Reviews in Medical Ethics

See Allen J. L. , “Geographical Knowledge and American Images of the Louisiana Territory,” Voyages of Discovery: Essays on the Lewis and Clark Expedition, Ronda J. P. ed., (Helena: Montana Historical Society Press, 1998): 39–58.

See generally University of NebraskaLincoln, Journals of the Lewis and Clark Expedition Online, avaialable at <http://lewisandclarkjournals.unl.edu/index.html> (last visited May 4, 2010).

Ambrose S. E. , Undaunted Courage: Meriwether Lewis, Thomas Jefferson, and the Opening of the American West (New York: Simon & Schuster, 1996): at 483.

At the time the book was published, Robert I. Field, J.D., M.P.H., Ph.D. was Chair of the Department of Health Policy and Public Health at the University of the Sciences in Philadelphia. Field is now Professor of Law at the Drexel University Earle Mack School of Law and Professor of Health Management and Policy at Drexel University School of Public Health.

Field R. I. , Health Care Regulation in America: Complexity, Confrontation, and Compromise (Oxford University Press, 2007).

Field discusses neither regulation pertaining to bioethics or the aging, nor the structure of regulatory entities such as state ombudsmen for the institutionalized elderly. Robert Gatter says this omission is understandable because such topics are “not essential to a survey of health law based on the themes of quality, access, and cost control.” Gatter R. , “Health Care Regulation in America,” (book review essay) Journal of Legal Medicine 28, no. 4 (2007): 593–599, at 598. I am not so sure. Quality, access, and cost control are often supplemented by a fourth key policy goal, autonomy. See, e.g., Furrow B. R. , Health Law: Cases, Materials and Problems , 1 edition (St. Paul: West Pub. 1987): xviii–xix; Mariner W. K. , “Toward an Architecture of Health Law,” American Journal of Law & Medicine 35, no. 1 (2009): 67–87, at 83; Hall M. A. , “The History and Future of Health Care Law: An Essentialist View,” Wake Forest Law Review 41, no. 2 (2006): 347–364, at 353. Since there was good reason to include the theme of autonomy, there was good reason to include a discussion of regulation associated with bioethics. See Rosoff A. J. , “Health Law at Fifty Years: A Look Back,” Health Matrix 14, no. 1 (2004): 197–212, at 203 (“It is difficult to imagine a comprehensive health law text that would not have a substantial section devoted to these topics … .”); Capron A. M. , “A Bioethics Approach to Teaching Health Law,” Journal of Legal Education 38, no. 3 (1998): 505–510.

See Field , supra note 5, at 191.

See, e.g., Provena Covenant Medical Center v. Illinois Department of Revenue, No. 107328, 2010 WL 966858 (Ill. Mar. 18, 2010); Strom S. , “States Move to Revoke Charities' Tax Exemptions,” New York Times, Feb. 28, 2010: A21.

31 U.S.C. §§ 3729–33. I discuss this omission in further detail, infra.

The entries would be more useful if each regulatory development were linked to a specific date, for example, “1965: Medicare and Medicaid enacted.”

See Pozgar G. D. , Legal Aspects of Health Care Administration , 10th ed. (Sudbury, MA: Jones & Bartlett, 2007).

See Miller R. D. , Problems in Health Care Law , 9th ed. (Sudbury, MA: Jones & Bartlett, 2006).

Field R. I. , Teacher's Guide for Health Care Regulation in America: Complexity, Confrontation, and Compromise (version 1.0, Aug. 2007), available at <http://www.healthcareregulation.net> (last visited May 5, 2010). Ideally, this website would not only promote the book but would also supplement the book. Using a website in such a way is a model successfully implemented by other books in this area. See for instance Hall M. A. Bobinski M. A. Orentlicher D. , website for Health Law and Ethics , 7th ed. (Austin: Wolters Kluwer Law & Business: Aspen, 2008), available at <http://indylaw.indiana.edu/instructors/orentlicher/public_html/home.html> (last visited May 5, 2010). While not in the healthcare area, a particularly good supplemental website is that supporting Klein W. A. Ramseyer J. M. Bainbridge S. M. , Business Associations: Agency, Partnerships and Corporations , 7th ed., (New York: Thomson Reuters/Foundation Press, 2009), avaliable at <http://www.business-associations.com> (last visited May 5, 2010).

