1 E.g., Bernstein, Gaia, Direct-to-Consumer Genetic Testing: Gatekeeping the Production of Genetic Information, 79 UMKC L. Rev. 283, 284 (2010)Google Scholar (discussing increasing prominence of a consumer model of genetic testing).

2 Our Service, 23andMe, https://www.23andme.com/service/ [https:\\perma.cc/EA44-VML8] [herinafter OurService].

3 See, e.g., Alexander, A., “Just Scanning Around” with Diagnostic Medical Ultrasound: Should States Regulate the Non-Diagnostic Uses of This Technology?, 16 Annals Health L. 1, 6 (2007)Google ScholarPubMed (discussing fetal ultrasound tests); Illes, Judy et al., Self-Referred Whole-Body CT Imaging: Current Implications for Health Care Consumers, 228 Radiology 346 (2003)CrossRefGoogle ScholarPubMed (discussing full body scans); Laurie Tarkan, Blood-Test Labs Bypass Doctors, Spurring Debate, N.Y. Times, Mar. 12, 2002, http://www.nytimes.com/2002/03/12/health/blood-test-labs-bypass-doctors-spurring-debate.html?pagewanted=print [http://perma.cc/9XHA-WCG8] (discussing blood tests); Bernstein, supra note 1 (discussing genetic testing).

4 Infra Part II.B.2; see, e.g., FDA, Avoid Fetal “Keepsake” Images, Heartbeat Monitors 1 (2015), http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm095508.htm [http://perma.cc/K395-C439] [hereinafter FDA, Avoid KFU] (“When the product is purchased over the counter and used without consultation with a health care professional taking care of the pregnant woman, there is no oversight of how the device is used.”) (internal quotation marks omitted).

5 E.g., Ruth R. Faden et al., A History and Theory of Informed Consent 127 (1986).

6 FDA, Avoid KFU, supra note 4.

7 Letter from Alberto Gutierrez, Dir., Office of In Vitro Diagnostics and Radiological Health, HHS, to Ann[e] Wojcicki, Chief Exec. Officer, 23andMe, Inc. 1 (Nov. 22, 2013), http://www.fda.gov/iceci/enforcementactions/warningletters/2013/ucm376296.htm [http://www.perma.cc/B9LB-BFWW]; see Press Release, 23andMe Launches New Customer Experience – Reports Include Carrier Status That Meet FDA Standards, Wellness, Traits, and Ancestry (Oct. 21, 2015), 23andMe, http://mediacenter.23andme.com/blog/2015/10/21/new-23andme/ [http://perma.cc/4K72-UJEM].

8 Presidential Comm'n for the Study of Bioethical Issues, Anticipate and Communicate: Ethical Management of Incidental and Secondary Findings in the Clinical, Research, and Direct-to-Consumer Contexts 98, 106 (2013), http://bioethics.gov/sites/default/files/FINALAnticipateCommunicate_PCSBI_0.pdf [http://perma.cc/B8GR-XNHW] [hereinafter Bioethics Comm'n, Anticipate and Communicate].

9 See, e.g., FDA, Avoid KFU, supra note 4.

10 See, e.g., Mehlman, Maxwell J., Fiduciary Contracting: Limitations on Bargaining Between Patients and Health Care Providers, 51 U. Pitt. L. Rev. 365, 367 (1990)Google Scholar (“The issue … is not only whether contracts should be allowed to change the rules of tort law, but also whether patients should be allowed to contract without the protection of these fiduciary principles.”).

11 See, e.g., Release and Waiver of Liability 2D, 3D, 4D Ultrasound, Pregnancy Treasures, LLC, http://www.pregnancytreasures.com/waiver.pdf [http://perma.cc/B3JX-L383] [hereinafter Pregnancy Treasures].

12 Bioethics Comm'n, Anticipate and Communicate, supra note 8, at 2 (“Incidental findings” are findings that are not the objective of the test at issue, but can still cause distress and anxiety in the recipient.).

13 See e.g., Andrew Pollack, 23andMe Will Resume Giving Users Health Data, N.Y. Times, Oct. 21, 2015, at B3.

14 Terms of Service, 23andMe, https://www.23andme.com/about/tos/ [hereinafter, 23andMe, Terms of Service] [http://prma.cc/X3DM-ZAXR] [hereinafter 23andMe].

15 See, e.g., id. (disclaiming “diagnos[ing] disease or medical conditions”).

16 See discussion infra Part II.A.2.

17 E.g., Beauchamp, Tom L., Informed Consent: Its History, Meaning, and Present Challenges, 20 Cambridge Q. Healthcare Ethics 515, 518 (2011).CrossRefGoogle ScholarPubMed

18 See, e.g., Jessica W. Berg et al., Informed Consent: Legal Theory and Practice 18-19 (2d ed. 2001) (presenting a brief ethical and legal history of informed consent as well as an in-depth practical guide to current application of the paradigm); Faden et al., supra note 5, at 23 (describing the history of informed consent from both a moral philosophical as well as legal viewpoint).

19 Beauchamp, supra note 17, at 519.

20 See Faden et al., supra note 5, at 179-87.

21 See, e.g., Hippocrates, The Oath (Francis Adams trans. 400 B.C.), http://classics.mit.edu/Hippocrates/hippooath.html [http://perma.cc/B2JH-86RE] (“I will follow that system of regimen which according to my ability and judgment I consider for the benefit of my patients….”).

22 E.g., Faden et al., supra note 5, at 10.

23 See generally Id. (discussing the shaping of medical ethics through the 1900s).

24 See, e.g., Schuck, Peter H., Rethinking Informed Consent, 103 Yale L.J. 899, 924 (1994)CrossRefGoogle ScholarPubMed (“Few if any choices are more private and intimate than those that concern the use made of one's own body, and thus society should not permit one's bodily integrity to be threatened by another unless one has knowingly and voluntarily consented ….”).

25 E.g., Berg et al., supra note 18, at 41.

26 E.g., Beauchamp, supra note 17, at 515 (“[M]edical and research ethics [has] gradually moved from a narrow focus on the physician's … obligation to disclose information to an emphasis on the quality of a patient's … understanding of information ….”).

27 E.g., Berg et al., supra note 18, at 18.

28 Faden et al., supra note 5, at 120.

29 Schloendorff v. Soc'y of N.Y. Hosp., 105 N.E. 92, 93 (N.Y. 1914); see also Lombardo, Paul A., Phantom Tumors and Hysterical Women: Revising Our View of the Schloendorff Case, 33 J.L. Med. & Ethics 791, 795 (2005)CrossRefGoogle ScholarPubMed (“Mary Schloendorff had no ordinary tumor … and the operation done against her will was a hysterectomy.”).

30 Lombardo, supra note 29, at 799 (“[T]he surgeon's declaration reveals that the only defense he could muster was that she had not directly refused his services…. So while this might be a case about the need for simple consent, it is hardly a case about informed consent.”).

31 Schloendorff, 105 N.E. at 93.

32 E.g., Morreim, E. Haavi, Litigation in Clinical Research: Malpractice Doctrines Versus Research Realities, 32 J.L. Med. & Ethics 474, 478 (2004).CrossRefGoogle ScholarPubMed

33 E.g., id. But see Lombardo, supra note 29, at 799 (arguing that “[a]t best Cardozo's opinion merely restates a maxim that could even at the time of trial be traced back through two hundred and fifty years in American law: surgery without consent is actionable; in some instances, it could even be considered a crime”).

34 E.g., Morreim, supra note 32.

35 Natanson v. Kline, 350 P.2d 1093, 1100 (Kan. 1960).

36 Id.

37 President's Comm'n for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research, 1 Making Health Care Decisions: The Ethical and Legal Implications of Informed Consent in the Patient-Practitioner Relationship 2 (1982), http://kie.georgetown.edu/nrcbl/documents/pcemr/makingdecisions.pdf [https://perma.cc/YRE8-EV4V] [hereinafter President's Comm'n, Making Health Care Decisions].

38 Salgo v. Leland Stanford Jr. Univ. Bd. of Trs., 317 P.2d 170, 181 (Cal. Ct. App. 1957) (“The instruction given should be modified to inform the jury that the physician has such discretion consistent, of course, with the full disclosure of facts necessary to an informed consent.”).

39 Faden et al., supra note 5, at 126.

40 Salgo, 317 P.2d at 181.

41 Id.

42 Faden et al., supra note 5, at 127 (adding that “[i]n Salgo, autonomy and beneficence met clumsily, unexpectedly, like two figures backing into each other in a darkened room, both struggling to reach the light”).

43 Canterbury v. Spence, 464 F.2d 772, 789 (D.C. Cir. 1972) (“That attitude presumes instability or perversity for even the normal patient, and runs counter to the foundation principle that the patient should and ordinarily can make the choice for himself.”).

44 E.g., Morreim, supra note 32, at 477 (“[C]ourts have felt free to call the physician-patient relationship fiduciary or at least a relationship of trust and confidence.”).

45 Moore v. Regents of the Univ. of Cal., 793 P.2d 479, 483 (Cal. 1990) (“[A] physician must disclose personal interests unrelated to the patient's health, whether research or economic, that may affect the physician's professional judgment ….”).

46 E.g., Beverly Hills Concepts, Inc. v. Schatz & Schatz, 717 A.2d 724, 730 (Conn. 1998) (“Professional negligence implicates a duty of care, while breach of a fiduciary duty implicates a duty of loyalty and honesty.”).

47 Hafemeister, Thomas L. & Bryan, Sarah P., Beware Those Bearing Gifts: Physicians' Fiduciary Duty to Avoid Pharmaceutical Marketing, 57 Kan. L. Rev. 491, 519 (2009)Google Scholar (“Over time, this doctrine has been extended beyond the trustee-beneficiary relationship to other relationships in which a party… is entrusted with the responsibility to act and make decisions on behalf of another individual… with the expectation that the fiduciary will seek to promote the beneficiary's welfare.”).

48 See Hafemeister, Thomas L. & Gulbrandsen, Richard M. Jr., The Fiduciary Obligation of Physicians to “Just Say No” if an “Informed” Patient Demands Services that Are Not Medically Indicated, 39 Seton Hall L. Rev. 335, 368 (2009)Google Scholar (“[F]iduciary obligations have been imposed on various professionals, and generally stem from (1) the beneficiary's vulnerability and dependence on the fiduciary, (2) the superior knowledge and related skills of the fiduciary, and (3) the trust placed in the fiduciary to protect and promote the best interests of the beneficiary.”).

