The patient had a history of chronic low back pain. In 2017, he had received a caudal epidural steroid injection that brought him complete relief for 2 years. In January 2020, he returned to his pain management doctor because his pain was back. The doctor performed the following:
- 1/22/2020: Caudal epidural steroid injection
- 2/5/2020: Bilateral lumbar L3/4 and L4/5 transforaminal epidural steroid injections
- 3/6/2020: "High LESI"
- 5/8/2020: "High LESI"
- 7/17/2020: "High LESI"
- 7/30/2020: possible "High LESI" (records unclear)
- 7/31/2020: Bilateral lumbar L3/4 and L4/5 transforaminal epidural steroid injections
The patient was scheduled for a percutaneous lumbar SCS trial on 8/21/2020, but was instead referred to the ED for elevated WBC counts "x2." He admitted to history of minimally productive cough, night sweats, and chills for several weeks to one month, but his main complaint was severe lower back pain. He was diagnosed with pneumonia and staph epidermidis bacteremia, with endocarditis. He was found to have extensive vegetation on his native tricuspid valve and on the RA lead of his pacemaker. Eight days later, he was also diagnosed with lumbar vertebral osteomyelitis / discitis of L4-5. He underwent numerous surgeries as a result.
Files:
Q: 1. Details of how epidural injections are needed. 2. Details about the medication injected and about the supplier of medication. 2. Lumbar spine imaging findings, spinal cultures. 3. Neurological findings.
A: —
Do you believe there might have been medical error?
While epidural steroid injections are common and safe, typically they are given in 3 to 6 month intervals for two reasons. 1) Pain relief typically is prompt and lasts for 3-5 months if administered properly. Subsequent injections often last for shorter durations but monthly injections is outside of the standard of care. 2) Frequent and frequent high dose epidural steroid injections carry with them added risk including: Infection Infections may occur generally within the body (systemic infection), affect the brain and/or spinal cord, or occur locally in the area of the injection. Examples include4: Epidural abscess: Accumulation of pus in the epidural space. Meningitis: Inflammation of the brain and spinal cord membranes. Osteomyelitis or discitis: Infection of the vertebral bone or disc. Soft tissue abscess: Accumulation of pus within the soft tissues at the site of injection
Do you believe there might have been causation (i.e. the medical error resulted in an injury)?
A breach of the standard of care (instrumenting the spine more frequently than a reasonable practitioner would, and administering a total cumulative dose of steroids higher than reasonable increases the risk for complications, in particular, infection.
What makes you a good expert for this case?
Not only do I have extensive experience reviewing medical malpractice cases, I also am a full-time clinician current and up to date on all the latest standards. I have taught at a majority of medical school and been published several times in peer-reviewed journals.
How often do you encounter cases similar to this one in your practice?
This complication is rare. I have seen it several times in my practice and reviewed a few cases similar to this. I am perfectly comfortable reviewing and rendering a confident opinion based on the facts.
Do you believe there might have been medical error?
Infection after multiple procedures. Likely faulty sterile technique. I've seen cases like this before.
Do you believe there might have been causation (i.e. the medical error resulted in an injury)?
Temporal relationship. The patient had a lot of procedures before the infection was noted. Patient suffered harm.
What makes you a good expert for this case?
I am a nationally recognized patient safety expert.
How often do you encounter cases similar to this one in your practice?
3times I've seen cases like this before.
Do you believe there might have been medical error?
There is a high probability that the epidural procedure introduced a bacterial infection. This may have occurred due to several possible reasons: 1. Sterile preparation and maintenance of sterile conditions were inadequate. 2. The medication used was contaminated either by the operator (by re-entering a previously used multi-dose vial without adequate sterile technique), or may have been contaminated at the pharmaceutical source (a notorious series of lawsuits involving spinal infections were directed against a compounding pharmacy having sold contaminated vials of injectable steroid for epidural use, under substandard conditions of manufacture (story reported nationally within the past 15-20 years). 3. Without adequate use or documentation of fluoroscopic findings at the time of injection, it is quite likely that one or more of the transforaminal injections actually entered the L4-5 disc space, which is notoriously susceptible to infection. The infection then spread to the adjacent vertebral bone, resulting in osteomyelitis and spread of infection via blood circulation (bacteremia) to the heart, resulting in the cardiac vegetations. If staph was cultured from the L4-5 disc and adjacent vertebra, and was identical to the staph found in the blood cultures and the cardiac vegetations) this would pretty much verify this hypothesis.
Do you believe there might have been causation (i.e. the medical error resulted in an injury)?
If there is no proof of pharmacy contamination, then the source of staph bacteria being introduced into the disc space falls on the care provider who performed the epidural injection, by way of faulty sterile technique. Staph is one of the most common skin bacteria, and staph infections result from a lapse in sterile technique at the time of needle placement, or introduction of bacteria into the medication vial through careless handling (performance of many procedures in a day). There is suggestion that the interventional pain practice responsible for this particular injection performs many injections given that the claimant was subjected to seven such injections over a six-month period, which would be considered unusually aggressive, with liability for other medical complications that are not detailed in the case report, such as osteoporosis or avascular hip necrosis or blood sugar complications. I am concerned that the claimant was experiencing symptoms of infection and severe back pain for several weeks without any appropriate action on the part of the care provider or providers who performed the epidurals, and that they were mainly interested in subjecting the claimant to yet another procedure (spinal cord stimulator insertion) without realizing that a serious infection had occurred. There is some suggestion of potential negligence, because any responsible interventionalist would recognize such symptoms immediately as a possible spinal infection and would address this urgently, and would not be planning on yet another spinal procedure (SCS).
What makes you a good expert for this case?
I have been in the practice of interventional pain management from 1987 through 2015, currently retired. I taught residents and fellows in training for 12 of those years. I have performed literally hundreds of these injections without complication, adhering to meticulous technique and published guidelines, making changes as necessary in consideration of the evolving medical literature and quality improvement. I have followed reports of complications from these procedures in professional publications, and have provided legal testimony in cases involving such complications.
How often do you encounter cases similar to this one in your practice?
In my 28 years of practice I have never experienced or been involved in a similar situation.
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