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Recent Developments in Health Law
Published online by Cambridge University Press: 01 January 2021
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- Copyright © American Society of Law, Medicine and Ethics 2011
References
References
Int’l Dairy Foods Ass’n v. Boggs, Nos. 09-3515, 09-3526, 2010 WL 3782193 (6th Cir. Sept. 30, 2010) (Int’l Dairy II).Google Scholar
Ohio Admin. Code 901:11-8-01 (2008), invalidated by Int’l Dairy II, 2010 WL 3782193, at *8-9.Google Scholar
Animal Drugs, Feeds, and Related Products; Sterile Sometribove Zinc Suspension, 58 Fed. Reg. 59946 (Nov. 12, 1993).Google Scholar
Interim Guidance on the Voluntary Labeling of Milk and Milk Products from Cows That Have Not Been Treated with Recombinant Bovine Somatotropin, 59 Fed. Reg. 6279, 6279–80 (Feb. 10, 1994).Google Scholar
21 U.S.C. § 343 (2006) (banning false or misleading labels).Google Scholar
Interim Guidance, 59 Fed. Reg. at 6280.Google Scholar
Ohio Admin. Code 901:11-8-01 (C)…Google Scholar
Int’l Dairy Foods Ass’n v. Boggs, Nos. 2:08-CV-628, 2:08-CV-629, 2009 WL 937045, at *4 (S.D. Ohio Apr. 2, 2009) (Int’l Dairy I).Google Scholar
Id., at *6.Google Scholar
See Int’l Dairy II, 2010 WL 3782193.Google Scholar
Id., at *4 (citing Zauderer v. Office of Disciplinary Counsel of the Sup. Ct. of Ohio, 471 U.S. 626, 637 (1985)).Google Scholar
Central Hudson Gas & Electric Corp. v. Pub. Serv. Comm’n, 447 U.S. 557, 566 (1980).Google Scholar
Int’l Dairy II, 2010 WL 3782193, at *6.Google Scholar
Id., at *5.Google Scholar
Id., at *6 (“[T]he composition claim “rbST free” at best informs consumers of a meaningful distinction between conventional and other types of milk and at worst potentially misleads them into believing that a compositionally distinct milk adversely affects their health.”)Google Scholar
Id., at *8 (citing Interim Guidance, 59 Fed. Reg. 6279, 6280).Google Scholar
Id. (“[T]he proof falls far short of establishing that Ohio consumers have been misled by dairy product labeling.”)Google Scholar
Id., at *9.Google Scholar
Statement of Wenonah Hauter, Exec. Dir. Food & Water Watch., Carol Goland, Exec. Dir., Ohio Ecological Food, and Farming Ass’n, & Joe Logan, Ohio Environmental Council Dir. of Agric., Court Restores Right to Know in Ohio and Throughout the U.S., September 30, 2010, Press Release, available at <http://www.foodandwaterwatch.org/press/press-releases/court-restores-right-to-know-in-ohio-and-throughout-the-u-s/> (last visited January 6, 2010) (“[T]his ruling is a victory for consumers in Ohio and throughout the U.S.”)+(last+visited+January+6,+2010)+(“[T]his+ruling+is+a+victory+for+consumers+in+Ohio+and+throughout+the+U.S.”)>Google Scholar
Int’l Dairy Foods Ass’n v. Amestoy, 92 F.3d 67 (2d Cir. 1996).Google Scholar
Id., at 73.Google Scholar
Id., at 74.Google Scholar
Moulton, L., Labeling Milk from Cows Not Treated with rBST: Legal in all 50 States as of September 29th, 2010, blog post on Columbia Science and Technology Review, October 28, 2010, available at <http://www.stlr.org/2010/10/labeling-milk-from-cows-not-treated-with-rbst-legal-in-all-50-states-as-of-september-29th-2010> (last visited January 6, 2010).+(last+visited+January+6,+2010).>Google Scholar
Interim Guidance, 59 Fed. Reg. at 6280 (“There is currently no way to differentiate analytically between naturally occurring bST and recombinant bST in milk, nor are there any measurable compositional differences between milk from cows that receive supplemental bST and milk from cows that do not.”)Google Scholar
See generally The Complete Patient, “Finally, the Main Event: FTCLDF vs FDA, Challenging Federal Ban on Inter-state Raw Milk Shipments,” available at <http://www.thecompletepatient.com/journal/2010/2/22/finally-the-main-event-ftcldf-vs-fda-challenging-federal-ban.html> (last visited January 6, 2010) (“[The FDA] resisted the efforts of consumer groups to involve the agency - feeling the matter was a local issue - until a federal judge in 1987 responded to a consumer group suit by ordering the agency to draft regulations about the interstate shipment of raw milk. Since then, it has shifted from reluctant participant to aggressive enforcer and warning source against raw milk consumption.”); see also Public Citizen v. Heckler, 653 F. Supp. 1229, 1242 (D.D.C. 1986) (ordering FDA to approve a rule banning interstate sales of raw milk products).+(last+visited+January+6,+2010)+(“[The+FDA]+resisted+the+efforts+of+consumer+groups+to+involve+the+agency+-+feeling+the+matter+was+a+local+issue+-+until+a+federal+judge+in+1987+responded+to+a+consumer+group+suit+by+ordering+the+agency+to+draft+regulations+about+the+interstate+shipment+of+raw+milk.+Since+then,+it+has+shifted+from+reluctant+participant+to+aggressive+enforcer+and+warning+source+against+raw+milk+consumption.”);+see+also+Public+Citizen+v.+Heckler,+653+F.+Supp.+1229,+1242+(D.D.C.+1986)+(ordering+FDA+to+approve+a+rule+banning+interstate+sales+of+raw+milk+products).>Google Scholar
