govinfo:USCOURTS-njd-1_08-cv-00008-6

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FOR PUBLICATION 
 
 UNITED STATES DISTRICT COURT 
DISTRICT OF NEW JERSEY 
 
 
 : 
IN RE: FOSAMAX (ALENDRONATE SODIUM) : 
PRODUCTS LIABILITY LITIGATION : 
 : 
_________________________________________ : 
 : 
BERNADETTE GLYNN and RICHARD GLYNN, : Civil Action No. 11-5304, 08-08 
 : 
 Plaintiffs, : OPINION 
 : 
 v . : 
MERCK SHARP & DOHME CORP, : 
 : 
 Defendant. : 
 : 
 
PISANO, District Judge 
 
  Plaintiffs Bernadette Glynn and Richard Glynn (“Plaintiffs”) brought this lawsuit against 
Defendant Merck, Sharp, & Dohme Corp. (“Defendant”), the manufacturer of Fosamax, which is 
a drug approved by the United States Food and Dr ug Administration (“FDA”) for the treatment 
and prevention of osteoporosis. This matter is part of the multi-distri ct litigation (“MDL”) 
concerning Fosamax and involves allegations that Fosamax causes atypical femur fractures 
(“AFFs 1 ”), it caused Plaintiff Mrs. Glynn’s femur fracture, and Defendant failed to warn 
physicians about Fosamax and AFFs. Presently before the Court is Defendant’s Motion for 
Summary Judgment based upon Federal Preempti on [docket # 25], Motion for Judgment as a 
Matter of Law pursuant to Rule 50(a) [docket # 198], Renewed Motion for Judgment as a Matter 
of Law pursuant to Rule 50(a) [docket # 209], and Renewed Motion for Judgment as a Matter of 
                                                             
1 The abbreviation of atypical femur fracture (singular) is “AFF.” PageID:
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Law pursuant to Rule 50(b) [docket # 216]. The i ssue in these Motions a nd before the Court is 
whether there is clear evidence that the FDA wo uld not have approved a stronger warning to the 
Fosamax label, thereby warranting preemption of Plaintiffs’ failure to warn claim. See Wyeth v. 
Levine, 555 U.S. 555 (2009). This Court heard oral argument on the federal preemption issue on 
March 8, 2013 and reserved decision until a trial record had been established. See Fed. R. Civ. 
P. 78. A jury trial took place from April 8, 201 3 to April 29, 2013. On April 29, 2013, the jury 
returned a verdict for Defendant, finding that Pl aintiff did not prove by a preponderance of the 
evidence that she experienced an AFF in April 2009. Because the record contains clear evidence 
that the FDA would not have a pproved a stronger warn ing to the Precautions section of the 
Fosamax label, this Court grants the Motions on federal preemption. 
I. BACKGROUND2 
A. Fosamax Approval & Mrs. Glynn’s Fosamax Use 
In September 1995, the FDA approved Fosama x 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 approved 
for the treatment and prevention of postmenopausal osteoporosis. 
In 2002, Dr. Murat Acemoglu first prescribed Fosamax to Mrs. Glynn after diagnosing 
her with “osteopenia – osteoporosis” [docket # 27, Confoy Dec., Ex. 27 & 28]. Mrs. Glynn took 
Fosamax until April 17, 2009, when she fractured her right femur. Final Pretrial Order ¶ 3. 
 
                                                             
2 This Background section contains facts that pertain to the federal preemption issue. For a more complete 
discussion of the facts of this case, see this Court’s Opinion dated April 11, 2013 [docket # 183]. PageID:
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B. History of Fosamax Label Change 
On June 13, 2008, the FDA contacted Defendant and other bisphosphonate 3 
manufacturers and requested any investigations they conducted “regar ding the occurrence of 
atypical fractures with bisphosphonate use,” any i nvestigational plans, a nd “all hip and femoral 
fracture case reports” they receiv ed [docket # 26, Decl aration of Karen A. Confoy in Support of 
the Motion for Summary Judgment and Motion for Summary Judgment Based Upon Federal 
Preemption (“Confoy Dec.”), Ex. 5; docket # 27, C onfoy Dec., Ex. 4]. 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 bis phosphonate exposure for all case reports.” Id. The 
FDA explained that it was “aware of reports re garding the occurrence of subtrochanteric hip 
fractures in patients using bisphosphonates” and is “concerned about th is developing safety 
signal.” Id. 
