top of page


New Jersey's High Court Rules On The Interplay Between The Discovery Rule and The Product Liability Act's Presumption Of Adequacy Of FDA Approved Warnings

February 27, 2012

Share to:

<p align="justify">In <em>Kendall v. Hoffman-LaRoche, Inc., et. al.</em>, New Jersey’s High Court found that plaintiff’s action for personal injuries arising out of her use of the prescription drug Accutane was timely, despite the fact that her first appearance of inflammatory bowel disease (the injury alleged) and her receipt of an FDA approved presumed adequate warning was more than 2 years (the relevant statute of limitations period pursuant to N.J.S.A. 2A:14-2) prior to her commencement of the action.</p>
<p align="justify"> Plaintiff was first prescribed Accutane in 1997. She had outbreaks of inflammatory bowel disease starting in 1999. Plaintiff was prescribed Accutane again in 1998, 2000 and 2003. Over that time period, the warnings associated with Accutane and inflammatory bowel disease became stronger, and plaintiff received said strengthened warnings and signed a consent form acknowledging as such in 2003. As a result, defendant contended that by 2003, plaintiff should have been aware of the possibility of a causal link, given that she had received increased warning. Plaintiff explained, however, that the warnings she had been given never specifically mentioned inflammatory bowel disease or ulcerative colitis. Moreover, critical in this case was the fact that plaintiff had been prescribed the drug for a significant period of time prior to her receipt of any warnings regarding a causal link between the drug and inflammatory bowel disease.</p>
<p align="justify"> In reaching its conclusion, New Jersey’s High Court considered New Jersey’s "discovery rule" and "whether the facts presented would alert a reasonable person exercising ordinary diligence that he or she was injured due to the fault of another." In addition, the High Court considered the effect of New Jersey’s Product Liability Act, if any, on the timeliness of plaintiff’s filing, and found that although the PLA provided a "presumption of adequacy" for the warnings (since the product had been approved by the FDA), such a presumption could be overcome if the plaintiff proved that a reasonable person in her circumstances would not have been aware, within the prescribed time period, that she had been injured by the defendant’s product. The Supreme Court held that because plaintiff, in this case and under these circumstances, proved that she <em>reasonably</em> failed to appreciate the cause of her injury by the requisite time, her filing of the complaint was timely.</p>
<p align="left"><a href=""></a></p>
<p align="justify"> </p>


bottom of page