H. (T.) v. NOVARTIS PHARMACEUTICALS CORPORATION

Appellants’ Supplemental Brief

Cal.September 20, 2017

SUPREME COURT COPY supreme court $233898 FILED SEP 2 0 2017 Jorge Navarrete Clerk IN THE SUPREME COURT OF CALIFORNIA Deputy T.H., A MINOR,ET AL., Plaintiffs and Appellants, v. NOVARTIS PHARMACEUTICALS CORPORATION, Defendant and Respondent. Review of a decision of the Court of Appeal, Fourth Appellate District, Division One Case No. D067839 Plaintiffs’ Supplemental Brief re: McNair v. Johnson & Johnson Corp. (4th Cir. May 30, 2017, No. 15-1806) Leslie A. Brueckner, Esq. BenjaminI. Siminou, Esq. PUBLIC JUSTICE,P.C. THORSNES BARTOLOTTA MCGUIRE LLP 555 12th Street, Suite 1230 2550 Fifth Avenue, 11th Floor Oakland, California 9460 San Diego, California 92103 Tel: (6510) 520-6205 Tel: (619) 236-9363 Fax: (510) 622-8155 | Fax: (619) 236-9653 Attorneys for Plaintiffs and Appellants T.H., a Minor,et al. 5233898 IN THE SUPREME COURT OF CALIFORNIA T.H., A MINOR,ET AL., Plaintiffs and Appellants, v. NOVARTIS PHARMACEUTICALS CORPORATION, Defendant and Respondent. Review of a decision of the Court of Appeal, Fourth Appellate District, Division One Case No. D067839 Plaintiffs’ Supplemental Brief re: McNair v. Johnson & Johnson Corp. (4th Cir. May 30, 2017, No. 15-1806) Leslie A. Brueckner, Esq. BenjaminI. Siminou, Esq. PUBLIC JUSTICE, P.C. THORSNES BARTOLOTTA MCGUIRE LLP 555 12th Street, Suite 1230 2550 Fifth Avenue, 11th Floor Oakland, California 9460 San Diego, California 92103 Tel: (510) 520-6205 Tel: (619) 236-9363 Fax: (510) 622-8155 Fax: (619) 236-9653 Attorneysfor Plaintiffs and Appellants T.H., a Minor,etal. TABLE OF CONTENTS Introduction ...........cccceesssesceeecsecsseceneeseeeeeeecuaaaaaeeeesesssaaaaaaaaaaasasensusaeeeseessaeneeeas 1 DISCUSSION .0.........ccsseeesesseveccneceesnceeceeceeceeeeeececeeeeeesesensseeeceseecasuueaseanaeeeseeeeeeeees 2 Conclusion .......ccccccsecececsccssneeeeeeeesssssnneeeeecceeeeeessseeeseeseseeececeesseseecesaeeeseseeeees 6 Certificate of Compliance ..........cccccccececcccseeseccecsssssnsnssessevecereeeaaasaneeeseseeeeeeees 7 TABLE OF AUTHORITIES Cases Conte v. Wyeth, Inc. (2008) 168 Cal.App.4th 89 ..........ccccccsccssessssssssssssssesececeececcesesssneeseseeeeseeees 4 Drager v. PLIVA USA, Inc. (Ath Cir. 2014) 741 F.3d 470.0... ccceccccssssssccecseeeceeeeecessesseeeeeseeeeseeesenens 3 Foster v. American Home Products Corp. (4th Cir. 1994) 29 F.3d 165...........cccesccssssssscecessseesseeseeseesseteesereseess passim McNair v. Johnson & Johnson Corp. (4th. Cir. May 30, 2017, No. 15-1806) 2017 WL 2333848........... passim Mutual Pharmaceutical Co. v. Bartlett (2018) 1838S. Ct. 2466.0... ccccccscsssseceeecessesseeeecccceneneauaneesereeeeeess 3, 4, 6 PLIVA, Inc. v. Mensing (2011) 564 U.S. 604...cccccccccsssssessessseeececeecceseeeeseessnatereseeeees 3, 4, 6 Wyeth, Inc. v. Weeks (Ala. 2014) 159 S0.3d 649 0.0... ccccesssssssseceeeeeeeeeeseeeeeerseaaeeeceseneesesseenes 3 Rules California Rules of Court, rule 8.520(d).........cecccccssssseseeesesersteeenseesenseesaees 1 li INTRODUCTION Plaintiffs submit this supplemental brief under California Rules of Court, rule 8.520(d) to advise the Court of recent appellate activity on the issue of whether a brand-name manufacturer may bear tort liability for injuries caused by generic version of the brand-name manufacturer’s drug. In particular, Plaintiffs seek to advise the Court of the Fourth Circuit's recent decision in McNair v. Johnson & Johnson Corp. (4th. Cir. May 30, 2017, No. 15-1806) 2017 WL 23338438, requesting that the Supreme Court of Appeals of West Virginia answerthe followingcertified question of law: Whether West Virginia law permits a claim of failure to warn and negligent misrepresentation against a branded drug manufacturer when the drug ingested was produced by a generic manufacturer.! This is essentially the same question the Fourth Circuit addressed in its seminal decision, Foster v. American Home Products Corp. (4th Cir. 1994) 29 F.3d 165, which arose under Maryland tort law. The fact the Fourth Circuit has certified the question in McNair a state supreme court rather than simply relying on its decision in Foster suggests the Fourth Circuit may have doubts about Foster’s broader viability, a fact that casts doubt on much of the authority relied on by Novartis and its amici. 