Johnny Jackson et al v. Mckesson Corporation et al

NOTICE OF MOTION AND MOTION to Dismiss Case

C.D. Cal.January 26, 2017

CASE NO. 2:17-cv-00354-R-FFM MCKESSON’S NOTICE OF MOTION AND MOTION TO DISMISS sd-693489 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 ERIN M. BOSMAN (CA SBN 204987) EBosman@mofo.com JULIE Y. PARK (CA SBN 259929) JuliePark@mofo.com MORRISON & FOERSTER LLP 12531 High Bluff Drive San Diego, California 92130-2040 Telephone: 858.720.5100 Facsimile: 858.720.5125 Attorneys for Defendant MCKESSON CORPORATION UNITED STATES DISTRICT COURT CENTRAL DISTRICT OF CALIFORNIA JOHNNY JACKSON; CHARLES ERIC PETERSON; JUDITH CAROL TRACY; JOAN EZELL; MARINA VICTORIA WILLIAMSON; BOBBY DWAIN STRICKLIN; DALLAS MESSER; TERRI JOSEPH GREEN; and ANNETTE PARKER, Individually and as Successor-In-Interest of the ESTATE OF EDWARD PARKER, JR., Plaintiffs, v. MCKESSON CORPORATION, a Delaware corporation; BRISTOL- MYERS SQUIBB COMPANY, a Delaware corporation; PFIZER INC., a Delaware corporation; and DOES 1 through 100, inclusive, Defendants. CASE NO. 2:17-cv-00354-R-FFM DEFENDANT MCKESSON CORPORATION’S NOTICE OF MOTION AND MOTION TO DISMISS COMPLAINT Date: March 6, 2017 Time: 10:00 a.m. Judge: Hon. Manuel L. Real Crtrm: 8 Case 2:17-cv-00354-R-AS Document 22 Filed 01/26/17 Page 1 of 2 Page ID #:962 CASE NO. 2:17-cv-00354-R-FFM 1 MCKESSON’S NOTICE OF MOTION AND MOTION TO DISMISS sd-693489 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 TO PLAINTIFFS AND THEIR COUNSEL OF RECORD: PLEASE TAKE NOTICE THAT on March 6, 2017, at 10:00 a.m., or as soon thereafter as the matter may be heard, in the United States District Court, Central District of California, Western Division, located at 312 North Spring St., Los Angeles, CA 90012, before the Honorable Manuel L. Real, Defendant McKesson Corporation (“McKesson”) will move, and hereby does move, for an Order dismissing Plaintiffs’ Complaint in its entirety as related to McKesson. This motion is made pursuant to Federal Rule of Civil Procedure 12(b)(6) on the grounds that Plaintiffs have failed to state a claim upon which relief can be granted, Plaintiffs’ claims are preempted by federal law, and Plaintiffs’ Complaint fails to plead allegations of fraud with particularity as required by Federal Rule of Civil Procedure 9(b). This motion is based on this Notice of Motion and Motion, the supporting Memorandum of Points and Authorities, the accompanying Request for Judicial Notice, the pleadings on file in this action, and on such other written or oral argument or evidence as may be presented at or before the time this motion is taken under submission. Dated: January 26, 2017 MORRISON & FOERSTER LLP By: /s/ Erin M. Bosman Erin M. Bosman Attorneys for Defendant MCKESSON CORPORATION Case 2:17-cv-00354-R-AS Document 22 Filed 01/26/17 Page 2 of 2 Page ID #:963 CASE NO. 2:17-cv-00354-R-FFM POINTS AND AUTHORITIES IN SUPPORT OF MCKESSON’S MOTION TO DISMISS sd-693492 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 ERIN M. BOSMAN (CA SBN 204987) EBosman@mofo.com JULIE Y. PARK (CA SBN 259929) JuliePark@mofo.com MORRISON & FOERSTER LLP 12531 High Bluff Drive San Diego, California 92130-2040 Telephone: 858.720.5100 Facsimile: 858.720.5125 Attorneys for Defendant MCKESSON CORPORATION UNITED STATES DISTRICT COURT CENTRAL DISTRICT OF CALIFORNIA JOHNNY JACKSON; CHARLES ERIC PETERSON; JUDITH CAROL TRACY; JOAN EZELL; MARINA VICTORIA WILLIAMSON; BOBBY DWAIN STRICKLIN; DALLAS MESSER; TERRI JOSEPH GREEN; and ANNETTE PARKER, Individually and as Successor-In-Interest of the ESTATE OF EDWARD PARKER, JR., Plaintiffs, v. MCKESSON CORPORATION, a Delaware corporation; BRISTOL- MYERS SQUIBB COMPANY, a Delaware corporation; PFIZER INC., a Delaware corporation; and DOES 1 through 100, inclusive, Defendants. CASE NO. 2:17-cv-00354-R-FFM MEMORANDUM OF POINTS AND AUTHORITIES IN SUPPORT OF DEFENDANT MCKESSON CORPORATION’S MOTION TO DISMISS COMPLAINT Date: March 6, 2017 Time: 10:00 a.m. Judge: Hon. Manuel L. Real Crtrm: 8 Case 2:17-cv-00354-R-AS Document 22-1 Filed 01/26/17 Page 1 of 20 Page ID #:964 TABLE OF CONTENTS Page CASE NO. 2:17-cv-00354-R-FFM i POINTS AND AUTHORITIES IN SUPPORT OF MCKESSON’S MOTION TO DISMISS 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 I. INTRODUCTION ........................................................................................ 1 II. PLAINTIFFS’ COMPLAINT ....................................................................... 2 III. FEDERAL REGULATORY FRAMEWORK .............................................. 3 A. FDA Requirements for Marketing of Drugs ........................................ 3 B. McKesson Is Not the NDA Holder for Eliquis .................................... 4 IV. ARGUMENT................................................................................................ 4 A. Plaintiffs’ Complaint Does Not Sufficiently Allege Facts Stating a Claim Against McKesson and Therefore Fails to Meet the Federal Pleading Standard................................................................... 4 B. Plaintiffs’ Claims Are Preempted ........................................................ 7 C. Plaintiffs’ Fraud-Based Claims Are Not Pled With Particularity and Should Be Dismissed ................................................................. 10 D. Plaintiff Annette Parker’s Wrongful Death Cause of Action Fails for the Same Reasons as Plaintiffs’ Other Claims ..................... 12 E. Leave to Amend Should Not Be Granted .......................................... 14 V. CONCLUSION .......................................................................................... 14 Case 2:17-cv-00354-R-AS Document 22-1 Filed 01/26/17 Page 2 of 20 Page ID #:965 CASE NO. 2:17-cv-00354-R-FFM ii POINTS AND AUTHORITIES IN SUPPORT OF MCKESSON’S MOTION TO DISMISS sd-693492 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 TABLE OF AUTHORITIES Page(s) Cases Aguilar v. McKesson Corp., No. 1:16-CV-00308-LJO-SKO, 2016 WL 2616529 (E.D. Cal. May 9, 2016) ............................................................................................................... 5 Arriaga v. CitiCapital Commercial Corp., 167 Cal. App. 4th 1527 (2008) ............................................................................ 5 Ashcroft v. Iqbal, 556 U.S. 662 (2009) ............................................................................................ 4 Bailey v. Janssen Pharm., Inc., 288 Fed. Appx. 597 (11th Cir. 2008) .................................................................. 6 Barrett v. Super. Ct., 222 Cal. App. 3d 1176 (1990) ........................................................................... 13 Bell Atl. Corp. v. Twombly, 550 U.S. 544 (2007) ........................................................................................ 4, 5 Classen Immunotherapies, Inc. v. Biogen Idec, 381 F. Supp. 2d 452 (D. Md. 2005)..................................................................... 7 Estate of Duran v. Chavez, No. 2:14-CV-02048-TLN-CKD, 2015 WL 8011685 (E.D. Cal. Dec. 7, 2015) ............................................................................................................. 13 In re Fosamax Prods. Liability Litig. (No. II), MDL No. 2243, 2012 WL 181411 (D.N.J. Jan. 17, 2012) ................................... 8 Golden Eagle Distrib. Corp. v. Burroughs Corp., 801 F.2d 1531 (9th Cir. 1986) ............................................................................. 5 Gomez v. Pfizer, Inc., 675 F. Supp. 2d 1159 (S.D. Fla. 2009) ................................................................ 7 Klamath-Lake Pharm. Ass’n v. Klamath Med. Serv. Bureau, 701 F.2d 1276 (9th Cir. 1983) ........................................................................... 14 Case 2:17-cv-00354-R-AS Document 22-1 Filed 01/26/17 Page 3 of 20 Page ID #:966 CASE NO. 2:17-cv-00354-R-FFM iii POINTS AND AUTHORITIES IN SUPPORT OF MCKESSON’S MOTION TO DISMISS sd-693492 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 Lancaster Cmty. Hosp. v. Antelope Valley Hosp. Dist., 940 F.2d 397 (9th Cir. 1991) ............................................................................. 