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FILED: KINGS COUNTY CLERK 01/16/2023 09:29 AM INDEX NO. 514577/2020
NYSCEF DOC. NO. 95 RECEIVED NYSCEF: 01/16/2023
EXHIBIT A
FILED: KINGS COUNTY CLERK 01/16/2023 09:29 AM INDEX NO. 514577/2020
NYSCEF DOC. NO. 95 RECEIVED NYSCEF: 01/16/2023
SUPREME COURT OF THE STATE OF NEW YORK
COUNTY OF KINGS
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BARBARA SACKAROFF, Index No.: 514577/2020
Plaintiff, EXPERT AFFIRMATION
-against-
SUDHIR DIWWAN, M.D., SUDHIR DIWAN. MD LLC,
ADVANCED SPIINE ON PARK AVENUE MSO, LLC,
MANHATTAN SPINE AND PAIN MANAGEMENT, PLLC,
IGOR AMIGUD, M.D., JANDE WEEKS, CRNA,
IGOR AMIGUD PHYSICAN P.C. and
FIFTH AVENUE SURGERY CENTER, LLC
Defendants.
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MARC S. KANCHUGER, M.D., a physician duly licensed to practice medicine in the
State of New York, affirms, under penalty of perjury, as follows:
1. I am a physician duly licensed to practice medicine in the State of New York. I am
Board Certified in Anesthesiology and have practiced medicine for over 40 years. I obtained my
medical degree from New York University School of Medicine in 1983, following which I
completed my Surgery Internship in 1984 and Surgery Residency in 1985 both at Tulane
University School of Medicine. In 1986, I completed by Transplantation Surgery fellowship at
State University of New York at Stony Brook. In 1989, I completed my Anesthesiology residency
at State University of New York at Stony Brook and in 1989 I served as Chief Resident during my
clinical fellowship in Cardiovascular and Thoracic Anesthesia. Thereafter, I was an Instructor in
the Department of Anesthesiology at New York University School of Medicine from 1989-1990
and an Assistant Professor of Anesthesiology at New York University School of Medicine from
1990-2003. I was Co-Chief of Cardiothoracic and Transplant Anesthesia at New York University
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Medical Center from 1999-2002 and Chief from 2002-2009. From 1999-2009, I was Chief of
Cardiothoracic and Transplant Anesthesia at Bellevue Hospital Center. Presently, I am an
Attending in the Department of Anesthesiology at both New York University Medical Center and
Bellevue Hospital Center, an Associate Professor of Anesthesiology at New York University
School of Medicine, I am currently Vice Chair Performance Improvement and Risk Management
Department of Anesthesia at NYU Langone Medical Center, as well as a full-time cardiothoracic
anesthesiologist. I have anesthetized over 10,000 individuals over the course of my career and
have monitored those patients post-operatively. I have performed both general and monitored
anesthesia care, have obtained informed consent forms and/or performed examinations on
thousands of patients, and have supervised CRNA providers.
2. Based on my education, training, and years of experience in Anesthesiology, I am
fully familiar with the standard of care as it pertains to the care and treatment rendered to plaintiff,
Barbara Sackaroff, who during an elective Corner-Loc sacroiliac joint stabilization procedure, was
noticed to have “coffee colored” secretions around her mouth and pillow, resulting in her coughing
during the procedure.
3. This Affirmation is submitted in support of the motion for summary judgment on
behalf of defendants IGOR AMIGUD, M.D. and IGOR AMIGUD PHYSICAN P.C. (hereinafter
referred to as “Dr. Amigud” or “defendants”). The opinions stated in this Affirmation are based
upon my education, training, skills, and expertise in Anesthesiology, and upon review of the
pleadings, Bill of Particulars, deposition transcripts including those of co-defendant Dr. Sudhir
Diwan, defendant Dr. Igor Amigud, defendant CRNA Jande Weeks, and the medical records from
defendant Fifth Avenue Surgery Center. All of my opinions expressed herein are stated within a
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reasonable degree of medical certainty. This Affirmation is submitted for the purposes of the
summary judgment motion. This Affirmation is limited to opinions on standard of care. If this case
proceeds to trial, my testimony will be consistent with, but not limited by, the statements herein.
4. Based on my review of the relevant materials, it is my opinion within a reasonable
degree of medical certainty that defendant Dr. Amigud conformed to the standard of care at all
times in the care and treatment he rendered to plaintiff and any alleged injury plaintiff sustained is
a potential side effect of being under MAC sedation.
PLAINTIFF’S CLAIMS
5. I am aware based on my review of the pleadings, including plaintiff’s Verified Bill
of Particulars, that plaintiff alleges in sum and substance that defendant deviated from the standard
of care in that he failed to recognize a past medical history of gastroesophageal reflux disease
(GERD), failed to recognize the significance of coughing during a procedure, failed to timely and
properly position plaintiff, failed to timely and properly intubate plaintiff, failed to timely and
properly suction plaintiff, failed to timely and properly administer H2 Blockers, Protein Pump
Inhibitors, and Prokinetics to reduce the risk of aspiration, failed to take a careful medical history
and physical exam, failed to coordinate and communicate with staff, and failed to properly
supervise staff.
6. Plaintiff has also asserted lack of informed consent allegations against defendant.
Plaintiff alleges that defendant failed to provide appropriate information concerning the proposed
operations, procedures, and/or medications, the alternatives to any operation, procedure, or
medication, the reasonably foreseeable risks of any operation, procedure, or medication, failed to
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explain in words understandable to plaintiff all the facts that would be explained by a reasonable
medical practitioner so that any consent was given with awareness of the patient’s existing physical
condition, the risks involved to the patient if there is no operation, procedure, or medication, and
the available alternatives and the risk and advantages of those alternatives.
7. As a result of the above allegations, plaintiff claims that she suffered aspiration
and related injuries, such as difficulty sleeping, vocal cord damage, scarring to the vocal cords,
lung damage, chemical burn to vocal cords, chemical burn to lungs, difficulty breathing, hoarse
voice, difficulty speaking, chemical bronchitis, chemical rhinitis, granuloma to the left lower lobe
of the lung, dysphonia, cough, chemical pneumonitis, chemical sinusitis, and respiratory airway
disease.
