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IN THE UNITED STATES DISTRICT COURT

FOR THE DISTRICT OF NEW JERSEY

IN RE: FOSAMAX (ALENDRONATE 

SODIUM): PRODUCTS LIABILITY 

LITIGATION

THIS DOCUMENT RELATES TO:

Zessin et al., v. Merck Sharp & Dohme 

Corp.

Civil Action No. 11-cv-3918 (JAP)(LHG)

Young v. Merck Sharp & Dohme Corp.

Civil Action No. 11-cv-3225 (JAP)(LHG)

Johnson v. Merck Sharp & Dohme Corp.

Civil Action No. 11-cv-5301 (JAP)(LHG)

DOCUMENT FILED 

ELECTRONICALLY

MDL No. 2243

Master Docket No. 08-08 (JAP)(LHG)

Civil No. 11-cv-3918 (JAP)(LHG)

Civil No. 11-cv-3225 (JAP)(LHG)

Civil No. 11-cv-5301 (JAP)(LHG)

DEFENDANT MERCK SHARP & DOHME CORP.’S 

MEMORANDUM OF LAW IN SUPPORT OF ITS MOTION

TO STRIKE DR. ROBERT MAKUCH FROM PLAINTIFFS’ RULE 26(a)(2) 

DISCLOSURE AND EXCLUDE HIS TESTIMONY AT TRIAL

Karen A. Confoy

FOX ROTHSCHILD, LLP

Princeton Pike Corporate Center

997 Lenox Drive, Building 3

Lawrenceville, NJ 08648

Telephone: (609) 896-3600

Facsimile: (609) 896-1469

Attorneys for Defendant Merck Sharp 

& Dohme Corp.

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TABLE OF CONTENTS

INTRODUCTION...........................................................................1

LEGAL ARGUMENT.....................................................................2

A Under this Court’s Case Management Orders, Plaintiffs 

in The First Four Bellwether Trials Were Required to 

Disclose General Causation Experts on October 15, 2012...............2

B. Plaintiff Zessin’s Disclosure of Dr. Makuch is Untimely 

and Should Be Excluded......................................................4

CONCLUSION.............................................................................10

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TABLE OF AUTHORITIES

Page(s)

CASES

Accord Newman v. GHS Osteopathic, Inc., Parkview Hosp. Div.,

60 F.3d 153 (3d Cir. 1995) ..............................................................................6

Bouder v. Prudential Fin., Inc.,

CIV.A.06-4359(DMC), 2010 WL 2026707 (D.N.J. May 21, 2010)...................7

D & D Assoc., Inc. v. N. Plainfield Bd. of Ed.,

2006 WL 1644742 (D.N.J.2006) ................................................................... 6, 7

Exxon Corp. v. Halcon Shipping Co., Ltd.,

156 F.R.D. 589 (D.N.J. 1994)............................................................................7

M. Eagles Tool Warehouse, Inc. v. Fisher Tooling Co.,

2007 WL 979854 (D.N.J. Mar. 30, 2007)..........................................................8

Roberts v. United States,

CIV.A. 09-6212 WJM, 2012 WL 2374656 (D.N.J. June 22, 2012)................ 6, 7

OTHER AUTHORITIES

Fed. R. Civ. P. 37(c)(1) ..........................................................................................6

Fed. R. Civ. P. 26(a)............................................................................... 1, 2, 3, 5, 6

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INTRODUCTION

Pursuant to Federal Rules of Civil Procedure 26 and 37, Defendant Merck 

Sharp & Dohme Corp. (“Merck”) moves to strike Dr. Robert Makuch from the 

Federal Rule of Civil Procedure 26(a)(2) Statement served by Plaintiff Deloris 

Zessin on April 1, 2013 (see Declaration of Karen A. Confoy, (“(Confoy Dec.”)

Exh. 1, Plaintiffs’ Rule 26(a) Disclosure, Apr. 1, 2013) and to exclude his 

testimony and references to his opinions at trial. Plaintiff’s disclosure of the 

general causation opinions of Dr. Makuch is clearly untimely. Allowing Plaintiff’s 

tardy disclosure months after Merck disclosed its general causation experts, and 

months after Merck deposed Plaintiff’s timely disclosed experts would prejudice 

Merck and further would waste the time and resources of the parties and the Court. 

Plaintiffs should not be permitted to jettison their initial general cause experts, Drs. 

Klein and Cornell, and replace them with a different expert disclosed nearly six 

months after the deadline. Neither the Court’s Case Management Orders 

(“CMOs”) nor the Federal Rules allow Plaintiffs a do-over on their general 

causation expert disclosures.

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LEGAL ARGUMENT

A. Under this Court’s Case Management Orders, Plaintiffs in The First 

Four Bellwether Trials Were Required to Disclose General Causation 

Experts on October 15, 2012. 

