Non-Invasive Testing,Non-Invasive Counseling

Agarwal A. , “Commercial Landscape of Noninvasive Prenatal Testing in the United States,” Prenatal Diagnosis 33, no. 6 (2013): 521–531, at 521.

Id.; Zettler P. , “23andMe, the Food and Drug Administration, and the Future of Genetic Testing,” JAMA Internal Medicine , February 17, 2014, available at <http://archinte.jamanetwork.com/article.aspx?articleid=1830023> (last visited April 17, 2015).

Rao R. , “Equal Liberty: Assisted Reproductive Technology and Reproductive Equality,” George Washington Law Review 76, no. 6 (2008): 1457–1489, at 1457.

Va. Code Ann. § 54.1–2957.20 (2014).

See, e.g., Hill M. , “Non-Invasive Prenatal Determination of Fetal Sex: Translating Research into Clinical Practice,” Clinical Genetics 80, no. 1 (2011): 68–75, at 70.

See, e.g., Sayres L. C. , “Cell-Free Fetal DNA Testing: A Pilot Study of Obstetric Healthcare Provider Attitudes toward Clinical Implementation,” Prenatal Diagnosis 31, no. 11 (2011): 1070–1076, at 1071.

Klitzman R. , Am I My Genes?: Confronting Fate and Family Secrets in the Age of Genetic Testing (Oxford: Oxford University Press, 2012): At 230.

Robertson J. A. , “Genetic Selection of Offspring Characteristics,” Boston University Law Review 76, no. 3 (1996): 421–482, at 427; King J. S. , “Not This Child: Constitutional Questions in Regulating Noninvasive Prenatal Genetic Diagnosis and Selective Abortion,” University of California Los Angeles Law Review 60, no. 1 (2012): 2–75, at 61.

Rebouché R. , “Testing Sex,” University of Richmond Law Review 49, no. 1 (2015): 519–577, at 562–569 (focusing on why sex selective bans may survive constitutional challenge).

Swanson A. , “Non-invasive Prenatal Testing: Technologies, Clinical Assays and Implementation Strategies for Women's Healthcare Practitioners,” Current Genetic Medicine Reports 1, no. 2 (2013): 113–121, at 114.

Wright C. F. Burton H. , “The Use of Cell-free Fetal Nucleic Acids in Maternal Blood for Non-invasive Prenatal Diagnosis,” Human Reproduction Update 15, no. 1 (2009): 139–151, at 139–140.

Id., at 139.

Id., at 142–143. There are different sequencing technologies laboratories can use: Massively parallel sequencing, targeted sequencing of specific chromosomal segments, or directed sequence analysis of single nucleotide polymorphisms.

Powell C. M. , “The Current State of Prenatal Testing in the United States,” in Parens E. Asch A. , eds., Prenatal Testing and Disability Rights (Washington, D.C.: Georgetown University Press, 2000): At 45.

Mujezinovic F. Alfirevic Z. , “Procedure-Related Complications of Amniocentesis and Chorionic Villous Sampling: A Systematic Review,” Obstetrics & Gynecology 110, no. 3 (2007): 687–694, at 687.

Driscoll D. A. Gross S. J. , “ACOG Practice Guidelines: Screening for Fetal Aneuploidy & Neural Tube Defects,” Genetics in Medicine 11, no. 11 (2009): 818–821, at 818.

Suter S. , “The Routinization of Prenatal Testing,” American Journal of Law & Medicine 28, nos. 2 & 3 (2002): 233–270, at 234.

Odeh M. , “Sonographic Fetal Sex Determination,” Obstetrics & Gynecology Survey 64, no. 1 (2009): 50–57, at 50.

See Driscoll Gross , supra note 16, at 818–821; American Congress of Obstetricians & Gynecologists, “ACOG Practice Bulletin No. 77: Screening for Fetal Chromosomal Abnormalities,” Obstetrics & Gynecology 109, no. 1 (2007): 217–220.

Devaney S. A. , “Noninvasive Fetal Sex Determination Using Cell-Free Fetal DNA,” JAMA 306, no. 6 (2011): 627–636, at 634; Palomaki G. E. , “DNA Sequencing of Maternal Plasma Reliably Identifies Trisomy 18 and Trisomy 13 as Well as Down Syndrome: An International Collaborative Study,” Genetics in Medicine 14, no. 3 (2012): 296–305, at 296.

