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

BACKGROUND: Reviews of malpractice claims in the United States show trends of increasing payments with statistically higher payouts for more debilitating and permanent injuries. OBJECTIVES: To examine lawsuits involving notable associated adverse reactions of isotretinoin. METHODS: 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. RESULTS: 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). LIMITATIONS: Cases settled or terminated before going to court could not be reviewed. CONCLUSIONS: Familiarity with malpractice trends through precedent-setting cases will increase physician awareness of common pitfalls, potentially mitigating litigation risk and improving patient care.

Medication associated with hearing loss: 25 years of medical malpractice cases in the United States.

OBJECTIVES: Many medications have the potential for ototoxicity. To potentiate management of this risk, this study examines malpractice litigation trends of lawsuits involving hearing loss associated with medication use. As experts in hearing loss, it may benefit otolaryngologists to be familiar with this information. STUDY DESIGN: Retrospective review. SETTING: All US civil trials. SUBJECTS AND METHODS: Court records of legal trials from 1987 to 2012 were obtained from 2 major computerized databases. Data were compiled on the demographics of the defendant and plaintiff, use of otolaryngologists as expert witnesses, medication used, legal allegations, verdicts, and judgments. RESULTS: Forty-six unique cases met inclusion criteria and were selected for review. Antibiotics (72%), specifically aminoglycosides (47%), were the most common medications cited as causing hearing loss. Eleven (22%) cases were resolved through a settlement before a verdict was reached. Verdicts in favor of the plaintiffs (37%) were awarded an average of $1,134,242. Pediatric patients were more likely to have outcomes in their favor (P = .03) compared to adults. Of the cases found in favor of the plaintiff, the most common reasons cited were inappropriate medication, dose, or duration (59%); failure to properly monitor (39%); and failure to choose a less toxic medication (18%). CONCLUSIONS: Physicians must be aware of the potential effects of the medications they prescribe. An understanding of potential drug interactions, proper monitoring, and appropriate substitution with less toxic medications are important to improve patient care. Analyzing litigation trends may be used to prevent future lawsuits and improve physician awareness.