`
`_________________________________________________
`
`United States Court of Appeals
`for the Second Circuit
`_________________________________________________
`BARBARA GAYLE, individually, NORMA CLARK, individually, LAURA FLORES,
`individually, DOROTHY JONES, individually, ROSALIE BUONAMANO AND
`ARNOLD BUONAMANO, individually and as husband and wife, CAROL MEIDL
`AND EDWARD MEIDL, individually and as husband and wife, CHRISTIE KELLY,
`individually, PEARLY COLEMAN, individually, MARA SCOTT AND RONNIE
`SCOTT, individually and as husband and wife, CHERRY RICHARDSON,
`individually, CHERYL DORSEY, individually, TAMMY AXELROD AND BRYAN
`AXELROD, individually and as husband and wife, CHARLIE JOHNSON,
`individually, TAWNYA LOCKHART, individually, LEONA RHETT AND TOMMIE
`A. RHETT, individually and as husband and wife, JACQUELYN LOVETT,
`individually, SHARON STEWART, individually, SHENNA ALBERT, individually,
`AND CARLETHA FOSTER, individually,
`Plaintiffs-Appellants,
`
`-versus-
`PFIZER, INC. AND MCKESSON CORPORATION,
`Defendants-Appellees.
`____________________________________________________________________________________________________________
`Appeal of Order of the United States District Court
`for the Southern District of New York (Pauley, J.)
`Case No. 1:19-cv-03451-WHP
`_____________________________________________________________________________________________________________
`BRIEF OF APPELLEE PFIZER INC.
`Michael H. McGinley
`Mark S. Cheffo
`DECHERT LLP
`Rachel Passaretti-Wu
`Cira Centre
`Mara Cusker Gonzalez
`2929 Arch Street,
`Lincoln Davis Wilson
`Philadelphia, PA 19104
`DECHERT LLP
`1095 Sixth Avenue
`New York, New York 10036
`Attorneys for Defendant-Appellee Pfizer Inc.
`
`_____________________________________________________________________________________________________________
`
`
`
`Case 20-1383, Document 62, 10/23/2020, 2959449, Page2 of 60
`
`CORPORATE DISCLOSURE STATEMENT
`Appellee Pfizer Inc. is a publicly traded company that has no parent
`corporation and there is no publicly traded company that owns ten
`percent or more of its stock.
`
`/s/ Mark S. Cheffo
`Mark Cheffo
`
`
`
`Case 20-1383, Document 62, 10/23/2020, 2959449, Page3 of 60
`
`TABLE OF CONTENTS
`
`Page
`
`TABLE OF AUTHORITIES ..................................................................... iv
`PRELIMINARY STATEMENT ................................................................. 1
`STATEMENT OF JURISDICTION .......................................................... 3
`STATEMENT OF ISSUES ........................................................................ 4
`STATEMENT OF THE CASE .................................................................. 4
`A.
`The 2012 Lipitor Label Change .............................................. 4
`B.
`The 2013-2018 Federal Lipitor Litigation .............................. 6
`C.
`The 2019 Gayle Complaint ..................................................... 8
`D.
`The 2020 Dismissal ............................................................... 10
`SUMMARY OF ARGUMENT ................................................................. 11
`STANDARD OF REVIEW....................................................................... 13
`ARGUMENT ........................................................................................... 14
`I.
`PLAINTIFFS’ POST-2012 CLAIMS ARE PREEMPTED. ............ 14
`A.
`To Survive Preemption, Plaintiffs’ Failure-to-Warn
`Claims Must Plead Pfizer Had “Newly Acquired
`Information.” ......................................................................... 16
`Plaintiffs’ Allegations of Adverse Event Reports,
`Without More, Do Not Constitute “Newly Acquired
`Information” That Could Support a CBE Label Change. .... 22
`1.
`The Alleged Adverse Event Reports Do Not
`Suggest Risks of a Different Type or Degree Than
`Previously Discussed.................................................... 23
`Adverse Event Reports Alone Do Not Allege “New
`Analyses of Previously Submitted Data.” .................... 28
`Adverse Event Reports Alone Do Not Give Rise to
`an Inference of Causality. ............................................ 31
`Adverse Event Reports Alone Can Be Generated
`and Alleged in Literally Every Case. ........................... 36
`ii
`
`3.
`
`4.
