Accutane Litigation

Annotate this Case
Justia Opinion Summary

This appeal arose from 532 product-liability claims filed against Hoffmann-La Roche Inc. and Roche Laboratories Inc. (collectively Roche), corporations with their principal places of business in New Jersey. Roche developed, manufactured, marketed, and labeled Accutane, a prescription medication for the treatment of severe and persistent cases of acne. Plaintiffs alleged Accutane caused them to contract inflammatory bowel disease (IBD) and that Roche failed to give adequate label warnings to advise them of the known risks of the medication. At issue for the New Jersey Supreme Court was : (1) what law governed whether Roche’s label warnings were adequate (the law of each of the 45 jurisdictions in which plaintiffs were prescribed and took Accutane or the law of New Jersey where the 532 cases are consolidated); and (2) the adequacy of the label warnings for the period after April 2002. The Court found that because Roche’s warnings received the approval of the FDA, they enjoyed a “rebuttable presumption” of adequacy under New Jersey’s Products Liability Act (PLA). The Court reversed all cases in which the Appellate Division reinstated plaintiffs’ actions against Roche. "New Jersey has the most significant interests, given the consolidation of the 532 cases for MCL purposes. New Jersey’s interest in consistent, fair, and reliable outcomes cannot be achieved by applying a diverse quilt of laws to so many cases that share common issues of fact. Plaintiffs have not overcome the PLA’s presumption of adequacy for medication warnings approved by the FDA. As a matter of law, the warnings provided physicians with adequate information to warn their patients of the risks of IBD." As a result, the 532 failure-to-warn cases brought by plaintiffs against Roche were dismissed.

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
Court. In the interest of brevity, portions of an opinion may not have been summarized.

                     In re: Accutane Litigation (A-26/27-17) (079933)

Argued April 23, 2018 -- Decided October 3, 2018

ALBIN, J., writing for the Court.

        This appeal arises from 532 product-liability claims filed against Hoffmann-La Roche
Inc. and Roche Laboratories Inc. (collectively Roche), corporations with their principal
places of business in New Jersey. Roche developed, manufactured, marketed, and labeled
Accutane, a prescription medication for the treatment of severe and persistent cases of acne.
Plaintiffs allege that Accutane, prescribed by their physicians, caused them to contract
inflammatory bowel disease (IBD) and that Roche failed to give adequate label warnings to
advise them of the known risks of the medication. Of the 532 plaintiffs, 18 are New Jersey
residents and 514 are residents of 44 other jurisdictions. Plaintiffs’ claims are designated as
Multicounty Litigation (MCL) and consolidated in the Atlantic County Superior Court.

        The Court considers two issues. The first is what law governs whether Roche’s label
warnings were adequate -- the law of each of the 45 jurisdictions in which plaintiffs were
prescribed and took Accutane or the law of New Jersey where the 532 cases are consolidated.
The second issue is the adequacy of the label warnings for the period after April 2002.
Because Roche’s warnings received the approval of the FDA, they enjoy a “rebuttable
presumption” of adequacy under New Jersey’s Products Liability Act (PLA). See  N.J.S.A.
2A:58C-4. That presumption provides pharmaceutical companies greater protection in New
Jersey than in many other jurisdictions.

        By April 10, 2002, Roche had generated a variety of FDA-approved Accutane
warning labels and materials for a target audience of prescribing physicians, pharmacists, and
patients. The physician label advises prescribing physicians that not only has IBD been
associated with the taking of Accutane, but that symptoms of the disease “have been reported
to persist after Accutane treatment has been stopped.” In addition, Roche provided
physicians with a Best Practices Guide, as well as a Patient Safety Packet to give to their
patients. Roche developed, in conjunction with the FDA, a Medication Guide for
pharmacists to distribute to Accutane patients when they received their prescriptions. Like
the Patient Safety Packet, the Medication Guide warned of “possible serious side effects”
from Accutane and described IBD symptoms in simple and plain language. Roche also
required pharmacists to dispense Accutane pills in “blister packaging” that again warned the
patient that Accutane could have serious gastrointestinal side effects. Accordingly, by 2002,
before taking Accutane, patients received the IBD warnings from their prescribing physicians
and from their pharmacies. The FDA reviewed and approved each of Roche’s warning tools.
                                               1
      Plaintiffs focus on excerpts from several internal Roche documents as evidence that
Roche should have given better warnings.

       In 2015, in a series of rulings, the trial court concluded that the New Jersey PLA
governed not only the 18 in-state claims but also the 514 claims that involved plaintiffs who
were prescribed and took Accutane in 44 other jurisdictions. The court granted Roche’s
motion for summary judgment, determining that plaintiffs failed to overcome the
presumption of adequacy that attached to the post-2002 Accutane label warnings approved
by the FDA. The court dismissed the 532 product-liability actions brought against Roche.

        The Appellate Division reversed in part and affirmed in part. Applying the relevant
sections of the Restatement (Second) of Conflict of Laws (“Restatement”), the panel
concluded that each individual case had to be judged under the substantive law of the
jurisdictions where each plaintiff was prescribed and took Accutane -- forty-five jurisdictions
in all. The panel affirmed the grant of summary judgment in favor of Roche in those cases
involving plaintiffs who were prescribed and took Accutane in seven states because “[i]t is
enough in these jurisdictions that IBD was referenced” in Roche’s label warnings to render
them adequate as a matter of law. The panel also affirmed the grant of summary judgment in
those cases involving the Texas plaintiffs because they had not overcome that jurisdiction’s
presumption of adequacy. The panel, however, found that the trial court improvidently
granted summary judgment in the cases of those plaintiffs from the remaining thirty-seven
jurisdictions because “the adequacy of the warnings could not be resolved as a matter of
law.” Under New Jersey’s PLA, the panel held that plaintiffs had presented sufficient
evidence to overcome the presumption of adequacy attached to Accutane’s FDA-approved
warnings and therefore genuine issues of material fact needed to be resolved by a jury.

        The Court granted Roche’s petition for certification,  231 N.J. 419 (2017), and
plaintiffs’ cross-petition,  231 N.J. 428 (2017).

HELD: The Court now reverses in all those cases in which the Appellate Division reinstated
plaintiffs’ actions against Roche. New Jersey has the most significant interests, given the
consolidation of the 532 cases for MCL purposes. New Jersey’s interest in consistent, fair,
and reliable outcomes cannot be achieved by applying a diverse quilt of laws to so many
cases that share common issues of fact. Plaintiffs have not overcome the PLA’s presumption
of adequacy for medication warnings approved by the FDA. As a matter of law, the
warnings provided physicians with adequate information to warn their patients of the risks of
IBD.

1. The Court applies New Jersey’s choice-of-law rules in determining whether this State’s or
another state’s law governs the action. The Court thus compares New Jersey’s PLA to the
product-liability laws or analogues of forty-four other jurisdictions and notes that New
Jersey’s rebuttable presumption of adequacy, which specifically attaches to FDA-approved
warnings, sets New Jersey law apart from most other states’ laws. That conflict of
substantive law requires choosing the law or laws that govern the 532 cases. (pp. 31-35)

                                              2
2. In this MCL setting, New Jersey’s PLA intersects with the laws of 44 other jurisdictions
in 514 cases. In Ginsberg v. Quest Diagnostics, Inc., the Court “acknowledge[d] that a
defendant-by-defendant choice-of-law analysis is not feasible in every matter,” particularly
“[i]n a complex case with many parties from different states.”  227 N.J. 7, 20 (2016). In such
a scenario, “the trial court retains the discretion to decline a defendant-by-defendant
approach and, utilizing a Restatement §§ 146, 145 and 6 analysis . . . apply the law of a
single state to claims asserted against all defendants.” Ibid. Under the most-significant-
relationship test in personal injury cases, the analysis begins with section 146 and the
presumption that the law of the state where the injury occurred applies. P.V. ex rel. T.V. v.
Camp Jaycee,  197 N.J. 132, 135-36 (2008). That presumption may be overcome if “some
other state has a more significant relationship with the parties and the occurrence based on an
assessment of each state’s contacts” viewed through the prism of section 145, which sets
forth general principles for tort actions, and section 6, which lists overarching choice-of-law
principles. McCarrell v. Hoffmann-La Roche, Inc.,  227 N.J. 569, 590 (2017). (pp. 35-38)

3. In the case of 514 plaintiffs, the injuries caused by the putative failure to give adequate
warnings occurred in forty-four other jurisdictions, but New Jersey is where the alleged
conduct causing the injury occurred -- the manufacturing and labeling of Accutane. Overall,
the section 145 contacts do not point to one ineluctable result. The Court next reviews
section 6 and notes that one reason for joining together so many cases before a single judge
is administrative efficiency. The two most significant Restatement factors in this MCL
matter are section 6 factors f (“certainty, predictability and uniformity of result”) and g
(“ease in the determination and application of the law to be applied”). Applying a single
standard to govern the adequacy of the label warnings in the 532 individual cases will ensure
predictable and uniform results. Each plaintiff can choose to bring suit in the state where he
or she resides and the injury occurred. In this MCL setting, New Jersey has the most
significant relationship to the occurrence and the parties, overcoming the presumption that
the law of the place of injury governs. The Court therefore applies the PLA to the 532 cases.
(pp. 38-46)

4. The PLA defines “an adequate warning or instruction” as “one that a reasonably prudent
person in the same or similar circumstances would have provided . . . , taking into account
the characteristics of, and the ordinary knowledge common to, the prescribing physician.”
 N.J.S.A. 2A:58C-4. The prescribing physician -- as a learned intermediary -- generally is in
the best position to advise the patient of the benefits and risks of a particular drug. Under the
learned intermediary doctrine, a pharmaceutical manufacturer generally discharges its duty to
warn by supplying physicians with information about the drug’s dangerous propensities.
Under  N.J.S.A. 2A:58C-4, a rebuttable presumption of adequacy attaches to a product’s label
warnings approved by the FDA. Ibid. (pp. 46-48)

5. The Court reviews the relevant FDA premarketing and postmarketing regulations
governing prescription drugs. Under federal law, the manufacturer is responsible for the
adequacy of a drug label’s warnings not only when it files a New Drug Application, but also
during the period the drug is on the market after FDA approval. In Wyeth v. Levine, the
United States Supreme Court concluded that state-law failure-to-warn lawsuits against
                                               3
manufacturers provide “a complementary form of drug regulation” in the postmarketing
phase, when the FDA’s monitoring is far from foolproof.  555 U.S. 555, 578-79 (2009).
(pp. 48-54)

6. In Perez v. Wyeth Laboratories, Inc., the Court addressed the role of the federal
regulatory process in relation to the PLA’s presumption of adequacy and held that “absent
deliberate concealment or nondisclosure of after-acquired knowledge of harmful effects,
compliance with FDA standards should be virtually dispositive of [product-liability and
failure-to-warn] claims.”  161 N.J. 1, 25 (1999). Perez was decided twenty years before
Wyeth’s discussion of a manufacturer’s duty to update label warnings in the postmarketing
phase. The Appellate Division in McDarby v. Merck & Co. “note[d] that close scrutiny . . .
commenced only after Perez was decided, and that scrutiny disclosed flaws in the regulatory
system.”  401 N.J. Super. 10, 64 (App. Div. 2008). In light of the limitations of the FDA
postmarketing oversight process, the McDarby court articulated a further basis for
overcoming the presumption of adequacy: a manufacturer’s “economically-driven
manipulation of the post-market regulatory process.” Id. at 63-64. In Cornett v. Johnson &
Johnson,  211 N.J. 362, 388 (2012), the Court recognized that exception. (pp. 54-58)

7. An FDA-approved warning for a drug on the market for many years may grow stale in
light of “newly acquired information” about “a clinically significant hazard” in the use of the
drug by certain consumers. 21 C.F.R. § 201.57(c); 21 C.F.R. § 314.70(c). Prior FDA
approval of a label’s warning is not a license for a manufacturer to withhold updating and
revising that warning in accordance with federal regulations. The PLA provides
manufacturers with the protection of a rebuttable presumption of adequacy of an FDA-
approved label warning.  N.J.S.A. 2A:58C-4. Consistent with Perez and McDarby, and the
federal regulatory scheme, the Court holds that the rebuttable presumption of adequacy
attaching to an FDA-approved drug label is overcome when a plaintiff presents clear and
convincing evidence that a manufacturer knew or should have known, based on newly
acquired information, of a causal association between the use of the drug and “a clinically
significant hazard” and that the manufacturer failed to update the label accordingly. See 21
C.F.R. § 201.57(c); 21 C.F.R. § 314.70(c). The Court adds one caveat. A manufacturer that
acts in a reasonable and timely way to update its label warnings with the FDA, in accordance
with its federal regulatory responsibilities, will receive the protection of the rebuttable
presumption. If not, it cannot seek shelter behind it. The standard articulated in this opinion
is a natural extension of the decisions in Perez and McDarby. Faced with clear and
convincing evidence of a label warning’s inadequacy based on the FDA’s label warning
updating requirements, a responsible drug manufacturer will take action to revise its drug
label warnings. The high standard for overcoming the rebuttable presumption of adequacy of
an FDA-approved label warning represents a balance that protects pharmaceutical companies
that act responsibly and the public that consumes their products. (pp. 59-64)

8. Three pathways are available to overcome the presumption of adequacy that attaches to
the FDA-approved post-April 2002 label warnings for Accutane. The first pathway is if a
plaintiff can establish deliberate concealment or nondisclosure of after-acquired knowledge
of harmful effects. The second is if a plaintiff can demonstrate economically driven
                                                4
manipulation of the postmarket regulatory process. The third is if a plaintiff can prove by
clear and convincing evidence that a manufacturer knew or should have known in the
postmarketing phase that the drug warnings were inadequate based on the label warning
updating requirements in a pertinent federal regulation. Plaintiffs have failed to show any of
those bases for overcoming the presumption of adequacy. In the absence of evidence
sufficient to rebut the presumption, as a matter of law, the warnings adequately conveyed to
medical professionals -- as well as to patients -- that usage of Accutane was associated with a
risk of IBD. Roche used multiple warning tools: the physician label and Best Practices
Guide, intended for physicians, and the Patient Safety Packet, Medication Guide, and blister
packaging, intended for patients. Plaintiffs’ principal criticism is that the physician label and
other warning materials should have used the language “causes” instead of “has been
associated with” to describe the relationship between Accutane and IBD. Plaintiffs,
however, have failed to present clear and convincing evidence that Roche’s use of the word
“associated” to describe the relationship between Accutane and IBD was inadequate. The
isolated examples plaintiffs have exhumed from the volumes of evidence do not support a
showing of deliberate nondisclosure to the FDA, economically driven manipulation of the
regulatory process, or clear and convincing evidence that Roche knew or should have known
of the inadequacy of the warnings in light of the relevant federal regulations. Plaintiffs argue
that Roche had internally concluded that Accutane was causally -- not just possibly -- related
to IBD. However, plaintiffs have failed to establish that Roche had in fact made such a
determination, engaged in deliberate concealment or nondisclosure of such knowledge, or
otherwise knew or should have known under the standard articulated above that the use of
the word “associated” was inadequate. Finally, whatever continuing concerns there may be
about the FDA’s postmarketing oversight capacity, there is no evidence in this record of
shortcomings in the FDA’s oversight of Accutane. (pp. 64-70)

9. The Court reverses the judgment of the Appellate Division in those cases in which it
vacated the grant of summary judgment in favor of Roche and affirms its judgment in those
cases in which it upheld the grant of summary judgment in favor of Roche. As a result, the
532 failure-to-warn cases brought by plaintiffs against Roche are dismissed. (p. 70)

       AFFIRMED in part and REVERSED in part.

