I Nre : Mirena Ius Levonorgestrel -Related Products Liability Litigation (n O . Ii)… v. Bayer Pharma Ag, Bayer O Y, Bayer Healthcare Pharmaceuticals Inc .

19-2155
In Re: Mirena IUS Levonorgestrel-Related Products Liability Litigation (No. II)
U NITED S TATES C OURT OF A PPEALS
F OR THE SECOND C IRCUIT
August Term 2020
(Argued: December 2, 2020 Decided: December 8,2020)
Docket No. 19-2155
I N RE : MIRENA IUS LEVONORGESTREL -R ELATED P RODUCTS LIABILITY
LITIGATION (N O . II)
ABRA CONING , K AYLA T ALLEY, T IFFANY H AUSNER, S HANE H AUSNER, S HELAIN
COOPER, ALLISON SIMPSON, AMELIA H OLMAN M ILES, J ONATHAN MILES,
J ESSICA G UGLIELMO , MEGAN R OBINSON , KIMBERLY BLACK , CHAQUITA D UDLEY ,
KELLY R IEGEL -G REEN, D ANISE H OFFMAN , J ACQUELINE G OYENA, J ANELLE
P ALLANSCH, B RITTANY G RECO , MISTY SOLOMON , DAPHNE H OUCK , H OLLY
ALLEN, J ENNIFER S ANTIAGO , MELANIE H OWE , MISTY MCCANDLESS , A NGELA
KLOPFENSTEIN, ADAM KLOPFENSTEIN, C ATIE KESSLER, J ACLYN SPETT , ABIGAIL
MICHEL , CHERIE M CGEE , BRITTANY WILSON, B REANNA P IETERS, ELLEN BURNS ,
I NDIVIDUALLY, DAVID BURNS, L AURA BURNS, W HITNEY W ALKER, J ESSICA
WATSON, KARNA L YNNE P ETTLON, A MBERLY B UCKNER, C ARLEY H AMILTON,
DANIELLA P AVELKA , ANDREA J OHNSON, CHRISTINA STEPHANIE ALBERTSON,
ABIGAIL T HIESING , AMANDA MASSIE , A MY EDWARDS, S HERRICKER R ODGERS,
ANNALISSA SANCHEZ, N ICOLE VINCENT, LIANA ERB , SARAH MARIE W ESSEL ,
KATIE MYERS, L AT OYA S. T HOMPSON, A SHLEY B ABICH-ZACHARIAS , B ETHANY
VINCENT , WHITNEY MANCHEL WASHINGTON, L AUREN H ARDWICK , B RITTANY
S. SMITH, ELIZABETH H EAGY , BARBARA ANDERSON, S HAMARA V ON L ANE ,
CRYSTAL VAZQUEZ , BRITTANY COLLINS, ASHLEY N OBLES-H OBBS, SHAKARA

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CARTER , MIRANDA G LEDHILL , MELISSA T OLBERT, DEVON MAHLSTEDT,
DANIELLE ADAMS , LAUREN CARMAN, ANNA CONLEY, S TEPHANIE D AWSON,
ANDREA G EE , VICTORIA LEE , LACEY LANGSTON S ANDERLIN , ASHLEY AMBER
COCKRELL , SHAWNA LOUISE COOPER, MARYSSA R EESE , CARNESHIA CASON,
KASEY G ARRISON , A SHLEY S TEED , STEFFANIE MICHELLE DENNIS, J ESSICA M ARIE
P ETERSON , KASEY J ACKSON, LESLIE MARIE COAPMAN, LATRICIA ANDERSON
J OHNSON , MARY M ARGARET COTTINGHAM, S HAMEKA M. BRIDGES, P ETERSON
BRIDGES, LATONYA H OSKIN, KRISTEN DENISE B RYAN, S AMANTHA LIFORD ,
CHRISTI U TLEY, J ESSICA STANLEY, M ACEY BEELER, N OELLE H ICKEY, C RYSTAL
T AYLOR , VALERIE T OWNSEND , ANDREA VEGA, AMANDA EVANS , BREANNA
WILLIAMS , MANDY MITLYNG , LYSSA KI RK , M ARSHA S APP H ANKINS, LEAH
F ACKRELL , T IARA M ITCHELL , S IOBHAN S CHALL , K ATHLEEN CHEEK , BILLY
CHEEK , N ICOLE H AMILL , KAREAMA P ATTERSON , K YLARA BOOTH, DANIEL
P ARSONS, CHRISTA DIEHL , V ANESSA B OURGOIN , DANIEL B OURGOIN , KARA
STANLEY, T IFFANY S AWYER, C AITLYN A BOULBA , KEYSA ELLIS, MARIA AGUILAR,
ELLEN B URNS, AS PERSONAL REPRESENTATIVE OR EXECUTRIX OR ADMINISTRATRIX
OF THE ESTATE OF A NNE ALDEN BURNS , AMANDA CLARK , T AQUOYA
KERYAWNA WILLIAMS, M ARIA P ITTS, H EATHER N ICOLLE MCMULLAN, N ICOLE
LASSO , R ANDI W HITE , H EATHER O NSUM STOOPS , J ANEKA H AYNES, SHENEQUA
P ERDUE , R ACHEL F REITAS , K ATRINA E VERETT-C AREY , N AYELI J UAREZ-G ARCIA,
MELISSA F RANCES H ALL , ELIZABETH ADAMS , SYLVIA G REER, N I 'MATULLAH
KING , M ARIE SHIVER, S USAN T OOMEY, MEGAN H ARRIS, K ATHRYN A SBEL , ASHLI
G ARNER, LISA V ALLERY, B RITTANY N ICOLE J AMES , SARA T ESS SANBORN,
R OBERT ZINN, KIMBERLY STIER, DEWAYNA DENILLE BROWN , LOIS MICHELLE
P ALMER , KELLI SALAZAR, J ESSICA R OBERSON, STACY BRYAN , STEVEN BRYAN ,
R EBECCA ELWOOD , AMBER H ANSON, R EBEKAH R OGERS, T ESSA W ATTS, SHEREE
MITCHELL , LASHONDA R OBINS, MISTY R EITZ, BERNESHA M EANS, SAMANTHA
DAVIS, T AMATHA T UCKER-W HITAKER, MISTY COLEMAN-W OODS, S HARON
CAIN, SHANNON W ALKER, STEPHANIE S CHLUETER , KATHARINE WELLS ,
CYNTHIA G UNN , J ESSICA H IXSON R OBINSON, J ESSICA G ARDNER, C ATHERINE
DIANNE B EITEL , CHRISTY N ICOLE MCGREGOR, A MBER D ARLENE P ROUT,
AMANDA LEEANN B ARBER , ALETA B REK R ICHARDS , ERICA SILVA, J OHN SILVA,
III, AMY H ODGE , J OANNA L YNN L UCERO , KELSEY R AMM , KATIE R EBECCA
LAWRENCE , KELLI B OYT R OWLAND , C ANDICE SMALL , J ADE A. L UDWIKOWSKI ,

