Source: s3://data.kl3m.ai/documents/govinfo/USCOURTS/USCOURTS-ca3-14-01900/USCOURTS-ca3-14-01900-0/pdf.json

Nature of Suit Code: 365
Nature of Suit: Personal Injury - Product Liability
Cause of Action: 

---

PRECEDENTIAL 

 

UNITED STATES COURT OF APPEALS 

FOR THE THIRD CIRCUIT 

_______________ 

Nos. 14-1900 et al.*

_______________ 

IN RE: FOSAMAX (ALENDRONATE SODIUM) 

PRODUCTS LIABILITY LITIGATION 

_______________ 

On Appeal from the United States District Court 

for the District of New Jersey 

(D.C. Nos. 3:08-cv-00008-FLW et al., MDL No. 2243) 

District Judge: Honorable Joel A. Pisano 

_______________ 

Argued June 30, 2016 

Before: FUENTES, CHAGARES, and RESTREPO, Circuit 

Judges

(Opinion Filed: March 22, 2017) 

David C. Frederick, Esq. [Argued] 

Kellogg Hansen Todd Figel & Frederick 

1615 M Street NW, Suite 400 

 

*

 This opinion applies to all appeals listed in Appendix A, 

attached. 

Case: 14-1900 Document: 003112569581 Page: 1 Date Filed: 03/22/2017
2 

Washington, DC 20036 

Edward Braniff, Esq. 

Michael E. Pederson, Esq. 

Weitz & Luxenberg 

700 Broadway 

New York, NY 10003 

Donald A. Ecklund, Esq. 

Carella Byrne Cecchi Olstein Brody & Agnello 

5 Becker Farm Road 

Roseland, NJ 07068 

Counsel for Appellant 

John H. Beisner, Esq. [Argued] 

Jessica D. Miller, Esq. 

Geoffrey M. Wyatt, Esq. 

Skadden Arps Slate Meagher & Flom 

1440 New York Avenue N.W. 

Washington, D.C. 20005 

Andrew T. Bayman, Esq. 

Chilton D. Varner, Esq. 

King & Spalding 

1180 Peachtree Street, N.E. 

Atlanta, GA 30309 

Karen A. Confoy, Esq. 

Fox Rothschild 

997 Lenox Drive 

Princeton Pike Corporate Center, Building 3 

Lawrenceville, NJ 08648 

Case: 14-1900 Document: 003112569581 Page: 2 Date Filed: 03/22/2017
3 

Wilfred P. Coronato, Esq. 

Hughes Hubbard & Reed 

101 Hudson Street, Suite 3601 

Jersey City, NJ 07302 

David J. Heubeck, Esq. 

Stephen E. Marshall, Esq. 

Paul F. Strain, Esq. 

Venable 

750 East Pratt Street, Suite 900 

Baltimore, MD 21202 

Counsel for Appellee 

Todd N. Hutchison, Esq. 

Alfred W. Putnam, Jr., Esq. 

Carol F. Trevey, Esq. 

Drinker Biddle & Reath 

18th & Cherry Streets 

One Logan Square, Suite 2000 

Philadelphia, PA 19103 

Counsel for Amicus Curiae Pharmaceutical Research and 

Manufacturers of America 

_______________ 

OPINION OF THE COURT 

_______________ 

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4 

FUENTES, Circuit Judge. 

Beginning in 2010, hundreds of plaintiffs filed 

personal-injury suits against the drug manufacturer Merck 

Sharp & Dohme, alleging that the osteoporosis drug Fosamax 

caused them to suffer serious thigh bone fractures. Each 

Plaintiff brought a state-law tort claim alleging that Merck 

failed to add an adequate warning of the risk of thigh 

fractures to Fosamax’s FDA-approved drug label. Many 

Plaintiffs also brought a variety of additional claims including 

defective design, negligence, and breach of warranty. 

Plaintiffs’ suits were consolidated for pretrial 

administration in a multi-district litigation in the District of 

New Jersey. Following discovery and a bellwether trial, the 

District Court granted Merck’s motion for summary judgment 

and dismissed all of Plaintiffs’ claims on the ground that they 

were preempted by federal law. The District Court based its 

ruling on the Supreme Court’s decision in Wyeth v. Levine,

1

which holds that state-law failure-to-warn claims are 

preempted when there is “clear evidence” that the FDA would 

not have approved the warning that a plaintiff claims was 

necessary. 

We will vacate and remand. Preemption is an 

affirmative defense, and Merck has not carried its burden to 

prove that it is entitled to that defense as a matter of law. The 

Wyeth “clear evidence” standard is demanding and factsensitive. It requires the factfinder to predict a highly 

probable outcome in a counterfactual world and, therefore, 

requires a court sitting in summary judgment to anticipate 

 

1

 555 U.S. 555 (2009). 

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both the range of conclusions that a reasonable juror might 

reach and the certainty with which the juror would reach 

them. Here, Plaintiffs have produced sufficient evidence for a 

reasonable jury to conclude that the FDA would have 

approved a properly-worded warning about the risk of thigh 

fractures—or at the very least, to conclude that the odds of 

FDA rejection were less than highly probable. Under Wyeth

and Rule 56, that is enough for Plaintiffs to defeat summary 

judgment and proceed to trial. 

I. BACKGROUND

A. Fosamax and Atypical Femoral Fractures 

Fosamax is a drug manufactured by Merck that 

belongs to a class of drugs known as bisphosphonates. The 

Food and Drug Administration (“FDA”) approved Fosamax 

in the 1990s for the treatment and prevention of osteoporosis 

in postmenopausal women. 

Fosamax treats osteoporosis by correcting an 

imbalance in the so-called “bone remodeling” process. 

Throughout a person’s life, bones are continuously broken 

down through a process called resorption and then reformed 

by the creation of new bone cells. In postmenopausal 

women, the rate of bone resorption exceeds that of bone 

formation, thereby causing bone loss. If bone loss continues 

unchecked, a person may develop osteoporosis, “a disease 

characterized by low bone mass and deterioration of bone 

structure that causes bone fragility and increases the risk of 

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fracture.”2

 Bisphosphonates like Fosamax slow the 

resorption process, restoring the balance between resorption 

and formation and reducing the risk of osteoporotic fracture. 

Plaintiffs claim, however, that Fosamax can actually 

increase the risk of certain bone fractures. They allege that 

by slowing resorption, bisphosphonates inhibit bone repair. 

According to Plaintiffs, bones frequently develop so-called 

“microcracks,” which are ordinarily repaired through the 

resorption process. An accumulation of microcracks can lead 

to incomplete bone fractures called “stress fractures.” The 

standalone term “stress fracture” typically connotes a fracture 

resulting from excessive loading of a normal bone, and is 

commonly seen in physically active individuals. A so-called 

“insufficiency stress fracture,” by contrast, is a fracture 

caused by normal loading of poor-quality bone. Plaintiffs 

claim that while stress fractures typically heal on their own, 

“some Fosamax users who develop insufficiency fractures 

have reduced bone toughness, and Fosamax prevents the 

normal repair of the fracture.”3

 According to Plaintiffs, these 

patients may then go on to develop what are known as 

“atypical femoral fractures”: severe, non-traumatic, lowenergy complete fractures of the femur. 

Plaintiffs in this case are all Fosamax users who 

suffered atypical femoral fractures. They allege, among other 

things, that (1) Fosamax caused these atypical fractures by 

slowing the resorption process and allowing microcracks to 

 

2

 U.S. Dep’t of Health & Human Servs., Bone Health and 

Osteoporosis: A Report of the Surgeon General 41 (2004). 

3

 Pls. Br. 15 (citing A 884.) 

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accumulate, and (2) Merck was aware of the risk of such 

fractures but acted unlawfully by failing to warn doctors and 

patients of those dangers. They claim that Merck should have 

included a warning about atypical femoral fractures in the 

federally-mandated drug warnings that accompany 

prescription drugs. The interplay, and potential collision, 

between state-law warning duties and federal regulatory 

requirements is the subject of this appeal. 

B. Regulatory Framework 

The Food, Drug, and Cosmetic Act (“FDCA”)4

regulates the marketing and sale of prescription drugs in the 

United States. Under the FDCA, a manufacturer must obtain 

approval from the United States Food and Drug 

Administration (“FDA”) before marketing a new drug.5

 As 

part of a new drug application, the manufacturer must submit 

a proposed package insert, commonly called the “drug label,” 

that sets out the drug’s medical uses (“indications”) and 

health risks.6

 “To obtain FDA approval, drug companies 

generally must submit evidence from clinical trials and other 

testing that evaluate the drug’s risks and benefits and 

demonstrate that it is safe and effective for all of the 

indications ‘prescribed, recommended, or suggested’ on the 

drug’s label.”7

 The FDA’s approval of a new drug 

 

4

 21 U.S.C. § 301 et seq. 

5 Id. § 355(a). 

6

 21 C.F.R. § 201.57(a); 21 U.S.C. § 355(b)(1)(F). 

7 In re Schering-Plough Corp. Intron/Temodar Consumer 

Class Action, 678 F.3d 235, 239 (3d Cir. 2012) (quoting 21 

U.S.C. § 355(d)). 

Case: 14-1900 Document: 003112569581 Page: 7 Date Filed: 03/22/2017
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application is conditioned on its approval of the exact text of 

the drug label.8

Drug labels includes two sections relevant to this 

litigation: a “Warnings and Precautions” section and an 

“Adverse Reactions” section. The Warnings and Precautions 

section must describe “clinically significant adverse 

reactions,” including any that are “serious even if 

infrequent.”9

 The Adverse Reactions section requires a 

description of “the overall adverse reaction profile of the drug 

based on the entire safety database,” including a list of all 

“undesirable effect[s], reasonably associated with use of a 

drug.”10 

After a drug is approved, the FDA retains the authority 

to approve or require amendments to the drug’s label.11 The 

fundamental premise of the federal drug labeling scheme, 

however, is that “manufacturers, not the FDA, bear primary 

 

8

 21 C.F.R. § 314.105(b), (c). 

9 Id. § 201.57(c)(6)(i). 

10 Id. § 201.57(c)(7). 

11 21 U.S.C. § 355(o)(4); 21; C.F.R. § 314.93; see also Wyeth, 

555 U.S. at 567 (observing that the 2007 FDCA amendments 

“granted the FDA statutory authority to require a 

manufacturer to change its drug label based on safety 

information that becomes available after a drug’s initial 

approval”). 

Case: 14-1900 Document: 003112569581 Page: 8 Date Filed: 03/22/2017
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responsibility for their drug labeling at all times.”12 The 

manufacturer is charged not only “with crafting an adequate 

label” as an initial matter, but also “with ensuring that its 

warnings remain adequate as long as the drug is on the 

market.”13

A manufacturer can fulfill its responsibility to revise 

the warnings on a drug label in two ways. 

First, the “Changes Being Effected” (“CBE”) 

regulation permits a manufacturer to unilaterally change a 

drug label to reflect “newly acquired information,” subject to 

later FDA review and approval.14 Under the CBE regulation, 

the manufacturer may, upon filing a supplemental application 

with the FDA, change a label to “add or strengthen a 

contraindication, warning, precaution, or adverse reaction”; it 

need not wait for FDA approval.15 To add a warning to the 

Warnings and Precautions section through a CBE submission, 

“there need only be ‘reasonable’ evidence of a causal 

association with the drug, a standard that could be met by a 

 

12 Wyeth, 555 U.S. at 579; see also 21 U.S.C. § 355(o)(4)(I) 

(“Rule of construction” clarifying that the 2007 amendments 

to the FDCA “shall not be construed to affect the 

responsibility of the responsible person . . . to maintain its 

label in accordance with existing requirements”). 

13 Wyeth, 555 U.S. at 571. 

14 21 C.F.R. § 314.70(c)(6)(iii); see also Wyeth, 555 U.S. at 

568 (discussing CBE amendment process). 

15 Id. § 314.70(c)(6)(iii)(A). 

Case: 14-1900 Document: 003112569581 Page: 9 Date Filed: 03/22/2017
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wide range of evidence.”16 Thus, a manufacturer can amend 

the label to address potential adverse effects even if the 

evidence for a causal connection would “not also support a 

higher evidentiary standard, such as a finding that there is a 

‘preponderance’ of evidence that a product actually causes a 

particular kind of adverse event.”17 

For purposes of the CBE regulation, “newly acquired 

information” includes “new analyses of previously submitted 

data.”18 This definition “accounts for the fact that risk 

information accumulates over time and that the same data 

may take on a different meaning in light of subsequent 

developments.”19 Thus, if a manufacturer were to 

“determine[ ] that existing warnings were insufficient based 

on . . . a new analysis of previously submitted data, [it] could 

still submit a CBE based on its new analysis of the previous 

data.”20 A manufacturer’s ability to change a label via the 

CBE process is not absolute, however. The FDA reviews 

 

16 73 Fed. Reg. 49,603, 49,604 (Aug. 22, 2008) (FDA notice 

regarding final amendment to CBE regulation); see also 21 

C.F.R. 201.57(c)(6)(iii) (Warnings and Precautions section 

“must be revised to include a warning about a clinically 

significant hazard as soon as there is reasonable evidence of a 

causal association with a drug; a causal relationship need not 

have been definitely established.”). 

17 73 Fed. Reg. at 49,604. 

18 21 C.F.R. § 314.3(b). 

19 Wyeth, 555 U.S. at 569. 

20 73 Fed. Reg. at 49,606. 

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CBE submissions and retains the power to reject proposed 

changes that do not meet the regulatory standards.21 

Second, manufacturers can implement “major 

changes” to a label by filing a so-called “Prior Approval 

Supplement” (“PAS”).22 Unlike a CBE change, a PAS 

change requires prior FDA approval before it can be 

implemented.23 The key distinction for present purposes is 

that a proposed label change that qualifies for a CBE 

supplement—including a proposal to “add or strengthen a 

contraindication, warning, precaution, or adverse reaction”—

need not be submitted through the PAS process and does not 

require prior FDA approval.24

It is important to recognize, however, that the FDA 

does not simply approve warnings out of an abundance of 

caution whenever the manufacturer posits a theoretical 

association between drug use and an adverse event. As the 

FDA has recognized, “[e]xaggeration of risk, or inclusion of 

speculative or hypothetical risks, could discourage 

appropriate use of a beneficial drug.”25 Moreover, “labeling 

that includes theoretical hazards not well-grounded in 

scientific evidence can cause meaningful risk information to 

lose its significance.”26 Accordingly, the FDA will reject a 

 

21 See 21 C.F.R. § 314.70(c)(4)-(6). 

22 Id. § 314.70(b). 

23 Id. § 314.70(b)(3). 

24 Id. § 314.70(b)(2)(v)(A); id. § 314.70(c)(6)(iii)(A) . 

25 73 Fed. Reg. 2848, 2851 (Jan. 16, 2008). 

26 Id. 

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PAS application or CBE amendment if there is insufficient 

evidence of a causal link between drug use and the adverse 

event.27 

C. Fosamax Labeling History 

Both Merck and the FDA have long been aware that 

anti-resorptive drugs like Fosamax could theoretically 

increase the risk of atypical femoral fractures. The question 

that both Merck and the FDA faced in the years following the 

drug’s approval was whether the developing evidence of a 

causal link between Fosamax and atypical fractures was 

strong enough to require adding a warning to the Fosamax 

drug label. As explained further in Section II of this opinion, 

the primary question in this appeal is whether, prior to 

September 2010, the FDA would have rejected an attempt by 

Merck to unilaterally amend the Fosamax label (via a CBE 

submission) to include a warning about the risk of atypical 

femoral fractures. The following evidence bears on that 

question. 

i. Early Studies Suggest a Possible Link 

Between Fosamax and Atypical Femoral 

Fractures 

During Fosamax’s development, Merck scientists and 

third-party researchers discussed the possibility that antiresorptive drugs could inhibit a bone’s ability to repair 

microdamage, potentially leading to stress fractures. In 1992, 

prior to FDA approval, Merck informed the FDA that 

“antiresorptive agents may inhibit microdamage repair by 

 

27 Id. 

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preventing . . . bone resorption at the sites of microdamage.”28 

Nonetheless, when the FDA approved Fosamax in 1995 for 

the treatment of osteoporosis in postmenopausal women, it 

did not require Merck to include a warning about bone 

fractures. Nor did it do so in 1997, when it approved 

Fosamax for the prevention of osteoporosis in 

postmenopausal women. 

Between 1995 and 2010, scores of case studies, 

reports, and articles were published documenting possible 

connections between long-term bisphosphonate use and 

atypical femoral fractures. Plaintiffs have directed our 

attention to six such studies from this period. None of these 

studies, however, concluded that Fosamax caused bone 

fractures, or even that Fosamax use was definitively 

associated with atypical fractures. Rather, they variously 

stated that Fosamax use “may . . . potentially” increase the 

risk of fracture29 or “may be associated” with insufficiency 

fractures,30 or that certain findings “raise[d] the possibility” 

that Fosamax use led to fractures.31 Merck’s assertion that 

the link between Fosamax and fracturing “remained 

hypothetical and unsubstantiated”32 may be an 

understatement, but not even Plaintiffs suggest that there was 

definitive proof of a causal connection at this time. 

