"At issue [is] a scientific, but not policy-making, determination as to whether each of the criteria listed in the regulation was met and the extent to which each such factor accurately indicated neurovirulence."
How later courts described this case
- "At issue [is] a scientific, but not policy-making, determination as to whether each of the criteria listed in the regulation was met and the extent to which each such factor accurately indicated neurovirulence."
- describing the FDA approval process applicable to the bone screw and similar devices
- "A waiver of immunity must be unequivocally expressed and is construed strictly in favor of the sovereign."
Written by the judges who cited it.
The opinion
Opinions of the United
2001 Decisions States Court of Appeals
for the Third Circuit
8-31-2001
In Re Orthopedic Litigation
Precedential or Non-Precedential:
Docket 00-3899
Follow this and additional works at: http://digitalcommons.law.villanova.edu/thirdcircuit_2001
Recommended Citation
"In Re Orthopedic Litigation" (2001). 2001 Decisions. Paper 202.
http://digitalcommons.law.villanova.edu/thirdcircuit_2001/202
This decision is brought to you for free and open access by the Opinions of the United States Court of Appeals for the Third Circuit at Villanova
University School of Law Digital Repository. It has been accepted for inclusion in 2001 Decisions by an authorized administrator of Villanova
University School of Law Digital Repository. For more information, please contact Benjamin.Carlson@law.villanova.edu.
Filed August 31, 2001
UNITED STATES COURT OF APPEALS
FOR THE THIRD CIRCUIT
Nos. 00-3899 through 00-3922, 00-3925 through
00-3977, 00-3982 through 00-3984, 00-3986 through
00-4019, 00-4021 through 00-4057, 00-4060 through
00-4095 and 00-4098 through 00-4109
IN RE: ORTHOPEDIC BONE SCREW
PRODUCT LIABILITY LITIGATION
J.T. Bradley and Kathy W. Bradley, Appellants in No.
00-3899
Regina M. Luellen and Eurston Luellen, Sr., Appellants in
No. 00-3900
Randal Jon Uribe, Appellant in No. 00-3901
Mitchell H. Walker and Kim S. Walker, Appellants in No.
00-3902
Jose Morfin, Appellant in No. 00-3903
Mary K. Mullen Schmelter and Kurt Allen Schmelter,
Appellants in No. 00-3904
Rita Jan McGill and Gary McGill, Appellants in No.
00-3905
Louis H. McDowell, Jr. and Patricia McDowell, Appellants
in No. 00-3906
Edward Briscoe, Gloria Briscoe, Dale Lewis Tamborella
and Angela Tamborella, Appellants in No. 00-3907
James E. Doiron and Katherine Doiron, Appellants in No.
00-3908
Jeannette Wade and Edwin Wade, Appellants in No.
00-3909
Leila Hartwell, William J. Hartwell, Jennifer J. Still and
Robert Still, Appellants in No. 00-3910
Fitz A. Reid, Etta A. Reid, Lillie Aycock, David Lindsey
Brook and Mary Jane Brook, Appellants in No. 00-3911
Gary L. Drake, David Louviere and Laura M. Louviere,
Appellants in No. 00-3912
Andrew Jackson Key and Linda C. Key, Appellants in No.
00-3913
Paul David Schneider and Linda Gale Schneider,
Appellants in No. 00-3914
Esperanza Prida and Jorge Prida, Appellants in No.
00-3915
Reyes Basilio and Consolacion Basilio, Appellants in No.
00-3916
Ruth Rogoff, Appellant in No. 00-3917
Juan Perez and Maria I. Perez, Appellants in No. 00-3918
Brian McPherson and Kim McPherson, Appellants in No.
00-3919
Audrey Collins, Appellant in No. 00-3920
Jessie H. Elliott, Jr., Appellant in No. 00-3921
Arvie Jernigan, Appellant in No. 00-3922
Lafiro Max Benavides and Irene Benavides, Appellants in
No. 00-3925
John Workman, Appellant in No. 00-3926
Thomas Craig McGowan and Lori L. McGowan, Appellants
in No. 00-3927
Max E. Dick, Sr., Appellant in No. 00-3928
Rhonda Renee P. Lawrence and William J. Lawrence,
Appellants in No. 00-3929
Raymond C. Cummings and Barbara Ann Cummings,
Appellants in No. 00-3930
2
Larry Dale Spooner and Terri Spooner, Appellants in No.
00-3931
William P. Arinder, Betty Arinder, Newman Hearn and
Deena Reese, Appellants in No. 00-3932
Randy W. McKenzie and Kimberly Sue McKenzie,
Appellants in No. 00-3933
Karen A. Dunn and Robert T. Dunn, Appellants in No.
00-3934
Bruce Austin and Frances Austin, Appellants in No.
00-3935
Joan Barton and Joseph Barton, Appellants in No.
00-3936
Joseph Collura and Josephine Collura, Appellants in No.
00-3937
Helene Phyllis Cohen, Appellant in No. 00-3938
Joanne Conley Brown, Appellant in No. 00-3939
Connie Ray Baxley, Jr., Angie Baxley, Dick Habour,
Brenda Sue Harbour, Terry Glen Johnson, Sr., Gerald
Dewayne Jones and Sherry Lynn Jones, Appellants in No.
00-3940
Jonathan Bruce Holley, Elise Holley, Jerry Frank Wetz
and Alice Wetz, Appellants in No. 00-3941
Leverne Anthony, Individually, and as Administrator of
the Estate of Joseph Douglas Anthony, Sr., Appellant in
No. 00-3942
Fred B. Basham and Claudia F. Basham, Appellants in
No. 00-3943
Stanley P. Eagle, Sr. and Ladonna M. Eagle, Appellants in
No. 00-3944
Charles E. Porter, Sr., Carol Jourdan Porter, Raymond
Richard and Goldie P. Richard, Appellants in No. 00-3945
Randall L. Metzler, Appellant in No. 00-3946
Lawrence Damion Hickey, Appellant in No. 00-3947
3
Patricia A. Orlick and Robert Orlick, Appellants in No.
00-3948
Kathy Stockdale and George Stockdale, Appellants in No.
00-3949
Phillip W. Worrell and Janice Ann Worrell, Appellants in
No. 00-3950
John H. O'Connell and Patricia O'Connell, Appellants in
No. 00-3951
Clifford Burt and Barbara Sue Burt, Appellants in No.
00-3952
Chester Allen Morris and Yolan Sybil Morris, Appellants
in No. 00-3953
Salvatore Cali and Genie Cali, Appellants in No. 00-3954
Dean W. Devine and Theresa Devine, Appellants in No.
00-3955
Jason Leigh, Appellant in No. 00-3956
Shirley Baker, Appellant in No. 00-3957
Richard Cullen, Appellant in No. 00-3958
Aline Frances Sears, Albert James Sears, III, John L.
Davis and Louise E. Davis, Appellants in No. 00-3959
Mary Alma Valdez and Alexander Valdez, Appellants in
No. 00-3960
Anthony Wilbur Kyle and Dixie K. Kyle, Appellants in No.
00-3961
Edward Allen, Roxana Paulette Allen, Denise K. Walker,
Allen K. Walker, Annette E. Freeman, Patsy Ruth Elrod
Bell and John Richard Bell, Jr., Appellants in No.
00-3962
Hettie Rovenia Crescini, Benjamin J. Crescini, Sr., James
Fussell, Sherry E. Fussell, Dale C. Hutchinson, Dollinda
Hutchinson, James Paul, Martha Lou Smith Paul, Bobby
Ray Smith, Alvy J. Smith and Martin Carroll, Appellants
in No. 00-3963
Dorris E. Harrell and Margie L. Harrell, Appellants in No.
4
00-3964
Wesley F. Stokes and Linda Gail Stokes, Appellants in No.
00-3965
Derrill B. Manley and Cindy Manley, Appellants in No.
00-3966
Aubrey J. Ledger, Appellant in No. 00-3967
Edward G. Herrera, Individually and as Administrator of
the Estate of Rosie A. Herrera, Appellant in No. 00-3968
William Daniel Stone, Appellant in No. 00-3969
Jerry Whitaker and Patricia G. Whitaker, Appellants in
No. 00-3970
Rita Gariby and Jesse Rubio Gariby, Appellants in No.
