Perdue v. Wyeth Pharm., Inc.

• Decision Date: 20 July 2016
• Docket Number: NO. 4:15-CV-208-FL,4:15-CV-208-FL
• Court: U.S. District Court — Eastern District of North Carolina
• Parties: Sara G. PERDUE, as Executor of the Estate of Marjorie S. Newton, Deceased, Plaintiff, v. WYETH PHARMACEUTICALS, INC.; Teva Pharmaceuticals USA, Inc.; Barr Laboratories, Inc.; and Zydus Pharmaceuticals USA, Inc., Defendants.

209 F.Supp.3d 847

Sara G. PERDUE, as Executor of the Estate of Marjorie S. Newton, Deceased, Plaintiff,

v.WYETH PHARMACEUTICALS, INC.; Teva Pharmaceuticals USA, Inc.; Barr Laboratories, Inc.; and Zydus Pharmaceuticals USA, Inc., Defendants.

NO. 4:15-CV-208-FL

United States District Court, E.D. North Carolina.

Signed July 20, 2016

Edward K. Wood, Jr., Wood Law Firm, LLC, Birmingham, AL, Joseph A. Schouten, Ward and Smith, P.A., Raleigh, NC, A. Charles Ellis, Ward & Smith, P.A., Greenville, NC, for Plaintiff.

Dana C. Lumsden, Bradley Arant Boult Cummings LLP, Charlotte, NC, Kimberly B. Martin, Amanda J. Turnage, Bradley Arant Boult Cummings LLP, Huntsville, AL, Kirk G. Warner, Christopher R. Kiger, Smith Anderson Blount Dorsett Mitchell & Jernigan, Leslie C. Packer, Nora F. Sullivan, Ellis & Winters, LLP, Raleigh, NC, Carla R. Karp, Glenn S. Kerner, Nilda M. Isidro, Goodwin Proctor LLP, New York, NY, Beth S. Rose, Vincent R. Lodato, Sills Cummis & Gross P.C., Newark, NJ, for Defendants.

ORDER

LOUISE W. FLANAGAN, United States District Judge

This matter comes before the court on defendants' motions to dismiss pursuant to Federal Rule of Civil Procedure 12(b)(6). (DE 23, 34, 41). Plaintiff has responded in opposition, and defendants have replied. In this posture, the issues raised are ripe for ruling. For the following reasons, defendants' motions are granted.

STATEMENT OF THE CASE

Plaintiff commenced this action on December 28, 2015, asserting state law claims for wrongful death premised upon defendants' allegedly fraudulent and negligent actions in promoting a drug under the name Cordarone ®/ amiodarone for off-label use, failing to adequately inform of dangers thereof, and failing to provide a medication guide to distributors. Defendant Wyeth Pharmaceuticals, Inc., ("Wyeth"), which manufactures brand-name Cordarone ®, moved to dismiss all claims against it on February 2, 2016. Defendants Barr-Laboratories, Inc. ("Barr"), Teva Pharmaceuticals USA, Inc. ("Teva"), and Zydus Pharmaceuticals USA, Inc. ("Zydus") (collectively, the "generic defendants"), which manufacture generic amiodarone, filed motions to dismiss all claims against them on February 29 and March 10, 2016. On March 18, 2016, the court denied plaintiff's motion to stay the case pending consideration of transfer for multidistrict litigation. On June 2, 2016, the court received a copy of an order by the United States Judicial Panel on Multidistrict Litigation denying transfer to multidistrict litigation.

STATEMENT OF FACTS

The facts alleged in the complaint may be summarized as follows. Defendant Wyeth manufactures, promotes, and sells Cordarone ®, which the Food and Drug Administration (FDA) approved in 1985 as a drug for use in "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." (Compl. ¶33). Defendant Wyeth has promoted Cordarone ® for use in controlling atrial fibrillation, which is a use not described in the FDA-approved labeling for the drug, thus constituting an "off-label" use. (Id. ¶34). The generic defendants manufacture, promote, and sell amiodarone, a generic formulation of Cordarone ® that the FDA approved in 1998. The generic defendants also promote amiodarone for the off-label use in controlling atrial fibrillation.

Marjorie S. Newton ("Newton") was plaintiff's mother. In 2006, Newton's doctor diagnosed Newton with atrial fribrillation not deemed life threatening, and prescribed Newton a course of 200mg amiodarone tablets. Newton filled the prescription at Realo Discount Pharmacy, with tablets manufactured, marketed, and distributed by the generic defendants. Newton was not aware that her doctor prescribed her amiodarone for an off-label use. Newton did not receive with her prescription a medication guide, which federal statute requires generic drug manufacturers to provide to drug distributors. Newton was not aware of side effects and dangers associated with her off-label use of amiodarone, including serious lung-related side effects that could lead to her death. Newton would not have taken amiodarone if she had received the medication guide.

In 2013, Newton began to experience many of the symptoms outlined in the medication guide, including shortness of breath, wheezing, trouble breathing, coughing, tiredness, and weakness. Her condition continued to deteriorate, and she experienced increasing pulmonary issues including shortening of breath, deep cough, and difficulty doing things she enjoyed at home. Newton died at Carolina East Medical Center on December 27, 2013, at age 82. Plaintiff is the administrator/executor of Newton's estate.

