19-2155

In Re: Mirena IUS Levonorgestrel-Related Products Liability Litigation (No. II)

UNITED STATES COURT OF APPEALS

FOR THE SECOND CIRCUIT

August Term 2020

(Argued: December 2, 2020 Decided: December 8,2020)

Docket No. 19-2155

IN RE: MIRENA IUS LEVONORGESTREL-RELATED PRODUCTS LIABILITY 

LITIGATION (NO. II)

ABRA CONING, KAYLA TALLEY, TIFFANY HAUSNER, SHANE HAUSNER, SHELAIN

COOPER, ALLISON SIMPSON, AMELIA HOLMAN MILES, JONATHAN MILES,

JESSICA GUGLIELMO, MEGAN ROBINSON, KIMBERLY BLACK, CHAQUITA DUDLEY,

KELLY RIEGEL-GREEN, DANISE HOFFMAN, JACQUELINE GOYENA, JANELLE 

PALLANSCH, BRITTANY GRECO, MISTY SOLOMON, DAPHNE HOUCK, HOLLY 

ALLEN, JENNIFER SANTIAGO, MELANIE HOWE, MISTY MCCANDLESS, ANGELA 

KLOPFENSTEIN, ADAM KLOPFENSTEIN, CATIE KESSLER, JACLYN SPETT, ABIGAIL 

MICHEL, CHERIE MCGEE, BRITTANY WILSON, BREANNA PIETERS, ELLEN BURNS,

INDIVIDUALLY, DAVID BURNS, LAURA BURNS, WHITNEY WALKER, JESSICA 

WATSON, KARNA LYNNE PETTLON, AMBERLY BUCKNER, CARLEY HAMILTON,

DANIELLA PAVELKA, ANDREA JOHNSON, CHRISTINA STEPHANIE ALBERTSON,

ABIGAIL THIESING, AMANDA MASSIE, AMY EDWARDS, SHERRICKER RODGERS,

ANNALISSA SANCHEZ, NICOLE VINCENT, LIANA ERB, SARAH MARIE WESSEL,

KATIE MYERS, LATOYA S. THOMPSON, ASHLEY BABICH-ZACHARIAS, BETHANY 

VINCENT, WHITNEY MANCHEL WASHINGTON, LAUREN HARDWICK, BRITTANY 

S. SMITH, ELIZABETH HEAGY, BARBARA ANDERSON, SHAMARA VON LANE,

CRYSTAL VAZQUEZ, BRITTANY COLLINS, ASHLEY NOBLES-HOBBS, SHAKARA 
2

CARTER, MIRANDA GLEDHILL, MELISSA TOLBERT, DEVON MAHLSTEDT,

DANIELLE ADAMS, LAUREN CARMAN, ANNA CONLEY, STEPHANIE DAWSON,

ANDREA GEE, VICTORIA LEE, LACEY LANGSTON SANDERLIN, ASHLEY AMBER 

COCKRELL, SHAWNA LOUISE COOPER, MARYSSA REESE, CARNESHIA CASON,

KASEY GARRISON, ASHLEY STEED, STEFFANIE MICHELLE DENNIS, JESSICA MARIE 

PETERSON, KASEY JACKSON, LESLIE MARIE COAPMAN, LATRICIA ANDERSON 

JOHNSON, MARY MARGARET COTTINGHAM, SHAMEKA M. BRIDGES, PETERSON 

BRIDGES, LATONYA HOSKIN, KRISTEN DENISE BRYAN, SAMANTHA LIFORD,

CHRISTI UTLEY, JESSICA STANLEY, MACEY BEELER, NOELLE HICKEY, CRYSTAL 

TAYLOR, VALERIE TOWNSEND, ANDREA VEGA, AMANDA EVANS, BREANNA 

WILLIAMS, MANDY MITLYNG, LYSSA KIRK, MARSHA SAPP HANKINS, LEAH 

FACKRELL, TIARA MITCHELL, SIOBHAN SCHALL, KATHLEEN CHEEK, BILLY 

CHEEK, NICOLE HAMILL, KAREAMA PATTERSON, KYLARA BOOTH, DANIEL 

PARSONS, CHRISTA DIEHL, VANESSA BOURGOIN, DANIEL BOURGOIN, KARA 

STANLEY, TIFFANY SAWYER, CAITLYN ABOULBA, KEYSA ELLIS, MARIA AGUILAR,

