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Prescription Labels: Physicians Still Have a Duty to Warn of Medication Side Effects

December 8, 2015

Home » Blog » Prescription Labels: Physicians Still Have a Duty to Warn of Medication Side Effects

The federal Food and Drug Administration (FDA) requires that drug manufacturers place labels on all approved medications, which set forth the various risks, side effects, and other relevant drug and medication information. Consumers and patients, when they fill their medications at the drug stores and pharmacies, receive labeling and packing inserts which provides much of the above information, including specific instructions and other information regarding the use of such medication.  

When Physicians Fail to Provide Medication Instructions

Often times, physicians, when prescribing such medications defer to the drug manufacturer’s labeling, inserts, and other packaging information, without taking the time to adequately inform the client.  In fact, many physicians believe that since the relevant and available drug labeling is available, that patients have the ability, on their own accord, to review such information, and puts the onus on the patients to review such information as opposed to taking the time to adequately explain or review such information with patients.  

The doctrine of informed consent requires and otherwise imposes a duty on South Carolina physicians to disclose the various risk, benefits, and other relevant information pertaining to the prescribing of medication. In fact, most physicians are completely “aware that they must obtain the informed consent of their patients before starting a treatment or medication” but “many do not know, however, that the failure to obtain and document high-quality informed consent or informed treatment refusals can give rise to a claim of professional negligence.”

What Constitutes Informed Consent?

Each state, including South Carolina, has its own requirements for what constitutes appropriate informed consent, and it is prudent to check the standard in the state in which you practice. As a rule of thumb, however, a patient must make a knowing, voluntary, and competent decision regarding his or her medical care, and that includes the decision to accept or to decline a medication. The basic standard is that a physician must disclose all the relevant information about your medical procedure. In South Carolina, the doctrine of informed consent states a physician has a duty to disclose the following with it comes to prescribing medications, including diagnosis, general nature of the medication to be prescribed, material risks, probability of success associated with the procedure, prognosis if the procedure is not carried out, and the existence of any alternatives to the procedure. In other words, a physician in South Carolina, cannot just assume because a particular medication has FDA approved labeling, that the patient will read such information or place the onus of doing so on the patient, but rather the physician must actively disclose the substantive risks and benefits to the patient being prescribed such medication.

Speak With an Attorney if Your Right to Informed Consent Was Breached

As an individual that has been injured as a result of a physician’s prescribing medication and failure to adequately provide informed consent, very complex and sophisticated legal issues may be involved in your claim. The Connell Law Firm, LLC. has seasoned and experienced attorneys who are prepared to perform a full and complete evaluation of your legal claims, injuries, and damages.