CHIEF JUSTICE RABNER and JUSTICES LaVECCHIA, FERNANDEZ-VINA,
SOLOMON, and TIMPONE join in JUSTICE ALBIN’s opinion. JUSTICE
PATTERSON did not participate.




                                               5
                                    SUPREME COURT OF NEW JERSEY
                                   A-26/
27 September Term 2017
                                               079933
IN RE: ACCUTANE LITIGATION



         Argued April 23, 2018 – Decided October 3, 2018

         On certification to the Superior Court,
         Appellate Division.

         Paul W. Schmidt (Covington & Burling) of the
         District of Columbia bar, admitted pro hac vice,
         and Edward J. Dauber (Greenberg Dauber Epstein &
         Tucker) argued the cause for appellants/cross-
         respondents Hoffmann-La Roche Inc. and Roche
         Laboratories Inc. (Gibbons, Dughi Hewit &
         Domalewski, and Covington & Burling, attorneys;
         Natalie H. Mantell, Russell L. Hewit, Paul W.
         Schmidt, and Michael X. Imbroscio (Covington &
         Burling) of the District of Columbia bar,
         admitted pro hac vice, of counsel and on the
         briefs).

         Bruce D. Greenberg and David R. Buchanan
         argued the cause for respondents/cross-appellants
         Angelo Annuzzi, et al. (Lite DePalma Greenberg,
         Seeger Weiss, Weitz & Luxenberg, and Beggs &
         Lane, attorneys; Bruce D. Greenberg, David R.
         Buchanan, Peter Samberg, and Mary Jane Bass
         (Beggs & Lane) of the Florida bar, admitted
         pro hac vice, on the briefs).

         Edward J. Fanning, Jr. argued the cause for
         amicus curiae HealthCare Institute of New
         Jersey (McCarter & English, and Reed Smith,
         attorneys; Edward J. Fanning, Jr., David R.
         Kott, Gary R. Tulp, Daniel K. Winters, and
         Philip W. Danziger, on the brief).

         Adam M. Slater argued the cause for amicus
         curiae New Jersey Association for Justice
         (Mazie Slater Katz & Freeman, attorneys;
         Adam M. Slater, of counsel and on the
         brief).


                               1
     JUSTICE ALBIN delivered the opinion of the Court.

     This appeal arises from 532 product-liability claims filed

against defendants Hoffmann-La Roche Inc. and Roche Laboratories

Inc. (collectively Roche), corporations with their principal

places of business in New Jersey.    Roche developed,

manufactured, marketed, and labeled Accutane, a prescription

medication for the treatment of severe and persistent cases of

acne.   Plaintiffs allege that Accutane, prescribed by their

physicians for the treatment of acne, caused them to contract

inflammatory bowel disease (IBD) and that Roche failed to give

adequate label warnings to advise them of the known risks of the

medication.   Of the 532 plaintiffs, 18 are New Jersey residents

and 514 are residents of 44 other jurisdictions.    Plaintiffs’

claims are designated as Multicounty Litigation (MCL) and

consolidated in the Atlantic County Superior Court, Law

Division, for administrative purposes.

     Two issues are before us.   The first is what law governs

whether Roche’s label warnings were adequate -- the law of each

of the 45 jurisdictions where plaintiffs were prescribed and

took Accutane or the law of New Jersey where the 532 cases are

consolidated for MCL purposes.   The second issue is the adequacy

of the label warnings for the period after April 2002.    Because

Roche’s warnings received the approval of the federal Food and



                                 2
Drug Administration (FDA), those warnings enjoy a “rebuttable

presumption” of adequacy under New Jersey’s Products Liability

Act (PLA).   See  N.J.S.A. 2A:58C-4.   That presumption provides

pharmaceutical companies greater protection in New Jersey than

in many other jurisdictions.

    After conducting a choice-of-law analysis, the trial court

determined that New Jersey’s PLA applies to each of the 532

consolidated cases and then concluded that plaintiffs failed to

overcome the presumption of adequacy that attached to Roche’s

Accutane warnings.    Accordingly, the court granted summary

judgment in favor of Roche.

    The Appellate Division came to a different result.      The

panel held that the law of each jurisdiction where plaintiffs

were prescribed and took Accutane would govern the adequacy of

the label warnings.    After conducting a state-by-state legal

analysis, the panel concluded that summary judgment in favor of

Roche was improvidently granted in all cases except those

governed by the laws of California, Colorado, Indiana, Maryland,

Mississippi, New York, Texas, and Virginia.   In other words,

under New Jersey’s PLA and the laws of thirty-six other

jurisdictions, the panel maintained that a genuine issue of

material fact remained concerning the adequacy of the warnings.

    We now reverse in all those cases in which the Appellate

Division reinstated plaintiffs’ actions against Roche.    Like the


                                  3
trial court and Appellate Division, we apply the Restatement

(Second) of Conflict of Laws (Am. Law Inst. 1971, amended 1988)

(“Restatement”), adopted for personal injury cases in McCarrell

v. Hoffmann-La Roche, Inc.,  227 N.J. 569, 593-94 (2017), and

P.V. ex rel. T.V. v. Camp Jaycee,  197 N.J. 132, 143 (2008).

Unlike the Appellate Division, we hold that New Jersey has the

most significant interests, given the consolidation of the 532

cases for MCL purposes in Atlantic County.   The aggregation of

hundreds of cases under MCL allows the resolution of common

issues of law.   A trial judge cannot be expected to gain a

mastery of the law of forty-five different jurisdictions.

Construing New Jersey’s PLA is challenging enough.   New Jersey’s

interest in consistent, fair, and reliable outcomes cannot be

achieved by applying a diverse quilt of laws to so many cases

that share common issues of fact.

    The PLA’s presumption of adequacy for medication warnings

approved by the FDA gives a reasonable measure of protection to

pharmaceutical companies, which are researching and developing

medications to combat diseases and maladies that afflict people

around the world.   New Jersey also has an interest in ensuring

that its companies are producing safe medications and attaching

warnings that advise the public of their risks and benefits.     On

the record before us, even when viewed in the light most

favorable to plaintiffs, we do not find that Roche withheld from


                                 4
the FDA material information that would have altered the nature

of the warnings or engaged in economically driven manipulation

of the regulatory process.    We also find that plaintiffs did not

present clear and convincing evidence that Roche knew or should

have known that the label warnings were inadequate.    Plaintiffs

therefore have not overcome the statutory presumption of

adequacy.

    Consequently, as a matter of law, the warnings provided

physicians with adequate information to warn their patients of

the risks of IBD.    We therefore reverse in part and affirm in

part the judgment of the Appellate Division and dismiss all

plaintiffs’ complaints.

                                 I.

                                 A.

    In this appeal, we address the adequacy of Roche’s FDA-

approved post-April 10, 2002 warnings for Accutane, the brand

name for isotretinoin, a prescription drug developed and

marketed nationwide by Roche for the treatment of severe cases

of acne.    See Kendall v. Hoffmann-La Roche, Inc.,  209 N.J. 173,

180 (2012).   Plaintiffs are 532 individuals from 45

jurisdictions, including New Jersey, who were prescribed

Accutane by their treating physicians for their acne conditions.

After taking the medication, plaintiffs claim they developed

IBD, which encompasses “a number of chronic, relapsing


                                  5
inflammatory diseases of the gastrointestinal tract.”     See

Tabor’s Cyclopedic Medical Dictionary 1252 (23d ed. 2017)

(“Tabor’s”).

    The two most common forms of IBD are ulcerative colitis and

Crohn’s disease.   The 532 plaintiffs in this case state that

they suffer from ulcerative colitis, “a chronic condition

characterized by ulceration of the colon and rectum,” which

leads to frequent and bloody bowel movements as well as fatigue,

dehydration, anemia, and abdominal pain.     See Kendall,  209 N.J.

at 181.   “The symptoms often wax and wane, but the condition is

regarded as permanent.”   Ibid.

    The heart of this case is plaintiffs’ contention that the

taking of Accutane caused their IBD and that Roche failed to

adequately warn of that risk.     A Long Form Complaint, filed on

behalf of all plaintiffs, alleges that Roche knew or should have

known that taking Accutane “was causally related” to IBD based

on information contained in its adverse event database and the

conclusions drawn by its scientists.    Plaintiffs further allege

Roche “did not adequately inform physicians or consumers of

[Accutane’s] propensity to induce, aggravate or cause IBD.”

Plaintiffs contend that Roche’s failure to provide adequate

warnings is the proximate cause of the “permanent physical and

emotional injuries” they continue to suffer, and therefore they

seek compensatory and punitive damages.


                                  6
       Roche moved for summary judgment, claiming that the

warnings were adequate as a matter of law.1   We start with the

relevant facts from the summary judgment record.

                                 B.

       In 1982, the Food and Drug Administration approved Roche’s

application to market Accutane for the treatment of recalcitrant

nodular acne.   As part of the FDA pre-approval process, Roche

conducted a human clinical study involving 523 patients who took

Accutane.   No reports of IBD arose from that clinical study,

although approximately twenty-two percent of the patients

suffered certain gastrointestinal side effects.    Roche submitted

the study to the FDA.

       When Roche launched Accutane commercially, the label

warnings did not mention IBD.    By 1983, during the postmarketing

phase and while monitoring the safety of Accutane use, Roche

received reports of six to eight patients -- out of a total

population of 300,000 -- who had taken Accutane and developed

IBD.   Those reports prompted Roche to issue label warnings in

1984 to prescribing physicians, generally dermatologists,

stating that Accutane “has been temporally associated with

inflammatory bowel disease (including regional ileitis) in


1  Because defendants moved for summary judgment, we consider the
facts in the light most favorable to the non-moving party,
plaintiffs. Brill v. Guardian Life Ins. Co. of Am.,  142 N.J. 520, 540 (1995).


                                  7
patients without a prior history of intestinal disorders.”

    Roche collected additional data as it continued to monitor

the effects of Accutane on patients.   Between 1985 and 2001,

Roche received at least twenty case reports called “challenge,”

“dechallenge,” and “rechallenge” events.   The reports described

patients who, while taking Accutane, suffered intestinal

disorders, with symptoms such as abdominal cramping and rectal

bleeding (the “challenge” event), which subsided when Accutane

use was discontinued (the “dechallenge” event), but reappeared

when the medication regimen resumed (the “positive rechallenge”

event).   Those reports, many filed by the patients’ treating

physicians, were registered with MedWatch, an FDA-administered

database that compiles adverse events concerning medications

approved by the FDA.

    In February 1999, the FDA asked Roche whether its data

demonstrated the “reversibility” of Accutane-associated IBD.     By

that time, Roche had received information concerning nearly 300

cases that associated Accutane usage with the onset of IBD.     An

internal Roche email explained that approximately two-thirds of

188 patients who stopped using Accutane recovered.   Although

Roche responded to the FDA inquiry by stating that there was

“not sufficient information to recommend additional label

changes related to [IBD],” the FDA nevertheless requested that

Roche remove from its label warning the word “temporally” and


                                 8
add that symptoms of IBD “have been reported to persist after

Accutane treatment has stopped.”       Roche complied.

    By April 10, 2002, Roche had generated a variety of FDA-

approved warning labels and materials for a target audience of

prescribing physicians, pharmacists, and patients.       The

information provided to physicians is of particular importance

because New Jersey has adopted the “learned intermediary”

doctrine, which recognizes that a prescribing doctor has the

primary responsibility of advising the patient of the risks and

benefits of taking a particular medication.       See  N.J.S.A.

2A:58C-4; see also Niemiera v. Schneider,  114 N.J. 550, 565-66

(1989) (“[I]t is the physician’s responsibility to pass on to

the parties the information that enables the patient to use the

product safely.”).

    Presented below are the five key warning tools that were

provided to physicians, pharmacists, and patients.

