
of relevant
education,
relevant
review 0f
and pertinent
pertinent medical
medical literature,
as well
well as
as my review
literature, as
education, training,
experience, and
training, experience,
of Jesus
medical
case will
will be
opinions in
in this
be
examination 0f
medical records,
Jesus Guzman. My opinions
personal examination
this case
records, and my personal
medical probability.
based
based upon a
a reasonable
degree of medical
reasonable degree
probability.
II have
also relied
and corresponding
corresponding report
have also
relied upon the
the expert
expert testing
testing and
repon from John Scott
Scott
Karolchuk,
is attached
as Exhibit B.
B.
attached hereto
hereto as
Karolchuk, MS, RPh,
RPh, FIACP, which is

RECORDS REVIEWED:
the time
reviewed the
records related
to this
As
of drafting
have reviewed
the following
related t0
this
following records
drafting this
0fthe
time of
this report,
report, I have
AS of
I

matter:
matter:

Medical
Medical Records
Records
(1)
(1)
(2)
(2)

Key-Whitman Eye
Center
Key—Whitman
Eye Center
Texas
Associates
Retina Associates
Texas Retina

DOS 1-18-17 to
to 5-18-17
3-21—17 to
DOS 3-21-17
to 6-1-17

Other Records
Records
(1)
(1)
(2)
(2)
' (3)
(3)
(4)
(4)
(5)
(5)

Business
MD.
Associates — Ashkan Abbey,
Retina AssociatesBusiness Card
Card from
from Texas Retina
Abbey, M.D.
Letter
Post-Operative Steroid
t0 Jesus
re: Post-Operative
Steroid Antibiotic
Antibietic
Letter from Key-Whitman to
Jesus Guzman re:
Injections
Injections
Online
Kcy—Whitman Surgery
Online Aliicle
Anicle re:
re: Medication
Medication Issue
Issue from
from Key-Whitman
Center;
Surgery Center;
Phmmacy.
FDA documents regarding
regarding October
October 2016 Guardian Pharmacy.
Expert
Scott Karolchyk,
hereto as
as
attached hereto
Expefl Rep01i
Repon of
John Scott
Karolchyk, MS, Rph,
[)f John
Rph, FIACP, attached
Exhibit
Exhibit B.
B.

Plaintiffs' Notice of Filing Expert Reports - Page 5 of 70

 have: also
II have
also been
the following
been provided
following definitions:
provided the
definitions:

“NEGLIGENCE,” when used
"NEGLIGENCE,"
with respect
respect to
the conduct
conduct of
0f Jack
Jack Munn
Mum and Guardian
Guardian
used with
t0 the
Pharmacy,
means
failure
to
use
ordinary
care,
that
is,
failing
to
do
that
which aa
means
failure
to
use
that
to
do
that
failing
ordinary
Pharmacy,
care,
is,
pharmacist/compounding
pharmacist/compounding pharmacy
0f ordinary
prudence would have
have done
done under
under the
the same
ordinary prudence
phannacy of
of
or
similar circumstances
or doing
a physician/nurse/health
care provider
provider of
circumstances or
that which a
or similar
doing that
physicianfnurse/heaith care
01'
ordinary
prudence would not
have done
done under
not have
the same or similar
similar circumstances.
circumstances.
ordinary prudence
under the
CARE,” when used
“ORDINARY CARE,"
"ORDINARY
Guardian
used with
with respect
respect to
t0 the
the conduct
conduct of
of Jack
Jack Munn
Mum and
and Guardian
Pharmacy,
care that
ordinary
ofm‘dinary
ofcare
degree of
pharmacist/compounding pharmacy
that degree
that a
a pharmacist/compounding
pharmacy of
Pharmacy, means that
use under the
the same or
or similar
similar circumstances.
prudence would use
circumstances.

