Malpractice Consult

By Lee J. Johnson, JD

Physician liability and drug recalls

Q: What is my potential liability if a drug I have prescribed either is taken off the market or is the subject of an FDA safety alert?

A: Whether a pharmaceutical manufacturer voluntarily withdraws a product or is instructed to do so by the FDA, you should take immediate steps to stop prescribing the drug. If you're in a group, make sure your colleagues know about the recall.

Follow guidelines issued by the FDA or the pharmaceutical manufacturer, and document your efforts. You may want to contact the patients who are currently taking the drug if the risk is serious or could require follow-up treatments.

Urge patients who've taken the recalled medicine to make an appointment for an evaluation to determine whether there are signs or symptoms of adverse effects. Send a letter by certified mail, return receipt requested, and strongly recommend that the patient come in for a physical examination. Use language such as, "Your health and well-being are important to me. I encourage you to contact my office or a physician of your choice to schedule this important follow-up appointment for a medical evaluation. If you have any questions, don't hesitate to call me."

Limit your correspondence and discussions to factual information. Don't speculate about litigation or the quality of the drugs. Avoid offering opinions on whether the caution exercised by the FDA was warranted.

Keep a copy of the letter in the patient's chart. If you don't receive a return receipt from the certified letter, have your staff continue trying to contact the patient, and document those attempts. If a patient balks at the cost of an examination, offer to perform it without charge.

Thoroughly document additional patient discussions and follow-up exams, especially since failure to diagnose the onset of side effects could result in a lawsuit.

Even if you've never prescribed the drug, you could face liability if you treat patients who've taken the medication under another doctor's care. Each new patient's history must include questions on prior use of the affected medication. The answers can alert you to look for problems and to provide appropriate follow-up care. Some offices have posted notices, such as, "Please tell the doctor if you've taken. . . . "

Contact your malpractice insurer's risk management department if you have any questions, if you've prescribed these drugs, or if a patient is taking them.

Finally, make sure that you're keeping up with current medical literature. If there's evidence that a particular medication may have potentially harmful side effects, you could fall below the standard of care if you fail to take action—even before the FDA acts. For example, as soon as studies came out on the relation of HIV to contaminated blood, or the connection between over-oxygenation to retrolental fibroplasia, liability was created for those who failed to keep abreast of the current literature and heed its warnings.

Check the FDA's Web site, www.fda.gov, for updates on recalls and safety alerts

The author, who can be contacted at 2402 Regent Drive, Mount Kisco, NY 10549, or at lj@bestweb.net, is a health care attorney who specializes in risk management issues. This department answers common professional-liability questions. It isn't intended to provide specific legal advice. If you have a question, please submit it to Malpractice Consult, Medical Economics magazine, 5 Paragon Drive, Montvale, NJ 07645-1742. You may also fax your question to 201-722-2688 or send it via e-mail to memalp@medec.com.

Lee Johnson. Malpractice Consult.

Medical Economics

2001;17:118.