discussing that the standard concerns what FDA officials "[were] thinking" and what their "motives and thought processes" were
How later courts described this case
- discussing that the standard concerns what FDA officials "[were] thinking" and what their "motives and thought processes" were
Written by the judges who cited it.
The opinion
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.
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
2
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
_______________
3
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 fact-
sensitive. 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).
4
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
5
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, low-
energy 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.)
6
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)).
7
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”).
8
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).
9
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.
10
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.
11
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 anti-
resorptive 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.
12
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.
13
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 low-
energy 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 low-
energy 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.
14
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.
15
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.
16
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 e-
mail 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.
17
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.
18
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.
19
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 long-
term [bisphosphonate] use and a specific type of
subtrochanteric and femoral shaft fracture.”51 The report
stated that although there was an association between long-
term 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.
20
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.
21
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
22
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.
23
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 state-
law 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.
24
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.
25
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-to-
warn 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.
26
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.
27
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.
28
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.
29
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)).
30
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.
31
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.
32
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 state-
law 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”).
33
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 failure-
to-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.
34
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.
35
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 state-
law 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.
36
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 Anti-
Discrimination 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).
37
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.
38
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
39
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.
40
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.
41
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”).
42
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.”).
43
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.
44
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.
45
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.
46
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 decision-
making 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).
47
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 non-
immigration 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.
48
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.
49
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.
50
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 stress-
fracture 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
51
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
52
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.
53
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.
54
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 decision-
making 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
55
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.
56
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.
57
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.
58
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 show-
cause proceeding.
59
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 Non-
Warning 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 show-
cause 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.
60
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.
61
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.
62
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.
63
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.
64
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 atypical-
fracture 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).
65
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).
66
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.
67
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
68
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.
69
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”).
70
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
71
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.
72
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.
73
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.
74
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.
75
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 non-
existence 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).
76
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).
77
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.
78
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
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
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
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
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
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
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
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, S14-2497 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
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 Mid 14-2519 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
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
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