Your Practice Made Perfect
This podcast series provides support, protection, and advice for today’s medical professionals. Brought to you by SVMIC, a mutual insurance company that is 100% owned and governed by our policyholders.
Aug. 31, 2018
Episode 031: The Case of the Black Box Warning
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"Indefensible Medicine" by Stephanie Deupree
Speaker 1: You are listening to Your Practice Made Perfect; support, protection and advice for practicing medical professionals, brought to you by SVMIC.
Brian: Hello and welcome to this episode of our podcast. My name is Brian Fortenberry. Today, we are going to look at a closed claim case here that is very interesting, and it looks like it could be tragic as well. We're going to get into the discussion and a synopsis of that in a minute, but joining me today to help make all of this make a little more sense is attorney Stephanie Deupree. Stephanie, thanks for being here.
Stephanie: Thanks for having me.
Brian: So, before we get into the case itself, Stephanie, why don't you tell our listeners a little bit about yourself, your background, your experience, and your time at SVMIC?
Stephanie: Sure. I received my bachelor's in nursing after finishing undergraduate. I went on to work as a nurse for approximately four years before returning to school. I went to law school after completing that. I actually worked as a courtroom attorney defending medical malpractice cases. I came to SVMIC in 2010 and have been here ever since.
Brian: Well, fantastic and once again, thank you so much for being here today to discuss this case. Before we get into our discussion, we owe it to our listeners to give them a brief background about what this case is about. So, let's do that now. Nathan Brown, a 55-year-old man, fell from a six-foot ladder outside his home while working on a home improvement project. Mr. Brown was able to get up and ambulate after the fall. The fall caused pain from his left shoulder blade down his rib cage and coccyx. He took over-the-counter medication for pain.
The next day, his pain unresolved. Mr. Brown presented to Dr. Joan Everly's office where he was seen by Elaine Smithson, PA. Mr. Brown rated the pain as moderate in intensity with aggravating factors of coughing, general movement, and walking. On examination, PA Smithson noted pain in the neck, left shoulder, and back with movement and tenderness in the left rib cage and scapula.
PA Smithson ordered an x-ray series of the ribs. The study showed a displaced closed rib fracture and two other possible fractures. PA Smithson planned to repeat the x-ray in two weeks. She prescribed Lortab and Flexeril and instructed Mr. Brown on heat therapy, ice therapy, and rest. The office scheduled a follow-up appointment for Mr. Brown in two weeks.
On the following day, Mr. Brown called the practice to report an increase in pain. NP Smithson prescribed Percocet, because the Lortab and Flexeril were not providing adequate pain relief. The Percocet failed to relieve Mr. Brown’s pain. In fact, Mr. Brown reported his pain as worsening when he went to the clinic again the next day.
At this second visit, he saw Lorelai Broadnax, NP. After examination, NP Broadnax decided to order a CT without contrast to further evaluate Mr. Brown’s chest. Unsure of how to treat Mr. Brown’s pain, NP Broadnax consulted with Dr. Everly, who recommended a Fentanyl transdermal patch but did not provide any guidance on dosing. Neither Dr. Everly nor NP Broadnax had previously prescribed a Fentanyl transdermal patch.
According to the visit note, NP Broadnax prescribed Fentanyl transdermal patch 40 mcg/1 dose apply 1 to clean, dry, intact skin every 72 hours for severe rib pain. However, Mr. Brown left the office with a prescription for Fentanyl transdermal patch 75 mcg/1 dose apply 1 to clean, dry, intact skin every 72 hours for severe rib pain. Mr. Brown went to the hospital for the CT scan before having his Fentanyl transdermal patch prescription filled and going home.
Late that afternoon, NP Broadnax checked to see if Mr. Brown’s CT results were ready. The report had not been dictated so NP Broadnax called Mr. Brown’s home and advised his wife that the results were not back yet. Mrs. Brown reported that Mr. Brown had applied a Fentanyl transdermal patch and was feeling better. NP Broadnax told Mrs. Brown she would call the next day when the CT results became available.
The next morning, Mrs. Brown called the office around 7:30 a.m. to report that Mr. Brown had been sleeping since 8 p.m. the night before and was not waking up. NP Broadnax spoke with Mrs. Brown and told her to check Mr. Brown’s breathing. Mrs. Brown assessed her husband and said he was snoring and his breathing was okay. NP Broadnax informed Mrs. Brown that the pain medication would make Mr. Brown sleepy and that she should continue to check on him periodically.
Around 10:30 a.m., NP Broadnax called the Brown home to inform Mr. Brown of his CT results. Mrs. Brown answered the call. While discussing the CT results, Mrs. Brown went to check on Mr. Brown. He was unresponsive, and Mrs. Brown told NP Broadnax that she did not think he was breathing. When NP Broadnax asked if the chest was moving, Mrs. Brown responded, “No.” NP Broadnax told Mrs. Brown to call 911 immediately.
The clinic staff later learned EMS could not resuscitate Mr. Brown. The medical examiner performed an autopsy. The autopsy report listed acute Fentanyl toxicity as a contributing cause in Mr. Brown’s death. Mrs. Brown filed suit against Dr. Everly and NP Broadnax.
