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American Journal of Law & Medicine and Harvard Law & Health Care Society

Published online by Cambridge University Press:  01 January 2021

Abstract

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Type
Recent Developments in Health Law
Copyright
Copyright © American Society of Law, Medicine and Ethics 2001

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References

The court in CVS defined fiduciary duty as instances where “one party reposed confidence in another and reasonably relied on the other's superior expertise or knowledge.” See Anonymous v. CVS Corp., New York Law Journal, March 9, 2001, at 19 (N.Y. Sup. Ct. March 5, 2001).Google Scholar
See Riccardi, M.A., “Pharmacies' Customers Win Class Status,” New York Law Journal, April 2, 2001, at 1.Google Scholar
CVS Corporation is a national drugstore chain that operates more than 4,000 stores in twenty-four states. See “New York: Court Rules Pharmacies May Owe Duty Regarding Privacy of Prescription Records,” BNA's Health Law Reporter, 438 (March 15, 2001).Google Scholar
Trio Drugs is a local pharmacy in New York. See Riccardi, supra note 2, at 1.Google Scholar
See Anonymous v. CVS Corp., supra note 1, at 19.Google Scholar
See id. at 20. The statutory obligation is created under N.Y. Comp. Codes R. & Regs. tit. 8, § 29.1(a), (b)(8).Google Scholar
See id. at 19.Google Scholar
Id. The statutory provision that permits pharmacies to sell their records is under N.Y. Educ. § 6812(1).Google Scholar
Pharmacies are required to maintain a patient medical profile for each customer for five years under N.Y. Comp. Codes R. & Regs. tit. 8, § 63.6(b)(7).Google Scholar
See Anonymous v. CVS Corp., supra note 1, at 19.Google Scholar
Id. at 20.Google Scholar
See id. (quoting N.Y. Comp. Codes R. & Regs. tit. 8, § 29.1(a), (b)(8)).Google Scholar
1999 WL 494114 (Mass. Super. Ct. June 29, 1999).Google Scholar
See Spies, A.R., “Recent Legal Cases: A Heads-Up for Pharmacists,” Drug Topics (March 20, 2000): 610, available at <http://dt.pdr.net/public.htm?path=content/journals/d/data/2000/0320/dce03b.html>.Google Scholar
See Weld, 1999 WL 494114, at *1. The program, known as the Patient Compliance Program, was intended to attract customers to try new prescription drugs and remind them to get their refills. It was completely funded by drug manufacturers. The program was terminated in February 1998 due to popular outcry. Id. at *1–2.Google Scholar
See id. at *45 (referencing Mass. Gen. Laws. ch. 214, § 1B).Google Scholar
See id. at *5. Judge Fremont-Smith also pointed to a statute in the Code of Massachusetts Regulations (Mass. Regs. Code tit. 247, § 9.01(19)) that protected patient confidentiality in the hands of pharmacists. Furthermore, the judge specifically emphasized the fact that Elensys had previously provided a similar service for a Maryland pharmacy, prompting the Maryland Board of Pharmacy to issue a warning that prior written waivers must be obtained beforehand from all of the pharmacy's customers before a targeted mailing campaign could commence. Id. at *2 n.9.Google Scholar
231 F.3d 1308, 1314 (11th Cir. 2000). “Pharmacists owe duties to their patients ranging from diligence in recommending medication to confidentiality in maintaining patient's records. …” Id.Google Scholar