49 Moore, 793 P.2d 479.

50 Id. at 480-83.

51 Id. at 483 (“This cause of action can properly be characterized either as the breach of a fiduciary duty to disclose facts material to the patient's consent or, alternatively, as the performance of medical procedures without first having obtained the patient's informed consent.”). Moore is unique in “allow[ing] an independent claim of breach of fiduciary duty [] against a medical doctor for harm other than cases involving release of confidential information without the patient's consent.” Forell, Caroline & Sortun, Anna, The Tort of Betrayal of Trust, 42 U. Mich. J.L. Reform 557, 586-87 (2009).Google Scholar

52 Moore, 793 P.2d at 483. But see Forell & Sortun, supra note 51, at 592 for a criticism of Moore's interpretation of fiduciary disclosures as part of the informed consent process as a conflation of obligations.

53 Restatement (Third) of Torts: Products Liability § 1 (Am. Law Inst. 1998) (“One engaged in the business of selling or otherwise distributing products who sells or distributes a defective product is subject to liability for harm to persons or property caused by the defect.”); Id. at § 2(c) (A product can be considered “defective because of inadequate instructions or warnings when the foreseeable risks of harm posed by the product could have been reduced or avoided by the provision of reasonable instructions or warnings by the seller or other distributor … and the omission of the instructions or warnings renders the product not reasonably safe.”).

54 While much of this discussion is also applicable to drugs, because the majority of DTC products are devices they will be the focus of this Article.

55 Martin v. Hacker, 628 N.E.2d 1308, 1311 (N.Y. 1993) (“The physician acts as an ‘informed intermediary’ between the manufacturer and the patient; and, thus, the manufacturer's duty to caution against a drug's side effects is fulfilled by giving adequate warning through the prescribing physician, not directly to the patient.”) (citation omitted).

56 Meaning of Intended Uses, 21 C.F.R § 801.4 (2015).

57 United States v. Evers, 453 F. Supp. 1141, 1148 (M.D. Ala. 1978). Historically this would be considered misbranding and constitutes a violation of the Food Drug and Cosmetic Act. See Id. (“When a manufacturer or anyone in the chain of distribution suggests to a patient that an approved drug may properly be used for unapproved uses for which it is neither labeled nor publicly advertised, that action constitutes a violation of the act and is punishable accordingly as a misbranding of the drug.”); see also 21 U.S.C § 331(a) (2012) (“The introduction or delivery for introduction into interstate commerce of any … device … that is adulterated or misbranded” is prohibited.). But the recent United States v. Caronia in the Second Circuit has called the constitutionality of this position into question. United States v. Caronia, 703 F.3d 149, 169 (2d Cir. 2012) (“We conclude simply that the government cannot prosecute pharmaceutical manufacturers and their representatives under the [Food, Drug, and Cosmetic Act] for speech promoting the lawful, off-label use of an FDA-approved drug.”). Although FDA has not changed its enforcement policy. US v. Caronia, One Year Later: FDA's Position on Off-Label Promotion Remains the Same, but Changes Are Looming, Policy and Medicine (Feb. 20, 2014), http://www.policymed.com/2014/02/us-v-caronia-one-year-later-fdas-position-on-off-label-promotion-remains-the-same-but-changes-are-looming.html#sthash.MPLsPtka.dpuf [http://perma.cc/D3BQ-4FJF].

58 FDA, Guidance for Industry: Good Reprint Practices for the Distribution of Medical Journal Articles and Medical or Scientific Reference Publications on Unapproved New Uses of Approved Drugs and Approved or Cleared Medical Devices 3 (2009), http://www.fda.gov/RegulatoryInformation/Guidances/ucm125126.htm [http://perma.cc/6RA8-45QM] [hereinafter FDA, Good Reprint Practices] (“Once a drug or medical device has been approved or cleared by FDA, generally, healthcare professionals may lawfully use or prescribe that product for uses or treatment regimens that are not included in the product's approved labeling ….”).

59 Smith, John J., Physician Modification of Legally Marketed Medical Devices: Regulatory Implications Under the Federal Food, Drug, and Cosmetic Act, 55 Food Drug L.J. 245, 252 (2000)Google ScholarPubMed; FDA, Off-Label and Investigational Use of Marketed Drugs, Biologics, and Medical Devices-Information Sheet (2014), http://www.fda.gov/regulatoryinformation/guidances/ucm126486.htm [http://perma.cc/APA8-CYKV] (stating that products prescribed for a new use by physicians “when the intent is the ‘practice of medicine’” do not require FDA evaluation or approval).

60 FDA, Good Reprint Practices, supra note 58.

61 21 U.S.C § 396 (2012) (“Nothing in this chapter shall be construed to limit or interfere with the authority of a health care practitioner to prescribe or administer any legally marketed device to a patient for any condition or disease within a legitimate health care practitioner-patient relationship.”); Smith, supra note 59.

62 Martin v. Hacker, 628 N.E.2d 1308, 1311 (N.Y. 1993).

63 See id.

64 Calabro, Sheryl, Note, Breaking the Shield of the Learned Intermediary Doctrine: Placing the Blame Where it Belongs, 25 Cardozo L. Rev. 2241, 2248 (2004).Google Scholar

65 Beck, James M. & Azari, Elizabeth D., FDA, Off-Label Use, and Informed Consent: Debunking Myths and Misconceptions, 53 Food & Drug L.J. 71, 100 (1998).Google ScholarPubMed

66 Berg et al., supra note 18, at 140.

67 Id. at 56 (internal quotation marks omitted).

68 Lyons v. Grether, 239 S.E.2d 103, 105 (Va. 1977) (“A physician's duty … springs from a consensual transaction, a contract, express or implied, general or special ….”).

69 Restatement (Second) of Contracts § 1 (Am. Law Inst. 1981) (“A contract is a promise or a set of promises for the breach of which the law gives a remedy, or the performance of which the law in some way recognizes as a duty.”).

70 Ash v. N.Y. Univ. Dental Ctr., 564 N.Y.S.2d 308, 310 (App. Div. 1990) (“[C]learly and unambiguously attempts to exempt a party only from liability for ordinary negligence will not be enforced by the courts of this State, if it is found to violate public policy either by way of conflicting with an overriding public interest or because it constitutes an abuse of a special relationship between the parties, or both.”). This inquiry focuses on the substance of the agreement rather than the bargaining process itself. Restatement (Second) of Contracts ch. 8, topic 1, intro. note (Am. Law Inst. 1981); see Id. at § 7, cmt.

71 Ash, 564 N.Y.S.2d at 310 (noting that it has been held that “clearly and unambiguously attempts to exempt a party only from liability for ordinary negligence will not be enforced by the courts of this State, if it is found to violate public policy either by way of conflicting with an overriding public interest or because it constitutes an abuse of a special relationship between the parties, or both”). This inquiry focuses on the substance of the agreement, rather than the bargaining process itself. Id. Restatement (Second) of Contracts ch. 8, topic 1, intro. note (Am. Law Inst. 1981); Id. at § 7, cmt.

72 Restatement (Second) of Contracts ch. 8, intro. note (Am. Law Inst. 1981) (“Sometimes … a court will decide that the interest in freedom of contract is outweighed by some overriding interest of society and will refuse to enforce a promise or other term on grounds of public policy…. The decision in a particular case will often turn on a delicate balancing of these considerations against those that favor supporting transactions freely entered into by the parties.”).

73 Mehlman, supra note 10, at 368-69.

74 Id.

75 Id.

76 See Id.; Devin Leonard, Is Concierge Medicine the Future of Health Care?, BloombergBusinessweek, Nov. 29, 2012, http://www.businessweek.com/articles/2012-11-29/is-concierge-medicine-the-future-of-health-care#p2 [http://perma.cc/R3ZX-HQLH].

77 Schuck, supra note 24, at 958.

78 Id. at 957 (internal quotation marks omitted) (“But a doctrine that treats all patients and physician-patient relationships as essentially homogeneous when in fact they are not exacts a price. Specifically, the law requires a level of informed consent that is different from the level that many consumers or groups of consumers want and for which they would be willing to pay if the choice were presented to them.”).

79 Id. at 957-58.

80 Shultz, Marjorie Maguire, From Informed Consent to Patient Choice: A New Protected Interest, 95 Yale L.J. 219, 281 (1985)CrossRefGoogle ScholarPubMed (arguing that “although patients may be incapable of supervising the quality and administration of care, they are capable, indeed uniquely so, of balancing ultimate costs and benefits of care decisions”).

81 See Hafemeister & Gulbrandsen, supra note 48, at 342 (“[P]atients are … in no position to engage in a traditional bargaining process.”).

82 Id. at 342.

83 Shultz, supra note 80, at 282 (“Although public knowledge about medicine has greatly increased, patients still rely on doctors for education and counsel, particularly about their individual condition and options.”).

84 Mehlman, supra note 10, at 389-91.

85 Id. at 391.

86 Id. at 391-93.

87 President's Comm'n, Making Health Care Decisions, supra note 37, at 37 (“[F]or reasons of history, tradition, expectations, and disparities in educational, class, and health status, patients and professionals often start out on substantially unequal footing, raising serious questions about the ability of many patients to have an effective role in shaping the relationship.”).

88 See id. at 39.

89 Mehlman, supra note 10, at 380.

90 See id.

91 Id. at 391-92 (“[D]isclosure of alternatives resembles a fiduciary rather than a contractual requirement.”).

92 See Id. at 384-85 (“When this assumption is called into question — such as when one party is impeded by an information deficit — contract theory is torn between enforcing the bargain notwithstanding, and deviating from the arm's length ideal. It resolves this conflict fitfully, and only requires disclosure in limited circumstances.”) (footnote omitted).

93 Epstein, Richard A., Unconscionability: A Critical Reappraisal, 18 J.L. & Econ. 293, 299 (1975)CrossRefGoogle Scholar; see Mehlman, supra note 10, at 387-88.

94 Mehlman, supra note 10, at 396-97.

95 Id. at 367.

96 Id. at 390 (“The protections of fiduciary law are intended to permit patients to take advantage of the providers' superior information and expertise with the expectation that the provider will use this information in the patient's best interests. This avoids the need for patients to expend significant resources to monitor the provider's behavior.”). (footnote omitted).