ELLEN BURNS, AS PERSONAL REPRESENTATIVE OR EXECUTRIX OR ADMINISTRATRIX 

OF THE ESTATE OF ANNE ALDEN BURNS, AMANDA CLARK, TAQUOYA 

KERYAWNA WILLIAMS, MARIA PITTS, HEATHER NICOLLE MCMULLAN, NICOLE 

LASSO, RANDI WHITE, HEATHER ONSUM STOOPS, JANEKA HAYNES, SHENEQUA 

PERDUE, RACHEL FREITAS, KATRINA EVERETT-CAREY, NAYELI JUAREZ-GARCIA,

MELISSA FRANCES HALL, ELIZABETH ADAMS, SYLVIA GREER, NI'MATULLAH 

KING, MARIE SHIVER, SUSAN TOOMEY, MEGAN HARRIS, KATHRYN ASBEL, ASHLI 

GARNER, LISA VALLERY, BRITTANY NICOLE JAMES, SARA TESS SANBORN,

ROBERT ZINN, KIMBERLY STIER, DEWAYNA DENILLE BROWN, LOIS MICHELLE 

PALMER, KELLI SALAZAR, JESSICA ROBERSON, STACY BRYAN, STEVEN BRYAN,

REBECCA ELWOOD, AMBER HANSON, REBEKAH ROGERS, TESSA WATTS, SHEREE 

MITCHELL, LASHONDA ROBINS, MISTY REITZ, BERNESHA MEANS, SAMANTHA 

DAVIS, TAMATHA TUCKER-WHITAKER, MISTY COLEMAN-WOODS, SHARON 

CAIN, SHANNON WALKER, STEPHANIE SCHLUETER, KATHARINE WELLS,

CYNTHIA GUNN, JESSICA HIXSON ROBINSON, JESSICA GARDNER, CATHERINE 

DIANNE BEITEL, CHRISTY NICOLE MCGREGOR, AMBER DARLENE PROUT,

AMANDA LEEANN BARBER, ALETA BREK RICHARDS, ERICA SILVA, JOHN SILVA,

III, AMY HODGE, JOANNA LYNN LUCERO, KELSEY RAMM, KATIE REBECCA 

LAWRENCE, KELLI BOYT ROWLAND, CANDICE SMALL, JADE A. LUDWIKOWSKI,
3

SHAHIRA OSMAN, NAQUASHA RISER, LAUREN ELIZABETH SINGLETON, JETTA 

ALLEN, JULIANA CATARINA HERNANDEZ, TIRZAH MARIE ELLET, KAYLA SCOTT,

TOMEKA WILLIAMS-JAMES, COURTNEY TRENNEPOHL, TIFFANY COLLINS, STACY 

CAMINO, KATHLEEN FOX, CHANTHINIA WHITE, BRIANNA PETERS, DEVINA 

WILLIAMS, CHAVON PLANGE, SADIE MILLER, STEPHANIE SELLERS, FREDDREKIA 

BRADLEY, STARLA MCCOLLUM, LACEY HUBERT, ANAIS FORCIER, JENNIFER URE,

RHONDA PEZZULLO, RACHAEL NIKL, ALECIA CONNER, KIMMI VESEY, DEANNA 

MOONEY, MARLENE MENDEZ, CIERA TURNER, TYSHEA MOTT, MELISSA 

POLOMSKY, HEATHER KURAMOTO, JESSICA BIHLER, LAMARA WALKER, CANDICE 

BAILEY, ALYSSA JOHNSON, KRISTIN CARRICO, GLORIBI PASTOR, CHANDRA 

BROWN, JULIA MEACHEM, SHAQUANDA MCMILLION, LAKEYSHIA TATE, ASHLEY 

MCLUCKIE, KATELYNN HAMMOND, DORETHA SMITH, LAUREN HOLLOBAUGH,

GEMBELLE HORLACHER, KIMBERLY BURKHART, KIMBERLY MACAULAY,

MARISOL MARCANO, ASHLYN HACKWORTH-WILLIAMS, NADINE KELLAM,

JONEL EDWARDS, ELIZABETH MONTANARO, STEPHANIE BREWER, ANGELINE 

STANGER, JESSICA ROSELAND, JACOB ROSELAND, NICOLE ASKIN, CHRISTIE 

EPPERLY, TIFFANY MOSLEY, NICOLE CLARK, NAOMI WILSON, PORSCHE 

PATTERSON, NATASHKA MILLER, KAREN CREAR, STACIE HUFFER, LATOYA 

