Off-label epidural steroid injections, or ESI, are used by millions of medical professionals to treat neck and back pain. However, patients often don’t realize “off-label” medical devices or medication are classified as such to highlight a crucial fact about their lack of FDA-approval. Though it does not require all products to obtain their approval, the FDA distinguishes off-label products as unregulated by the agency. ESI are quickly rising to the forefront as some of the most dangerous uses of off-label drugs, as the FDA does not approve corticosteroids for injection into the epidural spine.
In 2013, a 60-year-old woman underwent ESI with Kenalog, a drug which the FDA cautioned against its use of for epidural injection. After receiving 4 injections, she suffered a spinal cord infarction and lost complete sensation and motor function from the waist down. The patient pursued damages from the surgical center and was awarded $14.9 million. She will spend the rest of her life as a paraplegic as a result of this incident.
Informed Consent & Patient Safety
Ultimately, patient safety is of the utmost priority. As long as off-label medical products and drugs continue to raise questions about their risk-level, physicians and providers must ensure they uphold impeccable safety standards and employ effective patient communication before performing any procedures. If and only if patients are properly informed of any benefits, risks, or alternatives to their proposed procedure can they give or withhold consent.
Who is At Fault?
Physicians are not solely responsible for these errors. 2 years prior, the FDA had the opportunity to modify Kenalog’s warning label to read, “Not for Epidural Use.” This means whoever orders the medication should exercise a duty of care to alert the physician of any risks associated with the drug. The patient’s nurse is also responsible to a degree. He or she is accountable for ensuring the patient understands what is about to happen as well as ensuring the proper medication is administrated correctly. However, a medical professional’s liability doesn’t end there. If the nursing team is unfamiliar with Kenalog and it’s potential aftereffects, it is up to them to educate themselves on the matter.
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