1 See WILLIAM H. HELFAND, QUACK, QUACK, QUACK 14 (2002). Other theories link it to the German word for quicksilver (mercury), on the supposition that it was used to refer to healers, including Paracelsus, who prescribed the heavy metal to their patients. See, e.g., The History of Quackery, Wellness Directory of Minnesota http://www.mnwelldir.org/docs/history/quackery.htm (last visited February 25, 2005). Still others think it refers to someone who touts nostrums by making a noise like a duck. ANN ANDERSON, SNAKE OIL, HUSTLERS AND HAMBONES 7 (2000).

2 See HELFAND, supra note 1, at 13-14.

3 See id. at 14.

4 See ANDERSON, supra note 1, at 29.

5 PAUL STARR, THE SOCIAL TRANSFORMATION OF AMERICAN MEDICINE 96-97 (1982).

6 See ANDERSON, supra note 1, at 29.

7 SUSAN GILBERT, MEDICAL FAKES AND FRAUDS 32 (1989).

8 JAMES HARVEY YOUNG, THE MEDICAL MESSIAHS: A SOCIAL HISTORY OF HEALTH QUACKERY IN TWENTIETH –CENTURY AMERICA 4 (1974).

9 ANDERSON, supra note 1, at 22-23.

10 Id.

11 Id. at 22

12 Id. at 23.

13 Id.

14 Id.

15 See ANDERSON, supra note 1, at 23, 34-35; see also HELFAND, supra note 1, at 34; STARR, supra note 5, at 96-97.

16 See STARR, supra note 5, at 96-97.

17 See ANDERSON, supra note 1, at 34.

18 HELFAND, supra note 1, at 44.

19 See ANDERSON, supra note 1, at 29.

20 HELFAND, supra note 1, at 44 (quoting ROY PORTER, HEALTH FOR SALE 16 (1989)).

21 YOUNG, supra note 8, at 34.

22 Id. at 24.

23 Susan Gilbert attributes the popularity of modern-day quackery to desperation, vanity, laziness, fear of doctors, and deception. See GILBERT, supra note 7, at 42-47. But clearly there are other less pejorative explanations.

24 Jost, Timothy S., Oversight of the Quality of Medical Care: Regulation, Management or the Market?, 37 Ariz. L. Rev. 825, 840 (1995)Google Scholar.

25 James H. Young, Why Quackery Persists, available at http://www.quackwatch.org/01QuackeryRelatedTopics/persistance.html (last visited Dec. 16, 2004). Young believes that the quack's excellent rapport with the patient helps explain why therapeutic failure rarely reduces patient loyalty.

26 See Boozang, Kathleen, Is the Alternative Medicine? Managed Care Apparently Thinks So, 32 Conn. L. Rev. 567, 577-78 (2000)Google Scholar. Managed care expects to save money on surgery and prescription drugs; See John Weeks, Is Alternative Medicine More Cost-Effective?, MEDICAL ECONOMICS, Mar. 20, 2000, at 139.

27 See Smith, Monica & Carber, Lynne, Chiropractic Health Care in Health Professional Shortage Areas in the United States, 92 Am. J. Pub. Health 2001 (Dec. 2002)CrossRefGoogle ScholarPubMed.

28 See HELFAND, supra note 1, at 49 (” … one could obtain a proprietary product anonymously and no one else, including the physician, would ever know”).

29 See Fentiman, Linda C., Internet Pharmacies and the Need for a New Federalism: Protecting Consumers While Increasing Access to Prescription Drugs, 56 Rutgers L. Rev. 119, 122 (2003)Google Scholar; Ausness, Richard C., Will More Aggressive Marketing Practices Lead to Greater Tort Liability for Prescription Drug Manufacturers? 37 Wake Forest L. Rev. 97, 136 (2002)Google Scholar.

30 John Buescher, Spiritualism, DICTIONARY OF UNITARIAN UNIVERSALIST BIOGRAPHY, at http://www.uua.org/uuhs/duub/articles/spiritualism.html (last visited Jan. 28, 2005).

31 See Nobel, Barry, Religious Healing in the Courts: The Liberties and Liabilities of Patients, Parents, and Healers, 16 Puget Sound L. Rev. 599, 608 (1993)Google ScholarPubMed.

32 See Palmer, R.F. et al., A Randomized Trial of the Effects of Remote Intercessory Prayer: Interactions with Personal Beliefs on Problem-Specific Outcomes and Functional Status, 10 J. Alternative & Complimentary Med. 438-48 (2004)CrossRefGoogle ScholarPubMed.

