UNITED STATES DISTRICT COURT 

SOUTHERN DISTRICT OF NEW YORK

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IN RE: FOSAMAX PRODUCTS LIABILITY : 

LITIGATION : MDL No. 1789 

___________________________________x 1:06-md-1789 (JFK) 

This Document Relates to: : 

All actions MEMORANDUM OPINION 

 : & ORDER

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JOHN F. KEENAN, United States District Judge: 

 Before the Court is plaintiffs’ motion to compel the 

production of documents pursuant to Rule 26 of the Federal Rules 

of Civil Procedure. The gravamen of this motion is defendant 

Merck’s refusal to produce certain materials predating 2003. 

The Court finds that the pre-2003 materials are relevant to 

plaintiffs’ claims and must be produced, with certain 

significant restrictions that are detailed below. Plaintiffs’ 

motion is granted in part. 

BACKGROUND 

 This multidistrict litigation (“MDL”) now includes 

over 550 actions. Plaintiffs claim that their ingestion of 

Fosamax caused them to develop osteonecrosis of the jaw (“ONJ”) 

and other jaw-related injuries. Fosamax is an oral 

bisphosphonate used to treat osteoporosis and other bone 

disorders. It was approved by the United States Food and Drug 

Administration (“FDA”) on September 29, 1995, was first sold 

shortly thereafter, and has been on the market ever since. 

Reports of an association between ONJ and intravenously 

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administered bisphosphonates first appeared in the U.S. 

published medical literature in September of 2003. An 

association between ONJ and oral bisphosphonates such as Fosamax 

was published the following spring. In July of 2005, Merck at 

the behest of the FDA added a “precaution” to Fosamax’s label 

stating that ONJ has been reported in patients undergoing 

bisphosphonate therapy. 

 Plaintiffs used Fosamax at various times and for 

various durations throughout this span of years. Their 

complaints assert multiple causes of action against Merck, 

including strict liability for design defect and failure to 

warn, negligence and breach of warranty. To prevail on some of 

their claims, plaintiffs will have to prove, among other things, 

that Merck knew or should have known of a risk of ONJ before 

Fosamax allegedly caused their injuries, and that Merck failed 

to properly design and test Fosamax or warn of its risks. 

 Pursuant to Case Management Order (“CMO”) No. 3, 

discovery in this MDL is currently scheduled to be completed on 

the last day of this year. CMO No. 3. ¶ 10. Fact discovery in 

the twenty-five potential early trial cases is scheduled to end 

on August 1, 2008, less than two months away. CMO 10 ¶ 5 

(entered Jan. 31, 2007). These deadlines will be extended by 

two months, as stated in the final paragraph below, in light of 

this order compelling Merck to produce additional documents. 

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 The Court has already reviewed discovery in this case 

that was submitted last year in connection with plaintiffs’ 

unsuccessful motions for class certification. See

In re Fosamax Prods. Liab. Litig., 248 F.R.D. 349 n.1 (S.D.N.Y. 

Jan. 3, 2008). Included within this were the affidavit and 

deposition testimony of plaintiffs’ expert, Dr. Marx, who opined 

that a patient’s risk of developing ONJ is “small” or 

“insignificant” until she has used Fosamax continuously for 

three years. Id. at 394, 397 n.9. 

 Plaintiffs served their First Request for Production 

of Documents on November 21, 2006. Merck served its objections 

and responses to the requests on January 22, 2007. (Decl. of 

David J Heubeck, Exh. 1 (Def.’s Objections and Responses to 

Plaintiff’s First Request for Productions of Documents)). Merck 

objected generally to producing “any documents or information 

relating to FOSAMAX® prior to September 2003, the date when 

osteonecrosis of the jaw was first reported in the literature as 

occurring in temporal association with bisphosphonates.” Id. at 

¶ 4. Excepted from this date limitation were the official 

Investigational New Drug (“IND”) and New Drug Application 

(“NDA”) files, which Merck produced without any date limitation. 

These files contain documents relating to Merck’s communications 

with the FDA about the development, approval, and post-marketing 

surveillance of Fosamax. They account for 856,992 of the 

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roughly 1.4 million pages produced by Merck so far. (Def.’s Mem. 

at 7-8.) Besides these materials, Merck has also produced other 

categories of documents without any date limitation.1

 In a letter dated March 1, 2007, plaintiffs challenged 

Merck’s objections to their discovery requests, including its 

objection to producing documents predating September 2003. 

(Decl. of David Heubeck Exh. 2 (Mar. 1, 2007 Letter from the PSC 

to David Heubeck and William Beausoleil)). The parties met and 

conferred in New York on March 8, 2007. Merck then sent a 

letter dated April 27, 2007 addressing the discovery issues 

raised at the conference. (Id., Exh. 3 (Apr. 27, 2007 Letter 

from David Heubeck to James F. Green and Shelley Sanford)). The 

letter stated that ONJ first surfaced in temporal association 

with Fosamax in 2003 and that Merck would produce certain 

categories of documents only back to the beginning of that year. 

