From time to time, the FDA, manufacturers, and other agencies issue recalls or serious warnings about devices, drugs, instruments and other healthcare-related products. When one of these notices impacts your medical practice, it is important to follow a comprehensive process and document all the steps you have undertaken to avoid potential liability and to maintain care for patients. Facilities, physicians, advanced practice providers, pharmacists and other healthcare professionals may all become involved in such warnings and recalls.
Depending upon the situation, medical providers may want to seek legal counsel to clarify their duties and responsibilities. The following are some general guidelines and key considerations:
- Always start with the most recent and accurate information from the agency and/or manufacturer. In general, the warnings and recalls describe the risks, benefits, and potential actions.
- Recall and warning notices frequently contain the following types of actions, and you should be aware of these specifics for a given patient and a given biologic, drug, device, or other healthcare-related product:
- The recommended treatment or action for users to minimize risks or impact of the affected product to their patients.
- Actions to be taken such as correction or removal of the device.
- Necessary monitoring or additional steps for follow up with patients.
- Any available alternatives.
- Follow the manufacturer’s recommended action steps exactly, document those steps, and in the event that you cannot, document why you can’t. For individual patient encounters, your actions should also be documented in their personal medical record. In the case of patient non-compliance with your recommendations, document their informed refusal.
- Be aware that the manufacturers and pharmaceutical companies often put the responsibility for patient notification and counseling on the licensed healthcare providers. For example, typical language in recalls or warnings may read as follows: “[Manufacturer’s name] will not communicate with patients directly about this issue. If patients have been impacted as part of this issue, healthcare providers have the responsibility to inform patients and/or update a patient’s care pathway.”
- Use your patient lists, EHR, and other resources to try to identify all of your affected patients. This applies most importantly to when you were the prescriber, used the device, or implanted the materials into your patient. If the recall is a general over-the-counter medication or one that you did not prescribe, the extent to which you identify, notify, and counsel is likely reduced.
- If you are unable to reach affected patients, try at least two attempts, and ideally use multiple modes such as phone, emails, etc. In serious recalls, it may be necessary to send a “return receipt requested” letter and keep a copy.
- Some warnings and recalls may result in high volumes of patient calls, therefore, you should direct inquiries (as best as possible) to an informed respondent in your office or facility who can provide the guidance and who understands when scheduling appointments with the providers is necessary. It might be advisable for your “designated informed respondent” to have a script available. While the recalls and warnings are generally written at the provider level of understanding, many consider sending the patients the exact verbiage from the manufacturer. Document each and every phone call with patients.
One of the most complicated issues is the financial responsibility for all the above actions. In some instances, the necessary follow-up visits, procedures, and therapy are paid by the patient or their insurer, and patients may need to make claims against the manufacturer for reimbursement. In other instances, the manufacturer will describe the process by which they will assist patients and their insurance payers to reduce costs and any financial burden from the recalls or serious warnings.
Lastly, in the event of legal action against the manufacturer or entity responsible for the harm, it is important that the facilities, licensed providers, pharmacists and other healthcare professionals follow all of the above steps to avoid being also named. In general, the legal actions are against the manufacturer and not the healthcare professionals and facilities, however, each case (individual or class action) is very fact-based.
If you aren’t signed up for FDA alerts, you can do so by going to: www.fda.gov/safety/medwatch-fda-safety-information-andadverse-event-reporting-program/subscribe-medwatch-safety-alerts. If you receive notice that you are a party or potential party to any legal action, you should notify the Copic occurrence team by calling 720.858.6395.
The information provided herein does not, and is not intended to, constitute legal, medical, or other professional advice; instead, this information is for general informational purposes only. The specifics of each state’s laws and the specifics of each circumstance may impact its accuracy and applicability, therefore, the information should not be relied upon for medical, legal, or financial decisions and you should consult an appropriate professional for specific advice that pertains to your situation.
Article originally published in 2Q25 Copiscope.
