IN RE: ACCUTANE LITIGATION (MCL CASE NO. 271, ATLANTIC COUNTY AND STATEWIDE) (CONSOLIDATED)

NOT FOR PUBLICATION WITHOUT THE
APPROVAL OF THE APPELLATE DIVISION
This opinion shall not "constitute precedent or be binding upon any court."
Although it is posted on the internet, this opinion is binding only on the
parties in the case and its use in other cases is limited. R.1:36-3.
SUPERIOR COURT OF NEW JERSEY
APPELLATE DIVISION
DOCKET NO. A-4760-14T1
A-0164-15T1
IN RE: ACCUTANE LITIGATION
___________________________________________________
Argued May 16, 2017 – Decided July 25, 2017
Before Judges Fisher, Ostrer and Moynihan.
On appeal from the Superior Court of New
Jersey, Law Division, Atlantic County, Case
No. 271 (MCL).
Bruce D. Greenberg argued the cause for
appellants in A-4760-14 (Seeger Weiss, LLP,
Lite, DePalma, Greenberg, LLC, and Weitz &
Luxenberg, PC, attorneys; David R. Buchanan
and Peter Samberg, on the brief).
Mary Jane Bass (Beggs & Lane) of the Florida
bar, admitted pro hac vice, argued the cause
for appellants in A-0164-15 (Seeger Weiss,
LLP, Lite, DePalma, Greenberg, LLC, Weitz &
Luxenberg, P.C., and Ms. Bass, attorneys;
David R. Buchanan and Peter Samberg, on the
brief).
Paul W. Schmidt (Covington & Burling LLP) of
the District of Columbia bar, admitted pro hac
vice, argued the cause for respondents (in A-
4760-14) and respondents/cross-appellants (in
A-0164-15) Hoffmann-La Roche Inc. and Roche
Laboratories Inc. (Gibbons P.C., Dughi Hewit
& Domalewski, P.C. and Mr. Schmidt, attorneys;
Michelle M. Bufano, Natalie H. Mantell,
Russell L. Hewit, Mr. Schmidt, and Michael X.
Imbroscio (Covington & Burling LLP) of the
District of Columbia bar, admitted pro hac
vice, on the brief).
Edward J. Fanning, Jr., argued the cause for
amicus curiae The HealthCare Institute of New
Jersey in A-4760-14 (McCarter and English,
LLP, attorneys; Mr. Fanning and David R. Kott,
of counsel and on the brief; Gary R. Tulp, on
the brief).
PER CURIAM
These two appeals, calendared back-to-back, stem from orders
entered in this multicounty litigation (MCL). The first (A-4760-
14) concerns eighteen cases in which plaintiffs alleged that, on
various dates after April 10, 2002, they were prescribed and
ingested Accutane, a prescription acne drug manufactured by
defendants Hoffman-La Roche Inc. and Roche Laboratories Inc.
(collectively "defendants") in New Jersey. By that time, the
Accutane package insert or label had been amended to provide that
the drug had been "associated with inflammatory bowel disease."
In these cases, plaintiffs allege they developed ulcerative
colitis (an inflammatory bowel disease or IBD) from taking the
drug; the judge determined – by way of summary judgment – that the
post-2002 Accutane warnings were adequate as a matter of New Jersey
law.
The second appeal (A-0164-15) concerns the dismissal of 514
Accutane complaints involving plaintiffs who were prescribed and
2 A-4760-14T1
ingested Accutane in jurisdictions other than New Jersey. These
plaintiffs alleged they developed ulcerative colitis from
ingesting the drug and that the post-2002 warnings were inadequate.
In part one of a two-part opinion, the trial judge granted
defendants' omnibus motion for summary judgment by applying New
Jersey law. The judge did not conduct a choice-of-law analysis in
this part of his decision; instead he found New Jersey law applied
because of counsel's representations in the 2005 MCL petition. In
part two of his opinion, the judge held that if the law of other
jurisdictions applied to these out-of-state plaintiffs, he would
have granted defendants' motion for summary judgment dismissing
394 of the cases under the laws of twenty-one of the jurisdictions,
denied the motion as to 101 cases under the laws of twenty other
jurisdictions, and granted the motion dismissing the remaining
nineteen cases because the law of the state of injury in three
jurisdictions was so unclear New Jersey law should apply.
In this second appeal, plaintiffs argue the trial judge erred
in applying or interpreting New Jersey law and, also, that the
substantive law of the other jurisdictions required a denial of
summary judgment.1 In their cross-appeal, defendants argue the
1
All of the cases reviewed to date, except Kendall v. Hoffman-La
Roche, Inc. (Kendall I), No. A-2633-08 (App. Div. Aug. 5, 2010),
aff'd, 209 N.J. 173 (2012), involved the 1984 Accutane warning. In
3 A-4760-14T1
judge erred in his alternative disposition denying summary
judgment in 101 of the cases. We turn first to the issues in A-
4760-14 and then to those posed in A-0164-15.
I
In considering the issues raised in the first appeal, we
first (a) discuss the background of these cases, (b) the evidential
materials urged in opposition to summary judgment and the trial
judge's determination, (c) the general legal principles followed
when applying New Jersey products liability law to a claim based
on the use of a pharmaceutical drug, and (d) the application of
New Jersey law to these eighteen suits. In addition, even though
unnecessary to our determination, we briefly discuss (e)
plaintiffs' argument that the law-of-the-case doctrine barred the
trial judge's summary judgment ruling.
A
(1)
By way of background, we briefly observe that, in 2005, the
Supreme Court designated all pending and future statewide actions
Kendall, which has settled, the plaintiff received the 1984 warning
when she began taking Accutane in 1997, and received the amended
post-2002 warning after her diagnoses with ulcerative colitis. 209
N.J. at 182-86. Only one post-2000 warning case, Tanna v. Hoffman-
La Roche, Inc., ATL-L-3366-04, was tried; that case resulted in a
hung jury and has not been retried.
4 A-4760-14T1
involving Accutane as a mass tort pursuant to Rule 4:38A; all
cases were transferred to Atlantic County to be heard on a
coordinated basis. From 2007 to 2008, trials were conducted in the
three bellwether cases; those juries found the 1984 warning, which
warned that Accutane had been "temporally associated" with IBD,
was inadequate. McCarrell v. Hoffman-La Roche, Inc. (McCarrell I),
No. A-3280-07 (App. Div. 2009), certif. denied, 199 N.J. 518
(2009); Kendall I, supra, 209 N.J. at 182-86 (post-2000 warning
received after diagnosis); Sager v. Hoffman-La Roche, Inc., No.
A-3427-09 (App. Div. 2012), certif. denied, 213 N.J. 568 (2012).2
On March 20, 2008, Judge Carol Higbee denied defendants'
omnibus motion for summary judgment on the adequacy of the post-
2000 package insert warning in seventy-eight MCL cases, including
Tanna v. Hoffman-La Roche Inc., No. ATL-L-3366-04 (applying
California law), Alfano v. Hoffman-La Roche Inc., No. ATL-L-2650-
07, and Phillips v. Hoffman-La Roche Inc., No. ATL-L-1909-07 (a
2
We recognize that, as a general matter, Rule 1:36-3 precludes
the citation of unpublished opinions by our courts. That Rule,
however, provides an exception for the citation of unpublished
opinions when necessary for, among other things, res judicata and
collateral estoppel purposes. Although the Rule may not have
contemplated the use of an unpublished opinion in one or more
cases within a larger group of collectively-managed cases, such
as in this MCL litigation, we deem it appropriate not only to
refer to some of our unpublished opinions for reasons expressed
in the Rule's exceptions, but also to point out that the trial
judge remains bound to those unpublished opinions because they
arose out of the same MCL litigation.
5 A-4760-14T1
subject of this appeal). We denied defendants' motion for leave
to appeal.
On December 10, 2008, Judge Higbee denied defendants' omnibus
motion for summary judgment on the adequacy of the post-2001
warnings in eighty-four MCL cases, including Alfano, Tanna, and
Phillips. We denied defendants' motion for leave to appeal.
On January 16, 2009, Judge Higbee denied defendants' omnibus
motion for summary judgment in twenty-four cases filed by New
Jersey plaintiffs, including Phillips, on the adequacy of some of
the pre- and post-2000 warnings. And, in June 2010, Judge Higbee
denied defendants' motion for summary judgment based on federal
preemption in Weathersbee v. Hoffman-La Roche, Inc., No. ATL-L-
3260-04 and Falco v. Hoffman-La Roche, Inc., No. ATL-L-2646-08
(applying North Carolina law), where the plaintiffs received post-
2001 warnings.
Juries found the 1984 warning inadequate in four subsequently
tried cases. McCarrell v. Hoffman-La Roche, Inc. (McCarrell II),
No. A-4481-12 (App. Div. 2015), rev'd and remanded, 227 N.J. 569
(2017); Kendall v. Hoffman-La Roche, Inc. (Kendall II), No. A-0301-
14 (App. Div. 2016); Gaghan v. Hoffman-La Roche, Nos. A-2717-11,
A-3211-11, A-3217-11 (App. Div. 2014); and Rossitto v. Hoffman-La
Roche, Inc., No. A-1236-13 (App. Div. 2016), certif. denied, 228
N.J. 419 (2016).
6 A-4760-14T1
Meanwhile, on various dates from 2007 to 2013, the eighteen
plaintiffs in the first appeal at hand – plaintiffs who ingested
Accutane in New Jersey after April 10, 2002 – filed MCL complaints
against defendants seeking damages for, among other things, a
failure to warn under the New Jersey Product Liability Act (PLA),
N.J.S.A. 2A:58C-1 to -11.
In January 2015, defendants moved for summary judgment in
Alfano on the adequacy of the post-2002 warnings under either New
Jersey or Washington law. Alfano, however, dismissed her case with
prejudice for unrelated reasons, prompting defendants to file an
amended notice of motion for summary judgment (the subject of this
appeal) based on the adequacy of the warnings in all MCL cases
where plaintiffs first ingested Accutane after April 10, 2002.
On April 2, 2015, the newly-designated Accutane trial judge
issued a written opinion finding the post-April 10, 2002 Accutane
warnings were adequate as a matter of law under the PLA. An order
dismissing those eighteen cases was entered on May 11, 2015.
(2)
In light of the familiar Brill standard,3 which applies with
equal vigor in our review of summary judgment determinations,
Templo Fuente De Vida Corp. v. Nat'l Union Fire Ins. Co. of
3
Brill v. Guardian Life Ins. Co. of Am., 142 N.J. 520 (1995).
7 A-4760-14T1
Pittsburgh, 224 N.J. 189, 199 (2016), we consider the following
facts and circumstances in the light most favorable to plaintiffs.
Brill, supra, 142 N.J. at 540.
In 1982, the Food and Drug Administration (FDA) approved
defendants' new drug application (NDA) to market Accutane, "known
generically as isotretinoin, for the treatment of recalcitrant
nodular acne." McCarrell II, supra, 227 N.J. at 577. The drug is
a retinoid, derived from vitamin A, and is highly effective in
treating severe acne. Kendall I, supra, 209 N.J. at 180.
There is no dispute that Accutane "has a number of known side
effects, including dry lips, skin and eyes; conjunctivitis;
decreased night vision; muscle and joint aches; elevated
triglycerides; and a high risk of birth defects if a woman ingests
the drug while pregnant." Ibid. There is also evidence that
Accutane, originally studied for use in treating cancer, has an
effect on the gastrointestinal tract, McCarrell I, supra, slip op.
at 6, 23-26, as acknowledged in the Accutane patent applications,
Rossitto, supra, slip op. at 8. Pre-approval studies using dogs
also "revealed instances of dose-related gastrointestinal
bleeding." Id. at 6. Similarly, in defendants' Accutane clinical
study of 523 patients, 21.6% suffered gastrointestinal side
effects – primarily effects on mucous membranes – including such
minor effects as increased thirst and appetite, nausea, and
8 A-4760-14T1
anorexia, as well as more serious gastrointestinal bleeding. Ibid.
Gastrointestinal symptoms were also reported in 34% of the clinical
trial patients who took a chemically-similar drug (Vesanoid, the
brand name for tretinoin), manufactured by defendants to treat
leukemia. Ibid.
These Accutane cases concern the alleged propensity of the
drug to cause IBD, a chronic disease that primarily manifests as
one of two diseases: Crohn's disease or ulcerative colitis. Kendall
I, supra, 209 N.J. at 181.4 Ulcerative colitis – plaintiffs'
diagnosed condition – primarily involves inflammation of the
lining of the colon (large intestine), while Crohn's disease can
occur in any part of the digestive tract from the mouth to the
anus, although it primarily manifests in the small intestine (the
ileum) and the colon. Rossitto, supra, slip op. at 7. Both IBD
forms share the same core symptoms: abdominal pain, frequent and
often bloody bowel movements, and rectal bleeding. Kendall I,
supra, 209 N.J. at 181.
IBD's cause remains largely unknown; several triggers,
however, are associated with a statistically increased rate of
IBD, including family history, infections, some antibiotics,
4
We note that an appeal is pending in In re Accutane Litigation,
A-4698-14, from the trial judge's May 8, 2016 order that dismissed
MCL cases in which the plaintiffs alleged they developed Crohn's
disease as a result of taking Accutane.
9 A-4760-14T1
smoking, and possibly the use of oral contraceptives and
nonsteroidal anti-inflammatory drugs. Ibid. IBD's peak onset
occurs during adolescence, the same period individuals are likely
to take Accutane. Ibid.
(3)
Defendants "designed, manufactured, and labeled Accutane in
New Jersey and distributed the product from this State." McCarrell
II, supra, 227 N.J. at 577. The FDA did not require a warning
about IBD on the 1982 Accutane launch label, even though
defendants, "as the sponsoring pharmaceutical company, had
included information in its NDA indicating that the drug had an
effect on the gastrointestinal tract." Rossitto, supra, slip op.
at 8. Upon obtaining FDA approval, defendants began receiving
reports of IBD in Accutane patients. Id. at 9. Defendants amended
the "Adverse Reactions" section of the label in August 1983 to
provide that "IBD and mild gastrointestinal bleeding had been
reported in 'less than 1% of patients and may bear no relationship
to therapy.'" Ibid.
By letter dated September 8, 1983, Public Citizen, a nonprofit
consumer advocacy group, "petitioned the FDA for enhanced warnings
on Accutane about a variety of serious adverse reactions, including
IBD." Ibid. "Public Citizen expressed concern that the 'potential
10 A-4760-14T1
toxicity' of Accutane had been 'seriously under-emphasized'
because the drug had been approved on limited data, had received
'fast track' approval, and had been overprescribed by physicians."
Id. at 9-10. Public Citizen cited reports of patients developing
IBD, noting that because of underreporting the reported cases
underestimated IBD's actual occurrence, and recommended
defendants' inclusion of a warning about the risk of developing
the disease. Id. at 10.
Defendants amended the "Warnings" section of the Accutane
package insert provided to physicians in March 19845; that warning
remained in effect until 2000. It provided that "Accutane has been
temporally associated with [IBD] in patients without a prior
history of intestinal disorders" and that patients "experiencing
abdominal pain, rectal bleeding or severe diarrhea should
discontinue Accutane immediately." Ibid. At that same time,
defendants issued a "Dear Doctor" letter to prescribing
physicians, which explained that ten Accutane patients:
have experienced gastrointestinal disorders
characteristic of inflammatory bowel disease
(including 4 ileitis and 6 colitis). While
these disorders have been temporally
associated with Accutane administration,
i.e., they occurred while patients were taking
the drug, a precise cause and effect
5
The insert contained a "black box" warning about the risk of
birth defects and of developing pseudotumor cerebri (intercranial
hypertension), but not IBD.
11 A-4760-14T1
relationship has not been shown. [Defendants
are] . . . continuing to monitor adverse
experiences in an effort to determine the
relationship between Accutane . . . and these
disorders.
[McCarrell I, supra, slip op. at 7.]