References
Order Granting Administrative Stay, No. 10-5287 (D.C. Cir. Sept. 9, 2010); see also Sherley v. Sebelius, 704 F. Supp. 2d 63 (D.D.C. 2010) (order granting preliminary injunction).Google Scholar
The district court noted that stem cell research can also be conducted using induced pluripotent stem cells (IPSCs), although research using IPSCs are not at issue in this case. Sherley, 704 F. Supp. 2d at 66 (D.D.C. 2010). IPSCs are adult stem cells that are altered to resemble hESCs. Id. at 67. IPSCs were discovered in 2007 and stem cell research using IPSCs is still developing. Id.Google Scholar
The initial plaintiffs in this case also included Nightlight Christian Adoptions, Embryos, Shayne and Tina Nelson, William and Patricia Flynn, and Christian Medical Association, but their claims were dismissed for lack of standing and their dismissal was not challenged on appeal. Sherley, 686 F. Supp. 2d 1, 3 (D.D.C. 2009); Sherley, 610 F.3d 69, 71 (D.C. Cir. 2010).Google Scholar
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Id., at 70; see PresidentBush, George W., “President Discusses Stem Cell Research,” August 9, 2001, available at <http://georgewbush-whitehouse.archives.gov/news/releases/2001/08/20010809-2.html> (last visited January 7, 2011); Exec. Order No. 13,435, 72 Fed. Reg. 34,591 (June 20, 2007) (formalizing President Bush's stem cell policy and permitting federal funding of hESC research “derived without creating a human embryo for research purposes or destroying, discarding, or subjecting ot harm a human embryo or fetus.”).+(last+visited+January+7,+2011);+Exec.+Order+No.+13,435,+72+Fed.+Reg.+34,591+(June+20,+2007)+(formalizing+President+Bush's+stem+cell+policy+and+permitting+federal+funding+of+hESC+research+“derived+without+creating+a+human+embryo+for+research+purposes+or+destroying,+discarding,+or+subjecting+ot+harm+a+human+embryo+or+fetus.”).>Google Scholar
See Balanced Budget Downpayment Act, Pub. L. No. 104-99, § 128, 110 Stat. 26, 34 (1996); see also Omnibus Appropriations Act 2009, Pub. L. No. 111-8, § 509, 123 Stat. 524, 803 (2009). In pertinent part, the Dickey-Wicker Amendment prohibits federal funding for “(1) the creation of a human embryo or embryos for research purposes; or (2) research in which a human embryo or embryos are destroyed, discarded, or knowingly subjected to risk of injury or death greater than that allowed for research on fetuses in utero under” certain federal regulations. Balanced Budget Downpayment Act § 128.Google Scholar
National Institutes of Health Guidelines for Human Stem Cell Research, 74 Fed. Reg. 32,170, 32,173 (to be codified at 45 C.F.R. pt. 46).Google Scholar
Sherley v. Sebelius, 686 F. Supp. 2d 1, 4 (D.D.C. 2009). To establish constitutional standing, a claimant must “identify an ‘injury in fact’ that is ‘actual or imminent’ and ‘fairly trace[able]’” to the defendant's action, “and show it is ‘likely, as opposed to merely speculative, that [the plaintiffs’] injury will be redressed by a favorable decision.’” Sherley v. Sebelius, 610 F.3d 69, 72 (D.C. Cir. 2010) (quoting Lujan v. Defenders of Wildlife, 504 U.S. 555, 560 (1992)).Google Scholar
The court of appeals departed from the district court's reasoning that competitor standing can only be established “when the particular statutory provision [or regulation] invoker reflect a legislative purpose to protect a competitive interest.” Sherley, 686 F. Supp. 2d at 6 (quoting Hardin v. Ky. Util. Co., 390 U.S. 1, 6 (1968)) (internal quotation marks omitted). The district court held that the plaintiffs had not shown that the Dickey-Wicker Amendment was intended to insulate ASC research from competition for NIH grants. Id. The court of appeals departed from the district court's narrow application of competitor standing to find that competitor standing is established if the complainant faces “an actual or imminent increase in competition” which causes a subsequent injury. Sherley, 610 F.3d at 73. Therefore, the plaintiffs only needed to show that increasing funding for hESC would cause them “some competitive injury,” not necessarily that it would lower funding for ASC research. Id. (noting that such a specific showing would address the merits of the plaintiffs’ case, not the issue of constitutional standing).Google Scholar
