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    I used an FDA approved product off-label, now I have been sued

    David J. Goldberg, M.D. J.D.Dr. Hands, a prominent dermatologist, has recently been using hyaluronic acid fillers to treat aging hands. He knows that calcium hydroxyapatite filers are FDA approved for the hands; hyaluronic acid fillers, although FDA approved for several facial indications, are not cleared by the FDA for use on the hands.

    Recently, Dr. Hands injected a woman’s hands with hyaluronic acid and she unfortunately suffered a complications from the treatment. She has sued him for medical malpractice and alleges that he used the product for a non-FDA approved purpose. Should Dr. Hands be concerned about this particular allegation?

    READ: I have been sued under the ADA

    The Food and Drug Administration (FDA) is the federal agency that is responsible for regulating the safety, efficacy, marketing and distribution of medical drugs and devices (including hyaluronic acid fillers). Although the FDA imposes very rigorous standards for the approval (more appropriately termed “clearance”) of medical drugs and devices, it does permit physicians to exercise their authority in determining the most proper form of treatment for their patients. Such treatments often involve the use of drugs or devices for uses other than those for which they have been approved by the FDA. 

    Use of drugs in this manner (“off-label”) does not require additional approval by the FDA. Off-label use is not only recognized by, but, as has been suggested by some, is often encouraged by the FDA. The use of drugs and devices for conditions that are not otherwise indicated is widespread among physicians and is generally not considered experimental or investigational.

    ALSO READ: My patient’s law firm sues over medical record copy fees. Can I win?

    Off-label use of drugs is even a necessity in some medical specialties, especially in the areas of pediatrics and terminal illnesses. Off-label use is particularly necessary in these areas because the majority of medications that undergo review and approval by the FDA are tested on adults only, and because terminally ill patients have often exhausted the repertoire of available treatments.

    NEXT: Courts and FDA face numerous challenges

    David J. Goldberg, M.D., J.D.
    Dr. Goldberg is Director of Skin Laser & Surgery Specialists of New York and New Jersey, Director of Mohs Surgery and laser research, ...


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