In re Accutane Litig.
194 A.3d 503
N.J.
2018

Background

  • 532 plaintiffs from 45 jurisdictions (18 NJ residents, 514 elsewhere) sued Roche alleging Accutane caused inflammatory bowel disease (IBD) and that Roche failed to provide adequate warnings.
  • Cases were consolidated as Multicounty Litigation (MCL) in Atlantic County, NJ for administrative management.
  • Roche’s post-2002 physician label, Best Practices Guide, Patient Safety Packet, FDA Medication Guide, and blister packs warned of IBD; all were reviewed and approved by the FDA.
  • The trial court applied New Jersey’s Products Liability Act (PLA) to all cases and granted summary judgment for Roche, finding plaintiffs failed to rebut the PLA’s presumption that FDA‑approved warnings are adequate.
  • The Appellate Division reversed in most cases, holding that each plaintiff’s claim is governed by law where the drug was prescribed/taken and that plaintiffs showed genuine issues of fact to overcome the presumption in many jurisdictions.
  • The New Jersey Supreme Court reversed the Appellate Division, held New Jersey law applies to all consolidated MCL cases, adopted a heightened standard to rebut the PLA presumption, and found plaintiffs failed to overcome it for post‑April 2002 warnings.

Issues

Issue Plaintiff's Argument Defendant's Argument Held
Choice of law: whether NJ PLA or each plaintiff's home-state law governs adequacy of warnings Plaintiffs: individual home-state laws should apply; counsel’s earlier MCL request did not waive choice-of-law rights Roche: NJ has the predominant interest and MCL consolidation and administrative efficiency justify applying NJ PLA to all cases Held: NJ law (PLA) governs all consolidated MCL cases — Restatement §§145,146,6 factors favor NJ for uniformity and practicability
Standard to rebut PLA presumption for FDA‑approved warnings Plaintiffs: presumption should be easier to overcome given limits of FDA postmarketing oversight; evidence shows Roche knew of causal link and withheld it Roche: FDA approval and ongoing review support presumption; plaintiffs’ evidence is isolated and insufficient Held: Rebuttal requires clear and convincing evidence that (a) manufacturer knew or should have known of a causal association with a clinically significant hazard and failed to update labeling, or proof of deliberate nondisclosure or economically‑driven manipulation of the regulatory process
Whether plaintiffs overcame the presumption for Accutane post‑April 2002 warnings Plaintiffs: internal Roche documents and adverse-event reports show Roche knew or internally concluded causation and failed to disclose/update Roche: warnings expressly warned of association and persistence; Roche informed FDA and revised warnings when requested; no concealment or manipulation shown Held: Plaintiffs failed to present clear and convincing evidence of concealment, manipulation, or knowledge sufficient to require stronger warnings; summary judgment for Roche affirmed/dismissal of all claims
Adequacy of post‑2002 warning language (e.g., “has been associated with”) Plaintiffs: Roche should have used stronger causal language (e.g., "causes") Roche: "associated" fairly communicates to physicians that causation was not established; other materials warned of persistence and symptoms Held: "has been associated with" was adequate to communicate risk to prescribing physicians; plaintiffs did not prove that stronger causation language was required as a matter of law

Key Cases Cited

  • McCarrell v. Hoffmann-La Roche, Inc., 227 N.J. 569 (adopting Restatement choice-of-law approach for personal-injury cases)
  • P.V. ex rel. T.V. v. Camp Jaycee, 197 N.J. 132 (adopting Restatement §§145,146,6 most-significant-relationship test)
  • Perez v. Wyeth Labs., Inc., 161 N.J. 1 (PLA’s FDA‑approval presumption and circumstances to overcome it)
  • McDarby v. Merck & Co., 401 N.J. Super. 10 (App. Div.) (recognizing manipulation-of-regulatory-process basis to rebut presumption)
  • Wyeth v. Levine, 555 U.S. 555 (state failure-to-warn suits complement FDA regulation; manufacturers have continuing postmarket duty to update labels)
  • Rowe v. Hoffman-La Roche, Inc., 189 N.J. 615 (discussing PLA presumption effect and legislative purpose)
  • Cornett v. Johnson & Johnson, 211 N.J. 362 (discussing role of FDA regulation in PLA context)
  • Feldman v. Lederle Laboratories, 125 N.J. 117 (acknowledging PLA presumption may be overcome)
  • Kendall v. Hoffman-La Roche, Inc., 209 N.J. 173 (context on Accutane litigation)
  • In re Reglan Litig., 226 N.J. 315 (discussion of PLA as codification of tort principles)
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