00-3971
Patricia Armijo, Appellant in No. 00-3972
Vera L. Berrington and William J. Berrington, Appellants
in No. 00-3973
Terri H. Gibbs, Arlene F. Parker and William Parker,
Appellants in No. 00-3974
Allen J. Montecino, Jr. and Virginia Montecino, Appellants
in No. 00-3975
Gloria Huntman, Appellant in No. 00-3976
John M. Russo and Karen Russo, Appellants in No.
00-3977
Charles Thomas Wahlquist and Tina Rachelle Wahlquist,
Appellants in No. 00-3982
Sammy Melissa Case and Ronnie Case, Appellants in No.
00-3983
Robert Brozewicz and Denise Brozewicz, Appellants in No.
00-3984
Charles Parrott, Allan R. Whitlow, Dorothy Merle Manberg
and Charles Manberg, Appellants in No. 00-3986
Danny L. Harris, Sr. and Cathie B. Harris, Appellants in
No. 00-3987
5
Earl Hicks and Debra Hicks, Appellants in No. 00-3988
Amy Foote Weaselbear, Individually and as Administrator
of the Estate of Archie A. Weaselbear, Appellant in No.
00-3990
Laurie L. Coogler, Dennis K. Coogler, Pamela A.
Underferth, Thomas M. Underferth, Billie A.M. King, Cecil
C. King, James Roger Smith and Vermell M. Smith,
Appellants in No. 00-3991
Steve L. Thompson, Appellant in No. 00-3992
Eulalio "Bobby" Adami, Coy R. Griffin, Sr. and Wilma
Griffin, Appellants in No. 00-3993
Ronald Gene Penny and Teresa R. Penny, Appellants in
No. 00-3994
Shirley A. Plott, Appellant in No. 00-3995
Joan McGhee, Appellant in No. 00-3996
Melvin G. Burks, Appellant in No. 00-3997
Michael Seman, Appellant in No. 00-3998
Ginger Bentley and Henry L. Bentley, Appellants in No.
00-3999
Katherine Celia, Appellant in No. 00-4000
Connie Amelia Corley, Appellant in No. 00-4001
Lonnie Lowe, Appellant in No. 00-4002
Robert J. Berglund, Leslie Ann Berglund, Bruce D.
Bultman, Carol Ching Bultman, Gary L. Ewing, Janet
Walker Ewing, Timothy Scott Rushing and Joan Mary
Rushing, Appellants in No. 00-4003
Nancy G. Brown and Ronald E. Brown, Appellants in No.
00-4004
Candace L. Mathes and Stanley M. Mathes, III, Appellants
in No. 00-4005
Kathleen Burke and Earl Burke, Appellants in No.
00-4006
Clifford R. Swain and Savana G. Swain, Appellants in No.
6
00-4007
James C. Smith and Beverly D. Smith, Appellants in No.
00-4008
Alex A. Driggers and Margie Ann Driggers, Appellants in
No. 00-4009
Isidora Fuselier, Albert J. Fuselier, Michael Lee Andrus
and Mark A. Bullard, Appellants in No. 00-4010
Harry Alan Bowser and Ronda L. Bowser, Appellants in
No. 00-4011
Michael D. Holloway, Appellant in No. 00-4012
Lillian Marchegianni and John Marchegianni, Appellants
in No. 00-4013
Jerry DeWayne Harrison and Mary M. Harrison,
Appellants in No. 00-4014
M. Mary Coleman, Appellant in No. 00-4015
Jessie Flores and Mary I. Frias Flores, Appellants in No.
00-4016
Kap Jong Lee and Sung Wan Lee, Appellants in No.
00-4017
Richard Fontenot, Peggy Sue Fontenot and Perry Bang,
Appellants in No. 00-4018
Wallace Wade Prahser and Donna Prahser, Appellants in
No. 00-4019
James W. Ervin, Jr., Appellant in No. 00-4021
Larry Hugh Gibson and Connie Marine Gibson, Appellants
in No. 00-4022
Leonard Otis Smith and Hazel M. Smith, Appellants in
No. 00-4023
J.P. Parker, Appellant in No. 00-4024
Bruce W. Shepherd and Lorene B. Shepherd, Appellants
in No. 00-4025
James Toskes, Appellant in No. 00-4026
7
Priscilla Fontenot, Lester Joseph Fontenot, Lee Anna
Scott, Arthur Scott, Jr., John Goodman, Gertrude
Goodman, Janice Reed, David Reed, Deidre Guillory,
Barbara L. Comeaux and Leander Comeaux, Appellants in
No. 00-4027
Marilyn A. Greiner and Emil D. Greiner, Appellants in No.
00-4028
Jamie Lee Samuels and Thad J. Samuels, Appellants in
No. 00-4029
Merle L. Jensen, David Bernard Jensen and David
Rounkles, Appellants in No. 00-4030
Melissa Ann Chandler, Appellant in No. 00-4031
Thomas Levon Jones and Beverly Jones, Appellants in No.
00-4032
Irene Portillo, Appellant in No. 00-4033
Theodore N. Helton and Josephine T. Helton, Appellants
in No. 00-4034
Grant Edward Tingstrom, Cathy J. Carrick, David L.
Carrick, Sr., John Shaver and Diana Shaver, Appellants
in No. 00-4035
William D. Sipes and Thelma G. Sipes, Appellants in No.
00-4036
George Love and Rosemary Love, Appellants in No.
00-4037
Joseph Anthony Strange, Appellant in No. 00-4038
Frank L. Bowes and Lollie Bowes, Appellants in No.
00-4039
Bruce Anthony Davis and Mary Ann Davis, Appellants in
No. 00-4040
Gaty M. Jones and Janice A. Jones, Appellants in No.
00-4041
Elizabeth Bablitz and August E. Bablitz, Appellants in No.
00-4042
Caridad Perez, Rogelio Perez, Michael Joseph Smith,
Rebecca A. Smith and Maria C.P. Bezara, Appellants in
8
No. 00-4043
Vall R. Williams and Zolla Williams, Appellants in No.
00-4044
Kimberly DeRose, Michael J. DeRose, Salvatore Babriele,
Jr. and Sandee Gabriele, Appellants in No. 00-4045
Billy Hines and Brenda Hines, Appellants in No. 00-4046
Michael Scott Schirmer and Patsy Schirmer, Appellants in
No. 00-4047
Denis Ray Dunlap, Bernadette Dunlap, George R. Wiley,
Judy Mize Wiley, Jeffery Lynn Miller and Donna Miller,
Appellants in No. 00-4048
Cynthia Jo Lackey and Joseph Lackey, Appellants in No.
00-4049
Marsha Stites, Appellant in No. 00-4050
James Joseph Morway and Kristie Jo Morway, Appellants
in No. 00-4051
Sandy Price and Michael L. Price, Appellants in No.
00-4052
Robert Shehan and Cleta Shehan, Appellants in No.
00-4053
Theresa L. Fitzgerald and John Patrick Fitzgerald, Jr.,
Appellants in No. 00-4054
William G. Warthen, Appellant in No. 00-4055
Roy H. Dedman, Nicole Dedman, David P. Abeyta and
Lorri S. Abeyta, Appellants in No. 00-4056
Carroll D. Harris and Sharon Kay Harris, Appellants in
No. 00-4057
Jerry Dale Arnold, Bonnie Sue Arnold and Elizabeth
Cullen Ohrum, Appellants in No. 00-4060
Jackie C. Crenshaw and Rosetta A. Crenshaw, Appellants
in No. 00-4061
Linda Patten Hitchcock and Dennis A. Hitchcock,
Appellants in No. 00-4062
9
Frans R. Dorris and Dianne Reichenbacher-Dorris,
Appellants in No. 00-4063
James Stroderd and Paula Stroderd, Appellants in No.
00-4064
Kathy Diane Young and Billy Dale Young, Appellants in
No. 00-4065
Gregory H. Hardin, Appellant in No. 00-4066
Raymond Nolan, Jr., Appellant in No. 00-4067
Michael Galloway and Pat Galloway, Appellants in No.
00-4068
Frank L. Dachenhausen and Thelma I.F. Dachenhausen,
Appellants in No. 00-4069
Carmine A. Cilella and Gabriella Cilella, Appellants in No.
00-4070
Ronald Leroy Lee, Linda Lee Castleberry and H.L.
