In re Chantix (Varenicline) Prods. Liab. Litig.

889 F.Supp.2d 1272

In re CHANTIX (VARENICLINE) PRODUCTS LIABILITY LITIGATION.

No. 2:09–CV–2039–IPJ.

MDL No. 2092.

United States District Court,

N.D. Alabama,

Southern Division.

Aug. 21, 2012.

Albert J. Harb, Hodges Doughty & Carson PLLC, Knoxville, TN, Ernest Cory, Elizabeth Ellis Chambers, B. Kristian W. Rasmussen, Cory Watson Crowder & Degaris, Birmingham, AL, Barrett W. Stetson, Law Firm of Barrett W. Stetson, Dallas, TX, James C. Ferrell, Bradlyn James Cole, R.G. Taylor II & Associates, Houston, TX, Cale H. Conley, Conley Griggs LLP, Atlanta, GA, H. Blair Hahn, David L. Suggs, Christiaan A. Marcum, Richardson Patrick Westbrook & Brickman LLC, Mount Pleasant, SC, Christian C. Creed, Creed & Creed, Monroe, LA, Christopher A. Keith, Wettermark Holland & Keith LLC, Birmingham, AL, Jayne Conroy, Clinton Fisher, Hanly Conroy Bierstein Sheridan Fisher & Hayes LLP, New York, NY, Cynthia K. Garrett, Cynthia K. Garrett, Attorney at Law, Tulsa, OK, Daniel Paul Ruggiero, Ruggiero & Haas, Portsmouth, OH, Elizabeth E. Deemer, Levicoff Silko & Deemer PC, Pittsburgh, PA, Tara D. Sutton, Kate E. Jaycox, Gary L. Wilson, Robins Kaplan Miller & Ciersi LLP, Minneapolis, MN, Herbert J. Friedman, Friedman Law Offices, Lincoln, NE, Joe R. Whatley, Jr., WhatleyKallas LLC, Birmingham, AL, John M. Bailey, Law Offices of John M. Bailey, Memphis, TN, John J. Carey, Carey, Danis & Lowe, St. Louis, MO, John W. Degravelles, Degravelles, Palmintier, Holthaus & Fruge, LLP, Baton Rouge, LA, Michael D. Axline, John Evan Eickmeyer, Miller Axline and Sawyer, Sacramento, CA, Kenneth J. Ignozzi Dyer Garofalo Mann & Schultz LPA, Dayton, OH, Kevin D. Alexander, Guerriero & Guerriero, Monroe, LA, Lee L. Coleman, Hughes & Coleman, Bowling Green, KY, Marc David Grossman, Sanders Viener Grossman, LLP, Mineola, NY, Matthew Lopez, Lopez McHugh LLP, Newport Beach, CA, Philip Bohrer, Bohrer Law Firm LLC, Baton Rouge, LA, Ramon Rossi Lopez, Lopez McHugh LLP, Newport Beach, CA, Richard A. Griggs, Conley Griggs LLP, Atlanta, GA, Sara C. Hacker, Whatley Drake & Kallas LLP, Birmingham, AL, Saul C. Belz, Glankler Brown PLLC, Memphis, TN, Scott D. Levensten, The Levensten Law Firm PC, Philadelphia, PA, Shane Allen Romines, Copeland & Romines Law Office, PLLC, Corbin, KY, Sheila P. Hiestand, Bubalo, Hiestand & Rotman, PLC, Louisville, KY, Stephen R. Hunt, Jr., Cory Watson Crowder & Degaris PC, Birmingham, AL, Trent B. Miracle, Simons Browder Gianaris Angelides & Barnerd LLC, Altoon, IL, Vincent J. Desalvo, Baton Rouge, LA, William M. Audet, Audet & Partners, San Francisco, CA, William E. Winingham, Wilson Kehoe & Winingham, Indianapolis, IN, Adam S. Gober, Taylor Law Firm LLC, Fairhope, AL, Andrew Jason Geiger, Allan Berger, Allan Berger and Associates, New Orleans, LA, Andrea Witcher Brock, Andrea Brock PA, Forrest City, AR, Andrew G. Finkelstein, Andrew Finkelstein, Newburgh, NY, Angela Newell Gray, Gray Newell LLP, Greensboro, NC, Angela R. Shute, Kelley, Scritsmier Law Firm, North Platte, NE, Ann E. Brown–Graff, Brady & O'Shea PC, Cedar Rapids, IA, Antoinette Burgess, Law Offices of Fred Tromberg, Jacksonville, FL, Baharak Dejban, Khorrami LLP, Los Angeles, CA, Benedict James, Fears/Nachawati Law Firm, Dallas, TX, Benjamin E. Maxell, Adams & Sullivan PC, Papillion, NE, Brad J. Brady, Brady & O'Shea PC, Cedar Rapids, IA, Bradley Russell Irwin, Irwin & Boesen PC, Denver, Co, Bradley C. West, The West Law Firm, Shawnee, OK, Brian Goldstein, Cellino & Barnes PC, New York, NY, Carrie R. Capouellez, Lopez McHugh LLP, Philadelphia, PA, Catherine T. Heacox, The Lanier Law Firm, New York, NY, Charles S. Zimmerman, Zimmerman Reed PLLP, Minneapolis, MN, Christopher L. Garrison, Garrison Law Firm LLC, Indianapolis, IN, Dale M. Foreman, Law Offices of Dale M. Foreman, Wenatchee, WA, Daniel C. Burke, Parker Waichman LLP, Port Washington, NY, Daniel M. Delluomo, Delluomo & Crow, Oklahoma City, OK, for Plaintiff.

