¹ Relentless Virus, BOSTON GLOBE, Dec. 1, 1995, at 26.

² C. Everett Koop, A Do-it-Yourself AIDS Test, USA TODAY, June 22, 1994, at 13A.

³ Lauran Neergaard, U.S. to Consider Use of Home AIDS Tests, DETROIT FREE PRESS, June 21, 1994, at 5A.

⁴ Warren E. Leary, Government Panel Hears Call for Expanded AIDS Testing, N.Y. TIMES, June 23, 1994, at A18.

⁵ 42 U.S.C. § 300x-24, 300ff-61 (Supp. 1993); Marlene Cimons, FDA Panel Reopens Debate on Home HIV Test Kits, L.A. TIMES, June 23, 1994, at A10; Neergaard, supra note 3, at 5A.

⁶ See generally Gostin, Larry O., Public Health Strategies for Confronting AIDS: Legislative and Regulatory Policy in the Unites States, 261 JAMA 1621 (1989)Google Scholar [hereinafter Gostin, Public Health Strategies].

⁷ Id. at 1622, 1624.

⁸ Id. at 1622, 1626.

⁹ See, e.g., K.Y. REV. STAT. ANN. § 214.181 (Michie 1991); VA. CODE ANN. § 32.1-37.2 (Michie 1992).

¹⁰ Food and Drug Administration, Blood Products Advisory Committee, Center for Biologies Valuation and Research, 44th Meeting, June 22, 1994, at 117 [hereinafter Blood Products Advisory Committee Meeting].

¹¹ Epitote's Saliva-Based AIDS Screen Reduces False Positive Results, 15 MEDICAL DEVICES, DIAGNOSTICS & INSTRUMENTATION REP.: GRAY SHEET (F-D-C Rep., Ina) 9 (Apr. 10, 1989) [hereinafter Epitote's Saliva-Based AIDS Screen]. The FDA said it would consider only tests labeled for professional use. Id.

¹² Laura Beil, Idea of Home AIDS Test Creates Concern About Counseling, DALLAS MORNING NEWS, Oct. 23, 1994, at 11A (FDA's deputy commissioner says that home testing would be acceptable as long as test was properly designed); Home-Use HIV Sample Collection System Pilot Studies Recommended, 20 MEDICAL DEVICES, DIAGNOSTICS & INSTRUMENTATION REP.: GRAY SHEET (F-D-C Rep., Inc.) 6 (June 27, 1994) [hereinafter Home-Use HIV] (many panel members see “home … testing as … [an] inevitable development“); Glenn R. Simpson, Gingrich Aided Pharmaceutical Firm that Later Contributed to Foundation, ROLL CALL, Jan. 5, 1995, at 1, 26. If approved, home tests might be available within twelve months. Laurie Garrett, Panel Asks OK on Home AIDS Test HIV Detector Could Be on Market Within Year, NEWSDAY, June 23, 1994, at A7.

¹³ Home-Use HIV, supra note 12, at 6.

¹⁴ Home Specimen Collection Kit Systems Intended for Human Immunodeficiency Virus (HIV- 1 and/or HIV-2) Antibody Testing; Revision to Previous Guidance, 60 Fed. Reg. 10087 (1995) (proposed Feb. 23, 1995) [hereinafter Home Specimen Collection Kit].

¹⁵ Ann E. Tergesen, Johnson HIV Test Under Fire; AIDS Groups File Protest with Feds, RECORD (Bergen Co., N.J.), Nov. 10, 1994, at Dl. Additional similar tests are in the pipeline, including ones by Anonymous Test Services and Coonan Clinical Laboratories. Anonymous Test Services’ Home HIV Testing System, 20 MEDICAL DEVICES, DIAGNOSTICS & INSTRUMENTATION REP.: GRAY SHEET (F-D-C Rep., Inc.) 12-13 (Nov. 21, 1994).

¹⁶ Hanna Rosin, Bad Blood: AIDS Activists vs. the HIV Home Test, NEW REPUBLIC, June 27, 1994, at 12.

¹⁷ FDA Debates Home Test for AIDS, AIDS WKLY., July 4, 1994, at 6.

¹⁸ Id. The test in essence is not a home HIV test but a home collection kit. The user collects the blood sample and the laboratory tests the sample. Cimons, supra note 5, at A10. This Note does not address home tests that would allow the test taker to perform the test on the sample at home.

¹⁹ Id.

²⁰ FDA Debates Home Test for AIDS, supra note 17, at 6.

²¹ Id.

²² Bayer, Ronald et al., Testing for HIV Infection at Home, 332 NEW ENG. J. MED. 1296, 1296 (1995)Google Scholar.

²³ John Schwartz, FDA Panel Considers Home Test for HIV, WASH. POST, June 23, 1994, at A10; see also Cimons, supra note 5, at A10.

²⁴ Simpson, supra note 12, at 26.

²⁵ See Home Specimen Collection Kit, supra note 14.

²⁶ Epilote 's Saliva-Based AIDS Screen, supra note 11, at 9.

²⁷ Rosin, supra note 16, at 12; Fran Pollner, FDA Ban on Home Kits Debated, MED. WORLD NEWS, May 8, 1989, at 46, 46.

²⁸ See Debra J. Sanders, Counseling or Death, S.F. CHRON., June 27, 1994, at A19.

²⁹ Bayer, supra note 22, at 1297.

³⁰ Rosin, supra note 16, at 12.

³¹ Bayer, supra note 22, at 1297.

³² Neergaard, supra note 3, at 5A.

³³ MARY E. HOMBS, AIDS CRISIS IN AMERICA 8 (1992).