8. For the reasons fully set forth below, it is my opinion within a reasonable degree of
medical certainty that the above allegations of negligence are without merit. The medical records
and testimony demonstrate that on January 7, 2020, defendant obtained a signed informed consent
from plaintiff, had a conversation with plaintiff regarding the informed consent form and all
associated risk and alternatives, performed a physical examination of plaintiff, reviewed her
cardiovascular pathology and current medications, confirmed she was nothing by mouth, and along
with CRNA Jande Weeks, obtained her medical history prior to the surgical procedure. Further,
defendant monitored plaintiff during and after the surgical procedure and at all times confirmed
plaintiff was stable and in good health.
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STATEMENT OF FACTS
9. On January 7, 2020, plaintiff presented to co-defendant Dr. Sudhir Diwan at Fifth
Avenue Surgery Center, LLC for a Corner-Loc sacroiliac joint stabilization procedure. Defendant
Dr. Amigud was the anesthesiologist and co-defendant CRNA Jande Weeks was the nurse
anesthetist for the sacroiliac joint stabilization procedure.
10. Prior to plaintiff’s surgical procedure, Dr. Amigud reviewed plaintiff’s medical and
surgical history, prior experience with anesthesia, confirmed she had nothing by mouth for at least
8 hours prior to her surgical procedure, and performed a physical examination of plaintiff.
11. Plaintiff advised on January 7, 2020 that she was presently experiencing low back
and upper buttock pain, had hypercholesterolemia, anxiety, and a murmur, is allergic and/or had a
reaction to Cipro, Keflex, Iodine, Contrast, and shellfish, is presently taking the following
medications: Furosemide, Valacyclovir, Zolpidem, Rosuvastatin, Aleve, Cymbalta, Tylenol, and
Ambien. Prior to plaintiff’s surgical procedure, Dr. Amigud and CRNA Weeks both spoke to
plaintiff and documented that she had a history of hip surgery, shoulder surgery, caesarian section,
hernia repair surgery, and a tonsillectomy.
12. Dr. Diwan’s physical examination of plaintiff revealed that her cardiac, pulmonary,
HEENT (head, eyes, ears, nose, and throat), neurological, gastrointestinal/abdomen,
musculoskeletal, and extremities exams were all normal.
13. Dr. Amigud’s physical examination of plaintiff revealed that she had a normal
cardiac and pulmonary exam and that she had a normal mouth opening and normal range of motion
in her neck.
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14. During any of the pre-operative discussions and/or exams, plaintiff did not report
or mention any history of GERD or acid reflux. Further, none of plaintiff’s listed medications are
to treat GERD.
15. Dr. Diwan then explained to plaintiff that the Corner-Loc surgical procedure is a
minimally invasive procedure where an allogenic cortical bone graft is inserted by posterior
approach. Dr. Diwan explained to plaintiff in plain terms and great detail what the surgical
procedure entailed and the risk and/or complications associated with the procedure. Plaintiff
verbalized she understood and agreed to proceed with the surgical procedure and she signed the
written consent at 2:00 pm.
16. Dr. Amigud and CRNA Weeks explained to plaintiff that she would be undergoing
MAC (monitored anesthesia care), what that means, the risk and/or complications associated with
anesthesia, and the benefits of and alternatives to, the planned anesthetic. Such risks and
complications include, but are not limited to, nerve injury, hoarseness or voice change, slowing or
absence of breathing, and the possibility for general anesthesia and awareness during anesthesia.
Plaintiff understood and agreed to the anesthesia and signed the written consent, along with Dr.
Amigud’s signature.
17. CRNA Weeks did not sign a written consent form as she is not the provider
responsible for obtaining consent.
18. Plaintiff was then taken to the operating room and was placed in a prone position
with pillows under her stomach to reduce the lumbar lordosis.
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19. At 2:35 pm, monitored anesthesia was administered intravenously. Plaintiff
received 100 milligrams of Propofol, 100 milligrams of Fentanyl, and 150 mics of Versed that was
administered 5 milligrams at a time over a 45 minute time period.
20. At 2:51 pm, 4 milligrams of Zofran were administered to prevent plaintiff from
having post-operative nausea and vomiting.
21. At 3:22 pm, CRNA Nurse Weeks detected brownish or “coffee colored” secretion
around the plaintiff’s nose and the nasal canula had some of the secretions in it. Plaintiff proceeded
to cough a couple times at that precise time. In reaction, the nurse immediately called the attending
who assessed the patient and administered plaintiff .2 milligrams of intravenous Flumazenil to
reverse the sedation from benzodiazepine (Versed), and Narcan to reverse the narcotics (Fentanyl).
22. At 3:32 pm, plaintiff was alert and coherent. Her oxygen saturation was 95 percent
and her vitals were stable. At 3:35 pm, anesthesia was completely stopped.
23. While the plaintiff was alert, CRNA Weeks suctioned her airway through the
mouth. Surgery was then continued with plaintiff under light sedation.
24. After the surgical procedure was completed and plaintiff was being prepared to be
transported to the post anesthesia care unit, CRNA Weeks spoke with her and noted no significant
coughing or cause for concern.
25. At 3:40 pm, plaintiff was transferred to the post anesthesia care unit in stable
condition. In the post anesthesia care unit, plaintiff’s blood pressure was 123/62, heart rate of 100
beats per minute, 96 percent oxygen saturation, and had a respiratory rate of 16.
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26. Dr. Amigud was present inside the operating room at all times during critical
periods.
27. While in the post anesthesia care unit, plaintiff was monitored by Dr. Amigud.
28. At 5:20 pm, plaintiff was discharged home in stable condition.
OPINION
29. It is my opinion within a reasonable degree of medical certainty that treatment
rendered to plaintiff on January 7, 2020, was at all times in accordance with good and accepted
medical practice without any deviation or departure therefrom and plaintiff’s alleged injuries are
a known potential side effect of being under MAC sedation.
30. Plaintiff’s claim that defendant deviated from the standard of care when he failed
to recognize plaintiff’s past history of GERD, failed to recognize the significance of coughing
during a procedure, failed to timely and properly position plaintiff, failed to timely and properly
suction plaintiff, failed to timely and properly administer H2 Blockers, Protein Pump Inhibitors,
and Prokinetics to reduce the risk of aspiration, failed to take a careful medical history and a
physical exam, failed to coordinate and communicate with staff, and failed to properly supervise
said staff, is without merit and these minor allegations are known side effects of a well delivered
anesthetic, at times.
