In Re Reglan Litigation

SYLLABUS

(This syllabus is not part of the opinion of the Court. It has been prepared by the Office of the Clerk for the
convenience of the reader. It has been neither reviewed nor approved by the Supreme Court. Please note that, in the
interest of brevity, portions of any opinion may not have been summarized.)

In Re: Reglan Litigation (075269) (A-56-14)

Argued April 11, 2016 – Decided August 22, 2016

ALBIN. J., writing for a unanimous Court.

This appeal involves state-law claims of inadequate drug warnings asserted against certain generic drug
manufacturers by individuals who took the drug metoclopramide, the generic form of Reglan. The Court determines
whether plaintiffs’ state-law failure-to-warn claims under the New Jersey Product Liability Act (PLA), N.J.S.A.
2A:58C-1 to -11, are preempted by federal law.

In 2004, the brand-name manufacturer of Reglan received approval from the Food and Drug
Administration (FDA) to publish new label warnings about the dangers of the long-term use of metoclopramide
exceeding twelve weeks. Plaintiffs, who were prescribed and took metoclopramide after the FDA approved the
upgraded warnings, claim that defendants, who are generic manufacturers of the drug, did not timely upgrade their
label warnings to match the 2004 and 2009 FDA-approved brand-name label warnings. As a result, plaintiffs took
metoclopramide beyond the prescribed period, which they contend caused them to develop severe neurological
disorders.

Plaintiffs commenced suit against defendants in state court through nearly 1,000 individual lawsuits against
brand-name and generic manufacturers of metoclopramide. The action then proceeded through a master complaint
covering all plaintiffs. Plaintiffs asserted claims under the PLA based on defendants’ failure to warn of the harmful
effects of the long-term use of metoclopramide tablets. Plaintiffs assert that defendants failed to update their
labeling and packaging inserts to match the FDA-approved warnings until long after those warnings were issued,
which proximately caused the disorders which now afflict plaintiffs.

Defendants moved to dismiss plaintiffs’ state-law claims as preempted by federal law. The trial court
denied defendants’ motions for dismissal, finding that federal preemption did not apply because defendants had a
duty under state law to provide adequate labeling, and the labeling that they provided failed to match the brand-
name labeling. The Appellate Division affirmed the trial court’s determinations, finding that federal law did not
preempt plaintiffs’ claims because they do not place state law and federal law in conflict. The appellate panel stated
that plaintiffs’ claims are not premised on violations of federal law, but, rather, on defendants’ failure to give
adequate warnings under the PLA, and that it was possible for defendants to comply with both state and federal law.

This Court granted defendants’ motions for leave to appeal. 224 N.J. 278 (2014).

HELD: Plaintiffs’ state-law failure-to-warn claims under the PLA, based on the alleged inadequate labeling of
metoclopramide which did not match the brand-name labeling and warn of the dangers of the long-term use of the
drug, are not preempted by federal law, and may proceed before the trial court.

1. The doctrine of federal preemption is founded on the Supremacy Clause of the United States Constitution. The
doctrine recognizes that federal law shall be the Supreme Law of the land, notwithstanding any state law to the
contrary. When Congress legislates in a field where states have traditionally exercised their historic police powers,
the assumption is that Congress did not intend to supersede a state statute unless that was its clear and manifest
purpose. A state law that conflicts with a federal statute is naturally preempted. Conflict preemption applies where
compliance with both federal and state regulations is a physical impossibility, or where state law stands as an
obstacle to execution of the full purposes and objectives of federal law. (pp. 15-16)

2. Under the Federal Food, Drug and Cosmetic Act (FDCA), 21 U.S.C.A. §§ 301-399f, a manufacturer seeking
federal approval to market a new drug must prove that it is safe and effective, and that the proposed label is accurate
and adequate. Meeting the FDA’s approval requirements for a new drug involves costly and lengthy clinical testing,
the costs of which are reflected in the price of prescription drugs. In 1984, Congress passed the Drug Price
Competition and Patent Term Restoration (Hatch-Waxman) Act of 1981, Pub. L. No. 98-417, 98 Stat. 1585 (1984),
with the goal of making generic drugs more affordable and accessible. Hatch-Waxman streamlined the process for
the FDA’s approval of generic drugs. It allows a generic-drug manufacturer to gain FDA approval of a generic drug
by demonstrating that it is identical in active ingredients, safety, and efficacy to a brand-name drug approved by the
FDA. (pp. 17-18)

3. Under the FDCA, a brand-name drug manufacturer is responsible for the accuracy and adequacy of a drug’s
labeling, including when it seeks FDA approval for updated labeling to inform the public of previously unknown
adverse side-effects from the drug. However, a generic drug manufacturer is responsible for ensuring only that its
labeling is the same as the labeling approved for the brand-name drug. Under Hatch-Waxman, a generic drug
manufacturer cannot deviate from the labeling used by the brand name drug; the warning label must always be the
same. Because generic labeling must be the same as that of the brand-name drug, necessary updates to the labeling
of a generic drug should be made at the earliest possible time. (pp. 18-20)

4. The United States Supreme Court has recognized that, in adopting the FDCA, Congress did not intend to pre-
empt common-law tort actions, and state tort law may serve as a complementary tool in regulating the warnings on
prescription drugs that have potentially dangerous side effects. In particular, failure-to-warn suits lend force to the
FDCA’s premise that manufacturers, rather than the FDA, bear primary responsibility for their drug labeling at all
times. The PLA is an expression of New Jersey’s strong public policy of ensuring that manufacturers attach
adequate warnings and instructions to prescription drugs so that consumers will know of the relevant risks, dangers,
and precautions in taking such medications. The PLA provides that a warning or instruction approved under the
FDCA would enjoy a rebuttable presumption of adequacy under state law. The PLA is a codification of tort-law
principles in a field in which the state has traditionally exercised its historic police powers. Therefore, a failure-to-
warn claim under the PLA is not preempted unless Congress has expressed its clear and manifest purpose to do so.
(pp. 21-26)

5. Plaintiffs’ state-law failure-to-warn claims against defendants are not preempted by federal law. Defendants did
not conform their labeling to that of the brand-name drug, and therefore were in violation of the FDCA’s sameness
requirement. Federal preemption is inapplicable because defendants did not have to violate federal law in order to
comply with state law, and it was not impossible to comply with both federal and state law. Plaintiffs’ state law
claims highlight the inadequacy of the warnings for a drug, which if used for a prolonged period, could cause grave
harm. As a result, plaintiffs’ claims promote the full purposes and objectives of Congress in enacting the FDCA.
The Court therefore affirms the judgment of the Appellate Division, which upheld the trial court’s denial of
defendants’ motion to dismiss plaintiffs’ state-law failure-to-warn claims. (pp. 26-29)

6. In order to obtain safe-harbor protection from state-law claims under the FDCA’s sameness doctrine, a generic
drug manufacturer must exercise reasonable diligence to learn of updates to the brand-name labeling and to conform
to the FDCA’s sameness requirement. Should a generic drug manufacturer do so, federal preemption may bar a
state law failure-to-warn claim under the PLA. (p. 36)

The judgment of the Appellate Division is AFFIRMED, and the matter is REMANDED to the trial court
for further proceedings consistent with this opinion.

CHIEF JUSTICE RABNER, JUSTICES LaVECCHIA, FERNANDEZ-VINA and SOLOMON, join
in JUSTICE ALBIN’s opinion. JUSTICE PATTERSON and JUDGE CUFF (temporarily assigned) did not
participate.

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 SUPREME COURT OF NEW JERSEY
A-56 September Term 2014
075269

IN RE: REGLAN LITIGATION

Argued April 11, 2016 – Decided August 22, 2016

On appeal from the Superior Court, Appellate
Division.