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SHAHIRA OSMAN, N AQUASHA R ISER, L AUREN ELIZABETH S INGLETON , J ETTA
ALLEN, J ULIANA CATARINA H ERNANDEZ, T IRZAH MARIE ELLET, KAYLA SCOTT,
T OMEKA WILLIAMS -J AMES, C OURTNEY T RENNEPOHL , T IFFANY C OLLINS, STACY
CAMINO , KATHLEEN F OX, CHANTHINIA WHITE , B RIANNA P ETERS, DEVINA
WILLIAMS , CHAVON P LANGE , SADIE MILLER, STEPHANIE SELLERS, F REDDREKIA
BRADLEY, STARLA M C COLLUM , LACEY H UBERT , A NAIS F ORCIER, J ENNIFER URE ,
R HONDA P EZZULLO , R ACHAEL N IKL , ALECIA CONNER, KIMMI VESEY, DEANNA
MOONEY, MARLENE MENDEZ, CIERA T URNER , T YSHEA MOTT, MELISSA
P OLOMSKY, H EATHER KURAMOTO , J ESSICA BIHLER, L AMARA W ALKER, C ANDICE
BAILEY, A LYSSA J OHNSON, KRISTIN C ARRICO , G LORIBI P ASTOR, C HANDRA
BROWN, J ULIA MEACHEM, SHAQUANDA MC MILLION, L AKEYSHIA T ATE , ASHLEY
MC L UCKIE , KATELYNN H AMMOND , D ORETHA S MITH, LAUREN H OLLOBAUGH,
G EMBELLE H ORLACHER, KIMBERLY B URKHART, KIMBERLY M ACAULAY,
MARISOL MARCANO , ASHLYN H ACKWORTH-WILLIAMS, N ADINE KELLAM,
J ONEL EDWARDS , E LIZABETH MONTANARO , STEPHANIE BREWER, A NGELINE
STANGER, J ESSICA R OSELAND , J ACOB R OSELAND , N ICOLE ASKIN, C HRISTIE
EPPERLY, T IFFANY MOSLEY , N ICOLE CLARK , N AOMI WILSON, P ORSCHE
P ATTERSON, N ATASHKA MILLER, K AREN CREAR, STACIE H UFFER, LATOYA
H UNT , L AUREN R OBERTS, BRITTANY T HOMAS , AMBER H ODA, CHRISTAL BAUGH,
ARIN B OEHMER , J ENNIFER DRAYTON, C HRISTINA H OLLAND , N IKIA BROWN,
ALANA SIRMANS, R OSANNA KNUDSEN , MICHELLE MORGAN, M AUREEN
G ARRETT , N ICOLE PARKER, C ONSTANCE STEELE , AMANDA G OODLET, KIMBERLY
H ENAO , B RIANNA B LACKMAN , ANGELA N ORRED , J ESSIKA ALLEN, P ATRICE
R ENEE F RANK , CHRISTINA R EID , R EVA MC DONALD , CASSANDRA N. J OHNSON,
F AITH L AW , J ERALYN WILEY, J EFKIDA J OHNSON-STINSON, J ALISA CRAPO ,
STEPHANIE G RADY, SIMIN K ASHANI , I EACHA J ACKSON, ALEXANDRA H AINES,
H EIDI T HOMAS , L ATOYA KENDRIX, S ARAH A NNE MC L AUGHLIN, T IERRA H ALL ,
J AMISHA DYER , AMY AMMONS, STEPHANIE ADAMS, ANDREA L UCERO , J ESSICA
LYNN SIMMONS, KRISTEN C AMPBELL , L AURA BRYAN, AIDA LOZADA, T ABITHA
LEE , A MANDA P ICHLA, L ATORIA WOODALL , B RITTANY W ATKINS, E RENDIRA
CUEVAS , LINDSEY R OSS, CRYSTAL C OVERT, C ATHERINA A NDRADE , KENDRA
WICKWARE , KELLY CICHETTI , ASIA S HAKESPEARE , SAMANTHA S TAATS, H ALEY
H ENN, J ENNIFER LEGASSIE , D ESHONDA KNIGHT , T ABITHA SAYLOR, E LIZABETH
K. MOORE , SIERRA MOORE , T AMARA W HALIN , BRITTANY H ARSCH, K RISTEN N.