97 Id. at 389-91.

98 Rodwin, Marc A., Strains in the Fiduciary Metaphor: Divided Physician Loyalties and Obligations in a Changing Health Care System, 21 Am. J.L. & Med. 241, 244 (1995)Google Scholar (“Using their authority to ‘do justice,’ courts can refuse to enforce contracts that eliminate fiduciary obligations.”).

99 Austin Wakeman Scott & William F. Fratcher, The Law of Trusts § 2.5, at 43 (4th ed. 1987) (“If the fiduciary enters into a transaction with the beneficiary and … if the transaction is unfair to the beneficiary, it can be set aside by him.”).

100 Mehlman, supra note 10, at 366.

101 Dresser Indus., Inc. v. Page Petroleum, Inc., 853 S.W.2d 505, 507-08 (Tex. 1993) (“[A] release, or hold harmless agreement, is defined as: A contractual agreement whereby … one party agrees to hold the other without responsibility for damage or other liability arising out of the transaction involved ….”) (quoting BLACK'S LAW DICTIONARY 658 (5th ed. 1979).

102 Nelson, Robert S., Comment, The Theory of the Waiver Scale: An Argument Why Parents Should Be Able to Waive Their Children's Tort Liability Claims, 36 U.S.F. L. Rev. 535, 536 (2002).Google Scholar

103 Dresser, Indus., Inc., 853 S.W.2d at 507-08.

104 See e.g., Bituminous Cas. Corp. v. Williams, 17 So. 2d 98, 101 (Fla. 1944) (“When a particular contract, transaction, or course of dealing is not prohibited under constitutional or statutory provision, or prior judicial decision, it should not be struck down on the ground that it is contrary to public policy, except it be clearly injurious to the public good or contravene some established interest of society.”).

105 Nelson, supra note 102, at 537.

106 E.g., Doyle v. Bowdoin Coll., 403 A.2d 1206, 1207 (Me. 1979).

107 Nelson, supra note 102, at 544 (“Courts will therefore engage in detailed, fact-specific reviews of challenged exculpatory agreements to determine whether any unusual factors tilt the scales abnormally in favor of tort.”).

108 Id. at 550.

109 See, e.g., Tunkl v. Regents of Univ. of Cal., 383 P.2d 441, 444, 447 (Cal. 1963) (finding “that the hospital-patient contract clearly falls within the category of agreements affecting the public interest”).

110 Okura v. United States Cycling Fed'n, 186 Cal. App. 3d 1462, 1468 (1986) (holding that a release of liability for bicycle racing was not invalid because the transaction created a voluntary relationship between the parties and conditions did not exist to establish a contract of adhesion).

111 Emory Univ. v Porubiansky, 282 S.E.2d 903, 905 (Ga. 1981).

112 See generally Tunkl, 383 P.2d 441 (“While obviously no public policy opposes private, voluntary transactions in which one party, for a consideration, agrees to shoulder a risk which the law would otherwise have placed upon the other party, the above circumstances pose a different situation. In this situation the releasing party does not really acquiesce voluntarily in the contractual shifting of the risk, nor can we be reasonably certain that he receives an adequate consideration for the transfer.”).

113 Id. at 444.

114 Id. at 447.

115 Id. at 445.

116 Id.

117 Id.

118 Id. at 445-46.

119 Id. at 447.

120 Id. at 446.

121 Id. at 447 (“[W]hen the patient signed the contract, he completely placed himself in the control of the hospital; he subjected himself to the risk of its carelessness.”).

122 Id. at 441-42 (holding “that an agreement between a hospital and an entering patient affects the public interest and that, in consequence, the exculpatory provision included within it must be invalid”).

123 Schuck, supra note 24, at 911.

124 See e.g., Meiman v. Rehabilitation Ctr., 444 S.W.2d 78, 80 (Ky. Ct. App. 1969) (extending Tunkl's reasoning to physical therapists).

125 Ash v. N.Y. Univ. Dental Ctr., 564 N.Y.S.2d 308, 310 (App. Div. 1990).

126 Id. at 311 (“It is the very importance of such [public] clinics to the people who use them that would create an invidious result if the exculpatory clause in issue were upheld—i.e., a de facto system in which the medical services received by the less affluent are permitted to be governed by lesser minimal standards of care and skill than that received by other segments of society.”).

127 Palumbo, Francis B. & Mullins, C. Daniel, The Development of Direct-to-Consumer Prescription Drug Advertising Regulation, 57 Food & Drug L.J 423, 424-26 (2002)Google ScholarPubMed; see, e.g., Tarkan, supra note 3 (discussing the use of DTC blood tests).

128 Anna Wilde Mathews, Worried About Cholesterol? Order Your Own Tests, Wall St. J., Jan. 11, 2011, http://www.wsj.com/articles/SB10001424052748704458204576073913850150324; Tarkan, supra note 3.

129 Fenton, Joshua J. & Deyo, Richard A., Patient Self-Referral for Radiologic Screening Tests: Clinical and Ethical Concerns, 16 J. Am. Board Fam. Med. 494, 495 (2003).CrossRefGoogle ScholarPubMed

130 Id.

131 See, e.g., Gina Kolata, Cheaper Body Scans Spread, Despite Doubts, N.Y. Times, May 27, 2002, http://www.nytimes.com/2002/05/27/us/cheaper-body-scans-spread-despite-doubts.html?pagewanted=all (CAT Scan 2000 of Florida, which has dubbed itself the “Wal-Mart of scanning … [and has] mobile units that … stop[] at places like the North Park Church of Christ … charges $199 to scan a region of the body ….”).

132 E.g., Palmer, Jessica Elizabeth, Note, Genetic Gatekeepers: Regulating Direct-to-Consumer Genomic Services in an Era of Participatory Medicine, 67 Food & Drug L.J. 475, 489 (2012).Google Scholar

133 E.g., Letter from Alberto Gutierrez, Dir., to Ann[e] Wojcicki, supra note 7.

134 E.g., Leung, John Lai Yin & Pang, Samantha Mei Che, Ethical Analysis of Non-Medical Fetal Ultrasound, 16 Nursing Ethics 637, 638-39 (2009).CrossRefGoogle ScholarPubMed

135 Bioethics Comm'n, Anticipate and Communicate, supra note 8, at 101.

136 Id.

137 Id.

138 Ruger, Jennifer Prah, Health, Capability, and Justice: Toward a New Paradigm of Health Ethics, Policy and Law, 15 Cornell J.L. & Pub. Pol'y 403, 407 (2006).Google Scholar

139 Schuck, supra note 24, at 924 (arguing that “[t]he more private the choice—that is, the more it concerns the integrity of the individual's own projects and self-conception and the less it directly affects others—the more robust this right should be”).

140 This Article will not use either of these rhetorical misnomers. First, an article about informed consent would be bereft not to point out that all fetal ultrasounds are of course “elective” from the perspective that the patient must always consent to this diagnostic test if competent to do so. Second, suggesting that a medical service is for “entertainment” prematurely discounts any more formidable sociological benefit of such a practice.

141 Uhles, Jennifer M., Unsound Ultrasounds?: An Examination of State Legislation Regulating Non-Medical Ultrasound Use and Private Ownership, 28 J. Legal Med. 263, 265-66 (2007).CrossRefGoogle ScholarPubMed

142 Hudson, Kathy et al., ASHG Statement on Direct-to-Consumer Genetic Testing in the United States, 110 Obstetrics & Gynecology 1392, 1393 (2007).CrossRefGoogle ScholarPubMed

143 E.g., Wiseman, Claudia S. & Kiehl, Ermalynn M., Picture Perfect: Benefits and Risks of Fetal 3D Ultrasound, 32 Am. J. Maternal Child Nursing 102 (2007)CrossRefGoogle ScholarPubMed; Bioethics Comm'n, Anticipate and Communicate, supra note 8, at 2.

144 E.g., FDA, Fetal Keepsake Videos http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/PatientAlerts/ucm064756.htm [https://perma.cc/CY32-Y9RN?type=image].

145 Wiseman & Kiehl, supra note 143, at 103.

146 Id.

147 Id.

148 Alexandra Sifferlin, HD Ultrasounds: 4D Imaging of Your Unborn Child is the Future, Time, Dec. 19, 2013, http://lightbox.time.com/2013/12/19/hd-ultrasounds-4d-imaging-of-your-unborn-child-is-the-future/ [http://perma.cc/4ZCX-6JCS].

149 Rotten, D. & Levaillant, J. M., Two- and Three-Dimensional Sonographic Assessment of the Fetal Face. 1.A Systematic Analysis of the Normal Face, 3 Ultrasound in Obstetrics & Gynecology 224, 230 (2004).CrossRefGoogle Scholar

150 Merz, E. & Welter, C., 2D and 3D Ultrasound in the Evaluation of Normal and Abnormal Fetal Anatomy in the Second and Third Trimesters in a Level III Center, 26 Ultraschall Med. 9, 15 (2005)CrossRefGoogle Scholar (“The ability of 3D ultrasound to demonstrate any arbitrary plane in a stored volume or to provide images of the fetal surface with near-photographic clarity enables a better assessment of the severity of the fetal anomaly than the 2D scan… it is possible to convey the area of interest to the parents, providing them with a better understanding of the fetal malformation.”).

151 Goodnight, William & Chescheir, Nancy, Keepsake Prenatal Ultrasound: Pros and Cons of Non–Medically Indicated Imaging, 75 N.C. Med. J. 138, 138 (2014)Google ScholarPubMed (“Patient demand for ‘keepsake’ prenatal images has arisen because of a confluence of factors: 4-dimensional (4D) imaging now allows sonographers to capture 3-dimensional (3D) images in real time [and] the mother may want to ‘show’ her baby to family members who are not present during the medical exam ….”).

152 For example, the chair of the American Medical Association Council on Ethical and Judicial Affairs, “has oppose[d] profit-making sales of non-health-related goods in physicians' offices” generally because of the “significant concern for the impact [of a substantial product fee] on the physician-patient relationship.” Voelker, Rebecca, The Business of Baby Pictures: Controversy Brews Over “Keepsake” Fetal Ultrasounds, 293 JAMA 25, 26 (2005)Google ScholarPubMed (internal quotation marks omitted).

153 Press Release, Am. Inst. Of Ultrasound Med., AIUM Opposes Use of Ultrasound for Entertainment (Nov. 5, 2002), http://www.aium.org/press/viewRelease.aspx?id=61 [http://perma.cc/965B-GU8B] [hereinafter AIUM, Entertainment].

