UNITED STATES DISTRICT COURT
DISTRICT OF MASSACHUSETTS
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In re: NEURONTIN MARKETING,
SALES PRACTICES AND
PRODUCTS LIABILITY LITIGATION
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THIS DOCUMENT RELATES TO:
PRODUCTS LIABILITY ACTIONS
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MDL Docket No. 1629
Master File No. 04-10981
Judge Patti B. Saris
Magistrate Judge Leo T.
Sorokin
MEMORANDUM IN SUPPORT OF DEFENDANTS’ MOTION FOR APPOINTMENT
OF INDEPENDENT EXPERTS TO ADVISE THE COURT IN DETERMINING THE
ADMISSIBILITY OF PLAINTIFFS’ PROFFERED EXPERT TESTIMONY ON
GENERAL CAUSATION
Defendants Pfizer Inc. and Warner-Lambert Company LLC (“Defendants”) respectfully
submit this memorandum in support of their motion, pursuant to Rule 104(a) of the Federal
Rules of Evidence and this Court’s inherent authority, for the appointment of a panel of
independent scientific experts to advise the Court in its consideration of Defendants’ motion to
exclude the testimony of Plaintiffs’ expert witnesses on general causation, Drs. Trimble,
Kruszewski, and Blume. The Court has authority to appoint such experts, and circumstances
warrant the exercise of this authority at this critical stage of the proceedings. The motion to
exclude raises a potentially dispositive, highly technical issue. A panel of independent scientific
experts would assist the Court in organizing, interpreting, and evaluating the parties’ submissions
and the relevant data and scientific literature, and would provide guidance on the core scientific
issues the motion presents. Defendants seek by this motion simply to ensure that the Court has
all the resources it needs to reach a decision that reflects real, not junk, science.
Case 1:04-cv-10981-PBS Document 1214 Filed 04/09/2008 Page 1 of 10
A. The Court Has Inherent Authority to Appoint Independent Experts to
Advise the Court on Scientific and Technical Issues.
Federal district courts have inherent authority to appoint independent experts to provide
scientific and technical advice. See William W. Schwarzer & Joe S. Cecil, Management of
Expert Evidence in Reference Manual on Scientific Evidence 59 (Federal Judicial Center 2d ed.
2000) (“Supplementing the authority of Rule 706 is the broader inherent authority of the court to
appoint experts who are necessary to enable the court to carry out its duties. . . . Although few
cases deal with the inherent power of a court to appoint a technical advisor, the power to appoint
remains virtually undisputed.”); Reilly v. United States, 863 F.2d 149, 154 n.4, 156 (1st Cir.
1988) (affirming “the judiciary’s inherent power to appoint technical advisors”); Id. at 156
(quoting Ex parte Peterson, 253 U.S. 300 (1920)) (“[T]he Supreme Court recognized that trial
judges in the federal system possessed ‘inherent power to provide themselves with appropriate
instruments required for the performance of their duties,’ including the power to ‘appoint persons
unconnected with the court to aid judges in the performance of specific judicial duties, as they
may arise in the progress of a cause.’”); Ass’n of Mexican-Am. Educators v. State of California,
231 F.3d 572, 591 (9th Cir. 2000) (stating that “district courts retain inherent authority to appoint
technical advisors in appropriate cases”).
Daubert and its progeny established that trial judges must act as gatekeepers under
Federal Rule of Evidence 104(a), admitting expert opinion testimony only if it satisfies the
relevance and reliability requirements of the Federal Rules of Evidence:
Faced with a proffer of expert scientific testimony, then, the trial judge must
determine at the outset, pursuant to Rule 104(a), whether the expert is proposing
to testify to (1) scientific knowledge that (2) will assist the trier of fact to
understand or determine a fact in issue. This entails a preliminary assessment of
whether the reasoning or methodology underlying the testimony is scientifically
valid and of whether that reasoning or methodology properly can be applied to the
facts in issue.