11 In re Lipitor Mktg., Sales Practices & Prods. Liability Litig., No. 2:16-CV-0334, 2016 WL 7368203 (D.S.C. Nov. 1, 2016)............................ 8 Moretti v. Mutual Pharm. Co., 852 F. Supp. 2d 1114 (D. Minn. 2012), aff’d, 518 F. App’x 486 (8th Cir. 2013) .................................................................................................... 7 Mut. Pharm. Co. v. Bartlett, 133 S. Ct. 2466 (2013) ...................................................................................... 10 Neilson v. Union Bank of Cal., N.A., 290 F. Supp. 2d 1101 (C.D. Cal. 2003) ............................................................. 10 OCM Principal Opportunities Fund v. CIBC World Markets Corp., 157 Cal. App. 4th 835 (2007) ............................................................................ 11 Philipson & Simon v. Gulsvig, 154 Cal. App. 4th 347 (2007) ............................................................................ 11 PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011) .................................................................................... 7, 8, 9 Quiroz v. Seventh Ave. Ctr., 140 Cal. App. 4th 1256 (2006) .......................................................................... 13 Robbins v. Oklahoma, 519 F.3d 1242 (10th Cir. 2008) ........................................................................... 7 Sherman v. Stryker Corp., No. SACV 09-224 JVS (ANx), 2009 WL 2241664 (C.D. Cal. Mar. 30, 2009) ....................................................................................................... 6, 12 Small v. Fritz Cos., Inc., 30 Cal. 4th 167 (2003) ...................................................................................... 11 Stevens v. Community Health Care, Inc., No. ESCV200702080, 2011 WL 6379298 (Mass. Super. Oct. 5, 2011) .................................................................................................................. 8 Swartz v. KPMG LLP, 476 F.3d 756 (9th Cir. 2007) ................................................................. 10, 11, 12 Case 2:17-cv-00354-R-AS Document 22-1 Filed 01/26/17 Page 4 of 20 Page ID #:967 CASE NO. 2:17-cv-00354-R-FFM iv POINTS AND AUTHORITIES IN SUPPORT OF MCKESSON’S MOTION TO DISMISS sd-693492 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 Tyco Indus., Inc. v. Super. Ct., 164 Cal. App. 3d 148 (1985) ............................................................................. 10 Vess v. Ciba-Geigy Corp. USA, 317 F.3d 1097 (9th Cir. 2003) ..................................................................... 10, 12 Wyeth v. Levine, 555 U.S. 555 (2009) ............................................................................................ 7 Statutes, Rules, and Other Authorities 21 U.S.C. § 321 ....................................................................................................... 4 21 U.S.C. § 333 ................................................................................................... 4, 8 21 U.S.C. § 352 ....................................................................................................... 4 21 U.S.C. § 355 ....................................................................................................... 3 Cal. Civ. Proc. Code §§ 377.60-377.62 .................................................................. 13 21 C.F.R. § 314.50 ................................................................................................... 3 21 C.F.R. § 314.70 ................................................................................................... 4 21 C.F.R. § 314.71 ............................................................................................... 4, 8 21 C.F.R. § 314.80 ................................................................................................... 7 Fed. R. Civ. P. 8 ....................................................................................................... 4 Fed. R. Civ. P. 9 ..................................................................................................... 10 Case 2:17-cv-00354-R-AS Document 22-1 Filed 01/26/17 Page 5 of 20 Page ID #:968 CASE NO. 2:17-cv-00354-R-FFM 1 POINTS AND AUTHORITIES IN SUPPORT OF MCKESSON’S MOTION TO DISMISS sd-693492 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 I. INTRODUCTION McKesson Corporation (“McKesson”) distributes products for numerous pharmaceutical companies across the United States. As a distributor, McKesson’s role is limited to ensuring that finished, labeled pharmaceutical products such as the Eliquis at issue in this matter make it from the drug manufacturer to patient-facing entities such as pharmacies and hospitals. McKesson is not in the business of labeling Eliquis, promoting Eliquis to patients or doctors, or determining what warnings are appropriate. Despite McKesson’s limited role as a distributor of Eliquis and McKesson’s inability to change the warnings, Plaintiffs attempt to bring multiple causes of action against McKesson based on McKesson’s alleged failure to warn and its alleged fraudulent representations. Yet Plaintiffs have not even alleged facts sufficient to show that McKesson-and not another distributor-distributed the medication at issue. These allegations fail to meet the minimum pleading standard of plausibility. Indeed, the only plausible reason for Plaintiffs to have named McKesson in this case is to defeat diversity jurisdiction. In an effort to overcome this pleading deficiency, Plaintiffs make factual allegations against all “Defendants” to assert vague claims of negligence, design and manufacturing defect, failure to warn, breach of warranties, and fraud-based conduct that allegedly caused them injury. Not only do these allegations fail to meet federal pleadings standards, but they also fall far short of the specificity required for fraud-based claims. Finally, Plaintiffs ignore Supreme Court jurisprudence demonstrating that a pharmaceutical distributor cannot update its labeling and therefore any products liability claims based in failure to warn are preempted. Because these general allegations fail to state a claim against McKesson, Plaintiffs’ Complaint should be dismissed in its entirety, without leave to amend. Case 2:17-cv-00354-R-AS Document 22-1 Filed 01/26/17 Page 6 of 20 Page ID #:969 CASE NO. 2:17-cv-00354-R-FFM 2 POINTS AND AUTHORITIES IN SUPPORT OF MCKESSON’S MOTION TO DISMISS sd-693492 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 II. PLAINTIFFS’ COMPLAINT The Complaint makes clear that Plaintiffs have conducted little investigation into whether McKesson distributed the drugs at issue. Plaintiffs allege generally that McKesson “packaged, marketed, distributed, promoted and sold Eliquis in California and in Los Angeles County.” (Compl. ¶ 21.) Yet Plaintiffs allege only “[u]pon information and belief, McKesson supplied the Eliquis pills at issue in this Complaint.” (Id. ¶ 23 (emphasis added).) Nowhere in the Complaint do Plaintiffs allege where the drug was purchased or provide any other supporting facts for their assertion that McKesson distributed the Eliquis pills that they ingested. At the same time, Plaintiffs allege that Defendants Pfizer, Inc. (“Pfizer”) and Bristol- Myers Squibb Company (“BMS”) were “in the business of and did design, research, manufacture, test, advertise, promote, market, sell, and distribute the drug Eliquis for use as an oral anticoagulant throughout the United States and in the State of California, and in Los Angeles County.” (Id. ¶¶ 27, 29.) Based on these barebones allegations, Plaintiffs make broad and conclusory allegations such as all “Defendants failed to exercise ordinary care in the designing, researching, manufacturing, marketing, supplying, promoting, packaging, sale, testing, quality assurance, quality control, and distribution of Eliquis.” (Compl. ¶ 75.) Nowhere do Plaintiffs state what actions of McKesson, as a pharmaceutical distributor, would give rise to McKesson’s liability in this case. Despite the paucity of allegations against