154 Am. Inst. Of Ultrasound Med., Introduction of Legislation Against Non-Medical Use of Fetal Ultrasound (2004), at 2, http://www.aium.org/patients/entertainment/article1.pdf [http://perma.cc/W338-KJPV] [hereinafter AIUM, Introduction of Legislation] (“Even General Electric, the leading seller of 4D ultrasound machines, has joined… [others] to express its opposition to the use [sic] this equipment for nonmedical purposes.”). While some keepsake ultrasound providers purchase machines through national distributers, they are also available on websites such as eBay. Sam Lubell, The Womb as Photo Studio, N.Y. Times, Sept. 23, 2004, http://www.nytimes.com/2004/09/23/technology/circuits/the-womb-as-photo-studio.html?_r=0; 3D Ultrasound Machine, http://www.ebay.com/sch/i.html?_from=R40|R40|R40&_sacat=0&_nkw=3D%20ultrasound%20machine&rt=nc&_pppn=r1&_mPrRngCbx=1&_udlo=10000&_udhi=50000 (last visited Aug. 26, 2014) (however, many list the FDA disclaimer that: “The sale of this item may be subject to regulation by [FDA] and state and local regulatory agencies. If so, do not bid on this item unless you are an authorized purchaser. If the item is subject to FDA regulation, I will verify your status as an authorized purchaser of this item before shipping of the item”). See e.g., GE Logiq E Portable Ultrasound Machine http://www.ebay.com/itm/GE-Logiq-E-Portable-Ultrasound-Machine-/390580530643?pt=LH_DefaultDomain_0&hash=item5af069edd3 (last visited Aug. 26, 2014).

155 FDA, Avoid KFU, supra note 4 (“Ultrasound can heat tissues slightly, and in some cases, it can also produce very small bubbles (cavitation) in some tissues.”).

156 Chervenak, Frank A. & McCullough, Laurence B., An Ethical Critique of Boutique Fetal Imaging: A Case for the Medicalization of Fetal Imaging, 192 Am. J. Obstetrics & Gynecology 31, 32 (2005).CrossRefGoogle ScholarPubMed

157 Leung & Pang, supra note 134.

158 Id.

159 Ang, Eugenius S. B.C. Jr., et al., Prenatal Exposure to Ultrasound Waves Impacts Neuronal Migration in Mice, 103 Proc. Nat'l Academy Sci. USA 12903, 12903 (2006)CrossRefGoogle ScholarPubMed (“Our analysis of over 335 animals reveals that, when exposed to [ultrasound waves] for a total of 30 min or longer during the period of their migration, a small but statistically significant number of neurons fail to acquire their proper position and remain scattered within inappropriate cortical layers and/or in the subjacent white matter … [which] systematically increased with duration of exposure to [ultrasound waves].”).

160 Wiseman & Kiehl, supra note 143, at 106 (“[T]he time of exposure is a major concern in the practice of obstetrics, all professional organizations have supported limits for the maximum exposure time to 20 min for the developing fetus.”).

161 Leung & Pang, supra note 134, at 639 (“A prolonged scanning time resulting from inexperience would certainly have an impact on the possible detrimental effects of ultrasound on a developing fetus.”).

162 See, e.g., In-Office Ultrasound Packages, Baby Joy, http://babyjoy3d4dmobileultrasound.com/mobile-ultrasound-packages/ [http://perma.cc/5A2R-T6QF].

163 Wiseman & Kiehl, supra note 143, at 103.

164 Joshua A. Copel, Non-Clinical Use of Obstetric Ultrasound: Medico-Legal Implications in the USA, International Society for Ultrasound in Obstetrics and Gynecology Annual Meeting: Safety Symposium 2-3 (2007), http://files.aium.org/keepsake/safetysymposium.pdf [http://perma.cc/ER78-SFJS] [hereinafter Copel, Non-Clinical Use of Obstetric Ultrasound].

165 Goodnight & Chescheir, supra note 151.

166 Id.

167 Id.

168 Letter from Joshua A. Copel, Pres., Am. Inst. of Ultrasound Med., to Pat Wildlitz & Deborah Heinrich, Representatives, Connecticut State Legislature (Feb. 23, 2009) http://files.aium.org/keepsake/testimony.pdf [http://perma.cc/K75V-VHEP].

169 Voelker, supra note 152 (internal quotation marks omitted).

170 See AIUM, Entertainment, supra note 153.

171 Id.

172 American College of Obstetricians and Gynecologists Committee on Ethics, Committee Opinion: Nonmedical Use of Obstetric Ultrasonography, 104 Obstetrics & Gynecology 423, 423 (2004).CrossRefGoogle Scholar

173 Greene, Naomi & Platt, Lawrence D., Nonmedical Use of Ultrasound: Greater Harm Than Good?, 24 J Ultrasound Med. 123, 125 (2005).CrossRefGoogle ScholarPubMed

174 Copel, Non-Clinical Use of Obstetric Ultrasound, supra note 164, at 3 (“While there are anecdotal reports of missed diagnoses during entertainment scans, we have no systematic collection of data to understand the likelihood of missed diagnoses, or false positive diagnoses of anomalies.”) (footnote omitted).

175 Greene & Platt, supra note 173 (stating that detection of a fetal abnormality in the DTC setting “certainly has happened”).

176 Id. at 123 (discussing how “new controversies” have arisen since the “advent of 3- and 4-dimensional sonography”).

177 3D 4D Release, Prenatal Sneak Peek: 3D, 4D Ultrasounds, http://www.prenatalsneakpeek.com/upload/WavierRelease.pdf [http://perma.cc/2Q28-9SMF] [hereinafterPrenatal Sneak Peek, Release] (“Prenatal Sneak Peek offers elective 2D, 3D & 4D prenatal ultrasounds for an entertainment keepsake and to provide positive bonding experience for parents, family, and friends ….”); Disclaimer, Prenatal Sneak Peek: 3D, 4D Ultrasounds, http://www.prenatalsneakpeek.com/upload/Disclaimer_web.pdf [http://perma.cc/DRK6-ENGL]; Forms & Disclosures, Prenatal Sneak Peek: 3D, 4D Ultrasounds, http://www.prenatalsneakpeek.com/Forms---Disclosures.html [http://perma.cc/H8NQ-GS9C]; OB Form, Prenatal Sneak Peek: 3D, 4D Ultrasounds, http://www.prenatalsneakpeek.com/upload/OB-Form.pdf [http://perma.cc/RU4P-36KD]; Privacy Policy, Prenatal Sneak Peek: 3D, 4D Ultrasounds, http://www.prenatalsneakpeek.com/upload/WebPrivacyPolicy.pdf [http://perma.cc/F3W6-F63D].

178 Bioethics Comm'n, Anticipate and Communicate, supra note 8, at vi (“[Incidental] findings can be lifesaving, but also can lead to uncertainty and distress if they are unexpected or identify conditions for which no effective treatment is available.”).

179 Greene & Platt, supra note 173.

180 Id.

181 Wiseman & Kiehl, supra note 143, at 108.

182 Leung & Pang, supra note 134, at 639.

183 Chervenak & McCullough, supra note 156, at 32-33.

184 De Crespigny, L. et al., Editorial, Risky business: Applying Risk/Benefit Analysis Consistently in Entertainment Ultrasound, 34 Ultrasound Obstetrics Gynecology 613, 613 (2009).CrossRefGoogle ScholarPubMed

185 Doubilet, Peter M., Editorial, Entertainment Ultrasound, 24 J. Ultrasound Med. 251, 251 (2005).Google ScholarPubMed

186 Judith Reichman, Want a Keepsake of Your Baby in the Womb? Today, July 12, 2004, http://www.today.com/id/5417611/ns/today-today_health/t/want-keepsake-your-baby-womb/#.Vg7elbRViko, [http://perma.cc/C9UE-69CA]; see FDA, Avoid KFU, supra note 4.

187 Lyerly, Anne Drapkin et al., Risk and the Pregnant Body, 39 Hastings Ctr. Rep. 34, 34 (2009)CrossRefGoogle ScholarPubMed (arguing that “advice given to pregnant women on how to stay healthy in everyday life can seem capricious and overly cautious”).

188 See Doubilet, supra note 185, at 252 (“Few, if any, patients would fail to distinguish between a visit to a medical facility and a photographer's studio ….”).

189 Fletcher, John C. & Evans, Mark I., Maternal Bonding in Early Fetal Ultrasound Examinations, 308 New Eng. J. Med. 392, 392 (1983)CrossRefGoogle ScholarPubMed (“We have recently seen two cases in which women in the late first or early second trimester of pregnancy reported feelings and thoughts clearly indicating a bond of loyalty toward the fetus that we and others had associated only with a later stage of fetal development.”) (footnote omitted). See also Cari Romm, FDA Warning: Stay Away From ‘Keepsake' Ultrasounds', The Atlantic, Dec. 16, 2014, http://www.theatlantic.com/health/archive/2014/12/fda-warning-stay-away-from-keepsake-ultrasounds/383816/ [http://perma.cc/23UW-8264] (“FDA recognizes that fetal imaging can promote bonding between the parents and the unborn baby”). The language “unborn baby” was later replaced with “developing fetus.” FDA, Avoid KFU, supra note 4, at 2.

190 Goodnight & Chescheir, supra note 151.

191 To gather these forms, the terms “3D ultrasound” and “form” were input into the Google search engine and the first 50 results were reviewed. Forms available online that appeared incomplete were excluded. This review had several limitations including that it was only able to access forms that were posted online (which might have important differences from the types of forms that are available only onsite); forms posted online might be outdated or incomplete; and reviewing forms does not always paint an accurate description of the level of informed consent requested or achieved.

192 E.g., Consent Form, Baby Joy, http://babyjoy3d4dmobileultrasound.com/wp-content/uploads/2013/10/consent-2b-1.pdf [http://perma.cc/8KY9-PAMG] [hereinafter Baby Joy, Consent].

193 E.g., Waiver of Liability, 4D Mommies, http://www.4dmommies.com/wp-content/uploads/waiver.pdf [http://perma.cc/R3TG-FPYV] [hereinafter 4D Mommies].

194 Registration Form, Bella Baby LLC, http://www.bellababy4d.com/RequiredForm/Bella_Baby_pt_reg_form.pdf [http://perma.cc/Z4M5-HLWH] [hereinafter Bella Baby, Registration Form].

195 See, e.g., Physician Authorization Form, Precious De'but 4D Ultrasound, http://preciousdebut.com/data/documents/PERMISSION-FORM.pdf [http://perma.cc/DA8J-78G9].