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Daubert v. Merrell Dow Pharms., Inc., 509 U.S. 579, 592-93 (1993). In Daubert, the Supreme
Court identified four non-exclusive indicia of admissible “scientific knowledge” that may assist a
trial court in evaluating proffered theories and opinions of scientific expert witnesses. These
include (1) whether the theory or technique can be and has been tested; (2) whether the technique
has been subject to peer review and publication; (3) the technique’s known or potential rate of
error; and (4) the level of the theory or technique’s acceptance within the relevant discipline. Id.
at 593-94. In addition to these factors, as detailed in Defendants’ motion to exclude the subject
experts’ testimony, federal district courts have broad latitude to apply other factors to evaluate
reliability. Kumho Tire Co. v. Carmichael, 526 U.S. 137, 153 (1999); United States v. Monteiro,
407 F. Supp. 2d 351, 357 (D. Mass. 2006).
In a number of cases in which proffered expert testimony involved complex scientific and
technical issues – including, in particular, litigation in which a plaintiff’s expert witnesses have
claimed that use of a prescription medication caused suicide – courts have appointed independent
experts to provide scientific and technical advice on the scientific validity of an expert witness’s
reasoning, methodology and opinions on general causation. See e.g. Miller v. Pfizer, Inc., 356
F.3d 1326, 1329 (10th Cir. 2004) (court appointed two independent experts to provide advice
regarding the methodology and reliability of plaintiffs’ expert’s opinion that the antidepressant
medication Zoloft causes suicide); Domingo v. T.K., 289 F.3d 600, 606 (9th Cir. 2002) (court
relied on report of court-appointed expert to determine whether plaintiff’s expert’s theory of
medical causation in malpractice action met reliability requirement of Federal Rule of Evidence
702); Soldo v. Sandoz Pharms. Corp., 244 F. Supp. 2d 434, 441-42 (W.D. Pa. 2003) (“Following
the Daubert hearing . . . the Court appointed three medical experts who were directed to opine as
to whether the methodology or technique employed by the plaintiff’s medical experts in opining
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that Parlodel® can cause stroke . . . is scientifically reliable.”); Reid v. Albemarle Corp., 207 F.
Supp. 2d 499, 507 (M.D. La. 2001) (“[T]his expert was appointed solely to assist the court in
connection with the question of whether the plaintiff’s expert witness was qualified and whether
his opinions were based upon scientific methodology properly applied.”); Hall v. Baxter
Healthcare Corp., 947 F. Supp. 1387, 1392 & n.8, 1394 (D. Ore. 1996) (court appointed four
independent experts in silicone breast implant product liability litigation “[i]n view of the
complicated scientific and medical issues involved and in an effort to effectively discharge [the
court’s] role as ‘gatekeeper’ under Daubert I”).
B. The Determination Whether the Proffered Expert Testimony of Drs.
Trimble, Kruszewski, and Blume on General Causation is Admissible Under
Rules of Evidence 702 and 703 Raises Numerous Complex Scientific and
Technical Issues.
General causation is an essential element of the personal-injury product liability claims of
each Plaintiff in this multi-district litigation. Plaintiffs bear the burden of proving general
causation, that Neurontin is capable of causing suicide, attempted suicide, suicide gesture, and
suicide ideation (collectively, “suicide-related events”) in humans, and specific causation, that
Neurontin caused the suicide-related event at issue in each individual case. See, e.g., Norris v.
Baxter Healthcare Corp., 397 F.3d 878, 881 (10th Cir. 2005); Vanderwerf v.
SmithKlineBeecham Corp., 529 F. Supp. 2d 1294, 1306 (D. Kan. 2008); Grimes v. Hoffmann-
LaRoche, Inc., 907 F. Supp. 33, 38 (D.N.H. 1995); Wade-Greaux v. Whitehall Labs., Inc., 874 F.
Supp. 1441, 1448 (D.V.I. 1994). If Plaintiffs fail to adduce admissible scientific evidence of
general causation, their claims fail as a matter of law, because “without general causation, there
can be no specific causation.” Norris, 397 F.3d at 881 (absent evidence of general causation, “it
follows a fortiori that silicone breast implants could not have caused systemic injuries in
Plaintiff”); Vanderwerf, 529 F. Supp. 2d at 1309 (“Absent a basis to testify on general causation,
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Dr. Breggin cannot offer testimony on specific causation.”); Miller v. Pfizer, Inc., 196 F. Supp.
2d 1095, 1125 (D. Kan. 2002) (granting defendant’s motion for summary judgment where the
plaintiff’s expert’s opinion on general causation were found unscientific and inadmissible), aff’d,
356 F.3d 1326 (10th Cir. 2004); Renaud v. Martin Marietta Corp., 972 F.2d 304, 308 (10th Cir.
1992) (same); Vanderwerf, 529 F. Supp. 2d at 1309 (same) Grimes, 907 F. Supp. at 38 (same).