As compelled by law, 21 C.F.R. §§ 314.80-81 (2017), defendants
continued to: monitor the safety of Accutane; report to the FDA
any adverse drug experiences and any new information that might
affect the "safety, effectiveness or labeling of the drug product";
review the scientific literature; and review the data for evidence
of signals, that is, "potential safety issues that should be
included on the product label." Rossitto, supra, slip op. at 13.6
"From 1992 to 1998, defendants recorded several positive
rechallenge reports of IBD." Id. at 14. Dr. Alan Bess, defendants'
former Director of Drug Safety, admitted that a single positive
rechallenge could be significant enough to warrant inclusion of
the event on the label. Ibid. Dr. Martin Huber, another former
Director of Drug Safety, however, "stated it was 'very difficult
to interpret' positive rechallenge data for IBD, because it is a
6
"As part of that monitoring process, defendants collected data
on adverse drug experiences . . . or events through its call center
and through MedWatch, the FDA's voluntary reporting system." Ibid.
As required by 21 C.F.R. §314.80(f) (2017), defendants "recorded
the reports on an FDA form, listing among other information, a
description of the event and whether it abated after the patient
stopped using Accutane and returned after reintroduction (referred
to as 'challenge'/'dechallenge'/'rechallenge')." Id. at 13-14.
12 A-4760-14T1
permanent disease in which the symptoms wax and wane." Ibid.
Defendants also inputted data from reports of adverse drug
experiences (ADE) into their internal ADVENT database, which
contained a field reflecting defendants' assessment of
relatedness. Id. at 15. Defendants prepared periodic internal
causality reports, which were not required to be submitted to the
FDA, that evaluated the ADE reports. Ibid. In one internal
causality assessment, defendants set forth that from 1982 to 1994,
104 cases of IBD and related syndromes were reported in Accutane
users, "of which thirty-three were given a causality rating of
'possibly or probably related to the administration of the drug.'"
Ibid. Based on that information, Dr. Henry Lefrancq, a Roche
physician, stated in a February 24, 1994 internal memo – which was
not submitted to the FDA – that "[i]t is reasonable to conclude
from this data, that in rare cases, ROACCUTANE[7] may induce or
aggravate a preexisting colitis." Id. at 16. He explained "it was
reasonable to assume Accutane has the same effect on the intestinal
mucosa as on the other mucosae in the body such as the oral or
nasal mucosae" and that "these reactions have always been
reversible, the colitis which may develop in a relatively limited
7
Roaccutane, also spelled Roaccutan, is Accutane's European brand
name.
13 A-4760-14T1
number of patients can as well be regarded as reversible." In
their June 1994 "general data" report, defendants stated that
"[c]olitis appears as a possible Side [E]ffect of ROACCUTANE" and
that inflammation of the small intestine and colon "is a possible
side effect of ROACCUTANE in very rare cases, possibly in patients
predisposed to inflammatory gastro-intestinal diseases."
Meanwhile, defendants prepared periodic safety update reports
(PSUR) for the European market. In an August 17, 1988 report, Dr.
Peter Schifferdecker, a physician and product specialist, reviewed
the ADE reports received from patients using Accutane from January
1 to June 30, 1988, and reported that "[s]ince introduction,
R[oche] Drug Safety received [thirty-eight] case reports of
colitis and proctitis[8] in association with [Accutane] treatment."
Kendall I, supra, slip op. at 10. Schifferdecker wrote that:
[u]lcerative colitis and proctitis has an
incidence rate of approximately 6-8 cases per
100,000 population per year (U.S.A. and
western Europe). . . .
It appears that cases of colitis and proctitis
reported to R[oche] Drug Safety are within the
spontaneous incidence rates of the background
population, although underreporting of such
cases may occur. It should be stressed that
approximately one half of the patients were
at a certain risk for the development of
colitis prior to [Accutane] treatment.
8
Proctitis is an inflammation of the lining of the rectum.
14 A-4760-14T1
Although there is evidence from in vitro and
animal experiments that [Accutane] may protect
the organism from experimental colitis,[9] []
R[oche] Drug Safety will further monitor
closely cases of colitis and proctitis
reported in association with [Accutane]
treatment.
[Id. at 10-11.]
In a November 16, 2000 PSUR, which they also did not submit to the
FDA, defendants reviewed ADEs from September 1, 1999, to August
31, 2000, and concluded that "[i]sotretinoin has been found to be
causally associated with [IBD], including colitis."
(4)
In December 1997, as sales of Accutane were "escalating
sharply," there arose differences of opinion between defendants'
drug safety department and defendants' marketing department about
adopting a label change to warn about a different side effect
(depression) of Accutane. Rossitto, supra, slip op. at 17. Bess
testified that Frank Condella, defendants' vice-president of
marketing, "felt very strongly that any label change would hurt
U.S. sales." Ibid. "The marketing department's 'philosophy was to
protect the franchise' and 'build the product,' and thus Condella,
during a 'very loud disagreement,' 'made it very clear that he
9
Scientists have attempted to produce colitis in laboratory
animals through vascular impairment and immunological methods.
15 A-4760-14T1
wouldn't tolerate any action that would hurt the product.'" Ibid.
"Mike Carter, [a drug safety officer] who reported to Bess, agreed
that '[m]arketing was calling the shots.'" Id. at 17-18.
Russell Ellison, defendants' former chief medical officer,
who testified in Rossitto, Gaghan, and Kendall II, admitted
defendants "made a significant investment in marketing Accutane,
and that its investment strategy was to '[f]eed the goose that
lays the golden egg.'" Rossitto, supra, slip op. at 18. Ellison
acknowledged there were "disagreements" between marketing and drug
safety, and that safety-related label changes can hurt sales, but
he disputed that marketing "called the shots" and claimed that
marketing concerns "did not prevail because in February 1998 the
Accutane label was changed to include a stronger warning about
depression." Ibid.
In any event, in March 1998, the FDA warned defendants that
their advertising and promotional materials for Accutane
were "false or misleading" and promoted
"Accutane for an unapproved use." The FDA
found that Roche had failed to disclose "that
depression may be associated with the use of
Accutane," and had "misleadingly" suggested
"that Accutane therapy will minimize or
improve the patient's psychosocial status,
including depression," even though Roche had
"not systematically studied" the ability of
Accutane to modify or prevent depression.
According to the FDA, Roche's claim was
"particularly troublesome in light of
information recently presented in a Dear
16 A-4760-14T1
Doctor letter, that Accutane may cause
depression[.]" The FDA required Roche to cease
this promotional activity and to instruct its
sales personnel to stop disseminating the
materials.
[Id. at 18-19.]
As our record reflects, in February 1999, the FDA asked
defendants whether they had "enough data to observe" Accutane-
associated IBD "reversibility." This inquiry generated some
internal "confusion" because defendants understood IBD was a
permanent, irreversible condition. In considering defendants'
response, Carter observed that the Accutane label "says nothing"
about reversibility "particularly, therefore one would assume . .
. [FDA may feel wrongly] the event is reversible." In a series of
internal emails captioned "urgent," Huber sought help on the
"reversibility" issue.
In January 2000 – eleven months later – while then engaged
in negotiations with the FDA regarding finalizing a new Accutane
label – defendants responded to the FDA's inquiry by relying on a
report by Dr. John LaFlore, a Roche physician, and by proposing
no changes to the IBD label. In his October 1999 report, LaFlore
had stated that, from 1992 to 1999, there had been 206 "case
reports" "with IBD as a preferred term," but claimed there had
been only one "positive rechallenge," explaining:
17 A-4760-14T1
[t]he onset of these events during
isotretinoin use and the positive dechallenge
reports are sufficient to justify the current
warning in the label that IBD and regional
ileitis may temporally arise during therapy
and anyone with appropriate symptoms should
discontinue therapy. However, the reports do
not have the quality to revise this warning.
He concluded there was insufficient information
to recommend additional label changes related
to [IBD]. Some patients with known active
symptoms and diagnosis of . . . (IBD) are
treated with Accutane for their severe
recalcitrant acne without clinical sequel to
their IBD symptoms. . . . There is no
additional information to suggest an
association of isotretinoin use with
recurrence or prolongation of the symptoms of
the disease based on the etiology and
epidemiology of the disease.
Nonetheless, in May 2000, the FDA approved an amendment to
the "WARNINGS" section of the package insert or label – warnings
at issue in this appeal. These amendments, which were provided to
physicians but not patients, removed the word "temporally," and
this time warned that:
Accutane has been associated with inflammatory
bowel disease (including regional iletis) 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).
The "ADVERSE REACTIONS" section asserted that the "relationship
18 A-4760-14T1
of some" of the listed events "to Accutane therapy"
is unknown. Many of the side effects and
adverse reactions seen in patients receiving
Accutane are similar to those described in
patients taking very high doses of vitamin A
(dryness of the skin and mucous membranes,
e.g. of the lips, nasal passage, and eyes).
. . . .
Gastrointestinal inflammatory bowel disease
(see WARNINGS: inflammatory bowel disease)
. . . bleeding and inflammation of the gums,
colitis, ileitis, nausea, and other
nonspecific gastrointestinal symptoms.
Bess admitted that "[t]he term 'association' is susceptible of
different meanings within a package insert or label." Eileen Leach,
defendants' former Medical Director of Dermatology, testified that
"associated" does not mean "cause," and that if defendants had
concluded that Accutane caused IBD, it should have included that
finding on the label. Huber agreed there was a difference between
"association" and "causation." Huber similarly admitted it would
be inappropriate to state that a drug is "associated with" an
adverse event (such as birth defects) if defendants knew there was
a causal relationship. And he recognized that, if defendants
believed that an event was caused by a drug, they "had an
obligation to include that in [the] label."
(5)
Beginning in January 2002, defendants implemented a new
19 A-4760-14T1
pregnancy prevention program entitled "System to Manage Accutane
Related Tetatogenicity," or "S.M.A.R.T." Under that program, a
physician could only prescribe Accutane after obtaining a supply
of yellow Accutane stickers. To receive the stickers the physician
had to "[r]ead" the S.M.A.R.T. Guide to Best Practices, and "[s]ign
and return" a letter of understanding that stated:
 I know the risk and severity of fetal
injury/birth defects from Accutane.
 I know how to diagnose and treat the
various presentations of acne.
 I know the risk factors for unplanned
pregnancy and the effective measures for
avoidance of an unplanned pregnancy.
 . . . I will refer [the patient] for
expert, detailed pregnancy prevention
counseling and prescribing, reimbursed
by the manufacturer, OR I have the
expertise to perform this function and
elect to do so.
 I understand and will properly use
throughout the Accutane treatment
course, the S.M.A.R.T. procedures for
Accutane including monthly pregnancy
avoidance counseling, pregnancy testing
and use of the yellow self-adhesive
Accutane Qualification stickers.
This S.M.A.R.T. Guide to Best Practices provided to physicians,
however, focused almost exclusively on birth control and pregnancy
and only briefly warned about IBD in a section entitled "About
Accutane," prefaced with a statement that "Accutane is teratogenic
20 A-4760-14T1
and must not be used by pregnant women," following which it
acknowledged that
Accutane use is associated with other
potentially serious adverse effects, as well
as more frequent, but less serious side
effects. More frequent, less serious side
effects include cheilitis, dry skin, skin
fragility, pruritus, epistaxis, dry nose and
dry mouth and conjunctivitis.
Adverse Event Warnings include psychiatric
disorders . . . ; pseudotumor cerebri;
pancreatitis; hyperlipidemia; hearing
impairment; hepatotoxicity; inflammatory
bowel disease; skeletal changes . . . ; [and]
visual impairment.
These paragraphs were followed by a statement that "[p]atients
should be reminded to read the Medication Guide, distributed by
the pharmacist at the time Accutane is dispensed." Pharmacists
gave the "Medication Guide," published in January 2001, directly
to patients. In alerting of the "possible serious side effects"
of Accutane, the Guide described some of the symptoms of IBD but
did not refer to the disease by name:
Abdomen (stomach area) problems. Certain
symptoms may mean that your internal organs
are being damaged. These organs include the
liver, pancreas, bowel (intestines), and
esophagus . . . . 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; have trouble
swallowing or painful swallowing; get new or
worsening heartburn, diarrhea, rectal
21 A-4760-14T1
bleeding, yellowing of your skin or eyes, or
dark urine.
. . . .
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
clear up even after you stop taking Accutane.
Beginning in January 2002, physicians were also required to
provide patients with a patient brochure: a bright pink-colored,
metal-ring binder entitled "Be Smart/Be Safe/Be Sure." Kendall I,
supra, 209 N.J. at 183. As with the other materials referred to
above, the "binder materials primarily focused on the dangers of
becoming pregnant while taking Accutane." Ibid. The first section
of the Eighth and Ninth Edition warned of "serious side effects,"
without specifically referring to IBD. These editions also
included consent forms to be removed and signed by the patients,
one of which stated that the patient had read and understood the
provided written materials, and listed several side effects of
Accutane, including birth defects and the risk of depression and
suicide, but not IBD.10
10
Female patients also were required to sign a second "patient
information/consent" form, which stated that the patient had read
and understood the written material and had watched a video on
contraception.
22 A-4760-14T1
Similar warnings to patients were included on the blister
packaging, which again primarily warned about birth defects and
depression, but also warned of "other serious side effects to
watch for," without specifically referring to IBD:
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 . . . .
In September 1999, the American Journal of Gastroenterology
published a letter to the editor in which the mother of an Accutane
patient raised concerns about the latent onset of IBD. The writer
suggested defendants, who had not conducted any post-marketing
clinical or epidemiological studies to investigate a link between
Accutane and IBD, should conduct such a study. Defendants
internally expressed concern that they should look at this issue
"with some dispatch," and that "a letter in a fairly widely-read
journal . . . might add fuel to fires which are already set."
Ten years later (after trials in the first two Accutane cases,
McCarrell I and Kendall I), the first Accutane observational
23 A-4760-14T1
epidemiological studies11 were conducted by researchers, not
defendants; these studies yielded mixed results. Only one study
found a statistically-significant positive association between
Accutane and ulcerative colitis, although four studies found a
positive association between the drug and ulcerative colitis (but
not Crohn's disease).
(6)
Cheryl Blume, a pharmacologist and vice-president of a
pharmaceutical consulting company, testified as plaintiffs' expert
in regulatory affairs, pharmacovigilance, and drug labeling in all
11
There are two types of epidemiological studies: experimental
and observational. Reference Manual on Sci. Evidence 549, 555 (3d
ed. 2011), which may be found at the following location:
http://www.supremecourt.ohio.gov/LegalResources/LawLibrary/resou
rces/scientificEvidence.pdf. Experimental studies, or double-
blind randomized control trials, in which one group is exposed to
an agent and the other is not, are "considered the gold standard
for determining the relationship of an agent to a health outcome
or adverse side effect." Ibid. There are no Accutane experimental
studies because even though such studies have the potential to
provide higher quality evidence, they cannot ethically be
conducted if researchers suspect that a drug's side effects are
harmful. Id. at 555-56. Instead, all Accutane epidemiological
studies to date have been less rigorous observational studies.
Unlike experimental studies in which risk factors can be
controlled, observational studies generally focus on individuals
living in a community, "for whom characteristics other than the
one of interest, such as diet, exercise, exposure to other
environmental agents, and genetic background, may distort a
study's results." Id. at 556. "[T]he Achilles' heel of
observational studies is the possibility of differences in the two
populations being studied with regard to risk factors other than
exposure to the agent." Ibid.
24 A-4760-14T1
of the Accutane cases tried to date. Rossitto, supra, slip op. at
26. She opined that neither the 1984 warning, McCarrell I, supra,
slip op. at 108, Sager, supra, slip op. at 21-22; Rossitto, supra,
slip op. at 26, nor the amended 2000-warning, Kendall I, supra,
slip op. at 31-32, accurately reflected defendants' knowledge
concerning IBD.
In opposing defendants' summary judgment motion, plaintiffs
cited to Blume's testimony at the Tanna trial; there, she opined
the post-2000 warnings were inadequate because defendants failed
to disclose all information they possessed at that time:
information they had disclosed for other adverse events, including
birth defects and psychiatric disorders. She explained the package
insert was the "hub of all the information, and everything else
comes out of it" like spokes on a wheel. In her view, as a general
matter, the warning section of a label contains "the more serious
adverse events that have been observed with a product."
Blume testified that although defendants listed IBD in the
warnings section of the label, they failed to advise physicians
they had internally concluded Accutane was "causally associated"
with IBD, that several cases of IBD had been found to be "possibly"
or "probably" related to Accutane, and that Accutane can "induce
or aggravate a preexisting colitis." She testified that defendants
also failed to warn that IBD is a permanent, irreversible condition
25 A-4760-14T1
that cannot be treated, that there were several reported cases of
rechallenges, that there is a latent onset effect, and that the
drug was contraindicated for patients with a family history or
pre-existing IBD. And she asserted that Schifferdecker erroneously
reported in 1988 that adverse events of IBD were "within the
spontaneous incidence rates" because he failed to account for
underreporting.