Jay P. Lefkowitz, a member of the New York
bar, argued the cause for appellants
(Goldberg Segalla and Ulmer & Berne,
attorneys for PLIVA, Inc., Barr
Pharmaceuticals, LLC, Barr Laboratories,
Inc. and Watson Laboratories, Inc.; McElroy,
Deutsch, Mulvaney & Carpenter, Harris Beach,
Goodwin Procter, and Wood Smith Henning &
Berman, attorneys for Actavis Elizabeth LLC,
Teva Pharmaceuticals USA, Inc., Mutual
Pharmaceutical Company, Inc. and United
Research Laboratories, Inc.; Anita R.
Hotchkiss, Henry L. Miller, III, Joseph P.
Thomas, Joseph P. LaSala, Walter R.
Krzastek, Jr., Frederick H. Fern, Steven A.
Stadtmauer, Kelly E. Jones, Glenn S. Kerner,
and Kelly A. Walters, on the briefs).

Louis M. Bograd, a member of the District of
Columbia bar, argued the cause for
respondents Plaintiffs (Oshman & Mirisola,
attorneys; Theodore Oshman and Jason L.
Pullman, on the briefs).

Beth S. Rose submitted a brief on behalf of
amici curiae Amneal Pharmaceuticals, LLC,
Par Pharmaceuticals Co., Inc., Sandoz Inc.
and West-Ward Pharmaceuticals Corp. (Sills
Cummis & Gross, attorneys; Ms. Rose, of
counsel; Ms. Rose, James M. Hirschhorn, and
Vincent R. Lodato, on the brief).

1
 JUSTICE ALBIN delivered the opinion of the Court.

In 2004, the brand-name manufacturer of Reglan, known

generically as metoclopramide, received approval from the Food

and Drug Administration (FDA) to publish new label warnings

about the dangers of the long-term use of metoclopramide.

Plaintiffs are individuals who took metoclopramide, the generic

form of Reglan. They claim that defendant generic drug

manufacturers of metoclopramide did not timely upgrade their

label warnings to match the FDA-approved brand-name labeling.

Due to the allegedly inadequate generic drug warnings,

plaintiffs took metoclopramide beyond the prescribed period,

causing them to develop severe neurological disorders.

Plaintiffs filed failure-to-warn product-liability actions

against defendants in state court. Relying on PLIVA, Inc. v.

Mensing, 564 U.S. 604, 131 S. Ct. 2567, 180 L. Ed. 2d 580

(2011), defendants argue that federal law preempts plaintiffs’

state-law claims.

In Mensing, the United States Supreme Court explained that,

under federal law, generic drug manufacturers are obligated to

provide the same warning labels as those provided by the brand-

name manufacturer. Id. at 612-13, 131 S. Ct. at 2574, 180 L.

Ed. 2d at 588-89. On that basis, the Court concluded that

federal law preempted state-law tort claims against generic drug

manufacturers for failing to give warnings exceeding those on

2
brand-name labels. Id. at 618, 131 S. Ct. at 2577-78, 180 L.

Ed. 2d at 592. That conclusion followed because generic drug

manufacturers could not comply with state law without violating

federal law. Ibid.

The issue in this case is whether, under Mensing, a state-

law failure-to-warn claim is preempted when a generic drug

manufacturer gives warnings that are outdated and inferior to

the manufacturer’s brand-name warnings approved by the FDA.

The trial court denied defendants’ motions to dismiss

plaintiffs’ failure-to-warn claims, and similarly denied

defendants’ motions for summary judgment, finding that federal

preemption did not apply because defendant had a duty under

state law to provide adequate labeling, and here the labeling

did not match the brand-name labeling. The Appellate Division

affirmed, holding that plaintiffs’ claims are not premised on

violations of federal law, but rather on the failure to give

adequate warnings under New Jersey’s product-liability law.

We agree with the Appellate Division that plaintiffs’

failure-to-warn claims do not put state law and federal law in

conflict. Had defendants provided the same labeling as the

brand-name manufacturers, as required by federal law, defendants

would have enjoyed a safe harbor. Here, however, defendants did

not provide the same warning labels that the FDA approved for

the brand-name manufacturers. As alleged, defendants’

3
inadequate labeling breached a duty of care under the New Jersey

Product Liability Act (PLA), N.J.S.A. 2A:58C-1 to -11.

Complying with both federal and state law was not impossible

because, unlike in Mensing, defendants could have updated their

labeling without violating the FDA’s sameness requirement.

Plaintiffs’ claims arise under state law, not by the grace of a

federal regulatory scheme. Because plaintiffs’ failure-to-warn

claims are not preempted by federal law, we affirm the judgment

of the Appellate Division.

I.

A.

This case began with the filing of nearly 1000 individual

lawsuits against over fifty brand-name and generic manufacturers

of metoclopramide. This Court consolidated those individual

cases, and the trial court issued a case management order to

allow for the filing of a master complaint covering all

plaintiffs.1 Defendants -- PLIVA Inc., Barr Pharmaceuticals,

1 “[A] master complaint is an administrative device to manage
complex, consolidated cases efficiently and economically.”
Cornett v. Johnson & Johnson, 211 N.J. 362, 370 n.3 (2012)
(citing In re Mercedes-Benz Tele Aid Contract Litig., 257 F.R.D.
46, 56 (D.N.J. 2009)). “Although a single complaint is
designated the master complaint, each civil action remains
distinct for purposes of judgment.” Id. at 370-71 n.3 (citing
In re Propulsid Prods. Liab. Litig., 208 F.R.D. 133, 141 (E.D.
La. 2002)).

4
LLC, Barr Laboratories, Inc., Watson Laboratories, Inc.,

Actavis-Elizabeth LLC, Teva Pharmaceuticals USA, Inc., Mutual

Pharmaceutical Company, Inc., and United Research Laboratories,

Inc. -- are generic drug manufacturers of metoclopramide tablets

that did not change their labeling to match the 2004 and 2009

FDA-approved brand-name label warnings.2 Plaintiffs were

prescribed and used metoclopramide tablets after the FDA

approved upgraded warnings in 2004. Plaintiffs’ claims are

premised on defendants’ failure to warn of the harmful effects

of the long-term use of metoclopramide tablets.

Metoclopramide is a prescription drug used for the

treatment of symptomatic, gastroesophageal reflux and for relief

of symptoms associated with acute and recurrent diabetic

gastroparesis.3 It is “designed to speed the movement of food

through the digestive system.” Mensing, supra, 564 U.S. at 609,

131 S. Ct. at 2572, 180 L. Ed. 2d at 586.

The history of FDA approvals for labeling changes and the

2 Plaintiffs allege that defendants failed to comply with a 2009
FDA-approved black-box warning for metoclopramide, but that
claim appears to apply only to defendant Watson Laboratories.

3 Diabetic gastroparesis is a condition in which emptying of food
from the stomach is delayed. Taber’s Cyclopedic Medical
Dictionary 999 (22d ed. 2013). This may cause bloating,
abdominal pain, nausea, or vomiting and lead to the worsening of
gastroesophageal reflux. Gastroparesis, Nat’l Inst. of Diabetes
& Digestive & Kidney Diseases, U.S. Dep’t of Health & Hum.
Servs., https://www.niddk.nih.gov/health-information/health-
topics/digestive-diseases/gastroparesis/Pages/facts.aspx.

5
accompanying packaging inserts for metoclopramide tablets is not

disputed and is set forth in Mensing and, in part, in

plaintiffs’ amended master complaint. In 1980, the brand-name

manufacturer of Reglan obtained approval from the FDA to market

metoclopramide tablets. Id. at 609, 131 S. Ct. at 2572, 180 L.

Ed. 2d at 586. Since that time, “warning labels for the drug

have been strengthened and clarified several times.” Id. at

609, 131 S. Ct. at 2572, 180 L. Ed. 2d at 587. In 1985, the FDA

approved a label modification, warning that “‘[t]ardive

dyskinesia . . . may develop in patients treated with

metoclopramide,’ and the drug’s package insert added that

‘[t]herapy longer than 12 weeks has not been evaluated and

cannot be recommended.’” Ibid. (alterations in original)

(quoting Physician’s Desk Reference 1635-36 (41st ed. 1987)).