³⁴ Id. at 7.

³⁵ Helena Brett-Smith & Gerald H. Friedland, Transmission and Treatment, in AIDS LAW TODAY: A NEW GUIDE FOR THE PUBLIC 18, 40 (Scott Burris et al. eds., 1993).

³⁶ Gina Kolata, Discovery That AIDS Can Be Prevented in Babies Raises Debate on Mandatory Testing, N.Y. TIMES, NOV. 3, 1994, at B14 (reporting that transmission rate with AZT use is 8.3% while the rate without its use is 25.5%).

³⁷ Frerichs, Ralph R. & Seymour, Eugene, More on Office-Based Testing for HIV, 328 NEW ENG. J. MED. 1717, 1717 (1993)Google Scholar. Other estimates have placed the reduction of risk at 95 to 99%. Frerichs, Ralph R., Personal Screening for HIV in Developing Countries, 343 LANCET 960, 960 (1994)Google Scholar. A time lapse does exist where HIV infection is not picked up by HIV antibody testing. This window usually lasts four to six weeks and at least 95% of infections will show up within six months. Brett-Smith & Friedland, supra note 35, at 32.

³⁸ Frerichs, supra note 37, at 960. It must be noted that condoms provide protection on a continual basis, while the home test would provide protection as long as the partners remained monogamous.

³⁹ FDA Debates Home Test for AIDS, supra note 17, at 6.

⁴⁰ Id.

⁴¹ Rosin, supra note 16, at 12.

⁴² See Blood Products Advisory Committee Meeting, supra note 10, at 141, 234.

⁴³ Rosin, supra note 16, at 12.

⁴⁴ Peter Freiburg, Psychologists Wary of AIDS Home Test, APA MONITOR, Mar. 1995, at 34.

⁴⁵ Judy Mann, In the Privacy of Your Own Home, WASH. POST, Apr. 22, 1994, at E3.

⁴⁶ After hearing his results, a man jumped off the Golden Gate Bridge. Rosin, supra note 16, at 12; Gostin, Public Health Strategies, supra note 6, at 1621, 1624 (increased risk of suicide exists with HIV-positive blood test).

⁴⁷ See Hamil R. Harris, Medical Groups, AIDS Activists Assail At-Home Testing, WASH. POST, Apr. 9, 1994, at Gl, G5.

⁴⁸ See Blood Products Advisory Committee Meeting, supra note 10, at 215, 218, 288.

⁴⁹ The risk of suicide appears to be related to the appearance of symptoms, not the notification of HIV infection. Bayer, supra note 22, at 1297.

⁵⁰ Sources say the predictive value of a positive HIV test is approximately 50%. Frerichs & Seymour, supra note 37, at 1717. Others indicate the risk of a false positive is much smaller, With true positives occurring somewhere between 99 and 99.9% of the time. Enel, Patricia et al., Ethical Confusion: Detection of HIV Seropositives, 7 AIDS & PUB. POL'Y J. 42, 43 (1991)Google Scholar.

⁵¹ Frerichs & Seymour, supra note 37, at 1717.

⁵² See Richard A. Knox, Awareness of AIDS Low, Expert Warns, BOSTON GLOBE, Jan. 31, 1995, at 1, 36; Brett-Smith & Friedland, supra note 35, at 40.

⁵³ Rosin, supra note 16, at 12.

⁵⁴ Elaine Herscher, New Home Test for AIDS Stirs Old Controversies, S.F. CHRON., Dec. 18, 1994, at S1, S4; Freiburg, supra note 44, at 34. Other statistics indicate that only 14% of those who find out that they are HIV-positive receive any counseling at all. Schwartz, supra note 23, at A17.

⁵⁵ Home AIDS Test Debated, FOOD & DRUG LETTER (Wash. Bus. Information, Inc., Arlington, Va.) No. 342, June 23, 1989, at 3. Phone counseling has also been used for crises such as accidental poisoning and heart attacks. Home AIDS Test Kits Should Be Available Over the Counter, 51 PRESCRIPTION & OTC PHARMACEUTICALS: THE PINK SHEET (F-D-C Rep., Inc.) 6, 7 (May l, 1989).

⁵⁶ Home AIDS Test Debated, supra note 55, at 3.

⁵⁷ Blood Products Advisory Committee Meeting, supra note 10, at 189.

⁵⁸ Rosin, supra note 16, at 12.

⁵⁹ Id.

⁶⁰ Freiburg, supra note 44, at 34.

⁶¹ Rosin, supra note 16, at 12.

⁶² Home AIDS Test Kits Could Be Available Over the Counter, 15 MEDICAL DEVICES, DIAGNOSTICS & INSTRUMENTATION REP.: GRAY SHEET (F-D-C Rep., Inc.) 1 (May 1, 1989).

⁶³ Studies have shown that more people receive their test results when phone notification was an option, when compared to situations where face-to-face notification was the only option. Blood Product Advisory Committee Meeting, supra note 10, at 138.

⁶⁴ Rosin, supra note 16, at 12.

⁶⁵ Blood Product Advisory Committee Meeting, supra note 10, at 214.

⁶⁶ See Mark A. Hoffman, HIV Coverage Rules Set, BUS. INS., Oct. 16, 1995, at 2.

⁶⁷ All states currently allow insurers to test for HIV. Christensen, Burke A., AIDS and Life Insurance: A Brief History, [vol. 134] TRUSTS & ESTATES, Sept. 1995Google Scholar, at 89, 89. Currently, only five states have some sort of restriction on group health and life HIV testing. Jim Connolly, N.J. Proposes HIV Testing for Group Ins., NATIONAL UNDERWRITER: LIFE & HEALTH/FIN. SERVS. ED., Oct. 9, 1995, at 22.