Castleberry, Appellants in No. 00-4071
David Onger, Appellant in No. 00-4072
James T. Livingston, Jacqueline A. Livingston, Ronald
Wayne Dean, Nanni P. Dean, William E. Boyer, Sr, and
Melanie Kay Boyer, Appellants in No. 00-4073
Kenneth Kulhanek, Appellant in No. 00-4074
Rosemary K. Barotti, Peter W. Barotti, Kathryn McBratney
and Jeff McBratney, Appellants in No. 00-4075
Billy Holbrook and Sherrie Holbrook, Appellants in No.
00-4076
Robert Geib and Donna Marie Geib, Appellants in No.
00-4077
Joyce Ann Robichaud, As Administrator of the Estate of
Ray Robichaud, Appellant in No. 00-4078
Jimmy Shoemaker and Annette Shoemaker, Appellants in
No. 00-4079
Jose Luis Rivera, Concepcion Rivera, Roslyn Del Pradia
Wilson and Henry E. Wilson, Sr., Appellants in No.
10
00-4080
Bertha A. Salazar Vasquez and Hector G. Vasquez,
Appellant in No. 00-4081
Donald Lynn McKeown and Janice McKeown, Appellants
in No. 00-4082
Pauline Strickland White and Henry Willis White,
Appellants in No. 00-4083
Jerry Dale Lewis and Mary D. Lewis, Appellants in No.
00-4084
Opal A. Parham, Appellant in No. 00-4085
Hazel Dueitt Sweatt and Earl Lynn Sweatt, Appellants in
No. 00-4086
Marilyn Fitzgerald, Appellant in No. 00-4087
Alice McKinnon Clayton, Appellant in No. 00-4088
Maria De La Cruz and Miguel Angel De La Cruz,
Appellants in No. 00-4089
Barbara Ann Bruzer and Dale Eugene Bruzer, Appellants
in No. 00-4090
Joseph Lee Castle and Sandra Collins Castle, Appellants
in No. 00-4091
Patricia Ann Hill and William A. Hill, Appellants in No.
00-4092
Annie Ruth Fralick, Appellant in No. 00-4093
Thomas James Olsen and Gloria M. Olsen, Appellants in
No. 00-4094
Linda Newberry and Dave Newberry, Appellants in No.
00-4095
Estate/Heirs of Sharon Alderman*, Estate/Heirs of Ralph
C. Anderson*, Todd Anselmo, Judith E. Anselmo, Phil
Barber, Janice M. Barmore, Julie P. Barrack, Daniel W.
Bartelt, Robert E. Bennett, Lois K. Bergsjo, Andrew L.
Barry, Rebecca J. Boe, Clairce E. Boggs, Barbara Kay
Bremer, Pamela M. Brewster, Morton G. Brill, Lenore
Brill, Alonzo Brown, Vicki J. Brusewitz, James Buresh,
11
Betty Butler, John Butler, Arlene V. Carlson, Diane L.
Cassidy, Dennis Cassidy, Julie A. Charette, Dale Charette,
Brian K. Ciske, Denise Cook, Muriel A. Crowley, Lillie M.
Dabney, Timothy J. Dickau, James Douglas, Cheryl M.
Douglas, Leona S. Ehnert, Majorie A. Etzel, Daniel M.
Etzel, Cary M. Femrite, Robert L. Fields, Elizabeth A.
Fischman, Donald J. Flower, Scott Fullex, Dennis J.
Gallagher, Michael A. George, Calvin W. Gilbo, Sr., Donna
C. Green, Sharon L. Griffin, Eloy Guzman, Sr.*, Roberta
E. Hammerlind, Patricia L. Heidelberger, Raymond C.
Hermanson, Gail Hermanson, Mark W. Herrman, Cynthia
Herrman, Judith I. Hughes, Reginald F. Hughley, Todd W.
Illies, Michael W. Iverson, Gayle E. Johnson, Dale
Johnson, Janice M. Johnson, Daniel Johnson, Peter H.
Johnson, Peggy Johnson, Cindy Osborne Keim, Barbara
A. Kern, Karen M. Klein, Katherine E. Koehler, Barbara J.
Kunshier, Robert B. Kwasigroch, Estate/Heirs of Robert A.
Laessig*, Estate/Heirs of Frances Laessig*, David G.
Lewandowski, Donnie K. Lilly, Donald J. Lisk, Patricia A.
Lilly, Nancy L. Lisk, Craig W. Locher, Jodi Locher, Patricia
J. Mandli, Michael M. Martinson, Anthony Martorana,
Jean J. Martorana, Lorraine B. Mathis, Ethel McClain,
Michael R. McConnell, Donald R. McRae, Jacqueline E.
McRae, Virginia A. McVicker, William McVicker, Wendell
D. Meeker, Marjorie L. Melinski, Shirley A. Moen, Marcy
Myers, Jean A. Ness, James Ness, Jack C. Nicholson,
Kathleen L. Nicholson, Cheryl M. Novotny, Richard A.
Novotny, Larry J. Novotny, Claudette M. Novotny, Dennis
W. Olson, Margery Olson, Ronald W. Olson, Randy R.
Otto, Joan A. Pasowicz, Joseph Pasowicz, Stephen E.
Paxton, Lisa M. Lugo-Paxton, Frederick L. Peck, Tina J.
Peck, Estate/Heirs of George J. Pesek*, Estate/Heirs of
Katherine H. Pesek*, Estate/Heirs of Eugene S. Prantner*,
William Peters, Lucille L. Peterson, Suzanne R. Petrusic,
Walter Petrusic, Robert J. Plaksy*, Sharon Plaksy*, Ratsy
Rathke, Arlene E. Reed, Ronald Reed, Rick Reizer, Jeffrey
Richie, Debra A. Richie, Ricky K. Romaine, Lloyd Rose,
Larry S. Rudolph, Lee R. Rysdam, Marija Rysdam,
Richard H. Salverda, Rosemary Schibley, Phillip E.
Schmidt, Margaret A. Schmidt, Jeanne E. Skarda,
Raymond T. Sobotta, Lee A. Solomon, Michael J. Spartz,
Glee H. Spartz, Steven G. Starker, Edward J. Tentis,
12
Gerard A. Theis, George E. Toth, Barbara Toth, Victor
Towler, Barbara J. Venne, Mary Weinstein*, Milo D.
White, Stefanja Z. Wojtczak, Jay H. Wyttehove and John
W. Zink, Sr., Appellants in No. 00-4098
(*Caption amended per Court's Order dated 8/27/01)
James D. Bitzer, Charity A. Bitzer, James A. Mortensen,
Dennis Raymond, Marlene Raymond and Mary L. Yeager,
Appellants in No. 00-4099
Douglas J. Callaway, Dana Callaway, Ronald R. Sivak,
Ann M. Weiler and Norbert Weiler, Appellants in No.
00-4100
Richard E. Almquist, Patricia E. Almquist, Kathie L.
Avery*, Charles W. Avery, Gerald T. Baron, Margaret L.
Bennett, Geneva G. Bissonette, William D. Bolton, Jr.,
Joan Bolton, Jeanne A. Borkowicz, Ronald J. Borkowicz,
Mark A. Chapman, Arthur L. Cotter, Barbara A. Cotter,
Lynda M. Dahl-Kocurek, Silviu Dan*, Estate/Heirs of
James Domaszek*, George I. Florek, Jeanne Florek, Debra
G. Fox, Joseph Fox, Herman Haayer, Jr., Pamela Haayer,
Darlene D. Halder, Robert A. Hayes, Leah J. Henkel,
Donald E. Hereau, Dorothy J. Hereau, Steve C. Hesse*,
Nancy Hesse*, Estate/Heirs of Judy Jolly*, Wayne Jolly*,
Michael J. Kaiser, Jody A. Lagergren, Todd Lagergren,
Lois J. Lenzo, Gale R. Mattison, Ruby R. Pabelick,
Michael D. Platts, Kathy Platts, Richard A. Pynenberg,
Donna Rau, Glenn Rau, Judith G. Richart, Robert
Richart, Jeffrey Richie, Debra A. Richie, Robert L.
Schmalfeldt, Lori J. Schmalfeldt, Lonnie C. Shelley,
Sharon Shelley, Sharon L. Swanson, Joan M. Valenty,
Mary L. Yeager and Charles A. Zinn, Appellants in No.