Plaintiffs did not file this motion until April 18, 2008, 

almost a year later, claiming that discovery negotiations have 

finally reached an impasse. (Pls.’ Mem. at 5). 

 1

 These categories of documents are the following: IND/NDArelated internal correspondence (109 pages); Adverse Experience Review 

Team (“AERT”) minutes (49 pages); Periodic Safety Update Reports 

(“PSURS”) (26,634 pages); Fosamax Project Team and Product Development 

Team Meeting Minutes (6,992 pages); Background documentation from ONJ 

worldwide event (“WAES”) reports (1,817 pages); and the custodial 

files of six Merck scientists who had responsibility for Fosamaxrelated post-marketing surveillance, pre-clinical and clinical 

research and trial, and FDA submissions and communications (approx. 

418,000 pages). (Def.’s Mem. at 7-8.) 

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1. The 2003 Date Limitation 

 Merck has imposed the 2003 date limitation on the 

following categories of documents: Field Sales Bulletins; 

Responses to Physician Information Requests (“PIRs”); Sales 

Training Materials; Labeling Meeting Minutes; Board of Director 

Meeting Minutes; correspondence with the FDA’s Division of Drug 

Marketing, Advertising, and Communications (“DDMAC”); files from 

the Osteoporosis Marketing Team (“OMT”) and its predecessor 

groups, and Sales Representative Discovery. Merck’s rationale 

for withholding these pre-2003 materials is based on the fact 

that bisphosphonate-associated ONJ was not reported in the 

published medical literature until that year. Merck asserts 

that it could not have known of any association between ONJ and 

Fosamax before the first published reports, and that this is 

confirmed by the hundreds of thousands of pre-2003 documents 

that it has already produced. (Def.’s Mem. at 2, 13-14, 15-16.) 

Therefore, Merck contends, the pre-2003 documents are not 

relevant to plaintiffs’ claims. In addition, Merck claims that 

the expense of collecting, reviewing and producing the pre-2003 

documents would outweigh its likely benefit. (Id. at 2, 17, 19.) 

 Plaintiffs contend that the 2003 date limitation is 

unreasonable. They assert that cases of bisphosphonateassociated ONJ existed prior to 2003 and that this association 

could have been known or reasonably knowable to Merck before 

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then. (Pls.’ Mem. at 1, 8-9; Pls.’ Reply Mem. at 3-4.) Also, 

they maintain that their injury claims are not limited to ONJ 

but encompass other jaw-related injuries. (Pls.’ Mem. at 1, 8-

9.) Therefore, the requested documents are relevant and should 

be produced from the date Fosamax was first developed or, at the 

latest, 1995 — the year of Fosamax’s FDA-approval and market 

release.2 

a. Field Sales Bulletins 

 According to plaintiffs, field sales bulletins were 

used by Merck to disseminate new information, marketing 

instructions and promotional tools regarding Fosamax to Merck’s 

sales representatives. Such information includes “obstacle 

handlers,” which are scripted answers that a sales 

representative would provide in response to a physician’s 

questions and concerns. Plaintiffs claim that these bulletins 

may contain communications about a potential relationship 

between Fosamax therapy and ONJ or other jaw conditions. This 

 2

 As revealed at oral argument, the appropriate end date for 

production is also subject to some ambiguity. In this motion, 

plaintiffs seek discovery of the requested documents until the 

“present date.” In their First Request for Production, however, they 

sought these documents only up to November 21, 2006, the end date of 

the so-called “relevant period” for production. At oral argument, 

plaintiffs asserted that Merck should continue to produce documents 

within these categories as they come into Merck’s possession, pointing 

out that Merck has produced other types of documents in such manner. 

In its opposition to this motion, Merck has sought to impose an end 

date limitation on two categories of documents discussed belowcertain responses to Physician Information Requests and sales 

representative materials. Merck has not opposed producing the other 

categories of documents sought by plaintiffs up to the present date. 

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would be relevant to their claims of failure to warn and design 

defect, according to plaintiffs, because it could show that 

Merck had notice of a risk and instructed its sales 

representatives to understate it. (Pls.’ Mem. at 11-12.) 

 Merck has produced field sale bulletins created after 

2003, totaling 3,508 pages, but objects to producing any 

bulletins created before this date on grounds of irrelevance and 

burdensomeness, described above. (Def.’s Mem. at 7, 16-17.) 

 b. Responses to PIRs

 Plaintiffs have requested information that Merck 

provided in response to all inquiries about Fosamax from 

physicians. These documents are referred to as “concepts” or 

responses to “Physician Information Requests” (“PIRs”). 

Plaintiffs state that responses to PIRs “typically may contain 

summaries of both published and unpublished clinical trial data, 

comparisons to other drugs, discussions of medical literature, 

and/or product labeling.” (Pls.’ Mem. at 12.) Plaintiffs 

believe that the PIRs might contain admissions by Merck or 

concerns raised by Merck’s employees or physicians about ONJ or 

jaw-related issues. 