See Powell 14, supra note, at 48.

See Devaney , supra note, at 631–633. But see de Jong A. Maya I. van Litht J. , “Prenatal: Screening: Current Practice, New Developments, Ethical Challenges,” Bioethics 29, no. 1 (2015): 1–8, at 6 (noting that there is also a consistent reporting of false positives in NIPT studies).

Farrell R. M. , “Risk & Uncertainty: Shifting Decision Making for Aneuploidy Screening to the First Trimester of Pregnancy,” Genetics in Medicine 13, no. 5 (2011): 429–436, at 434.

de Jong A. , “Non-invasive Prenatal Testing: Ethical Issues Explored,” European Journal Human Genetics 18, no. 3 (2010): 272–277, at 273.

Id., at 273.

King J. S. , “Politics and Fetal Diagnostics Collide,” Nature 491, no. 7422 (2012): 33–34, at 34.

See, e.g., Illumina, Non-Invasive Prenatal Screening, “The Verifi Prenatal Test: The Proven Choice for NIPT,” available at <http://www.illumina.com/clinical/reproductive-genetic-health/patients/non-invasive-prenatal-screening.html/> (last visited May 6, 2015).

See Norton , infra note 31, at 849 (noting also that the age “cut off” for pregnancy has been discredited by many); see also S. Morain, Greene M. F. Mello M. M. , “A New Era in Noninvasive Prenatal Testing,” New England Journal of Medicine 369, no. 6 (2013): 499–501, at 501.

American College of Obstetricians and Gynecologists Committee on Genetics, Committee Opinion Number 545: Noninvasive Prenatal Testing for Fetal Aneuploidy (December 2012).

Bianchi D. W. , “At-Home Fetal DNA Gender Testing: Caveat Emptor,” Obstetrics & Gynecology 107, no. 2 (2006): 216–218, at 216.

Norton M. E. Rose N. C. Benn P. , “Noninvasive Prenatal Testing for Fetal Aneuploidy: Clinical Assessment and a Plea for Restraint,” Obstetrics & Gynecology 121, no. 4 (2013): 847–850, at 847–848 (stating that studies on NIPT rely on “archived samples with known karyotypes that intentionally included a large proportion of specimens from women with known aneuploidy fetuses”).

UnitedHealthcare, Medical Policy: Noninvasive Prenatal Diagnosis of Fetal Aneuploidy Using Cell-free Fetal Nucleic Acids in Maternal Blood, April 1, 2014, 1–13, at 3.

To date, companies have been somewhat cautious in direct-to-consumer advertising, but have developed sex determination tests consumers can buy online. Gail Javitt reports: “State laws vary with respect to whether [genetic] tests can be offered directly to consumers, and many states allow it. Moreover, even those tests that are currently physician mediated for the most part lack formal assurance from any of the traditional regulators that they provide information useful to health-care decision making.” Javitt G. H. , “Pink or Blue? The Need for Regulation Is Black and White,” Fertility & Sterility 86, no. 1 (2006): 13–15, at 14.

See, e.g., UnitedHealthcare, supra note, at 3; Weaver C. , “Tough Calls on Prenatal Tests,” Wall Street Journal , April 3, 2013, available at <online.wsj.com/news/articles/SB10001424127887324883604578398791568615644> (last visited April 18, 2015).

Washington State Health Care Authority, Washington Apple Health, Prenatal Genetic Testing Provider Guide , July 1, 2014, at 6 (covering an initial counseling session that does not exceed ninety-minute session and then two follow-up sessions not exceeding ninety minutes).

Priority Health, Genetics: Counseling, Testing, Screening, Medical Policy No. 91540-R9, (October 19, 2013): 1–26, at 3.

See Swanson , supra note 10, at 117.

See Agarwal , supra note 1, at 522.

See Morain , supra note 28, 499.

Daar J. F. , “ART and the Search for Perfectionism: On Selecting Gender, Genes, and Gametes,” Journal of Gender Race & Justice 9, no. 3 (2005): 241–272, at n.2.

Id., at 253, 261–262 (describing the “geneticization of assisted conception,” arguing that choices that PGD provides parents are similar to choices after amniocentesis or CVS and noting comparisons between abortion law and ART in assessing the status of the embryo).

