New Jersey Trial Court Grants Summary Judgment In Accutane Mass Tort Cases

Court Holds That Manufacturer's Post-April 2002 Labeling Is Adequate as a Matter of Law In an opinion issued on April 2, 2015, the Honorable Nelson C. Johnson, JSC, granted the motion of defendants Hoffmann-LaRoche, Inc. and Roche Laboratories, Inc. for summary judgment in the In re Accutane Multicounty (mass tort) Litigation (MCL) on the grounds that the defendants' post-April 2002 warnings for the prescription medication Accutane (isotretinoin) are adequate as a matter of law. The ruling, based on the New Jersey Products Liability Act, N.J.S.A. § 2A-58C (NJPLA), is dispositive of hundreds of Accutane products liability cases filed by New Jersey plaintiffs who started taking the medication after April 2002, and will also likely impact thousands of Accutane plaintiffs from other states with products liability laws similar to New Jersey's. Additionally, the decision reinforces and clarifies existing New Jersey products liability law with respect to the presumption of adequacy of FDA-approved labeling of prescription drugs under the NJPLA.

The court framed the question presented under the NJPLA as "taking into account the characteristics of, and the ordinary knowledge common to, the prescribing physician," regarding whether the warnings communicated adequate information that inflammatory bowel disease (IBD) was a risk associated with Accutane use. Before addressing the merits, the court reviewed the pertinent procedural history, in which the prior mass tort judge assigned to these consolidated cases had considered the adequacy of post-April 10, 2002 warnings.

After reviewing the five prior motions in which the adequacy of the warnings previously had been addressed, Judge Johnson determined that the law-of-the-case doctrine did not control disposition of Roche's current motion because "new facts and law eclipse the record on which prior rulings were based." As Judge Johnson noted in his decision, the prior judge did not have the benefit of Bailey v. Wyeth, Inc., 424 N.J. Super. 278 (Law Div. 2008), which granted summary judgment on plaintiffs' NJPLA claims because plaintiffs did not provide specific evidence necessary to overcome the rebuttable presumption of adequacy under the NJPLA of the FDA-approved labeling on the hormone replacement therapy products at issue. Specifically, the Bailey court found that N.J.R.E. 301 (which governs presumptions under the law of evidence) does not address the plaintiffs' substantive burden for overcoming the...