Tardive dyskinesia is a severe and oftentimes irreversible

neurological disorder, id. at 609-10, 131 S. Ct. at 2572-73, 180

L. Ed. 2d at 587, which is “marked by slow, rhythmical,

stereotyped movements, either generalized or in single muscle

groups,” Taber’s Cyclopedic Medical Dictionary 746 (22d ed.

2013).

In 2004, the then brand-name manufacturer secured the FDA’s

approval for a labeling change of Reglan tablets. The updated

labeling warned in the “Indications and Usage” section that

“[t]herapy should not exceed 12 weeks in duration,” and in the

6
“Dosage and Administration” section that “[t]herapy with

[R]eglan tablets should not exceed 12 weeks in duration.” In

2009, the FDA issued “a black box warning -- its strongest --

which state[d]: ‘Treatment with metoclopramide can cause

tardive dyskinesia, a serious movement disorder that is often

irreversible. . . . Treatment with metoclopramide for longer

than 12 weeks should be avoided in all but rare cases.’”

Mensing, supra, 564 U.S. at 610, 131 S. Ct. at 2573, 180 L. Ed.

2d at 587.

Plaintiffs allege in their complaint that defendant generic

manufacturers of metoclopramide tablets, through the early part

of 2009, did not update their labeling and packaging inserts to

match the FDA-approved warnings until long after those warnings

were issued.

Defendant Actavis-Elizabeth asserts that its metoclopramide

shipments contained the labeling change as of January 4, 2005 --

six months after the FDA approved revised warnings. Defendant

Teva Pharmaceuticals asserts that its metoclopramide shipments

contained the labeling change as of July 28, 2005 -- one year

after the revised warnings. Defendants Mutual Pharmaceutical

Company and United Research Laboratories assert that their

metoclopramide shipments contained that labeling change as of

January 31, 2006 -- one-and-one-half years after the revised

warnings. Defendant PLIVA claims that it was not informed of

7
the FDA-approved brand-name-label update through the end of 2008

-- that is, through the four-and-one-half-year period it

continued to manufacture metoclopramide. In December 2008,

defendant Watson Laboratories acquired the right from PLIVA to

manufacture metoclopramide tablets. Watson received notice from

the FDA on November 30, 2009, of the approved brand-name black-

box warning. Watson repackaged its metoclopramide with the

black-box warning more than ten months later, beginning October

18, 2010.

Plaintiffs claim that as a result of defendants’ failure to

update the warnings for metoclopramide tablets, they took the

drug beyond its prescribed period, causing them to develop

tardive dyskinesia or other movement disorders. See id. at 609,

131 S. Ct. at 2572, 180 L. Ed. 2d at 586 (“Evidence has

accumulated that long-term metoclopramide use can cause tardive

dyskinesia, . . . [and] [s]tudies have shown that up to 29% of

patients who take metoclopramide for several years develop this

condition.”) (citing McNeil v. Wyeth, 462 F.3d 364, 370 n.5 (5th

Cir. 2006)). According to plaintiffs, “[d]efendants knew or

should have known that the metoclopramide products cause

unreasonable, dangerous side-effects,” and defendants’ failure

to give adequate warnings -- the 2004 and 2009 FDA-approved

warnings -- proximately caused the disorders that have afflicted

8
plaintiffs.4

B.

The trial court denied defendants’ various motions to

dismiss plaintiffs’ failure-to-warn claims on federal-preemption

grounds.5 The court maintained that federal law required

defendant generic manufacturers of metoclopramide tablets to

adopt the brand-name labeling changes approved by the FDA.

Thus, the state tort-law duty of generic manufacturers to give

adequate warnings about the dangers of prolonged use of

metoclopramide -- consistent with brand-name-labeling changes --

did not conflict with federal law. The court declined to extend

the Mensing federal-preemption doctrine to “generic

4 Based on the representations of defendants in the summary-
judgment record, it appears that Watson Laboratories is the only
defendant that may have violated the 2009 FDA warnings.

5 The trial court dismissed a number of plaintiffs’ claims that
are not relevant to this appeal. A detailed rendition of the
procedural history is not necessary for our purposes.
Defendants initially filed motions to dismiss on the basis that
plaintiffs had “fail[ed] to state a claim upon which relief can
be granted,” R. 4:6-2(e), and other motions later on the basis
that the record as developed entitled them to an entry of
summary judgment, R. 4:46-2(c). In a Rule 4:6-2(e) motion, the
court reviews the complaint to determine whether the allegations
suggest a cause of action, see Printing Mart-Morristown v. Sharp
Elecs. Corp., 116 N.J. 739, 746 (1989) (quoting Velantzas v.
Colgate-Palmolive Co., 109 N.J. 189, 192 (1988)), whereas in a
Rule 4:46-2(c) motion, a court reviews the evidence of record
“in the light most favorable to the non-moving party” to
determine whether the moving party is entitled to judgment as a
matter of law. See Brill v. Guardian Life Ins. Co. of Am., 142
N.J. 520, 540 (1995); see also R. 4:46-2(c).

9
manufacturers of metoclopramide tablets [that] failed to update

the labels to be the same as the brand-name label.”

Following discovery, defendants moved for summary judgment,

claiming that they updated the metoclopramide tablet warnings to

conform to those of the brand-name labeling and did so within a

reasonable time. The court denied summary judgment, finding

that genuine issues of material fact remained concerning whether

defendants had timely updated the warnings and whether the

prior-used warnings were adequate.

The Appellate Division denied defendants’ motion for leave

to appeal. Thereafter, we granted defendants leave to appeal

and remanded to the Appellate Division for consideration of the

merits of defendants’ arguments.

C.

In an unpublished opinion, the Appellate Division affirmed

the trial court’s denial of defendants’ motions to dismiss for

failure to state a claim and for summary judgment regarding

plaintiffs’ failure-to-warn actions. The appellate panel found

that federal law did not preempt plaintiffs’ state-law claims

that were premised on defendants’ “failure to update their

warnings to conform to changes made to the brand-name warnings.”

The panel, moreover, held that allowing plaintiffs to proceed

with their state-law product-liability claims based on

defendants’ failure to provide adequate warnings about the

10
dangers of prolonged metoclopramide use would not frustrate

federal law. It concluded that preemption did not apply in this

case because it was possible for the generic drug manufacturers

to comply with both state and federal law. Last, the panel

rejected the argument that Cornett v. Johnson & Johnson, 211

N.J. 362 (2012), supports the dismissal of plaintiffs’ failure-

to-warn claims. It maintained that Cornett barred state-law

claims that interfered with the FDA’s exclusive authority to

enforce federal law. Here, according to the panel, the state-

law failure-to-warn claims fall “within a traditional area of

state concern and regulation” and are not premised solely on a

violation of federal law, quoting Cornett, supra, 211 N.J. at

390.

We granted defendants’ motion for leave to appeal. In re

Reglan Litig., 224 N.J. 278 (2014). We also granted the motion

of Amneal Pharmaceuticals, LLC, Par Pharmaceuticals Co., Inc.,

Sandoz, Inc., and Wes-Ward Pharmaceuticals Corp., which filed a

joint brief, to participate as amici curiae.

II.

A.