 Merck has produced all PIRs created after 2003, 

totaling 28,555 pages. Merck has also agreed to produce any 

responses to PIRs sent to a plaintiff’s prescribing physician, 

even those sent before 2003, but only up until six months after 

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that plaintiff’s last Fosamax prescription. However, Merck 

objects to producing all pre-2003 responses to PIRs, or 

responses sent to a plaintiffs’ prescribing physician more than 

six months after that plaintiffs’ last Fosamax prescription. 

(Def.’s Mem. at 17 & n. 18.) 

 c. Sales Training Materials 

 Plaintiffs have requested that Merck produce all sales 

representative training materials. These include both training 

materials relating specifically to Fosamax and those relating 

generally to sales representatives’ interactions with 

physicians. Plaintiffs assert that instructions given by Merck 

to its sales representatives regarding their communication with 

physicians, contained in these training materials, are “highly 

relevant to issues of notice, fraud, and failure to warn.” 

(Pls.’ Mem. at 14.) 

 Merck has already produced the Fosamax-specific 

training materials currently in use (1,157 pages), along with 

others created after 2003 (1,641 pages). (Def.’s Mem. at 7.) In 

addition, it has agreed to soon produce generic training 

materials created after 2003. However, Merck objects to turning 

over any Fosamax-specific or generic training materials 

predating 2003. 

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 d. Materials Related to Fosamax Labeling

 Plaintiffs have requested any summaries or minutes of 

internal meetings at which Fosamax labeling was discussed. They 

contend that these materials “may contain admissions and/or 

provide insight into the dialogue between Merck and regulatory 

agencies relating to the safety and efficacy disclosures for 

Fosamax. Further, this material may indicate whether Merck or 

regulatory agencies, independent of any scientific literature, 

had safety concerns about Fosamax or bisphosphonates generally 

prior to 2003.” (Pls.’ Mem. at 15.) Merck has produced minutes 

from meetings of three internal committees dating back to 2003, 

totaling 134 pages, but objects to producing minutes created 

before then. 

 There are a few other disputed issues regarding 

labeling-related materials. First, plaintiffs contend that 

Merck will only produce materials that specifically reference 

ONJ. (Pls.’ Mem. at 21.) Plaintiffs argue that all labeling 

materials should be produced without restriction, because they 

may contain admissions about the safety and efficacy of Fosamax, 

which they contend would be relevant to issues of fraud, 

causation, and failure to warn. (Id. at 21-22.) Plaintiffs also 

complain that limiting production to labeling materials that 

reference ONJ would exclude those referencing precursor symptoms 

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for ONJ and other jaw-related injuries alleged by plaintiffs. 

(Id. at 22) 

 Merck contends that the pre-2003 labeling materials 

have nothing to do with the jaw-related issues in this case, 

which surfaced “circa 2005 and thereafter.” (Def.’s Mem. at 18.) 

It points out that it has already produced labeling materials, 

including draft and final labels, that were submitted to the FDA 

as part of the NDA. (Id.) In addition, plaintiffs have received 

the custodial files of Merck employees who, according to Merck, 

would have been involved in labeling issues. (Id.) Merck claims 

(as it did in its April 27, 2007 letter) that it would be too 

burdensome to locate and produce label drafts not contained in 

the NDA and custodial files because Merck does not maintain a 

separate file for draft labeling. (Id.) 

 Plaintiffs respond that, if Merck considered label 

drafts containing different risk information than the drafts 

ultimately submitted to the FDA for approval, this would be 

relevant to plaintiffs’ failure to warn and fraudulent marketing 

claims. (Pls.’ Reply Mem. at 6-7.) Plaintiffs request that the 

Court order Merck to identify employees involved in Fosamax 

labeling and search their custodial files for the materials at 

issue. (Id.) 

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 Finally, Plaintiffs also complain that Merck has 

objected to producing materials relating to Merck’s overseas 

regulatory activities, including foreign labeling and animal or 

lab testing or analysis. (Pls.’ Mem. at 22; Def.’s Mem. at 18-

19.) Merck has produced the custodial files of the two 

employees primarily responsible for international regulatory 

issues regarding Fosamax from 2003- May 2006. At oral argument, 

Merck stated that collecting, translating and producing the 

regulatory documents submitted in the many countries around the 

world where Fosamax is sold would be highly burdensome. 

Plaintiffs responded that they would be willing to forego their 

request for foreign labeling materials, provided that Merck 

produce any “causality assessments” and source documentation 

related to Fosamax adverse event reports of ONJ or other jawrelated injuries that were reported in other countries. 

e. Board of Director Meeting Minutes

 Plaintiffs also seek the minutes of all Board of 

Director meetings at which Fosamax was discussed, asserting that 

“executive decisions relating to the development, testing, and 

marketing of Fosamax are highly relevant to [their] claims.” 

