Stelly v. Zydus Pharmaceuticals U S A Inc

BEVERLY STELLY v. ZYDUS PHARMACEUTICALS U S A INC

CASE NO. 6:20-CV-00570

UNITED STATES DISTRICT COURT WESTERN DISTRICT OF LOUISIANA LAFAYETTE DIVISION

February 22, 2021

JUDGE JUNEAU

MAGISTRATE JUDGE WHITEHURST

REPORT AND RECOMMENDATION

Before the Court is the Motion to Dismiss Plaintiff's Second Amended Complaint pursuant to F.R.C.P. Rule 12(b)(6) filed by Defendant Zydus Pharmaceuticals USA, Inc. (Rec. Doc. 43). Plaintiff, Beverly Stelly, opposed the Motion (Rec. Doc. 47), and Zydus replied (Rec. Doc. 52). The Motion was referred to the undersigned magistrate judge for review, report, and recommendation in accordance with the provisions of 28 U.S.C. §636 and the standing orders of this Court. Considering the evidence, the law, and the arguments of the parties, and for the reasons explained below, the Court recommends that Zydus's Motion be granted in part and denied in part.

Documents Considered

Ordinarily, in ruling on a F.R.C.P. Rule 12(b)(6) motion, the court is limited to the allegations of the complaint and any exhibits attached thereto; however, the court may also consider documents attached to the defendant's motion if they are referenced in the complaint and central to the plaintiff's claims. In re Katrina Canal Breaches Litig., 495 F.3d 191, 205 (5th Cir. 2007). The court is also permitted to take judicial notice of public records as well as facts which are not subject to reasonable dispute in that they are either (1) generally known within the territorial jurisdiction of the trial court or (2) capable of accurate and ready determination by resort to sources whose accuracy cannot reasonably be questioned. Funk v. Stryker Corp., 631 F.3d 777, 783 (5th Cir. 2011). The Fifth Circuit has also sanctioned consideration of certain documents which were attached to the plaintiff's opposition, where no party questioned the authenticity of the documents and the documents are sufficiently referenced in the complaint. Walch v. Adjutant Gen.'s Dep't of Texas, 533 F.3d 289, 294 (5th Cir. 2008).

In this case, Zydus attached correspondence from the Food and Drug Administration (FDA), Office of Generic Drugs, approving Zydus's Abbreviated New Drug Application for amiodarone (the drug at issue in this suit), and Zydus's Prescribing Information and Medication Guide, which Zydus states was reviewed and approved by the FDA (Rec. Doc. 43-2). Plaintiff attached copies of certain applicable federal regulations and decisions from other courts. (Rec. Doc. 47-1 through 47-4). The Court finds that documents reflecting federal law and judicial proceedings are public record and therefore subject to consideration. The Court will also consider FDA correspondence as public record. See Funk v. Stryker Corp., 631F.3d 777, 783 (5th Cir. 2011) (approving the district court's consideration of FDA documents in ruling a Rule 12(b)(6) motion to dismiss). The Court will also consider Zydus's Medication Guide, to the extent applicable, because Plaintiff did not object to its use, and it was referenced throughout the Complaint. Hence, the following facts are derived from Plaintiff's Second Amended Complaint, the documents attached to her original Complaint (Rec. Doc. 1-1 through 1-3), and the documents attached to Plaintiff's and Zydus's pleadings.

Factual Background

Plaintiff filed this diversity suit under 28 U.S.C. §1332 against Zydus, the manufacturer of the generic drug, amiodarone. She amended her Complaint twice, with Zydus now seeking to dismiss Plaintiff's Second Amendment Complaint.¹

Amiodarone is a generic drug for Cordarone, first developed and manufactured by Wyeth. Plaintiff alleges that this drug was "a drug of last resort for patients suffering from documented recurrent life-threatening ventricular fibrillation and ventricular tachycardia." Plaintiff alleges that Wyeth nonetheless marketed the drug for "off label" uses as a "first line anti-arrhythmic therapy." (Rec. Doc. 41, ¶31-32). She states that, in response to serious injuries caused by the drug, the FDAenacted a requirement that manufacturers provide a Medication Guide to go with the drug to patients. (Rec. Doc. 41, ¶37-40).

In 2008, Zydus received approval to manufacture and sell amiodarone, the generic version of Wyeth's drug. (Rec. Doc. 43-2; 41, ¶42). According to the Complaint, the FDA required Zydus to provide Medication Guides to patients which were identical to labels, warnings, and Medication Guides required of Wyeth's name brand drug. (Rec. Doc. 41, ¶42-44).

