In Re Reglan Litigation , 226 N.J. 315 ( 2016 )

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.
2
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.
35
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