Searching over 5,500,000 cases.


searching
Buy This Entire Record For $7.95

Download the entire decision to receive the complete text, official citation,
docket number, dissents and concurrences, and footnotes for this case.

Learn more about what you receive with purchase of this case.

Monk v. Wyeth Pharmaceuticals, Inc.

United States District Court, W.D. Texas, San Antonio Division

May 11, 2017

JO ANN MONK, Individually and as Personal Representative of the Estate of JESSE MONK, Plaintiff,
v.
WYETH PHARMACEUTICALS, INC., ET AL., Defendants.

          ORDER

          XAVIER RODRIGUEZ, UNITED STATES DISTRICT JUDGE

         On this 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.

         BACKGROUND

         I. Plaintiff's Factual Allegations

         Jesse 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).

         Jesse 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.

         When 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.

         Plaintiff's 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.

         Defendant 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.

         II. The FDA's Drug Approval Framework[1]

         Brand-name 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 5-6.

         The 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 process:

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, 2471 (2013).

Eckhardt v. Qualitest Pharm., Inc., 751 F.3d 674, 676 (5th Cir. 2014) (citations modified).

         Defendants 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 ...

Buy This Entire Record For $7.95

Download the entire decision to receive the complete text, official citation,
docket number, dissents and concurrences, and footnotes for this case.

Learn more about what you receive with purchase of this case.