United States District Court, D. South Carolina, Florence Division
Latham Sean Bean, individually and as Personal Representative of the Estate of Hubert E. Bean, Jr., deceased, Plaintiff,
Upsher-Smith Pharmaceuticals, Inc. and Taro Pharmaceuticals USA, Inc., Defendants.
Bryan Harwell United States District Judge
matter is before the Court on Defendant Upsher-Smith
Pharmaceuticals, Inc.'s [ECF No. 19] motion to dismiss
and Taro Pharmaceuticals USA, Inc.'s [ECF No. 22] motion
to dismiss. For the reasons stated below, the Court grants
the motions to dismiss.
Factual and Procedural
filed his Complaint on May 26, 2016, alleging claims against
Defendants Upsher-Smith Pharmaceuticals, Inc.
(“Upsher-Smith”) and Taro Pharmaceuticals USA,
Inc. (“Taro”) 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) wrongful death. The claims arise from Hubert E. Bean,
Jr.'s use of the pharmaceutical drug amiodarone for
treatment of his non-life threatening atrial fibrillation.
Plaintiff alleges that after ingesting amiodarone
manufactured by Upsher-Smith and Taro, Hubert Bean developed
pulmonary fibrosis, which eventually led to his death.
[Complaint, ECF No. 1 at ¶ 2]. The amiodarone tablets
were manufactured and sold as a generic version of
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. Plaintiff alleges Wyeth
aggressively and successfully marketed Cordarone® for
inappropriate “off label” uses as a “first
line anti-arrhythmic therapy.” Id. at ¶
30. Generally, Plaintiff alleges Hubert Bean was not in a
situation of last resort as to the management of his atrial
fibrillation. Id. at ¶ 34.
alleges that 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. at ¶ 31.
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.
Plaintiff asserts Defendants Upsher-Smith and Taro took
advantage of the pervasive promotional activities of Wyeth
and allege that Defendants' version of the drug directly
benefitted from Wyeth's marketing of the drug for
“off-label” uses. Id.
alleges Defendants were 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.
in October of 2013 and continuing through April of 2014, Bean
was prescribed a course of 200 mg amiodarone tablets for
treatment of his non-life threatening atrial fibrillation.
Id. at ¶ 35. Bean was not aware that his use of
amiodarone was for an “off-label” use and he did
not receive the required Medication Guide from Defendants.
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. Bean's prescription was for an
“off-label” use and without the benefit of the
FDA mandated Medication Guide. Id.
prescriptions for the amiodarone tablets were marked with the
numbers 51672-4025-04 and 00245-0147-60 and were manufactured
by Taro and Upsher-Smith. Id. at ¶ 36.
Plaintiff alleges the “off-label” prescription
and distribution of the drug to control non-life threatening
atrial fibrillation, also a direct result of the long term
promotional efforts of Defendants and without the required
Medication Guide, was a producing and proximate cause of
Bean's physical condition and injuries from amiodarone
toxicity. Id. Plaintiff alleges that if Bean 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.
winter and early spring of 2014, Bean 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. Bean's condition continued to
deteriorate and in May of 2014, he was admitted to McLeod
Regional Medical Center with severe shortness of breath.
Id. at ¶ 46. In June of 2014, Bean was admitted
to McLeod with shortness of breath and acute and chronic
respiratory failure. Id. Bean died on June 20, 2014.
alleges Defendants 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 Bean.
Id. at ¶ 49. Plaintiff alleges Defendants
failed to disclose to the FDA, healthcare professionals,
consumers, or Bean information concerning the incidents and
actual adverse events, injuries, and deaths suffered by
amiodarone users. Id. at ¶ 53.
alleges Defendants took advantage of the promotional efforts
of Wyeth for “off-label” uses, in addition to
their 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
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