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CHANDLER, B ARBARA N APIER, STEPHANIE BENNETT, J ESSICA KILBOURNE ,
DONISHA BISHOP , MARGARET BENDER , CHELSEA M. S AWYER, G UADALUPE
P INEDA, S HA.DEBRA COLLIER, VALERIE ARTHUR, CHRISTY S. MURPHY , J ESSICA
H UPMAN, J ENNIFER SAND -S HEQUEN, D ANA Y. C OOPER, J ENNIFER G UZDEK ,
T RICIA P ONICKI , T RACY D. G OULD , CORTNIE S HORT, DAVID R ODRIGUEZ, J ESSICA
N IESLAWSKI , KARLA M. D UELLEY, N ATALEE WILLIAMS, STEPHANIE BURT,
P AULA C. G ARCIA , J ULIE N ELSON, H EATHER B AKER, D APHNE F RANKLIN,
ANDREA MARTINEZ, ESHIA DAVIS, J UANITA F IGUEROA, D AWN BREEN, KINDRA
N ELSON, AMBER R. DRYDEN, ASHLEY P EARSON, MELISSA S. H OPKINS ,
MARQUITA W ILLIAMS, J ESSICA CASH , E LIZABETH BRYCE , N ICOLE P ERKINS,
MARY W ALKER, M ADISON F OWLER, A LAINA DICE , T ONI S TREETER, CHEETARR
J ACKSON, APRIL R OBERTSON , KELSEY H ARRIS, SIERRA R ADDEN, M ARQUSEY
EVANS, D ALIA J ASSO , KAITLYN SKLENAR, STEPHANIE P ELLETIER, SONYA
R AMSEY , CHEYLO C OLLADO , DETRA F ERGUSON, ALISON A SHCROFT, J EANIE
LASCELLES , LORI A NNALORA , STEPHANIE STOCKMAN , T IERRA J ACKSON, A MBER
OSTERMILLER-F ORD , AMANDA STEVENS, KATHERINE SOTELO , T ONI I VY, ERICKA
J ONES-G EORGE , DONNA R AWDON, P AULENA W HITE , STEPHANIE CLARK ,
J ESSICA C ROUSE , K ATI V ALENTINE , A NALYCIA SANCHEZ , ERICA S MITH,
G ABRIELLE H OFFMAN , S AMANTHA WILLIAMS, SHAQUETTA F ELDER, CHARMINA
LEWIS, T ANIA KENT, MARQUISA J OHNSON, N ICOLE J ACKSON, EMILLIE H OPPER,
KRISTY C OLLINS, S AMANTHA ALLEN, S ARA WASHBURN, STEPHANIE T REAT ,
KIMBERLY MC KINNEY, T ANIQUA BLETCHER, CRYSTAL R ODGERS, S ANDY T ATUM,
T IFFANY DEBUSK , AMANDA CRITES , A NISHA LONGMIRE , B ETH B URTON, K AY
P AGE , S HAVONTE J OHNSON, J ULIA F ERGUSON , D ESIREE SAENZ, T RISTYN
ARIYAN, DODIE ARNOLD , KIMBERLY M OULTON, J O AN R EDFIELD , R EBECCA
DURDEN, CAROLYN SUTTON , T YMEIKA BASKIN, L ILLIE BATTLE -EASON ,
R ACHELLE LILLY, A NGELA H ENDERSON , BRITTANY SHUMPERT, D ANIELLE
WEHRLEY , N ICHOLE H ITCHCOCK , J AMIE O'BRYAN, MEGAN D EAN, J OANNA
MOMOKO CLINE , S HARI H ERNANDEZ, K ATHERINE J ACOBSEN , LINDSAY MILLER,
ANGELA R OSE P ADILLA, J ASMAN AL -S HWAIYAT, CHESSICA MAUS, C HRISTINE
WILSON, J AIMER P ELLER, A RLENE CORDERO , J ULIE G ONZALEZ, J ENNIFER H ULL ,
WENDY B ROWN , A MANDA WAITE , T ANAZIA MC C ANTS , ALEXANDRIA ESTRADA,
ALEXIS W ALTON , K AYLA OWENS, CORNEISHA F OSTER, ERIKA N ACKE , BRIANA
G ARNER, ELIZABETH P AIGE , S HARLA BERNDT, KESHIA B ARNETTE , DEVON

