FDA Black Box Warning and Liability

“Dr Derm” has a thrivingcosmetic dermatology practice. He treats thousands of patients each year with a variety of lasers, fillers, and botulinum toxins. He uses all currently available neuromodulators. 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 that his treatment had nothing to do with her untimely death. Two months after her death, an attorney sent a letter to Dr Derm’s office asking for a copy of her medical records. Some 8 months later, he was served papers accusing him of medical malpractice in the wrongful death of his patient. The crux of the lawsuit hinged on the fact that Dr Derm was negligent in not warning his patient about the potential for death from botulinum toxins and not telling his patient about the black box warning associated with botulinumtoxin injections.

Any analysis of physician negligence must first begin with a legal description of the elements of negligence. There are 4 required elements for a cause of action in negligence. They are duty, breach of duty, causation, and damages. The suing plaintiff must show the presence of all 4 elements to be successful in their claim.

rawf8/Envato Elements

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 from a well-known textbook. It is also not articulated by any judge. The standard of care is defined by some as how an expert witness defines it 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 and have used the care and skill ordinarily possessed by a specialist in that field in the same or similar locality under similar circumstances. The dermatologist must also provide a patient with the reasonable risks of a procedure or provide the patient with the risks a reasonable patient would want to hear. A failure to fulfill such a duty may lead to loss of the lawsuit by that individual. If the jury accepts the suggestion that the physician mismanaged the case and that the negligence led to damages to the patient, then liability will ensue. Conversely, if the jury believes an expert who testifies on behalf of 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 anexpert physician.

Over a decade ago, the FDA mandated that industry must provide physicians, who would then provide 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 bythe FDA”

The basis of the lawsuit against Dr Derm is that he failed to provide this black box warning and his patient died without knowing that death could occur. Dr Derm will certainly contend that his patient’s death had nothing to do with the injection of botulinum toxin. More importantly, Dr Derm will contend that the 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 mandated black box warning without unduly frightening them.

There is no clear-cut answer to deal with this issue. Many suggest that a consent form should simply suggest that there is a black box warning and the dermatologist is happy to discuss it. Thankfully for Dr Derm, no physician has ever lost a case aboutthis issue.

David J. Goldberg, MD, JD, is medical director of Skin Laser and Surgery Specialists of New York and New Jersey; director of cosmetic dermatology and clinical research at Schweiger Dermatology Group in New York, New York; and clinical professor of dermatology and past director of Mohs Surgery and Laser Research at the Icahn School of Medicine at Mount Sinai in New York, New York.