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Zelenay, J.L.1
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Beck, J.M.1
Azari, E.D.2
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5
-
-
40649097289
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-
Beck & Azari, supra note 4, at 75, citing 21 C.F.R. §§ 314.1-314.560.
-
Beck & Azari, supra note 4, at 75, citing 21 C.F.R. §§ 314.1-314.560.
-
-
-
-
6
-
-
40649110526
-
-
Beck & Azari, supra note 4, at 75-76, citing 21 C.F.R. §§ 314.50(c)(5)(vi)(b)(viii), 314.50.
-
Beck & Azari, supra note 4, at 75-76, citing 21 C.F.R. §§ 314.50(c)(5)(vi)(b)(viii), 314.50.
-
-
-
-
7
-
-
40649087154
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-
Fritch DM. Speak no evil, hear no evil, harm the patient? Why the FDA needs to seek more, rather than less, speech from drug manufacturers on off-label drug treatments. Mich St U J Med L (2005); 9: 317 n.3. [Hereinafter Fritch].
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Fritch DM. Speak no evil, hear no evil, harm the patient? Why the FDA needs to seek more, rather than less, speech from drug manufacturers on off-label drug treatments. Mich St U J Med L (2005); 9: 317 n.3. [Hereinafter Fritch].
-
-
-
-
8
-
-
40649104135
-
-
Beck & Azari, supra note 4, at 76, citing 21 C.F.R. §§ 201.1-201.320.
-
Beck & Azari, supra note 4, at 76, citing 21 C.F.R. §§ 201.1-201.320.
-
-
-
-
9
-
-
40649094285
-
-
§321k, 2006
-
21 U.S.C. §321(k) (2006).
-
21 U.S.C
-
-
-
10
-
-
40649115465
-
-
See 21 U.S.C. §321(m).
-
See 21 U.S.C. §321(m).
-
-
-
-
11
-
-
40649120480
-
-
21 C.F.R. §202.1(l)(2) (1999).
-
21 C.F.R. §202.1(l)(2) (1999).
-
-
-
-
12
-
-
40649088612
-
-
Endejann, supra note 1, at 500, citing Kordel v. United States, 335 U.S. 345, 350 (1948).
-
Endejann, supra note 1, at 500, citing Kordel v. United States, 335 U.S. 345, 350 (1948).
-
-
-
-
13
-
-
40649114982
-
-
Endejann, supra note 1, at 500, citing Kordel, 335 U.S. at 349-350.
-
Endejann, supra note 1, at 500, citing Kordel, 335 U.S. at 349-350.
-
-
-
-
14
-
-
40649088869
-
-
Fritch, supra note 7, at 331 n.87, citing United States v. Urbeteit, 335 U.S. 355 (1948).
-
Fritch, supra note 7, at 331 n.87, citing United States v. Urbeteit, 335 U.S. 355 (1948).
-
-
-
-
15
-
-
0346617996
-
Comment, products liability and "off-label" uses of prescription drugs
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Hereinafter Stoffelmayr
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Stoffelmayr KJ. Comment, products liability and "off-label" uses of prescription drugs. U Chi L Rev (1996); 63: 279. [Hereinafter Stoffelmayr].
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-
Stoffelmayr, K.J.1
-
16
-
-
40649112354
-
supra
-
Fritch, note 7, at 347 n.178, citing 21 U.S.C. §§ 331(a, 352a
-
Fritch, supra note 7, at 347 n.178, citing 21 U.S.C. §§ 331(a), 352(a).
-
-
-
-
17
-
-
40649119885
-
-
§352a, 2004
-
21 U.S.C. §352(a) (2004).
-
21 U.S.C
-
-
-
18
-
-
40649087380
-
supra
-
Endejann, note 1, at 500, citing 21 U.S.C. §321n, 1994
-
Endejann, supra note 1, at 500, citing 21 U.S.C. §321(n) (1994).
