govinfo:USCOURTS-njd-1_08-cv-00008-7

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NOT FOR PUBLICATION 
 
 UNITED STATES DISTRICT COURT 
DISTRICT OF NEW JERSEY 
 
 
IN RE: FOSAMAX (ALENDRONATE 
SODIUM): PRODUCTS LIABILITY 
LITIGATION 
 
THIS DOCUMENT RELATES TO: 
All Actions 
 
 
MDL No. 2243 
Master Docket No. 08-08 (JAP)(LHG) 
 
 OPINION 
 
PISANO, District Judge 
 
 This matter is presently before the Court on an Order to Show Cause (“OTSC”) issued on 
August 15, 2013 [docket #2895], directing the Plaintiffs listed in Appendix A of the Order 
(collectively referred to as “Plaintiffs”), to show cause why their pre -September 14, 2010, injury 
claims should not be dismissed on preemption grounds pursuant to this Court’s ruling in the 
Bellwether Glynn case. See Glynn v. Merck Sharp & Dohme, Corp., Case Nos. 11-503, 08-08, --- 
F. Supp. 2d ---, 2013 WL 3270387 (D.N.J. Jun. 27, 2013). 
In response to the OTSC, the Court received the following briefs from Plaintiffs: (1) 
Plaintiff Deborah Thompson’s Response to the OTSC [docket #2931]; (2) Plaintiff Helen 
Stampliakas’s Response to the OTSC [docket #2932]; (3) Plaintiff Elaine How e’s Response to 
the OTSC [docket #17 on 11 -6657] (4) Plaintiffs’ Adverse Reactions and Long -Term-Use 
Failure-to-Warn Brief (“Adverse Reactions Brief”) [docket #2995(1)]; (5) Plaintiffs’ Design -
Defect and Other Non Failure to Warn Claims Brief (“Design Defe ct Brief”) [docket #2995(2)]; 
(6) Plaintiffs’ Procedural Brief [docket #2995(3)]; and (7) Plaintiffs’ Warnings and Precautions 
Brief [docket #2995(4)]. PageID:
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Merck replied to Plaintiffs’ response to the OTSC and filed the following briefs in 
support of its posi tion: (1) Reply to Plaintiff Helen Stampliakas's and Plaintiff Deborah 
Thompson's Responses to the Court's OTSC [docket #3030]; (2) Reply to Plaintiff Elaine Howe's 
Response to the Court's OTSC [docket #3041] (3) Reply to Plaintiffs' Adverse Reactions and 
Long-Term-Use Failure-to-Warn Brief (“Merck’s Adverse Reactions Brief”) [docket #3031]; (4) 
Reply to Plaintiffs' Design Defect and Other Non -Failure to Warn Claims Brief (“Merck’s 
Design Defect Brief”) [docket #3031(1)]; (5) Reply to Plaintiffs' Procedural Brief [docket 
#3031(3)]; and (6) Reply to Plaintiffs' Warnings and Precautions Failure to Warn Brief [docket 
#3031(2)]. 
By way of brief background, Plaintiffs brought this lawsuit against Merck, the 
manufacturer of Fosamax, which is a drug approved by th e United States Food and Drug 
Administration (“FDA”) for the treatment and prevention of osteoporosis. This matter is part of 
the multi-district litigation (“MDL”) concerning Fosamax and involves allegations that Fosamax 
causes atypical femur fractures (“ AFFs1”), it caused Plaintiffs’ injuries, and Defendant failed to 
warn physicians about Fosamax causing AFFs. For the reasons set forth below, Plaintiffs’ have 
failed to show cause why their pre-September 14, 2010, injury claims should not be dismissed on 
preemption grounds. Preemption was dispositive of Glynn and cuts across all pre -label change 
cases. Accordingly, Defendant is entitled to judgment as a matter of law on the Appendix A 
Plaintiffs’ claims. 
I. OVERALL PROCEDURAL HISTORY 
In May 2011, the Judicial Panel on Multidistrict Litigation centralized in this Court a 
number of related actions brought by patients who suffered femur fractures or similar bone 
 
1 The abbreviation of atypical femur fracture (singular) is “AFF.” PageID:
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injuries after taking Fosamax [docket #30]. On July 14, 2011, the Court orde red a process for 
selection of three or four Early Trial Cases and directed a schedule for expert discovery [docket 
#113]. On November 14, 2012, the Court designated trial dates for the four Early Trial Cases, 
with the earliest, Glynn, set for April 8, 20 13 [docket #1915]. General fact discovery closed on 
December 31, 2012, pursuant to Case Management Order No. 10 [docket #848]. 
On January 15, 2013, Merck moved for summary judgment in Glynn on federal 
preemption grounds, arguing that the Plaintiffs’ cla ims were preempted because the FDA’s 
rejection of Merck’s proposed Precaution disclosing a risk of low -energy femoral shaft fracture 
from Fosamax use made it impossible for Merck to warn the Plaintiffs’ of that risk [docket # 25 
in 11-5304]. This Court he ard oral argument on the federal preemption issue on March 8, 2013, 
and reserved decision until a trial record had been established. A jury trial took place in Glynn 
from April 8, 2013 to April 29, 2013. The parties then briefed the preemption issue thre e more 
times: a Rule 50(a) motion for judgment as a matter of law at the close of Plaintiffs’ case [docket 
# 198 in 11-5304]; a renewed Rule 50(a) motion at the close of all evidence [docket # 209 in 11-
5304]; and a Rule 50(b) renewed motion for judgment a s a matter of law [docket # 216 in 11-
5304]. 
On June 27, 2013, after considering all of the parties briefing, evidence, arguments, and 
the trial record, the Court granted Merck’s motion(s) and found that Plaintiff’s state law claim 
for failure to warn wa s preempted because clear evidence existed that the FDA would not have 
approved a stronger warning to the Fosamax label as of the date of Ms. Glynn’s injury. Glynn, 
2013 WL 3270387, at *1. On August 1, 2013, Merck then moved for an OTSC why the claims 
of all other Plaintiffs with injury dates prior to September 14, 2010, should not be dismissed 
pursuant to the Court’s preemption ruling in Glynn [docket #2857] . On August 5, 2013, PageID:
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Plaintiffs’ submitted a letter brief opposing the entry of an OTSC [docket # 2870], and Merck 
replied by letter on August 12, 2013 [docket #2881]. The Court, observing that it had 
“afford[ed] the Plaintiffs’ Steering Committee . . . and Glynn’s counsel repeated opportunities to 
present their evidence” and that the Glynn ruling tur ned on issues common to all Plaintiffs, 
granted Merck’s motion on August 15, 2013 [docket #2895]. 
As stated above, the parties submitted several briefs and filings in support of their 
responses to the OTSC. The Court will address each argument separately below. 
II. BACKGROUND 
A. History of the Fosamax Label Change 
In September 1995, the FDA approved Fosamax for the treatment of osteoporosis in 
postmenopausal women, and in April 1997, the FDA approved Fosamax for the prevention of 
osteoporosis in postmenopausal women. Since this time, Fosamax has remained FDA approv ed 
for the treatment and prevention of postmenopausal osteoporosis. On June 13, 2008, the FDA 
contacted Defendant and other bisphosphonate 2 manufacturers and requested any investigations 
they conducted “regarding the occurrence of atypical fractures with bisphosphonate use ,” any 
investigational plans, and “all hip and femoral fracture case reports” they received [docket # 
3032, Merck’s Preliminary Statement of Facts Relating to the Court’s Order to Show Cause 
(“Merck’s Statement of Facts”) ¶ 28 ]. The FDA also asked that Defendant and the other 
bisphosphonate manufacturers make an effort where possible “to clarify the fracture location and 
the duration of bisphosphonate e xposure for all case reports.” Id. at ¶ 44. The FDA explained 
that it was “aware of reports regarding the occurrence of subtrochanteric hip fractures in patie nts 
using bisphosphonates” and was “concerned about this developing safety signal.” Id. at ¶ 43. 
 
