H. (T.) v. NOVARTIS PHARMACEUTICALS CORPORATION

Amicus Curiae Brief of Consumer Attorneys of California and American Association for Justice

Cal.December 15, 2016

SUPREME COURT COPY SUPREME CouRT ILE DEC 15 2016 Jorge Navarrete Clerk IN THE SUPREME COURT—>>--— No.: S233898 eputy OF THE STATE OF CALIFORNIA T.H., etc., et al., Court of Appeal, Plaintiffs and appellants, Fourth Appellate District, Division 1 No.: D067839 vs. San Diego County Superior Court No.: 37-2013-00070440-CU-MMCTL NOVARTIS PHARMACEUTICALS CORPORATION, Defendant and respondent. On Review of a Judgment of Dismissal following an Order Sustaining a Demurrer Honorable Joan Lewis, Presiding APPLICATION TO FILE AND AMICUS CURIAE BRIEF OF CONSUMER ATTORNEYS OF CALIFORNIA AND AMERICANASSOCIATION FOR JUSTICE IN SUPPORT OF PLAINTIFFST.H. Alan Charles Dell’Ario, # 60955 Jeffery R. White (D.C.# 943027) ATTORNEY AT LAW ATTORNEY AT LAW 1561 Third Street, Suite B 777 Sixth St. NW,Suite 250 Napa, California 94559 Washington, DC 20001 707 - 666 - 5351 (202) 944-2839 charles@dellario.org Jeffrey.white@justice.org RECEIVED Attorneys for Amici Curiae . Consumer Attorneys of California and American Association for Justicetl 04 2016 CLERK SUPREME COURT No.: $233898 IN THE SUPREME COURT OF THE STATE OF CALIFORNIA T.H., etc., et al., Court of Appeal, Plaintiffs and appellants, Fourth Appellate District, Division 1 No.: D067839 vs. San Diego County Superior Court No.: 37-2013-00070440-CU-MMCTL NOVARTIS PHARMACEUTICALS CORPORATION, Defendant and respondent. On Review of a Judgment of Dismissal following an Order Sustaining a Demurrer Honorable Joan Lewis, Presiding APPLICATION TO FILE AND AMICUS CURIAE BRIEF OF CONSUMER ATTORNEYSOF CALIFORNIA AND AMERICAN ASSOCIATION FOR JUSTICE IN SUPPORT OF PLAINTIFFST.H. Alan Charles Dell’Ario, # 60955 Jeffery R. White (D.C.# 943027) ATTORNEY AT LAW ATTORNEY AT LAW 1561 Third Street, Suite B 777 Sixth St. NW,Suite 250 Napa, California 94559 Washington, DC 20001 707 - 666 - 5351 (202) 944-2839 charles@dellario.org Jeffrey.white@justice.org Attorneys for Amici Curiae Consumer Attorneys of California and American Association for Justice IN THE SUPREME COURT OF THE STATE OF CALIFORNIA No. 5233898 CERTIFICATE OF INTERESTED ENTITIES OR PERSONS This is the initial certificate of interested entities or persons submitted on behalf of Amici curiae for appellants T.H.et al., Consumer Attorneys of California, American Association for Justice in the case numberlisted above. The undersignedcertifies that there are no interested entities or persons that must be listed in this Certificate under California Rules of Court, rule 8.208. Dated: November30, 2016 By: Alan Charles Dell'Ario TABLE OF CONTENTS Page COVER PAGEoie... cccccccccsssssseccccssssesseseceesssneeeeecesseeecssseeeeessetsssesees 1 CERTIFICATE OF INTERESTED ENTITIES OR PERSONS.0......ccecccccccsssssecceeccceeccessesseessssaaeeaecceeceeeesessseeeeecessensssseceses 2 TABLE OF CONTENTS.0..........cecccccesessseececceeceeeeeesseceeeessesssnceseses 3 TABLE OF AUTHORITIES oo. cceccccccecccesssssececesseeesessseessessreeees 5 AMICUS CURIAEBRIEP 2.00... ccceccessseeeeeceeceesssseecsscsesenees 10 APPLICATION TO FILE AMICUSBRIEF......eee 10 STATEMENT OF INTEREST 00.00...eccesseeeeeseeesesseees 10 ARGUMENT. o.oo. cccscsssceecceeceeeesssesssssseeeceeeeensssneeessesesenes 12 I. The court of appeal’s conclusionsare rooted in well-settled California and national negligence law as applied to prescription drug manufacturers....... 13 A. For over40 years, this Court has recognized the drug manufacturer’s negligence-based duty to warn of its drug’s dangers. ..............ccssseeeeeseeee 14 B. Traditional tort law recognizes negligent misrepresentation resulting in physical harm as a distinct cause Of ActiON...............cccsessecceeesssssseseeeee 15 C. Novartis’s contrary argument confuses negligence andstrict liability. 0.0.0.0... ccieeeeeeesseeereeees 20 D. Pharmaceutical manufacturers are not entitled to immunity from liability for negligent misrepresentation.............ccccssessesceeesesseeeees 23 EK. The Court’s O’Neil decision does not aid Novartis...... 27 II. Federal labeling law compels a conclusion that the manufacturer’s duty of care extendsto patients who take generic equivalents.................ccccc000 28 III. Federal labeling law is a floor, not a ceiling, on a drug manufacturer’s liability... cececessssesseeeeeeeees 32 A. Both this Court and the U.S. Supreme Court have rejected the premise that FDA labeling law providesthesole limit of liability..........0000000..0.. 32 B. The drug manufacturers, not the FDA, have the responsibility for monitoring for adverse events that emerge post-marketing.............cccccesseeseees 35 IV. No special rules of superseding cause apply to a negligent drug manufacturer whosells its rights to the Arug. ..........cccccessssssssessssccessseccesseescssssceeeeeess 38 CONCLUSION 0.cccscssssssseecesesssneeeeessaeeeesessseeeessneeesensees 41 CERTIFICATE OF COMPLIANCE ...........ecccccecccccceessteeesssreeeeens 42 PROOF OF SERVICE. .........ccccecccscsssssceeeeeesesseecsseeeeceeeesseeessseneeeees 43 CO RW RR Y S a va g A e a i a h a h B e e TABLE OF AUTHORITIES Page Cases: Akins v. Cnty. of Sonoma (1967) 67 Cal.2d 185 ..eccscecccsssesssssessesssessseessessessuessecsesssecssccsves 40 Arreola v. Cnty. of Monterey (2002) 99 Cal.App.4th 722 oo....iicccceeccccssssccccceeessssssssssescesssees 40 Bank of Italy Nat. Trust & Sav. Assn. v. Bentley (1988) 217 Cal. 644 occceccecscecccssccesssssssssessessesseeees 21 Bates v. Dow Agrosciences LLC (2005) 544 U.S. 481 oocccccssssseesseeeesseceeseesseeeeceeeseaeesaes 34 Bd.ofEduc. of City of Chicago v. A, C & S, Inc. (1989) 1381 T1.2d 428 oeccccsccesccesssssssssssevesseeeeees 27 Brown v. Superior Court (Brown) (1988) 44 Cal.3d 1049 oieccsssseeessecesseeceeeeesseeecesssesceses 15 Carlin v. Superior Court (1996) 13 Cal.4th 1104 .oecccccccccsccscsssccsccssessecsessecsessessesseessessees 15 Cobbs v. Grant (Cobbs) (1972) 8 Cal.8d 229 oooceeccccccceesssssssseccsssssccessessseeeeceeecessssssceess 12 Consumer Fed’n ofAm. v. Upjohn Co. (D.C. 1975) 846 A.2d 725 oo...eecccccccessssscccsssscccccesesessssseseescessass 33 Conte v. Wyeth, Inc. (Conte) (2008) 168 Cal.App.4th 89 wou... eceesccsssssserreceeeseenens passim Erie R. Co. v. Tompkins (1938) 304 U.S. 64. ccecccccsseccescesecsessessessscssucssessessessessessecsucaseeass 21 Foster v. Am. House Prods. Corp. (4th Cir. 1994) 29 F.8d 165 oo...ccccccccccceesessssesseeeeceseaes 24 Fullington v. Pfizer, Inc. (8th Cir. 2018) 720 F.8d 739 oo... ceccscccccseessssseeeeeessesseeees 21 Gerrity v. R.J. Reynolds Tobacco Co. (Conn. 2008) 818 A.2d 769 oo... eccececscccssseessssceeesssscseesesseeseeaes 18 Greenman v. Yuba Power Prods., Inc. (1968) 59 Cal.2d 57 ooo. ceecssecccccccseesesscscscscccscceessssessoes 19, 20 In re Darvocet, Darvon, & Propoxyphene Prod. Liab. Litig. (6th Cir. 2014) 756 F.3d 917 woecceeeeeeeseccceeecessceeseseesesees 21 Johnson v. Teva Pharm. USA,Inc. (5th Cir. 2014) 758 F.8d 605 oo... ccesceeceseecccseeccsseseseessevees 21 Kellogg v. Wyeth (Kellogg) (D. Vt. 2010) 762 F.Supp.2d 694 oo... ceccccsssseccceeeeees 26, 27 Lawhon v. Ayres Corp. (Ark. Ct. App. 1999) 992 S.W.2d 162 oo.ecceeeeseseeeeee 18 Lymanv. Pfizer, Inc. (D. Vt. July 20, 2012) 2012 WL 2970627 ou...ceeecceeeeee 27 Martinez v. Vintage Petroleum, Inc. (1998) 68 Cal.App.4th 695 ooocccccccccccccceccccceteeseeessseesees 40 O’Neil v. Crane Co. (O’Neil) (2012) 58 Cal.4th 335 oooeccccccccsssccccececeeseeseeeesseeenes 27, 28 People v. Tully (2012) 54 Cal.4th 952 woecccccsccsececceeeeeesesesssssssssssssceees 35 PLIVA,Inc. v. Mensing (PLIVA) (2011) 564 U.S. 604 woeeecceseeetescesssssssseesseeeeneesees passim Rowlandv. Christian (1968) 69 Cal.2d 108 uuu.ececccccsessesccccccseesecscseeeevesscsseeees 31 Santisas v. Goodin (1998) 17 Cal.4th 599 veccccccsccecsecsecsessssssseesucsseseessessesssesseecssee 