OPINION & ORDER Barbara Gayle and twenty-three additional individual plaintiffs (collectively, “Plaintiffs”) allege that Lipitor — a cholesterol management drug manufactured by defendant Pfizer — caused their type 2 diabetes. Plaintiffs claim that had the Lipitor label warned their doctors of the risks of type 2 diabetes, their doctors would not have prescribed Lipitor for them. Pfizer moves for judgment on the pleadings under Federal Rule of Civil Procedure 12(c). (ECF No. 21.) While Plaintiffs do not allege when their claims arose, Pfizer argues that: (1) if their claims arose after the 2012 Lipitor label change, they are preempted; and (2) if their claims arose before April 2016, they are untimely. For the reasons that follow, Pfizer’s motion is granted. BACKGROUND I. Lipitor Lipitor is an FDA-approved statin prescribed for the prevention of cardiovascular disease and treatment of high cholesterol. (Compl., ECF No. 1-1 (“Compl.”), 39.) In 1996, the FDA approved Lipitor for marketing and sale. (Compl. 40.) In 2009, the FDA approved updated labeling for Lipitor in response to a clinical trial titled “Stroke Prevention by Aggressive Reduction in Cholesterol Levels” (“SPARCL”). (2009 Lipitor Packaging Insert, available at https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/020702Orig1s056.pdf (the “2009 Label”).) The 2009 Label included a description of the SPARCL trial, stating in pertinent part, “[d]iabetes was reported as an adverse reaction in 144 subjects (6.1 percent) in the atorvastatin group and 89 subjects (3.8 percent) in the placebo group.” (2009 Label, at 16.) In February 2012, the FDA issued a drug safety announcement directed at doctors and patients. (FDA Drug Safety Communication: Important Safety Label Changes to Cholesterol-Lowering Statin Drugs (Feb. 28, 2012), available at https://www.fda.gov/drugs/ drug-safety-and-availability/fda-drug-safety-communication-important-safety-label-changescholesterol- lowering-statin-drugs#sa (the “2012 Safety Announcement”).) The announcement addressed, in part, “clinical trial meta-analyses and epidemiological data from the published literature, information concerning an effect of statins on incident diabetes and increases in HbA1c and/or fasting plasma glucose was added to statin labels.” (2012 Safety Announcement.) However, despite this risk, the FDA concluded that it “continues to believe that the cardiovascular benefits of statins outweigh these small increased risks.” (2012 Safety Announcement.) Accompanying the 2012 Safety Announcement, the FDA again approved an update to the Lipitor label. (2012 Lipitor Packaging Insert, ECF No. 30-1 (“2012 Label”).) The updated label added the following language to its Warnings and Precautions section: “Increases in HbAlc and fasting serum glucose levels have been reported with HMG-CoA reductase inhibitors, including LIPITOR.” (2012 Label, at 78.) However, despite updating disclosures regarding risks relating to increases in HbA1c, the FDA did not alter the description of the diabetes risk contained in the SPARCL trial section. (2012 Label, at 42-43.) II. Procedural History On April 15, 2019, twenty-four individual plaintiffs filed this action in New York County Supreme Court. (Compl., at 1.) Pfizer removed the action on April 18, 2019, (see ECF No. 1), and answered the complaint the following day, (ECF No. 5). On September 16, 2019, Pfizer moved for judgment on the pleadings. (ECF No. 21.) First, Plaintiffs seek to amend their complaint and attach a Proposed Amended Complaint as an exhibit to their opposition brief. (ECF No. 27-1.) However, the Proposed Amended Complaint fails to cure any of the fatal deficiencies described below. Second, Plaintiffs request that Pfizer’s motion be converted into one for summary judgment and that they be allowed to conduct discovery. However, this is not warranted as no amount of discovery will cure the deficiencies in Plaintiffs’ claims. Finally, Plaintiffs request more time to respond. But Plaintiffs already received additional time to respond. For these reasons, Pfizer’s motion for judgment on