COURT'S DISCUSSION

A. Standard of Review

A motion to dismiss under Rule 12(b)(6) tests the legal sufficiency of the complaint but "does not resolve contests surrounding the facts, the merits of a claim, or the applicability of defenses." Republican Party v. Martin , 980 F.2d 943, 952 (4th Cir.1992). A complaint states a claim if it contains "sufficient factual matter, accepted as true, to ‘state a claim to relief that is plausible on its face.’ " Ashcroft v. Iqbal , 556 U.S. 662, 678, 129 S.Ct. 1937, 173 L.Ed.2d 868 (2009) (quoting Bell Atl. Corp. v. Twombly , 550 U.S. 544, 570, 127 S.Ct. 1955, 167 L.Ed.2d 929 (2007) ). "Asking for plausible grounds ... does not impose a probability requirement at the pleading stage; it simply calls for enough fact to raise a reasonable expectation that discovery will reveal [the] evidence" required to prove the claim. Twombly , 550 U.S. at 556, 127 S.Ct. 1955. In evaluating the complaint, "[the] court accepts all well-pled facts as true and construes these facts in the light most favorable to the plaintiff," but does not consider "legal conclusions, elements of a cause of action, ... bare assertions devoid of further factual enhancement [,] ... unwarranted inferences, unreasonable conclusions, or arguments." Nemet Chevrolet, Ltd. v. Consumeraffairs.com, Inc. , 591 F.3d 250, 255 (4th Cir.2009).

B. Analysis

1. Preemption

The generic defendants seek dismissal of plaintiff's claims against them primarily on the basis of preemption. As pertinent to the court's preemption analysis, plaintiff asserts wrongful death claims premised upon three theories of liability: (a) failure to warn adequately of dangers associated with amiodarone; (b) off-label promotion of amiodarone; and (c) failure to provide a medication guide to distributors. The court will address each theory in turn below.

a. Failure to Warn

Plaintiff includes multiple allegations in the complaint regarding defendants' alleged failure to warn properly of dangers associated with amiodarone. For example, plaintiff alleges:

[Promotional] campaigns were aggressive and in many situations, focused on the use of the drug for atrial fibrillation and failed to warn prescribing physicians of the potential dangers associated with amiodarone toxicity and dangers to atrial fibrillation patients. (Compl. ¶34) (emphasis added).

Defendants failed to disclose to the FDA, healthcare professionals, consumers, or [Newton], of the information they possessed concerning the incidents and actual adverse medical events, injuries, and deaths suffered by Cordarone ®/amiodarone users. (Compl. ¶82) (emphasis added).

[T]he Cordarone ®/amiodarone, manufactured and/or supplied by Defendants was and is unaccompanied by proper warnings regarding all possible adverse side effects and comparative severity and duration of such adverse effects; the warnings given did not and do not accurately reflect the severity or duration of the adverse side effects or the true potential and/or likelihood or rate of the side effects. This is particularly so with regard to ‘off label’ use. (Compl. ¶88) (emphasis added).

[T]he warnings for Cordarone ®/amiodarone, in effect during the relevant time period were vague, incomplete, and/or otherwise wholly inadequate , both substantively and graphically, to alert prescribing physicians, pharmacists, consumer patients and [Newton] of the actual risks associated with this drug. (Compl. ¶ 99) (emphasis added).

These claims against the generic defendants premised upon failure to provide adequate warnings accompanying the sale and distribution of amiodarone, however, are preempted by federal law. In particular, because the Food Drug Cosmetic Act (FDCA) and related regulations limit a generic manufacturer's ability to attach additional warnings to their drug, such failure-to-warn claims against the generic defendants are preempted. See PLIVA, Inc. v. Mensing , 564 U.S. 604, 618, 131 S.Ct. 2567, 180 L.Ed.2d 580 (2011) (citing 21 CFR § 314.150(b)(10) ); Drager v. PLIVA USA, Inc. , 741 F.3d 470, 479 (4th Cir.2014) (holding claims preempted where based on allegations "that, through its promotional and warning materials, [generic defendant] made negligent misrepresentations and fraudulently concealed information about the safety of its product from consumers and medical professionals").

In response to the generic defendants' motions to dismiss, plaintiff does not seek to advance her failure-to-warn claims. Rather, she argues that liability in this case is based instead upon defendants' promotion of amiodarone for off-label uses and defendants' failure to provide a medication guide. The court will address these theories of liability below. For present purposes, it suffices that plaintiff's failure-to-warn claims must be dismissed with prejudice on the basis of preemption.

b. Off-label promotion

Plaintiff asserts that defendants' off-label promotion of Cordarone ®>/amiodarone was in violation of the FDCA and related regulations, thus providing a basis for liability under a state law theory of negligence per se . This claim is preempted, although in a different manner than the failure-to-warn claims.

The FDCA does not provide a private right of action for a defendant's violation of its provisions. See ...