Recent developments in health law

Journal of Law, Medicine and Ethics

Volumn 35, Issue 3, 2007, Pages 495-507

  Gerber, Renee ^a   Murtagh, Lindsey ^a   Wolbert, Clinton J ^b   Tinkey, Nicole M ^b   Gobeille, Beth ^b  

^a HARVARD LAW SCHOOL   (United States)

^b BOSTON UNIVERSITY   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ADOLESCENT; ARTICLE; ATTITUDE TO HEALTH; CHILD; ETHICS; FEMALE; HUMAN; LEGAL ASPECT; MANDATORY PROGRAM; MASS IMMUNIZATION; PARENT; UNITED STATES; UTERINE CERVIX TUMOR; VIRUS INFECTION;

ADOLESCENT; ATTITUDE TO HEALTH; CHILD; FEMALE; HUMANS; MANDATORY PROGRAMS; MASS IMMUNIZATION; PAPILLOMAVIRUS INFECTIONS; PARENTS; UNITED STATES; UTERINE CERVICAL NEOPLASMS;

EID: 34547940061     PISSN: 10731105     EISSN: 1748720X     Source Type: Journal    
DOI: 10.1111/j.1748-720X.2007.00173.x     Document Type: Review

References (206)

1. Food and Drug Administration, FDA Licenses New Vaccine for Prevention of Cervical Cancer and Other Diseases in Females Caused by Human Papillomavirus, Press Release P06-77, available at http://www.fda.gov/bbs/topics/NEWS/2006/ NEW01385.html (last visited June 15, 2007) (hereinafter cited as FDA Press Release).
2. L. Udesky Push to Mandate HPV Vaccine Triggers Backlash in U.S.A. The Lancet 369, no. 9566 (2007 979 980 National Conference of State Legislatures, "HPV Vaccine," available at http://www.ncsl. org/programs/health/ HPVvaccine.htm (last visited June 15, 2007) (hereinafter cited as NCSL, HPV Vaccine).
3. Centers for Disease Control HPV Vaccine Questions and Answers August 2006, available at http://www.cdc.gov/std/ HPV/hpv-vaccine.pdf (last visited June 15, 2007) (hereinafter cited as CDC, HPV Vaccine).
4. Centers for Disease Control CDC Facts: Genital HPV Infection available at http://www.cdc.gov/std/HPV/hpv.pdf (last visited June 15, 2007) (hereinafter cited as CDC, Human Papillomavirus).
5. See CDC, HPV Vaccine, supra note 3.
6. See CDC, Human Papillomavirus, supra note 4.
7. See CDC, HPV Vaccine, supra note 3.
8. See FDA Press Release, supra note 1.
9. Id.
10. S.B. 1416 & 1417, 2005-2006 Leg., Reg. Sess. (Mich. 2006).
11. See NCSL, HPV Vaccine, supra note 2.
12. Id.
13. J. Elliott Panel Votes to Block HPV Vaccine Requirement Houston Chronicle, February 22, 2007, available at http://www.chron.com/disp/story.mpl/ spe-cial/07/legislature/4571812.html (last visited June 15, 2007).
14. C. Chmelynski States Consider Bills Mandating HPV Vaccine for Young Girls School Board News, National School Boards Association Web site, March 2007, available at http://www.nsba.org/site/doc_sbn_issue.asp?TRACKID=&VID= 55&CID=682&DID=40379 (last visited June 15, 2007 see NCSL, HPV Vaccine, supra note 2.
15. Id. (NCSL, HPV Vaccine); Kaiser Network, "Virginia Gov. Kaine Proposes Dropping Written Opt Out Requirement in HPV Vaccine Bill," March 27, 2007, available at http://www.kaiser-network.org/daily_reports/rep_index. cfm?hint=2&DR_ID=43850 (last visited June 15, 2007).
