Medical Malpractice Litigation Due to Off-Label Use of Bone Morphogenetic Protein

Abstract

Study design: Retrospective cohort study.

Objective: To analyze the incidence and characteristics of malpractice lawsuits pertaining to the off-label use of Bone morphogenetic protein (BMP).

Summary of background data: BMP continues to be a popular alternative to the use of autologous bone graft during spinal fusion procedures. However, ~85% of BMP is used in an off-label manner, which may expose surgeons to claims of malpractice.

Methods: Westlaw and VerdictSearch were queried for malpractice claims filed between 2000 and 2022 using the keywords "bone graft" and "spine." Case inclusion criteria were defined as a plaintiff's basis of litigation resting on a claim of medical malpractice due to off-label use of BMP. Additional collected data included the date of the case hearing, plaintiff's sex and age, defendants named in the lawsuit, verdict ruling, location of the filed claim, payment or settlement amount, sustained injuries, and additional allegations.

Results: Of 971 claims reviewed, 89 cases were due to off-label BMP use. The posterior approach was identified as the most common approach among the 89 cases. Of the 30 cases naming a surgeon defendant, 50% included allegations of insufficient informed consent. The most frequent adverse events were ectopic bone growth resulting in chronic pain or nerve damage. Zero cases involved heterotopic ossification, wound dehiscence, graft subsidence, hematoma, bladder retention, or retrograde ejaculation.

Conclusion: A clear understanding that on-label BMP use is specific to single-level, anterior or anterolateral approaches between L2-S1 with vendor-specific cages is crucial for mitigating malpractice disputes. 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. 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.