 

 

28 A 1774. 

29 A 1258. 

30 A 1237. 

31 A 1243. 

32 Merck Br. 8. 

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Merck kept the FDA informed of these and other 

studies suggesting a possible association between 

bisphosphonates and fractures, either citing or submitting 

them in communications with the agency. In March 2008, 

Merck submitted a periodic safety update to the FDA that 

included over 30 pages of information regarding atypical 

femur fractures and suppression of bone turnover. Merck 

reported that “recent publications” had “implicated a link 

between prolonged bisphosphonate therapy and atypical lowenergy non-vertebral fractures.”33 It also stated “the reporters 

related these findings to severely suppressed bone turnover 

that may develop during long-term” use of Fosamax.34 

Later that month, Merck forwarded to the FDA a letter 

published in the New England Journal of Medicine describing 

a “potential link between [bisphosphonate] use and lowenergy fractures of the femur.”35

In June 2008, the FDA informed Merck that it was 

“aware of reports regarding the occurrence of subtrochanteric 

hip fractures in patients using bisphosphonates.”36 It also 

stated that it was “concerned about this developing safety 

signal.”37 The FDA asked Merck to submit any 

investigations it had conducted or reports it had received 

regarding femoral fractures. Merck promptly complied. 

 

33 A 2597. 

34 Id. 

35 A 1928-33. 

36 A 1935. 

37 Id. 

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ii. Merck Attempts to Amend the Fosamax 

Label 

In September 2008, while the FDA was analyzing 

Merck’s data, Merck submitted a PAS to the FDA. As 

discussed above, a PAS is a label-change request that, unlike 

a CBE submission, requires prior approval from the FDA.38 

In the PAS, Merck proposed to add language to both the 

Warnings & Precautions and the Adverse Reactions sections 

of the label to address atypical femoral fractures. Merck 

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.”39 But because of the temporal association 

between these fractures and Fosamax use, Merck believed 

that it was “important to include an appropriate statement 

about them in the product label” to “increase physicians’ 

awareness of possible fractures in some osteoporotic patients 

at risk and allow early intervention, thereby possibly 

preventing the progression to complete fracture and/or other 

complications.”40 

Merck proposed adding the following language to the 

Warnings and Precautions section of the label: 

Low-Energy Femoral Shaft Fracture 

 

38 See supra Section I.B. 

39 A 1349. 

40 Id. 

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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 stress fracture, lower extremity 

arthritis or fracture, extreme or increased 

exercise, diabetes mellitus, chronic alcohol 

abuse), and receive appropriate orthopedic care. 

Interruption of bisphosphonate therapy in 

patients with stress fractures should be 

considered, pending evaluation of the patient, 

based on individual benefit/risk assessment.41 

Merck also proposed adding “low-energy femoral 

shaft fracture” to the list of reported adverse reactions in the 

Adverse Reactions section of the label,42 as well as the 

following statement to the Patient Package Insert: “Patients 

 

41 A 1371. 

42 A 1383. 

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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.”43 In support of its PAS application, Merck 

included an analysis of femur fractures in Fosamax users and 

cited to nine articles reporting cases of low-energy femoral 

fractures in Fosamax users. 

In April 2009, Merck representatives held a telephone 

conversation with Dr. Scott Monroe of the FDA. According 

to Merck’s internal notes, Dr. Monroe stated that the FDA 

could agree to add language in the Adverse Reactions section 

of the label, but that Merck’s “elevation of this issue to a 

precaution in the labeling” was prolonging review.44 The 

FDA wanted “to approach the issue of a precaution from the 

[perspective] of all bisphosphonates” and was “working with 

the Office of Safety and Epidemiology to do so.”45 Dr. 

Monroe also stated that because “the conflicting nature of the 

literature does not provide a clear path forward, . . . more time 

will be need[ed] for FDA to formulate a formal opinion on 

the issue of a precaution around these data.”46

Later in April 2009, an FDA liaison sent Merck an email stating that the FDA was not prepared to include 

language about low-energy femoral fractures in the Warnings 

and Precautions section of the label and would only approve a 

reference to atypical fractures in the “Adverse Reaction” 

 

43 A 2742. 

44 A 1970-71. 

45 A 1971. 

46 Id. 

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section.47 The FDA asked Merck to “hold off on the 

[Warnings and Precautions] language at this time” so that 

drug evaluators could “then work with [the FDA’s Office of 

Surveillance and Epidemiology] and Merck to decide on 

language for a [Warnings and Precautions] atypical fracture 

language, if it is warranted.”48

In May 2009, the FDA sent Merck a “Complete 

Response” letter, authored by Dr. Monroe. In the Complete 

Response, the FDA approved the addition of “low energy 

femoral shaft and subtrochanteric fractures” to the Adverse 

Reactions section, but the FDA rejected Merck’s proposed 

addition to the Warnings and Precautions section. Because 

the parties vigorously dispute the grounds for this rejection, it 

is worth excerpting the relevant portion of the FDA notice in 

full: 

 

47 A 1498. 

48 Id. 

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We have completed the review of your [PAS] 

applications, as amended, and have determined 

that we cannot approve these applications in 

their present form. We have described below 

our reasons for this action and our 

recommendation to address this issue. 

1. While the Division agrees that atypical and 

subtrochanteric fractures should be added to the 

ADVERSE REACTIONS, Post-Marketing 

Experience subsections of the [Fosamax] 

labels, your justification for the proposed 

PRECAUTIONS section language is 

inadequate. Identification of “stress fractures” 

may not be clearly related to the atypical 

subtrochanteric fractures that have been 

reported in the literature. Discussion of the risk 

factors for stress fractures is not warranted and 

is not adequately supported by the available 

literature and post-marketing adverse event 

reporting.49

The outcome of this case hinges in large part on how 

one reads (or really, on how a reasonable jury could read) this 

language in conjunction with the FDA’s accompanying 

actions and communications. Plaintiffs claim that the FDA 

was objecting only to Merck’s use of the imprecise and 

potentially misleading term “stress fractures,” and that the 

FDA would have approved a proposed warning that 

specifically discussed the risk of atypical femoral fractures 

while eliminating the general references to stress fractures. 

 

49 A 1500-01. 

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Merck claims that this letter, along with the FDA’s other 

communications, demonstrates that the FDA simply did not 

believe there was sufficient evidence of a causal link between 

Fosamax use and atypical fractures, and would have rejected 

any proposed warning relating to such a risk. 

iii. The FDA Revises its Position on the 

Link Between Bisphosphonates and 

Atypical Femur Fractures 

In March 2010, after reviewing the data submitted by 

Merck and other manufacturers, the FDA stated publicly that 

the data reviewed to date had “not shown a clear connection 

between bisphosphonate use and a risk of atypical 

subtrochanteric femur fractures.”50 The FDA announced that 

it would work with an outside expert task force to gather 

additional information. 

In September 2010, the task force published a report 

finding that “there is evidence of a relationship between longterm [bisphosphonate] use and a specific type of 

subtrochanteric and femoral shaft fracture.”51 The report 

stated that although there was an association between longterm bisphosphonate use and atypical fractures, the 

association had not been proven to be causal. The FDA 

responded by issuing a Drug Safety Communication stating 

that, “[a]lthough it is not clear if bisphosphonates are the 

cause [of fractures], these unusual femur fractures have been 

identified in patients taking these drugs.”52 Regarding the 

 

50 A 1508. 

51 A 1167. 

52 A 1512. 

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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.”53 

In October 2010, the FDA announced that it would 

require all bisphosphonate manufacturers to add information 

regarding the risk of atypical femoral fractures to the 

Warnings and Precautions section of the drug labels, based on 

the FDA’s conclusion that “these atypical fractures may be 

related to long-term . . . bisphosphonate use.”54 It reiterated 

that it was still “not clear if bisphosphonates are the cause,” 

but noted that “these unusual femur fractures have been 

predominantly reported in patients taking bisphosphonates.”55 

In a conference call accompanying the announcement, the 

FDA’s Deputy Director of the Office of New Drugs stated 

that the task force report made the FDA “confident” that 

atypical femur fractures are “potentially more closely related 

to” long-term use of bisphosphonates “than [the FDA] 

previously had evidence for.”56 

 

53 Id. 

54 A 1118. The FDA also announced that it would require a 

new Limitations of Use statement in the Indications and 

Usage section of the labels to “describe the uncertainty of the 

optimal duration of use of bisphosphonates for the treatment 

and/or prevention of osteoporosis.” Id. 

55 Id. 

56 A 1396. 

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The same day, the FDA wrote to Merck requesting that 

Merck add the following language to the Warnings and 

Precautions section of the Fosamax label: 

Atypical Subtrochanteric and Diaphyseal 

Femoral Fractures: 

Atypical, low-energy, or low trauma 

fractures of the femoral shaft have been 

reported in bisphosphonate-treated patients. 

These fractures can occur anywhere in the 

femoral shaft from just below the lesser 

trochanter to above the supracondylar flare and 

are transverse or short oblique in orientation 

without evidence of comminution. Causality 

has not been established as these fractures also 

occur in osteoporotic patients who have not 

been treated with bisphosphonates. 

Atypical femur fractures most commonly 

occur with minimal or no impact to the affected 

area. They may be bilateral and many patients 

report prodromal pain in the affected area, 

usually presenting as dull, aching thigh pain, 

weeks to months before a complete fracture 

occurs. A number of reports note that patients 

were also receiving treatment with 

glucocorticoids (e.g. prednisone) at the time of 

fracture. 

Any patient with a history of 

bisphosphonate exposure who presents with 

thigh or groin pain should be suspected of 

having an atypical fracture and should be 

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23 

evaluated to rule out a femur fracture. Subjects 

presenting with an atypical fracture should also 

be assessed for symptoms and signs of fracture 

in the contralateral limb. Interruption of 

bisphosphonate therapy should be considered, 

pending a risk/benefit assessment, on an 

individual basis.57

Merck responded by proposing additional language 

that, according to Merck, was intended to make clear that 

doctors should attempt to rule out stress fractures. The 

proposal contained five specific references to “stress 

fractures.” The FDA responded to this proposal by 

eliminating every instance of the phrase “stress fractures.” In 

rejecting Merck’s proposal, the FDA explained that “the term 

‘stress fracture’ was considered and not accepted. The 

Division believes that for most practitioners, the term ‘stress 

fracture’ represents a minor fracture and this would contradict 

the seriousness of the atypical femoral fractures associated 

with bisphosphonate use.”58 The FDA subsequently 

approved language nearly identical to its original October 

2010 proposal. That language was added to the Fosamax 

label in January 2011 and has remained there since. 

D. Procedural History 

After the label change, patients who had taken 

Fosamax and suffered atypical femur fractures filed lawsuits 

against Merck throughout the country. In May 2011, the 

Judicial Panel on Multidistrict Litigation consolidated these 

 

57 A 1516-17. 

58 A 1540. 

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24 

cases for pre-trial administration in a multi-district litigation 

(“MDL”) in the District of New Jersey.59 Since then, the 

MDL has been assigned to three different district judges60 and 

has swelled to over 1,000 cases, each involving a separate 

patient who allegedly suffered a femur fracture after taking 

Fosamax. 

Although no two complaints in the MDL are identical, 

all of the actions “share questions of fact arising from similar 

allegations that use of Fosamax . . . caused femur fractures or 

similar bone injuries.”61 The individual Plaintiffs in this 

appeal all allege that they were injured before September 14, 

2010, the date the outside expert task force published its 

report documenting an association between bisphosphonate 

use and atypical femur fractures. According to Plaintiffs,62 

the complaints filed by this cohort generally include a statelaw products liability claim for failure to warn, alleging that 

Fosamax was defective because Merck failed to warn 

Plaintiffs and their physicians about the risk of atypical femur 

fractures. Many complaints also claim that Fosamax was 

 

59 In re: Fosamax (Alendronate Sodium) Prods. Liab. Litig. 

(No. II), 787 F. Supp. 2d 1355 (J.P.M.L. 2011) (hereinafter, 

“Fosamax MDL Order”). 

60 The MDL is currently assigned to the Honorable Freda 

Wolfson. 

61 Fosamax MDL Order, 787 F. Supp. 2d at 1356. 

62 This appeal involves over 500 related cases, and the parties 

have wisely chosen not to include each complaint in the 

record. We are therefore necessarily reliant on the parties for 

information regarding the nature, prevalence and 

commonality of the plaintiffs’ claims. 

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25 

defectively designed because the risks of Fosamax exceeded 

the benefits, or because Fosamax was unreasonably 

dangerous or more dangerous than an ordinary consumer 

would expect. Many complaints also include claims for, 

among other causes of action, negligence, negligent 

misrepresentation, breach of express and implied warranties, 

unjust enrichment, punitive damages, and violations of state 

consumer fraud and deceptive trade practice statutes.63 

Merck has argued since the inception of the MDL that 

Plaintiffs’ state-law failure-to-warn claims are preempted by 

FDA regulations. The District Court decided to address 

preemption after developing a full record in a bellwether trial, 

the so-called Glynn trial. Typical of all plaintiffs in this 

MDL, the lead plaintiff in Glynn claimed that she suffered an 

atypical femur fracture that was proximately caused by 

Merck’s failure to include adequate fracture warnings on the 

Fosamax label.64 Merck moved for judgment as a matter of 

law on preemption grounds before and during trial, but the 

District Court reserved judgment.65 The jury returned a 

verdict for Merck on the merits, finding that Ms. Glynn failed 

to prove by a preponderance of the evidence that she 

 

63 Although the complaints exclusively plead state-law causes 

of action, the actions are in federal court on diversity grounds. 

64 Although the Glynn plaintiffs brought multiple claims, the 

only one they actually tried to verdict was a failure-to-warn 

claim. In re Fosamax (Alendronate Sodium) Prods. Liab. 

Litig. (Glynn v. Merck Sharp & Dohme Corp.), 951 F. Supp. 

2d 695, 700 & n.5 (D.N.J. 2013) (hereinafter, “Glynn”). 

65 Id. at 700-701. 

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26 

experienced an atypical femur fracture.66 Despite this verdict, 

the District Court announced that it would still decide 

whether the Glynns’ claims were preempted.67 

In June 2013, the District Court issued an opinion 

concluding that the Glynns’ failure-to-warn claim was 

preempted by federal law. Applying the Supreme Court’s 

decision in Wyeth, the court stated that state-law failure-towarn claims are preempted when “there is ‘clear evidence that 

the FDA would not have approved a change’ to the 

prescription drug’s label.”68 The District Court concluded 

that the Glynns’ claim was preempted because the FDA’s 

May 2009 denial of Merck’s request to add language about 

atypical femur fractures to the Warnings and Precautions 

section of the label was “clear evidence that the FDA would 

not have approved a label change to the Precautions section 

of the label prior to Ms. Glynn’s injury.”69 

Shortly after the Glynn decision, Merck moved for an 

order to show cause why all the cases in the MDL alleging 

injuries prior to the release of the September 2010 task force 

report should not be dismissed on preemption grounds. 

Plaintiffs opposed the motion on the ground that resolving 

their claims through a show-cause procedure would violate 

their due process right to individual trials. In August 2013, 

the District Court issued an Order to Show Cause why the 

 

66 Id. at 701. 

67 Id. 

68 Glynn, 951 F. Supp. 2d at 702 (quoting Wyeth, 555 U.S. at 

571). 

69 Id. at 703. 

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pre-September 2010 claims should not be dismissed on 

preemption grounds, and the parties submitted briefing. 

Although both sides disputed the propriety of the show-cause 

procedure and the substance of Merck’s preemption 

arguments, the parties and the District Court all agreed that 

Federal Rule of Civil Procedure 56 “provides the exclusive 

mechanism by which the Court can resolve the dispositive 

issues presented by Merck’s preemption defense before 

trial(s).”70 

After briefing, the District Court granted summary 

judgment to Merck and ruled that all claims made by 

plaintiffs who were injured prior to September 14, 2010 were 

preempted under Wyeth. Specifically, the court ruled that: (1) 

Merck had met its initial burden of demonstrating that there 

was no genuine issue of material fact as to preemption in 

Glynn, and that Plaintiffs therefore bore the burden of 

producing a genuine issue for trial; (2) Plaintiffs had failed to 

create a genuine issue as to preemption; (3) it was proper to 

use a show-cause proceeding to apply the Glynn preemption 

ruling to other MDL cases; (4) Plaintiffs’ design-defect and 

other non-warning claims were also preempted because they 

sounded in failure to warn; and (5) Plaintiffs’ alternate 

theories that Merck should have added information about 

fractures to the Adverse Reactions section of the label prior to 

 

70 In re Fosamax (Alendronate Sodium) Prods. Liab. Litig., 

MDL No. 2243, Master Dkt. No. 08-08 (JAP)(LHG), 2014 

WL 1266994, at *8 (D.N.J. Mar. 26, 2014) (hereinafter, 

“Summary Judgment Order”). The parties continue to agree 

that Rule 56 is the proper framework to apply, although they 

dispute how to apportion the parties’ burdens of production 

and persuasion. 

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2009 and should have warned that Fosamax’s long-term 

benefits were limited should be dismissed. 