00-4101
(*Caption amended per Court's Order dated 8/27/01)
Michael K. Bentley, Marlene E. Bergeron, Joyce A.
Bushrod, Robert R. Burns, Hanna Cahsai, Gail R.
Copeland, Faye R. Copeland, Denise Cook, Lillie M.
Dabney, Becky L. Dykes, Jerome T. Engel, Robert L.
Fields, Mark D. Frakes, Gina Frakes, George C. Gonzalez,
Brenda Gonzalez, William A. Green, Martha J. Green, Lois
A. Hartwig, David L. Hartwig, Charles W. Hughes, Deane
M. Hughes, Robert J. Johnson, Joan Johnson, Eileen E.
13
Kaiser, Cindy Osborne Keim, Allen Kline, Jeffrey A. Koch,
Laura J. Kollmer, Chris J. Kollmer, Michael A. Lachapelle,
Donald J. Lisk, Nancy L. Lisk, Mitchell Pezanoski, Mary
Pezanoski, Kenneth E. Retkowski, Gayle Retkowski,
Joseph P. Schoenborn, Dawn J. Shelton, Darryl C.
Shelton, Michael J. Spartz, Glee H. Spartz, Steven G.
Starker, Danette T. Tellijohn, Richard A. Theisen, Michael
Thompson, Victor Towler, Timothy P. Tucker, Mary
Weinstein*, Theresa Bichler Wichman and Mark J.
Wietzke, Appellants in No. 00-4102
(*Caption amended per Court's Order dated 8/27/01)
Holly Bair*, Walter Austin, Hubert W. Bellisle, Mary J.
Bellisle, Andrew L. Berry, Marlene M. Biggins, Thomas
Biggins, James J. Breen*, Thelma Breen*, Estate/Heirs of
Robert J. Brown*, Vivian Brown, Karen R. Callahan,
Cathleen A. Crandall, Albert A. DiCruttalo, III, John
Doherty, Robert C. Duisen, Jr., Carla J. Ford, Dana W.
Frank, Joann C. Frank, John C. Frank, Gail R. Frank,
Estella Gamez, Linda S. Gipson, Donald F. Goold, Joan
M. Goold, Mitchell E. Grav, Carolyn M. Hendley, Theron
Hendley, Timothy Hill, Patricia F. Kearns, Dorothy M.
Kinn, Florence I. (Wong) Lakin, Valerie E. Lennon, Jack
W. McGillivray, Beatrice McGillivray, Kurt R. Meintsma,
Brenda L. Moorer, Tillman E. Olson*, Victoria M. Olson,
Ruth H. Perkel, Malcolm Perry, Monica Perry, Jack
Robinson, Gregory Rubbo, George N. Ruzynski, June
Ruzynski, Anna M. Scully, Lee A. Scully, Scott Silva,
Michael J. Spartz, Glee H. Spartz, Steven Staudt, Tracy
Staudt, Allen R. Terry, A. Thorne, Sandy Thorne, Victoria
L. Valente, Ralph Abagian, Judy M. Walker, Estate/Heirs
of Gerald F. Wehler*, Marjorie Wehler, Frank J. Williams
and Angie Williams, Appellants in No. 00-4103
(*Caption amended per Court's Order dated 8/27/01)
Christine M. Anderson, Oscar Bernal, Gail R. Copeland,
Faye R. Copeland, Steve Ferguson, Cindy Osborne Keim,
Robert LaBlanc, Melvin Martin, Brooke Meyers, Riley L.
Norris, Joyce Norris, Daniel P. Monson, Janet Smith, Bob
Smith, William J. Vlasek, Doris Vlasek, William
Walkenbach, Paul B. Wall, Sandra Weaver and Judy M.
Walker, Appellants in No. 00-4104
James D. Ash, Cynthia Ash, Estate/Heirs of Sharon
Alderman*, James R. Ashley, Mary A. Aune, Holly Bair*,
14
Edward Barnes, Donald L. Beckman, Debra S. Beckman,
Emma L. Bennike, Robert E. Bennett, Nancy L. Brett,
Gregory Brett, Joyce A. Bushrod, Karen R. Callahan, Traci
W. Chapman, Gail A. Christian, Dorsey W. Cole, Carla J.
Colombo, Belinda M. Cook, Scott M. Daniels, Robert C.
Degeest, Thomas K. Dillon, Jeanne M. Garchek, Cecil P.
Gibby, Betty Gibby, Carolyn Gibson, Raymond A. Golden,
Estate/Heirs of Essie L. Goldsmith*, William A. Green,
Martha J. Green, Bobby Harrison, Everett E. Hendrickson,
Pat Hendrickson, Joan C. Hochbrunn, Thomas
Hochbrunn, Bertha E. Hokkanen, John Hokkanen, Julie
A. Hunt, Renee M. Janusz, Mary L. Johnson, Alan K.
Johnson, Thomas W. Keene, Rosalie G. Keene, Nancy J.
Kellam, James Kellam, Paul W. Kelly, Gerald J. Kernan,
Jeffrey A. Koch, Benjamin F. Korfe, John A. Kraus, Jr.,
Karen J. Lyons, Donald Lyons, Jr., Estate/Heirs of Mae
V. Martin*, Calvin Martin, Melvin Martin, Gary P.
McFarland, Jody McFarland, Alan R. McGee, Virginia A.
McVicker, William McVicker, Robert Mertens, Brooke
Meyers, Catherine J. Muha, Harold Mulcare, Randy A.
Murray, Tracy Murray, Maxine T. Narog, Steve R.
Newman, Linda Newman, Randy R. Otto, Freddie L.
Owens, Paulina Pappas, John R. Pappas, Kay Parr, James
H. Parsons, Janet S. Parsons, Estate/Heirs of Norman
Persten*, Richard J. Pietrzak, Karla Pietrzak, Frances H.
Popham, Ronald Richards, Wayne W. Richards, Debra
Richards, Kathleen Richardson, Luis Rivera, Roland C.
Roberts, Patricia Roberts, Rose M. Robinson, James F.
Robinson, Michael S. Ryan, John C. Salas, Howard D.
Sams, Marion A. Sams, David R. Scalise, Clarence I.
Seaburg, Joseph A. Sherry, William J. Skobjak, Annette
Skobjak, Beulah E. Skoog, Lee A. Solomon, David J.
Stanoch, Denise A. Stanoch, Marlette C. Steinke, Kathryn
L. Stout, Denzil L. Stout, Michael D. Supple, Mary B.
Supple, Danette T. Tellijohn, Gerrye W. Tippens, Jerry
Tippens, Albert E. Topolski, Brian Vaughn, Tom E.
Wadsworth, Estate/Heirs of Gerald F. Wehler*, Marjorie
Wehler and Roberta Zimmerman, Appellants in No.
00-4105
(*Caption amended per Court's Order dated 8/27/01)
15
Donald Lombard, William C. McPhail and Estate/Heirs of
Charles D. Reynolds*, Appellants in No. 00-4106
(*Caption amended per Court's Order dated 8/27/01)
Joanne Benton, Michael Sita, Beverly Sita, Gregory
Osburn, Joy Osburn, Kelly D. Cowan, James Smith, Judy
Smith, John Horton, Sandra Horton, Geraldo Feregrino,
Laura Feregrino, Phillis Driver, Julian Whitten, Debra
Whitten, Deva Buttram, Edward Buttram, Henry J. Klein,
Patricia LaBree, Amos Jenkins, Linda Jenkins, James H.
Reske, Sr., Ned Johnson, Maxine Johnson, Paula
Watkins, Eyssel Gurganus, Henry Gurganus, Victoria B.
Jones, Kirby Tharrington, Betty M. Brantley, Phyllis Perry,
Claude Perry, Mary Thatch, John Thatch, Leotha Forte,
Phyllis Forte, Emily Ennis, Lilyn D. Taux, Dilcy L. Hall,
Carlton Parris, Joseph Amos, Christopher Poole, Missouri
Garner, Victor Garner and Cynthia Esposito, Appellants in
No. 00-4107
Donna Marie Beauchemin, Aaron Wayne Calk, Debra
Calk, Vincent Foster Cochran, Peggy Joyce Cochran, Mary
N. Hix, John M. Hix, Nicholas Host, Debra Ann Host,
David S. Lambert, Donnalyn Acosta, Robert E. Lee, Kathi
Lewis, Shirley Lewis, Roger W. Lovell, Brenda Kay Graves
Lovell, Gilbert Martinez, Jr., Maria Martinez, Ralph M.