Blume explained the difference between the term "associated,"
which "simply means that the event occurred in some time proximity
to when the drug was taken," and "causally associated," meaning
"there's information linking the drug use with the adverse event."
She additionally testified that defendants, in warning about other
adverse events, had included: causal language (birth defects and
psychiatric disorders); a warning that the adverse event had been
found to be "possibly or probably related to Accutane"
(hepatotoxicity); and a warning that the event had subsided with
discontinuation of therapy and recurred with reinstitution of
therapy (psychiatric disorders). Consequently, she testified
defendants should similarly have included more information about
IBD, as they had for another rare disease (pseudotumor cerebri),
because the prescribing physicians were generally dermatologists
who may not have been familiar with the permanence and severity
of this gastrointestinal disease.
26 A-4760-14T1
Blume concluded that the amended 2000 label had not been
effective in warning physicians about IBD's severity and
permanence because defendants continued to receive reports of
rechallenges; that is, physicians continued to prescribe Accutane
even after patients developed gastrointestinal side effects. And
she opined that the other warning materials, including the
Medication Guide and the S.M.A.R.T. binders, did not make
sufficiently clear that IBD was a permanent disease that cannot
be cured with treatment. In fact, Blume found the risk of IBD was
minimized in both the Medication Guide and the S.M.A.R.T. binders
because the symptoms of the disease were grouped with other non-
relevant gastrointestinal problems such as painful swallowing and
dark urine.
B
Despite this evidence, the trial judge granted defendants'
motion for summary judgment, finding the post-2002 warnings
contained in the written literature were adequate as a matter of
law to alert prescribing physicians that IBD was a risk associated
with the ingestion of Accutane. In revisiting these issues, which
Judge Higbee had already considered and rejected, the judge alluded
to "new controlling authority," namely, Bailey v. Wyeth, Inc., 424
N.J. Super. 278, 314 (Law Div. 2008), aff'd, 422 N.J. Super. 360
27 A-4760-14T1
(App. Div. 2011), certif. denied, 211 N.J. 274 (2012), and
concluded plaintiffs failed to present "the type and quality of
evidence" required to "overcome the rebuttable presumption of
adequacy under the NJPLA afforded to the FDA-approved labeling
utilized by these [d]efendants in the marketing of Accutane."
Citing to the written warnings, and not to the testimony of Leach,
Bess, Huber or Blume, or defendants' internal documents, the judge
concluded that:
Both the substance and form of the warning
literature issued to prescribing physicians by
[d]efendants emanates a very forceful
seriousness of purpose; driving home the
message to physicians of ordinary skill, care
and diligence that is clear, accurate and
unambiguous, namely, You are about to
prescribe a medication that is associated with
risk of serious side effects. You are
responsible for counseling your patients of
these risks.
Taken as a whole, the warning system crafted
by [d]efendants conveys a meaning as to
potential risks and consequences that is
unmistakable. It is inconceivable to this
court that the reasonable dermatologist (or
any physician, generally) of ordinary
education, training and experience could
examine the materials comprising the warning
literature and not immediately conclude that
Accutane has been associated with life-
altering side effects, including IBD. At
multiple points, IBD is explicitly communi-
cated to the prescribing physician as a
potential risk of Accutane ingestion.
[T]he labeling and all the warning literature
issued to physicians by the manufacturer very
28 A-4760-14T1
ably disclose with ample detail and intensity
the risks associated with taking Accutane.
Viewed objectively, it is a striking package
of information for introducing a medication
to a prescribing physician. Any physician of
ordinary skill, care and diligence who ignored
the [d]efendants' warning system did []
patients a disservice. Such warnings are
entitled to the benefit of our state's
rebuttable presumption of adequacy and are
deemed adequate as a matter of law.
In our de novo review of this determination, we start with certain
general principles.
C
As a general matter, the adequacy of a warning presents a
jury question. Kendall I, supra, 209 N.J. at 195. At the same
time, we recognize that when a plaintiff fails to overcome the
PLA's rebuttable presumption of adequacy in pharmaceutical cases,
Bailey, supra, 424 N.J. Super. at 314, or where a warning is
accurate, clear and unambiguous, Banner v. Hoffmann-La Roche Inc.,
383 N.J. Super. 364, 378-80 (App. Div. 2006), certif. denied, 190
N.J. 393 (2007), a court may conclude that warnings are adequate
as a matter of law.
We also observe that the PLA was enacted "as a remedial
measure to limit the liability of manufacturers by establishing
'clear rules with respect to certain matters relating to actions
for damages for harm caused by products,'" and "[i]n particular,"
29 A-4760-14T1
to "reduce the burden on manufacturers of FDA-approved products
resulting from products liability litigation." Kendall I, supra,
209 N.J. at 194 (quoting N.J.S.A. 2A:58C-1(a)). In accordance with
common law principles, Feldman v. Lederle Labs., 125 N.J. 117, 144
(1991), cert. denied, 505 U.S. 1219, 112 S. Ct. 3027, 120 L. Ed.
2d 898 (1992), the PLA provides that a manufacturer shall be
rendered liable for harm caused by a product "not reasonably fit,
suitable or safe for its intended purpose" when the product
"fail[s] to contain adequate warnings." N.J.S.A. 2A:58C-2. The PLA
represents "an expression of New Jersey's strong public policy of
ensuring that manufacturers attach adequate warnings and
instructions to prescription drugs so that consumers, ultimately,
will be made aware of the relevant risks, dangers, and precautions
in taking such medications." In re Reglan Litig., 226 N.J. 315,
335 (2016).
In addition, we take note that the Supreme Court of the United
States has "articulated an overarching federal policy for
permitting state-law [failure-to-warn] suits," id. at 334, by
recognizing that the FDA:
has limited resources to monitor the 11,000
drugs on the market, and manufacturers have
superior access to information about their
drugs, especially in the postmarketing phase
as new risks emerge. State tort suits uncover
unknown drug hazards and provide incentives
for drug manufacturers to disclose safety
30 A-4760-14T1
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 [Federal Food,
Drug, and Cosmetic Act's] premise that
manufacturers, not the FDA, bear primary
responsibility for their drug labeling at all
times.
[Wyeth v. Levine, 555 U.S. 555, 578-79, 129
S. Ct. 1187, 1202, 173 L. Ed. 2d 51, 68-69
(2009).]
Of additional importance, the PLA incorporates the "learned
intermediary" doctrine by which a manufacturer's duty to warn
about the dangers of prescription drugs runs to the physician, not
the patient. N.J.S.A. 2A:58C-4; Perez v. Wyeth Labs., Inc., 161
N.J. 1, 10 (1999); Niemiera by Niemiera v. Schneider, 114 N.J.
550, 559 (1989). Significantly, the PLA recognizes "the important
role of the federal regulatory system over prescription drugs,"
Reglan Litig., supra, 226 N.J. at 335, and provides that an FDA-
approved drug warning constitutes "a rebuttable presumption" that
the warning is adequate, N.J.S.A. 2A:58C-4. In other words, "an
FDA-approved label is presumably adequate to inform a reasonable
person of the dangers of a product." Kendall I, supra, 209 N.J.
at 197. The Court also expressed an expectation that the
presumption would be overcome only in "rare cases." Perez, supra,
161 N.J. at 25.
We also recognize that, in accordance with the Federal Food,
31 A-4760-14T1
Drug, and Cosmetic Act (FDCA), 21 U.S.C.A. §§ 301-399f, all
pharmaceutical drugs must be FDA-approved before being marketed
in the United States. Reglan Litig., supra, 226 N.J. at 329. The
FDA, which regulates the manufacturing, packaging, and labeling
of drugs under the FDCA, approved all of the warnings at issue
here, including: the May 2000 package insert; the January 2001
Medication Guide; the January 2002 S.M.A.R.T. Guide to Best
Practices; the January 2002 "Be Smart/Be Safe/Be Sure" patient
brochure; and the blister packaging. See 21 U.S.C.A. § 355(a).
The FDCA requires a pharmaceutical manufacturer to prove,
prior to marketing, that a new drug "is safe and effective and
that the proposed label is accurate and adequate." PLIVA, Inc. v.
Mensing, 564 U.S. 604, 612, 131 S. Ct. 2567, 2574, 180 L. Ed. 2d
580, 588 (2011). These federal statutes and regulations are based
on the central premise 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." Wyeth,
supra, 555 U.S. at 570-71, 129 S. Ct. at 1197-98, 173 L. Ed. 2d
at 63. The FDCA renders a manufacturer responsible for "the
accuracy and adequacy" of a label "not only when it files a new
drug application, but also when it seeks FDA approval for updated
labeling to inform the public of previously unknown adverse side
32 A-4760-14T1
effects caused by a drug, 21 U.S.C.A. §§ 355(b)(1),(d),(j)(2)(A)."
Reglan Litig., supra, 226 N.J. at 330 (quoting Mensing, supra, 564
U.S. at 612, 131 S. Ct. at 2574, 180 L. Ed. 2d at 588).
In failure-to-warn claims involving pharmaceutical drugs, our
Legislature has acknowledged "the preeminent role of federal
regulation," Cornett v. Johnson & Johnson, 211 N.J. 362, 387
(2012), by affording manufacturers a "rebuttable presumption" that
FDA-approved warnings will be assumed "adequate." N.J.S.A. 2A:58C-
4. This presumption helps "to ensure that manufacturers are not
made guarantors against remotely possible, but not scientifically-
verifiable, side-effects of prescription drugs, a result that
could have 'a significant anti-utilitarian effect.'" Perez, supra,
161 N.J. at 25.
D
Notwithstanding, the PLA recognizes that compliance with FDA
regulations provides only "compelling" – "not absolute" – evidence
that "a manufacturer satisfied its duty to warn about the dangers
of its product." Kendall I, supra, 209 N.J. at 195; Perez, supra,
161 N.J. at 24. It was anticipated that this "virtually
dispositive" presumption would be difficult to overcome. Kendall
I, supra, 209 N.J. at 195-97; see Dreier, Keefe & Katz, Current
N.J. Products Liability & Toxic Torts Law 468-69 (2017). Yet the
33 A-4760-14T1
parties acknowledge the statutory presumption can be overcome.
They disagree, however, as to the precise effect and force of the
presumption. Plaintiffs argue that, "on its face, the statute does
not appear to require anything more than that necessary to overcome
a standard N.J.R.E. 301 presumption." We reject this view.
N.J.R.E. 301 provides that "[i]f evidence is introduced
tending to disprove the presumed fact, the issue shall be submitted
to the trier of fact for determination unless the evidence is such
that reasonable persons would not differ as to the existence or
nonexistence of the presumed fact." Latching on to this approach,
plaintiff argues the PLA created, in their words, only "a garden
variety rebuttable presumption" that should be viewed in the manner
prescribed by N.J.R.E. 301. But, when considering the PLA's intent
to limit the liability of drug manufacturers, it seems clear the
garden-variety presumption of N.J.R.E. 301 was discarded in favor
of what Perez described as something that "[f]or all practical
purposes," will not be overcome "absent deliberate concealment or
nondisclosure of after-acquired knowledge of harmful effects,
compliance with FDA standards should be virtually dispositive of
[failure-to-warn claims]." 161 N.J. at 25.
The Court confirmed that interpretation in Rowe v. Hoffman-
La Roche, Inc., 189 N.J. 615, 626 (2007). And, in Kendall I, supra,
209 N.J. at 195, the Court referred to its holding in Perez as
34 A-4760-14T1
having created "a super-presumption." Consequently, we reject
plaintiff's argument that the statutory presumption should be
approached in the manner described in N.J.R.E. 301. We recognized
as much when we affirmed the trial court's explanation in Bailey,
supra, 424 N.J. Super. at 314, that "the presumption of adequacy
afforded to a manufacturer's compliance with FDA requirements is
stronger and of greater evidentiary weight than the customary
presumption referenced in N.J.R.E. 301." See also Dreier, Keefe &
Katz, supra, at 468-69 (observing that the statutory presumption
described in Perez is much stronger than the typical presumption).
Consequently, this view of the presumption poses a question
relevant to this appeal: what type and degree of proof will rebut
the N.J.S.A. 2A:58C-4 "super presumption?" In Kendall I, supra,
slip op. at 53, we said the "strength of the statutory presumption
may be lessened . . . if the warning at issue is not the initial
warning approved by the FDA for the drug," as in these cases, "but
rather is a modified warning that was negotiated post-market
between the manufacturer and the FDA." And we recognized in McDarby
v. Merck & Co., 401 N.J. Super. 10, 65 (App. Div. 2008), appeal
dismissed, 200 N.J. 267 (2009), that, prior to 2007, the FDA did
not have the "authority to compel labeling changes, but instead
had to negotiate changes with the drug's sponsor." And, given the
manufacturers' "common resistance to such labeling changes, a
35 A-4760-14T1
revised label may be the result of a compromise, rather than a
unilateral expression of the FDA's preferred regulatory approach."
Kendall I, supra, slip op. at 54. In light of the ongoing
regulatory dynamics between drug companies and the FDA, the PLA's
presumption of adequacy is easier to overcome for a negotiated,
post-market label than for the original warning accompanying the
drug, which was not, to the same extent, the result of
"conciliatory processes." McDarby, supra, 401 N.J. Super. at 69.
See Wyeth, supra, 555 U.S. at 578-79, 129 S. Ct. at 1202, 173 L.
Ed. 2d at 68 (recognizing FDA's "limited" monitoring resources).
The presumption may also be overcome with: (1) evidence of a
deliberate concealment or nondisclosure of after-acquired
knowledge of harmful effects, Perez, supra, 161 N.J. at 25; Rowe,
supra, 189 N.J. at 626; or (2) substantial evidence of
economically-driven manipulation of the post-market regulatory
process, McDarby, supra, 401 N.J. Super. at 63, 66.
As to this first aspect, we note that the Court in Cornett,
supra, 211 N.J. at 390, upheld our reversal of a dismissal on the
grounds of federal preemption, because:
defendants withheld information from the
general public and the medical community about
the limitations of the device or safe use of
the device, including information that
instructions for post-implantation therapy
were not part of the [premarket approval
(PMA)] process, and misrepresented to the
36 A-4760-14T1
general public and medical community that the
[device] was non-thrombogenic. As stated, this
claim overcomes the PLA rebuttable presumption
of adequacy. Perez, supra, 161 N.J. at 25.
Such a claim falls within a traditional area
of state concern and regulation because fraud
on the FDA is not an element of the claim and
it can be proved by evidence other than by
evidence of fraud on the FDA.
On the other hand, Bailey presents an example of a plaintiff's
failure to overcome the presumption regarding a revised label.12
Applying the Perez/Rowe exceptions here, we must consider – through
the Brill prism – whether plaintiffs presented sufficient evidence
of deliberate concealment or nondisclosure of after-acquired
knowledge of harmful effects to suggest that a genuine dispute as
to whether the PLA's "super" presumption may be overcome.
Plaintiffs contend, as in other Accutane cases involving the
1984 warning, that they can overcome the presumption because of
evidence that defendants "failed to disclose information it had
on the risk of IBD with Accutane use, that economics drove its
12
In Bailey, a trial judge found the plaintiffs failed to overcome
the rebuttable presumption of adequacy afforded FDA-approved
labeling even though the label had been significantly revised on
multiple occasions since initial approval. 424 N.J. Super. at 304,
336. The Bailey trial judge found the plaintiffs "failed to present
any evidence of deliberate concealment or nondisclosure of after-
acquired knowledge" because there was no proof that defendants
withheld any information on safety, including adverse event
reports, prior to approval by the FDA. Id. at 315.
37 A-4760-14T1
decisions on drug safety and warnings, and that it withheld
information on the risk of the drug from the medical community and
the public." We commence our consideration of the evidential
materials by observing that in all other cases tried to date13
within this MLC matter, juries have found the 1984 FDA-approved
warning that Accutane had been temporally associated with IBD was
inadequate.
