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Botulinum neurotoxin-related lawsuits rare; most involved therapeutic applications

Very few cases of botulinum neurotoxin-related complications led to lawsuits and those that did were more likely to result from therapeutic rather than cosmetic applications, according to recent study results.

Researchers used the LexisNexis Academic database to search for federal and state legal cases between Jan. 1, 1985 and June 11, 2012 related to clinical complications of botulinum neurotoxin (BoNT) products. Search terms included generic names, trade names and pharmaceutical companies that produce FDA-approved BoNT products. Researchers also searched newspapers and wire services and included BoNT generic or trade names and legal terms.

Twenty-four relevant cases were identified, with 21 filed in state courts. In each case, the plaintiff alleged adverse events (AE) from onabotulinumtoxinA, and its manufacturer, Allergan Inc., was named as defendant. RimabotulinumtoxinB, abobotulinumtoxinA or incobotulinumtoxinA were not involved in any case. Physicians were co-defendants in three cases, one that included a dermatologist. OnabotulinumtoxinA was used therapeutically to treat migraine headaches, cervical dystonia, limb spasticity and hyperhidrosis in 16 cases.

Five jury trials were conducted, and in two cases, plaintiffs were awarded damages of $15 million (cosmetic use, resulting in alleged muscle weakness, paralysis and severe pain) and $212 million (therapeutic use, resulting in alleged brain injury and severe immune reaction), respectively. In the trial where the dermatologist was the co-defendant, the jury decided against the plaintiff. Ten cases were dismissed against Allergan, and six were settled.

“Considering that an estimated 2.6 million cosmetic BoNT type A injection procedures were performed in 2011, the small number of lawsuits is striking,” the study authors wrote. “The low rate of legal action is probably related to the overall low rate of serious AE … [and] the transient nature of toxin effect typically results in time-limited AE that partially or completely resolve before legal action can be initiated.”