By Mark Apostolos, Albany Government Law Review
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. Prescription drug products require “reasonable instructions or warnings regarding foreseeable risks of harm,” 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” 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.” 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.
In the recent case of Pliva v. Mensing, 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, effectively rendering generic drug manufacturers immune from state law failure-to-warn tort claims.