(Pls.’ Mem. at 15.) Merck has produced only the minutes 

generated after 2003, totaling 61 pages. Merck refuses to 

produce any minutes created before 2003, claiming that, even 

though Fosamax was discussed at those meetings, the minutes 

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“have almost nothing to do with Plaintiffs’ claims.” (Def.’s 

Mem. at 19.) 

f. DDMAC Correspondence

 Plaintiffs have requested Merck’s correspondence with 

the FDA’s Division of Drug Marketing, Advertising, and 

Communications (“DDMAC”). They assert that the DDMAC has cited 

Merck for engaging in misleading promotions of Fosamax in the 

past, pointing to four letters from the DDMAC that Merck 

received between 1997 and 2001, none of which involved ONJ or 

jaw-related injuries. (Pls.’ Mem. at 15; Pls. Reply Mem. at 5 

n.1.) Plaintiffs assert that “[t]he extent to which Merck has 

demonstrated a pattern and practice of misleading physicians 

about the safety and efficacy of Fosamax is critical to the 

claims and defenses asserted in this litigation. (Pls.’ Mem. at 

15-16.) Merck has produced 514 pages of DDMAC correspondence 

going back to 2003. Merck claims, again, that it could not have 

known of a potential ONJ association before 2003, therefore it 

could not have been cited by the DDMAC for misleading physicians 

about such an association before then. (Def.’s Mem. at 19.) 

g. Files of OMT and predecessor groups

 Plaintiffs assert that materials from the osteoporosis 

marketing team (“OMT”) and predecessor groups will reflect 

“Merck’s marketing strategies, programs, and concerns relating 

to Fosamax” and are highly relevant to their claims. (Pls.’ Mem. 

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at 16.) Merck has produced 40,552 pages of these materials 

going back to 2003. Merck claims that its marketing personnel 

could not have contemplated a risk of ONJ at a time when Merck’s 

scientists were unaware of it. (Def.’s Mem. at 20.) It also 

states that producing these materials from the time of Fosamax’s 

development would yield an additional 160,000 pages, given the 

very broad search terms used to identify responsive documents. 

(Id.) 

h. Sales Representative Discovery

 Plaintiffs initially requested the custodial files of 

all Merck sales representatives who called on plaintiffs’ 

prescribing physicians or their offices in the twenty-five 

potential early trial cases. (Pls.’ Mem. at 16-17.) The parties 

have reached an agreement in principle to narrow this request, 

but once again disagree on the appropriate date limitation. 

 Under the agreement, Merck will not produce the entire 

custodial files of all sales representatives who called upon 

plaintiffs’ prescribing physicians. Instead, Merck will 

initially produce the call details, call notes, call topics, 

customer beliefs, responses to questions and “My Call” 

presentations associated with sales representatives who called 

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on the physicians.3 The call and belief notes contain details of 

communications between sales representatives and physicians. 

They are stored in an electronic database called FACTS. In 

addition, Merck will produce materials reflecting Merck’s 

communications with prescribing physicians from eleven other 

electronic databases identified in Merck’s memorandum. (Def.’s 

Mem. at 20-21). After reviewing these materials, each 

plaintiff in the twenty-five potential early trial cases would 

select four sales representatives who called on their 

prescribing physician. Merck would make full personnel and 

custodial file productions for the four selected 

representatives. Plaintiffs then would select two of the four 

representatives for depositions. 

 Merck objects to producing any sales representative 

materials that predate 2003. In addition, Merck intends to cut 

off production of these materials at a date six months following 

a given plaintiffs’ last prescription for Fosamax. (Def.’s Mem. 

at 22.) 

 Plaintiffs contend that the pre-2003 materials are 

relevant because they will contain Merck’s safety and efficacy 

 3

 Merck has objected to producing materials for sales 

representatives who merely called the offices of the prescribing 

physicians but not the prescribing physicians themselves. (Def.’s Mem. 

at 22.) Although plaintiffs initially requested these materials, they 

have not pressed for them in this motion. 

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disclosures to its sales representatives; documents concerning a 

given physician’s prescribing habits; Merck’s marketing 

strategies and relationship with that physician; and any 

concerns raised by the physicians about Fosamax. (Pls.’ Mem. at 

17-18.) They claim that many of these materials exist in an 

easily-searchable electronic format, and that Merck has admitted 

to having begun collecting and reviewing these materials. (Id. 

at 19.) Plaintiffs also challenge Merck’s decision to cut off 

production at a date six months after each plaintiff’s last 

prescription for Fosamax. (Id. at 18-19; Pls.’ Reply Mem. at 8-

9). They assert that Merck’s more recent communications with 

prescribing physicians “may support or contradict the parties’ 

claims related to causation, notice, and failure to warn, and/or 

may bear on the bias or credibility of the physicians at issue.” 

(Pls.’ Reply Mem. at 8-9.) Also, some plaintiffs were not 

diagnosed with ONJ until after six months following their last 

Fosamax prescription. Plaintiffs maintain that, in such cases, 

the six month limitation would deny plaintiffs access to 

information during the critical period in which they informed 

their physicians that they had ONJ. (Id. at 9.) 

2. Other Issues

 Apart from the 2003 date limitation issue, the parties 

dispute the extent of Merck’s discovery obligations with respect 

to two categories of documents: 

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 a. Source Materials Underlying Adverse Event Reports

 Plaintiffs have requested production of Adverse Event 

Reports (“AERs”) for Fosamax. They have also requested the 

source documentation underlying AERs in which ONJ or jaw-related 

injuries were reported. Merck has produced source 

documentation for reports of ONJ, but has not produced 

documentation for reports of jaw-related injuries. (Pls.’ Mem. 

at 21; First Decl. of Jeffrey Grand, Exh. S (Mar. 31, 2008 email 

from David J. Heubeck)). 

