United States District Court, N.D. Alabama, Southern Division
MICHAEL W. ALLAIN, as Executor of the Estates of ROBERT EARL DREHER, SR., Deceased Plaintiff,
WYETH PHARMACEUTICALS, INC. Defendant.
OWEN BOWDRE CHIEF UNITED STATES DISTRICT JUDGE.
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.
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.
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.
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).
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).
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
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. (Id.at 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).
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
STANDARD OF REVIEW
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.
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.
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 ...