Perdue v. Wyeth Pharmaceuticals, Inc.

Citations: 209 F. Supp. 3d 847; 2016 U.S. Dist. LEXIS 94636; 2016 WL 3951091Docket: NO. 4:15-CV-208-FL

Court: District Court, E.D. North Carolina; July 20, 2016; Federal District Court

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Defendants' motions to dismiss under Federal Rule of Civil Procedure 12(b)(6) were granted by the court. The plaintiff initiated the lawsuit on December 28, 2015, alleging wrongful death based on defendants’ fraudulent and negligent promotion of the drug Cordarone®/amiodarone for off-label use without adequate warnings of its dangers or provision of a required medication guide. Wyeth Pharmaceuticals, the manufacturer of Cordarone, filed a motion to dismiss on February 2, 2016, while generic manufacturers Barr, Teva, and Zydus filed their motions on February 29 and March 10, 2016. The court denied the plaintiff's motion to stay the case for potential multidistrict litigation transfer, which was also denied by the United States Judicial Panel on Multidistrict Litigation on June 2, 2016.

The plaintiff's mother, Marjorie S. Newton, was prescribed amiodarone in 2006 for non-life-threatening atrial fibrillation, unaware it was for an off-label use. She did not receive the mandatory medication guide, which would have informed her of significant side effects, including potentially fatal lung issues. Newton suffered from severe pulmonary symptoms before passing away on December 27, 2013, at the age of 82. The plaintiff serves as the administrator of her estate. A motion to dismiss evaluates the complaint's legal sufficiency without addressing factual disputes or defenses.

A complaint must contain sufficient factual matter to present a plausible claim for relief, as established in Ashcroft v. Iqbal and Bell Atlantic Corp. v. Twombly. The pleading standard does not require a probability of success but necessitates enough facts to support a reasonable expectation that discovery will uncover evidence for the claim. Courts accept all well-pled facts as true and interpret them favorably for the plaintiff, while disregarding legal conclusions, bare assertions, and unwarranted inferences.

In the context of preemption, the generic defendants argue for the dismissal of wrongful death claims based on three liability theories: failure to warn about amiodarone's dangers, off-label promotion of the drug, and failure to provide medication guides. The plaintiff alleges that the defendants inadequately warned about the dangers of amiodarone, particularly regarding its use for atrial fibrillation, and failed to disclose adverse medical events associated with it. Specific allegations include the defendants' vague and inadequate warnings, which did not accurately reflect the risks of the drug.

However, these failure-to-warn claims against the generic defendants are preempted by federal law, specifically the Food Drug and Cosmetic Act (FDCA), which restricts generic manufacturers from adding warnings beyond those approved by the FDA. Precedent cases, including PLIVA, Inc. v. Mensing and Drager v. PLIVA USA, Inc., confirm that such claims are preempted when they challenge the adequacy of FDA-approved labeling. The plaintiff does not pursue the failure-to-warn claims in response to the defendants' motions to dismiss.

Liability in this case centers on the defendants’ off-label promotion of amiodarone and their failure to provide a medication guide. The court has determined that the plaintiff's failure-to-warn claims are dismissed with prejudice due to preemption. The plaintiff claims that the defendants' off-label promotion of Cordarone®/amiodarone violates the Federal Food, Drug, and Cosmetic Act (FDCA) and related regulations, constituting negligence per se. However, this claim is also preempted, as the FDCA does not allow private rights of action for its violations; enforcement is reserved for the federal government. Consequently, claims that rely solely on FDCA violations are impliedly preempted by the FDCA, as established in Buckman Co. v. Plaintiffs’ Legal Committee. For a state-law claim to survive, it must be based on traditional state tort law principles that existed prior to the FDCA and not solely on federal violations. The plaintiff's claim of negligence per se regarding the defendants’ off-label promotion fails to meet this criterion, as it is impliedly preempted under Buckman. The plaintiff alleges that the defendants' promotional activities violated FDCA provisions prohibiting manufacturers from promoting drugs for unapproved uses. While pharmaceutical companies may disseminate information about off-label uses, they must comply with strict FDCA requirements, including submitting applications for approval and providing unabridged materials to the FDA.

Pharmaceutical companies must provide federal regulators with advance copies of information they disseminate, as mandated by the FDCA. The plaintiff fails to identify any North Carolina laws that parallel the FDCA's requirements for off-label drug promotion, leading to the conclusion that her claims regarding off-label promotion are impliedly preempted under the Buckman decision. The FDCA's regulatory framework governs off-label promotion, balancing the benefits and potential harms of such use, which is widely accepted in the medical community. Prior court decisions reinforce that state law claims related to off-label promotion, which rely solely on FDCA regulations, are preempted.

The plaintiff's attempt to hold Anulex liable for off-label promotion of its X-close suture device is also preempted, as her claims exclusively derive from FDCA requirements. The plaintiff contends that her claim should survive preemption based on negligence per se, a principle allowing recovery for violations of health and safety statutes. However, under Buckman, a successful claim must include state-law causes of action that parallel federal safety requirements, which the plaintiff fails to establish for off-label promotion under North Carolina law.

Furthermore, claims regarding the failure to provide a medication guide are similarly preempted under Buckman. The obligation to provide such guides is based solely on the FDCA and its regulations, and the generic defendants are required to provide all FDA-approved labels and Medication Guides as stipulated. As a result, the plaintiff's claims related to both off-label promotion and the medication guide must be dismissed as a matter of law.

The generic defendants were found responsible under federal regulations for providing appropriate warning labels and Medication Guides to Newton. However, they failed to supply these guides to her distributor and pharmacist as mandated by FDA regulations, which is a violation of the requirement that each manufacturer ensures the availability of Medication Guides for distribution to patients. This failure specifically relates to warnings about amiodarone toxicity, which allegedly contributed to Newton's death. The claims based on the failure to provide a Medication Guide are preempted under Buckman, as these requirements are based solely on federal law, which did not exist under North Carolina common law. Consequently, the claims against the generic defendants must be dismissed.

Defendant Wyeth seeks dismissal of all claims against it because Newton is not alleged to have used Wyeth’s brand-name Cordarone, but only generic amiodarone from the generic defendants. Under North Carolina law, a defendant cannot be held liable for injuries caused by another's product. Courts have previously dismissed claims against brand-name manufacturers when the plaintiff only used generic drugs. Since the plaintiff has not presented any factual basis to hold Wyeth liable, the claims against Wyeth must also be dismissed.

In conclusion, the motions to dismiss from the defendants are granted. Claims against Teva, Barr, and Zydus are dismissed with prejudice, while claims against Wyeth are dismissed without prejudice.