Lee v. Mylan Inc et al
ORDER GRANTING 41 Motion for Summary Judgment. Ordered by Judge Marc Thomas Treadwell on 10/28/2011. (tlh)
IN THE UNITED STATES DISTRICT COURT
MIDDLE DISTRICT OF GEORGIA
BETHANI LEE, as Personal
Representative of the Estate of
Jonee Adair Lee-Livingston and
MYLAN INC., et. al,
CIVIL ACTION NO. 5:10-CV-361 (MTT)
This matter is before the Court on the Defendants’ Motion for Summary
Judgment. (Doc. 41). For the following reasons, the Motion is GRANTED.
Plaintiffs Bethani Lee and Calvin Livingston bring this action for the death of
Jonee Adair Lee-Livingston. The Plaintiffs did not respond to the Motion, and thus the
facts are not in dispute. M.D.G.A. Local R. 56. On October 2, 2008, Lee-Livingston’s
doctor prescribed for her 25 mcg/hr Mylan fentanyl transdermal system (“MFTS”)
patches manufactured by the Defendants. On October 12, 2008, Lee-Livingston died,
according to a medical examination, of the combined effects of fentanyl and alprazolam.
MFTS patches have been approved by the Federal Drug Administration, and can
only be obtained by prescription. MFTS patches, used to relieve pain, come in 25, 50,
75, and 100 mcg/hr dosages. MFTS patches are applied directly to the skin and
release fentanyl into a patient’s blood stream.
The Plaintiffs claim that numerous patients, including Lee-Livingston, have
received lethal doses of fentanyl from using the MFTS patches as prescribed, and that
the Defendants knew or should have known the drug could cause serious injury and/or
death. In short, the Plaintiffs claim that Lee-Livingston died because the MFTS patches
released lethal doses of fentanyl.
On April 15, 2011, this Court granted in part and denied in part the Defendants’
Motion to Dismiss. (Doc. 29). The remaining claims are negligent misrepresentation
and breach of warranty based upon a failure to warn third parties, and breach of
warranty based upon affirmations of fact or promises to Lee-Livingston. The Parties
later agreed to add Calvin Livingston, Lee-Livingston’s surviving spouse, as a plaintiff,
and the Court granted the Motion to Amend. (Docs. 37, 38).
Pursuant to the Court’s Scheduling and Discovery Order, the Plaintiffs had until
August 5, 2011, to disclose expert witnesses who may testify at trial, and the
Defendants had until September 5, 2011. The Defendants disclosed reports of four
expert witnesses. Dr. Gordon Flynn explained that the MFTS patches came with
adequate warnings, and were not defective when used properly. Dr. Graham Jones
concluded that the fentanyl level at the time of examination was likely higher than at the
time of her death, discussed the effects of other drugs, namely Xanax (alprazolam), and
concluded that the toxicity results of Lee-Livingston’s postmortem fentanyl level were
unreliable. Dr. Thomas Bennett opined that Lee-Livingston’s death likely was the result
of cardiovascular disease, rather than drug use. Dr. David Feigal reported that the
MFTS label provided adequate warnings to physicians and the Food and Drug
Administration. The Plaintiffs have not disclosed any expert witnesses.
Summary judgment must be granted if the pleadings, the discovery and
disclosure materials on file, and any affidavits show that there is no genuine issue as to
any material facts and that the movant is entitled to judgment as a matter of law. Fed.
R. Civ. P. 56(c). “A factual dispute is genuine only if ‘a reasonable jury could return a
verdict for the nonmoving party.’” Info. Sys. & Networks Corp. v. City of Atlanta, 281
F.3d 1220, 1224 (11th Cir. 2002) (quoting United States v. Four Parcels of Real Prop.,
941 F.2d 1428, 1437 (11th Cir. 1991)). The burden rests with the moving party to prove
that no genuine issue of material fact exists. Info. Sys. & Networks Corp. v. City of
Atlanta, 281 F.3d at 1224. The district court must “view all evidence in the light most
favorable to the nonmoving party, and resolve all reasonable doubts about the facts in
its favor.” Id.
Construed in the light most favorable to the Plaintiffs, Lee-Livingston died, in part,
from fentanyl toxicity ten days after she began using the MFTS patches. The Plaintiffs
have presented no evidence that the MFTS patches were defective, or that the
warnings to third parties were inadequate. However, the Defendants have presented
expert testimony that the warnings were adequate, that the prescribed patches could
not have delivered more than 25 mcg/hr of fentanyl when properly used, and that other
factors contributed to Lee-Livingston’s death.
Accordingly, under these undisputed facts, the Plaintiffs have not demonstrated
that the MFTS patches were defective, or that warnings to third parties were
inadequate, and thus the Motion must be granted.
For the foregoing reasons, the Defendants’ Motion for Summary Judgment is
SO ORDERED, this the 28th day of October, 2011.
S/ Marc T. Treadwell
MARC T. TREADWELL, JUDGE
UNITED STATES DISTRICT COURT
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