By Clifford Warren Lober, MD, JD, October 01, 2014
It’s a sunny afternoon and Bryan returns from court. His receptionist tells him Albert, a dermatologist, is on the telephone and seems quite upset. Bryan begins the conversation.
Bryan: Good afternoon, Albert! It’s good to hear from you.
Albert: Bryan, you wouldn’t believe it. One of my patients who took an oral medication had a severe blistering reaction that resulted in him being admitted to the hospital. He sued the pharmaceutical manufacturer, but was told that it was my fault since I was a “learned intermediary.” What is a learned intermediary?
Bryan: The concept of a learned intermediary is legal doctrine that has been used since 1966 by pharmaceutical and device manufacturers to have their liability transferred to the prescribing physician. Simply stated, the manufacturer’s duty to warn is shifted from warning the patient to warning the prescribing physician. Unless it can be shown that he or she was inadequately informed or misled, it is the prescribing physician who has the duty to inform the patient of risks, contraindications, and side effects of prescribed medications.
Albert: Why should the responsibility be the physician’s? After all, the manufacturer produces the medication.
Bryan: Although the manufacturer has a duty to inform patients of the risks associated with its products, it virtually never interacts directly with the patient as the prescribing physician does. This direct, in-person interaction allows the physician to convey information more effectively than the manufacturer could. Furthermore, only the physician knows the unique medical history of each patient and is unequivocally in the best position to determine which medication is optimal for each patient given his or her particular medical circumstances.
Thus, in his or her “intermediary” position between the patient and the pharmaceutical company, the doctor is uniquely qualified to prescribe medications and inform the patient of their benefits and risks. Please remember, also, that the physician has a separate fiduciary duty, unrelated to the pharmaceutical manufacturer, to inform the patients of recognized risks and side effects that may reasonably occur.
Albert: How can I avoid the responsibility being shifted to me?
Bryan: It would have to be shown that you were either inadequately informed or misled by the pharmaceutical company. Is this reaction mentioned in the package insert? Did you receive any promotional materials from the company’s representative when they visited your office? If so, was the possibility of developing a blistering eruption mentioned? Is this complication generally recognized by dermatologists who prescribe this class of medications?
Albert: Yes, I received some flashy promotional material, but I do not remember reading anything about a blistering eruption developing. This reaction is not mentioned in the package insert and is certainly not generally recognized by my colleagues who prescribe this type of medication.[pagebreak]
Bryan: That would suggest that either this reaction is an extremely rare, exceptional event or that you were inadequately informed. Should any potential allegation be raised against you, a court might also question whether you would have prescribed the medication if you had adequate and correct information at the time. In other words, if you had known that this medication might cause a severe blistering reaction, would you have prescribed it for the patient anyway? Perhaps it was the only medication available for this patient’s condition. If this was the case, the manufacturer’s failure to adequately warn would not have caused the patient’s injury since, it could be argued, he or she would have received the medication anyway.
Albert: Not at all! If I had known of this potential reaction I would have given the patient a different type of medication.
Bryan: If it was a reaction that was not reported in the package insert, contained in promotional materials given to you, and is not generally recognized by the profession, it is unlikely that a claim against you would prove successful.
Albert: Are there situations in which the learned intermediary doctrine does not apply?
Bryan: Some state courts have held that this doctrine does not apply in specific situations, such as in direct-to-consumer advertising where the patient’s involvement in decision making has been viewed as mitigating his or her reliance on the learned intermediary, or in mass vaccination programs where there is minimal or no direct physician involvement. That does not seem to be the case, however, in the present situation.
Albert: How can I avoid this situation in the future?
Bryan: You should be familiar with the approved indications for medications you prescribe. If you use a drug for an “off-label” reason, be familiar with the risks associated with that medication and obtain the patient’s informed consent. As in all cases, the documentation in your medical record will be critical. Please let me know if you hear anything further about this situation.
Albert: I certainly will. Thanks, Bryan!
If you have any suggestions for topics to be discussed in this column, please e-mail them to me at email@example.com. See the February 2013 issue of Dermatology World for disclaimers.
- The “learned intermediary” is a legal doctrine used by pharmaceutical and device manufacturers to shift liability to physicians.
- If the manufacturer adequately informs and does not mislead the physician, the latter is primarily responsible for conveying the risks to the patient.
- A manufacturer might not be held liable for failure to warn of risks or side effects if the physician would have been prescribed the medication despite having been aware of the risks. (This might be true, for example, if a particular drug was the only one available to treat a given condition.)
- If a side effect or risk is not mentioned in the package insert or promotional materials, or generally recognized by the profession, it is unlikely that the liability would be successfully shifted to the physician.