Nielsen, Marie J. Nielsen, David Perry, Brian Quinn,
Cheryl Ann Smith, Donald Smith, David L. Spottek,
James Swisher, Richard Lynn Thornton, Paul Williams,
Barbara Jean Wilson, B.E. Wilson, Catherine A. Wright,
Michael A. Bloomfield, Leslie J. Bloomfield, Kathleen
Burke and Earl Burke, Appellants in 00-4108
Sherry Adams, Daniel Ray Adams, Betty C. Alisouskas,
Vincent F. Alisouskas, Dwayne Junior Allen, Doylene
Todd Allen, Richard Lee Allen, John D. Austin, Tami
Austin, Robert Lee Baker, Cecil W. Barnett, Glenda Mae
Harper Barnett, Vivian K. Basham, Arice M. Basham,
Lucy Frances Bauman, Thomas Richard Bauman, Sr.,
Michael Belliveau, Lisa Belliveau, David Benavidez, Teresa
Garcia Benavidez, Betty Jean Bennett, Betty Joanne
Benning, Anthony P. Bertrand, Evelyn Sue Bertrand,
James Charles Besch, Bernice Ann Lay Besch, Deborah
Best, Joseph C. Best, Ronald Coburn Billings, Tina Marie
16
Billings, Patricia Ann Blackledge, Buddy W. Blackledge,
Sr., John William Blasko, Daniel L. Blemke, Beulah A.
Boatsman, Stanley Dale Boogs, Linda Carolyn Latham
Boggs, Lynn H. Boles, Juanita Frogge Boles, Aulpheda
Bonner, Jimmy T. Bonner, Melton Jack Book, Charlotte
Book, Dennis P. Borghesi, Gayle Borghesi, Dorothy H.
Bower, Marvin Lee Bower, Lora A. Bower, Bonnie F.S.
Brinegar, Rocio Mier Brodd, Wayne M. Brodd, Agnes Jean
Brothers, William L. Brothers, Marvin J. Brouillette, Sr.,
Mary Lois Brouillette, Edgar Steve Brown, Tina R. Miers
Brown, Lynn Jimette Brown, Michael Lynn Brown,
Leonard Bushnell, Katherine Bushnell, Larry G. Carlson,
Pamela G. Carlson, Luis H.G. Casanas, Arvie L. Causey,
Doyle E. Chamblee, Hilda M. Chamblee, James H.
Chambless, Richard D. Chandler, Stephanie W. Chandler,
Vyron Breen Cherry, Dana Delores Marvin Cherry, James
L. Christina, Susan Y. Christina, Ethel Coffman, Dennis
D. Compton, Jerri Sue Compton, Harry C. Conner, Sr.,
Melina J. Conner, Randall C. Corbello, Rita M. Corbello,
James Cottrell, Lois Couvillion, Estine Covillion, Peter L.
Covert, Susan K. Covert, Rodger K. Cox, Edith Mills-Cox,
Jack Craycraft, Phyllis Craycraft, Timothy Cunningham,
Jennifer Cunningham, Richard Daniel, Debra J. Daniel,
Mark Dixon DeHaven, Robin Lynn DeHaven, Lou Ella
DeVille, Ty Dwayne Dick, Audrey Ann Dick, Sally M.A.
Dickinson, Richard Dickinson, James Doherty, Shirley L.
Dollarhide, Gerald J. Dollarhide, Marion Domer, Valerie
Domer, Janice Miller Dowdy, William E. Dowdy, Richard
Drumheller, Patricia Ann Crane Dulny, Roberta N. Dunn,
Eugene D. Dunn, Jr., Lisa Hoens Guest DuPont-Aguillard,
Joseph M. DuPont, Russell G. Einolander, Phyllis Lynne
Elliott, Randall C. Elliott, Roger Keith Emrick, Penny Jae
Emrick, Judy Evans, Howard L. Evans, Fred Preston Cone
Evatt, Sr., Trubee Laverne Evatt, Edith G. Fewell, John
Thomas Fewell, Robert J. Firek, Kathleen Mary Firek,
Mary Frances Flory, Theresa M. Foltz, Louis Foltz, George
M. Fontenot, Juanita C. Fontenot, Wilbert Fontenot, Reata
Fontenot, Selby Clyde Ford, Dorothy C. Ford, Cynthia
A.O. Foxworth, Debbie Fredette, Ernest A. Freeman, Ellen
R. Fretty, Earl J. Fruge', Susan Fruge', Mark D. Fuller,
Rosalva Fuller, George E. Garcia, Sally A. Garcia, Maxine
Joan Gardetto, David T. Gardner, Leo Gardner, Jr.,
17
Beverly Sue Gardner, Gertrude Gautreaux, Kimberlee
Gavosto, Darrin Gavosto, Murry C. Gear, Claretta I. Getts
Gear, Greg Gillum, Jr., Ruth A. Gillum, Marietta L.
Gjertsen, Brian Todd Glowka, Kristi L. Glowka, Patricia
Grant, Forrest Griffin, Judith A. Potthast Griffin, Eva
Grimes, Jerry Grimes, John S. Hallmark, Sr., Wanda J.
Michaels-Hallmaker, Mark E. Hanson, Brenda Hanson,
David Earl Hardy, Gloria D. Brooks Hardy, Louis Edward
Hatsfelt, Sr., William Hayes, Linda E. Hayes, Patricia
Henderson, Frank L. Herron, Cassandra Herron, Marie
Black Hinson, Robert Steven Hinson, Nelson Hoffpauir,
Rose Marie Holder, Timothy L. Hurd, Brenda Hurd, Lanny
Jackson, Dora Ann Jackson, Joseph J. Jarmasek, Sr.,
Barbara Jarmasek, Walter Jeane, Mary H. Jeane, Carol
Elaine Jewitt, Michael H.A. Jewitt, Edward Grant
Johnson, Hazel Ross Johnson, L.C. Johnson, Dixie
Brannon Johnson, Edna Lee Jones, Merleyn C. Jones,
Victor L. Jones, Sharon Jones, Earl Jordy, Jr., Anita
Jordy, Robert Kaminski, Linda Kaminski, Richard D.
Kidd, Marlene Kidd, Thomas V. Kilgore, Penny
Kilgore-Thomas, Barbara L. King, Deryl D. King, Victor
Clyde Knapp, Jr., Deborah Kay Knapp, George Alvin
Knight, Linda Sue Knight, Mary Kroupa-Casey, Kevin P.
Casey, Andrew D. Kubiczki, Mary Kubiczki, Joanne L.
Kuci, Feta Hysen Kuci, James A. Kuhns, Clay Carlton
Kutscher, Helen Lamontagne-Eddy, Leona Lapradd,
Ronald D. Larabee, Peggy Larson, Everett Larson, Patsy A.
Lehmann, Paul Alton Livingston, Darrell W. Logan,
Rebecca Logan, Sylvia G. Loucks, John Foster Loy, James
E. Malenfant, Suzanne M. Malenfant, Zetty Malone, John
F. Manley, Carlene E. Mansfield, Richard Marble, Inda
Marble, Gary M. Marks, Clara D. Marrs, Gordon Ray
Marrs, Debra K. Martin, Lyle E. Martin, Sandra Mason,
Floyd Mason, Jacqueline B. Mauldin, Arthur Lewis
Mauldin, William Lee McDuell, Birdie J. McDuell, Kevin L.
McGaw, Becky Anderson, Arthur James McHugh, Mary
Ann McHugh, Tony McKnight, Alex Mercado, Joann
Mercado, Rachel Miller, Anthony Miranda, James Felton
Mitcham, Lynn Mitcham, Evelyn Marie Mitchon, Kenneth
H. Moore, Linda A. Moore, Ronnie Moore, Marva Moore,
Myra Helen Moreau, J.R. Moreau, Kathleen H. Morris,
Richard Morris, Donald Bruce Mountjoy, Kathleen
18
Connor, Paul Mouton, Patricia M. Mouton, Katheryn D.