`
`B.
`
`2.
`
`
`
`Case 20-1383, Document 62, 10/23/2020, 2959449, Page4 of 60
`
`II.
`
`PLAINTIFFS’ PRE-2016 CLAIMS ARE TIME-BARRED. ........... 39
`A.
`Plaintiffs’ Estoppel Argument, Raised for the First
`Time on Appeal, Is Meritless. ............................................... 40
`Plaintiffs’ Fraudulent Concealment Allegations Fail as
`a Matter of Law. .................................................................... 43
`The District Court Did Not Hold that Plaintiffs’ Post-
`2013 Claims Were Timely. .................................................... 45
`CONCLUSION ........................................................................................ 47
`
`B.
`
`C.
`
`iii
`
`
`
`Case 20-1383, Document 62, 10/23/2020, 2959449, Page5 of 60
`
`TABLE OF AUTHORITIES
`
` Page(s)
`
`Cases
`421-A Tenants Ass’n, Inc. v. 125 Court Str. LLC,
`760 F. App’x 44 (2d Cir. 2019) ............................................................ 46
`In re Abilify (Aripiprazole) Prods. Liab. Litig.,
`299 F. Supp. 3d 1291 (N.D. Fla. 2018) ............................................... 37
`Ambac Assurance Corp. v. U.S. Bank Nat’l Ass’n,
`328 F. Supp. 3d 141 (S.D.N.Y. 2018) .................................................. 14
`Aozora Bank, Ltd. v. Deutsche Bank Sec. Inc.,
`137 A.D.3d 685 (1st Dep’t 2016) ......................................................... 46
`Armstrong v. McAlpin,
`699 F.2d 79 (2d Cir. 1983) .................................................................. 43
`Ashcroft v. Iqbal,
`556 U.S. 662 (2009) ....................................................................... 30, 31
`AstraZeneca Pharm. LP v. Apotex Corp.,
`669 F.3d 1370 (Fed. Cir. 2012) ............................................................. 5
`In re AXA Equitable Life Ins. Co. COI Litig.,
`2019 WL 1382437 (S.D.N.Y. Mar. 27, 2019) ...................................... 43
`Bank of N.Y. v. First Millennium, Inc.,
`607 F.3d 905 (2d Cir. 2010) .................................................................. 2
`Biswas v. Rouen,
`2019 WL 5260821 (S.D.N.Y. Oct. 16, 2019) ....................................... 13
`Blackburn v. Shire US, Inc.,
`2017 WL 1833524 (N.D. Ala. May 8, 2017) .................................. 35, 36
`Buttry v. Gen. Signal Corp.,
`68 F.3d 1488 (2d Cir. 1995) .......................................................... 41, 42
`
`iv
`
`
`
`Case 20-1383, Document 62, 10/23/2020, 2959449, Page6 of 60
`
`Caraker v. Sandoz Pharm. Corp.,
`188 F. Supp. 2d 1026 (S.D. Ill. 2001) ............................................ 34, 35
`In re Carter-Wallace, Inc., Sec. Litig.,
`220 F.3d 36 (2d Cir. 2000) .................................................................. 32
`Caterpillar Inc. v. Lewis,
`519 U.S. 61 (1996) ................................................................................. 8
`In re Celexa & Lexapro Mktg. & Sales Practices Litig.,
`779 F.3d 34 (1st Cir. 2015) ........................................................... 17, 21
`Cerveny v. Aventis, Inc.,
`855 F.3d 1091 (10th Cir. 2017) ..................................................... 16, 19
`Chunn v. Amtrak,
`916 F.3d 204 (2d Cir. 2019) ................................................................ 13
`Corp. Trade, Inc. v. Golf Channel,
`563 F. App’x 841 (2d Cir. 2014) .................................................... 41, 43
`Cusimano v. Schnurr,
`137 A.D.3d 527 (1st Dep’t 2016) ......................................................... 43
`Del Valle v. PLIVA, Inc.,
`2011 WL 7168620 (S.D. Tex. Dec. 21, 2011), report and
`recommendation adopted sub nom. Del Valle v. Qualitest
`Pharm. Inc., 2012 WL 2899406 (S.D. Tex. June 22, 2012),
`aff’d sub nom. Lashley v. Pfizer, Inc., 750 F.3d 470 (5th
`Cir. 2014) ............................................................................................. 17
`DePriest v. AstraZeneca Pharm., L.P.,
`351 S.W.3d 168 (Ark. 2009) ................................................................ 18
`Dobbs v. Wyeth Pharm.,
`797 F. Supp. 2d 1264 (W.D. Okla. 2011) ............................................ 17
`Dolin v. GlaxoSmithKline LLC,
`901 F.3d 803 (7th Cir. 2018) ......................................................... 21, 36
`
`v
`
`
`
`Case 20-1383, Document 62, 10/23/2020, 2959449, Page7 of 60
`
`Drescher v. BraccoDiagnostics Inc.,
`2020 WL 699878 (D. Ariz. Jan. 31, 2020) ........................................... 27
