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Recent Developments in Health Law

Published online by Cambridge University Press:  01 January 2021

Cordaro Rodriguez  and
Elena Papoulias
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JLME Column
Information
Journal of Law, Medicine & Ethics , Volume 39 , Issue 1 , Spring 2011 , pp. 96 - 101
Copyright
Copyright © American Society of Law, Medicine and Ethics 2011

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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
Id.Google Scholar
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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
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Id. (“[T]he proof falls far short of establishing that Ohio consumers have been misled by dairy product labeling.”)Google Scholar
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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
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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
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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
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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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