“PROXLMATE CAUSE,"
CAUSE,” when used
"PROXIMATE
with respect
used with
respect to
t0 the
the conduct
conduct of
of Jack
Jack Munn and
and
Guardian
in bringing
about an
bringing about
that was a
factor in
GuaIdian Pharmacy,
a cause
cause that
a substantial
substantial factor
an
Pharmacy, means a
or injury,
or
occunence
and
without
which
cause
such
occurrence
or
injury
would
not
have
cause
Occurrence
have
not
without
ocaurrence or
such
injury
injury,
must be
occmTed. In
occurred.
In order
order to
to be
be a
a proximate
proximate cause,
the act
act or
or omission
omission complained
complained of
ofmust
be such
such
cause, the
that
ordinary care
that a
a phatmacist/compounding
using ordinary
care would have
have foreseen
foreseen that
that the
the
pharmacist/compounding pharmacy
pharmacy using
event,
or some similar
be more
similar event,
might reasonably
result therefrom.
therefrom. There
There may be
more than
than
event, or
event, might
reasonably result
one
an event.
of an
one proximate
event.
proximate cause
cause of
“GROSS NEGLIGENCE,"
"GROSS
NEGLIGENCE,“ when used
used with
with respect
respect to
t0 the
the conduct
conduct of
of Jack
Jack Munn and
and
Phatmacy,
means
an
act
or
omission,
which
when
viewed
objectively
from
the
Guardian
or
from
the
objectively
Guardian Pharmacy,
an act
omission, which
standpoint
risk,
an extreme
extreme: degree
degree of
the actor
actor at
occurrence involves
of the
at the
time of
of its
involves an
of risk,
the time
its occunence
standpoint of
considering
the probability
considering the
and magnitude
0f the
the potential
potential hatm
harm to
t0 others;
and of
of which the
the
magnitude of
probability and
others; and
actor
has actual,
the risk
nevertheless proceeds
actor has
subjective awareness
awareness of
ofthe
risk involved,
but nevertheless
proceeds with
with
involved, but
actual, subjective
01' welfare
conscious
welfare of
the rights,
others.
conscious indifference
indifference to
t0 the
of others.
rights, safety,
safety, or
BRIEF STATEMENT OF
0F RELEVANT FACTS
20] 7, Mr.
had cataract
cataract surgery
performed on his
his left
left eye
Mr. Jesus
Jesus Guzman had
On February
surgery perfmmed
February 16,
eye
16, 2017,
by
surgeon
Jeffrey
Whitman.
At
the
conclusion
of
the
procedure,
Dr.
Whitman
applied
a
common
applied a
by surgeon Jeffrey Whitman. At the conclusion ofthe procedure, Dr.
copy ofthis
injection formulation
trade name ofTri-Moxi.
formulation known by
the trade
of Tri—Moxi. An attempted
attempted copy
0f this patented
patented
injection
by the
Guardian’s
formulation
by Guardian
Guardian Health
Guardian's
product
was
injected
into
product
injected
into
formulation was
was compounded by
Health Systems.
Systems.
the eye
the cataract
the injection
injection
the
procedure. The purpose of the
the end
end of
cataract surgery
Ufthe
the vitreous
vitreous of
at the
0f the
surgery procedure.
eye at
was
post-operative prophylaxis
for ocular
ocular inflammation
inflammation and
and endophthalmitis
endophthalmitis with
with the
the
provide post-operative
prophylaxis for
was to
to provide
postexpectation
patient would not
need to
expectation that
that the
the patient
not need
lo use
use so
so many costly
and frequently
applied postfrequently applied
costly and
operative eye
operative
drops.
eye drops.
postDr.
Dr. Whitman noted
that Mr.
Mr. Guzman tolerated
tolerated the
the procedure
procedure well.
well. One week postnoted that
operatively,
on
2/24/17,
his
vision
in
the
left
eye
was
20/30-2
without
corrective
lenses
and
lenses
20/30-2 without corrective
and his
his
operatively, 0n 2/24/1 7, his vision in the left eye
acuity was
best
intra-ocular pressure
3/10/17 the
the patient
patient
20/25. His
pressure was 9.9.
9.9. On 3/10117
corrected visual
visual acuity
best cotTected
was 20/25.
His intra-ocular
was
opacity and
+11 posterior
with +
and cystoid
macular edema.
edema. His
His best
corrected
posterior capsule
capsule opacity
best conected
diagnosed with
cystoid macular
was diagnosed
visual
20/200.
visual acuity
acuity was 20/200.

