FINAL Chantix Motion to Compel Responses to Subpoenasi.bnet.com/blogs/chantix-april-19-2011-mot-to-compel-subp.pdf · MDL Case No. 2092 This Document Relates to: ALL CASES. Pfizer’s

UNITED STATES DISTRICT COURT NORTHERN DISTRICT OF ALABAMA

(SOUTHERN DIVISION)

IN RE: CHANTIX (VARENICLINE) PRODUCTS LIABILITY LITIGATION

Master File No. 2:09-CV-2039-IPJ MDL Case No. 2092

This Document Relates to: ALL CASES.

Pfizer’s Memorandum of Law in Support of Its Motion to Compel Responses to Third-Party Subpoenas

Joseph G. Petrosinelli Williams & Connolly LLP 725 Twelfth Street, N.W. Washington, D.C. 20005 Phone: (202) 434-5000 Email: [email protected]

Loren H. Brown DLA Piper LLP (US) 1251 Avenue of the Americas New York, NY 10020-1104 Phone: (212) 835-6000 Email: [email protected] F. M. (“Tripp”) Haston, III Bradley Arant Boult Cummings LLP 1819 Fifth Avenue North Birmingham, AL 35206 Phone: (205) 521-8303 Email: [email protected]

Lead Counsel for Defendants

FILED 2011 Mar-16 PM 05:07U.S. DISTRICT COURT

N.D. OF ALABAMA

Case 2:09-cv-02039-IPJ Document 214 Filed 03/16/11 Page 1 of 38

TABLE OF CONTENTS

Page

i

PRELIMINARY STATEMENT .............................................................................. 1 STATEMENT OF FACTS ....................................................................................... 5

A. Chantix ................................................................................................. 5 B. FDA’s Adverse Event Reporting System ............................................ 6 C. The Carter Albrecht Incident ................................................................ 8 D. The ISMP Report on Chantix ............................................................. 10

1. Thomas Moore ......................................................................... 11 2. Dr. Curt Furberg ....................................................................... 12 3. The ISMP Report Findings ...................................................... 14 4. Methodological Questions ....................................................... 16

E. Later ISMP Reports ............................................................................ 19 F. Chantix Data Today............................................................................ 19

PROCEDURAL HISTORY .................................................................................... 20 LEGAL ARGUMENT ............................................................................................ 24 THE COURT SHOULD COMPEL PRODUCTION IN RESPONSE TO

PFIZER’S SUBPOENAS ............................................................................. 24 A. The Information Sought by Pfizer Is Relevant .................................. 24

1. Communications with Plaintiffs’ Lawyers Are Relevant ........ 25 2. The Underlying Methodology and Data Are Relevant ............ 26

B. The Information Sought by Pfizer Is Not Privileged or Protected ............................................................................................. 28 1. Moore’s Retention as an Expert Does Not Shield Him ........... 29 2. The Other Asserted Privileges Do Not Apply ......................... 30

CONCLUSION ....................................................................................................... 33


ii

TABLE OF AUTHORITIES

Page(s) CASES

Adkins v. Christie, 488 F.3d 1324 (11th Cir. 2007) .......................................................................... 31

Auto-Owners Ins. Co. v. Southeast Floating Docks, Inc., 231 F.R.D. 426 (M.D. Fla. 2005) ....................................................................... 25

Coker v. Duke & Co., Inc., 177 F.R.D. 682 (M.D. Ala. 1998) ......................................................................... 4

Daubert v. Merrell Dow Pharms., Inc., 509 U.S. 579 (1993) ............................................................................................ 16

Deitchman v. E.R. Squibb & Sons, Inc., 740 F.2d 556, 566 (7th Cir. 1984) ................................................................ 26, 27

Eliasen v. Hamilton, 111 F.R.D. 396 (N.D. Ill. 1986) .......................................................................... 30

Grider v. Keystone Health Plan Central, Inc., No. 05-MC-40, 2005 WL 2030456 (M.D. Pa. July 28, 2005) ................. 4, 25, 29

In re Brand Name Prescription Drugs, 1995 WL 535077 (N.D. Ill. Sept. 5, 1995) ................................................... 26, 27

In re Methyl Tertiary Butyl Ether (“MTBE”) Prod. Liab. Litig., 269 F.R.D. 360 (S.D.N.Y. 2010) ........................................................ 4, 25, 27, 31

In re Rezulin Prods. Liab. Litig., 309 F. Supp. 2d 531 (S.D.N.Y. 2004) ................................................................ 14

In re Silicone Gel Breast Implants Prods. Liab. Litig., No. CV 92-P-10000S, 1996 WL 13582526 (N.D. Ala. April 11, 1996) ............ 27

Indus. Maritime Carriers, Inc. v. PT (Persero) Inka, 179 F.R.D. 153 (E.D. Pa. 1998) .......................................................................... 30

McClain v. Metabolife Int’l, Inc., 401 F.3d 1233 (11th Cir. 2005) ............................................................................ 7


iii

Parson & Whittemore Enter. Corp. v. Cello Energy LLC, No. 09-00631-CG-B, 2010 WL 1994857 (S.D. Ala. March 29, 2010) .............. 25

Rocky Mountain Natural Gas Co. v. Cooper Indus., Inc., 166 F.R.D. 481 (D. Colo. 1996) ..................................................................... 5, 29

Stewart v. Mitchell Transport, Civ. No. 01-2546, 2002 WL 1558210 (D. Kan. July 8, 2002) ........................... 31

University of Pennsylvania v. E.E.O.C., 493 U.S. 182 (1990) ............................................................................................ 31

RULES

Fed. R. Civ. P. 26(b)(1) ............................................................................................ 25

Fed. R. Civ. P. 45(c)(3)(B)(i) ................................................................................... 31


1

Defendant Pfizer Inc. respectfully submits this Memorandum of Law in

support of its Motion to Compel Responses to Third-Party Subpoenas.

PRELIMINARY STATEMENT

On May 21, 2008, the Institute for Safe Medication Practices (“ISMP”)

published a report on Chantix entitled, “Strong Safety Signal Seen for New

Varenicline Risks,” which reported that Chantix had the highest number of adverse

event reports during the last quarter of 2007. Unlike true clinical trial research,

adverse event reports lack a control group, they are submitted by members of the

public (e.g., healthcare providers, patients, family members, attorneys), they often

contain incomplete information, and they are not verified. On the face of the

report, the ISMP authors concede that “[a]dverse event reports in themselves do

not establish a causal link to the drug.” This conclusion is consistent with the

universal recognition by FDA and the scientific community that adverse event

reports are inadequate to establish a cause and effect relationship between an event

such as suicide and exposure to a medication such as Chantix.

