1. MassMEDIC Risk Management: Legal and Liability Issues with Home Healthcare Products Raymond C. Zemlin Goodwin Procter LLP (March 9, 2006) ©2006. Goodwin Procter LLP

2. Emerging Trends Complicated medical devices previously used in clinical settings by trained personnel now being used by patients and families in home settings Dialysis, blood testing, remote monitoring technologies, defibrillators and other medical devices migrating to home use Increased home use means increased product liability exposure

3. General Principles of Product Liability Claims must be based on: ­ negligence ­ strict liability ­ breach of warranty ­ product liability statutes Requirement for liability is a product defect

4. Types of Product Defects Manufacturing defects Design defects Marketing defects

5. Home Use of Medical Devices Same general product liability principles govern No new theory of liability applies to this area Preemption claims tied to Medical Device Amendments of 1976 generally rejected ­ MDA preempts any “state requirements” that “relate to the safety and effectiveness of the device.” ­ Courts were quite divided on issue ­ In Lohr v. Medtronic, U.S. Supreme Court concluded that “few, if any, common-law duties were preempted by the statute.”

6. Home Use of Medical Devices (cont.) Still need a defect However, a medical device that may not have been deemed defective in a hospital setting may be defective in a home-use setting

7. Product Liability in Home Setting -- Manufacturing Defects A defectively manufactured product can give rise to liability in both professional and home setting Would professionals detect the defect and minimize the impact through other steps? Are maintenance/calibration regimens likely to be followed?

8. Product Liability in Home Setting -- Design Defects Product properly designed for hospital use may not be adequately designed for home use Environmental variations ­ temperature ­ humidity ­ motion/vibration Attentiveness to alarms and warnings ­ no constant monitoring ­ background distractions

9. Product Liability in Home Setting -- Design Defects (cont.) Ease of use by wide range of ages and capabilities ­ use by elderly or medicated patients ­ pediatric usage ­ use by untrained patients and family members ­ use by harried/stressed caregivers ­ language issues Often key issue is whether other products (even more expensive ones) have features/design that would have prevented the harm Designers must anticipate and deter predictable misuse and product alteration

10. Product Liability in Home Setting -- Marketing Defects Adequate instructions ­ FDA regulations (21 CFR 801.5, 801.109 and 801.110) exempt many devices from requirements regarding adequate directions so long as devices used by licensed medical professionals ­ home use by lay caregivers means that this exemption won’t apply ­ therefore the manufacturer must include detailed instructions concerning the proper use and risks of the device

11. Product Liability in Home Setting -- Marketing Defects (cont.) Failure to warn ­ warnings understandable by clinicians may not be adequate for patients and untrained caregivers ­ risks obvious to medical professionals are not obvious to lay users and therefore must be warned against ­ be careful not to give too many warnings: confusing and may suggest fundamental design defects

12. Product Liability in Home Setting -- Recalls Much harder to track devices outside of clinical settings Much harder to implement product recalls outside of clinical settings No exemption from liability for failing to implement recall Trying hard is no defense

13. Specific Examples of Home Use Liability Patient dies while using a dialysis machine which allegedly malfunctions ­ patient unable to detect malfunction ­ hospital use by professionals would likely have detected and corrected malfunction Patient using home cold-therapy device suffers severe frostbite ­ alleges design flaws in thermostat Patient dies using transdermal patch ­ used in conjunction with heating pad, which triggered excess drug disposal

14. Suggestions for Reducing Liability KISS ­ Additional steps/requirements, more opportunity for error Understand thoroughly how device is used, and misused ­ User evaluation studies at prototype stage can identify unanticipated patterns of use and common types of misuse ­ Training given to users in evaluation studies should vary to match expected levels of actual training patients and caregivers will receive

15. Suggestions for Reducing Liability (cont.) Investigate nature and extent of user complaints/errors from similar products already training patients and caregivers will receive On the FDA’s CDRH website, links to reporting data on adverse events (MAUDE), MDRs (from 1992-1996) and recalls (since 2002) ­ Other websites that provide information concerning medical device safety issues include ­ www.mdsr.ecri.org www.mdsr.ecri.org ­ www.ismp.org/MSAarticles www.ismp.org/MSA ­ www.jcaho.org/sentinelevents www.jcaho.org/sentinel

16. Suggestions for Reducing Liability (cont.) Prioritize risks based on likeliness of occurring and expected magnitude of the hazard Mitigate problems by redesigning the device or the user interface to increase likelihood of proper usage

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