Plaintiffs' Notice of Filing Expert Reports - Page 6 of 70

 Mr.
then referred
referred to
of Texas
to his
due to
his
Associates due
Mr. Guzman was then
t0 Dr.
Dr. Ashkan Abbey of
Texas Retina
Retina Associates
his cataract
cataract surgery.
of pain,
bruning, and
vision following
surgery. Mr.
Mr. Guzman
complaints 0f
decreased vision
following his
complaints
and decreased
pain, burning,
was diagnosed
diagnosed with
cystoid macular
macular edema
edema following
On March 23,
23, 2017,
cataract surgery.
the
following cataract
with cystoid
2017, the
surgery. 0n
Center sent
sent Mr.
patients) aa letter
other patients)
letter
Mr. Guzman (apparently
along with
with other
Key-Whitman Eye
(apparently along
Eye Center
of
a
problem
with
a
indicating
Center
had
become
aware
with
a
compounded
indicating that
that the
the Key-Whitman
Center
had
aware
0f
a
Key—Whitman Eye
Eye
medication utilized
by Key-Whitman.
medication
Key~Whitman.
utilized by
postour cataract
Very
recently, some of
of our
cataract surgery
patients who received
received our
our customary
customary postsurgery patients
Very recently,
2—3 weeks later.
operative
antibiotic steroid
steroid injections
visual acuity
later.
operative antibietic
injections developed
developed decreased
decreased visual
acuity 2-3
determine why this
this
investigation to
This was
an investigation
to determine
This
was unusual
unusual and
and Key-Whitman has
has opened an
occurred.
occurred.

Based
examination MI.
Mr. Guzman has
has aa very
specific retinal
toxic event
event
retina] toxic
personal examination
upon my personal
Based upon
very specific
a
which
was destroyed.
destroyed.. His
optic nerve
however,
and
he
has
a
very
small
small
has
he
and
however,
which the
the retina
retina was
His optic
newe is
is normal,
very
normal,
of functional
see light.
Sadly, within
probability, this
section
light. Sadly,
reasonable medical
medical probability,
this
within reasonable
section of
functional vision
vision that
that can
can sec
functional
improve.
never improve.
vision will
Will never
functional vision
in
in

cited for
for several
several deficiencies
deficiencies following
an October 2016
Guardian
following an
Guardian Pharmacy
Pharmacy was cited
inspection
Food and
Drug Administration.
various deficiencies
but are
are not
not
deficiencies include,
include, but
inspection from
from the
the Food
and Drug
Administration. The various
limited
dispensation of
of drug
products, and
operating
failure to
to document the
the dispensation
drug products,
and operating
limited to,
issues, failure
sterilization issues,
t0, sterilization
materials to
of equipment and
and materials
in
adequate space
space for
a facility
that lacks
lacks adequate
for the
the orderly
placement of
t0
orderly placement
in a
facility that
prevent mix-ups between
between drug
and to
contamination.
prevent
drug products
products and
t0 prevent
prevent contamination.
01‘ injection,
of intraocular
(toxic anterior
With
anterior
one can
can see
see TASS (toxic
procedure or
intraocular procedure
injection, one
With any
kind 0f
any kind
non—iufectious
segment syndrome),
a
non-infectious
process.
I
expected
Mr.
to
have
vitreous
opacity
vitreous
a
process.
I
expected
Mr.
Guzman
to
have
opacity
syndrome),
of the
the posterior
posterior segment
However, Mr.
clear view of
and
cloudiness of
and cloudiness
of his
his vitreous.
vitreous. However,
Mr. Guzman had a
a clear
of
his eye
with
no
vitreous
opacities.
This
tells
us
that
what
was
put
in
his
eye
the
put
in
his
was toxic
toxic to
to the
tells
This
us
that
opacities.
of his
with
no
vitreous
eye
eye
retina and
and was
the result
infectious 0r
or inflammatory
not the
result of
0f an
an infectious
process.
retina
inflammatory process.
was not