On July 18, 2008, Defendant responded to the FDA’s request and included summary 
tables of clinical and post-marketing data, clin ical Council for Interna tional Organizations of 
Medical Sciences (“CIOMS”) reports, and pos t-marketing CIOMS reports [docket # 27, Confoy 
Dec., Ex. 6]. The FDA’s review of this data as well as the data from other bisphosphonate 
manufacturers “did not show an increase in . . . [the risk of atypica l subtrochanteric femur 
fractures] in women using these medications” [docket # 26, Confoy Dec., Ex. 7]. 
On September 15, 2008, Defendant submitted a Prior Approval Supplement (“PAS”) to 
the FDA, proposing “to add language to both the Precaution[s] and Adverse Reactions/Post-
Marketing Experience section[s] of the label to describe low-energy” subtrochanteric femoral 
                                                             
3 Fosamax belongs to a class of drugs known as bisphosphonates. PageID:
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fractures [docket # 27, Confoy Dec., Ex. 8]. Defenda nt explained that “[i] t is not possible with 
the present data to establish whether treatment w ith” Fosamax “increases the risk of [these] . . . 
low-energy subtrochanteric and/or proximal shaf t fractures,” but because there is a temporal 
association between these fractur es 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 experienced 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 
risk factors (e.g., vitamin D deficiency, malabsorption, 
glucocorticoid use, previous st ress fracture, lower extremity 
arthritis or fracture, extreme or increased exercise, diabetes 
mellitus, chronic alcohol abus e), and receive appropriate 
orthopaedic care. Interrupti on of bisphosphonate therapy in 
patients with stress fractures should be considered, pending 
evaluation of the patient, ba sed on individual benefit/risk 
assessment. 
[Id.] 
Additionally, Defendant proposed adding “low-ene rgy femoral shaft fracture” to the Adverse 
Reactions/Post-Marketing Experien ce section of the label and the following statement to the 
Patient Package Insert: “Patients have experienced fracture in a sp ecific part of the thigh bone. 
Call your doctor if you develop new or unusual pain in the hip or thigh.” Id. PageID:
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On April 15, 2009, an FDA representative e- mailed Defendant and stated that the 
proposed label change to the Adverse Reactions/P ost-Marketing Experience section of the label 
would be approved but the label change to th e Precautions section w ould not be approved 
[docket # 101, Cecchi Dec., Ex. 83; docket # 27, C onfoy Dec., Ex. 10]. Two days later, Mrs. 
Glynn fractured her femur. 
On May 22, 2009, one month after Mrs. Glynn’s fracture, the FDA formally responded to 
Defendant’s proposed label change, recommending that it add “low energy femoral shaft and 
subtrochanteric fractures” to the Adverse Reac tions/Post-Marketing Expe rience section of the 
label; however, the FDA did not approve the labe l change to the Precau tions section [docket # 
27, Confoy Dec., Ex. 11]. Moreove r, 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 information about femur fract ures to the Adverse Reactions/Post-Marketing 
Experience section of the label because th e FDA told Defendant that submitting a CBE 
supplement was the “quickest route to update th e [Product Circular] PC” for Fosamax [docket # 
27, Confoy Dec., Ex. 12]. On March 1, 2010, th e FDA approved the CBE supplement [docket # 
26, Confoy Dec., Ex. 9]. 