The plaintiffs alleged that Rite Aid of Alabama was committing fraud by charging non-insured customers a higher rate than insured customers. Id. at 1310. For a discussion of this case, see “Recent Developments in Health Law,” Journal of Law, Medicine & Ethics, 28, no. 4 (2000):405–6.Google Scholar
231 F.3d at 1314.Google Scholar
See Wight v. Fred Hutchinson Cancer Ctr., No. 01-2-008376 (Wash. Super. Ct. filed March 26, 2001), available at <http://www.sskrplaw.com/gene/wright/complaint1.html>..>Google Scholar
See “Seattle Cancer Care Alliance Summary of Current Arrangements,” at <http://www.fhcrc.org/visitor/hutch_story/scca.html> (last visited June 7, 2001).+(last+visited+June+7,+2001).>Google Scholar
See “Fred Hutchinson Cancer Research Center Summary of Revenues,” available at <http://www.fhcrc.org/response/fy_94-2000.pdf> (last visited June 7, 2001).+(last+visited+June+7,+2001).>Google Scholar
Ko, M., “Stamp to Support Breast Cancer Research,” Seattle Times, July 29, 1998, available at <http://archives.seattletimes.nwsource.com/cgi-bin/texis/web/vortex/display?slug=stmp&date=19980729>.Google Scholar
See “History of the Hutch,” at <http://www.fhcrc.org/visitor/hutch_story/history.html> (last visited June 7, 2001).+(last+visited+June+7,+2001).>Google Scholar
See Wight v. Fred Hutchinson Cancer Ctr., No. 01-2-008376, ¶ 31.Google Scholar
Wilson, and Heath, supra note 6.Google Scholar
See Wright v. Fred Hutchinson Cancer Ctr., No. 01-2-008376, ¶¶ 36, 38, 51.Google Scholar
Id. ¶¶ 1113.Google Scholar
See id. ¶¶ 3335. In January of 1981, one month after submitting Protocol 126 to the Human Subjects Review Committee of the Hutchinson Center, defendant Genetic Systems gave to defendant Hansen 250,000 shares of its stock and an $18,000 consulting fee. In addition, in the same month, Genetic Systems gave defendant Thomas 100,000 shares and a $3,000 per year board position; it also gave defendant Martin 10,000 shares of Genetic Systems stock. Id.Google Scholar
See id.15.Google Scholar
See id.37.Google Scholar
See id. ¶¶ 3940, 53, 73.Google Scholar
See id. ¶¶ 21, 41–42, 63–66, 72, 74–78.Google Scholar
See id. ¶¶ 4748.Google Scholar
See Wilson, and Heath, supra note 6.Google Scholar
See Wight v. Fred Hutchinson Cancer Ctr., No. 01-2-008376, ¶¶ 21, 8085.Google Scholar
Id. ¶¶ 21, 8792. citing 45 C.F.R. §§ 46.116–17 (1991)), 9398. referencing The Belmont Report), 99103 (common law fraud and intentional misrepresentation), 104106. Citing the Washington Health Care Provider Act, Wash. Rev. Code § 7.70.030(1), (2), (3)), 107109 (products liability).Google Scholar
Id. ¶¶ 21, 110112. citing Wash. Rev. Code § 19.86 et seq.).Google Scholar
See National Bioethics Advisory Committee, “Ethical and Policy Issues in Research Involving Human Participants” (May 18, 2001), available at <http://bioethics.gov/press/finalrecomm5-18.html>..>Google Scholar
Planned Parenthood of the Columbia/Willamette Inc. v. American Coalition of Life Activists, 244 F.3d 1007, 1019 (9th Cir. 2001).Google Scholar
See id. at 1017.Google Scholar
See id. at 1018.Google Scholar
Roe v. Wade, 410 U.S. 113 (1973).Google Scholar
Planned Parenthood, 244 F.3d at 1012.Google Scholar
See id. at 1012–13.Google Scholar
Id. at 1013 n.3. referencing Planned Parenthood of the Columbia/Willamette Inc. v. American Coalition of Life Activists, 41 F. Supp. 2d 1130, 1152 (D. Or. 1999)).Google Scholar
See id. at 1013.Google Scholar
