University of Chicago Business Law Review Online Edition V. 2024

About | HeinOnline Law Journal Library | HeinOnline Law Journal Library | HeinOnline

table,div,span,font,p{display:none}Please click here if you are not redirected within a few seconds.

2024 Univ. Chi. Bus. L. Rev. Online Edition 1 (2024)

handle is hein.journals/uvierschia2024 and id is 1 raw text is:

Fair Accountability for Pharmaceutical Companies:
It's Time to Discard the Learned Intermediary
Doctrine
Steven R. Salbu*

For over half a century, pharmaceutical companies have been shielded under the learned
intermediary doctrine should their products cause harm to patients. Under the doctrine,
physicians are considered learned intermediaries who understand drug risks and counsel their
patients accordingly, absolving the manufacturer of the duty to warn patients about potential
drug risks and dangers. Contemporary medical and commercial practices have fundamentally
changed the roles of both physicians and pharmaceutical manufacturers, such that it's time for
states to discard the learned intermediary doctrine and hold the drug companies themselves
accountable for failure to warn.

I. INTRODUCTION ................................................................................................................................ 1
II. ANALYSIS ....................................................................................................................................... 3
A. Direct To Consumer Advertising............................................................................................3
B. Direct-to-Patient Drug Sales ..................................................................................................4
C. More Patient Appointments are Now with Physician Assistants and Nurse Practitioners
Rather than with Doctors ............................................................................................................5
D. Inadequate Doctors Appointment Times ...............................................................................7
E. Aggressive Manufacturer Relationships with Physicians ....................................................8
III. CONCLUSION ...............................................................................................................................10

I. INTRODUCTION

Pharmaceutical manufacturers have a duty to warn consumers of product
risks that the company is aware of at the time of sale.1 However, under the
learned intermediary doctrine,2 a warning to an intermediary fulfills a
supplier's duty to warn consumers.3 The idea behind the doctrine is that
physicians function as professional conduits between patients and
manufacturers, so that if the manufacturer warns doctors of risks, the
manufacturer is not obligated to warn patients of those risks.4 Under the

* Cecil B. Day Chair in Business Ethics at the Georgia Institute of Technology Scheller College of
Business.
1 Pustejovsky v. Pliva, Inc., 623 F.3d 271, 276 (5th Cir. 2010) (citing Pavlides v. Galveston Yacht Basin,
Inc., 727 F.2d 330, 338 (5th Cir. 1984)). For purposes of explaining the learned intermediary doctrine, the
example of Texas law will be referred to here.
2 Some courts and other authorities refer to the learned intermediary doctrine as the learned
intermediary rule, as seen in some of the quotations in this essay. The two phrases refer to the same thing.
3 Ackermann v. Wyeth Pharmaceuticals, 526 F.3d 203, 207 (5th Cir. 2008) (citing Alm v. Aluminum Co.
of Am., 717 S.W.2d 588, 591-92 (Tex. 1986)).
4Id. (citing Porterfield v. Ethicon, Inc., 183 F.3d 464, 467-68 (5th Cir. 1999)).

1