0f Mr.
When II examined
and performed
both of
specular microscopy
performed specular
microscopy on both
patient and
examined this
this patient

Guzman's
eyes, II found
intraocular lens
lens in
in his
operative eye
and
Guzman’s eyes,
the intraocular
his operative
placed and
that the
found that
appropriately placed
eye was appropriately
within
reasonable
there
were
no
apparent
complications
related
thereto.
As
such,
within
reasonable
medical
AS such,
there Were no apparent complications related thereto.
Guzman’s injury
Mr. Guzman's
not aa complication
complication from inappropriate
probability,
or poorly-performed
poorly-performed
inappropriate or
is not
probability, Mr.
injury is
that
the
surgical
technique
performed
surgery.
The
specular
microscopy
indicates
that
the
surgical
technique
was
perfmmed
skillfully.
indicates
skillfully.
The
specular
microscopy
surgery.
1's
so early
It
highly unlikely
that Mr.
develop cystoid
cystoid macular
macular edema so
Mr. Guzman would
would develop
therefore that
It is highly
early
unlikely therefore
not there
following
pre-opcrativcly. Based on my
procedure if
if that
that condition
condition was not
there pre-operatively.
surgical procedure
this surgical
following this
examination
of the
medical records,
records, there
no evidence
that such
there is
is no
evidence that
such a
a
the patient
patient and
and the
the petiinent
pertinent medical
examination of
a direct
direct result
result of
the toxic
effects
of the
toxic effects
condition
was pre-existing.
presentation was a
pIe-existing. Rather,
the early
condition was
early presentation
Rather. the
Guzman’s retina.
of the medication
medication used
destroyed Mr.
Mr. Guzman's
This ultimately
retina.
Guardian Phatmacy.
used from
from Guardian
ultimately destroyed
Pharmacy. This
ofthe
Unfortunately,
Mr. Guzman is
is not
this compmmding
compounding formulary
affected by
patient affected
fonnulary
not the
the only
Unfortunately, Mr.
only patient
by this
error.
Rather,
least two
individuals (and
have been
two dozen individuals
that at
at least
(and likely
likely more)
more) have
error.
reports show
show that
Rather, reports
affected.
affected.

Plaintiffs' Notice of Filing Expert Reports - Page 7 of 70

 Additionally,
with regard
of the compound formulated
by
the testing
formulated by
regarding the
t0 the
testing ofthe
facts regarding
the facts
regard to
Additionally, with
Guardian Pharmacy
in this
matter, I would incorporate
incorporate the
testing of
Jack
Guardian
Jack Munn in
this matter,
the testing
of Jack
Pharmacy and Jack
as
Exhibit
B.
Karolchyk,
MS,
RPh,
FIACP,
a
report
from
whom
is
attached
a
report
from
is
attached
as
Exhibit
B.
Karolchyk,
RPh,
I