Despite these admitted limitations, the ISMP report acted as a catalyst for

this litigation, with one plaintiff attorney reportedly receiving 1,300 inquiries from

potential plaintiffs the day after ISMP published the report. Today, Plaintiffs rely

heavily on the ISMP report as a basis for their Master Complaint, citing it in

support of their claims that Chantix causes suicide and other injuries. The lead


2

authors of the ISMP report are Thomas Moore and Curt Furberg, both of whom

frequently serve as experts for plaintiffs’ lawyers in pharmaceutical litigation.

Moore, despite having no scientific training, frequently conducts analyses of

FDA’s adverse event database for members of the plaintiffs’ bar. Furberg is a

longtime critic of the pharmaceutical industry, and he has served as a “drug safety”

expert on behalf of plaintiffs’ lawyers in numerous pharmaceutical litigations.

Neither Moore nor Furberg disclosed this information in the ISMP report.

Because Plaintiffs cited the ISMP report in support of their allegations here,

on August 13-16, 2010—more than seven months ago—Pfizer served document

subpoenas on ISMP, Moore, Furberg, Michael Cohen (the third author of the

report), and Drug Safety Research (Moore’s litigation consulting company). The

subpoenas seek two categories of information: (1) any communications with

plaintiffs’ lawyers regarding Chantix; and (2) the underlying methodology and data

that form the basis of the ISMP report and subsequent reports by ISMP that also

discuss Chantix. These are routine third-party document subpoenas, no different

than subpoenas served by Plaintiffs on various non-parties, such as their May 24,

2010 subpoena to Dr. Douglas Jorenby, a smoking cessation expert at the

University of Wisconsin, which sought all documents and communications

received from and sent to Pfizer relating to the clinical study he conducted, “Long-

Term Varenicline Treatment for Smoking Cessation.” Pursuant to Pretrial Order


3

No. 4, Pfizer provided Plaintiffs with advance copies of the subpoenas, and

Plaintiffs asserted no objections whatsoever.

In October 2010, Steve Webster, counsel for the subpoena recipients,

refused to produce several of the requested categories of documents, including any

communications with plaintiff lawyers. At the time, Webster explicitly stated that

none of the subpoena recipients had been retained as experts by Plaintiffs in the

litigation, and thus that was no basis to object to the subpoenas. Pfizer then

reached a preliminary agreement with Webster for him to provide any (1) protocols

describing the methodologies ISMP used in its reports; (2) search terms used to

search FDA’s adverse event database; and (3) search results. Pfizer entered into

this arrangement in a good faith effort to obtain some of the material it was

seeking, but Pfizer expressly reserved its right to seek additional information.

Pfizer asserted that right when the material provided by Webster failed to

include any protocols or search terms and consisted of what appear to be random

search results. When Pfizer followed up with Webster, however, he now said—

seven months after the subpoenas had been served—that Plaintiffs were retaining

Moore as their expert, and he turned over his representation of the subpoena

recipients to Plaintiffs’ Lead Counsel in the MDL. Prior to this time, all of Pfizer’s

arrangements with Webster were made with the understanding that Moore had not

been retained as an expert in the litigation. Since then, Pfizer has learned from


4

Plaintiffs’ counsel that there were communications between Moore and one

plaintiff attorney regarding Chantix prior to Moore’s retention as an expert.

The parties have met and conferred on these issues. While Plaintiffs’

counsel initially expressed a willingness to produce communications with attorneys

and certain other materials, they have now withdrawn that offer because the parties

could not reach a complete agreement on production and because Pfizer would not

agree to forfeit its ability to seek additional information if necessary.

Pfizer is entitled to these communications and the underlying methodologies

and data that form the basis of the ISMP reports. This information is relevant to

Pfizer’s defenses, particularly under the broad criteria for relevance applied to

discovery subpoenas. See Coker v. Duke & Co., Inc., 177 F.R.D. 682, 685 (M.D.

Ala. 1998) (“Where there is a doubt over relevancy, the court should still permit

discovery.”); Grider v. Keystone Health Plan Central, Inc., No. 05-MC-40, 2005

WL 2030456, at *2 (M.D. Pa. July 28, 2005) (compelling production of

communications between plaintiffs’ lawyers and subpoena recipients); In re Methyl

Tertiary Butyl Ether (“MTBE”) Prods. Liab. Litig., 269 F.R.D. 360, 364-65

(S.D.N.Y. 2010) (finding non-profit organization’s study “highly relevant” and

compelling production of “any raw data from its MTBE study”).

Further, the information sought by Pfizer is neither privileged nor protected.

The fact that Plaintiffs’ counsel has now retained Moore as an expert witness does


5

not shield him or his materials from discovery because the subpoena seeks

information regarding factual matters that precede his retention as an expert. See

Rocky Mountain Natural Gas Co. v. Cooper Indus., Inc., 166 F.R.D. 481, 482 (D.

Colo. 1996) (“[R]ule 26(b)(4)(B) permits a party to engage in discovery with

respect to information consultative experts acquired prior to being retained by an

opposing party in anticipation of the underlying litigation.”) (emphasis in original).

STATEMENT OF FACTS

A. Chantix

Smoking is the leading cause of preventable disease and death in the world.1

Each year, approximately 443,000 people in the U.S. die prematurely from

smoking.2 Approximately 70% of smokers say they want to quit, and 45% try to

quit smoking each year, but only a fraction of that number have long-term

success.3 Before 2006, many smokers tried but failed to quit with older smoking

cessation products, like the nicotine patch, nicotine gum, and Zyban. This left the

public health community with a medical need for new options.

On May 10, 2006, the Food & Drug Administration (“FDA”) approved

Chantix as a safe and effective aid for smoking cessation.4 Since then, Chantix has

1 http://www.cdc.gov/tobacco/data_statistics/fact_sheets/fast_facts/ (last visited Mar. 9,

2011), Ex. 1. 2 Id. 3 Id. 4 FDA Letter, May 10, 2006, Ex. 2. Chantix is the brand name for varenicline.


6

helped a substantial number of smokers quit.5 Data from randomized clinical

trials—the gold standard of scientific evidence—have consistently shown that

Chantix is safe and the most effective smoking cessation therapy available to

patients today.6

B. FDA’s Adverse Event Reporting System

After approval, FDA continues to monitor the safety of medications through

its Adverse Event Reporting System (“AERS”).7 AERS is a computerized

database compiled from MedWatch forms, written reports of adverse drug events

submitted by manufacturers and the public.8 Anyone can submit a MedWatch

form, including patients, family members, friends, neighbors, and even attorneys.9

According to FDA, the purpose of AERS is to identify potential issues that

“indicate the need for further investigation, which may or may not lead to the

conclusion that the product caused the event.”10 FDA recognizes that adverse

event reports have significant limitations and that they do not provide reliable

evidence of causation for several reasons. For instance, the quality of MedWatch

5 Pfizer Response to CHMP, Nov. 25, 2008, at 26-33, 10-14, Ex. 3. 6 See, e.g., Harrington, EXPERT REV. RESP. MED. 2009;3(5):475-85, Ex. 4. 7 FDA, Adverse Event Reporting System, http://www.fda.gov/Drugs/Guidance

ComplianceRegulatoryInformation/Surveillance/AdverseDrugEffects/default.htm (last visited Mar. 9, 2011), Ex. 5.

