The information below is taken from a letter dated February 24, 2017, that was mailed to, among others, the following Duke Hospital and Duke Raleigh Hospital doctors and executive staff:

David Zaas, MD [Note: Upon learning of Dr. Zaas’s cancer diagnosis, a letter was sent to acting President

Leigh Bleecker, MBA, MHA  Asst. VP Finance & Divisional CFO]

John M. Kelsh, MD [department head for emergency medicine refused to accept certified letters and both were returned to me]- [noteworthy – Dr. Kelsh was the ONLY one to refuse the two certified letters that were sent him this year]

Timothy Plonk, MD

Hershell Cassell, MD

Eugene Washington, MD, MPH, MSc, President & CEO of Duke University Health System

Martin Estok, MD

Scott Gersh, MD

FYI-  At the end of the contents of Page Six, I have placed a copy of the response letter dated September 16, 2011 received from Ted Kunstling, Chief Medical Officer for Duke Raleigh Hospital and co-signed on the original letter by John Kelsch, MD Emergency Department.

Contents taken from Page Two “Response to Doctors Letter” and ends on Page Six of the same letter:

“What the EMS personnel and I did not know was that Mark was suffering from a potentiation of CIPRO/Tizanidine and had been in that state for over an hour and a half.   There is no “magic bullet” antidote that will stop the CIPRO and Tizanidine potentiation. Once it is initiated, it has to run its course. As I stated above, the intensity of the event is governed by the dosage amount of Tizanidine that the patient has taken. That dosage level is potentiated by CIPRO seven to ten times the regular Tizanidine dose taken. In Mark’s case he had taken 12 mg. of Tizanidine. Following the established scientific nature of CIPRO/Tizanidine potentiation, within 2 to 3 hours, it is plausible and probable that the amount of Tizanidine in Mark’s body was 84mg to 120 mg. The CIPRO infusion, which Mark had been given on the 12^th, for want of a better word, had plumped up Mark’s body with the CIPRO antibiotic.   That infusion could have easily caused him to achieve the full 120 mg poisoning number. His taking of the additional 500 mg oral dose of CIPRO with his night meds was akin to pouring gas on a raging fire.

The following information is taken from the Duke Raleigh Hospital Emergency Department Nursing Flowsheet filed out by someone with the initials of KY.    Note: “K” stands for “Kaitlyn”  The “Y” is supposedly the first letter of Kaitlyn’s last name.      The first entry for the 08/13/2011 sheet is at 0123. The last entry is 0633.

0123: Pt. found by wife unresponsive on couch. Pt. breathing and was only aroused by physical stimuli. [Note: 911 WAS CALLED BECAUSE THERE WAS NO RESPONSE TO MY EFFORTS TO REVIVE HIM] Pt seen on 8/12/11 for rectal bleeding and abd in DRAH ED. Pt given 12 mg morphine and dilaudin 1 mg ED. And then took prescribed oxycodone and oxycontin at home @ home

NOTE: The discharging nurse gave me a prescription for Percocet for Mark. I told her that (1) Mark had stated he needed no pain medicine. He had his pain medicine at home.   (2) Mark was allergic/reactive to codeine and it was in his medical record. (3) She would not take the script back . Upon our arriving home I shredded that prescription]

— Pt. arrived per EMS responsive to voice commands. Speech sluggish and slurred Pt. unable to accurately remember pertinent information and pt falling asleep in the middle of being asked questions charge nurse Lee @ bedside IV access acquired (with) Liter NS hung wide open. Pt. BP 69/48 Head of bed lowered Pt. A/O x 3, face/smile symmetrical able to hold arms up in front of himself (with) equal strength and no drift. Pt. breathing (with) no difficulty pulse OX 98% on monitor. Pt. appears slightly pale, cap. Refill <2 seconds KY

Next entry is 9 minutes later:

0132: Dr. Cassell @ bedside pt. BP in 70”s, Narcan 0.2 mg. ordered. Pt. A/O x 3, still sluggish (with) slurred speech easily arousable. But sts he is very tired and falling asleep while being asked questions. KY

Next entry is 13 minutes later:

0145: Narcan 0.2 mg given (with) no response BP 79/51 respirations 16? HR 57 on monitor. Pt. still responding to commands and questions. KY

Next entry is 24 minutes later:

0209: Pt. resting easily arousable. Family @ bedside KY

Next entry is 51 minutes later:

0300: Second liter of fluid started Pt. sleeping but arousable to commands. KY

Next entry is 60 minutes later:

0400: Dr. Gersch @ bedside. Pt. awake answering questions. wife@ bedside. Pt. A/O x 3 easily arousable KY

Next entry is 30 minutes later:

0430: Pt. A/O x 3 easily arousable KY

Next entry is 63 minutes later:

0533: Pt. resting but arouses upon entrance to room KY

Next entry is 27 minutes later:

0600: Pt. resting and easily arousable   KY

Last entry is 33 minutes later:

