New Jersey Supreme Court Confirms “Super Presumption” of FDA Label


Yesterday, the New Jersey Supreme Court decided the case of Kendall v. Hoffman-LaRoche, Inc., A-73-2010 (066802), in which it held that plaintiff’s case was not barred by New Jersey’s two-year statute of limitations. While the ultimate ruling was in plaintiff’s favor it is also narrow in scope and limited to the particular facts of the case. The underlying analysis of New Jersey’s presumption of adequacy for FDA-approved warnings, however, has much broader implications, because it presents an unqualified endorsement of the proposition that New Jersey’s presumption of adequacy as to FDA labels is “virtually dispositive” of failure-to-warn claims, and, indeed, a “super presumption.”

The case involved the prescription drug Accutane. Plaintiff was first prescribed Accutane in 1997 when she was 12 years old and was prescribed the drug intermittently over the next seven years. In 1999, plaintiff was diagnosed with ulcerative colitis (also known as inflammatory bowel disease (IBD)), a condition which can be treated but is permanent. Slip op. at 9-13. The entire time plaintiff was prescribed Accutane, the FDA-approved label accompanying the drug contained a warning of the possible link between Accutane and IBD. Slip op. at 6-9. Plaintiff testified that in January 2004 she saw a lawyer advertisement discussing the risks associated with Accutane with IBD and began to think it may have caused her IBD. Slip op. at 13. She filed this lawsuit on December 21, 2005.

At the trial level, defendant moved to dismiss the case arguing that the statute of limitations had expired. Following a hearing on the issue, the trial court ruled that plaintiff’s claim was not time-barred.

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