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FILED: NEW YORK COUNTY CLERK 12/15/2017 02:49 PM INDEX NO. 158161/2017
NYSCEF DOC. NO. 11 RECEIVED NYSCEF: 12/15/2017
STATE OF NEW YORK
SUPREME COURT COUNTY OF NEW YORK
PLAINTIFFS'
ESTHER PAONESSA OPPOSITION TO
DEFENDANTS BRISTOL-MYERS
Plaintiffs, SQUIBB COMPANY, PFIZER,
INC.'S MOTION TO DISMISS
v.
INDEX NO. 158161/2017
BRISTOL-MYERS SQUIBB CO. and
PFIZER, INC.,
Defendants.
DEFENDANTS'
PLAINTIFF'S MEMORANDUM OF LAW IN OPPOSITION TO
MOTION TO DISMISS
1
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TABLEOFCONTENTS
I. ~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~ 1
INTRODUCTION.....................................................................................................................
II. SUMMARY OF ALLEGED 2
FACTS.......................................................................................
.......................................................................................
DEFENDANTS'
III. MISAPPLY THE STANDARD FOR A DEMURRER............................... 4
IV. THE ADEQUACY OF THE WARNING LABEL IS NOT AN APPROPRIATE
DETERMINATION AT THE PRE-DISCOVERY PHASE...................................................
7
PLAINTIFFS'
V. THE ALLEGATIONS IN COMPLAINT DO NOT TRIGGER
PREEMPTION BECAUSE FEDERAL REGULATIONS ALLOW DEFENDANTS TO
COMPLY WITH STATE AND FEDERAL LAW SIMULTANEOUSLY 12
.........................
A. There isa Presumption against Preemption, Especially in These Kinds of Cases. .............
13
Plaintiffs'
B. Plaintiffs Failure to Warn Claims are not Conflict Preempted. 14
.........................................
i. Background on Wyeth v. Levine Preemption.................................14
ii. These claims are not Preempted Under Wyeth v. Levine. ..............15
iii. The clear evidence standard of Wyeth v. Levine is fact-
necessarily
specific. 1
..........................................................................................15
155
iv. The clear evidence precedent distinguishes between cases in which
the FDA carefully considered all relevant information and those
where itdid not...............................................................................16
v. Preemption under Wyeth v. Levine is fact based and therefore
premature........................................................................................18
Plaintiffs'
C. Plaintiff's
Plaintiffs Design Defect Claims are not Preempted...........................................................
19
VI. PLAINTIFFS HAVE PLED A VIABLE DESIGN DEFECT CLAIM 22
................................
VII. EACH CAUSE OF ACTION IS ADEQUATELY PLED AND PRESENT A FACT
QUESTION FOR THE JURY 24
..............................................................................................
Plaintiffs'
A. Fraud Claims are Properly 24
Pled..........................................................................
Plaintiffs'
B. Warranty Claims are Properly Plead ..................................................................
26
C. Plaintiffs Punitive Damages is Properly Pled. ....................................................................
28
CONCLUSION.............................................................................................................................
~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~ 29
..
11
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TABLE OF AUTHORITIES
Cases
Aikens Construction of Rome, Inc. v. Simons, 284 A.D.2d 946 (4th Dept. 2001) ..........................
8
Allen v. Takeda Pharm. N. Am., Inc. (In re Actos® (Pioglitazone) Prods. Liab. Litig.), No. MDL
No. 6:1 l-md-2299, 2014 U.S. Dist. LEXIS 121648 (W.D. La. Aug. 28, 2014) ..............
23
Ambers v. C.T. Industries, Inc., 161 AD2d 256, 554 N.Y.S.2d 903 32
...............................................
Amos v. Biogen IDEC Inc., 249 F. Supp. 3d 690 (W.D.N.Y. 14
2017).............................................
4'"
Apollo Capital Fund I I.C v. Roth Capital Partners, LLC, 158 Cal. App. 226 (2007)............12
Bates v. Dow Agrosciences, LLC, 544 U.S. 431 (2005) ...............................................................
19
Batoh v. McNeil PPC, In-c ,167 F..Supp. 3d 296 (D. Conn. 2016)..............................................
28
Browning v. 8'yeth, Inc., 831 N.Y.S.2d 804 (App. Div. 2007) ....................................................
13
Bukowski v. CooperVision, Inc., 185 A.D.2d 31, 35, 592 N.Y.S.2d 807 (3d Dept. 1993) 14
..........
(7'"
Camasta v. Jos. A. Bank Clothiers, Inc., 761 F.3d 732 Cir. 31
2014)...........................................
Compare Sholom & Zuckerbrot Realty Corp. v. Coldwell Banker Commercial Grp., Inc ,138.
Misc. 2d 799, 801, 525 N.Y.S.2d 541 (Sup. Ct. 1988) .......................................................
8
Cristallina SA. v. Christie, Manson & 8'oods International, Inc ,502 N.Y..S.2d 165 (1st Dept,
I ' ~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~
DaPuzzo v. Reznick Fedder & Silverman, 788 N.Y.S.2d 69 (1stDept. 2005) ...............................
