Title: Accutane Litigation

State: new-jersey

Issuer: New Jersey Supreme Court

Document:

SYLLABUS

This syllabus is not part of the opinion of the Court. It has been prepared by the Office of the
Clerk for the convenience of the reader. It has been neither reviewed nor approved by the
Court. In the interest of brevity, portions of an opinion may not have been summarized.

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

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

ALBIN, J., writing for the Court.

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

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

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

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

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

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

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

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

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

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

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

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