For example, in McCarrell II, supra, 227 N.J. at 577-78, the
plaintiff claimed that
the Accutane label and other warnings conveyed
the impression that the listed adverse
reactions to Accutane would arise while the
patient was taking the medication and that
discontinuing its use would resolve such
problems. Plaintiff also contends that the
warnings did not suggest that he could develop
an irreversible case of [IBD] after completion
of the Accutane regimen. He asserts that,
during the period he took Accutane, Roche knew
or should have known that Accutane not only
could trigger [IBD] after its use, but that
it also could cause irreversible damage to his
organs, and that Roche failed to provide
adequate warnings to him and his physician
about those risks.
We affirmed those findings in all of the cases raising the issue
of the adequacy of the 1984 warning. In fact, in McCarrell I,
supra, slip op. at 108, we rejected defendants' argument that the
13
McCarrell I and II, Kendall I and II, Sager, Gaghan, and
Rossitto.
38 A-4760-14T1
1984 Accutane label warning was adequate as a matter of law under
the PLA. In Kendall I, supra, slip op. at 88-89, we determined
that Blume's testimony was sufficiently persuasive to overcome the
statutory presumption. And, in Rossitto, supra, slip op. at 55-
57, we were satisfied plaintiff presented sufficient evidence to
overcome the presumption, stating:
As in McCarrell I and Kendall I, here there
was evidence that the 1984 warning, as it
existed when plaintiffs took the drug from
1992 to 1998, was inadequate even though it
specifically referred to IBD, because it did
not accurately reflect the knowledge the
company allegedly had. As we have noted, Dr.
Blume testified that during the sixteen years
that the label had remained unchanged (from
1984 to 2000), Roche had received information
through ADE reports that indicated both a
causal relationship between Accutane and IBD
and a latency effect, which she asserted was
critically important information for a
physician to have in making a risk/benefit
analysis. Dr. Blume also criticized Roche's
use of the term "temporally associated," which
was subject to differing definitions by the
company's own employees, and which she said
meant while a patient was taking the drug.
The labeling expert opined that the use of the
term "temporally" falsely suggested that the
disease was reversible, and that there was no
latent effect.
We recognize that the FDA approved the 1984
version of the label. Nevertheless, plaintiffs
marshalled sufficient competing evidence upon
which a jury reasonably could rely to overcome
the rebuttable statutory presumption of
adequacy. At a minimum, viewing the record
from this trial, as we must, in a light most
favorable to the respondents . . . there was
39 A-4760-14T1
potentially credible proof of the company's
"deliberate concealment or nondisclosure of
after-acquired knowledge of [Accutane's]
harmful effects[.]" Perez, supra, 161 N.J. at
25 (emphasis added); see also Rowe, supra, 189
N.J. at 626. On a retrial, the parties are
free to continue to litigate the general
causation issues bearing upon Accutane's
actual "harmful effects" and the adequacy of
the 1984 label, with the opportunity to expand
the proofs to include more recent scientific
studies further addressing those questions.
We have yet to directly address whether plaintiffs overcame
the presumption of adequacy as to the post-2000 warnings. In
Kendall I, supra, 209 N.J. at 182-84, the Court only considered
the post-2000 warnings as it related to the tolling of the statute
of limitations. In that case, the plaintiff was first prescribed
Accutane in 1997 (when the 1984 warning was in effect), was
diagnosed with IBD in April 1999, received her fifth course of
Accutane in December 2000, and her sixth course from 2003 to 2004
(when the 2000 warnings at issue here were in effect). Id. at 184-
86. The jury considered only the earlier warnings and found
defendants failed to provide an adequate warning to the treating
physician of the risks of IBD from Accutane that it either knew
or should have known prior to April 1999. We reversed and remanded
on other grounds but found Kendall had presented sufficient
evidence, regarding its pre-1999 warnings, to overcome the
presumption:
40 A-4760-14T1
There is ample factual proof in the present
record to justify the jury's determination
that the warnings supplied with Accutane, even
though they had been approved by the FDA, were
inadequate to have reasonably alerted
plaintiff and her physicians to the risks that
plaintiff would contract IBD from using the
drug.
. . . .
Among other things, the expert testimony of
plaintiff's labeling expert, Dr. Blume (who
was not countered by an equivalent defense
expert specifically called to opine
exclusively on labeling issues) was
sufficiently persuasive and tied to the proofs
that a reasonable juror could have found the
statutory presumptions were overcome.
[Kendall I, supra, slip op. at 88-89.]
The Supreme Court affirmed, holding that "Kendall's suit may
proceed because the evidence not only overcame the presumption,
but established that under all the circumstances, Kendall
reasonably was unaware that defendants caused her injury until
after December 21, 2003." Kendall I, supra, 209 N.J. at 198. The
Court wrote:
Although we can conceive of circumstances in
which the 2003 warning might have been
sufficient to alert a plaintiff of the
connection between Accutane and her disease,
it was certainly not sufficient, in these
circumstances, to cause Kendall to doubt her
physicians or to disregard the advice and
information that had been imparted to her by
them for the prior six years. That is
particularly so in light of the lack of a
41 A-4760-14T1
discernable link between Kendall's symptoms
and the ingestion of the drug.
[Id. at 199.]
The Accutane MCL trial judges have addressed this issue, but with
conflicting results on the adequacy of the post-2000 warnings.
In considering the adequacy of the post-April 10, 2002
warnings, it may be true that the warnings to physicians (May 2000
package insert and S.M.A.R.T. Guide to Best Practices), and to
patients (2001 Medication Guide, Be Smart/Be Safe/Be Sure binder,
and blister packaging) possess greater clarity than the 1984
warnings at issue in McCarrell I and II, Kendall I and II, Sager,
Gaghan, and Rossitto. "[T]emporally" was removed; without the
connotation conveyed by that word, physicians were warned that
Accutane is "associated" with IBD. Warnings were also added that
IBD symptoms had persisted in some cases after Accutane was
discontinued, thus coming closer to conveying that symptoms may
be permanent. In Rossitto, supra, slip op. at 45, we said "it is
manifestly clear that the 2000 warning . . . strengthen[ed] the
label's warning relating to IBD and gastrointestinal disorders by
removing the 'temporally associated' phrasing."
But the post-2002 warnings like the 1984 warnings still lack
causal language – what Blume said was "critically important"
information for physicians. Id. at 56. In fact, many of the
42 A-4760-14T1
treating physicians in the Accutane MCL cases have testified they
would have wanted to know if there was a causal relationship, and
if warned, they would have conveyed that warning to their patients.
Id. at 58-61. The warnings also lack information as to a latency
effect, and lack any statement that the disease is not reversible.
Indeed, the materials provided to patients, which were also
available to physicians, implied that if "treated" a patient would
not suffer "serious health problems." As Judge Higbee found in
denying defendants' previous motion for summary judgment, the
Medication Guide compounded the confusion as to causation by
failing to refer to IBD and by listing the symptoms of IBD along
with other non-relevant symptoms such as yellowing of the eyes and
dark urine.
The record also contains evidence that defendants had after-
acquired knowledge of these harmful effects that they failed to
disclose. For example, there was evidence that defendants had
internally concluded, based on information contained in ADE
reports, that in some cases there was a causal effect between the
drug and IBD, but defendants did not disclose that information to
the FDA or include it in the Accutane label. And there was evidence
that defendants included that information for other adverse
events, including strong warnings that "there is an extremely high
risk that a deformed infant can result if pregnancy occurs while
43 A-4760-14T1
taking Accutane," and warnings that Accutane "may cause"
psychiatric disorders."
The record also contains evidence that defendants received
several positive rechallenge reports, which they did not include
in the label as they had for psychiatric disorders. Consequently,
plaintiffs argue defendants may have misrepresented the number of
rechallenge events in responding to the FDA's inquiry. In addition,
defendants did not respond to the FDA's inquiry regarding whether
Accutane-induced IBD was reversible. Despite this after-acquired
knowledge of harmful effects, and the confusion as to whether the
disease was reversible, no changes to the 1984 label were proposed
by defendants in 2000.
In applying our familiar standard of review on summary
judgment dispositions, we conclude from this record that
plaintiffs presented sufficient evidence of defendants'
nondisclosure of after-acquired knowledge of Accutane's harmful
effects to overcome the rebuttable statutory presumption of
adequacy and to present a jury question as to the adequacy of the
warning. Although defendants specifically mentioned IBD in their
warnings, there is evidence from which a finder of fact could
conclude that, after FDA-approval, defendants internally concluded
there was a causal effect between Accutane and IBD and received
reports of rechallenges and a latency effect – critical information
44 A-4760-14T1
that defendants did not disclose in their post-2002 warnings.
Even though unnecessary to our disposition of this appeal –
because we conclude that plaintiffs overcame the statutory
presumption by presenting sufficient evidence under the first
prong – we briefly discuss the second prong, i.e., whether
plaintiffs presented substantial evidence of economically-driven
manipulation of the post-market regulatory process.
To give context to this argument we briefly discuss our
experiences with this second prong. In McDarby, supra, 401 N.J.
Super. at 50, the plaintiffs brought claims under the PLA against
a manufacturer of Vioxx for failure to warn of cardiovascular
risks. At the time of FDA approval, the defendant was aware of a
possible, but unconfirmed, risk of increased cardiovascular
events. Id. at 67. Defendant's post-approval study unintentionally
confirmed the increased risk. Ibid. The defendants, however,
sought "to dilute the labeling required as a result of [this]
study" and "to ensure" the results "were not communicated to
prescribing physicians by sales persons." Id. at 68. We concluded
this type of conduct can overcome the presumption, finding that
given the
admitted flaws in the FDA's control over
postmarket labeling in the years that Vioxx
was on the market, we are unwilling to accept
Merck's position that the presumption of
adequacy of a prescription drug's label can
45 A-4760-14T1
be overcome only upon proof of deliberate
concealment or nondisclosure. Facts unavail-
able to the Supreme Court at the time of the
Perez decision demonstrate that such a
restriction is too narrow.
[Id. at 66.]
A similar approach was taken by the trial judge in Bailey, supra,
424 N.J. Super. at 315-19.
Although the evidence here might not appear as strong as that
in McDarby, we conclude that for present purposes – requiring that
evidence be viewed in plaintiffs' favor – that this evidence also
required a denial of summary judgment.
In support of their arguments on this second prong of the
Perez/Rowe exception, plaintiffs refer to: (1) the "marketing
trumps safety" discussions regarding Accutane and depression; (2)
Ellison's comments that defendants' investment strategy was to
"feed the goose that lays the golden egg"; and (3) defendants'
failure to respond to the FDA's query regarding IBD reversibility.
Because the significance or weight of this evidence is a matter
for the trier of fact, we conclude that it was sufficient to
preclude summary judgment.
In granting summary judgment, the trial judge adopted a view
similar to defendants' conclusory assertion that "no reasonable
jury could conclude that Accutane's 2002 warnings failed to
adequately warn prescribers of the risk of IBD." The judge
46 A-4760-14T1
similarly concluded that the warnings are "clear, accurate and
unambiguous," and that the facts demonstrate
the labeling and all the warning literature
issued to physicians by the manufacturer very
ably disclose with ample detail and intensity
the risks associated with taking Accutane.
Viewed objectively, it is a striking package
of information for introducing a medication
to a prescribing physician. Any physician of
ordinary skill, care and diligence who ignored
[d]efendants' warning system did his/her
patients a disservice. Such warnings are
entitled to the benefit of our state's
rebuttable presumption of adequacy and are
deemed adequate as a matter of law.
We reject the judge's determination that the warning was
clear enough to negate a trial on the issue. The PLA provides that
a manufacturer shall be liable for harm caused by a product that
was "not reasonably fit, suitable or safe for its intended purpose"
because it "failed to contain adequate warnings." N.J.S.A. 2A:58C-
2. A manufacturer "shall not be liable for harm caused by a failure
to warn if the product contains an adequate warning," which is
defined 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 . . . in the case of prescription
drugs . . . the characteristics of, and the
ordinary knowledge common to, the prescribing
physician. . . .
[N.J.S.A. 2A:58C-4.]
47 A-4760-14T1
The PLA thereby incorporates the "learned intermediary" doctrine
under which a pharmaceutical manufacturer's duty to warn about the
dangers of prescription drugs runs to the physician, not the
patient. Perez, supra, 161 N.J. at 10; Niemiera, supra, 114 N.J.
at 559. "A product warning or instruction that does not comport
with" N.J.S.A. 2A:58C-4 is "defective." Banner, supra, 383 N.J.
Super. at 375.
Consequently, we reverse because we substantially agree with
the views expressed by Judge Higbee when she denied summary
judgment on this same issue. Judge Higbee emphasized, as do we,
that the summary-judgment procedure required a consideration of
the evidence in the light most favorable to plaintiffs:
Looking at the facts in [the] light most
favorable to plaintiff, the question is does
the warning convey in a clear, concise, and
sufficiently forceful way the risk of the
patient developing IBD which is a severe life
changing condition that is permanent even
after the drug is discontinued?
It may be that the facts about the disease are
not as represented by plaintiff's expert, but
for purposes of this motion the Court must
assume that Accutane causes IBD which is very
different from transient gastrointestinal
problems associated with many medications.
Even if the jury finds that plaintiff's
allegations about Accutane and IBD are all
true, they still can find this warning is
adequate. The jury can accept that even if
Accutane probably "causes" IBD, the words
"associated with" are sufficient. A warning
48 A-4760-14T1
can be adequate without using the word
"causes," but it can also be inadequate
depending on all the facts.
The jury may conclude this warning adequately
conveys to doctors the nature of the risk
because all doctors should understand IBD is
permanent and serious, but plaintiffs point
out that doctors who prescribe Accutane are
usually dermatologists, not gastroenterolo-
gists. A jury could decide the second and
third sentence [in the warning] suggests to a
doctor the lesser more transient conditions
of diarrhea and gastrointestinal pain that may
persist after removal from the drug, but which
eventually resolves especially by saying the
drug should be discontinued if there are these
common GI symptoms. This may be found to imply
to the physicians that stopping the treatment
would prevent the development of IBD.
A drug label does not have to have the best
possible warning, but it must be sufficient
to adequately convey the nature, extent, and
seriousness of the risk in a clear unambiguous
way to the prescribers of the drug. In this
case, as in most cases, the sufficiency of the
warning is for the jury.
The bottom line is this [c]ourt cannot find
as a matter of law that this warning was
inadequate, but also cannot find it was
adequate as a matter of law.
In addition, in denying defendants' omnibus motion for
summary judgment on the post-2000 package insert and the January
2001 Medication Guide warnings, Judge Higbee found that:
The question now is does the language in the
patient guide strengthen the 2000 warning and
make it so clear that the issue of adequacy
[] should be taken from the jury. As the
plaintiffs point out, the new language itself
49 A-4760-14T1
does not mention IBD. In fact, the new
language generally refers to "the liver,
pancreas, and bowel (intestines)." It is so
general it could be found to weaken the
information in the label, not strengthen it.
There is no direct reference to IBD.
The Medication Guide also states "[the
symptoms] may not get better even after you
stop taking Accutane." (emphasis added). It
is not disputed that if you have IBD, you will
not get "better," in the sense you will ever
be cured.
Additionally, the plaintiffs point out (and
the defendants ignore) additional language in
the Medication Guide in a paragraph at the
bottom of the "serious side effects" listings.
The language states that "[i]f [the symptoms
are] not treated, they could lead to serious
health problems. Even if these problems are
treated, they may not clear up after you stop
taking Accutane." (emphasis added). The "could
lead" and "may not" language are ambiguous.
The ambiguity of the warnings reflects the
defendants' position that there is no proof
of causation. Since the [c]ourt must accept
all facts in favor of the plaintiff, including
causation, which four juries have found does
exist, "could lead" and "may not" are just not
direct enough to render the warning adequate
as a matter of law even if they directly
discussed IBD which they do not. Again, it may
be adequate, but it clearly is a jury
question.
To be sure, defendants' arguments are colorable. We have
discussed the legal standards, which saddle plaintiffs with the
obligation to demonstrate that a reasonably prudent manufacturer
would have provided a stronger warning than the 2000 warning:
"Accutane has been associated with inflammatory bowel disease."
