H. (T.) v. NOVARTIS PHARMACEUTICALS CORPORATION

Amicus Curiae Brief of The Atlantic Legal Foundation

Cal.December 15, 2016

No. 8233898 SUPREME COURT IN THE SUPREME COURT FILED OF THE STATE OF CALIFORNIA / DEC 15 2016 T.H., a Minor,etc., et al., Jorge Navarrete Clerk Plaintiffs and Appellants Vv. Deputy NOVARTIS PHARMACEUTICALS CORPORATION, Defendant and Respondent Review of a Decision ofthe Court ofAppeal Fourth Appellate District, Division One, Case No. D067839 APPLICATION OF ATLANTIC LEGAL FOUNDATION FOR LEAVE TO FILE AMICUS CURIAE BRIEF; AND PROPOSED BRIEF IN SUPPORT OF RESPONDENT, NOVARTIS PHARMACEUTICALS CORPORATION Robert P. Charrow (CA 44962) Martin S. Kaufman (NY 1704824) Anna B. Laakmann (DC 1034951) Senior Vice President & GREENBERG TRAURIG, LLP General Counsel 2101 L Street, N.W. ATLANTIC LEGAL Washington, D.C. 20037 FOUNDATION Telephone: (202) 533-2396 2039 Palmer Avenue Facsimile: (202) 261-0163 Larchmont, NY 10538 charrowr@gtlaw.com Telephone:(914) 834-3322 laakmanna@gtlaw.com Facsimile: (914) 833-1022 mskaufman@atlanticlegal.com Attorneysfor Amicus Curiae ATLANTIC LEGAL FOUNDATION RECEIVES ULC 09 2616 CLERK SUPREME COURT TABLE OF CONTENTS PAGE APPLICATION FOR LEAVE TO FILE AMICUS CURIAE BRIEF ooo.csccsccceneecsneessesesneesecsesseesccsscersnesenaeesseeaseaeerseessneseeseasessusesesenssneseseneeenss 8 PROPOSED AMICUS CURIAE BRIEF.00... cee eeeeseseeseeceeseeeceeeseeeneenesseesessessesseeas 11 INTRODUCTION 00... ccesescseeesceceseeeseeneecesscersesenseseeeaseecscesseesseessseeesaeenseneseasens 1] ARGUMENT uo. eeeeccessesceeseeesessesscsessecsseessseecsaesessssseeseaeseeeseseeesaeeneesesieenesaesaeentees 14 I. State Law Must Yield to Federal Law Under the Supremacy Clause ofthe U.S. Constitution .......cccecesseeseceeeeeeeeeeeeereneeeeeees 14 A. The Court of Appeal’s Decision Collides With the Hatch-Waxman Act ......cceeccsscccccsseesseeseessceceeesssesseessseeseeseeeeaeeeseesees 15 l. Innovator Liability Disrupts the Legislative Compromise Between Brand and Generic Manufacturers .......c eee esseeescessessceseesessecsesesessnseeeseeseeeeaeeseenas 15 2. Predecessor Liability Conflicts With Federal Labeling Requirement...........eeesecssscceseceesecesneceeeeeesseeseees 19 B. The Court of Appeal’s Decision Collides With the Patent Acta... cccscccseecesseccsseeecsseesesseeeseeseseresseeceseeeeeenseceacesneeseeeeneees 25 1. Congress Has Exclusive Authority to Promulgate Patent Policy...eesseccesseeseeeeseseseesteesseesenees 25 2. Innovator Liability Levies a “Patent Tax” on Brand Manufacturers «0.0.0.0... cessecssceesesceceeseeeseeseseeeeenseateneseas 27 II. The Court ofAppeal’s Decision Conflicts With the Free Speech Clause of the First Amendment«00.0...ee eeeeeeeeeeeeeeseeeneeseseereeteaseneees 30 A. Speech That Is Unconnected To Commercial Sale Is Fully Protected By the First Amendment .......... ccc eeeeeeeeeeeeteeseeeeees 31 B. Manufacturers Cannot Be Compelled To Speak About Products That They Do Not Sell... eecseessceeseerenecsseesseessneesseeees 32 C. Manufacturers May Make Truthful Statements About Off-Label Uses For Their Products 0.0...eee cesessesseeseesaceeesteeeeeees 35 CONCLUSION.......csccescesseesteeereeeteesdesacsuensceesaeessacecsenseacessssssesesenaeeeensaeesoeeseensegoes 40 CERTIFICATION OF WORD COUNT......ccccccccsstecserecteeeenscnnneeesseesensensenereneeenees 41 TABLE OF AUTHORITIES Page(s) Cases Abbott Labs. v. Young, 920 F.2d 984 (D.C. Cir, 1990) oeceeesseceesseeeeeseeseeseesestseeneesaeeeeeesees 16 Amarin Pharm, Inc. v. FDA, 119 F. Supp. 3d 196 (S.D.NLY. 2015) oon. ceceeeseseeeeeteeseeeneeeeeseneeaes 36, 38 Amarin Pharma,Inc. v. FDA, No. 15-3588 (S.D.N.Y. Mar. 8, 2016)........:ccecssceeseceeseeeeeeeeeseaneerenneeesaes38 Biotech. Industry Org v. District ofColumbia, 496 F.3d 1362 (Fed. Cir, 2007) ......ccesesccsssccessseceeceterseeenees 26, 27, 28, 29 Board ofTrustees ofLeland Stanford Junior University v. Sullivan, 773 F.Supp. 472 (D.D.C. 1991) weeesesssceceessesesseeeeascserseeeseseneenneeeas32 Bolger v. Youngs Drug Products Corp., 463 U.S. 60 (1983) uu... ceccesscessesscsseeceneecsresseeccssaecenecseceessaeessssasenseesseeeeaes31 Bonito Boats, Inc. v. Thunder Craft Boats, Inc., ABO US. 141 (1989) vocecccceecsessecseeeeeneeesessaeeecseeesseeseecaeeseessseees 26, 27 Brazil v. Janssen Research & Development LLC, 2016 WL 3748771 (July 11, 2016) oo.cece ceccceeeeeetecteeeresseeenseesneeenees24 Buckman Co.v. Plaintiff's Legal Comm., 531 U.S. 341 (2001) weeeecccscsssseetecesesesesseeeceesseeeacecesaseasensensestanessnesens37 Inre Celexa & Lexapro Mktg. & Sales Practices Litig., 179 F.3d ..cccccssessssscccenseseceseeeneceeesecesersaeecssenseseeseeeserseeenesseseeesecseecseaeseeeseeees24 Citizens United v. Federal Election Comm’n, 130 S. Ct. 876 .occcccccccscccstccesecseseessesseessnesseecsseeeesesaccsenssssessneeasecseeeaseaeeens 35 Inre Darvocet, Darvon, Propoxyphene Products Liab. Litig., 756 F.3d 917 (6th Cir. 2014)ooeeeceseeeessseeeeseeessseseseesesssersneenes 22, 23 English v. Gen. Elec. Co., A496 U.S. 72 (1990) ...cceccccsscesccessessseccscccseessneccsssaceseeeseesecseeessseasenseesneeeenss 14 Escola v. Coca Cola Bottling Co., 150 P.2d 436 (Cal. 1944)... cccccssccsscteesessseceesseesesesecesseteressasearensaeens 12 First National Bank ofBoston v. Bellotti, A436 U.S. 765 (1978) w..ccccccsccsssscsssssceescesseesceecesseneesseesssseseeesseeeesenesers 31, 35 Inre Fosamax (Alendronate Sodium) Products Liab. Litig. (ID, No. MDL 2243 JAP-LHG,2012 WL 181411 (D.N.J. Jann. 17, 2012) veccccccccscescssssecesssseersescsesssaseseessesseeesersssesesesasesensneeneneseeneass24 Freightliner Corp. v. Myrick, 514 U.S. 280 (1995) ...cseessssssssssesesenessssseseeseeeessessseeeseneeseesesensnnegenecarates 14 Gade v. National Solid Wastes Management Assn., 505 U.S. 88 (1992) ..ceecssssssescssssecescsesessssessenesneessenssssssssesnesssensseatenssrenseeys 14 Greenman v. Yuba PowerProds., Inc., 59 Cal.2d 57 (1963) ..cccccscssssessssseseseessseeeseseeensesssssssseneseenseneneneresseneeness 11 Gregory v. Ashcroft, 501 U.S. 452 (1991) .eeeescccsssessesseesssssssenseserssesssesenessesessenenersenenserseess 14 Hines v. Davidowitz, 312 U.S. 52 (1941)wee eecesesssesssseeessseseteeneeesseesesseseeneenensenesaesntereenens 16, 19 Hunter Douglas, Inc. v. Harmonic Design, Inc., 153 F.3d 1318 ( Fed. Cir, 1998)... ccccceeseseseereseereteseeseneenesenseneneenenenens27 Keyishian v. Board ofRegents, 385 U.S. 589 (1967) ...ccccsesessscssseseseseeeensserseeeesecsssessesessneeseseseneeeeseseseees 32 King Instruments Corp. v. Perego, 65 F.3d 941 (Fed. Cir. 1995) ...cecscccessscesesceeeresscessensesseneeseseneersensenssenenes27 Maryland v. Louisiana, A51 U.S. 725 (1981) ccsssessssssssesssssseseneesesesesseeeesesenensssensnenensenenenenenscarsenaes 14 Mutual Pharm. Co.v. Bartlett, 133 S. Ct. 2466 (2013) oo. ccccssserseesseseeeereecereesseseeseesseneeesennees 12, 14, 15 Ohralik v. Ohio State Bar Assn., A36 U.S. 447 (1978) .cccecsesssssssessssseeneesenesseeaeeesseessseesesesenseneesennsnsnenseasessess31 Pacific Gas & Elec. Co.v. Public Util. Comm’n ofCal., AT5 U.S. 1 (1986) .cecseessssssssesessescsecsenenssseneneseeersssessnesesensrenenensnsnenesesseseas35 Patlex Corp. v. Mossinghoff, 758 F.2d 594 (Fed.Cir.1985) ....cscscsssssesssncsessersessesseenesesneesenenenessenseessess26 Pliva v. Mensing, . 