HUNT, LAUREN ROBERTS, BRITTANY THOMAS, AMBER HODA, CHRISTAL BAUGH,

ARIN BOEHMER, JENNIFER DRAYTON, CHRISTINA HOLLAND, NIKIA BROWN,

ALANA SIRMANS, ROSANNA KNUDSEN, MICHELLE MORGAN, MAUREEN 

GARRETT, NICOLE PARKER, CONSTANCE STEELE, AMANDA GOODLET, KIMBERLY 

HENAO, BRIANNA BLACKMAN, ANGELA NORRED, JESSIKA ALLEN, PATRICE 

RENEE FRANK, CHRISTINA REID, REVA MCDONALD, CASSANDRA N. JOHNSON,

FAITH LAW, JERALYN WILEY, JEFKIDA JOHNSON-STINSON, JALISA CRAPO,

STEPHANIE GRADY, SIMIN KASHANI, IEACHA JACKSON, ALEXANDRA HAINES,

HEIDI THOMAS, LATOYA KENDRIX, SARAH ANNE MCLAUGHLIN, TIERRA HALL,

JAMISHA DYER, AMY AMMONS, STEPHANIE ADAMS, ANDREA LUCERO, JESSICA 

LYNN SIMMONS, KRISTEN CAMPBELL, LAURA BRYAN, AIDA LOZADA, TABITHA 

LEE, AMANDA PICHLA, LATORIA WOODALL, BRITTANY WATKINS, ERENDIRA 

CUEVAS, LINDSEY ROSS, CRYSTAL COVERT, CATHERINA ANDRADE, KENDRA 

WICKWARE, KELLY CICHETTI, ASIA SHAKESPEARE, SAMANTHA STAATS, HALEY 

HENN, JENNIFER LEGASSIE, DESHONDA KNIGHT, TABITHA SAYLOR, ELIZABETH 

K. MOORE, SIERRA MOORE, TAMARA WHALIN, BRITTANY HARSCH, KRISTEN N.
4

CHANDLER, BARBARA NAPIER, STEPHANIE BENNETT, JESSICA KILBOURNE,

DONISHA BISHOP, MARGARET BENDER, CHELSEA M. SAWYER, GUADALUPE 

PINEDA, SHA.DEBRA COLLIER, VALERIE ARTHUR, CHRISTY S. MURPHY, JESSICA 

HUPMAN, JENNIFER SAND-SHEQUEN, DANA Y. COOPER, JENNIFER GUZDEK,

TRICIA PONICKI, TRACY D. GOULD, CORTNIE SHORT, DAVID RODRIGUEZ, JESSICA 

NIESLAWSKI, KARLA M. DUELLEY, NATALEE WILLIAMS, STEPHANIE BURT,

PAULA C. GARCIA, JULIE NELSON, HEATHER BAKER, DAPHNE FRANKLIN,

ANDREA MARTINEZ, ESHIA DAVIS, JUANITA FIGUEROA, DAWN BREEN, KINDRA 

NELSON, AMBER R. DRYDEN, ASHLEY PEARSON, MELISSA S. HOPKINS,

MARQUITA WILLIAMS, JESSICA CASH, ELIZABETH BRYCE, NICOLE PERKINS,

MARY WALKER, MADISON FOWLER, ALAINA DICE, TONI STREETER, CHEETARR 

JACKSON, APRIL ROBERTSON, KELSEY HARRIS, SIERRA RADDEN, MARQUSEY 

EVANS, DALIA JASSO, KAITLYN SKLENAR, STEPHANIE PELLETIER, SONYA 

RAMSEY, CHEYLO COLLADO, DETRA FERGUSON, ALISON ASHCROFT, JEANIE 

LASCELLES, LORI ANNALORA, STEPHANIE STOCKMAN, TIERRA JACKSON, AMBER 

OSTERMILLER-FORD, AMANDA STEVENS, KATHERINE SOTELO, TONI IVY, ERICKA 

JONES-GEORGE, DONNA RAWDON, PAULENA WHITE, STEPHANIE CLARK,

JESSICA CROUSE, KATI VALENTINE, ANALYCIA SANCHEZ, ERICA SMITH,

GABRIELLE HOFFMAN, SAMANTHA WILLIAMS, SHAQUETTA FELDER, CHARMINA 

LEWIS, TANIA KENT, MARQUISA JOHNSON, NICOLE JACKSON, EMILLIE HOPPER,

KRISTY COLLINS, SAMANTHA ALLEN, SARA WASHBURN, STEPHANIE TREAT,

