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[DO NOT PUBLISH]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) Case: 16-17356 Date Filed: 11/21/2017 Page: 2 of 7
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
2 Case: 16-17356 Date Filed: 11/21/2017 Page: 3 of 7
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
3 Case: 16-17356 Date Filed: 11/21/2017 Page: 4 of 7
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
4 Case: 16-17356 Date Filed: 11/21/2017 Page: 5 of 7
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
Free access — add to your briefcase to read the full text and ask questions with AI
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) Case: 16-17356 Date Filed: 11/21/2017 Page: 2 of 7
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
2 Case: 16-17356 Date Filed: 11/21/2017 Page: 3 of 7
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
3 Case: 16-17356 Date Filed: 11/21/2017 Page: 4 of 7
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
4 Case: 16-17356 Date Filed: 11/21/2017 Page: 5 of 7
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.
5 Case: 16-17356 Date Filed: 11/21/2017 Page: 6 of 7
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
6 Case: 16-17356 Date Filed: 11/21/2017 Page: 7 of 7
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.