2 Fosamax belongs to a class of drugs known as bisphosphonates. PageID:
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On July 18, 2008, Defendant responded to the FDA’s request and included summary 
tables of clinical and post -marketing data, clinical Council for International Organizations of 
Medical Sciences (“CIOMS”) reports, and post -marketing CIOMS reports. Id. at ¶ 47. The 
FDA’s review of this data as well as the data from other bisphosphonate man ufacturers “did not 
show an increase in . . . [the risk of atypical subtrochanteric femur fractures] in women using 
these medications .” [docket #3035, Declaration of Karen A Confoy in Support of Merck’s 
Replies to Plaintiffs’ Briefs in Response to Court’s Order to Show Cause and in Support of 
Merck’s Preliminary Statement of Facts (“Confoy Dec.”), Ex. 73]. 
On September 15, 2008, Defendant submitted a Prior Approval Supplement (“PAS”) to 
the FDA, proposing “to add language to both the Precaution [s] and Adve rse Reaction s/Post-
Marketing Experience section[s] of the label to describe low -energy” subtrochanteric femoral 
fractures. Merck’s Statement of Facts, ¶ 73. Defendant explained that “[i]t is not possible with 
the present data to establish whether treatment with” Fosamax “increases the risk of [these] . . . 
low-energy subtrochanteric and/or proximal shaft fractures,” but because there is a temporal 
association between these fractures and Fosamax, Defendant thought that it was “important to 
include an appropriate statement about them in the product label.” Id. Defendant sought to add 
the following language to the Precautions section of the label: 
Low-Energy Femoral Shaft Fracture 
Low-energy fractures of the subtrochanteric and proximal femoral 
shaft have been reported in a small number of bisphosphonate -
treated patients. Some were stress fractures (also known as 
insufficiency fractures) occurring in the absence of trauma. Some 
patients e xperienced prodromal pain in the affected area, often 
associated with imaging features of stress fracture, weeks to 
months before a complete fracture occurred. The number of 
reports of this condition is very low, and stress fractures with 
similar clinical features also have occurred in patients not treated 
with bisphosphonates. Patients with suspected stress fractures 
should be evaluated, including evaluation for known causes and PageID:
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risk factors (e.g., vitamin D deficiency, malabsorption, 
glucocorticoid use, previous stress fracture, lower extremity 
arthritis or fracture, extreme or increased exercise, diabetes 
mellitus, chronic alcohol abuse), and receive appropriate 
orthopaedic care. Interruption of bisphosphonate therapy in 
patients with stress fractures should be considered, pending 
evaluation of the patient, based on individual benefit/risk 
assessment. 
 
[Id. at ¶74]. 
 
Additionally, Defendant proposed adding “low -energy femoral shaft fracture” to the Adverse 
Reactions/Post-Marketing Ex perience section of the label and the following statement to the 
Patient Package Insert: “Patients have experienced fracture in a specific part of the thigh bone. 
Call your doctor if you develop new or unusual pain in the hip or thigh.” Id. 
On April 15, 2009, an FDA repre sentative e-mailed Defendant and stated that the label 
change to the Adverse Reactions /Post-Marketing Experience section of the label would be 
approved but the label change to the Precautions section would not be approved. Id. at ¶ 79. On 
May 22, 2009, th e FDA formally responded to Defendant’s proposed label change, 
recommending that it add “low energy femoral shaft and subtrochanteric fract ures” to the 
Adverse Reactions/Post-Marketing Experience section of the label; however, the FDA still did 
not approve the label change to the Precautions section. Id. at ¶ 80. Moreover, the FDA warned 
that Fosamax “may be considered to be misbranded under the Federal Food, Drug, and Cosmetic 
Act if [it is] . . . marketed with” these label changes “before [FDA] approval . . . .” Id. 
On July 2, 2009, Defendant submitted to the FDA a Changes Being Effected (“CBE”) 
supplement to add the FDA’s proposed language about femur fractures to the Adverse 
Reactions/Post-Marketing Experience section of the label, which was later approved. Id. at ¶ 81. 
On March 10, 2010, the FDA issued a Drug Safety Communication, in which it stated that “[a]t 
this point, the data that FDA has reviewed have not shown a clear connection between PageID:
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bisphosphonate use and a risk of atypical subtrochanteric femur fractures” Merck’s Statement of 
Facts, ¶ 85. The FDA did state, however, that it was “working closely with outside experts, 
including members of the . . . American Society of Bone and Mineral Research Subtrochanteric 
Femoral Fracture Task Force, to gather additional information that may provide more insight into 
this issue.” Id. 
On September 14, 2010, the American Society for Bone and Mineral Research 
(“ASBMR”) published an article entitled Atypical Subtrochanteric and Diaphyseal Fem oral 
Fractures: Report of a Task Force of the American Society for Bone and Mineral Research . Id. 
at ¶ 86. The report stated that although there is an association between long-term bisphosphonate 
use and AFFs, the association had not been proven to be ca usal. Id. The FDA responded to the 
report by issuing a Drug Safety Communication , in which it stated “[a]lthough it is not clear if 
bisphosphonates are the cause [of AFFs], these unusual femur fractures have been identified in 
patients taking these drugs.” Id. at ¶ 87. Regarding the ASBMR Task Force’s recommendation 
of a label change, the FDA stated that it “ has assembled and is thoroughly reviewing all long 
term data available on the products, as well as all safety reports …” and would be “considering 
label revisions.” Id. (emphasis added). 
In October 2010, the FDA issued another Drug Safety Communication, informing that it 
would require all bisphosphonate manufacturers to add information on AFFs to the Precautions 
section of the drug labels and require a new Limitations of Use statement in the Indications and 
Usage section of the label because “these atypical fractures may be related to long -term . . . 
bisphosphonate use.” Id. at ¶¶ 88 -89. It reiterated that it was still “not clear if bisphosphonates 
are the cause,” but noted that these “unusual femur fractures” may be related to long -term 
bisphosphonate use. Id. at ¶ 88. The FDA’s proposed labeling language noted that “[c] ausality PageID:
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has not been established as these fractures also occur in osteoporotic patients who have not been 
treated with bisphosphonates.” Id. at ¶ 89. On January 11, 2011, Defendant submitted the 
agreed upon label changes to the FDA. Id. 
Currently, the Fosamax label includes the following language: “Atypical, low -energy, or 
low trauma fractures of the femoral shaft have been reported in bisphosphonate -treated patients. 
. . . Causality has not been established as these fractures also occur in osteoporotic patie nts who 
have not been treated with bisphosphonates. Atypical femur fractures most commonly occur 
with minimal or no trauma to the affected area .” [docket #2996 , Declaration of Donald A. 
Ecklund (“Ecklund Dec.”), Ex. 9]. 
B. Glynn Ruling 
As noted above, before the Court in Glynn were several motions by Defendant 3, all of 
which were premised on federal preemption. The issue in these motions was whether clear 
evidence existed that the FDA would not have approved a stronger warning to the Fo samax 
label, thereby warranting preemption of the Glynn Plaintiffs’ failure to warn claim. See Wyeth v. 
Levine, 555 U.S. 555 (2009). This Court heard oral argument on the preemption issue on March 
8, 2013, and reserved decision until a trial record had b een established. See Fed. R. Civ. P. 78. 
A jury trial took place from April 8, 2013 to April 29, 2013, and the jury returned a verdict for 
Defendant, finding that Plaintiff Glynn did not prove that she experienced an AFF in April 2009 
by a preponderance of the evidence. 
On the day following the conclusion of the trial, the Court held an in -person status 
conference where it discussed the preemption issue and gave the Plaintiffs t wenty-one (21) days 
 