                                1.

    Roche’s primary means of communicating to healthcare

providers such information as Accutane’s dosages, drug

interactions, commonly occurring side effects, and serious side

effects is through the physician label (also known as a package

insert).   Roche’s approximately twenty-four-page package insert

provided medical professionals with specific IBD warnings.

    Physician Label


                                   9
          WARNINGS:
          . . .
          Inflammatory Bowel Disease: Accutane has been
          associated with inflammatory bowel disease
          (including regional ileitis) in patients
          without   a   prior    history   of intestinal
          disorders. In some instances, symptoms have
          been reported to persist after Accutane
          treatment   has   been    stopped.    Patients
          experiencing abdominal pain, rectal bleeding
          or severe diarrhea should discontinue Accutane
          immediately.       (see    ADVERSE  REACTIONS:
          Gastrointestinal). [2]


Importantly, this warning advises prescribing physicians that

not only has IBD been associated with the taking of Accutane,

but that symptoms of the disease “have been reported to persist

after Accutane treatment has been stopped.”

                               2.

     In addition, Roche provided physicians with a Best

Practices Guide, which, although mostly focused on the risks of

Accutane causing birth defects, also identified IBD as a

specific risk associated with Accutane use.   The Guide advised




2  The physician label also cross-referenced IBD in the ADVERSE
REACTIONS section:

          ADVERSE REACTIONS:    . . . .     The adverse
          reactions listed below reflect the experience
          from investigational studies of Accutane, and
          the    postmarketing    experience.       The
          relationship of some of these events to
          Accutane therapy is unknown.
          . . .
          Gastrointestinal: inflammatory bowel disease
          (see WARNINGS:   Inflammatory Bowel Disease)
          . . . .


                               10
physicians to fully counsel their patients “about the warnings

and precautions in the Accutane package insert.”

     Best Practices Guide

          Accutane   use   is  associated   with   other
          potentially serious adverse events, as well as
          more frequent, but less serious side effects.
          . . . .
          Adverse Event Warnings include . . .
          inflammatory bowel disease . . . .
          . . . .
          Patients should be reminded to read the
          Medication    Guide,   distributed   by    the
          pharmacist at the time Accutane is dispensed.

                                3.

     Roche also prepared a Patient Safety Packet for physicians

to give to their patients that explained in plain language the

risks and possible side effects of taking Accutane.   An attached

Informed Consent Form required the patient to acknowledge in

writing that he or she read and understood the Patient Safety

Packet.   It also required the prescribing doctor to certify that

the “benefits and risks” of Accutane treatment were “fully

explained” to the patient.3

     Patient Safety Packet

          You should be aware that certain SERIOUS SIDE
          EFFECTS have been reported in patients taking
          Accutane. Serious problems do not happen in
          most patients. If you experience any of the
          following side effects or any other unusual or
          severe problems, stop taking Accutane right
          away and call your prescriber because they may

3  Birth defects and psychiatric side effects are specifically
mentioned on the form, but IBD is not.


                                11
         result in permanent effects.
         . . . .
         Abdomen (stomach area) problems.     Certain
         symptoms may mean that your internal organs
         are being damaged. These organs include the
         . . . bowel (intestines). If your organs are
         damaged, they may not get better even after
         you stop taking Accutane.       Stop taking
         Accutane and call your prescriber if you get
         severe stomach or bowel pain, diarrhea, [or]
         rectal bleeding . . . .

                                4.

    Roche also developed, in conjunction with the FDA, a

Medication Guide for pharmacists to distribute to Accutane

patients when they received their prescriptions.   Like the

Patient Safety Packet, the Medication Guide warned of “possible

serious side effects” from Accutane and described IBD symptoms

in simple and plain language.

    Medication Guide

         Accutane has possible serious side effects
         . . . .
         Abdomen (stomach area) problems.       Certain
         symptoms may mean that your internal organs
         are being damaged. These organs include the .
         . . bowel (intestines) . . . . If your organs
         are damaged, they may not get better even
         after you stop taking Accutane. Stop taking
         Accutane and call your prescriber if you get
         severe stomach, chest or bowel pain . . .
         diarrhea, [or] rectal bleeding . . . .
         . . . .
         Serious permanent problems do not happen
         often. However, because the symptoms listed
         above may be signs of serious problems, if you
         get these symptoms, stop taking Accutane and
         call your prescriber.    If not treated, they
         could lead to serious health problems. Even
         if these problems are treated, they may not


                                12
         clear up after you stop taking Accutane.

The Medication Guide makes clear the potential permanency of

harm to the patient’s bowels and intestines by taking Accutane,

indicating to the patient that “[i]f your organs are damaged,

they may not get better even after you stop taking Accutane” and

that symptoms “may not clear up after you stop taking Accutane.”

                                5.

    Last, Roche required pharmacists to dispense Accutane pills

in “blister packaging” that again warned the patient that

Accutane could have serious gastrointestinal side effects.

    Blister Packaging

         Other serious side effects to watch for

         Stop taking Accutane and call your prescriber
         if you develop any of the problems on this
         list or any other unusual or severe problems.
         If not treated, they could lead to serious
         health problems. Serious permanent problems
         do not happen often.
         . . . .
             Severe stomach pain, diarrhea, rectal
              bleeding, or trouble swallowing.
         . . . .
         Other important information is found in the
         Medication Guide and in the booklet from your
         prescriber.

    Accordingly, by 2002, before taking Accutane, patients

received the IBD warnings from their prescribing physicians and

from their pharmacies when they filled their prescriptions.     The

FDA, moreover, reviewed and approved each of Roche’s warning

tools mentioned.   One senior FDA official commented before the


                                13
House Committee on Energy and Commerce that the agency took its

“regulatory responsibilities concerning [Accutane] very

seriously,” as evidenced by its involvement in monitoring

adverse reactions and updating the drug’s warning labels.

Issues Relating to the Safety of Accutane:    Hearing Before the

Subcomm. on Oversight & Investigations of the H. Comm. on Energy

& Commerce, 107th Cong. 27 (2002) (statement of Janet Woodcock,

Director, Center for Drug Evaluation and Research, U.S. Food and

Drug Administration).

     In 2009, Roche discontinued the marketing of Accutane in

the United States.   In 2010, the FDA issued an official Notice,

stating that the “FDA has independently evaluated relevant

literature and data for possible postmarketing adverse events

and has found no information that would indicate that [Accutane]

was withdrawn from sale for reasons of safety or effectiveness.”

 75 Fed. Reg. 39,024, 39,025 (July 7, 2010).

     In 2012, the FDA approved Absorbica, another brand-name

formulation of isotretinoin manufactured by a different company.

Absorbica’s FDA-approved physician label warnings about IBD are

functionally identical to those used by Roche in its post-2002

Accutane physician labels.4




4  The warning for the Absorbica physician label includes, in
pertinent part:



                                14
                                C.

    From the voluminous record in this case, plaintiffs focus

our attention on excerpts from several internal Roche documents

that reference Accutane and the potential risk of IBD as

evidence that Roche should have given better warnings.

Additionally, plaintiffs state that Roche failed to share the

“internal conclusions” in those documents with the FDA.

    One excerpt provided by plaintiffs is from a 1994 internal

Roche document that indicates that colitis is a “possible [s]ide

effect” of taking Accutane.   The document notes that the “reason

for inclusion [of colitis] as a side effect and not as a



         Isotretinoin   has    been   associated   with
         inflammatory    bowel    disease    (including
         regional ileitis) in patients without a prior
         history of intestinal disorders.      In some
         instances, symptoms have been reported to
         persist after isotretinoin treatment has been
         stopped.    Patients experiencing abdominal
         pain, rectal bleeding or severe diarrhea
         should discontinue Absorbica immediately [see
         Adverse Reactions (6.1)]
         . . . .
         Adverse Reactions
         . . . .
         The adverse reactions listed below reflect
         both clinical experience with Absorbica, and
         consider other adverse reactions that are
         known from clinical trials and the post-
         marketing     surveillance       with     oral
         isotretinoin.   The relationship of some of
         these events to isotretinoin therapy is
         unknown.
         . . . .
         Gastrointestinal:   . . . inflammatory bowel
         disease . . . .


                                15
contraindication is probably the fact that the data regarding

occurrence or aggravation of this condition . . . is

contradictory.”5   The document’s author refers to published and

unpublished data about Accutane and IBD-related disorders and

reaches some tentative conclusions:     (1) “Enterocolitis is a

possible side effect of [Accutane] in very rare cases, possibly

in patients predisposed to inflammatory gastro-intestinal

diseases”; (2) “[i]n patients with ileitis, enteritis or colitis

in the active phase of the disease [Accutane] is basically

contraindicated”; and (3) “a careful risk analysis should be

made” before administering Accutane to patients with a “history

of severe gastro-intestinal inflammatory diseases.”

     Another document referenced by plaintiffs is a 1994

memorandum from Dr. H. Lefrancq, a Roche physician, to an

inquirer within Roche concerning “the administration of

[Accutane] in patients with colitis.”    In that memorandum,

Lefrancq mentions information from a safety database, which

disclosed “a total of 33 cases of colitis [that] have been

spontaneously reported up to January 6, 1994, which were rated

as 'possibly’ or 'probably’ related to the administration of

[Accutane].”   Based on the data, Lefrancq believed it was


5  A “side effect” is “[a]n action or effect of a drug other than
that desired.” Tabor’s at 2153. A “contraindication” is “[a]
symptom or circumstance that makes treatment with a drug or
device unsafe or inappropriate.” Id. at 553.


                                16
“reasonable to conclude . . . that, in rare cases, [Accutane]

may induce or aggravate a preexisting colitis.”     Significantly,

however, Lefrancq recommended to the inquirer that he could re-

administer Accutane to his patient when the patient’s ulcerative

colitis reached the “inactive phase.”

    Plaintiffs also highlight less than one page of an 1197-

page report that Roche prepared for European regulatory

authorities in 2000 that describes a particular patient’s case.

In that case, a seventeen-year-old patient developed ulcerative

colitis one month after she stopped taking Accutane.      In the

analysis of that single case, a Roche physician noted that

Accutane “has been found to be causally associated with

inflammatory bowel disease, including colitis.”

    Finally, plaintiffs allude to a debate inside Roche between

the marketing and drug-safety employees about whether to

strengthen warnings about the psychiatric side effects of

Accutane.   IBD was not at issue.    In a general sales

presentation, the marketing department had described Accutane as

“the goose that lays the golden eggs” -- an obvious reference to

Roche’s strong financial interest in the continued success of

Accutane sales.   Despite the discussions, Roche strengthened the

warning, indicating that Accutane use could cause depression.

At an earlier Accutane trial, Roche’s former chief medical

officer testified that the marketing department did not make the


                                17
call over labeling decisions.

                                II.

                                 A.

     In 2005, for administrative purposes, this Court designated

all pending and future New Jersey product-liability actions

involving Accutane as Mass Tort Litigation -- now referred to as

Multicounty Litigation (MCL), see R. 4:38A -- and consolidated

all such actions in Atlantic County.    The law firm Seeger Weiss

LLP, which had requested that the Accutane cases be given the

designation of Mass Tort Litigation, was later appointed

plaintiffs’ liaison counsel.    In making that request, counsel

for Seeger Weiss wrote:   plaintiffs’ “claims share common issues

of law and fact, including whether . . . [Roche] violated the

New Jersey Products Liability Act in its marketing and sale of

Accutane.”

     In 2015, in a series of rulings, the trial court concluded

that the New Jersey PLA governed not only the 18 in-state claims

but also the 514 claims that involved plaintiffs who were

prescribed and took Accutane in 44 other jurisdictions. 6 The



 6  The trial court also conducted a state-by-state analysis as an
alternative ruling. Under that approach, the court granted
summary judgment in favor of Roche to plaintiffs who resided in
thirteen jurisdictions other than New Jersey. In light of our
ultimate disposition, a state-by-state review of the court’s
analysis is unnecessary.



                                 18
court then granted Roche’s motion for summary judgment,

determining that plaintiffs failed to overcome the presumption

of adequacy that attached to the post-2002 Accutane label

warnings approved by the FDA.

     In making its choice-of-law determination, the court

referenced the Seeger Weiss letter in which counsel represented

that the sixty-eight cases then pending in 2005, only two of

which were brought by New Jersey residents, shared a common

issue of law -- whether Roche violated New Jersey’s PLA.     The

court emphasized that nothing in Seeger Weiss’s correspondence

with this Court suggested that the out-of-state plaintiffs

“wish[ed] to bring the law of their states with them to New

Jersey” or that the court would have to engage in a state-by-

state choice-of-law analysis.7   The court did not find it

reasonable for our judiciary to apply the law of scores of

jurisdictions, “many of which express standards incompatible

with the NJPLA,” to thousands of claims involving cutting-edge

issues of science and law.

     The court noted that Accutane filings grew from less than

100 in March 2005 to more than 7500 by February 2015.     More than


7  Pursuant to MCL guidelines, the letter was directed to the
Administrative Director of the Courts. See New Jersey
Multicounty Litigation (Non-Asbestos) Resource Book 2 (4th ed.
Nov. 2014) (“MCL Resource Book”) (explaining that application
for MCL designation is made to Supreme Court “through the
Administrative Director”).


                                 19
4600 Accutane cases remained on the docket when the court

determined that applying each state’s law “is neither practical

. . . nor would it promote 'the values of uniformity and

predictability,’” quoting Camp Jaycee,  197 N.J. at 154.     The

court cited “the inability to assemble 'bellwether’ cases from

multiple jurisdictions which would produce meaningful results”

as another reason for applying the New Jersey PLA.   It also

asserted that applying the conflicting law of another state

would undermine the Legislature’s intent in passing the FDA

presumption-of-adequacy provision of the PLA, which was to

“reduc[e] the burden placed on [New Jersey manufacturers] by

product liability litigation,” quoting Rowe v. Hoffmann-La

Roche, Inc.,  189 N.J. 615, 626 (2007).