On July 14, 2011 and November 14, 2012, this Court signed and put into 

place CMO 4 and CMO 4A, respectively, which set forth the pretrial schedule for 

the “Early Trial Cases.” The “Early Trial Cases” included four cases: Glynn, 

Zessin, Young, and Soudelier (subsequently replaced by Johnson after Plaintiffs 

dismissed Soudelier). The plain language of CMO 4A makes clear that the 

deadlines for the parties’ Rule 26(a)(2) disclosures and expert depositions set forth 

in paragraph four apply to general causation experts for all four of the Early Trial 

Cases as well as all case-specific experts in the Glynn case. Compare Confoy Dec. 

Exh. 2, CMO 4A ¶ 4(A) (“Expert discovery on general causation (i.e. whether 

Fosamax or alendronate can be a cause of femur fractures), as well as all expert 

discovery in the Glynn case, shall be completed by January 11, 2013 in accordance 

with the following schedule”) (emphasis added) with CMO 4A ¶ 5(A) (“Expert 

discovery in the Zessin case, shall be completed by June 3, 2013 in accordance 

with the following schedule”) and CMO 4A ¶ 6(A) (“Expert discovery in the 

Young case, shall be completed by January 11, 2013 in accordance with the 

following schedule”). Notably, because the Court required expert discovery on 

general causation to be completed prior to the start of the Glynn trial for the four 

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Early Trial Cases that will be tried in quick succession, the paragraphs of CMO 4A 

dealing with deadlines for case-specific experts in the Zessin and Young cases do 

not include deadlines for disclosure of general causation experts. Those deadlines 

expired for Plaintiffs on October 15, 2012 and Merck on November 13, 2012. Id. 

The Court’s CMOs sensibly set forth an orderly procedure whereby 

Plaintiffs in the Early Trial Cases disclosed all their general cause experts, Merck 

responded with its general causation experts, and the Court addressed Daubert

concerns at a single time. Merck believed this was in fact done when, on October 

15, 2012, Plaintiffs served general causation expert reports for Dr. Cheryl Blume, 

Dr. David Madigan, Dr. Charles Cornell, and Dr. Michael Klein, which were 

followed by Merck serving its Rule 26(a)(2) disclosure for general causation 

experts and Glynn case-specific experts on November 13, 2012. See Confoy 

Dec.Exh. 3, Statement of Defendant Merck Sharp & Dohme Corp. Pursuant to 

Federal Rule of Civil Procedure 26(a)(2), Nov. 13, 2012).1 

 

1. The PSC recognizes the difference between general experts in the MDL, for 

which disclosure was required prior to commencement of the Glynn trial, from 

those designated for specific cases. For example, when arguing that Dr. Blume 

should not be questioned about monies made for her work on the general cases 

in the MDL, counsel for Plaintiff stated “[a]s the Court may be aware, I know 

the defendants are, Dr. Blume was prepared as a general expert by the 

plaintiffs’ steering committee here in the MDL for the entirety of the litigation. 

A great deal of her work, therefore, was generally applicable to I guess about 

1000 cases, not to mention she’s also designated generally in the New Jersey 

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It was never contemplated by the parties nor allowed for by the Court’s 

CMOs that the parties would engage in multiple rounds of general causation expert 

disclosures and general causation Daubert briefing in the Early Trial Cases.2 

Serial general causation expert discovery not only is inefficient for the Court and 

the parties, it is particularly prejudicial to Merck as it would afford Plaintiffs three 

opportunities for de facto unauthorized rebuttal reports. As discussed below, this 

potential prejudice is not just theoretical but in fact has played out in the Zessin

case.

B. Plaintiff Zessin’s Disclosure of Dr. Makuch is Untimely and Should 

Be Excluded.

On April 1, 2013, almost six months after the deadline for disclosure of 

general causation experts passed, Plaintiffs disclosed a new general causation 

expert – Dr. Robert W. Makuch – in their Zessin case specific expert disclosure. 

As Dr. Makuch explains in his report, he was asked to write a report to “delineate 

 

state court, so there are thousands of cases for which she prepared the general 

report.” Confoy Dec. Exh. 4, Glynn Trial Tr. at 539:21-540:4, Apr. 11, 2013. 

2. When the Court expressed concern with the “truckloads” of briefing that had 

been submitted by both sides prior to the Glynn trial, and expressed specific 

concern that it not “be given the volume of motions before [subsequent 

bellwether] cases get started because it’s simply impossible to deal with” PSC 

counsel represented that the first MDL bellwether trial is “when the freight train 

goes through of motion practice and all of this is decided basically once and 

then doesn’t have to be addressed again.” Confoy Dec. Exh. 5, Glynn Pre-Trial 

Hr’g Tr. at 4:9-5:9, Feb. 21, 2013. Obviously, if Daubert is to be redone as 

both sides act and react to each side’s new general expert disclosures, this 

would not be the case.