Plaintiff alleges that in February 2017, Dr. Dibbs prescribed her amiodarone for non-life-threatening atrial fibrillation. (Rec. Doc. 41, ¶ 48-49). In May 2019 she began to experience shortness of breath, wheezing, trouble breathing, coughing, inter alia and suffered damages after taking amiodarone. (Rec. Doc. 41, ¶56). Plaintiff alleges amiodarone was not approved for treatment of her particular condition, such that its use in this instance was an "off-label prescription." (Rec. Doc. 41, ¶49). She alleges that Zydus, like Wyeth, marketed the drug for such off-label uses, despite knowledge of injuries and death caused by the drug. She further alleges that Zydus failed to provide the required Medication Guide to her. (Rec. Doc. 41, ¶49). Had she known of the risks associated with taking amiodarone for her condition, she alleges she would not have taken the drug and sustained damages. (Rec. Doc. 41, ¶49 et seq). She asserts causes of action under the Louisiana Products Liability Act (LPLA) (First Cause of Action), negligence and gross negligence(Second and Third Causes of Action), "off label marketing" (Fourth Cause of Action), failure to provide the Medication Guide (Fifth Cause of Action), and strict liability (Sixth Cause of Action). Zydus now seeks to dismiss these claims on the grounds that Plaintiff's claims are encompassed by the LPLA and therefore preempted by federal law and that Plaintiff has no cause of action for the alleged failure to provide a Medication Guide.

Law and Analysis

When considering a motion to dismiss for failure to state a claim under F.R.C.P. Rule 12(b)(6), the district court must limit itself to the contents of the pleadings, including any attachments and exhibits thereto. Collins v. Morgan Stanley Dean Witter, 224 F.3d 496, 498 (5^th Cir.2000); U.S. ex rel. Riley v. St. Luke's Episcopal Hosp., 355 F.3d 370, 375 (5th Cir.2004). The court must accept all well-pleaded facts as true and view them in the light most favorable to the plaintiff. In re Katrina Canal Breaches Litigation, 495 F.3d 191, 205 (5^th Cir.2007) (internal quotations omitted) (quoting Martin K. Eby Constr. Co. v. Dallas Area Rapid Transit, 369 F.3d 464, 467 (5^th Cir.2004)); Baker v. Putnal, 75 F.3d 190, 196 (5^th Cir.1996). Conclusory allegations and unwarranted deductions of fact are not accepted as true, Kaiser Aluminum & Chemical Sales v. Avondale Shipyards, 677 F.2d 1045, 1050 (5^th Cir. 1982) (citing Associated Builders, Inc. v. Alabama Power Company, 505 F.2d 97, 100 (5^th Cir. 1974)); Collins v. Morgan Stanley, 224 F.3d at498. To survive a Rule 12(b)(6) motion, the plaintiff must plead "enough facts to state a claim to relief that is plausible on its face." Bell Atlantic, 127 U.S. at 570. The allegations must be sufficient "to raise a right to relief above the speculative level," and "the pleading must contain something more . . . than . . . a statement of facts that merely creates a suspicion [of] a legally cognizable right of action." Id. at 555 (quoting 5 C. Wright & A. Miller, Federal Practice and Procedure § 1216, pp. 235-36 (3d ed. 2004)).

I. Whether Plaintiff has stated a claim under the LPLA.

Zydus first urges the Court to consider Plaintiff's claims for negligence and what it deems as "fraud and misrepresentation" as claims consumed by the LPLA, which, as further discussed below, are subject to federal preemption.

To maintain a successful products liability action under the LPLA, a plaintiff must establish four elements: (1) that the defendant is a manufacturer of the product; (2) that the plaintiff's damage was proximately caused by a characteristic of the product; (3) that this characteristic made the product "unreasonably dangerous;" and (4) that the plaintiff's damage arose from a reasonably anticipated use of the product by the plaintiff or someone else. See La. R.S. 9:2800.54(A). A product is "unreasonably dangerous" under the LPLA if the product meets at least one of the following criteria:

(1) The product is unreasonably dangerous in construction or composition as provided in R.S. 9:2800.55;(2) The product is unreasonably dangerous in design as provided in R.S. 9:2800.56;

(3) The product is unreasonably dangerous because an adequate warning about the product has not been provided as provided in R.S. 9:2800.57; or

(4) The product is unreasonably dangerous because it does not conform to an express warranty of the manufacturer about the product as provided in R.S. 9:2800.58.

La. R.S. 9:2800.54(B).

"These statutory mechanisms for establishing that a product is unreasonably dangerous 'are predicated on principles of strict liability, negligence, or warranty.'" Stahl v. Novartis Pharm. Corp., 283 F.3d 254, 260-61 (5th Cir. 2002), citing Jefferson v. Lead Indus. Assoc., 930 F.Supp. 241, 245 (E.D.La.1996). "However, for causes of action arising after the effective date of the LPLA [1988], negligence, strict liability, and breach of express warranty are not available as theories of recovery against a manufacturer, independent from the LPLA." Id.

Plaintiff's express LPLA claim is for failure to warn under La. R.S. 9:2800.57. (Rec. Doc. 41, First Cause of Action, p. 24). Her Fourth Cause of Action (Off Label Marketing) and Fifth Cause of Action (Failure to Provide Medication Guide) likewise evoke failure to warn claims. See Wells v. Wyeth Pharm., Inc., No. A-16-CV-593-LY-ML, 2017 WL 8182749, at *3 (W.D. Tex. Apr. 12, 2017), report and recommendation adopted, No. 1:16-CV-593-LY, 2017 WL 8182839 (W.D. Tex. May...