    In concluding that the presumption of adequacy governing

Accutane’s FDA-approved warnings had not been overcome, the

court maintained that plaintiffs’ proofs did not establish

either a “deliberate concealment or nondisclosure of after-

acquired knowledge of harmful effects,” citing Perez v. Wyeth

Labs., Inc.,  161 N.J. 1, 25 (1999), and Rowe,  189 N.J. at 626,

or a “manipulation of the post-market regulatory process,”

citing McDarby v. Merck & Co.,  401 N.J. Super. 10, 63 (App. Div.

2008).   In addition, the court concluded that Roche’s label

warnings, in their totality, communicated a “clear, accurate and

unambiguous” message to physicians that Accutane “is associated


                                20
with risk of serious side effects.”   For those reasons, the

court dismissed the 532 product-liability actions brought

against Roche.

                                B.

     The Appellate Division reversed in part and affirmed in

part.   The panel found that the trial court erred in its choice-

of-law analysis by applying New Jersey’s PLA to the 514 cases in

which plaintiffs were prescribed and took Accutane in 44 other

jurisdictions.   The panel rejected the trial court’s position

that the representations made by the attorney seeking mass-tort

designation for the then less than 100 Accutane cases waived the

right of the now thousands of out-of-state plaintiffs to the

customary choice-of-law analysis.    The panel pointed to the

wording of the later-filed Long Form Complaint designated for

MCL cases, which indicates that plaintiffs’ claims are based on

the violation of New Jersey’s PLA or “the analogous law” of the

jurisdictions where Accutane was ingested or prescribed.    In

short, the panel held that counsel did not have the authority to

stipulate the choice of law for thousands of plaintiffs.

     Applying the relevant sections of the Restatement (Second)

of Conflict of Laws, adopted by this Court, the panel concluded

that each individual case had to be judged under the substantive

law of the jurisdictions where each plaintiff was prescribed and

took Accutane -- forty-five jurisdictions in all.    The panel


                                21
dismissed the notion that plaintiffs, by participating in mass-

tort litigation in New Jersey, surrendered their right to an

individual choice-of-law analysis and the application of their

states’ laws.   The panel maintained that although plaintiffs’

claims were consolidated for administrative purposes, each

plaintiff filed a separate complaint.

    The panel considered New Jersey’s PLA to be “sufficiently

different from most, if not all, [of] the other competing

jurisdictions,” and therefore reasoned that a choice-of-law

analysis was required.   The panel observed that, under section

146 of the Restatement, the law of the state where the injury

occurred is presumed to govern unless another state has “a more

significant relationship” to the litigation in light of the

principles enunciated in sections 145 and 6 of the Restatement.

The panel ruled that this State did not have a more significant

relationship to the litigation than those jurisdictions where

the “injury” occurred.   In the panel’s view, New Jersey’s PLA

gives greater protection to pharmaceutical companies than

analogous laws in other jurisdictions and therefore application

of our State’s law “might frustrate the other states’ policies

in deterring a broader scope of inadequate warnings” and be

inconsistent with the reasonable expectations of the parties.

The panel “reject[ed] the argument that simplification of

procedures and uniformity of results should govern the choice-


                                22
of-law questions presented.”   According to the panel,

“[i]nterests of judicial administration should not be accorded

undue weight,” and the demand for “efficient results” should not

yield to the strong state interests of other jurisdictions.     The

panel concluded that the law in each of the forty-five

jurisdictions where plaintiffs resided and ingested Accutane

would apply to their cases.

    The panel affirmed the grant of summary judgment in favor

of Roche in those cases involving plaintiffs who were prescribed

and took Accutane in California, Colorado, Indiana, Maryland,

Mississippi, New York, and Virginia because “[i]t is enough in

these jurisdictions that IBD was referenced” in Roche’s label

warnings to render them adequate as a matter of law.     The panel

also affirmed the grant of summary judgment in those cases

involving the Texas plaintiffs because they had not overcome

that jurisdiction’s presumption of adequacy.   The panel,

however, found that the trial court improvidently granted

summary judgment in favor of Roche in the cases of those

plaintiffs from the remaining thirty-seven jurisdictions because

“the adequacy of the warnings could not be resolved as a matter

of law.”

    Under New Jersey’s PLA, the panel held that plaintiffs had

presented sufficient evidence to overcome the presumption of

adequacy attached to Accutane’s FDA-approved warnings and


                                23
therefore genuine issues of material fact needed to be resolved

by a jury.   In particular, the panel stated that, based on Perez

and McDarby, the summary judgment record rebutted the

presumption of adequacy because Roche not only failed to

disclose to the FDA “after-acquired knowledge of Accutane’s

harmful effects,” but also engaged in an “economically-driven

manipulation of the post-market regulatory process.”    The panel

specifically determined that a factfinder could conclude that,

after FDA approval, Roche did not disclose critical information

in its post-2002 warnings -- that Roche “had internally

concluded there was a causative effect” between Accutane and

IBD.

       The panel also disagreed with the trial court’s assertion

that, even if the presumption of adequacy had been overcome, the

label warnings were “clear enough to negate a trial on the

issue.”

                                 C.

       We granted Roche’s petition for certification,  231 N.J. 419

(2017), and plaintiffs’ cross-petition,  231 N.J. 428 (2017).       We

also granted the motion of the New Jersey Association for

Justice to participate as amicus curiae.    The HealthCare

Institute of New Jersey, which participated as amicus curiae

before the Appellate Division, was allowed to appear in that

role before this Court pursuant to Rule 1:13-9(d).


                                 24
                                III.

                                 A.

                                 1.

    Roche argues that the Appellate Division erred in failing

to apply the New Jersey PLA to the 514 claims of out-of-state

plaintiffs.   Roche submits that a proper choice-of-law analysis

requires this Court to recognize New Jersey’s strong interest --

expressed through the PLA’s presumption of adequacy -- in

protecting this State’s pharmaceutical companies from

unmeritorious product-liability litigation from out-of-state

residents.    Roche also claims that the effective administration

of justice through the consolidation of many claims in a single

county under MCL calls for the application of this State’s PLA

to adequacy challenges brought by non-New Jersey plaintiffs.       On

that point, Roche emphasizes that plaintiffs sought MCL

designation on the basis that they shared a common issue of law

-- whether Roche violated the PLA.

    The interests in applying New Jersey law, Roche contends,

are not outweighed by plaintiffs’ home-state interests.

According to Roche, “a large number of states lack a clear

standard for determining precisely when pharmaceutical warnings

are adequate as a matter of law” and “nearly all other states

lack a clearly-defined presumption of adequacy like New

Jersey’s.”    Roche further contends that the application of the


                                  25 PLA to all 532 claims will promote “certainty, predictability

and uniformity of result,” quoting Restatement § 6(2)(f).     In

sum, Roche urges this Court to find, in analyzing the

Restatement factors, that New Jersey, where Accutane was

labeled, “has the most significant relationship to the adequacy

issue” in this appeal.

    Roche submits that the Appellate Division mistakenly

determined that non-dismissed plaintiffs had overcome the

presumption of adequacy attached to Accutane’s FDA-approved

warnings.   It claims that “the FDA helped formulate, repeatedly

reviewed, and consistently approved Accutane’s safety

communication tools,” which “repeatedly and directly addressed

the risk” of IBD.   Roche asserts that there is no evidence that

it concealed evidence from the FDA or engaged in “intentional

post-market manipulation of the FDA for economic reasons.”

Roche claims that plaintiffs “plucked isolated statements from

[its] internal documents” and wrongly accused Roche of

intentionally concealing them, even though the information in

those statements was known to the FDA through its submissions.

    Roche also states that “the overwhelming scientific record

now demonstrably fails to show any connection” between Accutane

and IBD, further validating the accuracy of its label warnings,

which it insists clearly and unambiguously warned physicians and




                                26
patients of the risk of IBD.8

                                 2.

     Amicus curiae the HealthCare Institute of New Jersey echoes

many of the arguments advanced by Roche.    It asserts that the

fallout from the Appellate Division’s decision is “that

potentially hundreds of juries [will] separately determine

whether Accutane’s FDA-approved IBD warnings are adequate,

presenting the risk of divergent outcomes regarding the same

warnings.”    It also posits that the panel’s decision undermines

the effectiveness of the PLA’s presumption of adequacy and will

burden pharmaceutical companies with unmeritorious lawsuits that

will threaten “the development of prescription medical devices

and drugs.”

                                 B.

                                 1.

     Plaintiffs urge this Court to uphold the Appellate

Division’s choice-of-law determination, which requires the

application of the law of the jurisdiction where each plaintiff

was prescribed and took Accutane.     Plaintiffs agree with the

panel that the trial court erred in deciding to apply New Jersey




8  In response to plaintiffs’ cross-petition, Roche maintains
that the Appellate Division correctly found that its warnings
were adequate under the laws of eight states and that summary
judgment was properly entered in its favor in the cases of those
plaintiffs from those states.


                                 27
law based on the 2005 letter written by the attorney -- later

selected as liaison counsel -- as support for consolidating the

Accutane cases into an MCL matter.    Plaintiffs point to the Long

Form Complaint in which plaintiffs expressly invoked the

analogous law of the states where plaintiffs were prescribed and

took Accutane.    Those states’ laws are implicated, plaintiffs

contend, because “Roche deliberately marketed and sold

[Accutane] in those jurisdictions.”    Plaintiffs maintain that an

analysis under the guiding principles of the Restatement favors

applying the law of the jurisdictions where Accutane was

prescribed and taken because those states have strong interests

in regulating commerce within their borders.    In plaintiffs’

view, New Jersey’s interest in effective judicial administration

should yield to the interests of interstate comity.     Plaintiffs

submit that, under each of those states’ laws, summary judgment

should have been denied because of the abundant evidence of the

inadequacies of Roche’s 2002 label warnings.

    Plaintiffs also maintain that the “Appellate Division

correctly determined that a reasonable jury could find that

substantial evidence overcomes [the PLA’s] rebuttable

presumption of adequacy” that attaches to Roche’s FDA-approved

label warnings.    They further claim that the evidence supports a

finding of inadequacy under the laws of all the jurisdictions at

issue.   Plaintiffs assert that they have presented


                                 28
“[substantial] evidence of Roche’s non-disclosure of critical

safety information and its economic motivation to thwart the

regulatory process,” both bases for overcoming the presumption

of adequacy of Roche’s label warnings.   Plaintiffs charge Roche

with withholding documents from the FDA that would have revealed

“that Roche had internally determined that there was a causal

link between Accutane and IBD/[ulcerative colitis].”    According

to plaintiffs, “[d]espite internal admissions that Accutane

'induces,’ 'may cause,’ and is 'causally associated with’ IBD,

Roche did not disclose this knowledge to physicians in its

warnings.”

    Plaintiffs insist that our jurisprudence does not

“establish[] a nearly irrebuttable presumption that exculpates

pharmaceutical manufacturers from failure-to-warn liability.”

Plaintiffs conclude we should affirm the Appellate Division,

which denied summary judgment in the cases of those plaintiffs

bound by the laws of thirty-seven jurisdictions, including New

Jersey, and reverse its grant of summary judgment in the cases

of those plaintiffs bound by the laws of eight other

jurisdictions.

                               2.

    Amicus curiae the New Jersey Association for Justice lends

support to the arguments made by plaintiffs.   It suggests the

“typical rebuttable presumption” of adequacy afforded to label


                               29
warnings was heightened in Perez based on an incomplete

understanding of the role the FDA plays in regulating and

approving label warnings after a prescription drug has been

marketed.   The Association submits that Perez’s declaration that

“compliance with FDA standards should be virtually dispositive”

of failure-to-warn claims does not account for the reality that

the FDA -- particularly in the postmarketing phase of a

prescription drug -- does not have “the financial,

technological, and human capital resources to fulfill its

mission.”

                                IV.

                                A.

    We first address the choice-of-law issue.    We must decide

which law or laws govern the 532 cases before us -- New Jersey’s

PLA or the failure-to-warn laws of each of the forty-five

jurisdictions where individual plaintiffs were prescribed and

took Accutane.

    The decisions of the trial court and Appellate Division

offer starkly different choice-of-law options.   The trial court

ruled that New Jersey’s PLA applies to all 532 cases.   The

Appellate Division reversed and determined that the law of the

jurisdiction where each plaintiff was prescribed and took

Accutane -- in all, forty-five jurisdictions -- governs each

action.   We review those choice-of-law decisions de novo, owing


                                30
no deference to the legal conclusions reached by either court,

unless persuaded by their reasoning.   McCarrell,  227 N.J. at
 583-84.

                                B.

     We apply New Jersey’s choice-of-law rules in determining

whether this State’s or another state’s law governs the action.

Id. at 583.   In doing so, the first inquiry “is whether the laws

of the states with interests in the litigation are in conflict.”

Id. at 584.   If there is not “an actual conflict” in “the

substance of the potentially applicable laws” of the two

jurisdictions, then “there is no choice-of-law issue to be

resolved,” Camp Jaycee,  197 N.J. at 143, and the forum state

applies its own law, McCarrell,  227 N.J. at 584.   A conflict of

law arises when the application of one or another state’s law

may alter the outcome of the case, see id. at 584, or when the

law of one interested state is “offensive or repugnant” to the

public policy of the other, see Continental Ins. Co. v.

Honeywell Int’l, Inc.,  234 N.J. 23, 46 (2018) (quoting DeMarco

v. Stoddard,  223 N.J. 363, 383 (2015)).

