Who would have thunk it , but bed rails are apparently rather dangerous for the elderly and strangling deaths are somewhat common.  This has resulted in a rash of new medical malpractice/product liability/negligence claims.  As this article makes clear, one of the interesting questions raised in the claims is whether bed rails are a consumer product or a medical device.  The answer, which is uncertain, is significant as medical devices are generally afforded greater legal protections than mere consumer products; medical devices are also more highly regulated.

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