 Plaintiffs contend that source documentation for all 

events involving jaw-related injuries is important because ONJ 

cases were likely underreported during clinical trials and postmarketing surveillance, for several reasons. First, they claim 

that there was no reporting code for ONJ during Fosamax’s 

clinical trials and so it may have been reported inconsistently. 

(Pls.’ Mem at 21; First Decl. of Jeffrey Grand, Exh. T (Mar. 28, 

2008 Dep. Tr. of Anastasia Daifotis, M.D.)). Second, they 

assert that Merck’s analysis of its clinical trials for the 

incidence of ONJ excluded events not requiring hospitalization, 

thereby overlooking cases of ONJ or jaw-related injuries 

diagnosed and treated in an outpatient environment. (Id.) 

Plaintiffs also claim that bisphosphonate-associated ONJ was not 

widely understood by physicians who prescribed Fosamax and 

participated in clinical trials. (Id.) Plaintiffs wish to 

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review the underlying source documentation for reports of jawrelated injuries to evaluate whether the adverse events reported 

were correctly diagnosed by the reporting physician or by Merck. 

(Id. at 20.) 

 Merck objects to this request on the ground of 

burdensomeness. Merck claims that the request, if granted, 

would require it to collect, review and produce hundreds of 

thousands, if not millions, of pages associated with the 

thousands of adverse events reported in the more than twelve 

years that Fosamax has been on the market.4 This would be an 

unnecessary burden, Merck contends, because plaintiffs 

themselves can locate the information they seek. The Periodic 

Safety Update Reports (“PSURs”), already produced, provide lineitem descriptions of all adverse events reported since 1995. 

Each line item is associated with a unique Worldwide Adverse 

Experience System (“WAES”) number. Merck suggests that 

plaintiffs should identify from the PSURs the ONJ or jaw-related 

events for which they desire the underlying source documentation 

and provide Merck with the corresponding WAES numbers. Merck 

will then trace the WAES number to whatever source materials 

exist for those adverse events and produce those materials. 

(Def’s Mem. at 23-24.) 

 4

 This claim is exaggerated because, as plaintiffs clarify in 

their reply memorandum, they only seek documentation for AERs 

reporting ONJ or jaw-related injuries. (Pls. Reply Mem. at 9.) 

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 Merck also points out that, in its April 27, 2007 

letter, it offered to search the WAES database as well as the 

clinical trial database to identify relevant adverse events and 

underlying information, using search terms that plaintiffs could 

suggest. (Id. at 24; Decl. of David Heubeck, Exh. 3 ¶ 25 (Apr. 

27, 2007 Letter from David Heubeck to James F. Green and Shelley 

Sanford)). Merck states that plaintiffs neither responded to 

this offer nor suggested search terms, but instead waited a year 

and filed this motion to compel. 

 Plaintiffs reply that Merck has already searched the 

WAES database with relevant search terms in an internal study 

undertaken by Merck to determine the incidence of ONJ among 

bisphosphonate users. (Pls.’ Reply Mem. at 10.) According to 

the study, Merck identified a certain number of “welldocumented” and “suspected” reports of ONJ between July 1993 and 

December 2006. (Id.; Second Decl. of Jeffrey Grand, Exh. 11.) 

At oral argument, plaintiffs also pointed to a 2004 FDA postmarketing safety review which found 12 reported cases of ONJ 

associated with Fosamax use between September 1995 and 2004. 

Plaintiffs seek the source material for all reports of ONJ and 

jaw-related adverse events so that they can conduct a similar 

review using their own experts. At a minimum, plaintiffs 

contend, Merck should produce the source documentation for the 

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reports that Merck identified in its internal study. (Pls.’ 

Reply Mem. at 10.) 

b. IMS Physician Level Data

 Plaintiffs initially requested data regarding the 

Fosamax prescribing history of plaintiffs’ prescribing and 

treating physicians. This data is maintained by IMS, a third 

party vendor to Merck and other pharmaceutical companies. 

Plaintiffs contend that changes in a physician’s prescribing 

habits in response to changing marketing and risk information 

available for Fosamax is relevant to plaintiffs’ failure to warn 

claims. (Pls.’ Mem. at 24.) 

 Merck objects only to providing IMS data for 

plaintiffs’ treating physicians, and does not object to 

producing such data for prescribing physicians. (Def.’s Mem. at 

24-25.) In their reply memorandum, Plaintiffs state that they 

are willing to accept IMS data for prescribing physicians only 

(and not treating physicians), if (1) such data can be shown to 

the prescribing physician at deposition or trial;5 and (2) Merck 

agrees to produce IMS data for treating physicians if Merck has 

 5

 Plaintiffs complain in their memoranda that Merck has 

conditioned producing IMS data for prescribing physicians on 

plaintiffs’ promise not to show that data to the prescribing 

physicians during deposition or trial. However, Merck does not 

mention any such condition in its memorandum. 