50 A-4760-14T1
The post-2000 warnings may be clearer than the 1984 warnings but
we are satisfied, substantially for the reasons expressed by Judge
Higbee quoted above, that plaintiffs have presented a sufficient
issue of material fact about the warning's adequacy. Defendants
still failed to use any causal language, warning instead that IBD
was "associated" with Accutane use, even though there was evidence
from which a jury could find that defendants had internally
concluded there was a causative effect. The word "associated" is
susceptible of different meanings and, when viewed in the light
most favorable to plaintiffs, would appear not to be sufficiently
"intens[e]" or "striking" – words used by the judge to describe
the warning – to suggest to a reasonably prudent reader that the
drug being "associated" with IBD was the same as the drug causing
IBD.14
14
We are not persuaded that our decision in Spinden v. Johnson &
Johnson, 177 N.J. Super. 605, 606 (App. Div.), certif. denied, 87
N.J. 376 (1981) requires a different result. There, the plaintiff
alleged warnings contained on packages of Ortho-Novum (birth
control pills) which referred to the risk of developing
thromboembolic disease were inadequate. The package insert
provided in relevant part that:
An increased risk of thrombo-embolic disease
associated with the use of hormonal
contraceptives has now been shown in studies
conducted in both Great Britain and the United
States.
51 A-4760-14T1
For these reasons, we reverse the entry of summary judgment
in favor of defendants.
E
Plaintiffs also argue that the trial judge erred in rejecting
Judge Higbee's prior rulings on the same subject matter. Although
not necessary to our disposition – since we reverse on the merits
– we briefly observe that we find no particular error in the
judge's revisiting of these issues.
The so-called law-of-the-case doctrine is a non-binding,
discretionary rule designed to prevent litigation of a previously
Retrospective studies of morbidity in Great
Britain and studies of morbidity in the United
States have shown a statistically significant
association between thrombophlebitis,
pulmonary embolism and cerebral thrombosis and
the use of oral contraceptives. . . .
[Id. at 607.]
The trial judge in Spinden found these warnings were adequate as
a matter of law and granted an involuntary dismissal. Ibid. In
affirming, we found the "trial judge's reasoning that the phrase
'a statistically significant association' means a cause and effect
relationship seems correct," mainly because it was expressed in
the context of a clearer and more elaborate warning about "'an
increased risk of thromboembolic disease associated with the use
of hormonal contraceptives . . . .'" Id. at 608 (quoting Goodson
v. Searle Labs, 471 F. Supp. 546, 547 (D. Conn. 1978)). This case
is distinguishable because here the label warns only that Accutane
has been "associated" with IBD – a term which, when used in a
label, even defendants' own employees conceded could be
susceptible to different meanings.
52 A-4760-14T1
resolved issue. Lombardi v. Masso, 207 N.J. 517, 538 (2011). The
doctrine requires "judges to respect unreversed decisions made
during the trial by the same court or a higher court regarding
questions of law." Sisler v. Gannett Co., 222 N.J. Super. 153, 159
(App. Div. 1987), certif. denied, 110 N.J. 304 (1988). "Prior
decisions on legal issues should be followed unless there is
substantially different evidence at a subsequent trial, new
controlling authority, or the prior decision was clearly
erroneous." Ibid.
An order denying summary judgment, however, "is not subject
to the law of the case doctrine because it decides nothing and
merely reserves issues for future disposition." Gonzalez v. Ideal
Tile Importing Co., 371 N.J. Super. 349, 356 (App. Div. 2004),
aff’d, 184 N.J. 415 (2005), cert. denied, 546 U.S. 1092, 126 S.
Ct. 1042, 163 L. Ed. 2d 857 (2006). The denial of summary judgment
"is always interlocutory, and never precludes the entry of judgment
for the moving party later in the case . . . ." Hart v. City of
Jersey City, 308 N.J. Super. 487, 498 (App. Div. 1998).
Because the prior ruling represented a denial of summary
judgment, the doctrine had no application. The trial judge was
entitled to revisit – in a sound exercise of discretion – that
interlocutory disposition at any time prior to entry of final
53 A-4760-14T1
judgment in the interests of justice. R. 4:42-2.15
II
The 514 plaintiffs involved in the second appeal filed MCL
Accutane complaints against defendants on various dates between
2005 and 2013. The long-form complaint, designated for use in
these MCL cases, contains their claim of defendants' failure to
warn under New Jersey's PLA, "and/or [sic] the analogous law of
plaintiff's state(s) of ingestion and/or [sic] prescription."
In January 2015, defendants moved for summary judgment in a
case scheduled for trial a few months later on the adequacy of the
post-2002 warnings under either New Jersey or Washington law; that
plaintiff, however, dismissed her case for unrelated reasons.
Defendants then amended their motion for summary judgment based
on the adequacy of the warnings in all MCL cases where plaintiffs
first ingested Accutane after April 10, 2002.
In deciding that motion, the judge issued a written opinion
explaining that, in his view, the warnings given by defendants on
or after April 10, 2002, were adequate as a matter of law under
15
Even if it were otherwise, the law-of-the-case doctrine is not
immutable; it is always to be balanced against "factors that bear
on the pursuit of justice," and should never "be used to justify
an incorrect substantive result." Hart, supra, 308 N.J. Super. at
498; see State v. K.P.S., 221 N.J. 266, 276 (2015); Toto v.
Princeton Twp., 404 N.J. Super. 604, 618 (App. Div. 2009).
54 A-4760-14T1
the PLA. The judge also sought supplementation of the parties'
submissions to allow for a determination as to which states
plaintiffs had ingested Accutane other than New Jersey during the
same time period.
The judge heard additional argument regarding any choice-of-
law determinations necessary in claims in which it was alleged
Accutane was ingested in places other than New Jersey. He also
sought the parties' views about the significance of counsel's
initial request for MCL treatment of these cases.16 At that time,
the judge provided a preliminary view:
an objective reading of [counsel's]
representations to the court indicates that
[p]laintiffs wished to consolidate the sixty-
eight cases in order that a determination may
be made regarding "whether defendant violated
the New Jersey Products Liability Act in its
marketing and sale of Accutane."
16
The judge referred to a January 25, 2005 letter, submitted by
plaintiffs' counsel, pursuant to Rule 4:38A, for classification
of Accutane cases as "a mass tort" (now known as "multicounty
litigation" or "MCL") and centralized case management. In that
letter, counsel advised of the sixty-eight Accutane cases pending
in New Jersey (sixty-two were venued in Atlantic County) and the
expectation of many more; he also asserted:
These claims share common issues of law and
fact, including whether Accutane causes the
injuries alleged by plaintiffs, whether
defendant adequately warned of the risks of
ingesting Accutane, and whether defendant
violated the New Jersey Products Liability Act
in its marketing and sale of Accutane.
[Emphasis added.]
55 A-4760-14T1
This preliminary opinion is deduced from the
fact that of the sixty-eight cases referenced
in the letter, only two were brought by New
Jersey residents. There is nothing in [the
letter] – nor [a] follow-up letter of March
15, 2005, referencing "95 cases pending in New
Jersey" – which advises . . . the [p]laintiffs
from "around the country . . . in
geographically disperse areas" wish to bring
the law of their states with them to New
Jersey.
There are now 4,600(+) cases pending in the
Accutane litigation. Of these, 35 are known
to be [pursued by] New Jersey residents. The
need for a state-by-state, choice-of-law
analyses, and a [p]laintiff-by-[p]laintiff
fact discovery deposition of every prescribing
physician of the remaining [p]laintiffs was
neither requested, advised of, nor alluded to
by [counsel] in his letters [seeking MCL].
Regardless of what may have transpired in
prior proceedings in the Accutane MCL, I have
serious concerns as to this court's obligation
to consider [p]laintiffs' claims under any
legal standards but those of the New Jersey
Products Liability Act, as requested [in the]
January 25, 2005 letter.
Eventually, the judge determined the PLA applied to claims
asserted by out-of-state plaintiffs because of counsel's statement
in the Rule 4:38A petition for MCL. And, because the judge had
determined that application of the PLA warranted entry of summary
judgment as to the post-2002 warnings were adequate as a matter
of law, he granted summary judgment in those matters. For reasons
set forth in our disposition of A-4760-14, we have determined that
56 A-4760-14T1
the judge's application of the PLA and New Jersey law was erroneous
and that the adequacy of the warnings could not be resolved as a
matter of law in any case in which New Jersey law applied.
Consequently, if we were to agree with the propriety of applying
New Jersey law to claims asserted by out-of-state plaintiffs, we
would reverse the summary judgments entered against those out-of-
state plaintiffs.
The judge, however, also provided an alternative basis for
granting summary judgment in many of the cases commenced by out-
of-state plaintiffs. Invoking the interests of "judicial economy,"
the judge conducted a choice-of-law analysis and found that, upon
applying the law of the jurisdictions in which these out-of-state
plaintiffs resided and ingested Accutane, defendants were entitled
to summary judgment. The judge granted summary judgment against
plaintiffs who resided in and ingested Accutane in twenty-one
other jurisdictions (Alabama, California, Colorado, Florida,
Georgia, Illinois, Indiana, Kentucky, Maryland, Mississippi,
Missouri, New Hampshire, New York, North Dakota, Puerto Rico,
Tennessee, Texas, Virginia, Washington, Wisconsin, and Wyoming).
He denied summary judgment under the laws of twenty other
jurisdictions (Arkansas, Connecticut, Delaware, District of
Columbia, Idaho, Iowa, Kansas, Maine, Massachusetts, Minnesota,
Montana, Nevada, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode
57 A-4760-14T1
Island, South Carolina, Utah and Vermont). With regard to
plaintiffs residing in three other jurisdictions (Louisiana,
Nebraska, and South Dakota), the judge deemed it appropriate to
apply New Jersey law. On July 24, 2015, the judge entered an order
dismissing 514 Accutane cases with prejudice.
Plaintiffs appeal, and defendants cross-appeal from that
order. In examining the issues posed in this appeal, we (a)
consider – and reject – the judge's determination that statements
made by the attorney who sought mass tort designation constituted
a waiver of the out-of-state plaintiffs' right to an appropriate
choice-of-law analyses. We then (b) consider – and conclude – that
application of New Jersey's choice-of-law rules requires adoption
of the substantive law of the jurisdictions in which plaintiffs
resided and ingested Accutane. And, we lastly examine (c) the
judge's specific determinations about the law of the other
applicable jurisdictions and whether or to what extent the law of
those other jurisdictions support the judge's rulings on
defendants' summary judgment motion in those cases.
A
Given the language of counsel's representations in seeking
the Supreme Court's May 2, 2005 order that granted MCL treatment
of these cases – which we have already partially quoted in footnote
58 A-4760-14T1
16, supra – the judge held that he was required to consider
all of the remaining claims and issues – in
this instance, warning adequacy – under New
Jersey law. This is so because it was the
[p]laintiffs who framed the limits of the MCL
jurisdiction by asking the court to
consolidate all claims on the question of
whether [d]efendants violated the [PLA] in its
marketing and sale of Accutane. By invoking
New Jersey law, [counsel's] letter highlights
why New Jersey law should control this MCL.
Plaintiffs wanted the benefit of having their
claims heard under the [PLA]. How this court's
predecessor handled this issue or the fact
that cases were tried under California and
Florida law is of no moment. The
representations of [p]laintiffs' petition for
MCL designation are unambiguous, and request
[] determination[s] under the [PLA].
Citing P.V. ex rel. T.V. v. Camp Jaycee, 197 N.J. 132, 154 (2008),
where the Court recognized that "[t]he interests of judicial
administration" require "consider[ation] [of] practicality and
ease of application, [which] further the values of uniformity and
predictability," the judge chose not to perform a choice-of-law
analysis in this part of his opinion, stating instead that such
analyses would not promote "the values of uniform and
predictability" but instead would:
(a) place Atlantic County jurors in the
incongruous position of hearing claims under
another state's law; (b) likely generate
inconsistent rulings; (c) as illustrated by
the decision in Sager . . . likely generate a
multiplicity of appeals for which there are
no binding precedents; and (d) impose an
59 A-4760-14T1
unreasonable burden upon the resources of the
judiciary.
And, relying on Veazey v. Doremus, 103 N.J. 244, 248 (1986),
where the Court observed that choice-of-law questions are "to be
determined on an issue-by-issue basis," the judge declared that a
choice-of-law analysis in those cases that might arguably be
governed by the law of forty-four other jurisdictions would impose
an undue burden on "the resources of the judiciary," which he
rhetorically enumerated:
First, is it likely that at the time of
entering its [o]rder of May 2, 2005, our
Supreme Court contemplated such an imbroglio
being thrust upon our trial courts?
Second, is it reasonable for the New Jersey
[c]ourt [s]ystem to assume responsibility for
resolving the claims of thousands of parties
from scores of foreign jurisdictions on
litigation involving cutting edge issues of
science and law, all the while applying the
law of other states, many of which express
standards incompatible with the [PLA]?
Third, in ten years there has been little to
no progress toward resolving this MCL. Is
there any reason to believe that this MCL will
be resolved within the next ten years by
applying choice-of-law analyses to each matter
that is selected for trial?
Fourth, is there another state court system
in the United States which has welcomed such
a flood of litigation against a corporate
citizen of that state wherein each of the
[p]laintiffs get to bring the law of their
home state with them?
60 A-4760-14T1
The judge responded that, from his "perspective," the answers to
all these question was: "not likely." He consequently found that:
As framed by plaintiffs' counsel, the choice-
of-law analysis for label adequacy would have
to be considered plaintiff-by-plaintiff,
doctor-by-doctor, totally dependent upon the
testimony of a prescribing physician. Such a
subjective standard militates against [a]
philosophy of creating a MCL proceeding. As
can be readily deduced, the choice-of-law
considerations raised by the Accutane MCL are
not those of a discrete and solitary claim
such as that in Camp Jaycee involving a single
claimant and a conflict regarding the
competing public policy interests over
charitable immunity. Here, there are thousands
of claimants from scores of states; the
conflicting interests and equitable
considerations are far more complex, or one
might say, muddled.
The judge concluded, with an additional emphasis on the age and
status of this MCL litigation, that "[a]pplying New Jersey law to
all the outstanding failure to warn cases will inject uniformity
and predictability which are sorely lacking." We reject the judge's
reasoning.
We turn first to the judge's determination that statements
made by an attorney – who had yet to be designated liaison counsel
– were binding on all out-of-state plaintiffs in this MCL. To be
sure, we would agree that a statement regarding the substantive
law to be applied to a claim may, at times, be binding upon parties
and, also, that parties may stipulate to the application of the
61 A-4760-14T1
substantive law even if a proper choice-of-law analysis would
generate a different result. See Fairfax Fin. Holdings Ltd. v.
S.A.C. Capital Mgmt., __ N.J. Super. __, __ (App. Div. 2017) (slip
op. at 36-40). But the judge's reliance on the 2005 request by
counsel for MCL treatment of these and other Accutane cases is,
at best, only a factor in the choice-of-law analysis, not its
alpha and omega.
In explaining, we start by rejecting the relevance or accuracy
of the judge's enumerated rhetorical concerns. As to the first,
only the Supreme Court can say, but we would think a future need
to conduct multiple or many choice-of-law analyses was
contemplated. The second rhetorical question seems to have no
bearing on the propriety of choice-of-law analyses in the cases
commenced by out-of-state plaintiffs. Although additional legal
questions may be presented for the courts, as they are here, those
questions are hardly so difficult as to represent an undue burden.
Nor has it been shown – as the judge suggests in his third
rhetorical question – that these choice-of-law questions have been
the cause of any perceived delay during the pendency of the MCL.
The fourth rhetorical – in which the judge questioned whether any
other state would undertake an MCL like this – seems irrelevant
in considering whether the court should take the easy way out and
simply apply New Jersey law in all cases because those plaintiffs
62 A-4760-14T1
chose to sue in defendants' home state.
Second, we find no evidence other than counsel's loose
statement in a letter written more than a decade ago to support a
waiver of all appropriate choice-of-law issues. Rule 4:38A
recognizes the authority of the Supreme Court to "designate a case
or category of cases as Multicounty Litigation [MCL] to receive
centralized management in accordance with criteria and procedures
promulgated by the Administrative Director of the Courts upon
approval by the Court." Here, in applying for MCL, counsel
represented in 2005 that the Accutane claims shared common issues
of law and fact, including "whether defendant violated the New
Jersey Products Liability Act in its marketing and sale of
Accutane." Counsel submitted that application before the selection
of liaison counsel and before the filing of the complaints at
issue on appeal; he did not have the authority to, nor did he,
stipulate to the choice of law for these plaintiffs. See, e.g.,
Banner v. Hoffmann-La Roche Inc., 383 N.J. Super. 364, 373 (App.
