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Allain v. Wyeth Pharmaceuticals, Inc.

United States District Court, N.D. Alabama, Southern Division

February 27, 2018

MICHAEL W. ALLAIN, as Executor of the Estates of ROBERT EARL DREHER, SR., Deceased Plaintiff,



         This matter is before the court on Defendant Wyeth Pharmaceuticals, Inc.'s Motion for Summary Judgment. (Doc. 96). Plaintiff Michael Allain, as executor of the estate of Robert Earl Dreher, Sr., sued Defendant Wyeth Pharmaceuticals for failure to warn, failure to provide medication guides to Mr. Dreher's pharmacy, and “off-label” promotion of the drug Cordarone, alleging each of these actions contributed to Mr. Dreher's wrongful death. On June 29, 2015, this court dismissed all Mr. Allain's claims against Wyeth except for the claim regarding the off-label promotion of Cordarone. (Doc. 58).

         As explained more fully below, the court now finds no genuine dispute as to any material fact in this case and Wyeth is entitled to judgment as a matter of law. Therefore, the court will enter summary judgment in favor of Wyeth and against Mr. Allain regarding his only remaining claim.


         Mr. Allain has not responded to Wyeth's motion for summary judgment. Therefore, whenever Allain has failed to dispute one of Wyeth's facts by not responding to the motion, the court will review Wyeth's cited evidence, and, if it in fact fairly supports Wyeth's factual assertion, it will accept Wyeth's fact as true.

         In 1985, Wyeth Pharmaceuticals received FDA approval to begin manufacturing and selling Cordarone in the United States. (Doc. 34 at 8). Cordarone is a prescription drug approved as a “drug of last resort” for patients suffering from life-threatening ventricular fibrillation or ventricular tachycardia and is only to be used in situations where the patient's condition would not respond to other available drugs and therapies. (Id. at 3-4). Wyeth was the sole manufacturer of Cordarone from 1985 until the FDA granted other companies approval to begin manufacturing and selling generic versions in 1998. (Id. at 10). Sandoz Pharmaceuticals Corporation then produced a generic version, which is the bioequivalent of Cordarone, known by the drug's chemical name, amiodarone hydrochloride. (Id. at 11).

         In 1985, the same year that the FDA approved Cordarone, Wyeth began aggressively marketing the drug. Although Wyeth was aware of the serious side effects of Cordarone and that Cordarone was approved only as a “drug of last resort, ” it nevertheless promoted Cordarone for “off-label” use -i.e. for a purpose other than that approved by the FDA. (Id. at 9). According to Mr. Allain, Wyeth's marketing campaign misled “an entire generation of physicians, ” id., and Wyeth's promotional activities “would have greatly affected” Mr. Dreher's physicians' decisions to prescribe generic versions of Cordarone to Mr. Dreher. (Id. at 12).

         In February of 2011, Mr. Dreher's physician, Dr. Macy Smith, prescribed him a ninety-day course of generic amiodarone tablets manufactured by Sandoz to treat Mr. Dreher's atrial fibrillation. (Id. at 11). Because Mr. Dreher suffered from atrial fibrillation, not ventricular fibrillation, and because his condition was not life threatening, his use of the drug was considered “off-label.”

         Dr. Smith is a member of the American College of Cardiology, the governing board in the United States for cardiology, and relies upon the organization's guidelines concerning how to treat atrial fibrillation patients. (Doc. 97-1 at 21-22). He also testified that those guidelines recommend the off-label use of amiodarone to treat such patients, especially when those patients have a structural abnormality, like Mr. Dreher had. ( 22). Dr. Smith further testified that he prescribed the amiodarone knowing the risks involved and understanding that it was for the purpose of an off-label use. (Id. at 23).

         From February 2011 to January 2012, Mr. Dreher experienced many of the symptoms associated with amiodarone use, including shortness of breath, wheezing, trouble breathing, coughing, and tiredness. (Doc. 34 at 16-17). Mr. Dreher's condition continued to deteriorate, and, on February 15, 2012, Mr. Dreher passed away at the age of eighty four. (Id. at 17). Mr. Allain alleges that Mr. Dreher died as a result of taking amiodarone. More specifically, Mr. Allain argues Wyeth's promotion of Cordarone's “off-label” use “was a producing and proximate cause” of Mr. Dreher's death. (Doc. 34 at 13).


         When a district court reviews a motion for summary judgment, it must determine two things: whether any genuine issues of material fact exist, and whether the moving party is entitled to judgment as a matter of law. See Fed. R. Civ. P. 56.

         The court must “view the evidence presented through the prism of the substantive evidentiary burden” to determine whether the non-moving party presented sufficient evidence on which a jury could reasonably find for the nonmoving party. Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 255 (1986). The court must not weigh the evidence and make credibility determinations because these decisions belong to a jury. See Id. at 254.

         Further, all evidence and inferences drawn from the underlying facts must be viewed in the light most favorable to the non-moving party. See Graham v. State Farm Mut. Ins. Co., 193 F.3d 1274, 1282 (11th Cir. 1999). The court must grant the motion only if no genuine issues of material fact exist and ...

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