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 ...
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Mensing Generic Preemption Decision Awaited in New Jersey

In 2011, the US Supreme Court’s landmark decision in PLIVA v. Mensing altered the world of pharmaceutical product liability litigation, holding that claims challenging the adequacy of warnings provided by generic drug makers were preempted.  The basic underpinning of the Supreme Court’s opinion was that, under federal law, a generic pharmaceutical had to be the same — and provide the same warnings — as the branded drug, and that any deviation by a generic manufacturer would run afoul of federal law.  Mensing involved claims against makers of metoclopramide – the generic version of Reglan – that the plaintiffs allege caused them to develop tardive dyskinesia, a disorder characterized by involuntary, repetitive facial grimaces and tongue and limb movements. In the months that have followed since Mensing was decided, many courts around ...
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