Here, in each of the more than 200 products liability cases before this Court that allege
suicide-related injury from use of Neurontin, Plaintiffs have disclosed the opinion testimony of
Drs. Trimble, Kruszewski, and Blume as their proof of a general causal relationship between
ingestion of Neurontin and suicide-related events. A cursory review of their reports, as well as
Plaintiffs’ opposition to Defendants’ Daubert motion, demonstrates that Plaintiffs’ experts rely
on varied theories and methodologies, all of which raise scientific questions and issues that
threaten to confuse the relatively straightforward analysis contemplated by Daubert. Technical
and scientific knowledge from independent experts in the various scientific fields relevant to
Plaintiffs’ experts’ theories would no doubt help in clarifying the issues and scrutinizing the
scientific reliability of Plaintiffs’ experts’ methodology and reasoning. Because of the centrality
and significance of the general causation issue, Defendants respectfully urge the Court to retain
and task independent, well-qualified experts to advise the Court on the scientific validity of
Plaintiffs’ experts’ general causation testimony and the methods and reasoning they claim to
have applied in reaching their opinions.
Defendants suggest further that independent experts should be tasked to advise the Court
on each of the specific technical and scientific issues that may best inform the Court’s judgment
regarding the admissibility of Plaintiffs’ experts’ general causation opinions. See Reilly, 863
F.2d 149, 159-60 (“We also think that there is much to commend the preformulation of a written
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“job description” for the advisor (or in lieu thereof, that the judge deliver comprehensive verbal
instructions to the advisor, on the record, in the presence of all counsel). At the conclusion of his
stint, the advisor should file an affidavit attesting to his compliance with the job description.” ).
The independent experts’ advice might be sought, for example, on subjects such as: (i) whether
the opinions of each of Plaintiffs’ experts’ meet the Daubert criteria (testing, peer review, rate of
error, general acceptance); (ii) whether Plaintiffs’ experts applied the scientifically reliable and
valid methodology for establishing causation between use of a drug and suicide-related events;
(iii) whether Plaintiffs’ experts have interpreted the data and literature that they cite in their
reports in a scientifically reliable and valid manner; (iv) whether Plaintiffs’ experts’ have ignored
contrary data in reaching their general causation opinions; and (v) whether, separately from the
opinions of Plaintiffs’ experts in this litigation, there exists any reliable scientific knowledge or
acceptance of Plaintiffs’ experts’ theories that Neurontin causes suicide-related events. The
independent experts could also provide explanations of technical, medical, or scientific terms or
concepts used in Plaintiffs’ experts’ reports, affidavits and testimony.
C. The Court Has Flexibility to Adopt Procedures for the Use of Independent
Experts from the Appropriate Scientific Disciplines to Fit the Specific Needs
of this Case.
Independent experts appointed by the Court to assist in its Fed. R. Evid. 104(a)
gatekeeper function are not subject to the procedural requirements of Federal Rule of Evidence
706. See Reilly, 863 F.2d at 155 (“Throughout its text, Fed .R. Evid. 706 refers not to ‘experts’
generally, but to a more exclusive class: ‘expert witnesses.’ Because the plain language of a
Civil Rule is the most reliable indicator of its meaning, we are constrained to conclude that the
grasp of Rule 706 is confined to court-appointed expert witnesses; the rule does not embrace
expert advisors or consultants.”); Reed v. Cleveland Bd. of Educ., 607 F.2d 737, 746 (6th Cir.
1979) (same); Renaud v. Martin Marietta Corp., 972 F.2d 304, 308 n. 8 (10th Cir. 1992) (same);
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Reid v. Albemarle Corp., 207 F. Supp. 2d 499, 507 (M.D. La. 2001) (same). The Court thus has
flexibility to determine the procedures that would be followed by any technical advisors that it
appoints.
Evaluation of the scientific and technical questions presented by the proffered expert
testimony of Drs. Trimble, Kruszewski, and Blume and Defendants’ motion to exclude their
testimony raises concepts, methods, and techniques drawn from multiple scientific disciplines.
Because of the scope of the sources of information and the multiple theories and inferences from
variegated literature and data that appear in Plaintiffs’ experts’ reports, it may be extremely
difficult to locate any single independent expert with the requisite training, education, and
expertise to thoroughly and accurately address the subject opinions and theories in full. For that
reason, Defendants recommend that the Court appoint a panel of at least three technical advisors
comprised of one expert from each of the following disciplines: (1) epidemiology (the study of
the distribution and causes of disease, including adverse effects of medicinal compounds); (2)
psychiatry (the field of medicine that studies mental and mood disorders and their
symptomatology and sequelae, including suicidality); and (3) neuropsychopharmacology (the
field of medical and pharmacological science that studies the effects of medicinal compounds on
the brain and neural anatomy).
