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Skin in the Game: Human Tissue as Property

Published online by Cambridge University Press:  24 March 2025

Lori Andrews
Lori Andrews*
Affiliation:
Chicago-Kent College of Law, Illinois Institute of Technology, Chicago, IL, USA
*
Email: loriandrewsjd@gmail.com
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Abstract

In 2023, Henrietta Lacks’ family won a settlement from Thermo Fisher Scientific on the grounds that the company had been “unjustly enriched” by the sale of products developed with Henrietta’s cells. Given that hundreds of thousands of people have tissue stored in the United States, this article explores how today’s patients might fare if they similarly sued professionals and companies that undertake unauthorized research on or commercialization of their tissue on the grounds of conversion, unjust enrichment, lack of informed consent, breach of fiduciary duty and, where government entities are involved, Fourteenth Amendment claims. The article notes that the practices that were subsequently seen as unethical in Henrietta Lacks’ care continue in some health care institutions today. It also analyzes how research and commercialization without consent can lead to a lack of trust in the research enterprise and the unwillingness of people to participate in research.

Keywords

unjust enrichmentHenrietta Lackshuman tissuebiotechnologyresearch ethicsinformed consenttissue banksproperty rights in the body

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Type
Articles
Information
American Journal of Law & Medicine , Volume 50 , Issue 3-4 , December 2024 , pp. 191 - 203
Copyright
© 2025 The Author(s). Published by Cambridge University Press on behalf of American Society of Law, Medicine & Ethics and Trustees of Boston University

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References

1 Thermo Fisher Scientific Reports Fourth Quarter and Full Year 2023 Results, https://ir.thermofisher.com/investors/news-events/news/news-details/2024/Thermo-Fisher-Scientific-Reports-Fourth-Quarter-and-Full-Year-2023-Results/ (January 31, 2024).

2 See Amended Civil Complaint & Request for Jury Trial at ¶¶ 11, 18, Lacks v. Thermo Fisher Sci., Inc., No. 21-cv-02524 (D. Md. Jan. 26, 2022), 2022 WL 2802235 [hereinafter Lacks Amended Complaint]. at ¶¶ 47–52.

3 Settlement Order, Lacks v. Thermo Fisher Sci., Inc., No. 21-cv-02524 (D. Md. Aug. 1, 2023) (dismissing the case due to voluntary settlement) [hereinafter Lacks Settlement Order]; Henrietta Lacks’ Family Reaches Settlement over Use of Immortal ‘HeLa Cells,’ CBS News (Aug. 1, 2023, 12:35 PM), https://www.cbsnews.com/baltimore/news/henrietta-lacks-family-settlement-lawsuit-hela-cells-thermo-fisher-scientific/ (describing all-day confidential settlement conference occurring on July 31, 2023).

4 See Civil Complaint & Request for Jury Trial at ¶¶ 73–79, Lacks v. Ultragenyx Pharm., Inc., No. 23-cv-02171 (D. Md. Aug. 10, 2023), 2024 WL 2273385 (alleging unjust enrichment from HeLa cell line, case is ongoing).

5 See, e.g., York v. Jones, 717 F. Supp. 421, 422 (E.D. Va. 1989); Amended Complaint, Greenberg v. Mia. Children’s Hosp. Rsch. Inst., Inc., 264 F. Supp. 2d 1064 (S.D. Fla. 2003) (No. 02-22244). I also authored amicus briefs. See Brief for Lori Andrews & Marjorie M. Schultz as Amici Curiae Supporting Plaintiff, Moore v. Regents of Univ. of Cal., 793 P.2d 479 (Cal. 1990) [hereinafter Andrews & Schultz]; Brief for Am. Med. Ass’n et al. as Amici Curiae Supporting Petitioners, Ass’n for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576 (2013) (No. 12-398). I also provided advice in Wash. Univ. v. Catalona, 490 F.3d 667 (8th Cir. 2007).

6 Lori B. Andrews, My Body, My Property, Hastings Ctr. Rep. Oct. 1986, at 28. I went on to publish over 40 more articles and a book that dealt with these issues, Lori Andrews & Dorothy Nelkin, Body Bazaar: The Market for Human Tissue in the Biotechnology Age (2001).