`Eastman Kodak Co. v. Henry Bath LLC,
`936 F.3d 86 (2d Cir. 2019) .................................................................. 14
`Ellul v. Congregation of Christian Bros.,
`774 F.3d 791 (2d Cir. 2014) ................................................................ 41
`Gibbons v. Bristol-Myers Squibb Co.,
`919 F.3d 699 (2d Cir. 2019) ........................................................ passim
`Goodell v. BayerHealthcare Pharm. Inc.,
`2019 WL 4771136 (D. Mass. Sept. 30, 2019) ...................................... 27
`Guilbeau v. Pfizer, Inc.,
`880 F.3d 304 (7th Cir. 2018) ............................................................... 17
`Haggerty v. Upjohn Co.,
`950 F. Supp. 1160 (S.D. Fla. 1996) ..................................................... 32
`Hodges v. Glenholme Sch.,
`713 F. App’x 49 (2d Cir. 2017) ............................................................ 44
`Hollander v. Sandoz Pharm. Corp.,
`289 F.3d 1193 (10th Cir. 2002) ........................................................... 33
`Ignacuinos v. Boehringer Ingelheim Pharm., Inc.,
`2020 WL 5659071 (D. Conn. Sept. 23, 2020) ...................................... 27
`Javens v. GE Healthcare Inc.,
`2020 WL 2783581 (D. Del. May 29, 2020) .......................................... 27
`Klein v. Bayer Healthcare Pharm. Inc.,
`2019 WL 3945652 (D. Nev. Aug. 21, 2019) ........................................ 27
`LeBlanc v. Cleveland,
`248 F.3d 95 (2d Cir. 2001) .................................................................... 8
`Levy v. BASF Metals Ltd.,
`917 F.3d 106 (2d Cir. 2019) ................................................................ 41
`
`vi
`
`
`
`Case 20-1383, Document 62, 10/23/2020, 2959449, Page8 of 60
`
`In re Lipitor,
`JCCP 4761 (Cal. Super. Ct.). ................................................................ 6
`In re Lipitor (Atorvastatin Calcium) Mktg., Sales Practices
`& Prods. Liab. Litig.,
`185 F. Supp. 3d 761 (D.S.C. 2016) .................................................. 7, 21
`In re Lipitor (Atorvastatin Calcium) Mktg., Sales Practices
`& Prods. Liab. Litig.,
`226 F. Supp. 3d 557 (D.S.C. 2017) ........................................................ 7
`In reLipitor (Atorvastatin Calcium) Mktg., Sales Practices
`& Prods. Liab. Litig.,
`227 F. Supp. 3d 452 (D.S.C. 2017) ........................................................ 7
`In re Lipitor (Atorvastatin Calcium) Mktg., Sales Practices
`& Prods. Liab. Litig. (No II) MDL 2502,
`892 F.3d 624 (4th Cir. 2018) ....................................................... 6, 8, 46
`Lynch v. City of New York,
`952 F.3d 67 (2d Cir. 2020) .................................................................. 13
`Lyons v. Boehringer Ingelheim Pharm., Inc.,
`2020 WL 5835125 (N.D. Ga. Sept. 29, 2020) ...................................... 27
`Mahnke v. Bayer Corp.,
`2020 WL 2048622 (C.D. Cal. Mar. 10, 2020) ...................................... 27
`Matrixx Initiatives, Inc. v. Siracusano,
`563 U.S. 27 (2011) ............................................................................... 33
`McClain v. Metabolife Int’l, Inc.,
`401 F.3d 1233 (11th Cir. 2005) ........................................................... 33
`McGrath v. Bayer Healthcare Pharm. Inc.,
`393 F. Supp. 3d 161 (E.D.N.Y. 2019)............................................ 27, 35
`Merck Sharp & Dohme Corp. v. Albrecht,
`139 S. Ct. 1668 (2019) ................................................................. passim
`
`vii
`
`
`
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`
`In re Mirena IUD Prods. Liab. Litig.,
`713 F. App’x 11 (2d Cir. 2017) ............................................................ 32
`Mut. Pharm. Co. v. Bartlett,
`570 U.S. 472 (2013) ............................................................................. 16
`Newman v. McNeil Consumer Healthcare,
`2013 WL 7217197 (N.D. Ill. Mar. 29, 2013) ................................. 17, 36
`Overall v. Estate of Klotz,
`52 F.3d 398 (2d Cir. 1995) .................................................................. 42
`PLIVA, Inc. v. Mensing,
`564 U.S. 604 (2011) ....................................................................... 17, 20
`Pompa v. Burroughs Wellcome Co.,
`696 N.Y.S.2d 587 (3d Dep’t 1999) ....................................................... 39
`Prohias v. Pfizer, Inc.,