131 S.Ct. 2567 (2011) wes eecsssesseseseeseeeceneenerseseessneneseseessesseneeneneens passim RJ. Reynolds Tobacco Co. v. Food & Drug Admin., 696 F.3d 1205 (D.C. Cir. 2012) .occsccceseseseereereretseseneteenessenenesneeteenssens34 Sanofi-Synthelabo v. Apotex, Inc., A70 F.3d 1368 (Fed.Cir.2006).......scccccesseseseeectereeessssenssensenserenesneneraenes26 Sorrell v. IMS Health Inc., 564 U.S. 552 (2011) weeecccssssccessseesceeeseeeecssseccessecsesseesens 32, 35, 36, 39 Southeastern Pennsylvania Transit Authority v. Gilead Sciences, Inc., 102 F. Supp. 3d 688 (E.D. Pa. 2015)... ccceccesssceseestsceseeeeseeeees 28, 29 Thompson v. Western States Medical Center, 535 U.S. 357 (2002) wo. ee eeesscsseeerserereneesa sceesseeecesteeceeeeeesateesessatesnseesnens 38 United States v. Caronia, 703 F.3d 149 (2nd Cir. 2012)oeeeeeeecseccneeeteeeeeteeeteeeenens 30, 36, 38 Va. Pharmacy Bd. V. Va. Consumer Council, 425 U.S. (1976) oo. ccesccssccceseessesesccecescessesesesenevsnesseesseesecesseseseesaeenseesseees34 Vess v. Ciba-Geigy Corp., 317 F.3d 1097 (9th Cir. 2003)... ceeescsssesssessecessessesessensceeesseeenes 33, 34 Virginia State Board ofPharmacy, 425 U.S. 748 (1976)), order vacated as moot sub nom. Washington Legal Foundation v. Henney, 202 F.3d 331 (D.C.Cir. 2000) oo.eeceeeseeeseseceteecseseesscteesaeseseeesessneees38 Washington Legal Foundation v. Friedman, 13 F.Supp.2d 51 (D.D.C. 1998) oooeeeeeeesteeereeeneeeenenns 30, 32, 33, 38 Wooley v. Maynard, 430 U.S. 705 (1977) weeccccccesccsssesscsesccecsseecssevsrecseeeeesseeeceesseseesenenseesaees34 Wyeth v. Levine, 555 U.S. 555 (2009) oeeeeeseeecseceecseeeeceaceneesceeseeseeeeseaeeseensenees 20, 21, 36 Zauderer v. Office ofDisciplinary 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)... escsssessesetsereeseteeetsersstsesteensenseerenseneeneey 37 Big Generic Pharma, The Economist, July 30, 2005, available at http://www.economist.com/node/4233872 ......sssesseereeens 18 FDA,Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book), available at http://www.fda.gov/Drugs/InformationOnDrugs/ucm1296 G2...cccccccceecccsscceccesscssccsesesscesseesesesescessssesaeesssssessenersacenensessseeseseeseneey25 FDA,Draft Guidance for Industry: Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices 2 (Dec. 2011) .....sessesssssernresestetensteneseess37 Jeffrey K. Shapiro, Does FDA’s Per Se Prohibition Against Off-Label Promotion Have a Future? The Short Answer: No, Food and Drug Law Institute’s Update Magazine, March/April 2016, available at http://www.hpm.com/pdf/FDLI%20mar%20apr%202016 M20jks%20off%o20labelAL...eecesesecseesseeeseesseesesseeesseeeesessessessseaes38 Rebecca Eisenberg, The Role ofthe FDA in Innovation Policy, Mich. Telecomm.Tech.L. Rev. 345 (2007)........cccssssessteeesteees 17 APPLICATION FOR LEAVE TO FILE AMICUS CURIAE BRIEF IN SUPPORT OF RESPONDENT, NOVARTIS PHARMACEUTICALS CORPORATION To the Honorable Chief Justice Tani Gorree Cantil-Sakauye and Associate Justices of the California Supreme Court: Atlantic Legal Foundation requests leaveto file an amicus curiae brief in this case in support of Respondent, NOVARTIS PHARMACEUTICAL CORPORATION,ontheissue regarding whether California imposesliability on a former manufacturer of a branded product for injuries allegedly caused by a competitor’s generic version ofthat product, although the former manufacturer divested all ownership interest in the branded productyears before the generic product was sold and allegedly causedinjuries. STATEMENT OF INTEREST Atlantic Legal Foundation is a non-profit public interest law firm founded in 1976 whose mandateis to advocate and protect the principles of less intrusive and more accountable government, a market-based economic system, and individual rights. It seeks to advancethis goal through litigation and other public advocacy and through education. Atlantic Legal Foundation’s board of directors and legal advisory council consist of legal scholars, corporate legal officers, private practitioners, business executives, and prominent scientists.’ Becauseofthe importance ofuniformity of law concerning interstate commerce and other federal questions, Atlantic Legal Foundation has frequently filed amicus briefs in cases in which the issue of preemptionis prominent. CORPORATE DISCLOSURE STATEMENT Amicus Curiae Atlantic Legal Foundation is a 26 U.S.C. § 501(c)(3) nonprofit, nonpartisan, public interest law firm incorporated as a Pennsylvania not for profit corporation. It has no shareholders, subsidiaries, or parent corporation. It does not issue stock or other securities. Neither the Respondent, Novartis Pharmaceuticals Corporation, nor its counselparticipated in drafting this amicus brief, nor did they fund its preparation.’ DATED:December7, 2016 Respectfully submitted, ATLANTIC LEGAL GREENBERG TRAURIG,LLP FOUNDATION I Joe Hollingsworth, a senior partner in Hollingsworth LLP, counsel for Respondent Novartis Pharmaceuticals Corporation, is a member of Atlantic Legal Foundation’s Board of Directors, but was recused from any discussion or consideration of the Foundation’s decision to file an amicus curiae brief in this case. 2 GlaxoSmithKline made a monetary contribution intended to fund the preparation ofthe brief. Martin S. Kaufman By: Kabef- Lem Robert P. Charrow Anna B. Laakmann Attorneys for Amicus Curiae ATLANTIC LEGAL FOUNDATION | 10 PROPOSED AMICUS CURIAE BRIEF IN SUPPORT OF RESPONDENT, NOVARTIS PHARMACEUTICALS CORPORATION INTRODUCTION Productsliability has long presupposed that a manufacturer cannot be held liable for injuries caused by a product that it did not manufacture or sell. Greenman v. Yuba Power Prods., Inc., 59 Cal.2d 57 (1963) (Traynor, J.). The Court of Appeal dispensed with that requirement in holding that a defendant could be held liable for a defectively labeled generic drug even though the defendant never manufactured that drug, no longer manufactured the branded version ofthat drug, and the generic drug that caused the alleged injury was manufactured by a putative competitor. The Court of Appeal’s decision is not the natural outgrowth of the evolution of commonlaw tort doctrine. Rather, the decision is a radical distortion of established liability principles in response to recent U.S. Supreme Court decisions holding that tort claims against generic drug manufacturers are preempted by federal law. In Pliva v. Mensing, the Supreme Court held that federal law preempts tort claims brought against generic manufacturers alleging that a generic drug was accompanied by inadequate warnings. 