33 See Wilkinson, D.S. et al., The Clinical Effectiveness of Healing Touch, 8 J. Alternative & Complimentary Med. 33–47 (2002)CrossRefGoogle ScholarPubMed.

34 Young describes 19th century patent medicine vendors as follows:

Young, supra note 8, at 21.

35 E.g., H.R. 2085, 108th Cong., (2003).

36 Horwin, Michael E., “War on Cancer”: Why Does the FDA Deny Access to Alternative Cancer Treatments?, 13 Alb. L. J. Sci. & Tech. 681, 695 (2003)Google Scholar.

37 See generally Mariner, Wendy K., Can Consumer-Choice Plans Satisfy Patients?: Problems with Theory and Practice in Health Insurance Contracts, 69 Brook. L. Rev. 485, 495–514 (2004)Google Scholar.

38 Morreim, Haavi, A Dose of Our Own Medicine: Alternative Medicine, Conventional Medicine, and the Standards of Science, 31 J.L. Med. & Ethics 222, 230 (2003)Google ScholarPubMed. As Morreim states:

Id.

39 It has become fashionable, for example, to claim that CAM is enjoying a resurgence. See Boozang, Kathleen M., Western Medicine Opens the Door to Alternative Medicine, 24 Am. J.L. & Med. 185, 194 (1998)Google ScholarPubMed (“The most recent alternative medicine resurgence largely results from a generational pursuit of independence and nonconformity.”); Knoll, Andrew M., The Reawakening of Complementary and Alternative Medicine at the Turn of the Twenty-First Century: Filling the Void in Conventional Biomedicine, 20 J. Contemp. Health L. Pol’Y 329, 335 (2004)Google ScholarPubMed (“[S]ome explanation must be given to justify the resurgence of CAM as more than mere desire for caring without substantive curing.”). Knoll basis his claim on the results of two studies which show an 8 percent increase in the number of respondents between 1993 and 1997 who stated that they used CAM. Id. at 330; Eisenberg, David M. et al., Unconventional Medicine in the United States, 328 New Eng. J. Med. 246, 248 (1993)CrossRefGoogle ScholarPubMed; Eisenberg, David M. et al., Trends in Alternative Medicine Use in the United States, 280 JAMA 1569, 1571 (1998)Google ScholarPubMed, cited in Knoll, supra, at footnotes 2 and 3. A Los Angeles Times Article states that sales of herbal remedies increased 100 percent between 1994 and 1998, and that “historians trace the resurgence of alternatives to the back-to-nature 1960's ….” Monmaney, Terence & Roan, Shari, Hope or Hype?; Alternative Medicine is Edging into the Mainstream, with Californians Leading the Way. The Appeal is Complex, and Debate Rages About its Effectiveness and Scientific Oversight, L.A. TIMES, Aug. 30, 1998Google Scholar, at A1. On the other hand, in an article criticizing Paul Starr's THE SOCIAL TRANSFORMATION OF AMERICAN MEDICINE for overstating the dominance of mainstream medicine, Michael Goldstein argues that what he calls “medical pluralism” has remained “omnipresent over time.” Goldstein, Michael, The Persistence and Resurgence of Medical Pluralism, 29 J. Health Pol. Pol’Y & Law 925, 928 (2004)Google ScholarPubMed. Goldstein adds that “the current usage reflects a pattern among the entire population that has continued for at least the past fifty years.” Id.

40 Ohio, Jacobellis v., 378 U.S. 184, 197 (1964)Google Scholar (Stewart, J., concurring).

41 HOUSE SELECT COMM. ON AGING, SUBCOMMITTEE ON HEALTH AND LONG TERM CARE, QUACKERY: A $10 BILLION SCANDAL, H.R. DOC. NO. 98-262, at 4 (1984).

42 Gilbert, supra note 7, at 15-16.

43 Morreim, supra note 38, at 222.

44 Id. at 223-25.

45 Id. at 225 (citing Bischoff, W.E. et al., Handwashing Compliance by Health Care Workers: The Impact of Introducing an Accessible, Alcohol-Based Hand Antiseptic, 160 Arch. Int. Med. 1017, 1017 (2000)CrossRefGoogle ScholarPubMed). Morreim also asserts that orthodox medicine wastes far more resources than alternative approaches. Id. at 227-28.