⁶⁸ Current testing can cost up to $75. Government Reviews HIV Tests, AIDS WKLY., Mar. 28, 1994, at 9, 9. Home tests would cost between $30 and $40. Home-Use HIV, supra note 12, at 8.

⁶⁹ CAL. HEALTH & SAFETY CODE § 199.47(a) (West Supp. 1995) (average cost per patient lifetime is $150,000). The annual cost of care for an adult with AIDS in 1990-1991 was estimated at $32,000. Mann, Jonathan et al., Towards a New Health Strategy to Control HIV/AIDS Pandemic, 22 J.L. MED. & ETHICS 41, 46 (1994)Google Scholar.

⁷⁰ See infra text accompanying note 79.

⁷¹ Bayer, supra note 22, at 1299.

⁷² Failure to produce direct evidence that the employer fired the employee because of his or her disability is not fatal to employee's claim under the Americans with Disabilities Act (ADA). Finley v. Cowles Bus. Media, No. 93 Civ. 5051 (PKL), 1994 U.S. Dist. LEXIS 8205, at *10 (S.D.N.V. June 20, 1994) (not reported in F. Supp.).

⁷³ See, e.g., ALA. CODE § 22-11A-51 (Michie Supp. 1994); ARIZ. REV. STAT. ANN. § 36-663 (1993); N.Y. PUB. HEALTH LAW § 2781 (McKinney 1993); FLA. STAT. ANN. § 381.004 (West 1993).

⁷⁴ Doe v. Equifax, CIV. A. No. 88-3872, 1989 WL 57348 (E.D. Pa. May 26, 1989) (informed consent in Pennsylvania applies only to doctors).

⁷⁵ Pub. L. No. 101-336, 104 Stat. 327 (codified as amended in scattered sections of tits. 29, 42, & 47 U.S.C.).

⁷⁶ Employer is defined as “a person engaged in an industry affecting commerce who has fifteen or more employees for each working day in each of twenty or more calendar weeks in the current or preceding calendar year, or any agent of such person.” 42 U.S.C. § 12111(5)(A).

⁷⁷ Id. § 12112(a).

⁷⁸ SENATE COMM. ON LABOR AND HUMAN RESOURCES, AMERICANS WITH DISABILITIES ACT OF 1989, S. REP.NO. 116, 101st Cong., 1st Sess. 22 (1989).

⁷⁹ 42 U.S.C. § 12112(d)(3).

⁸⁰ Id. § 12112(d)(4)(A).

⁸¹ Punitive damages are available if the plaintiff demonstrates that the defendant engaged in a discriminatory practice with malice or with reckless indifference to the plaintiffs federally protected rights. 42 U.S.C. § 1981a(b)(l).

⁸² An employer who carries the risk of an insurance group, instead of an insurance company, is a self-insured employer. Nearly one-half of firms with over 100 workers are self-insured. Inside the Beltway, WASH. HEALTH WK., Aug. 7, 1995, available in LEXIS, News Library, CURNWS File.

⁸³ 29 U.S.C.A. §§ 1002-1003 (West 1995).

⁸⁴ McGann v. H & H Music Co., 946 F.2d 401, 408 (5th Cir. 1991).

⁸⁵ Id. at 404.

⁸⁶ Id. at 408.

⁸⁷ See Carparts Distribution Ctr., Inc. v. Automotive Wholesaler's Ass'n, Inc., 37 F.3d 12, 16 (1st Cir. 1994); see also Karen Donovan, Health Fund Held Subject to ADA in AIDS Exemption, NAT'L L.J., Dec. 6, 1993, at 17 (discussing denial of summary judgment motion in Mason Tenders Dist. Council Welfare Fund v. Donaghey, 93 Civ. 1154).

⁸⁸ Carparts, 37 F.3d at 16.

⁸⁹ Donovan, supra note 87, at 22 (Section 501 of the ADA requires that the elimination of benefits was not a subterfuge); Palmer, Lizzette, Comment, ERISA Preemption and its Effects on Capping the Health Benefits of Individuals with AIDS: A Demonstration of Why the United States Health and Insurance Systems Require Substantial Reform, 30 Hous. L. REV. 1347, 1377 (1993)Google Scholar. Subterfuge is a disability-based disparate treatment not justified by the risks or cost associated with the disability. Id. at 1379.

⁹⁰ See Donovan, supra note 87, at 22; Palmer, supra note 89, at 1380.

⁹¹ Palmer, supra note 89, at 1380.

⁹² Id. at 1379-80.

⁹³ Donovan, supra note 87, at 22 (according to Christopher Bell, a former EEOC lawyer). A fair amount of data indicates no economic basis exists for excluding HIV when providing health benefits. New Jersey Proposes Rules Allowing HIV Testing of Insurance Applicants, Pens. & Ben. Daily (BNA) (Oct. 18, 1995), available in WESTLAW, BNA-PBD Database.

⁹⁴ Schwartz, supra note 23, at A10.

⁹⁵ Id.; see also Rosin, supra note 16, at 12.

⁹⁶ Id. For example, AIDS is the principle cause of death for Hispanic women between the ages of 25 and 34 in New York and New Jersey. 140 CONG. REC. E1917, E1918 (daily ed. Sept. 22, 1994) (statement of Rep. Valazquez); Hispanic-Americans make up approximately nine percent of the country's population yet account for over sixteen percent of all AIDS cases. Browning, Graeme, A Bold Step into the AIDS Debate, 26 NAT'L J. 2053, 2053 (1994)Google Scholar. The sources that refer to the infection rate among minorities do not define the term minorities.

