Testosterone therapy and lawsuits against prescribers: a legal case review from 2000 to 2024.

BACKGROUND

Testosterone therapy (TT) is widely prescribed for hypogonadism. It leads to symptomatic improvement but as with any medication carries risks, as outlined in US Food and Drug Administration (FDA) labels.

AIM: The current study analyzes TT lawsuits against providers to identify litigation patterns, adverse outcomes, and their implications, informing clinical practices for improved patient safety and reduced legal risk.

METHODS

We conducted a comprehensive search of the Westlaw and LexisNexis legal databases, covering cases from 2000 to 2024, using the keywords "testosterone" combined with "MD," "DO," or "Dr." We identified cases, excluding those against "Commissioner of Social Security" or ", Inc." entities, to narrow the focus to individual healthcare providers. A total of 306 cases from Westlaw and 683 from LexisNexis were reviewed. After applying the inclusion criteria, 25 cases were selected for final analysis, with data extracted on treatment type, adverse outcomes, provider specialty, and court rulings.

OUTCOMES: We sought to characterize common provider specialties, treatment patterns, adverse outcomes, and legal decisions associated with TT-related litigation.

RESULTS

Among the 25 cases involving TT, most involved internal medicine providers (12 cases, 48%), followed by family medicine (4 cases, 16%) and urology (2 cases, 8%). There were 3 cases from 2000 to 2010 and 22 cases from 2011 to 2023. The primary harms included withholding TT (10 cases, 40%), prostate cancer (4 cases, 16%), death (3 cases, 12%), cardiac events (3 cases, 12%), psychiatric effects (2 cases, 8%), and less frequent adverse outcomes, each observed in 1 case (4%), included virilization in female patients and infections or abscesses. Gels (6 cases, 24%) and testosterone injections (5 cases, 20%) were the most frequently involved treatments. Court rulings favored defendants in 9 cases (36%) and plaintiffs in 3 cases (12%). Nine cases (36%) were related to violations of the Eighth Amendment in incarcerated individuals. Seven cases (28%) remain unresolved.

CLINICAL IMPLICATIONS: Litigation related to TT often centers on nontreatment and oncologic complications, underscoring the need for guideline-concordant prescribing and thorough risk communication.

STRENGTHS AND LIMITATIONS: The strengths of this study include a two-decade review and focus on provider-level litigation patterns. Limitations include exclusion of settled or sealed cases, and absence of financial data or patient demographics. The small sample size may also limit generalizability.

CONCLUSION

TT-related lawsuits are increasing, particularly among nonurologists, highlighting the importance of documentation, risk stratification, and communication to reduce legal exposure and improve patient care.