Innovations-Magazine-April-2022 - 5

POLICY PERSPECTIVES
" customer-specific risk, " like a customer's
allergy to a particular drug ingredient,
but failed to warn the physician or
customer of that risk when dispensing
a prescription medication.
AI Will Not Obviate the Learned
Intermediary Doctrine
Plaintiffs have long argued that the learned
intermediary doctrine is outdated under
the current health care landscape and will
likely argue the same when it comes to a
physician's use or prescription of AI and
algorithm-based devices. But the reasoning
underlying the learned intermediary doctrine
is sound and generally unchanged by the
incorporation of AI and algorithm-based
devices into a patient's care. A physician, as
opposed to an untrained patient, remains in
the best position to understand and weigh
the risks associated with an AI or algorithmbased
device and make an informed decision
as to its use based on the physician's training,
expertise, and knowledge of a particular
patient. The use of AI and algorithm-based
devices in caring for patients, at least at
present, does not render a physician's role de
facto passive or any less " learned. " They, as
the medical experts, will continue to have
the duty to make individualized prescribing
decisions and counsel their patients about
those decisions.
In other words, in most circumstances
it will likely work as it always has. The
manufacturer has a duty to provide
adequate warnings to the physician. The
physician, as the learned intermediary and
medical expert, has the duty to warn the
patient of risks affiliated with the use of AI
and algorithm-based devices and obtain a
patient's informed consent.
For the foreseeable future, the learned
intermediary doctrine will also continue to
operate as it has regarding pharmacies and
pharmacists. A physician, not a pharmacist,
is in the best position to make a prescribing
decision for their patient and, therefore,
has the duty to warn the patient about
Many states have extended the applicability of the
learned intermediary doctrine to pharmacists - similar to
manufacturers. In those states, it is generally the duty of
the physician, not the pharmacist (or the manufacturer),
to warn the patient of potential risks or side effects of a
prescription medication.
risks affiliated with a prescription drug.
This is generally true regardless of whether
the physician has used any algorithmbased
solution to arrive at their prescribing
decision. However, the applicability of the
learned intermediary doctrine to pharmacies
and pharmacists may be impacted by their
own adoption or use of AI and algorithmbased
solutions aimed at providing more
individualized customer care. Public policy,
consumer expectations, and industry
innovations are driving changes in the
pharmacy industry, many of which may, in
the eyes of some courts, bring pharmacists
closer to the patient-physician relationship
by allowing pharmacists access to patientspecific
health information. Even with the
adoption of such technology, the duty
to warn should remain with the physician.
But the learned intermediary doctrine
may become less available to pharmacies
and pharmacists in jurisdictions that have
recognized the customer-specific risk
exception discussed above.
This article was written by Kate E.
Middleton, JD, and Jim Frederick, JD,
with Faegre Drinker Biddle & Reath LLP.
Please note, the opinions and views expressed
by Faegre Drinker Biddle & Reath do not
necessarily reflect the official views, opinions,
or policies of NABP or any member board
unless expressly stated.
For an overview on how artificial intelligence is being used to safeguard
public health protection, including responding to drug diversion, helping
with supply chain management, and managing drug recalls, see the
February 2021 issue of Innovations (pages 5-6).
APRIL 2022 | 3
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