Maggie O. Tsavaris v. Breckenridge Pharmaceutical, Inc., 16-17356

Tsavaris sued Breckenridge (generic drug manufacturer), alleging she developed breast cancer after taking generic Activella and asserting negligence, negligent misrepresentation, and strict liability claims.
The district court dismissed her negligence-based claims as preempted by federal law because Breckenridge could not have changed the generic drug’s formulation or labeling without violating federal requirements.
After judgment, Tsavaris (pro se) moved for leave to file a second amended complaint alleging Breckenridge violated federal reporting duties (21 U.S.C. § 355(k)/(e)) by failing to notify the FDA of studies linking the generic to breast cancer.
The district court denied leave to amend, finding (1) Rule 15 does not apply post-judgment absent relief under Rule 59(e) or Rule 60(b), and Tsavaris did not meet those standards, and (2) the proposed amendment would be futile because it was also preempted.
The Eleventh Circuit reviewed for abuse of discretion and affirmed, concluding the post-judgment amendment request was procedurally improper and substantively preempted as an attempt to enforce a federal reporting duty via state tort law.

Issue	Plaintiff's Argument	Defendant's Argument	Held
Whether Rule 15 allows post-judgment amendment to add negligence claim based on alleged failure to report to FDA	Tsavaris argued Rule 15 leave to amend should be freely given to add claim based on Breckenridge’s failure to notify FDA of adverse studies	Breckenridge argued amendment was untimely and barred because final judgment was entered; Rule 15 does not apply post-judgment without Rule 59/60 relief	Denied: Rule 15 doesn’t permit post-judgment amendment absent Rule 59(e) or Rule 60(b) relief, which Tsavaris did not seek or justify
Whether the proposed amendment would be futile because of federal preemption	Tsavaris contended the amendment presented a viable negligence claim outside preemption because it alleged duty-breaching conduct consistent with federal obligations	Breckenridge argued the claim seeks to enforce a federal reporting duty owed to the FDA and is thus preempted under Buckman/Mink	Denied as futile: claim preempted because it seeks to enforce a federal reporting duty and would not exist absent that federal duty

Mut. Pharm. Co. v. Bartlett, 133 S. Ct. 2466 (federal law can preempt state-law design-defect or labeling claims against generics)
PLIVA, Inc. v. Mensing, 564 U.S. 604 (generic manufacturers cannot be held liable under state law for failure to change labeling when federal law requires sameness with brand-name labeling)
Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341 (state-law claims alleging violations of duties owed to the FDA are preempted)
Mink v. Smith & Nephew, Inc., 860 F.3d 1319 (11th Cir.) (claims premised on a manufacturer’s failure to report adverse events to FDA are preempted under Buckman)
Jacobs v. Tempur-Pedic Int’l, Inc., 626 F.3d 1327 (11th Cir.) (post-judgment amendment via Rule 15 requires relief under Rule 59(e) or Rule 60(b))
Guarino v. Wyeth, LLC, 719 F.3d 1245 (11th Cir.) (discussing preemption of state-law claims against generic manufacturers)