1 By order dated August 30, 2017, the West Virginia Supreme Court of Appeals accepted the Fourth Circuit's certification and scheduled the case for argument on January 18, 2018. (See Exh. “A.”) DISCUSSION As this Court mayrecall from the parties’ briefing, the Fourth Circuit’s opinion in Foster v. American Home Products Corp. (4th Cir. 1994) 29 F.3d 165, was the lead case for the view that brand-name manufacturers should be categorically immunefrom liability for injuries caused by generic drugs. Like Novartis and its amici, virtually every subsequent appellate decision rejecting a claim against brand-name manufacturers by unwitting consumers of generic drugs either relies on Foster directly or cites to cases that were themselves inspired by Foster. (See, e.g., Pltfs’ Consolidated Answer to AmicusBriefs, at pp. 40—47.) But as this Court mayrecall from Plaintiffs’ briefing, the Foster court’s decision was largely the result of its belief that manufacturers of generic drugs “are also permitted to add or strengthen warnings and delete misleading statements on labels, even without prior FDA approval.” (Foster, supra, 29 F.3d at p. 170.) Based on this belief, Foster held that federal law does not “insulate generic drug manufacturers from liability for misrepresentations made regarding their products” and, therefore, that “fmjanufacturers of generic drugs’—not brand-name manufacturers—“are responsible for the representations they make regarding their products.” (Ibid.) But in PLIVA, Inc. v. Mensing (2011) 564 U.S. 604, 618, the US. Supreme Court expressly rejected the core premise underlying Foster when it held that federal law requires generic drug manufacturers to copy the corresponding brand-name manufacturer’s label “verbatim.” (See, e.g., Drager v. PLIVA USA,Inc. (4th Cir. 2014) 741 F.3d 470, 476 [“[Mensing and Bartlett] establish that under the FDCA a generic may not unilaterally change its labeling or change its design or formulation.”].) Mensing’s holding that generic drug manufacturers must copy the brand-namelabel “verbatim,” and are prohibited from changingtheir labels without prior FDA approval, have led several courts to question Foster’s continued viability. (E.g., Wyeth, Inc. v. Weeks (Ala. 2014) 159 So.3d 649, 670 [“The Foster court’s finding that manufacturers of generic drugs are responsible for the representations they make in their labeling regarding their products is flawed based on the ‘sameness’ requirement subsequently discussed in [Mensing].”].) It appears the skepticism about Foster's viability may have comefull circle, in light of the Fourth Circuit’s recent decision in McNair v. Johnson & Johnson Corp. (4th. Cir. May 30, 2017, No. 15-1806) 2017 WL 2333843. At issue in McNair is whether a brand-name manufacturercan be held liable under West Virginia tort law for injuries caused by a generic version of its drug. Arguing that Foster was no longergoodlaw,the plaintiffs in McNair S I E ot e asked the Fourth Circuit to certify the question to the West Virginia Supreme Court in lieu of a so-called “Erie guess” regarding how the West Virginia Supreme Court would decide the issue. The Fourth Circuit agreed. In its decision, the court acknowledged that, since Foster, some courts have resolved the issue in the plaintiffs’ favor: The McNairs’ theory of liability is not entirely without support. A few courts have held that the brand-name manufacturer may be liable for failure to warn when the plaintiffs injury was caused by the generic drug, basing their decisions largely on the foreseeability of physicians’ and patients’ reliance upon the brand-name manufacturer’s warning label. See Conte v. Wyeth, Inc., 168 Cal.App.4th 89, 85 Cal.Rptr.3d 299, 320-21 (2008) (holding that, under California law, the brand-name manufacturer owes a duty of care to patients who ingest the generic drug)... (McNair, supra, 2017 WL 2333843,at p. 4., additional citations omitted.) The McNair court then explained how its prior ruling in Foster is no longer settled law. Noting that “Foster’s reasoning, in large part, was that a manufacturer of generic products is responsible for the accuracy of labels, the McNair court then acknowledged that “after Mensing and Bartlett, it is no longer the case that generic manufacturers can alter FDA-approved labels.” (McNair, supra, 2017 WL 2333843,at p. 4.) Prudently, the McNair court, unlike so many federal courts before it, was unwilling to ignore the impact of Mensing by simply “speculat[ing] as to how the Supreme Court of Appeals of West Virginia would rule in an area of law where it has not spoken directly.” (McNair, supra, 2017 WL 2333848, at p. 5.) Instead, and in light of its belief that West Virginia “precedent leaves open the possibility that brand-name manufacturers may beliable for failure to warn whena plaintiff ingests the generic drug,” the McNair courtcertified the question to the West Virginia Supreme Court of Appeals. (Ibid.) It is possible, of course, that the Fourth Circuit, following a ruling from the West Virginia Supreme Court of Appeals, will ultimately reach the same conclusion as it did in Foster. If so, its decision will almost certainly be distinguishable from this case, for all the reasons previously explained. (See, e.g., Pltfs’ Consolidated Answer to Amicus Briefs, at pp. 40-47.) But the point here is that the certified question in McNair suggests that the Fourth Circuit itself may no longer regard Foster as good law. If so, that would provide ample reason to question the validity of the authorities cited by Novartis and its amici, the vast majority of which either relied on Foster directly or were part of the snowball effect of “me-too” jurisprudence that Foster set into motion. CONCLUSION Novartis and its amici rely heavily on the Fourth Circuit’s decision in Foster and its progeny in urging this Court to categorically reject any claim against brand-name manufacturers by consumers of mislabeled generic drugs. But the Fourth Circuit’s decision in McNairto certify that issue to the West Virginia Supreme Court of Appeals instead of simply relying on Foster suggests that the Fourth Circuit has serious—and understandable—doubts about Foster’s viability in light of the U.S. Supreme Court’s decisions in Mensing and Bartlett. In addition to unique, outcome-determinative characteristics of California’s tort law, Foster would provide yet another important basis to reject virtually all of the out-of-state authorities on which Novartis and its amici rely. September 19, 2017 By: s/ Leslie A. Brueckner Leslie A. Brueckner, Esq. PUBLIC JUSTICE P.C. By:s/ Benjamin I, Siminou Benjamin I. Siminou, Esq. THORSNES BARTOLOTTA MCGUIRE LLP Attorneys for Plaintiffs/Appellants, T.H. & C.H. CERTIFICATE OF COMPLIANCE As required by California Rules of Court, rule 8.520(d), I certify that, according to the word-count feature in Microsoft Word, this supplemental contains 1,229 words, including footnotes, but excluding any content identified in rule 8.520(c)(3), but that, in any event, the entire brief is less than 2,800 words. September 19, 2017 By: s/ Benjamin I. Siminou Benjamin I. Siminou, Esq. THORSNES BARTOLOTTA MCGUIRE LLP EXHIBIT A ali STATE OF WEST VIRGINIA At the Supreme Court of Appeals, continued and held at Charleston, Kanawha County, on August 30, 2017,the following order was made and entered in vacation: Kimmy McNair and Larry McNair, Petitioners vs.) No. 17-0519 Johnson & Johnson; ‘Janssen Pharmaceuticals, Incorporated; and Ortho-McNeil Pharmaceutical, Incorporated, Respondents ORDER The Court has reviewed and inspectedthe certification order entered in the United States Court of Appealsfor the Fourth Circuit on May 30, 2017 (Nos. 15-1806, 2:14-cv-17463). Upon consideration, the Court is of the opinion that this matter be scheduled for oral argument under Rule 20 of the Rules of Appellate Procedure on Tuesday, January 18, 2018, and this order constitutes the Notice of Argument pursuant to Rule 20(b). Justice Workman not participating. Counsel for the petitioners is hereby directedto file the petitioners’ brief and appendix on or before October 30, 2017, Pursuant to R.A,P, 17(a)(4), all parties to this matter are hereby directed to assist the petitioners in preparing a joint appendix of items contained in the record of the appellate court that are relevant to this Court’s considerationof the certified questions. Pursuant to R.A.P. 7(e), if no agreementis reached on the contents of the appendix, the petitioners mustpreparea list of the parts of the record that the petitioners intend to include in the appendix, and servethelist on the respondents on or before October 2, 2017. The respondents are directed to file a respondents’ brief on or before December 14, 2017, Anyreply brief deemed necessary shall befiled by the petitioners on or before January 3, 2018. A True Copy Attest: //s// Rory