Stephanie, obviously, a very tragic outcome in a case that all really began with a fall off of a six-foot ladder, trying to do a home improvement project. What kind of factors could make a physician instruct her NP to prescribe a medication neither was familiar with? That was kind of surprising.
Stephanie: I think there are a couple of factors that we have to look at. The first one is there are new medications coming on to the market all the time. In this instance, the Fentanyl patch was not new, but that is a scenario that we do see where a doctor may instruct their advanced practice provider to prescribe a medication that neither one of them is familiar with.
In this instance, I think the physician was trying to be helpful. Most physicians want to help. They see a problem and by nature, they want to fix it. This patient was in pain. Previous attempts at resolving the pain were not successful. Perhaps the doctor had heard of success with Fentanyl patches relieving pain from a colleague or perhaps something that she read in the literature. So again, I think this physician was trying to be helpful, and so was the advanced practice provider.
Of course there's nothing wrong with that. You just have to be mindful of the risk of medications, and there are numerous resources out there that they could have availed themselves of to better inform their decision and to make sure that there was appropriate dosing if they chose to continue with the Fentanyl after reading all of the warnings.
Brian: There was obviously no malicious intent here. They were just wanting to help the patient, and you can certainly appreciate that. Now I am not by any stretch of the imagination an expert when it comes to Fentanyl or anything of that nature. However, I understand that these Fentanyl patches have a black box warning on them. Did either provider realize this and the contraindications it would have for, say, an opioid naïve patient?
Stephanie: No, unfortunately not. Neither provider took the time to avail themselves of a PDR or an online resource or anything of that nature that would have shown the black box warning. They did not become aware of the black box warning until after the fact, until it was too late.
Brian: Really, that is probably a big part of this, is the fact of just the danger of prescribing something you're just not that familiar with, wouldn’t you say?
Brian: So, how does this case illustrate a good communication between a physician and an advanced practice provider under their supervision? Because that seems to be a key component here is you're seeing these nurse practitioners that are associated with the supervising physicians.
Stephanie: Well, actually, I don't think this case illustrates good communication whatsoever. I think quite the opposite. I think it shows you what not to do. There should have been more dialogue between the doctor and the nurse practitioner or questions asked, more follow up on both ends. The physician should have looked up the medication or at least delegated that task to the nurse practitioner. If she was unsure about the dosing or anything regarding the medication, had she noticed the contraindications, whatever the case may be, she should have gone back to her supervising physician and made her aware and asked questions. They could have called another physician, a pharmacist, any number of colleagues, but there should have been better communication between the two of them to hopefully prevent this type of tragic outcome.
Brian: This was indeed, as you say, a tragic outcome in this situation. What was the outcome of the lawsuit itself here, Stephanie?
Stephanie: This lawsuit was settled. Unfortunately, there just were not any mitigating factors in this situation. There was a lack of communication. There was a lack of documentation, and in fact, the dose that the nurse practitioner meant to write for is not an existing, or at least not at the time, an existing dose of the Fentanyl patch.
Brian: Wow. That goes to the lack of knowledge, obviously, when it came to these Fentanyl patches.
Stephanie: That's right.
Brian: What are some main takeaways that physicians and healthcare providers listening to our podcast can use from this case in particular to maybe help them and assist them in their practice moving forward?
Stephanie: Stop and take the time to look up new or unfamiliar medications. You're going to encounter new and unfamiliar medications probably on a regular basis, but you owe it to yourself and to your patient to take the time, look it up, follow up. You also want to document your reasoning for prescribing a medication that may be for an off-label reason. If there are contraindications listed perhaps in a warning, you need to consider that. If you decide in your medical judgment to still prescribe the medication despite the warnings and potential contraindications, you need to address that in your note. You also, as I've mentioned before, want to consult with colleagues as necessary. Use your resources. Don't be an island.
Brian: That is certainly strong advice. That would be applicable not only for the people that were involved in this case with hindsight, but certainly any of these practitioners going forward. I really appreciate you taking the time, Stephanie, to be with us today.
Stephanie: Thank you.
Speaker 1: Thank you for listening to this episode of Your Practice Made Perfect with your host, Bryan Fortenberry. Listen to more episodes, subscribe to the podcast and find show notes at SVMIC.com/podcast. The contents of this podcast are intended for informational purposes only and do not constitute legal advice. Policyholders are urged to consult with their personal attorney for legal advice as specific legal requirements may vary from state to state and change over time. All names in the case have been changed to protect privacy.
The contents of this Podcast are intended for educational/informational purposes only and do not constitute legal advice. Policyholders are urged to consult with their personal attorney for legal advice, as specific legal requirements may vary from state to state and/or change over time. All names have been changed to protect privacy.
About our Guest
Stephanie Deupree is a Senior Claims Attorney in the Memphis office. Ms. Deupree received her Bachelor of Science in Nursing from the University of Alabama. She worked as a registered nurse prior to enrolling in law school at the University of Memphis, where she obtained her Juris Doctor. Following graduation from law school, she worked in private practice primarily defending medical malpractice claims. Ms. Deupree joined SVMIC in 2010.
About our Host
Brian Fortenberry is Assistant Vice President of Underwriting at SVMIC where he assists in evaluating risk for the company and assisting policyholders with underwriting issues. He has been involved with medical professional liability insurance since 2007. Prior to his work at SVMIC, Brian worked in the clinical side of medicine and in broadcast media.