Title: Accutane Litigation
Citation: N/A
Docket Number: 
State: new-jersey
Issuer: new-jersey Supreme Court
Date: October 3, 2018

Accutane Litigation Annotate this Case Justia Opinion Summary This appeal arose from 532 product-liability claims filed against Hoffmann-La Roche Inc. and Roche Laboratories Inc. (collectively Roche), corporations with their principal places of business in New Jersey. Roche developed, manufactured, marketed, and labeled Accutane, a prescription medication for the treatment of severe and persistent cases of acne. Plaintiffs alleged Accutane caused them to contract inflammatory bowel disease (IBD) and that Roche failed to give adequate label warnings to advise them of the known risks of the medication. At issue for the New Jersey Supreme Court was : (1) what law governed whether Roche’s label warnings were adequate (the law of each of the 45 jurisdictions in which plaintiffs were prescribed and took Accutane or the law of New Jersey where the 532 cases are consolidated); and (2) the adequacy of the label warnings for the period after April 2002. The Court found that because Roche’s warnings received the approval of the FDA, they enjoyed a “rebuttable presumption” of adequacy under New Jersey’s Products Liability Act (PLA). The Court reversed all cases in which the Appellate Division reinstated plaintiffs’ actions against Roche. "New Jersey has the most significant interests, given the consolidation of the 532 cases for MCL purposes. New Jersey’s interest in consistent, fair, and reliable outcomes cannot be achieved by applying a diverse quilt of laws to so many cases that share common issues of fact. Plaintiffs have not overcome the PLA’s presumption of adequacy for medication warnings approved by the FDA. As a matter of law, the warnings provided physicians with adequate information to warn their patients of the risks of IBD." As a result, the 532 failure-to-warn cases brought by plaintiffs against Roche were dismissed. Read more Want to stay in the know about new opinions from the Supreme Court of New Jersey? Sign up for free summaries delivered directly to your inbox. Learn More › You already receive new opinion summaries from Supreme Court of New Jersey. Did you know we offer summary newsletters for even more practice areas and jurisdictions? Explore them here . SYLLABUSThis 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, 2018ALBIN, J., writing for the Court. This appeal arises from 532 product-liability claims filed against Hoffmann-La Roche Inc. and Roche Laboratories Inc. (collectively Roche), corporations with their principal places of business in New Jersey. Roche developed, manufactured, marketed, and labeled Accutane, a prescription medication for the treatment of severe and persistent cases of acne. Plaintiffs allege that Accutane, prescribed by their physicians, caused them to contract inflammatory bowel disease (IBD) and that Roche failed to give adequate label warnings to advise them of the known risks of the medication. Of the 532 plaintiffs, 18 are New Jersey residents and 514 are residents of 44 other jurisdictions. Plaintiffs’ claims are designated as Multicounty Litigation (MCL) and consolidated in the Atlantic County Superior Court. The Court considers two issues. The first is what law governs whether Roche’s label warnings were adequate -- the law of each of the 45 jurisdictions in which plaintiffs were prescribed and took Accutane or the law of New Jersey where the 532 cases are consolidated. The second issue is the adequacy of the label warnings for the period after April 2002. Because Roche’s warnings received the approval of the FDA, they enjoy a “rebuttable presumption” of adequacy under New Jersey’s Products Liability Act (PLA). See N.J.S.A. 2A:58C-4. That presumption provides pharmaceutical companies greater protection in New Jersey than in many other jurisdictions. By April 10, 2002, Roche had generated a variety of FDA-approved Accutane warning labels and materials for a target audience of prescribing physicians, pharmacists, and patients. The physician label advises prescribing physicians that not only has IBD been associated with the taking of Accutane, but that symptoms of the disease “have been reported to persist after Accutane treatment has been stopped.” In addition, Roche provided physicians with a Best Practices Guide, as well as a Patient Safety Packet to give to their patients. Roche developed, in conjunction with the FDA, a Medication Guide for pharmacists to distribute to Accutane patients when they received their prescriptions. Like the Patient Safety Packet, the Medication Guide warned of “possible serious side effects” from Accutane and described IBD symptoms in simple and plain language. Roche also required pharmacists to dispense Accutane pills in “blister packaging” that again warned the patient that Accutane could have serious gastrointestinal side effects. Accordingly, by 2002, before taking Accutane, patients received the IBD warnings from their prescribing physicians and from their pharmacies. The FDA reviewed and approved each of Roche’s warning tools. 1 Plaintiffs focus on excerpts from several internal Roche documents as evidence that Roche should have given better warnings. In 2015, in a series of rulings, the trial court concluded that the New Jersey PLA governed not only the 18 in-state claims but also the 514 claims that involved plaintiffs who were prescribed and took Accutane in 44 other jurisdictions. The court granted Roche’s motion for summary judgment, determining that plaintiffs failed to overcome the presumption of adequacy that attached to the post-2002 Accutane label warnings approved by the FDA. The court dismissed the 532 product-liability actions brought against Roche. The Appellate Division reversed in part and affirmed in part. Applying the relevant sections of the Restatement (Second) of Conflict of Laws (“Restatement”), the panel concluded that each individual case had to be judged under the substantive law of the jurisdictions where each plaintiff was prescribed and took Accutane -- forty-five jurisdictions in all. The panel affirmed the grant of summary judgment in favor of Roche in those cases involving plaintiffs who were prescribed and took Accutane in seven states because “[i]t is enough in these jurisdictions that IBD was referenced” in Roche’s label warnings to render them adequate as a matter of law. The panel also affirmed the grant of summary judgment in those cases involving the Texas plaintiffs because they had not overcome that jurisdiction’s presumption of adequacy. The panel, however, found that the trial court improvidently granted summary judgment in the cases of those plaintiffs from the remaining thirty-seven jurisdictions because “the adequacy of the warnings could not be resolved as a matter of law.” Under New Jersey’s PLA, the panel held that plaintiffs had presented sufficient evidence to overcome the presumption of adequacy attached to Accutane’s FDA-approved warnings and therefore genuine issues of material fact needed to be resolved by a jury. The Court granted Roche’s petition for certification, 231 N.J. 419 (2017), and plaintiffs’ cross-petition, 231 N.J. 428 (2017).HELD: The Court now reverses in all those cases in which the Appellate Division reinstated plaintiffs’ actions against Roche. New Jersey has the most significant interests, given the consolidation of the 532 cases for MCL purposes. New Jersey’s interest in consistent, fair, and reliable outcomes cannot be achieved by applying a diverse quilt of laws to so many cases that share common issues of fact. Plaintiffs have not overcome the PLA’s presumption of adequacy for medication warnings approved by the FDA. As a matter of law, the warnings provided physicians with adequate information to warn their patients of the risks of IBD.1. The Court applies New Jersey’s choice-of-law rules in determining whether this State’s or another state’s law governs the action. The Court thus compares New Jersey’s PLA to the product-liability laws or analogues of forty-four other jurisdictions and notes that New Jersey’s rebuttable presumption of adequacy, which specifically attaches to FDA-approved warnings, sets New Jersey law apart from most other states’ laws. That conflict of substantive law requires choosing the law or laws that govern the 532 cases. (pp. 31-35) 2 2. In this MCL setting, New Jersey’s PLA intersects with the laws of 44 other jurisdictions in 514 cases. In Ginsberg v. Quest Diagnostics, Inc., the Court “acknowledge[d] that a defendant-by-defendant choice-of-law analysis is not feasible in every matter,” particularly “[i]n a complex case with many parties from different states.” 227 N.J. 7, 20 (2016). In such a scenario, “the trial court retains the discretion to decline a defendant-by-defendant approach and, utilizing a Restatement §§ 146, 145 and 6 analysis . . . apply the law of a single state to claims asserted against all defendants.” Ibid. Under the most-significant- relationship test in personal injury cases, the analysis begins with section 146 and the presumption that the law of the state where the injury occurred applies. P.V. ex rel. T.V. v. Camp Jaycee, 197 N.J. 132, 135-36 (2008). That presumption may be overcome if “some other state has a more significant relationship with the parties and the occurrence based on an assessment of each state’s contacts” viewed through the prism of section 145, which sets forth general principles for tort actions, and section 6, which lists overarching choice-of-law principles. McCarrell v. Hoffmann-La Roche, Inc., 227 N.J. 569, 590 (2017). (pp. 35-38)3. In the case of 514 plaintiffs, the injuries caused by the putative failure to give adequate warnings occurred in forty-four other jurisdictions, but New Jersey is where the alleged conduct causing the injury occurred -- the manufacturing and labeling of Accutane. Overall, the section 145 contacts do not point to one ineluctable result. The Court next reviews section 6 and notes that one reason for joining together so many cases before a single judge is administrative efficiency. The two most significant Restatement factors in this MCL matter are section 6 factors f (“certainty, predictability and uniformity of result”) and g (“ease in the determination and application of the law to be applied”). Applying a single standard to govern the adequacy of the label warnings in the 532 individual cases will ensure predictable and uniform results. Each plaintiff can choose to bring suit in the state where he or she resides and the injury occurred. In this MCL setting, New Jersey has the most significant relationship to the occurrence and the parties, overcoming the presumption that the law of the place of injury governs. The Court therefore applies the PLA to the 532 cases. (pp. 38-46)4. The PLA defines “an adequate warning or instruction” as “one that a reasonably prudent person in the same or similar circumstances would have provided . . . , taking into account the characteristics of, and the ordinary knowledge common to, the prescribing physician.” N.J.S.A. 2A:58C-4. The prescribing physician -- as a learned intermediary -- generally is in the best position to advise the patient of the benefits and risks of a particular drug. Under the learned intermediary doctrine, a pharmaceutical manufacturer generally discharges its duty to warn by supplying physicians with information about the drug’s dangerous propensities. Under N.J.S.A. 2A:58C-4, a rebuttable presumption of adequacy attaches to a product’s label warnings approved by the FDA. Ibid. (pp. 46-48)5. The Court reviews the relevant FDA premarketing and postmarketing regulations governing prescription drugs. Under federal law, the manufacturer is responsible for the adequacy of a drug label’s warnings not only when it files a New Drug Application, but also during the period the drug is on the market after FDA approval. In Wyeth v. Levine, the United States Supreme Court concluded that state-law failure-to-warn lawsuits against 3 manufacturers provide “a complementary form of drug regulation” in the postmarketing phase, when the FDA’s monitoring is far from foolproof. 555 U.S. 555 , 578-79 (2009). (pp. 48-54)6. In Perez v. Wyeth Laboratories, Inc., the Court addressed the role of the federal regulatory process in relation to the PLA’s presumption of adequacy and held that “absent deliberate concealment or nondisclosure of after-acquired knowledge of harmful effects, compliance with FDA standards should be virtually dispositive of [product-liability and failure-to-warn] claims.” 161 N.J. 1, 25 (1999). Perez was decided twenty years before Wyeth’s discussion of a manufacturer’s duty to update label warnings in the postmarketing phase. The Appellate Division in McDarby v. Merck & Co. “note[d] that close scrutiny . . . commenced only after Perez was decided, and that scrutiny disclosed flaws in the regulatory system.” 401 N.J. Super. 10, 64 (App. Div. 2008). In light of the limitations of the FDA postmarketing oversight process, the McDarby court articulated a further basis for overcoming the presumption of adequacy: a manufacturer’s “economically-driven manipulation of the post-market regulatory process.” Id. at 63-64. In Cornett v. Johnson & Johnson, 211 N.J. 362, 388 (2012), the Court recognized that exception. (pp. 54-58)7. An FDA-approved warning for a drug on the market for many years may grow stale in light of “newly acquired information” about “a clinically significant hazard” in the use of the drug by certain consumers. 