In re Accutane Litig.

235 N.J. 229

194 A.3d 503

IN RE: ACCUTANE LITIGATION

A-26/27 September Term 2017

079933

Supreme Court of New Jersey.

Argued April 23, 2018

Decided October 3, 2018

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, Newark, Russell L. Hewit, Cranford, 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, Newark, 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, Newark, 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, Roseland, of counsel and on the brief).

JUSTICE ALBIN delivered the opinion of the Court.

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

Two issues are before us. The first is what law governs whether Roche's label warnings were adequate -- the law of each of the 45 jurisdictions where plaintiffs were prescribed and took Accutane or the law of New Jersey where the 532 cases are consolidated for MCL purposes. The second issue is the adequacy of the label warnings for the period after April 2002. Because Roche's warnings received the approval of the federal Food and Drug Administration (FDA), those warnings enjoy a "rebuttable presumption" of adequacy under New Jersey's Products Liability Act (PLA).

See N.J.S.A. 2A:58C-4. That presumption provides pharmaceutical companies greater protection in New Jersey than in many other jurisdictions.

After conducting a choice-of-law analysis, the trial court determined that New Jersey's PLA applies to each of the 532 consolidated cases and then concluded that plaintiffs failed to overcome the presumption of adequacy that attached to Roche's Accutane warnings. Accordingly, the court granted summary judgment in favor of Roche.

The Appellate Division came to a different result. The panel held that the law of each jurisdiction where plaintiffs were prescribed and took Accutane would govern the adequacy of the label warnings. After conducting a state-by-state legal analysis, the panel concluded that summary judgment in favor of Roche was improvidently granted in all cases except those governed by the laws of California, Colorado, Indiana, Maryland, Mississippi, New York, Texas, and Virginia. In other words, under New Jersey's PLA and the laws of thirty-six other jurisdictions, the panel maintained that a genuine issue of material fact remained concerning the adequacy of the warnings.

We now reverse in all those cases in which the Appellate Division reinstated plaintiffs' actions against Roche. Like the trial court and Appellate Division, we apply the Restatement (Second) of Conflict of Laws (Am. Law Inst. 1971, amended 1988) ("Restatement"), adopted for personal injury cases in McCarrell v. Hoffmann-La Roche, Inc., 227 N.J. 569, 593-94, 153 A.3d 207 (2017), and P.V. ex rel. T.V. v. Camp Jaycee, 197 N.J. 132, 143, 962 A.2d 453 (2008). Unlike the Appellate Division, we hold that New Jersey has the most significant interests, given the consolidation of the 532 cases for MCL purposes in Atlantic County. The aggregation of hundreds of cases under MCL allows the resolution of common issues of law. A trial judge cannot be expected to gain a mastery of the law of forty-five different jurisdictions. Construing New Jersey's PLA is challenging enough. New Jersey's interest in consistent, fair, and reliable outcomes cannot be achieved by applying a diverse quilt of laws to so many cases that share common issues of fact.

The PLA's presumption of adequacy for medication warnings approved by the FDA gives a reasonable measure of protection to pharmaceutical companies, which are researching and developing medications to combat diseases and maladies that afflict people around the world. New Jersey also has an interest in ensuring that its companies are producing safe medications and attaching warnings that advise the public of their risks and benefits. On the record before us, even when viewed in the light most favorable to plaintiffs, we do not find that Roche withheld from the FDA material information that would have altered the nature of the warnings or engaged in economically driven manipulation of the regulatory process. We also find that plaintiffs did not present clear and convincing evidence that Roche knew or should have known that the label warnings were inadequate. Plaintiffs therefore have not overcome the statutory presumption of adequacy.

Consequently, as a matter of law, the warnings provided physicians with adequate information to warn their patients of the risks of IBD. We therefore reverse in part and affirm in part the judgment of the Appellate Division and dismiss all plaintiffs' complaints.

I.

A.

In this appeal, we address the adequacy of Roche's FDA-approved post-April 10, 2002 warnings for Accutane, the brand name for isotretinoin, a prescription drug developed and marketed nationwide by Roche for the treatment of severe cases of acne. See Kendall v. Hoffman-La Roche, Inc., 209 N.J. 173, 180, 36 A.3d 541 (2012). Plaintiffs are 532 individuals from 45 jurisdictions, including New Jersey, who were prescribed Accutane by their treating physicians for their acne conditions. After taking the medication, plaintiffs claim they developed IBD, which encompasses "a number of chronic, relapsing inflammatory diseases of the gastrointestinal tract." See Tabor's Cyclopedic Medical Dictionary 1252 (23d ed. 2017) ("Tabor's").

The two most common forms of IBD are ulcerative colitis and Crohn's disease. The 532 plaintiffs in this case state that they suffer from ulcerative colitis, "a chronic condition characterized by ulceration of the colon and rectum," which leads to frequent and bloody bowel movements as well as fatigue, dehydration, anemia, and abdominal pain. See Kendall, 209 N.J. at 181, 36 A.3d 541. "The symptoms often wax and wane, but the condition is regarded as permanent." Ibid.

The heart of this case is plaintiffs' contention that the taking of Accutane caused their IBD and that Roche failed to adequately warn of that risk. A Long Form Complaint, filed on behalf of all plaintiffs, alleges that Roche knew or should have known that taking Accutane"was causally related" to IBD based on information contained in its adverse event database and the conclusions drawn by its scientists. Plaintiffs further allege Roche "did not adequately inform physicians or consumers of [Accutane's ] propensity to induce, aggravate or cause IBD." Plaintiffs contend that Roche's failure to provide adequate warnings is the proximate cause of the "permanent physical and emotional injuries" they continue to suffer, and therefore they seek compensatory and punitive damages.

Roche moved for summary judgment, claiming that the warnings were adequate as a matter of law.¹ We start with the relevant facts from the summary judgment record.

B.

In 1982, the Food and Drug Administration approved Roche's application to market Accutane for the treatment of recalcitrant nodular acne. As part of the FDA pre-approval process, Roche conducted a human clinical study involving 523 patients who took Accutane. No reports of IBD arose from that clinical study, although approximately twenty-two percent of the patients suffered certain gastrointestinal side effects. Roche submitted the study to the FDA.

When Roche launched Accutane commercially, the label warnings did not mention IBD. By 1983, during the postmarketing phase and while monitoring the safety of Accutane use, Roche received reports of six to eight patients -- out of a total population of 300,000 -- who had taken Accutane and developed IBD. Those reports prompted Roche to issue label warnings in 1984 to prescribing physicians, generally dermatologists, stating that Accutane"has been temporally associated with inflammatory bowel disease (including regional ileitis ) in patients without a prior history of intestinal disorders."

Roche collected additional data as it continued to monitor the effects of Accutane on patients. Between 1985 and 2001, Roche received at least twenty case reports called "challenge," "dechallenge," and "rechallenge" events. The reports described patients who, while taking Accutane, suffered intestinal disorders, with symptoms such as abdominal cramping and rectal bleeding (the "challenge" event), which subsided when...