              Case: 16-17356    Date Filed: 11/21/2017   Page: 1 of 7


                                                            [DO NOT PUBLISH]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 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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