A Tale of Six Implants: The Perez v. Wyeth Laboratories Norplant Case and the Applicability of the Learned Intermediary Doctrine to Direct-to-Consumer Drug Promotion
![handle is hein.journals/foodlj55 and id is 551 raw text is: A Tale of Six Implants: The Perez v. Wyeth Laboratories
Norplant Case and the Applicability of the Learned
Intermediary Doctrine to Direct-to-Consumer
Drug Promotion
MITCHELL S. BERGER*
I. THE PEREZ CASE-INTRODUCTION AND PROCEDURAL HISTORY
The issue in the Perez case of whether the learned intermediary doctrine should be
modified with respect to the direct-to-consumer (DTC) advertising of prescription drugs
remains an issue of general public importance that affects the health and well being of
the consuming public.' The suit started in May 1995 when plaintiffs filed suit against
Wyeth-Ayerst in New Jersey alleging failure to warn about the side effects of Norplant.
By 1999, 25 cases involving 46 plaintiffs had been consolidated in Middlesex County,
New Jersey.2 The plaintiffs insisted that when manufacturers such as Wyeth-Ayerst
engage in DTC advertising they must warn patients, as well as physicians, of potential
side effects (see below).3 Traditionally, under the learned intermediary rule, a drug manu-
facturer is not liable for injury to a patient, provided that the company has provided
adequate warning to that patient's physician. Citing In re Norplant Products Liability
Litigation4 the plaintiffs asked the court to decide whether the learned intermediary rule
applied to Norplant. The Texas court had ruled that the learned intermediary doctrine did
apply and granted summary judgment to Wyeth-Ayerst; the plaintiffs did not wish to
proceed further if the courts in New Jersey concurred.' With Wyeth-Ayerst's consent,
the court selected five bellwether plaintiffs, including Saray Perez, as test cases to
decide whether the learned intermediary doctrine should apply to Norplant directly
advertised to consumers.6
' Mr. Berger is a final-year J.D./M.P.H. joint degree Candidate at Emory University, School of
Law and Emory University, Rollins School of Public Health. I gratefully acknowledge my parents and
friends for their encouragement and support. I thank the staff of FDLI, the reviewers of the draft, and
the many authers I cite in this article.
Supreme Court Brief for Plaintiff-Petitioner at 1, 12, Perez v. Wyeth Lab., Inc., 734 A.2d
1245 (N.J. 1999) (No. A-2877-97T5F) [hereinafter Brief for Plaintiff-Petitioner].
2 Supreme Court Brief for Defendant-Respondent at I, Perez v. Wyeth Lab., Inc., 734 A.2d 1245
(N.J. 1999) (No. A-2877-97T5F) at I [hereinafter Brief for Defendant-Respondent]. The Brief by
Pharmaceutical Research Manufacturers Association incorporated the defense's version of the proce-
dural history by reference. See Brief of Amicus; Appellate Brief for Defendant-Respondent, at 3.
Perez v. Wyeth Lab., Inc., 713 A.2d 520 (N.J. Super. Ct. App. Div. 1998) (No. A-287797-T5)
[hereinafter Appellate Brief for Defendant-Respondent]. Brief for Plaintiff-Petitioner, at 6, Perez v.
Wyeth Lab., Inc., 713 A.2d 520 (N.J. Super. Ct. App. Div. 1998) (No. A-287797-T5) [hereinafter
Appellate Brief for Plaintiff-Petitioner].
Appellate Brief for Plaintiff-Petitioner, supra note 2, at 4.
955 F. Supp. 700 (E.D. Tex. 1997).
Brief for Defendant-Respondent, supra note 2, at 1. See also Julie Brienza, Norplant Maker Has
No Duty to Warn About Side Effects, TRIAL, May 1, 1999, at 97-98 (discussing the verdict in the Texas
case). The Fifth Circuit determined that the learned intermediary doctrine should apply, stating that the
women showed no evidence of seeing or relying on any advertisements. See In re Norplant Contracep-
tive Prod. Liab. Litig., 165 F.3d 374, 378 (5th Cir. 1999) (dismissing suit against Wyeth, stating that
direct advertising notwithstanding the final decision to prescribe remains with the physician).
6 Brief for Defendant-Respondent, supra note 2, at 1; Appellate Brief for Defendant-Respondent,
supra note 2, at 4; Brief for Plaintiff-Petitioner, supra note 1, at 3; Appellate Brief for Plaintiff-
Petitioner, supra note 2, at 3-4 (discussing the procedural history of the five bellwether plaintiffs).
525](ViewImageLocal?handle=hein.journals/foodlj55&div=46&collection=&method=preview&ext=.png&size=3)
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