30
DaSilva v. American Tobacco Company, 667 N.Y.S.2d 653 (N.Y.Sup. 1997)..............................
33
DiBartolo v. Abbott Labarotories, 914 F. Supp. 2d 601 (S.D.N.Y. 2012) ...................................
16
Dobbs v. 8'yeth Pharms., 797 F. Supp. 2d 1264 (W.D. Ok. 2011) 22
..............................................
4'"
Donabedian v. Mercury Ins Co., 116 Cal..App. 968 (2004) .................................................
10
Dorsett v. Sandoz, 699 F. Supp. 2d 1142 (C.D. Cal. 2010) ..........................................................
23
Estate of Cassel v. AI ZA Corp., No. 12-cv-771-wmc, 2014 U.S. Dist. LEXIS 27924 (W.D. Wis.
M ar. 5, 2014)...............................................................................................................
26, 27
Fleming v. Janssen Pharmaceuticals, Inc., 186 F. Supp. 3d 826 (W.D. Tenn. 2016)..................
28
Foley v. D'Agostino, 248 N.Y.S.2d 121 (1st Dept. 1964) 32
..............................................................
Forst v. Smithkline Beecham, 639 F. Supp. 2d 948 (E.D. Wis. 2009)..........................................
23
111
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Forte v. Weiner, 200 A.D.2d 421, 422, 606 N.Y.S.2d 220 (App. Div. 1994)..............................
..............................
13
Fraser v. Wyeth, 992 F. Supp. 2d 68 (D. Conn. 2014).................................................................
.................................................................
26
Gainer v. Mylan Bertek Pharm., Inc., No. 09-690 (JNE/JSM), 2010 U.S. Dist. LEXIS 58966 (D.
Minn. June 15, 2010)........................................................................................................
........................................................................................................
10
Gonzalez v. John T. Mather Mem'l Hosp., 559 N.Y.S.2d 467 (Sup. Ct. 1990).............................
.............................
8
Guenther v. Novartis Pharm. Corp., No. 6:08-CV-456-ORL-31, 2013 U.S. Dist. LEXIS 123696,
2013 WL 4648449 (M.D. Fla. Aug. 29, 2013).................................................................
.................................................................
25
Guidry v. Janssen Pharms., Inc.,,206
206 .F.F.Supp. 3d 1187 (E.D. La. 2016).....................................
26
H & M Associates v. City of El Centro, 109 Cal. App. 3d 399 12
(1980).........................................
.........................................
(4th
Hawly v. Travelers Indmenity Co., 90 A.D.2d 684 Dept. 1982)..............................................
..............................................
8
Hillsborough County Florida v. Automated Medical Laboratories, Inc., 471 U.S. 707 (1985) ..18
Hornbeck v. Medtronic, Inc., No. 13 C 7816, 2014 U.S. Dist. LEXIS 75015, 2014 WL 2510817
(N.D.
.D. Ill.
June 2, 31
2014)......................................................................................................
......................................................................................................
Huffman v. Bristol-Myers Squibb, Civil Action No. 2:16-cv-03714-LMA-KWR, ECF Doc. 27
(E.D.L.A.
~ ~ ~ ~ 10/17/16)....................................................................................................
33
~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~ 11,
Hurtado v. Purdue Pharma Co., 800 N.Y.S.2d 347 (Sup. Ct. 14
2005)...........................................
...........................................
In re Accutane Prods. No. MDL 1626 - IBD 2012 U.S. Dist. LEXIS 114701 (M.D.
Liab., TRACK,
Fla. July 24, 2012) 14
............................................................................................................
In re Actos (Pioglitazone) Products Liability Litigation (Allen), No. 6:12-cv-00064-RFD-PJH,
2014 WL 4364832 (W.D. La. 2014).................................................................................
23
In re Avandia Mktg., Sales Practices and Prods. Liab. Litig., 817 F. Supp. 2d 535 (E.D. Pa. 2011)
...........................................................................................................................................
16
(1st
In re Celexa & Lexapro, 779 F.3d 34 Cir. 24
2015)........................................................
20, 21,
In re Lipitor (Atorvastatin Calcium) Mktg., Sales Practices & Prods. Liab. Litig., 185 F. Supp. 3d
761 (D.S.C.
~ ~ 24
~ 2016).......................................................................................................
~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~ 21,
In re Testosterone Replacement Therapy Prods. Liab. Litig. Coordinated Pretrial Proceedings, No.
14 C 1748, 2014 U.S. Dist. LEXIS 176877 (N.D. Ill.Dec. 23, 31
2014)...............................
...............................
In re Tylenol (Acetaminophen) Mktg., No. 2436, 2015 U.S. Dist. LEXIS 153972, 2015 WL
7075949 (E.D. Pa. Nov. 13, 2015)....................................................................................
26
In re Xarelto (Rivaroxaban) Prods. Liab. Litig., No. 2592, 2017 U.S. Dist. LEXIS 58056 (E.D.
La. Apr. 17, 2017).............................................................................................................
17
In re Zofran (Ondansetron) Prods. Liab. Litig., No. MDL .No.No. 1:15-md-2657-FDS, 2016 U.S. Dist.