Id., at 74.Google Scholar
Id., at 75.Google Scholar
Sherley v. Sebelius, 704 F. Supp. 2d 63 (D.D.C. 2010).Google Scholar
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Id., at 70 (quoting Chevron, U.S.A., Inc. v. Natural Res. Def. Council, Inc. 467 U.S. 837, 842-43 (1984)).Google Scholar
Id. (quoting Chevron, 467 U.S. at 843).Google Scholar
Id., at 71.Google Scholar
Order, No. 09-1575 (D.D.C. September 7, 2010) (denying defendants’ emergency motion to stay preliminary injunction pending appeal).Google Scholar
Plaintiffs’ Motion for Summary Judgment, Sherley v. Sebelius, No. 09-CV-01575 (D.D.C. filed Sept. 9, 2010), ECF No. 55; Defendant's Motion for Summary Judgment, Sherley v. Sebelius, No. 09-CV-01575 (D.D.C. filed Sept. 27, 2010), ECF No. 58.Google Scholar
Order, No. 10-5287 (D.C. Cir. Sept. 9, 2010) (granting an administrative stay while the court determined whether to grant a temporary stay).Google Scholar
Order, No. 10-5287 (D.C. Cir. Sept. 28, 2010) (granting motion for stay pending appeal of preliminary injunction entered by district court).Google Scholar
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See Defendant's Objection to Plaintiffs' Related Case Designation, Sherley v. Sebelius, No. 09-CV-01575 (D.D.C. filed September 11, 2009), ECF No. 19 (citing Nightlight Christian Adoptions v. Thompson, No. 01-CV-00502 (D.D.C. March 8, 2001) and referring to the NIH guidelines in 65 Fed. Reg. 51,976 (August 25, 2000) and withdrawal of those guidelines in 66 Fed. Reg. 57,107 (November 14, 2001)).Google Scholar
Id. (citing withdrawal of NIH guidelines in 66 Fed. Reg. 57,107 (Nov. 14, 2001)). The district court in Sherley v. Sebelius declined to find that litigation related to Nightlight Christian Adoptions v. Thompson because the two cases involved different NIH guidelines and did not involve the exact same parties. Id.Google Scholar
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S. 5, 110th Cong. (2007) (as passed by Senate, April 11, 2007; as passed by House, June 6, 2007).Google Scholar
President Bush vetoed both Acts. See 74 Fed. Reg. 32,170, 32,173 (“This long-standing interpretation [that hESCs are not embryos under the Dickey-Wicker Amendment] has been left unchanged by Congress, which has annually reenacted the Dickey Amendment with full knowledge that HHS has been funding hESC research since 2001.”); see also Wadman, M., “Stem Cells: A Legal Round Table,” Nature.com website, September 23, 2010, available at <http://www.nature.com/news/2010/100923/full/news.2010.485.html> (last visited January 7, 2011) (The experts cite support for conflicting views. Robert George finds the Dickey-Wicker Amendment's legislative history supports the plaintiffs’ position. Alta Charo finds that the amendment's post-enactment history, including the passage of the Stem Cell Research Enhancement Acts of 2005 and 2007, and language contained in the committee reports, is consistent with the defendants’ interpretation of the amendment.)+(last+visited+January+7,+2011)+(The+experts+cite+support+for+conflicting+views.+Robert+George+finds+the+Dickey-Wicker+Amendment's+legislative+history+supports+the+plaintiffs’+position.+Alta+Charo+finds+that+the+amendment's+post-enactment+history,+including+the+passage+of+the+Stem+Cell+Research+Enhancement+Acts+of+2005+and+2007,+and+language+contained+in+the+committee+reports,+is+consistent+with+the+defendants’+interpretation+of+the+amendment.)>Google Scholar
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Id. Two bills that would codify President Obama's Executive Order have been referred to the House Subcommittee on Health. See Stem Cell Research Improvement Act of 2009, H.R. 872, 111th Cong. (2009); Stem Cell Research Enhancement Act of 2009, H.R. 873, 111th Cong. (2009).Google Scholar
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