-
-
-
-
19
-
-
40649083558
-
-
Endejann, supra note 1, at 500, citing 21 U.S.C. §352a, 1994
-
Endejann, supra note 1, at 500, citing 21 U.S.C. §352(a) (1994).
-
-
-
-
20
-
-
40649129498
-
-
§321n, 2006
-
21 U.S.C. §321(n) (2006).
-
21 U.S.C
-
-
-
21
-
-
40649109306
-
-
Stoffelmayr, supra note 17, at 279
-
Stoffelmayr, supra note 17, at 279.
-
-
-
-
22
-
-
40649126145
-
-
Beck & Azari, supra note 4, at 76
-
Beck & Azari, supra note 4, at 76.
-
-
-
-
23
-
-
40649123033
-
-
Barbosa, supra note 3, at 225
-
Barbosa, supra note 3, at 225.
-
-
-
-
24
-
-
40649104669
-
Safety, efficacy, and authenticity: The gap between Ethics and Law in FDA decisionmaking
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Hereinafter Fox
-
Fox D. Safety, efficacy, and authenticity: the gap between Ethics and Law in FDA decisionmaking. Mich St L Rev (2005); 2005: 1164. [Hereinafter Fox],
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-
Fox, D.1
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-
0019954649
-
Use of Approved Drugs for Unlabeled Indications, 12
-
citing FDA
-
citing FDA, Use of Approved Drugs for Unlabeled Indications, 12 FDA Drug Bull. 4-5 (1982).
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(1982)
FDA Drug Bull
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-
-
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26
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-
40649106728
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-
Fox, supra note 27, at 1164
-
Fox, supra note 27, at 1164.
-
-
-
-
27
-
-
40649109300
-
supra
-
Beck & Azari, note 4, at 78, quoting Pub.L. No. 105-115, § 214, 111 Stat. at 2348 (codified at 21 U.S.C. §396 FDCA § 906
-
Beck & Azari, supra note 4, at 78, quoting Pub.L. No. 105-115, § 214, 111 Stat. at 2348 (codified at 21 U.S.C. §396 (FDCA § 906)).
-
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-
-
28
-
-
40649116682
-
-
Beck & Azari, supra note 4, at 77, quoting 12 FDA Drug Bulletin 4-5 (1982) (cited in 59 Fed.Reg. 59,820, 59,821 (Nov 18, 1994)).
-
Beck & Azari, supra note 4, at 77, quoting 12 FDA Drug Bulletin 4-5 (1982) (cited in 59 Fed.Reg. 59,820, 59,821 (Nov 18, 1994)).
-
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-
-
29
-
-
40649101936
-
-
Beck & Azari, supra note 4, at 77, citing 59 Fed.Reg. at 59,821, 52 Fed.Reg. 8798, 8803 (Mar. 19, 1987), 48 Fed.Reg. 26,720, 26,733 (June 9, 1983), 40 Fed.Reg. 15,392, 15,393-394 (Apr. 7, 1975), 37 Fed.Reg. 16,503, 16,503-504 (Aug. 15, 1972), Food And Drug Administration, Compliance Program Guidance Manual, No. 7382.900 Part I, at 7 (1992).
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Beck & Azari, supra note 4, at 77, citing 59 Fed.Reg. at 59,821, 52 Fed.Reg. 8798, 8803 (Mar. 19, 1987), 48 Fed.Reg. 26,720, 26,733 (June 9, 1983), 40 Fed.Reg. 15,392, 15,393-394 (Apr. 7, 1975), 37 Fed.Reg. 16,503, 16,503-504 (Aug. 15, 1972), Food And Drug Administration, Compliance Program Guidance Manual, No. 7382.900 Part I, at 7 (1992).
-
-
-
-
30
-
-
40649104763
-
-
Fritch, supra note 7, at 335
-
Fritch, supra note 7, at 335.
-
-
-
-
31
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-
40649086194
-
-
Endejann, supra note 1, at 503
-
Endejann, supra note 1, at 503.