196 See, e.g., Verification of Care, Watch Me Grow Ultrasound, http://www.watchmegrowultrasound.com/pdf/verification_of_care.pdf [http://perma.cc/67ED-DCJW] [hereinafter Watch Me Grow Ultrasound] (the form is entitled, “Verification of Care”).

197 See, e.g., Baby Joy, Consent, supra note 192.

198 For example, Baby Joy 3D/4D Ultrasound, LLC in their “Consent Form for Elective Ultrasound” requires consumers to agree that they “hereby waive and hold harmless the imager for any negligence in any form whatsoever.” Id.

199 E.g., Prenatal Sneak Peek, Release, supra note 177.

200 E.g., Baby Joy, Consent, supra note 192 (“I understand that this ultrasound session is not performed for any medical reason, or to diagnose any medical condition. I understand that this service doesn't detect chromosomal, structural and obstetrical abnormalities but is provided only to provide photographic ultrasound images for family archival purposes.”). However, one Registration Form somewhat confusingly claims that while the ultrasound “is not used for diagnosis of any medical problems or conditions,” and “refunds are not available for any reason” as a “limited medical diagnostic study” is performed with each ultrasound. Bella Baby, Registration Form, supra note 194.

201 See, e.g., 4D Mommies, supra note 193 (“[W]hile ultrasound is believed to have no harmful effect on the mother or the fetus, future research or other information may disclose harmful or adverse effects that are presently unknown.”).

202 Prenatal Sneak Peek, Release, supra note 177 ([H]owever, “there is inherent risk in any activity involving a fetus and there are potential risks in this type of activity.”).

203 Id.

204 E.g., Elective 2D, 3D, and 4D Ultrasounds Consent Form, Tiny Toes Sono, LLC, http://www.tinytoessono.com/wp-content/uploads/2013/06/ConsentForm.pdf [http://perma.cc/BQ6W-ZGPW] [hereinafter Tiny Toes, Consent] (“Please understand that though [FDA] and the [AIUM] discourage ultrasounds due to the lack of information about long-term effects of ultrasound exposure, many OBGYN Physicians and Registered Technicians believe the risks to an expectant mother and fetus for a brief 15-30 minute elective ultrasound to be very minimal.”).

205 E.g., Pregnancy Treasures, supra note 11 (“The technician performing the ultrasound is not a doctor, nurse, or health care provider ….”).

206 Elective 3D and 4D Ultrasound Consent Form, Shannon Clinic, https://www.shannonhealth.com/media/7674/3d-consent.pdf, [https://perma.cc/4DGT-E3V2].

207 Tiny Toes, Consent, supra note 204.

208 Bella Baby, Registration Form, supra note 194.

209 See, e.g., Waiver and Release, Womb With a View, http://awombswindow.com/wp-content/uploads/2009/12/wwav_clientwaiverrelease.pdf [https://perma.cc/77DK-YX5D] [hereinafter Womb With a View] (“I am currently receiving prenatal care and my doctor has been informed and has no objections to my attending this sonography session.”).

210 See, e.g., Watch Me Grow Ultrasound, supra note 196 (requiring a health care provider's signature on the form).

211 E.g., Pregnancy Treasures, supra note 11 (“I understand I am responsible for contacting my healthcare provider if any questions arise concerning any issues relating to this ultrasound session or any aspect of my pregnancy.”).

212 E.g., Consent for 3D/4D Ultrasound Prenatal Portrait, Center for Maternal-Fetal Care, http://www.medfusion.net/templates/groups/3290/4762/3D-4D%20consent%20form%20for%20web.pdf [http://perma.cc/3FJF-WBJD] (“Although this ultrasound exam is not designed to detect abnormalities,” if one is detected “you will be informed and will have a discussion with a physician concerning the finding prior to your leaving the office.”).

213 See, e.g., Womb With a View, supra note 209.

214 Carol Rados, FDA Cautions Against Ultrasound ‘Keepsake’ Images, FDA Consumer Magazine, Jan.-Feb. 2004 [https://perma.cc/U5SM-9VUL?type=source].

215 FDA, Avoid KFU, supra note 4.

216 Id.

217 See Lubell, supra note 154 (quoting an FDA representative as stating: “[i]t's a gray area where our authority ends and the states' begins”); AIUM, Introduction of Legislation, supra note 154.

218 Lubell, supra note 154.

219 Copel, Non-Clinical Use of Obstetric Ultrasound, supra note 164, at 4.

220 Letter from Joshua A. Copel to Pat Wildlitz & Deborah Heinrich, supra note 168.

221 E.g., Louisiana State Board of Medical Examiners, Self-Referred Diagnostic Ultrasound Screening: Statement of Position 1 (2000) http://www.lsbme.la.gov/sites/default/files/documents/Statements%20of%20Position/UltrasoundScreening.pdf [http://perma.cc/N463-LGZJ].

222 Id.

223 Rayford v. State, 16 S.W.3d 203, 205 (Tex. App. 2000) (holding that the State “proved a misbranding violation of the [Food, Drug & Cosmetic Act] for Rayford's nondiagnostic use of the ultrasound scanner as a matter of law”); Uhles, supra note 141, at 269, 271.

224 Cf. Uhles, supra note 141, at 266 (“As a result of [concerns about a lack of regulation] state legislatures are attempting to pass legislation to regulate the keepsake ultrasound industry ….”).

225 E.g., Chervenak, Frank A. & Chervenak, Judith L., Medical Legal Issues in Obstetric Ultrasound, 34 Clinical Perinatology 299, 307 (2007)CrossRefGoogle ScholarPubMed (enumerating “nineteen possible ways to get sued for ultrasound”). See Sanders, Roger C., Changing Patterns of Ultrasound-Related Litigation: A Historical Survey, 22 J. Ultrasound Med. 1009, 1011 (2003)CrossRefGoogle ScholarPubMed (“Cases related to sonographers are unusual because, as a rule, the reporting physician is considered responsible for the interpretation of the study.”).

226 Our Service, supra note 2 (“The first and only genetic service available directly to you ….”).

227 Letter from Alberto Gutierrez, Dir., to Ann[e] Wojcicki, supra note 7.

228 Our Service, supra note 2.

229 Presidential Comm'n for the Study of Bioethical Issues, Privacy and Progress in Whole Genome Sequencing 113 (2012), http://bioethics.gov/sites/default/files/PrivacyProgress508_1.pdf [http://perma.cc/C9PR-YFXX] [hereinafter Bioethics Commission, Privacy and Progress].

230 Id. at 112-13.

231 E.g., Familial Adenomatous Polyposis, Genetics Home Reference, http://ghr.nlm.nih.gov/condition/familial-adenomatous-polyposis [http://perma.cc/P994-WL2C].

232 See, e.g., Donley, Greer, et al., Prenatal Whole Genome Sequencing: Just Because We Can, Should We?, 42 Hastings Ctr. Rep. 28, 32 (2012).CrossRefGoogle Scholar

233 U.S. National Library of Medicine, Genetics Home Reference Handbook: Help me Understand Genetics 142 (2015), http://ghr.nlm.nih.gov/handbook.pdf [http://perma.cc/Y7AU-3KJN] [hereinafter NLM, Home Reference].

234 Our Service, supra note 2.

235 See Kayte Spector-Bagdady, Welcome to FDA Enforcement, Center for Ethics and Humanities in the Life Sciences at Michigan State University (Jan. 2, 1014), http://msubioethics.com/2014/01/02/welcome-to-fda-enforcement/ [http://perma.cc/4CK6-6YW9] [hereinafter Spector-Bagdady, Welcome to FDA Enforcement].

236 See id.

237 Hudson et al., supra note 142.

238 Bair, Stephanie, Note, Direct-to-Consumer Genetic Testing: Learning from the Past and Looking Toward the Future, 67 Food & Drug L.J. 413, 417-18 (2012).Google ScholarPubMed

239 Joyce Ho, Genetic Counseling: The Missing Piece for 23andMe, KevinMD.com (Dec. 13, 2013), http://www.kevinmd.com/blog/2013/12/genetic-counseling-missing-piece-23andme.html [http://perma.cc/ZV3G-8KKN].

240 Anita Hamilton, Best Inventions of 2008, Time, Oct. 29, 2008, http://content.time.com/time/specials/packages/article/0,28804,1852747_1854493_1854113,00.html.

241 See Elizabeth R. Pike & Kayte Spector-Bagdady, Device-ive Maneuvers: FDA's Risk Assessment of Bifurcated Direct-to-Consumer Genetic Testing, in FDA in the 21st Century: The Challenges of Regulating Drugs and New Technologies 470-85 (Holly Fernandez Lynch & I. Glenn Cohen, eds., 2015) [hereinafter Pike & Spector-Bagdady, Device-ive Maneuvers] (an in-depth assessment of DTC genetic risk concerns, and how they play into currently existing regulatory structure).

242 Id. at 472.

243 Kishore, Deepthy, Comment, Test at Your Own Risk: Your Genetic Report Card and the Direct-to-Consumer Duty to Secure Informed Consent, 59 Emory L J. 1553, 1587 (2010)Google Scholar; Bioethics Comm'n, Anticipate and Communicate, supra note 8, at 17 (highlighting that “the benefits of DTC services are contingent upon the quality of the testing and analyses, and the informed and voluntary nature of the transaction”).

244 NLM, Home Reference, supra note 233, at 144.

245 E.g., Khoury, Muin J. et al., The Scientific Foundation for Personal Genomics: Recommendations from a National Institutes of Health–Centers for Disease Control and Prevention Multidisciplinary Workshop, 11 Genetics Med. 559, 562 (2009)CrossRefGoogle ScholarPubMed (“Even though there are no proven effective interventions to remediate risk, the results of these studies indicate that some people perceived this information to be useful by allowing them to prepare their families and arrange personal affairs including long-term care.”).

246 NLM, Home Reference, supra note 233 at 144.

247 HHS, U.S. System of Oversight of Genetic Testing: A Response to the Charge of the Secretary of Health and Human Services 5-6 (2008), http://osp.od.nih.gov/office-biotechnology-activities/sacghs/reports/SACGHS_oversight_report.pdf [http://perma.cc/FJP4-MGVS].

