Off-label use might be the standard of care
Off-label use might be the standard of care
Concerns about cases involving provider liability should not deter clinicians from off-label prescribing, says Samantha L. Prokop, Esq., an attorney with Brennan, Manna & Diamond, in Akron, OH.
“In fact, failure to use a drug or product off-label could also be considered malpractice, if the standard of care required off-label use,” she says.
Off-label use is permitted if it meets the standard of care, explains Prokop, and in some cases, it might constitute the standard of care.
Madelyn S. Quattrone, Esq., senior risk management analyst at ECRI Institute in Plymouth Meeting, PA, says, “To succeed in court on a claim of negligence, the plaintiff must prove that the off-label prescribing breached the standard of care, and that the drug, as prescribed, [or device] caused harm to the patient, or it was a substantial factor in causing harm to the patient.”
The use of a device or drug “off-label” does not imply that the physician has acted below an accepted standard of care, and for some conditions, off-label use has become the standard of care, says Quattrone. “But when there is lack of valid clinical evidence and published peer-reviewed literature to support off-label use” of a particular drug or device, the use involves “some degree of uncertainty and risk about safety and efficacy.”
Battle of experts
If a claim involving off-label use goes to trial, the jury will hear opposing expert opinion on whether the physician breached the standard of care and whether the use of the device or drug was the proximate cause of harm to the patient, says Quattrone.
In one claim, a plaintiff alleged that the risk of the off-label use of a YAG laser had not been fully explained to him. Janice M. Ginley, assistant claims manager for MIEC, an Oakland, CA-based malpractice carrier, says “Corrective surgery went well, but the patient claimed impairment to near and intermediate distance vision, clouding in the center of the eye and general reduced vision quality.”
The physician’s documentation of the risks and alternatives to treatment was poor. “Despite review by multiple ophthalmic surgeons, we could not find any support on the standard of care for the use of YAG laser ablation in the treatment of vitreous floaters,” adds Ginley.
In fact, several ophthalmologic surgery consultants explained that a YAG laser is too dangerous for treatment of vitreous floaters because there is too much risk of injury to the lens in this off-label application of the device, she explains.
“Although an independent medical examination demonstrated that the patient had a near-full recovery within months of the incident, because of the intentional acts, personal exposure and lack of expert support, the case was mediated and settled in the mid-six figure range,” says Ginley.
A plaintiff’s theory of liability against a physician using a medical device in an off-label manner might be shaped by the rules of evidence in the jurisdiction in which the litigation is filed, Quattrone says. Although the Food and Drug Administration (FDA) doesn’t regulate the practice of medicine, the rules of evidence may permit a manufacturer’s package insert (indicating FDA-approved uses) to be admitted into evidence, she says. As a result, the jury might consider that information as “some evidence of the standard of care” regarding the use of the device, she says.
“In other jurisdictions, the device package insert may be admitted into evidence to establish a prima facie standard of care for the use of the product, which, along with expert testimony concerning the standard of care, the defendant clinician must refute in order to prevail against a claim of negligence,” Quattrone says.
Know evidence base
A patient given a medication or device “off-label” might allege that he or she was harmed by the prescribing physician as a result of negligent prescribing, says Quattrone.
In 2008, several lawsuits were brought for the off-label use of pain pumps, which were being placed directly in a patient’s joint following orthopedic surgery. The plaintiffs argued the off-label use of the pumps destroyed the cartilage in their joints, which necessitated joint replacement and caused permanent damage.
Off-label use isn’t unlawful, and it doesn’t necessarily constitute malpractice, says Quattrone. “The FDA does not regulate the practice of medicine. That function is reserved for state boards of medicine,” she says.
Develop a policy and procedure for innovative off-label use of devices or medications, with a multidisciplinary task force including medical staff, pharmacists, risk management, and the ethics committee, says Quattrone. “A facility might take several approaches to off-label use,” she says. For example, it might not permit off-label prescribing at all, it might restrict off-label use to clinical research approved by an institutional review board, it might permit off-label use only if the use falls within the institution’s therapeutic guidelines, or it might approve off-label use based on clinical judgment of the provider that adequate evidence supports its use.
Institutions should encourage clinicians to discuss risks and benefits and alternatives related to the proposed off-label use with their patients, and document the discussion in the patient’s medical record, Quattrone says. (See related story on obtaining informed consent, below.)
Physicians must obtain consent for off-label use
Patients may successfully sue if you fail to properly obtain their consent when a drug or device is used in a manner that deviates from the purpose for which it was approved, warns Claudia Dobbs, loss prevention manager at MIEC, an Oakland, CA-based malpractice carrier. When there is a potential for serious side effects due to off-label use of medications or devices, Dobbs recommends considering these practices to reduce legal risks:
“Don’t make your patients angry by failing to ensure that there is coverage,” Dobbs says. Should the patient experience an unexpected injury from the drug, anger over the uncovered medication or medical device will add to the patient’s desire to seek the services from an attorney, she says.
Subscribe Now for Access
You have reached your article limit for the month. We hope you found our articles both enjoyable and insightful. For information on new subscriptions, product trials, alternative billing arrangements or group and site discounts please call 800-688-2421. We look forward to having you as a long-term member of the Relias Media community.