When are you held accountable for relaying botulinum toxin risks to patients?

Key Points

One year ago, he treated a patient with botulinum toxin who, after paying her bill, died in his office from a heart attack. Although saddened by the death of his patient, he was somewhat comforted by the fact that his treatment had had nothing to do with her untimely death.

Two months after her death, an attorney sent a letter asking for a copy of her records. Dr. Cosmetic had never heard another word about the patient until last week, when he was served papers accusing him of medical malpractice in the wrongful death of his patient.

Elements of negligence

Any analysis of physician negligence must first begin with a legal description of the elements of negligence. There are four required elements for a cause of action in negligence: duty, breach of duty, causation and damages. The suing plaintiff must show the presence of all four elements to be successful in his or her claim.

The duty of a physician performing botulinum toxin injections is to provide appropriate consent and perform that procedure in accordance with the standard of care. Although the elements of a cause of action in negligence are derived from formal legal textbooks, the standard of care is not necessarily derived in the same fashion. It also is not articulated by any judge.

The standard of care is defined by some as whatever an expert witness says it is, and what a jury will believe. In a case against any physician performing procedures in the field of cosmetic dermatology, the specialist must have the knowledge and skill ordinarily possessed by a specialist in that field. Additionally, the specialist must have used the care and skill ordinarily possessed by a specialist in that field in the same or similar locality under similar circumstances.

Likewise, the dermatologist must inform a patient of the reasonable risks of a procedure or the risks a reasonable patient would want to hear. A failure to fulfill such a duty may lead to loss of a lawsuit by the dermatologist.

If the jury accepts the suggestion that the provider mismanaged the case, and that the negligence led to damage of the patient, then liability will be found.

Conversely, if the jury believes an expert who testifies for a defendant dermatologist, then the standard of care in that particular case has been met, and the physician will win against the suing plaintiff. In this view, the standard of care is a pragmatic concept, decided on a case-by-case basis and based on the testimony of an expert physician.

In 2009, the Food and Drug Administration (FDA) mandated that industry must provide physicians, who would then provide to prospective patients, the following cosmetic botulinum toxin warnings:

"Read this information this time and every time you get botulinum toxin. Share this information with your family and caregivers. Problems with swallowing, speaking or breathing may occur after your botulinum toxin injections. These problems may occur weeks after injections. Swallowing problems may require a feeding tube. Muscle weakness may occur all over the body. Loss over bladder control may occur and death can happen. These problems could make it unsafe for you to drive a car or do other dangerous activities. This medication guide has been approved by the FDA."

The basis of the lawsuit against Dr. Cosmetic is that he failed to provide the "black box" warning and his patient died without knowing that death could occur. Dr. Cosmetic will certainly contend that his patient's death had nothing to do with the injection of botulinum toxin. More importantly, Dr. Cosmetic will contend that warning about death from the cosmetic use of botulinum toxin is unreasonable (death has occurred when much larger quantities of botulinum toxins have been used for medical purposes). In fact, many physicians are grappling with how to provide patients with the now-mandated "black box" warning without unduly frightening them.

Dr. Cosmetic, in this instance, will win any lawsuit brought against him, because, at the time of his patient's death, there was no requirement to provide the "black box" warning. The standard of care is determined at the time of treatment, not at the time of filing of a lawsuit.

David Goldberg, M.D., J.D., is director of Skin Laser & Surgery Specialists of New York and New Jersey; director of laser research, Mount Sinai School of Medicine; and adjunct professor of law, Fordham Law School.