With respect to the failure-to-warn claims, the District 

Court reiterated its conclusion from Glynn that “the fact that 

the FDA never required [Merck] to submit new language or 

change the label demonstrates that the FDA did not think that 

the label should have been changed at that time.”71 This 

evidence “remain[ed] unchanged” and provided “clear 

evidence that the FDA would have rejected a stronger 

Precautions warning because the FDA did reject a stronger 

Precautions warning.”72 As to the non-failure-to-warn claims 

(including claims for design defect, negligence, fraud, breach 

of warranty, deceptive trade practice, and unjust enrichment), 

the District Court concluded that that these claims “are based 

entirely on the premise that Fosamax had risks which should 

have been disclosed to consumers” and therefore “ultimately 

hinge[ ] on the adequacy of Fosamax’s warning.”73 Because 

these claims “rise and fall with a claim for failure to warn,” 

they too were preempted.74 This appeal followed.75

 

71 Id. at *16 (quoting Glynn, 951 F. Supp. 2d at 703-04) 

(alterations omitted). 

72 Id. 

73 Id. at *12, *14. 

74 Id. at *12, *14. 

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II. LEGAL BACKGROUND

The primary issue in this case is whether Plaintiffs’ 

state-law failure-to-warn claims are preempted by federal law 

under the Supreme Court’s decision in Wyeth. This is not a 

straightforward determination. Wyeth says only that a claim 

is preempted when there is “clear evidence” that the FDA 

would not have approved a label change. This standard is 

cryptic and open-ended, and lower courts have struggled to 

make it readily administrable. This appeal, however, requires 

us to do so. To assess whether Merck is entitled to summary 

judgment on its affirmative preemption defense, we must 

answer two questions: What is “clear evidence”? And who 

should determine whether clear evidence exists? 

 

75 This appeal involves only those Plaintiffs who alleged that 

they were injured before September 14, 2010. See, e.g., id. at 

*17 (granting summary judgment to Merck on “all claims 

made by the Plaintiffs . . . with injuries that occurred prior to 

September 14, 2010”). Plaintiffs inform us that there are 

“approximately 570 remaining cases in the MDL involving 

plaintiffs who were injured after September 14, 2010.” Pls. 

Br. 8; see also A 2067-80. In June 2015, the District Court 

conditionally dismissed these remaining actions without 

prejudice, concluding that they “are based on the alleged 

inadequacy of the pre-2011 Fosamax label” and that our 

decision here would “determine whether the claims of the 

remaining Plaintiffs in this litigation . . . remain viable or 

not.” A 2065. We express no view regarding the effect of 

today’s ruling on the remaining plaintiffs’ claims. 

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30 

For the following reasons, we conclude that (1) the 

term “clear evidence” refers solely to the applicable standard 

of proof, and (2) the ultimate question of whether the FDA 

would have rejected a label change is a question of fact for 

the jury rather than for the court. By describing the ultimate 

question as one of fact for the jury, we do not mean to suggest 

that summary judgment is categorically unavailable to a 

manufacturer asserting a preemption defense. When there is 

no genuine issue of material fact—that is, when no reasonable 

jury applying the clear-evidence standard of proof could 

conclude that the FDA would have approved a label change—

the manufacturer will be entitled to judgment as a matter of 

law. We simply hold that, at the summary judgment stage, 

the court cannot decide for itself whether the FDA would 

have rejected a change, but must instead ask whether a 

reasonable jury could find that the FDA would have approved 

the change. 

A. Federal Preemption Doctrine: Impossibility 

Preemption and the Supreme Court’s 

Decision in Wyeth v. Levine

i. Impossibility Preemption 

The Supremacy Clause establishes that federal law 

“shall be the supreme Law of the Land.”76 The Supremacy 

Clause, therefore, preempts “state laws that ‘interfere with, or 

are contrary to,’ federal law.”77 There are several varieties 

 

76 U.S. Const., Art. VI, cl. 2. 

77 Hillsborough Cty., Florida v. Automated Med. Labs., Inc., 

471 U.S. 707, 712 (1985) (quoting Gibbons v. Ogden, 22 U.S. 

1, 211 (1824)). 

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of preemption; the one at issue here is called “conflict” or 

“impossibility” preemption. Impossibility preemption 

applies, and state law must give way, when “it is ‘impossible 

for a private party to comply with both state and federal 

requirements.’”78 “The question for ‘impossibility’ is 

whether the private party could independently do under 

federal law what state law requires of it.”79 

In this case, Plaintiffs claim that state law obligated 

Merck to add a warning about atypical femur fractures to the 

Fosamax label. At issue is whether federal law—here, FDA 

regulations—prevented Merck from adding the type of 

warnings that Plaintiffs claim were required under state law. 

The Supreme Court confronted a similar question in Wyeth, 

and its opinion governs our analysis here. 

ii. The Wyeth Decision 

In Wyeth, the Supreme Court addressed whether and to 

what extent state-law failure-to-warn claims are preempted by 

the FDCA and federal drug-labeling regulations. The Court 

held that failure-to-warn claims against drug manufacturers 

generally are not preempted by FDA approval of the drug’s 

warning label. But such a claim is preempted by federal law 

when there is “clear evidence” that the FDA would not have 

approved the warning that a plaintiff claims was necessary. 

The plaintiff in Wyeth developed gangrene when a 

physician’s assistant injected her with the antinausea drug 

 

78 PLIVA, Inc. v. Mensing, 564 U.S. 604, 618 (2011) (quoting 

Freightliner Corp. v. Myrick, 514 U.S. 280, 287 (1995)). 

79 Id. at 620. 

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Phenergan. She brought a state-law failure-to-warn claim 

against Wyeth, the manufacturer of Phenergan, for failing to 

provide an adequate warning about the risks involved with 

various methods of administering the drug. A jury concluded 

that the plaintiff’s injury was caused by Wyeth’s inadequate 

warning label. Wyeth argued on appeal that the state-law 

failure-to-warn claims were preempted because it was 

impossible to comply with both state-law warning duties and 

federal labeling obligations.80

The Supreme Court rejected Wyeth’s argument. It 

began by citing the “central premise of federal drug 

regulation that the manufacturer bears responsibility for the 

content of its label at all times.”81 Under this rule, a 

manufacturer “is charged both with crafting an adequate label 

and with ensuring that its warnings remain adequate as long 

as the drug is on the market.”82 Thus, when the risks of a 

particular drug use become apparent, the manufacturer has “a 

duty to provide a warning that adequately describe[s] that 

risk.”83 

In response to Wyeth’s contention that federal law 

made it impossible to add the warnings the plaintiff claimed 

were necessary, the Court observed that drug manufacturers 

are allowed to strengthen an FDA-approved warning label 

without FDA approval through the CBE process.84 Wyeth 

 

80 Wyeth, 555 U.S. at 559-64. 

81 Id. at 570-71. 

82 Id. at 571. 

83 Id. 

84 Id. at 568. 

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therefore could not establish impossibility preemption 

because the CBE regulation “permitted [Wyeth] to provide . . 

. a warning [of the risk of gangrene] before receiving the 

FDA’s approval.”85 

 

The Supreme Court cautioned, however, that the mere 

availability of a CBE label amendment would not always 

defeat a manufacturer’s preemption defense, because the 

FDA “retains authority to reject labeling changes.”86 Thus, 

where there is “clear evidence that the FDA would not have 

approved a change” to the label, federal law preempts statelaw claims premised on the manufacturer’s failure to make 

that change.87 Impossibility preemption applies in that 

instance because the manufacturer would be legally prevented 

by the FDA from taking the very action that state law 

ostensibly requires.88 

 

 

85 Id. at 571. 

86 Id. 

87 Id. 

88 If a manufacturer retains a warning that the FDA has 

rejected, the drug may be deemed “misbranded” in violation 

of federal law. See 21 U.S.C. § 352(a) (drug shall be 

considered misbranded “[i]f its labeling is false or misleading 

in any particular”); A 1501 (FDA letter rejecting Merck’s 

PAS proposal to amend the Fosamax label and stating that 

“[t]hese products may be considered to be misbranded under 

the Federal Food, Drug, and Cosmetic Act if they are 

marketed with this change before approval of these 

supplemental applications”). 

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The manufacturer in Wyeth could not take advantage 

of the clear-evidence exception because it had “offered no 

such evidence” that the FDA would have rejected the warning 

sought by the plaintiff.89 But the Supreme Court made it 

clear that if a manufacturer does present “clear evidence” that 

the FDA would reject a plaintiff’s proposed warning, it would 

have a complete preemption defense to any state-law failureto-warn claims. 

In this case, Merck claims that the FDA’s 2009 

rejection of its proposed label amendment is just such “clear 

evidence.” 

B. Defining “Clear Evidence”

Courts applying the Wyeth preemption rule confront an 

immediate question: what is “clear evidence that the FDA 

would not have approved a change”? The Wyeth Court did 

not define the “clear evidence” standard or explain how 

courts should apply it. The only guidance the Court offered 

was to call impossibility preemption a “demanding 

defense.”90 In the absence of explicit direction or a coherent 

doctrinal framework, lower courts have been understandably 

reluctant to articulate firm definitions of the standard or its 

requirements. For example, several of our sister circuits have 

decided preemption cases by simply treating the facts of 

Wyeth as a yardstick: if the evidence for FDA rejection in a 

given case is less compelling than the manufacturer’s 

evidence in Wyeth, the thinking goes, then there is clear 

evidence that the FDA would not have approved a label 

 

89 Wyeth, 555 U.S. at 571-72. 

90 Id. at 573. 

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change and the manufacturer’s preemption defense fails.91 

Many district courts have adopted a similar, if more complex, 

approach of exhaustively surveying the post-Wyeth case law 

and then testing the facts of a particular case against prior 

decisions.92 Both approaches produce valid outcomes in 

individual cases, but neither clarifies or builds out the 

doctrine. The result is an anomaly in our preemption 

jurisprudence: the number of cases applying the clear 

evidence standard continues to grow, yet “the clear evidence 

standard remains undefined.”93

 

91 See Mason v. Smithkline Beecham Corp., 596 F.3d 387, 

392-96 (7th Cir. 2010) (stating that Wyeth provides an 

“intellectual anchor” because “if the evidence here is less 

compelling than it was in [Wyeth], we will not find 

preemption,” and holding that preemption was unwarranted 

because the manufacturer’s evidence was not “any more 

compelling”); Gaeta v. Perrigo Pharms. Co., 630 F.3d 1225, 

1235-37 (9th Cir. 2011) (observing that “the only guidance 

this court has is that the evidence presented in [Wyeth] was 

insufficient to meet the clear evidence standard” and holding 

that preemption was unwarranted “[b]ecause the evidence 

presented by Perrigo in this case is no more compelling than 

the evidence considered and rejected by the Supreme Court in 

[Wyeth]” (abrogated on other grounds, PLIVA, 564 U.S. 604). 

92 See, e.g., In re Incretin-Based Therapies Prods. Liab. 

Litig., 142 F. Supp. 3d 1108 (S.D. Cal. 2015); Seufert v. 

Merck Sharp & Dohme Corp., No. 13-cv-2169 AJB (MDD), 

2016 WL 3369512 (S.D. Cal. May 11, 2016). 

93 In re Incretin-Based Therapies Prods. Liab. Litig., 142 F. 

Supp. 3d at 1119. 

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36 

Today, we hold that the Supreme Court intended to 

announce a standard of proof when it used the term “clear 

evidence” in Wyeth. 

The Wyeth Court articulated the “clear evidence” 

exception as follows: “[A]bsent clear evidence that the FDA 

would not have approved a change to Phenergan’s label, we 

will not conclude that it was impossible for Wyeth to comply 

with both federal and state requirements.”94 This formula has 

three components: (1) a legal rule that defines the 

circumstances in which a manufacturer is absolved of statelaw liability (it must be impossible for the manufacturer to 

comply with both federal and state requirements); (2) a 

factual showing that satisfies the legal rule (the FDA would 

not have approved the proposed label change); and (3) a 

standard of proof that specifies how convincing the factual 

showing must be (the manufacturer must show that the FDA 

would not have approved the proposed label change by “clear 

evidence”). The term “clear evidence” therefore does not 

refer directly to the type of facts that a manufacturer must 

show, or to the circumstances in which preemption will be 

appropriate. Rather, it specifies how difficult it will be for the 

manufacturer to convince the factfinder that the FDA would 

have rejected a proposed label change. The manufacturer 

must prove that the FDA would have rejected a warning not 

simply by a preponderance of the evidence, as in most civil 

cases, but by “clear evidence.” 

Our conclusion that the Wyeth Court intended the term 

“clear evidence” to denote a standard of proof is supported by 

the Supreme Court’s prior usage of the term. For example, 

 

94 555 U.S. at 571. 

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the Court has consistently held that a complainant alleging 

official government misconduct must present “clear 

evidence” of unlawful behavior.95 “Clear evidence” in this 

context is understood to be a standard of proof, rather than a 

condition on the type of facts that must be proven.96 Similar 

examples are found in the bankruptcy and patent settings.97 

 

95 See, e.g., United States v. Chemical Found., Inc., 272 U.S. 

1, 14-15 (1926) (“The presumption of regularity supports the 

official acts of public officers, and, in the absence of clear 

evidence to the contrary, courts presume that they have 

properly discharged their official duties.”); United States v. 

Armstrong, 517 U.S. 456, 465 (1996) (criminal defendant 

alleging racially discriminatory prosecution must present 

“clear evidence” that prosecutorial policy had discriminatory 

effect and purpose); Reno v. American-Arab AntiDiscrimination Comm., 525 U.S. 471, 489 (1999) (selective 

prosecution claim requires “clear evidence” of unlawful 

action). 

96 See Reno, 525 U.S. at 489 (stating that clear evidence is 

“the standard for proving” a selective prosecution claim); 

United States v. Jarrett, 447 F.3d 520, 525 (7th Cir. 2006) 

(describing clear evidence as “[t]he standard of proof” for 

selective prosecution claims). 

97 See Oriel v. Russell, 278 U.S. 358, 362-63 (1929) (when a 

party seeks turnover in a bankruptcy proceeding, “[a] mere 

preponderance of evidence . . . is not enough” and the court 

deciding the motion “should therefore require clear 

evidence”); Microsoft v. I4I Ltd. P’ship, 564 U.S. 91, 97, 113-

14 (2011) (Federal Circuit’s interpretation of Patent Act as 

requiring “clear evidence” of invalidity accurately stated the 

statutory standard of proof). 

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38 

Nor must we look far to discern the meaning of “clear 

evidence,” as Supreme Court usage confirms that the term is 

synonymous with “clear and convincing evidence.”98 The 

latter is a well-recognized intermediate standard of proof—

more demanding than preponderance of the evidence, but less 

demanding than proof beyond a reasonable doubt. Black’s 

Law Dictionary defines clear and convincing evidence as 

“evidence indicating that the thing to be proved is highly 

probable or reasonably certain.”99 We adopt that definition 

here. It is consistent with both settled understanding and 

Wyeth’s instruction that the clear-evidence test is a 

“demanding defense” meant to represent a longstanding 

“presumption against pre-emption.”100 

 

We therefore conclude that for a defendant to establish 

a preemption defense under Wyeth, the factfinder must 

conclude that it is highly probable that the FDA would not 

have approved a change to the drug’s label. 

 

98 See Microsoft, 564 U.S. at 97, 113-14 (equating Federal 

Circuit’s “clear evidence” standard with “clear and 

convincing” standard); Oriel, 278 U.S. at 362-63 (equating 

“clear evidence” with “clear and convincing evidence”); 

accord Ramsey v. United Mine Workers of Am., 401 U.S. 302, 

307-09, 311 (1971) (interpreting statute requiring “clear 

proof” as requiring “clear and convincing evidence”). 

99 Black’s Law Dictionary 674 (10th ed. 2009). 

100 Wyeth, 555 U.S. at 571-73, 565 n.3. 

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39 

C. Whether the FDA Would Have Rejected a 

Label Change is a Question of Fact for the 

Jury

Once “clear evidence” is understood as a standard of 

proof rather than a condition on the type of facts to be proven, 

the Wyeth test narrows to a single inquiry: would the FDA 

have approved the label change that Plaintiffs argue was 

required? 

Oral argument in this case revealed a fundamental yet 

unexplored disagreement between the parties. Merck claimed 

that the Wyeth preemption test presents a pure question of law 

that must be decided by a court, not a jury. Plaintiffs argued 

that Wyeth preemption poses a mixed question of fact and law 

that may require jury factfinding in appropriate 

circumstances. The distinction is crucial in this case because 

it dictates the course of our summary judgment analysis. If 

the question of whether the FDA would have rejected 

Plaintiffs’ proposed warning is a question of law for the court, 

then we may simply answer it ourselves; but if it is a question 

of fact for the jury, then we must instead attempt to anticipate 

the range of answers that could be given by reasonable jurors 

applying the clear evidence standard and then determine 

whether summary judgment is appropriate. Having reviewed 

the case law and the parties’ supplemental briefing on the 

issue, we conclude that the question of whether the FDA 

would have rejected a proposed label change is a question of 

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40 

fact that must be answered by a jury.101 The court’s role at 

the summary judgment stage is therefore limited to 

determining whether there are genuine issues of material fact 

that preclude judgment as a matter of law. 

i. Conflict Preemption Can Require Fact 

Determinations by a Jury 

Merck makes two general, threshold arguments in 

favor of treating Wyeth preemption as a purely legal question 

to be answered by the court. 