Defendants contend that plaintiffs’ state-law claims are

barred by the doctrine of federal preemption and that Mensing

“marked the end of state-law product liability failure-to-warn

claims involving generic drugs.” They argue that the source of

11
their duty to update their labeling to conform to the FDA-

approved labeling is the Federal Food, Drug, and Cosmetic Act

(FDCA), 21 U.S.C.A. §§ 301-399f. They claim that, under 21

U.S.C.A. § 337, the federal government, not a private party, is

authorized to initiate a suit for noncompliance with the FDCA

and state courts cannot impose liability under state law for

violations of federal law. Defendants maintain that state law

does not require “a generic drug manufacturer to match its

labeling to the corresponding brand product.” Invoking Mensing,

defendants insist that “generic drug manufacturers have only a

federal duty of ‘sameneness’ and not a duty of ‘adequacy.’”

According to defendants, “[p]ermitting plaintiffs to proceed on

purported state-law claims of ‘adequacy’ after a brand-name

drug’s label is revised is tantamount to permitting plaintiffs

to enforce the federal duty of ‘sameness’” in contravention of

federal law. Defendants’ overarching premise is that

“plaintiffs may not frustrate Congress’s purposes and objectives

in vesting [the] FDA with exclusive authority to regulate

generic drug labeling, under the guise of a state-law claim.”

The amici curiae pharmaceutical companies echo defendants’

arguments. Their principal position is that the state-law

failure-to-warn claims are really “failure-to-timely-update”

claims to enforce the federal duty of sameness under the FDCA.

They view the Appellate Division and trial court decisions as an

12
end run around federal preemption. They maintain that the FDA,

not a jury impaneled in a state court, is in the best position

to determine whether a generic drug manufacturer has made a

timely labeling change to conform to the brand-name label and to

impose sanctions under federal law if it has not.

B.

Plaintiffs contend that their claims sound solely in New

Jersey’s product-liability law, which required defendants to

provide adequate warnings of the dangers of prolonged use of

metoclopramide. They assert that their state-law claims are not

private enforcement actions of federal law and that their claims

promote, rather than frustrate, Congress’s objectives under the

FDCA. They note that the responsibility of generic drug

manufacturers to adhere to the duty of sameness -- to provide

the same labeling as the brand-name drug -- is relevant only

because the breach of that duty deprives them of the protection

of federal preemption. According to plaintiffs, Mensing shields

generic drug manufacturers only from state-law claims that seek

to impose liability for their failure to provide warnings that

go beyond those approved by the FDA for brand-name drugs. They

submit that because federal law required defendants to provide

the FDA-approved brand-name warnings, state tort law can impose

liability for inadequate warnings that do not meet the federal

sameness requirement.

13
 Plaintiffs maintain that defendants’ duty to provide

adequate warnings for the generic drug under New Jersey’s

product-liability law runs parallel to their duty to provide the

same warnings as the brand-name label. Indeed, plaintiffs argue

that state-court lawsuits of this type promote the objectives of

the FDCA because the FDA cannot properly monitor the adequacy of

label warnings on the thousands of marketed drugs. Plaintiffs’

central premise is that “[d]efendants’ actions would have given

rise to liability even if the FDCA had never been enacted.”

Plaintiffs, moreover, posit that defendants’ failure to

warn of the dangers of the prolonged use of metoclopramide gave

them “a competitive advantage in the market because their label

misled doctors, pharmacies and consumers into believing that

their generic product was safer than the brand[-name drug].”

III.

The primary issue in this case is whether federal law

preempts plaintiffs’ state-law action. That issue requires that

we interpret federal law, and therefore our review is de novo.

St. Peter’s Univ. Hosp. v. N.J. Bldg. Laborers Statewide Welfare

Fund, 431 N.J. Super. 446, 462 (App. Div.) (“[T]he question of

preemption is a legal issue that we review de novo.”), certif.

denied, 216 N.J. 366 (2013); see also Farmers Mut. Fire Ins. Co.

of Salem v. N.J. Prop.-Liab. Ins. Guar. Ass’n, 215 N.J. 522, 535

(2013) (“In construing the meaning of a statute . . . , our

14
review is de novo[.]”).

IV.

The doctrine of federal preemption finds its source in the

Supremacy Clause of the United States Constitution. The

Supremacy Clause provides that federal law “shall be the supreme

Law of the Land,” notwithstanding any state law to the contrary.

U.S. Const. Art. VI, cl. 2. A state law that conflicts with a

federal statute is naturally preempted. Crosby v. Nat’l Foreign

Trade Council, 530 U.S. 363, 372, 120 S. Ct. 2288, 2294, 147 L.

Ed. 2d 352, 361 (2000) (citing Hines v. Davidowitz, 312 U.S. 52,

66-67, 61 S. Ct. 399, 85 L. Ed. 581 (1941); California v. ARC

America Corp., 490 U.S. 93, 100-01, 109 S. Ct. 1661, 1665, 104

L. Ed. 2d 86, 94-95 (1989); United States v. Locke, 529 U.S. 89,

109, 120 S. Ct. 1135, 146 L. Ed. 2d 69 (2000)). When Congress

legislates in a field where states have traditionally exercised

their “historic police powers,” the preemption inquiry begins

with the “assumption” that Congress did not intend to supersede

a state statute “unless that was [Congress’s] clear and manifest

purpose.” Medtronic, Inc. v. Lohr, 518 U.S. 470, 485, 116 S.

Ct. 2240, 2250, 135 L. Ed. 2d 700, 715 (1996) (first quoting

Rice v. Santa Fe Elevator Corp., 331 U.S. 218, 230, 67 S. Ct.

1146, 1152, 91 L. Ed. 1447, 1459 (1947); and then citing

Hillsborough Cty. v. Automated Med. Labs., Inc., 471 U.S. 707,

715, 105 S. Ct. 2371, 2376, 85 L. Ed. 2d 714, 722-23 (1985)).

15
 “Pre-emption may be either express or implied.” Gade v.

Nat’l Solid Wastes Mgmt. Ass’n, 505 U.S. 88, 98, 112 S. Ct.

2374, 2383, 120 L. Ed. 2d 73, 84 (1992). There are two forms of

implied preemption -- field preemption and conflict preemption.

Ibid. Field preemption applies “where the scheme of federal

regulation is ‘so pervasive as to make reasonable the inference

that Congress left no room for the States to supplement it.’”

Ibid. (quoting Fid. Fed. Sav. & Loan Ass’n v. de la Cuesta, 458

U.S. 141, 153, 102 S. Ct. 3014, 3022, 73 L. Ed. 2d 664, 675

(1982)). Conflict preemption applies “where ‘compliance with

both federal and state regulations is a physical

impossibility,’” ibid. (quoting Fla. Lime & Avocado Growers,

Inc. v. Paul, 373 U.S. 132, 142-43, 83 S. Ct. 1210, 1217, 10 L.

Ed. 2d 248, 257 (1963)), “or where state law ‘stands as an

obstacle to the accomplishment and execution of the full

purposes and objectives of Congress,’” ibid. (first quoting

Hines, supra, 312 U.S. at 67, 61 S. Ct. at 404, 85 L. Ed. at

587; and then citing Felder v. Casey, 487 U.S. 131, 138, 108 S.

Ct. 2302, 101 L. Ed. 2d 123 (1988); Perez v. Campbell, 402 U.S.

637, 649, 91 S. Ct. 1704, 29 L. Ed. 2d 233 (1971)). See also

Crosby, supra, 530 U.S. at 372-73, 120 S. Ct. at 2294, 147 L.

Ed. 2d at 361 (noting that preemption will be found “where it is

impossible for a private party to comply with both state and

federal law”).

16
 Our task here is to determine whether federal law governing

the labeling of generic drugs expressly or impliedly preempts a

state-law product-liability action alleging that defendants

failed to give adequate warnings explaining the dangers and safe

use of metoclopramide. We first turn to the federal scheme

controlling the approval and labeling of prescription drugs.

V.

A.

In accordance with the Federal Food, Drug, and Cosmetic

Act, 21 U.S.C.A. §§ 301-399f, “a manufacturer seeking federal

approval to market a new drug must prove that it is safe and

effective and that the proposed label is accurate and adequate.”