28 Schrock v. Wyeth, Inc. (10th Cir. 2013) 727 F.3d 1278 oiecee cccceccccesceeseeeeeees 21 Stevens v. Parke, Davis & Co. (Stevens) (19738) 9 Cal.3d 51 oo.ceeeesssesssssssssceesscccceessesesssseeeeees passim Teva Pharm. USA, Inc. v. Superior Court (2013) 217 Cal.App.4th 96 o...c.cccecessscsssceesseeesesssseeaes 12, 29 Thomasv. Winchester (1852) 6 N.Y. 897 ovciieeeecccceccseeccccesseesssssssccsssssscsssscsssccceseseeevees 17 Thompson v. Hardy Chevrolet-Pontiac-Buick, Inc. (Ga. Ct. App. 1992) 417 S.B.2d 358 oececeeeeeteeeeee 18, 19 Tingey v. E.F. Houghton & Co. (1947) 80 Cal.2d 97 ..ecececsecsessecssesseecsseessessessucsseseessessesssessseasee 14 United States v. DeGasso (10th Cir. 2004) 369 F.8d 1189 woceccssessseeseceeeseeenes 24 Virginia Dare Stores, Inc. v. Schuman (Md. 1938) 1 A.2d 897 o......eececcccsssscesececeesseeeeessssseneceessssesceens 19 Wyeth, Inc. v. Weeks (Weeks) (Ala. 2014) 159 S0.8d 649 oeeccccccssseeeessesseeees 24, 25, 26 Wyeth v. Levine (Wyeth) (2009) 555 U.S. 555 occccccsscssccesssseceeessssssneecececceeseesees passim Statutes: 21 C.F.R., § 201.80 occccccccscscccceesssececeseessseeeeeeeeeeees 22, 23, 36 21 C.F.R., § 814.80 oocccccccccsssscceesssseececeesssseececcecccseesssssacesens 30 21 C.F.R., § 814.81 eeeccccsssseecsssceesseeceeesssneecceceesssessssseeans 30 21 C.F.R., § 814.92 oiceecccccccccsssseccssecesssscecessseesecesessseeusesssaas 30 21 C.F.R., § 814.92 oiecccssssecsesecssssneeeeeeseeeceeeeenseesseessees 30 21 U.S.C. § 801 ooo. cccccscsssesssececeecessececeeeessssssecececeeesesssseseeeees 32 21 ULS.C. § 855 ooo. ccccccssssssssscccceesssaceeeecesssscccceccecceeessssseseeees 29 Bus. & Prof. Code, § 4073 ou... .ccecccesscccessssecscessessssssssssseeeeeees 11, 30 Constitutions: U.S. Const., 7th Amend. oi...icc eceeceeeesecceccccssssssccccesssccececeeeeeees 11 Other: 153 Cong. Rec. $11832 (daily ed. Sept. 20, 2007) wu... 38 B. Evans, Seven Pillars of a New Evidentiary Paradigm: The Food, Drug, and Cosmetic Act Enters the Genomic Era (2010) 85 Notre DameL. Rev. 419 wowccccsscsccessssssesesssseeees 36 CACI NO. 482 oeeee eeneecesscceeeceeseeseeecseecseessseeeeaeeeesseessnesseeenas 40 D. Kessler, et al., A Critical Examination of the FDA’s Efforts to Preempt Failure-to-Warn Claims (2008) 96 Geo. Lid. 4G1 ooocecccccccceccsccessccesureccssssscucessssssseseseeeseeees 36 E. Parasidis, Patients over Politics: Addressing Legislative Failure in the Regulation of Medical Products (2011) 2011 Wis. L. Rev. 929 oo... eeccseceseeeeeee 37 F. Harper,et al., Harper, James & Gray on Torts (2006) § 7G eeccccccssssssecssessesscecceeeecseesnseeesseeesesseeeeessaeeeesssessseeeseesssascees 18 FDA,Information for Healthcare Professionals- Intravenous Promethazine and Severe Tissue Injury, Including Gangrene (2009) o......eccccccssssseccececeeeeeseeeesscessesees 34 IOM,The Future of Drug Safety: Promoting and Protecting the Health of the Public (2007) ..........eee 37 J. Mann, FDA Adverse Event Reporting System: Recruiting Doctors to Make Surveillance A Little Less Passive (2015) 70 Food & Drug Ld. 871 oo.cceececccccsssssccseesseeeeeesseeeesseseneesees 37 La. Rev. Stat. Ann. § 9:2800.52 oo.....icceeececseeseceeseeeeeeeeesessessseceees 21 P. Hutt, The State of Science at the Food and Drug Administration (2008) 60 Admin. L. Rev. 481 oo.iccccccseecccceceseeeeessssssssssesssseeees 37 R. Adler, et al., Preemption and Medical Devices: The Courts Run Amok(1994) 59 Mo. L. Rev. 895 oo... eeeeescccesssssssssssesscserececceesesessesssseees 33 Restatement (Second) of Torts § 310 woiweeeeeeeeeececsseseceeees 16, 17 Restatement (Second) of Torts § 311 oo...eeeeeeeeeeee passim Restatement (Second) of Torts § 402A oo...eeeeeecceeseseeeeeee 20 Restatement, 2d, Torts, section 388 .........ecccccceeeeecceeeceeeeceneeees 14 T. Tiedt, The Drug Safety System Conundrum (2007) 62 Food & Drug Lid. 547 eee eceeccccccccccssceessessseseesssssecceseceeees 37 U.S. Gen. Accounting Office, GAO/T-HEHS-00-53 (2000) Adverse Drug Events: Substantial Problem But Magnitude Uncertain 000.0... ccccccccsceseceeeecssssssseccoees 37 V. Schwartzet al., Prosser, Wade and Schwartz’s Torts (10th ed. 2000) oi...ccccceeseeeeeceseeecssssseeeseessceuscssssccesesees 17 W.Prosser, et al., Prosser and Keeton on the Law of Torts (5th ed. 1984) (Prosser) ........cceeeeeecscscessseseseresseeseeees 15, 16 W. Prosser, Misrepresentation and Third Persons (1966) 19 Vand. L.Rev. 2381 oo... eeessecseeccecccceeeeeessssssccsssesseaeeeees 16 AMICUS CURIAE BRIEF BRIEF IN SUPPORTOFT.H., a minor, by CONSUMER ATTORNEYS OF CALIFORNIA and AMERICAN ASSOCIATION FOR JUSTICE APPLICATION TO FILE AMICUS BRIEF ConsumerAttorneysof California and the American Association for Justice request that the attached amicusbrief submitted in support of plaintiffs T.H., a minor,et al. be accepted for filing in this action. Counsel are familiar with all of the briefing filed in this action to date. The concurrently-filed amicus brief addresses fundamental public policy issues not otherwise considered or argued by the parties and amici believes the brief will assist this Court in its consideration of the issues presented. In particular, this brief discusses the common-law foundations of the defendant’s tort liability, its relationship to federal drug regulation and California principles of concurrent causation in the context presented by the case. No party to this action has provided support in any form with regard to the authorship, productionorfiling of this brief. STATEMENT OF INTEREST Consumer Attorneys of California [CAOC] is a voluntary membership organization representing over 6,000 associated consumer attorneys practicing throughout California. The organization was founded in 1962. Its membership consists 10 primarily of attorneys who represent individuals who are injured or killed becauseof the negligent or wrongful acts of others, includingvictims of mislabeled drugs. CAOC has taken a leading role in advancing andprotectingthe rights of Californians in both the courts and the Legislature. As an organization representative of the plaintiff's trial bar throughout California, including many attorneys who represent plaintiffs injured or killed as the result of negligence, CAOCis interested in the significant issues presented by the court of appeal’s decision in this case, particularly with respect to the determination of what duty is owed by brand-name drug manufacturers to consumers whoingest generic formsof their drugs. State law requires generic equivalents be available to patients even where brand-namedrugsare prescribed. (Bus. & Prof. Code, § 4073.) The American Association for Justice [AAJ] is a voluntary national bar association whosetrial lawyer membersprimarily representplaintiffs in personal injury lawsuits, civil rights and employment rights actions, and small businesslitigation. AAJ’s missionis to preserve theconstitutional right of access to the courts for redress of wrongful injury as well as the Seventh Amendmentrightto trial by jury in civil cases. AAJ is concerned that the broad immunity Novartis seeksin this case will remove the right to compensation for those wrongfully injured by pharmaceutical manufacturers’ misrepresentations along with a powerful financial incentive for safety that protectsall Americans. AAJ firmly believes that the court of appeals’ 11 decisions in that case as in this one werecorrect as a matter of law and reflect sound public policy that benefits Californians and, persuasively, all Americans. ARGUMENT “[C]ommon sense and the commonlawof California” recognize that drug manufacturers have a duty, soundingin negligence, to furnish adequate warnings of the knownrisksoftheir drugs.’ The ultimate decision to take terbutaline sulfate lay with the T.H. twins’ mother.” Without an adequate warning of the drug’s risks, mother could not give her informed consent to ingest it.? Federal and state law require generic drug manufacturers to mimic, on pain oftort liability, the warnings provided by the brand-name manufacturers. [BNMs]* This mandate and traditional California tort analysis require that a brand-name manufacturernot be relieved of its “general duty to use due care in disseminating product informationto those it knowsor should 1 Slip opn.at p. 14; e.g., Stevens v. Parke, Davis & Co. (1978) 9 Cal.3d 51, 64-65 (Stevens). 2 “[I]t is the prerogative of the patient, not the physician, to determine for himself the direction in which he believes his interests lie.”(Cobbs v. Grant (1972) 8 Cal.3d 229, 242 (Cobbs).) 3 Cobbs, supra, 8 Cal.3d at p. 245. * PLIVA, Inc. v. Mensing (2011) 564 U.S. 604, 613 (PLIVA) (“generic drug manufacturers have an ongoing federal duty of ‘sameness.”]; Teva Pharm. USA, Inc. v. Superior Court (2018) 217 Cal.App.4th 96, 112 [breach of “sameness” dutycreates liability]. 12 know arelikely to be harmedas a result of their physician's reliance on that information” including consumers whoingest generic, biologically-equivalent versions of its drugs.” Likewise, a brand-name manufacturer cannot berelieved of liability for negligent failure to warn merely becauseit sold the rights to the drug unless the manufacturer establishes the victim’s injury wastheresult of a superseding cause. California law has long been “well settled that an actor maybeliable if his negligence is a substantial factor in causing an injury, and heis not relieved of liability because of the interveningact of a third personif such act was reasonably foreseeable at the timeof his *® Because Novartis negligently failed to revisenegligent conduct. its label when obliged to do so, it cannot escapeliability merely by pointing out it no longer owned the brand when mother took terbutaline. Neither the court of appeal here nor the Conte court has departed from traditional, well-settled principles of California law. The Court should affirm. I. The court of appeal’s conclusions are rooted in well-settled California and national negligence law as applied to prescription drug manufacturers. Novartis characterizes the court of appeal’s opinion an “extraordinary expansion|] of traditional tort law” (OBM 9), and a dismantlingof “boundaries established over decadesof product > Contev. Wyeth, Inc. (2008) 168 Cal.App.4th 89, 111 (Conte); Slip Opn.at p. 18. 6 Stevens, supra, 9 Cal.3d at p. 69. 13 hiability law.” (RBM 10.) The companydecries Conte, on which the court of appeal heavily relied, as “impos[ing] a new and infinite duty upon a prescription drug manufacturer.” (OBM 31.) Conte is “anomalous,” has “gainedlittle traction,” and “has failed the test of time,” says Novartis. (OBM 25, 31, 33). But Novartis is wrong. Asboththe court of appeal and the Conte court recognized, the principle that a drug manufacturer maybe liable for negligently failing to warn or negligently misrepresentingits drug’s dangerousside effects is rooted in California law and commonsense.(Conte, supra, 168 Cal.App.4th at p. 102; Slip opn. at p. 14.) A. For over 40 years, this Court has recognized the drug manufacturer’s negligence-based duty to warnofits drug’s dangers. In 1973, the Court recognized that prescription drug manufacturers have a duty, sounding in negligence, to provide adequate warnings of the dangerousside effects of their drugs. (Stevens, supra, 9 Cal.3d at pp. 64-65.) Drug manufacturers must “exercise reasonable care to inform [users] of its [drug’s] dangerouscondition or of the facts which makeit likely to be dangerous.” (Id. at p. 64.) The question was not novel, even then, for the Court relied on the Restatement, 2d, Torts, section 388 andearlier decisions such as Tingey v. E.F. Houghton & Co. (1947) 30 Cal.2d 97, 102." (Stevens, supra, at pp. 64-65.) 7 “[A] manufacturer must give an appropriate warning of any known dangers whichtheuserof his product would not ordinarily discover.” 14 In Brown v. Superior Court (1988) 44 Cal.3d 1049 (Brown), the Court rejected a strict-liability failure-to-warn duty that extended to unknowndrugrisks. (/d. at p. 1069.) But the Court madeclear that manufacturers “are subject to liability for manufacturing defects, as well as under general principles of negligence, and for failure to warn of known or reasonably knowable sideeffects.” (Id. at p. 1069 fn. 12.) The Court again spoke on this issue in Carlin v. Superior Court (1996) 13 Cal.4th 1104. “Negligence law in a failure-to- warn case requires a plaintiff to prove that a manufacturer or distributor did not warn of a particular risk for reasons whichfell below the acceptable standardofcare, i.e., what a reasonably prudent manufacturer would have known and warnedabout.” (Id. at p. 1112.) No question exists that drug manufacturers have a duty to furnish adequate warnings of known drugrisks. B. Traditional tort law recognizes negligent misrepresentation resulting in physical harm asa distinct cause of action. The cause of action for physical harm caused by reasonable reliance on defendant’s misrepresentations is a separate and independentcause of action well within the mainstream of negligence law. The tort of misrepresentation hasits origins in the ancient common-law “writ of deceit known asearly as 1201.” (W. Prosser,et al., Prosser and Keeton on the Law of Torts (5th ed. 1984) 727 (Prosser).) This writ was later “superseded by an action on the case in the nature of deceit, which became the general commonlaw remedyfor fraudulent or even non- 15 fraudulent misrepresentation resulting in actual damage.”(Id. at p. 728.) That cause of action evolved into thetort of misrepresentation: There is a duty not to make a false representation to those to whom a defendantintends, for his own purposes, to reach andinfluence by the representation; to those to whom he hasa public duty created by statute or pursuant to a statute; and to those membersofa group or class that the defendant has special reason to expect to be influenced by the representation. (W. Prosser, Misrepresentation and Third Persons (1966)19 Vand. L.Rev. 231, 254.) Prosser and Keeton catalogue cases recognizing the tort of misrepresentation resulting in physical harm or injury dating back to at least 1905.(Prosser, supra, at p. 726, n.15.) The tort of misrepresentation in its modern form is set out in Restatement (Second) of Torts § 310 and § 311. Section 311(1) provides: (1) One who negligently gives false information to anotheris subject to liability for physical harm caused by action taken by the other in reasonable reliance upon such information, where such harm results (a) to the other, or (b) to such third persons as the actor should expect to be putin peril by the action taken. Section 310 restates a similar rule applicable to conscious misrepresentation. The comments andreporter’s notes to both sections makeclear that these torts apply to foreseeable third- party injurieslike those alleged here: 16 A misrepresentation may be negligent not only toward a person whose conductit is intended to influence but also toward all others whom the maker should recognize as likely to be imperiled by action taken in reliance upon his misrepresentation. (Restatement (Second) of Torts § 310, commentc andid. § 311, comment d.) Novartis’s misrepresentations were directed at pregnant womenandtheir doctors, imperiling the unborn children. The tort of misrepresentation “finds particular application whereit is a part of the actor’s businessor profession to give information upon which the safety of the recipient or a third person depends.” (/d. at § 311(1), comment b.) The duty imposed on Novartis in this case was not that of an “innovator” or even a “former manufacturer.” It was the duty of one whose business wasto supply information to physicians on which the safety of their patients depends. Oneof the earliest cases recognizingliability for negligent misrepresentation involved a medicinal product. In