⁹⁷ Schwartz, supra note 23, at A17; Rosin, supra note 16, at 12.

⁹⁸ Harris, supra note 47, at G5.

⁹⁹ Herscher, supra note 54, at S4. Investigators have found young males from minority groups to be among those who regard the home test most favorably. Karen Klinger, Surveys: Many Would Use Home AIDS Test, UPI, May 10, 1995, available in LEXIS, Nexis Library, UPI File.

¹⁰⁰ Harris, supra note 47, at G5; Gary Blonston, Committee Weighs Home HIV Test Kit, PHILA. INQ., June 23, 1994, at A2 (minorities alienated from an intimidating medical establishment).

¹⁰¹ Rosin, supra note 16, at 12.

¹⁰² A link between societal discrimination and vulnerability to AIDS has been established. Societal discrimination undermines the ability of people to have access to information and services. Thus, it is critical to HIV/AIDS prevention to promote the individual capacity to learn about and respond to AIDS. See Mann et al., supra note 69, at 49. The home HIV test would enable those who are discriminated against to gain access to information about HIV and their status in particular.

¹⁰³ Home AIDS Test Debated, supra note 55, at 2-4.

¹⁰⁴ Id.; Larry Gostin, Traditional Public Health Strategies, in AIDS LAW TODAY: A NEW GUIDE FOR THE PUBLIC, supra note 35, at 59, 71-72 [hereinafter Gostin, Traditional Public Health Strategies]. The CDC supports and funds states in conducting HIV reporting. Blood Products Advisory Committee Meeting, supra note 10, at 141.

¹⁰⁵ Frerichs & Seymour, supra note 37, at 1717.

¹⁰⁶ The CDC advocates for states and manufacturers to agree on terms under which summary data can be provided to the states. Blood Products Advisory Committee Meeting, supra note 10, at 142.

¹⁰⁷ Incidences could only be reported to state public health departments if the home state of the user was asked.

¹⁰⁸ Home-Use HIV, supra note 12, at 7 ('“introduction of alternatives will not lower standards' of HIV testing“).

¹⁰⁹ Rosin, supra note 16, at 12; see Home AIDS Test Debated, supra note 55, at 1 (test uses Elisha and Western Blot testing methods).

¹¹⁰ Home HIV Test Debated, supra note 55, at 3-4.

¹¹¹ Over-the-Counter HIV Home Test Kits May Receive FDA Approval within a Year, 9 AIDS ALERT 105, 105 (1994); Home AIDS Testing Would Be Inappropriate Public Health Practice, 15 MEDICAL DEVICES, DIAGNOSTICS & INSTRUMENTATION REP.: GRAY SHEET (F-D-C Rep., Inc.) 8 (Apr. 10, 1989).

¹¹² Home HIV Test Debated, supra note 55, at 4.

¹¹³ At least one company, Home Access, has indicated it plans to make counselors available to users before they start the test. Marianne Taylor, Firms Race for OK on Home HIV Test, CHI. TRIB., June 2, 1995, § 3 (Business), at 3.

¹¹⁴ See Frerichs & Seymour, supra note 37, at 1717.

¹¹⁵ See supra text accompanying notes 29-31.

¹¹⁶ Blood Products Advisory Committee Meeting, supra note 10, at 129, 145.

¹¹⁷ Id. at 200.

¹¹⁸ Strama, Brenda T., The AIDS Epidemic & Local Government Liability, in AIDS AND GOVERNMENT LIABILITY 3 (BrendaT. Strama ed., 1993)Google Scholar.

¹¹⁹ See, e.g., “Before any HIV test is performed “ ALA. CODE § 22-11A-51 (Michie Supp. 1994) (emphasis added); “[N]o person may order the performance of an HIV-related test … .“ ARIZ. REV. STAT. ANN. § 36-663(A) (1993) (emphasis added); “No person in this state shall perform a test designed to identify the human immunodeficiency virus or its antigen or antibody … .” FLA. STAT. ANN. § 381.004(3)(a) (West 1993) (emphasis added); “[N]o person shall order the performance of an HIV related test “ N.Y. PUB. HEALTH LAW § 2781(1) (McKinney 1993) (emphasis added).

¹²⁰ Some doctors in Colorado have argued that home HIV tests could not be legally marketed in the state. Colorado law requires HIV testing to be done with knowledge and consent, and home tests may possibly be used to test people without their consent. Home HIV Test Would Be Illegal in Colorado, COLO. SPRINGS GAZETTE TELEGRAPH, Feb. 9, 1995, at B4. The Colorado state Health Department and the AIDS council have yet to take a position on home HIV tests. Id. It could be argued that a home test company only violates an informed consent statute if it knowingly violates the statute, which it never does because it is at most unaware if it is testing without consent.

¹²¹ Gostin, Traditional Public Health Strategies, supra note 104, at 72.

¹²² Troyen A. Brennan, Patients and Health Care Workers, in AIDS LAW TODAY: A NEW GUIDE FOR THE PUBLIC, supra note 35, at 377, 392.

¹²³ Id.

¹²⁴ See supra text accompanying notes 103-05.

¹²⁵ Brennan, supra note 122, at 392. Additionally, the CDC recommends that anonymous testing and counseling be available. CDC Stresses Anonymous Testing to Clarify Federal Guidelines, AIDS POL'Y & L., Mar. 5, 1993, at 6, 6.

¹²⁶ See, e.g., FLA. STAT. ANN. § 381.004(3)(e) (West 1993); K.Y. REV. STAT. ANN. § 214.181(7)(g) (Michie 1991); 35 PA. CONS. STAT. § 7605(e)(1) (1993); VA. CODE ANN. § 32.1- 37.2(B) (Michie 1992).