21 C.F.R. § 201.57(c); 21 C.F.R. § 314.70(c). Prior FDA approval of a label’s warning is not a license for a manufacturer to withhold updating and revising that warning in accordance with federal regulations. The PLA provides manufacturers with the protection of a rebuttable presumption of adequacy of an FDA- approved label warning. N.J.S.A. 2A:58C-4. Consistent with Perez and McDarby, and the federal regulatory scheme, the Court holds that the rebuttable presumption of adequacy attaching to an FDA-approved drug label is overcome when a plaintiff presents clear and convincing evidence that a manufacturer knew or should have known, based on newly acquired information, of a causal association between the use of the drug and “a clinically significant hazard” and that the manufacturer failed to update the label accordingly. See 21 C.F.R. § 201.57(c); 21 C.F.R. § 314.70(c). The Court adds one caveat. A manufacturer that acts in a reasonable and timely way to update its label warnings with the FDA, in accordance with its federal regulatory responsibilities, will receive the protection of the rebuttable presumption. If not, it cannot seek shelter behind it. The standard articulated in this opinion is a natural extension of the decisions in Perez and McDarby. Faced with clear and convincing evidence of a label warning’s inadequacy based on the FDA’s label warning updating requirements, a responsible drug manufacturer will take action to revise its drug label warnings. The high standard for overcoming the rebuttable presumption of adequacy of an FDA-approved label warning represents a balance that protects pharmaceutical companies that act responsibly and the public that consumes their products. (pp. 59-64)8. Three pathways are available to overcome the presumption of adequacy that attaches to the FDA-approved post-April 2002 label warnings for Accutane. The first pathway is if a plaintiff can establish deliberate concealment or nondisclosure of after-acquired knowledge of harmful effects. The second is if a plaintiff can demonstrate economically driven 4 manipulation of the postmarket regulatory process. The third is if a plaintiff can prove by clear and convincing evidence that a manufacturer knew or should have known in the postmarketing phase that the drug warnings were inadequate based on the label warning updating requirements in a pertinent federal regulation. Plaintiffs have failed to show any of those bases for overcoming the presumption of adequacy. In the absence of evidence sufficient to rebut the presumption, as a matter of law, the warnings adequately conveyed to medical professionals -- as well as to patients -- that usage of Accutane was associated with a risk of IBD. Roche used multiple warning tools: the physician label and Best Practices Guide, intended for physicians, and the Patient Safety Packet, Medication Guide, and blister packaging, intended for patients. Plaintiffs’ principal criticism is that the physician label and other warning materials should have used the language “causes” instead of “has been associated with” to describe the relationship between Accutane and IBD. Plaintiffs, however, have failed to present clear and convincing evidence that Roche’s use of the word “associated” to describe the relationship between Accutane and IBD was inadequate. The isolated examples plaintiffs have exhumed from the volumes of evidence do not support a showing of deliberate nondisclosure to the FDA, economically driven manipulation of the regulatory process, or clear and convincing evidence that Roche knew or should have known of the inadequacy of the warnings in light of the relevant federal regulations. Plaintiffs argue that Roche had internally concluded that Accutane was causally -- not just possibly -- related to IBD. However, plaintiffs have failed to establish that Roche had in fact made such a determination, engaged in deliberate concealment or nondisclosure of such knowledge, or otherwise knew or should have known under the standard articulated above that the use of the word “associated” was inadequate. Finally, whatever continuing concerns there may be about the FDA’s postmarketing oversight capacity, there is no evidence in this record of shortcomings in the FDA’s oversight of Accutane. (pp. 64-70)9. The Court reverses the judgment of the Appellate Division in those cases in which it vacated the grant of summary judgment in favor of Roche and affirms its judgment in those cases in which it upheld the grant of summary judgment in favor of Roche. As a result, the 532 failure-to-warn cases brought by plaintiffs against Roche are dismissed. (p. 70) AFFIRMED in part and REVERSED in part.CHIEF JUSTICE RABNER and JUSTICES LaVECCHIA, FERNANDEZ-VINA, SOLOMON, and TIMPONE join in JUSTICE ALBIN’s opinion. JUSTICE PATTERSON did not participate. 5 SUPREME COURT OF NEW JERSEY A-26/ 27 September Term 2017 079933 IN RE: ACCUTANE LITIGATION Argued April 23, 2018 – Decided October 3, 2018 On certification to the Superior Court, Appellate Division. Paul W. Schmidt (Covington & Burling) of the District of Columbia bar, admitted pro hac vice, and Edward J. Dauber (Greenberg Dauber Epstein & Tucker) argued the cause for appellants/cross- respondents Hoffmann-La Roche Inc. and Roche Laboratories Inc. (Gibbons, Dughi Hewit & Domalewski, and Covington & Burling, attorneys; Natalie H. Mantell, Russell L. Hewit, Paul W. Schmidt, and Michael X. Imbroscio (Covington & Burling) of the District of Columbia bar, admitted pro hac vice, of counsel and on the briefs). Bruce D. Greenberg and David R. Buchanan argued the cause for respondents/cross-appellants Angelo Annuzzi, et al. (Lite DePalma Greenberg, Seeger Weiss, Weitz & Luxenberg, and Beggs & Lane, attorneys; Bruce D. Greenberg, David R. Buchanan, Peter Samberg, and Mary Jane Bass (Beggs & Lane) of the Florida bar, admitted pro hac vice, on the briefs). Edward J. Fanning, Jr. argued the cause for amicus curiae HealthCare Institute of New Jersey (McCarter & English, and Reed Smith, attorneys; Edward J. Fanning, Jr., David R. Kott, Gary R. Tulp, Daniel K. Winters, and Philip W. Danziger, on the brief). Adam M. Slater argued the cause for amicus curiae New Jersey Association for Justice (Mazie Slater Katz & Freeman, attorneys; Adam M. Slater, of counsel and on the brief). 1 JUSTICE ALBIN delivered the opinion of the Court. This appeal arises from 532 product-liability claims filedagainst defendants Hoffmann-La Roche Inc. and Roche LaboratoriesInc. (collectively Roche), corporations with their principalplaces of business in New Jersey. Roche developed,manufactured, marketed, and labeled Accutane, a prescriptionmedication for the treatment of severe and persistent cases ofacne. Plaintiffs allege that Accutane, prescribed by theirphysicians for the treatment of acne, caused them to contractinflammatory bowel disease (IBD) and that Roche failed to giveadequate label warnings to advise them of the known risks of themedication. Of the 532 plaintiffs, 18 are New Jersey residentsand 514 are residents of 44 other jurisdictions. Plaintiffs’claims are designated as Multicounty Litigation (MCL) andconsolidated in the Atlantic County Superior Court, LawDivision, for administrative purposes. Two issues are before us. The first is what law governswhether Roche’s label warnings were adequate -- the law of eachof the 45 jurisdictions where plaintiffs were prescribed andtook Accutane or the law of New Jersey where the 532 cases areconsolidated for MCL purposes. The second issue is the adequacyof the label warnings for the period after April 2002. BecauseRoche’s warnings received the approval of the federal Food and 2 Drug Administration (FDA), those warnings enjoy a “rebuttablepresumption” of adequacy under New Jersey’s Products LiabilityAct (PLA). See N.J.S.A. 2A:58C-4. That presumption providespharmaceutical companies greater protection in New Jersey thanin many other jurisdictions. After conducting a choice-of-law analysis, the trial courtdetermined that New Jersey’s PLA applies to each of the 532consolidated cases and then concluded that plaintiffs failed toovercome the presumption of adequacy that attached to Roche’sAccutane warnings. Accordingly, the court granted summaryjudgment in favor of Roche. The Appellate Division came to a different result. Thepanel held that the law of each jurisdiction where plaintiffswere prescribed and took Accutane would govern the adequacy ofthe label warnings. After conducting a state-by-state legalanalysis, the panel concluded that summary judgment in favor ofRoche was improvidently granted in all cases except thosegoverned by the laws of California, Colorado, Indiana, Maryland,Mississippi, New York, Texas, and Virginia. In other words,under New Jersey’s PLA and the laws of thirty-six otherjurisdictions, the panel maintained that a genuine issue ofmaterial fact remained concerning the adequacy of the warnings. We now reverse in all those cases in which the AppellateDivision reinstated plaintiffs’ actions against Roche. Like the 3 trial court and Appellate Division, we apply the Restatement(Second) of Conflict of Laws (Am. Law Inst. 1971, amended 1988)(“Restatement”), adopted for personal injury cases in McCarrellv. Hoffmann-La Roche, Inc., 227 N.J. 569, 593-94 (2017), andP.V. ex rel. T.V. v. Camp Jaycee, 197 N.J. 132, 143 (2008).Unlike the Appellate Division, we hold that New Jersey has themost significant interests, given the consolidation of the 532cases for MCL purposes in Atlantic County. The aggregation ofhundreds of cases under MCL allows the resolution of commonissues of law. A trial judge cannot be expected to gain amastery of the law of forty-five different jurisdictions.Construing New Jersey’s PLA is challenging enough. New Jersey’sinterest in consistent, fair, and reliable outcomes cannot beachieved by applying a diverse quilt of laws to so many casesthat share common issues of fact. The PLA’s presumption of adequacy for medication warningsapproved by the FDA gives a reasonable measure of protection topharmaceutical companies, which are researching and developingmedications to combat diseases and maladies that afflict peoplearound the world. New Jersey also has an interest in ensuringthat its companies are producing safe medications and attachingwarnings that advise the public of their risks and benefits. Onthe record before us, even when viewed in the light mostfavorable to plaintiffs, we do not find that Roche withheld from 4 the FDA material information that would have altered the natureof the warnings or engaged in economically driven manipulationof the regulatory process. We also find that plaintiffs did notpresent clear and convincing evidence that Roche knew or shouldhave known that the label warnings were inadequate. Plaintiffstherefore have not overcome the statutory presumption ofadequacy. Consequently, as a matter of law, the warnings providedphysicians with adequate information to warn their patients ofthe risks of IBD. We therefore reverse in part and affirm inpart the judgment of the Appellate Division and dismiss allplaintiffs’ complaints. I. A. In this appeal, we address the adequacy of Roche’s FDA-approved post-April 10, 2002 warnings for Accutane, the brandname for isotretinoin, a prescription drug developed andmarketed nationwide by Roche for the treatment of severe casesof acne. See Kendall v. Hoffmann-La Roche, Inc., 209 N.J. 173,180 (2012). Plaintiffs are 532 individuals from 45jurisdictions, including New Jersey, who were prescribedAccutane by their treating physicians for their acne conditions.After taking the medication, plaintiffs claim they developedIBD, which encompasses “a number of chronic, relapsing 5 inflammatory diseases of the gastrointestinal tract.” SeeTabor’s Cyclopedic Medical Dictionary 1252 (23d ed. 2017)(“Tabor’s”). The two most common forms of IBD are ulcerative colitis andCrohn’s disease. The 532 plaintiffs in this case state thatthey suffer from ulcerative colitis, “a chronic conditioncharacterized by ulceration of the colon and rectum,” whichleads to frequent and bloody bowel movements as well as fatigue,dehydration, anemia, and abdominal pain. See Kendall, 209 N.J.at 181. “The symptoms often wax and wane, but the condition isregarded as permanent.” Ibid. The heart of this case is plaintiffs’ contention that thetaking of Accutane caused their IBD and that Roche failed toadequately warn of that risk. A Long Form Complaint, filed onbehalf of all plaintiffs, alleges that Roche knew or should haveknown that taking Accutane “was causally related” to IBD basedon information contained in its adverse event database and theconclusions drawn by its scientists. Plaintiffs further allegeRoche “did not adequately inform physicians or consumers of[Accutane’s] propensity to induce, aggravate or cause IBD.”Plaintiffs contend that Roche’s failure to provide adequatewarnings is the proximate cause of the “permanent physical andemotional injuries” they continue to suffer, and therefore theyseek compensatory and punitive damages. 6 Roche moved for summary judgment, claiming that thewarnings were adequate as a matter of law.1 We start with therelevant facts from the summary judgment record. B. In 1982, the Food and Drug Administration approved Roche’sapplication to market Accutane for the treatment of recalcitrantnodular acne. As part of the FDA pre-approval process, Rocheconducted a human clinical study involving 523 patients who tookAccutane. No reports of IBD arose from that clinical study,although approximately twenty-two percent of the patientssuffered certain gastrointestinal side effects. Roche submittedthe study to the FDA. When Roche launched Accutane commercially, the labelwarnings did not mention IBD. By 1983, during the postmarketingphase and while monitoring the safety of Accutane use, Rochereceived reports of six to eight patients -- out of a totalpopulation of 300,000 -- who had taken Accutane and developedIBD. Those reports prompted Roche to issue label warnings in1984 to prescribing physicians, generally dermatologists,stating that Accutane “has been temporally associated withinflammatory bowel disease (including regional ileitis) in1 Because defendants moved for summary judgment, we consider the facts in the light most favorable to the non-moving party, plaintiffs. Brill v. Guardian Life Ins. Co. of Am., 142 N.J. 520, 540 (1995). 7 patients without a prior history of intestinal disorders.” Roche collected additional data as it continued to monitorthe effects of Accutane on patients. Between 1985 and 2001,Roche received at least twenty case reports called “challenge,”“dechallenge,” and “rechallenge” events. The reports describedpatients who, while taking Accutane, suffered intestinaldisorders, with symptoms such as abdominal cramping and rectalbleeding (the “challenge” event), which subsided when Accutaneuse was discontinued (the “dechallenge” event), but reappearedwhen the medication regimen resumed (the “positive rechallenge”event). Those reports, many filed by the patients’ treatingphysicians, were registered with MedWatch, an FDA-administereddatabase that compiles adverse events concerning medicationsapproved by the FDA. In February 1999, the FDA asked Roche whether its datademonstrated the “reversibility” of Accutane-associated IBD. Bythat time, Roche had received information concerning nearly 300cases that associated Accutane usage with the onset of IBD. Aninternal Roche email explained that approximately two-thirds of188 patients who stopped using Accutane recovered. AlthoughRoche responded to the FDA inquiry by stating that there was“not sufficient information to recommend additional labelchanges related to [IBD],” the FDA nevertheless requested thatRoche remove from its label warning the word “temporally” and 8 add that symptoms of IBD “have been reported to persist afterAccutane treatment has stopped.” Roche complied. By April 10, 2002, Roche had generated a variety of FDA-approved warning labels and materials for a target audience ofprescribing physicians, pharmacists, and patients. Theinformation provided to physicians is of particular importancebecause New Jersey has adopted the “learned intermediary”doctrine, which recognizes that a prescribing doctor has theprimary responsibility of advising the patient of the risks andbenefits of taking a particular medication. See N.J.S.A.2A:58C-4; see also Niemiera v. Schneider, 114 N.J. 550, 565-66(1989) (“[I]t is the physician’s responsibility to pass on tothe parties the information that enables the patient to use theproduct safely.”). Presented below are the five key warning tools that wereprovided to physicians, pharmacists, and patients. 