Thomasv. Winchester (1852) 6 N.Y. 397, defendant manufactured medicinal extracts, “putting up andfalsely labeling thejar of belladonna as the extract of dandelion.” (Jd. at p. 398.) The consumerplaintiff whoingested the product was seriously injured. The court rejected defendant’s privity argument and held that the defendant could be liable on the separate groundof negligent mislabeling. (/d. at p. 408.) A cause of action “for negligent misrepresentation or misstatement . . . is now recognized by nearly all courts where tangible injury to person or property results.” (V. Schwartzetal., 17 Prosser, Wade and Schwartz’s Torts (10th ed. 2000) 1010; see also F. Harper,et al., Harper, James & Gray on Torts (2006) § 7.6 (“Where misrepresentations entail the foreseeability of physical harm and such harmin fact results, the ordinaryrules of negligence have for some time been applied.”].) Asplaintiffs have demonstrated, this cause of action is firmly supported by California precedents, which establish that those who disseminate misinformation maybeliable for physical harm caused by foreseeable reliance on that information. Those precedents do not depend on the defendant’s duty as the makeror marketer of an injury-producing product. (ABM 23-25.) State courts from aroundthe country likewise recognize the tort of negligent misrepresentation resulting in physical injury, as set out in Restatement (Second) of Torts § 311, as a cause of action entirely separate from a product supplier’s failure to warn. For example, in Lawhon v. Ayres Corp. (Ark. Ct. App. 1999) 992 S.W.2d 162, a pilot was killed in a crash that was allegedly causedby a defective airplane wing. His widow wasallowedto pursuenot only productsliability claims against the manufacturer, but also misrepresentation claims against the companythat serviced the aircraft. (Id. at pp. 163-164.) Similarly, in Gerrity v. R.J. Reynolds Tobacco Co. (Conn. 20038) 818 A.2d 769, the court allowed plaintiff to pursue both consumer product-liability claims for injuries caused by defective tobacco products and Unfair Trade Practices Act claims for injuries caused by defendant’s misrepresentations. (Jd. at pp. 774—775.) In Thompson v. Hardy Chevurolet-Pontiac-Buick, Inc. (Ga. Ct. App. 1992) 417 S.E.2d 358, the court ruled that defendant auto dealership could be held liable for injuries a passenger sustained 18 in an auto accident caused by brakefailure, not because the dealership wastheseller of the vehicle, but because “Hardy Chevrolet negligently informed [the buyer] that the brakes on the vehicle she purchased had been inspected and were in good working order,” citing Restatement (Second) of Torts §311. (Thompson v. Hardy Chevrolet-Pontiac-Buick, Inc., supra, at pp. 360-61.) Marylandfirst recognized the tort of negligent misrepresentation in Virginia Dare Stores, Inc. v. Schuman (Md. 1938) 1 A.2d 897. A cleaning companysent its employee to a store to wash walls. Although the store manager assured him that a dress case wassafe to stand on, the case gave way, causing the workerto fall and suffer injury. Following “the weight of authority in otherjurisdictions,” the court upheld the cause of action for negligent misrepresentation. (Id. at p. 899.) In each of these examples, defendant was not held to any expanded duty for the manufactureror supplier of the injury- producing product. The defendant instead washeld responsible as a negligent supplier of incorrect information in circumstances whereforeseeable reliance on that information placed the plaintiff in peril. Thepolicies served by strict products liability make clear why the defendant’s liability in that circumstanceis tethered to its status as the supplier of the injury-causing product. This Court explained in Greenman v. Yuba Power Prods., Inc. (1963) 59 Cal.2d 57, “A manufactureris strictly liable in tort when an article he places on the market, . . . proves to have a defect that causes injury to a humanbeing.” (/d. at p. 62 (emphasis added).) “The purpose of such liability is to insure that the costs of injuries 19 resulting from defective products are borne by the manufacturers that put such products on the marketrather than by the injured persons whoare powerless to protect themselves.” (Id. at p. 63, emphasis added.) Thus, the policy under-girdingstrict products liability demands: [T]hat the burden of accidental injuries caused by products intended for consumption be placed upon those who market them, and be treated as a cost of production against whichliability insurance can be obtained; and that the consumerof such productsis entitled to the maximum of protection at the handsof someone, and the properpersonsto afford it are those who marketthe products. (Restatement (Second) of Torts § 402A (1965) comment c, emphasis added.) Misrepresentation, by contrast, looks to the conduct of the defendant in disseminating dangerous misinformation. Both policies protect the public, but in distinct ways. C. Novartis’s contrary argument confuses negligence andstrict liability. Novartis’s entire argumentrests upon the incorrect notion that its tort responsibility is measured solely by the law of productsliability, specifically the manufacturer’s duty to warn of the dangers associated with the products it places into the stream 20 of commerce. Indeed, manyof the (largely federal®) decisions the company relies upon proceed upon the premise that misrepresentation claims against drug makers are simply productliability claims in poor disguise. For example, one federal court predicted that all 22 states whose law would be applicable to the misrepresentation claims before it would construe those claims as productliability claims, either because the claims were subsumed understate productliability statutes, or because the court’s Erie®-prediction of state common law reachedthat result, or because state law did not recognize a separate duty to use due care to avoid misrepresentation. (In re Darvocet, Darvon, & Propoxyphene Prod. Liab. Litig. (6th Cir. 2014) 756 F.3d 917, 941-954; see also Johnson v. Teva Pharm. USA, Inc. (5th Cir. 2014) 758 F.3d 605, 615 [The Louisiana Products Liability Act provides an exclusive remedy and claimants “may not recover from a manufacturer for damage caused by a product on the basis of any theory ofliability that is not set forth in this Chapter,” quoting La. Rev. Stat. Ann. § 9:2800.52]; Pullington v. Pfizer, Inc. (8th Cir. 2018) 720 F.3d 739, 744 [misrepresentation claims are essentially “product liability claims” governed by Arkansas Product Liability Act and its requirement that the injury-causing product be identified as defendant’s]; Schrock v. Wyeth, Inc. (10th 8 Federal decisions no more than advisory in this Court. (Bank of Italy Nat. Trust & Sav. Assn. v. Bentley (1933) 217 Cal. 644, 653.) 9 Erie R. Co. v. Tompkins (19388) 304 U.S. 64, 77-78 [federal courts in diversity cases must apply state law].) 21 Cir. 2013) 727 F.3d 1273, 1283 [finding no duty under Oklahoma law to warn or avoid misrepresentation between parties not in a contractual relationship].) Novartis invents other terms, “former manufacturer” duty (OBM 9) and “drug innovator” duty (OBM 10), to argue that products liability principles should not be expanded to impose liability under the circumstances here. (RBM 13-22.) But the court of appeal imposed no new products-liability duties. In 2001, when Novartis owned the New Drug Application?