Kathy J. Owen, Brooke L. Killian, Raymond M. Williams, Raj Niranjan Shah, Loren H. Brown, David Jordan Pivnick, Christopher G. Campbell, Albert Edward Hartmann, DLA Piper U.S. LLP, Chicago, IL, Lela Hollabaugh, Clyde W. Steineker, Charles F. Spainhour, Nicholas J. Voelker, Andrew B. Johnson, Bradley Arant Boult Cummings LLP, Birmingham, AL, Amy K. Fisher, Katherine A. Winchester, Bonnie L. Gallivan, Ice Miller LLP, Indianapolis, IN, Sarah G. Cronan, Jamie K. Neal, Carol Dan Browning, Stites & Harbison, Louisville, KY, Michael K. Huffer, Charles F. Gotch, Cassem, Tierney Law Firm, Omaha, NE, Christopher C. Land, Clifford Chance US, LLP, New York, NY, Dwight E. Tarwater, Daniel C. Headrick, Paine Tarwater & Bickers LLP, Knoxville, TN, Kelly G. Juneau, John W. Sinnott, Irwin Fritchie Urquhart & Moore LLC, New Orleans, LA, Joseph M. Price, Faegre & Benson LLP, Minneapolis, MN, Peter J. Goss, Blackwell Burke PA, Minneapolis, MN, Alison Anne Verret, Eldridge Cooper Steichen & Leach PLLC, Tulsa, OK, Christopher Duke Baucom, Armstrong Teasdale LLP, St. Louis, MO, Matthew Joseph Rifino, David A. White, McCarter & English, LLP, Wilmington, DE, F. Chadwick Morriss, Covington & Burling LLP, Kimberly O. Branscome, Covington & Burling LLP, Washington, DC, Lyn Peeples Pruitt, Mitchell Williams Selig Gates & Woodyard PLLC, Little Rock, AR, Michael J. Sandmire, Ater Wynne, LLP, Portland, OR, Nancy J. Penner, Shuttleworth & Ingersoll, Cedar Rapids, IA, Prince C. Chambliss, Jr., Armstrong Allen Prewitt Gentry Johnston & Holmes, Memphis, TN, for Defendant.

MEMORANDUM OPINION and ALL CASES ORDER

INGE PRYTZ JOHNSON, District Judge.