Mueller, Allan G. Mueller, James Murphy, Beverly
Blassingane Murphy, Robert E. Murphy, Bonnie Murphy,
Kimberly Naglich, Mark T. Naglich, Steve A. Nave,
Katherine L. Nave, Jerry W. Newman, Mary Newman, Max
H. Nix, Marilyn Joyce Nix, Brigitte H. Noorlander, John A.
Noorlander, George E. O'Bryant, Alice Lightly O'Bryant,
Richard S. Parker, Sylvia Inez Parker, Bobby Pelfrey,
Stanley Perlstein, Gerald W. Pettifield, Ronald Plesz, Velda
B. Plesz, Carolyn Rene Posey-Bond, Robert Clayton Bond,
Michael G. Queen, Janice G. Queen, Kenneth P.
Rainwater, Darlene S. Rainwater, Vicki Diana Jarrell
Ramey, Richard Dale Ramey, Janet Ranney, Donald H.
Ranney, Deborah Dee Reimund, Terry Allen Reimund,
Sheri Lynn Revers, James Revers, Sharon Rewis, John
Rewis, Jr., Shelia A.H. Rinehart, Ellis W. Rinehart, Danny
Lee Ringo, Debra Ringo, Joan K. Roberts, Tommy L.
Roberts, Patricia Ann Roberts, Dexter Robinson, David L.
Ross, Carol Ross, John Ryan, Lawrence W. Salminen,
Teddy Salmon, Anita Joy Salmon, Keith Watson
Sandeford, Donna Baird Sandeford, Michael J. Schlaikjer,
Christina Lynn Schlaikjer, Carlton William Schmidt, Peggy
R.U. Schrier, Marylyn Ann Schultz, Roy Schultz, Leo G.
Scott, Sheila G. Scott, Louis Servin, Donna Servin, Steven
R. Shafer, Janice Shafer, Jane L. Shoe, Mary Ann Shores,
James B. Shores, Tommie C. Shoulders, Lorraine
Shoulders, Elton Son Shults, Thomas Dudley Sides, Rosa
F. Silva, Heriberto Silva, Martin Simmons, Diane
Dille-Simmons, William B. Skelton, Sr., Agnes Lucille
Skelton, Darrell Slape, Miriam P. Slavich, Ivan L. Slavich,
Alfred Andrew Smith, Martha Jane Smith, George Smith,
Elizabeth F. Smith, James Roger Smith, Vermell McBride
Smith, Terry Eugene Smith, Penny Talley Smith, Kevin G.
Spencer, Nikki Spencer, Charles F. Stacks, Sarah Jan
Stacks, Jerry Stephenson, Brenda J. Stinson, Max E.
Stinson, Paul H. Stockton, Nancy E. Stockton, Margie
A.B. Stone, Vernon Odell Stone, Richard W. Stull, Donna
Wojtasinski Stull, William P. Sturgeon, Audrey M. Tallant,
Roger Dennis Watkins, John Tarka, Lorriane A. Tarka,
Michael Franklin Taylor, Denise King Taylor, Nicholas
Tentzeras, Dwight H. Terrell, Billy P. Thaggard, Linda
Thaggard, Frances E. Thibodeau, Larry Thomas, Annette
19
Marie Thomas, James F. Thomason, Mark A. Thornton,
Donna L. Bonin Thornton, Terina Smith Threadgill, Larry
E. Threadgill, Jr., James E. Timberlin, Sr., Frank E.
Tomlinson, Donna Elizabeth Tomlinson, Diane Elaine
Tresfon, Dewey Ronald Tubb, Charlotte P. Tubb, Richard
C. Tucker, Deborah S.B. Turner, Harry D. Turner,
Virginia F. Turner, Wendell Turner, Sr., Brian P.
Vannatta, Charles P. Votruba, Denise C. Votruba,
Kenneth Wade, Dianna Wade, James C. Walston, Sr.,
Ethel Marie Walston, James A. Ward, Kathleen Ward,
Sharon R. Ward, Bruce L. Ward, John Layton Webb,
Clark Welcher, Sharyl Welcher, Marie D. White, James S.
White, Donald Edward Wilder, Betty Jane Murray Wilder,
Cecil Williams, Jane Watson Williams, M. Teresa Willis,
Larry N. Wilson, Octavia Wilson, Stephen W. Wilson, Lisa
Wilson, William C. Winders, Virginia Winders, Rondell
Vernon Wood, Dolores Laverne Wood, Tracy L. Workman,
Janine Lee Workman, Kristine E. Young, Charles Drake,
Priscilla Fontenot, Lester Joseph Fontenot, Thomas C.
McGowan and Lori L. McGowan, Appellants in No.
00-4109
On Appeal From the United States District Court
For the Eastern District of Pennsylvania
(MDL No. 1014)
District Judge: Honorable Louis C. Bechtle
Argued: June 28, 2001
Before: BECKER, Chief Judge, NYGAARD and
REAVLEY,* Circuit Judges.
(Filed August 31, 2001)
_________________________________________________________________
* Honorable Thomas M. Reavley, United States Circuit Judge for the Fifth
Circuit, sitting by designation.
20
John J. Cummings, III, Esquire
Frank C. Dudenhefer, Esquire
(Argued)
Cummings, Cummings, &
Dudenhefer, A.P.L.C.
416 Gravier Street
New Orleans, LA 70130
Karen Cody-Hopkins, Esquire
Ronald S. Goldser, Esquire
Zimmerman, Reed, P.L.L.P.
901 North Third Street, Suite 100
Minneapolis, MN 55401
David A. Vesel, Esquire
Law Offices of David A.
Vessel, P.A.
8212 Creedmoor Road,
Suite 101
Raleigh, NC 27613
Counsel For Appellants
Stuart E. Schiffer, Esquire
Acting Assistant Attorney General
Michael Levy, Esquire
United States Attorney
Eastern District of Pennsylvania
Mark B. Stern, Esquire
Charles W. Scarborough, Esquire
(Argued)
Attorneys, Appellate Staff
Civil Division, Room 9611
U.S. Department of Justice
601 D Street, NW
Washington, DC 20530-0001
21
Margaret Jane Porter, Esquire
Chief Counsel
Patricia J. Kaeding, Esquire
Associate Chief Counsel
Food and Drug Administration
5600 Fishers Lane
Rockville, MD 20857
Counsel For Appellee
OPINION OF THE COURT
REAVLEY, Ciircuit Judge.
This Federal Torts Claims Act (FTCA) claim against the
Food and Drug Administration (FDA) for granting clearance
to market certain types of pedicle screw fixation devices
(referred to generally as bone screws) was dismissed by the
District Court pursuant to the discretionary function
exception to the FTCA.1 Appellants contend here that this
jurisdictional exception should not apply because FDA
officials were guilty of misconduct in the process of granting
the clearance, and because Appellants should have been
given more opportunity to discover proof of that
misconduct. Moreover, Appellants argue that, even if the
discretionary function exception does apply to the aspect of
the bone screw clearance process challenged in their suit--
i.e., the clearance of bone screws based on their substantial
equivalence to devices already on the market--the exception
does not bar Appellants' claims because the FDA's
substantial equivalence determination does not involve the
requisite element of judgment and choice, and is not the
type of policy-based decision that the exception is designed
to protect. Because the record establishes the Court's lack
of jurisdiction, we will affirm.
BACKGROUND
Thousands of plaintiffs nationwide claim to have suffered
injuries resulting from the surgical implantation of bone
_________________________________________________________________
1. 28 U.S.C. S 2680(a).
22
screws in their spines and have sued their doctors and the
manufacturers of the screws; and, as is relevant here, some
two hundred have also sued the federal government. These
actions have been consolidated by the Judicial Panel on
Multidistrict Litigation and transferred to the Eastern
District of Pennsylvania as MDL No. 1014.2
1. Regulatory Process
Its is undisputed that marketing of the bone screws is
regulated by the Federal Food, Drug, and Cosmetic Act,3 as
amended by the Medical Device Amendments of 1976 (MDA).4
At the time the lawsuits were filed, the FDA had classified
the bone screws as Class III devices, a categorization
reserved for devices presenting "a potential unreasonable
risk of illness or injury."5 Before Class III devices can be
marketed, they must receive "premarket approval" from the
FDA6 or, alternatively, they must qualify for FDA clearance
based on a substantial equivalence determination. 7 It is a
criminal offense to introduce a Class III medical device into
commerce without approval or clearance.8
Because premarket approval is a lengthy, formal, and
thus costly process often involving clinical trials under FDA
supervision,9 most new Class III devices enter the market
through FDA clearance.10 New Class III devices qualify for
_________________________________________________________________
2. The circumstances of this litigation have received more comprehensive
attention elsewhere than is required in this appeal. See, e.g., Buckman
Co. v. Plaintiffs' Legal Comm., 121 S. Ct. 1012, 1015-16 (2001); In re
Orthopedic Bone Screw Prods. Liab. Litig., 193 F.3d 781, 784-87 (3d Cir.
