Recent Developments in Health Law

See National Institutes of Health, Fact Sheet: Stem Cell Research (dated Jan. 19, 1999) (visited Feb. 23, 1999) <http://www.nih.gov/news/pr/jan99/od∼19.htm> [hereinafter Fact Sheet: Stem Cell Research].

In normal conditions, stem cells have the potential to divide approximately fifty times, but scientists have developed techniques that increase that number to as many as 200 times. See Easterbrook G. , “Medical Evolution,” New Republic, Mar. 1, 1999, at 21.

See National Institute of Health, Pluripotent Stem Cells: A Primer (dated Jan. 28, 1999) (visited Feb. 23, 1999) <http://www.nih.gov/news/stemcell/primer.htm> [hereinafter Pluripotent Stem Cells].

The University of Wisconsin has a media kit on stem cell research and on James Thompson's work. See Stem Cell Press Kit (visited Mar. 16, 1999) <http://www.news.wisc.edu/emediakit>.

See Hearing on Stem Cell Research Before the Subcomm. on Labor, Health and Human Service, and Education of the Senate Comm. on Appropriations (Dec. 2, 1998) (statement of Dr. Harold Varmus, Director, National Institutes of Health) (visited Feb. 23, 1999) <http://www.nih.gov/welcome/director/120298.htm>.

See id. at 3; and Fact Sheet: Stem Cell Research, supra note 1. Geron Corporation owns the license to the stem cell discoveries made by Thomson and John Gearhart.

The announcement of this experiment prompted President Clinton to request, on November 14, 1998, that the National Bioethics Advisory Committee (NBAC) consider the ethical implications of such research. See letter from Bill Clinton, President, to Harold Shapiro, Chair, National Bioethics Advisory Commission (dated Nov. 14, 1998) (visited Feb. 27, 1999) <http://www.bioethics.gov/clinton_letter.html>. NBAC responded to the President's concerns on November 20, 1998, and indicated that the issues would also be addressed in NBAC's report on human stem cell research. See letter from Shapiro Harold T. , Chair, National Bioethics Advisory Commission, to Bill Clinton, President (dated Nov. 20, 1998) (visited Feb. 27, 1999) <http://www.bioethics.gov/shapiro_letter.html>.

See Pluripotent Stem Cells, supra note 3.

See Omnibus Consolidated and Emergency Supplemental Appropriations Act, Fiscal Year 1999, Pub. L. No. 105-277, §§ 511-513 (1999).

Compare the Code of Federal Regulation, which defines “human subject” as “a living individual about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information.” 45 C.F.R. § 46.102 (1998).

As paraphrased by Harold Varmus. See Hearing on Stem Cell Research: HHS Legal Ruling Before the Subcomm. on Labor, Health and Human Service, and Education of the Senate Comm. on Appropriations (Jan. 26, 1999) (statement of Dr. Harold Varmus, Director, National Institutes of Health) (visited Feb. 23, 1999) <http://www.senate.gov/∼appropriations.labor.varmus.htm>.

“Human fetal tissue” is defined as “tissue or cells obtained from a dead human embryo or fetus after a spontaneous or induced abortion, or after a stillbirth.” Public Health Service Act, § 498A, 42 U.S.C. § 289g-1(g) (1994 & Supp. II 1996).

In addition to President Clinton's ban on federal funding of human cloning research, legislation has been proposed to prevent cloning of humans. In 1998, the Human Cloning Prohibition Act was proposed in Congress to prohibit cloning, but further action on the bill has been delayed. See S. 1601, 105th Cong. (1998). The Prohibition of Cloning of Human Beings Act, which limited the uses of somatic cell nuclear transfer, was also proposed. See S. 1611, 105th Cong. (1998).

See Pimley D.W. , “Research: NIH Says Federal Law No Bar to Financing Stem Cell Research; Senate Support Sought,” 8 Health Law Reporter (BNA), at 131 (1999).

See NIH Position on Human Pluripotent Stem Cell Research (visited Mar. 11, 1999) <http://www.nih.gov/grants/policy/stemcells.htm>.