McKesson, Plaintiffs bring eight causes of action against all Defendants alleging injury from ingesting Eliquis: Negligence; Strict Products Liability-Design Defect; Strict Products Liability- Failure to Warn; Breach of Express Warranty; Breach of Implied Warranty; Negligent Misrepresentation; Deceit By Concealment; and Fraud. Plaintiffs’ claims for Negligent Misrepresentation, Deceit by Concealment, and Fraud (collectively, the “fraud-based claims”) make repeated allegations regarding all “Defendants” without identifying any particular statement, misrepresentation, or omission made Case 2:17-cv-00354-R-AS Document 22-1 Filed 01/26/17 Page 7 of 20 Page ID #:970 CASE NO. 2:17-cv-00354-R-FFM 3 POINTS AND AUTHORITIES IN SUPPORT OF MCKESSON’S MOTION TO DISMISS sd-693492 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 by McKesson. (See generally Compl.) Nor does the Complaint specify the time, place, or manner of any statements made by these “Defendants.” (Id.) Annette Parker (“Plaintiff Parker”) further brings a wrongful death cause of action against all Defendants based on the same allegations that fail to support any cause of action. III. FEDERAL REGULATORY FRAMEWORK Eliquis is an oral anticoagulant prescription drug indicated for the treatment of atrial fibrillation. (Compl. ¶¶ 37, 39.) As a prescription drug, it is subject to very specific federal requirements. A. FDA Requirements for Marketing of Drugs FDA regulations require that, prior to selling any new brand-name drug, the drug’s manufacturer must first secure FDA approval by submitting an NDA, which is the “vehicle through which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale and marketing in the [United States].” Request for Judicial Notice (“RJN”) ¶ 1, Ex. A. An NDA includes a compilation of materials concerning the drug, including full reports of any clinical investigations, relevant nonclinical studies, and “any other data or information relevant to an evaluation of the safety and effectiveness of the drug.” 21 C.F.R. §§ 314.50(d)(2), (5)(iv); see also 21 U.S.C. § 355(b)(1)(A) (clinical investigations). The NDA must also include the applicant’s proposed labeling for the drug. 21 U.S.C. § 355(b)(1)(F); 21 C.F.R. § 314.50(c)(2)(i). When the FDA approves a drug for sale and marketing in the United States, it also approves the drug’s labeling, including information about the drug’s risks and benefits, and instructions for physicians and patients regarding the appropriate use of the drug. 21 U.S.C. § 355(d). Once approved, only the FDA-approved labeling can be distributed to customers or provided to physicians. 21 U.S.C. § 355(a). Any change to the substance of the drug’s labeling, including any change to the product’s warnings, and to any related promotional or Case 2:17-cv-00354-R-AS Document 22-1 Filed 01/26/17 Page 8 of 20 Page ID #:971 CASE NO. 2:17-cv-00354-R-FFM 4 POINTS AND AUTHORITIES IN SUPPORT OF MCKESSON’S MOTION TO DISMISS sd-693492 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 informational materials accompanying the drug, requires FDA approval. 21 C.F.R. § 314.70(b)(2)(v)(A); 21 U.S.C. § 321(k),(m) (defining “labeling” to include all written, printed, or graphic material upon a drug, or accompanying the drug); 21 C.F.R. § 314.70(a)(4) (requiring that all promotional labeling and advertising remain consistent with the contents of the product labeling). FDA regulations provide that the only party that can seek to change or supplement the labeling or information materials accompanying a brand-name drug is the NDA applicant. 21 C.F.R. § 314.71(a). If a party other than the original applicant (e.g., a distributor such as McKesson) changes the FDA-approved labeling of the drug, the product is deemed misbranded under federal law. 21 U.S.C. § 352. Any unauthorized entity that makes changes to the FDA-approved product labeling is subject to civil and criminal penalties under federal law. 21 C.F.R. § 314.71(a); 21 U.S.C. § 333. Changes by any other party to the product’s labeling-including any warnings provided with the product- simply are not permitted. B. McKesson Is Not the NDA Holder for Eliquis Plaintiffs admit that McKesson is not the NDA holder for any formulation of Eliquis. (Compl. ¶ 25 (“Defendant BMS is the holder of the approved New Drug Application (‘NDA’) for Eliquis as well as the supplemental New Drug Application (‘sNDA’).”).) Therefore, McKesson is proscribed from ever altering Eliquis’ label, as defined by the FDA (i.e., including an expansive range of communications), without facing federal civil and criminal penalties. IV. ARGUMENT A. Plaintiffs’ Complaint Does Not Sufficiently Allege Facts Stating a Claim Against McKesson and Therefore Fails to Meet the Federal Pleading Standard Federal pleading standards require that a complaint set forth facts sufficient to show that the plaintiffs are entitled to relief. Fed. R. Civ. P. 8(a)(2); Ashcroft v. Iqbal, 556 U.S. 662 (2009); Bell Atl. Corp. v. Twombly, 550 U.S. 544 (2007). Case 2:17-cv-00354-R-AS Document 22-1 Filed 01/26/17 Page 9 of 20 Page ID #:972 CASE NO. 2:17-cv-00354-R-FFM 5 POINTS AND AUTHORITIES IN SUPPORT OF MCKESSON’S MOTION TO DISMISS sd-693492 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 Courts “are not bound to accept as true a legal conclusion couched as a factual allegation.” Twombly, 550 U.S. at 555 (citation omitted). Further, under the federal rules, attorneys must ensure that a pleading is “well-grounded in fact, . . . and that it is not filed for an improper purpose.” Golden Eagle Distrib. Corp. v. Burroughs Corp., 801 F.2d 1531, 1536 (9th Cir. 1986). Under California law, a distributor cannot be liable for injury caused by a product it did not distribute. See, e.g., Arriaga v. CitiCapital Commercial Corp., 167 Cal. App. 4th 1527, 1535 (2008) (listing factors in distributor liability); cf. Aguilar v. McKesson Corp., No. 1:16-CV-00308-LJO-SKO, 2016 WL 2616529, at *3 (E.D. Cal. May 9, 2016) (cataloguing cases where distributors were found not liable as a matter of law because they had not distributed the product about which the plaintiffs had complained). Therefore in order to survive a motion to dismiss, Plaintiffs must plausibly allege that McKesson distributed the pills at issue. Plaintiffs have failed to do so. Instead, Plaintiffs implicitly admit ignorance of the distributor that supplied the Eliquis at issue-Plaintiffs simply state the broad allegation that “[u]pon information and belief, McKesson supplied the Eliquis pills at issue in this Complaint.” (See Compl. ¶ 23.) Surely Plaintiffs had the ability to investigate these claims before bringing the lawsuit, and at the very least the ability to allege which pharmacy or pharmacies sold the Eliquis pills at issue. Yet the Complaint is conspicuously void of any such allegations. Having pled only the most conclusory allegation-on information and belief-that McKesson supplied the drug at issue, Plaintiffs’ Complaint fails to meet the federal pleading standard as the allegations “stop[] short of the line between possibility and plausibility of entitlement to relief.” Twombly, 550 U.S. at 557 (internal quotations omitted). For this reason, the Complaint should be dismissed. In addition, Plaintiffs do not specify any activity that might have given rise to liability. Instead, the Complaint is replete with conclusory allegations that all Case 2:17-cv-00354-R-AS Document 22-1 Filed 01/26/17 Page 10 of 20 Page ID #:973 CASE NO. 2:17-cv-00354-R-FFM 6 POINTS AND AUTHORITIES IN SUPPORT OF MCKESSON’S MOTION TO DISMISS sd-693492 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 “Defendants” were responsible for a litany of actions with respect to Eliquis. For example, Plaintiffs allege: • “At all relevant times, Defendants were in the business of and did design, research, manufacture, test, advertise, promote, market, sell and distribute Eliquis” (Compl. ¶ 37 (emphasis added)); • “Defendants failed to exercise ordinary care in the designing, researching, manufacturing, marketing, supplying, promoting, packaging, sale, testing, quality assurance, quality