KIMBERLY MCKINNEY, TANIQUA BLETCHER, CRYSTAL RODGERS, SANDY TATUM,

TIFFANY DEBUSK, AMANDA CRITES, ANISHA LONGMIRE, BETH BURTON, KAY 

PAGE, SHAVONTE JOHNSON, JULIA FERGUSON, DESIREE SAENZ, TRISTYN 

ARIYAN, DODIE ARNOLD, KIMBERLY MOULTON, JOAN REDFIELD, REBECCA 

DURDEN, CAROLYN SUTTON, TYMEIKA BASKIN, LILLIE BATTLE-EASON,

RACHELLE LILLY, ANGELA HENDERSON, BRITTANY SHUMPERT, DANIELLE 

WEHRLEY, NICHOLE HITCHCOCK, JAMIE O'BRYAN, MEGAN DEAN, JOANNA 

MOMOKO CLINE, SHARI HERNANDEZ, KATHERINE JACOBSEN, LINDSAY MILLER,

ANGELA ROSE PADILLA, JASMAN AL-SHWAIYAT, CHESSICA MAUS, CHRISTINE 

WILSON, JAIMER PELLER, ARLENE CORDERO, JULIE GONZALEZ, JENNIFER HULL,

WENDY BROWN, AMANDA WAITE, TANAZIA MCCANTS, ALEXANDRIA ESTRADA,

ALEXIS WALTON, KAYLA OWENS, CORNEISHA FOSTER, ERIKA NACKE, BRIANA 

GARNER, ELIZABETH PAIGE, SHARLA BERNDT, KESHIA BARNETTE, DEVON 
5

PINCKNEY, PORSCHE DAVIS, KHELEE SAWYER, DAFFNEY HICKS, ZEBERA 

LAUNIUS, CHARLA MYERS-PERKINS, WILMA F. MITCHELL, QUINEISHA JUDD,

MOKEDA ALEXANDER, KENDRA HILL, VALIENCIA PARKER, DARNESIA FINKLEY,

MARY NORTON, ASHLEY MANDOLINE, JESSICA WATSON, COURTNEY SMITH,

SARA SUTPHIN, KELLY HARRIGAN, JACQUELINE SHERLEY-DOUGLAS, NICOLE 

SWEITZER, TONJA ABIAKAM, JENNIFER DRAUGHN, HATTIE HANSEN, KHADIJAH 

ROBINSON, TONI E. COLEMAN, BRANDY FLETCHER, ANDREA ROBINSON, BRIANA 

STILLS, ALICIA THAMES, JESSICA GRABILL, VIVIAN DAIGLE, KELLY REIS, LESLIE 

MARTIN, ANGELA ROBINSON, GINGER KUCHLER, KARLENA JENKS, TESS MORSE,

TAMMI MILLER, TINA WEBBER, AMANDA HARVEY, LAUREN DONALDSON,

CATHERINE KING, BRANDI GEDDINGS, BRIGITTE COCKCROFT, ANN EVERETT,

PEGGY POSPICHEL, SHONTON L. BURTON, SHANEEN THOMPSON, NICOLE 

AMARO, MICHELLE WHITTED, TERI CARMICHEAL, LAURA GABRIEL, BRIANA 

MCCRANIE, HEATHER HEMBERGER, TAMI UNROE, CHARLENE GOMEZ, CHELSEA 

COULTER, ALIYA QUICK, ARIELLE CATRON, BRIDGET COBURN, ASHLEY 

ANTKOWIAK, KATIE LYNN ARABIE, JILL GENOVESI, STEPHANIE COEN, JULIE 

GARCIA, KAYLA FAULKNER, MELISSA SNOW, AISLYNN POUNDS, CORA CLEAR,

KARRIE SHIELDS, CHRISTON FORE, KIMBERLY HAMILTON, SHUNIKA 

HEMINGWAY, CASSANDRA BECKER, DANYELL RUSSELL, ERICA OWENS,

CATHERINE MARTINEZ, KIMBERLY GRANT, JACLYN HERALD, BROOKE BIRGE,

TIFFANI DALTON, STACY BETH SWENTON, BRANDI CARROLL, ASHLEY 

RODRIGUEZ, KRISTIN ANDRICK, KERI RICE, STEFANIE THACKER, LAURA FRISBY,

LINDSEY GRADY, BESS PATTERSON, ALYSTA ESPINAL, AISHA CUFFIE, EMILY 

COKRLIE, TAMMY SCHATZBERG, JAIME POWELL, SHELBY LUANN MCCAIN,