On March 10, 2010, the FDA issued a Drug Sa fety Communication, in which it stated 
that “[a]t this point, the data that FDA has re viewed have not shown a clear connection between 
bisphosphonate use and a risk of atypical subtrochanteric femur fractures” [docket # 26, Confoy 
Dec., Ex. 5]. The FDA did state, however, that it was “working closely with outside experts, PageID:
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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 Femoral 
Fractures: Report of a Task Force of the American Society for Bone and Mineral Research 
[docket # 26, Confoy Dec., Ex. 13]. 4 The report stated that although there is an association 
between long-term bisphosphonate use and AFFs, th e association has “not been proven to be 
causal.” Id. at 2269, 2287. The report concluded that although AFFs are rare, “they appear to be 
more common in patients who have been ex posed to long-term BP s [(“bisphosphonates”)], 
usually for more than 3 years . . . .” Id. at 2287. The report further provided that although “BPs 
are important drugs for the prevention of comm on osteoporotic fracture s,” “atypical femoral 
fractures are of concern, and more information is urgently needed both to assist in identifying 
patients at particular risk and to guide decision making about duration of BP therapy. Physicians 
and patients should be made aware of the possibi lity of atypical femoral fractures and of the 
potential for bilaterality through a change in labeling of BPs.” Id. 
                                                             
4 In this report, the ASBMR defined AFF by listing its Major Features, which are required to satisfy the definition of 
AFF, and Minor Features, which may be associated with AFFs but are not required characteristics of them [docket # 
26, Confoy Dec., Ex. 13]. The Major Features of an AFF ar e: (1) that it is “located anywhere along the femur from 
the distal to the lesser trochanter to just proximal to th e supracondylar flare”; (2) “as sociated with no trauma or 
minimal trauma, as in a fall from a standing height or less”; (3) transverse or shor t oblique configuration; (4) 
noncomminuted; and (5) complete fractures extend through both cortices and may be associated with a medial spike, 
incomplete fractures involve only the lateral cortex. Id. The Minor Features of an A FF are: (1) localized periosteal 
reaction of the lateral cortex; (2) generalized increase in cortical thickness of the diaphysis; (3) prodromal symptoms 
such as dull or aching pain in the groin or thigh; (4) bilateral fractures and symptoms; (5) delayed healing; (6) 
comorbid conditions (e.g., vitamin D deficiency, rheumatoid arthritis, hyposphosphotasia); and (7) use of 
pharmaceutical agents (e.g., bisphosphonates, glucocorticoids, and proton pump inhibitors). Id. PageID:
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The FDA responded to the repo rt 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” [docket # 26, Confoy Dec., Ex. 14]. 
Additionally, the FDA informed that the “optim al duration of bispho sphonate treatment for 
osteoporosis is unknown” but “clinical trial data . . . support[s] ef fectiveness for the reduction of 
common bone fractures for three to five years.” Id. Regarding the ASBMR Task Force’s 
recommendation of a label change, the FDA stated that it “has assemb led and is thoroughly 
reviewing all long term data av ailable on the products, as well as all safety reports, and is 
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 atypi cal fractures may be related to long-term . . . 
bisphosphonate use” [docket # 26, Confoy Dec., Ex. 15] . It reiterated that “[a]lthough it is not 
clear if bisphosphonates are the cau se, these unusual femur fractures have been predominantly 
reported in patients taking bisphosphonates.” Id. On January 11, 2011, Defendant submitted the 
agreed upon label change s to the FDA [docket # 27, Confoy D ec., Ex. 18]. Also in January 
2011, the FDA issued an update on femur fractur es and bisphosphonate use, stating “[a]lthough 
it is not clear that the drugs are a direct cause of these unusual fractures, they have mainly been 
reported in patients taking bisphosphonates” [docket # 26, Confoy Dec., Ex. 19]. 
Currently, the Fosamax label includes the fo llowing language: “Atypical, low-energy, or 
low trauma fractures of the femoral shaft have b een reported in bisphosp honate-treated patients. 
. . . Causality has not been esta blished as these fractures also occur in osteoporotic patients who PageID:
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have not been treated with bi sphosphonates. Atypical femur fractures most commonly occur 
with minimal or no trauma to the affected area” [docket # 26, Confoy Dec., Ex. 20]. 