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the risk of atypical subtrochanteric and diaphyseal fractures linked to 

bisphosphonate therapy, and in doing so, assess this aggregated evidence to 

establish, within a reasonable degree of scientific certainty, whether or not 

bisphosphonates are a significant contributing factor to atypical femoral fractures.” 

Confoy Dec. Exh. 6, Makuch Report at 4, Mar. 29, 2013. At the conclusion of Dr. 

Makuch’s report, he offers the following opinion: “I have reviewed literature that 

reports a range of risk found by various authors, but regardless the range in 

magnitude, population-based data in the medical literature support the assertion 

that there is a strong cause-effect association of increased risk of atypical femoral 

fractures with bisphosphonate use.” Id. at 32. Dr. Makuch’s report does not 

contain any case-specific opinions with respect to Plaintiff Zessin (or any other 

plaintiff). As such, Dr. Makuch discloses purely general causation opinions that 

were required to be disclosed pursuant to CMO 4A on October 15, 2012.3

Plaintiffs’ disclosure of a general causation expert six months after the 

deadline set by this Court in CMO 4A is a clear violation of Federal Rule of Civil 

Procedure 26(a)(2), which provides that “the parties must disclose their experts and 

 

3. As part of their expert disclosures in Zessin, Plaintiffs also disclosed Dr. 

Anthony Mechrefe. Dr. Mechrefe includes case-specific opinions relating to 

the Zessin case in addition to general cause opinions. Since Dr. Mechrefe’s 

general causation opinions relate to his timely disclosed case-specific opinions, 

Merck is not seeking to exclude his opinions here. Plaintiff Zessin also 

incorporated the general reports served previously by Drs. Blume and Madigan, 

but not Drs. Klein and Cornell.

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the contents of their reports within the time frame set by the Court.” Roberts v. 

United States, CIV.A. 09-6212 WJM, 2012 WL 2374656, at *3 (D.N.J. June 22, 

2012). A “failure to comply with the disclosure requirements of the Rule frustrates 

the purpose of the Rules – the elimination of unfair surprise and the conservation 

of resources.” D & D Assoc., Inc. v. N. Plainfield Bd. of Ed., 2006 WL 1644742, 

at *3 (D.N.J.2006). Thus, when a party fails to make the required disclosures in 

the time frame set forth by the court and as required by Rule 26 (a) or (e), “the 

party is not allowed to use that information or witness to supply evidence...unless 

the failure was substantially justified or is harmless.” Fed. R. Civ. P. 37(c)(1). 

Here, Plaintiffs failed to disclose Dr. Makuch in accordance with the

requirements of CMO 4A and such failure is neither substantially justified nor 

harmless. “The party who has failed to disclose information bears the burden to 

show that the nondisclosure was substantially justified or is harmless.” D & D 

Assoc., Inc., 2006 WL 1644742, at *3. Accord Newman v. GHS Osteopathic, Inc., 

Parkview Hosp. Div., 60 F.3d 153, 156 (3d Cir. 1995) (“Rule 37 is written in 

mandatory terms, and is designed to provide a strong inducement for disclosure of 

Rule 26(a) material.”). “Substantial justification requires justification to a degree 

that could satisfy a reasonable person that parties could differ as to whether the 

party was required to comply with the disclosure request. The proponent’s 

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position must have a reasonable basis in law and fact.” Id. at *4 (citations 

omitted). 

“Factors to consider when determining whether a failure was harmless 

include prejudice or surprise to a party against whom evidence is offered, the 

ability to cure the prejudice, likelihood of disruption to trial, and bad faith.” D &

D Assoc., Inc., 2006 WL 1644742, at *4 (citing In re Mercedes-Benz Anti-trust 

Litig., 225 F.R.D. 498, 505 (D.N.J. 2005)). Here, where the language in CMO 4A 

sets forth deadlines by which each party must complete “[e]xpert discovery on 

general causation,” reasonable people cannot differ as to whether Plaintiffs were 

required to comply with the Court’s deadlines for disclosure of general causation 

experts set forth in CMO 4A.4 See Confoy Dec. Exh. 2, CMO 4A ¶ 4(A). 