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evidence that such physician also prescribed Fosamax or other 

bisphosphonate therapies. (Pls.’ Reply Mem. at 11.) 

 Extended oral argument on the motion to compel was 

heard on June 2, 2008, and I reserved decision. 

APPLICABLE LAW 

 Rule 26(b)(1) of the Federal Rules of Civil Procedure 

provides in part that “[p]arties may obtain discovery regarding 

any non-privileged matter that is relevant to any party’s claim 

or defense.” Relevance is defined broadly under Rule 26(b)(1): 

“Relevant information need not be admissible at the trial if the 

discovery appears reasonably calculated to lead to the discovery 

of admissible evidence.” The term “reasonably calculated” means 

“any possibility” that the information sought may be relevant. 

See Daval Steel Products, a Div. of Francosteel Corp. v. M/V 

Fakredine, 951 F.2d 1357 (2d Cir. 1991) (citing Morse/Diesel, 

Inc. v. Fidelity and Deposit Co. of Maryland, 122 F.R.D. 447, 

449 (S.D.N.Y. 1988)). Where relevance is in doubt, the district 

court should be permissive. In re Honeywell Int’l, Inc. Sec. 

Litig., 230 F.R.D. 293, 301 (S.D.N.Y. 2003). 

 Despite the liberal construction afforded the federal 

discovery rules, “Rule 26 vests the trial judge with broad 

discretion to tailor discovery narrowly and to dictate the 

sequence of discovery.” Crawford-El v. Britton, 523 U.S. 574, 

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598 (1998). Subsection (b)(2)(c) requires a court to deny 

discovery of even relevant material if it finds that: 

(i) the discovery sought is unreasonably cumulative or 

duplicative, or can be obtained from some other source 

that is more convenient, less burdensome, or less 

expensive; (ii) the party seeking discovery has had 

ample opportunity to obtain the information by 

discovery in the action; or (iii) the burden or 

expense of the proposed discovery outweighs its likely 

benefit, considering the needs of the case, the amount 

in controversy, the parties’ resources, the importance 

of the issues at stake in the action, and the 

importance of the discovery in resolving the issues. 

Fed. R. Ci. P. 26(b)(c)(2). In addition, the Court has 

authority to shift some of the expense of discovery to the party 

seeking it. See See Oppenheimer Fund, Inc. v. Sanders, 437 U.S. 

340, 358 (1978) (stating in dicta that a district court has 

discretion to condition discovery on the requesting party's 

payment of costs); 8 Charles Alan Wright, Arthur R. Miller & 

Richard L. Marcus, FEDERAL PRACTICE AND PROCEDURE § 2008.1. It 

is clear that the court’s role at the discovery stage is largely 

discretionary. 

DISCUSSION 

1. The Requested Pre-2003 Materials Are Relevant 

 The association between bisphosphonate therapy and ONJ 

may have been known or reasonably knowable to Merck before it 

was first reported in the published medical literature in 

September 2003. Merck is in frequent communication with 

prescribing physicians about their patients’ experiences with 

Fosamax. It was reported in the media that Novartis 

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Pharmaceuticals Corporation, defendant in the In re Aredia and 

Zometa Products Liability Litigation, MDL No. 1760, received 

notice from a doctor of a potential association between its IVbisphosphonate drugs and ONJ well before the September 2003 

report was published. Geeta Anand, Jaw Ailment Shows Industry 

Moves Slowly on Drug Warnings, Wall St. J., Dec. 8, 2004, at B1 

(stating that Dr. Ruggiero claimed to have informed Novartis of 

a potential ONJ-association in 2001, and that Novartis officials 

claimed to have first heard from him in July 2002). Similarly, 

Merck may have received notice of a potential ONJ-association 

from doctors before 2003. Merck’s assertion that it could not 

have possibly known of any association before it was first 

reported in the published literature is questionable. 

 Many plaintiffs have alleged that their injuries stem 

at least in part from their pre-2003 use of Fosamax. What Merck 

knew or reasonably should have known about an association 

between Fosamax and ONJ or jaw-related injuries before that year 

is directly relevant to plaintiffs’ strict liability and 

negligence claims. Each of the categories of documents 

requested “appears reasonably calculated” to produce evidence of 

Merck’s knowledge. If doctors had contacted Merck before 2003 

to inquire about a potential ONJ association, Merck may have 

sent PIR responses to those doctors. Merck also might have 

created field sales bulletins and training materials instructing 

Case 1:07-cv-03459-JFK Document 34 Filed 06/05/2008 Page 22 of 29
23

its sales representatives on how to handle such inquiries. 

Merck also may have discussed them at internal meetings and 

possibly even addressed them tentatively in drafts of labels 

ultimately not submitted to the FDA. By the same token, Merck 

very well may have received no notice and taken none of these 

actions. But even the absence of such evidence would be 

relevant to plaintiffs’ claims and Merck’s defenses.6 Although 

some of these scenarios may be speculative, the requested 

documents are relevant and discoverable under Rule 26(b)(1). 

That is the nature of discovery in American Federal civil 

litigation. 