8 Id. 9 FDA, MedWatch, http://www.fda.gov/Safety/MedWatch/ HowToReport/default.htm (last

visited Mar. 9, 2011), Ex. 6.


7

reports is often poor, with critical information missing such as the description of

the adverse event, the patient’s medical history, or concomitant medications.11

FDA also recognizes that “there is almost always an underlying background rate

for any clinical event in a population,” so there is no reliable way to attribute an

event to the medication as opposed to the background rate.12 Further, adverse

event reports are “subject to a variety of reporting biases,” including being elevated

by publicity.13 In the context of suicide and neuropsychiatric events in particular,

FDA has said that adverse event data is “uninterpretable” with respect to

determining causation.14 Courts, including the Eleventh Circuit, also recognize

that adverse event reports are unreliable evidence of causation. See, e.g., McClain

v. Metabolife Int’l, Inc., 401 F.3d 1233, 1250 (11th Cir. 2005) (describing FDA

adverse event reports as “one of the least reliable sources to justify opinions about

both general and individual causation”).

In a smoking population, adverse event data is even more difficult to

interpret because smokers have a significantly higher rate of suicide and other

10 FDA, Guidance for Industry: Good Pharmacovigilance Practices & Pharmacoepide-

miologic Assessment, at 4 (Mar. 2005) (“Guidance for Industry”), Ex. 7. 11 Guidance for Industry, at 4 (“The quality of the reports is critical for [an] appropriate

evaluation of the relationship between the product and adverse events.”). 12 FDA, The Clinical Impact of Adverse Event Reporting, at 5 (Oct. 1996) (“Adverse Event

Reporting”), Ex. 8. 13 Guidance for Industry, at 9.


8

neuropsychiatric conditions compared to nonsmokers.15 Smokers are two-to-three

times more likely to commit suicide than nonsmokers.16 In addition, smokers

attempting to quit without any medication often report symptoms such as

depression, anxiety, irritability, and aggression, which are the same conditions at

issue in this litigation.17 As a result, FDA recognizes that it is “difficult to

evaluate” the Chantix adverse event data because “people who stop smoking

without using medications may also experience similar type symptoms due to

nicotine withdrawal.”18 For these reasons, it is impossible to tell from adverse

event data whether smokers trying to quit with Chantix have any higher risk of

neuropsychiatric events than smokers trying to quit without any medication at all.

C. The Carter Albrecht Incident

For the first 13 months that Chantix was on the market, the number of

adverse event reports was not significant, particularly given the millions of patients

using the medication.19 Then the Carter Albrecht incident occurred.

14 Testimony of Dr. Katz, FDA Jt. Mtg. Peripheral & Central Nervous System Drugs

Advisory Committee & Psychopharmacologic Drugs Advisory Committee, July 10, 2008, at 103, Ex. 9.

15 Miller, AM. J. PUBLIC HEALTH 2000;90(5):768-73, at 769, Ex. 10. 16 Miller, AM. J. PUBLIC HEALTH 2000;90(5):768-73; see also Gunnell, BMJ

2009;339:b3805, Ex. 11. 17 Hughes, DRUG & ALCOHOL DEPENDENCE 2008;98:169-178, at 172, Ex. 12. 18 Dr. Curtis Rosebraugh, FDA Tr. 7/01/2009, at 1, Ex. 13. 19 Response to CHMP, Nov. 25, 2008, at 37.


9

On September 3, 2007, a popular Texas musician named Carter Albrecht and

his girlfriend were drinking at a Dallas bar until approximately 3:00 a.m.20 Once at

home, Albrecht reportedly assaulted his girlfriend, and she locked him out of the

house. 21 Albrecht then wandered into his neighbor’s yard and, for reasons that are

unknown, began pounding loudly on his neighbor’s back door.22 The neighbor,

thinking Albrecht was a burglar, shot Albrecht in the head, and killed him.23

Because Albrecht had been taking Chantix at the time, his girlfriend publicly

blamed Chantix in the media, claiming that the medication was responsible for

Albrecht’s behavior and his death.24 The results of Albrecht’s autopsy were not

available until several days later, but they ultimately showed that Albrecht’s blood

alcohol level was three times the legal limit.25

The publicity surrounding Albrecht’s death was followed by an increase in

the number of adverse event reports for Chantix, which prompted an FDA Alert

that continued the trend of increased reporting, as illustrated below.

20 Eiserer, Carter Albrecht, Musician with Sorta, New Bohemians, Killed, THE DALLAS

MORNING NEWS, Sept. 4, 2007, Ex. 14. 21 Id. 22 Carlton, Musician Carter Albrecht Shot Dead by Girlfriend’s Neighbor, THE

BROWNSVILLE HERALD, Sept. 4, 2007, Ex. 15. 23 Id. 24 Brick, A Dallas Face in Controversy, THE DALLAS MORNING NEWS, Dec. 26, 2010, Ex.

16. 25 Herper, Tobacco-Free, FORBES, Dec. 10, 2007, Ex. 17.


10

26

This publicity also drew the attention of plaintiff lawyers, one of whom

wrote an article for the American Association of Justice (formerly the American

Trial Lawyers Association) in 2008 called “Chantix: The Next Mass Tort.” 27

D. The ISMP Report on Chantix

On May 21, 2008, ISMP published a report on Chantix entitled, “Strong

Safety Signal Seen for New Varenicline Risks.”28 ISMP is a non-profit

organization based in Pennsylvania devoted to the prevention of “medication

errors,” such as mistakes caused by similar drug names or confusing drug

26 Response to CHMP, Nov. 25, 2008, at 41. “USPI Update” indicates a change to the U.S.

Package Insert, meaning the Chantix label in the U.S. “SPC Update” indicates a change to the Summary of Product Characteristics, meaning the Chantix label in Europe.

