Avoiding Physician Liability for Off-Label Use of Drugs and Devices

Generally, the most common potential liability for off-label prescriptions will be a malpractice or negligence claim, in which the patient attacks the physician's decision, in her medical judgment, that a particular off-label use was appropriate for a particular patient. See Paul D. Rheingold & David B. Rheingold, Offense or Defense? Managing the Off-Label Use Claim, 37 Trial, Mar. 2001, at 52-55. The threat of malpractice liability effectively limits physicians' considerations of more obscure or extreme off-label uses for drugs and devices, because the physician must still show that the off-label use was an appropriate exercise of medical judgment given the information available to him or her at the time. In order to prevail on a malpractice or negligence claim in this scenario, the patient will be required to show that the physician's decision to use the drug or device in that manner failed to comport with “the skill and knowledge normally possessed by members of [the medical] profession ' in good standing in similar communities.” Restatement (Second) of Torts ' 299A (1965). The applicable standard of care is usually interpreted to be a national standard rather than local. See, e.g., Logan v. Greenwich Hospital Ass'n, 465 A.2d 294, 301 (Conn. 1983) (noting that many states have abandoned locality restrictions in favor of a national standard of care).