Products Liability Law Daily Accutane IBD warning label adequate under New Jersey ‘rebuttable presumption’
Thursday, October 4, 2018

Accutane IBD warning label adequate under New Jersey ‘rebuttable presumption’

By Leah S. Poniatowski, J.D.

The warning of the risk of developing inflammatory bowel disease (IBD) from use of the acne-treatment drug Accutane® met the presumption of adequacy under New Jersey law, and the patients in the multicounty litigation (MCL) against the drug’s manufacturer did not present clear and convincing evidence to overcome the presumption, the Supreme Court of New Jersey ruled, reversing appellate rulings against the manufacturers and affirming the grants of summary judgment in favor of the manufacturers (In re Accutane Litigation, October 3, 2018, Albin, B.).

A group of 532 patients filed lawsuits against Hoffman-La Roche Inc. and Roche Laboratories Inc. (collectively, Roche) alleging that the drug Accutane was not sufficiently labeled after April 10, 2002, to effectively warn them of the risk of developing IBD. Of the patients, 18 are New Jersey residents and the remaining are residents of 44 other jurisdictions. The lawsuits were consolidated as an MCL in New Jersey to facilitate litigation.

Trial court. According to the trial court, Hoffman-La Roche provided adequate warnings after April 10, 2002, of the risk of developing IBD from ingesting Accutane pursuant to the New Jersey Products Liability Act’s rebuttable presumption of adequate warnings for drugs that are approved by the Food and Drug Administration (FDA) [see Product Liability Law Daily’s July 27, 2015 analysis]. The trial court granted summary judgment to the manufacturers in 514 claims arising in 44 jurisdictions. In the event its order of dismissal was found to be in error, the court also conducted a choice-of-law analysis for each of the 44 jurisdictions in a ruling that would dismiss with prejudice the claims by the plaintiffs in most of them.

Appellate court. The patients filed an appeal, and a New Jersey appellate court reversed the trial court, holding that the drug’s warnings were not adequate as a matter of law with respect to the New Jersey residents’ claims see Product Liability Law Daily’s July 26, 2017 analysis]. The appellate court also determined that the lower court erred in finding that New Jersey substantive law applied in hundreds of other cases filed by residents of 44 other jurisdictions. Thus, the appellate court reversed summary judgment for the defendants in many of the states, but upheld it in others after making a state-by-state analysis of the relevant laws. The manufacturers petitioned, and the patients cross-petitioned, New Jersey’s high court.

New Jersey law. Under de novo review, the New Jersey Supreme Court considered the choice-of-law issue by first applying the state choice-of-law rules. The high court noted that New Jersey’s rebuttable presumption of adequacy of a product’s FDA-approved warnings was distinct from most other states. Nonetheless, several states had similar laws, which permitted the appellate court to uphold summary judgment for the manufacturers in those jurisdictions. The high court also observed that the state’s PLA could lead to a differing outcome than under another state’s law, leaving the court responsible for choosing which conflicting law to apply.

The most-significant-relationship test from the Restatement (Second) of Conflict of Laws, as adopted by New Jersey, applied to the case at bar. Under that test, the law of the state where the injury occurred is presumed to apply unless it is established that there is another state with "a more significant relationship with the parties and the occurrence based on an assessment of each state’s contacts." When weighing the contacts, the results were mixed, the supreme court stated.

Considering the "more significant relationship" factors—i.e., certainty, predictability, and uniformity of result, as well as ease in the determination and application of the law to be applied, among others—New Jersey law was favored. Specifically, the state high court held that New Jersey has the most significant interests in light of the MCL consolidation, and that MCL aggregation of hundreds of cases permits resolving common issues of law. The supreme court noted that a trial court "cannot be expected to gain a mastery of the law of forty-five different jurisdictions" and that "[c]onstruing New Jersey’s PLA is challenging enough."

Warning adequacy. Under New Jersey’s PLA, the presumption that a warning label is adequate when a drug has been approved by the FDA can be rebutted if the injured party can show clear and convincing evidence that the label did not reflect a "clinically significant hazard" from use of the drug in a reasonable and timely fashion. The presumption is rebuttable in consideration of the weakness of the federal regulatory system’s inability to monitor all information over every drug on the market. The presumption also provides a reasonable protection to drug manufacturers against unmerited lawsuits. The high court held that the record did not show that the manufacturers withheld material information that would have impacted the nature of the warnings or otherwise manipulate the approval process. The patients also did not provide clear and convincing evidence that the manufacturers knew or should have known that the label warnings were inadequate. Accordingly, the warnings were adequate with respect to the risk of developing IBD, and the 532 cases against the manufacturers were dismissed.

The case is No. 079933.

Attorneys: Paul W. Schmidt (Covington & Burling LLP) and Edward J. Dauber (Greenberg Dauber Epstein & Tucker) for Hoffmann-La Roche Inc. and Roche Laboratories Inc. Bruce D. Greenberg (Lite DePalma Greenberg, LLC) for Angelo Annuzzi. Edward J. Fanning, Jr. (McCarter & English LLP) for HealthCare Institute of New Jersey. Adam M. Slater (Mazie Slater Katz & Freeman LLP) for New Jersey Association for Justice.

Companies: Hoffmann-La Roche Inc.; Roche Laboratories Inc.; HealthCare Institute of New Jersey; New Jersey Association for Justice

MainStory: TopStory WarningsNews DrugsNews JurisdictionNews NewJerseyNews

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