27 Cory Watson Website, http://www.cwcd.com/kristian-rasmussen.php (last visited Mar. 9, 2011), Ex. 18.

28 ISMP, Strong Safety Signal Seen for New Varenicline Risks, May 21, 2008 (“ISMP Report”), Ex. 19.


11

packaging.29 Before publishing the report on Chantix, ISMP had no history of

criticizing medications themselves.30

1. Thomas Moore

Moore is the lead author of the ISMP report. Despite being listed as a

“Senior Scientist” on ISMP’s website, Moore has no medical or scientific

degrees.31 He is a former investigative journalist who, in the 1990s, wrote several

books criticizing FDA and the pharmaceutical industry, including DEADLY

MEDICINE and PRESCRIPTION FOR DISASTER: THE HIDDEN DANGERS IN YOUR

MEDICINE CABINET.32 In the latter book, Moore claimed that “there is no such

thing as a safe drug” and that prescription medications cause an estimated 100,000

deaths each year.33 Amazon.com called Moore a “drug doomsayer,” and Library

Journal wrote that Moore’s book “greatly accentuates the negative.”34

Today, Moore consults with plaintiff lawyers and others on issues relating to

drug safety, operating under the business name, Drug Safety Research. While the

29 ISMP Website, About ISMP, http://www.ismp.org/about/default.asp (last visited Mar. 6,

2011) (“ISMP Website”), Ex. 20. 30 See id. 31 ISMP Website, ISMP Staff, http://www.ismp.org/about/staff.asp (last visited Mar. 15,

2011) (“ISMP Staff”), Ex. 21; see also Deposition of Curt Furberg, In re Pfizer Inc. Sec. Litig., May 29, 2009, at 309:11-13 (“Securities Dep.”), Ex. 22.

32 Moore, DEADLY MEDICINE (1995); Moore, PRESCRIPTION FOR DISASTER: THE HIDDEN DANGERS IN YOUR MEDICINE CABINET (1998).

33 See http://www.amazon.com/Prescription-Disaster-Thomas-Moore/dp/0440234840 (last visited Mar. 15, 2011), Ex. 23.

34 Id.


12

full scope of Moore’s work with the plaintiffs’ bar is not defined, his website (until

approximately three weeks ago) indicated that his consulting work includes

analyzing FDA’s adverse event database for plaintiff lawyers:

I’ve published scholarly research and written reports for lawyers using the FDA’s database of adverse drug event reports.

As a litigation consultant I have also analyzed pharmaceutical company clinical trials and adverse reaction report data files.35

In the past three weeks, however, it appears that Moore removed extensive

material from his website, including information on his litigation consulting

activities.36

2. Dr. Curt Furberg

Furberg is the second author of the ISMP report. Furberg has a history as a

crusader against the pharmaceutical industry, but his methods have been criticized

and rejected by other members of the medical and scientific community. For

example, from 1989 to 2003, Furberg wrote a series of articles attacking calcium

channel blockers (medications used to treat high blood pressure), alternately

claiming that these medicines caused death, gastrointestinal bleeding, dementia,

35 See http://www.thomasjmoore.com/pages/myadverse.html (last visited Feb. 18, 2011), Ex.

24. 36 Compare http://www.thomasjmoore.com/ (last visited Mar. 9, 2011), Ex. 25, with

http://www.thomasjmoore.com/ (last visited Feb. 18, 2011), Ex. 26.


13

and heart attacks.37 Many members of the medical and scientific community

criticized Furberg’s methods as scientifically unsound and rejected his conclusions.

Below are a few examples:

• “[I]f one tried to think of all the things to do wrong in a meta-analysis, this paper [Furberg’s] would have all of them”;38

• “[Furberg’s] investigation disobey[s] virtually all of the principles of proper observational (case-control or cohort) studies”; 39 and

• “[T]here is no scientific basis for Furberg’s conclusions . . . [and] no serious clinical academic in the field agrees with his conclusions.”40

One article, titled “The Furberg Bias” or: The Manipulation of Evidence-

Based Medicine, takes further aim at Furberg’s scientific methods.41 In addition to

these criticisms, Furberg’s results were never replicated by others in subsequent

studies, and FDA never adopted his conclusions.

As a litigation expert, Furberg has testified repeatedly against the

pharmaceutical industry in a number of litigations, including the Baycol, Bextra,

Celebrex, Neurontin, Propulsid, Ortho-Evra patch, Omniscan, Fosamax, and

37 See Furberg, CIRCULATION 1995;92(5):1326-31, Ex. 27; Furberg, LANCET 1996;347:1061-

65, Ex. 28; Furberg, J. AM. GERIATR. SOC. 1997;45:1423-33, Ex. 29; Furberg, LANCET 2000;356:1949-54, Ex. 30.

38 Calcium Channel Blocker Debate Continues, THE PHARMA LETTER, Sept. 11, 1995, at 1, Ex. 31.

39 Kaplan, LANCET 1996;348:541-42 (Letter to the Editor), Ex. 32. 40 Chustecka, Experts Condemn Furberg’s Meta-Analysis Showing Calcium Channel

Blockers to be Inferior, HEARTWIRE, Sept. 1, 2000, at 2, Ex. 33. 41 Middeke, DTSCH. MED. WOCHENSCHR. 2001;126(6):151-52 (Commentary), Ex. 34.


14

Rezulin litigations.42 In one case, the court excluded Furberg from testifying about

corporate conduct, finding that Furberg’s position “is not an ‘expert’ opinion, but

rather a personal opinion about what standards [he] believes should apply to

pharmaceutical company conduct.” In re Rezulin Prods. Liab. Litig., 309 F. Supp.

2d 531, 560 (S.D.N.Y. 2004) (noting that judges should not be “deceived by the

assertions of experts who offer credentials rather than analysis”).

3. The ISMP Report Findings

According to the ISMP report, Chantix had the highest number of adverse

event reports during the last quarter of 2007, with 988 “serious” injuries reported

during that time period.43 The reported injuries purportedly include suicide,

homicidal ideation, paranoia, and hallucinations, as well as broad categories such

as “accidents and injuries,” “vision disturbance,” and “heart rhythm

disturbances.”44 While Moore and Furberg acknowledge that “media publicity

42 See, e.g., Deposition of Curt Furberg, Rushton v. Bayer Corp., Dec. 23, 2003 (“Baycol

Dep.”), Ex. 35; Deposition of Curt Furberg, In re Bextra & Celebrex Mktg. Sales Practices & Prod. Liab. Litig., Mar. 13, 2008 (“Bextra Dep.”), Ex. 36; Deposition of Curt Furberg, Valenzuela v. Warner-Lambert, July 31, 2002 (“Rezulin Dep.”), Ex. 37; Deposition of Curt Furberg, Sturgill v. Johnson & Johnson Co., Oct. 29, 2002 (“Propulsid Dep.”), Ex. 38; Deposition of Curt Furberg, In re Neurontin Mktg., Sales Practices, & Prods. Liab. Litig., Mar. 11, 2009 (“Neurontin Dep.”), Ex. 39.