See supra note 7.

See 45 C.F.R. §§ 46.201–.211 (1998).

See Hearing on Stem Cell Research, supra note 11.

See Andrews L. , “Legal, Ethical and Social Concerns in the Debate over Stem Cells,” Chronicles of Higher Education, Jan. 29, 1999, at B4.

See Public Health Service Act, § 498A, 42 U.S.C. § 289(g)-289g-2 (1994 & Supp. II 1996). The National Organ Transplant Act prohibits interstate acquisition, receipt, or any other transfer of a “human organ for valuable consideration for use in human transplantation.” 42 U.S.C. § 274e (1994). The term “organ” also includes fetal tissue and organs. See 42 U.S.C. § 273a (1994). State legislation regulating fetal tissue research is applicable to both privately and publicly funded research. See Uniform Anatomical Gift Act, 8 U.L.A 29–61 (1987).

NIH's budget in fiscal year 1999 is $15.6 million (a 14.4 percent increase on its budget in 1998). NIH has been allocated $15.9 million for the fiscal year 2000. See National Institutes of Health, Press Briefing: FY 2000 President's Budget (visited Feb. 23, 1999) <http://www4.od.nih.gov/ofm/budget/pressbriefing.stm>.

Legislation in many states currently bans embryo research, to varying degrees. See Fla. Stat. Ann. § 390.0111(5) (West Supp. 1998); La. Rev. Stat. Ann. § 9:122 (West 1991); Me. Rev. Stat. Ann. tit. 22, § 1593 (West 1992); Mass. Ann. Laws ch. 112, § 12J (Law. Co-op. 1991); Mich. Comp. Laws Ann. § 333.2685 (West 1992); Minn. Stat. Ann. § 145.422 (West 1989); N.H. Rev. Stat. Ann. § 168-B:15 (1994); N.D. Cent. Code § 14–02.2–01 (1991); 18 Pa. Cons. Stat. Ann. § 3216 (West Supp. 1997); and R.I. Gen. Laws § 11-54-1 (1994).

See Alpers A. and Lo B. , “Commodification and Commercialization in Human Embryo Research,” Stanford Law Policy Review, 6 (1995): 39–46.

A group of Italian scientists have also announced that stem cells taken from the brains of adult transgenic mice have successfully been turned into blood cells. Further research is necessary to determine whether stem cells similarly obtained from the brains of adult humans can be turned into blood cells or any other type of cell. See Bovsun M. , “Italian Bio-chemists Turn Brain Stem Cells into Blood,” Biotechnology Newswatch, Feb. 1, 1999, at 1.

See Andrews , supra note 19.

Institutional avoidance of a policy position in relation to fetal or embryo rights, which may offend some portion of the population, is illustrated by the decision in Roe v. Wade. Justice Blackmun, delivering in the opinion of the Court, stated: “When those trained in the respective disciplines of medicine, philosophy, and theology are unable to arrive at any consensus, the judiciary, at this point in the development of man's knowledge, [is] not in a position to speculate as to the answer.” Roe v. Wade, 410 U.S. 113, 159 (1973).

Recer P. , “Working Using Fetal Cells Draws Fire,” Boston Globe, Feb. 18, 1999, at A10.

Recer P. , “Stem Cell Research to Proceed,” Wisconsin State Journal, Feb. 24, 1999, at 5A. A letter signed by seven senators sent to Secretary Donna Shalala voiced similar objections. See Recer P. , “Shalala Defends Stem Cell Use,” Boston Globe, Feb. 24, 1999, at A11.

Hearing on Stem Cell Research: HHS Legal Ruling Before the Subcomm. on Labor, Health and Human Service, and Education of the Senate Comm. on Appropriations (Jan. 26, 1999) (statement of Richard M. Doerflinger, Committee for Pro-life Activities, National Conference of Catholic Bishops) (visited Mar. 11, 1999) <http://www.senate.gov/∼appropriations/abor/Doef1-26-99.htm>.