LEXIS 7638 (D. Mass. Jan. 22, 22
2016)..............................................................................
..............................................................................
.
1V
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Jackson v. Deft, Inc., 223 Cal. App. 3d 1305 11
(1990)....................................................................
Johnson v. Spence, 286 A.D.2d 481 (2d Dept. 2001).....................................................................
.....................................................................
8
Kandt v. Taser Int'l, Inc., No. 5:09-CV-0507 (NPM-ATB), 2012 U.S. Dist. LEXIS 96024
(N.D.N.Y.
.D.N.Y.
~ ~ ~ ~ July 10, ) 2012)..................................................................................................
~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~ 13
Koho v. Forest Labs., Inc.,,1717 .F.F.
Supp. 3d 1109 (W.D. Wash. 2014)....................................
....................................
22, 23
4th
Korean Am. Legal Advocacy Found. v. City of L.A., 23 Cal. App. 4 376 12
(1994).......................
Lane v. Mercury Record Corp., 252 N.Y.S.2d 1011 (1st Dept. 32
1964)...........................................
...........................................
v. Martinez, 84 N.Y.2d 83 (1994)........................................................................................
........................................................................................
10
Lindsay v. Ortho Pharm. Corp., 637 F.2d 87 (2d Cir. 1980) .......................................................
29
Macaluso, No. 2:16-cv-03673-LMA-KWR, ECF Doc. 26 (E.D.L.A. 10/18/16)...................
...................
11, 33
Martin v. Hacker, 83 N.Y.2d 1 (1993) .......................................................................
13, 15, 29, 30
(7th
Mason
CYCCQVll v. Smithkline
A3lltll)WSVttBeecham
DC Cl llLCllC
Corp., 596
J7V F.3d
l'»JV 387 I
JO (7
( I M»
Cir. 2010).............................................
.............................................
4
23J
3rd
Matter of Amoah v. Mallah Mgmt., LLC, 866 N.Y.S.2d 797 (App. Div. Dept. 2008)............
............
19
McDonnell v. Chelsea Mfrs., Inc.,,259
259 A.D.2d 674 (App. Div. 14
1999).........................................
.........................................
McDonnell v. Chelsea Mfrs., Inc.,,687
687 N.Y.S.2d 172 14
(1999).......................................................
McDowell v. Eli Lilly & Co., 58 F. Supp. 3d 391 (S.D.N.Y. 2014) 14
.............................................
Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996) ..............................................................................
19
Miglino v. Bally Total Fitness of Greater N.Y., Inc., 985 N.E.2d 128 (2013)..............................
..............................
15
Morris v. Taro Pharm. Indus., Ltd, etal, No. 11 CV 0470, 2012 U.S. Dist. LEXIS 39614 (S.D.N.Y.
20, 2012)...................................................................................................................
10
Murray v. New York, 372 N.E.2d 560 (1977)...............................................................................
...............................................................................
10
Mutual Pharm. Co. v. Bartlett, 133 S.Ct 2466 passim
(2013)...........................................................
...........................................................
v. Mensing, 131 S. Ct. 2567 (2011).....................................................................................
.....................................................................................
26
Raquel v. Abbot Inc. (In re Depakote No. 15-CV-702-NJR-
Labs., E.R.G.), 12-cv-55-NJR-SCW;
SCW, 2017 U.S. Dist. Lexis 112329 (S.D. Ill.July 19. 2017)...................................
...................................
16, 17
Rovello v Orofino Realty Co., 357 NE2d 970, 389 NYS2d 314 (1975).......................................
.......................................
15
Sabatino v. Pfizer Inc., 2005 NY Slip Op 30587(U)..............................................................
..............................................................
10, 13
Samuels v. Am. Cyanamid Co., 495 N.Y.S.2d 1006 (Sup. Ct. 1985) .....................................
19, 29
Sciortino v. Pepsi Co, Inc
Inc.,,108
108 F. Supp. .3d
3d 780, 791 n.2 (N.D. Cal. 2015) .................................
15
V
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Searle v. Suburban Propane Div. of Quantum Chem. Corp ,.263 A.D.2d 335 (App. Div. 2000) 29
Segovia v. Bristol M-yers Squibb Company and Pfizer, Inc., No. 15-00519 DKW-RLP, 2016 U.S.
Dist. LEXIS 52405 (D. Haw. Apr. 19, 2016) 11
...................................................................
Smith v. Boehringer Ingelheim Pharms., Inc., 886 F. Supp. 2d 911 (S.D. Ill. 2012) .............
17, 31
Smith v. Johnson & Johnson Co., 800 N.Y.S.2d 357 (Sup. Ct. 2004) .........................................
13
(5'"
Stahl v. Novartis Pharm. Corp. 283 F.3d 254 Cir. 2002).......................................................
17
(9'"
Stengel v. Medtronic, Inc., 704 F.3d 1224 Cir. 2013) ............................................................
19
Sullivan v. Aventis, Inc., No. 14-cv-2939-NSR, 2015 U.S. Dist. LEXIS 107360 (S.D.N.Y. Aug.