Div. 2006), certif. denied, 190 N.J. 393 (2007). For that reason
alone, we think it inimical to a just determination of the many
pending Accutane cases to interpret the 2005 letter as a waiver
of a choice-of-law analysis for out-of-state plaintiffs. Moreover,
this matter has long proceeded as if choice-of-law analyses would
occur. For example, after entry of the MCL order, plaintiffs filed
63 A-4760-14T1
long-form complaints alleging claims for failure-to-warn under New
Jersey's PLA "and/or [sic] the analogous law of plaintiff's
state(s) of ingestion and/or [sic] prescription." Our courts have
also addressed choice-of-law issues in cases contained in this MCL
matter without concerns for the so-called administrative problems
cited by the trial judge. See, e.g., McCarrell II, supra, 227 N.J.
at 582-99 (considering whether New Jersey's or Alabama's statute
of limitations applied). And, although no section of the Second
Restatement specifically addresses mass torts, we deem it
inappropriate to conclude that by participating in mass tort
litigation plaintiffs waive their right to a choice-of-law
analysis when the court is presented with a potential conflict
regarding the application of state law.17
17
As the popularity of mass torts at both the federal and state
levels gained in popularity, commentators have argued in favor of
modification to the choice-of-law practices to allow application
of a single state's law in complex litigation. See Larry Kramer,
Choice of Law in Complex Litigation, 71 N.Y.U. L. Rev. 547 (1996)
(challenging the "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"). In 1993, the American Law Institute adopted and submitted
to Congress for enactment, statutory recommendations for mass
torts. American Law Institute, Complex Litigation Project,
Proposed Final Draft (May 13, 1993). The Project proposed a set
of choice-of-law rules for "mass-tort" actions transferred to
federal courts, not state courts. Under that proposal, a court
would consider a list of enumerated factors modeled on the Second
Restatement, "with the object of applying, to the extent feasible,
a single state's law to all similar tort claims being asserted
64 A-4760-14T1
We, thus, reject this procedural bar to otherwise required
choice-of-law analyses in these matters.
B
As a result of the judge's erroneous finding of a waiver, we
must consider whether a choice-of-law analysis nevertheless
requires application of New Jersey law or whether the law of other
jurisdictions should apply.
As the forum state, we apply New Jersey choice-of-law rules.
McCarrell II, supra, 227 N.J. at 584. When a conflict of
substantive law arises – regardless of whether it happens to occur
in MCL litigation – our courts apply the principles set forth in
sections 146, 145, and 6 of the Restatement (Second) of Conflicts
of Law. McCarrell II, supra, 227 N.J. at 591. "Multi-faceted
choice-of-law principles, such as those expressed in the Second
Restatement, have been developed to assist judges in resolving
such conflicts." Ginsberg ex rel. Ginsberg v. Quest Diagnostics,
Inc., 441 N.J. Super. 198, 223 (App. Div. 2015), aff'd, 227 N.J.
7 (2016). See Kramer, supra, 71 N.Y.U. L.Rev. at 549 (recognizing
that "[b]ecause choice of law is part of the process of defining
the parties' rights, it should not change simply because, as a
against a defendant." Id. at § 6.01 (emphasis added). ALI's
Project, however, was not enacted.
65 A-4760-14T1
matter of administrative convenience and efficiency, we have
combined many claims in one proceeding; whatever choice-of-law
rules we use to define substantive rights should be the same for
ordinary and complex cases"). Our courts will also render, when
necessary, multiple individualized choice-of-law determinations
within the same suit. At times that choice may vary from one
defendant to another, Ginsberg, supra, 227 N.J. at 18, or from one
plaintiff to another, Fairfax, supra, __ N.J. Super. at __ (slip
op. at 35-36). That said, there may be times when an
individualized, party-by-party determination is not feasible. The
Ginsberg Court explained that in
very complex cases with many defendants and
multiple claims, a defendant-specific choice-
of-law analysis may generate a jury charge
that is unwieldy and unclear. . . . In a
complex case with many parties from different
states, the trial court retains the discretion
to decline a defendant-by-defendant approach
and, utilizing a Restatement [sections] 146,
145 and 6 analysis as described above, apply
the law of a single state to claims asserted
against all defendants.
[Ginsberg, supra, 227 N.J. at 20.]
Here, in contrast, although plaintiffs' claims were
coordinated for administrative purposes, each plaintiff filed a
separate complaint. Some cases have been tried individually and
others were tried with plaintiffs from the same state, thereby
alleviating any jury confusion about the applicable law that could
66 A-4760-14T1
compromise the trial in the manner of concern to the Court in
Ginsberg. Clearly, the MCL claims pursued by numerous plaintiffs
in separate proceedings does not pose the same potential for jury
confusion as in Ginsberg, where plaintiffs pursued claims against
numerous defendants of different jurisdictions in the same
proceeding. We therefore reject the argument that simplification
of procedures and uniformity of results should govern the choice-
of-law questions presented because plaintiffs in the cases
involved in this appeal reside and ingested Accutane elsewhere.
In the alternative, the trial judge conducted a choice-of-
law analysis utilizing sections 146, 145, and 6 of the Second
Restatement. He found the law of the state of injury applied in
forty-one of the forty-four jurisdictions. We agree with that
analysis, with the exception that we conclude the law of the
jurisdiction of the injury applied in all these cases, not just
forty-one of forty-four.
"The analytical framework for deciding how to resolve a
choice-of-law issue is a matter of law." McCarrell II, supra, 227
N.J. at 583; see also Mastondrea v. Occidental Hotels Mgmt. S.A.,
391 N.J. Super. 261, 283 (App. Div. 2007). Review of the trial
judge's choice-of-law determination is thus de novo. McCarrell,
supra, 227 N.J. at 583-84.
New Jersey's "choice-of-law jurisprudence has striven to
67 A-4760-14T1
structure rules that will lead to predictable and uniform results
that are fair and just and that will meet the reasonable
expectations of the parties." McCarrell II, supra, 227 N.J. at
573. The first inquiry is "whether the laws of the states with
interests in the litigation are in conflict." Id. at 584. If there
is no actual distinction, there is no choice-of-law issue to be
resolved, and the forum state applies its own substantive law.
Rowe v. Hoffman-La Roche, Inc., 189 N.J. 615, 621 (2007); see also
DeMarco v. Stoddard, 223 N.J. 363, 383 (2015), cert. denied, ___
U.S. ___, 137 S. Ct. 44, 196 L. Ed. 2d 28 (2016). The trial judge
did not make any specific findings as to how the laws conflict but
simply proceeded on an assumption of a conflict.
As we have already said here, the PLA, in combination with
common law principles, provides that a manufacturer shall be liable
for harm caused by a product that was "not reasonably fit, suitable
or safe for its intended purpose" because it "failed to contain
adequate warnings." N.J.S.A. 2A:58C-2. The PLA incorporates the
"learned intermediary" doctrine by which a manufacturer's duty to
warn about the dangers of prescription drugs runs to the physician,
not the patient. N.J.S.A. 2A:58C-4; Perez, supra, 161 N.J. at 10;
Niemiera, supra, 114 N.J. at 559. Significantly, the PLA also
provides that:
68 A-4760-14T1
If 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 the "Federal Food, Drug, and Cosmetic
Act," . . . a rebuttable presumption shall
arise that the warning or instruction is
adequate. . . .
[N.J.S.A. 2A:58C-4.]
In Perez, supra, 161 N.J. at 25, the Court held that "[f]or
all practical purposes, absent deliberate concealment or
nondisclosure of after-acquired knowledge of harmful effects,
compliance with FDA standards should be virtually dispositive of
[failure-to-warn claims]." See Kendall I, supra, 209 N.J. at 195
(where the Court recognized that "in Perez we created what can be
denominated as a super-presumption").
Although the other forty-four jurisdictions recognize
products liability claims based on a failure to adequately warn,
and the majority of those jurisdictions have adopted the learned
intermediary doctrine, there is a conflict between the laws of
most of the other implicated jurisdictions because only three of
the forty-four implicated jurisdictions have adopted statutory
rebuttable presumptions of adequacy for FDA-approved warnings
(Utah, Tennessee, and Texas).18 Those presumptions, however, appear
18
See Utah Code Ann. § 78B-6-703 (2017) (rebuttable presumption
that product is free from any defect where in conformance with
69 A-4760-14T1
different from New Jersey's because courts in those states have
not applied their rebuttable presumptions in precisely the same
way as the PLA's statutory presumption or determined in the same
way whether or to what extent the presumption may be overcome.
That is, in New Jersey it has been recognized that the PLA's
statutory presumption may be overcome by a showing of deliberate
concealment or nondisclosure of after-acquired knowledge of
harmful effects, Perez, supra, 161 N.J. at 25, or substantial
evidence of economically driven manipulation of the post-market
regulatory process, McDarby, supra, 401 N.J. Super. at 63-66.
Other states with a statutorily-created rebuttable presumption do
not appear to either recognize those exceptions or in quite the
same way.
Rather than analyze and compare each jurisdiction looking for
a conflict – or the absence of a conflict – we view our PLA as
sufficiently different from most, if not all, the other competing
jurisdictions as to warrant an assumption that all forty-four
jurisdictions are in conflict with (or at least different from)
New Jersey law on the particular questions posed by defendants'
government standards); Tenn. Code Ann. § 29-28-104 (2017)
(compliance with government standards creates rebuttable
presumption that the product "is not in an unreasonably dangerous
condition"); Tex. Civ. Prac. & Rem. § 82.007 (2015) (rebuttable
presumption that manufacturer is not liable for failure to provide
adequate warnings if the warnings were FDA-approved).
70 A-4760-14T1
motion for summary judgment.
Next, a court must identify "the state that is the place of
injury and presume[] that the law of that state governs the
action." Ginsberg, supra, 227 N.J. at 12. Section 146 of the Second
Restatement states that in an action for 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 [section] 6 to the occurrence and
the parties, in which event the local law of
the other state will be applied.
It is undisputed that in the Accutane cases before us there
are plaintiffs who resided – and ingested Accutane – in forty-four
other jurisdictions. Section 146 recognizes those forty-four
jurisdictions as "likely to have the predominant, if not exclusive,
relationship to the parties and issues in the litigation." Camp
Jaycee, supra, 197 N.J. at 144. That presumption is then "tested
against the contacts detailed in section 145 and the general
principles outlined in section 6 of the Second Restatement." Id.
at 136. A court must decide "whether the presumption in favor of
the law of the place of injury has been overcome by virtue of a
competing state's 'more significant relationship to the parties
and issues.'" Ginsberg, supra, 227 N.J. at 12 (quoting Camp Jaycee,
supra, 197 N.J. at 143). When "another state has a more significant
71 A-4760-14T1
relationship to the parties or issues," the presumption has been
overcome. Camp Jaycee, supra, 197 N.J. at 136.
Section 145(2) of the Second Restatement lists several
factors to be weighed in identifying the state with the most
significant interests:
(a) the place where the injury occurred,
(b) the place where the conduct causing the
injury occurred,
(c) the domicil, 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.
Application of those contacts supports a finding that the other
jurisdictions have a more significant relationship to these
lawsuits than New Jersey. Plaintiffs' injuries occurred in the
other jurisdictions, plaintiffs resided there, and plaintiffs were
prescribed and ingested the drug there. See Cornett v. Johnson &
Johnson, 414 N.J. Super. 365, 378-80 (App. Div. 2010), aff'd as
modified, 211 N.J. 362 (2012); Yocham v. Novartis Pharms. Corp.,
736 F. Supp. 2d 875, 882 (D.N.J. 2010).
It bears further mention that these contacts with plaintiffs'
home states were not fortuitous. Defendants deliberately marketed
and sold their product in those jurisdictions with the intention
that physicians prescribe and patients take the drug in those
72 A-4760-14T1
jurisdictions. The locus of the parties' relationship does not
compel a different result because, although defendants are located
and issued its warnings from New Jersey, plaintiffs and their
physicians received them and suffered from their omission in the
other jurisdictions.
Next, in measuring the significance of the section 145
contacts, courts look to section 6's cornerstone principles "to
determine whether the presumption has been overcome." Camp Jaycee,
supra, 197 N.J. at 143. In tort cases, the section 6 factors may
be grouped into five categories: "(1) the interests of interstate
comity; (2) the interests of the parties; (3) the interests
underlying the field of tort law; (4) the interests of judicial
administration; and (5) the competing interests of the states."
Fu v. Fu, 160 N.J. 108, 122 (1999). These factors "are not
exclusive," and their weight may vary "depending upon the
circumstances presented." Ginsberg, supra, 441 N.J. Super. at 239.
Here, as in Camp Jaycee, supra, 197 N.J. at 148, the competing
interest of the state and relevant tort law principles overlap.
New Jersey and all the other relevant jurisdictions have
established failure-to-warn laws intended to compensate injured
plaintiffs while deterring the manufacture and distribution of
unsafe products. See Reglan Litig., supra, 226 N.J. at 335; Gantes
v. Kason Corp., 145 N.J. 478, 490 (1996). "[O]f the two policy
73 A-4760-14T1
goals, the first is more important." Dreier, Keefe & Katz, supra,
at 563. Consequently, the state where the injured person resides
"is generally considered paramount." Ibid.
Our Legislature enacted the PLA "as a remedial measure to
limit the liability of manufacturers by establishing 'clear rules
with respect to certain matters'" relating to actions for damages
for harm caused by products, and "[i]n particular," to "reduce the
burden on manufacturers of FDA-approved products resulting from
products liability litigation." Kendall I, supra, 209 N.J. at 194
(quoting N.J.S.A. 2A:58C-1(a)). The PLA "impliedly accepts that
the presumption of adequacy will not be rebutted in all cases" and
"accepts FDA regulation as sufficient, at least in part, to deter
New Jersey pharmaceutical companies from manufacturing unsafe
prescription drugs." Rowe, supra, 189 N.J. at 625.
Arguably, there are conflicting policies – New Jersey's
interest in the uniform application of its limitation of a
manufacturers' liability and in deterring unsafe products – and
the competing interests of the other jurisdictions in regulating
the adequacy of warnings and in compensating injured victims. At
best, those interests are in equipoise. As we have already
observed, the fact that plaintiffs suffered injuries in other
jurisdictions was not fortuitous; defendants chose to market and
sell their product there. If the other jurisdictions' products
74 A-4760-14T1
liability laws are to have any deterrent effect it must apply in
the state where the plaintiff was injured. New Jersey's "interest
in deterring local manufacturing corporations from providing
inadequate product warnings, within the context of an FDA approved
drug," does not clearly outweigh the laws of the other
jurisdictions who have an interest in protecting their citizens
from harm and in compensating their citizens for injuries. See id.
at 629-30.
Interstate comity seeks to "further harmonious relations
between the states and to facilitate commercial intercourse
between them," Restatement, supra, § 6 cmt. d; see Camp Jaycee,
supra, 197 N.J. at 152, by ascertaining "whether application of a
competing state's law would frustrate the policies of other
interested states," Fu, supra, 160 N.J. at 122. By the same token,
this factor "must not be overemphasized," because, to some extent,
"every tort rule is designed both to deter other wrongdoers and
to compensate the injured person." Restatement, supra, § 145 cmt.
c.
Similarly, application of New Jersey law that limits
liability for FDA-approved warnings might frustrate the other
states' policies in deterring a broader scope of inadequate
warnings and would limit their ability to regulate the conduct of
manufacturers who sell products in their states. See Camp Jaycee,
75 A-4760-14T1
supra, 197 N.J. at 153. Moreover, New Jersey can continue to
protect its pharmaceutical manufacturers when they sell products
in this state.
In considering the interests-of-the-parties factor, it would,
generally speaking, "be unfair and improper to hold a person liable
under the local law of one state when he had justifiably molded
his conduct to conform to the requirements of another state."
Ginsberg, supra, 441 N.J. Super. at 243 (quoting Restatement,
supra, § 6 cmt. g). Defendants argue that New Jersey pharmaceutical
manufacturers are justified in expecting that a New Jersey law
designed to "re-balance the law in [their] favor," Rowe, supra,
189 N.J. at 623, would apply if they were sued in New Jersey. In
Camp Jaycee, supra, 197 N.J. at 154, the Court explained that in
Fu, supra, 160 N.J. at 135, it "dismissed the notion that a
corporation could reasonably expect automatic immunization when
conducting affairs outside the state" and observed that "however
reasonable may be a rental agency's reliance on New Jersey's
vicarious liability laws for purposes of an accident in this State,
any blanket reliance on this State's law as a defense to conduct
occurring in a foreign jurisdiction could not be justified."
