Legal Memorandum: Effect of Black Box Warning in Products Liability

Issue: What is the legal effect of a Food and Drug Administration (FDA) ‘Black Box Warning’ in product liability cases?

Area of Law: Administrative Law, Administrative Law & Regulation (Federal and State), Healthcare & Pharmaceutical Law Compliance, Personal Injury & Negligence
Keywords: Black box warning; Products liability; Food and Drug Administration (FDA)
Jurisdiction: Federal, New Jersey
Cited Cases: 913 F. Supp. 195; 795 F.2d 925; 662 A.2d 546; 269 N.J. Super. 289; 974 P.2d 224; 369 F.3d 293; 583 F. Supp. 2d 602; 635 A.2d 533
Cited Statutes: N.J. Stat. Ann. § 2A:58C-4
Date: 03/01/2014

The existence of a black box or boxed warning has implications not only for physicians and pharmacists, but also in products liability lawsuits.  See Judith E. Beach et al., Black Box Warnings in Prescription Drug Labeling: Results of a Survey of 206 Drugs, 53 Food & Drug L.J. 403 (1998), available at http://www.theblackriver.net/wobbler/bbwgent.pdf.  Some courts have determined that a black box warning sufficiently warns a physician of a drug-associated risk, protecting the manufacturer from product liability pursuant to the learned intermediary doctrine.  See id. at 409 n.36 (citing Hammock v. Hoffmann-LaRoche, Inc., 269 N.J. Super. 289, 293, 635 A.2d 533, 535 (1993); 142 N.J. 356, 662 A.2d 546 (1995) (determining that Hoffmann-LaRoche’s black box warning sufficiently informed physicians prescribing Accutane® of the drug’s potential to cause birth defects); Margaret Gilhooley, Learned Intermediaries, Prescription Drugs, and Patient Info., 30 St. Louis U. L.J. 633 (1986)).  The Hammock case (discussed in more detail below) is a bit of an anomaly, however; up until the year 2000, most courts did not regard black box warnings any differently than other prescription drug warnings.  See Raymond J. Mullady, Jr., Everything You Needed and Wanted to Know About Black Boxed Warnings, 68 Def. Couns. J. 50, 60 (Jan. 2001).

The Mullady article observed that, in most cases in which the defendant drug manufacturer moved for summary judgment in its favor based on the existence of a boxed warning, the court refused to grant […]

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