throbber
Case 20-1383, Document 62, 10/23/2020, 2959449, Page1 of 60
`
`_________________________________________________
`
`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
`
`

`

`Case 20-1383, Document 62, 10/23/2020, 2959449, Page9 of 60
`
`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
`
`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
`
`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
`
`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
`
`

`

`Case 20-1383, Document 62, 10/23/2020, 2959449, Page19 of 60
`
`rulings in their entirety. See In re Lipitor, 892 F.3d 624, 648 (4th Cir.
`
`2018).
`
`The 2019 Gayle Complaint
`C.
`Plaintiffs filed their Complaint in April 2019—more than seven
`
`years after the 2012 Lipitor label change, more than two years after the
`
`Lipitor MDL was dismissed and closed, and nearly a year after the
`
`Fourth Circuit affirmed. A27. Their claims alleging type 2 diabetes from
`
`Lipitor were virtually identical to those in the MDL. A29–48. Their
`
`Complaint, filed in New York state court, named twenty-five individuals
`
`from six states, all but one of whom was a non-New York resident and
`
`diverse from Pfizer. A29–34. Pfizer removed to the Southern District of
`
`New York and filed an answer, and the case was assigned to Hon.
`
`William Pauley. A7. To ensure federal jurisdiction, Plaintiffs agreed to
`
`dismiss the one non-diverse plaintiff. A12; Caterpillar Inc. v. Lewis, 519
`
`U.S. 61 (1996); LeBlanc v. Cleveland, 248 F.3d 95 (2d Cir. 2001).3
`
`Plaintiffs’ Complaint did not allege the dates on which any of them
`
`took Lipitor or were told they had diabetes. Pfizer moved for judgment
`
`3 The one non-diverse Plaintiff, Michelle O’Bremski, was dismissed by
`stipulation before entry of judgment. A12.
`
`8
`
`

`

`Case 20-1383, Document 62, 10/23/2020, 2959449, Page20 of 60
`
`on the pleadings because, no matter when Plaintiffs’ claims accrued, they
`
`were all necessarily barred. A76–100. First, all claims that accrued after
`
`the February 2012 label change were preempted because Plaintiffs had
`
`not pled any “newly acquired information” not disclosed to the FDA that
`
`would have permitted Pfizer to make another label change. A76–92.
`
`Second, all claims that accrued before April 2016 were barred by the
`
`statute of limitations. A93–96.
`
`In opposition to Pfizer’s motion to dismiss, Plaintiffs asked for leave
`
`to amend, attaching a Proposed Amended Complaint they sought to file.
`
`A105; A116–42. The Proposed Amended Complaint tried to plead “newly
`
`acquired information” by alleging that, in the three years following the
`
`label change—the same time in which thousands of lawsuits were filed—
`
`Pfizer “submitted more than 6,000 adverse event reports to the FDA
`
`identifying Diabetes as being an unexpected event for Lipitor.” A129. As
`
`to the statute-of-limitations, Plaintiffs simply asserted, without
`
`explanation, that Pfizer’s Motion “will need to be revised” due to
`
`unidentified new allegations in the Proposed Amended Complaint. A112.
`
`9
`
`

`

`Case 20-1383, Document 62, 10/23/2020, 2959449, Page21 of 60
`
`The 2020 Dismissal
`D.
`At Judge Pauley’s request, Pfizer filed the FDA’s Medical Review
`
`that addressed the risk of diabetes in connection with the 2012 label
`
`change. A186; A248–79. Judge Pauley then issued a decision granting
`
`Pfizer’s “clearly meritorious motion,” SA13, holding that neither the
`
`Proposed Amended Complaint nor “[any] amount of discovery” could
`
`“cure the deficiencies in Plaintiffs’ claims.” SA3.
`
`The District Court ruled that Plaintiffs’ post-2012 claims were
`
`preempted. To survive preemption, a products liability claim challenging
`
`the warning for a branded prescription medication must show that the
`
`manufacturer could have invoked the FDA’s “Changes Being Effected”
`
`(CBE) process to independently change the label. SA5–6. Applying this
`
`Court’s decision in Gibbons, the District Court held that, at a minimum,
`
`a CBE label change requires allegations of “newly acquired information,”
`
`a regulatory term of art. SA8 (quoting Gibbons, 919 F.3d at 708). The
`
`District Court held that the adverse event reports cited by Plaintiffs “do
`
`not constitute ‘newly acquired information.’” SA10. As a result,
`
`Plaintiffs’ post-2012 claims “fail[ed] at the first step,” just as in Gibbons.
`
`SA9.
`
`10
`
`