131 S.Ct. 2567 (2011). Two years later, the Supreme Court extended the scope ofthat decision by holding that federal law also preempts claims that generic drugs 11 were defectively designed. Mutual Pharm.Co. v. Bartlett, 133 S. Ct. 2466 (2013). These two decisions have curtailed consumers’ ability to pursue tort actions understate law against generic manufacturers, such as the manufacturer ofthe generic drug that allegedly harmedthe Plaintiffs. In this case, seeking to circumventthe effect of the Supreme Court’s preemptiondecisions, the Court of Appeal manipulated commonlawtort doctrine in order to give the Plaintiffs — along with all other consumers of generic drugs — an alternative defendantto sue. Imposing untethered duties on unsuspecting defendants by forcing them to pay damagescaused by their competitors has never been a function of tort law. As this Court has long recognized, one ofthe rationales for holding manufacturersstrictly liable for harms caused bytheir products is that a manufacturer can insure againstthe risk of injury and distribute the cost among the consuming public. See Escola v. Coca Cola Bottling Co., 150 P.2d 436, 462 (Cal. 1944) (Traynor, J., concurring) (reasoning that a manufacturer should be held liable for an injury caused by its product even if it is not negligent, because“therisk of injury can be insured by the manufacturer and distributed amongthe public as a cost of doing business”). Underthis well-entrenched tort principle, consumersofa branded drug may sue the brand manufacturer for harms allegedly caused by its product, and consumersof a generic drug may sue a generic manufacturer for harms allegedly caused by its generic version. 12 It is true that the Supreme Court’s preemption decisions in Plivav. Mensing and Mutual Pharm.Co. v. Bartlett have significantly restricted consumers’ ability to pursue tort actions against generic manufacturers. Congress can of course enactlegislation to override these decisionsif it wishes to do so. California, however, should not abandon basic common law principles in order to shift onto brand manufacturers the cost of insuring consumers of generic competitors’ products. The Court ofAppeal’s novel and expansive theory ofliability is so antithetical to the law oftorts that it collides with other fundamental principles embeddedin the Constitution and in federal law, including the Food, Drug, and Cosmetic Act, the Patent Act, and the First Amendment. First, the relationship between a branded drug andits generic versionsis regulated exclusively by the Drug Price Competition and Patent Term Extension Act of 1984, commonly known as Hatch-Waxman. The Court of Appeal’s decision upsets the delicate compromise between branded and generic drug manufacturers established by Hatch-Waxman. Second, the decision collides with the Patent Act, which vests in the federal government the exclusive right to promulgate patent policy. The courts have consistently held that state laws that seek to diminish the economic value of a patented product, which the Court of Appeal’s decision would do, impermissibly interfere with federal patent law. Third, given that the Plaintiffs aim to imposeliability on a defendantfor scientific speech thatis 13 unassociated with the product that caused injury, the Court of Appeal’s decision contravenesthe First Amendment. ARGUMENT I. State Law Must Yield to Federal Law Underthe Supremacy Clause of the U.S. Constitution The Supremacy Clause ofthe U.S. Constitution establishes that federal law “shall be the supreme Law ofthe Land...any Thing in the Constitution or Lawsofany State to the Contrary notwithstanding.” U.S. Const. art. VI, cl. 2. Under this federal system,“[a]s longasit is acting within the powers granted it under the Constitution, Congress may impose its will on the States.” Gregory v. Ashcroft, 501 U.S. 452, 460 (1991). “Accordingly, it has long been settled that state laws that conflict with federal law are ‘without effect.’” Bartlett, 133 S. Ct. at 2473 (quoting Maryland v. Louisiana, 451 U.S. 725, 746 (1981)). Federal law impliedly preempts state law “whereit is impossible for a private party to comply with both state and federal requirements.” Jd. at 2476-77 (quoting English v. Gen. Elec. Co., 496 US. 72, 79 (1990)). Conflict preemption also applies “where state law stands as an obstacle to the accomplishmentand execution ofthe full purposes and objectives of Congress.” Freightliner Corp. v. Myrick, 514 U.S. 280, 287 (1995) (internal quotation marks omitted). See also Gadev. National Solid Wastes 14 Management Assn., 505 U.S. 88, 108 (1992) ("[U]nder the Supremacy Clause, from which our pre-emption doctrine is derived, any state law, howeverclearly within a State's acknowledged power, which interferes with or is contrary to federal law, must yield" (internal quotation marks omitted)). A. The Court of Appeal’s Decision Collides With the Hatch-WaxmanAct 1. Innovator Liability Disrupts the Legislative Compromise Between Brand and Generic Manufacturers The imposition ofliability disrupts the federal Hatch-Waxman schemeeven if Novartis had not divested its new drug application (“NDA”) and had continuedto sell Brethine during the timethat the plaintiff took a generic version ofthe drug. As the United States Supreme Court has noted, the FDA drug approvalprocessis “onerous and lengthy.” Bartlett, 133 S. Ct. at 2471. To gain approval of a new drug, an innovative manufacturer must submit an NDAthat provides “substantial evidence that the drug will havetheeffect it...is represented to have.” 21 U.S.C. § 355(d)(5). To meet this burden, an innovative manufacturer must submit the results of “adequate and well-controlled investigations, includingclinical investigations, by experts qualified by scientific training and experience to evaluate the effectiveness of the drug involved.” Jd. § 355(d)(7). Because the process of submitting an NDAis onerous and expensive, Congress 15 passed the Hatch-WaxmanActin 1984 to “tmake available more low cost generic drugs byestablishing a generic drug approval procedure.” Mensing, 131 S. Ct. at 2574 (citing H.R. Rep. No. 98-857, pt. 1, p. 14 (1984)). Under Hatch-Waxman,a generic drug may be approvedby a manufacturer submitting an abbreviated new drug application ("ANDA") showingthat the drug is sufficiently similar to its branded counterpart and that "the [safety and efficacy] labeling proposed... is the same asthe labeling approvedfor the [branded] drug." 21 U.S.C. § 355G)(2)(A)(v). "The [Hatch-Waxman] Act emerged from Congress's efforts to balance two conflicting policy objectives: to induce brand name pharmaceutical firms to makethe investments necessary to research and develop new drug products, while simultaneously enabling competitors to bring cheaper, generic copies of these drugsto market." Abbott Labs.v. Young, 920 F.2d 984, 991 (D.C. Cir. 1990). The Court ofAppeal’s decision clashes with this federal scheme, because imposingliability on brand manufacturers for harms caused by generic drugs invariably alter s the quidpro quo underlying Hatch-Waxman and thereby undercuts Congress’s policy decisions. See Hinesv. Davidowitz, 312 U.S. 52, 67 (1941) (explaining that state law is preempted whenit “stands as an obstacle to the accomplishment and execution ofthe full purposes and objectives of Congress.”’). 