16. See CDC, HPV Vaccine, supra note 3.
17. One study estimates that current childhood immunizations prevent over 13 million cases of disease and 33,000 deaths each year. F. Zhou et al. Economic Evaluation of the 7-Vaccine Routine Childhood Immunization Schedule in the United States, 2001 Archives of Pediatrics and Adolescent Medicine 159, no. 12 (2005 1136 1144.
18. In a parallel situation, very few teenagers said they would stop having sex if parental consent were required to receive sexual health services. R. K. Jones et al. Adolescents' Reports of Parental Knowledge of Adolescents' Use of Sexual Health Services and Their Reactions to Mandated Parental Notification for Prescription Contraception JAMA 293, no. 3 (2005 340 348.
19. See, e.g., Kaiser Network HPV Vaccine Unlikely to Increase Teen Sexual Behavior, Researcher Says June 8, 2006, available at http://www.kaisernetwork. org/Daily_reports/rep_index.cfm?DR_ID=37783 (last visited June 15, 2007).
20. Subcommittee on Health and the Environment of the House Committee on Energy and Commerce, Childhood Immunizations at 103-106, 99th Cong., 2d Sess., (Comm. Print 1986) (recommended schedule of vaccines).
21. See CDC, HPV vaccine, supra note 3. See also FDA Press Release, supra note 1 (manufacturer agreeing "to conduct - additional studies to further evaluate general safety and long-term effectiveness K. Koch Vaccine Controversies: Are Today's Vaccines Safe Enough? Congressional Quarterly Researcher 10, no. 28 (2000 641 72, at 645.
22. See CDC, HPV Vaccine, supra note 3. ("Pap tests can also detect most, but not all, cervical cancers at an early, curable stage.").
23. See S. Coletti Taking Account of Partial Exemptors in Vaccination Law, Policy, and Practice Connecticut Law Review 36 (2004 1341 96, at 1349-69 (discussing the types of objections to vaccines, including religious prohibitions, views of the disease as a "rite of passage," fear of risk, and inconvenience of scheduling).
24. S. Weisbergh and D. Castellan Human Papilloma Virus Vaccination American College of Pediatricians Web site, available at http://acpeds.org?CONTEXT= art&cat=10006&art=140&BISKIT=1544652239 (last visited June 15, 2007).
25. R. Stein Debate Rages on Use of Cervical Cancer Vaccine San Francisco Chronicle, October 31, 2005, at A-4; see Kaiser Network, supra note 19.
26. Jacobson v. Commonwealth of Massachusetts, 197 U.S. 11 (1905) (upholding required vaccinations for the sake of public health).
27. See Childhood Immunizations, supra note 20, at 103 106.
28. Boone v. Boozman, 217 F. Supp. 2d 938, at 956-957 (E.D. Ark. 2002). The court made the same ruling in Brock v. Boozman, No. 4:01CV00760 SWW, 2002 U.S. Dist. LEXIS 15479 (E.D. Ark. August 12, 2002).
29. The exceptions, Mississippi and West Virginia, only allow medical exemptions. National Vaccine Information Center, "Legal Exemptions to Vaccination," available at http://www.909shot.com/state-site/legal- exemptions.htm (last visited June 15, 2007).
30. Id.
31. Virginia's bill that passed the legislature, for example, allows a parent to simply fill out a form refusing the vaccination after reviewing informational material. H.B. 2035 ER, 2007 Leg., Reg. Sess. (Va. 2007). Even so, the governor requested the language explicitly state that the decision is the parent's "sole discretion." H. B. 2035ER2, 2007 Leg., Reg. Sess. (Va. 2007).
32. States that would allow only the regular vaccination exemptions are Connecticut, Georgia, Massachusetts, Missouri, New Jersey, Ohio, Oklahoma, South Carolina, Texas, Vermont, and West Virginia. See NCSL, HPV Vaccine, supra note 2.