control, and distribution of Eliquis into interstate commerce” (id. ¶ 75 (emphasis added)); and • “Eliquis as designed, researched, manufactured, tested, advertised, promoted, marketed, sold and distributed by Defendants reached their intended users in the same defective and unreasonably dangerous condition in which Defendants’ Eliquis was manufactured.” (id. ¶ 108 (emphasis added)). These are just a few examples of the many allegations Plaintiffs make against all Defendants. Not once do Plaintiffs allege that McKesson (rather than all Defendants) engaged in any negligent activity with regard to Eliquis, or made or breached any warranty. (See generally Compl.) Nor can Plaintiffs in good faith so allege, as McKesson has only ever distributed the final pharmaceutical product on a pass-through basis. Because Plaintiffs do not specify which if any alleged wrongdoings were committed by McKesson, the Complaint should be dismissed. See, e.g., Sherman v. Stryker Corp., No. SACV 09-224 JVS (ANx), 2009 WL 2241664, at **4-5 (C.D. Cal. Mar. 30, 2009) (dismissing case against defendants where complaint failed to draw a link between the medication at issue and those defendants).1 1 See also Bailey v. Janssen Pharm., Inc., 288 Fed. Appx. 597, 609 (11th Cir. 2008) (affirming dismissal of negligence claim where complaint failed to plead Case 2:17-cv-00354-R-AS Document 22-1 Filed 01/26/17 Page 11 of 20 Page ID #:974 CASE NO. 2:17-cv-00354-R-FFM 7 POINTS AND AUTHORITIES IN SUPPORT OF MCKESSON’S MOTION TO DISMISS sd-693492 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 B. Plaintiffs’ Claims Are Preempted Plaintiffs’ causes of action against McKesson are all grounded in a failure to warn: negligence, strict products liability, breach of warranties, and fraud-based claims. Moretti v. Mutual Pharm. Co., 852 F. Supp. 2d 1114, 1118 (D. Minn. 2012), aff'd, 518 F. App’x 486 (8th Cir. 2013) (“Despite the different ‘labels’ given these claims, the essence of these claims is that important safety information as to [the drug] was not disseminated, or made clear, to the public or to the medical community.”). However, federal law prohibits McKesson from updating any warnings with regard to Eliquis because McKesson does not hold the Eliquis NDA. Accordingly, all of Plaintiffs’ claims are preempted. Supreme Court precedent holds that no entity other than the NDA holder may unilaterally update the warnings on the label. PLIVA, Inc. v. Mensing, 564 U.S. 604, 614 (2011). Under the comprehensive federal regulatory scheme governing prescription drugs such as Eliquis, “it has remained a central premise . . . that the [NDA holder] bears responsibility for the content of its label at all times.” Wyeth v. Levine, 555 U.S. 555, 570-71 (2009). Federal regulations require the NDA holder to “promptly review all adverse drug experience information obtained or otherwise received by the [NDA holder] from any source.” 21 C.F.R. § 314.80(b). That obligation rests squarely with the current NDA holder. See id. As acknowledged by Plaintiffs, McKesson is one of the distributors of Eliquis products and does not individual claims against individual defendants); Gomez v. Pfizer, Inc., 675 F. Supp. 2d 1159, 1163 (S.D. Fla. 2009) (dismissing claim where blanket allegations against two defendants made it “unclear what either of the Defendants’ respective duties are”); Classen Immunotherapies, Inc. v. Biogen Idec, 381 F. Supp. 2d 452 (D. Md. 2005) (dismissing complaint where general allegation failed to specify acts of each defendant and therefore failed to inform defendant of the basis for plaintiff’s claims). The pleading standard is not satisfied if the plaintiff uses “a list of the defendants named individually but with no distinction as to what acts are attributable to whom.” Robbins v. Oklahoma, 519 F.3d 1242, 1250 (10th Cir. 2008) (finding that complaint should have been dismissed because fair notice was not given). Case 2:17-cv-00354-R-AS Document 22-1 Filed 01/26/17 Page 12 of 20 Page ID #:975 CASE NO. 2:17-cv-00354-R-FFM 8 POINTS AND AUTHORITIES IN SUPPORT OF MCKESSON’S MOTION TO DISMISS sd-693492 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 hold the NDA. (See id. ¶ 25 (“Defendant BMS is the holder of the approved New Drug Application (‘NDA’) for Eliquis as well as the supplemental New Drug Application (‘sNDA’).”).) Therefore, McKesson cannot alter the Eliquis label without facing federal civil and criminal penalties. 21 C.F.R. § 314.71(a); 21 U.S.C. § 333. In Mensing, the Supreme Court found that a generic manufacturer of a pharmaceutical could not be held liable for state failure-to-warn claims based on the following deductive analysis: (1) federal law permits only the NDA holder to alter the label; (2) state failure-to-warn claims would require a generic manufacturer (i.e., non-NDA holder) to alter the label; and, therefore, (3) the state failure-to-warn claims were necessarily preempted by federal law, pursuant to the Supremacy Clause, because it would be “impossible” for the generic manufacturer to abide by both federal and state laws. Mensing, 564 U.S. at 618. The same syllogism applies to McKesson as a distributor: (1) federal law prohibits McKesson from altering the Eliquis label because McKesson does not hold the Eliquis NDA; (2) Plaintiffs’ state failure-to-warn claims against McKesson might penalize McKesson for not altering the label on Eliquis; and, therefore, (3) Plaintiffs’ state failure-to-warn claims must be preempted by federal law. Both a federal district court and a state superior court have applied this same analysis to find that state failure-to-warn claims against distributors, such as McKesson, are preempted by federal law. In re Fosamax Prods. Liability Litig. (No. II), MDL No. 2243 (JAP-LHG), 2012 WL 181411, at *1 (D.N.J. Jan. 17, 2012); Stevens v. Community Health Care, Inc., No. ESCV200702080, 2011 WL 6379298, at *1 (Mass. Super. Oct. 5, 2011); see also In re Lipitor Mktg., Sales Practices & Prods. Liability Litig., No. 2:16-CV-0334, 2016 WL 7368203, at *2 (D.S.C. Nov. 1, 2016) (finding same for pharmacy). Despite McKesson’s federal obligation not to alter Eliquis labels, Plaintiffs’ Complaint is premised on the theory that McKesson failed to warn of the alleged risks of Eliquis. For example: Case 2:17-cv-00354-R-AS Document 22-1 Filed 01/26/17 Page 13 of 20 Page ID #:976 CASE NO. 2:17-cv-00354-R-FFM 9 POINTS AND AUTHORITIES IN SUPPORT OF MCKESSON’S MOTION TO DISMISS sd-693492 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 • “[Defendants] [f]ailed to accompany their product with proper and accurate warnings regarding all possible adverse side effects associated with the use of Eliquis” (Compl. ¶ 81(b), Negligence); • Eliquis “was defective due to inadequate post-marketing surveillance and warnings because, after Defendants knew or should have known of the risks of serious side effects . . . , they failed to provide adequate warnings to users, consumers, or prescribing physicians of the product” (id. ¶ 125, Strict Products Liability); • “Defendants knew or should have known that, in fact, said representations and warranties were false, misleading and untrue in that Eliquis was not safe and fit for the use intended, and, in fact, produced serious injuries to the users that were not accurately identified and represented by Defendants” (id. ¶ 142, Breach of Express Warranty); and • “Defendants impliedly represented and warranted to the users of Eliquis and their physicians, healthcare providers, and the FDA that Eliquis was safe and of merchantable quality and fit for the ordinary purpose for which said product was to be used [and] . . . said representations and warranties aforementioned were false, misleading, and inaccurate in that Eliquis was unsafe, unreasonably dangerous, improper, not of merchantable quality, and defective” (id. ¶¶ 148-149, Breach of Implied Warranty). These allegations ignore the fact that McKesson was forbidden from providing warnings different than those on brand-name Eliquis. Mensing, 564 U.S. at 614. In other words, it was impossible for McKesson to