16 Before the passage of the Hatch-Waxman Act, the FDA required manufacturers of generic copies ofpreviously approved drugs to produce their own clinical data establishing their products’ safety and efficacy. Generic manufacturers lobbied Congress to lower regulatory barriers, while innovators argued that it was only fair that regulation effectively extended their exclusivity periods, because regulation also significantly shortened their patents’ effective lives. See Rebecca Eisenberg, The Role ofthe FDA in Innovation Policy, Mich. Telecomm.Tech. L. Rev. 345, 356-57 (2007). In passing Hatch-Waxman, Congress adopted a series of compromises between the interests of generic and innovator manufacturers. The complex federal legislative scheme streamlined FDA approval of generic drugs while simultaneously preserving sufficient incentives for innovators to invest in the research and developmentofnew drugs. Hatch-Waxman made several changesto patent law and the Food, Drug, and Cosmetic Act (the “FDCA”). Hatch-Waxman’s most transformative provision was the creation of the ANDAapplication for generic manufacturers. By filing an ANDA showingthat the applicant’s drug is “bioequivalent” to a previously approved product, Hatch-Waxman enabled generic manufacturers to bring off-patent products to market without performingcostly clinical trials. See FDCA § 505(j), codified at 21 U.S.C. § 355(j). As a result of this modification to the regulatory regime, generic manufacturers that utilize the ANDA pathway need only spend 17 about $2 million to complete the approval process,in stark contrast to the hundreds ofmillions of dollars that pioneers must invest to generate safety andefficacy data. See Big Generic Pharma, The Economist, July 30, 2005, available at http://www.economist.com/node/4233872 . Hatch-Waxman also exempted from patent infringementthe useofpatented inventions for research intended to generate information for ANDA submission. 35 U.S.C. § 271(e)(1). On the other side, Hatch-Waxman authorized patent term extensions for innovative drugs to compensate for patentlife lost during premarket review by the Food and Drug Administration (FDA) and created FDA-administered data exclusivities for new products and indications. See 35 U.S.C. § 156(c); 21 U.S.C. § 355()(5)(F)Gi),(iii). Hatch-Waxmanthusprescribes a comprehensive pathway for generic manufacturers to free ride on brand manufacturers’ research and developmentefforts and marketing expenditures. The federal scheme does not, however, force brand manufacturers to act as insurers for their generic competitors. The Hatch-Waxman schemereflects a deliberate legislative balance between innovative and generic manufacturers. Any realignment of the Hatch-Waxmanbalance can only be accomplished by Congress and not by the States. A bedrocktenet of productsliability law is that manufacturers are liable for harms caused by the products that they sell to consumers, not products that are sold by their competitors. Allowingplaintiffs to 18 circumvent this principle destroys Hatch-Waxman’scarefully structured and balanced compromise between innovative and follow-on manufacturers. The Court ofAppeal’s decision thus collides with federal law, because the imposition of liability against innovative manufacturers for alleged harmscaused by generic products “stands as an obstacle to the accomplishmentand execution of the full purposes and objectives of Congress”in its regulation of the pharmaceutical industry. See Hines, 312 USS.at 67. 2. Predecessor Liability Conflicts With Federal Labeling Requirements The Court of Appeal’s decision further collides with the Hatch- WaxmanAct, becauseit is impossible for Novartis to avoid tort liability without violating federal law. In a series of recent cases, the Supreme Court has addressed how principles of federal preemption apply to failure to warn claims against pharmaceutical manufacturers. These cases establish that the impossibility preemption doctrine applies to claims against all manufacturers that did not hold the NDAforthe allegedly harmful drug at the time of the plaintiff's injuries, because FDA regulations prohibit such manufacturers from altering the drug’s labeling. The general rule is that a manufacturer must obtain FDA approval for a proposed change before altering a drug’s label. 21 C.F.R. § 314.70(b)(2)(v)(A). However, under the Changes Being Effected (“CBE”) 19 regulation, id. § 314.70(c)(6)(iii), the current NDA holder can makecertain types of changesto its label prior to securing FDA approval. The change must“reflect newly acquired information,” id., and mustbe intended to enhancethe safety and effectiveness of the drug for its approved uses in certain specified ways. See id. (delineating the five authorized objectives of the CBE procedure). In Wyeth v. Levine, a jury found a drug manufacturer liable under Vermont law for what the jurors deemedto be an inadequate warning of risks in an FDA-approvedlabel. Wyeth v. Levine, 555 U.S. 555, 558 (2009). In rejecting the manufacturer's preemption defenseto liability under Vermontlaw, the Supreme Court pointed to the CBE regulation, "which both reflects the manufacturer's ultimate responsibility for its label and provides a mechanism for adding safety informationto the label prior to FDA approval." Jd. at 571. "Thus, whentherisk ... became apparent, Wyeth had a duty [underfederal law] to provide a warning that adequately described that risk, and the CBE regulation permitted it to provide such a warning before receiving the FDA's approval." Jd. Based on these observations, the Court foundthat state tort liability penalizing the manufacturer for not changingits label under the CBE regulation was not preempted. /d. at 581. Twoyearslater, the Supreme Court distinguished Wyeth, and sustained a preemption defenseto the imposition of tort liability on a 20 generic drug manufacturerfor failure to add a warningto its label. Mensing, 131 S.Ct. at 2581. The court observed two key aspects of the federal "drug labeling duties" that applied to generic manufacturers. Jd. at 2574. First, a generic manufacturer "is responsible for ensuringthatits warning label is the same as the brand name's." Jd. Second, "the CBE process wasnot open to [generic manufacturers]." Jd. at 2575. Therefore, the generic drug manufacturer in Mensing could not have changedits label without prior FDA approval, which it could only have obtained by proposing that the FDA require a change in the corresponding brandlabel. Id. at 2576. The Court foundthat the possibility that the FDA would have agreed to require a changeto the brand label in response to such a proposal did not preclude the court from concluding that compliance with bothstate and federal branding requirements was impossible. The Court explained that "[t]he question for ‘impossibility' is whetherthe private party could independently do under federal law what state law requiresofit." Jd. at 2579 (citing Wyeth, 555 U.S. at 573) (emphasis added). The Court limited Wyeth to situations in which the drug manufacturer can, "of its own volition, ... strengthen its label in compliance with its state tort duty." Mensing, 131 S.Ct. at 2581. The