3 The motions before the Court in Glynn were: (1) Defendant’s Motion for Summary Judgment based upon Federal 
Preemption [docket # 25 in 11-5304]; (2) Defendant’s Motion for Judgment as a Matter of Law pursuant to Rule 
50(a) [docket # 198 in 11-5304]; (3) De fendant’s Renewed Motion for Judgment as a Matter of Law pursuant to 
Rule 50(a) [docket # 209 in 11-5304]; and (4) Defendant’s Renewed Motion for Judgment as a Matter of Law 
pursuant to Rule 50(b) [docket # 216 in 11-5304]. PageID:
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to submit “proposed fact findings that [were] based upon the record in opposition to” the 
preemption motions. [docket #250 in 11 -5304, Hearing Tr. , 19:24-20:1; April 30, 2013]. 
Thereafter, on May 6, 2013, Defendant submitted its Renewe d Motion for Judgment as a Matter 
of Law pursuant to Rule 50(b) [docket # 216 in 11-5304], arguing that the Glynn Plaintiffs’ 
claims were preempted because Defendant submitted to the FDA all of the information relevant 
to a label change and tried to change the Precautions section of the label to include low -energy 
femoral fractures, but the FDA rejected this change. The Court agreed with Merck’s position 
and on June 27, 2013, granted Defendant’s motion(s). See Generally Glynn, 2013 WL 3270387. 
C. Arriving at the OTSC 
With the history of Glynn as a backdrop, it is necessary to address the evolution of the 
preemption issue, how the case has gotten to the point of having an OTSC on the issue, and the 
fact that the parties have been aware of the potential globa l effects preemption could have on the 
entire MDL for at least two (2) years. Throughout the entire pre -trial, trial, and post -trial 
proceedings in Glynn, the Court made it clear that, prior to ruling on preemption, it wanted the 
parties to introduce any and all relevant evidence to the issue because of the effects it could have 
on the MDL as a whole. During this time – even prior to any motions being filed by Defendant – 
Plaintiffs’ were aware of the exact position that Merck took surrounding preemption, how Merck 
planned to raise this argument, and the fact that Merck believed preemption likely hinged on the 
date of a Plaintiff’s injury. 
Indeed, before Ms. Glynn was even selected as the Bellwether case for trial, the parties 
appeared before the Court on May 14, 2012 , where counsel for Merck reiterated the fact that the 
date of injury was central to the analysis and a dvised the Court and Plaintiffs of Defendant’s 
position on preemption . [docket #13 97, Hearing Tr. , 13:25-14:2; 14:12-14:14; 15:16-15:19; PageID:
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22:5-22:7; May 14, 2012 (“MR. MARSHALL: . . . I want to focus in on some of the labeling 
issues because they’re going to be very important in the case . . . [it’s] going to be a very 
important point in these cases because we will be raising a preemption argument . . . [t]hat 
defense will be raised as a substantive legal motion . . . [and] it will be based upon when the 
injury occurred . . . [a] key factor . . . is the timing of the injury. . . .”)]. Stated differently, for 
almost an entire year prior to the Glynn trial, Plaintiffs were aware of Defendant’s position on 
preemption, the fact that it would be raised by way of substantive motion and that such motion 
would be directly related to the timing o f injury. Fact discovery closed seven (7) months 
thereafter and the preemption issue was then briefed four separate times. 
 As the Glynn trial moved closer, the parties were advised of the Court’s desire to have 
any and all arguments and evidence relevan t to preemption on the record. [docket #244 in 11 -
5304, Trial Tr., Vol. 9, 1885:7–1885:12; April 22, 2013 (“THE COURT:. . . I have indicated my 
intention to ultimately rule on that [preemption] motion after I’ve had the benefit of a complete 
trial record . . . I think I’m correct that a full trial record would benefit me and both sides before a 
ruling is made.”)]. Further, after the close of Plaintiff’s case in the Glynn trial, Plaintiffs were 
again made aware of the exact position Merck took with respect to the evidence set forth and the 
issues Merck planned to again raise surrounding preemption. Id. at 1908:12 – 1908:17 (“MR. 
MARSHALL: . . . The FDA had in its possession all of the information that plaintiffs now rely 
upon to say that a label change could be made. We tried to do it, it was rejected. We are 
precluded, prevented from doing it. That, your Honor, is the pre emption argument.”). Despite 
Merck’s contention that no dispute of fact existed for the jury to decide , the Court continued to 
reserve its decision on the preemption motion(s) to ensure a full trial record was established with 
all evidence relevant to the issue. PageID:
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 Immediately following the trial on April 30, 2013, the parties appeared before the Court 
to discuss the process of moving the MDL forward and, again, the Court reiterated that it has 
been urging Plaintiffs to come forward with any and all evidence on the preemption issue, as the 
parties all agreed that it would have widespread implications on the MDL as a whole: 
MR SEEGER : . . . I’m thinking that the preemption 
issue because it’s going to cut across all 3,000 cases. Pretty 
much if it goes the wro ng way for plaintiffs, it’s pretty much 
the end of the litigation. 
. . . 
THE COURT : There have been three iterations of the 
preemption motion and my position all along was to make – that 
I wanted to be sure, first of all, that I had a complete record 
from which to decide the preemption issue. And I thought the 
best way to do that was to try the Glynn case, because that was the 
case that was coming in, knowing that there was going to be 
evidence introduced which would bear upon Merck’s conduct 
with the FDA and whether there would be clear evidence that 
[the] FDA would not have permitted the label change , which is 
what Merck has to show under Wyeth v. Levine. 
. . . 
I don’t know what more you want to put in the record. I 
invited you, I invited the plaintiffs and I was urging the 
plaintiffs to put in what there could be bearing on the question. 
I don’t know what else there is. 
. . . 
The issue in the case is whether there’s anything in the 
regulatory record from which the Court would conclude that 
it’s clear the FDA would not have permitted the label change. 
Now, the label change was an issue in the Glynn case. It was an 
issue in the G lynn case that was addressed by Dr. Blume, it was 
addressed by Dr. Madigan and it certainly was addressed by Dr. 
Santora and Daifotis. 
I’m not so sure there’s anything else and if there was 
something else, I have been begging for it. 
. . . 
. . . It was clear to me and everybody else that there was 
substantial consequences to this motion. We've had a hundred 
conversations, all of us, since then where I have been saying the 
same thing, namely, that I wanted -- that it was important to 
decide this case, this issue one way or another so that there 
could be some appellate review and we get a sense of it, 
because we know we're holding 3300 cases hostage. PageID:
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[docket #250 in 11-5304, Hearing Tr., 5:10-5:13; 6:10-6:19; 7:13-7:17; 16:6-16:14; 18:15-18:21; 
April 30, 2013 (emphasis supplied)]. 
 Similarly, after the Court granted Merck’s preemption motion(s) in Glynn, the parties 
appeared before the Court on July 18, 2013, to again address, among other things, how the 
preemption issue would be treated going forward and the fact that preemption would cut across 
all of the cases in the MDL: 
THE COURT : I think it’s an accurate statement, Mr. 
Morris, that I have been consistent in asking the plaintiffs to 
come forward with any evidence that would bear upon that 
preemption decision and I didn’t decide it until I was satisfied 
that there had been a full opportunity to be heard on the 
question and the opinion stands for itself. 
. . . 
This business about all the plaintiffs having their own 
claims and their own injuries and their own doctors is all very well 
and fine and that’s true, but the focus from the preemption issue, 
the focus is more on Merck than on the plaintiffs. 
. . . 
THE COURT: . . . [W]hat I would expect then is there to be 
some sort of an effort by Merck to close the door on these cases. 
MR. MORRIS: Right, we expected that. . . 
 
