Five Legal Preparedness Challenges for Responding to Future Public Health Emergencies

See, e.g., The Centers for Law and the Public's Health, Model State Emergency Health Powers Act, 2001, available at <http://www.publichealthlaw.net/ModelLaws/MSEHPA.php> (last visited December 8, 2010); The National Conference of Commissioners on Uniform State Laws, Uniform Emergency Volunteer Health Practitioners Act, available at <http://www.uevhpa.org/DesktopDefault.aspx> (last visited December 8, 2010); Rosenbaum S. Harty M. Sheer J. , “State Laws Extending Comprehensive Legal Liability Protections for Professional Health-Care Volunteers During Public Health Emergencies,” Public Health Reports 123 (2008): 238–241; Hodge J. G. Anderson E. D. , “Principles and Practice of Legal Triage during Public Health Emergencies,” NYU Annual Survey of American Law 64 (2009): 249–291; Matthews G. W. Markiewicz M. , “Update on Emergency Liability Protection for Volunteer Entities,” Biosecurity and Bioterrorism: Biodefense Strategy, Practice, and Science 7, no. 1 (2009): 51–54.

See World Health Organization, Press Release, Statement by WHO Director-General, Chan Margaret Dr. : Swine Influenza (April 25, 2009), available at <http://www.who.int/mediacentre/news/statements/2009/h1n1_20090425/en/index.html> (last visited December 8, 2010). A list of declarations by country is maintained by the Sandra Day O'Connor College of Law, Global Legal Triage and the 2009 H1N1 Outbreak, available at <http://www.law.asu.edu/publichealthlaw/PublicHealthLaw/LegalTriage.aspx> (last visited December 8, 2010).

See Acting Secretary Johnson Charles E. , Department of Health and Human Services, Determination That a Public Health Emergency Exists, April 26, 2009, available at <http://www.flu.gov/professional/federal/h1n1emergency042609-html> (last visited December 8, 2010); Secretary Kathleen Sebelius, Department of Health and Human Services, Declaration under the Public Readiness and Emergency Preparedness Act, September 28, 2009, Federal Register 74, no. 190 (2009): 50968–50970; The White House, Declaration of a National Emergency with Respect to the 2009 H1N1 Influenza Pandemic, October 24, 2009, available at <http://www.whitehouse.gov/the-press-office/declaration-a-national-emergency-with-respect2009–h1n1-influenza-pandemic-0> (last visited December 8, 2010).

A list of declarations by state is maintained by the Sandra Day O'Connor College of Law. See Sandra Day O'Connor College of Law, supra note 2.

Sherman S. E. Foster J. Vaid S. , “Emergency Use Authorization and 2009 H1N1 Influenza,” Biosecurity and Bioterrorism: Biodefense Strategy, Practice, and Science 7, no. 3 (2009): 245–250.

Id; Birnkrant D. Cox E. , “The Emergency Use Authorization of Peramivir for Treatment of 2009 H1N1 Influenza,” New England Journal of Medicine 361, no. 23 (2009): 2204–2207; Food and Drug Administration, FDA 2009 H1N1 (Swine) Flu Page, available at <http://www.fda.gov/NewsEvents/PublicHealthFocus/ucm150305.htm> (last visited December 8, 2010). In addition, prior to H1N1, an EUA was issued for home supplies of doxycycline under a program for eligible United States Postal Service workers to volunteer to dispense antibiotics to the public following an anthrax attack.

Institute of Medicine, Forum on Medical and Public Health Preparedness for Catastrophic Events, Medical Countermeasures Dispensing: Emergency Use Authorization and the U.S. Postal Service Model, Washington, D.C., November 18, 2009; telephone conversation with Starr David Carr Kelly of the New York City Department of Health and Mental Hygiene, October 5, 2010.

Therefore, there is concern about whether PREP Act protections would apply. Id.

For example, in advance of emergencies, it could be helpful for local health departments to have some visibility into nearly-final versions of EUAs (sometimes referred to as “pre-EUAs”) to become familiar with their conditions, as well as have access to dosing and crushing instructions for pediatric formulations. During a sudden-onset emergency, because EUAs are not issued until an emergency occurs, a responding public health department in a city with millions of residents would be required to review and interpret the EUAs conditions at the time of the emergency. It may then, under a very compressed timeframe, have to print and distribute a sufficient number of fact sheets for the EUA product for the impacted population. See, e.g., Institute of Medicine and Starr Carr , supra note 8.

See, e.g., Institute of Medicine, Guidance for Establishing Crisis Standards of Care for Use in Disaster Situations: A Letter Report (Washington, D.C.: National Academies Press, 2009); Phillips S. J. Knebel A. , eds., Mass Medical Care with Scarce Resources: A Community Planning Guide , AHRQ, Publication No. 07–0001 (Rockville, MD: Agency for Healthcare Research and Quality, 2007).

Courtney B. Morhard R. Bouri N. Cicero A. , “Expanding Practitioner Scopes of Practice during Public Health Emergencies: Experiences from the 2009 H1N1 Pandemic Vaccination Efforts,” Biosecurity and Bioterrorism: Biodefense Strategy, Practice, and Science 8, no. 3 (2010): 223–231.