Mensing, supra, 564 U.S. at 612, 131 S. Ct. at 2574, 180 L. Ed.

2d at 588; see 21 U.S.C.A. §§ 355(b)(1)(A), (d). Meeting the

FDA’s approval requirements for a new drug “involves costly and

lengthy clinical testing.” Mensing, supra, 564 U.S. at 612, 131

S. Ct. at 2574, 180 L. Ed. 2d at 588. The costs related to

those rigorous approval requirements are reflected in the price

of prescription drugs. See id. at 612, 131 S. Ct. at 2574, 180

L. Ed. 2d at 588-89.

In 1984, Congress passed the Drug Price Competition and

Patent Term Restoration (Hatch-Waxman) Act of 1981, Pub. L. No.

98-417, 98 Stat. 1585 (1984). One of the goals of Hatch-Waxman

was to make generic drugs more affordable and accessible to the

17
public. FTC v. Actavis, Inc., __ U.S. __, __, 133 S. Ct. 2223,

2228, 186 L. Ed. 2d 343, 353-54 (2013). Hatch-Waxman

streamlined the process for the FDA’s approval of generic drugs.

Ibid.; Mensing, supra, 564 U.S. at 612-13, 131 S. Ct. at 2574,

180 L. Ed. 2d at 588-89. It allows a generic drug manufacturer

to gain FDA approval of a generic drug simply by showing that it

is “identical in active ingredients, safety, and efficacy” to a

brand-name drug (a reference listed drug) already approved by

the FDA. Mensing, supra, 564 U.S. at 612 & n.2, 131 S. Ct. at

2574 & n.2, 180 L. Ed. 2d at 588 & n.2. By this expedited

process, generic drugs can be developed “inexpensively, without

duplicating the clinical trials already performed on the

equivalent brand-name drug.” Id. at 612, 131 S. Ct. at 2574,

180 L. Ed. 2d at 588-89.

In effect, a generic drug manufacturer is able to piggyback

on the results of the process that led to FDA approval of both

the brand-name drug and the brand-name drug’s labeling. “As a

result, brand-name and generic drug manufacturers have different

federal drug labeling duties.” Id. at 613, 131 S. Ct. at 2574,

180 L. Ed. 2d at 589. Under the FDCA, “[a] brand-name

manufacturer . . . is responsible for the accuracy and adequacy

of [a drug’s] label[ing],” ibid., not only when it files a new

drug application, but also when it seeks FDA approval for

updated labeling to inform the public of previously unknown

18
adverse side effects caused by a drug, 21 U.S.C.A. §§ 355(b)(1),

(d), (j)(2)(A). On the other hand, a generic drug manufacturer

is responsible for ensuring only that its labeling “is the same

as the labeling approved for the [brand-name] drug.” Mensing,

supra, 564 U.S. at 612-13, 131 S. Ct. at 2574, 180 L. Ed. 2d at

589 (alteration in original) (quoting 21 U.S.C.A. §

355(j)(2)(A)(v)). Under Hatch-Waxman, a generic drug

manufacturer cannot deviate from the labeling used by the brand

name drug -- the warning label must always be the same. Ibid.;

see also 21 C.F.R. § 314.150(b)(10).

Because generic labeling must be the same as that of the

brand-name drug, “[updated labeling] should be made at the very

earliest time possible.” U.S. Dep’t of Health & Hum. Servs.,

Food & Drug Admin., Ctr. for Drug Evaluation & Research,

Guidance for Industry: Revising ANDA Labeling Following Revision

of the RLD Labeling 5 (2000) (emphasis added). Generic

manufacturers have been given the means to learn of brand-name-

labeling updates. The Office of Generic Drugs in the Office of

Pharmaceutical Science, Center for Drug Evaluation and Research,

at the FDA has directed generic manufacturers to “routinely

monitor the Labeling Review Branch Homepage . . . for

information on changes in labeling.” Ibid. The Office of

Generic Drugs “[p]lace[s] monthly updates of approved labeling

changes” for brand-name drugs with approved generic counterparts

19
“on the Labeling Review Branch Homepage.”6 Ibid. “All approved

labeling for [brand-name drugs] is [also] available from Freedom

of Information Staff” at the FDA. Ibid.

In sum, when a brand-name manufacturer strengthens its

labeling to take into account adverse reactions to a medication,

federal law requires that the generic drug manufacturer copy the

brand-name labeling.7 Under the sameness doctrine, a generic

6 When a labeling revision for a brand-name drug “warrants
immediate widespread professional notification,” a “Dear Doctor
letter” is sent to physicians and other health-care
professionals by a drug manufacturer or the FDA advising of
substantial new warning information. Ibid.; Mensing, supra, 564
U.S. at 615, 131 S. Ct. at 2576, 180 L. Ed. 2d at 590; see 21
C.F.R. § 200.5.

7 After a new drug’s labeling has been approved, a brand-name
manufacturer may seek prior approval from the FDA to update its
labeling. 21 C.F.R. § 314.70(b). Alternatively, the brand-name
manufacturer may file a “Changes Being Effected” (CBE)
supplement with the FDA, 21 C.F.R. § 314.70(c), to make changes
to a brand-name drug label to “add or strengthen a
contraindication, warning, precaution, or adverse reaction” or
to “add or strengthen an instruction about dosage and
administration that is intended to increase the safe use of the
drug product.” 21 C.F.R. § 314.70(c)(6)(iii)(A), (C). The CBE
supplement must be submitted to the FDA thirty days before
distribution, but the CBE process does not require FDA approval
before changes are made to the label. 21 C.F.R. § 314.70(c).

Unlike brand-name manufacturers, generic manufacturers are not
allowed to unilaterally strengthen their labels beyond the
brand-name warnings through the CBE process. Mensing, supra,
564 U.S. at 614, 131 S. Ct. at 2575, 180 L. Ed. 2d at 590. A
generic drug manufacturer may only use the CBE process to
“change[] its label to match an updated brand-name label or to
follow the FDA’s instructions.” Ibid. A generic manufacturer
can update its labeling without pre-approval by the FDA after
issuing the CBE supplement to the FDA. See 21 C.F.R. §
314.70(c)(6)(iii)(A).

20
drug manufacturer may not unilaterally “strengthen a generic

drug’s warning label” beyond the brand-name labeling, because to

do so “would violate the statutes and regulations requiring a

generic drug’s label to match its brand-name counter-part’s.”

Mensing, supra, 564 U.S. at 614, 131 S. Ct. at 2575, 180 L. Ed.

2d at 590 (citing 21 U.S.C.A. § 355(j)(4)(G); 21 C.F.R. §§

314.94(a)(8)(iii), 314.150(b)(10)).

B.

The United States Supreme Court addressed the preemption

doctrine in the context of federal drug labeling requirements in

Mensing and Wyeth v. Levine, 555 U.S. 555, 129 S. Ct. 1187, 173

L. Ed. 2d 51 (2009). In Mensing, supra, the United States

Supreme Court held that federal law preempted state-law failure-

to-warn lawsuits against the defendant generic drug

manufacturers, which had provided the same labeling as the

brand-name drug. 564 U.S. at 618, 131 S. Ct. at 2577-78, 180 L.

Ed. 2d at 592. The plaintiffs in that case alleged that, under

state law, the defendants were required “to use a different,

stronger label than the label they actually used.” Id. at 617,

131 S. Ct. at 2577, 180 L. Ed. 2d at 591. The generic label

conformed to the brand-name label. Id. at 610, 131 S. Ct. at

2573, 180 L. Ed. 2d at 587. The Court concluded that state and

federal law were in conflict because it was impossible for the

defendants to comply with both laws. Id. at 618, 131 S. Ct. at

21
2577, 180 L. Ed. 2d at 592. Although the plaintiffs contended

that the generic manufacturers had a state-law “duty to attach a

safer label to their generic metoclopramide,” federal law

demanded “that generic drug labels be the same at all times as

the corresponding brand-name drug labels.” Id. at 618, 131 S.