® [NDA] for Brethine, federal law required it to supply information to prescribing physicians concerning therisks associated with the drug. (21 C.F.R., § 201.80, subd. (e).) Whether Novartisis liable for a doctor’s reliance in 2007 on Novartis’s incomplete and inaccurate labeling that wasstill in force is, as the court below recognized, a factual question for the jury. (Slip opn.at p. 19.) The court of appeal held that Novartis could be liable, not merely becauseit supplied prescription drugs, but because it supplied information intendedto be relied upon by prescribing physicians, and ultimately, the consumers such as the mother here. Plaintiffs do not allege that the company should be liable for a defect in either Brethineor terbutaline. Rather, they claim that Novartis should be accountable for its own conduct in distributing misinformation concerning the drug. Novartis seeks a radical changein the law: absolute immunityforitself from liability for physical harm that was causedbyits distribution of misinformation knowing that prescribing physicians would rely 10 The NDA application is the vehicle through which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale and marketing in the U.S. 22 uponit, regardless of whether their patients would ultimately use Brethineorits identical generic equivalent. Novartis’s status as a product supplier does not insulateit from liability as a misinformation supplier. D. Pharmaceutical manufacturers are not entitled to immunity from liability for negligent misrepresentation. Novartis nonetheless argues that Restatement of Torts (Second) § 311 and the tort of negligent misrepresentation do not apply to pharmaceutical manufacturersof prescription medicines. First, Novartis contends that the court of appeal imposed “new”duties based solely on foreseeability. (RBM 12.) To the contrary, the duty to supplement label warningstoreflect newly discovered dangers is imposed byfederal law. FDA regulations provide that approved druglabeling “shall be revised to include a warningas soonasthere is reasonable evidenceof an association of a serious hazard with a drug.” (21 C.F.R., § 201.80, subd. (e) [emphasis added].) The appellate court’s discussion of reasonable foreseeability was in the context of whether it was reasonably foreseeable that plaintiff's prescribing physician would rely on Novartis’s 2001 labeling information in 2007. (Slip opn.at pp. 19-20.) The court of appeal did not determine the scope of Novartis’s duty based on foreseeability of harm. That duty was imposedbyfederal law. The court of appeal simply determined that reasonably foreseeable reliance by the treating physician could supporta jury finding of causation. (/d. at p. 20.) Second, Novartis relies on “the overwhelming judicial rejection of the Court of Appeal’s additional proposed duty on innovator 23 manufacturers.” (RBM 11.) But most of the decisions cited by Novartis are from federal courts and do not bind anystate court. (See United States v. DeGasso (10th Cir. 2004) 369 F.3d 1139, 1145[It is axiomatic that state courts are the final arbiters of state law.”].) And almost all those federal decisions are based on an Erie prediction that state courts would construe misrepresentation claimsas de facto productliability claims. California tort law, on the other hand, recognizes negligent misrepresentation as an entirely separate cause of action from productsliability. As the court of appeal observed, many of those decisions follow Foster v. Am. House Prods. Corp. (4th Cir. 1994) 29 F.3d 165, which held that generic drug manufacturers weresolely responsible for negligent misrepresentations in their warning labels. Ud. at p. 169.) Foster and the decisions that follow it do not withstand scrutiny in light of the Supreme Court’s subsequent conclusion that generic drug makers have no authority to alter label warnings furnished by the BNMs. (PLIVA, supra, 564 U.S.at p. 613.) Amici submit that those decisions which agree with the reasoning of the court of appeals in Conte, though fewerin number, are far more persuasive. The foremost comes from the Supreme Court of Alabama in Wyeth, Inc. v. Weeks (Ala. 2014) 159 So.3d 649 (Weeks). Its issues mirror the issues before this Court. Danny Weekswasafflicted with tardive dyskinesia, an irreversible neurological disorder of involuntary movements caused by long-term use of the prescription drug metoclopramide, which is the generic form of the brand-name drug Reglan. Weeks 24 brought suit in federal district court, alleging liability on the part of the makers of Reglan for misrepresentation of the dangers associated with the drug, including its generic equivalent. The federal court certified to the Alabama Supreme Court the question whether a drug company maybeliable under Alabama law “based on statements it made in connection with the manufacture or distribution of a brand-name drug,” where the plaintiff claims “physical injury from a generic drug manufactured anddistributed by a different company.” (Weeks, supra, 159 So.3d at p. 653.) The court first rejected defendants’ assertion that Weeks’ fraudulent misrepresentation claims, however pled, were in fact productsliability claims. As with California’s common-law principles, Alabama’s productslability statute “did not subsume a common-law negligence or wantonnessclaim.” (Weeks, supra, 159 So.3d at p. 656.) Andas did the court of appeal here, the Alabamacourt rejected defendants’ reliance on pre-PLIVA decisions. (Id. at pp. 664-666.) The court was skeptical of Wyeth’s contention that it had no duty becauseit lacked privity or other direct relationship with Weeks. “The Weeksesare not arguing that Wyeth owed them a duty. Instead, they are arguing that Wyeth owed Danny Weeks’s physician a duty and that, under the learned-intermediary doctrine, the Weeksesare entitled to rely on the representations made to Danny's physician.” (Weeks, supra, 159 So.3d at p. 664.) A prescription-drug manufacturerfulfills its duty to warn the ultimate usersof the risks of its product by providing adequate warnings to the learned intermediaries who prescribe the drug. . .. However, 25 if the warning to the learned intermediary is inadequate or misrepresents the risk, the manufacturer remains liable for the injuries sustainedby thepatient. .. . The substitution of a generic drug for its brand-nameequivalentis not fatal to the Weekses’ claim because the Weekses are not claiming that the drug Dannyingested was defective; instead, the Weekses' claim is that Wyeth fraudulently misrepresented or suppressed information concerning the waythe drug wasto be taken and, as discussed, the FDA mandatesthat the warning on a generic-drug label be the same as the warning on the brand-name-druglabel. (Weeks, supra, 159 So.3d at pp. 673-674.) The court concluded. [I]t is not fundamentally unfair to hold the brand- name manufacturerliable for warnings on a product it did not produce because the manufacturing process is irrelevant to misrepresentation theories based, not on manufacturing defects in the productitself, but on information and warning deficiencies, when those alleged misrepresentations were drafted by the brand-name manufacturer. (Weeks, supra, 159 So.3d at p. 677.) Kellogg v. Wyeth (D. Vt. 2010) 762 F.Supp.2d 694 (Kellogg), also followed Conte, imposingliability on a brand-name manufacturer for misrepresentation under Vermont law. The district court stated: [It] is reasonably foreseeable that a physician will rely upon a brand name manufacturer's representations--or the absence of representations-- about therisk of side effects of its drug, when 26 deciding to prescribe the drug for a patient, regardless of whether the pharmacistfills the prescription with a generic form of the drug. (Kellogg, supra, 762 F.Supp.2d at pp. 708-709.) “A reasonable jury could conclude that inadequate, misleading and inaccurate information provided by [defendants] was a proximate cause of [Kellogg’s] injury.” (Id. at p. 702.) Asdid the court of appeal here, these cases acknowledge that a causeof action for misrepresentation does not automatically render the brand-name manufacturerliable. In such cases, “the plaintiffs have significant hurdles to overcome,” including whetherreliance on older warningsis both foreseeable and reasonable. (Bd. of Educ. of City of Chicago v. A, C & S, Inc. (1989) 131 [ll.2d 428, 