Puri S. Nachtigall R. D. , “The Ethics of Sex Selection: A Comparison of the Attitudes and Experiences of Primary Care Physicians and Physician Providers of Clinical Sex Selection Services,” Fertility & Sterility 93, no. 7 (2010): 2107–2114, at 2110.

Perhaps the most significant difference is cost and thus access to PGD. PGD is an additional step in IVF and those two processes together can cost between $12,500 to $16,000, often paid out of pocket because IVF, and to a lesser extent PGD, is frequently not covered by health insurance. See Daar , supra note 40, at n.48.

Mutcherson K. , “Making Mommies: Law, Pre-implantation Genetic Diagnosis, and the Complications of Pre-Motherhood,” Columbia Journal of Gender & Law 18, no. 1 (2008): 313–390, at 331.

For example, PRENDA states that sex selection “trivializes human reproduction by making it depend on the selection of non-essential features of offspring.” Prenatal Nondiscrimination Act of 2011, H.R. 447, 113th Cong. § 2(a)(1)(K) (2013).

de Jong A. de Wert G. , “Prenatal Screening: An Ethical Agenda for the Near Future,” Bioethics 29, no. 1 (2015): 46–55, at 47.

Suter S. , “A Brave New World of Designer Babies?” Berkeley Technology Law Journal 22, no. 2 (2007): 897–969, at 944. See also de Jong de Wert , supra note 46, at 49.

Friedman J. M. , “Legal Implications of Amniocentesis,” University of Pennsylvania Law Review 123, no. 1 (1974): 92–156, at 107.

Guttmacher Institute, “Monthly State Updates: Major Developments in 2015,” available at <http://www.guttmacher.org/statecenter/updates/> (last visited May, 5 2015).

Rebouché R. Rothenberg K. , “Mixed Messages: The Intersection of Prenatal Genetic Testing and Abortion,” Howard Law Journal 53, no. 3 (2012): 983–1023, at 992–998; see also Javitt , supra note, at 14 (“For more than ten years, federal government officials have been discussing the need for improved oversight of genetic testing. Ten years and two Secretary-level advisory committees later, not a single piece of legislation— and little regulation—has been promulgated.”).

Id. (Rebouché and Rothenberg), at 987.

See Javitt , supra note, at 14; see also King , supra note 26, at 34 (“The FDA still has not developed a comprehensive regulatory scheme for genetic tests, despite repeated calls to do so from government advisory groups (such as the U.S. Secretary's Advisory Committee on Genetics, Health and Society) and nonprofit organizations (such as the Genetics and Public Policy Center).”).

Weiss R. L. , “The Long and Winding Regulatory Road for Laboratory Tests,” American Journal of Clinical Pathology 138, no. 1 (2012): 20–26, at 20.

Id. The FDA signaled closer monitoring of adult, direct-to-consumer testing in 2013 when it issued a warning letter to the company 23andMe. 23andMe previously sold testing kits for health-related genetic reports, but had come under increasing scrutiny for the inaccuracy and the indeterminate nature of the reports sent to consumers. See Zettler , supra note 2, at E1.

Benn P. A. Chapman A. R. , “Ethical Challenges in Providing Non-invasive Prenatal Diagnosis,” Current Opinion in Obstetrics & Gynecology 22, no. 2 (2010): 128–134, at 129.

See Norton , supra note 31, at 848.

57 Federal Register 7137 (1992) (codified at 42 C.F.R. § 493.1); Federal Food, Drug, Cosmetic Act, 21 U.S.C. §§ 321(h), 201(h) (standards for medical devices as opposed to laboratory-developed tests).

See Morain , supra note 28, at 500. The Center for Disease Control recommends the ACCE model for vetting prenatal genetic tests – analytic validity, clinical validity, clinical utility, and ELSI (or the ethical, legal, social implications). See, e.g., UnitedHealthcare, supra note, at 3.

Id., at 847–848.

Id., at 848.

Mo. Rev. Stat. § 191.320 (2011).

Okla. Stat. tit. 63, § 1–568 (2006).

Tenn. Code Ann. § 68-5-504(a)(1) (2010) (“procedures or services designed to search out disorders in unborn children that are not treatable shall not be provided for under this part”).