-
-
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32
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-
40649109551
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-
Beck & Azari, supra note 4, at 76
-
Beck & Azari, supra note 4, at 76.
-
-
-
-
33
-
-
40649083823
-
-
Endejann, supra note 1, at 503
-
Endejann, supra note 1, at 503.
-
-
-
-
34
-
-
40649121522
-
-
Fox, supra note 27, at 1165
-
Fox, supra note 27, at 1165.
-
-
-
-
35
-
-
40649115712
-
supra
-
Fritch, note 7, at 332, citing 21 U.S.C. §352
-
Fritch, supra note 7, at 332, citing 21 U.S.C. §352.
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36
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Off-label prescribing legal implications
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Hereinafter Henry
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Henry V. Off-label prescribing legal implications. J Legal Med (1999); 20: 374. [Hereinafter Henry].
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Henry, V.1
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40649124776
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Endejann, supra note 1, at 503-504, citing Final Guidance on Industry-Supported Scientific and Educational Activities, 62 Fed. Reg. 64,074, 64,079 (1997).
-
Endejann, supra note 1, at 503-504, citing Final Guidance on Industry-Supported Scientific and Educational Activities, 62 Fed. Reg. 64,074, 64,079 (1997).
-
-
-
-
38
-
-
40649086657
-
supra
-
Endejann, note 1, at 504, citing 21 U.S.C. §360aaa Suppl. 1998
-
Endejann, supra note 1, at 504, citing 21 U.S.C. §360aaa (Suppl. 1998).
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39
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-
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-
-
40
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-
40649115458
-
-
§396 1997
-
21 U.S.C. §396 1997.
-
21 U.S.C
-
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41
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-
40649116193
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False claims act liability for off-label promotion of pharmaceutical products
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Greene S. False claims act liability for off-label promotion of pharmaceutical products. Penn St L Rev (2005); 110: 48. [Hereinafter Greene].
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40649118992
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Greene, supra note 49, at 48, quoting Washington Legal Foundation v. Friedman, 13 F.Supp.2d 51, 65 (D.D.C. 1998).
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Greene, supra note 49, at 48, quoting Washington Legal Foundation v. Friedman, 13 F.Supp.2d 51, 65 (D.D.C. 1998).
-
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43
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-
40649105271
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Greene, supra note 49, at 48-49
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Greene, supra note 49, at 48-49.
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44
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-
40649111640
-
-
Fritch, supra note 7, at 336, citing Food and Drug Administration, Draft Policy Statement on Industry Supported Scientific and Educational Activities, 57 Fed. Reg. 56,412 (November 27, 1992).
-
Fritch, supra note 7, at 336, citing Food and Drug Administration, Draft Policy Statement on Industry Supported Scientific and Educational Activities, 57 Fed. Reg. 56,412 (November 27, 1992).
-
-
-
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45
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-
40649125567
-
-
Fritch, supra note 7, at 338
-
Fritch, supra note 7, at 338.
-
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-
46
-
-
40649088857
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supra
-
Fritch, note 7, at 340, citing 21 U.S.C. §360aaa
-
Fritch, supra note 7, at 340, citing 21 U.S.C. §360aaa.
-
-
-
-
47
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-
40649120934
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supra
-
Henry, note 44, at 374, citing 21 U.S.C. §301
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Henry, supra note 44, at 374, citing 21 U.S.C. §301.
-
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-
-
48
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-
40649113367
-
-
§360aaa(a) 1997
-
21 U.S.C. §360aaa(a) 1997.
-
21 U.S.C
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-
-
49
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-
40649084081
-
-
§360aaa(a)1, 5
-
21 U.S.C. §360aaa(a)(1)-(5).
-
21 U.S.C
-
-
-
50
-
-
40649101923
-
-
§360aaab
-
21 U.S.C. §360aaa(b).
-
21 U.S.C
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-
-
51
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-
40649112873
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-
§360aaa(b)(1)A
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21 U.S.C. §360aaa(b)(1)(A).
