Litigation Involving Intravitreal Injections in Ophthalmology: A Review of Legal Claims and Outcomes

Summary

Intravitreal injection litigation – 3 key causes are procedural lapses, poor informed consent, and regulatory failures. Retrospective, Westlaw database, 60 lawsuits.

Abstract

Purpose: Intravitreal (IVT) injections are among the most commonly performed procedures in ophthalmology. Although generally safe, they do carry some risk. This study aimed to characterize lawsuits related to IVT injections and identify trends and actionable insights relevant to clinical practice and patient safety.

Design: Retrospective medicolegal case review.

Subjects: Sixty IVT injection-related lawsuits.

Methods: The Westlaw database was queried for lawsuits involving IVT injections from 2000 to 2025 using key search terms. Trial court documents, trial court orders, cases, verdicts, and settlements were reviewed. Because all data were publicly available, institutional review board review was not required.

Main outcome measures: Case characteristics and litigation outcomes cited in lawsuits.

Results: Sixty IVT-related lawsuits were identified. Louisiana (32%) and California (20%) were the most commonly involved states. The most frequently cited agents were triamcinolone (33.3%), brolucizumab (13.3%), and bevacizumab (13.3%). Male patients comprised the most common plaintiff group (43%). Lawsuits against physicians accounted for 13% (n = 8) of cases, often involving male attending physicians (75%), Veterans Affairs settings (63%), and residents (38%). Common allegations included injection-related injuries and delayed treatment. Outcomes were primarily in favor of the defendant (50%), followed by settlements (undisclosed) in 2 cases (25%): 1 in favor of the plaintiff with an award of $1 607 683 (12.5%) and 1 with an unknown outcome (12.5%). Lawsuits (n = 37) against manufacturers commonly cited product liability (97%) and failure to warn (94%) as the legal claims, and often involved contaminated injections (57%). Twenty-nine cases (78.4%) were settled, including 18 patient claims against manufacturers (median settlement: $193 563; interquartile range [IQR]: $109 118-$258 161), 7 cases (18.9%) were decided for the defendant, and 1 (2.7%) for the plaintiff. Fifteen cases involved fraud claims, primarily Medicare fraud (n = 8) and improper billing (n = 4); among these, 4 were settled, 4 decided for the plaintiff, 4 for the defendant, and 3 remain ongoing. Eight fraud cases included financial awards (median: $2 335 919; IQR: $366 169-$34 999 361).

Conclusions: Three key areas of vulnerability emerged: procedural lapses, inadequate informed consent, and regulatory failures. Addressing these issues may reduce litigation risk and enhance patient safety surrounding IVT injections.