33. Bills in five states require both the regular exemption qualifications and that the parent review information about HPV and show informed consent. See H.B. 802, 94th Gen. Assem., 1st Reg. Sess. (Mo. 2007 S. 2286, 212th Leg., Reg. Sess. (N.J. 2006); H.B. 81, 127th Gen. Assem., Reg. Sess. (Ohio 2007); S.B. 110, 80th Leg., Reg. Sess. (Tex. 2007); H.B. 256, 2007 Leg., Reg. Sess. (Vt. 2007).
34. In re Brittany T. v. Shawna T., 2007 N.Y. Slip Op. 27078, at 10 (N.Y. Fam. Ct. Febrary 23, 2007).
35. Id., at 9. See also D. Patel Super-Sized Kids: Using the Law to Combat Morbid Obesity in Children Student Note, Family Court Review 43 (2005 164 173, at 169-171 (describing cases of court intervention regarding morbidly obese children).
36. Id. (Patel), at 167.
37. E. J. Sher Choosing for Children: Adjudicating Medical Care Disputes Between Parents and the State New York University Law Review 58 (1983 157 206, at 161.
38. See Brittany T., supra note 1, at 2.
39. Id., at 4.
40. Id., at 6.
41. Id., at 2.
42. Id., at 3.
43. Id., at 7. In evaluating the care provided by the parents, the court measures it "against the behavior of reasonable and prudent parents faced with the same circumstances." Id., at 9.
44. Id., at 4-5.
45. Id., at 8.
46. Id., at 10.
47. American Obesity Association, Childhood Obesity, available at < http://www.obesity.org/subs/childhood/prevalence.shtml > (last visited April 11, 2007). Between 1999 and 2000, 15.3 percent of children ages six to 11 were obese compared to seven percent between 1976 and 1980. For children ages 12 to 19, the prevalence for the same period increased from five percent to 15.5 percent.
48. National Center for Health Statistics, Center for Disease Control and Prevention, Prevalence of Overweight and Obesity Among Adults: United States, 2003-2004, available at http://www.cdc.gov/nchs/products/pubs/pubd/hestats/ overweight/overwght_adult_03.htm (last visited June 14, 2007).
49. S. Arani, Case Comment State Intervention in Cases of Obesity-Related Medical Neglect Boston University Law Review 82 (2002 875 894, at 876.
50. L. A. Kelley What Should Be the Standards for Intervening between Parent and Child? The Parental Prosecution for a Young Boy's Obesity Court Watch, Buffalo Women's Law Journal 9 (2000-2001 7 11, at 8.
51. M. Garrison Child Welfare Decision-making: In Search of the Least Drastic Alternative Georgetown Law Journal 75 (1986-1987 1745 1828, at 1775.
52. Id., at 1776.
53. E. E. Theran 'Free to Be Arbitrary and...Capricious': Weight-Based Discrimination and the Logic of American Antidiscrimination Law Cornell Journal of Law and Public Policy 11 (2001 113 201, at 170-171.
54. See Brittany T., supra note 1, at 2-5.
55. See Arani, supra note 16, at 892.
56. See Kelley, supra note 17, at 7, 9.
57. See Brittany T., supra note 1, at 5.
58. See Garrison, supra note 18, at 1747.
59. The estimated calories required by children range from 900 per day for a one-year-old to 1,800 per day for a teenage girl. See American Heart Association, Dietary Guidelines for Healthy Children, available at http://www.americanheart.org/presenter.jhtml?identifier=4575 (last visited June 15, 2007). The caloric intake required by starvation diets can be drastically below these guidelines. See Arani, supra note 16, at 877 (describing a case where the state ordered a diet limited to 550 calories per day).
60. See L. L. Birch and J. O. Fisher Development of Eating Behaviors Among Children and Adolescents Pediatrics 101, Supplement (1998 539 549, at 539 ("impos[ing]...stringent parental controls can potentiate preferences for high-fat, energy-dense foods, limit children's acceptance of a variety of foods, and disrupt children's regulation of energy intake by altering children's responsiveness to internal cues of hunger and satiety") S. L. Johnson and L. L. Birch Parents' and Children's Adiposity and Eating Style Pediatrics 94 (1994 653 661, at 659 (finding that greater parental control is predictive of worse weight outcomes).