This cause comes before the court on defendant's motions to exclude certain general causation and liability opinions offered by various plaintiffs' experts (doc. 578), and numerous briefs and evidence filed in support of and in opposition to said motions. Specifically, defendant challenges plaintiffs' designated experts Dr. Richard E. Olmstead, Dr. Curt Furberg, Dr. Shira Kramer, Dr. Antoine Bechara, Dr. Joseph Glenmullen, and Dr. Jon Wesley Boyd. In support of this motion, defendant filed one-hundred fifty-four exhibits (docs. 580 and 589), a brief titled “Introduction and Statement of Facts Relevant to all Daubert Motions” (doc. 582), and specific memoranda of points and authorities in support of its motion in regard to each of the six plaintiffs' experts they challenge under Daubert (docs. 583–588). The plaintiffs filed an “Omnibus Memorandum of Facts and Law” in opposition to defendant's motion (doc. 601), briefs in opposition to the motion in regard to each challenged expert (docs. 603–608), and approximatelytwo hundred and fifteen exhibits (doc. 609). Thereafter, the defendant filed an additional thirteen exhibits and four more depositions (docs. 618, 626), an introductory statement relevant to all of its reply memoranda (doc. 619), and reply memoranda in support of its motion to exclude specific experts of plaintiffs (docs. 620–625). The court has read all of the above pleadings and other submissions.

The defendant's motion was set for hearing on July 24, 2012, and a hearing was held at that time at which the defendant was present by and through its counsel of record and the plaintiffs were present by and through their designated counsel of record. The court heard argument in support of the defendant's motion and in opposition to said motion from the plaintiffs. Having carefully considered all of the filed pleadings, the exhibits and other evidence, the arguments of counsel and the relevant law, the court finds as follows:

RELEVANT FACTUAL BACKGROUND

As the court set forth in its Memorandum Opinion and Order of July 23, 2012, 881 F.Supp.2d 1333, 2012 WL 3030097 (N.D.Ala.2012), this is a multidistrict product liability action concerning the drug Chantix,¹ touted by defendant as a medication to aid in smoking cessation. The Food and Drug Administration (FDA) approved Chantix for sale in the United States in May 2006. Master Consolidated Complaint (doc. 36), at ¶ 17. Chantix works by reducing nicotine cravings in smokers trying to quit both by blocking nicotine from reaching receptors in the brain and also by causing a steady release of dopamine in the brain. Id., ¶ 26.

According to the plaintiffs, Chantix causes depression and other psychiatric disorders, some so severe that reports of suicide and attempted suicide from Chantix use have been made. Master Consolidated Complaint, ¶¶ 31–32. The plaintiffs allege defendant either knew or should have known about such side effects, but for defendant's intentional failure to design studies which were reflective of their targeted population. Master Consolidated Complaint, ¶¶ 27–31, 33–38. The defendant denies there is any merit to such allegations, and asserts that numerous studies show the side effects of Chantix to be in line with those of other nicotine replacement therapies (NRTs), such as nicotine patches.

As well explained by the District Court of Massachusetts,

In order to prevail in a pharmaceutical personal injury case, a plaintiff must establish two types of causation: general and specific. In re Bextra and Celebrex Mktg. Sales Practices and Prod. Liab. Litig., 524 F.Supp.2d 1166, 1171–72 (N.D.Cal.2007) (consumers alleging cardiovascular injury in a products liability suit against drug manufacturer); In re Rezulin Prods. Liab. Litig., 369 F.Supp.2d 398, 401–02 (S.D.N.Y.2005) (diabetes patients alleging liver injuries in products liability actions against drug manufacturer). As explained in the Federal Judicial Center's Reference Manual on Scientific Evidence, “General causation is established by demonstrating, often through a review of scientific and medical literature, that exposure to a substance can cause a particular disease.... Specific, or individual, causation, however, is established by demonstrating that a given exposure is thecause of an individual's disease....” Mary Sue Henifin et al., Reference Guide on Medical Testimony, in Reference Manual on Scientific Evidence 439,...