1. Roche’s primary means of communicating to healthcareproviders such information as Accutane’s dosages, druginteractions, commonly occurring side effects, and serious sideeffects is through the physician label (also known as a packageinsert). Roche’s approximately twenty-four-page package insertprovided medical professionals with specific IBD warnings. Physician Label 9 WARNINGS: . . . Inflammatory Bowel Disease: Accutane has been associated with inflammatory bowel disease (including regional ileitis) in patients without a prior history of intestinal disorders. In some instances, symptoms have been reported to persist after Accutane treatment has been stopped. Patients experiencing abdominal pain, rectal bleeding or severe diarrhea should discontinue Accutane immediately. (see ADVERSE REACTIONS: Gastrointestinal). [2]Importantly, this warning advises prescribing physicians thatnot only has IBD been associated with the taking of Accutane,but that symptoms of the disease “have been reported to persistafter Accutane treatment has been stopped.” 2. In addition, Roche provided physicians with a BestPractices Guide, which, although mostly focused on the risks ofAccutane causing birth defects, also identified IBD as aspecific risk associated with Accutane use. The Guide advised2 The physician label also cross-referenced IBD in the ADVERSE REACTIONS section: ADVERSE REACTIONS: . . . . The adverse reactions listed below reflect the experience from investigational studies of Accutane, and the postmarketing experience. The relationship of some of these events to Accutane therapy is unknown. . . . Gastrointestinal: inflammatory bowel disease (see WARNINGS: Inflammatory Bowel Disease) . . . . 10 physicians to fully counsel their patients “about the warningsand precautions in the Accutane package insert.” Best Practices Guide Accutane use is associated with other potentially serious adverse events, as well as more frequent, but less serious side effects. . . . . Adverse Event Warnings include . . . inflammatory bowel disease . . . . . . . . Patients should be reminded to read the Medication Guide, distributed by the pharmacist at the time Accutane is dispensed. 3. Roche also prepared a Patient Safety Packet for physiciansto give to their patients that explained in plain language therisks and possible side effects of taking Accutane. An attachedInformed Consent Form required the patient to acknowledge inwriting that he or she read and understood the Patient SafetyPacket. It also required the prescribing doctor to certify thatthe “benefits and risks” of Accutane treatment were “fullyexplained” to the patient.3 Patient Safety Packet You should be aware that certain SERIOUS SIDE EFFECTS have been reported in patients taking Accutane. Serious problems do not happen in most patients. If you experience any of the following side effects or any other unusual or severe problems, stop taking Accutane right away and call your prescriber because they may3 Birth defects and psychiatric side effects are specifically mentioned on the form, but IBD is not. 11 result in permanent effects. . . . . Abdomen (stomach area) problems. Certain symptoms may mean that your internal organs are being damaged. These organs include the . . . bowel (intestines). If your organs are damaged, they may not get better even after you stop taking Accutane. Stop taking Accutane and call your prescriber if you get severe stomach or bowel pain, diarrhea, [or] rectal bleeding . . . . 4. Roche also developed, in conjunction with the FDA, aMedication Guide for pharmacists to distribute to Accutanepatients when they received their prescriptions. Like thePatient Safety Packet, the Medication Guide warned of “possibleserious side effects” from Accutane and described IBD symptomsin simple and plain language. Medication Guide Accutane has possible serious side effects . . . . Abdomen (stomach area) problems. Certain symptoms may mean that your internal organs are being damaged. These organs include the . . . bowel (intestines) . . . . If your organs are damaged, they may not get better even after you stop taking Accutane. Stop taking Accutane and call your prescriber if you get severe stomach, chest or bowel pain . . . diarrhea, [or] rectal bleeding . . . . . . . . Serious permanent problems do not happen often. However, because the symptoms listed above may be signs of serious problems, if you get these symptoms, stop taking Accutane and call your prescriber. If not treated, they could lead to serious health problems. Even if these problems are treated, they may not 12 clear up after you stop taking Accutane.The Medication Guide makes clear the potential permanency ofharm to the patient’s bowels and intestines by taking Accutane,indicating to the patient that “[i]f your organs are damaged,they may not get better even after you stop taking Accutane” andthat symptoms “may not clear up after you stop taking Accutane.” 5. Last, Roche required pharmacists to dispense Accutane pillsin “blister packaging” that again warned the patient thatAccutane could have serious gastrointestinal side effects. Blister Packaging Other serious side effects to watch for Stop taking Accutane and call your prescriber if you develop any of the problems on this list or any other unusual or severe problems. If not treated, they could lead to serious health problems. Serious permanent problems do not happen often. . . . .  Severe stomach pain, diarrhea, rectal bleeding, or trouble swallowing. . . . . Other important information is found in the Medication Guide and in the booklet from your prescriber. Accordingly, by 2002, before taking Accutane, patientsreceived the IBD warnings from their prescribing physicians andfrom their pharmacies when they filled their prescriptions. TheFDA, moreover, reviewed and approved each of Roche’s warningtools mentioned. One senior FDA official commented before the 13 House Committee on Energy and Commerce that the agency took its“regulatory responsibilities concerning [Accutane] veryseriously,” as evidenced by its involvement in monitoringadverse reactions and updating the drug’s warning labels.Issues Relating to the Safety of Accutane: Hearing Before theSubcomm. on Oversight & Investigations of the H. Comm. on Energy& Commerce, 107th Cong. 27 (2002) (statement of Janet Woodcock,Director, Center for Drug Evaluation and Research, U.S. Food andDrug Administration). In 2009, Roche discontinued the marketing of Accutane inthe United States. In 2010, the FDA issued an official Notice,stating that the “FDA has independently evaluated relevantliterature and data for possible postmarketing adverse eventsand has found no information that would indicate that [Accutane]was withdrawn from sale for reasons of safety or effectiveness.” 75 Fed. Reg. 39,024, 39,025 (July 7, 2010). In 2012, the FDA approved Absorbica, another brand-nameformulation of isotretinoin manufactured by a different company.Absorbica’s FDA-approved physician label warnings about IBD arefunctionally identical to those used by Roche in its post-2002Accutane physician labels.44 The warning for the Absorbica physician label includes, in pertinent part: 14 C. From the voluminous record in this case, plaintiffs focusour attention on excerpts from several internal Roche documentsthat reference Accutane and the potential risk of IBD asevidence that Roche should have given better warnings.Additionally, plaintiffs state that Roche failed to share the“internal conclusions” in those documents with the FDA. One excerpt provided by plaintiffs is from a 1994 internalRoche document that indicates that colitis is a “possible [s]ideeffect” of taking Accutane. The document notes that the “reasonfor inclusion [of colitis] as a side effect and not as a Isotretinoin has been associated with inflammatory bowel disease (including regional ileitis) in patients without a prior history of intestinal disorders. In some instances, symptoms have been reported to persist after isotretinoin treatment has been stopped. Patients experiencing abdominal pain, rectal bleeding or severe diarrhea should discontinue Absorbica immediately [see Adverse Reactions (6.1)] . . . . Adverse Reactions . . . . The adverse reactions listed below reflect both clinical experience with Absorbica, and consider other adverse reactions that are known from clinical trials and the post- marketing surveillance with oral isotretinoin. The relationship of some of these events to isotretinoin therapy is unknown. . . . . Gastrointestinal: . . . inflammatory bowel disease . . . . 15 contraindication is probably the fact that the data regardingoccurrence or aggravation of this condition . . . iscontradictory.”5 The document’s author refers to published andunpublished data about Accutane and IBD-related disorders andreaches some tentative conclusions: (1) “Enterocolitis is apossible side effect of [Accutane] in very rare cases, possiblyin patients predisposed to inflammatory gastro-intestinaldiseases”; (2) “[i]n patients with ileitis, enteritis or colitisin the active phase of the disease [Accutane] is basicallycontraindicated”; and (3) “a careful risk analysis should bemade” before administering Accutane to patients with a “historyof severe gastro-intestinal inflammatory diseases.” Another document referenced by plaintiffs is a 1994memorandum from Dr. H. Lefrancq, a Roche physician, to aninquirer within Roche concerning “the administration of[Accutane] in patients with colitis.” In that memorandum,Lefrancq mentions information from a safety database, whichdisclosed “a total of 33 cases of colitis [that] have beenspontaneously reported up to January 6, 1994, which were ratedas 'possibly’ or 'probably’ related to the administration of[Accutane].” Based on the data, Lefrancq believed it was5 A “side effect” is “[a]n action or effect of a drug other than that desired.” Tabor’s at 2153. A “contraindication” is “[a] symptom or circumstance that makes treatment with a drug or device unsafe or inappropriate.” Id. at 553. 16 “reasonable to conclude . . . that, in rare cases, [Accutane]may induce or aggravate a preexisting colitis.” Significantly,however, Lefrancq recommended to the inquirer that he could re-administer Accutane to his patient when the patient’s ulcerativecolitis reached the “inactive phase.” Plaintiffs also highlight less than one page of an 1197-page report that Roche prepared for European regulatoryauthorities in 2000 that describes a particular patient’s case.In that case, a seventeen-year-old patient developed ulcerativecolitis one month after she stopped taking Accutane. In theanalysis of that single case, a Roche physician noted thatAccutane “has been found to be causally associated withinflammatory bowel disease, including colitis.” Finally, plaintiffs allude to a debate inside Roche betweenthe marketing and drug-safety employees about whether tostrengthen warnings about the psychiatric side effects ofAccutane. IBD was not at issue. In a general salespresentation, the marketing department had described Accutane as“the goose that lays the golden eggs” -- an obvious reference toRoche’s strong financial interest in the continued success ofAccutane sales. Despite the discussions, Roche strengthened thewarning, indicating that Accutane use could cause depression.At an earlier Accutane trial, Roche’s former chief medicalofficer testified that the marketing department did not make the 17 call over labeling decisions. II. A. In 2005, for administrative purposes, this Court designatedall pending and future New Jersey product-liability actionsinvolving Accutane as Mass Tort Litigation -- now referred to asMulticounty Litigation (MCL), see R. 4:38A -- and consolidatedall such actions in Atlantic County. The law firm Seeger WeissLLP, which had requested that the Accutane cases be given thedesignation of Mass Tort Litigation, was later appointedplaintiffs’ liaison counsel. In making that request, counselfor Seeger Weiss wrote: plaintiffs’ “claims share common issuesof law and fact, including whether . . . [Roche] violated theNew Jersey Products Liability Act in its marketing and sale ofAccutane.” In 2015, in a series of rulings, the trial court concludedthat the New Jersey PLA governed not only the 18 in-state claimsbut also the 514 claims that involved plaintiffs who wereprescribed and took Accutane in 44 other jurisdictions. 6 The 6 The trial court also conducted a state-by-state analysis as an alternative ruling. Under that approach, the court granted summary judgment in favor of Roche to plaintiffs who resided in thirteen jurisdictions other than New Jersey. In light of our ultimate disposition, a state-by-state review of the court’s analysis is unnecessary. 18 court then granted Roche’s motion for summary judgment,determining that plaintiffs failed to overcome the presumptionof adequacy that attached to the post-2002 Accutane labelwarnings approved by the FDA. In making its choice-of-law determination, the courtreferenced the Seeger Weiss letter in which counsel representedthat the sixty-eight cases then pending in 2005, only two ofwhich were brought by New Jersey residents, shared a commonissue of law -- whether Roche violated New Jersey’s PLA. Thecourt emphasized that nothing in Seeger Weiss’s correspondencewith this Court suggested that the out-of-state plaintiffs“wish[ed] to bring the law of their states with them to NewJersey” or that the court would have to engage in a state-by-state choice-of-law analysis.7 The court did not find itreasonable for our judiciary to apply the law of scores ofjurisdictions, “many of which express standards incompatiblewith the NJPLA,” to thousands of claims involving cutting-edgeissues of science and law. The court noted that Accutane filings grew from less than100 in March 2005 to more than 7500 by February 2015. More than7 Pursuant to MCL guidelines, the letter was directed to the Administrative Director of the Courts. See New Jersey Multicounty Litigation (Non-Asbestos) Resource Book 2 (4th ed. Nov. 2014) (“MCL Resource Book”) (explaining that application for MCL designation is made to Supreme Court “through the Administrative Director”). 