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McLeod v. Sandoz Inc

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

March 31, 2017

James E. McLeod and Glenda McLeod, Plaintiffs,
Sandoz, Inc., Defendant.


          R. Bryan Harwell United States District Judge.

         This 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.[1]

         Factual[2] and Procedural Background

         Plaintiffs, 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®.

         In 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. Id.

         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. 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.

         Plaintiffs 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.

         In 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” uses. Id.

         Sandoz 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.

         Before 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.

         Beginning 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.

         The 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.

         In the 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.

         Plaintiffs 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.

         Plaintiffs 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 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 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 information; 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.

         Plaintiffs 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.

         Plaintiffs 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 federal ...

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