comply with its obligations under federal law while simultaneously fulfilling the state-law duty to warn that Plaintiffs seek to impose. The only way for McKesson to avoid liability in these circumstances would be to stop distributing the product. But the Supreme Case 2:17-cv-00354-R-AS Document 22-1 Filed 01/26/17 Page 14 of 20 Page ID #:977 CASE NO. 2:17-cv-00354-R-FFM 10 POINTS AND AUTHORITIES IN SUPPORT OF MCKESSON’S MOTION TO DISMISS sd-693492 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 Court held in yet another pharmaceutical preemption case that the “‘stop-selling’ rationale [is] incompatible with our pre-emption jurisprudence. Our pre-emption cases presume that an actor seeking to satisfy both his federal- and state-law obligations is not required to cease acting altogether in order to avoid liability.” Mut. Pharm. Co. v. Bartlett, 133 S. Ct. 2466, 2477 (2013). There is only one possible result in such a predicament: federal law reigns supreme and state law is preempted. All of Plaintiff’s claims depend on her failure-to-warn allegations and are thus preempted by federal law. Plaintiffs’ Complaint should be dismissed against McKesson in its entirety. Additionally, because “under substantive law no liability exists, leave to amend should be denied, for no amendment could change the result.” Tyco Indus., Inc. v. Super. Ct., 164 Cal. App. 3d 148, 153 (1985). C. Plaintiffs’ Fraud-Based Claims Are Not Pled With Particularity and Should Be Dismissed Plaintiffs’ claims for fraud, negligent misrepresentation, and deceit by concealment should be dismissed against McKesson because they lack the specificity required for fraud-based claims. Rule 9(b) requires a complaint to state “with particularity the circumstances constituting” the fraud. Fed. R. Civ. P. 9(b). This means Plaintiffs must allege the time, date, place, and content of each fraudulent statement, and explain, in detail, why each statement was false at the time it was made. Swartz v. KPMG LLP, 476 F.3d 756, 764 (9th Cir. 2007). In the Ninth Circuit, it is well-established “that both claims for fraud and negligent misrepresentation must meet Rule 9(b)’s particularity requirements.” Neilson v. Union Bank of Cal., N.A., 290 F. Supp. 2d 1101, 1141 (C.D. Cal. 2003). The pleading must be “specific enough to give defendants notice of the particular misconduct . . . so that they can defend against the charge and not just deny that they have done anything wrong.” Vess v. Ciba-Geigy Corp. USA, 317 F.3d 1097, 1106 (9th Cir. 2003) (internal quotation omitted). Moreover, “Rule 9(b) does not Case 2:17-cv-00354-R-AS Document 22-1 Filed 01/26/17 Page 15 of 20 Page ID #:978 CASE NO. 2:17-cv-00354-R-FFM 11 POINTS AND AUTHORITIES IN SUPPORT OF MCKESSON’S MOTION TO DISMISS sd-693492 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 allow a complaint to merely lump multiple defendants together but requires plaintiffs to differentiate their allegations when suing more than one defendant . . . and inform each defendant separately of the allegations surrounding his alleged participation in the fraud.” Swartz, 476 F.3d at 764 (internal quotations, brackets, and citation omitted); see also Lancaster Cmty. Hosp. v. Antelope Valley Hosp. Dist., 940 F.2d 397, 405 (9th Cir. 1991) (plaintiff must plead with particularity “the role of each defendant in each scheme”). Plaintiffs’ fraud-based claims fall short of this heightened standard and should be dismissed. The five elements of fraud are: “(a) misrepresentation (false representation, concealment, or nondisclosure); (b) knowledge of falsity (or ‘scienter’); (c) intent to defraud, i.e., to induce reliance; (d) justifiable reliance; and (e) resulting damage.” Small v. Fritz Cos., Inc., 30 Cal. 4th 167, 173 (2003) (quoting Lazar v. Super. Ct., 12 Cal. 4th 631, 638 (1996)); Philipson & Simon v. Gulsvig, 154 Cal. App. 4th 347, 363 (2007). Negligent misrepresentation shares the same elements except it does not require intent to defraud. See OCM Principal Opportunities Fund v. CIBC World Markets Corp., 157 Cal. App. 4th 835, 845 (2007), as modified (Dec. 26, 2007). Plaintiffs’ allegations fail to meet these heightened pleading requirements. Not once do Plaintiffs specify a statement or omission attributable to McKesson. (See generally Compl.) Instead, Plaintiffs repeatedly make allegations regarding all “Defendants” in attempting to state their fraud-based claims. For example: • “Defendants negligently misrepresented . . . .” (Compl. ¶ 160); • “Defendants made the misrepresentations and omissions . . . .” (id. ¶ 161); and • “Defendants knew or should have known Eliquis was defective” (id. ¶ 167(d)). Throughout their fraud-based claims (id. ¶¶ 156-177), Plaintiffs consistently attribute statements and omissions to all “Defendants.” This is insufficient as these Case 2:17-cv-00354-R-AS Document 22-1 Filed 01/26/17 Page 16 of 20 Page ID #:979 CASE NO. 2:17-cv-00354-R-FFM 12 POINTS AND AUTHORITIES IN SUPPORT OF MCKESSON’S MOTION TO DISMISS sd-693492 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 allegations fail to “inform each defendant separately of the allegations surrounding his alleged participation in the fraud.” Swartz, 476 F.3d at 764-65. On this basis alone, Plaintiffs’ fraud-based claims should be dismissed. The Central District of California dismissed a plaintiff’s fraud claims under similar circumstances. Sherman, 2009 WL 2241664. There, like here, the plaintiff sued multiple defendants in a product liability case and alleged fraud. Id. at *1. Even though the plaintiff argued she pled all of the elements of her fraud-based claim, the court found this insufficient: But the issue is not whether [plaintiff] has pled all the elements of negligent misrepresentation, but whether she has done so with the requisite specificity. The Court finds that she has not. Aside from making allegations against the defendants in general, rather than any defendant in particular, [plaintiff] fails to specify who made the alleged representation, when the representation was made, where the representation was made, or how the representation was communicated. Id. at *3. Just as in Sherman, Plaintiffs here have not only lumped together multiple defendants, but have also failed to “specify who made the alleged representation, when the representation was made, where the representation was made, or how the representation was communicated.” Id. Without this information, Plaintiffs have not given McKesson sufficient “notice of the particular misconduct . . . so that [it] can defend against the charge . . . .” Vess, 317 F.3d at 1106. Finally, Plaintiffs cannot amend their Complaint to state fraud-based claims against McKesson with particularity, as McKesson was a distributor and not an advertiser or labeler of Eliquis and therefore did not make any representations about Eliquis. (See generally Compl. (Plaintiffs do not identify a single statement or omission attributable to McKesson).) Accordingly, Plaintiffs’ fraud-based claims should be dismissed against McKesson. D. Plaintiff Annette Parker’s Wrongful Death Cause of Action Fails for the Same Reasons as Plaintiffs’ Other Claims In California, wrongful death requires an underlying tort. Because Plaintiff Case 2:17-cv-00354-R-AS Document 22-1 Filed 01/26/17 Page 17 of 20 Page ID #:980 CASE NO. 2:17-cv-00354-R-FFM 13 POINTS AND AUTHORITIES IN SUPPORT OF MCKESSON’S MOTION TO DISMISS sd-693492 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 Annette Parker (“Plaintiff Parker”) has failed to state a tort claim against McKesson, her wrongful death claim should also be dismissed. California recognizes a wrongful death cause of action by statute. See Cal. Civ. Proc. Code §§ 377.60-377.62. Wrongful death is defined as a “cause of action for the death of a person caused by the wrongful act or neglect of another.” Cal. Civ. Proc. Code § 377.60. The elements are: (1) “tort (negligence or other wrongful act)”; (2) “resulting death”; and (3) “damages, consisting of pecuniary loss suffered by the heirs.” Quiroz v. Seventh Ave. Ctr., 140 Cal. App. 4th 1256, 1263 (2006). A “wrongful act” refers to an act of either negligence or intentional wrongdoing. Barrett v. Super. Ct., 222 Cal. App. 3d 1176, 1183, 1191 (1990) (interpreting former Cal. Civ. Proc. Code § 377, now Cal. Civ. Proc. Code § 377.60). In support of her wrongful death cause of action, Plaintiff Parker generically alleges that the “injuries and damages Plaintiff and Decedent suffered were caused by the wrongful acts, omissions, and fraudulent misrepresentations of Defendants.” (Compl. ¶ 186.) Plaintiff Parker alleges no additional facts supporting negligence or intentional wrongdoing by McKesson on which to base her cause of action. Instead, Plaintiff Parker’s wrongful death cause of action is predicated on the same allegations regarding Plaintiffs’ other negligence and fraud-based claims. As discussed above, Plaintiffs’ eight other claims warrant dismissal because they fail to plausibly allege that McKesson distributed the Eliquis at issue and are preempted by federal law. See Sections IV.A.