-
21 U.S.C
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-
-
52
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-
40649100543
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-
§360aaa(b)2
-
21 U.S.C. §360aaa(b)(2).
-
21 U.S.C
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-
-
53
-
-
40649083805
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-
§360aaa(b)3
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21 U.S.C. §360aaa(b)(3).
-
21 U.S.C
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-
-
54
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-
40649098459
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-
§360aaa(b)(4)A, B
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21 U.S.C. §360aaa(b)(4)(A)-(B).
-
21 U.S.C
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-
-
55
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-
40649112871
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-
§360aaa(b)5
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21 U.S.C. §360aaa(b)(5).
-
21 U.S.C
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56
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-
84894692320
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-
§360aaa(b)(6)(A)i, vi
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21 U.S.C. §360aaa(b)(6)(A)(i)-(vi).
-
21 U.S.C
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-
57
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-
40649112872
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-
§360aaa(b)(6)(A)i
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21 U.S.C. §360aaa(b)(6)(A)(i).
-
21 U.S.C
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-
-
58
-
-
84894692320
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-
§360aaa(b)(6)(A)ii
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21 U.S.C. §360aaa(b)(6)(A)(ii).
-
21 U.S.C
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-
-
59
-
-
84894692320
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-
§360aaa(b)(6)(A)iii
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21 U.S.C. §360aaa(b)(6)(A)(iii).
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21 U.S.C
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60
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-
40649104578
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Henry, supra note 44, at 374
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Henry, supra note 44, at 374.
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61
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40649090874
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Endejann, supra note 1, at 503
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Endejann, supra note 1, at 503.
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62
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Fritch, supra note 7, at 336, citing 21 C.F.R. §202.1(e)(7)(viii).
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Fritch, supra note 7, at 336, citing 21 C.F.R. §202.1(e)(7)(viii).
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40649089423
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21 C.F.R. §312.7(a)(1).
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21 C.F.R. §312.7(a)(1).
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65
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0027128055
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Fritch, supra note 7, at 329 n.80, quoting Draft Policy Statement on Industry Supported Scientific and Educational Activities, 57 Fed. Reg. 56,412, 56,412 (1992).
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Fritch, supra note 7, at 329 n.80, quoting Draft Policy Statement on Industry Supported Scientific and Educational Activities, 57 Fed. Reg. 56,412, 56,412 (1992).
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66
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40649129257
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40649126968
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Hixson, supra note 79, at 220, citing Miller v. Pfizer Inc., 196 F. Suppl. 2d 1095, 1121 (D.Kan. 2002).
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40649101648
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Michael, K.V.1
Hosp, R.2
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40649098460
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77
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40649106716
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40649128781
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-
Broderick v. Sofamor Danek Group, Inc., No. 95-8644-CIV-RYSKAMP, 1999 WL 1062135, at *3 (S.D.Fla. April 09, 1999), citing Upjohn Co. v. MacMurdo, 562 So.2d 680, 681 (Sup.Ct.Fla. 1990).
-
Broderick v. Sofamor Danek Group, Inc., No. 95-8644-CIV-RYSKAMP, 1999 WL 1062135, at *3 (S.D.Fla. April 09, 1999), citing Upjohn Co. v. MacMurdo, 562 So.2d 680, 681 (Sup.Ct.Fla. 1990).
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-
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-
83
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Relkin, supra note 90, at 231, quoting Greiner v. Sofamor, 1999 U.S. Dist. LEXIS 4484, *16 (D. Minn. March 08, 1999), quoting Brooks v. Medtronic Inc., 750 F.2d 1227, 1231 (4th Cir. 1984).
-
Relkin, supra note 90, at 231, quoting Greiner v. Sofamor, 1999 U.S. Dist. LEXIS 4484, *16 (D. Minn. March 08, 1999), quoting Brooks v. Medtronic Inc., 750 F.2d 1227, 1231 (4th Cir. 1984).