STANDARD OF CARE —
-JACK
JACK MUNN AND GUARDIAN PHARMACY

The standard
care requires
requires aa compounding pharmacy,
standard of
of care
such as
as Guardian
Guardian Pharmacy,
t0
Pharmacy, to
pharmacy, such
appropriately
its facilities
appropriately mix,
mix, package,
ship its
its compounded
and ship
maintain its
facilities and
and appropriately
package, and
appropriately maintain
formularies.
of care,
as aa compounding
In order
Guardian Phmmacy,
formularies. In
the standard
order to
standard of
to meet the
care, Guardian
Phannacy, as
pharmacy,
appropriate ingredients,
safely implement infection
control procedures,
procedures,
use appropriate
infection control
ingredients, must safely
pharmacy, must use
microbiological contamination
drug products,
products, must
must
must
procedures designed
must have
have procedures
lo prevent
prevent microbiological
contamination of
0f drug
designed to
utilize
equipment
in
the
manufacture
and
processing
of
drug
products
which
is
of
appropriate
0f
appropriate
utilize equipment in the manufacture and processing of drug products which is
design to
operations for
and must
must properly
its
test its
cleaning and
maintenance, and
for its
its cleaning
and maintenance,
facilitate operations
design
to facilitate
properly test
shipping.
before shipping.
medications before
compounded medications
of care
care requires
that the
poloxamer and
and the
Additionally,
the standard
standard of
requires that
the concentration
concentration of
0f poloxamer
the
Additionally, the
formulation
The standard
standard of
also requires
0f care
care also
requires that
that only
formulation pH are
are appropriate
appropriate for
for ocular
ocular safety.
safety. The
only
preparing the
the injection,
professionals should
specialized,
should be preparing
injection,
trained and
and knowledgeable professionals
specialized, highly
highly trained
following
strict procedures.
drugs is
patented drugs
is not
not
procedures. Compounding commercially
available, patented
following very
commercially available,
very strict
permitted by
permitted
the FDA compliance
compliance policy
and by
Practices.
guide and
policy guide
by the
by Good Compounding Practices.
to appropriately
of care
care requires
as aa compounding
compounding pharmacist,
pharmacist, to
appropriately
The
Jack Munn, as
requires Jack
standard 0f
The standard
mix,
package
and
ship
formularies,
while
using
appropriate
methods
for
to
package
and
ship
compounded
while
using
appropriate
methods
for safety
formularies,
mix,
safety to
prevent microbiological
care also
also requires
Jack Mum,
Munn, as
as aa
requires Jack
microbiological contamination.
standard of
of care
contamination. The standard
prevent
compounding pharmacist,
a compound.
to prepare
such a
prepare such
utilize appropriate
t0 utilize
appropriate methods to
pharmacist, to

care also
specialized, highly
The standard
of care
also requires
requires that
that only
trained and
and knowledgeable
knowledgeable
standard of
only specialized,
highly trained
professionals should
injection, following
very strict
procedures. Compounding
professionals
should be
be preparing
preparing the
the injection,
following very
strict procedures.
commercially available,
patented drugs
drugs
available, patented
commercially

is
is not
not permitted
permitted by
the FDA compliance
compliance policy
guide and
policy guide
by the

by
Practices.
by Good Compounding Practices.
VIOLATIONS OF THE STANDARD OF CARE —
- JACK MUNN AND GUARDIAN
PHARMACY

Guardian
Pharmacy fell
below the
the accepted
standard of
of care
regard to
procedures
care with
to its
its procedures
accepted standard
Guardian Pharmacy
fell below
with regard
of the
the compounded medication.
utilized
pharmacy and
the mixing
mixing of
and with
medication.
with the
its compounding pharmacy
utilized at
at its
Specifically,
did not
validate the
the FDA found
that Guardian
Guardian Pharmacy did
not properly
the
violations that
found violations
properly validate
Specifically, the
not have
have equipment
equipment of
sterilization
did not
0f
not test
test sterility
of each
each batch
batch of
of drug
drug product,
did not
sterilization process,
product, did
process, did
sterility of
did not
appropriate design
design to
and did
not properly
cleaning and maintenance,
for cleaning
maintenance, and
properly
operations for
t0 facilitate
facilitate operations
appropriate
handle
written and
and oral
related to
drug products.
products.
oral complaints
to drug
complaints related
handle written
According
the testing
by John
attached hereto
hereto as
as Exhibit
Scott Karolchyk,
According to
to the
testing perfmmed
performed by
John Scott
I(arolchyk, attached
fonnulated. Specifically,
B,
fmmulations from
Guardian Phmmacy
were incorrectly
incorrectly fmmulated.
Specifically, Mr.
the formulations
from Guardian
Pharmacy were
B, the
Karolchyk,
upon which II am relying
portions 0f
of my opinions,
opinions, found
found that
that
testing upon
for portions
through his
his testing
relying for
Karolchyk, through
Imprimis’ true
tmc formulation.
formulation.
of poloxamer
poloxamer is
is 5-10 times
higher than
the
concentration of
times higher
than Imprimis'
the concentration