-B., supra. Further, Plaintiffs’ fraud- based claims lack particularity and specificity. See Section IV.C., supra. Because Plaintiff Parker has not adequately alleged any negligence or intentional wrongdoing, her wrongful death cause of action has no underlying tort to rest on. See Estate of Duran v. Chavez, No. 2:14-CV-02048-TLN-CKD, 2015 WL 8011685, at *10 (E.D. Cal. Dec. 7, 2015) (dismissing wrongful death cause of action as to one defendant for plaintiffs’ failure to allege sufficient facts as to Case 2:17-cv-00354-R-AS Document 22-1 Filed 01/26/17 Page 18 of 20 Page ID #:981 CASE NO. 2:17-cv-00354-R-FFM 14 POINTS AND AUTHORITIES IN SUPPORT OF MCKESSON’S MOTION TO DISMISS sd-693492 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 underlying negligence). Plaintiff Parker’s wrongful death cause of action should therefore be dismissed. E. Leave to Amend Should Not Be Granted Under Ninth Circuit law, leave to amend should be freely granted unless amendment would be futile. Klamath-Lake Pharm. Ass’n v. Klamath Med. Serv. Bureau, 701 F.2d 1276, 1293 (9th Cir. 1983). Amendment would be futile here. Plaintiffs cannot overcome as a matter of law that their claims against McKesson- all based in failure to warn-are preempted by Supreme Court jurisprudence. See Section IV.B., supra. Further, because McKesson is a distributor with no responsibility for labeling the drug at issue, Plaintiffs could not plausibly state a claim against McKesson for claims based in fraud. Therefore leave to amend should not be granted. V. CONCLUSION With respect to McKesson, Plaintiffs’ Complaint should be dismissed in its entirety because Plaintiffs have failed to state a claim upon which relief can be granted, their claims are preempted by federal law, and Plaintiffs’ fraud-based claims lack essential allegations, rendering them fatally defective. Plaintiff Parker’s wrongful death cause of action fails in tandem. Moreover, Plaintiffs could not state their claims against McKesson even if granted leave to amend. For these reasons, McKesson respectfully requests that the Court dismiss, with prejudice, Plaintiffs’ Complaint in its entirety with respect to McKesson. Case 2:17-cv-00354-R-AS Document 22-1 Filed 01/26/17 Page 19 of 20 Page ID #:982 CASE NO. 2:17-cv-00354-R-FFM 15 POINTS AND AUTHORITIES IN SUPPORT OF MCKESSON’S MOTION TO DISMISS sd-693492 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 Dated: January 26, 2017 MORRISON & FOERSTER LLP By: /s/ Erin M. Bosman Erin M. Bosman Attorneys for Defendant MCKESSON CORPORATION Case 2:17-cv-00354-R-AS Document 22-1 Filed 01/26/17 Page 20 of 20 Page ID #:983 CASE NO. 2:17-cv-00354-R-FFM MCKESSON’S REQUEST FOR JUDICIAL NOTICE ISO MOTION TO DISMISS sd-693494 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 ERIN M. BOSMAN (CA SBN 204987) EBosman@mofo.com JULIE Y. PARK (CA SBN 259929) JuliePark@mofo.com MORRISON & FOERSTER LLP 12531 High Bluff Drive San Diego, California 92130-2040 Telephone: 858.720.5100 Facsimile: 858.720.5125 Attorneys for Defendant MCKESSON CORPORATION UNITED STATES DISTRICT COURT CENTRAL DISTRICT OF CALIFORNIA JOHNNY JACKSON; CHARLES ERIC PETERSON; JUDITH CAROL TRACY; JOAN EZELL; MARINA VICTORIA WILLIAMSON; BOBBY DWAIN STRICKLIN; DALLAS MESSER; TERRI JOSEPH GREEN; and ANNETTE PARKER, Individually and as Successor-In-Interest of the ESTATE OF EDWARD PARKER, JR., Plaintiffs, v. MCKESSON CORPORATION, a Delaware corporation; BRISTOL- MYERS SQUIBB COMPANY, a Delaware corporation; PFIZER INC., a Delaware corporation; and DOES 1 through 100, inclusive, Defendants. CASE NO. 2:17-cv-00354-R-FFM DEFENDANT MCKESSON CORPORATION’S REQUEST FOR JUDICIAL NOTICE IN SUPPORT OF MOTION TO DISMISS COMPLAINT Date: March 6, 2017 Time: 10:00 a.m. Judge: Hon. Manuel L. Real Crtrm: 8 Case 2:17-cv-00354-R-AS Document 22-2 Filed 01/26/17 Page 1 of 3 Page ID #:984 CASE NO. 2:17-cv-00354-R-FFM 1 MCKESSON’S REQUEST FOR JUDICIAL NOTICE ISO MOTION TO DISMISS sd-693494 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 TO THE COURT, ALL PARTIES AND THEIR ATTORNEYS OF RECORD: PLEASE TAKE NOTICE that Defendant McKesson Corporation (“McKesson”) hereby respectfully requests that the Court take judicial notice of the following document, attached as an exhibit hereto in support of McKesson’s Motion to Dismiss, filed concurrently herewith: 1. FDA webpage titled “New Drug Application (NDA),” and providing link to Application to Market a New Drug, Biologic, or An Antibiotic Drug For Human Use, which is attached hereto as Exhibit A and available at: http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDeveloped andApproved/ApprovalApplications/NewDrugApplicationNDA/default.htm. 2. Federal Rule of Evidence 201 authorizes a court to take judicial notice of facts that are “not subject to reasonable dispute” and are either: (1) “generally known within the trial court’s territorial jurisdiction; or (2) can be accurately and readily determined from sources whose accuracy cannot reasonably be questioned.” Fed. R. Evid. 201(b). The Court “must take judicial notice if a party requests it and the [C]ourt is supplied with the necessary information.” Fed. R. Evid. 201(c)(2). 3. Information available on the FDA website, including Exhibit A, is proper for judicial review because it can be accurately and readily determined from sources whose accuracy cannot be reasonably be questioned. See Fed. R. Evid. 201(b). Courts frequently take judicial notice of factual information that is publicly available on government websites or in the public records of government agencies like the FDA. See, e.g., Noble Asset Mgmt. v. Allos Therapeutics, Inc., No. CIVA- 04CV-1030-RPM, 2005 WL 4161977, at *2 (D. Colo. Oct. 20, 2005) (taking judicial notice, when ruling on a motion to dismiss, of the FDA’s “Guidance for Industry E9 Statistical Principles for Clinical Trials” and other information from the FDA’s official website, including an article explaining the role of advisory committees in the FDA approval process); Ries v. Hornell Brewing Co., No. 10- Case 2:17-cv-00354-R-AS Document 22-2 Filed 01/26/17 Page 2 of 3 Page ID #:985 CASE NO. 2:17-cv-00354-R-FFM 2 MCKESSON’S REQUEST FOR JUDICIAL NOTICE ISO MOTION TO DISMISS sd-693494 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 1139-JF (PVT), 2010 WL 2943860, at *5, n.3 (N.D. Cal. July 23, 2010) (background information on point of purchase labeling, “available on the FDA’s official website,” “is a matter of public record and is judicially noticeable”); Currey v. Homecomings Fin., LLC, No. C 09-0276 PJH, 2009 WL 1227010, at *3 (N.D. Cal. May 1, 2009) (“It is not uncommon for courts to take judicial notice of factual information found on the world wide web.”); Hansen Beverage Co. v. Innovation Ventures, LLC, No. 08-CV-1166-IEG (POR), 2009 WL 6597891, at *2 (S.D. Cal. Dec. 23, 2009) (“Information on government agency websites has often been treated as properly subject to judicial notice.”). 