46 The exception is a requirement in the administrative rules of West Virginia, pertaining to the content of technical and adult education courses, that students in a course entitled “Trends in Health Care Objectives” will “list four possible indicators of quackery.” W. VA. CODE ST. R. § 126- 44M-4 (2004).

47 Baker v. Haldeman-Julius, 88 P.2d 1065 (Kan. 1939).

48 Id. at 1066.

49 Id. at 1067.

50 Brinkley v. Fishbein, 110 F.2d 62 (5th Cir. 1940).

51 Id. at 64.

52 Hoxsey v. Fishbein, 83 F. Supp. 282 (N.D. Tex. 1949).

53 766 So. 2d 20 (Miss. Ct. App. 2000).

54 Id. at 24, (citing THE AMERICAN HERITAGE COLLEGE DICTIONARY 1116 (3d ed. 1993)).

55 State v. Hoffman, 558 P.2d 602 (Utah 1976).

56 Id. at 603.

57 Id. at 603-04.

58 Id. at 605-06. The court noted that “[t]his type of quackery also prevents people who may be or are in dire need of competent aid by their either delaying or foregoing proper treatment.” Id. at 606.

59 Curley v. State, 16 So. 2d 440, 442 (Fla. 1944).

60 Id. at 441.

61 Id. at 442.

62 Id.

63 Indeed, courts are divided over whether physicians must truthfully inform patients of their level of skill and experience as part of the informed consent process. In Johnson v. Kokemoor, 545 N.W.2d 495 (Wis. 1996), a patient suffering from headaches was referred to a neurologist, who operated on her for an enlarging aneurysm at the bifurcation of the basilar artery. The surgery left the patient an incomplete quadriplegic, unable to walk or control her bowel or bladder functioning and with partial impairment of her vision, speech, and upper body coordination. Prior to the surgery, the patient had questioned the surgeon about his experience, and was told that he had performed the surgery in question “dozens” and “lots” of times. In fact, although he had performed 30 aneurysm surgeries during his residency and 6 since then, he had operated on basilar bifurcation aneurysms only twice, and had never operated on a large basilar bifurcated aneurysm such as the plaintiff’s. The plaintiff contended that the surgeon should have advised her of his limited experience and referred her to a more experienced surgeon, who could have been found at the Mayo Clinic, only 90 miles away. A jury decided in favor of the plaintiff, but an appellate court reversed, stating that a physician had no duty to divulge the extent of his experience to patients. The Supreme Court of Wisconsin reinstated the verdict, holding that “[a] reasonable person in the plaintiff's position would have considered such information material in making an intelligent and informed decision about the surgery.” Id. at 505.

In 2002, the Supreme Court of New Jersey reached a similar result in Howard v. University of Medicine and Dentistry of New Jersey, 800 A.2d 73 (N.J. 2002). A defendant, Robert Heary, who was Professor of Neurosurgery and Director of the UMDNJ's Spine Center of New Jersey, performed surgery to correct the plaintiff's cervical myopathy secondary to cervical stenosis and a significantly large C3-C4 disc herniation. The patient was rendered a quadriplegic. According to the plaintiff, Dr. Heary had said that he was board-certified in neurosurgery and that he had performed 60 corpectomies during the 11 years he had practiced neurosurgery. In fact, Heary was only board-eligible, and he had performed only approximately twenty-four corpectomies. In addition to suing the physician for malpractice, the plaintiff's sought to sue him for fraud and deceit. The Supreme Court of New Jersey declined to permit the plaintiff to pursue the fraud-and-deceit claim, but held that he could proceed on the basis that the physician had failed to obtain his informed consent to the procedure. The court's reasoning includes an illuminating discussion of the difference between intrinsic and extrinsic risks:

Id. at 84-85.

But other cases have rejected this type of claim. In Ditto v. McCurdy, 947 P.2d 952 (Haw. 1997), the Supreme Court of Hawaii ruled that a physician does not have an affirmative duty to disclose his or her qualifications to a patient prior to providing treatment. The plaintiff had been disfigured as a result of breast-augmentation surgery. She claimed, among other things, that the physician, who was certified as a cosmetic surgeon by the American Board of Cosmetic Surgeons, which is not recognized by the American Society of Medical Specialties, had a duty to inform her that he was not boardcertified by the ASMS-recognized American Board of Plastic and Reconstructive Surgeons.