First, Merck notes that the vast majority of courts 

applying Wyeth have assumed, either explicitly or implicitly, 

that Wyeth preemption presents a question of law. This 

observation is only somewhat accurate and wholly 

unpersuasive. 

Wyeth does not indicate whether the “clear evidence” 

test poses a legal or factual question. Nor is it possible to 

divine a clear answer from the Supreme Court’s application 

 

101 Our discussion of the allocation of decision-making 

authority, both here and elsewhere in this Opinion, applies in 

cases tried to a jury. In a bench trial, of course, judicial 

factfinding will be both appropriate and necessary. 

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41 

of the test in Wyeth itself.102 However, the Supreme Court 

did decide that the evidence presented in Wyeth was not 

sufficient to pass the clear evidence test. Therefore, in light 

of the Court’s definitive holding that the evidence in Wyeth

did not pass muster, the many federal courts that have applied 

the Wyeth preemption test have simply compared the 

evidence presented in their cases to the evidence presented in 

Wyeth. For example, in Mason v. Smithkline Beecham Corp., 

the Seventh Circuit walked through the record evidence and 

concluded that, “in light of the extensive showing required by 

[Wyeth],” the manufacturer “did not meet its burden of 

demonstrating by clear evidence that the FDA would have 

 

102 Had Wyeth come up on appeal from a grant of summary 

judgment, for example, the Court would have been forced to 

address whether the question of what the FDA would have 

done should be answered by a court or by a jury. But Wyeth

was an appeal of a post-trial motion for judgment, following a 

full jury trial and post-verdict proceedings in which the trial 

court made explicit fact findings, based on the trial record, 

directed at the preemption issue. Wyeth, 555 U.S. at 561-63. 

The Supreme Court concluded on the basis of that complete 

record that there was “no . . . evidence” that the FDA would 

have rejected a warning. Id. at 572. The combination of (1) a 

complete fact record that (2) contained zero evidence to 

support preemption eliminated the need for remand, and 

thereby obviated the need to explain which judicial actor 

should make preemption-related findings in the first instance. 

And since the complete record contained no evidence

whatsoever indicating that the FDA would not have approved 

a label change, the Supreme Court had no reason to consider 

whether a jury could have reached a contrary conclusion. 

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rejected a label change.”103 The Ninth Circuit took a similar 

approach in Gaeta v. Perrigo Pharmaceuticals Co., and 

explicitly stated that since “the only guidance this court has is 

that the evidence presented in [Wyeth] was insufficient to 

meet the clear evidence standard,” the manufacturer would 

not meet the clear evidence standard if the “evidence in this 

case [is] less compelling than [that] in [Wyeth].”104 Many 

other circuits have followed this approach and have found no 

preemption because the evidence in those cases fell short of 

the record in Wyeth.

105

It is possible to characterize this approach as a tacit 

acknowledgment that the “clear evidence” test is a legal 

question to be answered directly by the court. Mason, for 

example, was an appeal of a grant of summary judgment, but 

the court did not engage in a Rule 56 disputed-facts analysis 

 

103 Mason, 596 F.3d at 393-96. 

104 Gaeta, 630 F.3d at 1235-36. 

105 See, e.g., Demahy v. Actavis, Inc., 593 F.3d 428, 446 (5th 

Cir. 2010) (“The record here contains nothing, let alone ‘clear 

evidence,’ that suggests the FDA would have rejected a 

labeling proposal from Actavis.”); Mensing v. Wyeth, Inc., 

588 F.3d 603, 610-11 (8th Cir. 2009) (“The record contains 

nothing, let alone ‘clear evidence,’ to suggest the FDA would 

have rejected a labeling proposal from any of them.”); but see 

Miller v. Smithkline Beecham Corp., 381 F. App’x 776 (10th 

Cir. 2010) (unpublished) (without any prior discussion, 

remanding “to give the [district] court the opportunity to 

make evidentiary findings and analyze the record in light of 

[Wyeth’s] new ‘clear evidence’ standard”). 

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or consider whether a reasonable jury could reach a contrary 

conclusion. At the same time the court also did not explain 

why the Wyeth test should be resolved by the court in the first 

instance. We do not lightly discount the wisdom of our sister 

circuits and the district courts that have grappled with these 

issues. But there is a difference between rejecting another 

court’s considered judgment, on the one hand, and taking up 

an issue that has not been thoroughly analyzed, on the other. 

Furthermore, the approach taken by our sister circuits would 

be entirely consistent with our decision that the “clear 

evidence” test is a fact question that is ultimately for a jury to 

decide. After all, by comparing the evidence presented in 

these cases with the evidence presented in Wyeth, these 

circuits are in fact engaging in a summary judgment analysis, 

even if they do not name it. 

 

Second, Merck asserts that conflict preemption always

presents a pure question of law. To be sure, we have made 

numerous offhand statements that seem to support Merck’s 

position.106 And as Merck points out, several district courts 

relying on similar language have concluded, albeit without 

substantial analysis, that a manufacturer’s entitlement to the 

 

106 See, e.g., In re Federal-Mogul Global Inc., 684 F.3d 355, 

364 n.16 (3d Cir. 2012) (“The scope of preemption presents a 

pure question of law, which we review de novo.”); Horn v. 

Thoratec Corp., 376 F.3d 163, 166 (3d Cir. 2004) (“This 

Court also exercises plenary review over a district court’s 

preemption determination, as it is a question of law.”). 

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Wyeth preemption defense is a question of law for the court 

rather than the jury.107 

 

The “rule” Merck cites, however, is one of thumb 

rather than law. It is true that most preemption cases present 

purely legal questions—for example, whether Congress 

intended to preempt state law, how to interpret the scope of 

an express preemption provision, or whether two regulatory 

schemes are facially incompatible. But it is equally clear that 

preemption can be, and sometimes must be, a fact question 

for the jury. 

 

 The Supreme Court’s opinion in Boyle v. United 

Technologies Corp.108 illustrates the distinction. In Boyle, as 

in Wyeth, the Supreme Court defined the scope of conflict 

preemption in a particular setting and announced the factual 

showing that a defendant must make to prove the affirmative 

preemption defense. Specifically, the Court held that 

“[l]iability for design defects in military equipment cannot be 

imposed, pursuant to state law, when (1) the United States 

approved reasonably precise specifications; (2) the equipment 

conformed to those specifications; and (3) the supplier 

warned the United States about the dangers in the use of the 

equipment that were known to the supplier but not to the 

United States.”109 The Court clarified that “whether the facts 

establish the conditions for the defense is a question for the 

 

107 See Dobbs v. Wyeth Pharms., 797 F. Supp. 2d 1264, 1267 

(W.D. Okla. 2011); In re Incretin-Based Therapies Prods. 

Liab. Litig., 142 F. Supp. 3d at 1114. 

108 487 U.S. 500 (1988). 

109 Id. at 512. 

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jury.”110 The proper question on summary judgment, 

therefore, was whether a “reasonable jury could, under the 

properly formulated defense, have found for the petitioner on 

the facts presented.”111 It would be error, the Court said, for a 

court to “assess[ ] on its own whether the defense had been 

established.”112 

While our court has not gone so far as to declare that 

any one species of preemption defense categorically requires 

jury factfinding, we have acknowledged that the availability 

of the defense can turn on questions of fact. In MD Mall 

Associates, LLC v. CSX Transportation, Inc.,113 we 

determined that the question of whether state-law storm water 

trespass claims conflicted with federal railroad-safety 

regulations had to be addressed “under the circumstances of 

this particular case.”114 We therefore held that whether the 

defendant railroad could reasonably comply with federal 

drainage requirements while also complying with 

Pennsylvania law regarding storm water trespass “is a 

question of fact.”115 Having so concluded, we remanded for 

further development of the factual record. 

 

 

110 Id. at 514. 

111 Id. 

112 Id. 

113 715 F.3d 479 (3d Cir. 2013). 

114 Id. at 496 (alteration omitted) (quoting Crosby v. Nat’l 

Foreign Trade Council, 530 U.S. 363, 373 (2000)). 

115 Id. 

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Boyle and MD Mall confirm that the availability of a 

conflict preemption defense is not automatically a question of 

law that must be kept from the jury. The question, therefore, 

is whether there are independent jurisprudential or practical 

reasons to conclude that Wyeth preemption, specifically, 

requires a legal or a factual determination. 

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ii. Whether the FDA Would Have 

Approved a Label Change is a Factual 

Question Appropriate for the Jury 

There are no general, hard-and-fast rules that we can 

use to distinguish fact questions from legal ones.116 The 

Supreme Court has candidly acknowledged that “the 

appropriate methodology for distinguishing questions of fact 

from questions of law has been, to say the least, elusive.”117 

In the absence of a governing principle, we look to the 

fact/law distinctions drawn by our court in similar cases, 

practical considerations regarding the allocation of decisionmaking authority between judge and jury, and the text of 

Wyeth itself. What we discern from these sources is that the 

question at the heart of the Wyeth test—would the FDA have 

approved the label change plaintiffs argue was required?—is 

little different from the type of fact questions that are 

routinely given to a jury. 

At root, Wyeth requires the decisionmaker to use an 

existing fact record to predict the outcome of a hypothetical 

scenario. The question posed to the decisionmaker in this 

case is: based on the contemporaneous medical literature and 

the interactions between Merck and the FDA that actually did

happen, what would have happened if Merck had proposed 

the warning plaintiffs say was required? We think this 

question is one of fact, for three reasons. 

 

116 See Pullman-Standard v. Swint, 456 U.S. 273, 288 (1982) 

(the Supreme Court has not devised a “rule or principle that 

will unerringly distinguish a factual finding from a legal 

conclusion”). 

117 Miller v. Fenton, 474 U.S. 104, 113 (1985). 

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First, we have recognized that an assessment of the 

probability of a future event should generally be categorized 

as a finding of fact, even if that finding automatically 

generates a legal consequence. In Kaplun v. Attorney 

General of the United States,

118 we held that a determination 

of the probability of future torture was a fact question subject 

to clear-error review. In so doing, we observed in general 

terms that “[a] present probability of a future event is 

something distinct from its legal effect that is made up of 

facts and actually exists but is not a tangible thing, or actual 

occurrence.”119 Even though the future event has not 

occurred, and even if the prediction as to that event’s 

likelihood is dispositive of a legal issue, “the likelihood itself 

remains a factual finding that can be made ex ante the actual 

outcome.”120 The Kaplun panel cited a number of other nonimmigration cases in which we or other circuits have held that 

inferences drawn from historical facts concerning the 

 

118 602 F.3d 260, 269 (3d Cir. 2010). 

119 Id. at 269 (alterations and internal quotations omitted). 

120 Id. at 269-70. In other words, the likelihood of an event 

occurring “is what a decision-maker in an adjudicatory 

system decides now as part of a factual framework for 

determining legal effect.” Id. at 269. 

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likelihood of future events are findings of fact, not law.121 

Here, the corresponding conclusion is that the task of 

assessing the probability that the FDA would have rejected a 

particular warning is a factual inquiry rather than a legal 

one.122

Second, Wyeth requires the decisionmaker to weigh 

conflicting evidence and draw inferences from the facts—

 

121 See United States v. Stewart, 452 F.3d 266, 273 (3d Cir. 

2006) (whether the release of an individual creates a 

substantial risk of future danger to society is a finding of 

fact); Martin v. Cooper Elec. Supply Co., 940 F.2d 896, 900 

(3d Cir. 1991) (inferences from historical facts are factual 

findings reviewed for clear error); Onishea v. Hopper, 171 

F.3d 1289, 1300-01 (11th Cir. 1999) (en banc) (district 

court’s finding as to the risk of future prison violence based 

on conflicting evidence was a factual determination reviewed 

for clear error). 

122 We recognize that the Wyeth test is something of an 

oddity. In a typical case, the historical facts are in dispute 

and the jury is tasked with figuring out what actually 

happened. In the case before us, the historical facts are 

largely undisputed, and the primary disputed fact is the 

ultimate fact of what would have happened. This fact is in 

turn wholly determinative of the legal question. The law is 

clear, however, that “an issue does not lose its factual 

character merely because its resolution is dispositive of the 

ultimate constitutional question.” Miller, 474 U.S. at 113. 

That is the same basic conclusion we reached in Kaplun: just 

because a fact finding completely resolves a legal issue does 

not alter its fundamentally “factual” character. 

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tasks that the Supreme Court tells us “are jury functions, not 

those of a judge.”123 

The present case is illustrative. Plaintiffs, for their 

part, rely heavily on the May 2009 letter from Dr. Scott 

Monroe of the FDA rejecting Merck’s proposed warning. 

According to Plaintiffs, the text of this letter demonstrates 

that the FDA (or at least Dr. Monroe) objected only to the 

allegedly misleading term “stress fractures,” and does not 

establish that the FDA was unconvinced of the link between 

bisphosphonate use and atypical femur fractures. Merck, 

meanwhile, directs our attention away from Dr. Monroe’s 

letter and instead toward a series of informal FDA 

communications from the same time period between Dr. 

Monroe and Merck, which they claim demonstrate that the 

FDA (or at least Dr. Monroe) was unconvinced of a 

scientifically-proven link between bisphosphonates and 

atypical fractures.124 In short: both sides ask us to (1) draw 

competing inferences from separate pieces of record evidence 

and (2) weigh those inferences against one another. These are 

tasks reserved for jurors, not judges. 

Third, the task of predicting the FDA’s likely actions 

requires multiple assessments of FDA officials’ motives and 

thought processes. Consider, for example, some of the 

questions that must be answered to arrive at a determination 

of whether the FDA would have rejected Plaintiffs’ warning. 

How convinced or skeptical were FDA officials of the link 

between bisphosphonates and atypical femur fractures? Even 

if FDA officials were unconvinced of a firm link, might they 

 

123 Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 255 (1986). 

124 See A 1498, 1971. 

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nonetheless have agreed that there was “reasonable evidence 

of a causal association,” as the CBE regulation requires? Did 

the FDA reject Merck’s 2009 proposal because it was 

unconvinced by the science or because it disliked the stressfracture language? What, if anything, can we infer from Dr. 

Monroe’s contemporaneous oral statement that the 

“conflicting nature of the literature” concerning a possible 

fracture link “does not provide a clear path forward”? 

Whatever the FDA’s position might have been on the 

association between bisphosphonates and atypical femur 

fractures, was that position an accurate predictor of its likely 

response to a proposed warning? In other words, how 

confidently can we extrapolate FDA officials’ hypothetical 

reactions from their previous statements and actions? 

These are all, essentially, inquiries about motive or 

state of mind: what were FDA officials thinking, and how 

would that disposition have conditioned their response to 

plaintiffs’ hypothetical proposed warning? And questions of 

motive, intent, and state of mind are typically understood to 

be fact questions committed to the jury rather than the 

court.125 

 

125 See Pullman-Standard, 456 U.S. at 288 (“Treating issues 

of intent as factual matters for the trier of fact is 

commonplace.”); Monteiro v. City of Elizabeth, 436 F.3d 397, 

405 (3d Cir. 2006) (“Motive is a question of fact that must be 

decided by the jury”); Grant v. City of Pittsburgh, 98 F.3d 

116, 125 (3d Cir. 1996) (“[T]he issue of state of mind will 

always be a question of fact”). 

One might object that the FDA acts as a body rather than 

through individuals, thereby rendering questions of “motive” 

and “intent” irrelevant in this setting. The key evidence in 

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this case belies that assumption. At oral argument, Merck’s 

counsel stated that the single best piece of evidence that the 

FDA would have rejected a revised warning is a set of notes, 

prepared by a Merck employee, recounting a telephone 

conversation with Dr. Monroe of the FDA—the same official 

who wrote the May 2009 letter formally rejecting Merck’s 

proposed additions to the Warnings and Precautions section. 

According to the employee’s notes, Dr. Monroe said that 

Merck’s “elevation of this issue to a precaution in the 

labeling” was prolonging review, that the “FDA would like to 

approach the issue of a precaution from the [perspective] of 

all bisphosphonates,” and that because the “conflicting nature 

of the literature does not provide a clear path forward, . . . 

more time [would] be need[ed] for [the] FDA to formulate a 

formal opinion on the issue of a precaution around these 

data.” A 1971. 

To gauge the import of these statements, a decisionmaker 

would need to, at a minimum, (1) make a credibility 

determination regarding the Merck employee who drafted the 

notes; (2) determine the veracity and accuracy of the notes; 

(3) determine the semantic meaning of Dr. Monroe’s 

statements; (4) infer Dr. Monroe’s intent and state of mind 

when making the statements; and (5) weigh that inference 

against whatever competing inferences can be drawn from Dr. 

Monroe’s subsequent letter rejecting Merck’s proposed 

warning. These are precisely the types of personal 

evaluations and weight-of-the-evidence assessments that we 

commit to jurors in the first instance. 

We acknowledge, of course, that the Wyeth inquiry may 

sometimes require the factfinder to impute motive or intent to 

the FDA as a whole. But as the Supreme Court has 

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As a fallback position, Merck argues that even if the 

Wyeth inquiry is factual in nature, it should be committed to 

the court rather than the jury for reasons of institutional 

competence.126 Merck relies heavily on Markman v. 