[docket #2998, Hearing Tr. , 10:3-10:8; 10:16 -10:20; 11:8 -11:10; July 18, 2013 (emphasis 
supplied)]. 
As a review of the record reveals, the preemption issue has existed since this MDL’s 
inception and preemption has almost certainly been the forefront of the litigation for the past two 
(2) years. It has never been a secret as to what Merck’s position is with respect to preemption, 
and Plaintiffs have long been aware that their case(s) may depend entirely on the date of injury. 
Further, as referenced above, for the past two (2) years the parties and the Court have been 
operating under the common understanding that this Court’s decision on preempt ion could 
impact the entire MDL. Stated differently, Plaintiffs and Defendant knew that while the motions PageID:
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before the Court in Glynn were specific to the date of Ms. Glynn’s injury, the Court’s decision 
on such motions would almost certainly have an effect on a substantial amount of Plaintiffs other 
than Ms. Glynn. Thus, the Court purposely reserved deciding the issue to ensure that any and all 
facts relevant to preemption would appear on the record. In doing so, the Court repeatedly urged 
Plaintiffs to come forward with all evidence bearing on preemption, allowed the parties several 
opportunities to brief the issue, entertained oral argument on the motion(s), conducted an entire 
trial which invited any evidence relevant to preemption, and addressed the is sue at various 
hearings. Then, after finally ruling on preemption in Glynn, the Court issued an OTSC – giving 
the parties yet another opportunity to brief the issue – to address what has long been known as a 
predominant issue in the case: namely, what eff ect does the Court’s preemption ruli ng have on 
the other Plaintiffs whose injuries occurred prior to the date of the label change? 
III. DISCUSSION 
A. Procedural Arguments 
The parties each submitted briefing on the procedural aspects of the Court’s OTSC in the 
context of an MDL. Plaintiffs’ and Defendant concede that Rule 56 provides the proper standard 
for the Court’s analysis here; however, the parties disagree over the burden shifting, as well as 
the Court’s ability to utilize an OTSC to apply the Glynn ruling to other Plaintiffs. This Court 
agrees with the parties’ contention that Rule 56 provides the exclusive mechanism by which the 
Court can resolve the dispositive issues presented by Merck’s preemption defense before trial(s). 
i. Procedural Analysis 
The Court must first address the proper standard to be applied pursuant to Rule 56 as well 
as where the appropriate burden lies in this OTSC context. Under Rule 56, summary judgment is 
applicable when the Court is satisfied that there is no genuine issue of material fact and the PageID:
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evidence establishes the moving party’s entitlement to judgment as a matter of law. See Celotex 
Corp. v. Catrett , 477 U.S. 3 17, 323, 106 S. Ct. 2548, 2553 (1986). “ If the moving party meets 
the initial burden of establishing that there is no genuine issue, the burden shifts to the 
nonmoving party to produce evidence of a genuine issue for trial. ” Degrange v. W. , 196 F. 
App'x 91, 93 (3d Cir. 2006). 
This Court agrees with Merck’s contention that Defendant’s initial burden pursuan t to 
Rule 56 has already been met by way of the briefing in Glynn. As stated above, Merck briefed 
the preemption issue four (4) separate times and in doing so, met its burden of establishing that 
there is no genuine issue(s) of fact with respect to preemp tion. This is further evidenced by the 
Court’s judgment as a matter of law in favor of Merck, holding that clear evidence exists that the 
FDA would not have approved a stronger warning prior to the date of Ms. Glynn’s injury.4 See 
Generally Glynn, 2013 WL 3270387. Thus, Merck has demonstrated the absence of any genuine 
issue of material fact surrounding preemption and the burden is therefore shifted to Plaintiffs to 
produce a genuine issue for trial by way of their briefing in response to the Court’s OTSC. 
 
4 It should be noted, however, that despite the Glynn ruling being specific to Ms. Glynn and the date of her injury, 
Merck’s briefing in Glynn is still relevant to all Plaintiffs’ identified in this Court’s OTSC because the briefs in 
Glynn centered generally on when clear evidence existed that the FDA would not have approved a label change. See 
Defendant Merck Sharp & Dohme Corp.’s Memorandum of Law in Support of Motion for Summary Judgment 
Based upon Federal Preemption , p. 18 [docket #25 in 11 -5304] (“. . . [I]t was not until the ASBMR report was 
issued in September 2010, reporting that bisphosphonates, when used long -term, may be related to femoral fractures, 
that the FDA determined available scientific evidence supported a Precaution.”) ; Defendant Merck Sharp & Dohme 
Corp.’s Memorandum of Law in Support of its Motion for Judgment as a Matter of Law , p. 2, 18 [docket #198 in 11-
5304] and Defendant Merck Sharp & Dohme Corp.’s Memorandum of Law in Support of its Renewed Motion for 
Judgment as a Matter of Law , p. 1, 12 [docket #209 in 11-5304] (“[Plaintiff’s] claims would be preempted because 
Merck proposed . . . such a Precaution and the FDA rejected it . . . such a rejection is “clear evidence” that the FDA 
would have rejected any warning about fractures . . .” and “Dr. Blume testifie d clearly an d repeatedly . . . that a 
pharmaceutical company’s duty to change its la bel to warn of an adverse event does not arise until there is 
‘reasonable evidence of a causal association’ under 21 C.F.R. § 201.57”); Merck Sharp & Dohme Corp.’s Reply in 
Support of Rule 50(B) Motion for Judgment as a Matter of Law , pp. 5-6 [docket #230 in 11 -5304] (“Simply put: the 
change in the FDA’s approach between 2008 and 2010 did not result from a change in FDA policy with respect to 
line-editing proposed warnings . . . Rather, it resulted from an evolution in the FDA’s views about the science 
relating to atypical femur fractures, which did not crystallize until late 2010.”). PageID:
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Plaintiffs’ assert that they have met this burden because subsequent to the Glynn ruling, 
there have been additional documents exchanged and additional expert testimony which creates a 
genuine issue of fact as to what Merck could have or should have done in connection with 
updating its label.5 However, what Merck could have or should have done is immaterial because 
we know what Merck did. Similarly, Wyeth v. Levine provides for preemption where there is 
clear evidence that the FDA would have rejected a label change, and again, we know that the 
FDA did reject it. Thus, any expert testimony relating to what Merck could have or should have 
done, and what the FDA would have done in response to the same, is purely speculation and does 
not rise to the lev el of being a genuine fac t dispute. Allowing Plaintiffs the opportunity to 
present individual expert testimony would also defeat the efficien cy of an MDL because 
Plaintiffs would go through expert after expert, and none of the testimony would change what 
actually transpired between Merck and the FDA. 
Further, the Court disagrees with Plaintiffs’ contention that their Seventh Amendment 
rights and the procedural protections safeguarded in Rule 56 are being circumvented. Plaintiffs’ 
suggest that the preempt ion determination must be made by a fact finder; however, if this were 
the case, the Court’s preemption ruling in Glynn would be improper. 6 This assertion is not 
convincing. Rather, as evidenced by t he cases cited to by Plaintiffs , where there is no factual 
dispute surrounding a preemption determination, summary judgment is proper. See Boyle v. 
United Technologies Corp. , 487 U.S. 50 0, 501, 108 S. Ct. 2510, 2513 (1988) (“If the evidence 
 