MELISSA FUSCO, JANELL DAVIS, ALICIA RUFFIN, ANGELA KOLEBUCK UTZ,

JENNIFER BAXTER, AIMEE GALLOWAY, TINA PERSONETTE, HANNAH RUTLEDGE,

KATIE ARABIE, TONINA BARTLES, CATHERINE JENSEN, BRIANNA SMITH,

SHANEKUA WATKINS, DESIREE LEMASTER, APRIL GALLOWAY, QUASHUNNA 

MILLER, RACHEL MCINTYRE, SUNDRIA CARROLL, DENISE FORD, VICTORIA 

KYAKUWA, SHANTELLA BROWN SANDERS, GRACE DIXON, CHANELL WINN,

ASHA' ANA THOMAS, LINDSEY CADWELL, ROBIN COLEMAN, AMANDA SAILORS,

LAURA BOYCE, MICHELLE THOMAS, LISA KUEHL, JERRY JANE WYNNE,

CHYNEICE OLIVER, CYNTHIA MAURO, DANIELLE HOLT, ANDREA NOVAK,

MICHELLE KAPLAN, LYCIA SLEDGE, QUANTASHIA MOSLEY-MORRIS, LATOYA 
6

STEVENSON, DONNA HARRIS, KAYLA CLAYTON, SEDONA BLAKE, KAMILLE 

TURNBOW, CINDEL DOWNS, CANDICE ARNWINE, ALYXIS FELTUS, DEVON 

PARKER, KIERA MCCLENDON, CATHERINE GODFREY, KATIE DECKER, LATASHA 

MONET, EBONY RAY, CHARLES MONET, ANDREA EASTER, WHITNEY ROBERTS,

SHANELLE HARRIS, JILL SNEED, JOY MYERS, KEONA BURTON, PAIGE OLSON,

MARY JO TRACEY, TANISHA JONES, CHRISTINA RAY, LATARSHA PASCHAL, EMILY 

SPRINGER, RACHEL ELIZABETH SAMMONS, ERICA RODRIGUEZ, LARISSA WAY,

MICHELLE VAETH, RIKKI SATTERFIELD, LEQUITA NEELY, TAMEKIA PERTEET,

MELISSA MARTIN, NICHOLE THOMAS, ELIZABETH OLSON, KIMBERLY TAFFER,

KAITLIN STRINGFELLOW, MAGAN WILLS, DAVID STRINGFELLOW, HOPE GAYLE,

ALFREDA BOLDEN, SYLVIA HAGANS, LAVONDA LEWIS, JENNIFER SISSON,

RICKEYA FREEMAN, CHANDRA MASON, CALLIE JORDAN, ROXANNE BENDICK,

ASHLEY MCCUNE, COSETTE POSORSKI, OLUSHOLA WALKER, MICHELLE 

RUTHERFORD, NIJA JOHNSON, AMBER LARGE, TASHENA EASON, KHALILAH 

BOWENS, SARAH JENKINS, LEAH SOUTHARD, MAURISSA HARRIS, CLARITY 

PAVON-MOORE, NICOLE MAJOR, TANKIA RHODES, CARRIE THOMPSON, CARRIE 

THOMPSON, DYONCHE WILLIS, KIMBERLY BARROW, ADRIENNE SEUZENEAU,

DAVITA ROBINSON, ROSEAN MOORE, JENNIFER DUCRE, MADONNA LYNN 

DUGAS, KALENA WILLIAMS, LARYNA LEWIS, MARIAN CALE, MARIAN CALE,

JULIE SPENCER, GASHIA WILLIAMS, TYRUNSIA LOWE, SHANTRELL TALTON,

ADRIAN CLARK, TONIA BLALOCK, ERICA WILLIAMS, SARAH HAFER, MEGAN 

MILLER, MONICA ANDERTON, KATOMIA MORRIS, MALKIA WOODWARD,

JASMINE HOWARD, AUDREY JOINES, ANDRIA REED, KRYSTLE WOOD, AMANDA 

SANTORO, TRUEMEKA WALLACE, KENDRA PATTERSON, CHERYL DANIELLE 

BRODFEHRER, LATOYA GREEN, TAMMY MICHELLE HOUSE, SUZIE DANGERFIELD,

SELENA IRVIN, LATOSHA LEWIS, MAGUILE SEYMOUR, ALECIA HENRY, CANDACE 

CROVETTO, GEORGIA FOSTER, KAQANTE BROWN, MAKEYTA ANDERSON,

TACHICKA ROBINSON, TIERRA SLACK, JERICA SCHAFFER, KATRICE ROUSSELL,