31. Defendant obtained a proper history from plaintiff when he met with her in the pre-
operative area, performed a physical examination of plaintiff, and took a review of her medical
history. During defendant’s physical examination of plaintiff, he confirmed that she was on
nothing by mouth protocol, listened to her heart, auscultation of the lungs, obtained bedside blood
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pressure and pulse oximetry, and created an anesthesia plan that corresponded to plaintiff’s
allergies, reactions, and medical history. At that time, plaintiff did not disclose a history of GERD
or acid reflux, nor was on any medications for such alleged disease. Further, CRNA weeks testified
that it was her custom and practice to ask. Regardless of which provider asked plaintiff if she had
a history of GERD or acid reflux, defendant testified that it would not have changed his plan for
anesthesia.
32. It is my opinion within a reasonable degree of medical certainty that the medical
history obtained by both defendant and co-defendant CRNA Weeks was adequate. Based on
plaintiff’s medical history, medical records, and the fact none of the medications she was on were
to treat GERD or acid reflux, there was no reason to assume she had GERD or acid reflux.
Defendant and CRNA Weeks both documented plaintiff’s medical history, allergies and/or allergic
reactions, prior surgeries, medication history to date, and current medical ailments such as
hypercholesterolemia, anxiety, and a heart murmur. Moreover, GERD or acid reflux is not an
ailment that can be detected by a physician’s pre-anesthesia physical exam. Therefore, it is my
opinion within a reasonable degree of medical certainty that even if the plaintiff had a history of
GERD or acid reflux, the management of plaintiff would have been the same. There is nothing in
plaintiff’s medical record or operative report that would indicate she had a history of GERD or
acid reflux, and knowing that she did would not have made any difference in the care and treatment
rendered to her by defendant or change the events that occurred during her January 7, 2022 surgical
procedure. Rather, even in the face of such history, the anesthesia plan was appropriate and in
accordance within the applicable standards of care.
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33. Further, it is my opinion within a reasonable degree of medical certainty that the
positioning of plaintiff in a prone position was within good and accepted medical practice.
Anesthesiologists are not the physician in a surgical operating room deciding what position the
patient should be placed in for an upcoming surgical procedure. That decision is left to the hands
of the surgeon, which is what happened in plaintiff’s case. Dr. Diwan chose the prone position as
he was the physician performing the Corner-Loc procedure and needed plaintiff to be in a certain
position to do his surgery. As described by Dr. Diwan, it was critical for him to position plaintiff
in a prone position as he needs plaintiff’s body in a particular curve in order to reach the lower
part of her spine. Therefore, plaintiff’s allegation that defendant failed to timely and properly
position plaintiff is simply not the case as positioning the plaintiff is within the surgeon, Dr.
Diwan’s, domain. The responsibility of the anesthesiologist is to make sure that no pressure points
are damageable once the plaintiff is positioned. In addition, plaintiff’s argument that defendant did
not position plaintiff’s head higher than her abdomen during the surgical procedure and timely
place her head in a tilt down position is also without merit.
34. It is my opinion within a reasonable degree of medical certainty that defendant
made sure that the plaintiff’s upper torso, including her head, neck, and arms, were placed in a
comfortable and safe prone position as is the usual customary practice of the anesthesia team.
Positioning of plaintiff during surgery is within the domain of Dr. Diwan and, regardless of who
put plaintiff in the prone position, it was the proper position for her to be in and ended up being
beneficial to plaintiff. Once there were secretions that were recognized and led to the patient
coughing, being in the prone position allowed any and all secretions to drain from her mouth and/or
nasal cavity and not pool in the inside of her throat. If plaintiff were to be placed supine, her
regurgitation could have pooled in the back of her throat and led to aspiration. Subsequently, there
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was no additional need to change plaintiff’s position, as the prone position was the most favorable
position for her to be in for the surgical procedure, for the removal of any regurgitated material,
and once plaintiff coughed up secretions, the surgical procedure was stopped, plaintiff was
awakened, and evaluated accordingly to determine the best plan of action to move forward. Given
her vital signs, the surgery could have continued as planned. Thus, the surgical procedure and
anesthesia were within good and accepted medical practice and there was no deviation from the
standard of care.
35. Additionally, it is my opinion within a reasonable degree of medical certainty that
there was no need to intubate plaintiff. Defendant chose MAC sedation as the anesthetic choice
for plaintiff’s surgical procedure, a procedure that did not require intubation. Under MAC sedation,
the patient is relaxed, calm, retains control of their airways, and are somewhat aware of their
surroundings, but comfortable during the surgical procedure. General Anesthesia is deeper form
of anesthesia where the patient is unconscious and might need assistance in respiration. Intubation
is often required when a patient undergoes General Anesthesia. Intubation is when a tube is placed
down the patients throat and into their trachea to maintain an open airway so they can breathe. The
risks associated with intubation are injury to the throat and trachea, bleeding, lung complications,
vocal cord damage, and aspiration as well.
36. Therefore, defendant and CRNA Week’s assessment when plaintiff coughed up
secretions to wake her up from MAC anesthesia and proceed with the surgery under light sedation
instead of changing course to induce General Anesthesia and intubation was within good and
accepted medical standards. “Coffee colored” secretions in and of itself are not alarming or a cause
for concern. Regurgitation is always expected to some extent and the anesthesia team takes all
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necessary and proper precautions to manage the regurgitation. Further, the color of the secretions
does not determine the level of acidity of stomach contents. There was no indication
physiologically that the patient aspirated these secretions into her lungs, nor was there any
physiological need for intubation at all. As explained by defendant, and in which I am of the same
opinion, the risk to induce general anesthesia was far greater, and includes flipping the patient over
and abandoning the procedure, then proceeding with light sedation. As evidenced by the medical
records, there was no reason to intubate plaintiff as she remained stable under light sedation, had
no further secretions, mild regurgitation happens all the time and is a potential side effect of being
under mild anesthetics, and the surgery was successfully completed without further complication.
