Jankowski v. Zydus Pharm. USA, Inc.
| Decision Date | 28 May 2021 |
| Docket Number | Civil Action No. 20-2458 (MAS) (TJB) |
| Parties | CHRISTINE JANKOWSKI, et al., Plaintiffs, v. ZYDUS PHARMACEUTICALS USA, INC. and DOES 1-50, Inclusive, Defendants. |
| Court | U.S. District Court — District of New Jersey |
NOT FOR PUBLICATION
This matter comes before the Court upon Defendant Zydus Pharmaceuticals USA, Inc.'s ("Zydus" or "Defendant") Motion to Dismiss the First Amended Complaint. (ECF No. 11.) Plaintiffs1 opposed (ECF No. 17) and Zydus replied (ECF No. 19).2 The Court has carefully considered the parties' submissions and decides the matter without oral argument pursuant to Local Civil Rule 78.1. For the reasons set forth below, Defendants' Motion to Dismiss is granted.
Zydus manufactures and sells Amiodarone, which is the generic form of Cordarone, a brand-name drug manufactured by Wyeth Pharmaceuticals, Inc. ("Wyeth"). Wyeth received approval from the Food and Drug Administration ("FDA") to market and sell Cordarone as a "drug of last resort for patients suffering from documented, recurrent, life threatening ventricular fibrillation and ventricular tachycardia." (FAC ¶ 166.) As a drug of last resort, the FDA approved its use only for individuals facing probable death and whose conditions would not respond to other available anti-arrhythmic drugs and therapies. (Id.)
Pursuant to the Hatch-Waxman Act of 1984, which amended the Food, Drug, and Cosmetic Act ("FDCA"), a generic manufacturer—like Zydus—is not required to repeat the FDA approval process undertaken by brand-name manufacturers. (Id. ¶ 162.) Instead, generic pharmaceutical manufacturers must submit an Abbreviated New Drug Application ("ANDA") to the FDA to obtain approval to manufacture a generic pharmaceutical following the FDA's approval of its brand-name equivalent. (Id.) The FDA approved Zydus's ANDA on March 30, 2001. (Id. ¶ 176 n.14.)
Plaintiffs allege that Wyeth aggressively and successfully marketed Cordarone for inappropriate "off-label" use as a "first line anti-arrhythmic therapy." (Id. ¶ 167.) An "off-label" use of a pharmaceutical occurs when it is used in a manner that has not been approved by the FDA. (Id.) According to Plaintiffs, the FDA repeatedly warned Wyeth to stop marketing Cordarone in a manner which downplayed its safety risks and promoted its off-label use. (Id.) Plaintiffs allege that as a result of Wyeth's pervasive and effective marketing activities, physicians did not appreciate the risks associated with Amiodarone and began to prescribe the drug as a first-line therapy for atrial fibrillation. (Id.) Plaintiffs allege that Defendant and other generic manufacturers "tookadvantage of Wyeth's marketing plan positioning Amiodarone as a 'first line anti-arrhythmic' . . . and directly benefited from the decades of marketing of the drug for 'off-label' uses by Wyeth." (Id.) The FDA also promulgated a regulation requiring manufacturers of Amiodarone to make available to distributors a medication guide ("Medication Guide") setting forth in plain terms the drug's medical uses and health risks. (Id. ¶ 179; see 21 C.F.R. § 208.24 (2020).)
According to Plaintiffs, Zydus failed to provide, or make available for distribution, the FDA-required Medication Guide to both distributors and patients. Plaintiffs further allege Zydus took advantage of Wyeth's promotional marketing of the drug for off-label use, and failed to inform physicians, distributors, or patients of the many potential dangers of Amiodarone, including that it was not intended for use as a first-line therapy for atrial fibrillation. (Id. ¶ 167.)
Plaintiffs assert claims for: (1) strict products liability for failure to warn; (2) negligent failure to warn; (3) negligent off-label marketing and sale of Amiodarone for treatment of atrial fibrillation; (4) negligence per se; (5) strict liability for manufacturing defect; (6) fraud and deceit; and (7) wrongful death.
District courts undertake a three-part analysis when considering a motion to dismiss pursuant to Federal Rule of Civil Procedure 12(b)(6). Malleus v. George, 641 F.3d 560, 563 (3d Cir. 2011). "First, the court must 'tak[e] note of the elements a plaintiff must plead to state a claim.'" Id. (quoting Ashcroft v. Iqbal, 556 U.S. 662, 675 (2009)) (alteration in original). Second, the court must accept as true all of the plaintiff's well-pled factual allegations and "construe the complaint in the light most favorable to the plaintiff." Fowler v. UPMC Shadyside, 578 F.3d 203, 210 (3d Cir. 2009) (quotation omitted). In doing so, the court is free to ignore legal conclusions or factually unsupported accusations that merely state "the-defendant-unlawfully-harmed-me."Iqbal, 556 U.S. at 678 (citing Bell Atl. Corp. v. Twombly, 550 U.S. 544, 555 (2007)). "[M]ere restatements of the elements of [a] claim[] . . . are not entitled to the assumption of truth." Burtch v. Milberg Factors, Inc., 662 F.3d 212, 224 (3d Cir. 2011) (alterations in original) (quotation omitted). Finally, the court must determine whether "the facts alleged in the complaint are sufficient to show that the plaintiff has a 'plausible claim for relief.'" Fowler, 578 F.3d at 211 (quoting Iqbal, 556 U.S. at 679). "The defendant bears the burden of showing that no claim has been presented." Hedges v. United States, 404 F.3d 744, 750 (3d Cir. 2005) (citation omitted).