`490 F. Supp. 2d 1228 (S.D. Fla. 2007) ................................................ 18
`Rheinfrank v. Abbott Labs., Inc.,
`680 F. App’x 369 (6th Cir. 2017) ......................................................... 17
`Ridings v. Maurice,
`444 F. Supp. 3d 973 (W.D. Mo. 2020) ................................................. 27
`In re Schering Plough Corp. Intron/Temodar Consumer
`Class Action,
`678 F.3d 235 (3d Cir. 2012) ................................................................ 18
`Sejin Precision Indus. Co., Ltd. v. Citibank, N.A.,
`726 F. App’x 27 (2d Cir. 2018) ............................................................ 46
`Seufert v. Merck Sharp & Dohme Corp.,
`187 F. Supp. 3d 1163 (S.D. Cal. 2016) ................................................ 17
`Shropshear v. Corp. Counsel of City of Chi.,
`275 F.3d 593 (7th Cir. 2001) ............................................................... 42
`Smith v. GE Healthcare Inc.,
`2020 WL 1880787 (W.D. La. Mar. 31, 2020) ...................................... 27
`viii
`
`
`
`Case 20-1383, Document 62, 10/23/2020, 2959449, Page10 of 60
`
`Soldov. Sandoz Pharm. Corp.,
`244 F. Supp. 2d 434 (W.D. Pa. 2003) .................................................. 34
`Strayhorn v. Wyeth Pharm., Inc.,
`737 F.3d 378 (6th Cir. 2013) ............................................................... 17
`Thomas v.Bracco Diagnostics Inc.,
`2020 WL 1016273 (W.D. La. Feb. 27, 2020) ....................................... 27
`Trisvan v. Heyman,
`305 F. Supp. 3d 381 (E.D.N.Y. 2018).................................................... 5
`United States v. Kelly,
`147 F.3d 172 (2d Cir. 1998) ................................................................ 40
`Update Art, Inc. v. Modiin Publ’g, Ltd.,
`843 F.2d 67 (2d Cir. 1988) .................................................................. 40
`Utts v. Bristol-Myers Squibb Co.,
`251 F. Supp. 3d 644 (S.D.N.Y. 2017) ............................................ 17, 34
`Williams v. Affinion Grp., LLC,
`889 F.3d 116 (2d Cir. 2018) ................................................................ 44
`Wyeth v. Levine,
`555 U.S. 555 (2009) ..................................................................... passim
`Zembiec v. Cty. of Monroe,
`468 F. App’x 39 (2d Cir. 2012) ............................................................ 13
`Statutes
`21 U.S.C. § 393 ........................................................................................ 18
`28 U.S.C. § 1291 ........................................................................................ 3
`28 U.S.C. § 1332 ........................................................................................ 3
`CPLR 202 ................................................................................................. 39
`CPLR 214-c .............................................................................. 4, 40, 41, 45
`
`ix
`
`
`
`Case 20-1383, Document 62, 10/23/2020, 2959449, Page11 of 60
`
`Rules
`Fed. R. Civ. P. 12 ..................................................................................... 14
`Fed. R. Civ. P. 8 ....................................................................................... 30
`Fed. R. Civ. P. 9 ................................................................................. 43, 44
`Regulations and Guidance
`21 C.F.R. § 202.1 ..................................................................................... 17
`21 C.F.R. § 310.305 ................................................................................. 31
`21 C.F.R. § 314.3 ............................................................................... 20, 38
`21 C.F.R. § 314.70 ........................................................................... passim
`21 C.F.R. § 314.80 ........................................................................... passim
`21 C.F.R. § 314.81 ................................................................................... 17
`FDA, Reporting Serious Problems to FDA, available at
`https://bit.ly/34j8GbU (accessed September 30, 2020) ....................... 37
`
`x
`
`
`
`Case 20-1383, Document 62, 10/23/2020, 2959449, Page12 of 60
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`PRELIMINARY STATEMENT
`
`The twenty-four Plaintiffs here allege that they developed type 2
`
`diabetes as a result of taking Pfizer’s cholesterol-lowering statin, Lipitor.