Supreme Court in Wyeth and Mensing thus drew line between labeling changes that can be independently made using the CBEregulation and labeling changesthat require prior FDA approval. Importantly, only 21 the current NDA holder mayrely on the CBE regulation to change a drug’s label. All other companies — regardless of whether they manufacture branded or generic drugs — are prohibited from altering a drug’s labeling. See In re Darvocet, Darvon, Propoxyphene Products Liab. Litig., 756 F.3d 917, 940 (6 Cir. 2014) (a companythat is not the NDA holder cannot change a drug’s label). Federal law thus prohibited Novartis from updating Brethine’s labeling after it sold its rights and interests in Brethine in 2001. Indeed,as the Court of Appeal recognized, Plaintiffs conceded that Novartis had no duty to warn afterits divestiture in 2001. See TH v. Novartis, 245 Cal. App.4" at 601. The Court of Appeal attempted to avoid this conflict between state and federal law by constructing a novel theory ofpredecessor liability. But construing a pre-2001 duty, the breach ofwhich exposes Novartis to liability for all harms to consumers whoingest terbutaline at any point after the breach,is no different from imposing a post-2001 duty to warn. Stripped ofits doctrinal machinations, the practical effect of the Court ofAppeal’s decision is the same. An allegation that Novartis acted negligently during the timethatit sold Brethine exposes Novartis toa lawsuit not only by those who took Brethine before 2001, but also byall persons who ingestedor will ingest either Brethine or generic terbutaline any time after Novartis divested its rights and interests in the NDA. 22 This expansive distortion of California tort doctrine creates a direct conflict with federal law. Assuming, arguendo, that Novartis breached a duty to warn during the time that it marketed Brethine, federal law prohibited Novartis from remedying the alleged breach after its divestiture in 2001. Asthe plaintiffs tacitly acknowledge, the FDCA doesnot allow a drug manufacturerto alter the labeling of a drugthat it no longer sells. See TH v. Novartis, 245 Cal. App.4"at 601 (notingthat the plaintiffs do not claim that Novartis had a duty to warn after it sold its rights and interests in the NDA). Imposing perpetualliability on Novartis for an alleged breach of a duty thatit had in the past does not merely disregard the fundamental policies of California’s statutes of limitations. The Court ofAppeal’s decision so distorts commonlaw tort doctrine that defendants cannot avoid liability without violating federal law, so it impermissibly clashes with the federal regulatory scheme. See Mensing, 131 S.Ct. at 2579 (explaining that state tort claims are preempted where a defendant cannot “independently do under federal law what state law requires ofit”). When a brand manufacturer does not hold the NDA fora drug,it has “no more powerto changethe label” of the drug than a generic manufacturer. Jn re Darvocet, Darvon, Propoxyphene Products Liab. Litig., 756 F.3d 917, 940 (6" Cir. 2014). Failure to warn claims are preempted against all companies who do not hold the NDAat the time of sale to the plaintiff, because in all such cases the CBE procedureis not 23 a s b t m s a e , Se ig e ea Be re e e available. See In re Celexa & Lexapro Mktg. & Sales Practices Litig., 779 F.3d at 41-43 (explaining that the Supreme Court’s opinions in Wyeth and Mensing “make{] clear that a necessary step in defeating [a brand manufacturer’s] preemption defenseis to establish that the complaint alleges a labeling deficiency that [the brand manufacturer] could have corrected using the CBE regulation.”) (emphasis added); Brazil v. Janssen Research & Development LLC, 2016 WL 3748771 (July 11, 2016) (holding that failure to warn claims against the manufacturer of a branded drug were preempted because the defendant wasnot the NDAapplicant); Jn re Fosamax (Alendronate Sodium) Products Liab. Litig.(I), No. MDL 2243 JAP-LHG,2012 WL 181411, at *4 (D.N.J. Jan. 17, 2012) (“Because [the defendant manufacturer] could not ‘independently do under federal law what state law requiresofit,’ the state law claims brought againstit are preempted.”) (quoting Mensing, 131 S.Ct. at 2579)). Impossibility preemption applies equally to brand and generic manufacturers. Only the NDA holdercan use the CBE process,therefore the Supreme Court’s holding in Mensing forecloses failure to warn claims against any entity that did not hold an NDAfora terbutaline productat the time ofPlaintiffs’ alleged injuries. Plaintiffs cannot avoid preemption by arguing that Novartis could have submitted a request to the FDA to change the labeling for terbutaline products. Since federal law prohibits Novartis from unilaterally altering the FDA approvedlabel in a mannerthat 24 Plaintiffs allege is mandated by state law, the Court ofAppeal’s decision inevitably runs up against federal preemption doctrine. See Mensing, 131 S.Ct. at 2580-81. B. The Court of Appeal’s Decision Collides With the Patent Act 1. Congress Has Exclusive Authority to Promulgate Patent Policy The Court ofAppeal’s decision also collides with the Patent Act. Brethine, like most innovative drugs, was protected by a patent. See “Orally active bronchospasmolytic compoundsandtheir preparation,” U.S. Patent 3,937,838. Indeed, virtually all drugs that are approved for marketing through submission of an NDAare protected by one or more patents for the limited period oftime prescribed by the federal patent laws. See FDA, Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book), available at http://www.fda.gov/Drugs/InformationOnDrugs/ucm129662.htm(listing patent and exclusivity information for drug products approved by FDA on the basis of safety and effectiveness). State tort liability laws that selectively target current and former NDAholdersthus invariably diminish the value of federal patent rights. The Constitution directs Congress “[t]o promote the Progress of Science and useful Arts, by securing for limited Times to Authors and Inventors the exclusive Rightto their respective Writings and Discoveries.” 