456; Lymanv. Pfizer, Inc. (D. Vt. July 20, 2012) 2012 WL 2970627, at *17—18 [similar in prescription drug case].) Those questions of reasonableness and foreseeability are questionsof fact for the jury. E. The Court’s O’Neil decision does not aid Novartis. Novartis relies heavily on O’Neil v. Crane Co. (2012) 53 Cal.4th 335 (O’Neil) but O’Neil does not even addressthe issues this case presents. The Court was facing the question of whether Crane Co., who made pumpsusedin navyships, could be liable for “a wrongful death allegedly caused by asbestos released from external insulation and internal gaskets and packing,all of which were madebythird parties and added to the pumps and valves post sale.” Ud. at p. 342.) In other words, beyond producing a 27 product into which asbestos-containing parts could be added later, Crane had nothing to do with the injury-causing agency. Not surprisingly, the Court declined to extend productliability in that context. An appellate decision is only authority on points “actually involved and decided.” (Santisas v. Goodin (1998) 17 Cal.4th 599, 620.) The O’Neil court was not faced with a situation analogous to this one. Its opinion does not even mention Conte. And Crane Co. did not stand in the type of relationship as do generic manufacturers with their federally-mandated duty to mimic the BNM-authored warnings. (PLIVA, supra, 564 U.S.at p. 616.) Moreover, the Court did conclude that liability attached where “the defendant participated substantially in creating a harmful combineduse of the products.” (O’Neil, supra, 53 Cal.4th at p. 342.) This is exactly what Novartis has done. It authored the warningsused for its products and the generic equivalents.It participated substantially in the harm by crating the inadequate, misleading warnings. The court of appeal recognized this distinction. (Slip opn. at pp. 23-24.) Nothing in the O’Neil opinion dilutes Conte’s and court of appeal’s duty analysis. II. Federal labeling law compels a conclusion that the manufacturer’s duty of care extends to patients who take generic equivalents. Consumersof prescription drugs receive information about them from varioussources, including brand-name manufacturers, generic manufacturers, pharmacies and physicians.In the case of a brand-name drug with generic equivalents, the ultimate source of that information is the same—the brand name manufacturer. 28 “[A] central premise of federal drug regulation that the manufacturer bears responsibility for the content of its label at all times.It is charged both with crafting an adequate label and with ensuring that its warnings remain adequate aslong as the drugis on the market. (Citation.)” (Wyeth v. Levine (2009) 555 U.S. 555, 570-571 (Wyeth).) Manufacturers of generic equivalents have a duty to follow the brand-name manufacturers. That is, they have “an ongoing federal duty of sameness regarding their warning labels” and may not take unilateral disclosure of additional perceived risks associated with a particular drug. (PLIVA, supra, 564 U.S.at p. 616.) Anyfailure to discharge this duty by the subjects them to liability to injured patients. (Teva Pharm. USA,Inc. v. Superior Court, supra, 217 Cal.App.4th at p. 112.) The BNMsobtain approval from the Federal Drug Administration to market a new prescription drug. (21 U.S.C. § 355.) Approval of the New Drug Application will be denied if clinical testing data and other information do not show that the drug is safe andeffective for use under the conditions prescribed, recommended,or suggested in the proposed labeling thereof, or if based on a fair evaluation of all material facts, such labeling is false or misleading in anyparticular. (21 U.S.C. § 355(d).) (Conte, supra, 168 Cal.App.4th at pp. 97-98.) Brand-name manufacturers have a duty to supply the FDA with “postmarketing reports,” which include reports of any serious and unexpected adversereactions suffered by a user of a 29 drug. (21 C.F.R., § 314.80.) The brand-name manufacturer also must submit annual reports to the FDA onsignificant information,including information that might affect the safety, effectiveness, or labeling of the product. (21 C.F.R. § 314.81.) Likewise, a generic manufactureris required to submit these reports to the FDA. (21 C.F.R. §§ 314.92, 314.98.) But they may not issue any new ordifferent information aboutthe drug. (PLIVA, supra, 564 U.S. at p. 616.) In Conte, the court of appeal undertook an exhaustive duty analysis of BNMsvis-a-vis consumers whotook their generic equivalents. (168 Cal.App.4th at pp. 103-107.) Like T.H.’s mother, Elizabeth Conte had taken a generic equivalent of the prescribed drug. The court saw no reason not to employ California’s well-settled duty principles. (168 Cal.App.4th at p. 103.) Starting with foreseeability, the court held, “we have no difficulty concluding that Wyeth [the BNM] should reasonably perceive that there could be injuriousreliance on its product information by a patient taking [the] generic [equivalent.]” (Conte, supra, 168 Cal.App.4th atp. 105.)"! Then court explored 1 Afterall, California pharmacists mayfill a prescription with a generic equivalent whenever requested unless the physician expressly orders otherwise. (Bus. & Prof. Code, § 4073.) As reported on National Public Radio, in 2016, more than half of all people with insurance will have some brand-name medications excluded from coverage. (A. Kodjak, Fight To Lower Drug Prices Forces Some To Switch Medication (N.P.R. 2016) http://www.npr.org/sections/health-shots/2016/01/25/463809474/ fight-to-lower-drug-prices-forces-some-to-switch-medication(as of 11/28/2016).) 30 in detail the other Rowland”factors the Court has established as the framework for duty analysis. After assessing those other factors, the court concluded: [W]e find the conclusion inescapable that Wyeth knowsor should know that a significant numberof patients whose doctors rely on its product information for [the brand name] Reglanare likely to have generic [equivalent] metoclopramide prescribed or dispensed to them. Wehold that Wyeth’s duty of care in disseminating product information extends to patients whoare injured by [the] generic [equivalent] as a result of prescriptions written in reliance on [the brand-name drug manufacturer’s] product informationfor[its brand-name drug].” (Conte, supra, 168 Cal.App.4th at p. 107.) Novartis owed this same duty of care to all the patients who ingested generic versionsofits drugs. 12 Rowlandv. Christian (1968) 69 Cal.2d 108. 31 "ro r g t o R e t t i g III. Federal labeling law is a floor, not a ceiling, on a drug manufacturer’s liability. A. Both this Court and the U.S. Supreme Court have rejected the premise that FDA labeling law providesthesole limit of liability. Just as it recognized a drug manufacturer’s duty to warn,the Court long ago rejected the notion that federal labeling law placed a ceiling on that duty. [M]ere compliance with regulationsor directives as to warnings, such as those issued by the United States Food and Drug Administration here, may not be sufficient to immunize the manufacturer or supplier of the drug from liability. The warnings required by such agencies maybe only minimalin nature and when the manufacturer or supplier knowsof, or has reason to know of, greater dangers not included in the warning, its duty to warn maynotbefulfilled. (Stevens, supra, 9 Cal.3d at p. 65.) The Court presaged the U.S. Supreme Court by nearly 40 years. As the high court would later hold, a major premise of the Federal Food, Drug, and Cosmetic Act}8 [FDCA], is that “[s]tate tort suits uncover unknown drug hazards and provide incentives for drug manufacturersto disclose safety risks promptly. They also serve a distinct compensatory function that may motivate injured persons to come forward with information.” (Wyeth, supra, 555 U.S.at p. 579.) 