5 Plaintiffs’ claim that “new evidence” presently before the Court includes Ex. 161 to the Declaration of Donald A. 
Ecklund, which was a statement from the FDA in December, 2010 about why it was rejecting the label change and 
that because the FDA struck out the term “stress fracture,” this Court cannot find that clear evidence exists that the 
FDA would have rejected a label change that did not use the “stress fracture” language. However, it should be noted 
that the December, 2010 statement from the FDA was before the Court in Glynn and therefore, this is not “new 
evidence” that the Court has not already considered in determining that no material fact dispute exists. See 
Declaration of Edward Braniff in Support of Plaintiff’s Opposition to Defendant’s Motion for Judgment as a Matter 
of Law, at Ex. 1 [docket #199 to 11-5304]. 
6 It should be noted that Plaintiff Glynn did not appeal this Court’s June 27, 2013, Order on preemption. PageID:
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presented in the first trial would not suffice, as a matter of la w, to support a jury verdict under 
the properly formulated [preemption] defense, judgment could properly be entered for 
respondent at once , without a new trial. It is unclear from the Court [s] of Appeals' opinion, 
however, whether it was in fact deciding t hat no reasonable jury could , under the properly 
formulated [preemption] defense, have found the petitioner on the facts presented, or rather was 
assessing on its own whether the defense had been established. The latter would be error , since 
whether the fa cts established the conditions for the [preemption] defense is a question for the 
jury.” (emphasis supplied)); Brown v. Earthboard Sports USA, Inc. , 481 F.3d 901, 913 (6th Cir. 
2007) (“Should the movants fail to meet their burden . . . such as if a genuine issue of material 
fact exists regarding the claim's actual qualification for federal preemption, the matter must be 
determined by the factfinder.” (emphasis supplied)). 
Plaintiffs’ procedural protections and Seventh Amendment argument is no more than a 
reiteration of the summary judgment standard. As the Court has already stated, Merck met its 
burden of proving that no there is no genuine issue of fact surrounding preemption by way of the 
briefing and trial record developed in Glynn. As a result, Plain tiffs are being afforded the 
procedural protections of Rule 56, and this Court is neither violating their Seventh Amendment 
rights nor “deciding factual disputes.” Were the Court to determine that there is a genuine 
dispute of fact, it would deny summary judgment; however, in determining that there is no 
factual dispute, the Court is not thereby “deciding factual disputes.” 
Moreover, utilizing an OTSC to apply a prior legal ruling to other Plaintiffs in an MDL is 
hardly inappropriate as suggested by Plaintiffs. Rather, several MDL courts have used an OTSC 
to do just that. See In re Darvocet, Darvon & Propoxyphene Products Liab. Litig. , 2012 WL 
3290145, at *1 and fn. 1 (E.D. Ky. Aug. 10, 2012) (“Here, the Court has previously determined PageID:
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that product liability claims against Generic Defendants are preempted . . . [The Show Cause 
Order] directed all plaintiffs with claims against any Generic Defendant to show cause why those 
claims should not be dismissed pursuant to the Court’s Memorandum Opinion and O rder 
Regarding Generic Defendants’ Motions to Dismiss.”); In re Allstate Ins. Co. Fair Labor 
Standards Act Litig., 2009 WL 3011042, at *1 (D. Ariz. Sept. 16, 2009)(“[I]n this MDL action . . 
. summary judgment would be granted in the defendants’ favor as to all claims of any Continuing 
Plaintiff who did not show cause in writing . . . explaining why the Court’s reasoning in the 
summary judgment order . . . which the Court entered in the . . . member case, should not be 
applied to him or her.”); In re Sulzer Hip Prosthesis & Knee Prosthesis Liab. Litig., 455 F. Supp. 
2d 709, 712-13 (N.D. Ohio 2006) (“In Moore, Sulzer moved for summary judgment on the 
ground that all of Moore's claims were preempted by federal law . . . In light of the Court's 
conclusion in Moore, Sulzer moved the Court to issue an Order requiring all similarly -situated 
plaintiffs . . . to show cause why their cases should not also be dismissed . The Court acquiesced 
to this request.”). In doing so, the Court is not applying a factual determination made in Glynn 
to the Plaintiffs identified in the OTSC, but a legal determination: namely, that there is clear 
evidence the FDA would have rejected a stronger Fosamax warning label, thereby preempting 
Plaintiffs’ claims. 
Further, the OTSC does not give an impermissible preclusive effect to the Glynn ruling 
because the Court is not automatically applying the holding in Glynn to other Plaintiffs. Instead, 
despite having been aware of the preemption issue for two (2) years, briefing the issue four (4) 
separate times, and conducting an entire trial whereby any evidence relevant to preemption could 
be introduced, the OTSC provides affected Plaintiffs another opportunity to identify genuine 
issues of material fact that would preclude summary judgment on t heir claims. Plaintiffs’ failure PageID:
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to meet their burden pursuant to Rule 56 does not then equate to issue and/or claim preclusion. 
Plaintiffs’ contention that further factual and expert discovery should be afforded these Plaintiffs, 
and that each MDL Plain tiff is entitled to litigate the preemption issue, is similarly misguided. 
The Court has repeatedly advised Plaintiffs’ counsel to come forward with any and all evidence 
surrounding preemption; thus, the failure to properly gather factual and expert disco very prior to 
this OTSC is no fault other than Plaintiffs. Additionally, in making these discovery related 
arguments, Plaintiffs are improperly focusing on the relationship between the individual 
Plaintiffs and Merck; however, as the Court has explicitly stated on the record, the preemption 
analysis is entirely dependent on the relationship between Merck and the FDA. 
The Court is not convinced that, whether clear evidence exists that the FDA would have 
rejected a stronger warning label to Fosamax, has any relevance to the individual Plaintiff and 
his or her potential factual differences. Rather, the material fact rele vant to the preemption 
determination and th e OTSC does not differ amongst the Plaintiffs listed in Appendix A – an 
injury that occurred prior to September 14, 2010. Plaintiffs have failed to show how uncovering 
additional information on behalf of each ind ividual Plaintiff would change the analysis or 
preclude summary judgment here and therefore an extension of discovery is not warranted. See 
Penn. Dep’t of Pub. Welfare v. Sebelius , 674 F.3d 139, 157 (3d Cir. 2012). Further, while the 
Court is sympathetic to the Plaintiffs and their respective injuries, to give each of the Plaintiffs 
identified in the Courts OTSC their “own day in court” to litigate a legal issue that has already 
been conclusively determined would n ot only be a waste of judicial resources but would be 
contradictory to the premise of pre -trial motions and summary judgment. While Ms. Glynn had 
her “day in court,” such was for the purpose of developing a complete trial record on the PageID:
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preemption issue; however, the Court need not have several hundred trial records, with the same 
evidence, to decide the very same issue. 
As Merck correctly points out, this case is distinguishable from In re TMI Litig., 193 F.3d 
613 (3d Cir. 1999) amended, 199 F.3d 158 (3d Cir. 2000) because there, the Third Circuit 
concluded that the District Court “could not properly extinguish the substantive rights of the 
1,900 Non-Trial Plaintiffs merely because all of the cases had been consolidated . . . because the 
Non-Trial Plainti ffs were not even litigating their claims and not presenting arguments to the 
District Court.” Id. at 725 (emphasis supplied). Here, the Court is not merely applying its ruling 
in Glynn to Plaintiffs, but has repeatedly urged Plaintiffs to come forward wi th evidence as to 
why their claims are not preempted, is giving Plaintiffs another opportunity in the context of the 
OTSC to present arguments to the Court as to why their claims are not preempted, and is 
applying the Rule 56 standard in doing so. 
The Court has consistently made clear that it expected Plaintiffs to present all of the 
pertinent evidence on the issue of preemption by the end of the Glynn trial. Thus, Plaintiffs’ 
argument that they have been denied the opportunity to develop expert testimon y relevant to the 
preemption issue is ill -advised. The Court is also satisfied that additional individualized factual 
discovery is unnecessary because the crux of the preemption inquiry focuses on the relationship 
between Merck and the FDA, and has nothin g to do with the facts or injuries of the individual 
Plaintiffs.7 Stated differently, facts relating to each individual Plaintiff will not have any effect 
on whether Merck had a duty to warn, and testimony from individual experts regarding what 
Merck and the FDA could or would have done will not change what Merck and the FDA did. 
Accordingly, the Court finds that utilizing an OTSC to apply the Glynn ruling to those Plaintiffs’ 
 