I ' ~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~
Thomas v. Leary, 15 AD2d 438, 225 N.Y.S.2d 137 32
......................................................................
Trahan v. Sandoz, Inc ,No. .3:13-CV-350-J-34MCR, 2015 U.S. Dist. LEXIS 66869, 2015 WL
2365502 (M.D. Fla. Mal. 26, 2015)..................................................................................
26
Varveris v. Orthopedic & Sports Assocs. of Long Island, 2011 NY Slip Op 32761(U) ..10, 13, 32
4'"
Wash. Mut. Bank v. Superior Court, 95 Cal. App. 606 12
(2002)................................................
Werner, Zaroff, Slotnick, Stern & Askenazy v. Lewis, 588 N.Y.S.2d 960 (Civ. Ct. 1992)...........35
(6'"
8'imbush v. Wyeth, 619 F.3d 632 Cir. 2010)..........................................................................
28
Wolfgruber v Upjohn Co., 72 AD2d 59 [1979] ......................................................................
29, 30
Wyeth, 555 U.S. 555 (2009) passim
..................................................................................................
(6'"
Yates v. Ortho Mcneil Jans-sen Pha-rms., Inc., 808 F.3d 281 Cir. 2015) .........................
27, 28
Yugler v. Pharmacia & Upj ohn Co., 2001 N.Y. Misc. LEXIS 1356 (Sup. Ct. Apr. 26, 2001)... 13,
19
~Re ulations
2
21 C.F.R. 7AAc(6 ..........................................................................................................
10
$ 314.700(6)(iii)
73 Fed. Reg. 49607 .......................................................................................................................
19
V1
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L INTRODUCTION
This lawsuit stems from Plaintiff's ingestion of Eliquis (apixaban) and the resulting
physical injuries from its use. Under New York law, Plaintiffs do not have to plead their causes
of action with particularity. New York law also establishes that Defendants cannot escape liability
Plaintiffs'
based on FDA-approved labeling nor does FDA bar Plaintiffs causes of action. Finally, New
York law establishes that the Plaintiffs have stated causes of action for strictliability, negligence,
breach of warranties, fraud, and for punitive damages.
Defendants'
Ultimately, ifthis Court decides in Defendants favor, drug companies would have free
rein so long as the FDA has approved the drug. Fortunately, a majority of courts reject this
position. The rulings by Judge Denise L. Cote in the Eliquis Multidistrict Litigation is not binding
precedent and should not be followed here. Plaintiffs strongly disagree with Judge Cote's decision.
First, Judge Cote decided fact-based questions regarding the adequacy of the warnings. Second,
she adjudicated facts to find impossibility preemption, which is another fact-intensive inquiry that
mandates a complete review of regulatory history which had not yet occurred in the Eliquis MDL.
Defendants'
Third, impossibility preemption is an affirmative defense that is burden to plead and
Plaintiffs'
prove and not to plead around. Fourth, Judge Cote improperly extended MutualPharm.
(2013),1
Co. v. Bartlett, 133 S.Ct 2466 (2013), a decision involving a generic drug, to this brand-name
Eliquis product. But Bartlett did not overturn the Supreme Court's holding in Wyeth, 555 U.S.
555, 574 (2009) which found no preemption for brand-name drugs period. In Wyeth, the High
Court observed that Congress declined to preempt state tort law at the time the FDCA was enacted,
and has continued to decline to preempt state tort law at any time since the its enactment. Id.
"[Congress'] silence on the issue, coupled with itscertain awareness of the prevalence of state tort
1 preemption of
Bartlettgranted generic drug manufacturers impossibility because a certain set of federal statutes
known as the Hatch-Waxman amendments, which allow a generic manufacturer to get a pharmaceutical product to
market more quickly. Specifically,under the Hatch-Waxman amendments, the generic manufacturer need only prove
thattheir generic drug is biologicallyidentical tothe brand name's drug, and thatthe warning label isconcurrently
identical.Thus, rather than submitting to the onerous, expensive, and lengthy process of the FDA's New Drug
Application ("NDA"), a generic manufacturer can geta drug on the market within a year or two by showing the FDA
that (1)its warning labelis identicalto that of the brand name manufacturer, and (2) thatthe product's design is
identicalto thatof thebrand name product. Inthe instantlitigation,no generic version of Eliquisis on themarket.
I
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litigation, is powerful evidence that Congress did not intend FDA oversight to be the exclusive
effectiveness."