C. Procedural History 
On September 15, 2011, Plaintiffs filed a Co mplaint in this Court against Defendant, 
alleging causes of action for: (1) failure to warn; (2) defective design; (3) negligence; (4) 
negligent misrepresentation; (5) breach of express warranty; (6 ) breach of implied warranty of 
fitness for a particular purpose; (7) breach of im plied warranty of mercha ntability; (8) violation 
of the Consumer Fraud Act, N.J.S.A. 56:8-2 et seq.; (9) violations of the New York General 
Business Law, N.Y. Gen. Bus. Law §§ 349 et seq. and 350 et seq.; (10) unj ust enrichment; (11) 
punitive damages pursuant to the New Jersey Product Liability Act, N.J.S.A. 2A:58C-1 et seq., 
and the New Jersey Punitive Damages Act, N. J.S.A. 2A:15-5.10, et seq.; and (12) loss of 
consortium on behalf of Plaint iff Richard Glynn [docket # 1]. 5 Defendant moved for summary 
judgment based on federal preemption on January 15, 2013, arguing that Plaintiffs’ claims, all of 
which ultimately concern a failure to warn, are preempted because the FDA rejected Defendant’s 
proposed label change and this constitutes clea r evidence that the FDA would not have approved 
a stronger warning to the Precautions section of the label [docket #25]. On March 8, 2013, the 
Court heard argument on the preemption issue and reserved decision on it [docket # 138]. On 
April 2, 2013, the Court reserved decision on the federal preem ption motion until there was a 
complete trial record in the case [docket # 156]. 
                                                             
5 Subsequently, Plaintiffs decided to pursue only the following claims: (1) failure to warn; (2) breach of the implied 
warranty of fitness for a particular purpose; (3) violatio ns of the New York General Business Law; and (4) punitive 
damages. The Court granted summary judgment on the New York General Business Law claims [docket # 183]. In 
addition, the Court granted a Motion for Judgment as a Matter of Law as to the breach of implied warranty of fitness 
for a particular purpose claim and punitive damages [docke t # 198]. Trial Tr. 1896:2-17; 2586:20-22. Thus, the 
failure to warn claim is the only claim that remains. Trial Tr. 2586:11-12. PageID:
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Trial began on April 8, 2013 and concluded on April 29, 2013. After the close of the 
Plaintiff’s case, on April 20, 2013, Defendant filed a Motion for Judgment as a Matter of Law 
pursuant to Federal Rule of Civil Procedure 50(a) [docket # 198]. Defendant argued that 
although it submitted to the FDA all the informati on relevant to a label change and tried to 
change the Precautions section of the label to include low-energy femoral fractures, the FDA 
rejected the label change. On April 26, 2013, Defendant renewed its Motion for Judgment as a 
Matter of Law, again arguing that Plaintiffs’ claims are preempted because Defendant proposed a 
change to the Precautions section of the Fosamax label and the FDA reject ed it [docket # 209]. 
On April 29, 2013, the jury returned a verdict for Defendant, finding that Plaintiffs did not prove 
by a preponderance of the evidence that Mrs. Glynn experienced an AFF in April 2009. The 
following day, the Court held an in-person status conference to discuss the preemption issue as 
well as other MDL issues. The Court explained that it previously de ferred decision on the 
preemption issue for “a complete record” and “the best way to do that was to try the” case. 
Hearing Tr., 6:10-14, April 30, 2013. Although Plai ntiffs had several opportunities to present 
evidence on preemption, they reque sted additional time to present more evidence on the issue. 