Plaintiffs' Notice of Filing Expert Reports - Page 8 of 70

 Concentrations of
Concentrations
of 6% and 12% were used
used in
in the
the Guardian
Guardian formulation
formulation as
as opposed to
t0 the
the Imprimis
lmprimis
formulation
poloxamer less
formulation which utilized
utilized poloxamer
less than
than 3%. (Imprimis
the manufacturer
created
(Imprimis is
manufacturer which created
is the
- of
and patented
developer-- along
Leignerthe
patented moxifloxacin.
moxifloxacin. Mr.
MI. Karolchyk
the developer
along with
with Jeffrey
Leigner
ofthe
Karolchyk was the
Jeffrey
moxifloxacin
moxifloxacin HCI injectable
injectable formulation).
formulation).
the testing
testing revealed
revealed that
that Guardian violated
care by
Further,
the standard
Further, the
violated the
ofcare
standard of
failing to
to have
have
by failing
aa formulation
ocular safety.
Guardian formulation
formulation pH which was appropriate
appropriate for
for ocular
the Guardian
formulation pH
Rather, the
safety. Rather,
(7.5-8.0)
too high
(7.5-8.0) was too
high for
for ocular
ocular safety.
Other tested
tested pH levels
levels were 6.6
6.6 and 7.2
different lots.
lots.
fur different
safety. Other
7.2 for
pI-l for
did these
Not only
only did
the standard
these violate
violate the
standard of
of care
care for
for being
being too
too high
high of
of pH
for ocular
ocular safety,
but
safety, but
Guardian violated
violated the
the standard
of
care
for
standard
Such varying
care for having
having such
levels which were
were Out of
vawing pH levels
0f
en‘ors and demonstrate
demonsn'ate a
Specifications,
and are
are likely
process enors
a lack
lack of
Specifications, and
0f quality
assurance by
likely process
quality assurance
by
Guardian.
Guardian.

President of
Jack Munn as
as President
0f Guardian
Guardian Pha1macy,
and a
a licensed
licensed pharmacist,
violated the
the
pharmacist, violated
Pharmacy, and
standard
standard of care
care by
failing to
to ensure
ensure that
that Guardian Pharmacy
Phmmacy properly
sterilization
validated the
the sterilization
properly validated
by failing
process,
failed to
dmg product,
to ensure
ensure that
that Guardian Phmmacy
tested the
the sterility
0f each
batch of
each batch
process, failed
sterility of
Pharmacy tested
uf drug
product,
failed
failed to
to ensure
ensure that
that Guardian
Guardian Pharmacy
0f appropriate
appropriate design
10 facilitate
facilitate
desigl to
Pharmacy had equipment of
operations
to properly
operations for
for cleaning
cleaning and maintenance,
maintenance, and
handle written
and failed
failed to
written and oral
oral complaints
complaints
properly handle
related
products.
t0 dmg
related to
drug products.