NAACP v. Claiborne Hardware Co., 458 U.S. 886, 929 (1982).Google Scholar
Planned Parenthood, 244 F.3d at 1014–15.Google Scholar
See id. at 1015.Google Scholar
See id. at 1016–17.Google Scholar
See id. at 1017–18.Google Scholar
See id at 1018.Google Scholar
See id. at 1018–19.Google Scholar
Buckman Co. v. Plaintiffs' Legal Committee, 121 S. Ct. 1012 (U.S. 2001).Google Scholar
See id. at 1015. citing the Federal Food, Drug, and Cosmetic Act (FDCA), 52 Stat. 1040, as amended by the Medical Device Amendments of 1976 (MDA), 90 Stat. 539, 21 U.S.C. § 301 (1994 ed. and Supp. IV)).Google Scholar
Id. at 1018.Google Scholar
Id. at 1020–21.Google Scholar
Under FDCA § 510(k), medical devices may be authorized for sale if they are substantially equivalent to a device already on the market. The 510(k) process is less rigorous than the pre-market approval process required for devices that are new. See id. at 1016–17. referencing 21 U.S.C. § 360e(b)(1)(B).Google Scholar
See In re Orthopedic Bone Screw Products Liability Litigation, 159 F.3d 817, 820 (3d Cir. 1998).Google Scholar
See Buckman, 121 S. Ct. at 1015.Google Scholar
See In re Orthopedic Bone Screw Products Liability Litigation, 1998 U.S. Dist. LEXIS 17656 (E.D. Pa. Nov. 3, 1998).Google Scholar
In re Orthopedic Bone Screw Products Liability Litigation, 159 F.3d at 820.Google Scholar
Medtronic Inc. v. Lohr, 518 U.S. 470 (1996).Google Scholar
See Buckman, 121 S. Ct. at 1017.Google Scholar
“Off-label use” is the “use of a [medical] device for some other purpose than that for which it has been approved by the FDA.” Id. at 1018.Google Scholar
Id. citing Beck, J.M. and Azari, E.D., “FDA, Off-Label Use, and Informed Consent: Debunking Myths and Misconceptions,” Food & Drug Law Journal, 53 (1998): 71, 76–77, for the fact that courts, some states, and the FDA “recognize the value and propriety of off-label use”).Google Scholar
See id. at 1019.Google Scholar
Id. at 1020. referencing Medtronic Inc. v. Lohr, 518 U.S. 470 (1996)).Google Scholar
Geier v. American Honda Motor Co., Inc., 120 S. Ct. 1913(2000).Google Scholar
Beck, J.M., “Pre-empting a State Tort Flood,” Corporate Counsel (January 9, 2001), available at <http://www.law.com/us_supreme_ct/commentary.html>.Google Scholar
42 U.S.C. § 1395dd (1994).Google Scholar
Roberts v. Galen of Virginia, Inc., No. 93-0544L-S, jury verdict (W.D. Ky. Feb. 22, 2001).Google Scholar
Roberts v. Galen of Virginia, Inc., 112 F. Supp. 2d 638, 638–39 (W.D. Ky. 2000).Google Scholar
EMTALA was enacted in 1986 as part of the Consolidated Omnibus Budget Reconciliation Act (COBRA), 42 U.S.C. § 1395dd.Google Scholar
See 42 U.S.C. § 1395dd.Google Scholar
See Scaduto, L.H., “The Emergency Medical Treatment and Active Labor Act Gone Astray: A Proposal to Reclaim EMTALA for Its Intended Beneficiaries,” UCLA Law Review, 46 (1999): 943–82.Google Scholar
See Thornton v. Southwest Detroit Hospital, 895 F.2d 1131 (6th Cir. 1990) (rejecting the defendant hospital's argument that its duty under EMTALA ended on a patient's admittance to the hospital).Google Scholar
See, e.g., Reynolds v. MaineGeneral Health, 218 F.3d 78 (1st Cir. 2000) (no duty to screen emergency patient for emergency medical conditions after patient has received initial screening and treatment for traumatic injuries).Google Scholar
Roberts v. Galen of Virginia, Inc., 111 F.3d 405 (6th Cir. 1997).Google Scholar