19 4600 Accutane cases remained on the docket when the courtdetermined that applying each state’s law “is neither practical. . . nor would it promote 'the values of uniformity andpredictability,’” quoting Camp Jaycee, 197 N.J. at 154. Thecourt cited “the inability to assemble 'bellwether’ cases frommultiple jurisdictions which would produce meaningful results”as another reason for applying the New Jersey PLA. It alsoasserted that applying the conflicting law of another statewould undermine the Legislature’s intent in passing the FDApresumption-of-adequacy provision of the PLA, which was to“reduc[e] the burden placed on [New Jersey manufacturers] byproduct liability litigation,” quoting Rowe v. Hoffmann-LaRoche, Inc., 189 N.J. 615, 626 (2007). In concluding that the presumption of adequacy governingAccutane’s FDA-approved warnings had not been overcome, thecourt maintained that plaintiffs’ proofs did not establisheither a “deliberate concealment or nondisclosure of after-acquired knowledge of harmful effects,” citing Perez v. WyethLabs., Inc., 161 N.J. 1, 25 (1999), and Rowe, 189 N.J. at 626,or a “manipulation of the post-market regulatory process,”citing McDarby v. Merck & Co., 401 N.J. Super. 10, 63 (App. Div.2008). In addition, the court concluded that Roche’s labelwarnings, in their totality, communicated a “clear, accurate andunambiguous” message to physicians that Accutane “is associated 20 with risk of serious side effects.” For those reasons, thecourt dismissed the 532 product-liability actions broughtagainst Roche. B. The Appellate Division reversed in part and affirmed inpart. The panel found that the trial court erred in its choice-of-law analysis by applying New Jersey’s PLA to the 514 cases inwhich plaintiffs were prescribed and took Accutane in 44 otherjurisdictions. The panel rejected the trial court’s positionthat the representations made by the attorney seeking mass-tortdesignation for the then less than 100 Accutane cases waived theright of the now thousands of out-of-state plaintiffs to thecustomary choice-of-law analysis. The panel pointed to thewording of the later-filed Long Form Complaint designated forMCL cases, which indicates that plaintiffs’ claims are based onthe violation of New Jersey’s PLA or “the analogous law” of thejurisdictions where Accutane was ingested or prescribed. Inshort, the panel held that counsel did not have the authority tostipulate the choice of law for thousands of plaintiffs. Applying the relevant sections of the Restatement (Second)of Conflict of Laws, adopted by this Court, the panel concludedthat each individual case had to be judged under the substantivelaw of the jurisdictions where each plaintiff was prescribed andtook Accutane -- forty-five jurisdictions in all. The panel 21 dismissed the notion that plaintiffs, by participating in mass-tort litigation in New Jersey, surrendered their right to anindividual choice-of-law analysis and the application of theirstates’ laws. The panel maintained that although plaintiffs’claims were consolidated for administrative purposes, eachplaintiff filed a separate complaint. The panel considered New Jersey’s PLA to be “sufficientlydifferent from most, if not all, [of] the other competingjurisdictions,” and therefore reasoned that a choice-of-lawanalysis was required. The panel observed that, under section146 of the Restatement, the law of the state where the injuryoccurred is presumed to govern unless another state has “a moresignificant relationship” to the litigation in light of theprinciples enunciated in sections 145 and 6 of the Restatement.The panel ruled that this State did not have a more significantrelationship to the litigation than those jurisdictions wherethe “injury” occurred. In the panel’s view, New Jersey’s PLAgives greater protection to pharmaceutical companies thananalogous laws in other jurisdictions and therefore applicationof our State’s law “might frustrate the other states’ policiesin deterring a broader scope of inadequate warnings” and beinconsistent with the reasonable expectations of the parties.The panel “reject[ed] the argument that simplification ofprocedures and uniformity of results should govern the choice- 22 of-law questions presented.” According to the panel,“[i]nterests of judicial administration should not be accordedundue weight,” and the demand for “efficient results” should notyield to the strong state interests of other jurisdictions. Thepanel concluded that the law in each of the forty-fivejurisdictions where plaintiffs resided and ingested Accutanewould apply to their cases. The panel affirmed the grant of summary judgment in favorof Roche in those cases involving plaintiffs who were prescribedand took Accutane in California, Colorado, Indiana, Maryland,Mississippi, New York, and Virginia because “[i]t is enough inthese jurisdictions that IBD was referenced” in Roche’s labelwarnings to render them adequate as a matter of law. The panelalso affirmed the grant of summary judgment in those casesinvolving the Texas plaintiffs because they had not overcomethat jurisdiction’s presumption of adequacy. The panel,however, found that the trial court improvidently grantedsummary judgment in favor of Roche in the cases of thoseplaintiffs from the remaining thirty-seven jurisdictions because“the adequacy of the warnings could not be resolved as a matterof law.” Under New Jersey’s PLA, the panel held that plaintiffs hadpresented sufficient evidence to overcome the presumption ofadequacy attached to Accutane’s FDA-approved warnings and 23 therefore genuine issues of material fact needed to be resolvedby a jury. In particular, the panel stated that, based on Perezand McDarby, the summary judgment record rebutted thepresumption of adequacy because Roche not only failed todisclose to the FDA “after-acquired knowledge of Accutane’sharmful effects,” but also engaged in an “economically-drivenmanipulation of the post-market regulatory process.” The panelspecifically determined that a factfinder could conclude that,after FDA approval, Roche did not disclose critical informationin its post-2002 warnings -- that Roche “had internallyconcluded there was a causative effect” between Accutane andIBD. The panel also disagreed with the trial court’s assertionthat, even if the presumption of adequacy had been overcome, thelabel warnings were “clear enough to negate a trial on theissue.” C. We granted Roche’s petition for certification, 231 N.J. 419(2017), and plaintiffs’ cross-petition, 231 N.J. 428 (2017). Wealso granted the motion of the New Jersey Association forJustice to participate as amicus curiae. The HealthCareInstitute of New Jersey, which participated as amicus curiaebefore the Appellate Division, was allowed to appear in thatrole before this Court pursuant to Rule 1:13-9(d). 24 III. A. 1. Roche argues that the Appellate Division erred in failingto apply the New Jersey PLA to the 514 claims of out-of-stateplaintiffs. Roche submits that a proper choice-of-law analysisrequires this Court to recognize New Jersey’s strong interest --expressed through the PLA’s presumption of adequacy -- inprotecting this State’s pharmaceutical companies fromunmeritorious product-liability litigation from out-of-stateresidents. Roche also claims that the effective administrationof justice through the consolidation of many claims in a singlecounty under MCL calls for the application of this State’s PLAto adequacy challenges brought by non-New Jersey plaintiffs. Onthat point, Roche emphasizes that plaintiffs sought MCLdesignation on the basis that they shared a common issue of law-- whether Roche violated the PLA. The interests in applying New Jersey law, Roche contends,are not outweighed by plaintiffs’ home-state interests.According to Roche, “a large number of states lack a clearstandard for determining precisely when pharmaceutical warningsare adequate as a matter of law” and “nearly all other stateslack a clearly-defined presumption of adequacy like NewJersey’s.” Roche further contends that the application of the 25 PLA to all 532 claims will promote “certainty, predictabilityand uniformity of result,” quoting Restatement § 6(2)(f). Insum, Roche urges this Court to find, in analyzing theRestatement factors, that New Jersey, where Accutane waslabeled, “has the most significant relationship to the adequacyissue” in this appeal. Roche submits that the Appellate Division mistakenlydetermined that non-dismissed plaintiffs had overcome thepresumption of adequacy attached to Accutane’s FDA-approvedwarnings. It claims that “the FDA helped formulate, repeatedlyreviewed, and consistently approved Accutane’s safetycommunication tools,” which “repeatedly and directly addressedthe risk” of IBD. Roche asserts that there is no evidence thatit concealed evidence from the FDA or engaged in “intentionalpost-market manipulation of the FDA for economic reasons.”Roche claims that plaintiffs “plucked isolated statements from[its] internal documents” and wrongly accused Roche ofintentionally concealing them, even though the information inthose statements was known to the FDA through its submissions. Roche also states that “the overwhelming scientific recordnow demonstrably fails to show any connection” between Accutaneand IBD, further validating the accuracy of its label warnings,which it insists clearly and unambiguously warned physicians and 26 patients of the risk of IBD.8 2. Amicus curiae the HealthCare Institute of New Jersey echoesmany of the arguments advanced by Roche. It asserts that thefallout from the Appellate Division’s decision is “thatpotentially hundreds of juries [will] separately determinewhether Accutane’s FDA-approved IBD warnings are adequate,presenting the risk of divergent outcomes regarding the samewarnings.” It also posits that the panel’s decision underminesthe effectiveness of the PLA’s presumption of adequacy and willburden pharmaceutical companies with unmeritorious lawsuits thatwill threaten “the development of prescription medical devicesand drugs.” B. 1. Plaintiffs urge this Court to uphold the AppellateDivision’s choice-of-law determination, which requires theapplication of the law of the jurisdiction where each plaintiffwas prescribed and took Accutane. Plaintiffs agree with thepanel that the trial court erred in deciding to apply New Jersey8 In response to plaintiffs’ cross-petition, Roche maintains that the Appellate Division correctly found that its warnings were adequate under the laws of eight states and that summary judgment was properly entered in its favor in the cases of those plaintiffs from those states. 27 law based on the 2005 letter written by the attorney -- laterselected as liaison counsel -- as support for consolidating theAccutane cases into an MCL matter. Plaintiffs point to the LongForm Complaint in which plaintiffs expressly invoked theanalogous law of the states where plaintiffs were prescribed andtook Accutane. Those states’ laws are implicated, plaintiffscontend, because “Roche deliberately marketed and sold[Accutane] in those jurisdictions.” Plaintiffs maintain that ananalysis under the guiding principles of the Restatement favorsapplying the law of the jurisdictions where Accutane wasprescribed and taken because those states have strong interestsin regulating commerce within their borders. In plaintiffs’view, New Jersey’s interest in effective judicial administrationshould yield to the interests of interstate comity. Plaintiffssubmit that, under each of those states’ laws, summary judgmentshould have been denied because of the abundant evidence of theinadequacies of Roche’s 2002 label warnings. Plaintiffs also maintain that the “Appellate Divisioncorrectly determined that a reasonable jury could find thatsubstantial evidence overcomes [the PLA’s] rebuttablepresumption of adequacy” that attaches to Roche’s FDA-approvedlabel warnings. They further claim that the evidence supports afinding of inadequacy under the laws of all the jurisdictions atissue. Plaintiffs assert that they have presented 28 “[substantial] evidence of Roche’s non-disclosure of criticalsafety information and its economic motivation to thwart theregulatory process,” both bases for overcoming the presumptionof adequacy of Roche’s label warnings. Plaintiffs charge Rochewith withholding documents from the FDA that would have revealed“that Roche had internally determined that there was a causallink between Accutane and IBD/[ulcerative colitis].” Accordingto plaintiffs, “[d]espite internal admissions that Accutane'induces,’ 'may cause,’ and is 'causally associated with’ IBD,Roche did not disclose this knowledge to physicians in itswarnings.” Plaintiffs insist that our jurisprudence does not“establish[] a nearly irrebuttable presumption that exculpatespharmaceutical manufacturers from failure-to-warn liability.”Plaintiffs conclude we should affirm the Appellate Division,which denied summary judgment in the cases of those plaintiffsbound by the laws of thirty-seven jurisdictions, including NewJersey, and reverse its grant of summary judgment in the casesof those plaintiffs bound by the laws of eight otherjurisdictions. 