In addition, discharge after plaintiff’s procedure was appropriate as there were no complications
or cause for concern. Plaintiff’s post-procedure course while in recovery was uneventful, her vitals
maintained stable, and there were referrals to an emergency department or documented complaints.
37. Further, plaintiff’s claim that defendant failed to recognize the significance of
plaintiff coughing throughout the Corner-Loc procedure is baseless. Regardless of the fact that
there is no indication in any of the records or depositions that would lead me to believe that plaintiff
was coughing throughout the entire procedure, plaintiff having coughed during the procedure is a
good sign as it reflects that a patient is not so deep under anesthesia with an inability to control
their breathing or upper airway reflexes. Coughing during a procedure in and of itself is not a sign
that plaintiff cannot breathe or is facing airway complications but is evidence that she has control
of her airways and is attempting to clear out her throat from any irritants.
38. In furtherance of my opinion that defendant did not deviate from the standard of
care once plaintiff coughed secretions, suctioning of plaintiff’s throat and nose were not necessary.
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Suctioning was not necessary as any secretions were drained by gravity. Even though it was not
necessary, CRNA Weeks testified that she suctioned plaintiff and nothing was able to be suctioned
out as all secretions drained naturally on their own. It is my opinion within a reasonable degree of
medical certainty that the maintenance of the plaintiff’s airway and all secretions were managed
appropriately by CRNA weeks.
39. Plaintiff’s allegation that defendant failed to timely administer anesthetic
medications to decrease the chance of aspiration and failed to timely and properly administer H2
Blockers, Proton Pump Inhibitors, and Prokinetics is likewise baseless and without merit. H2
Blockers reduce the amount of stomach acid secreted by the glands in the stomach, Proton Pump
Inhibitor’s reduce stomach acid, and Prokinetic’s help control acid reflux. These medications,
along with any other medications known to reduce the risk of aspiration, were not necessary to
administer to plaintiff. Plaintiff exhibited no signs, symptoms, or advised her physicians of a
medical history with GERD or acid reflux. Without any reason to believe plaintiff would need any
of the above stated medications, there would be no reason to administer them. Aspiration is a
known risk associated with any and all anesthesia. Medications should not be given to any patient
unless they have a history with GERD or acid reflux which would indicate a higher risk associated
with aspiration. Plaintiff did not report a history of GERD or acid reflux and did not inform any of
three medical providers who took her history that day of any history. Therefore, it is my opinion
within a reasonable degree of medical certainty, there was no deviation from the standard of care
in the administration of any medications given, or not given, to plaintiff by defendant and CRNA
Weeks.
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40. Defendant, CRNA Weeks, and Dr. Diwan, were in constant communication
throughout the entirety of plaintiff’s surgical procedure. It is my opinion within a reasonable
degree of medical certainty that the communication testified to between Dr. Diwan, defendant, and
CRNA Weeks, was well within the standard of care. Defendant, CRNA Weeks, and Dr. Diwan all
testified that they were in the room during the surgical procedure and cough episode, decided
together as a surgical team to wake up plaintiff, and the plan to proceed with light sedation. This
was a team of doctors and staff who communicated to each other and made decisions together
based on the best course of treatment for plaintiff. There is no evidence to suggest otherwise. It is
in my opinion within a reasonable degree of medical certainty that all communications testified to
were within the accepted standards of care.
41. Lastly, it is my opinion within a reasonable degree of medical certainty that
defendant’s written consent form and explanation to plaintiff was within the standard of care.
Informed consent is a crucial and critical step before any patient is put under anesthesia or sedation.
There is always risk associated with any surgical procedure and anesthesia. The written consent
form, along with the doctor’s explanation, details the associated risks, any complications related
to sedation and general anesthesia, any outcomes, and alternatives. Defendant testified, and the
written consent forms show, that he informed plaintiff of any associated risks, complications,
outcomes, and alternatives. Plaintiff testified that she signed the consent form for anesthesia and
understood the risks associated with anesthesia. Such risks include, transient breathing difficulty,
brain damage or stroke, heart attack or other heart damage, hoarseness or voice change, need for
medical breathing assistance, and the possibility that general anesthesia will be needed. Further,
plaintiff’s alleged injuries are a known potential side effect of being under MAC sedation. It is
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my opinion within a reasonable degree of medical certainty that defendant obtained informed
consent and there was no deviation from the standard of care.
42. In sum, it is my degree within a reasonable degree of medical certainty that the
January 7, 2020 administration of anesthesia was properly administered and maintained by Dr.
Amigud. Dr. Amigud, Dr. Diwan, and CRNA Weeks’ care and treatment of plaintiff was in
accordance with good and accepted medical practice and did not deviate from the standard of care.
For the reasons set forth in this Affirmation, it is my opinion within a reasonable degree of medical
certainty that the allegations in plaintiff’s Bill of Particulars are not supported by the evidence and
the case should be dismissed.
Dated: New York, New York
January 15, 2023
___________________________
Dr. Marc S. Kanchuger, M.D.