Ct. at 2578, 180 L. Ed. 2d at 592. Had the generic

manufacturers “independently changed their labels to satisfy

their state-law duty, they would have violated federal law.”

Ibid. The Court therefore reasoned that “it was impossible for

the Manufacturers to comply with both their state-law duty to

change the label and their federal-law duty to keep the label

the same.” Ibid.

Mensing does not directly address the issue before us

because, here, defendant generic manufacturers of metoclopramide

tablets did not comply with the FDCA requirement that their

labeling mimic the brand-name labeling. The question is whether

the preemption doctrine is applicable to plaintiffs’ failure-to-

warn claims when the generic drug manufacturers not only could

have given stronger warnings, but also were required to do so

under federal law.

Wyeth dealt with a scenario that is relevant to our

inquiry. There, the United States Supreme Court held that, even

though the FDA had approved Wyeth’s labeling of a brand-name

prescription drug, federal law did not preempt a state-law tort

22
action against it for giving inadequate warnings about the

significant risks of administering its drug. Wyeth, supra, 555

U.S. at 563, 581, 129 S. Ct. at 1193, 1204, 173 L. Ed. 2d at 59,

70. That result followed because in Wyeth, unlike in Mensing,

it was not impossible for the brand-name manufacturer to comply

with both federal law and a state-law duty by modifying the

drug’s labeling. Id. at 569, 573, 129 S. Ct. at 1196-97, 1199,

173 L. Ed. 2d at 62, 65.

The Supreme Court in Wyeth emphasized that the central

premise of the FDCA and FDA regulations is “that the

manufacturer bears responsibility for the content of its label

at all times [and] is charged both with crafting an adequate

label and with ensuring that its warnings remain adequate as

long as the drug is on the market.” Id. at 570-71, 129 S. Ct.

at 1197-98, 173 L. Ed. 2d at 63; see also 21 C.F.R. § 201.80(e)

(requiring manufacturer to update label “to include a warning as

soon as there is reasonable evidence of an association of a

serious hazard with a drug”). Accordingly, when the risk became

apparent to Wyeth that its drug might cause gangrene, “Wyeth had

a duty to provide a warning that adequately described that risk,

and the [FDCA’s] regulation permitted it to provide such a

warning before receiving the FDA’s approval.” Id. at 571, 129

S. Ct. at 1198, 173 L. Ed. 2d at 64. Based on the regulatory

authorization to issue pre-approval warnings, the Court

23
maintained that it was not “impossible for Wyeth to comply with

both federal and state requirements.” Ibid.

The Court also concluded that, in passing the FDCA,

Congress did not intend “to pre-empt common-law tort suits” and

that such suits serve “as a complementary form of drug

regulation.” Id. at 578, 129 S. Ct. at 1202, 173 L. Ed. 2d at

68. The Court articulated an overarching federal policy for

permitting state-law tort suits by stating:

The FDA has limited resources to monitor the
11,000 drugs on the market, and manufacturers
have superior access to information about
their drugs, especially in the postmarketing
phase as new risks emerge. State tort suits
uncover unknown drug hazards and provide
incentives for drug manufacturers to disclose
safety risks promptly. They also serve a
distinct compensatory function that may
motivate injured persons to come forward with
information. Failure-to-warn actions, in
particular, lend force to the FDCA’s premise
that manufacturers, not the FDA, bear primary
responsibility for their drug labeling at all
times.

[Id. at 578-79, 129 S. Ct. at 1202, 173 L.
Ed. 2d at 68-69 (footnote omitted).]

In light of the Supreme Court’s recognition that state tort

law may serve as a complementary tool in regulating the warnings

on prescription drugs that have potentially dangerous side

effects, we next look at this State’s product-liability law.

C.

The New Jersey Product Liability Act (PLA), N.J.S.A.

24
2A:58C-1 to -11, provides that “[a] manufacturer . . . of a

product shall be liable in a product liability action only if .

. . the product causing the harm was not reasonably fit,

suitable or safe for its intended purpose because it . . .

failed to contain adequate warnings or instructions.” N.J.S.A.

2A:58C-2. In the case of a prescription drug, the PLA defines

an adequate warning or instruction as one that a “reasonably

prudent person” would give and “that communicates adequate

information on the dangers and safe use of the product . . .

taking into account the characteristics of, and the ordinary

knowledge common to, the prescribing physician.” N.J.S.A.

2A:58C-4. The Legislature recognized the important role of the

federal regulatory system over prescription drugs and provided

that a warning or instruction approved under the FDCA would

enjoy “a rebuttable presumption” of adequacy. See ibid.

The PLA is an expression of New Jersey’s strong public

policy of ensuring that manufacturers attach adequate warnings

and instructions to prescription drugs so that consumers,

ultimately, will be made aware of the relevant risks, dangers,

and precautions in taking such medications. Cf. Gantes v. Kason

Corp., 145 N.J. 478, 490 (1996) (“[T]his State has a strong

interest in encouraging the manufacture and distribution of safe

products for the public and, conversely, in deterring the

manufacture and distribution of unsafe products within the

25
state.”). The Legislature understood, in the case of

prescription drugs, that the PLA must coexist with a federal

scheme that highly regulates the marketing of such drugs. See

Cornett, supra, 211 N.J. at 387. The PLA is a codification of

tort-law principles, where the state has traditionally exercised

its historic police powers. See Medtronic, supra, 518 U.S. at

485, 116 S. Ct. at 2250, 135 L. Ed. 2d at 715. As such, a

failure-to-warn claim under the PLA is not preempted unless

Congress has expressed its “clear and manifest purpose” to do

so. Ibid. (quoting Rice, supra, 331 U.S. at 230, 67 S. Ct. at

1152, 91 L. Ed. at 1459)).

VI.

A.

Plaintiffs’ state-law failure-to-warn claims against

defendant generic drug manufacturers are not barred by Mensing

and are permissible under Wyeth.

The defendant generic manufacturers of metoclopramide in

Mensing did precisely what the FDCA demanded -- they provided

the same labeling that appeared with the brand name. See

Mensing, supra, 564 U.S. at 609-10, 618, 131 S. Ct. at 2572-73,

2577-78, 180 L. Ed. 2d at 587, 592. Under Hatch-Waxman, generic

manufacturers do not have to replicate the costly and lengthy

clinical drug testing and research by brand-name manufacturers.

See id. at 612, 131 S. Ct. at 2574, 180 L. Ed. 2d at 588-89. In

26
turn, the FDCA also permits the generic manufacturer to rely on

the brand-name labeling and forbids them from issuing better or

stronger warnings. See id. at 614-15, 131 S. Ct. at 2575-76,

180 L. Ed. 2d at 588-89. Federal law preempted the state-law

claims in Mensing because those claims were premised on a duty

of generic manufacturers to give “safer” warnings than the FDA-

approved brand-name warnings for metoclopramide. Id. at 618,

131 S. Ct. at 2578, 180 L. Ed. 2d at 592. What state law

permitted was impossible under federal law. Ibid.

The case before us is not like Mensing. Here, defendant

generic manufacturers of metoclopramide tablets did not conform

their labeling to that of the brand-name drug and therefore were

in violation of the FDCA’s sameness requirement. Had defendants

complied with federal law, they would be entitled to the safe-

harbor protection afforded by Mensing. See id. at 613, 131 S.

Ct. at 2574-75, 180 L. Ed. 2d at 589. No law prevented

defendants from giving the same warnings that appeared on the

labeling of the brand-name drug -- the warnings that plaintiffs

contend the PLA required. Defendants did not have to violate

federal law to comply with state law. Unlike Mensing, here it

was not impossible to comply with both federal and state law.