means of ensuring drug s
Preview
FILED: NEW YORK COUNTY CLERK 12/15/2017 02:49 PM INDEX NO. 158161/2017 NYSCEF DOC. NO. 11 RECEIVED NYSCEF: 12/15/2017 STATE OF NEW YORK SUPREME COURT COUNTY OF NEW YORK PLAINTIFFS' ESTHER PAONESSA OPPOSITION TO DEFENDANTS BRISTOL-MYERS Plaintiffs, SQUIBB COMPANY, PFIZER, INC.'S MOTION TO DISMISS v. INDEX NO. 158161/2017 BRISTOL-MYERS SQUIBB CO. and PFIZER, INC., Defendants. DEFENDANTS' PLAINTIFF'S MEMORANDUM OF LAW IN OPPOSITION TO MOTION TO DISMISS 1 1 of 36 FILED: NEW YORK COUNTY CLERK 12/15/2017 02:49 PM INDEX NO. 158161/2017 NYSCEF DOC. NO. 11 RECEIVED NYSCEF: 12/15/2017 TABLEOFCONTENTS I. ~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~ 1 INTRODUCTION..................................................................................................................... II. SUMMARY OF ALLEGED 2 FACTS....................................................................................... ....................................................................................... DEFENDANTS' III. MISAPPLY THE STANDARD FOR A DEMURRER............................... 4 IV. THE ADEQUACY OF THE WARNING LABEL IS NOT AN APPROPRIATE DETERMINATION AT THE PRE-DISCOVERY PHASE................................................... 7 PLAINTIFFS' V. THE ALLEGATIONS IN COMPLAINT DO NOT TRIGGER PREEMPTION BECAUSE FEDERAL REGULATIONS ALLOW DEFENDANTS TO COMPLY WITH STATE AND FEDERAL LAW SIMULTANEOUSLY 12 ......................... A. There isa Presumption against Preemption, Especially in These Kinds of Cases. ............. 13 Plaintiffs' B. Plaintiffs Failure to Warn Claims are not Conflict Preempted. 14 ......................................... i. Background on Wyeth v. Levine Preemption.................................14 ii. These claims are not Preempted Under Wyeth v. Levine. ..............15 iii. The clear evidence standard of Wyeth v. Levine is fact- necessarily specific. 1 ..........................................................................................15 155 iv. The clear evidence precedent distinguishes between cases in which the FDA carefully considered all relevant information and those where itdid not...............................................................................16 v. Preemption under Wyeth v. Levine is fact based and therefore premature........................................................................................18 Plaintiffs' C. Plaintiff's Plaintiffs Design Defect Claims are not Preempted........................................................... 19 VI. PLAINTIFFS HAVE PLED A VIABLE DESIGN DEFECT CLAIM 22 ................................ VII. EACH CAUSE OF ACTION IS ADEQUATELY PLED AND PRESENT A FACT QUESTION FOR THE JURY 24 .............................................................................................. Plaintiffs' A. Fraud Claims are Properly 24 Pled.......................................................................... Plaintiffs' B. Warranty Claims are Properly Plead .................................................................. 26 C. Plaintiffs Punitive Damages is Properly Pled. .................................................................... 28 CONCLUSION............................................................................................................................. ~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~ 29 .. 11 2 of 36 FILED: NEW YORK COUNTY CLERK 12/15/2017 02:49 PM INDEX NO. 158161/2017 NYSCEF DOC. NO. 11 RECEIVED NYSCEF: 12/15/2017 TABLE OF AUTHORITIES Cases Aikens Construction of Rome, Inc. v. Simons, 284 A.D.2d 946 (4th Dept. 2001) .......................... 8 Allen v. Takeda Pharm. N. Am., Inc. (In re Actos® (Pioglitazone) Prods. Liab. Litig.), No. MDL No. 6:1 l-md-2299, 2014 U.S. Dist. LEXIS 121648 (W.D. La. Aug. 28, 2014) .............. 23 Ambers v. C.T. Industries, Inc., 161 AD2d 256, 554 N.Y.S.2d 903 32 ............................................... Amos v. Biogen IDEC Inc., 249 F. Supp. 3d 690 (W.D.N.Y. 14 2017)............................................. 4'" Apollo Capital Fund I I.C v. Roth Capital Partners, LLC, 158 Cal. App. 226 (2007)............12 Bates v. Dow Agrosciences, LLC, 544 U.S. 431 (2005) ............................................................... 19 Batoh v. McNeil PPC, In-c ,167 F..Supp. 3d 296 (D. Conn. 2016).............................................. 28 Browning v. 8'yeth, Inc., 831 N.Y.S.2d 804 (App. Div. 2007) .................................................... 13 Bukowski v. CooperVision, Inc., 185 A.D.2d 31, 35, 592 N.Y.S.2d 807 (3d Dept. 1993) 14 .......... (7'" Camasta v. Jos. A. Bank Clothiers, Inc., 761 F.3d 732 Cir. 31 2014)........................................... Compare Sholom & Zuckerbrot Realty Corp. v. Coldwell Banker Commercial Grp., Inc ,138. Misc. 2d 799, 801, 525 N.Y.S.2d 541 (Sup. Ct. 1988) ....................................................... 8 Cristallina SA. v. Christie, Manson & 8'oods International, Inc ,502 N.Y..S.2d 165 (1st Dept, I ' ~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~ DaPuzzo v. Reznick Fedder & Silverman, 788 N.Y.S.2d 69 (1stDept. 2005) ............................... 30 DaSilva v. American Tobacco Company, 667 N.Y.S.2d 653 (N.Y.Sup. 1997).............................. 