2. Amicus curiae the New Jersey Association for Justice lendssupport to the arguments made by plaintiffs. It suggests the“typical rebuttable presumption” of adequacy afforded to label 29 warnings was heightened in Perez based on an incompleteunderstanding of the role the FDA plays in regulating andapproving label warnings after a prescription drug has beenmarketed. The Association submits that Perez’s declaration that“compliance with FDA standards should be virtually dispositive”of failure-to-warn claims does not account for the reality thatthe FDA -- particularly in the postmarketing phase of aprescription drug -- does not have “the financial,technological, and human capital resources to fulfill itsmission.” IV. A. We first address the choice-of-law issue. We must decidewhich law or laws govern the 532 cases before us -- New Jersey’sPLA or the failure-to-warn laws of each of the forty-fivejurisdictions where individual plaintiffs were prescribed andtook Accutane. The decisions of the trial court and Appellate Divisionoffer starkly different choice-of-law options. The trial courtruled that New Jersey’s PLA applies to all 532 cases. TheAppellate Division reversed and determined that the law of thejurisdiction where each plaintiff was prescribed and tookAccutane -- in all, forty-five jurisdictions -- governs eachaction. We review those choice-of-law decisions de novo, owing 30 no deference to the legal conclusions reached by either court,unless persuaded by their reasoning. McCarrell, 227 N.J. at 583-84. B. We apply New Jersey’s choice-of-law rules in determiningwhether this State’s or another state’s law governs the action.Id. at 583. In doing so, the first inquiry “is whether the lawsof the states with interests in the litigation are in conflict.”Id. at 584. If there is not “an actual conflict” in “thesubstance of the potentially applicable laws” of the twojurisdictions, then “there is no choice-of-law issue to beresolved,” Camp Jaycee, 197 N.J. at 143, and the forum stateapplies its own law, McCarrell, 227 N.J. at 584. A conflict oflaw arises when the application of one or another state’s lawmay alter the outcome of the case, see id. at 584, or when thelaw of one interested state is “offensive or repugnant” to thepublic policy of the other, see Continental Ins. Co. v.Honeywell Int’l, Inc., 234 N.J. 23, 46 (2018) (quoting DeMarcov. Stoddard, 223 N.J. 363, 383 (2015)). Here, we must compare New Jersey’s PLA with the product-liability laws or analogues of forty-four other jurisdictions.99 Alabama, Arkansas, California, Colorado, Connecticut, Delaware, the District of Columbia, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Minnesota, Mississippi, Missouri, 31 New Jersey’s rebuttable presumption of adequacy, whichspecifically attaches to FDA-approved warnings, sets our lawapart from most other states’ laws. Texas also has apresumption of adequacy for FDA-approved warnings, but itspresumption is evidently more difficult to overcome than NewJersey’s presumption.10 Indiana, Kansas, North Dakota, Oklahoma,Oregon, Tennessee, Utah, and Wisconsin have a general rebuttablepresumption that applies to all product warnings, which can beovercome either by a mere preponderance of the evidence or bysufficient evidence.11Montana, Nebraska, Nevada, New Hampshire, New York, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, Wisconsin, and Wyoming.10 Plaintiffs can overcome the presumption of adequacy in Texas by showing that a defendant “withheld from or misrepresented to” the FDA mandatory material information that was “relevant to the performance of the product” and “causally related to the claimant’s injury.” See Tex. Civ. Prac. & Rem. Code Ann. § 82.007(b)(1). However, unlike New Jersey, Texas does not apparently recognize “economically-driven manipulation of the post-market regulatory process,” see McDarby, 401 N.J. Super. at 63, or clear and convincing evidence that a manufacturer knew or should have known in the postmarketing phase that the drug warning was inadequate, see infra Section V, as sufficient bases for overcoming the presumption of adequacy.11 Indiana (Ind. Code § 34-20-5-1; Cansler v. Mills, 765 N.E.2d 698, 705 (Ind. Ct. App. 2002), disapproved of on other grounds by Schultz v. Ford Motor Co., 857 N.E.2d 977 (Ind. 2006)); Kansas (Kan. Stat. Ann. § 60-3304(a)); North Dakota (N.D. Cent. Code § 28-01.3-09); Oklahoma (Okla. Stat. tit. 76, § 57.2); Oregon (Or. Rev. Stat. § 30.900, .910; Chong v. STL Int’l, Inc., 152 F. Supp. 3d 1305, 1317 (D. Or. 2016)); Tennessee (Tenn. Code Ann. § 29-28-104; Goins v. Clorox Co., 926 F.2d 559, 562 (6th 32 The laws of the remaining jurisdictions do not protect aproduct’s warnings with a presumption of adequacy. 12 Cir. 1991)); Utah (Utah Code Ann. § 78B-6-703(2); Egbert v. Nissan N. Am., Inc., 156 P.3d 1058, 1062 (2007)); Wisconsin (Wis. Stat. §§ 895.047(3)(b), 903.01).12 Arkansas (Ark. Code Ann. § 16-116-204, -205(a)); Connecticut (Conn. Gen. Stat. § 52-572q); Delaware (Lacy v. G.D. Searle & Co., 567 A.2d 398 , 400 (Del. 1989)); the District of Columbia (Payne v. Soft Sheen Prods., Inc., 486 A.2d 712 , 723 (D.C. 1985)); Florida (Thomas v. Bombardier Recreational Prods., Inc., 682 F. Supp. 2d 1297, 1300 (M.D. Fla. 2010)); Georgia (Weilbrenner v. Teva Pharm. USA, Inc., 696 F. Supp. 2d 1329, 1339 (M.D. Ga. 2010)); Idaho (Sliman v. Aluminum Co. of Am., 731 P.2d 1267, 1272 (Idaho 1986)); Illinois (Hernandez v. Schering Corp., 958 N.E.2d 447, 455 (Ill. App. Ct. 2011)); Iowa (Nationwide Agribus. Ins. Co. v. SMA Elevator Constr., Inc., 816 F. Supp. 2d 631, 654 (N.D. Iowa 2011)); Kentucky (Larkin v. Pfizer, Inc., 153 S.W.3d 758, 764-65 (Ky. 2004)); Maine (Doe v. Solvay Pharm., Inc., 350 F. Supp. 2d 257 , 272-74 (D. Me. 2004)); Massachusetts (MacDonald v. Ortho Pharm. Corp., 475 N.E.2d 65 , 70-71 (Mass. 1985)); Minnesota (Delude v. Johnson & Johnson, 726 F. Supp. 2d 1025, 1034 (D. Minn. 2010)); Missouri (Doe v. Alpha Therapeutic Corp., 3 S.W.3d 404 , 419 (Mo. Ct. App. 1999)); Montana (Hill v. Squibb & Sons, E.R., 592 P.2d 1383, 1387-88 (Mont. 1979)); Nebraska (Freeman v. Hoffmann-La Roche, Inc., 618 N.W.2d 827 , 841-42 (Neb. 2000)); Nevada (Allison v. Merck & Co., 878 P.2d 948 , 960-61 (Nev. 1994)); New Hampshire (Brochu v. Ortho Pharm. Corp., 642 F.2d 652, 657-58 (1st Cir. 1981)); Ohio (Seley v. G.D. Searle & Co., 423 N.E.2d 831, 836-37 (Ohio 1981)); Pennsylvania (Rowland v. Novartis Pharm. Corp., 34 F. Supp. 3d 556, 571-72 (W.D. Pa. 2014)); Puerto Rico (Guevara v. Dorsey Labs., Div. of Sandoz, Inc., 845 F.2d 364, 367 (1st Cir. 1988)); Rhode Island (Castrignano v. E.R. Squibb & Sons, Inc., 546 A.2d 775 , 782-83 (R.I. 1988)); South Carolina (Allen v. Long Mfg. N.C., Inc., 505 S.E.2d 354 , 357-58 (S.C. Ct. App. 1998)); South Dakota (McElhaney v. Eli Lilly & Co., 575 F. Supp. 228 , 231-32 (D.S.D. 1983)); Vermont (Town of Bridport v. Sterling Clark Lurton Corp., 693 A.2d 701 , 705-06 (Vt. 1997)); Washington (Laisure-Radke v. PAR Pharm., Inc., 426 F. Supp. 2d 1163, 1172 (W.D. Wash. 2006)); and Wyoming (Thom v. Bristol-Myers Squibb Co., 353 F.3d 848 , 853-55 (10th Cir. 2003)). 33 Nevertheless, in Alabama, California, Colorado, Indiana,Maryland, Louisiana, Mississippi, New York, and Virginia, a drugwarning is adequate as a matter of law if it provides clear andspecific information about a potential risk, such as IBD.13 NewJersey’s presumption of adequacy for FDA-approved label warningsseemingly gives greater protection to pharmaceutical companiesthan the laws of other states, but not necessarily so. TheAppellate Division granted summary judgment in favor of Roche inthe cases of plaintiffs governed by the laws of eight states butdenied summary judgment in the cases of those plaintiffsgoverned by New Jersey’s PLA and the laws of the thirty-sixremaining jurisdictions. Discerning the precise meaning of the laws of forty-fourjurisdictions -- other than New Jersey’s -- is an arduous andburdensome task. Our treatment of those laws here is far from13 See Louisiana (Stahl v. Novartis Pharm. Corp., 283 F.3d 254 , 267 (5th Cir. 2002)); Virginia (Ball v. Takeda Pharm. Am., Inc., 963 F. Supp. 2d 497, 504 (E.D. Va. 2013)); Indiana (Tucker v. SmithKline Beecham Corp., 701 F. Supp. 2d 1040, 1066 (S.D. Ind. 2010)); Colorado (Caveny v. Ciba-Geigy Corp., 818 F. Supp. 1404 , 1406 (D. Colo. 1992)); Alabama (Morguson v. 3M Co., 857 So. 2d 796 , 801-02 (Ala. 2003)); California (Brown v. Superior Court, 751 P.2d 470 , 477 (Cal. 1988)); Maryland (Nolan v. Dillon, 276 A.2d 36, 40-41 (Md. 1971)); Mississippi (Wyeth Labs., Inc. v. Fortenberry, 530 So. 2d 688 , 691 (Miss. 1988)); New York (Martin v. Hacker, 628 N.E.2d 1308 , 1312 (N.Y. 1993)). We disagree with the Appellate Division’s opinion that “it is enough in [Colorado, Indiana, Maryland, Mississippi, New York, and Virginia] that IBD was referenced” in Roche’s label warnings to render them adequate. 34 comprehensive or definitive. We proceed under the assumptionthat the application of New Jersey’s PLA may lead to an outcomedifferent from the application of the laws of those otherjurisdictions. Recognizing that the substantive laws of NewJersey and the other jurisdictions are in conflict requires thatwe choose the law or laws that govern the 532 cases before us. In Camp Jaycee, we adopted the Restatement’s most-significant-relationship test set forth in sections 146, 145,and 6 as the paradigm for deciding which state’s substantive lawapplies in personal injury cases involving more than one state. 197 N.J. at 142-43. The Restatement’s most-significant-relationship test embodies all the elements of this Court’sformer governmental-interest test and adds “a series of otherfactors deemed worthy of consideration.” Id. at 142 n.4.14 Thatmore nuanced approach is the one we apply here. In Camp Jaycee, the plaintiffs -- parents of a young womanwith mental disabilities from New Jersey -- brought suit in ourSuperior Court, Law Division, against a New Jersey not-for-profit corporation operating a summer program in which theparents had enrolled their daughter. Id. at 136-37. While14 Under the governmental-interest test, a court must “identify the governmental policies underlying the law of each state and how those policies are affected by each state’s contacts to the litigation and to the parties.” Veazey v. Doremus, 103 N.J. 244, 248 (1986). 35 under the defendant’s care at a Pennsylvania summer camp, theplaintiffs’ daughter was sexually assaulted by another camper.Ibid. The parents alleged that the defendant was negligent inits supervision of their daughter. Id. at 137. The defendantwas shielded from tort liability under New Jersey’s CharitableImmunity Act, but not under Pennsylvania law, which hadexpressly abolished the doctrine of charitable immunity. Id. at135, 143-44. The case thus presented a true conflict ofsubstantive law. Id. at 143-44. In applying the Restatementprinciples, we affirmed the Appellate Division’s determinationto apply Pennsylvania’s law. Id. at 155-56. We held that aweighing of all relevant factors did not overcome section 146’spresumption that the law of the place of injury applied. Id. at156. We found that Pennsylvania, which has a specific policy ofencouraging the exercise of due care by those residing withinits borders and assuring that those who suffer injuries from thenegligent acts of others receive compensation, had a moresignificant relationship to the case. Id. at 155-56. Unlike Camp Jaycee, where the only question was whether thelaw of New Jersey or Pennsylvania governed in a single personalinjury action, in this MCL setting, New Jersey’s PLA intersectswith the laws of 44 other jurisdictions in 514 cases. The casebefore us, therefore, presents challenges not posed in CampJaycee. 36 In Ginsberg v. Quest Diagnostics, Inc., “[w]eacknowledge[d] that a defendant-by-defendant choice-of-lawanalysis is not feasible in every matter,” particularly “[i]n acomplex case with many parties from different states.” 227 N.J. 7, 20 (2016). In such a scenario, “the trial court retains thediscretion to decline a defendant-by-defendant approach and,utilizing a Restatement §§ 146, 145 and 6 analysis . . . applythe law of a single state to claims asserted against alldefendants.” Ibid.15 It also bears mentioning that, amongacademic experts in the field of conflict of laws, there is a“consensus, at least, that ordinary choice-of-law practicesshould yield in suits consolidating large numbers of claims andthat courts should apply a single law in such cases” -- butthere are dissenting voices. See Larry Kramer, Choice of Law inComplex Litigation, 71 N.Y.U. L. Rev. 547, 547 (1996).1615 See In re Bendectin Litig., 857 F.2d 290, 293-95, 304-05 (6th Cir. 1988) (applying single body of substantive law to nationwide product-liability litigation); In re “Agent Orange” Prod. Liab. Litig., 580 F. Supp. 690 , 693, 700-06 (E.D.N.Y. 1984) (“[I]t is concluded that under the special circumstances of this litigation, all the transferor states would look to the same substantive law for the rule of decision on the critical substantive issues.”). 16 In 1993, the American Law Institute (ALI) submitted to Congress for enactment a proposed choice-of-law rule for “mass- tort” actions transferred to federal court. American Law Institute, Complex Litigation Project, Proposed Final Draft (May 13, 1993). The proposed rule listed a number of factors that a court should consider “with the objective of applying, to the extent feasible, a single state’s law to all similar tort claims 37 With those principles and concerns as background, we turnto the Restatement sections that apply the most-significant-relationship test in personal injury cases. Under that test,the analysis begins with section 146 and the presumption thatthe law of the state where the injury occurred applies. CampJaycee, 197 N.J. at 135-36. That presumption may be overcome if“some other state has a more significant relationship with theparties and the occurrence based on an assessment of eachstate’s contacts” viewed through the prism of section 145, whichsets forth general principles for tort actions, and section 6,which lists overarching choice-of-law principles. McCarrell, 227 N.J. at 590. Section 146 provides: In an action for a personal injury, the local law of the state where the injury occurred determines the rights and liabilities of the parties, unless, with respect to the particular issue, some other state has a more significant relationship under the principles stated in § 6 to the occurrence and the parties, in which event the local law of the other state will be applied. [Restatement § 146.] Because Roche marketed Accutane nationwide, it is notsurprising that plaintiffs hail from forty-four jurisdictionsother than New Jersey. The place of injury for the 532being asserted against a defendant.” Id. at § 6.01(a). The proposed rule was not enacted. 