4. For the foregoing reasons, McKesson respectfully requests that the Court take judicial notice of the document attached as Exhibit A. Dated: January 26, 2017 MORRISON & FOERSTER LLP By: /s/ Erin M. Bosman Erin M. Bosman Attorneys for Defendant MCKESSON CORPORATION Case 2:17-cv-00354-R-AS Document 22-2 Filed 01/26/17 Page 3 of 3 Page ID #:986 EXHIBIT A Case 2:17-cv-00354-R-AS Document 22-3 Filed 01/26/17 Page 1 of 5 Page ID #:987 1/25/2017 New Drug Application (NDA) http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/NewDrugApplicationNDA/default.htm 1/4 New Drug Application (NDA) Introduction For decades, the regulation and control of new drugs in the United States has been based on the New Drug Application (NDA). Since 1938, every new drug has been the subject of an approved NDA before U.S. commercialization. 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. The data gathered during the animal studies and human clinical trials of an Investigational New Drug (IND) (/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/InvestigationalNewDrugINDApplication/ default.htm) become part of the NDA. The goals of the NDA are to provide enough information to permit FDA reviewer to reach the following key decisions: Whether the drug is safe and effective in its proposed use(s), and whether the benefits of the drug outweigh the risks. Whether the drug's proposed labeling (package insert) is appropriate, and what it should contain. Whether the methods used in manufacturing the drug and the controls used to maintain the drug's quality are adequate to preserve the drug's identity, strength, quality, and purity. The documentation required in an NDA is supposed to tell the drug's whole story, including what happened during the clinical tests, what the ingredients of the drug are, the results of the animal studies, how the drug behaves in the body, and how it is manufactured, processed and packaged. The following resources provide summaries on NDA content, format, and classification, plus the NDA review process: Resources for NDA Submissions The following resources have been gathered to provide you with the legal requirements of a new drug application, assistance from CDER to help you meet those requirements, and internal NDA review principles, policies and procedures. Guidance Documents for NDAs Guidance documents represent the Agency's current thinking on a particular subject. These documents are prepared for FDA review staff and applicants/sponsors to provide guidelines to the processing, content, and evaluation/approval of applications and also to the design, production, manufacturing, and testing of regulated products. They also establish policies intended to achieve consistency in the Agency's regulatory approach and establish inspection and enforcement procedures. Because guidances are not regulations or laws, they are not enforceable, either through administrative actions or through the courts. An alternative approach may be used if such approach satisfies the requirements of the applicable statute, regulations, or both. For information on a specific guidance document, please contact the originating office. For the complete list of CDER guidances, please see the Guidance Index. (/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm121568.htm) For information on a specific guidance document, please contact the originating office. Guidance documents to help prepare NDAs (See list below) Laws, Regulations, Policies and Procedures The mission of FDA is to enforce laws enacted by the U.S. Congress and regulations established by the Agency to protect the consumer's health, safety, and pocketbook. The Federal Food, Drug, and Cosmetic Act (/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/default.htm) is the basic food and drug law of the U.S. With numerous amendments, it is the most extensive law of its kind in the world. The law is intended to assure consumers that foods are pure and wholesome, safe to eat, and produced under sanitary conditions; that drugs and devices are safe and effective for their intended uses; that cosmetics are safe and made from appropriate ingredients; and that all labeling and packaging is truthful, informative, and not deceptive. Code Of Federal Regulations (CFR) (http://www.gpoaccess.gov/cfr/index.html) The final regulations published in the Federal Register (http://www.gpoaccess.gov/fr/index.html) (daily published record of proposed rules, final rules, meeting notices, etc.) are collected in the CFR. The CFR is divided into 50 titles which represent broad areas subject to Federal regulations. The FDA's portion of the CFR interprets the Federal Food, Drug and Cosmetic Act (http://www.fda.gov/opacom/laws/fdcact/fdctoc.htm) and related statutes. Case 2:17-cv-00354-R-AS Document 22-3 Filed 01/26/17 Page 2 of 5 Page ID #:988 1/25/2017 New Drug Application (NDA) http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/NewDrugApplicationNDA/default.htm 2/4 Section 21 of the CFR (http://www.ecfr.gov/cgi-bin/text-idx? SID=3ee286332416f26a91d9e6d786a604ab&mc=true&tpl=/ecfrbrowse/Title21/21tab_02.tpl) contains all regulations pertaining to food and drugs. The regulations document all actions of all drug sponsors that are required under Federal law. 21CFR Part 314 (http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRsearch.cfm?CFRPart=314) - Applications for FDA Approval to Market a New Drug or an Antibiotic Drug. CDER's Manual of Policies and Procedures (MaPPs) (/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ManualofPoliciesProcedures/default.htm) These documents are approved instructions for internal practices and procedures followed by CDER staff to help standardize the new drug review process and other activities. MaPPs define external activities as well. All MaPPs are available for the public to review to get a better understanding of office policies, definitions, staff responsibilities and procedures. MaPPS of particular interest to NDA applicants can be found in the list below: Prescription Drug User Fee Act (PDUFA) On November 21, 1997, The President signed the Food and Drug Administration Modernization Act of 1997. This legislation includes authorization for FDA to continue to collect three types of user fees from applicants who submit certain new drug and biological product applications. FDA was first authorized to collect user fees under the Prescription Drug User Fee Act (PDUFA) of 1992. Prescription Drug User Fee Act Related Documents (/ForIndustry/UserFees/PrescriptionDrugUserFee/default.htm) NDA Forms and Electronic Submissions Form FDA-356h (/downloads/AboutFDA/ReportsManualsForms/Forms/UCM082348.pdf). Application to Market a New Drug, Biologic, or An Antibiotic Drug For Human Use Form FDA-356h instructions (/downloads/AboutFDA/ReportsManualsForms/Forms/UCM321897.pdf) Form FDA-3397 (/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm119184.htm). User Fee Cover Sheet Form FDA-3331 (/downloads/AboutFDA/ReportsManualsForms/Forms/UCM094853.pdf). New Drug Application Field Report Guidance Documents for Electronic Submissions (/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm121568.htm) For more information on electronic submissions, see ERSR (/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/ElectronicSubmissions/ucm085361.htm) Advisory Committees Advisory committees provide independent advice and recommendations to the FDA on scientific and technical matters related to the development and evaluation of products regulated by the Agency. CDER requests advice from advisory committees on a variety of matters, including various aspects of clinical investigations and applications for marketing approval of drug products. Committee members are scientific experts such as physician-researchers and statisticians, as well as representatives of the public, including patients. Although the committees provide recommendations to the Agency, final decisions are made by FDA. FDA Advisory Committees (http://www.fda.gov/AdvisoryCommittees/default.htm) CDER Advisory Committees (/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/default.htm) CFR 21 Part 14 Public Hearing Before a Public Advisory Committee (http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=14). Detailed description