25 U.S. CONST.art. I, § 8, cl. 8. Congress fulfilled this constitutional mandate by enacting the Patent Act, codified as amendedin Title 35 of the U.S. Code. The instrumental purposeofthe federal patent law is to induce inventors to incurthe costs of risky research and development with the promiseofa federally protected right to exclude competitors. Theright to exclude is valuable because it enables patent holders to obtain above- market profits during the patent term. Biotech. Industry Org v. District of Columbia, 496 F.3d 1362, 1372 (Fed. Cir. 2007). As the Supreme Court has noted, “The federal patent system thus embodiesa carefully crafted bargain for encouraging the creation and disclosure ofnew, useful, and nonobvious advancesin technology and design in return for the exclusive right to practice the invention for a period of years.” Bonito Boats, Inc.v. Thunder Craft Boats, Inc., 489 U.S. 141, 150-51 (1989). Patents play a central role in federal innovation policy. See, e.g., TLR. Rep. No. 98-857, at 17 (1984), U.S.C.C.A.N.pp. 2647, 2650 (1984) (“Patents...enable innovators to obtain greater profits than could have been obtainedifdirect competition existed. These profits act as incentives for innovative activities.”). The Federal Circuit, the specialized court with exclusive appellate jurisdiction over patent cases, has repeatedly reiterated that “the encouragement ofinvestment-basedrisk is the fundamental purpose ofthe patent grant...” Sanofi-Synthelabo v. Apotex, Inc., 470 F.3d 1368, 1383 (Fed.Cir.2006) (quoting Patlex Corp. v. Mossinghoff, 758 F.2d 26 594, 599 (Fed.Cir.1985)). See also King Instruments Corp. v. Perego, 65 F.3d 941, 950 (Fed. Cir. 1995) (“The economic rewards during the period of exclusivity are the carrot...Upon grant of the patent, the only limitation on the size of the carrot should be the dictates of the marketplace.”). The current patent system reflects a deliberate legislative balance between the competing federal objectives of rewarding inventors and preserving consumeraccess to innovative products. As the Federal Circuit has recognized, Congress has sole authority to calibrate patent law’s incentive structure. See Hunter Douglas, Inc. v. Harmonic Design, Inc., 153 F.3d 1318, 1333 ( Fed. Cir. 1998) (“[T]he objectives of the federal patent laws...are in some tension with one another, and Congress struck a balance between them.”). “Congress, as the promulgator of patent policy, is charged with balancing [the patent system’s] disparate goals.” Biotech. Industry Org v. District ofColumbia, 496 F.3d, at 1373. The Supreme Court has “madeclearthat state regulation of intellectual property must yield to the extent that it clashes with the balance struck by Congress in our patent laws.” Bonito Boats, 489 U.S.at 152. 2. Innovator Liability Levies a “Patent Tax” on Brand Manufacturers Asthe Federal Circuit has recognized, federal patent law preempts state laws that constrain the pecuniary rewards that innovators derive from a patent grant. In Biotech. Industry Org v. District ofColumbia,the court 27 applied this principle to conclude that federal patent law entirely preempted a District of Columbia (“D.C.”) statute setting price limits on patented drugs. 496 F.3d at 1373-74. The Federal Circuit explainedthat “the essential criteria for determining whethera state law is preemptedare the objectives of the federal patent laws.” Jd. at 1372 (internal quotations and citations omitted). It noted that any state law, howeverclearly within a state’s general police power, must yield if it interferes with the goals established by Congress in the patent laws. Id. at 1373-74. The court concludedthat the D.C. statute was preempted, because “[b]y penalizing high prices — and thus limiting the full exercise of the exclusionary power that derives from a patent — the District has chosen to re-balancethe statutory framework of rewardsandincentivesinsofaras it relates to inventive new drugs.” Jd. at 1374. The U.S.District Court for the Eastern District of Pennsylvania recently applied the Federal Circuit’s reasoning in Biotech. Industry Org v. District ofColumbia to dismiss a claim that Gilead Sciences, Inc. (“Gilead”), inter alia, violated the California Business & Professions Code § 17200 withits pricing schemeforthe sale ofits patented Hepatitis C drugs. See Southeastern Pennsylvania Transit Authority v. Gilead Sciences, Inc., 102 F. Supp. 3d 688 (E.D.Pa. 2015). The district court explained that the plaintiff could notuse state law to disrupt the federal patent system “by forcing Gilead to lowerits prices or disgorge profits from 28 the sale of its patented drugs.” Jd. at 703. Such claims were preempted, because they stood as an obstacle to the federal patent law’s balance of objectives. Id. at 702-03. State laws that diminish the economic value of a patent by capping the revenues derived from sales of a patented drug thus impermissibly clash with the Patent Act. Innovatorliability similarly clashes with federal patent law, because forcing an innovative manufacturer of a patented drug to shoulder the entire liability burden for harms caused by its generic competitors’ products diminishes —perhaps very considerably — the economic value ofthe innovator’s patents. Imposingliability on NDA holders for alleged harms caused by generic competitors effectively constitutes the imposition of a “patent tax” on innovative manufacturers. The Court of Appeal’s decision interferes with federal patent policy by manipulating commonlaw tort doctrine to attach a liability cost on patent rights granted by the federal government solely by reason of the defendant having beenthe first to discover the drug. “Congress has decided that patentees’ present amount ofexclusionary power, the present length of patent terms, and the present conditions for patentability represent the best balance between exclusionandfree use.” Biotech. Industry Org v. District ofColumbia, 496 F.3d, at 1373. Innovator liability disturbs this federal balance byaltering the economic value ofthe timelimited right to exclude. 29 II. The Court of Appeal’s Decision Conflicts With the Free Speech Clauseof the First Amendment The Court ofAppeal’s decision also collides with the Free Speech Clause of the First Amendment. The Plaintiffs assert two theories of liability: (1) Novartis should be held liable for promoting Brethine’s off- label use as a tocolytic during the time that it held the NDA;and (2) Novartis should be held liable for failing to communicate information about terbutaline’s risks beyond what was contained in the Brethine labelat the time ofNovartis’s divestiture. TH v. Novartis, 245 Cal. App.4" at 599. Neither theory is viable, because the imposition ofliability undereither theory infringes Novartis’s free speechrights. With respect to the first theory, manufacturers have a constitutional right to maketruthful statements aboutoff-label uses oftheir products. See United States v. Caronia, 703 F.3d 149,168 (2nd Cir. 2012) (holding that constitutional principles bar the government from penalizing “the truthful off-label promotion of FDA-approved prescription drugs”). With respect to the secondtheory, scientific information that is not connectedto the sale of a productis fully protected noncommercial speech. See Washington Legal Foundation v. Friedman, 13 F.Supp.2d 51, 62 (D.D.C. 1998) (“Scientific and academic speechresideat the core ofthe First Amendment.”) Novartis has a First Amendmentright to speak — or not to speak — about the benefits and risks of a drug that it does not sell. See First National Bank of 30 Boston v. Bellotti, 436 U.S. 765, 784 (1978) (the expression of views on matters of public importance does not lose First Amendmentprotection merely because a corporation seeks to utter the speech). A. Speech That Is Unconnected To CommercialSale Is Fully Protected By the First Amendment “TA]s a general matter, the First Amendment meansthat government has no powertorestrict expression because ofits message,its ideas,its subject matter or its content.” Bolger v. Youngs Drug Products Corp., 463 USS. 60, 65 (1983). The Supreme Court has drawn a distinction between noncommercial and commercial speech in considering the degree of protection afforded by the First Amendment. Whether a given communication constitutes commercial speech is predicated upon “the ‘commonsense’ distinction between speech proposing a commercial transaction...and other varieties of speech.” Bolger, 463 US.at 64 (quoting Ohralik v. Ohio State Bar Assn., 436 U.S. 447, 455-56 (1978)). With respect to noncommercial speech, content-basedrestrictions are permissible “only in the most extraordinary circumstances.” Jd. at 65. “There is no longer any room to doubt” that commercial speechis also entitled to the protection of the First Amendment, “albeit protection somewhatless extensive than that afforded ‘noncommercial speech.’” Zauderer v. Office ofDisciplinary Counsel ofSupreme Court ofOhio, 471 U.S. 626, 37 (1985). (quoting Bolger, 463 U.S.at 60). 