`

`Case 20-1383, Document 62, 10/23/2020, 2959449, Page22 of 60
`
`Judge Pauley also held that while Plaintiffs had not alleged when
`
`they developed diabetes, “to the extent th[eir] claims accrued before April
`
`2016, they are untimely” under New York’s three-year limitations period.
`
`SA12. He concluded that because “there is no possible overlap here
`
`where a claim could be timely and not federally preempted, Plaintiffs
`
`cannot state an actionable claim.” SA13.
`
`Finally, the District Court denied leave to amend because the
`
`Proposed Amended Complaint “fail[ed] to cure the deficiencies Pfizer
`
`notes in its motion.” SA14. That proposed amended pleading relied on
`
`adverse event reports that “do[] not enable Plaintiffs to circumvent
`
`preemption,” did not identify “when Plaintiffs’ claims accrued,” and
`
`“fail[ed] to demonstrate how Plaintiffs’ claims could be timely.” SA14.
`
`SUMMARY OF ARGUMENT
`
`To decide this appeal, the Court need determine only whether the
`
`Proposed Amended Complaint pled a plausible factual basis: (1) for post-
`
`2012 claims to survive preemption; and (2) for pre-2016 claims to survive
`
`the statute of limitations. The answer on both points is no.
`
`Plaintiffs’ post-2012 claims are preempted because the adverse
`
`event reports they alleged, without more, cannot constitute “newly
`
`11
`
`

`

`Case 20-1383, Document 62, 10/23/2020, 2959449, Page23 of 60
`
`acquired information.” The federal labeling scheme for prescription
`
`drugs makes “newly acquired
`
`information” the bare minimum
`
`requirement for a manufacturer to change a drug label without first
`
`obtaining FDA approval. It must be information not previously
`
`submitted to the FDA that shows a different type or degree of risk than
`
`previously considered, so that a new warning would be warranted.
`
`Spontaneous, anecdotal adverse event reports—especially
`
`those
`
`submitted in connection with a new, nationwide tort litigation—do not,
`
`standing alone, meet those criteria. They do not show a different degree
`
`or type of risk, and without any analysis, they cannot show causation.
`
`And because a plaintiff can always allege an adverse event report—i.e.,
`
`her own—allowing adverse event reports to meet the standard would
`
`render it meaningless. The District Court’s ruling dismissing post-2012
`
`claims as preempted should be affirmed.
`
`Likewise, Plaintiffs’ pre-2016 claims are untimely under the New
`
`York statute of limitations, which require

This document is available on Docket Alarm but you must sign up to view it.


Or .

Accessing this document will incur an additional charge of $.

After purchase, you can access this document again without charge.

Accept $ Charge
throbber

Still Working On It

This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.

Give it another minute or two to complete, and then try the refresh button.

throbber

A few More Minutes ... Still Working

It can take up to 5 minutes for us to download a document if the court servers are running slowly.

Thank you for your continued patience.

This document could not be displayed.

We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.

Your account does not support viewing this document.

You need a Paid Account to view this document. Click here to change your account type.

Your account does not support viewing this document.

Set your membership status to view this document.

With a Docket Alarm membership, you'll get a whole lot more, including:

  • Up-to-date information for this case.
  • Email alerts whenever there is an update.
  • Full text search for other cases.
  • Get email alerts whenever a new case matches your search.

Become a Member

One Moment Please

The filing “” is large (MB) and is being downloaded.

Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.

Your document is on its way!

If you do not receive the document in five minutes, contact support at support@docketalarm.com.

Sealed Document

We are unable to display this document, it may be under a court ordered seal.

If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.


Access Government Site

We are redirecting you
to a mobile optimized page.





Document Unreadable or Corrupt

Refresh this Document
Go to the Docket

We are unable to display this document.

Refresh this Document
Go to the Docket