¹²⁷ See supra text accompanying notes 61-64.

¹²⁸ 21 U.S.C.A. § 360k (West Supp. 1995).

¹²⁹ “[T]he Laws of the United States which shall be made in Pursuance thereof… shall be the supreme Law of the Land … any Thing in the Constitution or Laws of any State to the Contrary notwithstanding.” U.S. CONST, art. IV, cl. 2.

¹³⁰ See, e.g., Cipollone v. Liggett Group, Inc., 505 U.S. 504, 516 (1992).

¹³¹ Id. at 516 (citing Rice v. Santa Fe Elevator Corp., 331 U.S. 218, 230 (1947)).

¹³² Hillsborough County v. Automated Medical Labs, 471 U.S. 707, 715 (1985).

¹³³ Duvall v. Bristol-Myers-Squibb Co., 65 F.3d 392, 397 (4th Cir. 1995) (citing Cipollone, 505 U.S. at 516).

¹³⁴ Id.

¹³⁵ Subsection (b) allows a state to apply for exemption from preemption for state laws or regulation. See infra note 199 for further discussion of this process.

¹³⁶ 21 U.S.C.A. § 360k.

¹³⁷ 21 C.F.R. § 808.1(d) (1995).

¹³⁸ Chevron v. Natural Resources Defense Council, 467 U.S. 837, 843 (1984) (holding that courts should defer to an agency's reasonable interpretation of a statute if the statute is silent or ambiguous on the matter at issue).

¹³⁹ See, e.g., Ginochio v. Surgikos, Inc., 864 F. Supp. 948, 952 (N.D. Cal. 1994); Lohr v. Medtronic, Inc., 56 F.3d 1335, 1345 (11th Cir. 1995); Larsen v. Pacesetter Sys., Inc., 837 P.2d 1273, 1281 (Haw. 1992); King v. Collagen Corp., 983 F.2d 1130, 1134 (1st Cir. 1993). But see, e.g., Duvall v. Bristol-Myers-Squibb Co., 65 F.3d 392, 399 (4th Cir. 1995) (finding that § 360k did not meet threshold requirement that the statute at issue be silent or ambiguous, thus no need to determine whether agency interpretation was reasonable).

When reviewing FDA regulations on preemption, courts have generally avoided examining the examples, provided in the FDA regulation, of state requirements that do not merit preemption, such as § 808.1(d)(1), which concerns requirements of general applicability. Two cases, however, have done so and reached opposite conclusions. Talbott v. C.R. Bard, Inc., found that § 808.1(d)(1) conflicted with the clear intent of § 360k and thus must be disregarded. 865 F. Supp. 37, 49 (D. Mass. 1994). On the other hand, the court in Mulligan v. Pfizer, Inc., was satisfied that § 808.1(d)(1) was a reasonable construction. 850 F. Supp. 633, 635 (W.D. Ohio 1994). Neither case went into its reasoning. It is important to note however, that Mulligan involved a Class II device, while Talbott concerned a highly regulated Class III device.

¹⁴⁰ Ginochio, 864 F. Supp. at 952.

¹⁴¹ Id.; see also Lohr, 56 F.3d at 1344-45 (holding FDA's reading reasonable because literal reading would: (1) infer broad preemptive intent in face of well-settled presumption against such construction; (2) call into question almost all state law pertaining to MDA-regulated manufacturers; and (3) contradict legislative history suggesting not all state requirements preempted). As further evidence of the reasonableness of the FDA's interpretation in reflecting Congress's intent, courts have noted that Congress did not change § 360k, despite the existence of the FDA's interpretation in § 808.1(d), when it made amendments to the MDA in 1990. Ginochio, 864 F. Supp. at 952; Larsen, 837 P.2d at 1277.

¹⁴² See 21 U.S.C.A. § 360c (West Supp. 1995).

¹⁴³ 21 U.S.C.A. § 360c(a)(l)(A); 21 C.F.R. § 880.6230 (1995).

¹⁴⁴ 21 U.S.C.A. § 360c(a)(l)(B); 21 C.F.R. § 874.330 (1995).

¹⁴⁵ 21 U.S.C.A. § 360c(a)(l)(C); 21 C.F.R. § 870.3925 (1995).

¹⁴⁶ See King v. Collagen Corp., 983 F.2d 1130, 1131 (1^st Cir. 1993).

¹⁴⁷ Duvall v. Bristol-Myers-Squibb Co., 65 F.3d 392, 396 (4th Cir. 1995). There are two exceptions to PMA for Class III devices. If a device is substantially equivalent to a device marketed before the effective date of the MDA, it may be marketed after a premarket notification, otherwise known as a 510(k) notification, unless or until the FDA orders compliance. 21 U.S.C.A. § 360e(b)(l). Also, a device that obtains an investigational device exemption from the FDA may go through human clinical trials without being subject to PMA procedures. 21 U.S.C.A. § 360e(a).

¹⁴⁸ Talbott v. C.R. Bard, Inc., 865 F. Supp. 37, 43 (D. Mass. 1994) (citing 21 U.S.C. § 360e(c) (1994); 21 C.F.R. § 814.20). The purpose of PMA is to establish efficient and thorough device review that ensures that approved devices are safe and effective, and otherwise meet the statutory criteria for approval. 21 U.S.C.A. § 360e(d)(2)(A), (B) (West Supp. 1995); 21 C.F.R. § 814.2 (1995).

¹⁴⁹ Blood Products Advisory Committee Meeting, supra note 10, at 12.