`
`Their claims follow on the heels of a broader litigation that began more
`
`than seven years ago, after the FDA comprehensively reviewed the data
`
`on statin medications and type 2 diabetes. In 2012, the FDA ordered an
`
`updated warning to address reported increases in glucose for certain
`
`statins, including Lipitor. That label change spurred the filing of more
`
`than 6,000 claims against Pfizer in state and federal courts around the
`
`country. When a federal MDL judge scrutinized those claims, he granted
`
`summary judgment on the entire litigation due to lack of admissible
`
`evidence sufficient to prove causation. And the Fourth Circuit, more than
`
`two years ago, affirmed those rulings in their entirety.
`
`Then, in 2019, these Plaintiffs filed the same claims against Pfizer.
`
`They did not say when they took Lipitor or when they learned they had
`
`type 2 diabetes. But the timing of their filing, more than seven years
`
`after the FDA’s label change and a year after the final dismissal of the
`
`federal litigation, placed them between the horns of a dilemma. No
`
`matter when their claims accrued, they were either preempted by federal
`
`
`
`Case 20-1383, Document 62, 10/23/2020, 2959449, Page13 of 60
`
`law, barred by the statute of limitations, or both. The District Court
`
`(Pauley, J.) held that dilemma inescapable and dismissed Plaintiffs’
`
`claims with prejudice. This Court should affirm.
`
`First, Plaintiffs’ claims are preempted if they accrued after
`
`February 2012. As this Court held in Gibbons v. Bristol-Myers Squibb
`
`Co., 919 F.3d 699 (2d Cir. 2019), a plaintiff cannot challenge an FDA-
`
`approved warning label under state law unless she pleads that the
`
`defendant had “newly acquired information” not previously submitted to
`
`the FDA that could have supported a different warning. Id. at 708.
`
`Plaintiffs’ only attempt to plead “newly acquired information” was their
`
`allegation of 6,000 adverse event reports of diabetes that followed the
`
`FDA’s February 2012 label change. But those anecdotal event reports
`
`following the filing of the Lipitor litigation are not “newly acquired
`
`information.” They do not show risks different than those the FDA
`
`already considered and they are inherently incapable of showing
`
`causation. Plaintiffs’ post-2012 claims are preempted and were properly
`
`dismissed.
`
`Second, Plaintiffs’ claims are time-barred if they accrued before
`
`April 2016. Under the New York statute of limitations that controls here,
`
`2
`
`
`
`Case 20-1383, Document 62, 10/23/2020, 2959449, Page14 of 60
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`Plaintiffs had three years from the date they discovered their injury—
`
`that is, when they learned they had diabetes—to file their claims. Since
`
`Plaintiffs did not file until April 2019, any claims based on a diagnosis
`
`before April 2016 are barred. Nor have Plaintiffs pled any exception to
`
`the three-year rule. They do not plead with particularity any statements
`
`by Pfizer that prevented them from timely filing. And New York’s limited
`
`exception for a late discovery of causation does not apply here—especially
`
`because of the years-old, public litigation involving the same claims.
`
`Under any scenario of accrual, these twin defects are fatal to
`
`Plaintiffs’ claims as pled in their Proposed Amended Complaint. The
`
`District Court thus properly denied leave to amend as futile and this
`
`Court should affirm the judgment below.