     Here, we must compare New Jersey’s PLA with the product-

liability laws or analogues of forty-four other jurisdictions.9


9  Alabama, Arkansas, California, Colorado, Connecticut,
Delaware, the District of Columbia, Florida, Georgia, Iowa,
Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maine,
Maryland, Massachusetts, Minnesota, Mississippi, Missouri,


                                31
New Jersey’s rebuttable presumption of adequacy, which

specifically attaches to FDA-approved warnings, sets our law

apart from most other states’ laws.   Texas also has a

presumption of adequacy for FDA-approved warnings, but its

presumption is evidently more difficult to overcome than New

Jersey’s presumption.10   Indiana, Kansas, North Dakota, Oklahoma,

Oregon, Tennessee, Utah, and Wisconsin have a general rebuttable

presumption that applies to all product warnings, which can be

overcome either by a mere preponderance of the evidence or by

sufficient evidence.11



Montana, Nebraska, Nevada, New Hampshire, New York, North
Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode
Island, South Carolina, South Dakota, Tennessee, Texas, Utah,
Vermont, Virginia, Washington, Wisconsin, and Wyoming.

10 Plaintiffs can overcome the presumption of adequacy in Texas
by showing that a defendant “withheld from or misrepresented to”
the FDA mandatory material information that was “relevant to the
performance of the product” and “causally related to the
claimant’s injury.” See Tex. Civ. Prac. & Rem. Code Ann.
§ 82.007(b)(1). However, unlike New Jersey, Texas does not
apparently recognize “economically-driven manipulation of the
post-market regulatory process,” see McDarby,  401 N.J. Super. at 63, or clear and convincing evidence that a manufacturer knew or
should have known in the postmarketing phase that the drug
warning was inadequate, see infra Section V, as sufficient bases
for overcoming the presumption of adequacy.

11 Indiana (Ind. Code § 34-20-5-1; Cansler v. Mills,  765 N.E.2d 698, 705 (Ind. Ct. App. 2002), disapproved of on other grounds
by Schultz v. Ford Motor Co.,  857 N.E.2d 977 (Ind. 2006));
Kansas (Kan. Stat. Ann. § 60-3304(a)); North Dakota (N.D. Cent.
Code § 28-01.3-09); Oklahoma (Okla. Stat. tit. 76, § 57.2);
Oregon (Or. Rev. Stat. § 30.900, .910; Chong v. STL Int’l, Inc.,
 152 F. Supp. 3d 1305, 1317 (D. Or. 2016)); Tennessee (Tenn. Code
Ann. § 29-28-104; Goins v. Clorox Co.,  926 F.2d 559, 562 (6th


                                 32
     The laws of the remaining jurisdictions do not protect a

product’s warnings with a presumption of adequacy. 12 Cir. 1991)); Utah (Utah Code Ann. § 78B-6-703(2); Egbert v.
Nissan N. Am., Inc.,  156 P.3d 1058, 1062 (2007)); Wisconsin
(Wis. Stat. §§ 895.047(3)(b), 903.01).

12 Arkansas (Ark. Code Ann. § 16-116-204, -205(a)); Connecticut
(Conn. Gen. Stat. § 52-572q); Delaware (Lacy v. G.D. Searle &
Co.,  567 A.2d 398, 400 (Del. 1989)); the District of Columbia
(Payne v. Soft Sheen Prods., Inc.,  486 A.2d 712, 723 (D.C.
1985)); Florida (Thomas v. Bombardier Recreational Prods., Inc.,
 682 F. Supp. 2d 1297, 1300 (M.D. Fla. 2010)); Georgia
(Weilbrenner v. Teva Pharm. USA, Inc.,  696 F. Supp. 2d 1329,
1339 (M.D. Ga. 2010)); Idaho (Sliman v. Aluminum Co. of Am.,  731 P.2d 1267, 1272 (Idaho 1986)); Illinois (Hernandez v. Schering
Corp.,  958 N.E.2d 447, 455 (Ill. App. Ct. 2011)); Iowa
(Nationwide Agribus. Ins. Co. v. SMA Elevator Constr., Inc.,  816 F. Supp. 2d 631, 654 (N.D. Iowa 2011)); Kentucky (Larkin v.
Pfizer, Inc.,  153 S.W.3d 758, 764-65 (Ky. 2004)); Maine (Doe v.
Solvay Pharm., Inc.,  350 F. Supp. 2d 257, 272-74 (D. Me. 2004));
Massachusetts (MacDonald v. Ortho Pharm. Corp.,  475 N.E.2d 65,
70-71 (Mass. 1985)); Minnesota (Delude v. Johnson & Johnson,  726 F. Supp. 2d 1025, 1034 (D. Minn. 2010)); Missouri (Doe v. Alpha
Therapeutic Corp.,  3 S.W.3d 404, 419 (Mo. Ct. App. 1999));
Montana (Hill v. Squibb & Sons, E.R.,  592 P.2d 1383, 1387-88
(Mont. 1979)); Nebraska (Freeman v. Hoffmann-La Roche, Inc.,  618 N.W.2d 827, 841-42 (Neb. 2000)); Nevada (Allison v. Merck & Co.,
 878 P.2d 948, 960-61 (Nev. 1994)); New Hampshire (Brochu v.
Ortho Pharm. Corp.,  642 F.2d 652, 657-58 (1st Cir. 1981)); Ohio
(Seley v. G.D. Searle & Co.,  423 N.E.2d 831, 836-37 (Ohio
1981)); Pennsylvania (Rowland v. Novartis Pharm. Corp.,  34 F.
Supp. 3d 556, 571-72 (W.D. Pa. 2014)); Puerto Rico (Guevara v.
Dorsey Labs., Div. of Sandoz, Inc.,  845 F.2d 364, 367 (1st Cir.
1988)); Rhode Island (Castrignano v. E.R. Squibb & Sons, Inc.,
 546 A.2d 775, 782-83 (R.I. 1988)); South Carolina (Allen v. Long
Mfg. N.C., Inc.,  505 S.E.2d 354, 357-58 (S.C. Ct. App. 1998));
South Dakota (McElhaney v. Eli Lilly & Co.,  575 F. Supp. 228,
231-32 (D.S.D. 1983)); Vermont (Town of Bridport v. Sterling
Clark Lurton Corp.,  693 A.2d 701, 705-06 (Vt. 1997)); Washington
(Laisure-Radke v. PAR Pharm., Inc.,  426 F. Supp. 2d 1163, 1172
(W.D. Wash. 2006)); and Wyoming (Thom v. Bristol-Myers Squibb
Co.,  353 F.3d 848, 853-55 (10th Cir. 2003)).



                               33
Nevertheless, in Alabama, California, Colorado, Indiana,

Maryland, Louisiana, Mississippi, New York, and Virginia, a drug

warning is adequate as a matter of law if it provides clear and

specific information about a potential risk, such as IBD.13      New

Jersey’s presumption of adequacy for FDA-approved label warnings

seemingly gives greater protection to pharmaceutical companies

than the laws of other states, but not necessarily so.     The

Appellate Division granted summary judgment in favor of Roche in

the cases of plaintiffs governed by the laws of eight states but

denied summary judgment in the cases of those plaintiffs

governed by New Jersey’s PLA and the laws of the thirty-six

remaining jurisdictions.

     Discerning the precise meaning of the laws of forty-four

jurisdictions -- other than New Jersey’s -- is an arduous and

burdensome task.   Our treatment of those laws here is far from


13 See Louisiana (Stahl v. Novartis Pharm. Corp.,  283 F.3d 254,
267 (5th Cir. 2002)); Virginia (Ball v. Takeda Pharm. Am., Inc.,
 963 F. Supp. 2d 497, 504 (E.D. Va. 2013)); Indiana (Tucker v.
SmithKline Beecham Corp.,  701 F. Supp. 2d 1040, 1066 (S.D. Ind.
2010)); Colorado (Caveny v. Ciba-Geigy Corp.,  818 F. Supp. 1404, 1406 (D. Colo. 1992)); Alabama (Morguson v. 3M Co.,  857 So. 2d 796, 801-02 (Ala. 2003)); California (Brown v. Superior Court,
 751 P.2d 470, 477 (Cal. 1988)); Maryland (Nolan v. Dillon,  276 A.2d 36, 40-41 (Md. 1971)); Mississippi (Wyeth Labs., Inc. v.
Fortenberry,  530 So. 2d 688, 691 (Miss. 1988)); New York (Martin
v. Hacker,  628 N.E.2d 1308, 1312 (N.Y. 1993)).

     We disagree with the Appellate Division’s opinion that “it
is enough in [Colorado, Indiana, Maryland, Mississippi, New
York, and Virginia] that IBD was referenced” in Roche’s label
warnings to render them adequate.


                                34
comprehensive or definitive.   We proceed under the assumption

that the application of New Jersey’s PLA may lead to an outcome

different from the application of the laws of those other

jurisdictions.   Recognizing that the substantive laws of New

Jersey and the other jurisdictions are in conflict requires that

we choose the law or laws that govern the 532 cases before us.

     In Camp Jaycee, we adopted the Restatement’s most-

significant-relationship test set forth in sections 146, 145,

and 6 as the paradigm for deciding which state’s substantive law

applies in personal injury cases involving more than one state.

 197 N.J. at 142-43.   The Restatement’s most-significant-

relationship test embodies all the elements of this Court’s

former governmental-interest test and adds “a series of other

factors deemed worthy of consideration.”   Id. at 142 n.4.14    That

more nuanced approach is the one we apply here.

     In Camp Jaycee, the plaintiffs -- parents of a young woman

with mental disabilities from New Jersey -- brought suit in our

Superior Court, Law Division, against a New Jersey not-for-

profit corporation operating a summer program in which the

parents had enrolled their daughter.   Id. at 136-37.   While




14 Under the governmental-interest test, a court must “identify
the governmental policies underlying the law of each state and
how those policies are affected by each state’s contacts to the
litigation and to the parties.” Veazey v. Doremus,  103 N.J. 244, 248 (1986).


                                35
under the defendant’s care at a Pennsylvania summer camp, the

plaintiffs’ daughter was sexually assaulted by another camper.

Ibid.   The parents alleged that the defendant was negligent in

its supervision of their daughter.     Id. at 137.   The defendant

was shielded from tort liability under New Jersey’s Charitable

Immunity Act, but not under Pennsylvania law, which had

expressly abolished the doctrine of charitable immunity.      Id. at

135, 143-44.   The case thus presented a true conflict of

substantive law.    Id. at 143-44.    In applying the Restatement

principles, we affirmed the Appellate Division’s determination

to apply Pennsylvania’s law.    Id. at 155-56.    We held that a

weighing of all relevant factors did not overcome section 146’s

presumption that the law of the place of injury applied.      Id. at

156.    We found that Pennsylvania, which has a specific policy of

encouraging the exercise of due care by those residing within

its borders and assuring that those who suffer injuries from the

negligent acts of others receive compensation, had a more

significant relationship to the case.      Id. at 155-56.

       Unlike Camp Jaycee, where the only question was whether the

law of New Jersey or Pennsylvania governed in a single personal

injury action, in this MCL setting, New Jersey’s PLA intersects

with the laws of 44 other jurisdictions in 514 cases.       The case

before us, therefore, presents challenges not posed in Camp

Jaycee.


                                 36
     In Ginsberg v. Quest Diagnostics, Inc., “[w]e

acknowledge[d] that a defendant-by-defendant choice-of-law

analysis is not feasible in every matter,” particularly “[i]n a

complex case with many parties from different states.”      227 N.J.
 7, 20 (2016).    In such a scenario, “the trial court retains the

discretion to decline a defendant-by-defendant approach and,

utilizing a Restatement §§ 146, 145 and 6 analysis . . . apply

the law of a single state to claims asserted against all

defendants.”    Ibid.15   It also bears mentioning that, among

academic experts in the field of conflict of laws, there is a

“consensus, at least, that ordinary choice-of-law practices

should yield in suits consolidating large numbers of claims and

that courts should apply a single law in such cases” -- but

there are dissenting voices.     See Larry Kramer, Choice of Law in

Complex Litigation, 
71 N.Y.U. L. Rev. 547, 547 (1996).16


15 See In re Bendectin Litig.,  857 F.2d 290, 293-95, 304-05 (6th
Cir. 1988) (applying single body of substantive law to
nationwide product-liability litigation); In re “Agent Orange”
Prod. Liab. Litig.,  580 F. Supp. 690, 693, 700-06 (E.D.N.Y.
1984) (“[I]t is concluded that under the special circumstances
of this litigation, all the transferor states would look to the
same substantive law for the rule of decision on the critical
substantive issues.”).

 16 In 1993, the American Law Institute (ALI) submitted to
Congress for enactment a proposed choice-of-law rule for “mass-
tort” actions transferred to federal court. American Law
Institute, Complex Litigation Project, Proposed Final Draft (May
13, 1993). The proposed rule listed a number of factors that a
court should consider “with the objective of applying, to the
extent feasible, a single state’s law to all similar tort claims


                                   37
     With those principles and concerns as background, we turn

to the Restatement sections that apply the most-significant-

relationship test in personal injury cases.    Under that test,

the analysis begins with section 146 and the presumption that

the law of the state where the injury occurred applies.     Camp

Jaycee,  197 N.J. at 135-36.   That presumption may be overcome if

“some other state has a more significant relationship with the

parties and the occurrence based on an assessment of each

state’s contacts” viewed through the prism of section 145, which

sets forth general principles for tort actions, and section 6,

which lists overarching choice-of-law principles.    McCarrell,

 227 N.J. at 590.

     Section 146 provides:

          In an action for a personal injury, the local
          law of the state where the injury occurred
          determines the rights and liabilities of the
          parties,   unless,   with  respect   to   the
          particular issue, some other state has a more
          significant relationship under the principles
          stated in § 6 to the occurrence and the
          parties, in which event the local law of the
          other state will be applied.

