Arthur Drager v. PLIVA USA, 2014 U.S. App. LEXIS 1696

Background

Shirley Gross took PLIVA's generic metoclopramide (2006–2007) and developed permanent movement disorders; suit filed for state-law product claims; only PLIVA (generic) remained as defendant.
District court stayed the case pending the Supreme Court's decision in PLIVA v. Mensing; after Mensing, PLIVA moved for judgment on the pleadings arguing FDCA preemption.
Gross sought to amend her complaint to allege PLIVA failed to update warnings to match brand changes; she never filed a formal motion or proposed amended complaint.
The district court dismissed all state-law claims as preempted under Mensing and denied leave to amend as futile under Maryland law; plaintiff died and appeal continued by personal representative.
The Fourth Circuit reviewed de novo the Rule 12(c) dismissal and for abuse of discretion the denial of leave to amend, and affirmed dismissal and denial of leave to amend.

Issues

Issue	Plaintiff's Argument	Defendant's Argument	Held
Denial of leave to amend	Drager argued proposed amendments would state a Maryland claim and denial was abuse of discretion	PLIVA and district court noted Gross never filed a formal motion or proposed amended complaint; denial on futility grounds	Affirmed — court may decline to grant an amendment that was never properly moved for; denial not an abuse of discretion
FDCA preemption generally	Drager argued state tort claims (negligence, strict liability, warranties, fraud) are not preempted because they impose duties distinct from federal requirements	PLIVA argued Mensing/Bartlett bar any duty that would require a generic to change labeling/formulation or to stop selling; such state duties conflict with FDCA and Hatch-Waxman regime	Affirmed — state claims are preempted where compliance with both state duties and federal requirements is impossible
Negligence (including testing/surveillance)	Drager contended negligent testing/inspection/post-market surveillance are independent duties not preempted as they are not labeling duties	PLIVA argued these allegations are merely elements/instances of failure-to-warn or negligent sale and would require changing warnings/formulation or stopping sales	Preempted — Maryland negligence claims, as pleaded, would require actions barred by FDCA and thus are impossible to comply with simultaneously
Strict products liability / design-defect	Drager claimed strict liability survives because it imposes vendor responsibility irrespective of FDA labeling/formulation rules	PLIVA invoked Bartlett: generics cannot alter label/formulation and cannot be required to stop selling; consumer-expectation vs risk-utility differences do not avoid impossibility	Preempted — strict liability would force a generic to stop selling or change product/warnings, which FDCA forbids
Warranty and misrepresentation claims	Drager argued express and implied warranties and fraud/negligent misrepresentation are contract/tort claims distinct from labeling duties	PLIVA argued product descriptions/representations and warnings are federally dictated for generics; avoiding liability would require leaving market or changing federally-mandated materials	Preempted — both express/implied warranty and misrepresentation/ concealment claims would conflict with FDCA constraints

Key Cases Cited

PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (Sup. Ct.) (held state failure-to-warn claims impossible to reconcile with FDCA labeling rules for generics)
Mutual Pharmaceutical Co. v. Bartlett, 133 S. Ct. 2471 (Sup. Ct.) (held generics cannot be required to stop selling or change formulation to avoid state tort liability)
Crosby v. National Foreign Trade Council, 530 U.S. 363 (Sup. Ct.) (explains conflict preemption under the Supremacy Clause)
Gourdine v. Crews, 955 A.2d 769 (Md. Ct. App.) (sets Maryland strict products liability elements)
Fullington v. Pfizer, Inc., 720 F.3d 739 (8th Cir.) (discusses potential state-law nuances re: consumer-expectations test and preemption)