In Duttry v. Patterson, 771 A.2d 1255 (Pa. 2001), a throat cancer patient had questioned the surgeon about how often he had performed the type of surgery he had recommended. The surgeon allegedly told her that he did the procedure approximately once a month. In fact, he had only done it 9 times in the past 5 years. After the patient suffered complications following a rupture at the site of the surgery, she sued, claiming that the physician's misrepresentation deprived her of the ability to give her informed consent. The Supreme Court of Pennsylvania sided with the defendant, holding that “the evidence of a physician's personal characteristics and experience is irrelevant to an informed consent claim.” Importantly, the court added that this conclusion does not change even if the patient specifically asks about the physician's experience.

64 Baker, 88 P.2d at 1067.

65 Hoffman, 558 P.2d at 606.

66 GILBERT, supra note 7, at 19.

67 HOUSE SELECT COMMITTEE ON AGING, supra note 41, at ii (emphasis added).

68 See Brinkley, 110 F.2d at 64; Hoxey, 83 F. Supp. at 282.

69 Brinkley, 110 F.2d at 64; Hoxsey, 83 F. Supp. at 282 (emphasis added). Gilbert states: “Any remedy that lacks proof of its effectiveness is a fake. If the remedy is used to deceive people, it is called a fraud, a term that also describes the practice of this deception. Manufacturing or selling an unproved remedy is quackery.” Gilbert, supra note 7, at 15-16.

70 The precise scienter requirement varies from state to state. Connecticut defines fraud as an untrue statement whose maker knew it to be false. Billington v. Billington, 595 A.2d 1377, 1379 (Conn. 1991). In Ohio, fraud is a “knowing misrepresentation.” Gaines v. Pre-Term Cleveland, Inc. 514 N.E.2d 709, 712 (1987). Pennsylvania defines it as a representation “made falsely, with knowledge of its falsity or recklessness as to whether it is true or false,” Gibbs v. Ernst, 647 A.2d 882, 889 (Pa. 1994), as does Texas. Stone v. Lawyers Title Insurance Co., 554 S.W.2d 183, 185 (1977). Minnesota defines fraud as a false representation that the representer knows to be false, or “assert[s] it as of his own knowledge, without knowing whether it is true or false.” Davis v. Re-Trac Manufacturing Corp., 149 N.W.2d 37, 39 (Minn. 1967). Illinois defines fraud as a false statement that the maker knows or believes to be false. Soules v. General Motors Corp., 402 N.E.2d 599 (Ill. 1980).

71 31 U.S.C. § 3729(a)-(b) (2004).

72 42 U.S.C. § 1320-A-7b (2004).

73 See Blair, Douglas A., The “Knowingly and Willfully” Continuum of the Anti-Kickback Statute's Scienter Requirement: Its Origins, Complexities, and Most Recent Judicial Developments, 8 Ann. Health L. 1 (1999)Google ScholarPubMed.

74 See supra notes 43-45 and accompanying text.

75 STARR, supra note 5, at 97.

76 See Brown v. Shyne, 151 N.E. 197, 200 (N.Y. 1926) (Crane, J., dissenting) (“The theory of the chiropractics is that most, if not all, diseases come from pressure on the nerves caused by vertebra deviating from the normal.”).

77 Fan, Ruiping, Modern Western Science as a Standard for Traditional Chinese Medicine: A Critical Appraisal, 31 J.L. Med. & Ethics 213, 218 (2003)Google ScholarPubMed.

78 Id. at 219.

79 See Acupuncture, NIH Consensus Development Conference Statement (Nov. 5-7, 1997), at http://odp.od.nih.gov/consensus/cons/107/107_statement.htm.

80 Fan, supra note 77, at 219-20.

81 See Cohen, Michael H., Of Rogues and Regulation: A Review of the Role of Complementary and Alternative Medicine: Accommodating Pluralism, 27 Vt. L. Rev. 801, 812Google Scholar (“fraud control’ refers to preventing dangerous and deceptive practices … “).

82 Morreim, supra note 38, at 227.

83 I use the term “relatively” since it is a truism that no medical intervention is completely risk-free.

84 442 U.S. 544 (1979).

