Monthly Archives: October 2012

PLIVA v. Mensing: A Poor Outcome for Consumers

By Mark Apostolos, Albany Government Law Review[1]

Product manufacturers are generally required by state law to sell a product that: (1) is free of design or manufacturing defects, and (2) carries appropriate warnings putting customers on notice as to the reasonably foreseeable risks of using the product.[2]  Prescription drug products require “reasonable instructions or warnings regarding foreseeable risks of harm,”[3] which are to be provided to either “prescribing and other health-care providers who are in a position to reduce the risks of harm in accordance with the instructions or warnings”[4] or “the patient when the manufacturer knows or has reason to know that health-care providers will not be in a position to reduce the risks of harm in accordance with the instructions or warnings.”[5]  In addition, like any other negligence claim, a plaintiff may have a cause of action if that duty is breached and they are injured as a result of the manufacturer’s failure to warn the consumer with an adequate label.[6]

In the recent case of Pliva v. Mensing,[7] the Supreme Court rendered a decision whose holding undermines the well-established principles of product liability.  The Court held that generic drug manufacturers can no longer be liable for failure to warn claims where state law conflicts with federal law,[8] effectively rendering generic drug manufacturers immune from state law failure-to-warn tort claims.[9]

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