Westview Instruments, Inc.,127 in which the Supreme Court 

held that “construction of a patent, including terms of art 

within its claim, is exclusively within the province of the 

court.”128 The Markman Court based this conclusion, in part, 

on the general rule that “[t]he construction of written 

instruments is one of those things that judges often do and are 

likely to do better than jurors.”129 Here, the question of how 

the FDA would have responded to a proposed warning is 

 

recognized, the difficulty of assessing collective intent is not 

a reason to treat the assessment as something other than a 

factual inquiry. For example, the Court has held that the 

question of whether a corporation harbored discriminatory 

intent is a question of fact. Pullman-Standard, 456 U.S. at 

289 (“[D]iscriminatory intent . . . is not a question of law and 

not a mixed question of law and fact.”). Here too, the 

questions of why the FDA took certain actions or what can be 

inferred from its pronouncements are questions of fact for a 

jury. 

126 See Miller, 474 U.S. at 114 (“[T]he fact/law distinction at 

times has turned on a determination that, as a matter of the 

sound administration of justice, one judicial actor is better 

positioned than another to decide the issue in question.”). 

127 517 U.S. 370 (1996). 

128 Id. at 372. 

129 Id. at 388. 

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informed by the regulations that constrain FDA action—in 

this case, the CBE regulation. That regulation permits the 

FDA to add an adverse reaction in the Warnings and 

Precautions section “as soon as there is reasonable evidence 

of a causal association with a drug.”130 Agency guidance 

clarifies that “reasonable evidence” is “a standard that could 

be met by a wide range of evidence,” including evidence that 

“would not also support a higher evidentiary standard, such as 

a finding that there is a ‘preponderance’ of evidence that a 

product actually causes a particular kind of adverse event.”131 

Merck therefore claims that application of the clear evidence 

standard should be left to the courts because it “calls for the 

interpretation of regulations and agency records freighted 

with legal meaning.”132 

 

This argument misapprehends the nature of the 

factfinder’s task under Wyeth. That task is to predict how the 

FDA would have reacted in a hypothetical scenario. The jury 

therefore is not being asked to supply a plenary construction 

of the CBE regulation (or any other written instrument) in the 

first instance. It is instead being asked to apply the 

requirements of that regulation to the facts, in aid of a 

prediction as to the FDA’s behavior. 

The operative language in the CBE regulation is 

neither uncommon nor abstruse. The “reasonable evidence of 

a causal association” standard requires law-to-fact 

applications of the sort that courts routinely give to juries in 

 

130 21 C.F.R. § 201.57(c)(6)(i).

131 73 Fed. Reg. 49,603, 49,604 (Aug. 22, 2008). 

132 Merck Supp. Ltr. Br. 4. 

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tort cases. It combines two classic jury questions: (1) whether 

a causal link between two events is too attenuated, and (2) 

whether the evidence meets a certain proof threshold. These 

determinations are well within the province of a properly 

instructed jury, and we do not think that their inclusion in the 

larger Wyeth inquiry merits reallocation of the factfinding 

function. 

Plaintiffs, meanwhile, argue that judicial decisionmaking is required when a preemption determination 

“depends on construction of final, written regulatory actions 

by the FDA.”133 They further claim that the FDA’s May 2009 

response letter is just such a “final” document, and urge us to 

construe it “as a matter of law.”134 We will not go so far. As 

noted above, it is true that courts are typically charged with 

determining the construction (i.e., the legal effect) of a 

writing, as opposed to its interpretation (i.e., the semantic 

meaning of specific terms). But that general rule has little 

bearing on the disposition of this case. The question for 

preemption purposes is whether the FDA would have 

approved a different label amendment than the one it actually 

rejected in the May 2009 letter. The factfinder therefore must 

parse the FDA’s May 2009 letter not to determine its legal 

effect in the first instance, but rather to discern what it 

suggests about the FDA’s likely response to a differently 

worded proposal. This too is an appropriate task for the 

jury.135 

 

133 Pls. Supp. Ltr. Br. 3. 

134 Id. 4. 

135 We do not opine on Plaintiffs’ contention that the May 

2009 letter rejecting Merck’s PAS application was a “final 

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regulatory action.” If in future cases a court is confronted 

with a formal regulatory pronouncement that has the force or 

effect of law, it may be necessary for the court to determine 

the scope of its legal effect before submitting the ultimate fact 

question to the jury. A request for such a ruling could be 

made by motion in limine or at summary judgment. But that 

exercise is unnecessary here because the immediate “legal” 

effect of the May 2009 letter, if any, was simply to reject 

Merck’s proposed warning. That limited determination 

informs but does not answer the larger question of whether 

the FDA would have approved a differently-worded warning. 

Pivoting to the merits, Plaintiffs direct our attention to an 

FDA regulation stating that an FDA response letter must 

“describe all of the specific deficiencies that the agency has 

identified” in an application. 21 C.F.R. § 314.110(a). 

Plaintiffs claim that since the May 2009 FDA response letter 

did not mention any concern over the scientific evidence of a 

causal association between Fosamax and fractures, we can 

determine as a matter of law that the FDA would have 

accepted a proposal that eliminated reference to stress 

fractures. This is a step too far. Again, the question for the 

factfinder is whether the FDA would have approved a 

different warning from the one it rejected. The combination 

of § 314.110’s “complete description” requirement and the 

FDA’s silence in the May 2009 response letter could certainly 

permit an inference about the FDA’s contemporaneous 

thinking, and thereby an additional inference about how the 

FDA would have responded to a different warning. But it 

does not, and cannot, prove as a matter of law that the FDA 

would have accepted a warning of the type proposed by 

Plaintiffs. 

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Accordingly, we do not see any convincing prudential 

reasons to commit the Wyeth inquiry to a court rather than a 

jury. The basic question that Wyeth poses to a factfinder—in 

a counterfactual setting, what do you think the FDA would 

have done?—requires an evaluative inference about human 

behavior based on correspondence, agency statements, 

contemporaneous medical literature, the requirements of the 

CBE regulation, and whatever intuitions the factfinder may 

have about administrative inertia and agency decision-making 

processes. This assessment is certainly complex, but it does 

not require any special legal competence or training. 

We therefore conclude that the question of whether the 

FDA would have approved a plaintiff’s proposed warning is a 

question of fact for the jury. A state-law failure-to-warn 

claim will only be preempted if a jury concludes it is highly 

probable that the FDA would not have approved a label 

change. 

 

Nor, for that matter, are we ready to blindly accept Plaintiffs’ 

implicit assumption that Dr. Monroe, the author of the May 

2009 letter, followed § 314.110 to a T or had its requirements 

foremost in mind when drafting. After all, Merck’s 

contention is that Dr. Monroe gave additional reasons for the 

rejection, not disclosed in the May 2009 letter, in his 

telephone communications with Merck. We of course do not 

mean to impugn Dr. Monroe or to suggest that the May 2009 

letter did not in fact comply with § 314.110. But the facts of 

this case demonstrate that we cannot presume the existence of 

undisputed facts based solely on anticipated compliance with 

a regulatory rule. 

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This decision would change how the preemption 

defense is presented and utilized in only a subset of cases. As 

before, drug manufacturers are free to raise a preemption 

defense, and either party may move for summary judgment 

on this issue after discovery. Upon summary judgment, 

district courts will compare the evidence presented with the 

evidence in Wyeth, to determine whether it is more or less 

compelling. This is in effect what the other circuits have 

done. A trial by jury would only be necessary in those cases 

where the evidence presented is more compelling than that in 

Wyeth but no “smoking gun” rejection letter from the FDA is 

available. And this need not be at a great expense to either 

the litigants or the taxpayers. A combined trial may be 

conducted on both the liability and the defense—similar to 

patent infringement cases where the plaintiffs present their 

infringement case at the same time as the defendants present 

their patent invalidity defense—particularly because the 

evidence presented will likely overlap. In sum, today’s 

holding will not drastically change how defendants will 

litigate the preemption defense. 

 

III. ANALYSIS 

Having clarified the “clear evidence” standard, we 

now turn to the merits of Merck’s preemption defense.136 

Plaintiffs’ causes of action fall into three groups. The 

first group comprises Plaintiffs’ claims that Merck failed to 

warn Fosamax users of the risk of atypical femur fractures by 

failing to add a warning to the Warnings and Precautions 

 

136 The District Court had subject matter jurisdiction under 28 

U.S.C. § 1332. We have jurisdiction under 28 U.S.C. § 1291. 

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section of the label before September 2010 (the “Warnings 

and Precautions Claims”). The second group comprises 

Plaintiffs’ claims that Merck failed to warn Fosamax users of 

the risk of femur fractures by failing to add atypical femur 

fractures to the Adverse Reactions section of the label prior to 

May 2009 (the “Adverse Reactions Claims”). The third 

group comprises all of Plaintiffs’ non-failure-to-warn claims, 

including design defect, negligence, breach of implied and 

express warranties, and violations of state consumer fraud and 

trade practice statutes (the “Non-Warning Claims”). The 

District Court ruled that the Warnings and Precautions claims 

were preempted under Wyeth; that the Adverse Reactions 

claims failed on the merits; and that the Non-Warning Claims 

were functionally indistinguishable from the Warnings and 

Precautions Claims and therefore preempted to the same 

extent. 

Plaintiffs present four arguments on appeal. First, 

Plaintiffs argue that the Warnings and Precautions Claims are 

not preempted as a matter of law because a reasonable jury 

could conclude that the FDA would have approved a properly 

worded atypical-fractures warning. Second, Plaintiffs argue 

that Merck is not entitled to summary judgment on Plaintiffs’ 

Adverse Reactions Claims because those claims were 

properly pleaded and there is sufficient evidence for a 

reasonable jury to find for the Plaintiffs. Third, Plaintiffs 

argue that even if both sets of failure-to-warn claims are 

preempted, Plaintiffs’ remaining claims are not preempted 

because they do not “sound in failure to warn” and are 

supported by competent evidence. Fourth, Plaintiffs claim 

that the District Court misapplied Rule 56 when it tried to 

resolve Merck’s affirmative preemption defense via a showcause proceeding. 

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For the reasons set forth below, we conclude that (1) 

the Warnings and Precautions claims are not preempted as a 

matter of law because a reasonable jury could find it less than 

highly probable that the FDA would have rejected Plaintiffs’ 

proposed warning; (2) Merck is not entitled to summary 

judgment on the Adverse Reactions claims; and (3) the NonWarning Claims are not preempted as a matter of law. 

Because we are vacating the District Court’s summary 

judgment order, we do not reach the propriety of the showcause order. 

A. Summary Judgment Standard 

Our review of a District Court’s grant of summary 

judgment is plenary,137 and we affirm only if “there is no 

genuine dispute as to any material fact and the movant is 

entitled to judgment as a matter of law.”138 Because Merck 

moved for summary judgment, we must draw all reasonable 

inferences in the Plaintiffs’ favor when considering the 

evidence.139 Our inquiry is confined to “whether the evidence 

of record is such that a reasonable jury could return a verdict 

for the nonmoving party.”140 We therefore cannot grant 

summary judgment in Merck’s favor “unless a reasonable 

 

137 Reedy v. Evanson, 615 F.3d 197, 210 (3d Cir. 2010). 

138 Fed. R. Civ. P. 56(a). 

139 Anderson, 477 U.S. at 255. 

140 Reedy, 615 F.3d at 210. 

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juror would be compelled to find its way on the facts needed 

to rule in its favor on the law.”141 

Special considerations arise in the preemption context. 

Impossibility preemption is an affirmative defense142 on 

which Merck bears the burdens of production and 

persuasion.143 Crucially, “the inquiry involved in a ruling on 

a motion for summary judgment . . . necessarily implicates 

the substantive evidentiary standard of proof that would apply 

at the trial on the merits.”144 As discussed above, Wyeth’s 

“clear evidence” standard of proof requires the manufacturer 

to prove that it is highly probable that the FDA would not 

have approved a change to the drug’s label. Therefore, the 

question for summary judgment purposes is not just whether a 

reasonable juror could find that the FDA would have 

approved Plaintiffs’ proposed warning. It is whether a 

reasonable juror could find that it is highly probable that the 

FDA would have rejected the warning. Put differently: even 

if it seems possible or plausible that the FDA would have 

rejected the proposed warning, could a reasonable juror 

nonetheless conclude that the odds of rejection were 

something less than highly probable? In El v. Southeastern 

Pennsylvania Transportation Authority, we said that “if there 

is a chance that a reasonable factfinder would not accept a 

moving party’s necessary propositions of fact, pre-trial 

 

141 El v. Se. Pa. Transp. Auth., 479 F.3d 232, 238 (3d Cir. 

2007). 

142 PLIVA, 564 U.S. at 634. 

143 El, 479 F.3d at 237 & n.6. 

144 Anderson, 477 U.S. at 252. 

Case: 14-1900 Document: 003112569581 Page: 61 Date Filed: 03/22/2017
62 

judgment cannot be granted.”145 The corresponding 

proposition here is: if there is a chance that a reasonable 

factfinder would not find that it is highly probable that the 

FDA would have rejected Plaintiffs’ warning, pre-trial 

judgment cannot be granted. 

 

In summary: to affirm the District Court’s decision 

that the Warnings and Precautions Claims are preempted, we 

must find that no reasonable juror could conclude that it is 

anything less than highly probable that the FDA would have 

rejected Plaintiff’s proposed atypical-fracture warning had 

Merck proposed it to the FDA in September 2010. 

B. Merck is Not Entitled to Summary Judgment 

on Plaintiffs’ Warnings and Precautions 

Claims

Merck’s ultimate task under Wyeth is to prove by clear 

evidence that the FDA would not have approved the warning 

about the link between Fosamax use and atypical femur 

fractures that Plaintiffs say was required under state law. 

Merck’s primary argument on appeal is that prior to 

September 2010, the FDA would have opposed any warning 

about atypical femur fractures in the Warnings and 

Precautions section because the FDA did not believe that the 

science supported such a warning. As Merck points out, the 

FDA sought and analyzed information regarding atypical 

femur fractures in 2008; Merck responded with data and then 

proposed warning language for both the Warnings and 

Precautions and Adverse Reactions sections of the Fosamax 

label; the FDA rejected Merck’s proposed language for the 

 

145 El, 479 F.3d at 238. 

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Warnings and Precautions section; and in correspondence 

surrounding the rejection, FDA officials stated that the 

“conflicting nature of the literature does not provide a clear 

path forward,” and “more time [would] be need[ed] for [the] 

FDA to formulate a formal opinion on the issue of a 

precaution around these data.”146 Given this sequence of 

events, Merck argues that there is clear evidence that the FDA 

would not have approved a CBE submission adding an 

atypical-fracture warning to the Warnings and Precautions 

section. 

It is undisputed that the FDA was aware of the 

possible link between Fosamax and atypical fractures well 

before September 2010. In March 2008, Merck submitted a 

comprehensive safety update to the FDA reporting the 

existence and results of numerous studies suggesting just such 

an association. The FDA responded that it was concerned 

about this “safety signal,” but did not require Merck to update 

its label.147 In March 2010, after reviewing the data 

submitted by Merck and other manufacturers, the FDA stated 

that the data reviewed to date had “not shown a clear 

connection between bisphosphonate use and a risk of atypical 

subtrochanteric femur fractures.”148 And in October 2010, an 

FDA Deputy Director stated that the September 2010 task 

force report was the finding that for the first time made the 

FDA “confident” that atypical femur fractures are “potentially 

more closely related to” bisphosphonates “than [the FDA] 

 

146 A 1971; see also A 1498. 

147 A 1935-36. 

148 A 1508. 

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previously had evidence for.”149 Merck argues that this 

evidence demonstrates that prior to September 2010, the FDA 

would have rejected any CBE application that attempted to 

add an atypical fractures warning to the Fosamax label 

because the FDA had concluded that there was no reasonable 

evidence of a causal link. 

Merck also emphasizes the FDA’s April 2009 e-mail 

asking Merck to “hold off on the [Warnings and Precautions] 

language at this time” so that drug evaluators could “work 

with [the FDA’s Office of Surveillance and Epidemiology] 

and Merck to decide on language for a [Warnings and 

Precautions] atypical fracture language, if it is warranted.”150 

After the task force issued its report in September 2010, by 

contrast, the FDA revised Merck’s proposed language and 

quickly approved a label amendment. Merck argues that the 

“only logical conclusion from this course of proceedings is 

that the FDA thought adequate scientific support showing a 

connection between bisphosphonates and atypical femur 

fractures was lacking in 2009 but present in 2010 after the 

[task force] report, all of which accords with the FDA’s 

public statements on the issue.”151

Merck also rejects Plaintiffs’ theory that the FDA 

rejected Merck’s proposed warning based on a “language 

quibble” about stress fractures rather than a fundamental 

disagreement about the science. Merck’s strongest argument 

for summary judgment is that Plaintiffs’ theory of the case 

 

149 A 1396. 

150 A 1498 (emphasis added). 

151 Merck Br. 50. 

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65 

rests on an unreasonable inference: that the FDA 

(1) recognized a need to include risk information about 

atypical femur fractures and therefore would have accepted a 

properly-worded warning about such fractures, but (2) was so 

troubled by the “stress fracture” language that it “preferred to 

deprive physicians of that risk information rather than allow 

Merck to add its proposed language or authorize inclusion of 

revised language.”152 Merck buttresses this argument by 

pointing to statutory language requiring the FDA to notify a 

drug manufacturer when it “becomes aware of new safety 

information that [it] believes should be included in the 

labeling of the drug” and to “initiate discussions to reach 

agreement on whether the labeling for the drug should be 

modified to reflect the new safety information” if it is 

dissatisfied with the manufacturer’s response.153 Merck 

points out that if the FDA actually thought that an atypicalfracture warning was warranted, it could have proposed 

revisions rather than simply rejecting Merck’s proposal. The 

FDA engaged in just such a revision process in 2010 after it 

directed Merck to add a warning and Merck responded by 

adding stress-fracture language. The fact that the FDA did 

not similarly reach out in 2009, Merck says, demonstrates that 

it would not have accepted Plaintiffs’ proposed warning prior 

to the issuance of the task force report in September 2010. 