0633: Pt. resting KY

Given the reality of how the sequence of events would have proceeded with a CIPRO/Tizanidine potentiation, it is impossible for the above Nursing Flowsheet to be a documented sequence of events as they would have actually occurred. It is my opinion that this entire flowsheet was created to fit an opiate drug overdose. The nurse “KY” entered in the notation that Pt was A/O x 3 throughout the narrative part of the Nursing Flowsheet. This grading system, used by medical personnel to evaluate a patient’s state of awareness, helps reveal levels of conscious functioning abilities as to who they are and where they are. The most common questions are:

(1) person — Can you tell me who you are ? A/O x 1

(2) place   — Do you know where you are?    A/O x 2

(3) time     —   Do you know what day it is?    A/O x 3

(4) event   —   Do you know what happened?   A/O x 4

The high amount of the potentiated Tizanidine overdose at 0123 would not have permitted any interaction with my husband by hospital personnel.   The “alternate facts” of face/smile symmetrical – able to hold arms up in front of himself (with) equal strength and no drift simply could not be possible.   The reality of the CIPRO/Tizanidine potentiation at 0123, would have dictated a catastrophic systemic Tizanidine poisoning event to be cascading throughout Mark’s entire body. The fact that he had taken his night meds at 11:00 PM, on Friday night, August 12^th, the timeline for the adverse interaction would have been at 2 hours 23 minutes. Total potentiating time for CIPRO/Tizanidine is 3 hours.   At his time of arrival to DRAH-ED Mark had not yet reached the 3-hour rule for maximum potentiation strength at 0123.   His blood pressure was continuing to decrease and the blood pressure readings recorded by “KY” in the Nursing Flowsheet are not reflective of what a severe potentiation of a CIPRO/Tizanidine hypotensive event would be. I witnessed blood pressure readings continuing down, with one such reading at around 0300 being 48/38.

Seeing my husband’s blood pressure that low alarmed me. I walked out of Mark’s room and confronted Dr. Cassell who was standing behind the nursing area near the computer. I asked him if my husband was going to die. He said that he did not know, that they were doing some tests. He said,   “We cannot get him to wake up.”   Again, as I had been doing, I told him that Mark had taken only his regular night meds. I started reciting the names of those drugs in his night meds. When I mentioned 12 mgs of Tizanidine, Dr. Cassell heard “12 mgs of Tizanidine”.   It stopped him dead in his tracks. He stuck his face in mine and said that I had to be mistaken, that I could not be right. When I told him that Mark had been taking that same dose at night since 2005, his reply was “No doctor in his right mind would have prescribed that dosage amount for a patient.” I replied that Rex Pain Management had made 12mg of Tizanidine part of Mark’s treatment plan for back pain. By the time I was finishing that sentence, I was talking to Dr. Cassell’s back. He was hurriedly walking towards what I thought might be offices at the back of the ED.  I walked back to Mark’s bed and saw that his blood pressure reading had gotten lower while I had been talking with Dr. Cassell. I performed a capillary refill test on Mark. Squeezing his finger nail bed, upon release of the pressure, I was able to count to 4. Previously, at home I had checked Mark’s capillary refill response. It was almost 3. I looked at my husband’s face and all I saw was what I had been seeing, still and expressionless. He looked to be in no pain. In tears, I continued praying and asking God to help Mark. It is worth noting here that in the Nursing Flowsheet, under the 0123 entry, Nurse “KY” noted a “cap refill of <2”.

It was almost 4:00 AM when medical staff began arriving to observe my husband’s rapidly deteriorating condition. CIPRO/Tizanidine potentiation causes severe hypotension. Without good blood pressure our bodies cannot have sufficient flow of blood and oxygen carried to the brain, the optical and auditory systems, kidneys, thyroid and other organs in the body.   Mark was in acute kidney failure and his thyroid had stopped functioning in the Emergency Department. His other body systems and organs were also experiencing damage. It is not probable or logical to think otherwise. Post injury tests performed after Mark’s devastating hypotensive event in the DRAH-ED would later reveal injuries consistent with a severe and near fatal CIPRO/Tizanidine potentiation.

If you return to the information in the Nursing Flowsheet on pages 3 & 4 of this letter, the omission of any reference to CIPRO/Tizanidine potentiation stands out. Even when Mark was admitted as an in-patient to the hospital there is no mention of the CIPRO/Tizanidine potentiation happening. The omission of this information greatly hampered my efforts to communicate with other health care providers. Actually, it proved to be a bone of contention with certain health care providers that were familiar with both Mark and me. It is probable that it also placed limits on the attorney who was trying to help us to be fairly compensated for injuries and disabilities caused to Mark by the deadly CIPRO/Tizanidine adverse event.  Like us, they had no idea that Mark’s medical record of events on the dates of August 13–16, 2011, at Duke Raleigh Hospital & Emergency Department were not accurately documented.

When I confronted Dr. Estok on the morning of August 16, 2011, with my knowledge and awareness as to the CIPRO/Tizanidine adverse event in the early morning of August 13, 2011, he seemed astonished.   He made the comment, “well, that explains the reason that the Narcan did not work in the ambulance.” At the time he made that comment I wasn’t thinking about the doses of Narcan given to Mark. It was only much later that I keyed in on what he had said about that ambulance dose of Narcan. After I confronted him about what had happened, it wasn’t very long until the nurse came in and said that Mark was being released.   DRAH did release Mark that day and I brought him home. Looking back now, I realize just how fortunate we were that Mark left that hospital alive. I am also thankful that at that time, I did not have knowledge of the coming hell that Mark and I would walk through together. I had no idea at what cost the upcoming battle for Mark’s life was going to have upon both our families and us.

