[DO NOT PUBLISH]

IN THE UNITED STATES COURT OF APPEALS

FOR THE ELEVENTH CIRCUIT

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No. 16-17356

Non-Argument Calendar

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D.C. Docket No. 1:15-cv-21826-KMM

MAGGIE O. TSAVARIS, 

 Plaintiff-Appellant,

 versus

PFIZER, INC., et al.,

Defendants,

BRECKENRIDGE PHARMACEUTICAL, INC., 

a Delaware corporation,

Defendant-Appellee.

_______________________

Appeal from the United States District Court

for the Southern District of Florida

________________________

(November 21, 2017)

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Before WILLIAM PRYOR, ROSENBAUM and FAY, Circuit Judges.

PER CURIAM: 

Maggie Tsavaris 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 after the district court entered judgment against 

her first amended complaint as preempted by federal law. We 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 federal law 

because Breckenridge could not have undertaken the actions that Tsavaris alleged 

that it should have performed without violating federal laws that prohibited 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 moved “that [the] Court freely give leave” to amend her complaint

under Federal Rule of Civil Procedure 15(a)(2). Tsavaris’s proposed second 

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amended complaint alleged 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 Federal Drug Administration of scientific studies 

that connected the 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 

considered 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.’” 

The district court denied Tsavaris’s motion on the ground that its judgment 

“le[ft] no room for Tsavaris to renew her negligence claim against Breckenridge.” 

The district court rejected as “misguided” Tsavaris’s reliance on a sentence 

describing her burden to state a claim of negligence “as giving her leave to refile 

her negligence claim against Breckenridge.” The sentence relied on by Tsavaris 

stated, “To present a viable state tort negligence claim that falls outside the scope 

of federal preemption, [Tsavaris] must allege that Breckenridge: (1) breached its 

duty 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 . . . [sentence] out of context,” the 

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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 review 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 rule “has no application once 

the district court has dismissed the complaint and entered final judgment for the 

defendant. Post-judgment, [a] plaintiff may seek leave 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 supported her claim] or manifest errors of law or 

fact” in the judgment, as required to obtain relief under Rule 59(e), see id. 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 

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dispute that the allegations of negligence 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 requesting leave to amend her complaint.

Even if we were to assume that Tsavaris had satisfied the procedural rules

governing the amendment of her pleading, we cannot say the district court abused 

its discretion by denying Tsavaris’s motion. Any amendment 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. In 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 

orthopedic 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.

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And recently, based on Buckman, we held that preemption prohibits plaintiffs from 

bringing private causes of action to enforce a duty owed to a federal agency. Mink, 

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 was based on “alleg[ations] a manufacturer failed to tell the 

FDA those things required by federal law.” Id. at 1330.

Tsavaris, like the 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 failing to 

fulfill its duty to report findings about its product to the Administration. Her

complaint is based entirely on a provision of 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 

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the violation of FDCA requirements” and a complaint based “on traditional state 

tort law principles 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 the denial of Tsavaris’s motion for leave to amend.

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