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Published online by Cambridge University Press: 06 January 2021
1 2006 WL 947302 (6th Cir. Apr. 13, 2006).
2 Id.
3 Id. at *1.
4 Id. at *1. The treatment regimen that FDA approved was, within forty-nine days of gestation, the oral administration of 600 mg of mifepristone followed two days later by the oral administration of 0.4 mg of misoprostol. Id.
5 Id. at *1.
6 Id. at *1.
7 Id. at *1 (“Off-label use does not violated federal law or FDA regulations because the FDA regulates the marketing and distribution of drugs in the United States, not the practice of medicine, which is the exclusive realm of individual states.”).
8 Id. at *1. The Schaff protocol has gained national acceptance, and was endorsed by the National Abortion Federation and Planned Parenthood Federation of America. The Schaff protocol also provided for the oral administration of 200 mg of mifepristone followed one to three days later by 0.8 mg of misoprostol administered vaginally. Id.
9 Id. at *1.
10 OHIO REV. CODE ANN. § 2919.123(A) (LexisNexis 2004).
11 Id. at *2.
12 § 2919.123(F)(1).
13 Id. at *2.
14 Id. at *2-3.
15 Id. at *3.
16 Id. at *3.
17 Id. at *4 (citing Ayotte v. Planned Parenthood of N. New Eng., 126 S. Ct. 961, 967 (2006) (“[O]ur precedents hold, that a State may not restrict access to abortions that are necessary, in appropriate medical judgment, for preservation of the life or health of the mother.”); Stenberg v. Carhart, 530 U.S. 914, 931 (2000) (“[T]he governing standard requires an exception where it is necessary in appropriate medical judgment for the preservation of the life or health of the mother.”)). While the Sixth Circuit asserts its proposition as a logical deduction of the Supreme Court holdings, it should be noted that the proposition is not logically derivable, as it is the inverse (which is not logically equivalent) of the Supreme Court holdings, not their contrapositive (which is logically equivalent).
18 Id. at *5.
19 d. at *5.
20 Id. at *5-6 (citing court cases from the First, Fourth, Eighth, and Ninth Circuits).
21 Id. at *5-6.
22 Id. at *7 (quoting Stenberg, 530 U.S. at 938).
23 Id. at *7 (citing Stenberg, 530 U.S. at 931).
24 Id. (citing Stenberg, 530 U.S. at 931).
25 Id. (citing Stenberg, 530 U.S. at 934).
26 Id.
27 Id.
28 Id.
29 Id.
30 Id. at *8 (explaining that plaintiffs’ physician witness testified that methotrexate, which can be used for medical abortions, is also a cancer agent).
31 Stenberg, 530 U.S. at 938.
32 Id at *10 (quoting Stenberg, 530 U.S. at 936-937).
33 Id. at *10.
34 Id. at *11 (citing Ayotte, 126 S. Ct. at 961).
35 Ayotte, 126 S. Ct. at 963.
36 Taft, 2006 WL 947302, at *12 (quoting Ayotte, 126 S. Ct. at 964, 969).
37 Id. at *12.
38 Id. at *12 (citing Ayotte, 126 S. Ct. at 969).
39 See Robert M. Goldberg, Speak No Good: The Tragedy of FDA Gag Rules, NAT’L CENTER FOR POL’Y ANALYSIS, Sept. 27, 1996, http://www.ncpa.org/ba/ba214.html.
40 Bennett, William M., Off-Label Use of Approved Drugs: Therapeutic Opportunity and Challenges, 15 J. AM. SOC’Y OF NEPHROLOGY 830, 830 (2004)CrossRefGoogle ScholarPubMed (listing examples of current treatments founded on off-label drug uses).