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supra note 1, at 524, citing Davis v. Wyeth Laboratories Inc
-
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-
(1968)
399 F.2d 121 (9th Cir
-
-
Endejann1
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85
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40649100319
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-
Endejann, supra note 1, at 524, citing Stephens v. G.D. Searle & Co., 602 F.Supp. 379 (E.D.Mich. 1985); Odgers v. Ortho Pharm. Corp., 609 F.Supp. 867 (E.D.Mich. 1985). 'However, most jurisdictions decline to recognize a contraceptive exception.' Endejann, supra note 1, at 524 n.199, citing MacPherson v. Searle & Co., 775 F. Supp 417 (D.D.C. 1991); Reaves v. Ortho Pharm. Corp., 765 F.Suppl. 1287 (E.D.Mich. 1991); Zanzuri v. G.D. Searle & Co., 748 F.Suppl. 1511 (S.D.Fla. 1990).
-
Endejann, supra note 1, at 524, citing Stephens v. G.D. Searle & Co., 602 F.Supp. 379 (E.D.Mich. 1985); Odgers v. Ortho Pharm. Corp., 609 F.Supp. 867 (E.D.Mich. 1985). 'However, most jurisdictions decline to recognize a contraceptive exception.' Endejann, supra note 1, at 524 n.199, citing MacPherson v. Searle & Co., 775 F. Supp 417 (D.D.C. 1991); Reaves v. Ortho Pharm. Corp., 765 F.Suppl. 1287 (E.D.Mich. 1991); Zanzuri v. G.D. Searle & Co., 748 F.Suppl. 1511 (S.D.Fla. 1990).
-
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86
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40649099339
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Endejann, supra note 1, at 524. Jurisdictions are split over whether the FDA-Mandate exception precludes the use of the learned intermediary doctrine. See Endejann, supra note 1, at 524 n.200. Further, 'most jurisdictions, however, decline to recognize a contraceptive exception.' Endejann, supra note 1, at 524 n.199, citing MacPherson, 775 F.Suppl. 417; Reaves, 765 F.Suppl. 1287; Zanzuri, 748 F.Suppl. 1511.
-
Endejann, supra note 1, at 524. Jurisdictions are split over whether the FDA-Mandate exception precludes the use of the learned intermediary doctrine. See Endejann, supra note 1, at 524 n.200. Further, 'most jurisdictions, however, decline to recognize a contraceptive exception.' Endejann, supra note 1, at 524 n.199, citing MacPherson, 775 F.Suppl. 417; Reaves, 765 F.Suppl. 1287; Zanzuri, 748 F.Suppl. 1511.
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87
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Robak v. Abbott Laboratories, 797 F.Suppl. 475, 476 (D.Md. 1992), citing Weinberger v. Bristol-Myers Co., 652 F.Suppl. 187 (D.Md. 1986).
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Broderick, 1999 WL 1062135 at *3, citing Barrow v. Bristol-Meyers Squibb, Co., No. 96-689-CIV-ORL-19B, 1998 WL 812318 (M.D.Fla. 1998).
-
Broderick, 1999 WL 1062135 at *3, citing Barrow v. Bristol-Meyers Squibb, Co., No. 96-689-CIV-ORL-19B, 1998 WL 812318 (M.D.Fla. 1998).
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89
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Davenport v. Medtronic, Inc., 302 F.Supp.2d 419, 440 (E.D.Pa. 2004), citing Little v. Depuy Motech Inc., No. 96CV0393-L JAH, 2000 WL 1519962, at *9 (S.D.Cal. June 13, 2000); Cox v. Depuy Motech Inc., No. 95-3838, 2000 WL 1160486, at *8-9 (S.D.Cal. March 29, 2000).
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90
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Polin D. Cause of Action Against Manufacturer for Personal Injuries Arising from Use of Diet Drug Fenfluramine (Fen-Phen) or Dexfenfluramine (Redux), 12 Causes of Action 2d 1, §13 (2006), citing Perez, 313 N.J. Super. 646.
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Fox, supra note 27, at 1164.