43 ISMP Report, at 1. 44 Id. at 1-2.


15

about FDA warnings or other actions” can increase adverse event reports, they do

not mention the Albrecht incident and discount that possibility with Chantix.45

Moore and Furberg do concede that “[a]dverse event reports in themselves

do not establish a causal link to the drug.”46 They even concede that “it is likely

that some individual reports will describe complex events for which there are

alternative causes or contain other information to render a relationship to the drug

less likely.”47 Therefore, at best, they say that their findings represent “a signal

that requires further investigation and confirmation.”48

Notwithstanding these limitations, the ISMP report functioned as a catalyst

for this litigation. On the day after ISMP published the report, the same plaintiffs’

attorney who wrote that Chantix was the “next mass tort” said that his firm had

“received 1,300 inquiries from concerned Chantix users since the release of the

[ISMP] report late Wednesday [May 21, 2008].”49 Shortly thereafter, the same

attorney—who communicated with Moore and also has a history of working with

45 Id. at 11. 46 Id. at 1. Furberg has admitted in depositions that adverse event data “has limitations,” and

he has characterized AERS as a “crude method for assessing drug safety.” Securities Dep. at 311:12-20; Furberg & Pitt, J. AM. COLL. CARDIOL. 2001;37(5):1456-60, at 1459, Ex. 40.

47 ISMP Report, at 9. 48 Id. at 10. 49 HealthandSurvival.com, Latest Chantix Safety Concerns Add to Pfizer’s Aches, Pains,

May 22, 2008, http://healthandsurvival.com/2008/05/22/latest-chantix-safety-concerns-add-to-pfizers-aches-pains/ (last visited Mar. 9, 2011), Ex. 41.


16

Furberg—filed the first Chantix lawsuit.50 Today, in the Master Complaint,

Plaintiffs continue to rely on the ISMP report to support their claims that Pfizer

ignored safety data showing an association between Chantix and various injuries.51

4. Methodological Questions

In peer-reviewed medical journals, it is standard practice for authors to

include a “methods” section describing their methodology so that other scientists

can replicate those methods and thereby test the results. This process of replication

and testing is the hallmark of scientific inquiry. See Daubert v. Merrell Dow

Pharms., Inc., 509 U.S. 579, 593 (1993) (“Scientific methodology today is based

on generating hypotheses and testing them to see if they can be falsified; indeed,

this methodology is what distinguishes science from other fields of human

inquiry.”). The ISMP report—which was not published in a peer-reviewed

medical journal—has no methods section, leaving a number of methodological

questions.

Moore’s “Third” Approach. The ISMP report acknowledges that there are

two traditional approaches for analyzing adverse event data—the “case series”

approach and a process known as “data mining.”52 Both of these methods are

50 Compl. at 51, Collins v. Pfizer, Inc., No. 08-cv-0888 (S.D. Ind. July 2, 2008), Ex. 42. 51 See Master Compl. ¶¶ 57-61, 63, Ex. 43. 52 ISMP Report, at 5.


17

endorsed by FDA.53 Rather than follow these traditional approaches, however,

Moore opted instead for his own “third approach, which was to monitor the flow of

quarterly reports in order to detect changes in the numbers of serious events and

other trends.”54 This third approach is never defined or validated in any way, nor

is there any explanation for why Moore abandoned the two traditional techniques.

No Database Description. While the report is based on an analysis of

FDA’s AERS database, the raw AERS data generally has to be “cleaned” by an

outside vendor so that it can be searched and used for research purposes. Based on

communications with Plaintiffs’ counsel, it appears that Moore does not use an

outside vendor but instead cleans and modifies the raw AERS data himself. The

ISMP report on Chantix does not address this issue at all, although Moore refers to

“our master database” in subsequent reports.55 How and to what extent Moore

modifies the raw AERS data to create his own database remains unknown. This

information is critical because, in order to replicate and test his results, one has to

know where to begin, and Moore’s database is the starting point.

No Description of Search Terms. In a broad sense, searching for adverse

event data is similar to searching for cases on Westlaw or Lexis. The results

depend in large part on the search terms. While the ISMP report refers to the use

53 Guidance for Industry, at 4-12. 54 ISMP Report, at 5.


18

of “standardized MedDRA queries” or “SMQs”—prepackaged search terms

devised from the Medical Dictionary for Regulatory Activities (“MedDRA”)—the

ISMP report never identifies the SMQs or describes the actual search terms used.56

More significantly, the ISMP report suggests that the search terms were not

definitive, saying “these selection criteria do not provide definitive assessments but

rather are intended to identify potential cases for additional review.”57 This raises

questions not only of what search terms were used, but how they were selected,

and what additional criteria Moore or Furberg applied to the search results.

No Description of Event Counts. How events were counted in the ISMP

report also remains unclear. For example, Moore and Furberg fail to explain

whether their analysis of the fourth quarter of 2007 is based on counting adverse

events for Chantix that occurred during that period or simply those that were

reported during that period.58 The ISMP report also concedes that events may be

counted multiple times, saying that a single event “could be counted in multiple

categories, and classifications are not definitive.”59 To replicate the ISMP report,

however, it is necessary to understand the extent to which Moore and Furberg

double- or triple-counted events and what the actual number of reports were.

55 QuarterWatch: 2008 Quarter 3 (May 7, 2009), at 3, Ex. 44. 56 See ISMP Report, at 7. 57 Id. 58 Id. at 1-2.


19

E. Later ISMP Reports

In addition to its first report, which focused exclusively on Chantix, ISMP

has published eight “QuarterWatch” reports.60 These reports purportedly analyze

FDA’s AERS database on a quarter-by-quarter basis, highlighting the medications

with the highest numbers of adverse event reports each quarter. Many of the

reports discuss Chantix.

The later ISMP reports also raise several methodological questions. Moore

and Furberg admit that their methodology “continues to evolve” and change from

one report to the next.61 These changes include “edit[ing] and correct[ing] our

master database of adverse events,”62 correcting a “software error” that led to an

“overstatement of the growth in reports compared to the previous quarter,”63 and

applying “revised criteria” to classify certain events.64 Yet, while Moore and

Furberg mention these changes, they do not describe them in any detail.

