Oral isotretinoin: 29 years of medical malpractice cases in the United States

• Published in: Journal of the American Academy of Dermatology 2021-08, Vol.85 (2), p.404-408
• Main Authors: Martell, David W., Ruhl, Douglas S.
• Format: Article
• Language: English
• Subjects: acne; adverse effects; isotretinoin; lawsuits; litigation; malpractice
• ISSN: 0190-9622; 1097-6787
• DOI: 10.1016/j.jaad.2016.12.025

Reviews of malpractice claims in the United States show trends of increasing payments with statistically higher payouts for more debilitating and permanent injuries. To examine lawsuits involving notable associated adverse reactions of isotretinoin. Court records of US legal trials from 1985 to 2014 were obtained from a major computerized database: LexisNexis. Data were compiled on the demographics of the defendant and plaintiff, litigation over adverse drug reaction, legal allegations, verdicts, and ruling decisions. Seventy unique cases met inclusion criteria and were selected for review. Forty-four cases cited physicians, and 26 cited a pharmaceutical company. When data from physician and pharmaceutical company litigations were combined, individuals 17 years or younger were more likely to be granted litigation outcomes in their favor compared with adults (P = .0016). Cases alleging failure to monitor were associated with an outcome in favor of the plaintiff (P = .0379). Cases settled or terminated before going to court could not be reviewed. Familiarity with malpractice trends through precedent-setting cases will increase physician awareness of common pitfalls, potentially mitigating litigation risk and improving patient care.