38 plaintiffs whose cases are before us is where their physiciansprescribed Accutane, where they took the medication, and wherethey developed IBD. Typically, all three events occurred in thesame jurisdiction, but not necessarily. Thus, the place ofinjury may not be so easily identified. In the case of 514 plaintiffs, the place of injury is ajurisdiction other than New Jersey. Therefore, we mustdetermine whether New Jersey has a more significant relationship“to the occurrence and the parties,” first looking to section145, the general principles for tort actions, and then tosection 6, the universal guiding principles for choice-of-lawissues. Camp Jaycee, 197 N.J. at 140-41. Under Restatement section 145, the contacts weighed inmaking that assessment include: (a) the place where the injury occurred, (b) the place where the conduct causing the injury occurred, (c) the domicil[e], residence, nationality, place of incorporation and place of business of the parties, and (d) the place where the relationship, if any, between the parties is centered. [Restatement § 145.] “These contacts are to be evaluated according to theirrelative importance with respect to the particular issue.”Ibid. A weighing of those contacts yields mixed results. Theinjuries caused by the putative failure to give adequate 39 warnings occurred in forty-four other jurisdictions, but NewJersey is “where the [alleged] conduct causing the injuryoccurred” -- the manufacturing and labeling of Accutane. Seeibid. “When both conduct and injury occur in a singlejurisdiction, with only 'rare exceptions, the local law of thestate where conduct and injury occurred will be applied’ todetermine an actor’s liability.” Fu v. Fu, 160 N.J. 108, 125-26(1999) (quoting Restatement § 145 cmt. d). The logic is that “astate has an obvious interest in regulating the conduct ofpersons within its territory and in providing redress forinjuries that occurred there.” Id. at 126 (quoting Restatement§ 145 cmt. d). Thus, in Camp Jaycee the conduct (the failure ofthe defendant to act with due care) and the injury (the sexualassault of the plaintiff) both occurred in Pennsylvania, thejurisdiction whose law we applied in that case. 197 N.J. at 136. Unlike Camp Jaycee, in 514 cases, we do not have theconvergence in one jurisdiction of both the conduct causing theinjury and the occurrence of the injury. In this case, moreover, 514 plaintiffs are residents of 44other jurisdictions, and Roche is a corporation that has itsprincipal place of business in New Jersey. That indicates arather diffuse interest among the states. Although therelationship between the parties is not centered in one place,Roche marketed Accutane in the jurisdictions where plaintiffs 40 resided. Had plaintiffs brought their actions in the stateswhere they were prescribed and took Accutane, those state courtspresumably would have applied the law of their jurisdictionsbecause each state has a strong interest in ensuring that safeproducts are marketed within its borders. See, e.g., McLennanv. Am. Eurocopter Corp., 245 F.3d 403 , 426 (5th Cir. 2001)(“Texas has a strong interest in enforcing its productsliability laws against manufacturers operating in the State.”);Fed. Ins. Co. v. J.K. Mfg. Co., 933 F. Supp. 2d 1065, 1077 (N.D.Ill. 2013) (“Indiana has an interest in ensuring that safeproducts are used within its borders.”). Overall, the section145 contacts do not point to one ineluctable result. We next review the overarching principles of section 6 toguide us in deciding whether New Jersey “has a more significantrelationship . . . to the occurrence and the parties.”Restatement § 146. Section 6 prescribes that the factors relevant to the choice of the applicable rule of law include (a) the needs of the interstate and international systems, (b) the relevant policies of the forum, (c) the relevant policies of other interested states and the relative interests of those states in the determination of the particular issue, (d) the protection of justified expectations, 41 (e) the basic policies underlying the particular field of law, (f) certainty, predictability and uniformity of result, and (g) ease in the determination and application of the law to be applied. [Restatement § 6(2).] Our interstate system recognizes that the forum stateshould not apply its choice-of-law principles in a way thatdiscriminates against out-of-state residents. That is theessence of comity. The tort systems of all the jurisdictionsinvolved share the same general goals -- ensuring thatpharmaceutical companies market drugs that are reasonably safefor consumption by the public and that the drugs’ label warningsadequately inform the physicians who prescribe the medicationsand the patients who use them of the medications’ potentialbenefits and risks. Each jurisdiction regulates, in some way, apharmaceutical company’s responsibility for the accuracy of itslabel warnings in the initial marketing and postmarketing phasesof a drug. The differences in each jurisdiction’s law aresometimes subtle, and the precise meaning of anotherjurisdiction’s law is many times far from self-evident. In someinstances, we have difficulty construing our own State’s laws,particularly when legislation is written in broad terms andlegislative history gives little guidance for the interpretiveprocess. Our discussion of New Jersey’s PLA later in this 42 opinion illustrates the challenges of applying a broadly wordedstatute to specific circumstances. The parties’ expectations “ordinarily play[] little or nopart in a choice-of-law question in the field of torts.” Fu, 160 N.J. at 123 (citing Restatement § 145 cmt. b). Nonetheless,to the extent that the parties’ expectations are relevant, is itrealistic that plaintiffs should expect to carry with them theforty-four different laws of their home states or the statewhere their injuries occurred when their cases are consolidatedfor administrative purposes under the umbrella of MCL -- adesignation intended to make more manageable the processing ofhundreds and sometimes thousands of cases? One of the reasonsfor joining together so many cases before a single judge is togain the benefits of administrative efficiency. Under Rule 4:38A, “[t]he Supreme Court may designate a caseor category of cases as [MCL] to receive centralized managementin accordance with [promulgated] criteria and procedures.” MCLis a grouping of “mass tort” cases that typically involvesubstantial numbers of claims associated with a single product,a mass disaster, or a complex environmental event. MCL ResourceBook 1. One of the criteria for MCL status is whether the cases“involve[] many claims with common, recurrent issues of law andfact.” Id. at 4. Other criteria include “whether centralizedmanagement is fair and convenient to the parties, witnesses and 43 counsel” and “whether the cases require specialized expertiseand case processing.” Id. at 4-5.17 The two most significant Restatement factors in this MCLmatter are section 6 factors f (“certainty, predictability anduniformity of result”) and g (“ease in the determination andapplication of the law to be applied”). Applying a singlestandard to govern the adequacy of the label warnings in the 532individual cases will ensure predictable and uniform results --rather than disparate outcomes among similarly situatedplaintiffs, who took the same medications and were presumablyadvised by their physicians of the same risks and benefits basedon the label warnings. Removed from the equation will be thefortuity of the place where individual plaintiffs reside andwhere the injury occurred. Of course, each plaintiff controlshis or her fate. Plaintiffs can choose to bring suit in thestate where they reside and the injury occurred and probablyenjoy the benefit -- if it is a benefit -- of their own statelaw. See Bristol-Myers Squibb Co. v. Superior Court, ___ U.S.17 Either an Assignment Judge or an interested attorney may apply to this Court to have the case(s) classified as MCL. Id. at 2. If the Court classifies a case as MCL, it is assigned to a particular judge. Id. at 4. Currently, the nearly-twenty active MCLs in New Jersey are assigned to courts in three designated counties: Atlantic, Bergen, and Middlesex. New Jersey Courts, Multicounty Litigation -- Frequently Asked Questions, https://www.njcourts.gov/attorneys/mcl/mclfaq.html (last visited Aug. 17, 2018). 44 ___, ___, 137 S. Ct. 1773, 1783 (2017). There can be no question that administrative ease andefficiency favor the application of New Jersey’s PLA. A singlejudge presiding over highly complex Multicounty Litigationcannot be expected to gain a mastery of the laws of forty-fivejurisdictions. That is a wholly unworkable scheme. It wouldlead to more errors and more appeals, and therefore greaterdelays in resolving cases -- cases that would languish in ourcourt system for many years. In the long run, applying New Jersey’s PLA in suchcircumstances as here is not an approach that advantages oneside or the other. In this case, plaintiffs apparently believethat New Jersey law is not as beneficial to their cause as thelaws of other jurisdictions. However, as viewed by theAppellate Division, the Roche warnings are adequate under thelaws of eight other jurisdictions. Today, plaintiffs complainabout the application of New Jersey law in this MCL case.Tomorrow, in another such case, defendants may be thedisappointed party. Interestingly, in McCarrell, the out-of-state plaintiff clamored for the application of New Jersey’sstatute of limitations whereas Roche angled for the applicationof the law of the plaintiff’s home state. See 227 N.J. at 582-83. In Rowe, the plaintiff did not want Michigan’s law togovern because Michigan had an irrebuttable presumption of 45 adequacy for FDA-approved label warnings. 189 N.J. at 618. It is understandable that the parties want to apply the lawof the jurisdiction that will give them the greatest advantage.In this case, we are not picking sides or winners, but merelyestablishing a reasonable rule of law that can be implemented byour courts and that can best advance the administration ofjustice. Here, we find that, under the principles stated in section6, New Jersey has the most significant relationship to theoccurrence and the parties, thus overcoming section 146’spresumption that the law of the place of injury governs. Wetherefore apply this State’s PLA to the 532 cases before us. V. We now address the standard for overcoming the presumptionof adequacy of FDA-approved warnings during the postmarketingphase of a prescription medication. A. In 1987, New Jersey passed the Products Liability Act, L.1987, c. 197, codified at N.J.S.A. 2A:58C-1 to -11. In enactingthe PLA, the Legislature intended to both codify the existingcommon law and provide “some sense of order and clarity toproducts liability cases within New Jersey.” Governor’sStatement to S. 2805; accord N.J.S.A. 2A:58C-1; see also In reReglan Litig., 226 N.J. 315, 335 (2016) (“The PLA is a 46 codification of tort-law principles, where the state hastraditionally exercised its historic police powers.”). Under N.J.S.A. 2A:58C-4, the manufacturer or seller is notliable if a product “contains an adequate warning orinstruction” about the dangers of the product. (emphasisadded). The PLA defines “an adequate warning or instruction” as one that a reasonably prudent person in the same or similar circumstances would have provided with respect to the danger and that communicates adequate information on the dangers and safe use of the product, taking into account the characteristics of, and the ordinary knowledge common to, the persons by whom the product is intended to be used, or in the case of prescription drugs, taking into account the characteristics of, and the ordinary knowledge common to, the prescribing physician. [ N.J.S.A. 2A:58C-4 (emphasis added).] In the case of prescription drugs, the PLA codifies what iscommonly referred to as the learned intermediary doctrine -- adoctrine that acknowledges that “the physician acts as theintermediary between the manufacturer and the [patient].”Niemiera, 114 N.J. at 559. The prescribing physician -- as alearned intermediary -- generally is in the best position toadvise the patient of the benefits and risks of taking aparticular drug to treat a medical condition. See Perez, 161 N.J. at 17-18. Under the learned intermediary doctrine, “apharmaceutical manufacturer generally discharges its duty to 47 warn the ultimate user of prescription drugs by supplyingphysicians with information about the drug’s dangerouspropensities.” Id. at 10 (quoting Niemiera, 114 N.J. at 559). Under the PLA, a presumption of adequacy attaches to aproduct’s label warnings approved by the Food and DrugAdministration. N.J.S.A. 2A:58C-4 provides that [i]f the warning or instruction given in connection with a drug or device or food or food additive has been approved or prescribed by the federal Food and Drug Administration under [federal laws], a rebuttable presumption shall arise that the warning or instruction is adequate. [(emphasis added).] The Legislature, by attaching a presumption of adequacy toFDA-approved warnings, “recognized the preeminent role offederal regulation of drugs and medical devices.” Cornett v.Johnson & Johnson, 211 N.J. 362, 387 (2012); accord Rowe, 189 N.J. at 625 (noting that PLA accepts FDA regulation andenforcement mechanisms as ordinarily “sufficient . . . to deterNew Jersey pharmaceutical companies from manufacturing unsafeprescription drugs”). Given the importance of the federalregulatory process in relation to the PLA, a brief overview ofthe relevant FDA premarketing and postmarketing regulationsgoverning prescription drugs will be helpful. B. The FDA is responsible for “promot[ing] the public health 48 by promptly and efficiently reviewing [drug manufacturers’]clinical research and taking appropriate action on the marketingof regulated products in a timely manner.” 21 U.S.C.§ 393(b)(1). Before a pharmaceutical company can market any newdrug, it must complete the process for a New Drug Application(NDA), during which the FDA conducts a rigorous review to ensurethat the drug is “safe and effective.” See 21 C.F.R. § 314.2;see generally, 21 C.F.R. § 314.1 to .170. As part of the NDA,the FDA requires extensive information, including theingredients of the drug, its biological mechanisms, and theresults of animal studies and clinical tests. 21 C.F.R.§ 314.50. The FDA also ensures that the drug label summarizes“the essential scientific information needed for the safe andeffective use of the drug” and describes potential safetyhazards associated with use of the drug. 21 C.F.R. § 201.56(a);accord 21 C.F.R. § 314.50 (requiring that NDA include contentfor labeling). The FDA’s oversight is at its peak before a new drug goesto market. See David A. Kessler & David C. Vladeck, A CriticalExamination of the FDA’s Efforts to Preempt Failure-To-WarnClaims, 96 Geo. L.J. 461, 465 (2008) (“Kessler & Vladeck”)(noting that when FDA approves new drug, it “is in the bestposition to be the exclusive arbiter of a drug’s safety andeffectiveness” because it then “has had access to and has 49 devoted considerable resources to reviewing carefully all of theextant health and safety data relating to the drug”).18 Theclinical trials of a drug, however, may not identify all of thedrug’s risks by the time of FDA approval. 