59 Id. at 1. 60 QuaterWatch: 2008 Quarter 1 (Oct. 23, 2008), Ex. 45; QuarterWatch: 2008 Quarter 2 (Jan.

15, 2009), Ex. 46; QuarterWatch: 2008 Quarter 3 (May 7, 2009), Ex. 47; QuarterWatch: 2008 Quarter 4 (Oct. 8, 2009), Ex. 48; QuarterWatch: 2009 Quarters 1-3 (Feb. 25, 2010), Ex. 49; QuarterWatch: 2009 Quarter 4 (June 17, 2010), Ex. 50; QuarterWatch: 2010 Quarter 1 (Nov. 4, 2010), Ex. 51; QuarterWatch: 2010 Quarter 2 (January 27, 2011), Ex. 52.

61 QuarterWatch: 2008 Quarter 3 (May 7, 2009), at 7. 62 Id. at 3. 63 QuarterWatch: 2008 Quarter 4 (Oct. 8, 2009), at 6. 64 QuarterWatch: 2008 Quarter 3 (May 7, 2009), at 14.


20

F. Chantix Data Today

As noted above, the purpose of adverse event reporting is not to determine

causation but to identify potential issues that “indicate the need for further

investigation” through more reliable scientific tools, such as clinical trials or

observational studies.65 Since ISMP published its first report on Chantix, a number

of clinical trials and observational studies have been published, and none of them

have confirmed the ISMP findings. The largest, an observational study of 80,660

smokers in the U.K. found “no clear evidence of an increased risk of self-harm,

suicidal thoughts, or depression in people prescribed varenicline [Chantix]

compared with those prescribed other smoking cessation products.”66 Pfizer is also

conducting a large clinical trial to investigate “the incidence of mental health

symptoms in people trying to stop smoking.”67

PROCEDURAL HISTORY

On August 13-16, 2010, Pfizer served subpoenas duces tecum on ISMP,

Moore, Moore’s consulting company Drug Safety Research, Furberg, and Cohen.68

The subpoenas requested materials related to the underlying methodology used to

generate the ISMP reports and communications between the subpoena recipients

65 Guidance for Industry, at 4. 66 Gunnell, BMJ 2009;339:b3805, at 6. 67 Dr. Curtis Rosebraugh, FDA Tr. 7/01/2009, at 1. 68 See Pfizer Subpoenas, Ex. 53.


21

and plaintiffs’ attorneys.69 Before serving the subpoenas, Pfizer gave Plaintiffs’

counsel copies of the subpoenas, pursuant to Pretrial Order No. 4, and they did not

object.70

On August 25, 2010, attorney Steve Webster contacted Pfizer’s counsel and

said that he represented all the subpoena recipients.71 Webster confirmed that none

of the subpoena recipients had been retained as experts in this litigation. Even

though Webster refused to provide certain materials—like communications with

plaintiffs’ lawyers—Pfizer’s counsel reached an agreement with Webster on a

preliminary production of certain materials, including any protocols describing

ISMP’s methodology, a list of the search terms used, and a copy of the search

results.72 Pfizer also explicitly reserved its rights “to seek additional information at

a later time.”73

Webster then provided Pfizer with a package of materials.74 The materials

did not comply with the agreement, however, as they contained no protocol and no

69 Id. 70 Holian Letter, July 29, 2010, Ex. 54; Pretrial Order No. 4: Discovery Plan, Feb. 24, 2010, at 2 (“No party to the Plan may conduct any discovery not expressly authorized by the Plan absent further Order of this Court or express agreement of the parties. This provision shall not preclude third party discovery; provided, however, that any party intending to serve third party discovery shall give ten (10) days written notice to the other party of the third party discovery to be served.”), Ex. 55. 71 Webster E-mail, Aug. 25, 2010, Ex. 56. 72 Campbell Letter, Oct. 7, 2010, Ex. 57. 73 Id. at 2. 74 Webster Letter, Oct. 26, 2010, Ex. 58.


22

search terms. The materials provided appeared to be the results of some search,

but, without any understanding of the search terms or the ISMP report to which

they applied, they were useless. Pfizer’s counsel then followed up with a more

specific request for the missing materials, as well some other items, all of which

were covered by the original subpoenas.75 After several weeks with no response,

Webster reported that Plaintiffs had retained Moore as an expert witness and that

Plaintiffs’ Lead Counsel would be handling all issues related to the subpoenas.76

On February 25, 2011, Pfizer’s counsel sent Plaintiffs’ counsel a summary

of the discussions to date and reiterated its request for the following materials:

(a) all materials that have been publicly disclosed such as papers, presentations including PowerPoint slides, and speeches (these are the materials that Webster originally agreed to provide in his September 2, 2010 e-mail, but were never provided);

(b) all communications between the recipients of the subpoenas and any plaintiff attorneys regarding Chantix (for Mr. Moore, this would not apply for dates after his retention);

(c) any research protocols or guidelines, including all versions or drafts of protocols that were used for data analysis;

(d) any search terms used, including lists of any search terms used, including but not limited to standardized medical queries, or “SMQs”;

(e) a copy of the database searched or a sufficient description of the database to allow us to reproduce the searches (for example, if Mr. Moore simply searched the FDA AERS database without alteration,

75 Campbell Letter, Jan. 12, 2011, Ex. 59. 76 Webster E-mail, Feb. 18, 2011, Ex. 60.


23

tell us that, or let us know how his database differs from the FDA AERS database);

(f) results of any searches (but please identify the results by date and search terms so that we can tell which results are tied to which searches);

(g) any inclusion and exclusion criteria, with criteria specifically defined;

(h) any adverse event reports excluded from the analyses;

(i) any specific definitions used in collecting or analyzing the data;

(j) a copy of the ISMP QuarterWatch dictionary referred to in Mr. Moore’s most recent publication, which is discussed below;

(k) a copy of any Freedom of Information Act requests regarding any adverse event data related to Chantix and the results of any such requests; and

(l) log files for all statistical analyses run.77

On March 1, 2011, Plaintiffs’ counsel responded to Pfizer.78 Despite

acknowledging that there were e-mail communications between Moore and at least

one plaintiffs’ attorney that would be responsive to the subpoenas, as well as other

requested materials, Plaintiffs’ counsel refused to produce these items because they

were not part of Pfizer’s original arrangement with Webster in October 2010:

Request: “(b) all communications between the recipients of the subpoenas and any plaintiff attorneys regarding Chantix (for Mr. Moore, this would not apply for dates after his retention);

77 Haston E-mail, Feb. 25, 2011, Ex. 61. 78 Cory E-mail, Mar. 1, 2011, Ex. 62.


24

Plaintiffs’ Response: “This request is outside the scope of the October letter agreement, I understand that most are emails between Kristian Rasmussen and Mr. Moore. Again, We might be willing to produce these documents if we can come to a permanent resolution of this dispute.”79

Pfizer informed Plaintiffs’ counsel that the October 2010 arrangement with

Webster included an express reservation of Pfizer’s right to seek additional

information under the subpoenas. In response, Plaintiffs offered to produce only

the same materials that Webster previously provided, but for all of the ISMP

reports to date.80 Pfizer’s counsel made clear that it required a full production of

the items listed above, but Plaintiffs refused to agree.