`
`STATEMENT OF JURISDICTION
`
`This Court has jurisdiction under section 28 U.S.C. § 1291 over
`
`Plaintiffs’ timely notice of appeal from the District Court’s judgment. The
`
`District Court had diversity jurisdiction under 28 U.S.C. § 1332 because
`
`Plaintiffs voluntarily dismissed the sole non-diverse party before
`
`3
`
`
`
`Case 20-1383, Document 62, 10/23/2020, 2959449, Page15 of 60
`
`judgment and each Plaintiff’s claims place at least $75,000 in
`
`controversy. A12; A13.1
`
`STATEMENT OF ISSUES
`
`1.
`
`If a plaintiff challenges an FDA-mandated warning as
`
`inadequate under state law, are allegations of subsequent adverse event
`
`reports of the alleged injury, without more, “newly acquired information”
`
`sufficient to overcome federal preemption?
`
`2.
`
`Are personal injury claims time-barred under New York law
`
`where they arose more than three years before filing and the plaintiff
`
`does not plead a factual basis to invoke CPLR 214-c(4) or fraudulent
`
`concealment?
`
`STATEMENT OF THE CASE
`
`The 2012 Lipitor Label Change
`A.
`Lipitor is a branded form of atorvastatin calcium—a member of the
`
`statin class of mediations—approved by the FDA as safe and effective for
`
`the prevention of cardiovascular disease and treatment of hyperlipidemia
`
`(high cholesterol) in both men and women. The FDA has never found a
`
`1 This brief cites the Appendix as “A__” and the Special Appendix as
`“SA__.”
`
`4
`
`
`
`Case 20-1383, Document 62, 10/23/2020, 2959449, Page16 of 60
`
`causal association between Lipitor and type 2 diabetes. The FDA-
`
`approved label has, however, listed hyperglycemia—i.e., elevated blood
`
`sugar—as an adverse event reported in the metabolic and nutritional
`
`systems. A204.2 As of 2009, the Lipitor label stated that, in one clinical
`
`trial, “[d]iabetes was reported as an adverse reaction in 144 subjects
`
`(6.1%) in the [80mg] atorvastatin group and 89 subjects (3.8%) in the
`
`placebo group.” See A231.
`
`In February 2012, the FDA completed a comprehensive safety
`
`review of statins that resulted in a labeling change for Lipitor and several
`
`other statins. While the FDA’s review focused on the risk of diabetes,
`
`A266–67, the FDA did not find that Lipitor—or any other statin—causes
`
`diabetes. Nor did it require a warning to that effect. Instead, the FDA
`
`updated the “Warnings and Precautions” section of the label to state that
`
`“[i]ncreases in HbA1c and fasting serum glucose levels”—that is, blood
`
`The Court may take judicial notice of this FDA regulatory record,
`2
`including Pfizer’s submissions, the FDA’s public announcements, and the
`FDA-approved labeling, which are cited in Plaintiffs’ Complaint and
`readily available as public records. A36; AstraZeneca Pharm. LP v.
`Apotex Corp., 669 F.3d 1370, 1378 n.5 (Fed. Cir. 2012); see also, e.g.,
`Trisvan v. Heyman, 305 F. Supp. 3d 381, 400 (E.D.N.Y. 2018) (collecting
`cases taking judicial notice of FDA-approved labeling).
`
`5
`
`
`
`Case 20-1383, Document 62, 10/23/2020, 2959449, Page17 of 60
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`sugar levels—“have been reported with [statins], including” Lipitor.
`
`A267. And despite this change, the FDA emphasized in a press release
`
`that it “continues to believe that the cardiovascular benefits of statins
`
`outweigh these small increased risks.” See A85.
`
`The FDA Medical Review explaining the basis for the label change
`
`cited a study showing an “increase in investigator-reported diabetes
`
`mellitus” in patients treated with another statin. A266. The FDA’s
`
`Review also discussed the purported “effect of statins on incident
`
`diabetes, and increases in HbA1c and/or fasting plasma glucose” and
`
`reviewed medical literature relating to statins and diabetes. A267. In
`
`January 2014, nearly two years after the label change, the FDA again
`
`noted that some statin trials had “reported” diabetes, but it made no
`
`further labeling changes. See A86.
`
`The 2013-2018 Federal Lipitor Litigation
`B.
