Half-Truths, Off-Label Indications, and the Specter of RICO Liability Exposure

“Beware of the half-truth. You may have gotten hold of the wrong half.”
– Anonymous

Pharmaceutical companies cannot advertise drugs for uses other than those approved by the Food and Drug Administration (FDA) but can provide information upon an unsolicited request related to “off-label” uses in certain situations. Off-label indications raise a host of ethical and legal concerns for hospitals and medical professionals. Courts have held that evidence showing that a drug was prescribed by a physician for uses not specifically approved by the FDA can be introduced for purposes of showing that the physician departed from the standard of care in medical malpractice actions, and neglecting to inform a patient that a drug is being prescribed for an off-label use can expose the prescribing doctor to liability for failure to obtain informed consent.

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