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P INCKNEY , P ORSCHE DAVIS , K HELEE SAWYER, DAFFNEY H ICKS, ZEBERA
LAUNIUS, CHARLA MYERS-P ERKINS, WILMA F. MITCHELL , Q UINEISHA J UDD ,
MOKEDA ALEXANDER, KENDRA H ILL , VALIENCIA P ARKER, DARNESIA F INKLEY ,
MARY N ORTON , ASHLEY M ANDOLINE , J ESSICA W ATSON, C OURTNEY SMITH,
SARA S UTPHIN, KELLY H ARRIGAN, J ACQUELINE S HERLEY-D OUGLAS , N ICOLE
SWEITZER, T ONJA A BIAKAM , J ENNIFER DRAUGHN, H ATTIE H ANSEN , KHADIJAH
R OBINSON , T ONI E. COLEMAN , BRANDY F LETCHER , ANDREA R OBINSON , BRIANA
STILLS, ALICIA T HAMES, J ESSICA G RABILL , VIVIAN DAIGLE , KELLY R EIS, LESLIE
MARTIN , ANGELA R OBINSON , G INGER KUCHLER, KARLENA J ENKS, T ESS MORSE ,
T AMMI MILLER, T INA WEBBER , AMANDA H ARVEY , LAUREN DONALDSON,
CATHERINE KING , B RANDI G EDDINGS, B RIGITTE C OCKCROFT , ANN EVERETT,
P EGGY P OSPICHEL , S HONTON L. B URTON, S HANEEN T HOMPSON, N ICOLE
AMARO , MICHELLE W HITTED , T ERI CARMICHEAL , LAURA G ABRIEL , B RIANA
MC C RANIE , H EATHER H EMBERGER, T AMI UNROE , CHARLENE G OMEZ, CHELSEA
COULTER, ALIYA Q UICK , ARIELLE CATRON, BRIDGET COBURN , ASHLEY
ANTKOWIAK , K ATIE LYNN ARABIE , J ILL G ENOVESI , STEPHANIE COEN, J ULIE
G ARCIA , KAYLA F AULKNER , MELISSA S NOW, AISLYNN P OUNDS, CORA CLEAR,
KARRIE S HIELDS, C HRISTON F ORE , KIMBERLY H AMILTON, S HUNIKA
H EMINGWAY, C ASSANDRA BECKER, D ANYELL R USSELL , ERICA OWENS,
CATHERINE MARTINEZ, KIMBERLY G RANT, J ACLYN H ERALD , BROOKE B IRGE ,
T IFFANI D ALTON , STACY BETH SWENTON , BRANDI CARROLL , ASHLEY
R ODRIGUEZ, KRISTIN ANDRICK , KERI R ICE , STEFANIE T HACKER, L AURA F RISBY,
LINDSEY G RADY , B ESS P ATTERSON, ALYSTA ESPINAL , AISHA CUFFIE , EMILY
COKRLIE , T AMMY S CHATZBERG , J AIME P OWELL , S HELBY L UANN MC C AIN,
MELISSA F USCO , J ANELL DAVIS , ALICIA R UFFIN , A NGELA KOLEBUCK UTZ,
J ENNIFER BAXTER , AIMEE G ALLOWAY , T INA P ERSONETTE , H ANNAH R UTLEDGE ,
KATIE A RABIE , T ONINA B ARTLES, CATHERINE J ENSEN, B RIANNA SMITH,
SHANEKUA W ATKINS, DESIREE LEMASTER, APRIL G ALLOWAY , QUASHUNNA
MILLER, R ACHEL M C I NTYRE , SUNDRIA CARROLL , DENISE F ORD , VICTORIA
KYAKUWA, S HANTELLA BROWN S ANDERS, G RACE DIXON, CHANELL WINN,
ASHA' ANA T HOMAS, LINDSEY CADWELL , R OBIN COLEMAN , AMANDA SAILORS ,
LAURA B OYCE , MICHELLE T HOMAS, LISA K UEHL , J ERRY J ANE WYNNE ,
CHYNEICE OLIVER, CYNTHIA MAURO , DANIELLE H OLT, A NDREA N OVAK ,
MICHELLE KAPLAN, LYCIA SLEDGE , QUANTASHIA MOSLEY-MORRIS, L ATOYA

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STEVENSON, DONNA H ARRIS, KAYLA C LAYTON, S EDONA BLAKE , K AMILLE
T URNBOW , CINDEL DOWNS, CANDICE ARNWINE , ALYXIS F ELTUS, DEVON
P ARKER, KIERA MC CLENDON , CATHERINE G ODFREY , KATIE DECKER, LATASHA
MONET , E BONY R AY , CHARLES MONET , ANDREA EASTER, WHITNEY R OBERTS,
SHANELLE H ARRIS , J ILL SNEED , J OY MYERS, KEONA B URTON , P AIGE O LSON,
MARY J O T RACEY , T ANISHA J ONES, C HRISTINA R AY, L ATARSHA P ASCHAL , E MILY
SPRINGER, R ACHEL ELIZABETH SAMMONS, E RICA R ODRIGUEZ, L ARISSA WAY,
MICHELLE VAETH, R IKKI SATTERFIELD , L EQUITA N EELY, T AMEKIA P ERTEET,
MELISSA MARTIN , N ICHOLE T HOMAS, ELIZABETH OLSON , KIMBERLY T AFFER,
KAITLIN S TRINGFELLOW , M AGAN WILLS, D AVID STRINGFELLOW , H OPE G AYLE ,
ALFREDA BOLDEN, SYLVIA H AGANS, L AVONDA LEWIS, J ENNIFER SISSON,
R ICKEYA F REEMAN, CHANDRA M ASON , CALLIE J ORDAN , R OXANNE BENDICK ,
ASHLEY MC C UNE , COSETTE P OSORSKI , OLUSHOLA WALKER, MICHELLE
R UTHERFORD , N IJA J OHNSON , AMBER L ARGE , T ASHENA EASON, K HALILAH
BOWENS, SARAH J ENKINS, LEAH S OUTHARD , MAURISSA H ARRIS, CLARITY
P AVON-M OORE , N ICOLE MAJOR, T ANKIA R HODES, CARRIE T HOMPSON , CARRIE
T HOMPSON, DYONCHE WILLIS, KIMBERLY BARROW, ADRIENNE SEUZENEAU,
DAVITA R OBINSON, R OSEAN MOORE , J ENNIFER DUCRE , M ADONNA LYNN
DUGAS, K ALENA WILLIAMS, L ARYNA LEWIS, M ARIAN C ALE , MARIAN CALE ,
J ULIE SPENCER, G ASHIA WILLIAMS, T YRUNSIA LOWE , SHANTRELL T ALTON,
ADRIAN C LARK , T ONIA BLALOCK , ERICA WILLIAMS, S ARAH H AFER , MEGAN
MILLER, MONICA ANDERTON, K ATOMIA MORRIS , MALKIA WOODWARD ,
J ASMINE H OWARD , AUDREY J OINES, ANDRIA R EED , KRYSTLE WOOD , AMANDA
SANTORO , T RUEMEKA W ALLACE , KENDRA P ATTERSON, CHERYL D ANIELLE
BRODFEHRER, LATOYA G REEN , T AMMY MICHELLE H OUSE , S UZIE D ANGERFIELD ,
SELENA I RVIN, L ATOSHA LEWIS, M AGUILE SEYMOUR, ALECIA H ENRY , C ANDACE
CROVETTO , G EORGIA F OSTER , KAQANTE BROWN, MAKEYTA ANDERSON,
T ACHICKA R OBINSON, T IERRA SLACK , J ERICA SCHAFFER, KATRICE R OUSSELL ,
LAVONDA DAVENPORT, B RITNEY T HOMPSON, L AUREN D AVREN, BONNIE
CEDANO , DESHAUNNA J OHNSON, C HASSIDY F RUGE , KEISHA SEWARD , F ALLON
EVANS, N ICOLE W HITE , KELLY CASNAVE , T YNA R EESE , LORI H ARTFORD ,
WILLETTE SMITH, B RANDI F AVORS, S HONTAE BLOUNT , J EVON BOGAN,
SHADANA R ELIFORD -P ALMER, KATHLEEN MOLINA, L'T ICIA SIAS, J ESSICA
OQUELI , ANITA LONG , J ENNIFER LYNN CARR-A MONETT, CIARA H AYES, N ADIA