We do not discount the force of this evidence or its 

potential to sway a jury. The problem for Merck, however, is 

that we are not assessing in the first instance whether there 

was clear evidence that the FDA would have rejected a 

 

152 Id. 48. 

153 21 U.S.C. §§ 355(o)(4)(A) and (C). 

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change. We are instead trying to anticipate whether a 

reasonable juror, looking at all the evidence and trying to 

reconstruct a hypothetical event, could conclude that it is less 

than highly probable that the FDA would have rejected the 

change. And crucially for the Plaintiffs, we are drawing all 

reasonable inferences in their favor. This confers a unique 

advantage when the factfinder’s task is to guess what could 

have happened in a counterfactual setting. 

Plaintiffs’ argument against preemption centers on two 

claims: first, that there was sufficient evidence of a causal 

link to allow Merck to unilaterally amend the Fosamax label 

via the CBE process; and second, that the FDA’s rejection of 

Merck’s PAS application was based on Merck’s misleading 

use of the term “stress fractures” rather than any fundamental 

disagreement with the underlying science. In our view, a 

reasonable jury could accept both contentions and conclude 

that the FDA would not have rejected Plaintiffs’ proposed 

warning—or, at least, that the FDA was not highly probable 

to do so. 

First, a reasonable jury could conclude that Merck 

could have amended the Fosamax label via the CBE process. 

To add a warning to the Warnings and Precautions section of 

a drug label through a CBE submission, “there need only be 

‘reasonable’ evidence of a causal association with the drug, a 

standard that could be met by a wide range of evidence.”154 

To gain FDA approval, therefore, the agency does not need to 

 

154 73 Fed. Reg. at 49,604. The same “reasonable evidence” 

standard that governs whether a manufacturer can submit a 

CBE application also governs whether the FDA should 

approve it. 21 C.F.R. § 201.57(c)(6)(i). 

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67 

be affirmatively convinced of a causal link between the drug 

and the adverse event. Here, there is evidence that the FDA 

recognized a fracture risk and the possible need for warnings 

before September 2010. In June 2008, for example, the 

FDA stated that it was “aware of reports regarding the 

occurrence of subtrochanteric hip fractures in patients using 

bisphosphonates,” that these and atypical femoral fractures 

were “reportedly rare in patients with osteoporosis not on 

bisphosphonates,” and that it was “concerned about this 

developing safety signal.”155 And in May 2009, the FDA 

approved Merck’s request to add a reference to “low energy 

femoral shaft and subtrochanteric fractures” in the Adverse 

Reactions section of the label.156 Even if the FDA did not 

perceive a “clear connection” between Fosamax and atypical 

fractures, as it said in early 2010, a juror could conclude that 

the FDA would still have determined that “reasonable 

evidence” of a link existed—or more precisely, that the 

possibility of rejection was less than highly probable. 

 

 

155 A 1145. 

156 A 1500-01. As Plaintiffs point out, warnings can only be 

added to the Adverse Reactions section if they are 

“reasonably associated with use of’” a drug and “there is 

some basis to believe there is a causal relationship between 

the drug and the occurrence of the adverse event.” 21 C.F.R. 

§ 201.57(c)(7) (FDA regulation describing requirements of 

“Adverse Reactions” section of label). A juror could 

therefore infer from the FDA’s approval of the Adverse 

Reactions language that the FDA would have also agreed that 

there was “reasonable evidence of a causal association” 

between Fosamax and atypical femoral fractures. 

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Second, a reasonable jury could also conclude that the 

FDA rejected Merck’s proposed warning about femoral 

fractures in 2009 not because it denied the existence of a 

causal link between Fosamax and fractures, but because 

Merck repeatedly characterized the fractures at issue as 

“stress fractures.” Merck’s proposed warning used the phrase 

“stress fractures” six times.157 According to Plaintiffs’ expert, 

 

157 The following is the text of Merck’s proposed addition to 

the Warnings and Precautions section, with references to 

“stress fractures” bolded: 

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 stress fracture, 

lower extremity arthritis or fracture, extreme or 

increased exercise, diabetes mellitus, chronic 

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stress fractures are commonly seen in physically active 

people; atypical femoral fractures are, as the name suggests, 

highly unusual.158 Stress fractures are usually incomplete 

fractures that heal with rest, while atypical femoral fractures 

often are complete fractures that require surgical 

intervention.159 The FDA’s response to Merck’s PAS 

application stated: “Your justification for the proposed 

PRECAUTIONS section language is inadequate. 

Identification of ‘stress fractures’ may not be clearly related 

to the atypical subtrochanteric features that have been 

reported in the literature. Discussion of the risk factors for 

stress fractures is not warranted and is not adequately 

supported by the available literature and post-marketing 

adverse event reporting.”160 The FDA did not give any other 

reason for rejecting Merck’s proposed warning. 

 

In 2010, when Merck attempted to revise the FDA’s 

proposed warning by adding references to stress fractures, the 

 

alcohol abuse), and receive appropriate 

orthopedic care. Interruption of bisphosphonate 

therapy in patients with stress fractures

should be considered, pending evaluation of the 

patient, based on individual benefit/risk 

assessment. A 2720. 

158 A 868 ¶ 22; A 881 ¶ 74; A 882 ¶ 76; see also A 1147 (task 

force report describing atypical femoral fractures as occurring 

with “relative rarity”). 

159 A 884 ¶ 83-84; see also A 1149 (task force report 

describing atypical femoral fractures as “[c]omplete 

fractures”). 

160 A 1500-01. 

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FDA again struck out the stress-fracture references. It 

explained that “the term ‘stress fracture’ was considered and 

was not accepted” because “for most practitioners, the term 

‘stress fracture’ represents a minor fracture and this would 

contradict the seriousness of the atypical femoral fractures 

associated with bisphosphonate use.”161

As discussed above, Merck argues that if the FDA had 

been truly concerned about the risk of atypical fractures, it 

could have revised and approved a warning without the 

offending stress-fracture references. As a matter of law, 

however, the burden and the responsibility to correct a drug 

label rests with the manufacturer, not the FDA.162 Once the 

FDA rejected Merck’s proposal, the ball was back in Merck’s 

court to submit a revised, corrected proposal. A reasonable 

juror could therefore conclude that it was Merck’s failure to 

re-submit a revised CBE or PAS without stress-fracture 

language, rather than the FDA’s supposedly intransigent 

stance on the science, that prevented the FDA from approving 

a label change. 

 

161 A1540. 

162 See Wyeth, 555 U.S. at 570-71 (“[T]hrough many 

amendments to the FDCA and to FDA regulations, it has 

remained a central premise of federal drug regulation that the 

manufacturer bears responsibility for the content of its label at 

all times.”); 21 U.S.C. § 355(o)(4)(I) (“Rule of construction” 

clarifying that the 2007 FDCA amendments “shall not be 

construed to affect the responsibility of the responsible person 

. . . to maintain its label in accordance with existing 

requirements”). 

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Plaintiffs’ evidence certainly does not compel the 

conclusion that the FDA would have accepted an atypical 

fracture warning that omitted the language about stress 

fractures. But our inquiry at this stage is not about who has 

the best evidence; it is about what a reasonable jury applying 

a heightened standard of proof could conclude on the basis of 

the evidence. Because the Wyeth test requires the factfinder 

to speculate about hypothetical scenarios using inferences 

drawn from historical facts, reasonable jurors could reach a 

broad range of conclusions when confronted with this record. 

To that inherent uncertainty we then add all the reasonable 

inferences that Rule 56 requires us to draw in Plaintiffs’ 

favor: the FDA would have agreed that the evidence of an 

association was “reasonable” prior to 2010; the FDA rejected 

Merck’s proposed warning because it was primarily 

concerned with the misleading references to stress fractures 

rather than the underlying science; the FDA refrained from 

counter-proposing an acceptable warning in 2009 because it 

considered it Merck’s responsibility to submit a revised 

warning; the FDA affirmatively reached out to Merck in 2010 

because it recognized that the science was now so strong that 

amending the label was a legal imperative, not because it was 

acknowledging a sufficient risk for the first time. 

 

A reasonable juror reviewing the evidence in this case 

could find it less than highly probable that the FDA would not 

have approved a warning about the risk of atypical femur 

fractures that eliminated or revised references to “stress 

fractures.” Accordingly, Merck is not entitled to summary 

judgment on its preemption defense to Plaintiffs’ Warnings 

and Precautions claims.163

 

163 Our ruling today concerns only the correctness of the 

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72 

 

District Court’s March 24, 2014 decision that Merck was 

entitled to summary judgment on its affirmative preemption 

defense. We express no view as to whether or how our ruling 

should be applied to any individual action in the MDL going 

forward. 

One of the reasons Merck gave for treating Wyeth preemption 

as a pure question of law was that doing so would allegedly 

ensure consistency of its application across the hundreds of 

claims in this MDL. We of course do not decide issues by 

considering how many lawsuits our ruling will extinguish or 

revive. At any rate, the suits in this MDL pose numerous 

binary jury questions that conceivably apply across the board. 

Fosamax either causes atypical femoral fractures or it does 

not; Merck either knew about the alleged risks of fracture or it 

did not; the risks of Fosamax either outweighed its benefits or 

they did not; the list goes on. Ontologically speaking, there is 

an “objective” right answer to each of these questions that 

does not vary from case to case. And treating each issue as 

one of pure law to be disposed at a swoop of the judge’s pen 

would certainly speed matters along. But neither 

consideration is an adequate basis to shift the traditional line 

between judge and jury functions. Of course, if the 

manufacturer shows that there is no genuine dispute as to any 

material fact bearing on Wyeth preemption, then a judge can 

indeed decide as a matter of law that the defense is 

established. But that showing was not made here. The FDA 

either would have approved Plaintiffs’ warning or they would 

not; we cannot say. 

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73 

C. Merck is Not Entitled to Summary Judgment 

on Plaintiffs’ Adverse Reactions Claims

Plaintiffs’ failure-to-warn claims focus primarily on 

the assertion that Merck should have added a fractures 

warning to the Warnings and Precautions section of the 

Fosamax label prior to September 2010. But Plaintiffs also 

contend that their failure-to-warn claims encompass a related 

but distinct allegation that Merck should have added atypical 

fractures to the Adverse Reactions section prior to May 2009 

(the date the FDA actually approved Merck’s addition of 

atypical fractures to the Adverse Reactions section), and that 

Merck’s failure to do so proximately caused their injuries.164 

The District Court ruled that this claim was insufficiently pled 

and not supported by the evidence, and entered summary 

judgment for Merck on the merits. This ruling was in error. 

 

Treating preemption as a jury issue does not automatically 

condemn Merck to a thousand individual jury trials. The 

MDL parties could, for example, hold a bellwether trial on 

the preemption question, after which the prevailing party 

would be free to argue that the other side should be 

collaterally estopped from re-litigating preemption in 

individual cases. See Markman, 517 U.S. at 391 (recognizing 

that treating a question as a factual issue does not leave it 

“wide open in every new court” because “principles of issue 

preclusion would ordinarily foster uniformity”). Again, we 

express no view on the merits or likely outcomes of such an 

approach. 

164 See A 1501. 

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74 

As an initial matter, the Adverse Reaction Claims are 

not preempted by Wyeth, and Merck does not argue 

otherwise. Merck requested that atypical fractures be added 

to the Adverse Reactions section in 2009, and the FDA 

approved the request. Merck has not shown by clear evidence 

that the FDA would have rejected such a warning had Merck 

proposed it earlier. 

Turning to the merits, the District Court dismissed the 

Adverse Reactions claims on two grounds.165 The first basis 

for the District Court’s ruling was its conclusion that 

Plaintiffs did not specifically plead a failure-to-warn claim 

based on the Adverse Reactions label section in any of their 

complaints. Whether or not this is an accurate assessment—

we do not have every MDL complaint before us to confirm, 

and there is no indication that the District Court reviewed 

each of the hundreds of complaints at issue either—we think 

it beside the point. Plaintiffs direct us to a number of 

complaints alleging generally that the Fosamax label did not 

adequately warn patients and doctors of the fracture risk, 

without specifying the particular warnings that should have 

been included or the particular failings of each label 

 

165 Although it does not appear to have been a basis for its 

decision, the District Court observed that a large number of 

Plaintiffs alleged injuries occurring after the FDA added the 

Adverse Reactions warning. According to the District Court, 

these Plaintiffs would only be able to assert a failure-to-warn 

claim based on the absence of a warning in the Warnings and 

Precautions section of the label. We disagree, as these 

Plaintiffs remain free to argue that their injuries were caused 

by their use of Fosamax prior to the addition of the Adverse 

Reactions warning. 

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75 

section.166 The parties and the District Court all accept that 

these general allegations adequately pled the Warnings and 

Precautions theory discussed above. It is therefore difficult to 

understand why the District Court faulted the same 

complaints for failing to specify every section of the label that 

should have included a warning. At any rate, such specificity 

is not required by the Federal Rules of Civil Procedure.167 

Merck does not argue that the complaints failed to put it on 

notice of the Adverse Reactions claim, and that concession 

closes the door on any claim that the complaints themselves 

failed to adequately plead the Adverse Reactions theory. 

The District Court also stated, without elaboration, that 

Plaintiffs had failed to “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.”168 Even if true, 

this does not justify summary judgment on the merits. The 

proper inquiry for summary judgment purposes is whether 

there was sufficient evidence to permit a reasonable juror to 

conclude that a doctor would not have prescribed Fosamax if 

fracture language had been added to the Adverse Reactions 

section prior to 2009. To this end, Plaintiffs submitted 

several declarations from their treating physicians declaring 

 

166 See A 2245 ¶ 54, 2249 ¶ 76, 2190 ¶ 123, 2333 ¶ 57. 

167 See Oneida Indian Nation v. Cty. of Oneida, 617 F.3d 114, 

132 (2d Cir. 2010) (complaint need not specify the legal 

theory underlying its claims so long as it contains sufficient 

facts to support liability); Kirksey v. R.J. Reynolds Tobacco 

Co., 168 F.3d 1039, 1041 (7th Cir. 1999) (same). 

168 Summary Judgment Order, 2014 WL 1266994, at *15. 

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76 

that if they had been informed that Fosamax posed a risk of 

femoral fractures, they likely would not have prescribed 

Fosamax or likely would have discontinued treatment.169 

These declarations do not specify which sections of the label 

should have contained such a warning. A reasonable juror 

could conclude that some of these physicians would not have 

prescribed Fosamax if atypical femur fractures had been 

listed in the Adverse Reactions section. Accordingly, the 

District Court should not have granted Merck summary 

judgment on the merits of Plaintiffs’ Adverse Reactions 

failure-to-warn claims. 

There is a deeper problem lurking in the District 

Court’s decision to grant Merck a merits judgment in all of 

the MDL cases. A mass tort MDL is not a class action. It is a 

collection of separate lawsuits that are coordinated for pretrial 

proceedings—and only pretrial proceedings—before being 

remanded to their respective transferor courts.170 Some 

purely legal issues may apply in every case. But merits 

questions that are predicated on the existence or nonexistence of historical facts unique to each Plaintiff—e.g., 

whether a particular Plaintiff’s doctor would have read a 

warning in the Adverse Reactions section and ceased 

prescribing Fosamax as a result—generally are not amenable 

to across-the-board resolution. Each Plaintiff deserves the 

opportunity to develop those sort of facts separately, and the 

District Court’s understandable desire to streamline 

proceedings cannot override the Plaintiffs’ basic trial 

 

169 See, e.g., A 792 ¶ 10, 794 ¶ 9, 796-97 ¶ 9, 798 ¶ 8. 

170 28 U.S.C. § 1407(a). 

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77 

rights.171 As a technical matter, Merck’s actual burden at the 

summary judgment stage was to prove that there is no 

genuine dispute in every single MDL case that Plaintiffs’ 

doctors would have continued to prescribe Fosamax even if 

the fracture warning had been added to the Adverse Reactions 

section before May 2009. It could not do so, and the District 

Court’s grant of summary judgment on the merits was 

therefore erroneous. 