19 Id. at 470. Afterthe drug goes to market, the manufacturer may receive criticalnew information about the risks, benefits, and optimal use ofthe drug. See 21 U.S.C. § 314.80(b). During the postmarketingperiod, when the drug is widely prescribed, risks emerge thatwere not “foreseen by the drug’s manufacturer or the FDA and,for that reason, are not addressed on the label.” Kessler &Vladeck at 466.18 The Kessler & Vladeck article has been cited by state and federal courts for its insights regarding the FDA’s approval process and postmarketing efforts. See, e.g., Wyeth, 555 U.S. 555 , 579 n.12 (2009); Huck v. Wyeth, Inc., 850 N.W.2d 353, 397- 98 (Iowa 2014); McDarby, 401 N.J. Super. at 57-58, 64-66. One of the authors of the article, David A. Kessler, is a former FDA Commissioner. 19 Premarket research has obvious limitations. Kessler & Vladeck at 470. According to the authors, [p]rior to FDA approval, drugs are tested on relatively small populations of patients, for durations rarely exceeding a year or two. Thus, pre-approval testing generally is incapable of detecting adverse effects that occur infrequently, have long latency periods, or affect subpopulations not included or adequately represented in the studies (for example, the elderly, ethnic minorities, and pregnant women). [Id. at 471, cited in Mut. Pharm. Co. v. Bartlett, 570 U.S. 472, 500 (2013).] 50 Under federal law, the manufacturer is responsible for theadequacy of a drug label’s warnings not only when it files anNDA, 21 U.S.C. § 355(b)(1), (d), (j)(2)(A), but also during theperiod when the drug is on the market after FDA approval, see 21C.F.R. § 314.70. After a manufacturer becomes aware of apreviously unknown significant risk about a drug, themanufacturer must update the label to account for that risk inaccordance with 21 C.F.R. §§ 314.70 (“Supplements and otherchanges to an approved NDA”) and 601.12 (“Changes to an approvedapplication”). The FDA requires a manufacturer to change adrug’s “labeling to reflect newly acquired information” incertain circumstances. 21 C.F.R. § 314.70(c)(6)(iii). Forexample, a manufacturer must “add or strengthen acontraindication, warning, precaution, or adverse reaction forwhich the evidence of a causal association satisfies thestandard for inclusion in the labeling under [21 C.F.R.]§ 201.57(c).” 21 C.F.R. § 314.70(c)(6)(iii)(A). In turn, 21C.F.R. § 201.57(c)(6) requires that a drug’s “labeling must berevised to include a warning about a clinically significanthazard as soon as there is reasonable evidence of a causalassociation with a drug; a causal relationship need not havebeen definitely established.” 21 C.F.R. § 201.57(c)(6). Thus, federal regulations make clear that drugmanufacturers are responsible for the postmarketing surveillance 51 of their products, 21 C.F.R. § 314.80(b), and have a continuingresponsibility “to maintain their labeling and update thelabeling with new safety information,” 73 Fed. Reg. 49,603,49,605 (Aug. 22, 2008). See Wyeth v. Levine, 555 U.S. 555 , 570-71 (2009). In Wyeth, the United States Supreme Court focused on thefederal regulatory process that holds drug manufacturersaccountable for revising their warning labels after a new drughas been on the market and on the role state tort law plays inenforcing that regulatory process. 555 U.S. at 567-68, 577-79.The Court in Wyeth held that federal law did not preempt astate-law tort action against a manufacturer of a prescriptionbrand-name drug for its failure to give adequate warnings aboutthe significant risks of administering the drug. Id. at 563,581. Indeed, one of the central premises of the Federal Food,Drug, and Cosmetic Act (FDCA) and FDA regulations is “that themanufacturer bears responsibility for the content of its labelat all times” and “is charged both with crafting an adequatelabel and with ensuring that its warnings remain adequate aslong as the drug is on the market.” Id. at 570–71. The Courtnoted that under the “changes being effected” (CBE) regulation,21 C.F.R. § 314.70(c), a manufacturer can unilaterallystrengthen label warnings before the FDA’s approval. Id. at568-71. The CBE regulation, in defined circumstances, provides 52 that a manufacturer may make a label change when it files asupplemental application with the FDA -- and before FDA approval-- “that is intended to increase the safe use of the drugproduct.” Id. at 568 (citing 21 C.F.R. § 314.70(c)(6)(iii)(A),(C)).20 In Wyeth, when the risk became apparent to themanufacturer that its drug might cause serious harm, “[themanufacturer] had a duty to provide a warning that adequatelydescribed that risk, and the CBE regulation permitted it toprovide such a warning before receiving the FDA’s approval.”Id. at 571. Significantly, the Supreme Court concluded that failure-to-warn lawsuits against manufacturers provide “a complementaryform of drug regulation” in the postmarketing phase. Id. at578. In that phase, the Court recognized, the FDA’s monitoringis far from foolproof. As the Court observed, [t]he FDA has limited resources to monitor the 11,000 drugs on the market, and manufacturers have superior access to information about their drugs, especially in the postmarketing phase as new risks emerge. State tort suits uncover unknown drug hazards and provide incentives for drug manufacturers to disclose safety risks promptly. They also serve a distinct compensatory function that may motivate injured persons to come forward with information. Failure-to-warn actions, in particular, lend force to the FDCA’s premise20 The CBE regulation identifies several other categories of changes “reflect[ing] newly acquired information” which the manufacturer (or corresponding party) may implement prior to approval by the FDA. 21 C.F.R. § 314.70(c). 53 that manufacturers, not the FDA, bear primary responsibility for their drug labeling at all times. [Id. at 578–79 (footnote omitted).] C. With the federal regulatory process as prologue, we turn tothe rebuttable presumption of adequacy that attaches to an FDA-approved warning. N.J.S.A. 2A:58C-4. The presumption ofadequacy necessarily “helps to ensure that manufacturers are notmade guarantors against remotely possible, but notscientifically-verifiable, side-effects of prescription drugs,”Perez, 161 N.J. at 25, and “reduc[es] the burden placed on[manufacturers of medications with FDA-approved warnings] byproduct liability litigation,” Rowe, 189 N.J. at 626. TheLegislature, however, gave no precise guidance either in theProducts Liability Act or in its legislative history suggestingthe proofs necessary to overcome the rebuttable presumption ofadequacy of FDA-approved warnings. In Feldman v. Lederle Laboratories, the Court acknowledgedthat the PLA’s “plain language defies the conclusion that thepresumption cannot be overborne.” 125 N.J. 117, 157 (1991).Feldman, however, did not detail the proofs necessary toovercome the presumption, despite its reference to the generalmeans of overcoming a presumption. Ibid. (citing McCormick onEvidence § 344, at 978–79 (E. Cleary ed., 3d ed. 1984)). The 54 Court in Perez for the first time addressed the role of thefederal regulatory process in relation to the PLA’s presumptionof adequacy that attaches to FDA-approved drugs. 161 N.J. at 25. In Perez, the Court primarily focused on the learnedintermediary doctrine, holding that the doctrine did not applywhen a pharmaceutical company engaged in direct marketing of aproduct to consumers. Id. at 11-22. Within that context, theCourt also declared that “in the area of direct-to-consumeradvertising of pharmaceuticals, the same rebuttable presumption[of adequacy] should apply when a manufacturer complies with FDAadvertising, labeling and warning requirements.” Id. at 24. The Court made clear that “FDA regulations are pertinent indetermining the nature and extent of any duty of care thatshould be imposed on pharmaceutical manufacturers” and that “FDAregulations serve as compelling evidence that a manufacturersatisfied its duty to warn the physician about potentiallyharmful side effects of its product.” Ibid. Significantly, theCourt generally cited FDA advertising regulations and did notdistinguish between FDA regulations governing pharmaceuticaldrugs in the premarketing and postmarketing phases. See id. at22-24. In the absence of statutory language or legislative historysuggesting the standard to overcome the rebuttable presumption, 55 the Court in Perez turned to the punitive damages section of thePLA for guidance. Id. at 25. N.J.S.A. 2A:58C-5(c) states inpart that punitive damages are not available “if a drug . . . isgenerally recognized as safe and effective pursuant to” theFDA’s “packaging and labeling regulations,” except “where theproduct manufacturer knowingly withheld or misrepresentedinformation required to be submitted under the agency’sregulations, which information was material and relevant to theharm in question.” Adapting that language to the rebuttablepresumption of adequacy accorded to FDA-approved label warnings,the Court held that “absent deliberate concealment ornondisclosure of after-acquired knowledge of harmful effects,compliance with FDA standards should be virtually dispositive of[product-liability and failure-to-warn] claims.” Perez, 161 N.J. at 25. The Court acknowledged that “[t]his presumptiveeffect is in accordance with legislative intent that we discernfrom the punitive damages provision of the [PLA]” concerning“FDA labeling and pre-marketing requirements.” Ibid. (emphasisadded). Notably, Perez was decided twenty years before Wyeth’sexpansive discussion of a manufacturer’s duty to update labelwarnings under FDA regulations in the postmarketing phase.Indeed, the Appellate Division in McDarby “note[d] that closescrutiny of the FDA and its regulatory power in a labeling 56 context commenced only after Perez was decided, and thatscrutiny disclosed flaws in the regulatory system.” 401 N.J.Super. at 64. The McDarby court surveyed the FDA’s role in thepostmarketing phase of a drug and came to conclusions similar tothose of the Wyeth Court. 401 N.J. Super. at 63-66. Itobserved that “[c]ommentators and courts have since [Perez]recognized that, whereas pre-market approvals of drugs aregenerally thorough in nature, the ability of the FDA, post-market, 'to detect unforeseen adverse effects of [a] drug and totake prompt and effective remedial action’ is considerablyless.” Id. at 64 (third alternation in original) (quotingKessler & Vladeck at 465); see also Reglan, 226 N.J. at 337(noting that Wyeth acknowledged “that the FDA does not have theresources to monitor the labeling of thousands of drugs afterthey are marketed”). The “flaws in that post-marketing oversight process,” theAppellate Division reasoned, “render[ed] the dictum of Perezless all-encompassing than it might then have appeared” and“provide[d] the foundation for [a] further exception to thepresumption of adequacy” enunciated in McDarby. McDarby, 401 N.J. Super. at 64. McDarby did not deal with a manufacturer deliberatelyconcealing or not disclosing after-acquired knowledge of adrug’s harmful effects from the FDA, the bases for overcoming 57 the presumption of adequacy of FDA-approved label warningsrecognized in Perez. See id. at 63. In McDarby, themanufacturer had disclosed information about the drug’scardiovascular risk to the FDA but deliberately delayed amendingthe warning label to identify that risk, “despite the universalopinions of the FDA’s advisory committee and medical reviewers –- and indeed, initially, the FDA regulators, themselves -- thata warning was appropriate.” 21 Id. at 69. In light of thelimitations of the FDA postmarketing oversight process and theevidence in that case, the Appellate Division articulated afurther basis for overcoming the presumption of adequacy: amanufacturer’s “economically-driven manipulation of the post-market regulatory process.” Id. at 63-64. In Cornett, 211 N.J.at 388, this Court recognized the McDarby exception. D.21 The conduct in question occurred before the 2007 Amendments to the Food, Drug, and Cosmetic Act, during which the FDA “did not have the [statutory] authority to compel labeling changes, but instead had to negotiate changes with the drug’s sponsor.” McDarby, 401 N.J. Super. at 65 (alteration in original) (quoting Kessler & Vladeck at 466). As a result of the 2007 Amendments, the FDA now has enhanced postmarketing oversight powers. See Pub. L. No. 110-85, 121 Stat. 823. Those increased powers include the authority to require drug manufacturers to conduct postmarketing studies and clinical trials for approved drugs and products, 21 U.S.C. § 355(o)(3), and to mandate a labeling change it “deems appropriate to address . . . new safety information,” 21 U.S.C. § 355(o)(4)(E). However, as discussed below, there are still resource-related concerns about the FDA’s capacity to fully carry out its postmarket responsibilities. 58 The FDA’s postmarketing oversight of drug label warnings isstill hobbled by resource problems, according to a December 2015report by the Government Accountability Office (GAO). Thatreport indicated that the “FDA’s lack of reliable, readilyaccessible postmarket safety data has prevented the agency frompublishing required reports in a timely manner and hasrestricted its ability to conduct systematic oversight.” U.S.Gov’t Accountability Office, Drug Safety: FDA Expedites ManyApplications, But Data for Postapproval Oversight NeedImprovement 22 (Dec. 2015).22 We are mindful of Perez’s general directive that federalregulations are of the utmost significance in determiningwhether “a manufacturer satisfied its duty to warn the physicianabout potentially harmful side effects of its product.” SeePerez, 161 N.J. at 24. Those regulations, in the postmarketingphase of a drug, require a manufacturer to revise a label toinclude a warning “about a clinically significant hazard as soonas there is reasonable evidence of a causal association with a22 In particular, the GAO found that the FDA’s database had inaccurate and incomplete data, in part due to delays in staff reviewing submissions. Id. at 23. The GAO estimated that the FDA failed to review in a timely manner more than half of the submissions associated with 1400 postmarket studies of drugs on the market. Id. at 23-24. 59 drug.” 21 C.F.R. § 201.57 (c)(6);23 see also 21 C.F.R.