In re Neurontin Mktg., Sales Prac., & Prod. Liab.
| Decision Date | 05 May 2009 |
| Docket Number | Civil Action No. 04-10981-PBS.,MDL NO. 1629. |
| Citation | 612 F.Supp.2d 116 |
| Parties | In re NEURONTIN MARKETING, SALES PRACTICES, AND PROUCTS LIABILITY LITIGATION. This Document Relates to: All Products Liability Actions. |
| Court | U.S. District Court — District of Massachusetts |
Terry P. Abeyta, Abeyta Nelson, Yakima, WA, Keith L. Altman, Finkelstein & Partners, LLP, Newburgh, NY, Leasa M.W. Anderson, Blank Rome LP, Washington, DC, Ronald Judah, Aranoff Bernstein, Liebhard LLP, New York, NY, Bryan Frederick, Aylstock Aylstock, Witkin, Kreis & Overholtz, PLLC, Pensacola, FL, Gordon Ball, Ball & Scott Bank of America, Knoxville, TN, Don Barrett, Barrett Law Office, Lexington, MS, Thomas F. Basile, The Calwell Practice, W. Stuart Calwell, The Calwell Practice, Charleston, WV, Bradley Douglas, Daniel E. Becnel, Jr., Becnel Law offices of Daniel E. Becnel, Jr., Reserve, LA, Robert M. Becnel, Law Offices of Robert M. Becnel, Laplace, LA, George S. Bellas, Bellas & Wachowski, Ridge, IL, Richard Bemporad, Lowey Dannenberg, Bemporad & Selinger, P.C., Jeanne F. D'Esposito, Lowey Dannenberg Bemporad & Selinger, P.C., White Plains NY, Steve W. Berman, Hagens Berman, Sobol Shapiro LLP, Seattle, WA, Pavel Bespalko, Law Office of Joel Eigerman, Joel Z. Eigerman, Joel Z. Eigerman, Attorney-at-Law, Boston, MA, Robert J. Bonsignore, Bonsignore & Brewer, Medford, MA, Levi Boone, III, Boone Law Firm PA, John R. Climaco, Climaco Lefkowitz Peca Wilcox & Garofoli, Cleveland, OH, Rainey Cawthon, Booth Littlepage & Booth, Pensacola, FL, Derek T. Braslow, Pogust & Braslow LLC, Conshohocken, PA, Eugene Brooks, Brooks Law Firm, Savannah, GA, William L. Bross, Heninger, Garrison & Davis, LLC, Andrew P. Campbell, Campbell Waller & Poer LLC, Timothy C. Davis, Heninger, Garrison Davis, LLC, Birmingham, AL, David L. Browne, Dugan & Browne, PLC, Joseph M. Bruno, Stephanie M. Bruno, Bruno & Bruno LLP, Dane S. Ciolino, Dane S. Ciolino, Attorney at Law, James R. Dugan, II, Dugan & Browne PLC, James R. Dugan, II, Murray Law Firm, New Orleans, LA, Ronald J. Campione, Budd Larner, PC, Short Hills, NJ, Kathleen C. Chavez, Lane Geneva, IL, Robert A. Clifford, Clifford Law Offices, P.C., Chicago, IL, Daniel M. Cohen, Cuneo Gilbert & LaDuca, Washington, DC, Richard W. Cohen, Lowey Dannenberg Bemporad & Slelinger, P.C., White Plains, N.Y. Jonathan S. Coleman, Johnson, Pope, Okor, Ruppel & Burns LLP, Tampa, FL, John A. Commerford, Meyers Taber & Meyers PC, Phoenix, AZ, Charles Horne Cooper, Jr., Cooper & Elliott, Columbus, OH, Susan G. Copeland, Law Office of J. Doyle Fuller, Montgomery, AL, W. Lloyd Copeland, Taylor, Martino & Hedge, P.C., Charles H. Dodson, Jr., Sims, Graddick & Dodson, P.C., Mobile, AL, Silas G. Cross, Jr., Cross, Poole & Smith, LLC, Tuscaloosa, AL, Rebecca Cunard, Cunard Law Firm, Baton Rouge, LA, Daniel D'Angelo, Gilman and Pastor, LLP, Boston, MA, Michael A.K. Dan, Michael A.K. Dan Law Office, Los Angeles, CA, Samuel J. DeMaio, Girards Law Firm, Dallas, TX, Neil A. Dean Rice, Dean & Kelsey LLC, Topeka, KS, Christopher Brooks, Harrisburg, PA, John J. Driscoll, The Driscoll Firm, P.C., St. Louis, MO, James T. Dulin, Dulin & Dulin, Gulfport, MS, J. Blake Dutcher, Jr., Godlove Joyner Mayall Dzialo Dutcher & Erwin, Lawton, OK, Donald S. Edgar, Law Office of Donald S. Edgar, Santa Rosa, CA, Mark L. Edwards, Stipe Law Firm, Tony W. Edwards, McAlester, OK, Wanda Jean Edwards, Fayard & Honeycutt, Denham Springs, LA, Richard Mark Eldridge, Eldridge Cooper Steichen & Leach PLLC, Tulsa, OK, for Consolidated Plaintiffs.