See Dobbs D. B. Hayden P. T. Bublick E. M. , Teacher's Manual to Torts and Compensation, Personal Accountability and Social Responsibility for Injury , 6th Standard and Concise Edition (St. Paul: West, 2009).

42. U.S.C. § 11101.

Greely H. T. , “Some Thoughts on Academic Health Law,” Wake Forest Law Review 41, no. 2 (2006): 391–410, at 398 (“[H]ealth law is hard because it is largely state law.…”). Field does often use his home state of Pennsylvania as an example.

Another great example of federal-state tension, not discussed in Health Care Regulation in America, concerns the regulation of medical marijuana and the drugs used in physician-assisted suicide. See generally Gonzales v. Raich, 545 U.S. 1 (2005); Gonzales v. Oregon, 546 U.S. 243 (2006).

Field R. I. , “Why Is Health Care Regulation So Complex?” Pharmacy & Therapeutics 33, no. 10 (2008): 607–608, at 608.

The ERISA enforcement scheme, as interpreted by the courts, is bewilderingly complex. Judge Edward Becker described the ERISA regime as “unjust and increasingly tangled” and a “Serbonian bog.” DiFelice v. Aetna U.S. Healthcare, 346 F.3d 442, 453–54 (3d Cir. 2003) (Becker, J., concurring); see also Aetna Health, Inc. v. Davila, 542 U.S. 200, 222 (2004) (Ginsburg, J., concurring) (quoting Judge Becker's concurrence in DiFelice).

See, e.g., American Medical Sec., Inc. v. Bartlett, 111 F.3d 358 (4th Cir. 1997).

See, e.g., Aetna Health Inc. v. Davila, 124 S. Ct. 2488 (2004).

See, e.g., Golden Gate Restaurant Ass'n v. City & County of San Francisco, No. 08–1515 (U.S. June 5, 2009) (petition for a writ of certiorari filed); Retail Industry Leaders Ass'n v. Fielder, 475 F.3d 180 (4th Cir. 2007).

Field does briefly mention qui tam actions in a discussion of the anti-kickback statute and Stark Amendments. Field , supra note 5, at 187. But he omits any mention of the False Claims Act.

Field incidentally mentions criminal liability when briefly mentioning that the Department of Justice supplements the enforcement actions of the Office of Inspector General in the Department of Health and Human Services. Field , supra note 5, at 188–89. Unlike the Office of Inspector General, he looks at neither the structure of the Department of Justice nor the nature of its regulation.

Field , supra note 5, at viii.

Id.

Gatter calls this a “critical hole.” Gatter , supra note 6, at 597.

In addition to omitting significant indirect regulation of health care, Field omits discussion of some regulation that is specifically targeted at health care: International health law. See for instance Jost T. S. , “Comparative and International Health Law,” Health Matrix 14, no. 1 (2004): 141–147; Gostin L. O. Taylor A. L. , “Global Health Law: A Definition and Grand Challenges,” Public Health Ethics 1, no. 1 (2008): 53–63.

Centers for Medicare and Medicaid Services, National Health Statistics Group, National Health Expenditure Data, available at <http://www.cms.hhs.gov/NationalHealthExpendData/> (last visited May 7, 2010).

Bloche M. G. , “The Invention of Health Law,” California Law Review 91, no. 2 (2003): 247–322, at 249–50; Mariner , supra note 6, at 68 (“[D]octrines and principles grounded in other legal domains have come to apply to health problems with less and less special adaptation … .”).

Mariner , supra note 6, at 69.

Havighurst C. C. Richman B. D. , “Distributive Injustice(s) in American Health Care,” Law & Contemporary Problems 69, no. 4 (2000): 7–82, at 65 (“It is conceptually sound to view the malpractice system as a key element of the regulatory regime … as a form of regulation.”); Epstein R. A. , “The Unintended Revolution in Products Liability Law,” Cardozo Law Review 10, no. 8 (1989): 2193–2226, at 2193 (“There is an even greater recognition that tort law writ large is a form of government regulation … .”).

See Brennan T. A. , “The Role of Regulation in Quality Improvement,” Milbank Quarterly 76, no. 4 (1998): 709–731, at 720 (“Many do not consider tort law when addressing regulation of health care quality, despite the fact that this branch of law has as one of its major social goals … the deterrence of behavior that leads to medical injuries.”); Eremia A. D. , “When Self-Regulation, Market Forces, and Private Legal Actions Fail: Appropriate Government Regulation and Oversight is Necessary to Ensure Minimum Standards of Quality in Long-Term Health Care,” Annals Health Law 11, no. 1 (2002): 93–124, at 104 (“[S]elf-regulation, market forces, and private tort actions all serve important roles in the promotion of quality … .”); Furrow B. , “The Legal Implications of Health Care Cost Containment: Medical Malpractice and Cost Containment, Tightening the Screws,” Case Western Law Review 36, no. 4 (1986): 985–1032.