D. Merck is Not Entitled to Summary Judgment 

on Plaintiffs’ Non-Warning Claims

The District Court held that Plaintiffs’ Non-Warning 

Claims sounded in failure to warn and were therefore 

preempted to the same extent as the Warning and Precautions 

Claims. Accordingly, our decision vacating the District 

Court’s preemption ruling as to the Warnings and Precautions 

 

171 The District Court and the parties could have, but did not, 

choose to have the Plaintiffs assemble a single “master 

complaint” that superseded the individual complaints. See In 

re Refrigerant Compressors Antitrust Litig., 731 F.3d 586, 

590-91 (6th Cir. 2013). 

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78 

Claims reinstates the Non-Warning Claims as well.172 We 

pass no judgment on the merits of those claims or on whether 

they do in fact sound in failure to warn. 

IV. CONCLUSION

For the foregoing reasons, we will vacate the District 

Court’s grant of summary judgment to Merck and remand for 

further proceedings consistent with this opinion. 

 

172 Merck argues that the non-warning claims are separately 

preempted by the Supreme Court’s decision in Mutual 

Pharmaceutical Co. v. Bartlett, 133 S. Ct. 2466 (2013). 

Merck admits, however, that it did not raise this argument 

below—indeed, Merck appears to have explicitly disavowed 

the argument so it could characterize its defense as being 

based solely on Wyeth. Merck Br. 68; A 1727-28. “It is well 

established that arguments not raised before the District Court 

are waived on appeal.” DIRECTV Inc. v. Seijas, 508 F.3d 

123, 125 n.1 (3d Cir. 2007). We see no reason to deviate 

from that rule here. 

Case: 14-1900 Document: 003112569581 Page: 78 Date Filed: 03/22/2017
Appendix A

Case Name Appeal No. DNJ No.

