In other words, HN9[ ] by granting premarket approval, the FDA requires the manufacturer of an approved device to place the device on the market in the form—and accompanied by the warnings and indications for use— approved by the agency, but does not prevent physicians from using the device in a different manner. See 21 U.S.C. § 396 (providing HN10[ ] "[n]othing in [the FDCA] shall be construed to limit or interfere with the authority of a health care practitioner to prescribe or administer any legally marketed device to a patient for any condition or disease within a legitimate health care practitioner- patient relationship"); Buckman, 531 U.S. at 350 be separated into its component parts for purposes of conducting a preemption analysis, the suture was not so much a component of the TVT-O as a device made of the same material. The court thus rejected the notion that the FDA's grant of premarket approval for a device made of a particular material constituted approval of that material for all purposes, explaining, by way of analogy: "If a specific type of metal were approved for use in a bone screw via the premarket approval process, [*33] it would not follow that that same type of metal was safe in all medical devices, no matter what their function in the human body.

The FDA does not regulate the practice of medicine, and physicians are free to use cleared and approved devices for any purpose they see fit, including off-label uses. 21 U.S.C. § 396; see also Am. Compl. ¶ 126.

For example, it imposed an outright prohibition on previous FDA efforts to limit the authority of physicians to put FDA- approved products to off-label uses. See 21 U.S.C. § 396 (providing that “nothing in [the FDCA] shall be construed to limit or interfere with the authority of a health care practitioner to prescribe or administer any legally marketed device to a patient for any condition or disease within a legitimate health care practitioner-patient relationship.”).

Case 1:12-cv-11354-FDS Document 45 Filed 06/30/14 Page 8 of 31 3 practice of medicine, however, and physicians are free to prescribe drugs––and frequently do so– –for any purpose they deem appropriate in their medical judgment, regardless of whether the use is off-label. 21 U.S.C. § 396; see also Wash. Legal Found., 202 F.3d at 333 (“[I]t is undisputed that the prescription of drugs for unapproved uses is commonplace in modern medical practice and ubiquitous in certain specialties.”).

Moreover, even assuming off-label promotion is unlawful, doctors are expressly permitted to prescribe drugs for off-label uses. 21 U.S.C. § 396; Wash. Legal Found. v. Henney, 202 F.3d 331, 333 (D.C. Cir. 2000).

Id. at 350 (quoting 21 U.S.C. § 396); see also Perez, 711 F.3d at 1115 (quoting Buckman). Furthermore, as the Second Circuit has recognized, the FDCA “and its accompanying regulations do not expressly prohibit . . . off-label promotion.”

fDisciplinary Counsel ofSupreme Court ofOhio, AT1 US. 626 (1985)oo.eeeeccsseeesecseesseeeeceeseetaeceeeeneeseeessesaeensenecenss 31, 36 Statutes and Regulations QL CAFR. §312.2(d) veessssssecsssssscssesessuscesssssssessevsssseceessusecssnecserseveceesasesessneesses37 21 CAFR. § 314.70(b)(2)(V)(A) cccscssesecssssscccsseccessesscssucscessuceesseseecesssscessuveenes 19 21 CLE.R. § 314.70(C)(6)(iii) ..esecseescscesscccseessccsececssecscsssscecsseceesssecessssseesssnecen20 QL U.S.C. § 355(d)(5)escscccesecsseccsussccsuecssssesecessecsessuecssuecsseseessussesessnusesssueesses 15 QL U.S.C. § 355(d)(7)ecccsssesscssescssesessusccssssssscssecesssesesesssecessevesssevecsesseseessneceass 15 21 U.S.C. § 355(j) ccecssccsssseceecseccesevcessvtecessvecesssecesssueeessuseessesssessessecessusesssneeen 17 21 U.S.C. § 355(j)(2)(A)(W) sesesssesssssecccccecesceeceseeseceeessstunsssssssunennnsnnssansansenne 16 21 U.S.C. § 355(j)(5)(F)(di), (ii) cssssssssscecccssecceeeeeeeesesstussssssssssessnusssnnansanne 18 21 U.S.C. § 396 cessevesesssessessssssssssssssecsssceceeeeceeceeseeeceeeesiinnsssssssunnunnusssnanansnset37 35 U.S.C. § 156(C) seeseecesesessssssssssssssscessecsceeceseeeeeseceeeeestiusssssssineesessnusssnnnane 18 35 U.S.C. § 271 (e)(L)sesessssssssssssesssssscccscccccecceceeseeeceeceestessssssnssnsesssssasanassesse 18 Cal. Bus. & Prof, Code § 17200 vesesesssssssssssssseesesssseeseeeeseeennees fssesnsnnssene28 Cal, Civ. Code § 425.16 sesccssssssssssssssssssssseesssssseseseceesceseessessteesecesssnnnnnnnnsnnanee 33 Legislative Materials HLR.Rep. No. 98-857 (1984).....:cceeceee sense ee eee nese esate ne eenen eee 16, 26 Constitutions US. Const. art. 1, § 8, Cl. 8 occ eeesesseseeseneeereeeesnesssenenenneneessnensnnsaeteesenseses26 U.S. Const. art. VI, Cl. 2... cecccecccescecssscessesseeseeessnensensersesessensenenseesseestneniees 14 Other Authorities Am. Acad.ofPediatrics, Comm. on Drugs, Uses ofDrugs Not Described in the Package Insert (Off-Label Uses), 110 PediatricS 181 (2002)... escsssessesetsereese

............................................................................................................. 28, 29, 34 21 U.S.C. § 331 ............................................................................................................................. 32 21 U.S.C. § 331(a)......................................................................................................................... 32 21 U.S.C. § 333 ............................................................................................................................. 32 21 U.S.C. § 333(a)......................................................................................................................... 32 21 U.S.C. § 355(d) .......................................................................................................................... 7 21 U.S.C. § 372 ............................................................................................................................. 32 21 U.S.C. § 396 ............................................................................................................................. 33 Case 1:04-cv-10981-PBS Document 60 Filed 03/17/2005 Page 8 of 25 Page viii 42 Pa. C.S. § 5524(7) .................................................................................................................... 39 Ala. Code § 8-19-10(e) (2005)...................................................................................................... 26 Ala. Code § 8-19-10(f) (2005) ...................................................................................................... 26 Ala. Code § 27-1-10.1 (2005) ....................................................................................................... 16 Cal. Civ. Code § 1782 (2005) ....................................................................................................... 26 Cal.