31 Any communication about a drugthat is unconnectedto the sale of a product is noncommercial speech thatis fully protected by the First Amendment. This type ofscientific exchange constitutes pure speechthat lies at the core of First Amendmentprotection. See Friedman, 13 F.Supp.2d at 62; Board ofTrustees ofLeland Stanford Junior University v. Sullivan, 773 F.Supp. 472, 474 (D.D.C. 1991) (“[T]Jhe First Amendment protects scientific expression and debatejust as it protects political and artistic expression.”). See also Keyishian v. Board ofRegents, 385 US. 589, 604 (1967) (“Because First Amendment freedoms need breathing space to survive, government mayregulate in the area only with narrow specificity.”) (internal quotation andcitation omitted). “Lawmakers may no more silence unwanted speech by burdeningits utterance than by censoring its content.” Sorrell v. IMS Health Inc., 564 U.S. 552, 566 (2011). B. Manufacturers Cannot Be Compelled To Speak About Products That They Do NotSell The Court of Appeal decision cites several articles about the risks and benefits of using terbutaline to prevent pre-term labor publishedin medical journals in the decades preceding plaintiffs’ injuries. See 7.Hy. Novartis, 245 Cal. App.4th at 596-98. Yet neither the Court ofAppeal nor Plaintiffs contend that the numerous members ofthe medical community who published these studies breached a legal duty to the plaintiffs’ to warn their mother’s physician ofthe risks of terbutaline. Indeed, such an 32 assertion would be manifestly untenable. The law is clear that noncommercial speech that conveysscientific or clinical information about a drugis fully protected by the First Amendment. See Washington Legal Foundation v. Friedman, 13 F.Supp.2d at 62 (“It is beyond dispute that whenconsidered outside the context of manufacturer promotion oftheir drug products, CME seminars, peer-reviewed medical journal articles and commercially-available medical textbooks merit the highest degree of constitutional protection.”). The Ninth Circuit Court of Appeal decision in Vess v. Ciba-Geigy Corp., 317 F.3d 1097 (9th Cir. 2003), illustrates the scope andstrength of the constitutional right to speak aboutthe clinical effects and uses of lawfully marketed drugs. The plaintiffs in Vess alleged that the American Psychiatric Association (“APA”), publisher of the Diagnostic and Statistical Manual of Mental Disorders (“DSM”), and the nonprofit advocacy group Children and Adults with Attention Deficit/Hyperactivity Disorder (“CHADD”), conspired with the manufacturer of the drug Ritalin to increaseits sales by listing ADHD as a mental disorder in the DSM. Vess, 317 F.3d at 1101. After affirming the district court’s holding that the plaintiffs failed to state a claim, the Ninth Circuit determined thatthe suit constituted a “Strategic Lawsuit Against Public Participation (““SLAPP”) suit within the meaning of Cal. Civ. Code § 425.16. Jd. at 1109-10. The court granted the APA’s and CHADD’s motionto strike under California’s 33 anti-SLAPPstatute, concludingthat the plaintiff's lawsuit violated the APA’sright to publish the DSM and CHADD’:right to engagein public advocacyactivities in connection with the use of Ritalin. Jd. at 1110. Physicians, researchers, medical organizations, and patient advocacy groupsthus enjoy robust First Amendmentrights that allow them to freely engagein scientific exchange. The First Amendmentalso protects their right not to speak. See Va. Pharmacy Bd. V. Va. Consumer Council, 425 U.S., 478, 756 (1976) (“Freedom of speech presupposes a willing speaker.”). “Both the right to speak and the right to refrain from speaking are ‘complimentary components ofthe broader concept of individual freedom of mind’ protected by the First Amendment.” R.J. Reynolds Tobacco Co. v. Food & Drug Admin., 696 F.3d 1205, 1211 (D.C.Cir. 2012) (quoting Wooley v. Maynard, 430 U.S. 705, 74 (1977)). Plaintiffs seek to deprive Novartis of the free speech rights enjoyed by other members ofthe biomedical community. Their failure to warn claims are based on the notion that Novartis — unlike the numerous others whohadpublished information about terbutaline’s risks and benefits— was required to communicate informationto plaintiffs’ mother’s physician because Novartis had previously sold a product that was similarto the generic drug that their mother ingested. Yet, at the time plaintiff's mother was taking terbutaline, information about the drug’s risks and benefits was entirely unrelated to any commercialtransaction in which Novartis was 34 involved. Indeed, the Brethine label was completely detached from any commercial product sold by Novartis in 2007. This information therefore comprised noncommercial speech at the time of Plaintiffs’ alleged injuries. Novartis had the same constitutional right to speak — or not to speak — about terbutaline as did clinicians and researchers who had previously published information aboutterbutaline. See Sorrell, 564 U.S. 566-67 (explaining that the First Amendment requires heightened scrutiny wheneverthe governmentcreates a restriction on protected expression based on the content of speech andthe identity of the speaker). See also Citizens United v. Federal Election Comm’n, 130 S. Ct. 876, 899 (“The Court has recognized that First Amendmentprotection extends to corporations.”); Pacific Gas & Elec. Co. v. Public Util. Comm’n ofCal., 475 US. 1, 8 (1986) (plurality opinion) (“Corporations and other associations,like individuals, contribute to the ‘discussion, debate, and the dissemination of information andideas’ that the First Amendmentseeksto foster.”) (quoting Bellotti, 436 U.S. at 783). C. Manufacturers May Make Truthful Statements About Off-Label Uses For Their Products The imposition of tort liability conflicts with Novartis’s First Amendmentrights even if Novartis’s statements about Brethine are deemed to permanently and perpetually constitute commercial speech. “[T]he extension of First Amendmentprotection to commercial speechis justified 35 principally by the value to consumersofthe information such speech provides.” Zauderer, 471 U.S. at 651. This principle “has