As a result of the discrepancy between the brand-name and

generic labeling of metoclopramide tablets, consumers of Reglan

tablets were informed that “[t]herapy should not exceed 12 weeks

27
in duration,” whereas the plaintiff generic consumers were

informed only that “[t]herapy longer than 12 weeks has not been

evaluated and cannot be recommended.”8 Based on the inadequacy

of the generic warnings, plaintiffs allege that they used

metoclopramide beyond the prescribed period and therefore

developed tardive dyskinesia, a serious neurological disorder.

Under Wyeth, supra, plaintiffs’ state-law claims are not at

odds with the FDCA, but are “a complementary form of drug

regulation.” 555 U.S. at 578, 129 S. Ct. at 1202, 173 L. Ed. 2d

at 68. In keeping with Wyeth, each defendant generic drug

“manufacturer bears responsibility for the content of its label

at all times,” and each “had a duty to provide a warning that

adequately described that risk, and the [FDCA’s] regulation

permitted it to provide such a warning.” See id. at 570-71, 129

S. Ct. at 1197-98, 173 L. Ed. 2d at 63-65.

This case drives home the point made in Wyeth that the FDA

does not have the resources to monitor the labeling of thousands

of drugs after they are marketed, and to the extent that

“[s]tate tort suits uncover unknown drug hazards[, they] provide

incentives for drug manufacturers to disclose safety risks

promptly.” See id. at 578-79, 129 S. Ct. at 1202, 173 L. Ed. 2d

8 While the drug labels are initially disseminated to doctors and
pharmacists, they, in turn, inform their patients, passing the
warnings on to consumers. See Niemiera v. Schneider, 114 N.J.
550, 559 (1989).

28
at 68-69. Thus, state law promotes rather than “stands as an

obstacle to the accomplishment and execution of the full

purposes and objectives of Congress” in passing the FDCA. See

Gade, supra, 505 U.S. at 98, 112 S. Ct. at 2383, 120 L. Ed. 2d

at 84 (first quoting Hines, supra, 312 U.S. at 67, 61 S. Ct. at

404, 85 L. Ed. at 587; and then citing Felder, supra, 487 U.S.

at 138, 108 S. Ct. 2302, 101 L. Ed. 2d 123; Perez, supra, 402

U.S. at 649, 91 S. Ct. 1704, 29 L. Ed. 2d 233). Here,

plaintiffs’ state-law failure-to-warn claims shined a light on

the inadequacy of warnings of a drug, which if used for a

prolonged period could cause grave harm. The PLA provides a

remedy to plaintiffs, if they can prove their claims to a jury,

and the pursuit of those claims is not barred by federal law.

B.

Importantly, plaintiffs’ state-law claims run parallel to,

but are not dependent on, federal law. Plaintiffs could proceed

on their failure-to-warn claims under the PLA even if the FDCA

and Hatch-Waxman did not exist. From that perspective, the

present case is not comparable to Buckman Co. v. Plaintiffs’

Legal Committee, 531 U.S. 341, 121 S. Ct. 1012, 148 L. Ed. 2d

854 (2001), on which defendants rely.

In Buckman, the United States Supreme Court held that the

Medical Device Amendments to the FDCA preempted a state-law tort

action premised on a claim that the defendant medical-device

29
manufacturer committed a fraud on the FDA. Id. at 348, 121 S.

Ct. at 1017, 148 L. Ed. 2d at 861. In that case, the defendant

allegedly made fraudulent representations to the FDA to secure

approval for the marketing of defective orthopedic bone screws

that directly caused injuries to a class of plaintiffs. Id. at

343, 121 S. Ct. at 1015, 148 L. Ed. 2d at 858. Preemption

applied because “the federal statutory scheme amply empower[ed]

the FDA to punish and deter fraud against the Agency,” by

referring criminal charges, seizing the device, and seeking

civil penalties and injunctive relief. Id. at 348-49, 121 S.

Ct. at 1017-18, 148 L. Ed. 2d at 861-62. The Court concluded

that the fraud-on-the-agency claim was not based on traditional

state tort law because a “critical element” of those claims was

dependent on the Medical Device Amendments. Id. at 353, 121 S.

Ct. at 1020, 148 L. Ed. 2d at 864.

The Court pointedly distinguished Buckman from Medtronic.

In Medtronic, preemption did not apply to state-law negligence

claims against a manufacturer for allegedly producing defective

pacemakers because those claims did not arise “solely from the

violation of FDCA requirements.” Id. at 352-53, 121 S. Ct. at

1019-20, 148 L. Ed. 2d at 864. The Supreme Court in Buckman

indicated that “Medtronic can be read to allow certain state-law

causes of actions that parallel federal safety requirements,”

ibid., which is precisely what the Court later held in Wyeth,

30
supra, 555 U.S. at 581, 129 S. Ct. at 1204, 173 L. Ed. 2d at 70,

and what we hold today. The present case is different from

Buckman because, here, the “critical element” to plaintiffs’

claims is not defendants’ violation of the FDCA, but defendants’

failure to give adequate warnings about the prolonged use of

metoclopramide.

Defendants’ reliance on Cornett is also misplaced. In

Cornett, supra, we came to the unremarkable conclusion that,

under the Medical Device Amendments, federal law preempted

state-law tort actions against the defendants premised on a

fraud on the FDA. 211 N.J. at 389. That result was commanded

by Buckman. Ibid. We made clear, however, that a failure-to-

warn claim alleging that the defendants withheld information

from or made misrepresentations to the general public and the

medical community about the safe use of the medical device at

issue fell “within a traditional area of state concern and

regulation.” Id. at 390. That claim could proceed under the

Product Liability Act “because fraud on the FDA is not an

element of the claim.” Ibid.

Accordingly, allowing the failure-to-warn claims in the

present case to proceed is compatible with the preemption

principles articulated in both Buckman and Cornett.

C.

Our conclusion that plaintiffs’ state-law failure-to-warn

31
claims are not preempted by federal law is supported by Fulgenzi

v. PLIVA, Inc., 711 F.3d 578 (6th Cir. 2013), and case law in

other jurisdictions. In Fulgenzi, like here, PLIVA, a generic

manufacturer of metoclopramide, failed to update its labeling to

conform to the 2004 FDA-approved brand-name-labeling change.

Id. at 580. As a result of the inadequate labeling, the

plaintiff alleged that she prolonged her use of metoclopramide,

which led to her developing tardive dyskinesia. Ibid. The

plaintiff filed a product-liability failure-to-warn suit under

Ohio law, seeking damages. Id. at 581-82. The United States

Court of Appeals for the Sixth Circuit determined that federal

preemption did not bar the state claims. Id. at 580. After

reviewing Mensing, Wyeth, and Buckman, the Sixth Circuit

concluded that state laws providing damages for inadequate

warnings -- warnings that did not comply with the federal duty

of sameness -- did not conflict with the FDCA or Hatch-Waxman.

Id. at 585-86.

The federal appeals court maintained that the plaintiff’s

suit was not “premised on [a] violation of federal law, but

rather on an independent state duty” and that “[t]he federal

duty of sameness [was] not ‘a critical element’ in [the

plaintiff’s] case.” Id. at 587 (quoting Buckman, supra, 531

U.S. at 353, 121 S. Ct. at 1020, 148 L. Ed. 2d at 864). It

reasoned that the adequacy of PLIVA’s warnings was not relevant

32
to its duty under federal law and that “[a] jury need not know

about the duty of sameness at all to determine whether the

warning label used by PLIVA in 2004 and 2006 was inadequate, and

whether the failure to include the updated warning was a

proximate cause of [the plaintiff’s] injuries.” Ibid. Last,

Fulgenzi noted that, at trial, “[t]o avoid Mensing preemption,

[the plaintiff] must use the language of the 2004 FDA-approved

label in her proximate-cause argument, not (or not merely) the

fact of the failure to update.” Id. at 588.9

A number of federal and state courts, like the Sixth

Circuit in Fulgenzi, have found that federal law does not

preempt state-law claims arising from the failure of generic

drug manufacturers to update labeling to conform to that of the

brand name. See, e.g., In re Fosamax Prods. Liab. Litig., 965

F. Supp. 2d 413, 417 (S.D.N.Y. 2013); Phelps v. Wyeth, Inc., 938

F. Supp. 2d 1055, 1063-66 (D. Or. 2013); Teva Pharms. USA, Inc.

v. Superior Court, 158 Cal. Rptr. 3d 150, 156-61 (Ct. App.),

review denied, 2013 Cal. LEXIS 7909 (2013), cert. denied, __

U.S. __, 135 S. Ct. 1152, 190 L. Ed. 2d 911 (2015); Huck v.

