United States District Court, D. South Carolina, Florence Division
James E. McLeod and Glenda McLeod, Plaintiffs,
Sandoz, Inc., Defendant.
Bryan Harwell United States District Judge.
matter is before the Court on Defendant Sandoz, Inc.'s
[ECF No. 6] motion to dismiss. For the reasons stated below,
the Court grants in part and denies in part Defendant Sandoz,
Inc.'s motion to dismiss.
Factual and Procedural
James E. and Glenda McLeod, filed their Complaint on May 23,
2016, alleging claims against Defendant Sandoz, Inc. for: 1)
strict products liability - failure to warn; 2) negligence -
failure to warn; 3) negligence - “off label”
marketing and sale; 4) negligence per se -
“off label” marketing/sale and failure to provide
Medication Guide; 5) fraud and deceit; and 6) loss of
consortium. The claims arise from Plaintiff James E.
McLeod's use of the pharmaceutical drug amiodarone for
treatment of his non-life threatening atrial fibrillation.
Plaintiffs allege that after ingesting amiodarone, which was
manufactured by Defendant Sandoz, Inc.
(“Sandoz”), McLeod developed and was diagnosed
with shortness of breath and chronic obstructive and
progressive pulmonary disease. [Complaint, ECF No. 1, at
¶ 18]. The amiodarone tablets were manufactured and sold
by Sandoz as a generic version of Wyeth's Cordarone®.
1985, brand manufacturer Wyeth (who is not a party to this
litigation) received FDA approval to market and sell the
anti-arrhythmic heart medication Cordarone® (amiodarone
hydrochloride) under a special “needs” approval
without the usual FDA approved, double-blind, randomized
clinical trials. Id. at ¶ 29. The customary and
rigorous randomized clinical trials now required by the FDA
for all new drug applications have never been conducted for
Cordarone® or its generic equivalent, amiodarone.
approved Cordarone® (amiodarone hydrochloride) only as a
drug of “last resort” for patients suffering from
documented recurrent life-threatening ventricular
fibrillation and ventricular tachycardia when these
conditions would not respond to other available
anti-arrhythmic drugs and therapies. Id. at ¶
30. Plaintiffs allege Wyeth, however, aggressively and
successfully marketed Cordarone® for inappropriate
“off label” uses as a “first line
anti-arrhythmic therapy.” Id. Generally,
Plaintiff alleges he was not in a situation of last resort as
to the management of his atrial fibrillation.
contend Wyeth also instituted and maintained an active
promotional campaign touting the anti-arrhythmic benefits of
amiodarone, from which generic manufacturers such as Sandoz
still benefit. Id. at ¶ 31. As a result of
Wyeth's off-label promotion, amiodarone became a first
line therapy for atrial fibrillation because physicians were
not warned of many of the potential dangers of the drug.
Id. Wyeth's alleged fraudulent and misleading
marketing campaigns resulted in warning letters from the FDA
to stop the false and misleading promotion of the drug that
downplayed the risks and promoted the drug as a first line
anti-arrhythmic therapy. Id. The FDA letters noted
it is unlawful for a manufacturer to promote any drug for a
use not described in the approved labeling of the drug.
Id. Unapproved uses are deemed
“off-label” because they have not been approved
by the FDA. Id.
1998, Wyeth received approval for the manufacture, marketing,
sale and distribution of the generic formulation of
Cordarone®, amiodarone hydrochloride. Id. at 32.
Plaintiffs assert Defendant Sandoz took advantage of the
pervasive promotional activities of Wyeth and allege that
Sandoz's version of the drug directly benefited from
Wyeth's marketing of the drug for “off-label”
was required to provide patients prescribed amiodarone with
all FDA approved labels, warnings and Medication Guides with
information exactly as required of the brand formulation
manufacturer, Wyeth. Id. at ¶ 33. The
Medication Guide for amiodarone outlined serious side
effects, such as lung damage, shortness of breath, wheezing,
trouble breathing, coughing, tiredness, weakness,
nervousness, irritability, restlessness, decreased
concentration, and depression. Id. at ¶ 39.
being prescribed amiodarone, Plaintiff James McLeod was
diagnosed with atrial fibrillation that was not deemed life
threatening. Id. at ¶ 34. The management of
McLeod's atrial fibrillation was not considered a medical
situation of “last resort.” Id.
in June of 2014 and continuing through November 2015, McLeod
was prescribed a course of 200 mg amiodarone tablets for
treatment of his non-life threatening atrial fibrillation.
Id. at ¶ 35. McLeod was not aware that his use
of amiodarone was for an “off-label” use and he
did not receive the required Medication Guide from Sandoz.
