Executive Summary
Malpractice suits involving adverse outcomes from medications with a black box warning are defensible if physicians are supported by the prevailing community standard in the decision to prescribe. To reduce risks, physicians can:
Obtain written informed consent when there is the potential for serious risks.
Show that effective alternatives were considered first.
Document the rationale for their decision to prescribe.
Document rationale for prescribing
Did a patient experience an adverse outcome from a medication with a black box warning?
Such malpractice claims "aren’t necessarily indefensible," according to Lizabeth Brott, JD, regional vice president of risk management at ProAssurance Companies in Okemos, MI. (See story on claim involving a medication with a black box warning, p. 139.)
The central issue in malpractice claims involving complications arising from FDA-approved medications, including those with black box warnings, is whether the physician acted prudently within the community standard in prescribing the device or medication given the patient’s history, physical condition, and all relevant laboratory and imaging data, says Richard F. Cahill, Esq., vice president and associate general counsel at The Doctors Company, a Napa, CA-based medical malpractice insurer.
"In evaluating the appropriate treatment course, the physician must consider whether there are any overriding circumstances that, despite the potential benefits of the product, would make the device or medication contra-indicated, including any published black box warnings," says Cahill.
A physician who is supported by the prevailing community standard in the decision to prescribe a medication with a black box warning, where an appropriate informed consent was obtained from the patient "should prevail in any subsequent claim," he says.
Significant safety data
Black box warnings "emphasize significant and serious safety data for prescription drugs," says Allen J. Vaida, PharmD, FASHP, executive vice president of the Institute for Safe Medication Practices (ISMP).
The ISMP’s National Medication Errors Reporting Program has received multiple reports of situations in which drugs were prescribed or dispensed in a way that is cautioned against in the boxed warning and resulted in serious consequences for patients. "For example, opioid-naïve patients and postoperative patients have been prescribed transdermal fentanyl patches for pain, resulting in death," says Vaida.
Brott encourages physicians to consider these practices when prescribing medications with black box warnings:
• Obtain the patient’s informed consent in writing.
"When there is the potential for serious risks to occur, it’s important to discuss such risks with patients," says Brott. Physicians’ informed consent discussions might include an explanation of the black box warning and increased risks; the nature of the proposed treatment; the risks, potential benefits, and alternative treatment options; the rationale for the specific treatment, and the risk of failure to treat.
"Ask patients to verbally describe their understanding of your treatment recommendation to verify they understand the risks," advises Brott. "Document your conversation with the patient, and the patient’s agreement, in the medical record. Include the patient’s signed informed consent in the medical record."
• Document the rationale for their decision to prescribe a medication with a black box warning.
"We can always defend a well-reasoned decision. What we can’t defend is a decision without support," says Brott.
Physicians might document why they thought the benefits outweighed the risks for a particular patient, or the fact that a particular risk occurred only in a small percentage of patients.
Rationale is important
It would be helpful for the defense to have an expert witness testify that most physicians would be likely to prescribe the drug in the given scenario, says Brott, but contemporaneous documentation of the physician’s rationale for prescribing is also important evidence.
Prescribing a medication with a black box warning "may be appropriate in certain cases, but physicians should be prepared to explain why," she says.
Was physician negligent?
Occasionally a pharmaceutical company or the FDA will issue a medication alert reporting new data on previously unreported side effects and contra-indications.’
"Depending on the timing and nature of the alert or recall, physicians may be named as a defendant in a professional negligence suit," says Cahill.
Assuming that the physician’s original decision to prescribe was appropriate, he says that the plaintiff’s attorney will next determine when and how the practitioner subsequently became aware of the new data. This awareness might have occurred through direct contact by the pharmaceutical company, or the plaintiff could argue that the physician should have reasonably been aware of the information available in the medical literature.
"If the physician failed to act in a timely manner or to provide a sufficient notification to his patients involved with the medication, and physician’s inadequate response proximately resulted in damage to the patient, liability may be established, and an adverse verdict may be rendered in a subsequent lawsuit," says Cahill.
- Lizabeth Brott, JD, Regional Vice President, Risk Management, ProAssurance Companies, Okemos, MI. Phone: (800) 282-1036, ext. 6217. Fax: (205) 414-1192. Email: [email protected]
- Richard F. Cahill, Esq., Vice President & Associate General Counsel, The Doctors Company, Napa, CA. Phone: (800) 421-2368 ext. 4202. Fax: (707) 226-0370. Email: [email protected].
