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Patient Safety
and Risk Resources


When Prescribing Drugs, a Physician Has a Duty to Warn Patients

Prescribing physicians have a primary duty to warn patients about the risks and complications of prescribed medications. While legal arguments have been made that the drug manufacturer should be responsible for this duty to warn, courts continue to hold physicians accountable.

In a recent lawsuit, a patient claimed a prescribed medication caused lupus-like symptoms and that the manufacturing company, along with three physicians, failed to adequately warn of the drug’s risks and in fact overemphasized its benefits. Two physician defendants settled with the patient, while the third physician was dismissed. The trial resulted in a $4.7 million jury verdict against the manufacturer.

The company appealed, claiming it had no duty to directly warn the patient after providing the patient’s prescribing physician with adequate warning. Based on the legal doctrine of “learned intermediary,” the court ruled in favor of the manufacturer. The doctrine states that a prescribing physician acts as a “learned intermediary” between manufacturer and patient: the manufacturer has a duty to inform the physician about drug uses and hazards, and the physician has a duty to relay to each patient the dangers of using the prescribed medication. As such, the prescribing physician has the responsibility or “duty to warn” a patient of a prescription drug’s side effects.

Review these tips to ensure you fulfill your duty to warn:

  • Stay abreast of FDA prescription drug warnings and recalls.
  • Use PDR Network as a reference for FDA-approved drug labeling and as a source for drug safety information.
  • Be aware of prescription drug manufacturer product disclosures and warnings.
  • Determine if additional information about the drug is available, including studies suggesting dangers that the FDA has yet to act on.
  • Require that patients provide a list of all prescription and over-the-counter drugs being taken.
  • Advise patients of other available medications and the medical rationale for the one being prescribed.
  • Counsel patients about the difference between brand-name and generic drugs.
  • Inform patients of potential drug-food and drug-drug interactions.
  • Document all disclosures and warnings made to patients.
  • Instruct patients to read drug labels.
  • Provide patients with written, simplified dosing instructions.
  • Obtain written informed consent when prescribing for off-label use.
  • Date and archive product manufacturer disclosures and warnings.
  • Seek legal or risk management guidance when uncertainty arises.


The guidelines suggested here are not rules, do not constitute legal advice, and do not ensure a successful outcome. The ultimate decision regarding the appropriateness of any treatment must be made by each healthcare provider in light of all circumstances prevailing in the individual situation and in accordance with the laws of the jurisdiction in which the care is rendered.



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