Okla. Stat. Ann. tit. 63, §§ 1–738.2, −741.12 (2011). Arizona Senate passed a similar bill. Associated Press, “Senate Approves Bill on ‘Wrongful Births,”’ Arizona Capitol Times , March 6, 2012, available at <http://azcapitoltimes.com/news/2012/03/06/senate-approves-bill-on-wrongful-births> (last visited April 18, 2015).

H.B. 1305, § 2(1)(b), 63d Leg. Assemb. (N.D. 2013) (including “any physical disfigurement, scoliosis, dwarfism, Down syndrome, albinism, or any other type of physical or mental disability, abnormality, or disease”).

H.B. 386, 97th Gen. Assemb., 2013 Sess. (Mo. 2013). The bill included a list of conditions covered by the phrase “fetal diagnosis,” such as Down syndrome.

See, e.g., Utah Code Ann. § 76-7-302 (2010); Md. Code Ann., Health-Gen. § 20–209(b)(2)(ii) (1982); Tex. Health & Safety Code § 170.002(b)(3) (1998).

Ga. Code Ann. § 31–9B-2; Vernon's Texas Statutes and Codes Annotated § 171.046; West's Utah Code Annotated § 76-7-302; West's Louisiana Statutes Annotated § 1299.30.1.

2014 MS H.B. 1400.

Ariz. Rev. Stat. Ann. § 13–3603.02 (2011).

Okla. Stat. tit. 63, § 1–731.2.B (2012).

S.B. 353, Gen. Assemb., 2013 Sess. (N.C. 2013).

H.B. 2377, 84th Leg. Assemb., 2011 Reg. Sess. (Kan. 2011).

H.R. 1305, 63d Leg. Assemb., Reg. Sess. (N.D. 2013).

S.D. Codified Laws § 34–23A (2014).

18 Pa. Cons. Stat. Ann. § 3204(c) (1982) (“No abortion which is sought solely because of the sex of the unborn child shall be deemed a necessary abortion.”); 720 Ill. Comp. Stat. Ann. 510/6-(8) (1975); Ariz. Rev. Stat. Ann. § 13–3603.02 (2011) (note that Arizona is the only state to currently ban both sex and race-based abortions); Okla. Stat. tit. 63, § 1–731.2(B) (2011).

S.D. Codified Laws § 34–23A-10.1 (2014).

Id., § 34–23A-34 (2014).

PRENDA § 2(a)(1)(C).

PRENDA § 250(h)(2). The race provisions of PRENDA suggest troubling stereotypes and are difficult to understand. PRENDA devotes only two pages of the twenty-five page bill to race-based terminations. It is unclear how a provider would determine that abortion is “because the child or a parent of the child is of an undesired race” or “motivated by race bias.” Id., § 2(c). As many commentators have noted rightly, the overly simplistic and confused invocation of race and racial eugenics “promotes anti-immigrant sentiments, stigmatizes and discriminates against women of color by suggesting they cannot be trusted to make their own reproductive health care decisions.” The American Civil Liberties Union challenged, unsuccessfully, Arizona's law banning race-based abortions. See Mason Pieklo J. , “Advocates Ask Ninth Circuit to Reinstate Challenge to Arizona Race- and Sex-Selection Abortion Ban,” RH Reality Check, March 13, 2014, available at <http://rhrealitycheck.org/article/2014/03/13/advocates-ask-ninth-circuit-reinstate-challenge-arizona-race-sex-selection-abortion-ban/> (last visited April 18, 2015).

Id., § 250(b).

See, e.g., S.D. Cod. Laws § 34–23A-34 (2004).

Okla. Stat. Ann. tit 63, §§ 1–738i-738p (2010).

Fla. Stat. Ann. § 390.0112 (West 2013).

Ariz. Rev. Stat. Ann. § 13–3603.02 (2011).

Kohm L. M. , “Sex Selection Abortion and the Boomerang Effect of a Woman's Right to Choose: A Paradox of the Skeptics,” William and Mary Journal of Women & the Law 4, no. 1 (1997): 91–128, at 120.

National Society for Genetic Counselors, State Laws, available at <http://nsgc.org/p/cm/ld/fid=19> (states with licensing laws are California, Delaware, Illinois, Indiana, Massachusetts, Nebraska, New Mexico, Ohio, Oklahoma, Pennsylvania, South Dakota, Tennessee, Washington).