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BODY, ALINKIE J OSEPH, J ULIE LA VIGNE , EBONEE R ICHARDSON, ELIZABETH
DAMRON , N EDRA BELL , N ATASHA MANNING , ANITRA W ADE , LESLIE BERRY ,
CARRIE B REAUX, J ESSICA J ETT , T RICHELLE H ARRISON R OBINSON, SCHAMEKA
SANTA CRUZE , ANNE G UILLOT , P ATRICE WEBSTER , F ELITA D OOLEY, T RASULA
CLARK , S HANTELL F IELDS, ANGELINA SHARIDAN, T ERRAINE ZENO , SHARON
T OUPS, A LISHA SCUDDER, KAYTLIN R AINES, LESLEE DIAZ, EBONY T AYLOR, J ILL
J OHNSON , SHERRIE LEWIS, S HARISH D AVIS, MELINDA J OSEPH, B RIGETTE MORRIS,
P AULA D'AMICO , L EONA J IMMERSON, J ENNIFER G IBLIANT, QUINTELLA L ANDRY,
R ENEE P ILCHER, DELILAH P EREZ, LESLIE F ATZ, LEIGH R ODERICK , J ERRELDA
SANDERS, H AILEY S HELTON , CINDY N. BEST, KATHLEEN R ENATA SEEGERS,
N ICHOLE H ILLER, J ENNIFER S ULLIVAN, K ELSEY J ACKSON, KEMISHA WILDER,
ANNE WILSON, Q UIANA BRYANT, KIMBERLY D AVIS , H EATHER G ARCIA, J ESSICA
F ULLER, L AT ONYA H ILLIARD , AMANDA WILSON, AMBER F ENNELL , N AOMI
WILLIAMS , KELLY K ENNEDY, MELISSA DI LOSA, KIMBERLY J ACKSON, SHAWN
AUGUST, KAREN F RANCIS, BETTY WEMPE , H EATHER CRUVER, SEQUILLA
G ARRETT , SHAMIKKI SHIPP , KATRINA STEVENSON , KEIONNE T HOMPSON,
DONISHA BUTLER, S HELIA SPEARMAN , D ANIELLE S CHMIDT, R OBIN G UIDRY, KIA
BARNES, AMBER BRUEGGERT , J ASMINE B AYNHAM, MONIQUE DUNMILES,
J OZZETTE R ANDLE , ALEXIS G ALLIEN, LISA CLANTON, J ESSICA WHITE , I NGRID
BUSTOS, R HONDA DIAMOND , J ODIE SWOFFER, CHELSEY BAUDOIN, DENISE
ANCAR, T ANIKA BRUMFIELD , MARY S MITH, ANGELL N AVARRE , E VE SIMS,
DANIELLE BUTLER, KYONDRA ALBERT, ANDREA BRUNO , K EYSHARA ARMSTEAD ,
BRIDGETTE BLUNT, KASSANDRA H ALSTEAD , LINDSAY B OONE , J ERESA MORGAN,
J AMIE WHITELY, BRAYANNE F ORD , R OSE R AINEY, N ORMA T HOMAS, K IMBERLY
LANDRY, KIMBERLY STEWART , T ONYA A LLEN, ARRIELLE H UGHES, H ILLERY
T HOMPSON, CIERA LAMB , C HELSEA M ARIE BRYANT, T EXAS BLUNDELL , F LORA
J ORDAN, J ESSICA J EFFERSON , S HEENA C HENEAU, CAROLINA R OMERO , J ASMINE
LEFORT , D ORIONNE H UNTINGTON, J ASMINE SHORT, M ARY DORAN, C AROL
J ACKSON, T ONIA R OUEGE , T AMIKA H YDE , EBONI S HAW , B RIANNE T RIGGER,
CHELSEA VAN WERT, T ANERA D ALE -N APPER, N ICOLE LOWRY, CIERRA DENISE
G ARNER, G INA B AKER, AMANDA WOLTERS, A MANDA G ARCIA, CRYSTAL
BARLOW, CHRISTOPHER B ARLOW, N ATALIE STEVANUS , KATRENA WARR,
BRENDA Y EAROUT, MYLAH N WANKWO , CLARA A LLEN, ANGELA SCHNEIDER,
J ACQUELYN SEIFERT, T AMMIE WIRE , KEISHA CURRIE , DIANA LEONARD , CONICA