Although defendants might legitimately have expected
protection under the PLA's presumption, they could not reasonably
expect that protection to apply in other states with no interest
76 A-4760-14T1
in reducing the liability burden on New Jersey pharmaceutical
manufacturers. Thus, the application of the laws of other
jurisdictions to these out-of-state claims is consistent with the
reasonable interests of the parties.
The interests of judicial administration obligate courts to
consider "practicality and ease of application, factors that in
turn further the values of uniformity and predictability." Camp
Jaycee, supra, 197 N.J. at 154. The comments to the Second
Restatement illuminate these interests:
To the extent that [these values] are attained
in choice of law, forum shopping will be
discouraged. These values can, however, be
purchased at too great a price. In a rapidly
developing area, such as choice of law, it is
often more important that good rules be
developed than that predictability and
uniformity of result should be assured through
continued adherence to existing rules.
Predictability and uniformity of result are
of particular importance in areas where the
parties are likely to give advance thought to
the legal consequences of their transactions.
[Restatement, supra, § 6 cmt. i.]
Interests of judicial administration should not be accorded undue
weight; they "are of lesser importance and must yield to a strong
state interest implicated by the [other] factors." Fu, supra, 160
N.J. at 124; see also Erny v. Estate of Merola, 171 N.J. 86, 102
(2002). Ultimately, as we observed in Ginsberg, supra, 441 N.J.
Super. at 245, applying one state's law indiscriminately to all
77 A-4760-14T1
of the claims against out-of-state defendants would be "pragmatic"
but would not promote "a sound or fair result."
To be sure, as the trial judge observed, MCL litigation poses
unique challenges to judicial administration and efficiency. And
we agree New Jersey's judicial-administration interest should be
given greater weight in an MCL case than in a standard tort case.
Certainly, application of New Jersey's substantive law to the
adequacy of pharmaceutical warnings would, to some degree, present
more efficient results. But this factor should yield to the other
jurisdictions' strong state interests for a number of reasons.
First, a multistate analysis is feasible in this MCL case.
See Ginsberg, supra, 227 N.J. at 12. As one commentator pointed
out, resolving choice-of-law questions in complex mass tort cases
"may not be fun, but it is far from impossible." Kramer, supra,
71 N.Y.U. L. Rev. at 584. One solution to efficiently resolve MCL
cases is to group cases involving states with similar laws, thereby
reducing the number of conflicts to a manageable number. Such
grouping has, in fact, has already occurred in this MCL litigation.
And modern means of research – Lexis and Westlaw – reduce the
burden of conducting a fifty-state search that would have proved
daunting in former times.
Second, there is no reason to believe the parties anticipated
that this MCL case would become an "imbroglio being thrust upon"
78 A-4760-14T1
the court, as viewed by the trial judge. It is likely plaintiffs
expected to try a few "bellwether" cases, thereby "enhancing
prospects of settlement or for resolving common issues or claims."
Perez, supra, 161 N.J. at 7 n.2 (quoting In re Chevron, U.S.A.,
Inc., 109 F.3d 1016, 1019-20 (5th Cir. 1997)). The fact that only
one Accutane MCL case has settled does not weigh in favor of
applying New Jersey's law to all of the pending out-of-state
claims.
We also reject the notion that application of the substantive
laws of the jurisdiction in which a plaintiff's injury occurred
will encourage a "flood of litigation" against defendants in this
state. Plaintiffs have filed claims in New Jersey because
defendants' business is located here and because the Court approved
the MCL application. Moreover, application of out-of-state law has
resulted in the dismissal of some of the Accutane cases. And we
affirm the dismissal of others here.
Lastly, the fact that application of other jurisdictions'
laws may lead to inconsistent results does not weigh in favor of
the application of New Jersey law; such results are entirely fair
and appropriate in products liability actions brought by
plaintiffs from different states. See Kramer, supra, 71 N.Y.U. L.
Rev. at 579 (recognizing "[s]ome differences in outcome reflect
the fact that different states with legitimate interests have made
79 A-4760-14T1
different judgments about how to handle tort problems").
For these reasons, we are satisfied the presumption in favor
of the law of the state of the injury was not overcome, and we
conclude the trial judge erred in part one of his opinion in
applying New Jersey law to these claims.
C
The judge also examined the law of forty-four jurisdictions.
Because we have determined that New Jersey law doesn't provide the
substantive law applicable to claims asserted by plaintiffs who
resided and ingested Accutane in other jurisdictions, the judge's
alternative rulings about the law of those other jurisdictions has
taken on greater relevance.
We start with the fact that, of the forty-four jurisdictions,
the judge found application of the law of eighteen – Arkansas,
Connecticut, Delaware, District of Columbia, Idaho, Iowa, Kansas,
Maine, Massachusetts, Minnesota, Montana, Nebraska, Oregon,
Pennsylvania, Rhode Island, South Carolina, Utah, and Vermont –
required the denial of summary judgment. The judge also denied
summary judgment in cases governed by the law of two states – Ohio
and Oklahoma – because those states recognize an exception to the
learned intermediary doctrine for materials disseminated directly
to patients. Defendants' cross-appeal seeks reversal of the denial
80 A-4760-14T1
of summary judgment in those cases governed by the law of those
twenty jurisdictions. We find insufficient merit in defendants'
arguments regarding those cases to warrant further discussion in
a written opinion. R. 2:11-3(e)(1)(E).
Consequently, we turn to the other twenty-four jurisdictions
– as to which the judge granted summary judgment in defendants'
favor – and separately examine the judge's determinations as they
relate to: (1) three jurisdictions, which espouse, in the trial
judge's view, substantive law that is either "irrational" or
"unclear"; (2) fourteen jurisdictions in which the learned
intermediary doctrine had been adopted in a manner that, in the
judge's view, permitted a determination of a drug label's adequacy
as a matter of law; and (3) seven jurisdictions in which the
adequacy of the warning was viewed as determinable as a matter of
law for other reasons.
(1) The First Group
In cases where it was alleged plaintiffs resided and ingested
Accutane in Louisiana, Nebraska and South Dakota, the judge applied
New Jersey law for reasons other than those discussed earlier. We
reject those reasons and conclude, for the following reasons, the
judge was obligated to ascertain the law of those jurisdictions
and determine whether it permitted a disposition of the issues
81 A-4760-14T1
presented as a matter of law.
a. Louisiana
We first consider Louisiana law, which the judge disregarded
because he found it "irrational."
Courts that have applied the "Louisiana Products Liability
Act," La. Rev. Stat. Ann. § 9:2800.51-.60 (2016), have understood
that a drug manufacturer has "satisfied its duty to warn under the
learned intermediary doctrine," Stahl v. Novartis Pharms. Corp.,
283 F.3d 254, 268 (5th Cir.), cert. denied, 537 U.S. 824, 123 S.
Ct. 111, 154 L. Ed. 2d 34 (2002) – a circumstance that can be
decided in an appropriate case as a matter of law, Anderson v.
McNeilab, Inc., 831 F.2d 92, 93 (5th Cir. 1987) – when "a
particular adverse effect is clearly and unambiguously mentioned
in a warning label and the prescribing physician unequivocally
states that he or she was adequately informed of that risk by the
warning," Stahl, supra, 283 F.3d at 268.
Here, the trial judge observed that "the net result" of such
a standard
grants the prescribing physician what amounts
to a veto on the adequacy of a drug label. If
a competent physician read and understood the
manufacturer's warnings, then the warning is
adequate; if another physician is unable to
"unequivocally state[] that he or she was
inadequately informed of that risk by the
warning" then the warning is inadequate. Such
82 A-4760-14T1
a subjective standard is incompatible with how
New Jersey courts strive to adjudicate
disputes.
When the Legislature adopted the [PLA] it
sought to level the courtroom floors and
respect the rights of both consumers and
manufacturers. When balancing the competing
interests of Louisiana's apparent policy of
protecting consumers by accepting or rejecting
the adequacy of a drug label based on the
observations of the prescribing physicians,
anyone of whom may be more or less
conscientious, informed or attentive than
another, with New Jersey's interests in
insuring that all its litigants be accorded a
trial based upon predictable and rational
standards, New Jersey's public policy
interests prevail.
The judge concluded he would "not subject a New Jersey corporate
resident to such an irrational standard" and chose, instead, to
apply New Jersey law.
This was erroneous. In conducting a choice-of-law analysis,
"it is the forum state's duty to disregard its own substantive
preference." Fu, supra, 160 N.J. at 131 (quoting O'Connor v. Busch
Gardens, 255 N.J. Super. 545, 550 (App. Div. 1992). The inquiry
does not concern whether Louisiana or New Jersey "passed the better
law; that is a normative judgment best suited for the legislative
process." Rowe, supra, 189 N.J. at 629. Louisiana law must apply
because New Jersey does not have a more significant relationship
under the principles stated in section 6 to the occurrence and the
parties.
83 A-4760-14T1
We conclude that summary judgment was not appropriate when
applying Louisiana law to cases in which Accutane was either
prescribed or ingested in Louisiana because defendants did not
demonstrate that the prescribing physicians had unequivocally
acknowledged receipt of an adequate warning.
b. Nebraska and South Dakota
The judge also applied New Jersey law in cases where
plaintiffs were injured in Nebraska and South Dakota, finding the
law of those states too sparse to apply.
We suppose that, in a vacuum – if it could ever be concluded
there is "no law" on a subject – choice-of-law principles would
not apply because the absence of law would not conflict with a
forum's existing law. But, the mere fact that a state's courts and
legislature have not spoken on a particular topic doesn't mean
that state lacks legal principles that would illuminate the
disposition of a dispute. For example, even if it could be shown
the courts or legislature of a particular state never uttered any
product-liability principles, that state's view on the subject
could conceivably be extrapolated from other common-law principles
recognized by that jurisdiction. On the other hand, we don't
disagree that a state with sparse law on a subject may possess a
lesser interest in governing a dispute than another interested
84 A-4760-14T1
state possessing well-established legal principles. This
circumstance, however, is merely a factor to be considered; it is
not conclusive. McCarrell II, supra, 227 N.J. at 596.
Having said all that, we reject the trial judge's
determination that not enough has been said by the legislatures
or the courts of Nebraska and South Dakota to allow an accurate
understanding of their substantive law on the subject. To the
contrary, Nebraska's highest court has observed that failure-to-
warn claims sound in negligence and strict liability and has also
recognized and applied the learned intermediary doctrine in a
claim based on the ingestion of Accutane. Freeman v. Hoffman-La
Roche, Inc., 618 N.W.2d 827, 842 (Neb. 2000).
Similarly, in South Dakota, S.D. Codified Laws § 20-9-10.1
(2016) provides that:
In any product liability action based upon
negligence or strict liability, whether the
design, manufacture, inspection, testing,
packaging, warning, or labeling was in
conformity with the generally recognized and
prevailing state of the art existing at the
time the specific product involved was first
sold to any person not engaged in the business
of selling such a product, may be considered
in determining the standard of care, whether
the standard of care was breached or whether
the product was in a defective condition or
unreasonably dangerous to the user.
In South Dakota, a manufacturer has "a duty to warn based on what
it knew or should have known at the time the drug was administered
85 A-4760-14T1
to plaintiff." McElhaney v. Eli Lilly & Co., 575 F. Supp. 228, 231
(D.S.D. 1983), aff'd, 739 F.2d 340 (8th Cir. 1984). And federal
courts applying South Dakota law have utilized the learned
intermediary doctrine. Ibid.; Yarrow v. Sterling Drug, Inc., 263
F. Supp. 159, 162 (D.S.D. 1967), aff'd, 408 F.2d 978 (8th Cir.
1969).
From these principles, we conclude that, under both Nebraska
and South Dakota law, plaintiffs presented sufficient evidence to
demonstrate a genuine dispute about whether the warnings were
accurate, clear and unambiguous and that those plaintiffs
presented evidence that defendants knew but failed to warn of a
causal and latency effect. We conclude the judge erred in
dismissing the cases governed by Nebraska or South Dakota law.
(2) The Second Group
We find reasons to distinguish among the fourteen
jurisdictions that adopted the learned intermediary doctrine19 as
19
Each of these fourteen jurisdictions has adopted the learned
intermediary doctrine. See Stone v. Smith, Kline & French Labs.,
447 So. 2d 1301, 1305 (Ala. 1984); Carlin v. Superior Court, 920
P.2d 1347, 1348-54 (Cal. 1996); O'Connell v. Biomet, Inc., 250
P.3d 1278, 1281 (Colo. App. 2010); Felix v. Hoffmann-La Roche,
Inc., 540 So. 2d 102, 104 (Fla. 1989); Presto v. Sandoz Pharms.
Corp., 487 S.E.2d 70, 73 (Ga. Ct. App. 1997); Kirk v. Michael
Reese Hosp. & Med. Ctr., 513 N.E.2d 387, 393 (Ill. 1987); Tucker
v. SmithKline Beecham Corp., 701 F. Supp. 2d 1040, 1066 (S.D. Ind.
2010); Hyman & Armstrong, P.S.C. v. Gunderson, 279 S.W.3d 93, 109
86 A-4760-14T1
to which the trial judge granted summary judgment. Consequently,
we break this group into two smaller groups: (a) one group that
requires reversal, and (b) a second that requires affirmance.
a. Alabama, Florida, Georgia,
Illinois, Kentucky, Puerto Rico,
Tennessee, and Washington
Products liability law in Alabama is governed by the
judicially-created Alabama Extended Manufacturer's Liability
Doctrine (AEMLD). Atkins v. Am. Motors Corp., 335 So. 2d 134, 137
(Ala. 1976); Casrell v. Altec Indus., Inc., 335 So. 2d 128, 130
(Ala. 1976). Here, the trial judge relied on Morguson v. 3M Co.,
857 So. 2d 796, 802 (Ala. 2003), where the court held in a medical
device case that the warning was adequate as a matter of law
because it warned "against the exact acts and errors committed"
by the hospital staff in assembling the device; we find this
circumstance to be distinguishable. We also observe that our
Supreme Court has rejected defendants' argument under either New
Jersey or Alabama law that the 1984 label, which specifically
referred to IBD, was adequate as a matter of law. McCarrell I,
(Ky. 2008); Janssen Pharmaceutica, Inc. v. Bailey, 878 So. 2d 31,
58 (Miss. 2004); Martin v. Hacker, 628 N.E.2d 1308, 1311 (N.Y.
1993); De Oca v. Adventis Pharma, 579 F. Supp. 2d 222, 227 (D.P.R.
2008); Pittman v. Upjohn Co., 890 S.W.2d 425, 429 (Tenn. 1994);
Pfizer, Inc. v. Jones, 272 S.E.2d 43, 44 (Va. 1980); Estate of
LaMontagne v. Bristol Meyers Squibb, 111 P.3d 857, 862 (Wash. Ct.
App. 2005).
87 A-4760-14T1
supra, slip op. at 108. These same principles require a reversal
of the summary judgment entered in the thirteen cases governed by
Alabama law.
In this setting, Florida law requires that a plaintiff prove
a manufacturer "did not adequately warn of a particular risk that
was known or knowable in light of the generally recognized and
prevailing best scientific and medical knowledge available at the
time of the manufacture and distribution." Thomas v. Bombardier
Rec. Prods. Inc., 682 F. Supp. 2d 1297, 1300 (M.D. Fla. 2010). In
determining the adequacy of the warning under Florida law, the
critical inquiry is whether it was adequate to warn the physician
of the possibility that the drug caused the plaintiff's injury.
Upjohn Co. v. MacMurdo, 562 So. 2d 680, 683 (Fla. 1990). "The
sufficiency and reasonableness of the warnings are questions of
fact best left for the jury unless the warnings are accurate,
clear, and unambiguous." Thomas, supra, 682 F. Supp. 2d at 1300.
Consequently, the judge erred in dismissing thirty-nine cases
under Florida law because, as discussed earlier in this opinion,
plaintiffs presented evidence that the warnings were not accurate,
clear and unambiguous.
