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overwriting one patient’s information with another’s; ( 2) errors of omission or transmission, such as the loss or corruption of vital patient data; ( 3) errors in data analysis, including medication dosing errors of several orders of magnitude; and ( 4) incompatibility between multi-vendor software applications and systems, which can lead to any of the above.174
Additionally, there has been considerable critical research regarding “alert fatigue” and other problems with the interfaces used by HIT products.175 There is little doubt that product liability models would apply to HIT devices and their mobile extensions.176 Indeed, the HIT industry has been heavily criticized for attempting to shift such risks to providers.177 There is slightly less certainty that product liability-type theories apply to stand-alone apps ( i.e., software without hardware) or to consumer-facing apps. However, the few courts that have faced the issue seem to agree that there is potential liability for “[c]omputer software that fails to yield the result for which it was designed”178 by analogy to liability found in cases involving defective aeronautical charts.179
A. Product Liability
State law product liability actions may be brought for personal or property injury caused by product defects associated with manufacture, design or inadequate warning.180 However, substantial limitations apply with regard to FDA-regulated medical devices because of application of the preemption
174. Testimony of Jeffrey Shuren, Health Information Technology (HIT) Policy Committee Adoption/Certification Workgroup (Feb. 25, 2010), http:// www.cchfreedom.org/pr/Health%20IT%20Deaths%20%20FDA%20jeffrey%20Shuren.pdf; see generally U.S. FOOD & DRUG ADMIN., FDASIA HEALTH IT REPORT (2014), http://www. fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsand Tobacco/CDR/ CDRHReports/UCM391521.pdf. 175. See generally Nicolas Terry, Foreword: Drug-Drug Interaction Warnings as Technological Iatrogenesis, 5 ST. LOUIS U. J. HEALTH L. & POL’Y, 251, 251–55 (2012); see also Nicolas Terry, Pit Crews With Computers: Can Health Information Technology Fix Fragmented Care? 14 HOUS. J. HEALTH L. & POL’Y, 129 (2014). 176. See generally Sharona Hoffman & Andy Podgurski, E-Health Hazards: Provider Liability and Electronic Health Record Systems, 24 BERKELEY TECH. L.J. 1523, 1579 (2009). 177. Ross Koppel & David Kreda, Health Care Information Technology Vendors’ “Hold Harmless” Clause: Implications for Patients and Clinicians, 301 JAMA 1276, 1276 (2009). 178. Winter v. G.P. Putnam’s Sons, 938 F.2d 1033, 1036 (9th Cir. 1991); cf. Wilson v. Midway Games, Inc., 198 F. Supp. 2d 167, 172 (D. Conn. 2002) (ruling against plaintiff in video game case but not necessarily disagreeing with liability in Winters-type cases involving “harm resulting from reliance on instruction manuals, cookbooks, navigational charts and similar materials”). 179. See generally T. Randolph Beard et al., Tort Liability for Software Developers: A Law & Economics Perspective, 27 J. MARSHALL J. COMPUTER & INFO. L. 199, 208–09 (2009). 180. See RESTATEMENT (THIRD) OF TORTS: PRODUCTS LIABILITY § 2, § 6 (AM. LAW INST. 1998); cf. U.C.C. §2–314 (AM. LAW INST. & UNIF. LAW COMM’N 1977) (explaining that parallel claims may also be brought for breach of the implied warranty of merchantability).