Although the parties met and conferred on these issues, an agreement could

not be reached. Plaintiffs’ counsel initially expressed a willingness to produce

communications with attorneys and certain other materials. They later withdrew

their offer, however, because the parties could not reach a complete agreement on

production and because Pfizer would not agree to forfeit its ability to seek

additional information if necessary.

79 Id. 80 Cory E-mail, Mar. 10, 2011, Ex. 63.


25

LEGAL ARGUMENT

THE COURT SHOULD COMPEL PRODUCTION IN RESPONSE TO PFIZER’S SUBPOENAS

A. The Information Sought by Pfizer Is Relevant

To compel production in response to a subpoena, the party seeking

enforcement must make a threshold showing that discovery is relevant to its claims

or defenses. See Parson & Whittemore Enter. Corp. v. Cello Energy LLC, No. 09-

00631-CG-B, 2010 WL 1994857, at *2 (S.D. Ala. Mar. 29, 2010). Relevance is

construed broadly. Id. The Federal Rules of Civil Procedure permit discovery of

“any nonprivileged matter that is relevant to any party’s claim or defense.” Fed. R.

Civ. P. 26(b)(1); see also Parson, 2010 WL 1994857, at *2 (“The term ‘relevant’

should be ‘construed broadly to encompass any matter that bears on, or that

reasonably could lead to other matter that bears on, any issue that is or may be in

the case.’”) (quoting Auto-Owners Ins. Co. v. Southeast Floating Docks, Inc., 231

F.R.D. 426, 430 (M.D. Fla. 2005)).

1. Communications with Plaintiffs’ Lawyers Are Relevant

As noted above, Pfizer seeks two categories of information. The first is

communications with plaintiffs’ lawyers. In similar cases, courts have held that

such communications are relevant and compelled their production. In In re Methyl

Tertiary Butyl Ether (“MTBE”) Products Liability Litigation, the MDL court

compelled a non-profit organization, the Hamner Institute, to produce both its raw


26

data and “any communications between [defendant] ExxonMobil and the Institute

relating to the study.” 269 F.R.D. at 365; see also Grider, 2005 WL 2030456, at

*2 (compelling production of communications between plaintiffs’ lawyers and

subpoena recipients, a physician association and the association’s vice president);

In re Brand Name Prescription Drugs Antitrust Litig., MDL No. 997, 1995 WL

535077, at *3 (N.D. Ill. Sept. 5, 1995) (holding communications between non-

profit organization and defense counsel “are not shielded from discovery”).

As mentioned, Plaintiffs’ counsel recently admitted that there were

communications between at least one plaintiff attorney and Moore prior to Moore’s

recent retention as a plaintiff expert. These communications are relevant. Given

Moore’s and Furberg’s ties to the plaintiffs’ bar and their involvement in other

pharmaceutical litigations, the communications are necessary to explore the extent

to which, if at all, litigation interests may have influenced the ISMP reports.

2. The Underlying Methodology and Data Are Relevant

The second category of information that Pfizer seeks is materials describing

the methodology and data underlying the ISMP reports. Such materials, too, have

been found relevant and compellable in other similar cases. For example, in

Deitchman v. E.R. Squibb & Sons, Inc., a pharmaceutical product liability case, the

Seventh Circuit vacated the lower court’s decision denying the defendant’s motion

to compel. 740 F.2d 556, 566 (7th Cir. 1984). In that case, the defendant drug


27

manufacturer subpoenaed the underlying data from a University of Chicago

registry and its custodian, Dr. Arthur Herbst, because the registry formed the

foundation of several studies central to the litigation. Id. at 557-58. In vacating

the lower court’s ruling, the Seventh Circuit recognized that, if the defendant were

not given access to the underlying data, then it would be deprived of its ability to

effectively challenge Dr. Herbst’s findings:

What [the defendant] is threatened with is having Dr. Herbst as a potential expert witness against it without his ever taking the stand or being subject to cross-examination. The situation is unique because there is placed in the hands of a nonwitness the capability of influencing the verdict far beyond that enjoyed normally by the most qualified expert witness who does take the stand. . . . Certainly, Squibb is entitled to cross-examine plaintiffs’ experts on the data underlying their opinions regarding DES.

Id. at 561-62 (emphasis added); see also In re MTBE Prods. Liab. Litig., 269

F.R.D. at 365 (noting that non-profit organization’s study is “highly relevant” and

compelling production of “any raw data from its MTBE study”); In re Brand Name

Prescription Drugs, 1995 WL 535077, at *3 (compelling production of underlying

documents compiled by non-party economic association).

And, in a similar dispute before this Court in the breast implant MDL

presided over by Judge Pointer in the 1990s, the subpoena recipient, Brigham and

Women’s Hospital, voluntarily turned over the type of data and methodology

information that Pfizer is seeking here. See In re Silicone Gel Breast Implants


28

Prods. Liab. Litig., No. CV 92-P-10000S, 1996 WL 1358526, at *1 (N.D. Ala.

Apr. 11, 1996) (Pointer, J.) (noting that the subpoena recipient “has largely

complied with the subpoena, producing various documents describing the grant

applications, protocols and methodology of the study, including blank

questionnaires”).

Here, Pfizer’s request for materials describing the methodology and data

underlying the ISMP reports is relevant because these materials provide the

foundation for the ISMP reports, which were a catalyst for this litigation and form

a basis for Plaintiffs’ claims in the litigation.81 Indeed, Pfizer’s subpoena requests

are no different than Plaintiffs’ own third-party subpoenas to discover the

underlying data for a Chantix clinical trial.82 As noted above, the ISMP reports

provide only a general description of the methodology that Moore and Furberg

employed, and that methodology changes over time.83 This information is central

to Pfizer’s ability to challenge the science underlying Plaintiffs’ claims and to

cross-examine Plaintiffs’ experts. Also, because Moore, Furberg, and the other

subpoena recipients are the only ones in possession of the requested information,

Pfizer cannot obtain it from another source. Thus, Pfizer has satisfied the broad

criteria for relevance.

81 Master Compl. ¶¶ 53-63. 82 Subpoena to Dr. Douglas E. Jorenby, May 24, 2010, Ex. 64.


29

B. The Information Sought by Pfizer Is Not Privileged or Protected

On March 10, 2011, Plaintiffs filed objections to Pfizer’s subpoenas in

which they asserted several privileges, namely the “attorney-client privilege, the

consulting expert privilege, the peer review material privilege, the pre-publication

research privilege, the journalistic privilege, or any other privilege.”84 None of

these privileges bar the production Pfizer is seeking.