7 See Lori Andrews, Between Strangers: Surrogate Mothers, Expectant Fathers, and Brave New Babies viii (1989); Andrews, Lori B., Beyond Doctrinal Boundaries: A Legal Framework for Surrogate Motherhood, 81 Va. L. Rev. 2343, 2349–50 (1995)Google Scholar.

8 Lori B. Andrews, Inside the Genius Farm, Parents Mag., Oct. 1980, at 82; Lori B. Andrews, The Clone Age: Adventures in the New World of Reproductive Technology 126 (1999).

9 See, e.g., Sarah R. Blenner et al., Privacy Policies of Android Diabetes Apps and Sharing of Health Information, 315 JAMA 1051 (2016); Lori Andrews, A New Privacy Paradigm in the Age of Apps, 53 Wake Forest L. Rev. 421 (2018); Lori B. Andrews et al., An Alternative Strategy for Studying Adverse Events in Medical Care, 349 Lancet 309 (1997); Lori Andrews, Studying Medical Error in SITU: Implications for Malpractice Law and Policy, 54 DePaul L. Rev. 357 (2005).

10 See generally William J. Curran, The Boston University Law-Medicine Research Institute: Doctor and Lawyer Get Together, Bos. Med. Q., Dec. 1958, at 117.

11 Rebecca Skloot, The Immortal Life of Henrietta Lacks 16–17, 31–32 (2010).

12 Id. at 33.

13 Id.

14 Id. at 30.

15 Id.

16 See id. at 30, 58.

17 See infra note 23.

18 Skloot, supra note 11, at 40–41.

19 See generally Henrietta Lacks: Science Must Right a Historical Wrong, Nature, Sept. 3, 2020, at 7, 7 (2020) (discussing Lacks’ granddaughter’s experience experimenting with HeLa cells in high school and the prominence of the cells’ use in the medical field).

20 Her Story, Lacks Fam., https://lacksfamily.com/her-story [https://perma.cc/M7XW-NQY9] (last visited June 29, 2024); see also Skloot, supra note 11, at 2.

21 Her Story, supra note 20.

22 See Takeo Ohnishi et al., Detection of DNA Damage Induced by Space Radiation in Mir and Space Shuttle, 43 J. Radiation Rsch. S133, S133–34 (2002).

23 See Her Story, supra note 20 (reporting over 50 million metric tons of the cells have been distributed); Product Information for CRM-CCL-2 HeLa Cells, Am. Type Culture Collection, https://www.atcc.org/products/crm-ccl-2 [https://perma.cc/HXB9-GYY7] (last visited Oct. 1, 2024) (listing the price of one order of cells as $931).

24 Harriet A. Washington, Human Guinea Pigs, Emerge, Oct. 1994, at 24, 29.

25 Henrietta Lacks: The Mother of Modern Medicine, Franklin Cnty. Pub. Health (Feb. 16, 2022), https://myfcph.org/henrietta-lacks-the-mother-of-modern-medicine/ [https://perma.cc/GZ45-XED7].

26 See Jonathan J.M. Landry et al., The Genomic and Transcriptomic Landscape of a HeLa Cell Line, 3 G3 1213, 1213–24 (2013).

27 Lacks Family Reach Understanding to Share Genomic Data of HeLa Cells, Nat’l Insts. of Health (Aug. 7, 2013), https://www.nih.gov/news-events/news-releases/nih-lacks-family-reach-understanding-share-genomic-data-hela-cells [https://perma.cc/U5FL-AMKT].

28 John Arnst, Sharing the Whole HeLa Genome, Am. Soc’y for Biochem. & Molec. Biology (Feb. 1, 2017), https://www.asbmb.org/asbmb-today/science/020117/sharing-the-whole-hela-genome [https://perma.cc/8EPN-P7JM].

29 Nat’l Insts. of Health, supra note 27.

30 See Summary of the NIH HeLa Genome Data Use Agreement, Nat’l Insts. of Health (Aug. 7, 2013), https://www.nih.gov/sites/default/files/institutes/foia/summary-data-use.pdf [https://perma.cc/NE5E-DDYE]; see also The NIH-Lacks Family Agreement, Nat’l Insts. of Health Sci. Data Sharing, https://sharing.nih.gov/data-management-and-sharing-policy/protecting-participant-privacy-when-sharing-scientific-data/the-nih-lacks-family-agreement [https://perma.cc/FG6W-38C6] (last visited Oct. 1, 2024).