In the early morning hours of August 13, 2011, it had to be Duke doctors and a Duke nurse who decided to create the fictional “truth” as to what the admitting condition and subsequent condition entries of my husband actually were. However, they failed to do the one thing that was critical to their narrative being able to stand on what they had written. Not one of them understood, or, and this is my personal opinion here, had a clue about the vast amount of scientific facts that have been established and published during in the past 10 years as to how devastating to the human body a CIPRO and Tizanidine potentiation is.  The inconvenient truth for them was that based on their written statements of Mark’s condition they proved themselves to be untruthful. At the time of Mark’s admittance to DRAH=ED, using the manufacturer of Tizanidine’s formula for calculating potentiation strength, speed and time for maximum Tizanidine poisoning to occur, Mark would have had an amount of Tizanidine in his body at 84 mg to 120 mg. It would have rendered Mark physically and mentally incapable of being in any state of consciousness. That is a documented scientific fact. That fact allows for no other “truths” to be the reality of his condition.

By their actions of slanting Mark’s real diagnosis of CIPRO and Tizanidine potentiation to read more like one of an opiate overdose, it biased the treatment options open to him. Doctors that were consulted for advice trusted the Duke medical records about what had occurred at the hospital. They relied on the written reports and because of that he was seen as an opiate overdose patient. Mark was so sick he could not present his own case to new doctors. Had those doctors received the real facts from Duke about Mark’s condition being due to the CIPRO/Tizanidine hurricane that all but took his life, it is my sincere feeling that they would have responded differently.

On August 19, 2011, I did send out a letter to DRAH telling them about what had happened to Mark. On September 16, 2011, I did receive a letter reply from Ted Kunstling, Chief Medical Officer and co-signed by John Kelsch, MD Director of Emergency Department.   It was a nice sterile answer to someone who has submitted a complaint letter. When I look at this letter now, I have to wonder if they knew about the real facts that were responsible for what happened to my husband. I certainly know now that we had no idea of it at the time of his crisis. I wonder if they knew about the apparently false information that was placed in Mark’s medical record. I most certainly did not! Sometimes I catch myself thinking about how many more patients have had medical records compromised in similar situations. My belief is that there are many. Falsification of medical records whether accidental or intentional is a betrayal of the public trust and it is a crime.”

In the above paragraph, I mentioned a letter that I received dated September 16, 2011,  from Chief Medical Officer Ted Kunstling and co-signed by John Kelsch, MD, Director of the Emergency Department.  In that letter, Dr. Kunstling admitted that upon further investigation, he had confirmed that Mark had suffered from a drug interaction.  Here’s a copy of that letter for your convenience.  A copy of this letter will be placed in the web page document library.  Note, John Kelsch’s signature stands out on the original copy.

[I DukeMedicine                                                       Duke Raleigh Hospital

Ted A. Kunstling, M.D., F.C.C.P.

Chief Medical Officer

September 16, 2011

Mr. and Mrs. Mark Carter

5951 Hwy 96 West

Youngsville, NC 27596

Dear Mr. and Mrs. Carter:

We are in receipt of your letter of August 19; 2011, regarding Mr. Carter’s recent experience at Duke Raleigh Hospital. Your letter is a very eloquent description of the potential devastation that drug interactions could have on our patients.

First of all, we hope Mr. Carter has fully recovered from what was likely a drug interaction, in addition to his probable colitis. Thank you for taking the time to communicate with us about his experience as we take medication safety seriously and seek to learn from events of this type. While Duke Raleigh does not yet have an electronic system that would alert the physicians to a drug to drug interaction such as Cipro and Tizanidine, it wes not mean that we cannot assess our current state, research what is available and amend our processes.

These discussions are currently ongoing between the Director of Pharmacy, Patient Safety Officer, Emergency Department Physicians and Hospitalists.

Finally, prevention of future reactions depends on everyone’s alertness – physicians, pharmacists and patients. We are confident that you will share this reaction in detail with your health care providers in the future. We understand that you made a mindful decision regarding the use of two different pharmacies for your family but there may be merit in obtaining all prescriptions from a single pharmacy as some are able to provide alerts of drug interactions if all drugs are on record in one location; you might ask about this.

Thank you for the opportunity to respond to your concerns regarding your recent experience at Duke Raieigh. Again, we regret that both of you suffered this experience, and we recognize that you have awarded us the opportunity to correct this concern. At Duke Raleigh we respect the privilege our community extends to us in delivering their health care. We hope that you will allow us the opportunity to rebuild your trust in the future. If you have further questions, Dr. Kunstling can be reached at 919-954-3106.

Respectfully,

!

/                        t\

Ted R. Kunstling MD, Fct:P / Chief Medical Officer                             /

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