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FILED: KINGS COUNTY CLERK 01/16/2023 09:29 AM INDEX NO. 514577/2020 NYSCEF DOC. NO. 95 RECEIVED NYSCEF: 01/16/2023 EXHIBIT A FILED: KINGS COUNTY CLERK 01/16/2023 09:29 AM INDEX NO. 514577/2020 NYSCEF DOC. NO. 95 RECEIVED NYSCEF: 01/16/2023 SUPREME COURT OF THE STATE OF NEW YORK COUNTY OF KINGS -------------------------------------------------------------------------X BARBARA SACKAROFF, Index No.: 514577/2020 Plaintiff, EXPERT AFFIRMATION -against- SUDHIR DIWWAN, M.D., SUDHIR DIWAN. MD LLC, ADVANCED SPIINE ON PARK AVENUE MSO, LLC, MANHATTAN SPINE AND PAIN MANAGEMENT, PLLC, IGOR AMIGUD, M.D., JANDE WEEKS, CRNA, IGOR AMIGUD PHYSICAN P.C. and FIFTH AVENUE SURGERY CENTER, LLC Defendants. -------------------------------------------------------------------------X MARC S. KANCHUGER, M.D., a physician duly licensed to practice medicine in the State of New York, affirms, under penalty of perjury, as follows: 1. I am a physician duly licensed to practice medicine in the State of New York. I am Board Certified in Anesthesiology and have practiced medicine for over 40 years. I obtained my medical degree from New York University School of Medicine in 1983, following which I completed my Surgery Internship in 1984 and Surgery Residency in 1985 both at Tulane University School of Medicine. In 1986, I completed by Transplantation Surgery fellowship at State University of New York at Stony Brook. In 1989, I completed my Anesthesiology residency at State University of New York at Stony Brook and in 1989 I served as Chief Resident during my clinical fellowship in Cardiovascular and Thoracic Anesthesia. Thereafter, I was an Instructor in the Department of Anesthesiology at New York University School of Medicine from 1989-1990 and an Assistant Professor of Anesthesiology at New York University School of Medicine from 1990-2003. I was Co-Chief of Cardiothoracic and Transplant Anesthesia at New York University 8739932 FILED: KINGS COUNTY CLERK 01/16/2023 09:29 AM INDEX NO. 514577/2020 NYSCEF DOC. NO. 95 RECEIVED NYSCEF: 01/16/2023 Medical Center from 1999-2002 and Chief from 2002-2009. From 1999-2009, I was Chief of Cardiothoracic and Transplant Anesthesia at Bellevue Hospital Center. Presently, I am an Attending in the Department of Anesthesiology at both New York University Medical Center and Bellevue Hospital Center, an Associate Professor of Anesthesiology at New York University School of Medicine, I am currently Vice Chair Performance Improvement and Risk Management Department of Anesthesia at NYU Langone Medical Center, as well as a full-time cardiothoracic anesthesiologist. I have anesthetized over 10,000 individuals over the course of my career and have monitored those patients post-operatively. I have performed both general and monitored anesthesia care, have obtained informed consent forms and/or performed examinations on thousands of patients, and have supervised CRNA providers. 2. Based on my education, training, and years of experience in Anesthesiology, I am fully familiar with the standard of care as it pertains to the care and treatment rendered to plaintiff, Barbara Sackaroff, who during an elective Corner-Loc sacroiliac joint stabilization procedure, was noticed to have “coffee colored” secretions around her mouth and pillow, resulting in her coughing during the procedure. 3. This Affirmation is submitted in support of the motion for summary judgment on behalf of defendants IGOR AMIGUD, M.D. and IGOR AMIGUD PHYSICAN P.C. (hereinafter referred to as “Dr. Amigud” or “defendants”). The opinions stated in this Affirmation are based upon my education, training, skills, and expertise in Anesthesiology, and upon review of the pleadings, Bill of Particulars, deposition transcripts including those of co-defendant Dr. Sudhir Diwan, defendant Dr. Igor Amigud, defendant CRNA Jande Weeks, and the medical records from defendant Fifth Avenue Surgery Center. All of my opinions expressed herein are stated within a 2 8739932 FILED: KINGS COUNTY CLERK 01/16/2023 09:29 AM INDEX NO. 514577/2020 NYSCEF DOC. NO. 95 RECEIVED NYSCEF: 01/16/2023 reasonable degree of medical certainty. This Affirmation is submitted for the purposes of the summary judgment motion. This Affirmation is limited to opinions on standard of care. If this case proceeds to trial, my testimony will be consistent with, but not limited by, the statements herein. 4. Based on my review of the relevant materials, it is my opinion within a reasonable degree of medical certainty that defendant Dr. Amigud conformed to the standard of care at all times in the care and treatment he rendered to plaintiff and any alleged injury plaintiff sustained is a potential side effect of being under MAC sedation. PLAINTIFF’S CLAIMS 5. I am aware based on my review of the pleadings, including plaintiff’s Verified Bill of Particulars, that plaintiff alleges in sum and substance that defendant deviated from the standard of care in that he failed to recognize a past medical history of gastroesophageal reflux disease (GERD), failed to recognize the significance of coughing during a procedure, failed to timely and properly position plaintiff, failed to timely and properly intubate plaintiff, failed to timely and properly suction plaintiff, failed to timely and properly administer H2 Blockers, Protein Pump Inhibitors, and Prokinetics to reduce the risk of aspiration, failed to take a careful medical history and physical exam, failed to coordinate and communicate with staff, and failed to properly supervise staff. 6. Plaintiff has also asserted lack of informed consent allegations against defendant. Plaintiff alleges that defendant failed to provide appropriate information concerning the proposed operations, procedures, and/or medications, the alternatives to any operation, procedure, or medication, the reasonably foreseeable risks of any operation, procedure, or medication, failed to 3 8739932 FILED: KINGS COUNTY CLERK 01/16/2023 09:29 AM INDEX NO. 514577/2020 NYSCEF DOC. NO. 95 RECEIVED NYSCEF: 01/16/2023 explain in words understandable to plaintiff all the facts that would be explained by a reasonable medical practitioner so that any consent was given with awareness of the patient’s existing physical condition, the risks involved to the patient if there is no operation, procedure, or medication, and the available alternatives and the risk and advantages of those alternatives. 7. As a result of the above allegations, plaintiff claims that she suffered aspiration and related injuries, such as difficulty sleeping, vocal cord damage, scarring to the vocal cords, lung damage, chemical burn to vocal cords, chemical burn to lungs, difficulty breathing, hoarse voice, difficulty speaking, chemical bronchitis, chemical rhinitis, granuloma to the left lower lobe of the lung, dysphonia, cough, chemical pneumonitis, chemical sinusitis, and respiratory airway disease. 