 In addition, Merck’s decision to cut off production of 

certain PIR responses and sales representative materials at a 

date six months following a given plaintiff’s last prescription 

of Fosamax is unjustified. Merck’s communications with a 

plaintiff’s physician, either before or after the plaintiff used 

Fosamax, may contain evidence of notice or causation that is 

relevant to that plaintiff’s case or the cases of other 

plaintiffs. Finally, Merck has not challenged the relevance of 

source documentation for AERs relating to ONJ and jaw-related 

injuries or of IMS data for prescribing physicians. These 

 6

 It also may be the case that such evidence of knowledge or 

notice, if it exists, would be in the pre-2003 scientific materials 

that Merck already has produced. However, this cannot be determined 

with such certainty to justify denying the relevant documents sought 

on the ground of cumulativeness. 

Case 1:07-cv-03459-JFK Document 34 Filed 06/05/2008 Page 23 of 29
24

materials are also discoverable, with certain restrictions 

detailed below. 

 Merck argues that plaintiffs must show good cause in 

order to obtain the requested discovery, for two reasons. The 

first one is based on the 2000 amendments to Rule 26(b)(1). 

Prior to those amendments, the rule permitted a party to obtain 

discovery of anything relevant “to the subject matter involved 

in the pending action.” In 2000, the rule was changed to permit 

discovery of anything relevant to “any party’s claims or 

defenses,” narrowing the scope of material that is discoverable 

as of right. Under the amended Rule 26(b)(1), if a party seeks 

discovery of material that is merely relevant to the subject 

matter of the action, but not to any party’s claim or defense, 

the court may order discovery for good cause shown. See 2000 

Adv. Comm. Notes to F.R.C.P. 26(b)(1). Merck claims that 

materials pre-dating 2003 are not relevant to any claim or 

defense in this MDL, but merely to its subject matter. See

Def.’s Mem. at 8-10. This argument fails because, as discussed 

above, the pre-2003 materials sought are relevant to plaintiffs’ 

claims. Rule 26 does not require plaintiffs to show good cause. 

 Merck also asserts that, because this motion to compel 

was filed so late, it is tantamount to a request to amend the 

fast-approaching discovery deadlines. The disruption caused by 

this motion, although primarily attributable to plaintiffs’ 

Case 1:07-cv-03459-JFK Document 34 Filed 06/05/2008 Page 24 of 29
25

unreasonable delay, arguably is attributable in part to Merck’s 

refusal to produce relevant material. 

2. Plaintiff’s Requests Will Be Restricted 

 Although Merck must produce the pre-2003 materials, 

the production will be subject to several limitations. An 

overarching reason for limitation is plaintiffs’ delay in 

bringing this issue to the Court’s attention. Plaintiffs 

learned of Merck’s intended date limitation in January 2007. 

Merck reaffirmed its position in its April 27, 2007 letter. 

Plaintiffs nevertheless waited until April 18, 2008, about a 

year later and less than four months before the scheduled 

conclusion of fact discovery in the early trial pool cases, to 

file this motion. Some restrictions appear necessary to keep 

proceedings in this MDL moving apace. 

 First, the date limitation imposed on each category of 

discovery (unless otherwise specified below) will be November 

1, 1998, which is roughly the three-year anniversary of 

Fosamax’s market release. Plaintiff’s expert Dr. Marx has 

affirmed that the risk of ONJ from Fosamax is “insignificant” 

until three years of use. This does not rule out the 

possibility of a case of ONJ occurring after a shorter duration 

of Fosamax use. But it does make it very unlikely that Merck 

received any notice of a risk of ONJ from physicians, or 

discussed any such risk internally, before that time. The 

Case 1:07-cv-03459-JFK Document 34 Filed 06/05/2008 Page 25 of 29
26

 

benefit of going further back would be outweighed by the burden. 

This is especially so in light of the fact that plaintiffs have 

pointed to little from the copious pre-2003 materials already 

produced suggesting that bisphosphonate-associated ONJ was known 

or reasonably knowable to Merck before that time. 

 Second, plaintiffs will shoulder some of the expense 

of this additional production by paying Merck ten cents per page 

of electronic or hard copy document produced in compliance with 

this order. The aggregate cost to plaintiffs is to be capped at 

$150,000. The Court recognizes that most of the expense of this 

additional discovery, in the hours spent collecting and 

reviewing documents, will still fall on Merck. Shifting some of 

the cost is intended to create an incentive for plaintiffs to 

narrow their requests to focus on the documents they really 

want.7 Within thirty days after the end of the first bellwether 

trial, Merck shall provide plaintiffs with an account of the 

pages produced in compliance with this order, broken down by 

document category. The PSC shall pay Merck the amount owed 

within thirty days, and shall apportion the cost among 

 7 The ten cents per page figure is not intended to 

approximate Merck’s actual costs of production. While plaintiffs 

argue that Merck incurs little cost reproducing documents already 

stored in electronic form, Merck estimates that the cost of reviewing 

these documents is over two dollars per page. All production other 

than that ordered compelled herein remains governed by the terms of 

CMO 13, which the parties stipulated to last year when Merck withdrew 

its motion for cost-shifting. 