National Council of State Boards of Nursing, Changes in Healthcare Professions' Scope of Practice: Legislative Considerations (October 2009), available at <https://www.ncsbn.org/ScopeofPractice.pdf> (last visited December 8, 2010); Sorrel A. L. , “Medicine Scores Legal Victories in Scope of Practice,” AmedNews, May 11, 2009, available at <http://www.ama-assn.org/amednews/2009/05/11/prsa0511.htm> (last visited December 9, 2010); Institute of Medicine, Report Brief: Nurses Should Practice to the Full Extent of Their Education and Training (Washington, D.C.: National Academies Press, 2010), available at <http://www.iom.edu/Reports/2010/TheFuture-of-Nursing-Leading-Change-Advancing-Health/Report-Briefaspx?page=2> (last visited October 8, 2010).

See, e.g., The Centers for Law and the Public's Health and National Conference of Commissioners on Uniform State Laws, supra note 1.

See, e.g., Cauchemez S. Ferguson N. M. Wachtel C. , “Closure of Schools During an Influenza Pandemic,” The Lancet Infectious Diseases 9 (2009): 473–481; Wu J. T. Cowling B. J. Lau E. H. Y. , “School Closure and Mitigation of Pandemic (H1N1) 2009, Hong Kong,” Emerging Infectious Diseases (2010); Leung G. M. Nicoll A. , “Reflections on Pandemic (H1N1) 2009 and the International Response”, PLoS Medicine 7, no. 10 (2010); Lee V. J. Yap J. Cook A. R. , “Effectiveness of Public Health Measures in Mitigating Pandemic Influenza Spread: A Prospective Sero-Epidemiological Cohort Study,” Journal of Infectious Diseases 202, no. 9 (2010): 1319–1326; Inglesby T. V. Nuzzo J. B. O'Toole T. Henderson D. A. , “Disease Mitigation Measures in the Control of Pandemic Influenza,” Biosecurity and Bioterrorism, Biodefense Strategy, Practice, and Science 4, no. 4 (2006): 366–375.

Center for Biosecurity of UPMC, The Next Challenge in Healthcare Preparedness: Catastrophic Health Events, Baltimore, MD, 2009, available at <http://www.upmc-biosecurity.org/website/resources/publications/2010/pdf/2010-01-29prepreport.pdf> (last visited October 8, 2010).

See Institute of Medicine, supra note 11; Levin D. Cadigan R. O. Biddinger P. D. , “Altered Standards of Care During an Influenza Pandemic: Identifying Ethical, Legal, and Practical Principles to Guide Decision Making,” Disaster Medicine and Public Health Preparedness 3, Supp. 2 (2009): 1–9.

Fink S. , “Strained by Katrina, a Hospital Faced Deadly Choices,” New York Times, August 25, 2009, at MM28, available at <http://www.nytimes.com/2009/08/30/magazine/30doctors.html> (last visited December 8, 2010); see Institute of Medicine, supra note 11; Hodge J. G. Courtney B. , “Assessing the Legal Standard of Care in Public Health Emergencies,” JAMA 303, no. 4 (2010): 361–362; Gostin L. O. Hanfling D. Hodge J. G. , “Standard of Care - In Sickness and In Health and In Emergencies,” New England Journal of Medicine 363, no. 14 (2010): 1378–1380; Rothstein M. A. , “Malpractice Immunity for Volunteer Physicians in Public Health Emergencies: Adding Insult to Injury,” Journal of Law, Medicine & Ethics 38 (2010): 149–153.

See Fink , supra note 18.

Makin K. , “Top Court Dismisses SARS Suits in Ontario,” Globe and Mail, May 8, 2009, (updated September 24, 2009), available at <http://www.theglobeandmail.com/news/national/article1131382.ece> (last visited December 8, 2010).

For more detailed discussions on this topic, see Hodge J. G. Jr. Garcia A. M. Anderson E. D. , “Emergency Legal Preparedness for Hospitals and Health Care Personnel,” Disaster Medicine and Public Health Preparedness 3, Supp. 1 (2009): S37–S44, at S41–S43; Fink S. , “The New Katrina Flood: Hospital Liability,” New York Times, January 1, 2010, available at <http://www.nytimes.com/2010/01/03/weekinreview/03fink.html> (last visited December 8, 2010); McMenamin J. P. , “Pandemic Influenza: Is There a Corporate Duty to Prepare?” Food and Drug Law Journal 64, no. 69 (2009): 69–100.

LaCoste v. Pendleton Methodist Hospital, L.L.C. , 06–1268 (La. App. 4 Cir. 12/6/06); 947 So. 2d 150,152 (2006); Barrow B. , “Pendleton Memorial Methodist Hospital Generator Concerns Weren't Passed Along, Former CEO Testifies,” Times-Picayune, January 16, 2010, available at <http://blog.nola.com/hurricane_impact/print.html?entry=/2010/01/pendleton_memorial_methodist_h_2.html> (last visited December 8, 2010); see Fink , supra note 21.

“New Orleans Hospital Settles Post-Katrina Wrongful Death Lawsuit,” Insurance Journal, January 28, 2010 available at <http://www.insurancejournal.com/news/southcentral/2010/01/28/106964.htm> (last visited December 8, 2010); see Barrow , supra note 22.

See Hodge Garcia Anderson , supra note 21, at S42.

See, e.g., Perkins J. Youdelman M. , Summary of State Law Requirements Addressing Language Needs in Health Care (National Health Law Program, 2008), available at <http://www.healthlaw.org/images/stories/issues/nhelp.lep.state.law.chart.final.0319.pdf> (last visited December 8, 2010).