great relevance in the fields of medicine and public health, where information can save lives.” Sorrell, 564 U.S. at 566. Moreover, because “manufacturers have superior access to information about their drugs,” Levine, 555 U.S.at 578- 79, they are frequently the most well-informed speakers in the information marketplace. Restricting manufacturers’ speech therefore degradesthe quality of information accessible to physicians, researchers, patients, and payers. A manufacturer’s dissemination oftruthful information about off- label uses ofits products is fully protected by the First Amendment. See Caronia, 703 F.3d at 168 (holding that constitutional principles bar the government from penalizing “the truthful off-label promotion ofFDA- approvedprescription drugs”). “Off-label drug usage is not unlawful, and the FDA’sdrug approval process generally contemplates that approved drugswill be used in off-label ways.” Jd. at 166. See also Amarin Pharm, Inc. v. FDA, 119 F. Supp. 3d 196, 224 (S.D.N.Y. 2015) (concluding that “the FDA maynot bring [an enforcement] action based on truthful promotional speech alone, consistent with the First Amendment.”). Congress declined, when it enacted the FDCA,to “limit or interfere with the authority of a health care practitioner to prescribe or administer any legally marketed device to a patientfor any condition or disease.” 21 36 U.S.C. § 396 (emphasis added). Similarly, federal regulations expressly leave unregulated “the use in the practice of medicine for an unlabeled indication of a new drug product approved” by FDA. 21 C.F.R. §312.2(d). This federal regulatory policy reflects the fact that off-label use “is an accepted and necessary corollary of the FDA’s mission to regulate in this area without directly interfering with the practice of medicine.” Buckman Co. v. Plaintiff's Legal Comm., 531 U.S. 341, 350 & n.5 (2001). FDA acknowledgesthat off-label use “may even constitute a medically recognized standard of care” for certain conditions. FDA, Draft Guidance for Industry: Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices 2 (Dec. 2011); see also Am, Acad. of Pediatrics, Comm. on Drugs, Uses ofDrugs Not Described in the Package Insert (Off-Label Uses), 110 PediatricS 181, 182 (2002) (stating that, because “[t]he full and ultimate role of a drug is rarely evident at the time ofits initial approval and labeling,” limiting a drugtoits approved uses only would drastically and artificially restrict its value). Federal court decisions makeclear that the First Amendmentaffords significant protection to commercial speech about off-label uses ofFDA- approved products. As the District of Columbia district court explained in the seminal case Washington Legal Foundation v. Friedman, “[i]n choosing between the dissemination ofmore or less information‘[i]t is precisely this kind of choice, between the dangers of suppressing information, and the 37 dangersofits misuseifit is freely available, that the First Amendment makesfor us.’” 13 F. Supp. 2d at 73-74 (quoting Virginia State Board of Pharmacy, 425 U.S. 748, 770 (1976)), order vacated as moot sub nom. Washington Legal Foundation v. Henney, 202 F.3d 331, 336-37 (D.C. Cir. 2000). See also Caronia, 703 F.3d at 168; Amarin Pharma, Inc. v. FDA, 119 F. Sup. 3d 196, 236 (S.D.N.Y. 2015). Cf Thompson v. Western States Medical Center, 535 U.S. 357 (2002); Sorrell v. IMS Health, Inc., 564 US. 552 (2011). In Caronia, the Second Circuit declined to construe the FDCA to criminalize pharmaceutical manufacturers’ promotion of a drug’s off-label use, “because such a construction — and a conviction obtained underthe government’s application of the [FDCA] - would run afoul of the First Amendment.” 703 F.3d at 161. The DepartmentofJustice (“DOJ”) did not seek Supreme Court review ofthe Second Circuit’s decision. “That tactical decision speaks volumes about DOJ’s assessmentofthe probable outcome.” Jeffrey K. Shapiro, Does FDA’s Per Se Prohibition Against Off- Label Promotion Have a Future? The Short Answer: No, Food and Drug Law Institute’s Update Magazine, March/April 2016, available at http://www.hpm.com/pdf/FDLI%20mar%20apr%202016%20jks%200ff%2 Olabel.pdf. See also Amarin Pharma, Inc. v. FDA, No. 15-3588 (S.D.N.Y. Mar.8, 2016)(litigation settlement entered into by FDA that expressly 38 permits continued truthful and non-misleading off-label promotion without sanction). The Court ofAppeal’s decision subjects Novartis to liability for injuries allegedly caused by generic terbutaline based on promotional statements that Novartis allegedly made aboutan off-label use for Brethine. In its practical operation, therefore, the Court ofAppeal’s decision imposes a burden based on the content ofNovartis’s speech about terbutaline and the identity of the speaker. Since the decision creates a content-based and speaker-based burden,the imposition of such tort duty is subject to “heightened judicial scrutiny.” See Sorrell, 564 U.S. at 557. In Sorrell, the Supreme Court instructedthat “[s]peech in aid of pharmaceutical marketing...is a form of expression protected by the Free Speech Clause of the First Amendment.” Jd. Therefore, where a manufacturer makestruthful and non-misleading statements about howits approved products may be lawfully used, anyrestriction on that speech — whetherit is a regulatory ban or liability burden — must “directly advance[] a substantial governmentinterest” and be carefully “drawn to achieve that interest.” Jd. at 565-66, 572. Theliability burden imposed by the Court of Appeal doesnotsatisfy the constitutional requirement that the speech restriction advance a “substantial governmentinterest” and be “carefully drawn.” A desire to provide consumersofgeneric manufacturers’ drugs with an alternative 39 defendant to sue in the wake ofthe Supreme Court’s preemption decisions in Mensing and Bartlett is not a “substantial governmentinterest” within the meaning of the Supreme Court’s First Amendmentjurisprudence.It is up Congress to decide whether to amend federal law to permit consumers of generic drugs to sue generic manufacturersfor alleged harms caused by their products. States, however, may not manipulate fundamental common law principles to create tort duties that infringe on the constitutional rights of innovative brand drug manufacturers. CONCLUSION Forthe reasonsstated above, Atlantic Legal Foundation respectfully requests that the decision of the Court of Appealbe reversed and the cause remandedto thetrial court with directions to enter judgment for Novartis. DATED:December7, 2016 Respectfully submitted, ATLANTIC LEGAL GREENBERG TRAURIG, LLP FOUNDATION 2 -, Martin S. Kaufman By: (0bet Chen Robert P. Charrow Anna B. Laakmann Attorneys for Amicus Curiae ATLANTIC LEGAL FOUNDATION 40 CERTIFICATION OF WORD COUNT Pursuantto rule 8.204(c)(1) of the California Rules of Court and in reliance on the word count of the computer program used to prepare this brief, counsel certifies that this Amicus Curiae brief was produced using 13-point type and contains 6,776 words. Dated: December 7, 2016 lobe Char Robert P. Charrow 41