"Rule 12 prohibits the court from considering matters outside the pleadings in ruling on a motion to dismiss for failure to state a claim . . . and a court's consideration of matters outside the pleadings converts the motion to a motion for summary judgment." Kimbugwe v. United States, No. 12-7940, 2014 WL 6667959, at *3 (D.N.J. Nov. 24, 2014). "[A]n exception to the general rule is that a document integral to or explicitly relied upon in the complaint may be considered without converting the motion to dismiss into one for summary judgment." In re Burlington Coat Factory Secs. Litig., 114 F.3d 1410, 1426 (3d Cir. 1997) (emphasis omitted) (internal quotation marks omitted). Notwithstanding these principles, courts may not consider claims raised for the first time in a plaintiff's opposition to a motion to dismiss. See Pennsylvania ex rel. Zimmerman v. PepsiCo, Inc., 836 F.2d 173, 181 (3d Cir. 1988) .
Defendant moves to dismiss Plaintiffs' claims on preemption grounds and for failure to state a claim. "The doctrine of preemption has constitutional roots in the Supremacy Clause," which provides that federal law is "supreme." Sikkelee v. Precision Airmotive Corp., 907 F.3d 701, 709 (3d Cir. 2018) (). While there is no expresspreemption clause in the FDCA that applies to prescription drugs, Riegel v. Medtronic, Inc., 552 U.S. 312, 327 (2008), the FDCA may impliedly preempt a drug product liability claim. Wyeth v. Levine, 555 U.S. 555, 568, 573 (2009). It is true that there is a presumption against preemption in areas that are traditionally within the states' police powers, such as health and safety. Bruesewitz v. Wyeth Inc., 561 F.3d 233, 240 (3d Cir. 2009). Yet a state law claim that "stands as an obstacle to Congressional objectives" will be preempted. Id. at 239. And, similarly, a state law claim will be preempted if it is "impossible for a private party to comply with both state and federal requirements." Mut. Pharm. Co. v. Bartlett, 570 U.S. 472, 480 (2013) (citation omitted).
"Impossibility" preemption issues arise with some regularity in litigation asserting state-law tort claims against prescription-drug manufacturers. In Wyeth v. Levine, the Court held that a state-law failure-to-warn claim against a brand-name drug manufacturer was not preempted because FDA regulations allow those manufacturers to change labels without immediate agency approval. 555 U.S. at 568. Wyeth, which involved a branded drug, left unaddressed the case of a generic drug, which is subject to a different regulatory regime. "Under federal law, a generic drug manufacturer may produce a drug that is identical to one made by a brand-name manufacturer, but when it receives permission to do so, it must use the same FDA-approved design and warning labels as the brand-name manufacturer." Sikkelee, 907 F.3d at 712. Unlike brand-name manufacturers, then, a generic manufacturer cannot unilaterally change its label consistent with federal law. Id. In PLIVA, Inc. v. Mensing, which dealt with a generic pharmaceutical, the Court distinguished Wyeth and explained that "[t]he question for 'impossibility' is whether the private party could independently do under federal law what state law requires of it." PLIVA, Inc. v. Mensing, 564 U.S. 604, 620 (2011) (emphasis added). "[W]hen a party cannot satisfy its stateduties without the Federal Government's special permission and assistance, . . . that party cannot independently satisfy those state duties for pre-emption purposes." Id. at 623-24.
And finally, "when a plaintiff's claims 'exist solely by virtue of the FDCA['s] . . . requirements,' state law claims are impliedly preempted." Frei v. Taro Pharm. U.S.A., Inc., 443 F. Supp. 3d 456, 468 (S.D.N.Y. 2020) (quoting Buckman Co. v. Plaintiffs' Legal Comm., 531 U.S. 341, 352 (2001)). Courts must, therefore, analyze "whether there is an underlying state tort duty and make the preemption decision based on the existence or absence of this duty." Polt v. Sandoz, Inc., 462 F. Supp. 3d 557, 565 (E.D. Pa. 2020). "Except in circumstances not relevant here, 'all such proceedings for the enforcement, or to restrain violations, of [the FDCA] shall be by and in the name of the United States.'" McDaniel v. Upsher-Smith Labs., Inc., 893 F.3d 941, 944 (6th Cir. 2018) (quoting 21 U.S.C. § 337(a)). "The FDCA leaves no doubt that it is the Federal Government rather than private litigants...
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