31 See generally Skloot, supra note 11.

32 Salamishah Tillet, Oprah Winfrey on ‘The Immortal Life of Henrietta Lacks,’ N.Y. Times (Apr. 12, 2017), https://www.nytimes.com/2017/04/12/arts/television/oprah-winfrey-on-the-the-immortal-life-of-henrietta-lacks.html [https://perma.cc/Y4KC-UDPK].

33 1 Nat’l Bioethics Advisory Comm’n, Research Involving Human Biological Materials: Ethical Issues and Policy Guidance 1, 14 (1999). This number has likely only grown in the intervening years. The Secretary’s Advisory Committee on Human Research Protections (SACHRP), Attachment D: FAQ’s Terms and Recommendations on Informed Consent and Research Use of Biospecimins, U.S.

Dᴇᴘ’ᴛ Of Hᴇᴀʟᴛʜ & Hᴜᴍᴀɴ Sᴇʀᴠs., https://www.hhs.gov/ohrp/sachrp-committee/recommendations/2011-october-13-letter-attachment-d/index.html [https://perma.cc/2VHL-3P88] (last updated Oct. 13, 2011) (“While there is no accurate catalog of the number or locations of specimens, there are reasonable estimates that billions of specimens are now stored in laboratories, repositories and ‘tissue banks’ across the country[.]”).

34 Diane B. Paul & Jeffrey P. Brosco, The PKU Paradox: A Short History of a Genetic Disease 54–71 (2013); see also Legal Liability and Quality Assurance in Newborn Screening (Lori B. Andrews ed., 1985).

35 See, e.g., Minn. Stat § 144.125 (2023) (establishing that the Department of Health may store the infant’s blood samples and test results, but that the parents can elect to have the samples discarded at any time); Cal. Code Regs. tit. 17, § 6505(f) (2024) (establishing that collected samples become property of California and can be used for de-identified research approved by the Department of Health and Human Services); see Michelle H. Lewis et al., State Laws Regarding the Retention and Use of Residual Newborn Screening Blood Samples, 127 Pediatrics 703, 706 & tbl. 1 (2011) (surveying the status of state newborn screening laws regarding retention and residual use).

36 Astronaut’s Hair Sparks Legal Hubbub, NBC News (June 1, 2005, 3:12 PM), https://www.nbcnews.com/id/wbna8062442 [https://perma.cc/626X-KJC4].

37 Steven Morris, Hair of the Gods: Locks from Elvis and Michael Jackson to Go on Sale, Guardian (Oct. 13, 2009, 6:38 AM), https://www.theguardian.com/music/2009/oct/13/michael-jackson-hair-auction-pepsi [https://perma.cc/DKY7-VFD6].

38 See Andrews & Nelkin, supra note 6, at 6–7.

39 Donation & Transplantation History, Health Res. & Servs. Admin., https://www.organdonor.gov/learn/history [https://perma.cc/3CAB-DWZJ] (last visited Oct. 11, 2024).

40 The modern age of biotechnology dates back to 1980 with the first IPO of a biotech company. See Jonathan Smith, Humble Beginnings: The Origin Story of Modern Biotechnology, Labiotech (June 24, 2022), https://www.labiotech.eu/in-depth/history-biotechnology-genentech/ [https://perma.cc/N7AJ-6NV9].

41 Lori Andrews, Harnessing the Benefits of Biobanks, 33 J.L. Med. & Ethics 22, 22 (2005); see also Storm Theunissen, How Much Is a Body Worth? I Set Out to Find Out, Guardian (Aug. 13, 2012, 8:29 AM), https://www.theguardian.com/commentisfree/2012/aug/13/body-worth-more-dead-alive (“In America, once a cadaver has been disarticulated into about 60 different tissues, the body parts are processed and made into medical products, which together are worth up to $250,000 on the open market.”).

42 See S.M. Thomas et al., Ownership of the Human Genome, 380 Nature 387, 388 (1996) (“[I]nclusion of DNA sequence information in patent claims was essential to secure intellectual property rights to erythropoietin, currently biotechnology’s highest earning drug at $1.5 billion a year.”).