The Court gave Plaintiffs twenty-one days to submit “proposed fa ct findings that are based upon 
the record in opposition to” the preemption motions. Id. at 19:24-20:1. Thereafter, on May 6, 
2013, Defendant submitted a Renewed Motion for Judgment as a Matter of Law pursuant to Rule 
50(b) [docket # 216]. Plaintiffs submitted an opposition brief and Defendant submitted a reply 
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II. DISCUSSION 
A. Standard 
 “If a court does not grant a motion for judg ment as a matter of law made under Rule 
50(a), the court is considered to have submitted th e action to the jury subject to the court’s later 
deciding the legal questions raised by the motion.” Fed. R. Civ. P. 50(b). The movant may then 
file a renewed motion for judgment as a matter of law, and in “ruling on the renewed motion, the 
court may: (1) allow judgment on the verdict, if the jury returned a verdict; (2) order a new trial; 
or (3) direct the entry of judgment as a matter of law.” Id. 
 B. Plaintiffs’ Claims Are Preempted 
 Defendant argues that Plaintiffs’ claims are preempted under federal law because it 
proposed a label change to the Precautions sec tion of the Fosamax label to include a warning 
about low-energy femur fractures, and the FDA re jected the label chan ge after Mrs. Glynn’s 
fracture. Defendant asserts that this constitutes clear evidence that the FDA would have rejected 
any warning about these fractures prior to Mrs. Glynn’s femur fracture. Moreover, Defendant 
contends that Plaintiffs’ claims are preempted for three additional reasons: (1) Plaintiffs did not 
present evidence that the FDA rejected the propos ed label change for using the phrase “stress 
fracture” as opposed to AFF; (2) Plaintiffs did not show that th e label change could have been 
successfully presented through a CBE supplement; and (3) Plaintiffs did not show that Defendant 
withheld any information from the FDA. 
Plaintiffs, however, argue that Defendant has not shown clear evidence that the FDA 
would have rejected language about AFFs in th e Precautions section of the Fosamax label prior 
to Mrs. Glynn’s fracture. Plain tiffs assert that preemption is im proper for the following reasons: PageID:
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(1) the FDA rejected the PAS because Defendant used the phrase “stress fracture” instead of 
“atypical” fracture, and the FDA would have appr oved an appropriately worded warning; (2) 
Defendant could have changed the label through a CBE supplement; (3) Defendant did not 
provide all of the information it had on femur fractures and Fosamax to the FDA, and had it done 
so, the FDA would have approved a properly worded warning in 2008; and (4) Defendant failed 
to warn the FDA as soon as there was reasonab le evidence of a causa l association between 
Fosamax and AFFs. 
Defendant submitted a reply brief, again arguing that preemption is proper because 
Defendant proposed a label change in 2008 and the FDA rejected it in 2009, after Mrs. Glynn’s 
fracture. Defendant asserts that the FDA did not reject the label change because Defendant used 
the phrase “stress fracture” since references to “stress fractures” were included to aid in the early 
identification of low-energy femur fractures. Moreover, Defendant contends that it did not fail to 
submit information to the FDA. Lastly, Defenda nt points out that the evidence Plaintiffs 
presented in their brief was not in troduced at trial and thus, is not properly before this Court on 
this Motion; even if it was properly before this Court, the evidence does not change the fact that 
clear evidence exists that the FDA would not ha ve approved a stronger warning to the Fosamax 
label. 
The Supremacy Clause provides that the “Constitution, and Laws of the United States . . . 
shall be the supreme Law of the Land . . . .” U.S. Const. art. VI, cl. 2. It “invalidates state laws 
that interfere with, or are contrary to, federal law.” Hillsborough County, Florida v. Automated 
Medical Laboratories, Inc., 471 U.S. 707, 712 (1985) (internal quotation omitted). Federal law 
preempts state law in three ways: (1) express preemption; (2) fi eld preemption, and (3) conflict 
preemption. Farina v. Nokia Inc. , 625 F.3d 97, 115 (3d Cir. 2010), cert. denied, 132 S.Ct. 365 PageID:
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(2011); Dobbs v. Wyeth Pharmaceuticals , 797 F. Supp. 2d 1264, 1268 n.3 (W.D. Okla. 2011). 