Wyeth, Inc., 850 N.W.2d 353, 364 (Iowa 2014), cert. denied, __

U.S. __, 135 S. Ct. 1699, 191 L. Ed. 2d 695 (2015); Franzman v.

9 Fulgenzi also acknowledged that at trial “[f]ederal standards
are also likely to arise in determining the adequacy of PLIVA’s
warning, since FDA approval and industry practices may be
relevant to the state duty of care.” Id. at 588-89.

33
Wyeth, Inc., 451 S.W.3d 676, 679 (Mo. Ct. App. 2014).

In contrast, Morris v. PLIVA, Inc., 713 F.3d 774, 777 (5th

Cir. 2013) (per curiam), found that Mensing preempts failure-to-

warn claims against generic manufacturers who have not updated

their warnings. There, the United States Court of Appeals for

the Fifth Circuit held that a state-law claim against the

generic manufacturer PLIVA for its failure to adopt the 2004

FDA-approved brand-name-warning label for metoclopramide was “a

claim that PLIVA breached a federal labeling obligation [that]

sounds exclusively in federal (not state) law, and is

preempted.” Ibid. (citing 21 U.S.C.A. § 337(a); Buckman, supra,

531 U.S. at 349 n.4, 121 S. Ct. at 1018 n.4, 148 L. Ed. 2d at

862 n.4). The Fifth Circuit, however, did not give any detailed

analysis or reasoning for that conclusion.10

We do not find Morris persuasive. Instead, we join those

courts, such as the Sixth Circuit in Fulgenzi, that have

concluded that federal preemption does not apply to failure-to-

warn claims, such as those in the present case. We reject the

notion that a plaintiff can proceed with a state-law failure-to-

warn claim against a brand-name drug manufacturer that used FDA-

approved warnings, as was true in Wyeth, but not against a

10Without citing any authority, the Morris court asserted that
“[t]ort liability does not arise for failure to attach an
inadequate label.” See Morris, supra, 713 F.3d at 777. The
labeling cases cited in this opinion indicate otherwise.

34
generic manufacturer that provides warnings that do not even

match the FDA-approved brand-name labeling. Congress could not

have intended such an absurd result.

VII.

Here, plaintiffs claim that the generic drug manufacturers’

inadequate warnings of the dangers of the prolonged use of

metoclopramide proximately caused neurological disorders, such

as tardive dyskinesia. In 2004, with FDA approval, brand-name

manufacturers updated their labeling to indicate that the use of

metoclopramide “should not exceed 12 weeks in duration.”

Although generic drug labeling is required to be the same as

that of the brand name under federal law, defendant generic

manufacturers, apparently, did not update their labeling “at the

very earliest time possible” in accordance with the directive of

the U.S. Department of Health and Human Services, Food and Drug

Administration, Center for Drug Evaluation and Research.

Guidance for Industry: Revising ANDA Labeling Following Revision

of the RLD Labeling 5 (2000). The FDA’s Office of Generic Drugs

had directed generic manufacturers to “routinely monitor [its]

Labeling Review Branch Homepage” for labeling updates that were

made monthly on the Homepage. Ibid. Generic manufacturers were

also advised that information about brand-name labeling changes

was available from the FDA’s Freedom of Information Staff. See

ibid.

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 Some lag time is inevitable before a generic drug

manufacturer can conform to the FDA’s sameness requirement. For

example, the updates on the FDA website appear monthly. See

ibid. Needless to say, if a generic drug manufacturer is

seeking safe-harbor protection under the sameness doctrine, then

it must exercise reasonable diligence to learn of updates to the

brand-name labeling. If the trial court determines that any

defendant updated its labeling “at the very earliest time

possible,” ibid., the state law claim would be preempted.

Whether preemption applies is a matter of law to be decided by

the court, not a jury. See Fulgenzi, supra, 711 F.3d at 583.

Despite the easy access to information about brand-name

labeling changes and the time-sensitive need to make those

changes, defendant generic manufacturers delayed updating their

labeling -- defendant Actavis-Elizabeth for six months,

defendant Teva Pharmaceuticals for one year, defendants Mutual

Pharmaceutical Company and United Research Laboratories for one-

and-one-half years. Defendant PLIVA did not update its labeling

for the four-and-one-half years that it continued to manufacture

metoclopramide through 2008. Watson Laboratories did not

include the 2009 FDA-approved black-box warning in its

metoclopramide shipments until more than ten months after

receiving notice of the labeling change.

A violation of the FDCA’s sameness requirements is not an

36
element of plaintiffs’ claims. Plaintiffs’ claims do not “exist

solely by virtue of” a federal regulatory scheme. See Buckman,

supra, 531 U.S. at 353, 121 S. Ct. at 1020, 148 L. Ed. 2d at

864. Their state-law cause of action is not a disguised means

of enforcing a federal law or regulation. Rather, plaintiffs

are availing themselves of protections long available under this

State’s product-liability law. States have traditionally

exercised their powers to promote the health and welfare of

their citizens by regulating the safety of products through

state tort law. Plaintiffs’ claims run parallel to the FDCA’s

sameness requirement for labeling warnings, but they are not

based on that requirement. To be sure, to avoid a clash with

Mensing and Hatch-Waxman, plaintiffs may not contend that

defendant generic manufacturers had a duty to provide warnings

beyond those that the FDA approved for the brand name.

Under state law, plaintiffs must prove the inadequacy of

defendants’ labeling of metoclopramide. This State’s product-

liability law requires defendant generic manufacturers to

“communicate[] adequate information on the dangers and safe use

of [metoclopramide], taking into account . . . knowledge common

to[] [a] prescribing physician.” See N.J.S.A. 2A:58C-4.

Plaintiffs therefore must demonstrate that a reasonably prudent

generic manufacturer of metoclopramide tablets after July 2004

would have provided a stronger warning than the 1985 warning:

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“Therapy longer than 12 weeks has not been evaluated and cannot

be recommended.” In short, plaintiffs must show that defendant

generic drug manufacturers had a duty to give a stronger warning

than the one provided and that the failure to do so proximately

caused their injuries. See Fulgenzi, supra, 711 F.3d at 588.

Our charge here is merely to determine whether federal law

preempts plaintiffs’ claims. We conclude that federal law does

not. Whether plaintiffs can prove that defendants breached

their state-law duty to provide adequate warnings and, if so,

whether the breach of that duty proximately caused plaintiffs’

injuries is a matter for another day.

VIII.

For the reasons expressed, plaintiffs’ state-law failure-

to-warn claims based on the alleged inadequate labeling of

metoclopramide -- labeling that did not mimic the brand-name

labeling -- are not preempted by federal law. We therefore

affirm the judgment of the Appellate Division, which upheld the

trial court’s denial of defendants’ motions to dismiss those

claims. We remand to the trial court for proceedings consistent

with this opinion.

CHIEF JUSTICE RABNER, JUSTICES LaVECCHIA, FERNANDEZ-VINA
and SOLOMON, join in JUSTICE ALBIN’s opinion. JUSTICE PATTERSON
and JUDGE CUFF (temporarily assigned) did not participate.

38