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Bean v. Upsher-Smith Pharmaceuticals Inc.

United States District Court, D. South Carolina, Florence Division

September 29, 2017

Latham Sean Bean, individually and as Personal Representative of the Estate of Hubert E. Bean, Jr., deceased, Plaintiff,
v.
Upsher-Smith Pharmaceuticals, Inc. and Taro Pharmaceuticals USA, Inc., Defendants.

          ORDER

          R. Bryan Harwell United States District Judge

         This 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.[1]

         Factual[2] and Procedural Background

         Plaintiff 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 Wyeth's Cordarone®.

         The FDA 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.

         Plaintiff 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.

         In 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.

         Plaintiff 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.

         Beginning 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.

         The 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.

         In the 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. Id.

         Plaintiff 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.

         Plaintiff 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 pharmacists;
c) Formulation of unlawful conspiracies with certain medical marketing and medical “education” entities to promote - without appearing to promote - “off-label” uses;
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 “off-label” uses;
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 ...

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