Additionally,
by not
Jack Munn
Mum) violated
violated the
the accepted
accepted standard
standard of
0f care
care by
not ensuring
ensuring that
that the
the
Additionally, Jack
formulation
and for
formulation pH was proper
for ocular
proper for
ocular safety
for failing
failing to
to ensure
ensure consistency
0f pH levels
levels
consistency of
safety and
lots. Therefore,
among the
the lots.
the formulations
formulations were Out of Specifications.
Specifications. Further,
Therefore, the
Mr. Munn
Further, Mr.
violated
violated the
the standard
standard of care
care by
the commercially
available and patented
patented dmg
commercially available
drug
by compounding the
moxifloxacin.
moxifloxacin.
The compounded medication
medication was inappropriate
caused injury
inappropriate and
and caused
to Jesus
Jesus Guzman for
for the
injury to
the
reasons
reasons listed
listed below.
below.
MEDICAL CAUSATlON
CAUSATION
Pharmacists
blend, and then
Pharmacists have
have to
t0 emulsify,
then disperse
disperse homogeneous formulations
formulations to
to
mix, blend,
emulsify, mix,
prepare
compounded
medications.
Compounding
itself
is
the
mixing
of
dmgs
by
a
skilled
prepare
medications.
itself is the
0f drugs by a skilled
pharmacist
order to
pharmacist and in
preperly compound, this
requires appropriate
in order
t0 properly
this requires
appropriate homogenization
homogenization
technology.
a part
which
sound
energy
used to
Sonication is
is a
part of the
the compounding process,
is used
which
to
technology. Sonication
process, by
energy is
by
create
particles. In
create agitation
agitation within
within particles.
In order
order to
to appropriate
appropriate sonicate
a phmmaceutical,
sonicate a
pharmaceutical, there
must be
be
there must
compounding
appropriate
appropriate amplitude
amplitude and
and time
time period.
period. Additionally,
the facility
the act
act of
ofcompounding
Additionally, the
facility where the
occurs
appropriate safety
and validation
occurs must have appropriate
validation testing
measures and
testing to
to ensure
ensure the
the safety
0f its
its
safety measures
safety of
compounds before
before shipping.
shipping.
If
If a
a compound is
is not
not properly
or if
if it
it contains
contains bacterial
bacterial contaminate,
then the
the
sonicaled, or
contaminate, then
properly sonicated,
patient’s
inj ury when it
compound causes
is
placed
in
a
patient's
eye
post-operatively.
Additionally,
before
causes injury
it is plaCed in a
eye past-operatively. Additionally, before
patient’ss eye,
any
avoid
fmmulation is
is placed
placed into
into a
a patient'
it must
must be
be of
of a
a proper
proper pH level
level in
in order
order to
to avoid
any fmmulation
eye, it
patient’s
In
this
pmiicular
case,
the
contaminated
pharmaceutical
was
placed
injury
to
the
patient's
eye.
to
the
In
this
particular
the
contaminated
pharmaceutical
placed
case,
injury
eye.
onto
the retina
retina of
following his
onto the
of Mr.
Mr. Guzman following
his appropriately-performed
appropriately-performed procedure.
procedure. Although
Although the
the
procedure
the fmmula
The pH level
procedure itself
itself was appropriate,
not.
level was too
formula was not.
appmpriate, thc
and the
too high,
the
high, and
poloxamer concentration
concentration was
too high.
high. Therefore,
degradation of
of the
the fmmula
Therefore, degradation
of components of
was too
formula

