Innovations-Magazine-April-2022 - 4

POLICY PERSPECTIVES
Will Artificial Intelligence Impact Application of the Learned
Intermediary Doctrine to Pharmacists?
Kate E. Middleton, JD
Faegre Drinker Biddle & Reath LLP
Artificial intelligence (AI) and algorithmbased
solutions are innovating how health
care is delivered. AI has long been used
in diagnostic imaging and is increasingly
being incorporated into almost every
aspect of the clinical experience.
Pharmacies, likewise, are also embracing
AI and algorithm-based solutions in
a variety of applications, including
those that help to inform pharmacists'
dispensing decisions. This technology will
inevitably drive certain changes in the law
- technological advances always do. But
many long-standing legal doctrines, such
as the learned intermediary doctrine found
in tort, are perfectly capable of addressing
AI without alteration. The learned
intermediary doctrine is one such example.
Jim Frederick, JD
Faegre Drinker Biddle & Reath LLP
AI in Health Care and Pharmacy
AI is used in health care in a variety of
clinical settings. It is used to inform
clinical diagnoses and to monitor the
administration of intravenous medications.
AI is being incorporated into implantable
medical devices like insulin pumps and
pacemakers, and into robots that perform
surgery. The level of autonomy of any AI
solution varies widely by the type of AI and
its clinical application. But in all instances,
a physician or medical professional is
involved in the administration of care
augmented by AI solutions.
Pharmacies, similarly, are utilizing AI
and algorithm-based tools at an increasing
rate. Pharmacy management software, for
example, may use AI to identify dispensing
red flags and drug contraindications. The
industry's use of these tools is expanding and
becoming more sophisticated. AI is being
incorporated into pharmacists' workflow
through applications that visually verify
medications in real time. The future of AI
is aimed at driving customized care by, for
example, synthesizing data on pharmacy
customers and identifying if a patient may be
more likely to experience serious side effects
from a medication.
2 | APRIL 2022
The Learned Intermediary Doctrine
These incredible advancements in
technology, however, are unlikely to alter
the way the law views the patient-physician
relationship in the product-liability context,
at least for the foreseeable future. To address
this, most states have adopted the learned
intermediary doctrine, under which drug
and device manufacturers owe no duty to
warn a patient of the risks affiliated with a
drug or device. The basis for the doctrine
is the understanding that a physician (a
" learned intermediary " ), not a manufacturer,
is in the best position to make a prescribing
decision based on their medical training,
knowledge of the risks affiliated with a
particular device or medication, and an
individual patient's unique medical history.
A physician's use or prescription of a device
that utilizes AI, instead of one that does not,
should not change that dynamic. As long
as a manufacturer has provided adequate
warnings to the prescribing physician, it has
satisfied its duty to warn.
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.
Over the years, litigants have argued
for exceptions to the learned intermediary
doctrine with varying success, two of which
may be relevant here. First, plaintiffs have
argued that where a physician plays a passive
or reduced role regarding a patient's use of
a drug or device, the learned intermediary
doctrine should not apply. Some courts have
recognized this exception in the context of
mass immunizations, for example, where
a patient-physician relationship may never
be formed, as well as in some instances of
direct-to-consumer marketing.
Second, some courts have declined to
apply the learned intermediary doctrine
where a pharmacist was aware of a

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