William A. Alford, III, Scott William Anderson, Shook Hardy & Bacon, Kansas City, MO, Ray M. Aragon, McKenna Long & Aldridge LLP, Washington, DC, Richard M. Barnes, Goodell DeVries, Leech & Dann, LLP, Baltimore, MD, Catherine Marie, Valerio Barrad Sidley Austin, LLP, Kimberly H. Clancy, Sidley Austin Brown & Wood LLP, Los Angeles, CA, Charles F. Barrett, Barrett & Associates PA, Nashville, TN, Leslie Anne Benitez, Clark Thomas & Winters, Austin, TX, John A. Boyle, Marino & Associates, Newark, NJ, Carol D. Browning, Stites & Harbison, Louisville, KY, Susan E. Burnett, Clark Thomas & Winters, Austin, TX, Carter H. Burwell, Davis Polk & Wardwell, Mark S. Cheffo, Skadden, Arps, Slate, Meagher & Flom LLP, Paul F. Corcoran, Davis & GIlbert LLP, Charles E. Dorkey, III, McKenna, Long & Aldridge, Scott A. Edelman, Milbank, Tweed, Hadley & McCloy LLP, New York, NY, Philip Henry Butler, Bradley, Arant, Rose & White LLP, Montgomery, AL, David C. Campbell, Williams Kastner & Gibbs, PLLC, Portland, OR, David B. Chaffin, White and Williams LLP, Daniel J. Dwyer, Hanify & King Professional Corporation, Boston, MA, Evan W. Davis, Dechert LLP, Philadelphia, PA, for Consolidated Defendant.
Ian Crawford, Todd & Weld LLP, Boston, MA, for Intervenor.
I. INTRODUCTION .................................................................. 121
II. BACKGROUND .................................................................... 122
A. A Brief History of Neurontin Litigation ................................... 122
B. The Legal Backdrop and the Current Motion ................................. 123
C. A Scientific Primer ....................................................... 125
1. Evidence of Causation in Medicine & the Courtroom ...................... 125
a. Epidemiological Studies and Statistics ............................. 125
b. Non-epidemiological Evidence ....................................... 127
2. Neurotransmitters ...................................................... 127
3. How Gabapentin Works: The Scientific Debate ............................ 128
III. DISCUSSION ................................................................... 130
A. The Court's Gatekeeping Role .............................................. 130
B. Epidemiological Evidence of an Association between Neurontin and
Suicide ................................................................... 132
1. Hiking Bradford Hill ................................................... 132
2. The FDA Study .......................................................... 133
a. Dr. Gibbons' Critique ............................................... 137
b. Does the FDA Study Withstand Dr. Gibbons' Critique? ................. 139
c. Drug Specific Evidence .............................................. 140
3. The Collins and McFarland Study ........................................ 144
C. Plaintiffs' Theory of Biological Plausibility ............................. 145
1. Does Gabapentin Increase the Amount of GABA in the Brain? .............. 145
2. Does Gabapentin Lead to a Decrease in Monoamines? ...................... 145
a. In vitro studies .................................................... 145
b. In vivo studies ..................................................... 147
c. Kumho Wrestling ..................................................... 149
3. Does a Decrease in Monoamines Lead to Depression and Suicidality? ...... 150
a. Serotonin and Mood .................................................. 151
b. Serotonin and Suicide ............................................... 151
D. Additional Evidence: Adverse Event Data ................................... 153
1. Adverse Events in Pre- and Post-Approval Clinical Trials ............... 153
2. Dechallenge/Rechallenge Events ......................................... 154
3. Periodic Safety Update Reports ......................................... 156
4. Peer-Reviewed Literature ............................................... 156
5. Trimble's Research for Defendants ...................................... 156
E. Expert-Specific Challenges ................................................ 157
F. Conclusion ................................................................ 158
IV. ORDER ......................................................................... 159
In these products liability cases, Plaintiffs allege that they, or their decedents, suffered suicide-related injuries when their doctors prescribed the drug Neurontin, manufactured by defendants Pfizer and Warner-Lambert Company ("Defendants").1 Specifically, they allege that Neurontin caused behavioral disturbances, depression, and ultimately suicidal actions (including completed suicide) in over one hundred individuals. Defendants have moved to exclude Plaintiffs' expert testimony on the issue of general causation— that is, the question of whether Neurontin has the capacity to cause the alleged suicide-related events (suicide attempt, gesture, ideation, and/or completed suicide). (Docket No. 1157.)
After a three-day hearing,2 conducted jointly with Justice Marcy S. Friedman of the New York State Supreme Court,3 and review of the voluminous briefing and submissions,4 the motion is DENIED.
Defendants manufacture and distribute the prescription drug Neurontin, or gabapentin (generic).5 In December 1993, the Food and Drug Administration ("FDA") approved Neurontin for use as an "adjunctive therapy" (i.e., second-line treatment) in the treatment of partial seizures in adults with epilepsy. See In re Neurontin Mktg. and Sale Practices Litig., 244 F.R.D. 89, 92 (D.Mass.2007). In May 2002, the FDA approved Neurontin for the management of post-herpetic neuralgia (pain resulting from nerve damage caused by shingles or herpes zoster) in adults. Id. In the late 1980s and early 1990s, Parke-Davis, a division of Warner-Lambert, filed patent applications for Neurontin as a treatment for depression, neurodegenerative disease, mania, and bipolar disorder; Parke-Davis, however,...
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