43 Moore v. Regents of Univ. of Cal., 793 P.2d 479, 481–82 (Cal. 1990).

44 See id. at 481.

45 Interviews by Lori Andrews with John Moore.

46 Andrews & Nelkin, supra note 6, at 28; Harriet A. Washington, Deadly Monopolies 11 (2011) (quoting John Moore as saying: “How does it feel to be patented? There was a sense of betrayal. I mean, they owned a part of me that I could never recover. I certainly have no objection to scientific research … but it was like a rape. In a sense, you’ve been violated, for dollars. My genetic essence is held captive.”). The author of this article (Lori Andrews) also interviewed John Moore and his family members in person.

47 Moore v. Regents of Univ. of Cal., 249 Cal. Rptr. 494, 498-99 (Cal. Ct. App. 1988), aff’d in part, rev’d in part 793 P.2d 479 (Cal. 1990).

48 Lugosi v. Universal Pictures, 603 P.2d 425, 431 (Cal. 1979) (acknowledging Lugosi’s right with the qualification that it was personal to Lugosi and did not survive him).

49 Moore, 249 Cal. Rptr. at 508.

50 See id. at 506.

51 Id. at 509.

52 Moore v. Regents of Univ. of Cal., 793 P.2d 479, 487–89 (Cal. 1990).

53 See Andrews & Schultz, supra note 5.

54 Moore, 793 P.2d at 485.

55 Code of Med. Ethics § 7.3.9(a) (Am. Med. Ass’n 2016).

56 Id. § 7.3.9(c).

57 Moore, 793 P.2d at 484.

58 Id. at 481.

59 See id. at 494–95.

60 Id. at 494.

61 Am. Type Culture Collection, http://www.atcc.org [https://perma.cc/SQ44-M4QC] (last visited Sept. 25, 2024).

62 Product Information for Mo [Mo T] Cell-Line – CRL-8066, Am. Type Culture Collection, https://www.atcc.org/products/crl-8066 [https://perma.cc/3H3S-6ZUP] (last visited Sept. 25, 2024).

63 Id.

64 Id.; U.S. Patent No. 11,391,726 (issued July 19, 2022).

65 ATCC Celebrates Building Expansion with Groundbreaking Ceremony, Am.Type Culture Collection (Nov. 7, 2019), https://www.atcc.org/about-us/newsroom/2019-news-releases/atcc-celebrates-building-expansion-with-groundbreaking-ceremony. That certainly sounds like cells are property — just not the individual’s property!

66 Greenberg v. Mia. Children’s Hosp. Rsch. Inst., Inc., 208 F. Supp. 2d 918, 921–22 (N.D. Ill. 2002).

67 See id. at 928–29; Greenberg v. Mia. Children’s Hosp. Rsch. Inst., Inc., 264 F. Supp. 2d 1064, 1068 (S.D. Fla. 2003).

68 Fla. Stat. § 760.40(2)(a) (2021), amended by 2021 Fla. Laws ch. 216 (effective Oct. 1, 2021).

69 See Greenberg, 264 F. Supp. 2d at 1075.

70 See id. at 1074.

71 Id. at 1072–73.

72 See Lacks Amended Complaint, supra note 2, at ¶¶ 47–52; Lacks Settlement Order, supra note 3, at 1.

73 Andrews, supra note 6, at 29, 33.

74 Moore v. Regents of Univ. of Cal., 793 P.2d 479, 493 (Cal. 1990).

75 See York v. Jones, 717 F. Supp. 421, 422 (E.D. Va. 1989).

76 See Skloot, supra note 11, at 31–32.

77 York, 717 F. Supp. at 424.

78 Id.

79 1st U.S. Frozen Embryo Baby Born in L.A., L.A. Times (June 5, 1986), https://www.latimes.com/archives/la-xpm-1986-06-05-me-9460-story.html [https://perma.cc/W7YE-9KFC].

80 York, 717 F. Supp. at 424.

81 Del Zio v. Presbyterian Hosp., No. 74 Civ. 3588, 1978 U.S. Dist. LEXIS 14450, at *1–2 (S.D.N.Y. Nov. 9, 1978); see also Marilyn Church, Test Tube Baby (illustration), in Drawing Justice: Significant and Landmark Cases, Libr. of Cong., https://www.loc.gov/exhibitions/drawing-justice-courtroom-illustrations/about-this-exhibition/significant-and-landmark-cases/frozen-embryos-as-personal-property/ [https://perma.cc/T7TS-EFQG] (last visited Oct. 15, 2024) (sketch of court scene from Del Zio).

