Is A Medical Device Cyber Vulnerability A Design Defect?

Law360, New York (October 16, 2015, 4:09 PM EDT) -- October is National Cyber Security Awareness Month (yes, that's a thing), so it seems fitting to write about an unprecedented alert recently released by the U.S. Food and Drug Administration to health care providers that warned of a medical device's vulnerability to cyberattack. The subject device was a now-discontinued infusion pump system made by Hospira that was capable of communicating with the health care provider's network. As such — by definition, really — it could be hacked (though evidently with greater ease than usual here). Interestingly, though, the FDA warning read a lot like an FDA response to a verified product defect. Perhaps that makes sense. But should cybersecurity vulnerabilities really be treated the same as design defects under traditional products liability law? While government-issued medical device security standards from the FDA and U.S. Department of Homeland Security appear inevitable and necessary, cyber vulnerabilities seem distinguishable from conventional design defects in the medical products liability context for several reasons....

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