In Georgia, the "manufacturer's duty to warn is limited to
an obligation to advise the prescribing physician of any potential
dangers that may result from the drug's use." Bryant v. Hoffmann-
88 A-4760-14T1
La Roche, Inc., 585 S.E.2d 723, 730 (Ga. Ct. App. 2003) (quoting
Hawkins v. Richardson-Merrell, Inc., 249 S.E.2d 286, 288 (Ga. Ct.
App. 1978)). Georgia law also recognizes that "[t]he adequacy of
drug warnings is generally a question of fact, but it can 'become
a question of law where the warning is accurate, clear and
unambiguous.'" Weilbrenner v. Teva Pharms. USA, Inc., 696 F. Supp.
2d 1329, 1339 (M.D. Ga. 2010) (quoting Thom v. Bristol-Meyers
Squibb Co., 353 F.3d 848, 853 (10th Cir. 2003). Nevertheless, we
conclude the judge erred in dismissing twenty-four claims governed
by Georgia law because plaintiffs presented sufficient evidence
that the warnings were not accurate, clear and unambiguous.
In Illinois, "[t]he duty to warn of the dangers of
prescription drugs is owed to the physician, and therefore, the
adequacy of the warning must be judged by whether it sufficiently
apprises physicians of the risks associated with the use of the
drug." Hernandez v. Schering Corp., 958 N.E.2d 447, 455 (Ill. App.
Ct. 2011). Although "[t]he sufficiency of the warning can become
a question of law where the warning is clear, accurate and
unambiguous," ibid., for the reasons already outlined regarding
the other jurisdictions in this group, we conclude that the judge
erred in dismissing twenty-six cases under Illinois law;
plaintiffs presented sufficient evidence that the warnings were
not accurate, clear and unambiguous.
89 A-4760-14T1
In Larkin v. Pfizer, Inc., 153 S.W.3d 758, 764 (Ky. 2004),
Kentucky's highest court has recognized that an adequate warning
is that which "sufficient[ly] [] apprise[s] the general
practitioner as well as the 'unusually sophisticated medical man'
of the dangerous propensities of the drug," McEwen v. Ortho Pharm.
Corp., 528 P.2d 522, 529 (Or. 1974) (quoting Parke-Davis & Co. v.
Stromsodt, 411 F.2d 1390, 1400 (9th Cir. 1969)). It is, the Court
held, "incumbent upon the manufacturer to bring the warning home
to the doctor." Larkin, supra, 153 S.W.3d at 764. The judge erred
in dismissing twelve cases under Kentucky law because plaintiffs
presented sufficient evidence that defendants did not "bring the
warning home" to the prescribing physician as to Accutane's
causative effect.
In Puerto Rico, a plaintiff must prove in a products liability
case that "(1) the manufacturer knew, or should have known of the
risk inherent in the product; (2) there were no warnings or
instructions, or those provided were inadequate; (3) the absence
of warnings made the product inherently dangerous; (4) the absence
of adequate warnings or instructions was the proximate cause of
plaintiff's injury." Cruz-Vargas v. R.J. Reynolds Tobacco Co., 348
F.3d 271, 276 (1st Cir. 2003), cert. denied, 543 U.S. 959, 125 S.
Ct. 413, 160 L. Ed. 2d 323 (2004).
"If the warning should suffice to alert the general
90 A-4760-14T1
practitioner as well as the specialist, it is adequate, and the
manufacturer is not liable for the injuries caused by the drug."
Guevara v. Dorsey Labs., Div. of Sandoz, Inc., 845 F.2d 364, 367
(1st Cir. 1988).
The judge erred in dismissing one case under the law of Puerto
Rico because there was sufficient evidence, including expert and
other testimony, that the warnings were not accurate, clear and
unambiguous to submit the question to the jury.
In Tennessee, products liability is governed by statute.
Tenn. Code Ann. § 29-28-104 (2016) provides:
Compliance by a manufacturer or seller with
any federal or state statute or administrative
regulation existing at the time a product was
manufactured and prescribing standards for
design, inspection, testing, manufacture,
labeling, warning or instructions for use of
a product, shall raise a rebuttable
presumption that the product is not in an
unreasonably dangerous condition in regard to
matters covered by these standards.
"Warnings concerning prescription drugs generally are
adequate when they contain a full and complete disclosure of the
potential adverse reactions to the drug." Pittman, supra, 579 F.
Supp. 2d at 429. The adequacy of a drug manufacturer's warnings
is usually a question of fact. Ibid. "It becomes a question of law
only when the instructions are accurate and unambiguous." Ibid.
"[A]ll causation issues, are 'ordinarily jury questions, unless
91 A-4760-14T1
the uncontroverted facts and inferences to be drawn from them make
it so clear that all reasonable persons must agree on the proper
outcome.'" Payne v. Novartis Pharms. Corp., 767 F.3d 526, 528 (6th
Cir. 2014) (quoting Haynes v. Hamilton Cty., 883 S.W.2d 606, 612
(Tenn. 1994)). The judge erred in dismissing eighteen cases under
Tennessee law because there was enough evidence to support the
contention that the warnings were not sufficiently accurate or
clear to require disposition of that question by the factfinder.
In Washington, products liability is governed by Wash. Rev.
Code Ann. § 7.72 to 7.72.070 (2016). "A warning for a prescription
drug may be adequate as a matter of law if it provides specific
and detailed information about the risks of using the drug."
Estate of LaMontagne, supra, 111 P.3d at 862. But "[b]ecause the
FDA regulations provide only the minimum requirements for drug
manufacturers, compliance with those regulations does not
necessarily establish warnings were adequate." Ibid. Instead,
"[t]o determine whether a warning is adequate requires an analysis
of the warnings as a whole and the language used in the package
insert." Laisure-Radke v. PAR Pharm., Inc., 426 F. Supp. 2d 1163,
1172 (W.D. Wash. 2006). A court "must examine the meaning and
context of the language and the manner of expression to determine
if the warning is accurate, clear and consistent and whether the
warning portrays the risks involved in taking the prescription
92 A-4760-14T1
drug." Ibid. In light of this fact-sensitive issue, we conclude
that the judge erred in dismissing nineteen cases governed by
Washington law.
b. California, Colorado,
Indiana, Maryland, Mississippi,
New York, Texas, and Virginia
With the exception of Texas, which we discuss separately,
these other jurisdictions all possess similar legal principles.
And each applies the learned intermediary doctrine. See cases
cited in footnote 17, supra. For the reasons that follow, we affirm
the summary judgment entered in favor of defendants in the cases
governed by the law of these jurisdictions.
Under California law, prescription-drug manufacturers are
strictly liable for injuries caused by a failure to warn of a
product's known or reasonably, scientifically-knowable, dangerous
propensities available when manufactured and distributed. Johnson
v. Am. Standard, Inc., 179 P.3d 905, 910 (Cal. 2008). This
obligation has been interpreted, as a matter of California law,
to require a determination that a drug warning is adequate as a
matter of law if it directly warns "in plain and explicit terms"
of the specific risk that has caused injury. Kearl v. Lederle
Labs., 218 Cal. Rptr. 453, 467 (Cal. Ct. App. 1985), disapproved
on other grounds, Brown v. Superior Court, 751 P.2d 470, 482 (Cal.
93 A-4760-14T1
1988).
Notably, in the MDL Accutane case, the federal district court
granted defendants' motion for summary judgment under California
law on the adequacy of later IBD warnings, In re Accutane Prods.
Liab., No. MDL 1626, 2014 U.S. Dist. LEXIS 155313, at *15 (M.D.
Fla. Sep. 23, 2014), finding:
The Physician Package Insert plainly and
prominently identified inflammatory bowel
disease by name as a possible consequence of
taking isotretinoin. This risk information
appeared in the "WARNINGS" and "ADVERSE
REACTIONS" sections of the insert. It also
identified the common symptoms of IBD and
instructed what should be done if those
symptoms appeared. Likewise, the Medication
Guide warned that isotretinoin may result in
permanent damage to the bowels. The Medication
Guide and patient brochures also broadly
communicated that isotretinoin "can cause"
serious side effects and proceeded to list
permanent damage to various organs, including
the bowels, among such potential serious side
effects. This language tracked the WARNINGS
section of the Physician Package Insert, which
notified physicians that isotretinoin "has
been associated with" IBD. Both independently
and taken together, these formulations
communicated the same essential message to
prescribing physicians: IBD is a potential
risk of isotretinoin. Accordingly, under
California law, summary judgment is
appropriate as a matter of law under these
circumstances.
[Id. at *14-15.]
We view the law of the other jurisdictions in this group –
Colorado, Caveny v. Ciba-Geigy Corp., 818 F. Supp. 1404, 1406 (D.
94 A-4760-14T1
Colo. 1992); Indiana, Tucker, supra, 701 F. Supp. 2d at 1066;
Maryland, Nolan v. Dillon, 276 A.2d 36, 40 (Md. 1971); Mississippi,
Austin v. Will-Burt Co., 361 F.3d 862, 868 (5th Cir. 2004); New
York, Martin, supra, 628 N.E.2d at 1312-13; and Virginia, Ball v.
Takeda Pharms. Am., Inc., 963 F. Supp. 2d 497, 504 (E.D. Va. 2013)
– to require the same result. It is enough in these jurisdictions
that IBD was referenced to render the warning adequate as a matter
of law.
In Texas, the adequacy of a product's warning generally
presents a fact question. Murthy v. Abbott Labs., 847 F. Supp. 2d
958, 968 (S.D. Tex. 2012) (citing McNeil v. Wyeth, 462 F.3d 364,
368 (5th Cir. 2006)). "In prescription drug cases involving the
learned intermediary doctrine," however, a warning that
"specifically mentions the circumstances complained of" is
adequate as a matter of law, ibid., as in the other jurisdictions
contained in this particular grouping. But Texas also has a
statutory rebuttable presumption of adequacy for prescription
drugs, Tex. Civ. Prac. & Rem. § 82.007 (2015), which can be
rebutted only if a plaintiff can show: (1) the defendant "withheld
from or misrepresented to" the FDA "required information that was
material and relevant to the performance of the product and was
causally related to the claimant's injury"; (2) the product was
sold or prescribed "after the effective date of an order" to remove
95 A-4760-14T1
it from the market; (3) the defendant engaged in off-label
promotion that was causally related to the plaintiff's injury; and
(4) the defendant engaged in criminal violation of federal anti-
bribery law. So heavy is this burden, that even if a plaintiff
could show a defendant withheld information about causation,
permanency, and latency from the FDA, the action could proceed
only if the FDA itself found fraud. Lofton v. McNeil Consumer &
Specialty Pharms., 672 F.3d 372, 381 (5th Cir. 2012); Willis v.
Alaven Pharm. LLC, 62 F. Supp. 3d 560, 563 (E.D. Tex. 2014). There
is no evidence in this record that would support a principled
basis for overcoming Texas's unique statutory presumption.
We, thus, affirm the summary judgment entered in favor of
defendants insofar as it dismissed the cases governed by the
substantive law of this subgroup.
(3) The Third Group
The trial judge granted summary judgment under the laws of
the seven states that make up our third and final group.20 We find
20
These jurisdictions recognize the learned intermediary doctrine.
See Doe v. Alpha Therapeutic Corp., 3 S.W.3d 404, 419 (Mo. Ct.
App. 1999); Brochu v. Ortho Pharm. Corp., 642 F.2d 652, 656 (1st
Cir. 1981) (applying New Hampshire law); Ehlis v. Shire Richwood,
Inc., 233 F. Supp. 2d 1189, 1196 (D.N.D. 2002) (applying North
Dakota law), aff'd, 367 F.3d 1013 (8th Cir. 2004); Menges v. Depuy
Motech, Inc., 61 F. Supp. 2d 817, 830 (N.D. Ind. 1999) (applying
Wisconsin law); Thom, supra, 353 F.3d at 852 (applying Wyoming
law).
96 A-4760-14T1
the substantive law of this group – Missouri, New Hampshire, North
Dakota, Wisconsin and Wyoming – to be similar and, for the reasons
that follow, conclude for the reasons that briefly follow that the
judge erred in granting summary judgment in cases governed by the
law of those jurisdictions.
In Missouri, the focus in a failure-to-warn case rests "on
what the manufacturer knew rather than on the product." Moore v.
Ford Motor Co., 332 S.W.3d 749, 764 (Mo. 2011). In addition,
"Missouri courts have held that in cases involving manufacturers
of prescription drugs, the manufacturer has 'a duty to properly
warn the doctor of the dangers involved and it is incumbent upon
the manufacturer to bring the warning home to the doctor.'" Doe,
supra, 3 S.W.3d at 419 (quoting Krug v. Sterling Drug, Inc., 416
S.W.2d 143, 146 (Mo. 1967)). Our discussion of the factual record
in the earlier part of this opinion demonstrates plaintiffs
presented evidence that the warning failed to "bring home to the
doctor" latency, permanency and causation.
In New Hampshire, "[t]he duty to warn is concomitant with the
general duty of the manufacturer, which 'is limited to foreseeing
the probable results of the normal use of the product or a use
that can reasonably be anticipated.'" Thibault v. Sears, Roebuck
& Co., 395 A.2d 843, 847 (N.H. 1978) (quoting McLaughlin v. Sears,
Roebuck & Co., 281 A.2d 587, 588 (1971)). "An adequate warning is
97 A-4760-14T1
one reasonable under the circumstances." Brochu, supra, 642 F.2d
at 657. "A warning may be inadequate in factual content, in
expression of the facts, or in the method by which it is conveyed."
Ibid. So stated, we view the application of New Hampshire law to
the warnings in question as generated a question of fact for a
jury to determine.
North Dakota law holds that "in order to be adequate the
warning must satisfactorily convey the seriousness of the danger
such that a reasonable physician would be alerted to the danger."
Ehlis, supra, 233 F. Supp. 2d at 1196. Again, plaintiffs presented
evidence that the warning failed to convey the seriousness of the
danger.
Wisconsin has adopted comments g and i to Restatement (Second)
of Torts § 402A (1965), which explain "that a product is defective
if it is 'in a condition not contemplated by the ultimate consumer,
which will be unreasonably dangerous to him [or her]'; and that
for a product to be considered 'unreasonably dangerous,' it must
be 'dangerous to an extent beyond that which would be contemplated
by the ordinary consumer who purchases it, with the ordinary
knowledge common to the community as to its characteristics.'"
Mohr v. St. Paul Fire & Marine Ins. Co., 674 N.W.2d 576, 589 (Wis.
Ct. App. 2003).
"Although compliance with FDA standards generally will
98 A-4760-14T1
foreclose negligence per se, . . . such compliance . . . does not
preclude a finding of negligence." Kurer v. Parke, Davis & Co.,
679 N.W.2d 867, 876 (Wis. Ct. App. 2004). And, "[w]hether a warning
is adequate is generally an issue of fact to be determined by the
jury." Mohr, supra, 674 N.W.2d at 589. A warning may be found
adequate as a matter of law only when the warning "[c]learly and
repeatedly" warns of the risks associated with the drug. See Kurer,
supra, 679 N.W.2d at 878 (emphasis added). Here, plaintiffs
presented sufficient evidence that the warnings did not clearly
or repeatedly warn of the causal and latency effect.
In Wyoming, "a plaintiff may show a 'defect' by establishing
that the manufacturer failed to warn about dangers associated with
the product." Rohde v. Smiths Med., 165 P.3d 433, 441 (Wyo. 2007).
"[A] drug manufacturer is required to warn only of those adverse
effects of which it knows or reasonably should know." Jacobs v.
Dista Prob. Co., 693 F. Supp. 1029, 1033 (D. Wyo. 1988). But
"[i]mplicit in this holding is a continuing duty of drug
manufacturers to provide notification of side effects subsequently
discovered." Id. at 1034.
"Although the adequacy of warnings concerning drugs is
generally a question of fact, it can 'become a question of law
where the warning is accurate, clear and unambiguous.'" Thom,
supra, 353 F.3d at 853 (quoting Felix, supra, 540 So. 2d at 105).
99 A-4760-14T1
For the reasons expressed regarding other jurisdictions with a
similar approach, we find the judge erred in granting summary
judgment on cases governed by Wyoming law.
III
To briefly summarize our holdings in both appeals, we reverse
the summary judgment entered in A-4760-14, and we reverse in part
and affirm in part the order granting summary judgment in A-0164-
15.
100 A-4760-14T1