82 See Tabitha M. Powledge, A Report from the Del Zio Trial, Hastings Ctr. Rep., Oct. 1978, at 15, 15–17.

83 Del Zio, 1978 U.S. Dist. LEXIS 14450, at *11 (detailing the jury verdict); id. at *24–25 (holding that the jury verdict was “fair, reasonable, and lawful”).

84 Lori B. Andrews, Birth of a Motion, Student Law., Apr. 1990, at 25, 27. The dangers I’d warned about over 30 years ago, regarding claiming personhood in an embryo case came to pass in the 2024 IVF case after a couple used a wrongful death cause of action in a case involving the destruction of their embryo. The parents sued under the Wrongful Death of Minor Act, Ala. Code § 6-5-391 (1975); see also LePage v. Ctr. for Reprod. Med., P.C., No. SC-2022-0515, -0579, 2024 WL 656591, at *1 (Ala. Feb. 16, 2024). The issue of property was not raised in the Alabama Supreme Court case. See id. at *2 (noting that plaintiffs pleaded common-law claims “only in the alternative” and “only … should the Courts of [Alabama] or the United States Supreme Court ultimately rule that [an extrauterine embryo] is not a minor child, but is instead property”). The court’s ruling recognizing the embryo as a person has sparked concern among legal scholars over its potential impact on the legality of IVF in Alabama. See, e.g., Joshua Sharfstein, The Alabama Supreme Court’s Ruling on Frozen Embryos, Johns Hopkins Bloomberg Sch. of Pub. Health (Feb. 27, 2024), https://publichealth.jhu.edu/2024/the-alabama-supreme-courts-ruling-on-frozen-embryos [https://perma.cc/3Z37-WUT2].

85 See York, 717 F. Supp. at 426–27.

86 Id. at 425.

87 Id. at 426–27.

88 Whaley v. County of Tuscola, 58 F.3d 1111, 1114–16 (6th Cir. 1995).

89 See Newman v. Sathyavaglswaran, 287 F.3d 786, 798 (9th Cir. 2002); see also Cal. Gov’t Code § 27491.47(a)(2) (“Notwithstanding any other law, the coroner may, in the course of an autopsy, authorize the removal and release of corneal eye tissue from a body within the coroner’s custody, if … [t]he coroner has no knowledge of objection to the removal … .”).

90 U.S. Const. amend. XIV, § 1; see Newman, 287 F.3d at 788.

91 See Whaley, 58 F.3d at 1113.

92 See id.

93 See id.

94 See id.

95 His agreement with the county gave him access to the eyes if he paid “all the counties’ expenses in performing the autopsies whenever corneas were removed, and half those expenses when they were not.” See id.

96 Id. at 1112.

97 See id. at 1116.

98 Id.; but see Ga. Lions Eye Bank, Inc. v. Lavant, 335 S.E.2d 127, 128–29 (Ga. 1985) (holding that state’s enactment of statute for removal of corneas overrode common law rules). The court in Georgia Lions Eye Bank failed to acknowledge that U.S. Constitutional constraints can override state statutes.

99 A university e-mail stated “Bill Catalona wants to send nearly 2,000 documented samples to Hybertech for free [for research on a diagnostic test for prostate cancer]. Just from a cost recovery scenario, this should be worth nearly $100,000 to the university.” Lori Andrews, “Who Owns Your Body? A Patient’s Perspective on Washington University v. Catalona,” 34 J.L. Med. & Ethics 398-407 (2006).

100 Complaint, ¶¶ 14, 53, Washington Univ. v. Catalona, (Docket No. 4:03-cv-01065, E.D. Mo.) (on record with author).

101 Andrews, supra note 99, at 402; Wash. Univ. v. Catalona, 437 F. Supp. 2d 985, 990 (E.D. Mo. 2006), aff’d, 490 F.3d 667 (8th Cir. 2007).