7 Individualized discovery may be appropriate if the parties were disputing causation such as the Plaintiffs in TMI; 
however, the preemption analysis here is dependent on whether Merck had a state law duty to update its warning 
label. PageID:
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whose injuries occurred prior to September 14, 2010, without allowing additional discovery is 
not improper. 
B. Design Defect and Other Non-Failure to Warn Claim Arguments 
The parties each submitted briefing with respect to whether the Court should utilize t he 
OTSC to apply the Glynn preemption ruling to Plaintiffs’ design defect and other non -failure to 
warn claims. In support of their position, Plaintiffs’ argue that the Court’s preemption ruling in 
Glynn only applied to a state law failure to warn claim a nd therefore did not address, and cannot 
be applied to , state law claims for design defect, negligence, fraud, breach of warranties, 
consumer protection/deceptive trade practices, and unjust enrichment. Specifically, Plaintiffs’ 
argue that these claims d o not “emanate from a general theory that Merck failed to provide an 
adequate warning about the risk of atypical femur fractures” and therefore, Defendant has not 
met its Rule 56 burden to obtain summary judgment on these claims. See Plaintiffs’ Design 
Defect Brief, at p. 8. 
i. Design Defect and Other Non-Failure to Warn Claim Analysis 
As discussed in the procedural analysis, Merck’s Rule 56 burden surrounding preemption 
was met by way of the briefing in Glynn. Plaintiffs’ contention that applying the Glynn ruling to 
design defect and other non-failure to warn claims would improperly relieve Merck of its burden 
to show that it is entitled to judgment on such claims is, in the abstract, persuasive. Importantly, 
however, Plaintiffs’ design defect and other non -failure to warn claims are based entirely on the 
premise that Fosamax had risks which should have been disclosed to consumers . Thus, these 
claims rise and fall with a claim for failure to warn and utilizing an OTSC to preempt Plaintiffs’ 
design defect and other non -failure to warn claims based on this Court’s ruling in Glynn is not 
improper. See Cooper v. Bristol -Myers Squibb Co. , 2013 WL 85291 , at *9 (D.N.J. Jan. 7, PageID:
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2013)(“Therefore, having already determined that Plaintiff is unable to establish any triable issue 
with respect to his failure-to-warn claim, Plaintiff's design claim correspondingly fails.”); Begley 
v. Bristol-Myers Squibb Co. , 2013 WL 144177 , at *9 (D.N.J. Jan. 11, 2013) (“. . . [A] product 
bearing an adequate warning is not in [a] defective condition, nor is it unreasonably dangerous . . 
. Hence, Plaintiff's defective design claim fails because she has not demonstrated that the 
[product’s] warning was inadequate. ” (internal citations omitted)); Stafford v. Wyeth , 411 F. 
Supp. 2d 1318, 1320 (W.D. Okla. 2006) (granting summary judgment to Defendant where 
plaintiff failed to establish that Defendant’s failure to warn was the proximate cause of her injury 
and plaintiff’s non-failure to warn claims, including negligence and design defect, “all hinge on 
defendant’s alleged failure to warn.”); Chatman v. Pfizer, Inc. , 2013 WL 1305506 , at *4 (S.D. 
Miss. Mar. 28, 2013) (“. . . [T] he national consensus is that [plaintiff’s] other claims are poorly 
camouflaged failure-to-warn claims, and therefore most courts have rebuffed plaintiffs' attempts 
to recover under alternative state -law theories of liability including negligence and fraud. . . If 
[plaintiff’s] remaining claims are disguised failure-to-warn claims, then they are unquestionably 
subject to [the failure to warn] preemption analysis” . . . Further, “[t] here can be no doubt that 
[plaintiff’s design defect] claims are [also] based on the inadequacy of the warning she was 
given, and therefore these claims are subject to [preemption] . . .” (internal citation omitted)). 
Plaintiffs’ contend that neither their negligent design defect nor strict liability design 
defect claims sound in failure to warn, but that fact questions e xist as to whether Fosamax was 
unreasonably dangerous, or whether Merck was negligent in failing to conduct adequate testing 
and use due care in the design and manufacture of Fosamax. In support of this argument, 
however, Plaintiffs’ advance only a summar y of the law and tests that may be applied to 
determine if a product is defectively designed but offer no law as to which test applies here and PageID:
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no facts and/or evidence to show that Fosamax was in fact defectively designed or that Merck 
acted negligently. Further, aside from the pleadings, this appears to be the first time in a six (6) 
year-long litigation, after a two (2) year focus on preemption, discovery, numerous briefs on the 
preemption issue and an entire trial worth of evidence , that Plaintiffs’ be lieve Fosamax was 
defectively designed or that Merck was negligent in conducting testing of the drug. The entire 
MDL has centered on Merck’s conduct in failing to update Fosamax’s warning label. 
To this end, Plaintiffs’ make a conclusory statement that their complaints have “typically 
alleged” facts in support of their non -failure to warn, strict liability and negligence based design 
defect claims, but offer no facts as to which, or how many Plaintiffs have in fact pled such 
claims. Plaintiffs’ are conf lating the standard to withstand a Federal Rule of Civil Procedure 
12(b)(6) motion to dismiss with the standard to be applied here, which is that of a Rule 56 
motion for summar y judgment. Surely, Plaintiffs general description of what some complaints 
“typically allege” may constitute plain sta tements showing that Plaintiffs are entitled to relief, 
see Bell Atl. Corp. v. Twombly, 550 U.S. 544, 557, 127 S.Ct. 1955 (2007) ; however, meeting the 
threshold requirement of Rule 12(b)(6) is hardly sufficient to def eat Merck’s showing that it is 
entitled to judgment as a matter of law on preemption grounds. 
Indeed, Merck has met this burden. Plaintiffs’ design defect and other non -failure to 
warn claims are merely disguised failure to warn causes of action, which i s evidenced b y the 
pleadings that Plaintiffs attach as exhibits in response to the OTSC and the fact that the entire 
litigation, focus of the parties ’ discovery, and evidence put before the Court has been based 
entirely on Fosamax’s warning. In fact, one of the complaints cited to by Plaintiffs in support of 
the argument that the design defect claims are independent of the warning specifically states that 
“Fosamax, as researched, tested, developed, designed, licensed, manufactured, packaged, PageID:
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labeled, distributed, sold and marketed by Defendant was defective due to inadequate warnings 
and instructions .” See [docket #2996, Ecklund Dec. , Ex. 167 at ¶ 97 (e mphasis supplied)]. 
Plaintiffs have not alleged that Fosamax’s chemical composition could have been changed, but 
rather, that the product was unreasonably dangerous because it was not accompanied by a proper 
warning. Similarly, Plaintiffs’ negligent design defect claims allege that Me rck failed to 
properly test the drug, and had Merck exercised due care in testing the product, Fosamax’s label 
would have been updated sooner. Again, however, these contentions are nothing more than 
speculation and while Plaintiffs’ design defect and othe r non-failure to warn arguments begin by 
focusing on the product and/or Merck’s conduct on the front end, they conclude by focusing on 
how the consequence – the label – may have been different as a result. See Estate of Popolizio v. 
Ford Motor Co., 2013 U.S. Dist. LEXIS 79361, at *5 -6 (D.N.J. June 5, 2013)(“the non -moving 
party cannot rely on unsupported assertions, bare allegations, or speculation to defeat summary 
judgment.”). 
The Court also disagrees with Plaintiffs’ contention that state law design defect claims 
cannot be preempted under the federal Food, Drug, and Cos metic Act (“FDCA”). Plaintiffs 
make this assertion by stating that every Federal Circuit Court to address whether the FDCA 
preempts design defect claims has found no preemption; however, instead of providing the Court 
with an analysis of how, or if, the cases are even applicabl e to the facts here, Plaintiffs merely 
list the case names and citations. As Merck correctly points out, t he cases cited to by Plaintiffs 
are distinguishable fro m the instant matter and therefore, carry little weight with respect to 
whether Plaintiffs’ design defect claims can be preempted.8 
 