Express preemption occurs when Congress states “in express terms” that it is preempting state 
law. Hillsborough County, Florida , 471 U.S. at 713. Field preemption occurs when Congress 
intends to preempt state law “in a particular area” or in other words “the scheme of federal 
regulation is sufficiently comprehensive . . . [so] Congress ‘left no room’ for supplementary state 
regulation.” Id. Conflict preemption is when a “state la w is in actual conflict with federal law”; 
this exists “where it is impossible for a priv ate party to comply with both state and federal 
requirements . . . or where state law stands as an obstacle to the accomplishment and execution 
of the full purposes and objectives of Congress.” Sprietsma v. Mercury Marine, a Div. of 
Brunswick Corp. , 537 U.S. 51, 64 (2002) (internal quotation omitted). This case concerns 
conflict preemption because Defendant argues that it was impossible to comply with the state 
law duty to warn and the FDA’s regulations 6 since Plaintiffs argue that a warning about low-
energy femur fractures should have been included in the Fosamax label but the FDA rejected a 
proposed warning. 
Conflict preemption, however, “is a demanding defense.” Wyeth, 555 U.S. at 573. As a 
result, generally, FDA approval or compliance with FDA labeling regulations is not a complete 
defense to a state failure to warn claim. Id. at 559. If, however, there is “clear evidence that the 
FDA would not have approved a change” to the prescription drug’s label, then it is impossible to 
comply with both federal and state requirements 7 and the state failure to warn claim is 
                                                             
6 Federal regulations “preempt state laws in the same fashion as congressional statutes.” Farina, 625 F. 3d at 115 
(citing Fid. Fed. Sav. & Loan Ass’n v. de la Cuesta, 458 U.S. 141, 153 (1982)). 
7 Federal regulations require that a drug’s label “be revised to include a warning about a clinically significant hazard 
as soon as there is reasonab le evidence of a causal association with a drug; a causal relationship need not have been 
definitely established.” 21 C.F.R. § 201.57. PageID:
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preempted. Id. at 571. Wyeth does not define “clear evidence, ” so “application of the clear 
evidence standard is necessarily fact specific.” Dobbs, 797 F. Supp. 2d at 1270. 
Here, preemption is warranted because there is clear evidence that the FDA would not 
have approved a change to the Precautions sect ion of the Fosamax label prior to Mrs. Glynn’s 
fracture. In September 2008, Defendant submitted a PAS to the FDA, seeking to add language 
about low-energy femur fractures to the Precautions and Adverse Reactions sections of the label. 
In May 2009, approximately one m onth after Mrs. Glynn’s fractur e, the FDA sent Defendant a 
letter approving the change to the Adverse Reactions section of the label but denying the change 
to the Precautions section of the label. The FDA’s rejection constitutes clear evidence that the 
FDA would not have approved a label change to the Precautions section of the label prior to Mrs. 
Glynn’s injury. See Robinson v. McNeil Consumer Healthcare , 615 F.3d 861, 8 73 (7th Cir. 
2010) (finding clear evidence that the FDA would not have approved a label change because the 
FDA did not approve “a reference to SJS/TEN on the label of over-the-counter drugs containing 
ibuprofen, when it had been asked to do so in a submission”); Dobbs, 797 F. Supp. 2d at 1276-77 
(finding clear evidence that the FDA would have rejected an e xpanded warning for Effexor after 
the FDA rejected the warning added by Defendant); see also Wyeth, 555 U.S. at 571-72 (holding 
that Wyeth “failed to demonstrate that it was impossible for [it] . . . to comply with both federal 
and state requirements” and reas oning that it “offered no such ev idence” and never argued “that 
it attempted to give” a warning but “was prohibited from doing so by the FDA”). 