State Licensure for Genetic Counselors, Model Legislative Provisions, available at <http://nsgc.org/p/cm/ld/fid=18> (last visited April 18, 2015).

Neb. Stat. Rev. § 38-186-24 (2012).

Va. Code Ann. § 54.1–2957.20 (2014).

National Society of Genetic Counselors, Genetic Counselor Scope of Practice, available at <http://www.cap.org/apps/docs/statline/pdf/nsgc_genetic_counselor_scope_of_practice.pdf> (last visited April 18, 2015); Va. Code Ann. § 54.1–2900 (2014); Neb. Stat. Rev. § 38-186-15 (2012).

Mich. Comp. Law §§ 333.17020 (2)(a-f) (1978).

Minna Stern A. , Telling Genes: The Story of Genetic Counseling in America (Baltimore: Johns Hopkins University Press, 2012): At 166–167 (describing, with the introduction of amniocentesis, the debate among bioethicists about the permissible reasons for abortion and whether counselors should take a value-neutral view or try to dissuade individuals from termination for particular reasons, like sex).

Thomson-Deveaux A. , “Fetal Abnormalities: The Next Minefield in the Abortion Wars?” American Prospect , April 9, 2014, available at <http://prospect.org/article/fetal-abnormalities-next-minefield-abortion-wars> (last visited April 18, 2015).

Gold R. B. , “Lessons from Before Roe: Will Past Be Prologue?” Guttmacher Institute, March 2003, 1–11: At 10, available at <http://www.guttmacher.org/pubs/tgr/06/1/gr060108.pdf> (last visited April 18, 2015) (“In some states, especially between 1967 and 1973, a woman also could receive approval for an abortion if it were deemed necessary to protect her physical or mental health.”).

Dorr G. M. , “Protection or Control? Women's Health, Sterilization Abuse, and Reif v. Weinberger,” in Lombardo P. , ed., A Century of Eugenics: From the Indiana Experiment to the Human Genome Era (Bloomington: Indiana University Press, 2011): At 163 (describing the history of laws on involuntary sterilization and noting practices of involuntary sterilization); see also Daar, supra note 40, at 216 (by the 1930s, thirty states had involuntary sterilization laws).

See Mutcherson , supra note 44, at 342–343.

See Stern , supra note 104, at 174.

Id., at 15.

Id., at 9.

Id., at 95.

Bernhardt B. A. , “Women's Experiences Receiving Abnormal Prenatal Chromosomal Microarray Testing Results,” Genetics in Medicine 15, no. 2 (2013): 139–145, at 140.

Id., at 140.

See Mutcherson , supra note 44, at 324–325.

See Klitzman , supra note 7, at 233.

See Bernhardt , supra note 103, at 143.

See Farrell , supra note 23, at 6.

Rothman B. , “The Tentative Pregnancy: Then and Now,” in Rothenberg K. H. Thompson E. J. , eds., Women and Prenatal Testing: Facing the Challenges of Genetic Technology (Columbus: The Ohio State University Press, 1994): At 260; Rothenberg K. H. , “The Law's Response to Reproductive Genetic Testing: Questioning Assumptions about Choice, Causation, and Control,” Fetal Diagnosis & Therapy 8, no. 1 (1993): 160–163, at 160.

Prenatally & Postnatally Diagnosed Conditions Awareness Act , Pub. L. No. 110–374, § 3, 122. Stat. 4051, 4051–54 (2008) (amending the Public Health Service Act 42, U.S.C. § 254c-8(e) (2006)).

See de Jong , supra note 24, at 274.

See Benn Chapman , supra note 55, at 131.

See Stern , supra note 95, at 147 (describing the evolution of genetic counseling as more patients sought prenatal diagnosis).

Farrell R. M. , “Women and Prenatal Genetic Testing in the 21st Century,” Health Matrix 23, no. 1 (2013): 1–13, at 7–8.

See Melhman M. , “Modern Eugenics and the Law,” in Lombardo P. , ed., A Century of Eugenics: From the Indiana Experiment to the Human Genome Era (Bloomington: Indiana University Press, 2011): At 221 (describing modern incentives, which straddle private decision-making and state regulation, that “encourage or discourage the birth of specific types of individuals”).