 

4. Courts in this circuit have consistently excluded expert testimony for failure to 

comply with disclosure requirements. See, e.g., Roberts v. United States, 

CIV.A. 09-6212 WJM, 2012 WL 2374656, at *5 (D.N.J. June 22, 2012) 

(excluding expert testimony where“[a]llowing additional witnesses (who could 

have been disclosed long ago) would require” defendants to spend additional 

time and resources on the trial, noting that permitting newly designated experts 

without limitation would create “an untenable situation for opposing counsel 

preparing for trial”) (internal citations omitted); Bouder v. Prudential Fin., Inc., 

CIV.A.06-4359(DMC), 2010 WL 2026707, at *5 (D.N.J. May 21, 2010) 

(granting defendant’s motion to strike report and preclude testimony of 

plaintiffs’ expert where expert was not timely disclosed); Exxon Corp. v. 

Halcon Shipping Co., Ltd., 156 F.R.D. 589, 591-92 (D.N.J. 1994) (upholding 

exclusion of expert in liability phase of trial where the party offering the expert 

“failed to conform” with the court’s scheduling orders and did not provide a 

satisfactory explanation, noting that although “the exclusion of expert witness 

testimony is a drastic sanction, the Court understands the need to maintain 

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Plaintiffs’ tardy disclosure is not substantially justified. Dr. Makuch relies 

on materials that were available long before the October 15, 2012 deadline and 

thus his general causation opinions could have been disclosed in a timely fashion. 

In fact, Dr. Makuch discusses in his report the same publications relied upon by 

other general causation experts disclosed in October 2012 (although Dr. Makuch 

performs different analyses of these publications than Plaintiffs’ other experts). 

Thus, there is no credible explanation for why Plaintiffs waited six months after 

the deadline to disclose Dr. Makuch’s general causation opinions.

Nor is Plaintiff’s long-delayed disclosure of Dr. Makuch harmless. In his 

report, Dr. Makuch specifically comments upon and attempts to rebut opinions 

offered by one of Merck’s general causation experts, Dr. Stephen Kimmel. See, 

e.g., Confoy Dec. Exh. 6, Makuch Report at 22 (“This careful assessment refutes 

the remarks of Dr. Stephen Kimmel in his expert report . . .”); id. at 31 (“Dr. 

Stephen Kimmel is incorrect in several statements contained within his expert 

report”). The Court’s CMOs do not contemplate rebuttal reports by Plaintiffs nor 

are such rebuttal reports expressly authorized under the Federal Rules. Plaintiffs’ 

 

control over the discovery process,” “the parties are entitled to some certainty 

as to their preparation for trial, and if newly designated experts ... [are] 

permitted to enter upon the scene without limitation the need for discovery 

could be endless”) (citations and quotation marks omitted); M. Eagles Tool 

Warehouse, Inc. v. Fisher Tooling Co., 2007 WL 979854, at * 12 n. 12 (D.N.J. 

Mar. 30, 2007) (granting motion to strike introduction of supplemental expert 

report and new affidavit from expert after expert discovery deadline had 

passed).

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attempt at bestowing upon themselves the right to rebuttal expert reports should 

not be allowed.

Merck is prejudiced in other ways, too. In these Early Trial Cases, which 

were scheduled for trial closely together, Merck already responded to and deposed 

Plaintiff’s initial general causation experts, Drs. Klein and Cornell, and further has 

cross-examined Dr. Cornell in the Glynn trial. Plaintiffs have the benefit of seeing 

Merck’s attacks on Plaintiffs’ general causation theory of the case and are now 

attempting to navigate around those attacks. In essence, Plaintiffs are asking this 

Court for a mulligan – plainly dissatisfied with the admissions Drs. Klein and 

Cornell gave in their depositions, Plaintiffs want a do-over and to try out a new 

general cause expert. Of course this time that new general cause expert will have 

had the opportunity to review and respond to Merck’s experts and Merck’s crossexamination of Plaintiffs’ other general causation experts. CMO 4 did not set forth 

a process by which Plaintiffs in the Early Trial Cases have several opportunities to 

audition and then settle on general causation experts after Merck has disclosed its 

experts for those cases. In these circumstances, such a do-over does violence to 

the very set-up contemplated by this bellwether process, where four cases with 

certain commonalities -- and differences -- are to be tried in quick succession on a 

shared discovery schedule.

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CONCLUSION

Because Plaintiffs failed to timely disclose Dr. Makuch and such failure is 

neither substantially justified nor harmless, Merck respectfully requests that the 

Court strike Dr. Makuch from Plaintiffs’ Zessin Rule 26(a) disclosure and exclude 

his testimony and any references to his opinions from being introduced at trial. 

Respectfully submitted,

FOX ROTHSCHILD, LLP

By: /s/ Karen A. Confoy

KAREN A. CONFOY

kconfoy@foxrothschild.com

Attorney for Defendants 

Merck Sharp & Dohme Corp.

(f/k/a Merck & Co., Inc.) 

Dated: April 17, 2013

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