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WINSTON , AMY C HOLEWINSKI , CARLA WALCOTT , VICTORIA H ONPY, J AMI
OLSON, D ANIELLE K ORTE , BRITTNEY M. G ENTRY , J OSHUA G ENTRY , KRISTA
BURKE , S ARAH BOETTGER, C ARMEN MORALES, S ABRINA BOISAUBIN , N ORA
MATA , J ENNA T RUE , STEPHANIE BAKER , KATELYN T OWER, C HARLOTTE
STRIBLING , H EIDI R OSENOW, B RITNEY M URPHY, H OPE G ARCIA, ASHTON SILVIS,
EMILIE SITZMAN, R OCHELL MYLES, ANJ ANET COLEMAN , S AMANTHA D ARBY ,
KATE J ENSEN, CIERA COLE , DENISE KEIDERLING , LISA F RAZIER, E RICKA T URNER,
J ASMIN T HURMAN, KATIE SCHUBEL , K ATHLEEN F RIZZELL , SHAKEEMA MOORE ,
J ESSICA W EIN, J AYDE SEAFORD , J ENA C OOK , H OLLY J ONES, KEISHA P IERCE ,
MELISSA LOVE , DE SHERA M YERS, G RACEANN R OBINSON, SARAH O TTMAR,
N ICOLE NUNERY, A SHLEY D AVIS, L AURA D ACUS , G LORIA F IELDS, APRIL
J OHNSON , MARIA R ODRIGUEZ , KATHLEENA H AYS, LISA SETTLE , T IFFANY F ITCH,
N ICOLE MAZZANTI , W HITNEY H OMER, MEGAN I SHAM, D ANICA H ENDRICKS,
MELINDA DOBSON , CHARLOTTE BROWN , MARY B URDETTE ,
Plaintiffs-Appellants,
v.
BAYER P HARMA AG, BAYER O Y, B AYER H EALTHCARE P HARMACEUTICALS I NC .,
Defendants-Appellants.∗
O N A PPEAL FROM THE U NITED S TATES D ISTRICT C OURT
FOR THE SOUTHERN D ISTRICT OF NEW Y ORK
Before:
S ACK , C HIN, and LOHIER , Circuit Judges.
∗ The Clerk of the Court is respectfully directed to amend the official caption to
conform to the above.

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Appeal from a judgment of the United States District Court for the
Southern District of New York (Engelmayer, J.) granting summary judgment in
favor of defendants-appellees dismissing plaintiffs-appellants' products liability
claims after precluding, pursuant to Daubert v. Merrell Dow Pharmaceuticals, Inc.,
509 U.S. 579 (1993), the opinions of plaintiffs-appellants' expert witnesses as to
general causation.
AFFIRMED.
MAXWELL K ENNERLY, Kennerly Loutey LLC, Elkins
Park, Pennsylvania (Lawrence L. Jones II, Jones
Ward PLC, Louisville, Kentucky, and Martin D.
Crump, Davis & Crump, P.C., Gulfport,
Mississippi, on the brief), for Plaintiffs-Appellants.
L ISA S. B LATT (F. Lane Heard III, Matthew J. Greer,
Kimberly Broecker, on the brief), Williams &
Connolly LLP, Washington, D.C.; Paul W.
Schmidt, Michael X. Imbroscio, Phyllis A. Jones,
Covington & Burling LLP, New York, New York,
and Washington, D.C.; Elmore James Shepherd,
Shook, Hardy & Bacon, LLP, Houston, Texas; and
Shayna S. Cook, Goldman Ismail Tomaselli
Brennan & Baum LLP, Chicago, Illinois, for
Defendants-Appellees.

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PER C URIAM :
Plaintiffs-appellants ("plaintiffs") appeal the district court's
judgment entered June 21, 2019, in favor of defendant-appellee Bayer
Pharmaceuticals Inc. ("Bayer") and dismissing all claims. By opinion and order
entered October 24, 2018, the district court granted Bayer's motion pursuant to
Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579 (1993), to exclude the
testimony of all of plaintiffs' experts. In re Mirena IUS Levonorgestrel-Related
Prods. Liab. Litig., 341 F. Supp. 3d 213 (S.D.N.Y. 2018). By opinion and order
entered June 11, 2019, the district court granted Bayer's motion for summary
judgment on the ground that the remaining evidence was insufficient to establish
general causation, or in other words, that plaintiffs failed to offer evidence to
suggest that Bayer's product is capable of causing the type of injuries from which
plaintiffs claim to suffer. In re Mirena IUS Levonorgestrel-Related Prods. Liab. Litig.,
387 F. Supp. 3d 323 (S.D.N.Y. 2019).
On appeal, plaintiffs argue that the district court improperly
excluded the opinions of their experts on general causation, erred in granting
summary judgment for Bayer, and denied plaintiffs their right to obtain and
produce evidence in discovery. We reject plaintiffs' arguments, and for

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substantially the reasons set forth in the district court's thorough opinions, we
affirm its judgment.
BACKGROUND
The Mirena Intrauterine System ("Mirena") is a plastic T-shaped
intrauterine device ("IUD"), manufactured by Bayer, that releases a synthetic
steroid hormone called levonorgestrel ("LNG") into the uterus to prevent
pregnancy. Plaintiffs are women from across the country who allege that they
developed idiopathic intracranial hypertension ("IIH") as a result of using
Mirena.1 The Judicial Panel on Multidistrict Litigation ("JPML") consolidated
plaintiffs' cases in the Southern District of New York for pretrial proceedings,
where plaintiffs filed their consolidated amended complaint alleging negligence,
manufacturing defect, design defect, failure to warn, breach of implied and
express warranties, negligent misrepresentation, fraudulent misrepresentation,
fraud, and state consumer fraud violations.
On June 21, 2017, the district court entered a scheduling order giving
"priority" to the issue of "whether plaintiffs have admissible evidence sufficient
1 IIH is known by multiple names, including pseudotumor cerebri ("PTC") and
benign intracranial hypertension ("BIH").