Barber P. L. , “Prenatal Diagnosis: An Ethical and a Regulatory Dilemma,” Houston Journal of Health, Law and Policy 13, no. 2 (2013): 329–351; Deans Z. Newson A. J. , “Should Non-Invasiveness Change Informed Consent Procedures for Prenatal Diagnosis?” Health Care Analysis 19, no. 2 (2011): 122–123, at 122; Schmitz D. , “An Offer You Can't Refuse? Ethical Implications of Non-Invasive Prenatal Diagnosis,” Nature Reviews Genetics 10, no. 8 (2009): 515–516, at 515.

See Stern , supra note 95, at 174.

See de Jong Maya van Litht , supra note 22, at 8.

American College of Obstetricians and Gynecologists Committee on Genetics, The Society for Maternal-Fetal Medicine, Committee Opinion No. 545, Noninvasive Prenatal Testing for Fetal Aneuploidy (December 2012).

See Benn Chapman , supra note 56, at 130.

See Suter , supra note 17, at 233.

See de Jong , supra note 24, at 273; Mutcherson, supra note 44, at 325.

Donley G. , “Prenatal Whole Genome Sequencing: Just Because We Can, Should We?” Hastings Center Report 42, no. 4 (2012): 28–40, at 28–30.

Dickens B. , “Ethical and Legal Aspects of Noninvasive Prenatal Genetic Diagnosis,” International Law Journal of Gynecology & Obstetrics 124, no. 2 (2014): 181–185, at 182 (“safe access to fetal DNA might make fetuses amenable to techniques that test for a much broader range of genetic abnormalities such as susceptibility to breast cancer and late-onset disorders, and even extend to whole-genome or whole-exome sequencing”).

See de Jong , supra note 24, at 275; Dickens, supra note 126, at 183.

Id., at 274.

Gregory Feero W. , “Genomic Medicine—An Updated Primer,” New England Journal of Medicine 362, no. 21 (2010): 2001–2011; Burke W. Brown Trinidad S. Wright Clayton E. , “Seeking Genomic Knowledge: The Case for Clinical Restraint,” Hastings Law Journal 64, no. 6 (2013): 1650–1664, at 1649.

Garel M. , “Ethical Decision-Making in Prenatal Diagnosis and Termination of Pregnancy: A Qualitative Survey among Physicians and Midwives,” Prenatal Diagnosis 22, no. 9 (2002): 811–817, at 812–813.

See Benn Chapman , supra note 56, at 130.

See de Jong de Wert , supra note 46, at 52.

Id., at 52.

Id., at 52–53.

See Dickens , supra note 138, at 182.

The International Federation of Gynecology and Obstetrics (FIGO) Ethical Guidelines on Conscientious Objection require that, “Practitioners provide [their] patients with timely access to medical services, including giving information about the medically indicated options of procedures for their care and of any such procedures in which their practitioners object to participate on grounds of conscience.”

Chachkin C. J. , “What Potent Blood: Non-Invasive Prenatal Genetic Diagnosis and the Transformation of Modern Prenatal Care,” American Journal of Law & Medicine 33, no. 1 (2007): 9–53, at 23–24.

See Stern , supra note 95, at 10.

See Dickens , supra note 125, at 183.

See Benn Chapman , supra note 56, at 132.

Ranji U. Salginicoff A. , Focus on Health Reform: Access to Abortion Coverage and Health Reform (Washington, D.C.: The Henry J. Kaiser Family Foundation, 2010): At 1, 6.

Guttmacher Institute, State funding of Abortion under Medicaid, 2014.

Take for example the Priority Health coverage policy. The coverage policy requires counseling and informed consent before testing. See Priority Health, supra note 6, at 1.

In describing the routine coverage of private plans and public programs, the IOM report stated: “Pregnant women should receive…prenatal screening and testing for neural tube defects (for all women at elevated risk) and chromosomal abnormalities (for all women at “elevated risk”), including, but not limited to amniocentesis, chorionic villus sampling, and ultrasound.” Commission on Preventive Services for Women, Clinical Preventive Services For Women: Closing the Gaps (Washington, D.C.: Institute of Medicine, 2011): At 61.

See Priority Health, supra note 6, at 7.

See Stern , supra note 95, at 122, 136.

See Farrell , supra note 116, at 9–11 (problematizing the “voluntariness” of NIPT, based on women's experiences with amniocentesis and CVS).

See de Jong Maya van Litht , supra note 22, at 8.