¹⁵⁰ See infra notes 151, 153 for some of these cases. Most of these cases have concerned preemption of state common law claims, as opposed to state statutes or regulations. However, these cases have firmly established that state common law claims are requirements within the meaning of the MDA. See, e.g., King, 983 F.2d at 1134; Stamps v. Collagen Corp., 984 F.2d 1416, 1420-21 (5th Cir. 1993). Thus these cases are insightful into the scope of preemption under the MDA, in general.

¹⁵¹ See, e.g., Lamontagne v. E.I. Du Pont De Nemours & Co., 41 F.3d 846, 853 (2d Cir. 1994); Stamps, 984 F.2d at 1421; King, 983 F.2d at 1134; Bravman v. Baxter Health Care Corp., 842 F. Supp. 747, 756 (S.D.N.Y. 1994); Hunsaker v. Surgidev Corp., 818 F. Supp. 744, 751 (M.D. Pa. 1992). The third step is essentially a clarification of step one. FDA requirements applicable to the device concern either safety and effectiveness or other requirements made applicable by the MDA.

¹⁵² Anguiano v. E.I. Du Pont De Nemours & Co., 44 F.3d 806, 809 (9th Cir. 1995); King, 983 F.2d at ll34.

¹⁵³ See, e.g., Talbott v. C.R. Bard, Inc., 63 F.3d 25, 27 (1st Cir. 1995); Anguiano, 44 F.3d at 810 (dictum); Martello v. CIBA Vision Corp., 42 F.3d 1167, 1169 (8th Cir. 1994); Stamps, 984 F.2d at 1421; King, 983 F.2d at 1134; Slater v. Optical Radiation Corp., 961 F.2d 1330, 1333 (7th Cir. 1992); Richman v. W.L. Gore & Assoc., 881 F. Supp. 895, 901 (S.D.N.Y. 1995); English v. Mentor Corp., No. 93-2725, 1994 U.S. Dist. LEXIS 7941, *8 (E.D. Pa. June 13, 1994); Bravman, 842 F. Supp. at 761. But see, e.g., Ministry of Health v. Shiley Inc., 858 F. Supp. 1426, 1440 (CD. Cal. 1994) (state claims against Class III device manufacturer survive if the legal duty underlying state claim has basis independent of MDA's focus on the device's safety and effectiveness, or arises from the manufacturer and not the state); Larsen v. Pacesetter Sys., Inc., 837 P.2d 1273, 1282 (Haw. 1992) (statutes and regulations governing PMA set forth general procedural requirements therefore not triggering preemption analysis under § 808.1(d)).

¹⁵⁴ Lohr v. Medtronic, Inc., 56 F.3d 1335, 1345-46 (11th Cir. 1995).

¹⁵⁵ Anguiano, 44 F.3d at 810; Richman, 881 F. Supp. at 901-02; Talbott v. C.R. Bard, Inc., 865 F. Supp. 37, 44-45 (D. Mass. 1994).

¹⁵⁶ Cases in note 153 that find preemption, also find that the PMA requirements are specific requirements. However, not all explicitly state this. For a list of cases that explicitly state PMA constitutes a specific requirement, see Talbott, 865 F. Supp. at 44.

¹⁵⁷ Lohr, 56 F.3d at 1345-46.

¹⁵⁸ See supra text accompanying notes 118-20 for informed consent, notes 121-25 for reporting, and notes 126-27 for counseling.

¹⁵⁹ General electrical codes and the warranty of fitness provision of the Uniform Commercial Code are given by the FDA regulations as examples of requirements relating to products in addition to devices. 21 C.F.R. § 808.1(d)(1) (1995). These examples are quite different from the state HIV testing statutes at issue.

¹⁶⁰ Advisory Op. by Joseph P. Hile, Assoc. FDA Comm'r for Regulatory Affairs, Docket No. B3A-0140/AP (Mar. 2, 1984), cited in Ministry of Health v. Shiley Inc., 858 F. Supp. 1426, 1435 (CD. Cal. 1994).

¹⁶¹ Shiley Inc., 858 F. Supp. at 1435. The court found no preemption if the legal duty underlying the state claim either had a basis independent of the MDA's focus on the device's safety and effectiveness, or arose from the manufacturer and not the state. Id. at 1440.

¹⁶² FDA Meeting Notice, 45 Fed. Reg. 67,321 (1980).

¹⁶³ The provisions related to powers of seizure and embargo of devices, which were broader than the powers of the FDA. Id. at 67,321.

¹⁶⁴ Id. at 67,322.

¹⁶⁵ Id.

¹⁶⁶ See supra text accompanying notes 118-27 for how statutes at issue could establish requirements for the home HIV test.

¹⁶⁷ See supra note 148 and accompanying text.

¹⁶⁸ Id. § 360c(a)(2)(A).

¹⁶⁹ Id. § 360c(a)(2)(C).

¹⁷⁰ One commentator refers to this difference in terms of primary and secondary safety and effectiveness. Although he does not make the distinction based on individual health effects vs. public health effects, his concept is similar. Primary concerns the immediate safety and effectiveness of the device. Secondary concerns the consequential safety and effectiveness. Thus, a product that, if properly used, is not the proximate cause of an unacceptable level of harm to the user, is primarily safe and effective. An intervening cause of harm, such as the user's traumatic response to the product is an issue of secondary safety and effectiveness. Salbu, Steven R., HIV Home Testing and the FDA: The Case for Regulatory Restraint, 46 HASTINGS L.J. 403, 405 n.14, 444-45 (1995)Google Scholar.