8. For the reasons fully set forth below, it is my opinion within a reasonable degree of medical certainty that the above allegations of negligence are without merit. The medical records and testimony demonstrate that on January 7, 2020, defendant obtained a signed informed consent from plaintiff, had a conversation with plaintiff regarding the informed consent form and all associated risk and alternatives, performed a physical examination of plaintiff, reviewed her cardiovascular pathology and current medications, confirmed she was nothing by mouth, and along with CRNA Jande Weeks, obtained her medical history prior to the surgical procedure. Further, defendant monitored plaintiff during and after the surgical procedure and at all times confirmed plaintiff was stable and in good health. 4 8739932 FILED: KINGS COUNTY CLERK 01/16/2023 09:29 AM INDEX NO. 514577/2020 NYSCEF DOC. NO. 95 RECEIVED NYSCEF: 01/16/2023 STATEMENT OF FACTS 9. On January 7, 2020, plaintiff presented to co-defendant Dr. Sudhir Diwan at Fifth Avenue Surgery Center, LLC for a Corner-Loc sacroiliac joint stabilization procedure. Defendant Dr. Amigud was the anesthesiologist and co-defendant CRNA Jande Weeks was the nurse anesthetist for the sacroiliac joint stabilization procedure. 10. Prior to plaintiff’s surgical procedure, Dr. Amigud reviewed plaintiff’s medical and surgical history, prior experience with anesthesia, confirmed she had nothing by mouth for at least 8 hours prior to her surgical procedure, and performed a physical examination of plaintiff. 11. Plaintiff advised on January 7, 2020 that she was presently experiencing low back and upper buttock pain, had hypercholesterolemia, anxiety, and a murmur, is allergic and/or had a reaction to Cipro, Keflex, Iodine, Contrast, and shellfish, is presently taking the following medications: Furosemide, Valacyclovir, Zolpidem, Rosuvastatin, Aleve, Cymbalta, Tylenol, and Ambien. Prior to plaintiff’s surgical procedure, Dr. Amigud and CRNA Weeks both spoke to plaintiff and documented that she had a history of hip surgery, shoulder surgery, caesarian section, hernia repair surgery, and a tonsillectomy. 12. Dr. Diwan’s physical examination of plaintiff revealed that her cardiac, pulmonary, HEENT (head, eyes, ears, nose, and throat), neurological, gastrointestinal/abdomen, musculoskeletal, and extremities exams were all normal. 13. Dr. Amigud’s physical examination of plaintiff revealed that she had a normal cardiac and pulmonary exam and that she had a normal mouth opening and normal range of motion in her neck. 5 8739932 FILED: KINGS COUNTY CLERK 01/16/2023 09:29 AM INDEX NO. 514577/2020 NYSCEF DOC. NO. 95 RECEIVED NYSCEF: 01/16/2023 14. During any of the pre-operative discussions and/or exams, plaintiff did not report or mention any history of GERD or acid reflux. Further, none of plaintiff’s listed medications are to treat GERD. 15. Dr. Diwan then explained to plaintiff that the Corner-Loc surgical procedure is a minimally invasive procedure where an allogenic cortical bone graft is inserted by posterior approach. Dr. Diwan explained to plaintiff in plain terms and great detail what the surgical procedure entailed and the risk and/or complications associated with the procedure. Plaintiff verbalized she understood and agreed to proceed with the surgical procedure and she signed the written consent at 2:00 pm. 16. Dr. Amigud and CRNA Weeks explained to plaintiff that she would be undergoing MAC (monitored anesthesia care), what that means, the risk and/or complications associated with anesthesia, and the benefits of and alternatives to, the planned anesthetic. Such risks and complications include, but are not limited to, nerve injury, hoarseness or voice change, slowing or absence of breathing, and the possibility for general anesthesia and awareness during anesthesia. Plaintiff understood and agreed to the anesthesia and signed the written consent, along with Dr. Amigud’s signature. 17. CRNA Weeks did not sign a written consent form as she is not the provider responsible for obtaining consent. 18. Plaintiff was then taken to the operating room and was placed in a prone position with pillows under her stomach to reduce the lumbar lordosis. 6 8739932 FILED: KINGS COUNTY CLERK 01/16/2023 09:29 AM INDEX NO. 514577/2020 NYSCEF DOC. NO. 95 RECEIVED NYSCEF: 01/16/2023 19. At 2:35 pm, monitored anesthesia was administered intravenously. Plaintiff received 100 milligrams of Propofol, 100 milligrams of Fentanyl, and 150 mics of Versed that was administered 5 milligrams at a time over a 45 minute time period. 20. At 2:51 pm, 4 milligrams of Zofran were administered to prevent plaintiff from having post-operative nausea and vomiting. 21. At 3:22 pm, CRNA Nurse Weeks detected brownish or “coffee colored” secretion around the plaintiff’s nose and the nasal canula had some of the secretions in it. Plaintiff proceeded to cough a couple times at that precise time. In reaction, the nurse immediately called the attending who assessed the patient and administered plaintiff .2 milligrams of intravenous Flumazenil to reverse the sedation from benzodiazepine (Versed), and Narcan to reverse the narcotics (Fentanyl). 22. At 3:32 pm, plaintiff was alert and coherent. Her oxygen saturation was 95 percent and her vitals were stable. At 3:35 pm, anesthesia was completely stopped. 23. While the plaintiff was alert, CRNA Weeks suctioned her airway through the mouth. Surgery was then continued with plaintiff under light sedation. 24. After the surgical procedure was completed and plaintiff was being prepared to be transported to the post anesthesia care unit, CRNA Weeks spoke with her and noted no significant coughing or cause for concern. 25. At 3:40 pm, plaintiff was transferred to the post anesthesia care unit in stable condition. In the post anesthesia care unit, plaintiff’s blood pressure was 123/62, heart rate of 100 beats per minute, 96 percent oxygen saturation, and had a respiratory rate of 16. 7 8739932 FILED: KINGS COUNTY CLERK 01/16/2023 09:29 AM INDEX NO. 514577/2020 NYSCEF DOC. NO. 95 RECEIVED NYSCEF: 01/16/2023 26. Dr. Amigud was present inside the operating room at all times during critical periods. 27. While in the post anesthesia care unit, plaintiff was monitored by Dr. Amigud. 28. At 5:20 pm, plaintiff was discharged home in stable condition. OPINION 29. It is my opinion within a reasonable degree of medical certainty that treatment rendered to plaintiff on January 7, 2020, was at all times in accordance with good and accepted medical practice without any deviation or departure therefrom and plaintiff’s alleged injuries are a known potential side effect of being under MAC sedation. 30. Plaintiff’s claim that defendant deviated from the standard of care when he failed to recognize plaintiff’s past history of GERD, failed to recognize the significance of coughing during a procedure, failed to timely and properly position plaintiff, failed to timely and properly suction plaintiff, failed to timely and properly administer H2 Blockers, Protein Pump Inhibitors, and Prokinetics to reduce the risk of aspiration, failed to take a careful medical history and a physical exam, failed to coordinate and communicate with staff, and failed to properly supervise said staff, is without merit and these minor allegations are known side effects of a well delivered anesthetic, at times. 