33 DiBartolo v. Abbott Labarotories, 914 F. Supp. 2d 601 (S.D.N.Y. 2012) ................................... 16 Dobbs v. 8'yeth Pharms., 797 F. Supp. 2d 1264 (W.D. Ok. 2011) 22 .............................................. 4'" Donabedian v. Mercury Ins Co., 116 Cal..App. 968 (2004) ................................................. 10 Dorsett v. Sandoz, 699 F. Supp. 2d 1142 (C.D. Cal. 2010) .......................................................... 23 Estate of Cassel v. AI ZA Corp., No. 12-cv-771-wmc, 2014 U.S. Dist. LEXIS 27924 (W.D. Wis. M ar. 5, 2014)............................................................................................................... 26, 27 Fleming v. Janssen Pharmaceuticals, Inc., 186 F. Supp. 3d 826 (W.D. Tenn. 2016).................. 28 Foley v. D'Agostino, 248 N.Y.S.2d 121 (1st Dept. 1964) 32 .............................................................. Forst v. Smithkline Beecham, 639 F. Supp. 2d 948 (E.D. Wis. 2009).......................................... 23 111 3 of 36 FILED: NEW YORK COUNTY CLERK 12/15/2017 02:49 PM INDEX NO. 158161/2017 NYSCEF DOC. NO. 11 RECEIVED NYSCEF: 12/15/2017 Forte v. Weiner, 200 A.D.2d 421, 422, 606 N.Y.S.2d 220 (App. Div. 1994).............................. .............................. 13 Fraser v. Wyeth, 992 F. Supp. 2d 68 (D. Conn. 2014)................................................................. ................................................................. 26 Gainer v. Mylan Bertek Pharm., Inc., No. 09-690 (JNE/JSM), 2010 U.S. Dist. LEXIS 58966 (D. Minn. June 15, 2010)........................................................................................................ ........................................................................................................ 10 Gonzalez v. John T. Mather Mem'l Hosp., 559 N.Y.S.2d 467 (Sup. Ct. 1990)............................. ............................. 8 Guenther v. Novartis Pharm. Corp., No. 6:08-CV-456-ORL-31, 2013 U.S. Dist. LEXIS 123696, 2013 WL 4648449 (M.D. Fla. Aug. 29, 2013)................................................................. ................................................................. 25 Guidry v. Janssen Pharms., Inc.,,206 206 .F.F.Supp. 3d 1187 (E.D. La. 2016)..................................... 26 H & M Associates v. City of El Centro, 109 Cal. App. 3d 399 12 (1980)......................................... ......................................... (4th Hawly v. Travelers Indmenity Co., 90 A.D.2d 684 Dept. 1982).............................................. .............................................. 8 Hillsborough County Florida v. Automated Medical Laboratories, Inc., 471 U.S. 707 (1985) ..18 Hornbeck v. Medtronic, Inc., No. 13 C 7816, 2014 U.S. Dist. LEXIS 75015, 2014 WL 2510817 (N.D. .D. Ill. June 2, 31 2014)...................................................................................................... ...................................................................................................... Huffman v. Bristol-Myers Squibb, Civil Action No. 2:16-cv-03714-LMA-KWR, ECF Doc. 27 (E.D.L.A. ~ ~ ~ ~ 10/17/16).................................................................................................... 33 ~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~ 11, Hurtado v. Purdue Pharma Co., 800 N.Y.S.2d 347 (Sup. Ct. 14 2005)........................................... ........................................... In re Accutane Prods. No. MDL 1626 - IBD 2012 U.S. Dist. LEXIS 114701 (M.D. Liab., TRACK, Fla. July 24, 2012) 14 ............................................................................................................ In re Actos (Pioglitazone) Products Liability Litigation (Allen), No. 6:12-cv-00064-RFD-PJH, 2014 WL 4364832 (W.D. La. 2014)................................................................................. 23 In re Avandia Mktg., Sales Practices and Prods. Liab. Litig., 817 F. Supp. 2d 535 (E.D. Pa. 2011) ........................................................................................................................................... 16 (1st In re Celexa & Lexapro, 779 F.3d 34 Cir. 24 2015)........................................................ 20, 21, In re Lipitor (Atorvastatin Calcium) Mktg., Sales Practices & Prods. Liab. Litig., 185 F. Supp. 3d 761 (D.S.C. ~ ~ 24 ~ 2016)....................................................................................................... ~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~ 21, In re Testosterone Replacement Therapy Prods. Liab. Litig. Coordinated Pretrial Proceedings, No. 14 C 1748, 2014 U.S. Dist. LEXIS 176877 (N.D. Ill.Dec. 23, 31 2014)............................... ............................... In re Tylenol (Acetaminophen) Mktg., No. 2436, 2015 U.S. Dist. LEXIS 153972, 2015 WL 7075949 (E.D. Pa. Nov. 13, 2015).................................................................................... 26 In re Xarelto (Rivaroxaban) Prods. Liab. Litig., No. 2592, 2017 U.S. Dist. LEXIS 58056 (E.D. La. Apr. 17, 2017)............................................................................................................. 