85 See id. at 556 (observing that “an otherwise harmless drug can be dangerous to any patient if it does not produce its purported therapeutic effect (citation omitted). But if an individual suffering from a potentially fatal disease rejects conventional therapy in favor of a drug with no demonstrable curative properties, the consequences can be irreversible”). This may explain why none of the definitions of quackery in the case law mentions harm, but focus instead on the idea that quackery provides no benefit to the patient. Rutherford involved efforts by the Food and Drug Administration to prevent the sale of laetrile, a substance made from apricot pits touted for its supposed ability to treat cancer. For a history of the Laetrile controversy, see JAMES HARVEY YOUNG, AMERICAN HEALTH QUACKERY 205-34 (1992). Interestingly, the plaintiffs in the Rutherford case were terminal cancer patients, meaning that they had exhausted conventional remedies. As the District Court noted, “the vast majority of Laetrile patients first underwent the relevant conventional treatments.” Rutherford v. United States, 487 F. Supp. 1287, 1296 (W. D. Okla. 1977), remanded, 582 F.2d 1234 (10th Cir. 1978), rev’d, 442 U.S. 544 (1979).

86 See Morreim, supra note 38, at 222-26; see also supra note 45 and accompanying text.

87 A concept of quackery that focused on the threat of direct or indirect patient harm also would tend to exclude relatively harmless interventions for conditions for which there were no effective treatments.

88 JAMES HARVEY YOUNG, THE HEALTH ROBBERS: A CLOSE LOOK AT QUACKERY IN AMERICA 457 (1993), available at http://www.quackwatch.org/01QuackeryRelatedTopics/persistance.html.

89 For a thorough discussion of the placebo effect, see Boozang, Kathleen, The Therapeutic Placebo: The Case for Patient Deception, 54 Fla. L. Rev. 687 (2002)Google ScholarPubMed. There is a peculiar tendency to consider a placebo effect not to be “real.” In State v. Hoffman, for example, the court complained that “These ill people think they are being cured, when, in fact, they are receiving no real help.” 555 P.2d at 606 (emphasis added). The court does not distinguish between no benefit and a placebo benefit.

90 Hrobjartsson, Asbjorn & Gotzsche, Peter C., Is the Placebo Powerless?: An Analysis of Clinical Trials Comparing Placebo with No Treatment, 344 New Eng. J. Med. 1594 (2001)CrossRefGoogle ScholarPubMed.

91 Hrobjartsson, Asbjorn & Gotzsche, Peter C., Is the Placebo Powerless?: Update of a Systematic Review with 52 New Randomized Trials Comparing Placebo with No Treatment, 256 J. Internal Med. 91 (2004)CrossRefGoogle ScholarPubMed.

92 187 U.S. 94 (1902).

93 Id. at 104.

94 Jurich v. General Motors Corp., 539 S.W.2d 595, 600 (Mo. Ct. App. 1976).

95 See Boozang, supra note 89, at 719-45.

96 Cf. id. at 720 (stating that “even while balking at patient deception, most ethical literature reserves the right to lie under necessary circumstances, including, in the medical context, the administration of placebos”).

97 See NIH Consensus Conference, Helicobacter pylori in Peptic Ulcer Disease, 272 JAMA 65, 68 (1994)Google Scholar (“The discovery of H pylori as a gastrointestinal pathogen [in the 1980s] has had a profound effect on current concepts of the pathogenesis of peptic ulcer disease.”), cited in Noah, Lars, Medicine's Epistemology: Mapping the Haphazard Diffusion of Knowledge in the Biomedical Community, 44 Ariz. L. Rev. 373, 424 n.224 (2002)Google Scholar.

98 See Siwek, Jay, Is a Stomach Ulcer an Infectious Disease?, WASH. POST, Nov. 9, 1993Google Scholar, at Z19. Researchers thought that the bacteria they detected on their slides of stomach tissue was a contaminant.

99 See 21 U.S.C. § 355 (2000); 21 U.S.C. § 360(e) (2000).

100 Gunning v. Cooley, 281 U.S. 90, 95 (1930).

101 See Kessler, David, The Regulation of Investigational Drugs, 320 New Eng. J. Med. 281 (1989)CrossRefGoogle ScholarPubMed.

102 See Dietary Supplement Safety Act: How is FDA Doing 10 Years Later?: Hearing before the Senate Committee on Government Affairs, 108th Cong. (2004) (statement of Ronald Davis, M.D.), available at http://hsgac.senate.gov/index.cfm?Fuseaction=Hearings.Testimony&HearingID=179&WitnessID=642&IsTextOnly=1.

103 21 U.S.C. § 343(r)(6)(2004).

104 Your Guide to the Most Popular Nutritional Supplements and Dietary Supplements, at http://www.nutritional-supplement-info.com (last visited Feb. 23, 2005).

105 See REPORT OF THE COMMISSION ON DIETARY SUPPLEMENT LABELS 2 (1997), available at http://www.health.gov/dietsupp/final.pdf.