Indeed, the evidence presented at trial establishes that the FDA would not have approved 
a label change to the Precautions section of the Fo samax label prior to Mrs. Glynn’s injury. In 
fact, Dr. Cheryl Blume (“Dr. Blume”), one of Plai ntiffs’ experts who was “central” to Plaintiffs’ 
preemption analysis, testified that the FDA “r ejected” Defendant’s PAS. Hearing Tr., 12:24- PageID:
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13:13, April 2, 2013; Trial Tr., 661:10-14. Moreover, Dr. Lisa Rarick (“Dr. Rarick”), one of 
Defendant’s experts who worked for the FDA for fifteen years, testified that the FDA “rejected a 
precaution” to the Fosamax label in their May 22, 2009 letter to Defendant. Trial Tr., 2436:22-
24; 2501:7-9. Dr. Rarick further testified th at although the FDA had the authority to ask 
Defendant to submit “alternative precautionary la nguage” if it was “still contemplating [that] 
they might accept a precaution,” the FDA did not do so, thereby indicating that it would not 
accept a label change to the Pr ecautions section of the Fosa max label at that time. Id. at 
2501:10-2502:1. Furthermore, Dr. Rarick testified that the FDA had the authority to request that 
Defendant “make a label change to include reports of low-energy spontaneous subtrochanteric or 
atypical femur fractures,” but they never made such a request. Id. at 2485:4-8; 2578:2-12. Thus, 
clear evidence exists that the FDA would not ha ve approved a label change to the Precautions 
section of the Fosamax label prior to Mrs. Glynn’s fracture because Defendant submitted a label 
change and the FDA rejected it, and the FDA never required Defendant to submit new language 
or change the label, which demonstrates that the FDA did not th ink that the label should have 
been changed at that time. 
Plaintiffs did not present any ev idence at trial to refute preemption. First, Plaintiffs did 
not offer any evidence that Defendant’s PAS was rejected due to language, specifically the use of 
“stress fracture” instead of “A FF,” or that the FDA would have approved a properly worded 
label change. Instead, it would have been improper for Defendant to use the term “AFF” in 2008 
when they submitted the PAS because, as Dr. Blume testified, the phrase “atypical femur 
fractures . . . wasn’t even contrived until 2010 or 2011.” Id. at 725:22-24. In addition, Dr. 
Cornell, the Clinical Director of Orthopaedic Surgery at the Hospital for Special Surgery and one 
of Plaintiffs’ experts, explained that Fosamax “can lead to . . . subsequent stress fracture PageID:
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formation,” and when he wrote about these fractures, he was “t alking about atypical femur 
fractures.” Id. at 1264:20-1265:8. Moreover, Dr. Rarick te stified that in rejecting Defendant’s 
PAS, the FDA did not conclude that the label was “confusing to doctors” or that “stress fractures 
didn’t look as severe and significan t as . . . atypical femur fractur es”; instead, Dr. Rarick stated 
that the FDA rejected the PAS because the “dat a didn’t support the precaution language.” Id. at 
2512:10-18. This testimony dem onstrates that the FDA did not reject the PAS due to 
Defendant’s use of the phrase “stress fracture. ” Not only was the phrase AFF not coined in 
2008, but some doctors used “stress fracture” as a term to refer to low-energy subtrochanteric 
fractures. 
Second, Plaintiffs did not offer any evidence that Defendant could have submitted a CBE 
supplement to change the Precautions section of the Fosamax label. A CBE supplement gives a 
“manufacturer . . . the ability to cha nge the label without FDA approval.” Mason v. SmithKline 
Beecham Corp., 596 F.3d 387, 392 (7th Cir. 2010); Dobbs, 797 F. Supp. 2d at 1271 (citing 21 
C.F.R. § 314.70(c)(6)(iii)) (stating it is “an excepti on to the requirement of advance approval for 
label changes under certain circumstances”). A CBE supplement “allows a pre-approval label 
change by the manufacturer where the change is n eeded to add or strengthen a contraindication, 
warning, precaution or information about an adverse reaction.” Dobbs, 797 F. Supp. 2d at 1271 
(citing 21 C.F.R. § 314.70(c)(6)(ii i)(A)). Like a PAS, the “pr oposed change must be based on 
‘reasonable evidence of’ an a ssociation between a hazard and the drug at issue; however, a 
causal relationship need not have been definitely established.” Id. (citing C.F.R. § 
201.57(c)(6)(i)). After th e label change has been affected , the “FDA has the opportunity to 
consider whether or not it will accept the change.” Mason, 586 F.3d at 392. Drs. Blume and 
Rarick testified that if the FDA rejects a CBE label change, the manufacturer must change the PageID:
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label, otherwise it will be misbranded. Trial Tr. 733:16-734:9; 2502:8-16. Thus, 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 rejected in the PAS, and any changes Defendant made using the CBE 
supplement would cause the drug to be misbranded. In addition, Dr. Rarick testified that the 
FDA could have requested that Defendant submit the label change using the CBE instead of the 
PAS method, but the FDA did not do so. Id. at 2489:19-22. Moreover, Dr. Rarick opined that 
the CBE method was not “the appropriate met hod to submit” a label change regarding low-
energy subtrochanteric femur fractures because this “topic . . . was under FDA’s review . . . .” 