Roberts v. Galen of Virginia, Inc., 119 S. Ct. 685 (1999).Google Scholar
See Roberts, 112 F. Supp. 2d at 639.Google Scholar
See Roberts, 111 F.3d at 408 n.1. (citing Thornton, 895 F.2d at 1134).Google Scholar
“Respondents argue that the record demonstrates that … the hospital properly screened Johnson, which terminated its duty under EMTALA. We express no opinion as to the factual correctness or legal dispositiveness of these claims, and leave their resolution to the courts below on remand.” Roberts, 119 S. Ct. at 687 n.2.Google Scholar
“EMTALA: Federal Jury Exonerates Kentucky Hospital of EMTALA Violation in Patient Transfer Case,” BNA's Health Law Reporter, 10 (2001): 365. The U.S. Court of Appeals for the Sixth Circuit has found that “EMTALA specifically restricts ‘transfers’ of unstable patients from hospitals.” See Roberts, 112 F. Supp. 2d at 640. (citing EMTALA, 42 U.S.C. § 1395dd(c)). “EMTALA defines ‘transfer’ as … ‘the movement (including the discharge) of an individual outside a hospital's facilities at the direction of any person employed by (or affiliated or associated, directly or indirectly, with) the hospital.’” See id. quoting EMTALA, 42 U.S.C. § 1395dd(e)(4).Google Scholar
See “EMTALA: Federal Jury Exonerates Kentucky Hospital of EMTALA Violation in Patient Transfer Case,” supra note 14.Google Scholar
See Roberts, 119 S. Ct. at 686–87.Google Scholar
Ingram v. Muskogee Regional Medical Center, 235 F.3d 550 (10th Cir. 2000).Google Scholar
42 U.S.C. § 1395dd (1994).Google Scholar
See Ingram, 235 F.3d at 550–51.Google Scholar
See id. at 552. (citing 42 U.S.C. § 1395dd(c)(1)(B) and quoting § 1395dd(c)(2).Google Scholar
See id. at 551.Google Scholar
See id. at 552.Google Scholar
Repp v. Anadarko Municipal Hospital, 43 F.3d 519, 522 (10th Cir. 1994).Google Scholar
See Ingram, 235 F.3d at 552. (citing Repp, 43 F.3d at 522.Google Scholar
Oleszko v. State Compensation Insurance Fund, 243 F.3d 1154 (9th Cir. 2001).Google Scholar
Id. at 1155.Google Scholar
Jaffee v. Redmond, 518 U.S. 1 (1996).Google Scholar
See Oleszko, 243 F.3d at 1155.Google Scholar
See id. at 1156. (quoting Jaffee, 518 U.S. at 15.Google Scholar
Id. at 1156–57. (citing Jaffee, 518 U.S. at 18.Google Scholar
See id. at 1157.Google Scholar
Id. at 1157–58.Google Scholar
Id. at 1158.Google Scholar
Association of Washington Public Hospital Districts v. Philip Morris, Inc., 241 F.3d 696 (9th Cir. 2001).Google Scholar
See id. at 700. (referencing Association of Washington Public Hospital Districts v. Philip Morris, Inc., 79 F. Supp. 2d 1219 (WD. Wash. 1999)).Google Scholar
See id. at 700–1.Google Scholar
See id. at 700.Google Scholar
See Oregon Laborers-Employers Health & Welfare Trust Fund v. Philip Morris, Inc., 185 F.3d 957 (9th Cir. 1999) (holding that the trust's antitrust, RICO, and state common law claims against tobacco firms for conspiracy failed because the injuries were not proximately caused by the defendants' wrongdoing).Google Scholar
See Association of Washington Public Hospital Districts, 241 F.3d at 701. (citing Section 4 of the Clayton Act, 15 U.S.C. § 15 (federal antitrust). 18 U.S.C. § 1964(c) (RICO).Google Scholar
See id. at 701–2. (citing Holmes v. Securities Investor Protection Corp., 503 U.S. 258, 269–70 (1992). Associated General Contractors of California, Inc. v. California State Council of Carpenters, 459 U.S. 519, 545 (1983)).Google Scholar
