2016 Liability for Mobile Health & Wearable Technologies 85
disease monitoring app. Would such a patient be entitled to additional risk disclosures? Some courts have held that when a device is used in an experimental or novel way, informed consent from patients must be obtained.167 Should a provider offer additional disclosures if a prescription app was prescribed for an off-label use?168 Some courts have allowed that question to reach a jury.169 An informed consent theory especially would be of particular value to plaintiffs in the slight minority of jurisdictions that apply a patient expectations approach to informed consent rather than the professional standard used elsewhere.170 However, the informed consent avenue of liability may be moot. The conventional wisdom suggests that the risk- disclosure duty is exclusively owed by physicians and not by institutional providers.171 Although one recent case held that a “hospital has an independent duty to obtain informed consent” when it allowed “the use of equipment that is not part of the hospital’s usual inventory,”172 any more generalized informed consent duty owed by hospitals seems to remain problematic.
V. PRODUCT LIABILITY, WARRANTY, UCC, & RELATED CLAIMS
Many provider-facing apps are essentially extensions of traditional HIT devices, such as EMRs and CDS products that already have risk profiles.173 By 2010, the FDA was collecting reports of HIT-related safety concerns, classifying them as follows:
( 1) errors of commission, such as accessing the wrong patient’s record or
167. See, e.g., Estrada v. Jaques, 321 S.E.2d 240, 254 (N.C. Ct. App. 1984). 168. See Osburn v. Danek Med., Inc., 520 S.E.2d 88, 95 (N.C. Ct. App. 1999); see Yadin David & William Hayman, Issues Associated with Off Label Use of Medical Devices, INST. OF ELECTRICAL AND ELECTRONICS ENGINEERS 3556, 3356-57 (Aug. 2007). 169. See, e.g., DeNeui v. Wellman, 2008 WL 4065816, at 7 (D.S.D. 2008); see also 40 PA. STAT. § 1303.504(a)( 5) (2002) (requiring informed consent for “using an experimental device or using an approved medication or device in an experimental manner”). 170. See Culbertson v. Mernitz, 602 N.E.2d 98, 101 (Ind. 1992) (applying majority “professional standard” rule and discussing authorities in detail); cf. Largey v. Rothman, 540 A.2d 504, 506 (N.J. 1988) (applying patient standard). 171. See, e.g., Pauscher v. Iowa Methodist Med. Ctr., 408 N. W.2d 355 (Iowa 1987); Ward v. Lutheran Hosps. & Homes Soc’y of Am., 963 P.2d 1031, 1034 (Alaska 1998) (stating, “Alaska is the only state that imposes on hospitals a non-delegable duty to provide quality emergency medical care. Unless the patient selects the physician herself, a general acute care hospital will be liable for the physician’s negligence in the emergency room”). 172. Nguyen v. IHC Med. Servs., 288 P.3d 1084, 1092 (Utah Ct. App. 2012). 173. Although the app/wearable space is new, many of the liability issues are similar to those raised by the deployment of more conventional health information technologies. See, e.g., Nicolas Terry, When the Machine That Goes ‘Ping’ Causes Harm: Default Torts Rules and Technologically-Mediated Health Care Injuries, 46 ST. LOUIS U. L.J. 37, 47–59 (2002).