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Pause for Thought

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Pause for Thought

By Jock Hoffman, CRICO

Related to: Communication, Documentation, Primary Care, Informed Consent, Medication

Background

When Kevin Coombes struck and killed a child with his car, he was suffering from (known) side effects of prescribed medications. The Massachusetts Supreme Judicial Court ruled that if the prescribing physician failed to adequately warn Mr. Coombes about the side effects—and of the dangers of driving while medicated—then the physician could be viewed as contributing to the cause of the child’s death…and thus liable for damages.

Coombes is far from the first case of this type in the United States. Several cases cited in the ruling extend to third parties the duty to protect innocent bystanders from knowable harm caused by mental instability, medications, alcohol, and guns. At the very least, Coombes has given health care providers pause for thought and an opportunity to examine reasonable practice.

Our Recommendation

Obviously, Coombes is most relevant to Massachusetts health care providers, but clinicians practicing in other jurisdictions may also find these recommendations helpful.

  1. Careful adherence to the long established duty to warn patients about medication side effects and restricted activities (in particular, driving)—and documentation that such warnings were presented and understood—should be sufficient to protect a physician from claims from a non-patient harmed by his or her patient.
  2. The physician’s primary duty is to prescribe the most efficacious therapy, then to warn the patient of associated risks and potentially dangerous activities.
  3. The extent of such warnings should be measured against the actual risk, factoring in the patient’s history, mental capacity, overall health, and the specific medications prescribed.
  4. The physician’s responsibility is to give the patient adequate information related to medication side effects and warn of potential dangers so that the patient can make an informed decision about his or her actions.
  5. A physician who is concerned that a patient may choose to engage in dangerous behavior despite such warnings, may want to further counsel the patient about the potential risks. A physician’s extreme level of concern may warrant a call to the organization's risk manager or legal counsel.
  6. Patients at significant risk for dangerous side effects need to be informed of that risk by the physician who is prescribing the medication. This serves to dispel the notion that a drug is safe simply because the physician prescribed it. Physicians should not rely on the pharmacist dispensing the medication to convey the side effects and potential risks to the patient.

A flood of cases similar to Coombes seems unlikely, but not implausible. Physicians who adequately inform and warn their patients (and document those discussions) greatly diminish the likelihood of such circumstances.

Additional Materials

Coombes v Florio [pdf]


July 1, 2008
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