8 In Desiano v. Warner-Lambert & Co., 467 F.3d 85 (2d Cir. 2006), the Second Circuit held that because Plaintiff’s 
state law causes of action merely required some proof of fraud on the FDA but such proof was not conclusive, the 
Supreme Court’s holding in Buckman Co. v. Plaintiffs’ Legal Comm. , 531 U.S. 341, 121 S. Ct. 1012 (2001) that all 
fraud on the FDA claims are preempted did not app ly to automatically preempt Plaintiff’s state law claims which PageID:
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Accordingly, because Plaintiffs’ design defect and other non -failure to warn claims are 
entirely based, and ultimately hi nge, on the adequacy of Fosamax’s warning, these claims are 
preempted and must fail as a matter of law. Regardless of what state law applies to each 
Plaintiff’s individual design defect and other non-failure to warn claims, Merck simply cannot be 
liable for not having a warning on its product that was rejected by the FDA as of the date of a 
Plaintiff’s injury. Because the Court has already found that pursuant to Wyeth v. Levine, clear 
evidence exists that the FDA would have rejected a stronger warning lab el, and the crux of 
Plaintiffs’ design defect and non -failure to warn claims is the adequacy of the warning, 
Defendant is entitled to summary judgment on these claims. 
 
 
 
only incidentally involved fraud. The Court in Desiano did note that state based tort liability falls within a state 
legislature’s prerogative to regulate matters of health and safety and ther efore, a presumption against preemption 
should apply; however, the Court went on to state that “there may be reasons to override that presumption [against 
preemption].” See Desiano, 467 F.3d at 94. Here, however, the Court is not applying preemption base d on a fraud 
on the FDA theory to automatically preempt Plaintiffs’ remaining claims that incidentally relate to fraud but rather, 
after giving Plaintiffs’ an opportunity to be heard, is applying preemption based on a failure to warn ruling to 
preempt Plaintiffs’ remaining claims that are based entirely on this same theory. 
Abbot by Abbot v. Am. Cyanamid Co. , 844 F.2d 1108 (4th Cir. 1988) is similarly distinguishable to the 
instant matter because there, the Court was faced with a preemption analysis spec ific to vaccines. Notably, as the 
Abbot Court pointed out, Congress expressly dealt with vaccines in 1986 and 1987 and did not preempt state law; 
thus, the legislative intent surrounding vaccines weighed against preemption. Further, the Court’s holdi ng 
ultimately stands for the pro position that preemption is not automatic, as the Court stated that “[p]reemption does 
not follow immediately from the comprehensive federal regulation of prescription biological products. Every subject 
that merits congressional legislation is, by definition, a subject of national concern. That cannot mean, however, that 
every federal statute [automatically] ousts all related state law.” Id. at 1112 (emphasis supplied)(internal citation 
omitted). The other cases cited to by Plai ntiffs’ reach a similar conclusion when dealing with vaccines. See Hurley 
v. Lederle Labs. Div. of Am. Cyanamid Co. , 863 F.2d 1173, 1178 (5th Cir. 1988)(“. . . we believe that any case for 
preemption is doomed by the National Childhood Vaccine Injury [“NC VI”] Act of 1986.”); Graham by Graham v. 
Wyeth Labs., Div. of Am. Home Products Corp. , 906 F.2d 1399, 1405 (10th Cir. 1990)(indicating that federal 
preemption does not automatically apply to bar plaintiff’s state tort law claims relating to an improperly 
manufactured vaccine just because such vaccine met the FDA’s minimum standards. (emphasis supplied)). 
Similarly Wimbush v. Wyeth , 619 F.3d 632 (6th Cir. 2010) dealt with whether state law claims relating to 
negligence by a defendant that occurred prior to FDA approval are preempted by the FDA’s subsequent approval of 
the drug. There, the Court specifically stated that it “hold[s] merely that FDA approval does not automatically 
preempt state law tort claims for negligence.” Id. at 646 (emphasis supplied). Further, the Court notes that, of all the 
cases cited to by Plaintiffs’ in support of their argument that design defect claims ar e not preempted by the FDCA, 
Wimbush is the only case that was decided after Wyeth v. Levine , 555 U.S. 555 (2009), and notably, Wimbush has 
the most narrow holding with respect to preemption. PageID:
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C. Adverse Reaction and Long-Term-Use Failure to Warn Arguments 
Plaintiffs argue that their failure to warn claims cannot be preempted because Glynn was 
specific to Merck’s failure to update the Precautions section of the Fosamax label, but that Merck 
has not met its burden to show clear evidence exists that the FDA would have r ejected a change 
to the Adverse Reactions section of the label or a change relating to the long -term use/shifting 
risk-benefit profile of Fosamax. While Plaintiffs acknowledge that Merck did in fact update the 
Adverse Reactions section of the Fosamax label in June 2009, Plaintiffs argue that a genuine 
dispute of fact exists as to whether Merck could have updated the Adverse Reactions section of 
the label before that time. 
i. Adverse Reaction and Long-Term Use Analysis 
There are several issues surrounding P laintiffs’ arguments. First, as stated above, Merck 
updated the Adverse Reactions section of its label in June, 2009. The OTSC has instructed 
Plaintiffs’ with injuries occurring prior to September 14, 2010, to show cause why their claims 
should not be pr eempted. Upon review of the Plaintiffs’ listed in Appendix A of the OTSC, 
nearly half of them have injuries which occurred between June, 2009 and September 14, 2010. 
Thus, to state that Plaintiffs’ failure to warn claims are not preempted because they ar e based on 
the Adverse Reactions section of the label and not the Precautions section is illogical. Rather , 
almost half of the Plaintiffs identified in the OTSC were injured when there was already an 
Adverse Reactions warning on the label 9; therefore, the only plausible failure to warn clai ms 
available to such Plaintiffs would have to be based on the Precautions section. 
Second, to the extent that Plaintiffs’ injuries occurred prior to the June, 2009 Adverse 
Reactions label change, Plaintiffs assert that there is evidence showing that a fact question exists 
with regard to whether Merck should have updated this section of the label sooner. A s an initial 
 