Id. Correction of atrial fibrillation and any use
except in situations of last resort were never FDA approved
uses of Cordarone® or its generic equivalents.
Id. McLeod's prescription was for an
“off-label” use and without the benefit of the
FDA mandated Medication Guide. Id.
prescription for the amiodarone tablets was marked with the
numbers 00185-0144-60 and was manufactured by Sandoz.
Id. at ¶ 36. Plaintiffs allege the
“off-label” prescription and distribution of the
drug to control a non-life threatening atrial fibrillation,
also a direct result of the long term promotional efforts of
Sandoz and without the required Medication Guide, was a
producing and proximate cause of James McLeod's physical
condition and injuries from amiodarone toxicity. Id.
Plaintiffs allege that if McLeod had received the Medication
Guide, he would have been aware of the serious lung related
side effects and would not have taken amiodarone.
Id. at ¶¶ 38-39.
fall of 2014-2015, McLeod began to experience many of the
symptoms outlined in the Medication Guide including shortness
of breath, wheezing, trouble breathing, coughing, tiredness,
weakness, nervousness, irritability, restlessness, decreased
concentration, and depression. Id. at ¶ 44.
McLeod's condition continued to deteriorate and in March
of 2015, he was admitted to McLeod Regional Medical Center
with severe shortness of breath. In October 2015, McLeod was
diagnosed with COPD. Id. at ¶ 46.
allege Sandoz received direct notice of adverse events
resulting from the use of amiodarone including pulmonary
toxicity, pulmonary fibrosis, lung damage, hepatic damage and
failure, neurotoxicity, peripheral neuropathy, neonatal
hypothyroidism, optic neuritis, toxic optic neuropathy,
blindness, serious exacerbation of arrhythmias, and
congestive heart failure such as that experienced by McLeod.
Id. at ¶ 49. Plaintiffs assert Sandoz failed to
disclose to the FDA, healthcare professionals, consumers, or
McLeod information concerning the incidents and actual
adverse events, injuries, and deaths suffered by amiodarone
users. Id. at ¶ 53.
also allege Sandoz took advantage of the promotional efforts
of Wyeth for “off-label” uses, in addition to its
own efforts, including the following:
a) Direct-to-physician and direct-to-pharmacist promotion
through sales representatives;
b) Promotion through funding and manipulation of so-called
“educators” who organize and arrange continuing
medical education (CME) courses for physicians and
c) Formulation of unlawful conspiracies with certain medical
marketing and medical “education” entities to
promote - without appearing to promote -
d) Sponsorship and funding of the production of CME
materials; e) Cultivation and development of so-called
“opinion leaders” in local medical communities
and support for the careers and research of those physicians,
pharmacists, and researchers who advocate off-label uses; f)
Sponsorship of journal supplements and symposia on
g) Placing (through sponsorship of limited trials, studies,
and surveys) of medical literature databases showing positive
effects (already established) on risk factors with the twin
purposes of overwhelming any independent study showing
negative effects on different risk factors, and causing
earnest but time-crunched physicians to be impressed with the
sheer quantity of favorable (but redundant) studies on
MedLine, or medical library, search;
h) Media advertisements and brochures, some of which were
disguised as “educational materials”;
i) Coordination of physician-to-physician interactions that
are biased toward “off-label” usages;
j) Internet listings that omit important warnings and
k) Various other forms of marketing and promotion.
Id. at ¶ 53. Despite FDA warnings and thousands
of adverse patient experiences, Sandoz continued their
alleged fraudulent marketing, promotional, and sales
practices. Id. at ¶ 56.
allege the amiodarone manufactured and/or supplied by Sandoz
was not accompanied by proper warnings regarding all possible
adverse side effects and comparative severity and duration of
such side effects. Id. at ¶ 58. Plaintiffs
further allege the amiodarone manufactured, distributed,
and/or supplied by Sandoz was defective due to inadequate
post-marketing warning and instruction because, after Sandoz
knew or should have known of the risk of injury from
amiodarone, especially in “off-label” use, Sandoz
failed to provide adequate warnings to physicians and
consumers, including Plaintiff McLeod, and continued to
aggressively sell amiodarone for “off-label” use.
Id. at ¶ 61. Plaintiffs contend the warnings
for amiodarone were vague, incomplete, and/or otherwise
wholly inadequate. Id. at ¶ 67.
allege Sandoz owed a duty to engage in honest and
non-deceptive practices; exercise due care under the
circumstances; exercise due care in the design, manufacture,
marketing, promotion, sale, and distribution of amiodarone;
to provide a reasonably safe and non-defective drug; to
provide adequate and appropriate warnings; to comply with