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to establish general causation of the harms alleged." S. App'x at 212.
Accordingly, the district court scheduled a hearing pursuant to Daubert, "as to all
expert evidence bearing on general causation." S. App'x at 214. The district court
held its Daubert hearing April 9-11, 2018, at which plaintiffs and Bayer put
forward seven and twelve expert witnesses, respectively, on the issue of general
causation. Plaintiffs' experts were (1) Dr. Vincenzo Salpietro, (2) Dr. Conrad
Johanson, (3) Dr. Philip Darney, (4) Dr. Lemuel Moyé, (5) Dr. James Wheeler, (6)
Dr. Frederick Fraunfelder, and (7) Dr. Laura Plunkett.
On October 24, 2018, the district court issued its 156-page opinion
and order granting Bayer's Daubert motion as to all of plaintiffs' experts and
denying as moot plaintiffs' motion to preclude Bayer's experts.
Bayer then moved for summary judgment, arguing that without
expert witnesses, plaintiffs had insufficient evidence to establish general
causation. On June 11, 2019, the district court granted Bayer's summary
judgment motion, and on June 21, 2019, entered judgment and closed all of the
cases in the MDL. This appeal followed.

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DISCUSSION
I. Standard of Review
We review a "district court's decision to admit or exclude expert
testimony under a highly deferential abuse of discretion standard." Zuchowicz v.
United States, 140 F.3d 381, 386 (2d Cir. 1998) (citing Gen. Elec. Co. v. Joiner, 522
U.S. 136, 141 (1997)). "A decision to admit or exclude expert scientific testimony
is not an abuse of discretion unless it is manifestly erroneous." Amorgianos v.
Nat'l R.R. Passenger Corp., 303 F.3d 256, 265 (2d Cir. 2002) (internal quotation
marks omitted). "Significantly, the abuse of discretion standard 'applies as much
to the trial court's decisions about how to determine reliability as to its ultimate
conclusion.'" Id. (quoting Kumho Tire Co. v. Carmichael, 526 U.S. 137, 152 (1999)).
Thus, the trial judge has broad discretion in determining "what method is
appropriate for evaluating reliability under the circumstances of each case." Id.
We review a grant of summary judgment de novo, "construing the
facts in the light most favorable to the non-moving party and drawing all
reasonable inferences in that party's favor." Burns v. Martuscello, 890 F.3d 77, 83
(2d Cir. 2018).

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II. Daubert
Under Federal Rule of Evidence 702, lower courts perform a
"gatekeeping" function and are charged with "the task of ensuring that an
expert's testimony both rests on a reliable foundation and is relevant to the task
at hand." Daubert, 509 U.S. at 597. But while "Rule 702 sets forth specific criteria
for the district court's consideration, the Daubert inquiry is fluid and will
necessarily vary from case to case." Amorgianos, 303 F.3d at 266. Similarly, while
the Court in Daubert identified four factors bearing on reliability that district
courts may consider -- (1) whether a theory or technique "can be (and has been)
tested"; (2) "whether the theory or technique has been subjected to peer review
and publication"; (3) a technique's "known or potential rate of error," and "the
existence and maintenance of standards controlling the technique's operation";
and (4) whether a particular technique or theory has gained "general acceptance"
in the relevant scientific community, Daubert, 509 U.S. at 593-94 -- the Court
cautioned that "[t]hese factors do not constitute . . . a 'definitive checklist or test.'"
Amorgianos, 303 F.3d at 266 (quoting Daubert, 509 U.S. at 593). So long as "an
expert's analysis [is] reliable at every step," it is admissible. Id. at 267.

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Plaintiffs argue that the district court abused its discretion by
(1) focusing on plaintiffs' experts' conclusions rather than their methodologies,
(2) requiring the experts to back their opinions with published studies that
definitively supported their conclusions, and (3) taking a "hard look" at the
experts' methodology. Appellant Br. at 14-15. Each argument is rejected.
We start with plaintiffs' third argument: that the district court erred
by taking a "hard look" at each expert's methodology. This argument is central to
plaintiffs' appeal, as they argue the district court's analysis of each expert was too
searching. But as noted, an expert's methodology must be reliable at every step
of the way, and "[i]n deciding whether a step in an expert's analysis is unreliable,
the district court should undertake a rigorous examination of the facts on which
the expert relies, the method by which the expert draws an opinion from those
facts, and how the expert applies the facts and methods to the case at hand."
Amorgianos, 303 F.3d at 267 (emphasis added). Accordingly, not only was it
appropriate for the district court to take a hard look at plaintiffs' experts' reports,
the court was required to do so to ensure reliability.
Plaintiffs' contention that the district court impermissibly focused on
plaintiffs' experts' conclusions instead of their methodologies is similarly

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unavailing. The district court provided in-depth analysis of whether the experts
applied their methodologies reliably. S. App'x at 52 (discussing in detail how
Moyé's analysis "is flawed by serious methodological deficiencies"), 70-71
(explaining the "number of methodological flaws" with Plunkett's analysis), 84
(Wheeler's methodology was "flawed in multiple respects"), 102 (discussing the
"hallmarks of unreliability" throughout Fraunfelder's analysis), 119, 121 (noting
that Darney's report suffers from a broad overarching lapse of methodology and
two speculative leaps rendering it unreliable), 139 ("infirmities precluding a
finding of reliability as to three of the four steps" of Johanson's method), 149
(Salpietro's opinion "does not meet any of the Daubert criteria for reliability").
Plaintiffs may (and do) challenge whether the reliability analysis was correct, but
plaintiffs have no basis to argue that the district court did not engage in a
detailed analysis of their experts' methodologies.
Next, plaintiffs argue that the district court erred by requiring the
experts to back their opinions with studies definitively supporting their
conclusions. Even assuming the district court did impose such a requirement, it
did not err in doing so. We have held that "[w]here an expert otherwise reliably
utilizes scientific methods to reach a conclusion, lack of textual support may go

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to the weight, not the admissibility of the expert's testimony." Amorgianos, 303
F.3d at 267 (internal quotation marks and citations omitted). In other words, an
expert need not back his or her opinion with published studies that support his
or her conclusion if he or she has utilized reliable scientific methods to reach that
conclusion. But here, because the district court found that plaintiffs' experts did
not "otherwise reliably utilize[] scientific methods," and the conclusions were not
supported by other studies, the experts' reports were properly excluded. Id.; see
Joiner, 522 U.S. at 146. Further, the court was well within its discretion to
consider whether plaintiffs' experts' conclusions were generally accepted by the
scientific community. The "general acceptance" of an expert's conclusion is one
of the four enumerated considerations in Daubert, 509 U.S. at 594, and while a
court need not consider the Daubert factors, it does not abuse its discretion in
doing so.
In sum, the district court appropriately undertook a rigorous review
of each of plaintiffs' experts, and based on that review reasonably found that the
experts' methods were not sufficiently reliable and that their conclusions were
not otherwise supported by the scientific community. Accordingly, the district
court did not abuse its discretion in precluding the experts' conclusions.