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Fritch, supra note 7, at 361 n.240.
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Farley & Waters, supra note 103, at 1, citing United States v. Parke-Davis, 147 F.Supp.2d 39, 44 (D.Mass. 2001, quoting Buckman Co. v. Plaintiffs' Legal Comm., 531 U.S. 341 (2001).
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Polubinski, supra note 71, at 998.
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Beck & Azari, supra note 4, at 79, quoting Promotion of Drugs and Medical Devices for Unapproved Uses: Hearing Before the Human Resources and Intergovernmental Relations Subcomm. of the House Comm. on Gov't Operations, 102d Cong., 1st Sess. 103 (1991) (statement of George Lundberg, M.D.).
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Hixson, supra note 79, at 215.
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Henry, supra note at 63, at 379.
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Fox, supra note 27, at 1166, citing Off-Label Drug Use and FDA Review of Supplemental Drug Applications, Hearing Before the Subcomm. on Human Resources and Intergovernmental Relations of the H. Comm. on Government Reform and Oversight, 104th Cong. 1 (1996) (statement of Abbey S. Meyers, President, Nat'l Org. of Rare Disorders).
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Stoffelmayr, supra note 17, at 278, citing United States General Accounting Office, Pub No GAO/PEMD-91-14, Off-Label Drugs: Reimbursement Policies Constrain Physicians in Their Choice of Cancer Therapies 19 (1991).
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Stoffelmayr, supra note 17, at 278, citing United States General Accounting Office, Pub No GAO/PEMD-91-14, Off-Label Drugs: Reimbursement Policies Constrain Physicians in Their Choice of Cancer Therapies 22, 25 (1991).
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Beck & Azari, supra note 4, at 80.
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Alvarez v. Smith, 714 So.2d 652, 653 (Fla.Ct.App. 1998), citing In re Orthopedic Bone Screw Products Liability Litigation, No. 1014, 9408-0002, 1996 WL 107556 (E.D.Pa. 1996); Weaver, 866 F.2d 194; Femrite v. Abbott Northwestern Hosp., 568 N.W.2d 535 (Minn.Ct.App. 1997); Klein, 673 N.E.2d at 231; Staudt v. Froedtert Mem'l Lutheran Hosp., 580 N.W.2d 361 (Wis.Ct.App. 1998); Wyttenhove v. Fairview Hosp. & Healthcare Servs., No. 95-14941, affirmed, 1997 WL 585813, *1 (Minn.Ct.App. 1997); Connors v. Hepner, No. 95-C-113 (N.H. Superior Court 1996); Piazza v. Myers, No. 1914 (Philadelphia County Court of Common Pleas 1992).
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Beck & Azari, supra note 4, at 77, quoting N.J. Stat.Ann. §26:1A-36.9(d), (e), (g) (1997).
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Richardson v. Miller, 44 S.W.3d 1, 15 (Tenn.Ct.App. 2000), citing Staudt, 580 N.W.2d at 363; Femrite, 568 N.W.2d at 542.
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Klein, 673 N.E.2d at 231.
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40649103663
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Retkwa, 584 N.Y.S. at 713.
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Retkwa, 584 N.Y.S. at 713.
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155
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40649093076
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Retkwa, 584 N.Y.S. at 712.
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Retkwa, 584 N.Y.S. at 712.
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156
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40649126143
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Retkwa, 584 N.Y.S. at 712 n.6.
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Retkwa, 584 N.Y.S. at 712 n.6.
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157
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40649114254
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Richardson, 44 S.W.3d at 15.
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Richardson, 44 S.W.3d at 15.
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158
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40649086674
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Richardson, 44 S.W.3d at 8.
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Richardson, 44 S.W.3d at 8.
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159
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40649128780
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Richardson, 44 S.W.3d at 17.
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Richardson, 44 S.W.3d at 17.
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160
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40649125566
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Richardson, 44 S.W.3d at 22.
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Richardson, 44 S.W.3d at 22.
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