13 21 U.S.C. § 301, et seq. 32 The high court observed, “If Congress thought state-law suits posed an obstacle to its objectives, it surely would have enacted an express pre-emptionprovision at some point during the FDCA’s 70-yearhistory.“ (Wyeth, supra, 555 U.S. at p. 574 & n.7.) Yet, Congress has expressly and repeatedly rejected proposals to do just that, and has instead preserved state tort remedies. (See also Consumer Fed’n ofAm. v. Upjohn Co. (D.C. 1975) 346 A.2d 725, 731 [explaining that a private right of action was omitted from the FDCA because “it would create an unnecessary federal action duplicative of state remedies”]; R. Adler, et al., Preemption and Medical Devices: The Courts Run Amok, (1994) 59 Mo. L. Rev. 895, 924 & n.130 [Congress intendedto preserve existing common-law causesof action for injury caused by prescription drugs)].) “Evidently,” the Supreme Court concluded, Congress “determined that widely available state rights of action provided appropriaterelief for injured consumers. (Wyeth, supra, 555 U.S. at p. 574.) This “is powerful evidence that Congress did not intend FDAoversight to be the exclusive meansof ensuring drug safety and effectiveness.” ([d. at p. 575.) The Wyeth Court continued: In keeping with Congress’ decision not to pre-empt common-lawtort suits, it appears that the FDA traditionally regarded state law as a complementary form of drug regulation. The FDAhaslimited resources to monitor the 11,000 drugs on the market, and manufacturers have superior access to information about their drugs, especially in the postmarketing phase as new risks emerge. State tort _ suits uncover unknowndrug hazards and provide incentives for drug manufacturers to disclose safety 33 risks promptly. They also serve a distinct compensatory function that may motivate injured persons to come forward with information. Failure-to- warn actions, in particular, lend force to the FDCA’s premise that manufacturers, not the FDA, bear primary responsibility for their drug labelingatall times. Thus, the FDA long maintainedthat state law offers an additional, and important, layer of consumerprotection that complements FDA regulation. (Wyeth, supra, 555 U.S. at pp. 578-579 [emphasis added]; see also Bates v. Dow Agrosciences LLC (2005) 544 U.S. 481, 451 [state tort suits “can serve as a catalyst” for federal agency action by aiding in the exposure of new dangers and prompting a manufactureror the federal agency to decide that a revised label is required].) Oneinstanceof this “layer of consumerprotection” emerged after the Court’s Wyeth decision. Diana Levine, the victim, had developed gangrene,and her forearm had to be amputated when a physician’s assistant injected her artery with the anti-nausea drug Phenerganbyusing the “IV push” method of intravenous injection. Subsequently, the FDA’s analysis of “post marketing reports of severe tissue injury” with respect to promethazine (the generic form of Phenergan) led the FDA to require a boxed warning against injection by this method, which so tragically affected Ms. Levine. (See FDA, Information for Healthcare Professionals - Intravenous Promethazine and Severe Tissue Injury, Including Gangrene (2009) http://www.fda.gov/Drugs/ DrugSafety/ 34 PostmarketDrugSafetyInformationforPatientsandProviders/ DrugSafetyInformationforHeathcareProfessionals/ ucm182169.htm (as of 11—-27-2016).) FDA regulation depends heavily upon reporting of adverse events by drug manufacturers themselves. State tort law holding drug companies accountable for their negligence in promoting their products in no wayconflicts with Congress’s plan for FDA regulation. To the extent that potential tort liability supplies a financial incentive for brand-name drug companiesto provide prompt and accurate reports of adverse events to prescribing physicians, private causes of action protect the public from unanticipated dangers posed by prescription drugs. B. The drug manufacturers, not the FDA, have the responsibility for monitoring for adverse events that emergepost- marketing. In its reply brief Novartis contendsfor thefirst time‘ that imposing liability on brand-name drug manufacturers for misrepresentations that harm usersof the generic version must not “stand as an obstacle to the accomplishment and execution of the full purposes and objectives of Congress.” (RBM 30.) Novartis further claims that liability for misrepresentation would “nullify federal law policy judgments governingthe regulation of prescription drugs.” (Ibid.) Novartis proposes instead that its 14 This conflict-preemption argument wasnot raised in Novartis’ Opening Brief on the Merits and should be deemed waived. “It is axiomatic that arguments madeforthefirst time in a reply brief will not be entertained becauseof the unfairness to the other party.” (People v. Tully (2012) 54 Cal.4th 952, 1075.) 35 responsibility be limited to the FDA’s administrative requirements. That is, Novartis argues any responsibility for failure by an NDAholder to revise the drug label to warn of hazards discovered post-marketing, as required by 21 C.F.R., § 201.80, subd. (e), ends when the ownersells its NDA, even where the owner’s prior failures to revise the label have resulted in serious injury. (RBM 23 (“A subsequent drug manufactureris solely responsible for the safety and labelingof its drug from the momentit purchases the NDA.”) (emphasis in original).) In Novartis’s view, immunity from any broaderprivate right of action is warranted because “courts are not institutionally qualified to balance the complex, interrelated, and divergent policy considerations in determininglabeling andliability obligations of brand and generic pharmaceuticals.” (RBM 31.) But imposingtort liability in this context does not conflict with Congress’ objectives or with FDA labeling regulation. Indeed, Congress, the FDA and the U.S. Supreme Court view private tort litigation as a necessary complementto the efforts of the FDA. (Wyeth, supra, 555 U.S. at p. 579.) As a former FDA Commissionerhas observed, pre-approval testing of prescription drugs generally is incapable of detecting adverseeffects that occur infrequently, have long latency periods, or affect sub-populations not adequately represented in the studies, including pregnant women.(D. Kessler, et al., A Critical Examination of the FDA’s Efforts to Preempt Failure-to-Warn Claims (2008) 96 Geo. L.J. 461, 471.) Commentatorscite estimates that “as manyas half of all new drugs haveat least one serious adverse effect that is unknownatthe time of drug approval.” (B. Evans, Seven Pillars of a New Evidentiary 36 Paradigm: The Food, Drug, and Cosmetic Act Enters the Genomic Era (2010) 85 Notre DameL. Rev. 419, 430, citing B. Furberg, et al., Evaluating Clinical Research 8 (2d ed. 2007).) Indeed, experts believe that only one to ten percent of adverse events are reported to FDA, and the quality of those reports is poor. (J. Mann, FDA Adverse Event Reporting System: Recruiting Doctors to Make Surveillance A Little Less Passive (2015) 70 Food & Drug L.J. 371, 380—84, see also U.S. Gen. Accounting Office, GAO/T-HEHS-00—-53 (2000) Adverse Drug Events: Substantial Problem But Magnitude Uncertain 6; T. Tiedt, The Drug Safety System Conundrum (2007) 62 Food & Drug L.J. 547, 551-55 [summarizingcriticisms of the FDA’s post-market oversight].) The FDAfaces serious challenges in addressing the mammoth workload before it. The Institute of Medicine of the National Academies ([OM)has concluded that FDA “lacks the resources to accomplish its large and complex mission today,let alone to position itself for an increasingly challenging future.” (IOM, The Future of Drug Safety: Promoting and Protecting the Health of the Public (2007) 193, available at http://www.fda.gov/oc/reports/ i0m013007.pdf; see also E. Parasidis, Patients over Politics: Addressing Legislative Failure in the Regulation of Medical Products (2011) 2011 Wis. L. Rev. 929, 932 [FDAis “an agency with expandedresponsibilities, stagnant resources, and the consequentinability to implementor enforce its statutory mandates,” quoting P. Hutt, The State of Science at the Food and Drug Administration (2008) 60 Admin. L. Rev. 431].) 