          [Restatement § 146.]

     Because Roche marketed Accutane nationwide, it is not

surprising that plaintiffs hail from forty-four jurisdictions

other than New Jersey.   The place of injury for the 532



being asserted against a defendant.”   Id. at § 6.01(a).   The
proposed rule was not enacted.


                                 38
plaintiffs whose cases are before us is where their physicians

prescribed Accutane, where they took the medication, and where

they developed IBD.    Typically, all three events occurred in the

same jurisdiction, but not necessarily.    Thus, the place of

injury may not be so easily identified.

    In the case of 514 plaintiffs, the place of injury is a

jurisdiction other than New Jersey.    Therefore, we must

determine whether New Jersey has a more significant relationship

“to the occurrence and the parties,” first looking to section

145, the general principles for tort actions, and then to

section 6, the universal guiding principles for choice-of-law

issues.   Camp Jaycee,  197 N.J. at 140-41.

    Under Restatement section 145, the contacts weighed in

making that assessment include:

           (a)   the place where the injury occurred,

           (b) the place where the conduct causing the
           injury occurred,

           (c) the domicil[e], residence, nationality,
           place of incorporation and place of business
           of the parties, and

           (d) the place where the relationship, if any,
           between the parties is centered. [Restatement
           § 145.]

    “These contacts are to be evaluated according to their

relative importance with respect to the particular issue.”

Ibid.   A weighing of those contacts yields mixed results.   The

injuries caused by the putative failure to give adequate


                                  39
warnings occurred in forty-four other jurisdictions, but New

Jersey is “where the [alleged] conduct causing the injury

occurred” -- the manufacturing and labeling of Accutane.       See

ibid.   “When both conduct and injury occur in a single

jurisdiction, with only 'rare exceptions, the local law of the

state where conduct and injury occurred will be applied’ to

determine an actor’s liability.”      Fu v. Fu,  160 N.J. 108, 125-26

(1999) (quoting Restatement § 145 cmt. d).      The logic is that “a

state has an obvious interest in regulating the conduct of

persons within its territory and in providing redress for

injuries that occurred there.”     Id. at 126 (quoting Restatement

§ 145 cmt. d).   Thus, in Camp Jaycee the conduct (the failure of

the defendant to act with due care) and the injury (the sexual

assault of the plaintiff) both occurred in Pennsylvania, the

jurisdiction whose law we applied in that case.      197 N.J. at
 136.    Unlike Camp Jaycee, in 514 cases, we do not have the

convergence in one jurisdiction of both the conduct causing the

injury and the occurrence of the injury.

       In this case, moreover, 514 plaintiffs are residents of 44

other jurisdictions, and Roche is a corporation that has its

principal place of business in New Jersey.      That indicates a

rather diffuse interest among the states.      Although the

relationship between the parties is not centered in one place,

Roche marketed Accutane in the jurisdictions where plaintiffs


                                 40
resided.   Had plaintiffs brought their actions in the states

where they were prescribed and took Accutane, those state courts

presumably would have applied the law of their jurisdictions

because each state has a strong interest in ensuring that safe

products are marketed within its borders.     See, e.g., McLennan

v. Am. Eurocopter Corp.,  245 F.3d 403, 426 (5th Cir. 2001)

(“Texas has a strong interest in enforcing its products

liability laws against manufacturers operating in the State.”);

Fed. Ins. Co. v. J.K. Mfg. Co.,  933 F. Supp. 2d 1065, 1077 (N.D.

Ill. 2013) (“Indiana has an interest in ensuring that safe

products are used within its borders.”).     Overall, the section

145 contacts do not point to one ineluctable result.

    We next review the overarching principles of section 6 to

guide us in deciding whether New Jersey “has a more significant

relationship . . . to the occurrence and the parties.”

Restatement § 146.    Section 6 prescribes that

           the factors relevant to the choice of the
           applicable rule of law include

           (a) the    needs   of  the    interstate    and
           international systems,

           (b)   the relevant policies of the forum,

           (c) the relevant policies of other interested
           states and the relative interests of those
           states in the determination of the particular
           issue,

           (d) the       protection     of        justified
           expectations,



                                 41
           (e) the    basic   policies   underlying   the
           particular field of law,

           (f) certainty, predictability and uniformity
           of result, and

           (g) ease in the determination and application
           of the law to be applied.

           [Restatement § 6(2).]

    Our interstate system recognizes that the forum state

should not apply its choice-of-law principles in a way that

discriminates against out-of-state residents.    That is the

essence of comity.    The tort systems of all the jurisdictions

involved share the same general goals -- ensuring that

pharmaceutical companies market drugs that are reasonably safe

for consumption by the public and that the drugs’ label warnings

adequately inform the physicians who prescribe the medications

and the patients who use them of the medications’ potential

benefits and risks.   Each jurisdiction regulates, in some way, a

pharmaceutical company’s responsibility for the accuracy of its

label warnings in the initial marketing and postmarketing phases

of a drug.   The differences in each jurisdiction’s law are

sometimes subtle, and the precise meaning of another

jurisdiction’s law is many times far from self-evident.     In some

instances, we have difficulty construing our own State’s laws,

particularly when legislation is written in broad terms and

legislative history gives little guidance for the interpretive

process.   Our discussion of New Jersey’s PLA later in this


                                   42
opinion illustrates the challenges of applying a broadly worded

statute to specific circumstances.

    The parties’ expectations “ordinarily play[] little or no

part in a choice-of-law question in the field of torts.”     Fu,

 160 N.J. at 123 (citing Restatement § 145 cmt. b).     Nonetheless,

to the extent that the parties’ expectations are relevant, is it

realistic that plaintiffs should expect to carry with them the

forty-four different laws of their home states or the state

where their injuries occurred when their cases are consolidated

for administrative purposes under the umbrella of MCL -- a

designation intended to make more manageable the processing of

hundreds and sometimes thousands of cases?     One of the reasons

for joining together so many cases before a single judge is to

gain the benefits of administrative efficiency.

    Under Rule 4:38A, “[t]he Supreme Court may designate a case

or category of cases as [MCL] to receive centralized management

in accordance with [promulgated] criteria and procedures.”     MCL

is a grouping of “mass tort” cases that typically involve

substantial numbers of claims associated with a single product,

a mass disaster, or a complex environmental event.     MCL Resource

Book 1.   One of the criteria for MCL status is whether the cases

“involve[] many claims with common, recurrent issues of law and

fact.”    Id. at 4.   Other criteria include “whether centralized

management is fair and convenient to the parties, witnesses and


                                  43
counsel” and “whether the cases require specialized expertise

and case processing.”    Id. at 4-5.17

       The two most significant Restatement factors in this MCL

matter are section 6 factors f (“certainty, predictability and

uniformity of result”) and g (“ease in the determination and

application of the law to be applied”).   Applying a single

standard to govern the adequacy of the label warnings in the 532

individual cases will ensure predictable and uniform results --

rather than disparate outcomes among similarly situated

plaintiffs, who took the same medications and were presumably

advised by their physicians of the same risks and benefits based

on the label warnings.    Removed from the equation will be the

fortuity of the place where individual plaintiffs reside and

where the injury occurred.    Of course, each plaintiff controls

his or her fate.    Plaintiffs can choose to bring suit in the

state where they reside and the injury occurred and probably

enjoy the benefit -- if it is a benefit -- of their own state

law.   See Bristol-Myers Squibb Co. v. Superior Court, ___ U.S.




17 Either an Assignment Judge or an interested attorney may
apply to this Court to have the case(s) classified as MCL. Id.
at 2. If the Court classifies a case as MCL, it is assigned to
a particular judge. Id. at 4. Currently, the nearly-twenty
active MCLs in New Jersey are assigned to courts in three
designated counties: Atlantic, Bergen, and Middlesex. New
Jersey Courts, Multicounty Litigation -- Frequently Asked
Questions, https://www.njcourts.gov/attorneys/mcl/mclfaq.html
(last visited Aug. 17, 2018).


                                 44
___, ___,  137 S. Ct. 1773, 1783 (2017).

      There can be no question that administrative ease and

efficiency favor the application of New Jersey’s PLA.       A single

judge presiding over highly complex Multicounty Litigation

cannot be expected to gain a mastery of the laws of forty-five

jurisdictions.   That is a wholly unworkable scheme.    It would

lead to more errors and more appeals, and therefore greater

delays in resolving cases -- cases that would languish in our

court system for many years.

      In the long run, applying New Jersey’s PLA in such

circumstances as here is not an approach that advantages one

side or the other.    In this case, plaintiffs apparently believe

that New Jersey law is not as beneficial to their cause as the

laws of other jurisdictions.    However, as viewed by the

Appellate Division, the Roche warnings are adequate under the

laws of eight other jurisdictions.    Today, plaintiffs complain

about the application of New Jersey law in this MCL case.

Tomorrow, in another such case, defendants may be the

disappointed party.    Interestingly, in McCarrell, the out-of-

state plaintiff clamored for the application of New Jersey’s

statute of limitations whereas Roche angled for the application

of the law of the plaintiff’s home state.    See  227 N.J. at 582-

83.   In Rowe, the plaintiff did not want Michigan’s law to

govern because Michigan had an irrebuttable presumption of


                                 45
adequacy for FDA-approved label warnings.    189 N.J. at 618.

    It is understandable that the parties want to apply the law

of the jurisdiction that will give them the greatest advantage.

In this case, we are not picking sides or winners, but merely

establishing a reasonable rule of law that can be implemented by

our courts and that can best advance the administration of

justice.

    Here, we find that, under the principles stated in section

6, New Jersey has the most significant relationship to the

occurrence and the parties, thus overcoming section 146’s

presumption that the law of the place of injury governs.     We

therefore apply this State’s PLA to the 532 cases before us.

                               V.

    We now address the standard for overcoming the presumption

of adequacy of FDA-approved warnings during the postmarketing

phase of a prescription medication.

                               A.

    In 1987, New Jersey passed the Products Liability Act, L.

1987, c. 197, codified at  N.J.S.A. 2A:58C-1 to -11.   In enacting

the PLA, the Legislature intended to both codify the existing

common law and provide “some sense of order and clarity to

products liability cases within New Jersey.”   Governor’s

Statement to S. 2805; accord  N.J.S.A. 2A:58C-1; see also In re

Reglan Litig.,  226 N.J. 315, 335 (2016) (“The PLA is a


                               46
codification of tort-law principles, where the state has

traditionally exercised its historic police powers.”).

    Under  N.J.S.A. 2A:58C-4, the manufacturer or seller is not

liable if a product “contains an adequate warning or

instruction” about the dangers of the product.    (emphasis

added).   The PLA defines “an adequate warning or instruction” as

          one that a reasonably prudent person in the
          same or similar circumstances would have
          provided with respect to the danger 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 persons by
          whom the product is intended to be used, or in
          the case of prescription drugs, taking into
          account the characteristics of, and the
          ordinary knowledge common to, the prescribing
          physician.

          [ N.J.S.A. 2A:58C-4 (emphasis added).]

    In the case of prescription drugs, the PLA codifies what is

commonly referred to as the learned intermediary doctrine -- a

doctrine that acknowledges that “the physician acts as the

intermediary between the manufacturer and the [patient].”

Niemiera,  114 N.J. at 559.   The prescribing physician -- as a

learned intermediary -- generally is in the best position to

advise the patient of the benefits and risks of taking a

particular drug to treat a medical condition.    See Perez,  161 N.J. at 17-18.   Under the learned intermediary doctrine, “a

pharmaceutical manufacturer generally discharges its duty to



                                47
warn the ultimate user of prescription drugs by supplying

physicians with information about the drug’s dangerous

propensities.”    Id. at 10 (quoting Niemiera,  114 N.J. at 559).

    Under the PLA, a presumption of adequacy attaches to a

product’s label warnings approved by the Food and Drug

Administration.    N.J.S.A. 2A:58C-4 provides that

         [i]f the warning or instruction given in
         connection with a drug or device or food or
         food additive has been approved or prescribed
         by the federal Food and Drug Administration
         under [federal laws], a rebuttable presumption
         shall arise that the warning or instruction is
         adequate.

         [(emphasis added).]

    The Legislature, by attaching a presumption of adequacy to

FDA-approved warnings, “recognized the preeminent role of

federal regulation of drugs and medical devices.”    Cornett v.

Johnson & Johnson,  211 N.J. 362, 387 (2012); accord Rowe,  189 N.J. at 625 (noting that PLA accepts FDA regulation and

enforcement mechanisms as ordinarily “sufficient . . . to deter

New Jersey pharmaceutical companies from manufacturing unsafe

prescription drugs”).    Given the importance of the federal

regulatory process in relation to the PLA, a brief overview of

the relevant FDA premarketing and postmarketing regulations

governing prescription drugs will be helpful.

                                 B.

    The FDA is responsible for “promot[ing] the public health


                                 48
by promptly and efficiently reviewing [drug manufacturers’]

clinical research and taking appropriate action on the marketing

of regulated products in a timely manner.”    21 U.S.C.

§ 393(b)(1).   Before a pharmaceutical company can market any new

drug, it must complete the process for a New Drug Application

(NDA), during which the FDA conducts a rigorous review to ensure

that the drug is “safe and effective.”     See 21 C.F.R. § 314.2;

see generally, 21 C.F.R. § 314.1 to .170.     As part of the NDA,

the FDA requires extensive information, including the

ingredients of the drug, its biological mechanisms, and the

results of animal studies and clinical tests.    21 C.F.R.

