Analysis of botulinum toxin products and litigation in the United States.

BACKGROUND

Botulinum neurotoxin (BoNT) has diverse cosmetic and therapeutic applications, spanning multiple medical specialties. Recent lawsuits alleging complications from its clinical use have raised significant questions about medicolegal risk.

OBJECTIVE

To identify and assess legal cases related to clinical complications of BoNT products.

METHODS AND MATERIALS: Using the LexisNexis Academic online database, a search of U.S. federal and state cases between 1985 and 2012 was performed. A second search of U.S. newspapers and wires was also completed. In all but one case, the plaintiffs' legal complaints were obtained for review.

RESULTS

Twenty-four relevant legal cases were found, mostly in state courts. All cases alleged adverse effects from onabotulinumtoxinA, and each named its manufacturer, Allergan, Inc., as a defendant. Most lawsuits against Allergan, Inc. were dismissed or settled. In three cases, physicians were codefendants, including one dermatologist. In two cases, jury verdicts resulted in multimillion-dollar judgments in favor of the plaintiffs. None of the lawsuits named a dermatologist when the complication arose from on-label indications and cosmetic use.

CONCLUSION

Lawsuits related to complications from BoNT products are uncommon, are more likely to result from therapeutic than cosmetic applications, and typically involve product liability claims against the manufacturer.