17 In re Zofran (Ondansetron) Prods. Liab. Litig., No. MDL .No.No. 1:15-md-2657-FDS, 2016 U.S. Dist. LEXIS 7638 (D. Mass. Jan. 22, 22 2016).............................................................................. .............................................................................. . 1V 4 of 36 FILED: NEW YORK COUNTY CLERK 12/15/2017 02:49 PM INDEX NO. 158161/2017 NYSCEF DOC. NO. 11 RECEIVED NYSCEF: 12/15/2017 Jackson v. Deft, Inc., 223 Cal. App. 3d 1305 11 (1990).................................................................... Johnson v. Spence, 286 A.D.2d 481 (2d Dept. 2001)..................................................................... ..................................................................... 8 Kandt v. Taser Int'l, Inc., No. 5:09-CV-0507 (NPM-ATB), 2012 U.S. Dist. LEXIS 96024 (N.D.N.Y. .D.N.Y. ~ ~ ~ ~ July 10, ) 2012).................................................................................................. ~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~ 13 Koho v. Forest Labs., Inc.,,1717 .F.F. Supp. 3d 1109 (W.D. Wash. 2014).................................... .................................... 22, 23 4th Korean Am. Legal Advocacy Found. v. City of L.A., 23 Cal. App. 4 376 12 (1994)....................... Lane v. Mercury Record Corp., 252 N.Y.S.2d 1011 (1st Dept. 32 1964)........................................... ........................................... v. Martinez, 84 N.Y.2d 83 (1994)........................................................................................ ........................................................................................ 10 Lindsay v. Ortho Pharm. Corp., 637 F.2d 87 (2d Cir. 1980) ....................................................... 29 Macaluso, No. 2:16-cv-03673-LMA-KWR, ECF Doc. 26 (E.D.L.A. 10/18/16)................... ................... 11, 33 Martin v. Hacker, 83 N.Y.2d 1 (1993) ....................................................................... 13, 15, 29, 30 (7th Mason CYCCQVll v. Smithkline A3lltll)WSVttBeecham DC Cl llLCllC Corp., 596 J7V F.3d l'»JV 387 I JO (7 ( I M» Cir. 2010)............................................. ............................................. 4 23J 3rd Matter of Amoah v. Mallah Mgmt., LLC, 866 N.Y.S.2d 797 (App. Div. Dept. 2008)............ ............ 19 McDonnell v. Chelsea Mfrs., Inc.,,259 259 A.D.2d 674 (App. Div. 14 1999)......................................... ......................................... McDonnell v. Chelsea Mfrs., Inc.,,687 687 N.Y.S.2d 172 14 (1999)....................................................... McDowell v. Eli Lilly & Co., 58 F. Supp. 3d 391 (S.D.N.Y. 2014) 14 ............................................. Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996) .............................................................................. 19 Miglino v. Bally Total Fitness of Greater N.Y., Inc., 985 N.E.2d 128 (2013).............................. .............................. 15 Morris v. Taro Pharm. Indus., Ltd, etal, No. 11 CV 0470, 2012 U.S. Dist. LEXIS 39614 (S.D.N.Y. 20, 2012)................................................................................................................... 10 Murray v. New York, 372 N.E.2d 560 (1977)............................................................................... ............................................................................... 10 Mutual Pharm. Co. v. Bartlett, 133 S.Ct 2466 passim (2013)........................................................... ........................................................... v. Mensing, 131 S. Ct. 2567 (2011)..................................................................................... ..................................................................................... 26 Raquel v. Abbot Inc. (In re Depakote No. 15-CV-702-NJR- Labs., E.R.G.), 12-cv-55-NJR-SCW; SCW, 2017 U.S. Dist. Lexis 112329 (S.D. Ill.July 19. 2017)................................... ................................... 16, 17 Rovello v Orofino Realty Co., 357 NE2d 970, 389 NYS2d 314 (1975)....................................... ....................................... 15 Sabatino v. Pfizer Inc., 2005 NY Slip Op 30587(U).............................................................. .............................................................. 10, 13 Samuels v. Am. Cyanamid Co., 495 N.Y.S.2d 1006 (Sup. Ct. 1985) ..................................... 19, 29 Sciortino v. Pepsi Co, Inc Inc.,,108 108 F. Supp. .3d 3d 780, 791 n.2 (N.D. Cal. 2015) ................................. 15 V 5 of 36 FILED: NEW YORK COUNTY CLERK 12/15/2017 02:49 PM INDEX NO. 158161/2017 NYSCEF DOC. NO. 11 RECEIVED NYSCEF: 12/15/2017 Searle v. Suburban Propane Div. of Quantum Chem. Corp ,.263 A.D.2d 335 (App. Div. 2000) 29 Segovia v. Bristol M-yers Squibb Company and Pfizer, Inc., No. 15-00519 DKW-RLP, 2016 U.S. Dist. LEXIS 52405 (D. Haw. Apr. 19, 2016) 11 ................................................................... Smith v. Boehringer Ingelheim Pharms., Inc., 886 F. Supp. 2d 911 (S.D. Ill. 2012) ............. 17, 31 Smith v. Johnson & Johnson Co., 800 N.Y.S.2d 357 (Sup. Ct. 2004) ......................................... 