3 ms·

EHR systems are not medical devices and fall into a different category than pacemakers, spinal nerve stimulation, and similar.

• skissane 4y ago
  If you read the judgement, it simply turned on the application of standard Virginia product liability law - nothing in the case turned on what category of product an EHR is. As far as I am aware, Virginia product liability law does not treat medical devices specially - they are subject to the same fundamental principles as any other product. Can you cite any sources to the contrary?
  • shagie 4y ago
    https://www.reichandbinstock.com/blog/strict-liability-for-defective-medical-devices/ https://www.reichandbinstock.com/blog/strict-liability-for-d... https://www.whiteandwilliams.com/resources-alerts-Medical-Device-Manufacturers-Liability-Pennsylvania-Law https://www.whiteandwilliams.com/resources-alerts-Medical-De... https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6173549/ https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6173549/ https://biotech.law.lsu.edu/courses/drugsf02/rest_3_6.htm https://biotech.law.lsu.edu/courses/drugsf02/rest_3_6.htm > (a) A manufacturer of a prescription drug or medical device who sells or otherwise distributes a defective drug or medical device is subject to liability for harm to persons caused by the defect. A prescription drug or medical device is one that may be legally sold or otherwise distributed only pursuant to a health-care provider's prescription. > (b) For purposes of liability under Subsection (a), a prescription drug or medical device is defective if at the time of sale or other distribution the drug or medical device: > (1) contains a manufacturing defect as defined in § 2(a) [i.e., when the product departs from its intended design even though all possible care was exercised in the preparation and marketing of the product]; or
    • deleted 4y ago
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    • skissane 4y ago
      The text you've quoted is from the "Restatement (Third) of the Law of Torts: Products Liability". That's not the actual law – that's a "Restatement" published by the American Law Institute (ALI), a body dominated by law professors, but also including some judges and practising lawyers among its membership. It is their summary of what they think the law is, mixed (in some cases) with their opinions on what the law ought to be. It is also trying to distill common general principles from the laws of all US states, so whatever it says may not be true in all states. They've found it helpful to have a section specific to prescription drugs and medical devices – but that doesn't mean that the fundamental legal principles regarding them are different from those applying to other products. Courts in the US frequently accept the ALI's "Restatements" as persuasive but not binding, and when they conflict with statute or relevant case law, the later takes precedence. You appear to be claiming that "strict liability" is something specific to industrial and medical products – but under the law of many US states, "strict liability" applies to design defects in all products. In fact, in the case of Brown v. Superior Court, 44 Cal. 3d 1049, 245 Cal. Rptr. 412, 751 P.2d 470 (1988) [0], the Supreme Court of California concluded that the the "strict liability" standard which applies to design defects in ordinary products should not apply to prescription drugs, because it threatened to increase the expense and risk of new drug development to the point that it might discourage it, thereby harming public health. A number of subsequent decisions, including Hufft v. Horowitz, 4 Cal.App.4th 8 (Cal. Ct. App. 1992) [1], extended that ruling to implantable medical devices. So, contrary to your assertions that medical devices are under some special legal regime which is stricter than that applicable to ordinary products, California product liability law is actually (at least in this regard) weaker for prescription drugs and (implantable) medical devices than for consumer goods, since it exempts them from one of the product liability rules which apply to almost every other category of goods. [0] https://casetext.com/case/brown-v-superior-court-5 https://casetext.com/case/brown-v-superior-court-5 [1] https://casetext.com/case/hufft-v-horowitz https://casetext.com/case/hufft-v-horowitz