[DO NOT PUBLISH]

IN THE UNITED STATES COURT OF APPEALS
FOR THE ELEVENTH CIRCUIT

________________________ No. 16

- 17356 Non

- Argument Calendar

________________________ D.C. Docket No. 1:15

- cv - 21826

- KMM

MAGGIE O. TSAVARIS, Plaintiff

- Appellant,

versus PFIZER, INC., et al., Defendants, BRECKENRIDGE PHARMACEUTICAL, INC., a De laware corporation,

Defendant

- Appellee.

_______________________ Appeal from the United States District Court for the Southern District of Florida

________________________ ( November 21, 2017 ) Case: 16-17356 Date Filed: 11/21/2017 Page: 1 of 72 Before WILLIAM PRYOR , ROSENBAUM and FAY , Circuit Judges.
PER CURIAM: Maggie Tsav aris appeals pro se the denial of her motion for leave to file a second amended complaint of negligence against Breckenridge Pharmaceutical,
Inc. Tsavaris , with the assistance of counsel, moved for leave to amend under Federal Rule of Civil Procedure 15 af ter the district court entered judgment against her first amended complaint as preempted by federal law. W e affirm. In her first amended complaint , Tsavaris alleged claims of negligence, negligent misrepresentation, and strict liability against Breckenridge, a drug
manufacturer . Tsavaris alleged that she developed breast cancer after she ingested the generic version of the drug Activella, a hormone replacement therapy drug. The district court ruled that Tsavaris ’s complaint was preempted by fede ral law because Breckenridge could not have undertake n the actions that Tsavaris alleged that it should have performed without violating federal laws that prohibit ed the
company from changing the formulation of or the labeling approved for the brand name drug. See Mut. Pharm. Co. v. Bartlett , 133 S. Ct. 2466 (2013) ; PLIVA, Inc. v. Mensing , 564 U.S. 604 (2011) ; Guarino v. Wyeth, LLC , 719 F.3d 1245, 1248 (11th Cir. 2013)

. Tsavaris mo ved “ that [the] Court freely give leave” to amend her complaint under Federal Rule of Civil Procedure 15(a)(2). Tsavaris ’s proposed second

Case: 16-17356 Date Filed: 11/21/2017 Page: 2 of 73 amended complaint allege d that she would not have been harmed had Breckenridge not “failed in its federally mandated duty , ” under “21 U.S.C. § 355(e)[ and] (k),” to notify the Fede ral Drug Administration of scientific studies that connected t he use of the generic version of Activella to breast cancer

. Tsavaris argued that the denial of her amendment would be “inconsistent with the spirit of the Federal Rules” to “serve the Court and the parties’ interest in efficiently addressing [her] claims.” Tsavaris also argued that her “amendment cannot be conside red an exercise in futility . . . because [it] is based squarely on this Court’s Order and ‘present[s] a viable state tort negligence claim that falls outside the scope of federal preemption. ’ ”
T he district court denied Tsavaris’s motion on the ground tha t its judgment “le[ft] no room for Tsavaris to renew her negligence claim against Breckenridge.” The district court r ejected as “misguided” Tsavaris ’s reliance on a s entence describing her burden to state a claim of negligence “as giving her leave to refile her negligence claim against Breck en ridge.” Th e s entence relied on by Tsavaris
state d, “To present a viable state tort negligence claim that falls outside the scope of federal preemption, [Tsavaris] must allege that Breckenridge: (1) breached its du ty to exercise reasonable care and (2) could have taken actions in line with its federal law obligations that would have also allowed it to discharge its duty to exercise reasonable care.” Tsavaris “read[] the

. . . [s entence ] out of context,” the

Case: 16-17356 Date Filed: 11/21/2017 Page: 3 of 74 district court stated, because it had “go[ne] on to state: ‘ Breaking [Tsavaris’s] negligence claim down, it is clear that there is no action that Breckenridge could have taken to discharge its duty under state negligence law without violating federal law. ’ ”
We re view the denial of Tsavaris’s postjudgment motion for leave to amend for abuse of discretion. Jacobs v. Tempur

- Pedic Int ’ l, Inc. , 626 F.3d 1327, 1345 (11th Cir. 2010)

. The district court did not abuse its discretion when it denied Tsavaris’s postjudgment motion to amend

. Rule 15 governs the procedures for amending and supplementing pleadings

. Fed. R. Civ. P. 15. But that r ule “ has no application once the district court has dismissed the complaint and entered final judgment for the defendant. Post