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III. Summary Judgment
We turn to whether the court correctly granted summary judgment
in favor of Bayer. We conclude that it did, for we agree that no reasonable juror
could find that it was more likely than not that general causation had been
established based on plaintiffs' admissible evidence.
State law controls on the question of what evidence is necessary to
prove an element of a state law claim, such as general causation. See Amorgianos,
303 F.3d at 268. The district court concluded that all fifty states "require some
evidence of general causation in products liability cases involving complex
products liability (or medical) issues." S. App'x at 175. This question was
presented to us in a previous MDL regarding Mirena, and we affirmed the
district court's holding to that effect there. See Mirena MDL Plaintiffs v. Bayer
HealthCare Pharms. Inc. (In re Mirena IUD Prods. Liability Litig. I), 713 F. App'x 11,
15-16 (2d Cir. 2017) (summary order). Plaintiffs attack that conclusion from the
previous Mirena IUD MDL case and the district court's holding below, but, as
the district court noted and is still true now, plaintiffs have failed to point to any
state that does not have a general causation requirement for the type of claims at
issue here. Rather, plaintiffs argue that some states allow evidence on specific

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causation before or in conjunction with the presentment of evidence on general
causation, but that is a challenge to the way in which the district court managed
the litigation -- which is discussed below -- not the substantive state law that the
district court applied. Accordingly, we are not persuaded that the district court
erred in holding that there is a general causation requirement across all states.
Alternatively, plaintiffs argue that even if they were required to
satisfy a threshold general causation showing, their failure to do so was because
the district court prevented them from obtaining and presenting such evidence.
We also reject this argument.
"A district court has wide latitude to determine the scope of
discovery, and we ordinarily defer to the discretion of district courts regarding
discovery matters. A district court abuses its discretion only when the discovery
is so limited as to affect a party's substantial rights." Twinam v. Dow Chem. Co. (In
re Agent Orange Prod. Liab. Litig.), 517 F.3d 76, 103 (2d Cir. 2008) (internal
quotation marks and alteration omitted). In other words, "[a] party must be
afforded a meaningful opportunity to establish the facts necessary to support his
claim." Id.

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Plaintiffs first argue that the district court erred in granting Bayer's
summary judgment motion for lack of evidence of general causation because the
district court excluded all of their experts' reports instead of just portions of
them. Plaintiffs therefore are suggesting that the testimony that they believe
should have been carved out as admissible would have been sufficient to
establish general causation. But plaintiffs have not explained which portions of
their experts' reports should have been carved out as admissible (assuming, as
the plaintiffs ask us to on this issue, that the district court's Daubert analysis was
correct but warranted exclusion of only portions of their experts' reports) nor do
they explain how those portions would have established general causation. We
cannot credit a nonmovant's merely speculative assertion that some evidence
that they have not specifically identified could have created a genuine dispute
regarding general causation. See DiStiso v. Cook, 691 F.3d 226, 229-30 (2d Cir.
2012).
Plaintiffs next argue that the district court erred in precluding
differential-diagnosis evidence, which they argue would have established that
Mirena may have been the likely cause of their IIH.2 But whether Mirena
2 A differential diagnosis is "a patient-specific process of elimination that medical
practitioners use to identify the 'most likely' cause of a set of signs and symptoms from

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actually caused plaintiff's IIH is an issue of specific causation, not general
causation, the latter of which concerns whether Mirena is even capable of
causing IIH. See Amorgianos, 303 F.3d at 268. And while we have declined to
adopt a bright-line rule that "a differential diagnosis may never provide a
sufficient basis for an opinion as to general causation," we have explained that
the "district judge has broad discretion in determining whether in a given case a
differential diagnosis is enough by itself to support such an opinion." Ruggiero,
424 F.3d at 254. Here, plaintiffs failed to explain below or on appeal how "the
rigor of differential diagnosis performed, the expert's training and experience,
the type of illness or injury at issue, or some other case-specific circumstance"
militates in favor of admitting that evidence to establish general causation. Id.
Accordingly, the district court did not abuse its broad discretion in excluding
differential-diagnosis evidence.
Plaintiffs also argue that the district court improperly precluded
them from obtaining other general-causation discovery. But the district court did
not abuse its broad discretion in managing discovery. After the parties notified
the district court of numerous discovery disputes, the court issued rulings from
a list of possible causes." Ruggiero v. Warner-Lambert Co., 424 F.3d 249, 254 (2d Cir.
2005).

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the bench ordering Bayer to produce millions of documents from more than fifty
custodians. Forty-one of those custodians had been identified in the previous
Mirena IUD MDL, but the court allowed plaintiffs to obtain documents from
eleven new custodians. Despite plaintiffs' arguments to the contrary, the district
court considered relevance and proportionality when resolving the discovery
disputes. We conclude that the district court's thorough and well-reasoned
discovery orders throughout the litigation were well within its wide discretion.
CONCLUSION
For the foregoing reasons, the district court's judgment is
AFFIRMED.

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