COLELLA

v.

NOVARTIS PHARMACEUTICALS CORPORATION

Before the Court are: 1. Defendant Novartis Pharmaceuticals Corporation’s Motion for Certification for Interlocutory Appeal (Doc. 92 (“Motion”)); and 2. Plaintiff’s Memorandum in Opposition to Defendant’s Motion for Certification for Interlocutory Appeal (Doc. 93). Defendant’s Motion is due to be denied. In this drug MDL member case, Defendant previously moved for judgment on the pleadings, arguing that Plaintiff’s claims are preempted because no newly acquired information was discovered that would have allowed Defendant to change the label without FDA approval. (Doc. 87.) The Court denied that motion, holding that Plaintiff need not plead around the affirmative defense of preemption in her Complaint and the Complaint sufficiently alleged newly acquired information requiring a label change. (Doc. 91, pp. 2–4; Case No. 6:21-md-3006, Doc. 50, pp. 13:1–14:10.) Defendant now moves this Court to certify the issue to the U.S. Court of Appeals for the Eleventh Circuit for interlocutory review under 28 U.S.C. § 1292(b). (Doc. 92.)

“Because permitting piecemeal appeals is bad policy, permitting liberal use of § 1292(b) interlocutory appeals is bad policy.” McFarlin v. Conseco Servs., LLC, 381 F. 3d 1251, 1259 (11th Cir. 2004); see also Prado-Steiman ex rel. Prado v. Bush, 221

F. 3d 1266, 1276 (11th Cir. 2000) (“[I]nterlocutory appeals are inherently disruptive, time-consuming, and expensive, and consequently are generally disfavored.” (cleaned up)). A movant seeking interlocutory review bears the burden of showing that the case is a “rare exception” to the piecemeal appeal rule and that the issue

“involves a controlling question of law upon which there is . . . a substantial ground for difference of opinion, and . . . immediate appeal from the order may materially advance the ultimate termination of the litigation.” Cont’l 332 Fund, LLC v. Albertelli, No. 2:17-cv-41, 2018 WL 3656472, at *2 (M.D. Fla. Aug.², 2018) (cleaned up). Here, Defendant meets none of the elements required for the Court to consider certification. Defendant argues that the Court should not have accepted as true the factual allegations in Plaintiff’s Complaint indicating that Defendant had newly acquired information—asserting instead that this is a legal conclusion. (Doc. 92.) But this is not a pure question of law for the Eleventh Circuit’s consideration; it is a question of applying “settled law to facts,” which is not an appropriate subject of interlocutory review. See Mamani v. Berzain, 825 F. 3d 1304, 1313 (11th Cir. 2016); Albertelli, 2018 WL 3656472, at *2. Of course, there can be no grounds for a difference of opinion on the black-letter law that the Court must accept factual allegations as true at this stage. See United Techs. Corp. v. Mazer, 556 F. 3d 1260, 1269 (11th Cir. 2009); White v. State Nat’l Ins. Co., No. 8:12-cv-2828, 2013

WL 12156318, at *1 (M.D. Fla. Apr. 12, 2013). That is exactly what the Court did, citing to the specific factual allegations in the Complaint supporting the conclusion that Defendant had newly acquired information.¹ (See Doc. 91, p. 4 (citing Doc. 1, ¶ 38 (“This newly acquired information came in the form of (1) multiple reports from their clinical investigators, (2) multiple medical studies and reports, (3) data from a phase 3 randomized clinical trial, and (4) adverse event information gathered in a Novartis global safety database.”)).) Nor can there be grounds for a difference of opinion on whether Defendant, not Plaintiff, bears the burden of proving its own affirmative defense—a burden that is particularly “demanding” when the defense is preemption. See Wyeth v. Levine, 555 U.S. 555, 573 (2009); see also La Grasta v. First Union Sec., Inc., 358 F. 3d 840, 845 (11th Cir. 2004) (“[P]laintiffs are not required to negate an affirmative defense in their complaint.” (cleaned