1999).
3. Federal Food, Drug, and Cosmetic Act of 1938, ch. 675, 52 Stat. 1040
(1938) (codified as amended at 21 U.S.C. SS 301-397).
4. Medical Device Amendments of 1976, Pub. L. No. 94-295, 90 Stat. 539
(codified as amended in scattered sections of 21 U.S.C.).
5. 21 U.S.C. S 360c(a)(1)(C)(ii)(II).
6. Id. S 360e(a).
7. Id. S 360e(b)(1); see also Buckman, 121 S. Ct. at 1015-16 (describing
the FDA approval process applicable to the bone screw and similar
devices).
8. See 21 U.S.C. S 331(a); In re Orthopedic Bone Screw, 193 F.3d at 786.
9. See generally 21 C.F.R. pt. 812.
10. See Medtronic Inc. v. Lohr, 518 U.S. 470, 479-80 (1996) (citing D.
Kessler, S. Pape, & D. Sundwall, The Federal Regulation of Medical
Devices, 317 New England J. Med. 357, 359 (1987)).
23
clearance when the FDA determines they are "substantially
equivalent" to a legally marketed "predicate device" (usually
a device that was marketed before the Medical Device
Amendments went into effect on May 28, 1976).11 The
process by which this clearance is granted is known as the
"S 510(k) process," in reference to the relevant MDA section.
The process requires submission of the following:
1. "[p]roposed labels, labeling, and advertisements
sufficient to describe the device, its intended use,
and the directions for its use,"
2. "[a] statement indicating the device is similar to
and/or different from other products of comparable
type in commercial distribution, accompanied by
data to support the statement,"
3. "[a] statement that the submitter believes, to the
best of his or her knowledge, that all data and
information submitted in the premarket notification
are truthful and accurate and that no material fact
has been omitted," and
4. "[a]ny additional information regarding the device
requested by the [FDA] Commissioner that is
necessary for the Commissioner to make a finding
as to whether or not the device is substantially
equivalent to a device in commercial distribution."12
The FDA grants clearance through the S 510(k) process
when the new device has the same intended use as the
predicate device and the FDA determines that it possesses
the same technological characteristics or is as safe and
effective as the predicate device.13
_________________________________________________________________
11. 21 U.S.C. S 360e(b)(1)(B).
12. 21 C.F.R. S 807.87; see also Buckman, 121 S. Ct. at 1016.
13. See 21 U.S.C. S 360c(i)(1); 21 C.F.R. S 807.100(b). According to
S 360c(i)(1), a device is "substantially equivalent" to a predicate device
if
it "has the same intended use as the predicate device" and if the FDA
has found it:
(i) has the same technological characteristics as the predicate
device, or
24
2. Appellants' Allegations
In 1984, Zimmer Inc. applied for S 510(k) clearance for
the Edwards Sacral Screw Device. After two rejections and
the submission of additional supporting information,
Zimmer was ultimately granted clearance. Appellants allege
that the reasons for the FDA's reversal of position are
unknown, and that the clearance decision was erroneous
because the evidence presented to the FDA revealed no
predicate device substantially equivalent to the Edwards
screw on the market. Following this determination, the FDA
granted S 510(k) clearance to other bone screws. Appellants
allege these applications were granted due to the erroneous
clearance of the Edwards screw. Appellants also claim that
the FDA granted clearance to Danek Medical to market the
IFS/Luque Device for non-spinal use when it knew or
should have known that the screw was intended solely for
spinal use. They allege that Danek first described the screw
as the "Interpedicular Segmental Fixation System" but
changed its name to "Warsaw Orthopedic Bone Plates" and
"Warsaw Orthopedic Cancellous Bone Screws" after its
initial S 510(k) application was denied. Along with the name
change, Danek removed all references to use of the device
in the spine, describing its application as only for long or
flat bones. The FDA then granted clearance. Appellants
make similar complaints regarding the S 510(k) process for
some of the other screws. And furthermore, they allege that
an FDA official proposed the idea of changing the intended
use of the screws in order to obtain clearance and provided
advice on circumventing FDA rules.
Appellants claim that the FDA's conduct in granting
_________________________________________________________________
(ii) (I) has different technological characteristics and the
information submitted that the device is substantially
equivalent to the predicate device contains information,
including appropriate clinical or scientific data if deemed
necessary by the Secretary or a person accredited under section
360m of this title, that demonstrates that the device is as safe
and effective as a legally marketed device, and (II) does not raise
different questions of safety and effectiveness than the predicate
device.
25
clearance for each of the screws was negligent, intentionally
erroneous,14 and in violation of its own policy. They further
contend that this misconduct resulted in the marketing and
subsequent use of the bone screws that ultimately injured
them. The government argues that the discretionary
function exception to the FTCA precludes Appellants'
claims, regardless of their merit.
DISCUSSION
a.
Appellants first seek to get around the discretionary
function exception by arguing that, because they have
alleged that the FDA's conduct in clearing bone screws for
the market was intentionally erroneous, and possibly even
criminal, the exception is not applicable at all. In the
Appellants' submission, the discretionary function
exception was never intended to shield a government
agency from liability for such dishonest and criminal
conduct, and thus Appellants should be permitted to
pursue their claims of intentional and criminal misconduct
against the FDA without having to overcome the
discretionary function bar. We are constrained to disagree.
Even prior to reaching the discretionary function
exception issue, Appellants bear the burden of
demonstrating that their claims fall within the scope of the
FTCA's waiver of government immunity.15 Under the FTCA,
the federal government only waives its immunity for
injuries "caused by the negligent or wrongful act or
omission of any employee of the Government . . . under
circumstances where the United States, if a private person,
would be liable to the claimant in accordance with the law
of the place where the act or omission occurred."16 As the
quoted language makes clear, the FTCA does not itself
create a substantive cause of action against the United
_________________________________________________________________
14. Plaintiffs-Appellants accuse FDA officials of dishonest and even
criminal conduct.
15. See Cato v. United States, 70 F.3d 1103, 1107 (9th Cir. 1995).
16. 28 U.S.C. S 1346(b)(1).
26
States; rather, it provides a mechanism for bringing a state
law tort action against the federal government in federal
court. Thus, "the extent of the United States' liability under
the FTCA is generally determined by reference to state law."17
To state a viable FTCA claim based on their allegations of
intentional and possibly criminal misconduct on the part of
the FDA in the S 510(k) clearance process, Appellants need
to demonstrate that such conduct amounted to a "negligent
or wrongful act or omission" for which a private individual
would be held liable under applicable state tort law.
Appellants, however, face several hurdles to making this
showing. First, we have examined the face of Appellants'
complaints, and note that the complaints do not appear to
allege that the FDA's behavior amounted to intentional or
possibly criminal misconduct. Rather, in their complaints,
Appellants contend that the FDA acted negligently and in
violation of its own policies and procedures.18
Even if we were inclined to read Appellants' complaints
liberally as stating claims based on the FDA's intentional
and potentially criminal misconduct, we do not believe that
these claims fall within the scope of the FTCA's sovereign
_________________________________________________________________
17. Reo v. U.S. Postal Serv., 98 F.3d 73, 75 (3d Cir. 1996) (quoting
Molzof
v. United States, 502 U.S. 301, 305 (1992)) (internal quotation marks
omitted).
18. In fact, even in their appellate briefing, Appellants continued to
emphasize that the FDA's clearance decisions were wrongful because
they were made negligently and in violation of the FDA's policies and
procedures, and not because the FDA's behavior represented intentional
misconduct or potentially criminal behavior. See Appellants' Opening
Brief at 10 ("Plaintiffs allege that the FDA was negligent, careless,
failed
to exercise reasonable care and violated its own policy, practice and
procedure with respect to substantial equivalence determinations in
granting the requests by various manufacturers [for] 510(k) clearance.").
