FDA-Approved Warnings Insufficient to Start Limitations Clock

In Kendall v. Hoffman-LaRoche, Inc., (February 27, 2012), the New Jersey Supreme Court rejected the argument that an FDA-approved warning – entitled to a “superpresumption” of adequacy under the New Jersey Product Liability Act (PLA) – is automatically sufficient to trigger the start of the statute of limitations.  Under New Jersey’s discovery rule, a person’s two-year time window to file a claim for personal injuries, including product liability claims, does not begin to run until s/he knows, or reasonably should know, of the alleged link between the product and the harm.    

Kendall involved use of the anti-acne drug Accutane.  The plaintiff first was prescribed the drug in January 1997 when she was 12 years old and received three subsequent courses between July 1997 and September 1998.  In April 1999, while not on Accutane, she was hospitalized with bloody diarrhea and abdominal pain and diagnosed with ulcerative colitis.  In December 2000, with the knowledge of her gastroenterologist, the plaintiff’s dermatologist prescribed a fifth course of Accutane, and she took a sixth and final course beginning in September 2003.  She filed suit in December 2005, alleging that the drug’s warnings failed to advise her or her physicians of the risk of developing ulcerative colitis.

Under the PLA,“[i]f the warning or instruction given in connection with a drug or food or food additive has been approved or prescribed by the . . . [FDA] … a rebuttable presumption shall arise that the warning or instruction is adequate.”  This presumption was converted into a “superpresumption” in Perez v. Wyeth Labs Inc., 161 NJ 1 (1999), which held that compliance with an FDA-approved warning “should be virtually dispositive” of failure to warn claims.   

Relying on the fact that the FDA-approved warnings for Accutane contained information regarding inflammatory bowel disease, abdominal pain, and bloody diahhrea throughout the time the plaintiff used the drug, the defendants argued that the warnings’ presumption of adequacy should be sufficient, in the plaintiffs’ alleged absence of actual knowledge that her condition may be related to her Accutane use, to impute such knowledge to her and trigger the start of the statute of limitations.  The plaintiff countered that the presumption of a warning’s adequacy under the PLA does not apply to the discovery rule, but only to the merits of a failure-to-warn claim.

The Court chose the middle road, ruling that the presumption of adequacy is relevant, but not automatically dispositive, to the discovery rule and the triggering of the statute of limitations.  While this result seems somewhat counterintuitive (if an FDA-approved warning is presumed to be adequate to alert physicians and users of the potential risks and dangers of a drug, why would it not also be adequate to alert patients experiencing warned-about side-effects of the possible link to their use of the drug?), significantly more puzzling are the Court’s reasons for finding that, despite Accutane’s warnings, this plaintiff “was reasonably unaware that the defendants caused her injury until after December 21, 2003,” thus rendering her suit timely.     

As pointed out by Judge Wefing’s strong dissent, the Court could only reach this result by finding, in effect, that the Accutane warnings were inadequate – which of course directly contradicts the strong presumption of adequacy under the PLA.  Judge Wefing also noted that to reach its conclusion, the Court had to excuse the plaintiff’s own failure to read the warning information she was given.

It remains to be seen just what impact this decision will have on future failure-to-warn cases in New Jersey.  It may be, as Philip Yannella and Michael Carroll of Ballard Spahr have suggested, that this decision will have little real effect on the application of the discovery rule in New Jersey because the focus remains on what reasonably was known or should have been known.  Nevertheless, now that this argument has been broached, it is safe to assume that more defendants will seek to employ it in appropriate cases.

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