Botulinum toxin treatments safe, but adverse event lawsuits on the rise

Boston - Botulinum toxin treatments are considered to be safe, particularly when used for on-label indications and in the cosmetic arena. A recent study finds, however, that lawsuits associated with botulinum toxin treatments are on the rise, underscoring the need for physicians to be wary and “handle with care.”

“The troves of clinical data gathered following millions of treatments suggest that botulinum toxin products are exceptionally safe, especially for cosmetic applications. Nevertheless, botulinum toxin lawsuits alleging complications from its clinical use are making headlines and given how ubiquitous these treatments have become in our specialty, practicing dermatologists may want to carefully consider how and in which scenarios they use the toxin,” says John B. Korman, M.D., department of dermatology, Massachusetts General Hospital, Harvard Medical School, Boston.

Adverse event cases

Dr. Korman recently conducted a review study to identify and assess lawsuits involving complications from the clinical administration of botulinum toxin products. Using the LexisNexis Academic online database, he conducted a search for federal and state cases filed between 1985 and 2012. He also performed a second search of U.S.-based newspapers and wires using the same research database.

Only cases that involved alleged adverse events arising from the cosmetic or therapeutic use botulinum toxin type A or botulinum toxin type B products approved by the Food and Drug Administration were included in the study. In total, 24 relevant legal cases were identified, of which three were tried in federal courts, while 21 remained at the state level.

“Our findings are very interesting and present two very contrasting sides to the story. Of the 27 years of data reviewed, we could only find 24 cases related to botulinum toxin complications, which is relatively quite a small number. However, two of the 24 cases have resulted in multimillion-dollar jury verdicts in favor of the plaintiffs,” Dr. Korman says.

Study data showed that all 24 cases alleged adverse effects from onabotulinumtoxinA, and each named its manufacturer, Allergan, as a defendant. Most of the lawsuits against Allergan, however, were either dismissed or settled. Sixteen cases involved therapeutic uses of onabotulinumtoxinA, including treatment of migraine headaches, cervical dystonia, limb spasticity and hyperhidrosis.

The data also showed that physicians, including a dermatologist, were codefendants in three cases, and none of the lawsuits named a dermatologist when the complication arose from on-label indications and cosmetic use.

Landmark case

Two of the cases generated multimillion-dollar judgments, Dr. Korman says, one of which was named by Lawyers Weekly USA as one of the top 10 jury verdicts of 2011, after a federal district court jury found Allergan liable for $212 million. According to Dr. Korman, this landmark case involved the therapeutic use of botulinum toxin that resulted in alleged severe immune reaction and brain injury.

“Looking at our own experiences as well as the study data, it must be said that botulinum toxin treatments are safe, especially for cosmetic applications, which is what is very pertinent for dermatologists,” he says. “However, it is important to remember that trial lawyers only have to convince a jury of peers and not a panel of physician scientists. Having said that, the facts do matter, but so does perception.”

Since the FDA initially approved the use of onabotulinumtoxinA in 1989 for the treatment of strabismus and blepharospasm - and further approved its cosmetic application in 2002 for the correction of glabellar lines - the potential utilities for the toxin have been ever expanding. With novel on- and off-label clinical uses and increased patient demand, several other botulinum toxin products have also gained FDA approval.

Along with the increase in popularity of botulinum toxin used for cosmetic and therapeutic indications - as well as the expanding potential clinical uses of the toxin - Dr. Korman says some lawsuits appear to be surfacing, albeit in small numbers when compared to the number of treatments being performed every day nationwide.

The reason for the relatively small amount of lawsuits seen, he says, could be related to the overall low rate of serious adverse events associated with botulinum toxin treatments as documented in the medical literature, or to the transient nature of toxin effect that typically results in time-limited adverse events that partially or completely resolve before legal action can be initiated.

According to Dr. Korman, “the sky is not falling,” but nevertheless, caution is warranted.

“Though lawsuits have been brought, their small numbers are reassuring. With the ever-increasing interest in cosmetic and medical botulinum toxin treatments, physicians should be informed about the medical-legal issues surrounding this very commonly performed treatment across different specialties,” Dr. Korman says.

Disclosures: Dr. Korman reports no relevant financial interests.