`In the years following that label change, some 6,000 individuals,
`
`overwhelmingly women, filed lawsuits against Pfizer alleging they
`
`developed type 2 diabetes from Lipitor. See, e.g., In re Lipitor
`
`(Atorvastatin Calcium) Mktg., Sales Practices & Prods. Liab. Litig. (No
`
`II) MDL 2502, 892 F.3d 624, 629 (4th Cir. 2018); In re Lipitor, JCCP 4761
`
`6
`
`
`
`Case 20-1383, Document 62, 10/23/2020, 2959449, Page18 of 60
`
`(Cal. Super. Ct.). Pfizer had to report the legal cases as “adverse event
`
`reports” to the FDA, “whether or not considered drug related.” 21 C.F.R.
`
`§ 314.80(a).
`
`The Lipitor diabetes litigation coalesced in a federal multi-district
`
`litigation (MDL) assigned to Judge Richard M. Gergel in the United
`
`States District Court for the District of South Carolina. In the end, that
`
`entire MDL, embracing more than 3,000 claims, was dismissed on the
`
`merits. In 2016, Judge Gergel held there was no admissible expert
`
`evidence that Lipitor could cause diabetes at three of its four available
`
`doses and no evidence that Lipitor caused any particular plaintiff to
`
`develop diabetes. See In reLipitor (Atorvastatin Calcium) Mktg., Sales
`
`Practices & Prods. Liab. Litig., 227 F. Supp. 3d 452, 491 (D.S.C. 2017);
`
`In re Lipitor, 226 F. Supp. 3d 557, 584 (D.S.C. 2017); In re Lipitor, 185 F.
`
`Supp. 3d 761, 770–71 (D.S.C. 2016). Then, in 2017, Judge Gergel granted
`
`summary judgment for Pfizer across the whole MDL case inventory due
`
`to lack of evidence of causation. See In re Lipitor, 227 F. Supp. 3d 452,
`
`491 (D.S.C. 2017); In re Lipitor, 226 F. Supp. 3d 557, 584 (D.S.C. 2017).
`
`And in 2018, the Fourth Circuit unanimously affirmed the MDL court’s
`
`7
`
`
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`Case 20-1383, Document 62, 10/23/2020, 2959449, Page19 of 60
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`rulings in their entirety. See In re Lipitor, 892 F.3d 624, 648 (4th Cir.
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`2018).
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`The 2019 Gayle Complaint
`C.
`Plaintiffs filed their Complaint in April 2019—more than seven
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`years after the 2012 Lipitor label change, more than two years after the
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`Lipitor MDL was dismissed and closed, and nearly a year after the
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`Fourth Circuit affirmed. A27. Their claims alleging type 2 diabetes from
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`Lipitor were virtually identical to those in the MDL. A29–48. Their
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`Complaint, filed in New York state court, named twenty-five individuals
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`from six states, all but one of whom was a non-New York resident and
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`diverse from Pfizer. A29–34. Pfizer removed to the Southern District of
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`New York and filed an answer, and the case was assigned to Hon.
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`William Pauley. A7. To ensure federal jurisdiction, Plaintiffs agreed to
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`dismiss the one non-diverse plaintiff. A12; Caterpillar Inc. v. Lewis, 519
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`U.S. 61 (1996); LeBlanc v. Cleveland, 248 F.3d 95 (2d Cir. 2001).3
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`Plaintiffs’ Complaint did not allege the dates on which any of them
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`took Lipitor or were told they had diabetes. Pfizer moved for judgment
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`3 The one non-diverse Plaintiff, Michelle O’Bremski, was dismissed by
`stipulation before entry of judgment. A12.
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`8
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`Case 20-1383, Document 62, 10/23/2020, 2959449, Page20 of 60
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`on the pleadings because, no matter when Plaintiffs’ claims accrued, they
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`were all necessarily barred. A76–100. First, all claims that accrued after
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`the February 2012 label change were preempted because Plaintiffs had
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`not pled any “newly acquired information” not disclosed to the FDA that
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`would have permitted Pfizer to make another label change. A76–92.
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`Second, all claims that accrued before April 2016 were barred by the
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`statute of limitations. A93–96.
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`In opposition to Pfizer’s motion to dismiss, Plaintiffs asked for leave
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`to amend, attaching a Proposed Amended Complaint they sought to file.