To facilitate identification and retention of suitable independent experts, Defendants
suggest the following selection process. First, each party would provide the Court with a list and
current curricula vitae nominating one to three candidate experts within each discipline. Second,
counsel for the parties would jointly interview the recommended experts to screen candidates for
biases or conflicts of interest. Third, the parties would attempt to agree on a mutually acceptable
expert in each field. If the parties cannot agree, Magistrate Judge Sorokin could interview the
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proposed experts by telephone and recommend to the Court one independent expert in each
discipline. Fourth, the parties would have an opportunity to file objections to the Magistrate
Judge’s recommendations before the Court selected the panel. See Reilly, 863 F.2d at 159-
60 (“We think it advisable in future cases that the parties be notified of the expert's identity
before the court makes the appointment, and be given an opportunity to object on grounds such
as bias or inexperience.”).
Defendants propose the following schedule to allow appointment of independent experts
in time for the experts to attend the Daubert/Frye hearing presently scheduled for July 19-20,
2008. Each party shall submit its list of proposed experts within 10 days of this Court’s Order.
Within 20 days of the submission of this Court’s Order, the parties shall file a joint report as to
the outcome of their efforts to reach an agreement. If no agreement is reached on an expert in a
particular field, the Magistrate Judge will make recommendations to the Court within 30 days of
this Court’s Order.
Defendants suggest further that the panel of technical advisors be supplied with complete
copies of the reports, cited references, and deposition transcripts of each of Plaintiffs’ experts,
along with the Daubert briefing, and be tasked by the Court to evaluate and prepare a written
report setting forth their answers to specific questions submitted by the Court. The costs of the
independent experts’ time and services should be shared equally between the parties.
Defendants would also recommend that the Court provide the technical advisors with
detailed instructions, as suggested in the accompanying proposed order, regarding: (1) the
questions or topics on which the experts are to express opinions; (2) the standards that the
experts should apply in answering these questions; (3) the scope of permissible communications
between the experts, the Court, the parties, and others whom the experts wish to consult; (4) the
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procedures that should be followed for all communications between the experts and others; (5)
the scope of materials that the experts may review; (6) the work product expected from the panel;
and (7) whether the experts are instructed to keep notes and drafts for future discovery. See
William W. Schwarzer & Joe S. Cecil, Management of Expert Evidence in Reference Manual on
Scientific Evidence 61-63 (Federal Judicial Center 2d ed. 2000) (listing procedural issues that
should be addressed in court order to appoint independent experts). Contemporaneously with
this motion, Defendants are filing as Exhibit A hereto a Proposed Order Appointing Independent
Experts that sets forth in detail their recommended instructions to the Court-appointed technical
advisors.
CONCLUSION
Currently pending before this Court is Defendants Pfizer Inc and Warner-Lambert
Company LLC’s Motion to Exclude the Testimony of Doctors Trimble, Kruszewski, and Blume
on the Issue of General Causation, and Product Liability Plaintiffs’ Memorandum of Law in
Opposition. As explained more fully in Defendants’ motion, the proffered expert testimony of
Doctors Trimble, Kruszewski, and Blume on general causation is unreliable and falls far short of
the admissibility requirements for expert opinion established in Rules 702 and 703 of the Federal
Rules of Evidence. Determining whether Plaintiffs’ proffered expert opinions on general
causation are admissible involves numerous complex scientific and technical issues. Defendants
therefore request the Court to appoint a panel of independent technical advisors with expertise in
epidemiology, psychiatry, and neuropsychopharmacology to evaluate and advise the Court on
whether the methods, reasoning, and opinions expressed by Plaintiffs’ experts constitute
scientifically valid and reliable knowledge.
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Dated: April 9, 2008 Respectfully submitted,
DAVIS POLK & WARDWELL
By: /s/ James P. Rouhandeh
James P. Rouhandeh
450 Lexington Avenue
New York, NY 10017
Tel: (212) 450-4000
-and-
SHOOK, HARDY & BACON L.L.P.
By: /s/ Scott W. Sayler
Scott W. Sayler
2555 Grand Blvd.
Kansas City, MO 64108-2613
Tel: (816) 474-6550
-and-
HARE & CHAFFIN
By: /s/ David B. Chaffin
David B. Chaffin
160 Federal Street
Boston, MA 02110
Tel: (617) 330-5000
Attorneys for Defendants Pfizer Inc. and
Warner-Lambert Company LLC
CERTIFICATE OF SERVICE
I hereby certify that this document filed through the ECF system has been served
pursuant to Case Management Order #3 on April 9, 2008.
/s/David B. Chaffin
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