31. Defendant obtained a proper history from plaintiff when he met with her in the pre- operative area, performed a physical examination of plaintiff, and took a review of her medical history. During defendant’s physical examination of plaintiff, he confirmed that she was on nothing by mouth protocol, listened to her heart, auscultation of the lungs, obtained bedside blood 8 8739932 FILED: KINGS COUNTY CLERK 01/16/2023 09:29 AM INDEX NO. 514577/2020 NYSCEF DOC. NO. 95 RECEIVED NYSCEF: 01/16/2023 pressure and pulse oximetry, and created an anesthesia plan that corresponded to plaintiff’s allergies, reactions, and medical history. At that time, plaintiff did not disclose a history of GERD or acid reflux, nor was on any medications for such alleged disease. Further, CRNA weeks testified that it was her custom and practice to ask. Regardless of which provider asked plaintiff if she had a history of GERD or acid reflux, defendant testified that it would not have changed his plan for anesthesia. 32. It is my opinion within a reasonable degree of medical certainty that the medical history obtained by both defendant and co-defendant CRNA Weeks was adequate. Based on plaintiff’s medical history, medical records, and the fact none of the medications she was on were to treat GERD or acid reflux, there was no reason to assume she had GERD or acid reflux. Defendant and CRNA Weeks both documented plaintiff’s medical history, allergies and/or allergic reactions, prior surgeries, medication history to date, and current medical ailments such as hypercholesterolemia, anxiety, and a heart murmur. Moreover, GERD or acid reflux is not an ailment that can be detected by a physician’s pre-anesthesia physical exam. Therefore, it is my opinion within a reasonable degree of medical certainty that even if the plaintiff had a history of GERD or acid reflux, the management of plaintiff would have been the same. There is nothing in plaintiff’s medical record or operative report that would indicate she had a history of GERD or acid reflux, and knowing that she did would not have made any difference in the care and treatment rendered to her by defendant or change the events that occurred during her January 7, 2022 surgical procedure. Rather, even in the face of such history, the anesthesia plan was appropriate and in accordance within the applicable standards of care. 9 8739932 FILED: KINGS COUNTY CLERK 01/16/2023 09:29 AM INDEX NO. 514577/2020 NYSCEF DOC. NO. 95 RECEIVED NYSCEF: 01/16/2023 33. Further, it is my opinion within a reasonable degree of medical certainty that the positioning of plaintiff in a prone position was within good and accepted medical practice. Anesthesiologists are not the physician in a surgical operating room deciding what position the patient should be placed in for an upcoming surgical procedure. That decision is left to the hands of the surgeon, which is what happened in plaintiff’s case. Dr. Diwan chose the prone position as he was the physician performing the Corner-Loc procedure and needed plaintiff to be in a certain position to do his surgery. As described by Dr. Diwan, it was critical for him to position plaintiff in a prone position as he needs plaintiff’s body in a particular curve in order to reach the lower part of her spine. Therefore, plaintiff’s allegation that defendant failed to timely and properly position plaintiff is simply not the case as positioning the plaintiff is within the surgeon, Dr. Diwan’s, domain. The responsibility of the anesthesiologist is to make sure that no pressure points are damageable once the plaintiff is positioned. In addition, plaintiff’s argument that defendant did not position plaintiff’s head higher than her abdomen during the surgical procedure and timely place her head in a tilt down position is also without merit. 34. It is my opinion within a reasonable degree of medical certainty that defendant made sure that the plaintiff’s upper torso, including her head, neck, and arms, were placed in a comfortable and safe prone position as is the usual customary practice of the anesthesia team. Positioning of plaintiff during surgery is within the domain of Dr. Diwan and, regardless of who put plaintiff in the prone position, it was the proper position for her to be in and ended up being beneficial to plaintiff. Once there were secretions that were recognized and led to the patient coughing, being in the prone position allowed any and all secretions to drain from her mouth and/or nasal cavity and not pool in the inside of her throat. If plaintiff were to be placed supine, her regurgitation could have pooled in the back of her throat and led to aspiration. Subsequently, there 10 8739932 FILED: KINGS COUNTY CLERK 01/16/2023 09:29 AM INDEX NO. 514577/2020 NYSCEF DOC. NO. 95 RECEIVED NYSCEF: 01/16/2023 was no additional need to change plaintiff’s position, as the prone position was the most favorable position for her to be in for the surgical procedure, for the removal of any regurgitated material, and once plaintiff coughed up secretions, the surgical procedure was stopped, plaintiff was awakened, and evaluated accordingly to determine the best plan of action to move forward. Given her vital signs, the surgery could have continued as planned. Thus, the surgical procedure and anesthesia were within good and accepted medical practice and there was no deviation from the standard of care. 35. Additionally, it is my opinion within a reasonable degree of medical certainty that there was no need to intubate plaintiff. Defendant chose MAC sedation as the anesthetic choice for plaintiff’s surgical procedure, a procedure that did not require intubation. Under MAC sedation, the patient is relaxed, calm, retains control of their airways, and are somewhat aware of their surroundings, but comfortable during the surgical procedure. General Anesthesia is deeper form of anesthesia where the patient is unconscious and might need assistance in respiration. Intubation is often required when a patient undergoes General Anesthesia. Intubation is when a tube is placed down the patients throat and into their trachea to maintain an open airway so they can breathe. The risks associated with intubation are injury to the throat and trachea, bleeding, lung complications, vocal cord damage, and aspiration as well. 36. Therefore, defendant and CRNA Week’s assessment when plaintiff coughed up secretions to wake her up from MAC anesthesia and proceed with the surgery under light sedation instead of changing course to induce General Anesthesia and intubation was within good and accepted medical standards. “Coffee colored” secretions in and of itself are not alarming or a cause for concern. Regurgitation is always expected to some extent and the anesthesia team takes all 11 8739932 FILED: KINGS COUNTY CLERK 01/16/2023 09:29 AM INDEX NO. 514577/2020 NYSCEF DOC. NO. 95 RECEIVED NYSCEF: 01/16/2023 necessary and proper precautions to manage the regurgitation. Further, the color of the secretions does not determine the level of acidity of stomach contents. There was no indication physiologically that the patient aspirated these secretions into her lungs, nor was there any physiological need for intubation at all. As explained by defendant, and in which I am of the same opinion, the risk to induce general anesthesia was far greater, and includes flipping the patient over and abandoning the procedure, then proceeding with light sedation. As evidenced by the medical records, there was no reason to intubate plaintiff as she remained stable under light sedation, had no further secretions, mild regurgitation happens all the time and is a potential side effect of being under mild anesthetics, and the surgery was successfully completed without further complication. In addition, discharge after plaintiff’s procedure was appropriate as there were no complications or cause for concern. Plaintiff’s post-procedure course while in recovery was uneventful, her vitals maintained stable, and there were referrals to an emergency department or documented complaints. 