Albrecht, Doris 14-1900 3-12-cv-03287

Molnar, Phyllis 14-2109 3-09-cv-05630

Gozdziak, Margaret 14-2110 3-09-cv-05693

Duke, Dolores 14-2111 3-08-cv-03545

Schultz, Susan 14-2112 3-10-cv-04839

Hines, Cynthia 14-2113 3-10-cv-05461

Goodwin, Joan 14-2114 3-10-cv-05462

Moline, Barbara 14-2115 3-10-cv-06282

Wheeler, Kathryn 14-2117 3-11-cv-00033

Denker, Elayne 14-2118 3-11-cv-00570

Heaton, Nancy 14-2119 3-11-cv-00571

Bonne, Virginia 14-2120 3-11-cv-00586

Lefebvre, Alice 14-2121 3-11-cv-00587

Hogan, Marie 14-2122 3-11-cv-00589

Karch, Lillie 14-2123 3-11-cv-00869

Walraed, Susan 14-2124 3-11-cv-01498

Kolb, Lauren 14-2126 3-11-cv-01886

Dematto, Mary 14-2127 3-11-cv-03165

Germino, Virginia Lee14-2128 3-11-cv-03168

Chaires, Jeanette 14-2129 3-11-cv-03169

Salvatore, Sheila 14-2130 3-11-cv-03170

Collins, Lucille 14-2131 3-11-cv-03174

Miller, Betty 14-2132 3-11-cv-03225

Young, Marilyn 14-2133 3-11-cv-03309

Sunshine, Beverly 14-2134 3-11-cv-03310

Sutton, Barbara 14-2135 3-11-cv-03369

Granato, Irene 14-2136 3-11-cv-03645

Graves, Barbara 14-2137 3-11-cv-03867

Brown, Elizabeth 14-2138 3-11-cv-03911

Van, Mary Evelyn 14-2139 3-11-cv-03919

Zessin, Deloris 14-2140 3-11-cv-03930

Wirth, Carol 14-2141 3-11-cv-04160

Lyman, Patricia 14-2142 3-11-cv-04171

Foley, Peggy 14-2143 3-11-cv-04242

O'Brien, Molly 14-2144 3-11-cv-04242

O'Brien, Molly 14-2145 3-11-cv-04277

Evans, Laura 14-2146 3-11-cv-04956

Krieg, Julia 14-2147 3-11-cv-05025

Cortez, Lorice 14-2148 3-11-cv-05077

Hardy, Shirley 14-2149 3-11-cv-05079

Marks, Martha 14-2150 3-11-cv-05083

Grassucci, Shirley 14-2151 3-11-cv-05295

Clougherty, Mary Pat14-2153 3-11-cv-05300

Edwards, Sybil 14-2154 3-11-cv-05301

Johnson, Susan 14-2155 3-11-cv-05302

Onaka, Eleanor 14-2156 3-11-cv-05303

Scott, Sylvia 14-2157 3-11-cv-05335

Whitt, Betty Jean 14-2158 3-11-cv-05703

Case: 14-1900 Document: 003112569581 Page: 79 Date Filed: 03/22/2017
Appendix A

Penigian, Jean 14-2159 3-11-cv-05720

Berlin, Ruth 14-2160 3-11-cv-05826

Collins, Joann 14-2161 3-11-cv-05912

Brogna, Loretta 14-2162 3-11-cv-06162

Hodge, Helen 14-2163 3-11-cv-06164

Stark, Vivian 14-2164 3-11-cv-06347

Voss, Betty 14-2165 3-11-cv-06387

Schornick, Lori (Indiv 14-2166 3-11-cv-06411 

Panouis, Androniki 14-2167 3-11-cv-06415

Blackford, June 14-2168 3-11-cv-06417

Krakovitz, Pearl 14-2169 3-11-cv-06419

Pisarz, Josephine 14-2170 3-11-cv-06420

Strominger, Betty 14-2171 3-11-cv-06421

Schick, Joan 14-2172 3-11-cv-06451

Chee, Paula 14-2173 3-11-cv-06452

Gribben, Angela 14-2174 3-11-cv-06468

Ourecky, Roberta 14-2175 3-11-cv-06469

Price, Carolyn 14-2176 3-11-cv-06657

Howe, Elaine 14-2177 3-11-cv-06694

Care, Margaret 14-2178 3-11-cv-06817

Hanel, Kannika 14-2179 3-11-cv-06912

Standish, Debbie 14-2180 3-11-cv-06945

Wilkins, Edith 14-2181 3-11-cv-06946

Covey, Janet 14-2182 3-11-cv-06947

Radford, Shirley 14-2183 3-11-cv-06948

Poynor, Sherry 14-2184 3-11-cv-06959

Johnson, Janet 14-2185 3-11-cv-06983

Sontag, Marian 14-2186 3-11-cv-07020

Nelson, Edward 14-2187 3-11-cv-07104

Haviland, Barbara 14-2188 3-11-cv-07145

Matney, Rosemary 14-2189 3-11-cv-07185

McGill, Barbara 14-2190 3-11-cv-07208

Schwalbe, Linda 14-2191 3-11-cv-07345

Nation, Karleen 14-2192 3-11-cv-07401

Misner, Anita 14-2193 3-11-cv-07429

Burke, Louise 14-2194 3-11-cv-07432

Carter-Morcomb, Pat14-2195 3-11-cv-07491

Messerli, Donna 14-2196 3-11-cv-07493

McKee, Eleanor 14-2197 3-11-cv-07516

Mayes, Claudice 14-2198 3-11-cv-07517

Joyce, Michael 14-2199 3-11-cv-07518

Hensley, Mary 14-2200 3-11-cv-07519

Degen, Patricia 14-2201 3-11-cv-07520

Mahan, Caroline 14-2202 3-11-cv-07521

Mistretta, Wilma 14-2203 3-11-cv-07522

Sorrentino, Theresa 14-2204 3-11-cv-07523

Tucker, Assunta 14-2205 3-11-cv-07524

Green, Mariella 14-2206 3-11-cv-07525

Greenway, Ann 14-2207 3-11-cv-07557

Case: 14-1900 Document: 003112569581 Page: 80 Date Filed: 03/22/2017
Appendix A

Ivey, Jane 14-2208 3-11-cv-07558

Driver, Virginia 14-2209 3-11-cv-07613

Juth, Joann 14-2210 3-11-cv-007614

Buitron, Catherine 14-2211 3-11-cv-07619

Wallis, Russell 14-2212 3-12-cv-00012

Carter, Ann 14-2213 3-12-cv-00014

Murphy, Betty 14-2214 3-12-cv-00015

Sutton, Catrinia (Indi 14-2215 3-12-cv-00016

Duffy, Joan 14-2216 3-12-cv-00017

Pinkney, Lani 14-2217 3-12-cv-00018

Nagy, Norma 14-2218 3-12-cv-00019

Richardson, Lee 14-2219 3-12-cv-00021

Skinner, Leone 14-2220 3-12-cv-00022

Steinert, Julie 14-2221 3-12-cv-00023

Lopes, Mary 14-2222 3-12-cv-00082

Shepherd, Madge 14-2223 3-12-cv-00168

Pappas, Diane (Indivi 14-2224 3-12-cv-00227

Anderson, Barbara (I 14-2225 3-12-cv-00268

Nesbitt, Craig 14-2226 3-12-cv-00269

Coventry, Melinda 14-2227 3-12-cv-00270

Adams, Brenda 14-2228 3-12-cv-00271

Yancu, Milly 14-2229 3-12-cv-00272

Franklin, Suzane 14-2230 3-12-cv-00273

Davis, Patricia 14-2231 3-12-cv-00278

Foland, Bobbie (Indiv 14-2232 3-12-cv-00310 

Gerardo, Claudia 14-2233 3-12-cv-00312

Mueller, Eileen 14-2234 3-12-cv-00360

Held, Mary 14-2235 3-12-cv-00374

Weiss, Linda 14-2236 3-12-cv-00375

Hunt, Betty Burch 14-2237 3-12-cv-00391

Eisen, Ella 14-2239 3-12-cv-00392

Rangel, Elvia 14-2240 3-12-cv-00403

Thomasson, Patsy M 14-2241 3-12-cv-00404

Schendle, Carolyn 14-2242 3-12-cv-00464

Hogan, Charlotte 14-2243 3-12-cv-00503

Baldridge, Wilemina 14-2244 3-12-cv-00504

McCabe, Doreen 14-2245 3-12-cv-00508

McCabe, Judith 14-2246 3-12-cv-00564

Huenefeld, Catherine14-2247 3-12-cv-00566

Gregori, Carolyn 14-2248 3-12-cv-00567

Heinonen, Marie 14-2249 3-12-cv-00568

Rath, Carolyn 14-2250 3-12-cv-00569

Rousey, Shirlie 14-2251 3-12-cv-00570

Simpson, Esther 14-2252 3-12-cv-00571

Wilson, Sharon 14-2253 3-12-cv-00572

Stotts, Wilma 14-2254 3-12-cv-00588

Everly, Myrna 14-2255 3-12-cv-00589

Kraynick, Judith 14-2256 3-12-cv-00590

Begany, Helen 14-2257 3-12-cv-00591

Case: 14-1900 Document: 003112569581 Page: 81 Date Filed: 03/22/2017
Appendix A

Finn, Barbara 14-2258 3-12-cv-00592

Scott, Lois 14-2259 3-12-cv-000593

Migatulski, Mary 14-2260 3-12-cv-00594

Reitz, Alice 14-2261 3-12-cv-00595

Cooper, Eva 14-2262 3-12-cv-00622

Delagarza, Margaret 14-2263 3-12-cv-00623

Shapiro, Ellen 14-2264 3-12-cv-00625

Frangos, Artemis 14-2265 3-12-cv-00626

Freelin, Stephanie 14-2266 3-12-cv-00627

Grassel, Sara 14-2267 3-12-cv-00628

Halpern, Beverly 14-2268 3-12-cv-00629

Harvey, Robert 14-2269 3-12-cv-00631

Jones, Renae 14-2270 3-12-cv-00640

Singh, Priscilla 14-2271 3-12-cv-00643

Worthington, Renee 14-2272 3-12-cv-00644

Palmer, Richard 14-2273 3-12-cv-00645

James, Claudia 14-2274 3-12-cv-00647

Kozloski, Margaret 14-2275 3-12-cv-00648

Matthews, Roxie Mo 14-2276 3-12-cv-00649

Newman, Lula 14-2277 3-12-cv-00650

Dirks, Susan 14-2278 3-12-cv-00651

Carpenter, Julia Ann 14-2279 3-12-cv-00654

Madary, Roberta 14-2280 3-12-cv-00655

Rimstidt, Nelda 14-2281 3-12-cv-00656

Taylor, Sherri 14-2282 3-12-cv-00657

Balsam, Barbara 14-2283 3-12-cv-00658

Mester, Dorothy 14-2284 3-12-cv-00659

Raven, Arleen 14-2285 3-12-cv-00660

Garrett, Barbara 14-2286 3-12-cv-00663

Dwyer, Marion 14-2287 3-12-cv-00664

Eck, Marlene 14-2288 3-12-cv-00665

Uselton, Lynnita 14-2289 3-12-cv-00666

Still, Nanette 14-2290 3-12-cv-00667

Wheeler, Jo 14-2291 3-12-cv-00688

Smith, Richard 14-2292 3-12-cv-00689

Bucher, Rose 14-2293 3-12-cv-00690

Giarratano, Ruth 14-2294 3-12-cv-00691

Goheen, Patty 14-2295 3-12-cv-00692

Powers, Peggy 14-2296 3-12-cv-00693

Muller, Eleanor 14-2297 3-12-cv-00694

Lemley, Sheila 14-2298 3-12-cv-00695

Curry, Nellie 14-2299 3-12-cv-00707

Thomas-Walsh, Ther 14-2300 3-12-cv-00714

Swanson, Nancy 14-2301 3-12-cv-00715

Erickson, Doris 14-2302 3-12-cv-00750

Pearson, Linda 14-2303 3-12-cv-00762

Underhill, Mary Lee 14-2304 3-12-cv-00789

Nord, Elayne Barbara14-2305 3-12-cv-00790

Bryant, Jane 14-2306 3-12-cv-00791

Case: 14-1900 Document: 003112569581 Page: 82 Date Filed: 03/22/2017
Appendix A

Ciraolo, Joanna 14-2307 3-12-cv-00855

Savoy, Josephine 14-2308 3-12-cv-00928

Gentile, Emma 14-2309 3-12-cv-00936

Factor, Rosalyn Rena 14-2310 3-12-cv-00943

Walker, Sherry 14-2311 3-12-cv-00950

McCune, Bonnie 14-2312 3-12-cv-00974

Meldon, Virginia 14-2313 3-12-cv-01009

Greenberg, Carla 14-2314 3-12-cv-01013

Armstrong, Bobbie 14-2315 3-12-cv-01020

Garman, Rose Ann 14--2316 3-12-cv-01021

Goggin, Carol 14-2317 3-12-cv-01035

Goodman, Susan Jan 14-2318 3-12-cv-01036

Drouet, Renee 14-2319 3-12-cv-01038

Stroh, Kerry 14-2320 3-12-cv-01065

Medina, Laarni 14-2321 3-12-cv-01075

Whitman, Ethel 14-2322 3-12-cv-01093

D'Angelo, Kimiko 14-2323 3-12-cv-01107

Hollander, Carol 14-2324 3-12-cv-01111

Harrow, Ronnie 14-2325 3-12-cv-01132

Hardy, Yvette 14-2326 3-12-cv-01133

Lynn, Vivian 14-2327 3-12-cv-01134

Hill, Laura Lee 14-2328 3-12-cv-01135

Gitter, Blossom 14-2329 3-12-cv-01177

Clow, Edna 14-2330 3-12-cv-01179

Hulik, Linda 14-2331 3-12-cv-01180

Lyons, Janet 14-2332 3-12-cv-01181

Fitzpatrick, Nora 14-2333 3-12-cv-01185

Suehiro, Tokia 14-2334 3-12-cv-01186

Brown, Linton 14-2335 3-12-cv-01187

Seims, Marcie 14-2336 3-12-cv-01200

Andrejasich, Anne 14-2337 3-12-cv-01203

Edwards, Sally 14-2338 3-12-cv-01204

Kakareka, Edith 14-2339 3-12-cv-01205

Jones, Denman 14-2340 3-12-cv-01220

Morris, Joyce 14-2341 3-12-cv-01221

Murphy, Cheryl 14-2342 3-12-cv-01222

Spires, Evelyn 14-2343 3-12-cv-01277

Davis, Anna M. 14-2345 3-12-cv-01322

Jefferies, Gail 14-2346 3-12-cv-01325

Ross, Betty Jo 14-2347 3-12-cv-01326

Jepson, Norma 14-2348 3-12-cv-01327

Fifer, Ladonna 14-2349 3-12-cv-01328

Moore, Marlene 14-2350 3-12-cv-01329

Bryant, Sharon 14-2351 3-12-cv-01344

Bishop, Rosemary 14-2352 3-12-cv-01356

Burleson, Jacqueline 14-2354 3-12-cv-01373

Fenton, Carole 14-2355 3-12-cv-01387

Yost, Marilyn 14-2356 3-12-cv-01395

Richard-Amato, Patri 14-2357 3-12-cv-01397

Case: 14-1900 Document: 003112569581 Page: 83 Date Filed: 03/22/2017
Appendix A

Wang, Su-Mei 14-2358 3-12-cv-01398

Zimmerman, Martha 14-2359 3-12-cv-01399

Flower, Gail 14-2360 3-12-cv-01410

Cross, Katherine 14-2361 3-12-cv-01449

Mejia, Teresita 14-2362 3-12-cv-01450

Agrow, Rosalie 14-2363 3-12-cv-01468

Crook, Patricia 14-2364 3-12-cv-01476

Courville, Paula 14-2365 3-12-cv-01484

Bielecky, Margaret 14-2366 3-12-cv-01487

Wright, Judith 14-2367 3-12-cv-01549

Hayes, Mavis 14-2368 3-12-cv-01552

Hanson, Nelda 14-2369 3-12-cv-01566

Stencler, Roxanna 14-2370 3-12-cv-01567

Lowell, Sarah 14-2371 3-12-cv-01568

Collier, Marion 14-2372 3-12-cv-01569

Waldrup, Roberta 14-2373 3-12-cv-01715

Bohn, Edward (Attor 14-2375 3-12-cv-01754

Freay, Onnolee 14-2376 3-12-cv-01817

Sheehan, Yvonne The14-2377 3-12-cv-01845

Merrell, Preston 14-2378 3-12-cv-01846

Jones, Alice 14-2379 3-12-cv-01847

Fracaro, Fern Lee 14-2380 3-12-cv-01849

McKelvey, Elizabeth 14-2381 3-12-cv-01850

Keaser, Barbara 14-2382 3-12-cv-01875

Brenner, Lois 14-2383 3-12-cv-01876

Azar, Bernice 14-2384 3-12-cv-01967

Hubbard, Linda 14-2385 3-12-cv-01975

Arnold, Doris 14-2386 3-12-cv-01996

Halligan, Carla 14-2387 3-12-cv-01997

Frei, Miryam 14-2388 3-12-cv-01998

Besser, Deborah (Ind 14-2389 3-12-cv-01999

Dandridge, Earlene 14-2390 3-12-cv-02000

Weissberger, Kathryn14-2391 3-12-cv-02002

Stone, Harriet 14-2392 3-12-cv-02048

Pustilnik, Jean 14-2393 3-12-cv-02121

Pickett, Theodore 14-2394 3-12-cv-02127

Bowden, Gregory 14-2395 3-12-cv-02150

Kniffen, Donna 14-2396 3-12-cv-02159

Mayer, Christine 14-2397 3-12-cv-02210

Lynch, Kiersten 14-2398 3-12-cv-02211

Dunn, Lucille 14-2399 3-12-cv-02258

Nelson, Susan 14-2400 3-12-cv-02265

Lindenmeier, Janet 14-2401 3-12-cv-02302

Frye, Barbara 14-2402 3-12-cv-02371

Sandfort, Irma 14-2403 3-12-cv-02451

Odum, Connie 14-2404 3-12-cv-05581

Latta, Theresa 14-2405 3-12-cv-02559

Kirkpatrick, Judy 14-2406 3-12-cv-02560

Canaday, Connie 14-2407 3-12-cv-02561

Case: 14-1900 Document: 003112569581 Page: 84 Date Filed: 03/22/2017
Appendix A

Edwards, Donna 14-2408 3-12-cv-02594

Lackey, Karen 14-2409 3-12-cv-02596

Evans, Dorothy 14-2410 3-12-cv-02598

Brown, Towanda 14-2411 3-12-cv-02600

Tressler, Vera 14-2412 3-12-cv-02647

Heldberg, Judith 14-2413 3-12-cv-02771

Hen, Azucena 14-2414 3-12-cv-02833

Sias, Diana Van Pelt N14-2415 3-12-cv-02837

Otto, Harriet 14-2416 3-12-cv-02838

Best, Bettie 14-2417 3-12-cv-03017

Davis, Betty Saki 14-2418 3-12-cv-03021

Roberts, Margaret 14-2419 3-12-cv-03022

Goias, Geraldine 14-2420 3-12-cv-03023

Lona, Lucille 14-2421 3-12-cv-03025

McMurray, Deborah 14-2422 3-12-cv-03026

Doriott, Angelita 14-2423 3-12-cv-03027

Thieman, Donna 14-2424 3-12-cv-03259

White, Claudia 14-2425 3-12-cv-03260

Eshelman, Stephanie 14-2426 3-12-cv-03261

Grillo, Maria 14-2427 3-12-cv-03286

Stefanowski, Lucy 14-2428 3-13-cv-07894

Burghardt, Pamela 14-2429 3-12-cv-03326

Gerber, Marilyn 14-2430 3-12-cv-03328

Tong, Lucy 14-2431 3-12-cv-03329

Venner, Vida 14-2432 3-12-cv-03330

Uslan, Sharon 14-2433 3-12-cv-03331

Goldberg, Ethel 14-2434 3-12-cv-03335

Hudson, Laraine 14-2435 3-12-cv-03345

Rittenhouse, Carolyn 14-2436 3-12-cv-03346

Budd, Randal 14-2437 3-12-cv-03347

Myers, Eva 14-2438 3-12-cv-03348

Dykes, Marsha 14-2439 3-12-cv-03358

Foree, Edith 14-2440 3-12-cv-3366

Indich, Terry 14-2441 3-12-cv-03399

Travor, Lois Annette 14-2442 3-12-cv-03429

Steen, Barbara 14-2443 3-12-cv-03511

Charms, Shirley 14-2444 3-12-cv-03696

Denham, Janice 14-2445 3-12-cv-03705

Tanglao, Lourdes 14-2446 3-12-cv-03730

Disosway, Linda 14-2447 3-12-cv-03769

Lare, Sandra 14-2448 3-12-cv-03770

Nealen, Arlene 14-2449 3-12-cv-03789

DerHarootunian, Car 14-2450 3-12-cv-03795

Yacoub, Caroline 14-2452 3-12-cv-03878

Baker, Alma 14-2453 3-12-cv-03879

Palma, Lucita 14-2454 3-12-cv-03904

Mateo, Yoshie 14-2455 3-12-cv-03939

Terranova, Patricia 14-2456 2-12-cv-03959

Hill, Mary 14-2457 3-12-cv-04014

Case: 14-1900 Document: 003112569581 Page: 85 Date Filed: 03/22/2017
Appendix A

Wilson, Selma 14-2458 3-12-cv-04190

Toland Kathleen 14-2459 3-12-cv-04423

Fillippello, Margaret 14-2460 3-12-cv-04424

Harris, Ramona 14-2461 3-12-cv-04426

Lane, Sharon 14-2462 3-12-cv-04440

Whisenant, Louise 14-2463 3-12-cv-04453

Carter, Joan 14-2464 3-12-cv-04454

Glenn, Sue 14-2465 3-12-cv-04566

Sweet, Karen 14-2466 3-12-cv-04599

Hutton, Nancy 14-2467 3-12-cv-04601

Hernandez, Antonia 14-2468 3-12-cv-04604

Favor, Judith 14-2469 3-12-cv-04611

Parker, Esther 14-2471 3-12-cv-04638

Mitchell, Cheryl 14-2472 3-12-cv-04656

Paralikis, Pamela 14-2473 3-12-cv-04663

Bottari, Donna 14-2474 3-12-cv-04664

Hedgepeth, Betty 14-2475 3-12-cv-04721

Sperber, Bernice 14-2476 3-12-cv-04760

Currie, Marlene 14-2477 3-12-cv-04762

Worthington, Jerrene14-2478 3-12-cv-04773

Patrina, Chester (Ind 14-2479 3-12-cv-04802 

Falcone, Patricia 14-2480 3-12-cv-04806

Anselmo, Victoria 14-2481 3-12-cv-04836

Patterson, Ethel 14-2482 3-12-cv-05018

Haslam, Martha 14-2483 3-12-cv-05019

Julius, Diana 14-2484 3-12-cv-05020

Mott, Leann 14-2485 3-12-cv-05060

Theberge, Jeanne 14-2486 3-12-cv-05085

Walker, Shirley 14-2487 3-12-cv-05094

Bedsworth, Alan (Ind 14-2488 3-12-cv-05108 

Crew, Nellie 14-2489 3-12-cv-05205

Astrug, Debra 14-2490 3-12-cv-05269

Dixon, Carolyn 14-2491 3-12-cv-05271

Edgil-Rogers, Judee 14-2492 3-12-cv-05297

Gilmer, Marjorie 14-2493 3-12-cv-05364

Kovalick, Carole 14-2494 3-12-cv-05383

Knutson, Josephine 14-2495 3-12-cv-05384

Smith, Regina 14-2496 3-12-cv-05385

Hamilton-Gamman, S 14-2497 3-12-cv-05389

Needles, Josephine 14-2498 3-12-cv-05391

Kendrick, Billie 14-2499 3-12-cv-05392

Paxton, Mary 14-2500 3-12-cv-05393

Stanwood, Peggy 14-2501 3-12-cv-05485

Knopick, Carol 14-2502 3-12-cv-05557

Osburn, Gaile 14-2503 3-12-cv-05560

Miller, Dolores 14-2504 3-12-cv-02549

Heckard, Shirley 14-2505 3-12-cv-05681

Cline, Diane 14-2506 3-12-cv-05776

Cummings, Sarah 14-2507 3-12-cv-05975

Case: 14-1900 Document: 003112569581 Page: 86 Date Filed: 03/22/2017
Appendix A

Jodszuweit, Armida 14-2508 3-12-cv-05978

Collier, Nancy 14-2509 3-12-cv-05993

Sayers, Sheila 14-2510 3-12-cv-06028

Cook, Shirley 14-2511 3-12-cv-06029

Wiegand, Mary 14-2512 3-12-cv-06155

Roland, Annie 14-2513 3-12-cv-06182

Bridgeman, Max 14-2514 3-12-cv-06187

Wong, Anita 14-2515 3-12-cv-06191

Hayden, Jane 14-2516 3-12-cv-06192

McGrath, Sheila 14-2517 3-12-cv-06216

Van Blaricom, Betty 14-2518 3-12-cv-06237

Thomas, Eugune Mid14-2519 3-12-cv-06264

Fuerstnau, Barbara 14-2520 3-12-cv-06266

Halfmann, Mary 14-2521 3-12-cv-06267

Kimizuka, Yoshie 14-2522 3-12-cv-06269

Hofmann, Kathleen 14-2523 3-12-cv-06275

Duggan, Doris 14-2524 3-12-cv-06289

Andorka-Aceves, Deb14-2525 3-12-cv-06301

Herndon, Lucy Mae 14-2526 3-12-cv-06351

Delikat, Ellen 14-2527 3-12-cv-06365

Mouser, Donna 14-2528 3-12-cv-06366

Hulsman, Elaine 14-2529 3-12-cv-06376

Kempfer, Faye 14-2530 3-12-cv-06377

Lotter, Dolores 14-2531 3-12-cv-06378

Cummings, Irene Lilli 14-2532 3-12-cv-06397

Irving, Zepher 14-2533 3-12-cv-06430

Marcus, Rita 14-2534 3-12-cv-06432

Halpern, Marion 14-2535 3-12-cv-06433

Ogle, Ann 14-2536 3-12-cv-06434

Bittner, Marcella 14-2537 3-12-cv-06437

Wade, Kay 14-2538 3-12-cv-06439

Ahern, Frances 14-2539 3-12-cv-06443

Boshell, Marsha 14-2540 3-12-cv-06444

Sandt, Faye 14-2541 3-12-cv-06445

Holmes, Leanne 14-2542 3-12-cv-06446

Napoli, Anna 14-2543 3-12-cv-06450

Vaughn, Patricia 14-2544 3-12-cv-06451

Irizarry, Sheila 14-2545 3-12-cv-06453

Kort, Barbara 14-2546 3-12-cv-06454

Kosvick, Melinda 14-2547 3-12-cv-06455

Homa, Barbara 14-2548 3-12-cv-06456

Stepanski, Mary Jo 14-2549 3-12-cv-06457

Lare, Barbara 14-2550 3-12-cv-06458

Nguyen, Susan 14-2551 3-12-cv-06459

Jeet, Lalita 14-2552 3-12-cv-06460

Naik, Khadijah 14-2553 3-12-cv-06461

Bartlett, Ann 14-2554 3-12-cv-06462

Aydin, Jean 14-2555 3-12-cv-06463

Dowd, Jeanette 14-2556 3-12-cv-06464

Case: 14-1900 Document: 003112569581 Page: 87 Date Filed: 03/22/2017
Appendix A

Van Gosen, Helen 14-2557 3-12-cv-06465

Huddleston, Shirley 14-2558 3-12-cv-06466

Griffin, Jennifer 14-2559 3-12-cv-06469

Crisci, Stephen N. (Pr 14-2560 3-12-cv-06550 

Jones, Geraldine 14-2561 3-12-cv-06711

McKinney, Carlene 14-2562 3-12-cv-06719

Karantza, John 14-2563 3-12-cv-06770

Bozue, Dorothy 14-2564 3-12-cv-06840

Cline, Beatrice 14-2565 3-12-cv-06841

Broadstone, Judith 14-2566 3-12-cv-06845

Schmitt, Luise Gerlin 14-2567 3-12-cv-06846

Cherco, Patricia 14-2568 3-12-cv-06850

Neuman, Janet 14-2569 3-12-cv-06859

Isom, Leann 14-2570 3-12-cv-06860

Heiny, Joyce 14-2571 3-12-cv-06863

Vertuccio, Lana 14-2572 3-12-cv-06877

Williams, Susanne 14-2573 3-12-cv-06899

Stevenson, Nada 14-2574 3-12-cv-06900

Elison, Linda 14-2575 3-12-cv-06901

Lingo, Melba 14-2576 3-12-cv-06903

Baylor, Richard 14-2577 3-12-cv-06905

Thompson, Loralee 14-2578 3-12-cv-06907

Miller, Esther 14-2579 3-12-cv-06952

Orr, June 14-2580 3-12-cv-06954

Maki, Gale 14-2581 3-12-cv-06955

Collins, John 14-2582 3-12-cv-06956

McAnulty, Joan 14-2583 3-12-cv-06957

Abney, Virginia 14-2584 3-12-cv-07023

Altson, Amy 14-2585 3-12-cv-07048

Harris, Hope (Individ 14-2586 3-12-cv-07443 

Jaeger, Bernadette 14-2587 3-12-cv-07819

Couture, Diane 14-2588 3-13-cv-00001

VanDyke, Patricia 14-2589 3-13-cv-00137

Antoff, Christine 14-2590 3-13-cv-00171

Wyly, Lois Ann 14-2592 3-13-cv-00442

Conner, Cheryl 14-2593 3-13-cv-00718

Kardon, Koula 14-2594 3-13-cv-00720

Bialkowski, Mary 14-2595 3-13-cv-00816

Affronti, Joanne 14-2599 3-13-cv-00818

Bannon, Gladys 14-2600 3-13-cv-00894

Golden, Jane 14-2601 3-13-cv-00926

Pitts, Shirley Ann 14-2602 3-13-cv-00928

Slinkman, William Ric14-2603 3-13-cv-01062

Albert, Elizabeth 14-2604 3-13-cv-01063

Hawk, Joycelyn 14-2605 3-13-cv-01071

Pritchard, Helen 14-2606 3-13-cv-01215

Myers, Susan 14-2607 3-13-cv-01314

Brooks, Betty 14-2608 3-13-cv-01337

Hawkins, Amy 14-2609 3-13-cv-01340

Case: 14-1900 Document: 003112569581 Page: 88 Date Filed: 03/22/2017
Appendix A

Edmondson, Maxine 14-2610 3-13-cv-01352

Kamienski, Mary 14-2611 3-13-cv-01369

Neuman, Delores 14-2612 3-13-cv-01370

Peters, Alohoa 14-2613 3-13-cv-01371

Routhieaux, Marguer14-2614 3-13-cv-01378

Alberg, Evelyn 14-2615 3-13-cv-01415

Goodman, Carol Ann 14-2616 3-13-cv-01476

Samuelson, Johann 14-2618 3-13-cv-01884

Rudolph, Joyce 14-2619 3-13-cv-02616

Romeo, Alice 14-2620 3-13-cv-02617

Grems, Mary 14-2621 3-13-cv-2649

McKeon-Cincotta, Le 14-2622 3-13-cv-02735

Jernigan, Mary Lou 14-2623 3-13-cv-02827

Wicker, Marie 14-2624 3-13-cv-02836

Stampliakis, Helen 14-2625 3-13-cv-02958

Crook, Judith 14-2626 3-13-cv-03211

London, Phyllis 14-2627 3-13-cv-03342

Connor, Ruth 14-2628 3-13-cv-03353

Mulqueen, Mary 14-2629 3-13-cv-03474

Bergmann, Ruth 14-2630 3-13-cv-03741

Spallone, Josephine 14-2631 3-13-cv-03929

Maddern, Karen 14-2632 3-13-cv-04075

Marcelles, Sara 14-2634 3-13-cv-05984

Tolston, Betty 14-2635 3-13-cv-06090

Oakes, Miriam 14-2636 3-11-cv-05082

Murphy, Nancy 14-2813 3-12-cv-06282

Gaynor, Barbara 14-3267 3-12-cv-01492

Case: 14-1900 Document: 003112569581 Page: 89 Date Filed: 03/22/2017