248 Kira Peikoff, I Had My DNA Picture Taken, with Varying Results, N.Y. Times, Dec. 31, 2013, http://www.nytimes.com/2013/12/31/science/i-had-my-dna-picture-taken-with-varying-results.html (“23andMe said my most elevated risks … were for psoriasis and rheumatoid arthritis…. But according to Genetic Testing Laboratories, my lowest risks were for—you guessed it—psoriasis … and rheumatoid arthritis ….”).

249 Letter from Alberto Gutierrez, Dir., to Ann[e] Wojcicki, supra note 7 (“FDA is concerned about the public health consequences of inaccurate results from the [Personal Genome Service] device; the main purpose of compliance with FDA's regulatory requirements is to ensure that the tests work.”).

250 Our Service, supra note 2 (emphasis added). The only carrier-status screen officially cleared by FDA is for Bloom Syndrome. See Anne Wojcicki, A Note to Our Customers Regarding the FDA, 23andMe blog, (Feb. 19, 2015), http://blog.23andme.com/news/a-note-to-our-customers-regarding-the-fda/ [http://perma.cc/7V34-P7RA] [hereinafter 23andMe, Note]. But, in so doing FDA also exempted future autosomal recessive carrier screening tests from premarket review, see Press Release, FDA, FDA Permits Marketing of First Direct-to-Consumer Genetic Carrier Test for Bloom Syndrome (Feb. 19, 2015), http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/UCM435003 [http://perma.cc/733U-TZLX] [hereinafter FDA, Bloom Syndrome].

251 Javitt, Gail H. et al., Direct-to-Consumer Genetic Tests, Government Oversight, and the First Amendment: What the Government Can (and Can't) Do to Protect the Public's Health, 57 Okla. L. Rev. 251, 253 (2004).Google ScholarPubMed

252 Letter from Alberto Gutierrez, Dir., to Ann[e] Wojcicki, supra note 7. Certain mutations on the BRCA gene are associated with an increased risk in breast and cervical cancer. BRCA Gene Test for Breast and Ovarian Cancer Risk, Mayo Clinic, http://www.mayoclinic.org/tests-procedures/brca-gene-test/basics/definition/prc-20020361 [http://perma.cc/LNZ7-NU4Z].

253 Letter from Alberto Gutierrez, Dir., to Ann[e] Wojcicki, supra note 7. 23andMe is not currently offering either of these tests. Our Service, supra note 2.

254 See, e.g., Green, Robert C. & Farahany, Nita A., Comment, Regulation: The FDA is Overcautious on Consumer Genomics, 505 Nature 286, 286 (2014).CrossRefGoogle ScholarPubMed

255 See, e.g., id. (“Data from more than 5,000 participants suggest that consumer genomics does not provoke distress or inappropriate treatment.”).

256 Green & Farhany, supra note 254, at 286-87; Roberts, J. Scott &Ostergren, Jenny, Direct-to-Consumer Genetic Testing and Personal Genomics Services: A Review of Recent Empirical Studies, 1 Current Genetic Med. Rep. 182, 182 (2013).CrossRefGoogle ScholarPubMed

257 Ostergren, Jenny E. et al., How Well Do Customers of Direct-to-Consumer Personal Genomic Testing Services Comprehend Genetic Test Results? Findings from the Impact of Personal Genomics Study, 18 Pub. Health Genomics 216 (2015).CrossRefGoogle ScholarPubMed

258 However, “comprehension varied by demographic characteristics, numeracy and genetic knowledge, and types and format of the genetic information presented.” Id.

259 23andMe, Terms of Service, supra note 14.

260 Id. (“[I]f you have concerns or questions about what you learn through 23andMe, you should contact your physician or other health care provider.”).

261 Id.

262 Id.

263 Roberts & Ostergren, supra note 256, at 187-88.

264 23andMe, Terms of Service, supra note 14.

265 Id.

266 Presidential Comm'n for the Study of Bioethical Issues, Meeting 13, Session 6 Transcript: Incidental Findings in the Direct to Consumer Context 18 (2013), http://bioethics.gov/node/1620 [http://perma.cc/6SHK-L6S9] [hereinafter DTC Testimony].

267 In 2013, the document was called Consent and Legal Agreement and is still available online: Consent and Legal Agreement, 23andMe, https://www.23andme.com/about/consent/?version=1.3 [http://perma.cc/MUB6-GSPU] [hereinafter Consent and Legal Agreement].

268 DTC Testimony, supra note 266 at 17-18.

269 23andMe, Terms of Service, supra note 14.

270 Bioethics Comm'n, Anticipate and Communicate, supra note 8, at 108.

271 DTC Testimony, supra note 266, at 18, 20.

272 Id. at 18.

273 Bioethics Comm'n, Anticipate and Communicate, supra note 8, at vi, 2. Another type of incidental finding discloses blood relationships between family members, or the lack thereof (e.g., you are not biologically related to the man that you identify as your father); while this Article is focusing on medical findings and considers this a genealogical finding, for an interesting look at this issue in the 23andMe context see Julia Belluz, Genetic Testing Brings Families Together and Sometimes Tears Them Apart, VOX, Dec. 18, 2014, http://www.vox.com/2014/9/9/6107039/23andme-ancestry-dna-testing [http://perma.cc/NG6F-NVFS].

274 DTC Testimony, supra note 266, at 28.

275 Id.

276 For an in-depth discussion of these events see Spector-Bagdady, Kayte & Pike, Elizabeth, Consuming Genomics: Regulating Direct-to-Consumer Genetic and Genomic Information, 92 Neb. L. Rev. 677, 705-10 (2014)Google Scholar[hereinafter Spector-Bagdady & Pike, Consuming Genomics].

277 Our Service, supra note 2; see Spector-Bagdady & Pike, Consuming Genomics, supra note 276.

278 Class Action Complaint at 1-2, Lisa Casey v. 23andMe, Inc., (No. 13CV2847) (S.D. Cal. Nov. 27, 2013).

279 Perez v. Wyeth Labs. Inc., 734 A.2d 1245, 1253 (N.J. 1999) (“Because situations may exist when the health-care provider assumes a ‘much-diminished role as an evaluator or decisionmaker,’ it is appropriate to impose a duty on the manufacturer to warn the patient directly.”); see also State ex rel. Johnson & Johnson Corp. v. Karl, 647 S.E.2d 899, 907 (W. Va. 2007) (“Significant changes in the drug industry have post-dated the adoption of the learned intermediary doctrine in the majority of states in which it is followed. We refer specifically to the initiation and intense proliferation of [DTC] advertising, along with its impact on the physician/patient relationship ….”).

280 See, e.g., Calabro, supra note 64, at 2314-15, 2272 (arguing that “it seems unreasonable to place sole liability on the physician where the pharmaceutical company has communicated directly with the consumer and the consumer has initiated such treatment”).

281 Kishore, supra note 243, at 1605-06.

282 Id. at 1605 (“Where genetic testing services are marketed and sold directly to consumers, diminishing the medical professional's gatekeeping role, the required level of disclosure should be the same as that under the doctrine of informed consent.”).

283 Id. at 1608.

284 Kishore, supra note 243, at 1600 (“The term ‘heightened electiveness’ describes a situation where the patient received elective treatment and the court subsequently found that the medical professional had a duty to provide greater information about potential side effects than is ordinarily required.”); e.g., Perez, 734 A.2d at 1257 (arguing that when “elective treatments cause significant side effects without any curative effect, increased consumer protection becomes imperative, because these [treatments] are, by definition, not medically necessary”).

285 Dresser, Rebecca & Frader, Joel, Off-Label Prescribing: A Call for Heightened Professional and Government Oversight, 37 J.L. Med. & Ethics 476, 481 (2009)CrossRefGoogle Scholar (arguing that “prescribing products off-label to improve patients' appearance or lifestyle is ethically justifiable only when very strong evidence demonstrates product safety”).

286 Kishore, supra note 243, at 1600.

287 LabCorp Services, https://www.labcorp.com/wps/portal/!ut/p/c0/04_SB8K8xLLM9MSSzPy8xBz9CP0os_hACzO_QCM_IwMLo1ALAyNj1yBnQxNfAwN3A_2CbEdFANEm0r8!/ [https://perma.cc/9RS6-HV9D].

288 E.g., Prenatal Sneak Peek, Release, supra note 177.

289 Lung Cancer Screening at GW Hospital, The George Washington University Hospital, http://www.gwhospital.com/hospital-services/lung-cancer-screening-at-gw-hospital [http://perma.cc/6P4Z-VNNQ] (“No referrals are necessary for a Lung Screening at GW Hospital.”).

290 Ultrasonic Pulsed Doppler Imaging System, 21 C.F.R. §§ 892.1550 (2014) (“An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics….”); See Id. §§ 892, 892.1560-892.1570. Letter from Alberto Gutierrez, Dir., to Ann[e] Wojcicki, supra note 7 (“This product is a device within the meaning of section 201(h) of the FD&C Act, 21 U.S.C. 321(h), because it is intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or is intended to affect the structure or function of the body.”).

291 E.g., Pregnancy Treasures, supra note 10.

292 23andMe, Terms of Service, supra note 14.

293 23andMe, Note, supra note 251; FDA, Bloom Syndrome, supra note 250.

294 Bioethics Comm'n, Anticipate and Communicate, supra note 8, at 100 (“DTC providers interact in both the business and medical realms, and could find themselves subject to the ethical principles pertinent to business transactions as well as those of medical care.”).

295 Infra note 301.

296 Infra Part IV.A.2.

297 See, e.g., T.M. Scanlon, What We Owe to Each Other 224-28 (1998).

298 E.g., Henry S. Richardson, Moral Entanglements: The Ancillary-Care Obligations of Medical Researchers 60 (2012) [hereinafter Richardson, Moral Entanglements].

299 Id.

300 Id. at 60-61.

301 Heyman, Steven J., Foundations of the Duty to Rescue, 47 Vand. L. Rev. 673, 755 (1994).Google Scholar

302 See Thomas Donaldson & Thomas W. Dunfee, Ties that Bind: A Social Contracts Approach to Business Ethics 19 (1999).

303 See generally Id. (“There are, we will suggest, agreements that exist within industries, national economies, trade groups, and corporations; further, we will argue that these implicit ‘contracts’ are critical for understanding business ethics.”).

304 E.g., Donaldson, Thomas & Dunfee, Thomas W., Ties That Bind in Business Ethics: Social Contracts and Why They Matter, 26 J. Banking & Fin. 1853 (2002)CrossRefGoogle Scholar [hereinafter Donaldson & Dunfee, Social Contracts and Why They Matter].