Plaintiffs' Notice of Filing Expert Reports - Page 9 of 70

 likely
and high
high pH level
level was toxic.
toxic. The toxicity
of the
caused a
occurred and
the formulation
formulation caused
a breakdown
toxicity of
likely occurred
of the
of Mr.
Guzman's retina.
retina.
Mr. Guzman‘s
of
the tissue
tissue 0f
Mr. Guzman‘s
Guzman's eye
eye is
a classic
alkaline injury,
meaning that
in reasonable
The injury
injury to
t0 Mr.
is a
classic aLkaline
that in
reasonable
injury, meaning
medical
something with
with aa pH of
with the
the eye
eye of
of Mr.
contact with
medical probability,
of greater
greater than
than 7.0
7.0 came into
into contact
probability, something
Guzman, causing
injury. For
reasonable medical
it was the
the
medical probability,
causing injury.
For Mr.
Mr. Guzman,
in reasonable
probability, it
Guzman,
Guzman, in
moxifloxacin
than 7.0
caused his
his alkaline
If the
the pH 0f
of the
alkaline injury.
the
with a
of greater
moxifloxacin with
greater than
7.0 which caused
injury. If
a pH of
the eye,
eye, then
then injury
compound is
within aa tolerable
will occur.
range for
for the
the confined
confined space
space of
0fthe
occur.
tolerable range
not within
is not
injmy will
For
Guzman, too
high of
of aa pH (as
this case)
case) has
has aa toxic
toxic effect
on the
effect on
thé tissue
tissue by
For Mr.
MI. Guzman,
too high
occurred in
in this
(as occurred
by
supply is
is diminished
diminished (due
to a
a shrinking
shrinking
restricting
blood supply
supply to
the blood
blood supply
restricting the
the blood
to the
the tissue.
tissue. Once the
(due to
ischemic injury
oxygen traveling
the retina
retina is
is reduced,
and ischemic
occurs
blood
0f oxygen
reduced, and
traveling to
the amount of
injury occurs
blood vessel),
to the
vcssal), the
as
direct result.
as a
a direct
result.

This
is ineversible,
ineversible, based
based upon
of Mr. Guzman. The
This breakdown
breakdown of
of tissue
tissue is
upon my examination
examination ofMI'.
blindness of
the retinal
proximate cause
cause ofthe
of the blindness
of Mr. Guzman
degradation and
and death
death of
degradation
0f the
retinal tissue
tissue was a
a proximate
in
in his
his left
lefi eye.
eye.
Further,
medical probability,
due to
conditions set
set f01ih
forth
optical conditions
within reasonable
reasonable medical
to the
the optical
Further, within
probability, due
be
to
license
obtain
herein,
Mr.
Guzman
will
not
regain
vision
in
his
left
eye
and
will
not
be
able
to
obtain
a
license
to
able
in
to
his
will not regain Vision
lefi eye and Will not
a
herein, Mr.
drive
a commercial
commercial vehicle
vehicle at
future.
in the
the future.
point in
at any
drive a
any point
Based
above-stated definitions,
definitions, for
set forth
is my opinion
opinion
herein, it
Based upon
upon the
the above-stated
for the
the reasons
reasons set
forth herein,
it is
acted both
both negligently
and
that
Guardian Pharmacy
PhaI'maCy acted
negligently and
that Guardian
that within
reasonable medical
medical probability
within reasonable
probability that
grossly
and its
negligence was
was aa proximate
proximate cause
cause of
injury to
0f injury
t0
gross negligence
negligence and
its negligence
and gross
negligently, and
grossly negligently,
Jesus Guzman.
Jesus
it is
reasons Set
Based
the reasons
set forth
is my opinion
opinion
forth herein,
herein, it
above-statcd definitions,
definitions, for
Based upon
upon the
the above-stated
for the
that
within
reasonable
medical
probability
that
Jack
Munn
acted
both
negligently
and
grossly
that
Jack
Murm
acted
both
and
reasonable
medical
that within
probability
negligently
grossly
negligently, and
and his
negligence was aa proximate
proximate cause
cause of
of injury
to Jesus
Jesus
his negligence
negligence and
and gross
gross negligence
injmy to
negligently,
Guzman.
Guzman.

I reserve
reserve the
right to
inf01mation become available.
available.
t0 amend my rep01i
repon should
should additional
additional information
the right
I

.

Respgptfill

Wesley K. Herman, M.D.

Plaintiffs' Notice of Filing Expert Reports - Page 10 of 70