Case 1:07-cv-03459-JFK Document 34 Filed 06/05/2008 Page 26 of 29
27

f. DDMAC correspondence relating to Fosamax dated from 

November 1, 1998 to the date of this order. 

plaintiffs on a per plaintiff basis. Any dispute about the 

amount owed or the apportionment among plaintiffs shall be 

brought before Magistrate Judge Francis. 

 In addition, Merck’s production of the pre-2003 

materials, along with its production of source materials for 

AERs and IMS physician level data, will be subject to certain 

category-specific limitations, described below. 

3. What Merck Must Produce 

a. Field sales bulletins relating to Fosamax created between 

November 1, 1998 and the date of this order. 

b. Responses to all PIRs for Fosamax sent between November 1, 

1998 and the date of this order. 

c. All Fosamax-specific and generic sales training materials 

created between November 1, 1998 and the date of this 

order. 

d. From the date Fosamax was first developed until the date of 

this order: (1) all summaries or minutes of internal 

meetings at which Fosamax labeling was discussed; and (2) 

all draft labeling referencing ONJ or jaw-related injuries, 

provided that such drafts (a) are not contained in the NDA 

and custodial files already produced; and (b) can be 

located by Merck after a reasonably diligent search. Merck 

shall provide plaintiffs with a description of the efforts 

it intends to undertake to locate the labeling drafts. 

Merck need not produce foreign labeling materials, but 

must produce any “causality assessments” and source 

documentation that relate to foreign AERS of ONJ or 

osteomyelitis, dated from November 1, 1998 to the date of 

this order. 

e. Minutes for board of director meetings at which Fosamax was 

discussed, created between November 1, 1998 and the date of 

this order. 

Case 1:07-cv-03459-JFK Document 34 Filed 06/05/2008 Page 27 of 29
28

g. Materials relating to the Osteoporosis Marketing Team and 

its predecessors, created between November 1, 1998 and the 

date of this order. The parties shall try in good faith to 

agree on a narrower set of search terms to be employed in 

searching for these materials. 

h. Sales Representative Materials: From the FACTS database, 

all call details, call notes, call topics, customer 

beliefs, responses to questions and “My Call” presentations 

associated with all of the sales representatives who called 

on the prescribing physicians of plaintiff in the early 

trial pool cases, created between November 1, 1998 (if 

available) and the date of this order. Merck shall also 

produce, for the same time period, sales representative 

discovery from the other electronic databases identified on 

pages 20-21 of its memorandum. Merck need not produce 

discovery for sales representatives who called the offices 

of plaintiffs’ prescribing physicians but not the 

physicians themselves. 

After reviewing these materials, each plaintiff will 

select four sales representatives and Merck will make full 

personnel and custodial file productions for those 

representatives. Plaintiffs then may select two of the 

four representatives for depositions. 

i. Source Materials Underlying Adverse Event Reports: Merck 

shall produce the source documentation for the “well 

documented” and “suspected” reports of ONJ that Merck 

identified in the internal study that plaintiffs filed as 

exhibit 11 to Jeffrey Grand’s second declaration. If 

plaintiffs wish to receive the source materials for any 

other AERs (other than those covered by subsection (d) 

above), they must identify the events from the PSURs and 

provide Merck with the corresponding WAES numbers by July 

25, 2008. Merck shall promptly produce any source 

materials relating to the events so identified by 

plaintiffs. The November 1, 1998 date limitation shall 

not apply to this category of documents. 

j. IMS Physician Level Data: Merck must produce IMS data 

for all prescribing physicians, but need not produce IMS 

data for physicians who treated but did not prescribe 

Fosamax to plaintiffs. Plaintiffs may show the IMS data to 

prescribing physicians at deposition or trial. The 

November 1, 1998 date limitation shall not apply to this 

category of documents. 

Case 1:07-cv-03459-JFK Document 34 Filed 06/05/2008 Page 28 of 29
CONCLUSION 

Plhlnt I f =sf rnotion r,o ~=or?:pe: is cjr-a~?t-etl in par!:. The 

uecldllne Tor- the c~,mplction elf 1 disco\/c~:;: 111 I >lVIDL, set 

fr,rrt? ln paraqraph lr3 ; CMO 3, is ct;anqed t~7 Mdrcll 2, 2003. 

The deadlin~ to 1 fact. disco-.le~y I!; t.he potential ca1-:lr 

trial c:ases, set fnrtk. in par-aqrapll 5 W) 10 i~l:terwA Lat;. 

31, 2,307), 1s changed tc; 0c::rjGer i, 230E. The parcles shd-11. 

rcnt;-lc:t Judge Franci :I t.o schei?~lle a disco7re-rh- r;l.at:us c!onfe~-l.+~~,-e 

wi t!~:ti sixty days r_if 1-his or-der- and elTel;. sixty days thereafrt.~.. 

SO ORDERED. 

Dated: New York, New York 

June 5, 2008 

A 

I., 1 JOHN F. KEENAN \ 

United States District Judge 

Case 1:07-cv-03459-JFK Document 34 Filed 06/05/2008 Page 29 of 29