61. J. S. Savage, J. O. Fisher, and L. L. Birch Parental Influence on Eating Behavior: Conception to Adolescence Journal of Law Medicine & Ethics 35, no. 1 (2007 22 34, at 29.
62. See, e.g., In re D.K., 58 Pa. D. & C.4th at 358-359 (stating that the court should strive to preserve family integrity, but finding the mother's obesity would inhibit her ability to meet her son's medical needs).
63. J. Alderman, J. A. Smith, E. J. Fried, and R. A. Daynard. Application of Law to the Childhood Obesity Epidemic Journal of Law, Medicine & Ethics 35, no. 1 (2007 90 112, at 90.
64. B. A. Fisher Community-Based Efforts at Reducing America's Childhood Obesity Epidemic: Federal Lawmakers Must Weigh In DePaul Law Review 55 (2005-2006 711 743, at 729.
65. M. B. Schwartz and K. D. Brownell Actions Necessary to Prevent Childhood Obesity: Creating the Climate for Change Journal of Law, Medicine & Ethics 35, no. 1 (2007 78 89, at 80.
66. L. Smith and B. A. Liang Childhood Obesity: A Public Health Problem Requiring a Policy Solution Journal of Medicine and Law 9 (2005 37 54, at 40.
67. See Brittany T., supra note 1, at 10.
68. Id., at 2, 10.
69. Id., at 4, 6.
70. See Fisher, supra note 31, at 34.
71. See Smith and Liang, supra note 33, at 51.
72. A. C. Lindsay, K. M. Sussner, J. Kim, and S. Gortmaker The Role of Parents in Preventing Childhood Obesity The Future of Children 16 (2006 169 186, at 172.
73. Id.
74. Id., at 170.
75. See Brittany T., supra note 1, at 8. See also, J. E. Smiles A Child's Due Process Right to Legal Counsel in Abuse and Neglect Dependency Proceedings Family Law Quarterly 37 (2003 485 502, at 486.
76. Desiano v. Warner-Lambert & Co., 467 F.3d 85 (2d Cir. 2006).
77. Food, Drug and Cosmetic Act (FDCA), 21 U.S.C. § 301 (2000); Medical Device Act (MDA), 21 U.S.C. § 360e(b)(1)(A)-(B) (2000).
78. Mich. Comp. Laws Ann. § 600.2946(5) (West 2000) (providing, in pertinent part, that "a product that is a drug is not defective or unreasonably dangerous, and the manufacturer or seller is not liable, if the drug was approved for safety and efficacy by the United States Food and Drug Administration..." but such exemption does not apply if the defendant "intentionally withholds from or misrepresents to the United States Food and Drug Administration information concerning the drug that is required to be submitted...").
79. See Desiano, supra note 1, at 98.
80. Id., at 88.
81. Id.
82. Id.
83. Id.
84. Id.
85. Id., at 88-89.
86. Garcia v. Wyeth-Ayerst Labs., 385 F.3d 961 (6th Cir. 2004).
87. Buckman Co. v. Plaintiffs' Legal Committee, 531 U.S. 341 (2001).
88. See Desiano, supra note 1, at 89.
89. Factors, Etc. v. Pro Arts, Inc., 652 F.2d 278 (2d Cir. 1981).
90. Id., at 283.
91. See Desiano, surpa note 1, at 89.
92. Id., at 90 (citing Factors, Etc., supra note 14, at 279).
93. Id., at 91.
94. Id., at 90.
95. Id., at 91 (citing Menowitz v. Brown, 991 F.2d 36, 40 [2d Cir. 1993]).
96. Id., at 92-98.
97. See Buckman, supra note 12, at 347 (quoting Rice v. Santa Fe Elevator Corp., 331 U.S. 218, 230 [1947]).
98. See Desiano, supra note 1, at 98.
99. See Buckman, supra note 12, at 350.
100. See Desiano, supra note 1, at 94.
101. Medtronic v. Lohr, 518 U.S. 470, 485 (1996) ("[B]ecause the States are independent sovereigns in our federal system, we have long presumed that Congress does not cavalierly pre-empt state-law causes of action.").