the pleadings dismissing this action is granted. DISCUSSION I. Legal Standard “The standards to be applied for a motion for judgment on the pleadings pursuant to [Federal Rule of Civil Procedure] 12(c) are the same as those applied to a motion to dismiss pursuant to Rule 12(b).” Estate of Smith v. Cash Money Records, Inc., 2018 WL 2224993, at *2 (S.D.N.Y. May 15, 2018) (quotation marks omitted); accord Hayden v. Paterson, 594 F.3d 150, 160 (2d Cir. 2010). Thus, to survive a motion for judgment on the pleadings, “a complaint must contain 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, 677 (2009) (quoting Bell Atl. Corp. v. Twombly, 550 U.S. 544, 570 (2007)). A court must accept the complaint’s allegations as true and draw all reasonable inferences in the plaintiff’s favor. Kirkendall v. Halliburton, Inc., 707 F.3d 173, 178 (2d Cir. 2013). A judgment under Rule 12(c) is proper if, from the pleadings, the moving party is entitled to judgment as a matter of law. See United States v. Watts, 786 F.3d 152, 176 (2d Cir. 2015); Burns Int’l Sec. Servs., Inc. v. Int’l Union, 47 F.3d 14, 16 (2d Cir. 1995). II. Preemption Pfizer argues that to the extent Plaintiffs’ claims arose after February 2012, they are preempted by federal law. This Court agrees. A. FDA Approval of Drug Labels Under the Federal Food, Drug, and Cosmetic Act (“FDCA”), 21 U.S.C. §301 et seq., the FDA closely controls the label for all FDA-approved drugs and therapies. During a drug’s initial application, the FDA must approve the label. See 21 U.S.C. §355; 21 C.F.R. §314.105(b). Relevant here, the label includes risks that the FDA determines are necessary to warn patients. The label must: describe clinically significant adverse reactions (including any that are potentially fatal, are serious even if infrequent, or can be prevented or mitigated through appropriate use of the drug), other potential safety hazards (including those that are expected for the pharmacological class or those resulting from drug/drug interactions), limitations in use imposed by them (e.g., avoiding certain concomitant therapy), and steps that should be taken if they occur (e.g., dosage modification). 21 C.F.R. §201.57(c)(6)(i). To warn of potential adverse reactions caused by the drug, the label must also: describe the overall adverse reaction profile of the drug based on the entire safety database. For purposes of prescription drug labeling, an adverse reaction is an undesirable effect, reasonably associated with use of a drug, that may occur as part of the pharmacological action of the drug or may be unpredictable in its occurrence. This definition does not include all adverse events observed during use of a drug, only those adverse events for which there is some basis to believe there is a causal relationship between the drug and the occurrence of the adverse event. 21 C.F.R. §201.57(c)(7). Notably, this disclosure “does not include all adverse events observed during use of a drug, only those adverse events for which there is some basis to believe there is a causal relationship between the drug and the occurrence of the adverse event.” 21 C.F.R. §201.57(c)(7) (emphasis added). This is a backstop to prevent manufacturers from warning of every possible adverse reaction in an effort to insulate themselves from any conceivable liability. Over-disclosure dilutes warnings of more significant adverse reactions both by likelihood and severity of the reaction and can unjustifiably deter patients from a helpful drug or therapy. See, e.g., Supplemental Applications Proposing Labeling Changes for Approved Drugs, Biologics, and Medical Devices, 73 Fed. Reg. 2848, 2851 (Jan. 16, 2008). However, the FDCA and FDA regulations contemplate the inevitable advancement of scientific knowledge. Even after receiving approval, various constituencies — including the manufacturers — continue to conduct studies on FDA-approved drugs. As a result, labels may need to be updated periodically to recognize advancements in scientific knowledge. Label updates can reflect new adverse reactions, remove previously disclosed