Accordingly, the government's brief did not deal with this issue.
Appellants did argue that the stay of discovery imposed by the District
Court should be lifted because Appellants believed that they would
obtain evidence of the FDA's intentional and possibly criminal
misconduct, but it was not until oral argument on appeal that
Appellants contended that their allegations regarding the FDA's
intentional or criminal misbehavior should prevent any application of the
discretionary function exception to Appellants' claims.
27
immunity waiver. Appellants have cast their allegations
regarding the FDA's intentional misconduct and potentially
criminal behavior only in generalized terms, and our
treatment of these claims is, of necessity, similarly
generalized. We do not believe that intentionally improper
or even criminal behavior, in the abstract, constitutes the
type of "negligent or wrongful act or omission" for which the
FTCA grants a waiver of sovereign immunity.19 Appellants
have not pointed us to (and we could find no) precedent
standing for this general proposition, and, mindful of the
fact that a government's waiver of its sovereign immunity
must be construed narrowly,20 we believe it is improper for
us to conclude that Appellants' claims based on the FDA's
allegedly intentionally dishonest and possibly criminal
behavior fall within the scope of the FTCA's immunity
waiver. Furthermore, to the extent that Appellants' claims
have the state law analog necessary under the FTCA, we
believe that the pertinent state cause of action is one for
some type of intentional tort of fraud or deceit. Such
intentional conduct, however, is explicitly exempted from
the FTCA's waiver of sovereign immunity.21
b.
Appellants' claims do allege that the FDA acted
negligently, and in violation of its own policies and
procedures. This set of claims would fall within the FTCA's
general waiver of sovereign immunity, and we must
therefore determine whether the District Court's application
of the discretionary function exception to these claims was
correct.
_________________________________________________________________
19. We express no opinion on the question whether a specific set of
factual allegations supporting the contention that a government agency
acted in an intentionally wrongful or criminal manner could also support
a contention that the government's behavior was"negligent or wrongful"
within the meaning of the FTCA.
20. See Clinton County Comm'rs v. EPA, 116 F.3d 1018, 1021 (3d Cir.
1997) ("A waiver of immunity must be unequivocally expressed and is
construed strictly in favor of the sovereign.") (internal quotation marks
and citations omitted).
21. See 28 U.S.C. S 2680(h) (stating that the FTCA does not apply inter
alia to "[a]ny claim arising out of . . . misrepresentation, deceit").
28
In Berkovitz v. United States,22 the Supreme Court held
that the discretionary function exception applies when (1)
the act involves "an element of judgment or choice" and (2)
that discretion "is of the kind that the discretionary
function exception was designed to shield."23 This inquiry
does not focus on anyone's subjective intent in the exercise
of that discretion, however. Instead, the inquiry focuses on
"the nature of the actions taken and on whether they are
susceptible to policy analysis."24
Appellants assert that both prongs of the Berkovitz
inquiry support their position. They argue that the
discretionary function exception does not apply to the
S 510(k) clearances because (1) the FDA improperly granted
the clearances, violating statutory and regulatory duties
that do not allow for the exercise of any discretionary
judgment or choice, and (2) the S 510(k) process involves
merely scientific tasks rather than the exercise of policy-
based discretion such as the exception was designed to
protect. We disagree.
Under Berkowitz's first prong, "[t]he requirement of
judgment or choice is not satisfied if a `federal statute,
regulation, or policy specifically prescribes a course of
action for an employee to follow,' because `the employee has
no rightful option but to adhere to that directive.' "25 FDA
determinations concerning substantial equivalency are
governed by 21 U.S.C. S 360c(i)(1) and 21 C.F.R.
S 807.100(b), which explicitly grant the FDA discretion to
require additional information "if deemed necessary" and to
set standards for evaluation of safety and efficacy.
Specifically, S 807.100(b) requires only (1) that the new
device and the predicate device have the same intended
use, (2) that the devices have the same technological
characteristics or that data demonstrates the new device is
as safe and effective as the predicate, and (3) that neither
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22. 486 U.S. 531 (1988).
23. Id. at 536; see also Gotha v. United States, 115 F.3d 176, 179 (3d
Cir. 1997).
24. United States v. Gaubert, 499 U.S. 315, 325 (1991).
25. Id. at 322. (1991) (quoting Berkowitz, 486 U.S. at 536).
29
the Commissioner nor the courts have taken specific action
against the new device.
Appellants contend that the FDA granted clearance for
the screws even though it knew or should have known that
screws had an altogether new intended use (namely,
fixation to the vertebral pedicles of the spine), even though
the screws had different technological characteristics, and
even though the screws were not as safe or effective as the
predicate devices. Appellants further allege that, by so
doing, the FDA failed to perform the mandatory duties
required by law for granting S 510(k) clearance, and thus
did not exercise the judgment or choice necessary under
Berkowitz's first prong to trigger the discretionary function
exception.
The government argues that the statutory and regulatory
provisions grant it discretion to decide what information is
relevant in the S 510(k) process. Moreover, it points out that
no mandatory authority dictates how it should go about
determining whether devices have the same intended use,
same technological characteristics, or similar performance
in safety and efficacy. Accordingly, the government
contends that the S 510(k) process requires the FDA to
make discretionary choices utilizing its expertise. We agree.
When S 510(k) applications are brought before the FDA,
regulators must decide what data and other information is
relevant, what is reliable, and how much is sufficient.
Certainly in weighing evidence and comparing medical
devices in this manner, the FDA utilizes judgment and
choice. Appellants' suggestion that the FDA violated
statutory and regulatory provisions is, in reality, a claim
that the FDA's judgment is wrong. Because substantial
equivalence determinations as well as the manner in which
those decisions get made are functions committed to the
discretion of the FDA, we will not second guess their
outcomes. The first step of the Berkovitz test is met.
Next, Appellants argue under the second Berkovitz prong
that the S 510(k) process involves merely scientific tasks
rather than the exercise of policy-based discretion. They
rely on language in Griffin v. United States26 for the
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26. 500 F.2d 1059, 1066 (3d Cir. 1974).
30
proposition that scientific decisions do not fall within this
exception. But their reliance is misplaced. Griffin concludes
that some scientific determinations or measurements may
not implicate policymaking discretion, not that science-
based decisions never involve policymaking.27 Because the
S 510(k) process implicates such considerations as safety,
efficacy, and cost, Griffin is not applicable. Furthermore, we
have previously questioned the continuing authority of
Griffin in light of subsequent Supreme Court decisions.28
The FDA's regulatory judgment in the S 510(k) process is
susceptible to policy analysis and therefore falls within the
kind of discretion the exception is designed to protect. The
S 510(k) process requires judgment regarding what evidence
is relevant, how well that evidence demonstrates safety and
efficacy, and what weight should be given conflicting
evidence and opinions. Implicit in this judgment is the
balancing of values such as safety and cost. Decisions
made in this context reflect policy choices and cannot be
categorized as ministerial. Thus the second step of the test
is also met. The FDA's actions were protected by the
discretionary function exception.
2. Stay of Discovery
The District Court stayed discovery in this case while it
considered the government's motion to dismiss. Our
standard of review of questions concerning the scope or
opportunity for discovery is for abuse of discretion.29
Appellants argue that the stay was improper and prevented
them from uncovering evidence of wrongdoing by the FDA.
But because Appellants' proposed discovery was aimed at
supporting claims that, for the reasons stated in part 1.a,
fall outside the FTCA, and because the District Court had
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27. See id. ("At issue [is] a scientific, but not policy-making,
determination as to whether each of the criteria listed in the regulation
was met and the extent to which each such factor accurately indicated
neurovirulence.").
28. See, e.g., Smith v. Johns-Manville Corp. , 795 F.2d 301, 309 (3rd.
Cir.
1986).
29. See Brumfield v. Sanders, 232 F.3d 376, 380 (3rd. Cir. 2000).
31
no jurisdiction over these claims, it was appropriate to stay
discovery. The District Court acted within its discretion.30
The judgment of the District Court will be AFFIRMED.
A True Copy:
Teste:
Clerk of the United States Court of Appeals
for the Third Circuit
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30. Cf. id.
32