United States District Court, W.D. Texas, San Antonio Division
JO ANN MONK, Individually and as Personal Representative of the Estate of JESSE MONK, Plaintiff,
WYETH PHARMACEUTICALS, INC., ET AL., Defendants.
RODRIGUEZ, UNITED STATES DISTRICT JUDGE
date, the Court considered Defendant Teva
Pharmaceuticals' Motion to Dismiss (Docket no. 21),
Defendants Eon Labs and Sandoz Inc.'s Motion to Dismiss
(Docket no. 22), and the corresponding responses and replies.
After careful consideration, the motions to dismiss are
GRANTED IN PART AND DENIED IN PART.
Plaintiff's Factual Allegations
Monk had atrial fibrillation. Docket no. 18 at 6. Doctors
prescribed amiodarone as a treatment. Id. He never
received a Medication Guide describing certain risks
associated with his use of amiodarone and his pharmacy did
not have Medication Guides to provide to him. Id. at
7. After taking amiodarone as prescribed for approximately
eight years, Monk died in January 2015. Id. at 1, 6.
His autopsy revealed that the cause of death was amiodarone
poisoning. Id. at 8. Monk's spouse, Jo Ann Monk,
is the plaintiff in this lawsuit, and brings claims
individually and as personal representative of Jesse
Monk's estate. Id. at 1. Defendants Teva
Pharmaceuticals USA, Inc., Eon Labs, Inc., and Sandoz, Inc.
are distributors of a generic form of amiodarone.
Id. at 6. Defendants are required by Food and Drug
Administration (“FDA”) regulations and the Food,
Drug, and Cosmetics Act (“FDCA”) to provide
Medication Guides to Monk via his pharmacy. Id. at
7-8; see 21 C.F.R. § 280.24(b).
Monk was prescribed amiodarone “off label”-that
is, for a use for which it was not fully approved by the FDA.
Id. at 6. In particular, amiodarone was approved by
the FDA through a limited “special needs”
process, meaning that it was only approved “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 5-6. Despite being approved
only for these purposes, doctors prescribed amiodarone to
Monk for treatment of atrial fibrillation. Id.
Monk had his prescription filled at a local Walgreen's
pharmacy, he was never given a Medication Guide. Id.
at 7. According to the complaint, Monk did not know that he
was prescribed amiodarone off label or of the risks of taking
amiodarone, the Medication Guide would have given him this
information, and he would not have taken amiodarone had he
been fully informed. Id.
live complaint asserts causes of action for negligence,
negligence per se, and gross negligence:
[Defendants] have a duty to market amiodarone in such a way
as to avoid unreasonable harm to patient consumers.
[Defendants] were required to provide a Medication Guide . .
. They failed to comply with that requirement and in doing so
breached parallel Texas State law duties. [Defendants']
failure to provide amiodarone Medication Guides as required
breached the Texas state common law duty to adequately warn
of risks association with prescription medicines.
Id. at 11.
Teva filed a motion to dismiss on March 14, 2017. Docket no.
21. Defendants Eon and Sandoz filed a similar motion that
same day. Docket no. 22.
The FDA's Drug Approval Framework
prescription drugs must be approved by the FDA before they go
to market. Docket no. 18 at 5. To begin this process, the
sponsor of a drug submits a new drug application
(“NDA”). Id. NDAs include a litany of
information relating to a drug's safety, effectiveness,
proposed uses, warnings, and potential adverse reactions.
Id. In 1984, Wyeth, a pharmaceutical company that
was initially named as a defendant in this lawsuit but has
since been voluntarily dismissed by Plaintiff, sponsored
approval of amiodarone under the brand name Cordarone.
Id. at 5; see also Docket no. 20. In doing
so, however, Cordarone obtained FDA approval under an
abbreviated “special needs” process whereby a
drug is not subject to the full rigor of an NDA but is
approved only for certain, limited “special
needs.” Docket no. 18 at 5. As such, Cordarone
“was approved 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
above procedure applied only to the initial approval of a
Wyeth's brand-name formulation of amiodarone,
but the remaining defendants in this action are manufacturers
of a generic form of amiodarone. Id. at 5.
As such, they are governed by a slightly different regulatory
In 1984, through the Hatch-Waxman Amendments, Congress
modified these procedures for generic drug manufacturers,
creating an expedited process for approving generic drugs.
See Drug Price Competition and Patent Term
Restoration Act of 1984, Pub. L. 98-417, 98 Stat. 1585
(codified in scattered sections of 21 and 35 U.S.C.). In
essence, these amendments allow a generic drug manufacturer
to piggy-back on the FDA approval of a brand name
drug-greatly accelerating the process for receiving
approval-provided that the generic drug has active
ingredients and labeling identical to that of the
FDA-approved brand name drug. PLIVA, Inc. v.
Mensing, 564 U.S. 604, 612-13, n. 2 (2011). After the
generic drug receives approval, the generic manufacturer is
prohibited from making changes to the drug itself or from
unilaterally changing the drug's label. See Mutual
Pharmaceutical Co., Inc. v. Bartlett, 133 S.Ct. 2466,
Eckhardt v. Qualitest Pharm., Inc., 751 F.3d 674,
676 (5th Cir. 2014) (citations modified).
all received FDA approval to manufacture, market, sell, and
distribute their generic formulas of amiodarone. Docket no.
18 at 6. Accordingly, they were required by the FDA and FDCA
to provide certain labels, warnings, and information.
Id. Most notably for purposes of this lawsuit, the
FDCA and its regulations require generic drug manufacturers
to disseminate Medication Guides:
(b) Each manufacturer who ships a container of drug product
for which a Medication Guide is required under this part is
responsible for ensuring that Medication Guides are available
for distribution to patients by either:
(1) Providing Medication Guides in sufficient numbers to
distributors, packers, or authorized dispensers to permit the
authorized dispenser to provide a Medication Guide to each
patient receiving a prescription for the drug product; or
(2) Providing the means to produce Medication Guides in
sufficient numbers to distributors, packers, or authorized
dispensers to permit the authorized dispenser to provide a
Medication Guide to each patient receiving a prescription for
the drug product. . . .
(e) Each authorized dispenser of a prescription drug product
for which a Medication Guide is required under this part
shall, when the product is dispensed to a patient (or to a
patient's agent), provide a Medication Guide directly to
each patient (or to the ...