13 (5'" Stahl v. Novartis Pharm. Corp. 283 F.3d 254 Cir. 2002)....................................................... 17 (9'" Stengel v. Medtronic, Inc., 704 F.3d 1224 Cir. 2013) ............................................................ 19 Sullivan v. Aventis, Inc., No. 14-cv-2939-NSR, 2015 U.S. Dist. LEXIS 107360 (S.D.N.Y. Aug. I ' ~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~ Thomas v. Leary, 15 AD2d 438, 225 N.Y.S.2d 137 32 ...................................................................... Trahan v. Sandoz, Inc ,No. .3:13-CV-350-J-34MCR, 2015 U.S. Dist. LEXIS 66869, 2015 WL 2365502 (M.D. Fla. Mal. 26, 2015).................................................................................. 26 Varveris v. Orthopedic & Sports Assocs. of Long Island, 2011 NY Slip Op 32761(U) ..10, 13, 32 4'" Wash. Mut. Bank v. Superior Court, 95 Cal. App. 606 12 (2002)................................................ Werner, Zaroff, Slotnick, Stern & Askenazy v. Lewis, 588 N.Y.S.2d 960 (Civ. Ct. 1992)...........35 (6'" 8'imbush v. Wyeth, 619 F.3d 632 Cir. 2010).......................................................................... 28 Wolfgruber v Upjohn Co., 72 AD2d 59 [1979] ...................................................................... 29, 30 Wyeth, 555 U.S. 555 (2009) passim .................................................................................................. (6'" Yates v. Ortho Mcneil Jans-sen Pha-rms., Inc., 808 F.3d 281 Cir. 2015) ......................... 27, 28 Yugler v. Pharmacia & Upj ohn Co., 2001 N.Y. Misc. LEXIS 1356 (Sup. Ct. Apr. 26, 2001)... 13, 19 ~Re ulations 2 21 C.F.R. 7AAc(6 .......................................................................................................... 10 $ 314.700(6)(iii) 73 Fed. Reg. 49607 ....................................................................................................................... 19 V1 6 of 36 FILED: NEW YORK COUNTY CLERK 12/15/2017 02:49 PM INDEX NO. 158161/2017 NYSCEF DOC. NO. 11 RECEIVED NYSCEF: 12/15/2017 L INTRODUCTION This lawsuit stems from Plaintiff's ingestion of Eliquis (apixaban) and the resulting physical injuries from its use. Under New York law, Plaintiffs do not have to plead their causes of action with particularity. New York law also establishes that Defendants cannot escape liability Plaintiffs' based on FDA-approved labeling nor does FDA bar Plaintiffs causes of action. Finally, New York law establishes that the Plaintiffs have stated causes of action for strictliability, negligence, breach of warranties, fraud, and for punitive damages. Defendants' Ultimately, ifthis Court decides in Defendants favor, drug companies would have free rein so long as the FDA has approved the drug. Fortunately, a majority of courts reject this position. The rulings by Judge Denise L. Cote in the Eliquis Multidistrict Litigation is not binding precedent and should not be followed here. Plaintiffs strongly disagree with Judge Cote's decision. First, Judge Cote decided fact-based questions regarding the adequacy of the warnings. Second, she adjudicated facts to find impossibility preemption, which is another fact-intensive inquiry that mandates a complete review of regulatory history which had not yet occurred in the Eliquis MDL. Defendants' Third, impossibility preemption is an affirmative defense that is burden to plead and Plaintiffs' prove and not to plead around. Fourth, Judge Cote improperly extended MutualPharm. (2013),1 Co. v. Bartlett, 133 S.Ct 2466 (2013), a decision involving a generic drug, to this brand-name Eliquis product. But Bartlett did not overturn the Supreme Court's holding in Wyeth, 555 U.S. 555, 574 (2009) which found no preemption for brand-name drugs period. In Wyeth, the High Court observed that Congress declined to preempt state tort law at the time the FDCA was enacted, and has continued to decline to preempt state tort law at any time since the its enactment. Id. "[Congress'] silence on the issue, coupled with itscertain awareness of the prevalence of state tort 1 preemption of Bartlettgranted generic drug manufacturers impossibility because a certain set of federal statutes known as the Hatch-Waxman amendments, which allow a generic manufacturer to get a pharmaceutical product to market more quickly. Specifically,under the Hatch-Waxman amendments, the generic manufacturer need only prove thattheir generic drug is biologicallyidentical tothe brand name's drug, and thatthe warning label isconcurrently identical.Thus, rather than submitting to the onerous, expensive, and lengthy process of the FDA's New Drug Application ("NDA"), a generic manufacturer can geta drug on the market within a year or two by showing the FDA that (1)its warning labelis identicalto that of the brand name manufacturer, and (2) thatthe product's design is identicalto thatof thebrand name product. Inthe instantlitigation,no generic version of Eliquisis on themarket. I 7 of 36 FILED: NEW YORK COUNTY CLERK 12/15/2017 02:49 PM INDEX NO. 158161/2017 NYSCEF DOC. NO. 11 RECEIVED NYSCEF: 12/15/2017 litigation, is powerful evidence that Congress did not intend FDA oversight to be the exclusive effectiveness." means of ensuring drug s