102. See Desiano, supra note 1, at 94; id., at 94, n. 5 (discussing the State Senate Fiscal Agency's analysis of motivations for enacting section 600.2946).
103. Id., at 88 (listing state common law tort claims averred by the plaintiffs in the instant case).
104. Id., at 93-96.
105. Id., at 95.
106. Proximate causation is a required factor in tort actions. The plaintiff must show that an actor's conduct or breach of duty was a substantial factor in bringing about harm to that plaintiff. 57A Am. Jur. 2d Negligence § 414 (2007).
107. See Desiano, supra note 1, at 95.
108. Id.
109. The court remarks that the very strong state interest in providing for the health of its citizens by preserving duties of care by pharmaceutical companies to their customers implies that the presumption against preemption is "at its strongest" in the instant action. Id., at 95 n. 7.
110. See, e.g., R. A. Epstein Why the FDA Must Preempt Tort Litigation: A Critique of Chevron Deference and a Response to Richard Nagareda Journal of Tort Law 1, no. 1, art. 5 (2006 1 33, at 33 ("We should all hope that preemption will cut the tort system out of an area where it cannot do any systematic good...").
111. "President Bush Participates in Round-table on Health Care Initiatives," the White House Web site, January 25, 2007, transcript available at http://www.whitehouse.gov/news/releases/2007/01/20070125-1.html (last visited June 27, 2007). ("We need to... prevent these frivolous lawsuits from running up the cost of your medicine, and running good docs [sic] out of practice.").
112. A. Sachdev Bush Renews Call for Tort Reform Chicago Tribune, February 8, 2007.
113. See Epstein, supra note 35, at 26.
114. Gulfcoast Medical Supply, Inc. v. Secretary, Department of Health and Human Services, 468 F.3d 1347 (11th Cir. 2006).
115. Id.
116. 42 U.S.C. §§ 1395j to 1395w-4 (2000).
117. 468 F.3d at 1349 (citing United States v. R&F Properties of Lake County, Inc., 433 F.3d 1349, 1351 [11th Cir.2005]).
118. 42 U.S.C. § 1395y (a) (2000).
119. 42 U.S.C. § 1395u (2000).
120. Id.
121. See Gulfcoast, supra note 1, at 1349.
122. Id., at 1349-50.
123. Id., at 1350.
124. Id.
125. Id.
126. Id.
127. Id.
128. 42 U.S.C. § 1395(j)(2)(B) (2000).
129. See Gulfcoast, supra note 1, at 1351 (citing Chevron U.S.A., Inc. v. Natural Res. Def. Council, Inc., 467 U.S. 837 [1984]).
130. See id. (Chevron), at 842-43.
131. Id., at 842.
132. Id., at 843.
133. Id.
134. Id., at 844.
135. See Gulfcoast, supra note 1, at 1351.
136. Id. (quoting Maximum Comfort, Inc. v. Thompson, 323 F.Supp.2d 1060, 1068 [E.D. Cal. 2004]).
137. Id., at 1351-52.
138. Id., at 1351.
139. Id.
140. Id., at 1352.
141. MacKenzie Medical Supply, Inc. v. Leavitt, 419 F.Supp.2d 766, 771 (D. Md. 2006).
142. See Gulfcoast, supra note 1, at 1352.
143. Id. (citing 42 U.S.C. § 1395m[j][2][A] [2000]).
144. Id., at 1351-52.
145. 42 U.S.C. § 1395m(j)(2)(A)(2000).
146. See Gulfcoast, supra note 1, at 1352.
147. Id.
148. Id.
149. Id. The Medicare Act authorizes carriers to audit suppliers' records to assure that payments are proper; 42 U.S.C. § 1395u(a)(1)(C) (2000).