Id. at 2493:11-22. As a result, the evidence does not show that Defendant could have changed 
the Precautions section of the Fosamax label using a CBE supplement. 
Third, Plaintiffs did not show that Defendant failed to provide all the information it had 
on femur fractures to the FDA and that Defendant failed to warn the FDA as soon as there was 
reasonable evidence of a causal association between Fosamax and AFFs. Instead, Dr. Blume and 
Dr. Santora, Defendant’s employee who is res ponsible for Fosamax, testified that Defendant 
supplied the Odvina report, Goh report, Advers e Event Reports, and data it obtained from 
physicians; Defendant also submitted informa tion when the FDA requested it in 2008. Id. at 
729:5-730:21; 2175:16-21; 2176:4-10; 2254:15-19; 2261:13-2262:8. Regarding the timing of 
Defendant’s proposed label change, there is no evidence that Defendant failed to submit the label 
change when it had reasonable evidence of a causal association between Fosamax and femur 
fractures. Defendant submitted the PAS three months after the FDA requested information from 
bisphosphonate manufacturers, and as late as March 2010, the FDA did not see a “clear 
connection between bisphosphonate use and a risk of atypical subtrochanteric femur fractures” 
[docket # 26, Confoy Dec., Ex. 5]. PageID:
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Not only did Plaintiffs fail to offer any evid ence at trial to refute preemption but the 
exhibits Plaintiffs cited in their opposition brief were not presented at trial [docket # 218]. This 
is inappropriate on a Motion for Judgment as a Ma tter of Law where “the court is limited to the 
trial record and nothing else.” Laymon v. Lobby House, Inc. , 613 F. Supp. 2d 504, 510 (D. Del. 
2009). Even if the evidence Plaintiffs cited were part of the trial reco rd, this Court is not 
persuaded that it would change the fact that ther e is clear evidence that the FDA would not have 
approved a stronger warning prior to Mrs. Glynn’s fracture. 
Therefore, preemption is warranted in this case. Defendant submitted a PAS in 2008 
seeking to change the Precautions section of the Fosamax label to include information on low- 
energy subtrochanteric femur fractures, but th e FDA rejected the PAS in May 2009, one month 
after Mrs. Glynn’s fracture. Th is constitutes clear evidence that the FDA would not have 
approved a stronger warning prior to Mrs. Glynn’s fracture. Although Plaintiffs have had several 
opportunities to introduce ev idence in opposition to preemption, they have not refuted the fact 
that clear evidence exists. Consequently, based on the record before the Court, Plaintiffs’ failure 
to warn claim is preempted. 
III. CONCLUSION 
For the reasons outlined above, this Court grants Defendant’s Motion for Summary 
Judgment based upon Federal Preemption [docket # 25], Motion for Judgm ent as a Matter of 
Law [docket # 198], second Motion for Judgment as a Matter of Law [docket # 209], and 
Renewed Motion for Judgment as a Matter of Law [docket # 216] and enters judgment in favor 
of Defendant. An appropriate Order accompanies this Opinion. 
Dated: June 27, 2013 /s/ Joel A. Pisano 
 J O E L A . P I S A N O , U . S . D . J . PageID:
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