of advisory committees from the Code of Federal Regulations. Guidance for Industry: Advisory Committees (/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM079765.pdf). Includes information on membership, conflict of interest, scheduling, and action on recommendations. List of Tentative Meeting Dates for Advisors and Consultants Staff (ssLINK/ucm160665.htm). Several dates have been set aside by CDER advisory committees for possible future meetings. The subject matter and location of the meetings (if they are held) will be published in the Federal Register in the month prior to the meeting date. FDA Meeting Transcripts 1995 to Present (http://www.fda.gov/ohrms/dockets/ac/acmenu.htm). Recent transcripts includes minutes, briefing information, slides and other documents. Guidance Documents to help prepare NDA's Case 2:17-cv-00354-R-AS Document 22-3 Filed 01/26/17 Page 3 of 5 Page ID #:989 1/25/2017 New Drug Application (NDA) http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/NewDrugApplicationNDA/default.htm 3/4 Title  Issued Date  Bioavailability and Bioequivalence Studies Submitted in NDAs or INDs - General Considerations (PDF - 805KB) (/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM389370.pdf) 03/17/14 Changes to an Approved NDA or ANDA (PDF - 173KB) (/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM077097.pdf) 04/01/04 Changes to an Approved NDA or ANDA: Questions and Answers (PDF - 35KB) (/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM122871.pdf) 01/01/01 Container Closure Systems for Packaging Human Drugs and Biologics (PDF - 164KB) (/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM070551.pdf) 05/01/99 Format and Content of the Microbiology Section of an Application* (PDF - 546KB) (/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM075101.pdf) 01/01/90 Format and Content of the Clinical and Statistical Sections of an Application (PDF - 1.1MB) (/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM071665.pdf) 07/01/88 Summary for New Drug and Antibiotic Applications--Format and Content of the Summary for New Drug and Antibiotic Applications (PDF - 1.3MB) (/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM072058.pdf) 02/01/87 Formatting, Assembling and Submitting New Drug and Antibiotic Applications* (PDF - 1.7MB) (/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM071676.pdf) 02/01/87 GUIDELINE FOR SUBMITTING SUPPORTING DOCUMENTATION IN DRUG APPLICATIONS FOR THE MANUFACTURE OF DRUG PRODUCTS (/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm149499.htm) NDAs: Impurities in Drug Substances (PDF - 11KB) (/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM070577.pdf) 02/01/00 Format and Content of the Human Pharmacokinetics and Bioavailability Section of an Application (PDF - 519KB) (/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM072112.pdf) 02/01/87 Format and Content of the Nonclinical Pharmacology/Toxicology Section of an Application* (PDF - 1.3MB) (/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM079234.pdf) 02/01/87 Providing Clinical Evidence of Effectiveness for Human Drug and Biological Products (PDF - 129KB) (/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM078749.pdf) Drug Master Files: Guidelines (/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm122886.htm) 09/01/89 FDA IND, NDA, ANDA, or Drug Master File Binders (/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/DrugMasterFilesDMFs/ucm073080.htm) PET Drug Applications - Content and Format for NDAs and ANDAs_2011 (PDF - 429KB) (/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM078738.pdf) 08/31/11 CDER's Manual of Policies and Procedures (MAPPs) Title  Issued Date  Review of Grouped Product Quality Supplements (PDF - 90KB) (/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ManualofPoliciesProcedures/UCM079567.pdf) 04/19/16 NDAs and BLAs: Filing Review Issues (PDF - 76KB) (/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ManualofPoliciesProcedures/UCM081990.pdf) 12/17/13 NDAs/BLAs/Efficacy Supplements: Action Packages and Taking Regulatory Actions (PDF - 282KB) (/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ManualofPoliciesProcedures/UCM082010.pdf) 06/14/16 Refusal to Accept Application for Filing From Applicants in Arrears (PDF - 76KB) (/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ManualofPoliciesProcedures/UCM082029.pdf) 04/18/12 Case 2:17-cv-00354-R-AS Document 22-3 Filed 01/26/17 Page 4 of 5 Page ID #:990 1/25/2017 New Drug Application (NDA) http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/NewDrugApplicationNDA/default.htm 4/4 Title  Issued Date  Requesting and Accepting Non-Archivable Electronic Material for CDER Applications (PDF - 104KB) (/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ManualofPoliciesProcedures/UCM082135.pdf) 09/03/13 Related Topics Combination Products (/CombinationProducts/default.htm) Electronic Regulatory Submissions and Review Helpful Links (/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/ElectronicSubmissions/ucm085361.htm) Information for Clinical Investigators (INDs) (/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/InvestigationalNewDrugINDApplication/ucm176259.htm) CDER Small Business & Industry Assistance (SBIA) (/Drugs/DevelopmentApprovalProcess/SmallBusinessAssistance/default.htm) Surveillance: Post Drug-Approval Activities (/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/default.htm) Resources for You Investigational New Drug (IND) Application (/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/InvestigationalNewDrugINDApplication/default.htm) Therapeutic Biologics Applications (BLA) (/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/default.htm) Abbreviated New Drug Application (ANDA): Generics (/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/AbbreviatedNewDrugApplicationANDAGenerics/default.htm) Botanical Drug Review (/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/NewDrugApplicationNDA/BotanicalDrugReview/default.htm) More in New Drug Application (NDA) (/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/NewDrugApplicationNDA/default.htm) Case 2:17-cv-00354-R-AS Document 22-3 Filed 01/26/17 Page 5 of 5 Page ID #:991 CASE NO. 2:17-cv-00354-R-FFM [PROPOSED] ORDER GRANTING MCKESSON’S MOTION TO DISMISS sd-693497 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 UNITED STATES DISTRICT COURT CENTRAL DISTRICT OF CALIFORNIA JOHNNY JACKSON; CHARLES ERIC PETERSON; JUDITH CAROL TRACY; JOAN EZELL; MARINA VICTORIA WILLIAMSON; BOBBY DWAIN STRICKLIN; DALLAS MESSER; TERRI JOSEPH GREEN; and ANNETTE PARKER, Individually and as Successor-In-Interest of the ESTATE OF EDWARD PARKER, JR., Plaintiffs, v. MCKESSON CORPORATION, a Delaware corporation; BRISTOL- MYERS SQUIBB COMPANY, a Delaware corporation; PFIZER INC., a Delaware corporation; and DOES 1 through 100, inclusive, Defendants. CASE NO. 2:17-cv-00354-R-FFM [PROPOSED] ORDER GRANTING DEFENDANT MCKESSON CORPORATION’S MOTION TO DISMISS COMPLAINT Date: March 6, 2017 Time: 10:00 a.m. Judge: Hon. Manuel L. Real Crtrm: 8 Case 2:17-cv-00354-R-AS Document 22-4 Filed 01/26/17 Page 1 of 2 Page ID #:992 CASE NO. 2:17-cv-00354-R-FFM 1 [PROPOSED] ORDER GRANTING MCKESSON’S MOTION TO DISMISS sd-693497 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 The motion of McKesson Corporation to dismiss Plaintiffs’ Complaint came on regularly for hearing on March 6, 2017 at 10:00 a.m. in Courtroom 8 of the above-entitled court, the Honorable Manuel L. Real, Judge Presiding. After considering the moving and opposition papers, arguments of counsel, and all other matter presented to the Court, and for good cause shown, IT IS HEREBY ORDERED that McKesson Corporation’s Request for Judicial Notice is GRANTED, and its motion to dismiss is GRANTED. Plaintiffs’ Complaint, in its entirety, as related to McKesson Corporation, is dismissed with prejudice pursuant to Federal Rules of Civil Procedure 12(b)(6) and 9(b). IS IT SO ORDERED. Dated: , 2017 Honorable Manuel L. Real UNITED STATES DISTRICT JUDGE Case 2:17-cv-00354-R-AS Document 22-4 Filed 01/26/17 Page 2 of 2 Page ID #:993