- judgment , [a] plaintiff may seek l eave to amend if [s] he is granted relief under Rule 59(e) or Rule 60(b)(6) ” of the Federal Rules of Civil Procedure. Jacobs , 626 F.3d at 1344

– 45 (quoting U.S. ex rel. Atkins v. McInteer , 470 F.3d 1350, 1361 (11th Cir. 2006) ) (citations omitted)

. Tsavaris failed to identify either “newly

- discovered evidence [that support ed h er claim] or manifest errors of law or fact” in the judgment , as required to obtain relief under Rule 59(e), see i d. at 1344 (quoting Arthur v. King , 500 F.3d 1335, 1343 (11th Cir. 2007) ), or a “ justification so compelling that the district court was required to vacate its order” under Rule 60(b), see Cano v. Baker , 435 F.3d 1337, 1342 (11th Cir. 2006) . Tsavaris did not

Case: 16-17356 Date Filed: 11/21/2017 Page: 4 of 75 dispute that the allegations of negli gence in her first amended complaint were preempted by federal law , and she could not use her postjudgment motion to “ raise [ her ] argument [about the failure of Breckenridge to comply with section 355] . . . that could have been raised prior to the entry of judgment , ” Jacobs , 626 F.3d at 1344 (brackets omitted)

. Tsavaris failed to abide by the Rules of Civil Procedure when request ing leave to amend her complaint

. Even if we were to assume that Tsavaris had satisfied the procedural rules governing the amendment of he r pleading , we cannot say the district court abused its discretion by denying Tsavaris’s motion . Any a mendment of her complaint would have been futile. Tsavaris’s proposed second amended complaint is also preempted by federal law. See Buckman Co. v. Plaintiffs’ Legal Committee , 531 U.S. 341 (2001) ; Mink v. Smith & Nephew, Inc. , 860 F.3d 1319 (11th Cir. 2017). Preemption occurs when the federal government has exclusive power to punish an individual or entity for a violation of a federal statute or regulation

. See Buckman , 531 U.S. at 348. I n Buckman , the Supreme Court concluded that a plaintiff ’s complaint about the violation of state law based on fraudulent representations made by a medical device manufacturer to obtain approval for
ort hopedic bone screws was preempted by federal law that empowered the Federal Drug Administration to punish and deter fraud perpetrated against it. Id

. at 347

– 52.

Case: 16-17356 Date Filed: 11/21/2017 Page: 5 of 76 And recently, b ased on Buckman , we held that preemption prohibits plaintiffs from bringing priv ate causes of action to enforce a duty owed to a federal agency. M ink , 860 F.3d at 1327, 1330. In Mink , the plaintiff’s complaint of negligence was premised on the alleged failure of a manufacturer of a hip joint replacement system to report adverse events involving its system to the Administration. Id. at 1323

– 24

. We concluded that Mink’s complaint, like the complaint in Buckman , was preempted because it w as based on “alleg[ations] a manufacturer failed to tell the FDA those things required by federal law. ” Id. at 1330. Tsavaris , like th e plaintiffs in Buckman and Mink , complains of a violation of a federal reporting duty owed to a federal agency, not to her

. Tsavaris complains that Breckenridge, a federally regulated drug company , was negligent for fail ing to fulfill its duty to report findings about its product to the Administration

. Her complaint is based entirely on a provision o f the federal Drug Price Competition and Patent Term Restoration Act that requires Breckenridge to submit “ data relating to clinical experience and other data or information, received or otherwise obtained ” about the safety, effectiveness, or labeling of its drug to the Administration , 21 U.S.C. § 355(k). The premise of Tsavaris’s complaint is that Breckenridge was negligent because it violated section 355(k), not because it failed to satisfy a duty of care owed to her under state law. See Buckman , 531 U.S. at 352 (differentiating between the preempted complaint, which was drawn “ solely from

Case: 16-17356 Date Filed: 11/21/2017 Page: 6 of 77 the violation of FDCA requirements ” and a complaint based “ on traditional state tort law prin ciples of the duty of care owed” by a defendant). Because Tsavaris seeks to enforce a duty owed to a federal agency and her cause of action would not exist in the absence of that duty, her proposed second amended complaint is preempted.
We AFFIRM t he denial of Tsavaris’s motion for leave to amend. Case: 16-17356 Date Filed: 11/21/2017 Page: 7 of 7