The distinction between primary and secondary safety and effectiveness is manipuable. Arguably, a suicidal response to a positive result is equivalent to a negative physiological response to the use of a device (i.e., infection from pricking of finger). The suicidal response may be a product of one's “psychological constitution,” such as clinical depression.

I prefer a distinction based on individual versus public health concerns because it corresponds with the statutory definition of safety and effectiveness. Thus, the possible response of a user of the home test is within the scope of FDA review since it is an issue “with respect to persons for whose use the device is represented or intended.“

¹⁷¹ Laws mandating face-to-face counseling are primarily concerned with the reaction of the person tested to a positive result, and the services that are available for HIV-positive people. Even for a negative result, face-to-face counseling is focused on conveying the information necessary to avoid exposure to HIV. A public health aspect does motivate requiring face-to-face counseling, in that it could be argued that face-to-face counseling better provides people tested the information needed to reduce the spread of HIV, whether or not they are positive. This focus, however, is secondary to the individual's health.

¹⁷² Arguably a reason for name reporting exists that concerns the individual health of the person whose status is reported. If a cure or breakthrough in treatment occurs then those HIV-positive people whose names or other identifying information has been reported, can be informed.

¹⁷³ It could be argued that autonomy values, such as informed consent, are necessary to achieve the most beneficial balancing of benefits and risks to health, and thus are within the scope of that balancing.

¹⁷⁴ See supra text accompanying note 151 for scope of preemption analysis. The statutes at issue potentially do not fall within the third part of the preemption analysis. Additionally, within the first part of the preemption analysis, it can also be argued that if safety and effectiveness is limited to issues of individual health, the FDA does not have authority to establish requirements that cover the areas of informed consent and reporting.

¹⁷⁵ Under the Chevron test, if the statute is ambiguous or silent concerning the issue at hand, courts will defer to a reasonable agency construction of the provisions. Chevron v. Natural Resources Defense Council, 467 U.S. 837, 843 (1984).

¹⁷⁶ See Salbu, supra note 170, at 455 (FDA has been given substantial administrative discretion in defining comprehensiveness of its mandate). In fact, the FDA has stated that PMA for the home test includes an evaluation of safety and effectiveness with respect to the public health at large. Blood Products Advisory Committee Meeting, supra note 10, at 124.

¹⁷⁷ It is important to note that although the arguments against preemption are not strong, and most courts when reviewing Class III devices have found preemption, some courts have resisted expansive preemption. See, e.g.. Ministry of Health v. Shiley Inc., 858 F. Supp. 1426, 1440 (CD. Cal. 1994) (state claims against Class III device manufacturer survive if the legal duty underlying state claim has basis independent of MDA's focus on the device's safety and effectiveness, or arises from the manufacturer and not the state); Larsen v. Pacesetter Sys., Inc., 837 P.2d 1273, 1282 (Haw. 1992) (statutes and regulations governing PMA set forth general procedural requirements therefore not triggering preemption analysis under § 808.1(d)); Feldt v. Mentor Corp., 61 F.3d 431, 436 (Sth Cir. 1995) (nexus between state and federal requirement necessary to trigger preemption); Lohr v. Medtronic, Inc., 56 F.3d 1335, 1345 (11th Cir. 1995) (the term specific narrows the scope of preemption). Thus, one cannot be certain that all courts will find broad preemption. For this reason, and the possibility of exemption from preemption via 21 U.S.C.A. § 360k(b), other legal arguments as to why the state statutes at issue are not applicable to home HIV tests are discussed infra in text accompanying notes 197-230.

¹⁷⁸ Home Specimen Collection Kit, supra note 14, at 10087. Guidelines represent practices the FDA considers acceptable to meet its regulatory requirements. Guidelines give a manufacturer some insight into the FDA's interpretation of various requirements. Although guidelines have no legal force, and manufacturers can follow other practices as long as they meet the same ends of compliance with regulations, in practice, the FDA has placed substantial reliance on such guidelines. Rodney R. Munsey & Howard M. Holstein, Medical Device Regulation, In Transition, in FOOD AND DRUG LAW 371 (Richard M. Cooper ed„ 1991). Thus, the guidelines in this instance are the FDA's interpretation of PMA requirements as applied to the home HIV test.

¹⁷⁹ Home Specimen Collection Kit, supra note 14, at 10087.

¹⁸⁰ Id.

¹⁸¹ Id.

¹⁸² Id. at 10087-88.

¹⁸³ Id. at 10087.

¹⁸⁴ Id.

¹⁸⁵ Id.

¹⁸⁶ Id.

¹⁸⁷ Id. at 10088. The notice does not specify whether the reporting of results by trained counselors includes both positive and negative results. It would seem unnecessary to require a person to give out negative results. As long as a taped message explains the significance of the negative result, i.e., the potential latency period of the virus, a trained counselor is not needed. It would be prudent, however, to allow the option of speaking to a counselor even for a negative result.

¹⁸⁸ Id. at 10087; 42 U.S.C.A. § 263a (West 1991).

¹⁸⁹ Id.

¹⁹⁰ Id. at 10088 (emphasis added).

¹⁹¹ Id.

¹⁹² Id.

¹⁹³ Id.

¹⁹⁴ Name reporting would require the user to provide his or her name on the test sample. The current tests before the FDA are completely anonymous.

¹⁹⁵ Approval appears likely. See supra text accompanying notes 23-24.

¹⁹⁶ See H.R. REP. No. 853, 94th Cong., 2d Sess., at 45-46 (1976).

¹⁹⁷ See supra note 177.

¹⁹⁸ See infra part III.F.

