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Off-label drug prescriptions and medical malpractice liability

We began speaking in our last post about litigation that has been initiated against GlaxoSmithKline in connection with Zofran. As we noted, the lawsuits accuse the manufacturer of failing to warn patients about the risks the drug presents for pregnant women, which include the possibility of birth defects. The issue we raised last time was what liability may attach to doctors who choose to prescribe medications for an off-label use, as is the case with Zofran as used by pregnant women.

One important point is that prescribing medications for an off-label use is not all that uncommon, and physicians are allowed to do so as long as these prescriptions do not veer into the realm of "research." The distinction, generally speaking, is that research is characterized by interventions aimed at testing of a hypothesis and ultimately contributing to increased knowledge. In cases where research is being conduct with the off-label use of a drug, physicians must take steps to follow established safety protocol and supervision to ensure safety and effectiveness. Patients must also be fully informed of the risks. Failure to do so opens a physician up to liability.  

In terms of medical malpractice liability, physicians who prescribe a medication for an off-label use must make sure that their patients have been given informed consent. Another factor that reduces the possibility of medical malpractice liability is that, in prescribing a medication for an off-label use, the physician is basing the prescription on his or her own opinion, and is primarily motivated by the desire to treat the individual patient rather than benefit the medical community. Also, an off-label use is less likely to get a physician in trouble with medical malpractice liability if that use is generally supported by other local physicians and it is supported by peer-reviewed literature.

Patients who have been seriously harmed by a physician's prescription of a drug for an off-label use should always work with an experienced attorney to have their case accurately evaluated and, if necessary, zealously advocated. Doing so ensures the best possible opportunity for receiving adequate compensation.

Source: Hematology & Oncology News & Issues, "Physicians' liability for off-label prescriptions," James B. Riley, Jr. & P. Aaron Basilius, May/June 2007.

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