§ 314.50.    The FDA also ensures that the drug label summarizes

“the essential scientific information needed for the safe and

effective use of the drug” and describes potential safety

hazards associated with use of the drug.     21 C.F.R. § 201.56(a);

accord 21 C.F.R. § 314.50 (requiring that NDA include content

for labeling).

    The FDA’s oversight is at its peak before a new drug goes

to market.   See David A. Kessler & David C. Vladeck, A Critical

Examination of the FDA’s Efforts to Preempt Failure-To-Warn

Claims, 
96 Geo. L.J. 461, 465 (2008) (“Kessler & Vladeck”)

(noting that when FDA approves new drug, it “is in the best

position to be the exclusive arbiter of a drug’s safety and

effectiveness” because it then “has had access to and has


                                 49
devoted considerable resources to reviewing carefully all of the

extant health and safety data relating to the drug”).18        The

clinical trials of a drug, however, may not identify all of the

drug’s risks by the time of FDA approval. 19 Id. at 470.     After

the drug goes to market, the manufacturer may receive critical

new information about the risks, benefits, and optimal use of

the drug.    See 21 U.S.C. § 314.80(b).   During the postmarketing

period, when the drug is widely prescribed, risks emerge that

were not “foreseen by the drug’s manufacturer or the FDA and,

for that reason, are not addressed on the label.”     Kessler &

Vladeck at 466.



18 The Kessler & Vladeck article has been cited by state and
federal courts for its insights regarding the FDA’s approval
process and postmarketing efforts. See, e.g., Wyeth,  555 U.S. 555, 579 n.12 (2009); Huck v. Wyeth, Inc.,  850 N.W.2d 353, 397-
98 (Iowa 2014); McDarby,  401 N.J. Super. at 57-58, 64-66. One
of the authors of the article, David A. Kessler, is a former FDA
Commissioner.
19 Premarket research has obvious limitations.     Kessler &
Vladeck at 470. According to the authors,

            [p]rior to FDA approval, drugs are tested on
            relatively small populations of patients, for
            durations rarely exceeding a year or two.
            Thus, pre-approval testing generally is
            incapable of detecting adverse effects that
            occur infrequently, have long latency periods,
            or affect subpopulations not included or
            adequately represented in the studies (for
            example, the elderly, ethnic minorities, and
            pregnant women).

            [Id. at 471, cited in Mut. Pharm. Co. v.
            Bartlett,  570 U.S. 472, 500 (2013).]


                                 50
    Under federal law, the manufacturer is responsible for the

adequacy of a drug label’s warnings not only when it files an

NDA, 21 U.S.C. § 355(b)(1), (d), (j)(2)(A), but also during the

period when the drug is on the market after FDA approval, see 21

C.F.R. § 314.70.     After a manufacturer becomes aware of a

previously unknown significant risk about a drug, the

manufacturer must update the label to account for that risk in

accordance with 21 C.F.R. §§ 314.70 (“Supplements and other

changes to an approved NDA”) and 601.12 (“Changes to an approved

application”).     The FDA requires a manufacturer to change a

drug’s “labeling to reflect newly acquired information” in

certain circumstances.     21 C.F.R. § 314.70(c)(6)(iii).   For

example, a manufacturer must “add or strengthen a

contraindication, warning, precaution, or adverse reaction for

which the evidence of a causal association satisfies the

standard for inclusion in the labeling under [21 C.F.R.]

§ 201.57(c).”    21 C.F.R. § 314.70(c)(6)(iii)(A).   In turn, 21

C.F.R. § 201.57(c)(6) requires that a drug’s “labeling must be

revised to include a warning about a clinically significant

hazard as soon as there is reasonable evidence of a causal

association with a drug; a causal relationship need not have

been definitely established.”     21 C.F.R. § 201.57(c)(6).

    Thus, federal regulations make clear that drug

manufacturers are responsible for the postmarketing surveillance


                                  51
of their products, 21 C.F.R. § 314.80(b), and have a continuing

responsibility “to maintain their labeling and update the

labeling with new safety information,”  73 Fed. Reg. 49,603,

49,605 (Aug. 22, 2008).    See Wyeth v. Levine,  555 U.S. 555, 570-

71 (2009).

       In Wyeth, the United States Supreme Court focused on the

federal regulatory process that holds drug manufacturers

accountable for revising their warning labels after a new drug

has been on the market and on the role state tort law plays in

enforcing that regulatory process.     555 U.S.  at 567-68, 577-79.

The Court in Wyeth held that federal law did not preempt a

state-law tort action against a manufacturer of a prescription

brand-name drug for its failure to give adequate warnings about

the significant risks of administering the drug.    Id. at 563,

581.    Indeed, one of the central premises of the Federal Food,

Drug, and Cosmetic Act (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.   The Court

noted that under the “changes being effected” (CBE) regulation,

21 C.F.R. § 314.70(c), a manufacturer can unilaterally

strengthen label warnings before the FDA’s approval.     Id. at

568-71.   The CBE regulation, in defined circumstances, provides


                                 52
that a manufacturer may make a label change when it files a

supplemental application with the FDA -- and before FDA approval

-- “that is intended to increase the safe use of the drug

product.”     Id. at 568 (citing 21 C.F.R. § 314.70(c)(6)(iii)(A),

(C)).20   In Wyeth, when the risk became apparent to the

manufacturer that its drug might cause serious harm, “[the

manufacturer] had a duty to provide a warning that adequately

described that risk, and the CBE regulation permitted it to

provide such a warning before receiving the FDA’s approval.”

Id. at 571.

       Significantly, the Supreme Court concluded that failure-to-

warn lawsuits against manufacturers provide “a complementary

form of drug regulation” in the postmarketing phase.     Id. at

578.    In that phase, the Court recognized, the FDA’s monitoring

is far from foolproof.    As the Court observed,

            [t]he 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

20 The CBE regulation identifies several other categories of
changes “reflect[ing] newly acquired information” which the
manufacturer (or corresponding party) may implement prior to
approval by the FDA. 21 C.F.R. § 314.70(c).


                                  53
         that manufacturers, not the FDA, bear primary
         responsibility for their drug labeling at all
         times.

         [Id. at 578–79 (footnote omitted).]

                                C.

    With the federal regulatory process as prologue, we turn to

the rebuttable presumption of adequacy that attaches to an FDA-

approved warning.    N.J.S.A. 2A:58C-4.   The presumption of

adequacy necessarily “helps to ensure that manufacturers are not

made guarantors against remotely possible, but not

scientifically-verifiable, side-effects of prescription drugs,”

Perez,  161 N.J. at 25, and “reduc[es] the burden placed on

[manufacturers of medications with FDA-approved warnings] by

product liability litigation,” Rowe,  189 N.J. at 626.    The

Legislature, however, gave no precise guidance either in the

Products Liability Act or in its legislative history suggesting

the proofs necessary to overcome the rebuttable presumption of

adequacy of FDA-approved warnings.

    In Feldman v. Lederle Laboratories, the Court acknowledged

that the PLA’s “plain language defies the conclusion that the

presumption cannot be overborne.”     125 N.J. 117, 157 (1991).

Feldman, however, did not detail the proofs necessary to

overcome the presumption, despite its reference to the general

means of overcoming a presumption.   Ibid. (citing McCormick on

Evidence § 344, at 978–79 (E. Cleary ed., 3d ed. 1984)).      The


                                54
Court in Perez for the first time addressed the role of the

federal regulatory process in relation to the PLA’s presumption

of adequacy that attaches to FDA-approved drugs.     161 N.J. at
 25.

      In Perez, the Court primarily focused on the learned

intermediary doctrine, holding that the doctrine did not apply

when a pharmaceutical company engaged in direct marketing of a

product to consumers.   Id. at 11-22.   Within that context, the

Court also declared that “in the area of direct-to-consumer

advertising of pharmaceuticals, the same rebuttable presumption

[of adequacy] should apply when a manufacturer complies with FDA

advertising, labeling and warning requirements.”    Id. at 24.

      The Court made clear that “FDA regulations are pertinent in

determining the nature and extent of any duty of care that

should be imposed on pharmaceutical manufacturers” and that “FDA

regulations serve as compelling evidence that a manufacturer

satisfied its duty to warn the physician about potentially

harmful side effects of its product.”   Ibid.   Significantly, the

Court generally cited FDA advertising regulations and did not

distinguish between FDA regulations governing pharmaceutical

drugs in the premarketing and postmarketing phases.    See id. at

22-24.

      In the absence of statutory language or legislative history

suggesting the standard to overcome the rebuttable presumption,


                                55
the Court in Perez turned to the punitive damages section of the

PLA for guidance.    Id. at 25.    N.J.S.A. 2A:58C-5(c) states in

part that punitive damages are not available “if a drug . . . is

generally recognized as safe and effective pursuant to” the

FDA’s “packaging and labeling regulations,” except “where the

product manufacturer knowingly withheld or misrepresented

information required to be submitted under the agency’s

regulations, which information was material and relevant to the

harm in question.”   Adapting that language to the rebuttable

presumption of adequacy accorded to FDA-approved label warnings,

the Court held that “absent deliberate concealment or

nondisclosure of after-acquired knowledge of harmful effects,

compliance with FDA standards should be virtually dispositive of

[product-liability and failure-to-warn] claims.”    Perez,  161 N.J. at 25.   The Court acknowledged that “[t]his presumptive

effect is in accordance with legislative intent that we discern

from the punitive damages provision of the [PLA]” concerning

“FDA labeling and pre-marketing requirements.”     Ibid. (emphasis

added).

    Notably, Perez was decided twenty years before Wyeth’s

expansive discussion of a manufacturer’s duty to update label

warnings under FDA regulations in the postmarketing phase.

Indeed, the Appellate Division in McDarby “note[d] that close

scrutiny of the FDA and its regulatory power in a labeling


                                  56
context commenced only after Perez was decided, and that

scrutiny disclosed flaws in the regulatory system.”      401 N.J.

Super. at 64.   The McDarby court surveyed the FDA’s role in the

postmarketing phase of a drug and came to conclusions similar to

those of the Wyeth Court.    401 N.J. Super. at 63-66.   It

observed that “[c]ommentators and courts have since [Perez]

recognized that, whereas pre-market approvals of drugs are

generally thorough in nature, the ability of the FDA, post-

market, 'to detect unforeseen adverse effects of [a] drug and to

take prompt and effective remedial action’ is considerably

less.”   Id. at 64 (third alternation in original) (quoting

Kessler & Vladeck at 465); see also Reglan,  226 N.J. at 337

(noting that Wyeth acknowledged “that the FDA does not have the

resources to monitor the labeling of thousands of drugs after

they are marketed”).

    The “flaws in that post-marketing oversight process,” the

Appellate Division reasoned, “render[ed] the dictum of Perez

less all-encompassing than it might then have appeared” and

“provide[d] the foundation for [a] further exception to the

presumption of adequacy” enunciated in McDarby.   McDarby,  401 N.J. Super. at 64.

    McDarby did not deal with a manufacturer deliberately

concealing or not disclosing after-acquired knowledge of a

drug’s harmful effects from the FDA, the bases for overcoming


                                57
the presumption of adequacy of FDA-approved label warnings

recognized in Perez.   See id. at 63.     In McDarby, the

manufacturer had disclosed information about the drug’s

cardiovascular risk to the FDA but deliberately delayed amending

the warning label to identify that risk, “despite the universal

opinions of the FDA’s advisory committee and medical reviewers –

- and indeed, initially, the FDA regulators, themselves -- that

a warning was appropriate.”    21 Id. at 69.   In light of the

limitations of the FDA postmarketing oversight process and the

evidence in that case, the Appellate Division articulated a

further basis for overcoming the presumption of adequacy:         a

manufacturer’s “economically-driven manipulation of the post-

market regulatory process.”    Id. at 63-64.    In Cornett,  211 N.J.

at 388, this Court recognized the McDarby exception.

                                   D.



21 The conduct in question occurred before the 2007 Amendments
to the Food, Drug, and Cosmetic Act, during which the FDA “did
not have the [statutory] authority to compel labeling changes,
but instead had to negotiate changes with the drug’s sponsor.”
McDarby,  401 N.J. Super. at 65 (alteration in original) (quoting
Kessler & Vladeck at 466). As a result of the 2007 Amendments,
the FDA now has enhanced postmarketing oversight powers. See
Pub. L. No. 110-85,  121 Stat. 823. Those increased powers
include the authority to require drug manufacturers to conduct
postmarketing studies and clinical trials for approved drugs and
products, 21 U.S.C. § 355(o)(3), and to mandate a labeling
change it “deems appropriate to address . . . new safety
information,” 21 U.S.C. § 355(o)(4)(E). However, as discussed
below, there are still resource-related concerns about the FDA’s
capacity to fully carry out its postmarket responsibilities.



                                   58
     The FDA’s postmarketing oversight of drug label warnings is

still hobbled by resource problems, according to a December 2015

report by the Government Accountability Office (GAO).     That

report indicated that the “FDA’s lack of reliable, readily

accessible postmarket safety data has prevented the agency from

publishing required reports in a timely manner and has

restricted its ability to conduct systematic oversight.”    U.S.

Gov’t Accountability Office, Drug Safety:   FDA Expedites Many

Applications, But Data for Postapproval Oversight Need

Improvement 22 (Dec. 2015).22

     We are mindful of Perez’s general directive that federal

regulations are of the utmost significance in determining

whether “a manufacturer satisfied its duty to warn the physician

about potentially harmful side effects of its product.”     See

Perez,  161 N.J. at 24.   Those regulations, in the postmarketing

phase of a drug, require a manufacturer to revise a label to

include a warning “about a clinically significant hazard as soon

as there is reasonable evidence of a causal association with a




22 In particular, the GAO found that the FDA’s database had
inaccurate and incomplete data, in part due to delays in staff
reviewing submissions. Id. at 23. The GAO estimated that the
FDA failed to review in a timely manner more than half of the
submissions associated with 1400 postmarket studies of drugs on
the market. Id. at 23-24.