305 Id. at 1854.

306 DTC Testimony, supra note 266, at 5-8.

307 Donaldson & Dunfee, Social Contracts and Why They Matter, supra note 304, at 1854, 1859.

308 Contemporary Approaches to the Social Contract, Stanford Encyclopedia of Philosophy, http://plato.stanford.edu/entries/contractarianism-contemporary/ (last visited July 16, 2014).

309 Donaldson & Dunfee, Social Contracts and Why They Matter, supra note 304, at 1855.

310 Id. at 1859.

311 Id. at 1856.

312 Presidential Comm'n for the Study of Bioethical Issues, Meeting 14, Session 1 Transcript: Opening Remarks and Session 41 (2013), http://bioethics.gov/node/2783 [http://perma.cc/DJ3L-F9J5] [hereinafter Opening Remarks Transcript].

313 Donaldson & Dunfee, Social Contracts and Why They Matter, supra note 304, at 1859 (“[Integrative Social Contracts Theory] entails mechanisms that utilize market freedom but correct its ethical shortcomings.”).

314 Id. at 1859, 1862 (“In short, market freedom is fine, but requires ethics to be complete.”).

315 Id. at 1857.

316 Id. at 1858; DTC Testimony, supra note 266, at 5-8.

317 Donaldson & Dunfee, Social Contracts and Why They Matter, supra note 304, at 1859 (For example: “A social contract in which a minority of women are forced to submit to sexual harassment or risk losing their jobs, or social contracts that, while not coercive, allow bribery, environmental degradation, or government corruption, might formally count as ‘voluntary’ while nonetheless offending fundamental principles of fairness.”).

318 See generally Richardson, Moral Entanglements, supra note 298 (discussing and offering support for the “Partial-Entrustment Model”).

319 Id. at 75-78.

320 Id. at 2.

321 Belsky, Leah & Richardson, Henry S., Medical Researchers' Ancillary Clinical Care Responsibilities, 328 British Med. J. 1494, 1494 (2004).CrossRefGoogle ScholarPubMed

322 Richardson, Moral Entanglements, supra note 298, at 2-4.

323 Id. at 23.

324 Id. at 2. However these claims for such care are influenced by several factors such as “vulnerability,” “dependence,” “engagement,” “gratitude,” and “cost.” Id. at 42.

325 Opening Remarks Transcript, supra note 312, at 16-20.

326 Id. at 16-23.

327 Id.

328 But see, e.g., Richardson, Moral Entanglements, supra note 298, at 77-79 (explaining that where “[a] massage therapist notices a dangerous-looking mole on the client's [body]” a massage therapist-patient relationship exists, and “the acceptance of privacy waivers can overcome a potential defeasor of the duty to warn”).

329 Id. at 60.

330 Id. at 61.

331 Id.

332 Id. at 62.

333 An example Richardson himself outlines in his book is that of a tax accountant with an ancillary obligation of talking to a client regarding a potential gambling addiction, apparent from his financial documentation. Richardson, Moral Entanglements, supra note 298, at 72. For an argument applying Richardson's model to the DTC setting see Opening Remarks Transcript, supra note 312, at 16-20 (“In the clinical sphere you might say that the duty [to warn] is super justified or over determined…. In the research context you got some fiduciary duty and you have something like [Richardson's] partial entrustment model at work. And then finally in the DTC area we seem to be simply left with something like the partial entrustment model.”).

334 Bioethics Comm'n, Anticipate and Communicate, supra note 8, at 106.

335 These expectations have been codified by the Federal Trade Commission, which disallows false or misleading advertising and generally works to reduce “fraud, deception, and unfair business practices in the marketplace.” FTC, About the FTC, https://www.ftc.gov/about-ftc [https://perma.cc/N4AB-3K62?type=image].

336 21 U.S.C. § 331 (2012) (“The following acts and the causing thereof are prohibited: (a) The introduction or delivery for introduction into interstate commerce of any food, drug, device, tobacco product, or cosmetic that is adulterated or misbranded.”).

337 15 U.S.C. § 52(a) (“It shall be unlawful for any person … to … disseminate[], any false advertisement … for the purpose of inducing … the purchase in or having an effect upon commerce, of … devices ….”).

338 Class Action Complaint at 4, Lisa Casey v. 23andMe, Inc., (No. 13CV2847) (S.D. Cal. Nov. 27, 2013).

339 23andMe, Consent and Legal Agreement, supra note 267.

340 E.g., Prenatal Sneak Peek, Release, supra note 177.

341 Leung and Pang reached a similar conclusion in their article, Ethical Analysis of Non-Medical Fetal Ultrasound. Leung & Pang, supra note 134, at 642 (arguing that “[a]lthough customer relations and profit making are special considerations in non-medical fetal ultrasound, the safety precautions and procedures must be identical with those in the medical setting. In our opinion, the duty of the ultrasound operator to safeguard the health of the fetus and mother should not be overridden, regardless of the professional status of the operator and the indication for the scan”).

342 Class Action Complaint at 4, Lisa Casey v. 23andMe, Inc., (No. 13CV2847) (S.D. Cal. Nov. 27, 2013).

343 STD Test, Gonorrhea (DNA/Urine), AnyLabTestNow!, http://www.anylabtestnow.com/tests/gonorrhea-std-test/ [http://perma.cc/M5H9-4FSJ].

344 E.g., Prenatal Sneak Peek, Release, supra note 177.

345 Bioethics Comm'n, Anticipate and Communicate, supra note 8, at 106.

346 Heyman, supra note 301.

347 Bioethics Comm'n, Anticipate and Communicate, supra note 8, at 105.

348 Id. at 104 (“Companies should clearly communicate the scope of procedures and the types of findings that the companies could or will discover and disclose, as well as any findings that they know in advance will not be disclosed.”).

349 “Therapeutic misconception” has been defined as “the belief that the purpose of a clinical trial is to benefit the individual patient rather than to gather data for the purpose of contributing to scientific knowledge.” The Nat'l Bioethics Advisory Comm'n, 1 Ethical and Policy Issues in International Research: Clinical Trials in Developing Counties vii-viii (2001), https://bioethicsarchive.georgetown.edu/nbac/clinical/Vol1.pdf [https://perma.cc/6784-64UP].

350 Berg et al., supra note 18, at 56.

351 Supra Part III.C.3 explains that forms surveyed do have limited disclosures regarding providers, with two stating that they are not medical professionals. e.g., 4D Mommies, supra note 193 (“The technician who performs this ultrasound, while qualified to provide such ultrasound services, is not a doctor, nurse or healthcare provider ….”). Two others provide a more robust description. See, e.g., Tiny Toes, Consent, supra note 204 (offering a “highly trained, experienced and/or Registered Ultrasound Technician[s].”).

352 Several providers are already making this type of disclosure. e.g., Tiny Toes, Consent, supra note 204 (“Please understand that … FDA] and the [AIUM] discourage ultrasounds due to the lack of information about long-term effects of ultrasound exposure ….”).

353 See Beck & Azari, supra note 65, at 100.

354 Richardson, Moral Entanglements, supra note 298, at 98.

355 Bioethics Comm'n, Anticipate and Communicate, supra note 8, at 101 (“By gaining access to and intervening in consumers' lives on a commercial basis, and by virtue of providers' superior knowledge and skills, DTC professionals have responsibilities to respond appropriately to the consequences of their services.”).

356 Opening Remarks Transcript, supra note 312, at 23. DTC companies might try to limit their ethical responsibilities by trying to screen out any type of unexpected or incidental finding, by, for example, blacking out part of a scan before the practitioner looks at it. See id. at 33. Richardson argues that if practitioners are filtering in such a way with the primary goal of avoiding moral responsibility for unexpected information they might otherwise uncover this is at least “morally criticizable.” Id. (“It seems to me like going to the beach and you are a great swimmer, and you know there is this likelihood you are going to be interrupted by some kid out there who thinks he needs to be rescued so you are going to avoid that bothersome necessity of having to jump up to rescue kids out of the water by getting yourself blotto drunk so nobody would think of calling on you.”).

357 See Rados, supra note 214.

358 Greene & Platt, supra note 173, at 125.

359 E.g., Pregnancy Treasures, supra note 11 (giving Pregnancy Treasures, LLC rights for the “use of photos, videos, 3D/4D movie in whole or in part”).

360 See Richardson, Moral Entanglements, supra note 298, at 85; Opening Remarks Transcript, supra note 312, at 40 (“As an analogy, consider the legal duty we impose on some professionals[—]teachers, psychiatrists, police[—]to report concern about child abuse or neglect just because of the good epistemic vantage point some of these individuals occupy.”).

361 Hudson et al., supra note 142.

362 Supra Part IV.A. For example, Donaldson has argued that if a pharmaceutical company has the only intellectual property available to cure a disease, it might have a special ethical obligation to make that medication accessible. DTC Testimony, supra note 266, at 5-6 (“Clothing the naked, feeding the hungry — this is not usually an obligation assigned to a corporation… except — and it's generally agreed — in rescue situations things can change. And that is [sic] implications for incidental findings.”).

363 Id. (“[I]t's generally agreed [that] in rescue situations things can change…. If I run Merck and my company has [the] only intellectual property that's capable of curing river blindness, I may have a special obligation … that … may extend beyond my obligation to enrich my shareholders. It may even mean that the firm has to sacrifice profits ….”).

364 Id. at 22 (there are “certain norms, certain hyper norms, such as the right to privacy, that are going to flow through all of these”).

365 For further guidance regarding this obligation in the genetics context is the American College of Medical Genetics and Genomics' recommendations regarding actively looking for and reporting variants underlying 24 specific phenotypic traits. See generally Green, Robert C. et al., ACMG Recommendations for Reporting of Incidental Findings in Clinical Exams and Genome Sequencing, 15 Genetics in Med. 565 (2013)CrossRefGoogle Scholar (“[We recommend] that when a report is issued for clinically indicated … genome sequencing, a minimum list of conditions, genes, and variants should be routinely evaluated and reported ….”).

366 Opening Remarks Transcript, supra note 312, at 37 (“[I]n the case where the duty is strongest, like the clinical sphere, you might say that even relatively insignificant harm might come to the floor, might be something to worry about ….”). Some have pointed out that if one attempted to apply the Partial Entrustment Model for ancillary care to the clinical context it would do no work above and beyond a physician's already existent fiduciary duties. Id. (“As I've argued in the context of medical research ethics, the specialized ancillary care obligation adds a lot. In relation to traditional clinical medicine, I don't think the traditional ancillary care obligation adds much.”).