37. Further, plaintiff’s claim that defendant failed to recognize the significance of plaintiff coughing throughout the Corner-Loc procedure is baseless. Regardless of the fact that there is no indication in any of the records or depositions that would lead me to believe that plaintiff was coughing throughout the entire procedure, plaintiff having coughed during the procedure is a good sign as it reflects that a patient is not so deep under anesthesia with an inability to control their breathing or upper airway reflexes. Coughing during a procedure in and of itself is not a sign that plaintiff cannot breathe or is facing airway complications but is evidence that she has control of her airways and is attempting to clear out her throat from any irritants. 38. In furtherance of my opinion that defendant did not deviate from the standard of care once plaintiff coughed secretions, suctioning of plaintiff’s throat and nose were not necessary. 12 8739932 FILED: KINGS COUNTY CLERK 01/16/2023 09:29 AM INDEX NO. 514577/2020 NYSCEF DOC. NO. 95 RECEIVED NYSCEF: 01/16/2023 Suctioning was not necessary as any secretions were drained by gravity. Even though it was not necessary, CRNA Weeks testified that she suctioned plaintiff and nothing was able to be suctioned out as all secretions drained naturally on their own. It is my opinion within a reasonable degree of medical certainty that the maintenance of the plaintiff’s airway and all secretions were managed appropriately by CRNA weeks. 39. Plaintiff’s allegation that defendant failed to timely administer anesthetic medications to decrease the chance of aspiration and failed to timely and properly administer H2 Blockers, Proton Pump Inhibitors, and Prokinetics is likewise baseless and without merit. H2 Blockers reduce the amount of stomach acid secreted by the glands in the stomach, Proton Pump Inhibitor’s reduce stomach acid, and Prokinetic’s help control acid reflux. These medications, along with any other medications known to reduce the risk of aspiration, were not necessary to administer to plaintiff. Plaintiff exhibited no signs, symptoms, or advised her physicians of a medical history with GERD or acid reflux. Without any reason to believe plaintiff would need any of the above stated medications, there would be no reason to administer them. Aspiration is a known risk associated with any and all anesthesia. Medications should not be given to any patient unless they have a history with GERD or acid reflux which would indicate a higher risk associated with aspiration. Plaintiff did not report a history of GERD or acid reflux and did not inform any of three medical providers who took her history that day of any history. Therefore, it is my opinion within a reasonable degree of medical certainty, there was no deviation from the standard of care in the administration of any medications given, or not given, to plaintiff by defendant and CRNA Weeks. 13 8739932 FILED: KINGS COUNTY CLERK 01/16/2023 09:29 AM INDEX NO. 514577/2020 NYSCEF DOC. NO. 95 RECEIVED NYSCEF: 01/16/2023 40. Defendant, CRNA Weeks, and Dr. Diwan, were in constant communication throughout the entirety of plaintiff’s surgical procedure. It is my opinion within a reasonable degree of medical certainty that the communication testified to between Dr. Diwan, defendant, and CRNA Weeks, was well within the standard of care. Defendant, CRNA Weeks, and Dr. Diwan all testified that they were in the room during the surgical procedure and cough episode, decided together as a surgical team to wake up plaintiff, and the plan to proceed with light sedation. This was a team of doctors and staff who communicated to each other and made decisions together based on the best course of treatment for plaintiff. There is no evidence to suggest otherwise. It is in my opinion within a reasonable degree of medical certainty that all communications testified to were within the accepted standards of care. 41. Lastly, it is my opinion within a reasonable degree of medical certainty that defendant’s written consent form and explanation to plaintiff was within the standard of care. Informed consent is a crucial and critical step before any patient is put under anesthesia or sedation. There is always risk associated with any surgical procedure and anesthesia. The written consent form, along with the doctor’s explanation, details the associated risks, any complications related to sedation and general anesthesia, any outcomes, and alternatives. Defendant testified, and the written consent forms show, that he informed plaintiff of any associated risks, complications, outcomes, and alternatives. Plaintiff testified that she signed the consent form for anesthesia and understood the risks associated with anesthesia. Such risks include, transient breathing difficulty, brain damage or stroke, heart attack or other heart damage, hoarseness or voice change, need for medical breathing assistance, and the possibility that general anesthesia will be needed. Further, plaintiff’s alleged injuries are a known potential side effect of being under MAC sedation. It is 14 8739932 FILED: KINGS COUNTY CLERK 01/16/2023 09:29 AM INDEX NO. 514577/2020 NYSCEF DOC. NO. 95 RECEIVED NYSCEF: 01/16/2023 my opinion within a reasonable degree of medical certainty that defendant obtained informed consent and there was no deviation from the standard of care. 42. In sum, it is my degree within a reasonable degree of medical certainty that the January 7, 2020 administration of anesthesia was properly administered and maintained by Dr. Amigud. Dr. Amigud, Dr. Diwan, and CRNA Weeks’ care and treatment of plaintiff was in accordance with good and accepted medical practice and did not deviate from the standard of care. For the reasons set forth in this Affirmation, it is my opinion within a reasonable degree of medical certainty that the allegations in plaintiff’s Bill of Particulars are not supported by the evidence and the case should be dismissed. Dated: New York, New York January 15, 2023 ___________________________ Dr. Marc S. Kanchuger, M.D. 15 8739932