Medical Malpractice Litigation Due to Off-Label Use of Bone Morphogenetic Protein.
Journal
Spine
ISSN: 1528-1159
Titre abrégé: Spine (Phila Pa 1976)
Pays: United States
ID NLM: 7610646
Informations de publication
Date de publication:
15 Nov 2023
15 Nov 2023
Historique:
received:
03
10
2022
accepted:
08
12
2022
medline:
30
10
2023
pubmed:
3
2
2023
entrez:
2
2
2023
Statut:
ppublish
Résumé
Retrospective cohort study. To analyze the incidence and characteristics of malpractice lawsuits pertaining to the off-label use of Bone morphogenetic protein (BMP). 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. 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. 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. 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.
Sections du résumé
STUDY DESIGN
METHODS
Retrospective cohort study.
OBJECTIVE
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
BACKGROUND
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
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
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
CONCLUSIONS
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.
Identifiants
pubmed: 36728790
doi: 10.1097/BRS.0000000000004563
pii: 00007632-202311150-00004
doi:
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
1575-1580Informations de copyright
Copyright © 2023 Wolters Kluwer Health, Inc. All rights reserved.
Déclaration de conflit d'intérêts
W.C. is a Cervical Spine Research Society committee member. He reports paid consulting for DePuy, Orthofix, and Medtronic. Dr. Cheng owns stock from Presidyan, and receives research grants from Medtronic and DePuy. He also serves on the editorial board for the International Journal of Spine Surgery, and is a speaker for Radius and an expert witness for Exam Works. O.D. serves on the board of directors for the Musculoskeletal Transplantation Foundation. He performs consulting for Spineart and Stryker and receives royalties from Globus Medical. The remaining authors declare no conflicts of interest.
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