102 See Catalona, 490 F.3d at 671.

103 See 45 C.F.R. § 46.116(b)(8) (2024).

104 See id. § 46.116(a)(6).

105 Andrews, supra note 99, at 401.

106 See id.

107 See Profile of James Ellis, Walker’s Rsch., http://www.walkersresearch.com/profilePages/Show_Executive_Title/Executiveprofile/J/James_D_Ellis_100006411.html [https://perma.cc/6ZTA-PYV3] (last visited Oct. 1, 2024); Nate Raymond, James Ellis (10) AT&T Inc., Am. Law. Media (July 18, 2007), https://www.law.com/corpcounsel/almID/900005486364/.

108 See Walker’s Rsch., supra note 107.

109 Wash. Univ. v. Catalona, 490 F.3d 667, 676–77 (8th Cir. 2007).

110 See 45 C.F.R. §§ 46.116(a)(8), (b)(2) (2024).

111 See discussion supra accompanying notes 75–85.

112 See Andrews & Nelkin, supra note 6, at 27–28 (describing commercial sale of Mo-cell line, derived from John Moore, to biotechnology company).

113 See Jana Bommersbach, Arizona’s Broken Arrow: Did Arizona State University Genetically Rape the Havasupai Tribe?, Phx. Mag., Nov. 2008, at 134, https://janabommersbach.com/arizonas-broken-arrow-did-arizona-state-university-genetically-rape-the-havasupai-tribe/ [https://perma.cc/3SGY-2SPX].

114 See Complaint at 10, 14, Havasupai Tribe v. Ariz. Bd. of Regents, 204 P.3d 1063 (Ariz. App. 2008) (No. 1 CA-CV 07-0454).

115 See id. at 14; see also Erin Blakemore, Why the Navajo Nation Banned Genetic Research, History (July 11, 2023), https://www.history.com/news/why-the-navajo-nation-banned-genetic-research [https://perma.cc/Y62D-F99R].

116 Nanibaa’ A. Garrison, Genomic Justice for Native Americans: Impact of the Havasupai Case on Genetic Research, 38 Sci. Tech. & Hum. Values 201, 204 (2012).

117 Tilousi v. Ariz. State Univ. Bd. of Regents, No. 04-CV-1290, 2005 WL 6199562, at *6-7 (D. Ariz. Mar. 3, 2005) (order denying in part and granting in part motion to dismiss).

118 Amy Harmon, Indian Tribe Wins Fight to Limit Research of Its DNA, N.Y. Times (Apr. 21, 2010), https://www.nytimes.com/2010/04/22/us/22dna.html [https://perma.cc/BX3M-HGRQ].

119 Id.; Katie Shoultz, ABOR Settles Lawsuit with Havasupai Tribe Over Blood Samples, State Press (Apr. 22, 2010, 4:00 PM), https://www.statepress.com/article/2010/04/abor-settles-lawsuit-with-havasupai-tribe-over-blood-samples# [https://perma.cc/P78D-NDP7].

120 Consent to Medical Care Agreement, Form 43004, Nw. Med. (Apr. 2024), https://www.nm.org/-/media/northwestern/resources/patients-and-visitors/northwestern-medicine-universal-consent-form.pdf [https://perma.cc/L4E8-EB6L].

121 States, through the adoption of their versions of the Uniform Anatomical Gift Act, give rights to individuals to control what is done with their tissue after they die. Unif. Anatomical Gift Act §10 (Unif. L. Comm’n 2006) (amended 2009); see also Uniform Anatomical Gift Act, Unif. L. Comm’n (2024), https://www.uniformlaws.org/committees/community-home?CommunityKey=015e18ad-4806-4dff-b011-8e1ebc0d1d0f [https://perma.cc/2XJY-6XZ6] (showing map of state enactment). However, states generally have not adopted statutes providing that tissue is the property of the living individual. That protection, where available, is a common law one. The exception is genes, where some states have decreed DNA and/or genetic information as the property of the individual. In the insurance context, see Colo. Rev. Stat. § 10-3-1104.7(1)(a) (2024); Fla. Stat. § 760.40(2) (2024); Ga. Code Ann. § 33-54-1(1) (2024); La. Stat. Ann. § 22:1023(E) (2024). However, Colorado, Georgia, and Louisiana permit the use of “genetic information” for research purposes when the identity of the individual is not disclosed. Colo. Rev. Stat. § 10-3-1104.7(5) (2024); Ga. Code Ann. § 33-54-6 (2024); La. Stat. Ann. § 22:1023(D)(4) (2024)