adverse reactions, or note changes in efficacy. Two avenues exist for manufacturers to update their drug labels. First, manufacturers may update a label with FDA approval, similar to the approval process for the initial label. See 21 C.F.R. §314.70(b). Second, manufacturers may update a label — without prior FDA approval — through the “changes being effected” (“CBE”) regulation. See 21 C.F.R. §314.70(c). The CBE regulation allows a manufacturer to change its label unilaterally to “add or strengthen a contraindication, warning, precaution, or adverse reaction,” 21 C.F.R. §314.70(c)(6)(iii)(A), as soon as there is “reasonable evidence of a causal association,” 21 C.F.R. §201.57(c)(6)(i). However, “a causal relationship need not have been definitely established.” 21 C.F.R. §201.57(c)(6)(i). Further, the CBE regulation allows manufacturers to “add or strengthen an instruction about dosage and administration that is intended to increase the safe use of the drug product,” 21 C.F.R. §314.70(c)(6)(iii)(C), or “delete false, misleading, or unsupported indications for use or claims for effectiveness,” 21 C.F.R. §314.70(c)(6)(iii)(D). However, labeling changes pursuant to the CBE regulation may only be made on the basis of “newly-acquired information.” 21 C.F.R. §314.70(c)(6)(iii). The regulations define “newly-acquired information” as: [D]ata, analyses, or other information not previously submitted to the [FDA], which may include (but is not limited to) data derived from new clinical studies, reports of adverse events, or new analyses of previously submitted data (e.g., meta-analyses) if the studies, events, or analyses reveal risks of a different type or greater severity or frequency than previously included in submissions to FDA. 21 C.F.R. §314.3(b). As with the initial labeling, speculative or exaggerated risks do not warrant a labeling update. The label may be “revised to include a warning about a clinically significant hazard as soon as there is reasonable evidence of a causal association with a drug.” 21 C.F.R. §201.57(c)(6)(i). However, “a causal relationship need not have been definitely established.” 21 C.F.R. §201.57(c)(6)(i). B. Preemption Generally The doctrine of preemption reflects the Supremacy Clause’s core mandate that federal law prevails where it conflicts with state law. U.S. Const. art. VI, cl. 2; see Murphy v. Nat’l Collegiate Athletic Ass’n, 138 S. Ct. 1461, 1479-80 (2018) (holding that when “Congress enacts a law that imposes restrictions or confers rights on private actors” and “a state law confers rights or imposes restrictions that conflict with the federal law[,]…the federal law takes precedence and the state law is preempted”). In general, three types of preemption exist: “(1) express preemption, where Congress has expressly preempted local law; (2) field preemption, where Congress has legislated so comprehensively that federal law occupies an entire field of regulation and leaves no room for state law; and (3) conflict preemption, where local law conflicts with federal law such that it is impossible for a party to comply with both or the local law is an obstacle to the achievement of federal objectives.” Figueroa v. Foster, 864 F.3d 222, 227-28 (2d Cir. 2017) (quotation marks omitted). Preemption is “ultimately a question of statutory construction,” and courts “look to the intent of Congress to determine the preemptive force of a statute” and the agency’s intent “in evaluating preemption by a regulation.” N.Y. Pet Welfare Ass’n, Inc. v. City of New York, 850 F.3d 79, 87 (2d Cir. 2017) (quotation marks omitted). Finally, the “same ordinary pre-emption principles [apply] whether the relevant federal law is a statute or a regulation.” N.Y. Pet Welfare Ass’n, 850 F.3d at 87. The party “asserting that federal law preempts state law bears the burden of establishing preemption.” In re Methyl Tertiary Butyl Ether (MTBE) Prod. Liab. Litig., 725 F.3d 65, 96 (2d Cir. 2013). Here, Pfizer predicates its preemption arguments on conflict preemption. The burden to establish conflict preemption is a demanding one and requires