367 Bioethics Comm'n, Anticipate and Communicate, supra note 8, at 91 (“Because researchers have obligations both to research participants and the creation of generalizable knowledge, their obligations to deliberately seek secondary findings that are outside the primary purpose of their research are less extensive than obligations of clinicians. Researchers have no general duty to actively look for secondary findings. Researchers are not, however, precluded from pursuing, disclosing, and managing secondary findings should they so choose.”).

368 McIntyre, Alison, Guilty Bystanders? On the Legitimacy of Duty to Rescue Statutes, 23 Phil. & Pub. Aff. 157, 157 (1994)CrossRefGoogle Scholar; see Ames, James Barr, Law and Morals, 22 Harv. L. Rev. 97, 112 (1908)CrossRefGoogle Scholar (“The law does not compel active benevolence between man and man. It is left to one's conscience whether he shall be the good Samaritan or not.”).

369 McIntyre, supra note 368, at 158-59.

370 Heyman, supra note 301, at 676.

371 McIntyre, supra note 368, at 159. For example, in Kline v. 1500 Mass. Ave. Apartment Corp., the D.C. Circuit Court recognized a special relationship between a landlord and his tenants such that the landlord was in the “best position” to protect them from crime. Kline v. 1500 Mass. Ave. Apartment Corp., 439 F.2d 477, 481 (D.C. Cir. 1970) (“The rationale of the general rule exonerating a third party from any duty to protect another from a criminal attack has no applicability to the landlord-tenant relationship in multiple dwelling houses. The landlord is no insurer of his tenants' safety, but he certainly is no bystander.”).

372 Pellegrino, Edmund D., The Internal Morality of Clinical Medicine: A Paradigm for the Ethics of the Helping and Healing Professions, 26 J. Med. Phil. 559, 576 (2001).CrossRefGoogle ScholarPubMed

373 Roberts & Ostergren, supra note 256, at 185. (“[M]embers' main motivations for pursuing personal genomics services were curiosity about their genes (81 %), a desire to find out about risk for disease (78 %), and to improve their health (78 %).”). For example, a 2009-10 study researched 1,048 consumers who purchased DTC genetic testing and found that the top reason cited for such purchase was to “satisfy their curiosity.” Press Release, The American Society of Human Genetics, Researchers Shed Light on Implications and Impact of Using Direct-to-Consumer and Clinical Genetic Testing in Disease Risk Assessment (Oct. 20, 2010), http://www.ashg.org/pdf/PR_DTC_Clinical_110510.pdf [http://perma.cc/83DF-XAL4].

374 Hafemeister & Gulbrandsen, supra note 48, at 368; supra Part II.A.2.

375 But see, e.g., Hafemeister & Gulbrandsen, supra note 48 at 369-70. (“In 1956, a California Court of Appeals declared that ‘[t]he doctor-patient relationship is a fiduciary one.’”).

376 Mehlman, supra note 10, at 367; supra Part II.B.1.

377 Testimony of Anne Wojcicki before the Energy & Commerce Committee, U.S. House of Representatives, 21st Century Cures Roundtable: Digital Health Care, at 39:11 (June 24, 2014) http://energycommerce.house.gov/event/21st-century-cures-roundtable-digital-health-care#sthash.XwVx7Cis.dpuf [http://perma.cc/9TNF-C7YM].

378 Restatement (Second) of Contracts ch. 8, intro. note (Am. Law Inst. 1981).

379 Nelson, supra note 102, at 551.

380 See supra Part II.B.2.c.

381 Baby Joy, Consent, supra note 192 (emphasis added).

382 23andMe, Terms of Service, supra note 14 (emphasis added).

383 See id.

384 See, e.g., Pregnancy Treasures, supra note 11.

385 Tunkl v. Regents of Univ. of Cal., 383 P.2d 441, 444, 447 (Cal. 1963); supra Part II.B.2.c.

386 Id. at 445.

387 See id.

388 Id.

389 If a consumer does not have health insurance, the real problem of great importance is the lack of access to clinical care, not DTC services.

390 McIntyre, supra note 368, at 182 (internal quotation marks omitted) (“The state has a duty to protect the general welfare, and one way of carrying out this duty is to “deputize” citizens to function as part of a monitoring system and, in circumstances in which assistance can be easily provided, as surrogates for professional rescuers.”).

391 See id.

392 There are no genetic tests currently with high clinical utility that are only available DTC. But, it is possible that a consumer would only purchase a DTC test, and not a clinical one, leaving the DTC provider still in the only, or best, position to warn that consumer.

393 Tunkl, 383 P.2d at 445.

394 E.g., 3-D Keepsake Imaging, www.3dkeepsakeimaging.com [http://perma.cc/7PE4-CKCL] (“[S]ee what your baby is going to look like before birth!”); Welcome, www.23andMe.com [https://perma.cc/8T9V-WQDS?type=image] (entices consumers to “[f]ind out what your DNA says about you and your family”).

395 Lung Cancer Screening at GW Hospital, supra note 289 (“If you are at high risk for developing lung cancer, Lung Screening at the George Washington University Hospital offers low-dose [CT] scans …. [n]o referrals are necessary ….”).

396 Spector-Bagdady & Pike, Consuming Genomics, supra note 276 at 726-27.

397 Tunkl, 383 P.2d at 446.

398 Tunkl, 383 P.2d at 447 (“The admission room of a hospital contains no bargaining table where, as in a private business transaction, the parties can debate the terms of their contract.”).

399 A lack of access to clinical care is a serious health policy concern, but, because of the many limitations of DTC medical services, enhanced access in the DTC setting is not a policy solution to this inadequacy. See Lia Steakley, A Conversation About the Benefits and Limitations of Direct-to-Consumer Genetic Tests, Scope (June 6, 2011), http://scopeblog.stanford.edu/2011/06/06/direct-to-consumer-genetic-testing-qa/ [http://perma.cc/629T-GGQ2].

400 Tunkl, 383 P.2d at 447.

401 Id. at 446.

402 See, e.g., Baby Joy, Consent, supra note 192 (twelve of the fifteen surveyed included exculpatory language).

403 23andMe, Terms of Service, supra note 14.

404 Tunkl, 383 P.2d at 446.

405 See Pike & Spector-Bagdady, Device-ive Maneuvers, supra note 241, at 466-67, (“[O]ne risk of genomic information stems from actions a consumer might take in response to the information received. Controlling genomic information on the basis of potential actions is unusual, although not unprecedented.”); Letter from Alberto Gutierrez, Dir., to Ann[e] Wojcicki, supra note 7.

406 23andMe, Terms of Service, supra note 14.

407 Tunkl, 383 P.2d at 444.

408 Id. at 443 (internal quotation marks omitted).

409 Id. at 447.

410 For a similar analysis see Jones v. Dressel, 623 P.2d 370, 377-78 (Co. 1981) (“While it is not necessary for a contract to embody all of the characteristics set forth in Tunkl … we conclude that an insufficient number of these characteristics are present in the instant case … because the service provided by Free Flight was not an essential service, it did not possess a decisive advantage of bargaining strength over Jones; and the contract was not an adhesion contract.”).

411 Tunkl, 383 P.2d at 447.

412 Discussion supra Part IV.B.2.

413 See Contemporary Approaches to the Social Contract, supra note 308. Indeed the modern understanding of social contact theory is “agreement,” as opposed to mere consent. Id.

414 Mehlman, supra note 10, at 380.

415 And, once again, FDA has acknowledged that DTC information can be considered a “risk.” See Letter from Alberto Gutierrez, Dir., to Ann[e] Wojcicki, supra note 7 (“Assessments for drug responses carry the risks that patients relying on such tests may begin to self-manage their treatments through dose changes or even abandon certain therapies depending on the outcome of the assessment.”).

416 Mehlman, supra note 10, at 389-91.

417 Id. at 416; see discussion supra Part II.B.2.a.

418 For further discussion regarding the “heightened electiveness” standard see Perez v. Wyeth Labs. Inc., 734 A.2d 1245, 1257 (N.J. 1999). For an argument in favor of applying this standard to DTC genetic testing services see Kishore, supra note 243, at 1601.

419 E.g., Grimes v. Kennedy Krieger Inst., Inc., 782 A.2d 807, 851 (Md. 2001) (arguing that this relationship is founded in the fact that “investigators are in a better position to anticipate, discover, and understand the potential risks to the health of their subjects”).

420 See, e.g., AIUM, Introduction of Legislation, supra note 154.

421 See Martin v. Hacker, 628 N.E.2d 1308, 1311 (N.Y. 1993).

422 There are, of course, several other interesting areas of liability inquiry in the DTC context. For example, at least one scholar has advocated that DTC providers should be held to the standard of clinical informed consent with a common law duty of care to ensure adequate disclosures. Kishore, supra note 243, at 1560-61 (“Recognizing that federal regulations alone would be insufficient to fully protect consumers, this Comment argues that courts should apply principles of informed consent to impose a common law duty of care on DTC genetic testing companies that would ensure adequate disclosures about the risks of genetic testing.”). In addition, some courts have held that DTC drug advertising (for products available via physician prescription) alters the doctor patient relationship to the extent that the drug company should not be fully protected under the learned intermediary doctrine and again take up the brunt of products liability — an argument that could also be extended to the DTC setting. e.g., State ex rel. Johnson & Johnson Corp. v. Karl, 647 S.E.2d 899, 907 (W. Va. 2007); Kishore, supra note 243, at 1605 (“By adopting the reasoning of [State ex rel. Johnson & Johnson Corp.] courts should find that the duty to provide a consumer with adequate warnings about undergoing a genetic test falls to the DTC genetic testing company.”). Others have argued (at least in the research setting) that legal liability could be incurred for a lack of disclosure of incidental findings. Pike, Elizabeth R. et al., Finding Fault? Exploring Legal Duties to Return Incidental Findings in Genomic Research, 102 Geo. L.J. 795, 813 (2014)Google ScholarPubMed (“There is growing concern that research participants who later develop a disease that could have been predicted may bring suit against the researcher who knew about the potential harm but did not disclose it.”).

423 Indeed, at least three times during the publication of this Article.

424 DTC Testimony, supra note 266, at 6 (“And this will sound odd, because I'm not an opponent of regulation; but, one of the things we have seen in the context of innovation that pushes the need for microsocial norms are the limits of regulation.”).