§ 314.70(c)(6)(iii)(A) (stating that, based on “newly acquiredinformation,” manufacturers must “add or strengthen acontraindication, warning, precaution, or adverse reaction forwhich the evidence of a causal association satisfies thestandard for inclusion in the labeling under [21 C.F.R.]§ 201.57(c)”). Even when manufacturers forward newly acquired informationabout a drug’s risks to the FDA, Wyeth and the federalregulatory system make clear that manufacturers bear theultimate responsibility for monitoring the effects of the drugsthey place on the market. 555 U.S. at 570-71. Themanufacturer’s postmarketing obligation to update a label’swarnings consistent with 21 C.F.R. § 201.57(c) and 21 C.F.R.§ 314.70(c) is especially significant given that the FDA’soversight capabilities are limited due to overstretchedresources in monitoring thousands of drugs on the market. Id.at 578.23 21 C.F.R. § 201.57 applies to prescription drug products for which an NDA or efficacy supplement was approved by the FDA between June 30, 2001 and June 30, 2006, was pending on June 30, 2006, or was submitted anytime on or after June 30, 2006. 21 C.F.R. § 201.56(b)(1). All other prescription drug products are subject to the requirements in 21 C.F.R. § 201.80. Ibid. Under § 201.80, manufacturers are required to revise the labeling if there is reasonable evidence of an association -- not a causal association -- of a serious hazard with the drug. 21 C.F.R. § 201.80(e). 60 Thus, an FDA-approved warning for a drug on the market formany years may grow stale in light of “newly acquiredinformation” about “a clinically significant hazard” in the useof the drug by certain consumers. 21 C.F.R. § 201.57(c); 21C.F.R. § 314.70(c). Prior FDA approval of a label’s warning isnot a license for a manufacturer to withhold updating andrevising that warning in accordance with federal regulations.See ibid. The PLA provides manufacturers with the protection of arebuttable presumption of adequacy of an FDA-approved labelwarning. N.J.S.A. 2A:58C-4. An adequate warning for aprescription drug is one that “a reasonably prudent”manufacturer would have provided concerning dangers related tothe drug’s use “taking into account the characteristics of, andthe ordinary knowledge common to, the prescribing physician.”Ibid. “A duty to warn arises if [a manufacturer] actually knewor should have known of the need to issue a particular warning.”N.J. Model Civil Jury Charges 5.40C (Model Civil Jury ChargesComm. 2017) (model charge for Failure to Warn/Instruct); seealso McDarby, 410 N.J. Super. at 72 (finding that juryappropriately directed “to consider what [manufacturer] knew orshould have known, when facts sufficient to require a warningbecame known, and whether it acted reasonably, given theinformation that it possessed”). 61 Consistent with Perez and McDarby, and the federalregulatory scheme, we hold that the rebuttable presumption ofadequacy attaching to an FDA-approved drug label is overcomewhen a plaintiff presents clear and convincing evidence that amanufacturer knew or should have known, based on newly acquiredinformation, of a causal association between the use of the drugand “a clinically significant hazard” and that the manufacturerfailed to update the label accordingly. See 21 C.F.R.§ 201.57(c); 21 C.F.R. § 314.70(c). We add one caveat. Amanufacturer that acts in a reasonable and timely way to updateits label warnings with the FDA, in accordance with its federalregulatory responsibilities, will receive the protection of therebuttable presumption. If not, it cannot seek shelter behindit. The heightened standard of clear and convincing evidence isin keeping with the high threshold set by Perez. Clear andconvincing evidence is evidence that produces “a firm belief orconviction” in the truth of the alleged facts. N.J. Model CivilJury Charges 1.19 (Model Civil Jury Charges Comm. 2017) (modelcharge for Burden of Proof -- Clear and Convincing Evidence).More descriptively, “it is evidence so clear, direct, weighty interms of quality, and convincing as to cause [one] to come to aclear conviction of the truth of the precise facts in issue.”Ibid. We reject the argument by amicus curiae New Jersey 62 Association for Justice that the usual evidentiary standard forovercoming the presumption should apply. The standard articulated here is a natural extension of thedecisions in Perez and McDarby. It is a standard protective ofresponsible drug manufacturers. Faced with clear and convincingevidence of a label warning’s inadequacy based on the FDA’slabel warning updating requirements set forth in 21 C.F.R.§ 201.57(c) and 21 C.F.R. § 314.70(c), a responsible drugmanufacturer will take action to revise its drug label warnings. The PLA’s rebuttable presumption of adequacy that attachesto label warnings gives pharmaceutical companies the protectionnecessary to research and develop the drugs that will improveand extend the lives of people around the world. Thepresumption of adequacy protects manufacturers fromunmeritorious lawsuits. See Perez, 161 N.J. at 25; Rowe, 189 N.J. at 626. The Legislature, however, envisioned that, in appropriatecircumstances, the presumption would be overcome. See Feldman, 125 N.J. at 157 (“[The PLA’s] plain language defies theconclusion that the presumption cannot be overborne.”). Inpassing the PLA, the Legislature affirmed New Jersey’s“substantial interest in deterring its manufacturers fromdeveloping, making, and distributing unsafe products, includinginadequately labeled prescription drugs.” See McCarrell, 227 63 N.J. at 597; Governor’s Statement to S. 2805 (July 23, 1987)(“This legislation responds to the well documented need for theestablishment of clear rules regarding legal actions seekingdamages for harm caused by products.”). The high standard for overcoming the rebuttable presumptionof adequacy of an FDA-approved label warning represents abalance that protects pharmaceutical companies that actresponsibly and the public that consumes their products. VI. With the above principles in mind, we must now determinewhether plaintiffs have presented the necessary evidence toovercome the presumption of adequacy that attaches to the FDA-approved post-April 2002 label warnings for Accutane. See N.J.S.A. 2A:58C-4. Three pathways are available to overcome the presumption ofadequacy. The first pathway is if a plaintiff can establish“deliberate concealment or nondisclosure of after-acquiredknowledge of harmful effects.” Perez, 161 N.J. at 25. Thesecond is if a plaintiff can demonstrate “economically-drivenmanipulation of the post-market regulatory process.” McDarby, 401 N.J. Super. at 63. The third is if a plaintiff can prove byclear and convincing evidence that a manufacturer knew or shouldhave known in the postmarketing phase that the drug warningswere inadequate based on the label warning updating requirements 64 in 21 C.F.R. § 201.57(c), 21 C.F.R. § 314.70(c), or any otherpertinent federal regulation. On the record before us, plaintiffs have failed to show anyof those bases for overcoming the presumption of adequacy. Inthe absence of evidence sufficient to rebut the presumption, asa matter of law, the warnings adequately conveyed to medicalprofessionals -- as well as to patients -- that usage ofAccutane was associated with a risk of IBD. The post-April 2002 label warnings expressly informedphysicians and, through them, patients that Accutane had beenassociated with a risk of IBD. Nevertheless, our focus is notonly on the physician label, the primary means by which Rochecommunicated to prescribing physicians the risks of Accutane,but also on other IBD-related warnings that informed patients. Roche used multiple warning tools: the physician label andBest Practices Guide, intended for physicians, and the PatientSafety Packet, Medication Guide, and blister packaging, intendedfor patients. The physician label -- written for trainedhealthcare professionals -- identified IBD by name (“Accutanehas been associated with inflammatory bowel disease . . . .”)and listed the most common symptoms of IBD (“Patientsexperiencing abdominal pain, rectal bleeding or severe diarrheashould discontinue Accutane immediately.”). Moreover, thephysician label noted the potentially permanent nature of the 65 condition (“In some instances, symptoms have been reported topersist after Accutane treatment has been stopped.”). It alsospecifically warned prescribing physicians that patients with noprior history of intestinal problems might be at risk of IBD(“Accutane has been associated with [IBD] in patients without aprior history of intestinal disorders.”). Plaintiffs’ principal criticism is that the physician labeland other warning materials should have used the language“causes” instead of “has been associated with” to describe therelationship between Accutane and IBD. Plaintiffs, however,have failed to present clear and convincing evidence thatRoche’s use of the word “associated” to describe therelationship between Accutane and IBD was inadequate. We lookto the scientific understanding of “association” as a physicianwould understand the term. According to the Reference Manual onScientific Evidence, an association includes the possibility ofcausation but is not in itself causation. Reference Manual onScientific Evidence 619 (3d ed. 2011) (“Association does notnecessarily imply a causal relationship.”). By use of the word“associated,” Roche informed physicians that it was possible --though not proven -- that, in the case of some patients,Accutane may have caused IBD. Roche had reports that somepatients, after taking Accutane, developed symptoms of IBD.That one followed the other does not prove cause and effect. 66 See In re: Accutane Litig., ___ N.J. ___, ___ (2018) (slip op.at 12-15). Moreover, we do not find that the isolated examplesplaintiffs have exhumed from the volumes of evidence support ashowing of deliberate nondisclosure to the FDA, economicallydriven manipulation of the regulatory process, or clear andconvincing evidence that Roche knew or should have known of theinadequacy of the warnings in light of the relevant federalregulations. Plaintiffs cite to the 1994 memorandum in whichDr. Lefrancq, a Roche physician, notes that Accutane “may induceor aggravate a preexisting colitis.” Another 1994 excerptedinternal Roche document noted that colitis was identified as a“possible” side effect of Accutane. Those memoranda are farfrom clear and convincing evidence that the language “Accutanehas been associated with [IBD]” was an inadequate warning.24 Plaintiffs argue that Roche had internally concluded thatAccutane was causally -- not just possibly -- related to IBD.24 Plaintiffs further cite the latter 1994 document as evidence that the use of Accutane was contraindicated in all patients with IBD or a family history of the disease. However, the document specifically indicates that the data regarding Accutane’s association with IBD is “contradictory” and that there was not sufficient data to describe it as a contraindication. The document did note, however, that Accutane should be contraindicated for patients in the active phase of IBD. Significantly, the label warnings advised both physicians and patients that patients should discontinue Accutane use immediately if they experienced any IBD-related symptoms. 67 However, plaintiffs have failed to establish that Roche had infact made such a determination, engaged in deliberateconcealment or nondisclosure of such knowledge, or otherwiseknew or should have known under the standard articulated abovethat the use of the word “associated” was inadequate. Rather,in support of that claim, plaintiffs point to another isolatedstatement from a 2000 regulatory report culled from thevoluminous discovery. In that report, a physician, while discussing and analyzingan individual patient’s medical history while on Accutane,states that Accutane “has been found to be causally associatedwith inflammatory bowel disease, including colitis.” The recorddoes not reflect the basis for that physician’s comment. Nordoes that statement suggest a consensus by other Rochephysicians or employees about a causal connection betweenAccutane usage and IBD. Indeed, we do not know whether thestatement represents anything more than one physician’sunderstanding (or misunderstanding) of the relationship betweenAccutane and IBD. To be sure, that single statement is notclear and convincing evidence that Roche knew or should haveknown that the use of the word “associated” was inadequate. Additionally, there is no evidence that Roche deliberatelyconcealed or withheld any material information from the FDA orengaged in economically driven manipulation of the regulatory 68 process. In fact, Roche’s early postmarket monitoring led tothe identification of IBD as a possible risk. At the urging ofthe FDA, Roche revised the initial warning language about IBD,removing the word “temporally” to more precisely align thewarning with the evidence it had on hand regarding the potentialpermanency of IBD symptoms associated with Accutane. Nor is there any evidence that Roche avoided necessarylabel changes for economic reasons. Roche’s marketing personnelcertainly expressed an interest in Accutane’s financial success;it would have been surprising if it were otherwise. However,there is no evidence that Roche’s financial interest inAccutane’s success led it to withhold necessary IBD-relatedwarnings. Cf. McDarby, 401 N.J. Super. at 69 (notingmanufacturer’s “strenuous, economically driven, opposition” toincluding cardiovascular risk in drug label). Roche was notaverse to using causation language when appropriate. Forexample, Roche included label warnings that the use of Accutaneposed “an extremely high risk” of causing birth defects and that“Accutane may cause depression.” Finally, the record shows that the FDA actively engaged inthe postmarketing oversight of Accutane and proactivelyrecommended strengthening warnings about IBD -- a recommendationfollowed by Roche. Whatever continuing concerns there may beabout the FDA’s postmarketing oversight capacity, there is no 69 evidence in this record of shortcomings in the FDA’s oversightof Accutane. VII. For the reasons expressed, we reverse the judgment of theAppellate Division in those cases in which it vacated the grantof summary judgment in favor of Roche and affirm its judgment inthose cases in which it upheld the grant of summary judgment infavor of Roche. As a result, the 532 failure-to-warn casesbrought by plaintiffs against Roche are dismissed. CHIEF JUSTICE RABNER and JUSTICES LaVECCHIA, FERNANDEZ- VINA, SOLOMON, and TIMPONE join in JUSTICE ALBIN’s opinion. JUSTICE PATTERSON did not participate. 70