LAVONDA DAVENPORT, BRITNEY THOMPSON, LAUREN DAVREN, BONNIE 

CEDANO, DESHAUNNA JOHNSON, CHASSIDY FRUGE, KEISHA SEWARD, FALLON 

EVANS, NICOLE WHITE, KELLY CASNAVE, TYNA REESE, LORI HARTFORD,

WILLETTE SMITH, BRANDI FAVORS, SHONTAE BLOUNT, JEVON BOGAN,

SHADANA RELIFORD-PALMER, KATHLEEN MOLINA, L'TICIA SIAS, JESSICA 

OQUELI, ANITA LONG, JENNIFER LYNN CARR-AMONETT, CIARA HAYES, NADIA 
7

BODY, ALINKIE JOSEPH, JULIE LAVIGNE, EBONEE RICHARDSON, ELIZABETH 

DAMRON, NEDRA BELL, NATASHA MANNING, ANITRA WADE, LESLIE BERRY,

CARRIE BREAUX, JESSICA JETT, TRICHELLE HARRISON ROBINSON, SCHAMEKA 

SANTA CRUZE, ANNE GUILLOT, PATRICE WEBSTER, FELITA DOOLEY, TRASULA 

CLARK, SHANTELL FIELDS, ANGELINA SHARIDAN, TERRAINE ZENO, SHARON 

TOUPS, ALISHA SCUDDER, KAYTLIN RAINES, LESLEE DIAZ, EBONY TAYLOR, JILL 

JOHNSON, SHERRIE LEWIS, SHARISH DAVIS, MELINDA JOSEPH, BRIGETTE MORRIS,

PAULA D'AMICO, LEONA JIMMERSON, JENNIFER GIBLIANT, QUINTELLA LANDRY,

RENEE PILCHER, DELILAH PEREZ, LESLIE FATZ, LEIGH RODERICK, JERRELDA 

SANDERS, HAILEY SHELTON, CINDY N. BEST, KATHLEEN RENATA SEEGERS,

NICHOLE HILLER, JENNIFER SULLIVAN, KELSEY JACKSON, KEMISHA WILDER,

ANNE WILSON, QUIANA BRYANT, KIMBERLY DAVIS, HEATHER GARCIA, JESSICA 

FULLER, LATONYA HILLIARD, AMANDA WILSON, AMBER FENNELL, NAOMI 

WILLIAMS, KELLY KENNEDY, MELISSA DILOSA, KIMBERLY JACKSON, SHAWN 

AUGUST, KAREN FRANCIS, BETTY WEMPE, HEATHER CRUVER, SEQUILLA 

GARRETT, SHAMIKKI SHIPP, KATRINA STEVENSON, KEIONNE THOMPSON,

DONISHA BUTLER, SHELIA SPEARMAN, DANIELLE SCHMIDT, ROBIN GUIDRY, KIA 

BARNES, AMBER BRUEGGERT, JASMINE BAYNHAM, MONIQUE DUNMILES,

JOZZETTE RANDLE, ALEXIS GALLIEN, LISA CLANTON, JESSICA WHITE, INGRID 

BUSTOS, RHONDA DIAMOND, JODIE SWOFFER, CHELSEY BAUDOIN, DENISE 

ANCAR, TANIKA BRUMFIELD, MARY SMITH, ANGELL NAVARRE, EVE SIMS,

DANIELLE BUTLER, KYONDRA ALBERT, ANDREA BRUNO, KEYSHARA ARMSTEAD,

BRIDGETTE BLUNT, KASSANDRA HALSTEAD, LINDSAY BOONE, JERESA MORGAN,

JAMIE WHITELY, BRAYANNE FORD, ROSE RAINEY, NORMA THOMAS, KIMBERLY 

LANDRY, KIMBERLY STEWART, TONYA ALLEN, ARRIELLE HUGHES, HILLERY 

THOMPSON, CIERA LAMB, CHELSEA MARIE BRYANT, TEXAS BLUNDELL, FLORA 

JORDAN, JESSICA JEFFERSON, SHEENA CHENEAU, CAROLINA ROMERO, JASMINE 

LEFORT, DORIONNE HUNTINGTON, JASMINE SHORT, MARY DORAN, CAROL 

JACKSON, TONIA ROUEGE, TAMIKA HYDE, EBONI SHAW, BRIANNE TRIGGER,

CHELSEA VAN WERT, TANERA DALE-NAPPER, NICOLE LOWRY, CIERRA DENISE 

GARNER, GINA BAKER, AMANDA WOLTERS, AMANDA GARCIA, CRYSTAL 