L.Perry II Clerk of Court PROOF OF SERVICE I, the undersigned, say: I am over 18 years of age, employed in the County of San Diego, California, and not a party to the subject cause. My business address is 2550 Fifth Ave., Ste. 1100, San Diego, California, 92103. On September 19, 2017, I served the attached “Plaintiffs’ Supplemental Brief re: McNair v. Johnson & Johnson Corp. (4th Cir. May 30, 2017, No. 15-1806),” of which a true and correct copy of the documentfiled in the cause is affixed by placing a copy thereof in a separate envelope for each addressee named hereafter, addressed to each such addressee respectively as follows: See attached servicelist. Each envelope was then sealed, and with the postage thereon fully prepaid, deposited in the United States mail by me at San Diego, California, on September 19, 2017. I declare under penalty of perjury that the foregoing is true and correct, and this declaration was executed at San Diego, California, on September 19, 2017. hourKCl) Diane DeCarlo H. (T.) v. Novartis Pharmaceuticals Corporation Case Number 8233898 Service List Party Defendant and Respondent Novartis Pharmaceuticals Corporation Pacific Legal Foundation - Amicus curiae ConsumerAttorneys of California - Amicus curiae American Association for Justice- Amicus curiae Public Citizen - Amicus curiae AARP - Amicus curiae Attorney Eric G. Lasker Katharine R. Latimer Hollingsworth LLP 1350 I Street, N.W., Ninth Floor Washington, DC 20005 Erin McCalmon Bosman Julie Yongsun Park Morrison & Foerster LLP 12531 High Bluff Drive, Suite 100 San Diego, CA 92130 Anastasia Paulinna Boden Pacific Legal Foundation 930 G Street Sacramento, CA 95814 Alan Charles Dell'Ario Attorney at Law 1561 Third Street, Suite B Napa, CA 94559 Alan Charles Dell'Ario Dell'Ario & LeBoeuf, PC 1561 Third Street, Suite B Napa, CA 94559 Nance Felice Becker Chavez & Gertler LLP 42 Miller Avenue Mill Valley, CA 94925 William Alvarado Rivera AARP Foundation Litigation 601 E. Street, NW Washington, DC 20049 H. (T.) v. Novartis Pharmaceuticals Corporation Case Number $233898 Service List Party AARP Foundation - Amicus curiae Pharmaceutical Research and Manufacturers of America - Amicus curiae Washington Legal Foundation- Amicuscuriae Product Liability Advisory Council, Inc. - Amicus curiae Attn: Hugh F. Young, Jr. 1850 Centennial Park Drive, Suite 510 Reston, VA 20191 International Association of Defense Counsel and Federation of Defense & Corporate Counsel - Amicuscuriae Chamber of Commerce of the United States of America - Amicus curiae Attorney William Alvarado Rivera AARPFoundation Litigation 601 E. Street, NW Washington, DC 20049 Jeffrey Michael Davidson Covington and Burling LLP One Front Street, Floor 35 San Francisco, CA 94111 Gregory Herbers Washington Legal Foundation 2009 Massahusetts Avenue, NW Washington, DC 20036 David E. Stanley Reed Smith LLP 355 South Grand Avenue, #2900 Los Angeles, CA 90071 Mary-Christine Sungaila Haynes and Boone, LLP 600 Anton Boulevard, Suite 700 Costa Mesa, CA 92626 Kannon K. Shanmugam Connor S.Sullivan Allison Jones Rushing Williams & Connolly LLP 725 Twelfth Street, N.W. Washington, DC 20005 H. (T.) v. Novartis Pharmaceuticals Corporation Case Number 8233898 Service List Party Civil Justice Association of California - Amicus curiae National Association of Manufactures - Amicus curiae American Tort Reform Association - Amicus curiae The Atlantic Legal Foundation- Amicus curlae Genentech, Inc. - Amicus curiae California Life Sciences Association - Amicus curiae Attorney Fred J. Hiestand Attorney at Law 3418 Third Avenue, Suite 1 Sacramento, CA 95817 Paul B LaScala Gabriel Scott Spooner Shook Hardy & Bacon LLP 5 Park Plaza, #1600 Irvine, CA 92614 Paul B LaScala Gabriel Scott Spooner Shook Hardy & Bacon LLP 5 Park Plaza, #1600 Irvine, CA 92614 Robert P. Charrow Anna B. Laakmann Greenberg Traurig LLP 2101 L. Street, N.W. Washington, DC 20037 Alicia Jane Donahue Shook Hardy & Bacon, LLP One Montgomery Tower, Suite 2700 San Francisco, CA 94104 Alicia Jane Donahue Shook Hardy & Bacon, LLP One Montgomery Tower, Suite 2700 San Francisco, CA 94104 San Diego County Superior Court Hon. Joan M. Lewis 330 West Broadway San Diego, CA 92101 H. (T.) v. Novartis Pharmaceuticals Corporation Case Number 8233898 Service List Party Attorney Clerk of the Court Fourth District Court of Appeal Division One 750 B Street, Suite 300 San Diego, CA 92101