See id. at 703.Google Scholar
See id. at 704.Google Scholar
See id. at 704–5. (quoting Bhan v. NME Hospitals, Inc., 772 F.2d 1467, 1470 (9th Cir. 1985)).Google Scholar
See id. at 705. (quoting American Ad Management, Inc. v. General Telephone Co., 190 F.3d 1051, 1057 (9th Cir. 1999)).Google Scholar
See Washington Consumer Protection Act, Wash. Rev. Code Ann. §§ 19.86.020, 19.86.030.Google Scholar
See Association of Washington Public Hospital Districts, 241 F.3d at 705. (citing Wash. Rev. Code Ann. §19.86.090. Washington State Physicians Insurance Exchange & Association v. Fisons Corp., 858 P.2d 1054, 1060 (Wash. 1993)).Google Scholar
See id. at 706.Google Scholar
See id. at 706–7.Google Scholar
Beville v. Curry, No. 88330, 2001 WL 38680 (Okla. Jan. 16, 2001).Google Scholar
Id. at *1. This action was brought under Combinations in Restraint of Trade and Unfair Discrimination or Competition, Okla. Stat. tit. 79, § 1 et seq. (1991). Id. at *10 n.1. These statutes were repealed in 1998 and replaced by the Oklahoma Antitrust Reform Act, Okla. Stat. tit. 79, § 201 et seq. (1998). id.Google Scholar
Id. at *1.Google Scholar
Teleradiology is a method of practicing radiology from a distance where either a patient or X-ray is submitted from a distance to the radiologist for interpretation.Google Scholar
Id. at *2.Google Scholar
Id. at *1.Google Scholar
Id. at *2.Google Scholar
Id. at *4.Google Scholar
Id. at *7.Google Scholar
Id. at *5.Google Scholar
Id. at *6.Google Scholar
Id. at *4.Google Scholar
Id. at *6. (citing Retina Associations, P.A. v. Southern Baptist Hospital of Florida, Inc., 105 F.3d 1376 (11th Cir. 1997)).Google Scholar
Id. at *7.Google Scholar
Renaldi v. Sears Roebuck & Co., No. 97-C6057, 2001 U.S. Dist. LEXIS 3536, at *5 (N.D. Ill. Mar. 21, 2001).Google Scholar
See id. at *7.Google Scholar
See id. at *89.Google Scholar
See id. at *1415.Google Scholar
See id. at *8.Google Scholar
See id. at *1819.Google Scholar
See id. at *2425.Google Scholar
29 U.S.C. § 1001 et seq.Google Scholar
See Renaldi, 2001 U.S. Dist. LEXIS 3536, at *3132.Google Scholar
See id. at *33. If a health-care plan administrator has “discretionary authority to determine eligibility for benefits or to construe the terms of the plan,” then that administrator's decisions are not reviewed de novo. Id. at *3233. (quoting Firestone Tire & Rubber Co. v. Bruch, 489 U.S. 101, 103 (1989). Instead, a court is restricted to deciding whether the decision was “arbitrary and capricious.” Id. at *33. (referencing Russo v. Health, Welfare & Pension Fund, 984 F.2d 762, 765–66 (7th Cir. 1993)).Google Scholar
See id. at *3738.Google Scholar
See id. at *61.Google Scholar
See id. at *47.Google Scholar
See id. *4748.Google Scholar
See id. at *53.Google Scholar
See id. at *58.Google Scholar
See id. at *61.Google Scholar
No. 99C5806, 2001 WL 303692, at *1(N.D. Ill. Mar. 28, 2001).Google Scholar
31 U.S.C. §§ 3729–33.Google Scholar
See Obert-Hong, 2001 WL 303692, at *1.Google Scholar
42 U.S.C. §§ 1320a-7(b).Google Scholar
42 U.S.C. § 1395nn.Google Scholar
See Obert-Hong, 2001 WL 303692, at *1.Google Scholar
See id. at *2.Google Scholar
See id. (quoting Fed. R. Civ. P. 9(b).Google Scholar
See id. (quoting Bankers Trust Co. v. Old World Republic Insurance Co., 959 F.2d 677, 683 (7th Cir. 1992)).Google Scholar
See id. at *3.Google Scholar