See National Institutes of Health, Fact Sheet: Stem Cell Research (dated Jan. 28, 1999) (visited Feb. 23, 1999) <http://www.nih.gov/news/pr/jan99/od-28.htm>. Concerns about private control are not completely eliminated by federal funding of research projects. NIH exploits the commercial potential of genes discovered by federally funded scientists and also encourages researchers to enter into joint ventures with private companies. See Andrews , supra note 19.

Goodrich v. Aetna U.S. Healthcare, Inc., No. RCV020499 (Cal. App. Dep't Super. Ct. Jan. 20, 1999).

See Marquis J. , “Jury Returns Record Award Against HMO,” Los Angeles Times, Jan. 21, 1999, at Al.

See “Liability: California Jury Awards Record Damages Against Aetna for Treatment Decision,” Health Law Reporter (BNA), at 32 (Jan. 28, 1999) [hereinafter “California Jury Awards Record Damages”].

See id. at 31.

See id. at 32; and The Goodrich Case: Statement of Facts ¶ 5 (visited Feb. 26, 1999) <http://www.aetna.com/news/1999/goodrich-stmnt-of-facts.htm>.

See Cal. Civ. Code § 3294 (West 1998); and Marquis , supra note 2, at Al.

See Aetna U.S. Healthcare's Statement on the Goodrich Verdict (visited Feb. 26, 1999) <http://www.aetna.com/news/1999/pr_19990121.htm>.

See The Goodrich Case, supra note 5, ¶ 12.

See Aetna U.S. Healthcare's Statement, supra note 7.

See 29 U.S.C. § 1003(b) (1998).

See “California Jury Awards Record Damages,” supra note 3, at 32.

See Access to Quality Care Act of 1999, H.R. 216, 106th Cong. (1999) (visited Mar. 10, 1999) <http://thomas.loc.gov/cgi-bin/query/z?cl06:H.R.216:>; and Marquis , supra note 2, at Al.

See Questions and Answers About the Goodrich Case, Question 7 (visited Feb. 26, 1999) <http://www.aetna.com/news/1999/goodrich_g_and-a.htm>.

A 1993 California jury verdict of $89 million in a malpractice suit against a health maintenance organization was reduced on appeal. An undisclosed settlement was subsequently reached. See “California Jury Awards Record Damages,” supra note 3, at 33.

See Questions and Answers, supra note 13, at Questions 5, 6.

See “Managed Care: HCFA Announces HMO Risk Adjuster, Including Five-Year Phase-In Period,” 8 Health Law Reporter (BNA), Jan. 21, 1999, at 113 [hereinafter “Managed Care”].

See Loewenberg S. , “Health Plans Off to Fast Start,” Legal Times, Feb. 1, 1999, at 4.

See “Managed Care,” supra note 1, at 113.

See Graham J. , “Proposed Medicare Changes Irk HMOs: Payments Would Be Adjusted for Risk,” Chicago Tribune, Jan. 16, 1999, at 4.

See McGinley L. , “Clinton Administration to Phase In Changes in Medicare Payments to HMOs,” Wall Street Journal, Jan. 15, 1999, at B6.

See Loewenberg , supra note 2, at 4.

See Graham , supra note 4, at 4.

See McGinley , supra note 5, at B6.

See Graham , supra note 4, at 4.

See “Medicare Risk Adjustment Phase-In Expected to Save Plans $1.4 Billion in 2000,” Health News Daily, Vol. 11, no. 11, Jan. 19, 1999.

See Loewenberg , supra note 2, at 4.

See Pack T. , “Medicare Cuts Threaten Florida HMOs,” Orlando Sentinel, Jan. 31, 1999, at A1.

See Loewenberg , supra note 2, at 4.

See Graham , supra note 4, at 4.

See Pack , supra note 12, at A1.

See “Managed Care,” supra note 1, at 113.

Id.

See id.

See “Medicare + Choice Adjustments Legislation,” Health News Daily, Vol. 11, no. 22, Feb. 3, 1999; and H.R. 491, 106th Cong. (1999).