In Re Reglan Litigation, 142 A.3d 725

Background

Plaintiffs are users of generic metoclopramide (Reglan) who developed tardive dyskinesia and other movement disorders after prolonged use; brand-name Reglan labeling was updated in 2004 (and with a black-box in 2009) to warn therapy should not exceed 12 weeks.
Nearly 1,000 consolidated suits were filed under New Jersey’s Product Liability Act (PLA) alleging generic manufacturers failed to timely update warnings to match FDA-approved brand labeling, causing plaintiffs’ prolonged use and injuries.
Defendants (generic manufacturers) argued federal preemption under the FDCA and the sameness requirement (Hatch-Waxman) — relying on PLIVA, Inc. v. Mensing — because generics must match brand labels and cannot unilaterally strengthen warnings.
Trial court and Appellate Division denied dismissal, holding plaintiffs’ PLA failure-to-warn claims did not conflict with federal law because generics had not in fact matched brand labels and thus could comply with both state and federal law.
The New Jersey Supreme Court affirmed: state-law failure-to-warn claims are not preempted where generics’ labels were outdated and inferior to FDA-approved brand labeling; whether a defendant exercised reasonable diligence to learn and adopt brand updates may establish preemption as a safe harbor.

Issues

Issue	Plaintiff's Argument	Defendant's Argument	Held
Whether federal law preempts PLA failure-to-warn claims when generic labels lag behind FDA-approved brand labels	PLA imposes an independent state duty to provide adequate warnings; plaintiffs’ claims are ordinary state torts not attempts to enforce federal law	Mensing preempts such claims because generics have only a federal duty of sameness; allowing state claims would effectively enforce federal obligations and conflict with the FDCA	Not preempted where generics did not match brand labeling; plaintiffs’ claims proceed because compliance with both state and federal law was possible
Whether Mensing bars suits where generics provided labels identical to brand labels	N/A (distinguishes Mensing)	Mensing supposedly bars all generic failure-to-warn suits	Mensing applies where generics complied with sameness; here it does not because generics failed to conform, so Mensing does not preempt
Whether state suits would frustrate FDCA objectives by duplicating FDA enforcement authority	State suits complement FDCA by incentivizing timely risk disclosure and compensating injured persons	State suits would frustrate federal scheme and improperly deputize juries to police federal labeling timing	State tort suits can complement FDA objectives and do not obstruct Congress’s purpose; they are permitted when not impossible to satisfy both regimes
Whether a safe-harbor preemption exists if a generic exercises reasonable diligence to adopt brand updates	N/A (plaintiffs must prove inadequacy/proximate cause)	If generic reasonably and promptly matched brand labeling, Mensing safe harbor should preempt state claims	Court recognizes a safe-harbor: reasonable diligence to learn and conform to brand updates may establish preemption as a matter of law

Key Cases Cited

PLIVA, Inc. v. Mensing, 564 U.S. 604 (federal preemption barred state failure-to-warn claims when generics matched brand labeling)
Wyeth v. Levine, 555 U.S. 555 (state-law failure-to-warn suits against brand manufacturers are complementary to FDCA and not preempted where compliance with both is possible)
Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341 (fraud-on-the-FDA claims are preempted because they seek to enforce federal regulatory regime)
Medtronic, Inc. v. Lohr, 518 U.S. 470 (presumption against preemption where states regulate historically occupied fields)
Fulgenzi v. PLIVA, Inc., 711 F.3d 578 (6th Cir.) (held no preemption where generic failed to adopt brand labeling; supports plaintiff-side rule)
Cornett v. Johnson & Johnson, 211 N.J. 362 (N.J. 2012) (distinguishes fraud-on-the-FDA claims from traditional state failure-to-warn torts)