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`A105; A116–42. The Proposed Amended Complaint tried to plead “newly
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`acquired information” by alleging that, in the three years following the
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`label change—the same time in which thousands of lawsuits were filed—
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`Pfizer “submitted more than 6,000 adverse event reports to the FDA
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`identifying Diabetes as being an unexpected event for Lipitor.” A129. As
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`to the statute-of-limitations, Plaintiffs simply asserted, without
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`explanation, that Pfizer’s Motion “will need to be revised” due to
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`unidentified new allegations in the Proposed Amended Complaint. A112.
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`9
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`Case 20-1383, Document 62, 10/23/2020, 2959449, Page21 of 60
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`The 2020 Dismissal
`D.
`At Judge Pauley’s request, Pfizer filed the FDA’s Medical Review
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`that addressed the risk of diabetes in connection with the 2012 label
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`change. A186; A248–79. Judge Pauley then issued a decision granting
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`Pfizer’s “clearly meritorious motion,” SA13, holding that neither the
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`Proposed Amended Complaint nor “[any] amount of discovery” could
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`“cure the deficiencies in Plaintiffs’ claims.” SA3.
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`The District Court ruled that Plaintiffs’ post-2012 claims were
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`preempted. To survive preemption, a products liability claim challenging
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`the warning for a branded prescription medication must show that the
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`manufacturer could have invoked the FDA’s “Changes Being Effected”
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`(CBE) process to independently change the label. SA5–6. Applying this
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`Court’s decision in Gibbons, the District Court held that, at a minimum,
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`a CBE label change requires allegations of “newly acquired information,”
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`a regulatory term of art. SA8 (quoting Gibbons, 919 F.3d at 708). The
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`District Court held that the adverse event reports cited by Plaintiffs “do
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`not constitute ‘newly acquired information.’” SA10. As a result,
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`Plaintiffs’ post-2012 claims “fail[ed] at the first step,” just as in Gibbons.
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`SA9.
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`10
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`Case 20-1383, Document 62, 10/23/2020, 2959449, Page22 of 60
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`Judge Pauley also held that while Plaintiffs had not alleged when
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`they developed diabetes, “to the extent th[eir] claims accrued before April
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`2016, they are untimely” under New York’s three-year limitations period.
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`SA12. He concluded that because “there is no possible overlap here
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`where a claim could be timely and not federally preempted, Plaintiffs
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`cannot state an actionable claim.” SA13.
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`Finally, the District Court denied leave to amend because the
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`Proposed Amended Complaint “fail[ed] to cure the deficiencies Pfizer
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`notes in its motion.” SA14. That proposed amended pleading relied on
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`adverse event reports that “do[] not enable Plaintiffs to circumvent
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`preemption,” did not identify “when Plaintiffs’ claims accrued,” and
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`“fail[ed] to demonstrate how Plaintiffs’ claims could be timely.” SA14.
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`SUMMARY OF ARGUMENT
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`To decide this appeal, the Court need determine only whether the
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`Proposed Amended Complaint pled a plausible factual basis: (1) for post-
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`2012 claims to survive preemption; and (2) for pre-2016 claims to survive
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`the statute of limitations. The answer on both points is no.
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`Plaintiffs’ post-2012 claims are preempted because the adverse
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`event reports they alleged, without more, cannot constitute “newly
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`11
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`Case 20-1383, Document 62, 10/23/2020, 2959449, Page23 of 60
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`acquired information.” The federal labeling scheme for prescription
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`drugs makes “newly acquired
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`information” the bare minimum
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`requirement for a manufacturer to change a drug label without first
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`obtaining FDA approval. It must be information not previously
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`submitted to the FDA that shows a different type or degree of risk than
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`previously considered, so that a new warning would be warranted.
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`Spontaneous, anecdotal adverse event reports—especially
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`those
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`submitted in connection with a new, nationwide tort litigation—do not,
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`standing alone, meet those criteria. They do not show a different degree
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`or type of risk, and without any analysis, they cannot show causation.
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`And because a plaintiff can always allege an adverse event report—i.e.,
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`her own—allowing adverse event reports to meet the standard would
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`render it meaningless. The District Court’s ruling dismissing post-2012
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`claims as preempted should be affirmed.
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`Likewise, Plaintiffs’ pre-2016 claims are untimely under the New
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`York statute of limitations, which require