a showing that “compliance with federal and state law is an impossibility.” In re MTBE, 725 F.3d at 97 (quotation marks omitted). This occurs, for example, when state law “penalizes what federal law requires,” or when state law claims “directly conflict[] with federal law.” In re MTBE, 725 F.3d at 97 (quotation marks omitted) (collecting Supreme Court cases). Demonstrating that state law poses an “obstacle to the accomplishment and execution of the full purposes and objectives of Congress” is also a heavy burden. In re MTBE, 725 F.3d at 101. It requires a showing of “actual conflict with the overriding federal purpose and objective” and a “repugnance or conflict [to be] so direct and positive that the two acts cannot be reconciled.” In re MTBE, 725 F.3d at 101-02 (quotation marks omitted). In analyzing preemption, “the purpose of Congress is the ultimate touchstone.” Wyeth v. Levine, 555 U.S. 555, 565 (2009) (quotation marks omitted). Finally, while the Second Circuit disfavors preemption in areas traditionally entrusted to the states, that presumption generally does not apply to a sphere “where there has been a history of significant federal presence.” N.Y. SMSA Ltd. P’ship v. Town of Clarkstown, 612 F.3d 97, 104 (2d Cir. 2010). C. Preemption by the FDCA and FDA Regulations Since the FDCA and FDA regulations require that the FDA approve a drug’s initial label and significantly limit manufacturers’ ability to update that label, state law failure-towarn claims can be preempted. However, “[b]ecause manufacturers may unilaterally update a drug’s label if the change complies with the CBE regulation, a state law failure-to-warn claim that depends on newly acquired information — information that Defendants could have added to their label without FDA approval — is not preempted.” Gibbons v. Bristol-Myers Squibb Co., 919 F.3d 699, 708 (2d Cir. 2019). Thus, the Second Circuit has established a test to determine when failure to warn claims are preempted. “[T]o state a claim for failure-to-warn that is not preempted by the FDCA, a plaintiff must plead a labeling deficiency that [Defendants] could have corrected using the CBE regulation.” Gibbons, 919 F.3d at 708 (second alteration in original) (quotation marks omitted). “If the plaintiff meets that standard, the burden shifts to the party asserting a preemption defense to demonstrate that there is clear evidence that the FDA would not have approved a change to the [prescription drug's] label.” Gibbons, 919 F.3d at 708 (alteration in original) (quotation marks omitted). The issue of what constitutes “clear evidence” such that the FDA would not have approved the change is a “critical question not as a matter of fact for a jury but as a matter of law for the judge to decide.” Merck Sharp & Dohme Corp. v. Albrecht, 139 S. Ct. 1668, 1679 (2019). “In sum, if the plaintiff can point to the existence of ‘newly acquired information’ to support a labeling change under the CBE regulation, the burden then shifts to the manufacturer to show by ‘clear evidence’ that the FDA would not have approved the labeling change made on the basis of this newly acquired information.” Utts v. Bristol-Myers Squibb Co., 251 F. Supp. 3d 644, 661 (S.D.N.Y. 2017), aff’d sub nom. Gibbons v. Bristol-Myers Squibb Co., 919 F.3d 699 (2d Cir. 2019). D. Application of Preemption to Plaintiffs’ Claims Plaintiffs do not specify when their claims arose. However, as Pfizer argues, to the extent that Plaintiffs’ claims arose after the 2012 Lipitor label change, they would be preempted. “Plaintiffs’ claims here fail at the first step because…they consist of conclusory and vague allegations and do not plausibly allege the existence of newly acquired information that could have justified Defendants’ revising the [Lipitor] label through the CBE regulation.” Gibbons, 919 F.3d at 708 (quotation marks omitted). Plaintiffs’ complaint does not identify any “newly acquired information” on which Pfizer could have altered the Lipitor label. Plaintiffs begin with conclusory allegations that Pfizer knew that Lipitor causes type 2 diabetes. (Compl.
