Off-label use of bone morphogenic protein for spinal fusions has been widespread for years and could expose surgeons to malpractice allegations. But how often do those allegations lead to plaintiff wins?
Not often, according to a study published in the journal Spine.
Researchers examined data from malpractice claims filed from 2000 to 2022 focused on spine and bone graft procedures. The study authors reviewed 971 claims and found 89 centered on off-label BMP use. According to the report, around 85% of BMP is used off-label as an alternative to autologous bone graft.
There were 30 cases naming the surgeon as the defendant and half of the cases alleged the patients weren't sufficiently informed of BMP use. Adverse events mentioned in the lawsuits included ectopic bone growth that left the patient in chronic pain or caused nerve damage.
"Though off-label use of BMP may incite litigation, the findings suggest court rulings are favorable for defendants, as zero cases resulting in plaintiff verdicts," the study authors concluded. "Nevertheless, surgeons should balance the potential benefits of off-label use of BMP with the increased risk of litigation, and it may be advisable to disclose the use of BMP, whether on-label or off-label, in the informed consent."