BARLOW, CHRISTOPHER BARLOW, NATALIE STEVANUS, KATRENA WARR,

BRENDA YEAROUT, MYLAH NWANKWO, CLARA ALLEN, ANGELA SCHNEIDER,

JACQUELYN SEIFERT, TAMMIE WIRE, KEISHA CURRIE, DIANA LEONARD, CONICA 
8

WINSTON, AMY CHOLEWINSKI, CARLA WALCOTT, VICTORIA HONPY, JAMI 

OLSON, DANIELLE KORTE, BRITTNEY M. GENTRY, JOSHUA GENTRY, KRISTA 

BURKE, SARAH BOETTGER, CARMEN MORALES, SABRINA BOISAUBIN, NORA 

MATA, JENNA TRUE, STEPHANIE BAKER, KATELYN TOWER, CHARLOTTE 

STRIBLING, HEIDI ROSENOW, BRITNEY MURPHY, HOPE GARCIA, ASHTON SILVIS,

EMILIE SITZMAN, ROCHELL MYLES, ANJANET COLEMAN, SAMANTHA DARBY,

KATE JENSEN, CIERA COLE, DENISE KEIDERLING, LISA FRAZIER, ERICKA TURNER,

JASMIN THURMAN, KATIE SCHUBEL, KATHLEEN FRIZZELL, SHAKEEMA MOORE,

JESSICA WEIN, JAYDE SEAFORD, JENA COOK, HOLLY JONES, KEISHA PIERCE,

MELISSA LOVE, DESHERA MYERS, GRACEANN ROBINSON, SARAH OTTMAR,

NICOLE NUNERY, ASHLEY DAVIS, LAURA DACUS, GLORIA FIELDS, APRIL 

JOHNSON, MARIA RODRIGUEZ, KATHLEENA HAYS, LISA SETTLE, TIFFANY FITCH,

NICOLE MAZZANTI, WHITNEY HOMER, MEGAN ISHAM, DANICA HENDRICKS,

MELINDA DOBSON, CHARLOTTE BROWN, MARY BURDETTE,

Plaintiffs-Appellants,

v.

BAYER PHARMA AG, BAYER OY, BAYER HEALTHCARE PHARMACEUTICALS INC.,

Defendants-Appellants.

∗

ON APPEAL FROM THE UNITED STATES DISTRICT COURT

FOR THE SOUTHERN DISTRICT OF NEW YORK

Before:

SACK, CHIN, and LOHIER, Circuit Judges.

∗ The Clerk of the Court is respectfully directed to amend the official caption to 

conform to the above.
9

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 KENNERLY, 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.

LISA S. BLATT (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.
10

PER CURIAM:

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 
11

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"). 
12

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.
13

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). 
14

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. 
15

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 
16

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 
17

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. 
18

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 
19

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.
20

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 
21

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).
22

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.