37 Amici underscore a hard truth that was voiced on the Senate floor by the chief Senate sponsorof the 2007 FDCA Amendments- -the FDA cannot be expected to assume exclusive responsibility for protecting the public. Clearly, the resources of the drug industryto collect and analyze post-market safety data vastly exceed the resources of the FDA, and no matter what wedo, they will always have vastly greater resources to monitor the safety of their products than the FDA does. It is absurd to argue that the FDA, even with the enhanced resources and authorities provided by this legislation, commandsthe field whenit comesto postmarket safety. The drug companies have the capacity to do a far more comprehensivejob. 153 Cong. Rec. S11832 (daily ed. Sept. 20, 2007) (remarksof Sen. Ted Kennedy). Congresshaslongrelied on state tort causes of action to provide the financial incentive for drug companies to supply medical providers with prompt and accurate information concerningtherisks associated with their products discovered post-marketing. Nothing about Novartis’ status as the prior brand-name manufactureralters that reliance. IV. No special rules of superseding cause apply to a negligent drug manufacturer whosells its rights to the drug. Asthe prior NDAholder, Novartis is like any other tortfeasor who claims that subsequent, third-party tortious conduct extinguishedits liability. In Stevens, the Court confirmed the application of superseding cause analysis in cases of a negligent 38 drug company’s failure to warn. The defendant had asserted that the negligence the prescribing doctor was a superseding cause who exoneratedit from liability. (Stevens, supra, 9 Cal.3d at p. 67.) Rejecting the claim, the Court hewedto the general principles that govern when a tortfeasor contends that an intervening actor’s conduct excusesits liability. It is well settled that “an actor may be lable if his - negligence is a substantial factor in causing an injury, and heis not relieved of liability because of the interveningact of a third person if such act was reasonably foreseeable at the timeof his negligent conduct. (Citations.) Moreover,if the likelihood that a third person mayact in a particular manneris the hazardor one of the hazards which makesthe actor negligent, such an act whetherinnocent, negligent, intentionally tortious or criminal does not prevent the actor from being liable for harm caused thereby.” (Citation.) (Stevens, supra, 9 Cal.3d at p. 69.) Thus, even wherethe prescribing doctor testified that he was aware of the dangerous qualities of the drug, the jury could properly conclude that Parke, Davis’s advertising overcame the warningsit gave. (Stevens, supra, 9 Cal.3d at p. 69) In other words, before Novartis can be exonerated by any negligence of its subsequent NDA holder,it must plead and prove that the holder’s negligence in not curing Novartis’s defective warningis superseding cause. As the Court explained nearly 50 years ago: This issue is concerned with whetheror not, assuming that a defendant was negligent and that 39 sa ot ea ge ri te t a m t a e his negligence wasan actual causeofthe plaintiff's injury, the defendant should be held responsible for the plaintiffs injury where the injury was brought about by a later cause of independentorigin. This question, in turn, revolves around a determination of whetherthe later cause of independentorigin, commonly referred to as an intervening cause, was foreseeable by the defendantor,if not foreseeable, whetherit caused injury of a type which was foreseeable. If either of these questions is answered in the affirmative, then the defendantis not relieved from liability towardstheplaintiff; if, however,it is determined that the intervening cause was not foreseeable and that the results which it caused were not foreseeable, then the intervening cause becomes a supervening cause and the defendantis relieved from liability for the plaintiffs injuries. (Akinsv. Cnty. of Sonoma (1967) 67 Cal.2d 185, 199.) “Normal, but negligent, intervening responsewill not supersede but an extraordinarily negligent response will supersede.” (Martinez v. Vintage Petroleum, Inc. (1998) 68 Cal.App.4th 695, 701.) The T.H. plaintiffs have alleged facts that would support a finding that “it was foreseeable physicians and patients would continueto rely on Novartis’s product label for adequate warnings.” (Slip. opn.at p. 19.) Any negligence of the current NDA holder cannot be a superseding cause of plaintiffs’ harm. Moreover, whether a subsequent actor or force amounts to a superseding cause is an affirmative defense all elements of which must be proved by the defendant. (Arreola v. Cnty. of Monterey (2002) 99 Cal.App.4th 722, 760; see CACI 482.) This is not a matter which can be resolved on demurrer. 40 CONCLUSION Neither the Conte court nor the court of appeal created new or novel theoriesof liability. Their holdings pose no threat to or conflict with federal drug regulation but instead compliment that regulation as Congress intended. Their conclusionsare firmly grounded in the commonlaw of California and commonsense. The Court should affirm. Respectfully submitted, Dated: November 30, 2016 By: Alan Charles Dell'Ario Attorney for Amici curiae Consumer Attorneysof California and American Association for Justice 41 CERTIFICATE OF COMPLIANCE This brief is set using 13-pt Century Schoolbook. According to TypeLaw.com, the computer program used to prepare this brief, this brief contains 7,520 words, excluding thecover, tables, signature block, and thiscertificate. The undersigned certifies that this brief complies with the form requirements set by California Rules of Court, rule 8.204(b) and contains fewer words than permitted by rule 8.520(c) or by Orderof this Court. Dated: November30, 2016 By: Alan Charles Dell'Ario Attorney for Amici Curiae for T.H. 42 IN THE SUPREME COURTOF THE STATE OF CALIFORNIA No. 5233898 PROOF OF SERVICE I declare: At the time of service I was at least 18 years of age and not a party to this legal action. My business addressis 1561 Third Street, Suite B, Napa, CA 94559. I served document(s) described as Amicus Curiae Briefas follows: By U.S. Mail On November29, 2016, I enclosed a copy of the document(s) identified above in an envelope and deposited the sealed envelope(s) with the US Postal Service with the postagefully prepaid, addressedasfollows: San Diego County Superior Court Attn: Hon. Joan Lewis Central Division 220 & 330 W Broadway San Diego, CA, 92101 Kevin F. Quinn Thorsnes Bartolotta McGuire 2550 Fifth Avenue, Suite 1100 San Diego, CA (for T. H. et al.) 43 Benjamin Israel Siminou Thorsnes Bartolotta McGuire LLP 2550 Fifth Avenue, Eleventh Floor San Diego, CA (for T. H. et al.) Leslie A. Brueckner Public Justice Pe 555 12th Stret, Suite 1230 Oakland, CA (for T. H.et al.) Eric G. Lasker Hollingsworth LLP 1350 I Street NW Washington, DC (for Novartis Pharmaceuticals Corporation) Erin McCalmon Bosman Morrison & Foerster LLP 12531 High Bluff Drive, Suite 100 San Diego, CA (for Novartis Pharmaceuticals Corporation) Julie Yongsun Park Morrison & Foerster 12531 High Bluff Drive, Suite 100 San Diego, CA (for Novartis Pharmaceuticals Corporation) Katharine R. Latimer Hollingsworth LLP 1350 I Street, N.W., Ninth Floor Washington, DC (for Novartis Pharmaceuticals Corporation) 44 California Court of Appeal Fourth District, Division One 750 B Street, Suite 300 San Diego, California 92101 I am a resident of or employed in the county where the mailing occurred (Napa, CA). I declare under penalty of perjury underthe lawsof the State of California that the foregoing is true and correct. Dated: November 29, 2016 By: Alan Charles Dell'Ario 45