150. Id.
151. Home Health Monday California Court Rules CMN Is Proof Enough for Reimbursement July 12, 2004, available at http://enews.penton.com/enews/ homecare/homecare_monday/2004_july_12_homecare_monday/display (last visited June 27, 2007).
152. L. G. Rodrigue Certificate of Medical Necessity (CMN) May Not Be Enough To Prove Item 'Reasonable and Necessary,' Louisiana Law Blog, available at http://www.louisianalawblog.com/health-law-certifcate-of-medical-neces-sity-cmn- may-not-be-enough-to-prove-item-reasonable-and-necessary.html (last visited June 27, 2007).
153. See Home Health Monday, supra note 38.
154. S. M. Azia and E. W. Sokol from The Power Mobility Coalition, Letter to Mark McClellan, Administrator, Centers for Medicare and Medicaid Services, November 25, 2005, available at http://www.pmcoalition.org/presscenter/ 112505_IF-Rcomments.pdf (last visited February 20, 2007).
155. Id.
156. Id.
157. Catholic Charities of the Diocese of Albany v. Serio, 7 N.Y.3d 510 (2006).
158. N.Y. Ins. Law § 3221(1)(16) (2002).
159. See Catholic Charities, supra note 1, at 518.
160. Id.
161. Id., at 519.
162. N.Y. Ins. Law § 3221(1)(16)(A) (2002).
163. N.Y. Ins. Law § 3221(1)(16)(A)(1) (2002).
164. N.Y. Ins. Law § 3221(1)(16)(B) (2002).
165. See Catholic Charities, supra note 1, at 527.
166. Id., at 520.
167. Id.
168. Id.
169. Id., at 520-21.
170. Id., at 521, 524 (Quoting from the U.S. Const. amend. I, "Congress shall make no law respecting an establishment of religion, or prohibiting the free exercise thereof." Quoting from the N.Y. Const. art. I, § 3, "The free exercise and enjoyment of religious profession and worship, without discrimination or preference, shall forever be allowed in this state to all humankind....").
171. Id., at 510.
172. Id., at 521-22 (citing Employment Division v. Smith, 494 U.S. 872 [1990]).
173. Id., at 521-22 (citing id., at 878).
174. Id., at 522.
175. Id., at 522-24.
176. Id., at 522.
177. Id.
178. Id., at 523.
179. Id.
180. Id., at 523-24.
181. Id.
182. Id., at 524.
183. Id.
184. Id.
185. N.Y. Const. art. I, § 3.
186. See Catholic Charities, supra note 1, at 525.
187. Id., at 525.
188. Black's Law Dictionary, 8th ed, s.v. "strict scrutiny.".
189. See Catholic Charities, supra note 1, at 526.
190. Id., at 527.
191. Id.
192. Id., at 527-28.
193. Id., at 528.
194. Id.
195. U.S. Const. amend. I.
196. See Catholic Charities, supra note 1, at 528 (quoting Larson v. Valente, 456 U.S. 228, 244 [1982]).
197. Id. (citing Larson).
198. Id.
199. See Catholic Charities, supra note 1, at 528-29.
200. Id.
201. Id., at 529.
202. "N.Y. High Court Rejects Dioceses' Challenge to Birth Control Law," Andrews Health Law Litigation Reporter 14, no. 7 (2006 6 7.
203. Blue Cross Blue Shield of North Carolina, Health Care Cost Estimator: Pregnancy and Childbirth, available at http://www.businessgrouphealth.org/pdfs/ healthypregnancy.pdf (last visited June 27, 2007).
204. Washington Business Group on Health, Promoting Healthy Pregnancies: Counseling and Contraception as the First Step: Report of a Consultation with Business and Health Leaders, 2000, at 6, available at http://www.businessgrou- phealth.org/pdfs/healthypregnancy.pdf (last visited June 27, 2007).
205. See Catholic Charities, supra note 1, at 528.
206. See N.Y. Ins. Law § 3221(16)(A)(1)(c) (2002).