9 Plaintiffs do not dispute the adequacy of the Adverse Reactions label. PageID:
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matter, Plaintiffs do not plead this theory of liability in any of their complaints, nor have 
Plaintiffs set forth evidence indicating that any doctor would not have prescribed Fosamax if the 
occurrence of low -energy femoral shaft fractures had been mentioned in the Adverse Reactions 
section prior to 2009. Further, Plaintiffs’ argument is one that was already made – also at the last 
hour – in Glynn and, prior to trial, Plaintiffs asserted that the evidence would show that Merck 
should have acted sooner to report the information it was receiving about fractures to the FDA. 
Hearing Tr., 71:20-22; 72:8-10, March 8, 2013 (“MR. HONNOLD: The argument is, is the data 
was clearly there and the evidence will be Merck did not act upon it. . . it could have and should 
have been done differently based upon the information that Merck had in its possession and sat 
on and d id nothing with.”)(emphasis supplied); see also Plaintiff’s Preemption Supplement in 
Opposition to Defendant’s Motion for Summary Judgment Based Upon Federal Preemption, 
Rule 50(a), and Rule 50(b) Motions [docket #218 at 11-5304] (“[T]here is considerable evidence 
demonstrating that Merck should have at a minimum updated the [A]dverse [R]eactions section 
of its label as early as 1999.”). 
This argument is again dependent on the communication of information between Merck 
and the FDA, and is of no consequenc e to the in dividual Plaintiff. Plaintiffs presented evidence 
on this issue during the Glynn trial and argued that such evidence proves that Merck should have 
acted sooner; however, this Court was not convinced. The argumen t being presented by 
Plaintiffs now is no different than that which was already considered in Glynn because the 
evidence relevant to this claim is what Merck submitted to the FDA and such communications 
are the exact same regardless of which Plaintiff is before the Court. Thus, as in Glynn, the Court 
is still not convinced and Plaintiffs cannot recharacterize their failure to warn claims at this stage 
of the litigation as one involving the Adverse Reactions section of the label in order to overcome PageID:
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the preemption issue. See In re Fosamax Prods. Liab. Litig. (Boles v. Merck & Co.) , 2010 WL 
1257299, at *5 (S.D.N.Y. Mar. 26, 2010) (“[Plaintiff] cannot recharacterize her claim during trial 
in an effort to overcome the lack of evidence…”). 
Third, Plaintiffs’ risk -benefit argument surroundi ng the efficacy of Fosamax was also 
already considered in Glynn. The Court did not accept Plaintiffs’ efficacy argument in Glynn for 
the same reason it will not accept this argument here: the omission of efficacy information does 
not constitute a failure to warn about a drug’s risks and therefore, does not raise a genuine issue 
of material fact as to whether Plaintiffs’ failure to warn claims are preempted. See LaBarre v. 
Bristol-Myers Squibb Co. , 2013 WL 6053840 , at *4 (3d Cir. Nov. 18, 2013) (“In short, [the 
drug’s] efficacy is irrelevant to [Plaintiff’s] failure to warn claim, and the physicians’ purported 
lack of information about it is of no consequence to the adequacy of the warnings.”). 
In sum, Plaintiffs’ contention that the Adverse Reaction section of the label should have 
been updated prior to 2009, or that efficacy information should have been communicated on the 
Fosamax label, do not fall outside the scope of Glynn and the OTSC nor do they raise genuine 
issues of material fact with regard to whether clear evidence exists that the FDA would have 
rejected a label change. Accordingly, Plaintiffs’ failure to warn claim(s) are preempted. 
D. Warnings and Precautions Failure to Warn Arguments 
Plaintiffs argue that their failure to warn cla ims are not preempted because 
communications from the FDA reflect that clear evidence does not exist as to whether the FDA 
would have rejected a warning that was accurately stated and properly supported by Merck. In 
support of this argument, Plaintiffs contend that Merck misstated the relevant risk in its PAS 
submission and the FDA’s rejection of Defendant’s proposed label is not clear evidence because 
the agency lacked information to make an informed judgment. PageID:
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i. Warnings and Precautions Failure to Warn Analysis 
Plaintiffs’ argument that its claims are not preempted because clear evidence does not 
exist as to whether the FDA would have rejected a stronger warning to the Precautions section of 
the label is nothing more than an attempt to gain a second bite at the apple. Plaintiffs fail to raise 
any facts and/or arguments with regard to the Precautions section of the label that were not 
already considered and rejected by this Court. Plaintiffs assert that there is new evidence which 
was not before the Court i n Glynn that changes the Precautions analysis; however, the “new 
evidence” provided by Plaintiffs is merely expert opinion on the very same evidence that existed 
in Glynn. Stated differently, while Plain tiffs were able to find an expert to agree with their 
contention that Merck should have acted differently with respect to updating the Precautions 
section of its warning, they did not set forth any evidence which suggests that the FDA thought 
the same. The evi dence surrounding whether the FDA felt that a label change was necessary 
remains unchanged, and importantly, provides clear evidence that the FDA would have rejected a 
stronger Precautions warning because the FDA did reject a stronger Precautions warning. See 
Glynn, 2013 WL 3270387, at *7 (“the [fact that the] FDA never required Defendant to submit 
new language or change the label [ ] demonstrate[s] that the FDA did not think that the label 
should have been changed at that time.”). 
Plaintiffs further rely on this new expert opinion to argue that a fact question exists as to 
whether Merck should have warned about the risk of fractures associated with Fosamax by way 
of a CBE submission while the FDA decided on class labeling. Again, however, the Court 
already rejected this argument in Glynn and stated that “since the FDA rejected Defendant’s 
PAS, it would not have approved a CBE seeking to add the same language to the label that it just PageID:
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rejected in the PAS, and any changes Defendant made using the CBE suppl ement would cause 
the drug to be misbranded.” Id. at *8. 
Moreover, to the extent that Plaintiffs claim that Merck withheld information from the 
FDA and clear evidence does not exist as to whether the FDA, if fully informed, would have 
rejected a stronger label, this does not defeat Defendant’s showing that it is entitled to judgment 
as a matter of law on preemption grounds. As an initial matter, Defendant disputes that it 
withheld information from the FDA; however, e ven assuming it did, Plaintiffs have failed to 
show that providing such information to the FDA would have changed the FDA’s conclusion 
that a Precaution was not warranted. Instead, Plaintiffs’ contention appears to be a fraud -on-the-
FDA theory which was rejected by the Supreme Court in Buckman Co. v. Plaintiffs’ Legal 
Committee, 531 U.S. 341, 121 S. Ct. 1012, 148 L. Ed. 2d 854 (2001), or alternatively, is based 
largely on speculation and cannot defeat summary judgment. See Webster v. Pacesetter, Inc. , 
259 F.Supp.2d 27, 37 (D.D.C. 2003) (“ Nor can plaintiffs create an issue of fact regarding their 
defective warning claim by speculating that if the FDA had known of the delayed perforation and 
tamponade incidents during the clinical trials and if defendant had investigated all the adverse 
incidents, the FDA would have either recalled the lead or placed it on alert .” (emphasis in 
original)); In re Trasylol Products Liab. Litig., 2010 WL 4259332 (S.D. Fla. Oct. 21, 2010)(“[An 
expert] may not speculate as to what the FDA would have done in hypothetical circumstances.”). 
Accordingly, Plaintiffs have failed to show that there is a genuine dispute of fact 
surrounding failure to warn claims based on the Precautions section of the label. Thus, these 
claims are preempted and Defendant is entitled to judgment as a matter of law. PageID:
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IV. CONCLUSION 
For the reasons outlined above, Defendant is entitled to judgment as a matter of law on 
all claims made by the Plaintiffs listed in Appendix A of the OTSC with injuries that occurred 
prior to Septemb er 14, 2010, be cause Plaintiffs have failed to show cause why their claims are 
not preempted under this Court’s ruling in Glynn. An appropriate Order accompanies this 
Opinion. 
 
Dated: March 26, 2014 /s/ Joel A. Pisano 
 JOEL A. PISANO, U.S.D.J. PageID:
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