                                59
drug.”    21 C.F.R. § 201.57 (c)(6);23 see also 21 C.F.R.

§ 314.70(c)(6)(iii)(A) (stating that, based on “newly acquired

information,” manufacturers must “add or strengthen a

contraindication, warning, precaution, or adverse reaction for

which the evidence of a causal association satisfies the

standard for inclusion in the labeling under [21 C.F.R.]

§ 201.57(c)”).

     Even when manufacturers forward newly acquired information

about a drug’s risks to the FDA, Wyeth and the federal

regulatory system make clear that manufacturers bear the

ultimate responsibility for monitoring the effects of the drugs

they place on the market.     555 U.S.  at 570-71.   The

manufacturer’s postmarketing obligation to update a label’s

warnings consistent with 21 C.F.R. § 201.57(c) and 21 C.F.R.

§ 314.70(c) is especially significant given that the FDA’s

oversight capabilities are limited due to overstretched

resources in monitoring thousands of drugs on the market.     Id.

at 578.


23 21 C.F.R. § 201.57 applies to prescription drug products for
which an NDA or efficacy supplement was approved by the FDA
between June 30, 2001 and June 30, 2006, was pending on June 30,
2006, or was submitted anytime on or after June 30, 2006. 21
C.F.R. § 201.56(b)(1). All other prescription drug products are
subject to the requirements in 21 C.F.R. § 201.80. Ibid. Under
§ 201.80, manufacturers are required to revise the labeling if
there is reasonable evidence of an association -- not a causal
association -- of a serious hazard with the drug. 21 C.F.R.
§ 201.80(e).


                                 60
    Thus, an FDA-approved warning for a drug on the market for

many years may grow stale in light of “newly acquired

information” about “a clinically significant hazard” in the use

of the drug by certain consumers.      21 C.F.R. § 201.57(c); 21

C.F.R. § 314.70(c).    Prior FDA approval of a label’s warning is

not a license for a manufacturer to withhold updating and

revising that warning in accordance with federal regulations.

See ibid.

    The PLA provides manufacturers with the protection of a

rebuttable presumption of adequacy of an FDA-approved label

warning.     N.J.S.A. 2A:58C-4.   An adequate warning for a

prescription drug is one that “a reasonably prudent”

manufacturer would have provided concerning dangers related to

the drug’s use “taking into account the characteristics of, and

the ordinary knowledge common to, the prescribing physician.”

Ibid.   “A duty to warn arises if [a manufacturer] actually knew

or should have known of the need to issue a particular warning.”

N.J. Model Civil Jury Charges 5.40C (Model Civil Jury Charges

Comm. 2017) (model charge for Failure to Warn/Instruct); see

also McDarby,  410 N.J. Super. at 72 (finding that jury

appropriately directed “to consider what [manufacturer] knew or

should have known, when facts sufficient to require a warning

became known, and whether it acted reasonably, given the

information that it possessed”).


                                  61
      Consistent with Perez and McDarby, and the federal

regulatory scheme, we hold that the rebuttable presumption of

adequacy attaching to an FDA-approved drug label is overcome

when a plaintiff presents clear and convincing evidence that a

manufacturer knew or should have known, based on newly acquired

information, of a causal association between the use of the drug

and “a clinically significant hazard” and that the manufacturer

failed to update the label accordingly.   See 21 C.F.R.

§ 201.57(c); 21 C.F.R. § 314.70(c).   We add one caveat.     A

manufacturer that acts in a reasonable and timely way to update

its label warnings with the FDA, in accordance with its federal

regulatory responsibilities, will receive the protection of the

rebuttable presumption.   If not, it cannot seek shelter behind

it.

      The heightened standard of clear and convincing evidence is

in keeping with the high threshold set by Perez.     Clear and

convincing evidence is evidence that produces “a firm belief or

conviction” in the truth of the alleged facts.     N.J. Model Civil

Jury Charges 1.19 (Model Civil Jury Charges Comm. 2017) (model

charge for Burden of Proof -- Clear and Convincing Evidence).

More descriptively, “it is evidence so clear, direct, weighty in

terms of quality, and convincing as to cause [one] to come to a

clear conviction of the truth of the precise facts in issue.”

Ibid.   We reject the argument by amicus curiae New Jersey


                                62
Association for Justice that the usual evidentiary standard for

overcoming the presumption should apply.

    The standard articulated here is a natural extension of the

decisions in Perez and McDarby.    It is a standard protective of

responsible drug manufacturers.    Faced with clear and convincing

evidence of a label warning’s inadequacy based on the FDA’s

label warning updating requirements set forth in 21 C.F.R.

§ 201.57(c) and 21 C.F.R. § 314.70(c), a responsible drug

manufacturer will take action to revise its drug label warnings.

    The PLA’s rebuttable presumption of adequacy that attaches

to label warnings gives pharmaceutical companies the protection

necessary to research and develop the drugs that will improve

and extend the lives of people around the world.    The

presumption of adequacy protects manufacturers from

unmeritorious lawsuits.   See Perez,  161 N.J. at 25; Rowe,  189 N.J. at 626.

    The Legislature, however, envisioned that, in appropriate

circumstances, the presumption would be overcome.     See Feldman,

 125 N.J. at 157 (“[The PLA’s] plain language defies the

conclusion that the presumption cannot be overborne.”).     In

passing the PLA, the Legislature affirmed New Jersey’s

“substantial interest in deterring its manufacturers from

developing, making, and distributing unsafe products, including

inadequately labeled prescription drugs.”    See McCarrell, 227


                                   63 N.J. at 597; Governor’s Statement to S. 2805 (July 23, 1987)

(“This legislation responds to the well documented need for the

establishment of clear rules regarding legal actions seeking

damages for harm caused by products.”).

    The high standard for overcoming the rebuttable presumption

of adequacy of an FDA-approved label warning represents a

balance that protects pharmaceutical companies that act

responsibly and the public that consumes their products.

                                 VI.

    With the above principles in mind, we must now determine

whether plaintiffs have presented the necessary evidence to

overcome the presumption of adequacy that attaches to the FDA-

approved post-April 2002 label warnings for Accutane.     See

 N.J.S.A. 2A:58C-4.

    Three pathways are available to overcome the presumption of

adequacy.   The first pathway is if a plaintiff can establish

“deliberate concealment or nondisclosure of after-acquired

knowledge of harmful effects.”   Perez,  161 N.J. at 25.    The

second is if a plaintiff can demonstrate “economically-driven

manipulation of the post-market regulatory process.”    McDarby,

 401 N.J. Super. at 63.   The third is if a plaintiff can prove by

clear and convincing evidence that a manufacturer knew or should

have known in the postmarketing phase that the drug warnings

were inadequate based on the label warning updating requirements


                                 64
in 21 C.F.R. § 201.57(c), 21 C.F.R. § 314.70(c), or any other

pertinent federal regulation.

    On the record before us, plaintiffs have failed to show any

of those bases for overcoming the presumption of adequacy.     In

the absence of evidence sufficient to rebut the presumption, as

a matter of law, the warnings adequately conveyed to medical

professionals -- as well as to patients -- that usage of

Accutane was associated with a risk of IBD.

    The post-April 2002 label warnings expressly informed

physicians and, through them, patients that Accutane had been

associated with a risk of IBD.   Nevertheless, our focus is not

only on the physician label, the primary means by which Roche

communicated to prescribing physicians the risks of Accutane,

but also on other IBD-related warnings that informed patients.

    Roche used multiple warning tools:    the physician label and

Best Practices Guide, intended for physicians, and the Patient

Safety Packet, Medication Guide, and blister packaging, intended

for patients.   The physician label -- written for trained

healthcare professionals -- identified IBD by name (“Accutane

has been associated with inflammatory bowel disease . . . .”)

and listed the most common symptoms of IBD (“Patients

experiencing abdominal pain, rectal bleeding or severe diarrhea

should discontinue Accutane immediately.”).   Moreover, the

physician label noted the potentially permanent nature of the


                                 65
condition (“In some instances, symptoms have been reported to

persist after Accutane treatment has been stopped.”).    It also

specifically warned prescribing physicians that patients with no

prior history of intestinal problems might be at risk of IBD

(“Accutane has been associated with [IBD] in patients without a

prior history of intestinal disorders.”).

    Plaintiffs’ principal criticism is that the physician label

and other warning materials should have used the language

“causes” instead of “has been associated with” to describe the

relationship between Accutane and IBD.   Plaintiffs, however,

have failed to present clear and convincing evidence that

Roche’s use of the word “associated” to describe the

relationship between Accutane and IBD was inadequate.    We look

to the scientific understanding of “association” as a physician

would understand the term.   According to the Reference Manual on

Scientific Evidence, an association includes the possibility of

causation but is not in itself causation.     Reference Manual on

Scientific Evidence 619 (3d ed. 2011) (“Association does not

necessarily imply a causal relationship.”).     By use of the word

“associated,” Roche informed physicians that it was possible --

though not proven -- that, in the case of some patients,

Accutane may have caused IBD.   Roche had reports that some

patients, after taking Accutane, developed symptoms of IBD.

That one followed the other does not prove cause and effect.


                                66
See In re:     Accutane Litig., ___ N.J. ___, ___ (2018) (slip op.

at 12-15).

     Moreover, we do not find that the isolated examples

plaintiffs have exhumed from the volumes of evidence support a

showing of deliberate nondisclosure to the FDA, economically

driven manipulation of the regulatory process, or clear and

convincing evidence that Roche knew or should have known of the

inadequacy of the warnings in light of the relevant federal

regulations.    Plaintiffs cite to the 1994 memorandum in which

Dr. Lefrancq, a Roche physician, notes that Accutane “may induce

or aggravate a preexisting colitis.”     Another 1994 excerpted

internal Roche document noted that colitis was identified as a

“possible” side effect of Accutane.     Those memoranda are far

from clear and convincing evidence that the language “Accutane

has been associated with [IBD]” was an inadequate warning.24

     Plaintiffs argue that Roche had internally concluded that

Accutane was causally -- not just possibly -- related to IBD.




24 Plaintiffs further cite the latter 1994 document as evidence
that the use of Accutane was contraindicated in all patients
with IBD or a family history of the disease. However, the
document specifically indicates that the data regarding
Accutane’s association with IBD is “contradictory” and that
there was not sufficient data to describe it as a
contraindication. The document did note, however, that Accutane
should be contraindicated for patients in the active phase of
IBD. Significantly, the label warnings advised both physicians
and patients that patients should discontinue Accutane use
immediately if they experienced any IBD-related symptoms.


                                  67
However, plaintiffs have failed to establish that Roche had in

fact made such a determination, engaged in deliberate

concealment or nondisclosure of such knowledge, or otherwise

knew or should have known under the standard articulated above

that the use of the word “associated” was inadequate.     Rather,

in support of that claim, plaintiffs point to another isolated

statement from a 2000 regulatory report culled from the

voluminous discovery.

    In that report, a physician, while discussing and analyzing

an individual patient’s medical history while on Accutane,

states that Accutane “has been found to be causally associated

with inflammatory bowel disease, including colitis.”     The record

does not reflect the basis for that physician’s comment.     Nor

does that statement suggest a consensus by other Roche

physicians or employees about a causal connection between

Accutane usage and IBD.   Indeed, we do not know whether the

statement represents anything more than one physician’s

understanding (or misunderstanding) of the relationship between

Accutane and IBD.   To be sure, that single statement is not

clear and convincing evidence that Roche knew or should have

known that the use of the word “associated” was inadequate.

    Additionally, there is no evidence that Roche deliberately

concealed or withheld any material information from the FDA or

engaged in economically driven manipulation of the regulatory


                                68
process.    In fact, Roche’s early postmarket monitoring led to

the identification of IBD as a possible risk.    At the urging of

the FDA, Roche revised the initial warning language about IBD,

removing the word “temporally” to more precisely align the

warning with the evidence it had on hand regarding the potential

permanency of IBD symptoms associated with Accutane.

    Nor is there any evidence that Roche avoided necessary

label changes for economic reasons.    Roche’s marketing personnel

certainly expressed an interest in Accutane’s financial success;

it would have been surprising if it were otherwise.    However,

there is no evidence that Roche’s financial interest in

Accutane’s success led it to withhold necessary IBD-related

warnings.   Cf. McDarby,  401 N.J. Super. at 69 (noting

manufacturer’s “strenuous, economically driven, opposition” to

including cardiovascular risk in drug label).    Roche was not

averse to using causation language when appropriate.     For

example, Roche included label warnings that the use of Accutane

posed “an extremely high risk” of causing birth defects and that

“Accutane may cause depression.”

    Finally, the record shows that the FDA actively engaged in

the postmarketing oversight of Accutane and proactively

recommended strengthening warnings about IBD -- a recommendation

followed by Roche.    Whatever continuing concerns there may be

about the FDA’s postmarketing oversight capacity, there is no


                                 69
evidence in this record of shortcomings in the FDA’s oversight

of Accutane.

                               VII.

    For the reasons expressed, we reverse the judgment of the

Appellate Division in those cases in which it vacated the grant

of summary judgment in favor of Roche and affirm its judgment in

those cases in which it upheld the grant of summary judgment in

favor of Roche.   As a result, the 532 failure-to-warn cases

brought by plaintiffs against Roche are dismissed.



     CHIEF JUSTICE RABNER and JUSTICES LaVECCHIA, FERNANDEZ-
VINA, SOLOMON, and TIMPONE join in JUSTICE ALBIN’s opinion.
JUSTICE PATTERSON did not participate.




                                70