¹⁹⁹ The state requirement may be exempted from preemption, after notice and opportunity for oral hearing, if the requirement is more stringent than a requirement under the MDA, or if the requirement is required by compelling local conditions, and compliance with the requirement would not cause the device to violate any applicable requirement under the MDA. 21 U.S.C.A. § 360k(b) (West Supp. 1995). The statutes at issue could fall within the “more stringent” option. It is within the discretion of the FDA to grant such exemption. See Massachusetts v. Hayes, 691 F.2d 57, 61 (Ist Cir. 1982).

²⁰⁰ See, e.g., CONN. GEN. STAT. ANN. § 19A-582(A) (West Supp. 1994); MONT. CODE ANN. § 50-16-1007(1) (1993); N.Y. PUB. HEALTH LAW § 2781(1) (McKinney 1993).

²⁰¹ See, e.g., CAL. HEALTH & SAFETY CODE § 199.22(a) (West 1990); HAW. REV. STAT. § 325- 16(a) (1991).

²⁰² ALA. CODE § 22-11A-51 (Michie Supp. 1994); DEL. CODE ANN. tit. 16, § 1202(a) (Supp. 1994); FLA. STAT. ANN. § 381.004(3)(a) (West 1993).

²⁰³ If the manufacturer were to contract-out the actual testing of the samples, this discussion would be equally applicable to that facility.

²⁰⁴ N.M. STAT. ANN. § 24-2B-5(E) (Michie 1994) (informed consent not required where the identity of the test subject is unknown); VA. CODE ANN. § 32.1-37.2(A)(i) (Michie 1992) (seeking of anonymous testing implies informed consent).

²⁰⁵ Doe v. Equifax, CIV. A. No. 88-3872, 1989 WL 57348 (E.D. Pa. May 26, 1989) (informed consent in Pennsylvania applies only to doctors). The doctrine of informed consent has been discussed in broader terms, but still within the context of the health care treatment setting. Peter H. Schuck, Rethinking Informed Consent, 103 YALE L.J. 899, 910 (1994).

²⁰⁶ Scott Burris, Testing, Disclosure, and the Right to Privacy, in AIDS LAW TODAY: A NEW GUIDE FOR THE PUBLIC, supra note 35, at 115, 124.

²⁰⁷ “It is … well established that ‘[w]here Congress uses terms that have accumulated settled meaning under … the common law, a court must infer, unless the statute otherwise dictates, that Congress means to incorporate the established meaning of these terms.'” Community for Creative Nonviolence v. Reid, 490 U.S. 730, 739 (1989) (citing NLRB v. Amax Coal Co., 453 U.S. 322,329 (1981)).

²⁰⁸ Cost Analysis Questions Value of Routine HIV Testing, 8 AIDS ALERT 120, 123 (1993).

²⁰⁹ Id.

²¹⁰ For example, a person's name, address, or phone number.

²¹¹ All but seven states have anonymous testing. Brennan, supra note 122, at 392.

²¹² 429 U.S. 589(1977).

²¹³ Id. at 599-600.

²¹⁴ Id. at 598 (holding that “enactment of the patient-identification requirement was a reasonable exercise of New York's broad police powers.“).

²¹⁵ Id. at 600-02.

²¹⁶ Mary Anne Bobinski & William S. LeMaistre, HIV Testing and Confidentiality, in AIDS AND GOVERNMENT LIABILITY, supra note 118, at 7, 22.

²¹⁷ Doe, 15 F.3d 264, 267 (1994). A number of other courts have also found a constitutional right to privacy which protects against the disclosure of HIV-related information. See generally Doughty, Roger, Comment, The Confidentiality of HIV-Related Information: Responding to the Resurgence of Aggressive Public Health Interventions in the AIDS Epidemic, 82 CAL. L. REV. 111, 151 (1994)Google Scholar.

²¹⁸ Doe, 15 F.3d at 269.

²¹⁹ The City of New York commission on human rights revealed the details to the public of Doe's conciliation agreement, stemming from an employment discrimination claim that arised in part from his HIV-positive status. The release by the commission did not name Doe, but provided enough information to allow those who knew or worked with him, to identify him. Id. at 265.

²²⁰ See supra text accompanying notes 208-09. In South Carolina, a bill is before the legislature that would exempt labs that process home HIV tests from the requirement of reporting the names of HIV-positive individuals. Legislative Report, POST & COURIER (Charleston, S.C.), Apr. 20, 1995, at A10.

²²¹ Doughty, supra note 217, at 153.

²²² Bobinski & LeMaistre, supra note 216, at 25.

²²³ Id. at 21; Gostin, Traditional Public Health Strategies, supra note 104, at 72.

²²⁴ Bobinski & LeMaistre, supra note 216, at 25.

²²⁵ Gostin, Traditional Public Health Strategies, supra note 104, at 72.

²²⁶ Face-to-face counseling requirements are also the most likely to be preempted because the FDA has explicitly indicated that certain counseling requirements exist for the home test. See supra text accompanying note 192.

²²⁷ FLA. STAT. ANN. § 381.004(3)(e) (West 1993).

²²⁸ Id. §381.004(2)(b).

²²⁹ Id. §381.004(1).

²³⁰ For example, Texas has passed a statute legalizing the use of the home test on approval by the FDA. Sylvia Moreno, State Lawmakers Didn't Forget Bubba; New Bills Affect Ordinary Texans, DALLAS MORNING NEWS, May 28, 1995, at 1A, 18A. The statute was enacted to exempt the test from Texas's face-to-face counseling requirements. See Sylvia Moreno, Panel Oks Home Testing Kits, DALLAS MORNING NEWS, Feb. 22,1995, at 12D.