1. Moore’s Retention as an Expert Does Not Shield Him

Neither the attorney-client privilege nor the consulting expert privilege

shield Moore from Pfizer’s subpoenas. The attorney-client privilege does not

protect communications between an attorney and an expert. See Grider, 2005 WL

2030456, at *3 (expert’s communications with plaintiffs’ attorneys were “clearly

not protected by the attorney-client privilege”). Here, Plaintiffs’ objections state

that they have retained Moore as a consulting expert.85 Because Plaintiffs’ counsel

do not represent Moore, the attorney-client privilege does not apply. The attorney-

client privilege likewise does not extend to Furberg or any of the other subpoena

recipients, who have neither been retained as experts nor are represented by

Plaintiffs’ counsel.86

83 See supra at 16-19. 84 Pls.’ Resp. and Objections to Non-Party Subpoenas 5, Mar. 10, 2011, Ex. 65. 85 Id. at 4. 86 Id.


30

The so-called “consulting expert” privilege also does not apply. A party’s

retention of an expert does not shield that expert from discovery regarding facts

that took place prior to the retention. See Rocky Mountain Natural Gas Co. v.

Cooper Indus., Inc., 166 F.R.D. at 482 (“[R]ule 26(b)(4)(B) permits a party to

engage in discovery with respect to information consultative experts acquired prior

to being retained by an opposing party in anticipation of the underlying

litigation.”); Indus. Maritime Carriers, Inc. v. PT (Persero) Inka, 179 F.R.D. 153,

155 (E.D. Pa. 1998) (same); Eliasen v. Hamilton, 111 F.R.D. 396, 403 (N.D. Ill.

1986) (same). This longstanding rule is captured in Pretrial Order No. 4, which

states regarding experts that “nothing in this agreement is intended to bar discovery

of documents that are otherwise discoverable from a party or third party outside of

the context of expert discovery.”87 Accordingly, the fact of Moore’s retention,

which took place more than six months after being served with Pfizer’s subpoenas

and more than two years after writing the first ISMP report on Chantix, is no

barrier to a full response to the subpoenas.

2. The Other Asserted Privileges Do Not Apply

Plaintiffs’ assertion of a “peer review material” privilege, “pre-publication

research” privilege, or journalistic privilege also fail to shield the subpoena

recipients from Pfizer’s subpoenas or apply in this case.

87 Pretrial Order No. 4: Discovery Plan 21, Feb. 24, 2010.


31

Any privilege based upon peer review materials does not apply to the ISMP

reports because they were not peer reviewed. Peer review refers to the process in

which medical and scientific journals circulate potential articles to groups of

anonymous reviewers, who then provide input on the scientific validity of the

articles’ methods and conclusions.88 As mentioned above, the ISMP reports were

not peer reviewed or published in a medical journal, but were simply self-

published by ISMP without any independent verification of their scientific rigor.

In addition, the Eleventh Circuit does not recognize a privilege for peer-reviewed

materials. See Adkins v. Christie, 488 F.3d 1324, 1326 (11th Cir. 2007)

(“declining to recognize a privilege for documents relating to medical peer review

proceedings”); see also Univ. of Pa. v. E.E.O.C., 493 U.S. 182 (1990) (declining

“to create a new privilege against the disclosure of peer review materials”).

What Plaintiffs refer to as the “pre-publication research” privilege also does

not apply. While Rule 45 recognizes a protection for “confidential research” under

Rule 45(c)(3)(B)(i), it is the burden of the subpoena recipients to make that

showing, and they cannot satisfy their burden here. Stewart v. Mitchell Transport,

Civ. No. 01-2546, 2002 WL 1558210, at *7 (D. Kan. July 8, 2002). The phrase

“confidential research” remains undefined in Rule 45, but, in the context of non-

88 Federal Judicial Center, REFERENCE MANUAL ON SCIENTIFIC EVIDENCE 74-75 (2d ed. 2000), Ex. 66.


32

profit organizations or academic institutions, courts have interpreted “confidential

research” to mean any information that if disclosed would discourage the

willingness of research subjects to participate in studies or share private

information. See In re MTBE Prods. Liab. Litig., 269 F.R.D. at 364-65.

Pfizer is not seeking confidential research here. First of all, any

communications between the subpoena recipients and plaintiffs’ attorneys

regarding Chantix do not fit anyone’s definition of “confidential research.”

Second, Pfizer’s request for information regarding the methodologies that Moore

and Furberg used in writing the ISMP reports is also not confidential. The ISMP

reports themselves purport to describe their methodologies, even though the

descriptions are vague and lacking in sufficient detail for another researcher to

replicate them, and ISMP used the media to disseminate its conclusions. Third,

the underlying data that Pfizer is seeking is not confidential because AERS

contains no private patient information. 89 Pfizer is merely seeking to understand

how Moore “cleans” or modifies the raw AERS data in order to create his own

database, so that Pfizer can accurately replicate his methods.

89 Plaintiffs also object to producing any documents “that contain or constitute trade secrets,

proprietary, or confidential business information,” but they provide no basis for the objection. Pls.’ Resp. and Objections to Non-Party Subpoenas at 5.


33

Any additional privileges asserted by Plaintiffs are unsupported and do not

apply in this case. Therefore, Plaintiffs should provide complete responses to

Pfizer’s subpoenas.

CONCLUSION

For the reasons stated above, the Court should grant Pfizer’s motion to

compel.

Respectfully submitted,

/s/ Joseph G. Petrosinelli Joseph G. Petrosinelli Williams & Connolly LLP 725 Twelfth Street, N.W. Washington, D.C. 20005 Phone: (202) 434-5000 Email: [email protected]

Loren H. Brown DLA Piper LLP (US) 1251 Avenue of the Americas New York, NY 10020-1104 Phone: (212) 835-6000 Email: [email protected] F.M. (“Tripp”) Haston, III Bradley Arant Boult Cummings LLP One Federal Place 1819 Fifth Avenue North Birmingham, AL 35206 Phone: (205) 521-8303 Email: [email protected] Lead Counsel for Defendants


34

CERTIFICATE OF SERVICE

I hereby certify that on March 16, 2011, I electronically filed the foregoing

with the Clerk of the Court using the CM/ECF system which will send notification

to the attorneys of record.

/s F. M. Haston, III Of Counsel


FINAL Chantix Motion to Compel Responses to Subpoenasi.bnet.com/blogs/chantix-april-19-2011-mot-to-compel-subp.pdf · MDL Case No. 2092 This Document Relates to: ALL CASES. Pfizer’s

Documents