GAO, Information on False Claims Act Litigation, GAO-06-320R (Jan. 31, 2006).

Id.; see also Sylvia C. M. , The False Claims Act: Fraud Against the Government § 2:14 (St. Paul: Thomson/West 2009).

GAO, supra note 34; Sylvia , supra note 35.

Pub. L. No. 111–21 (May 20, 2009); H.R. 3590, 111th Cong., 1st Sess. (2009) § 6402, enacted as Pub. L. No. 111–148 (Mar. 23, 2010).

Carhart S. , “Restructuring, Consolidation in Healthcare Make Reform Top Health Law Issue for 2010,” BNA Health Law Reporter 19 (Jan. 7, 2010): 5–16; Rhoad R. T. Fornataro M. T. , “A Gathering Storm: The New False Claims Act Amendments and their Impact on Healthcare Fraud Enforcement,” Health Law 21, no. 6 (2009): 14–22.

18 U.S.C. § 287.

18 U.S.C. § 1001.

18 U.S.C. § 1341.

18 U.S.C. § 1343.

See, e.g., Miller , supra note 12, at 681 (noting an “explosive growth” in applying criminal law to health care providers); Jost T. S. , “Health Law and Administrative Law: A Marriage Most Convenient,” St. Louis University Law Journal 49, no. 1 (2004): 1–34, at 9 (“Criminal prosecutions … have also taken on an increasingly important role in health care in recent years.”); see also Boese J. T. , “Healthcare Behind Bars: The Use of Criminal Prosecution in Forcing Corporate Compliance,” Journal of Health & Life Science Law 3, no. 1 (2009): 91–131.

Harris G. , “Pfizer Pays $2.3 Billion to Settle Marketing Case,” New York Times, Sept. 3, 2009: At B4.

See Frabrikant R. , Health Care Fraud: Criminal, Civil, and Administrative Law § 3.03 (New York: Law Journal Press 2009).

“Maclaren USA Recalls to Repair Strollers Following Fingertip Amputations,” NEWS from CPSC: U.S. Consumer Product Safety Commission, Release # 10–033 (November 2009), available at <http://www.cpsc.gov/cpscpub/prerel/prhtml10/10033.html> (last visited May 6, 2009).

Strom B.L. , “How the US Drug Safety System Should be Changed,” JAMA 295, no. 17 (2006): 2072–2075.

Knox R. , “Merck Pulls Arthritis Drug Vioxx from Market,” National Public Radio, September 30, 2004, available at <http://www.npr.org/templates/story/story.php?storyId=4054991> (last visited May 7, 2010).

Brewer T. Colditz G. A. , “Postmarketing Surveillance and Adverse Drug Reactions,” JAMA 281, no. 9 (1999): 824–829.

“FDA's Sentinel Initiative,” U.S. Food and Drug Administration (December 2009), available at <http://www.fda.gov/Safety/FDAsSentinelInitiative> (last visited May 7, 2010).

Schneeweiss S. Avorn J. , “A Review of Uses of Health Care Utilization Databases for Epidemiologic Research,” Jorunal of Clinical Epidemiology 58, no. 4 (2005): 232–237.

Schneeweiss S. , “Developments in PostMarketing Comparative Effectiveness Research,” Clinical Pharmacology & Therapeutics 82, no. 2 (2007): 143–156.

García-Cortés M. Lucena M. I. Andrade R. J. Camargo R. Alcántar R. , “Is the Naranjo Probability Scale Accurate Enough to Ascertain Causality in Drug-Induced Hepatotoxicity?” Annals of Pharmacotherapy 38, no. 9 (2004): 1540–1541.

Maro J. C. Platt R. Holmes J. H. Strom B. L. Hennessy S. Lazarus R. Brown J. S. , “Design of a National Distributed Health Data Network,” Annals of Internal Medicine 151, no. 5 (2009): 341–344.

Avorn J. Schneeweiss S. , “Managing Drug-Risk Information – What to do With All Those New Numbers,” New-England Journal of Medicine 361, no. 7 (2009): 647–649.