In Re Diet Drugs (Phentermine/Fenfluramine/Dexfenfluramine) Product Liability Litigation , 706 F.3d 217 ( 2013 )


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  •                                PRECEDENTIAL
    UNITED STATES COURT OF APPEALS
    FOR THE THIRD CIRCUIT
    _____________
    No. 12-1180
    _____________
    In Re: DIET DRUGS
    (PHENTERMINE/FENFLURAMINE/
    DEXFENFLURAMINE)
    PRODUCT LIABILITY LITIGATION,
    Carmen Cauthen and Ricky Leon Cauthen,
    Appellants
    _______________
    On Appeal from the United States District Court
    for the Eastern District of Pennsylvania
    (D.C. Nos. 2-99-cv-20593, 2-12-md-01203)
    District Judge: Hon. Harvey Bartle, III
    _______________
    Argued
    November 13, 2012
    Before: SCIRICA, FISHER, and JORDAN, Circuit Judges.
    (Filed: January 28, 2013)
    _______________
    W. Steven Berman
    Napoli Bern Ripka & Associates
    1 Greentree Center - #201
    Marlton, NJ 08053
    Paul J. Napoli
    Napoli, Kaiser, Bern & Associates
    3500 Sunrise Highway - #T-207
    Great River, NJ 11739
    Denise A. Rubin [ARGUED]
    Napoli, Bern, Ripka & Shkolnik
    350 Fifth Avenue - #7413
    New York, NY 10118
    Counsel for Appellants
    Heidi L. Levine
    DLA Piper LLP (US)
    1251 Avenue of the Americas
    New York, NY 10020
    Raymond M. Williams
    DLA Piper LLP (US)
    1650 Market Street - #4900
    Philadelphia, PA 19103
    Anand Agneshwar [ARGUED]
    Arnold & Porter LLP
    399 Park Avenue
    New York, NY 10022
    2
    Geoffrey J. Michael
    Anna K. Thompson
    Daniel S. Pariser
    Arnold & Porter LLP
    555 Twelfth Street, NW
    Washington, DC 20004
    Counsel for Appellees Wyeth LLC
    And Wyeth Pharmaceuticals Inc.
    Michael D. Fishbein
    Laurence S. Berman
    Arnold Levin
    Mary E. Gately
    Levin, Fishbein, Sedran & Berman
    510 Walnut Street - #500
    Philadelphia, PA 19106
    Charles R. Parker
    Locke Lord
    600 Travis Street - #3600
    Houston, TX 77002
    Counsel for Class Counsel and Plaintiffs Liaison
    Counsel
    Jules S. Henshell
    Semanoff, Ormsby, Greenberg & Torchia
    2617 Huntingdon Pike
    Huntingdon Valley, PA 18974
    Counsel for AHP Settlement Trust
    _______________
    OPINION OF THE COURT
    _______________
    3
    JORDAN, Circuit Judge.
    In November 1999, Wyeth L.L.C. (“Wyeth”) entered
    into a nationwide class action settlement agreement (the
    “Settlement Agreement”) with the users of certain diet drugs
    linked to various health problems. The United States District
    Court for the Eastern District of Pennsylvania certified the
    settlement class and entered a pre-trial order enjoining
    members of the class from suing Wyeth for injuries related to
    those drugs. Appellants Carmen and Ricky Leon Cauthen
    brought a lawsuit against Wyeth in the Court of Common
    Pleas of Philadelphia County, Pennsylvania, seeking to
    redress Ms. Cauthen‟s injuries from primary pulmonary
    hypertension (“PPH”), a condition that she alleges was caused
    by the diet drugs. Wyeth moved the District Court to enjoin
    the suit, arguing that it did not qualify under the Settlement
    Agreement as a cause of action that could proceed despite the
    settlement. The District Court agreed and enjoined the
    Cauthens‟ lawsuit. For the reasons that follow, we will
    affirm.
    I.    Background
    A.     Class Action Suit and Settlement Agreement
    Between 1994 and 1997, American Home Products
    Corporation, now Wyeth, marketed and sold fenfluramine and
    dexfenfluramine, prescription weight loss drugs. After
    studies linked the drugs to valvular heart disease, and
    following a U.S. Food and Drug Administration (“FDA”)
    public health advisory, Wyeth withdrew the drugs from the
    4
    market in 1997. Thousands of individuals subsequently filed
    suit, alleging that they had been injured by the drugs.
    In December 1997, the Judicial Panel on Multidistrict
    Litigation entered an order transferring all diet drug cases in
    federal court to the United States District Court for the
    Eastern District of Pennsylvania for consolidated pre-trial
    proceedings. Nearly two years later, Wyeth entered into a
    Settlement Agreement with users of the diet drugs in the
    United States and presented the agreement to the District
    Court for approval. On August 28, 2000, the District Court
    certified the class, approved the Settlement Agreement, and
    entered Pre-Trial Order (“PTO”) No. 1415. That order
    provided that the District Court “retains continuing and
    exclusive jurisdiction over this action and each of the Parties,
    including [Wyeth] and the class members, to administer,
    supervise, interpret and enforce the Settlement in accordance
    with its terms.” (Supplemental App. at 8.)
    Aside from certain narrow exceptions, the Settlement
    Agreement enjoins class members from suing Wyeth for all
    diet drug-related injuries. One of the exceptions is at issue in
    this case: the Settlement Agreement allows class members to
    sue Wyeth if they can demonstrate that they developed PPH1
    through the use of the diet drugs. To qualify for the
    exception, a class member must draw on “[m]edical records”
    to demonstrate the “exclus[ion]” of certain medical
    1
    PPH is a condition that “deprives the lungs of oxygen
    [and] can cause hypoxemia and hypercapnia, resulting in
    ventilator insufficiency.” 14 Roscoe N. Gray & Louise J.
    Gordy, Attorneys’ Textbook of Medicine ¶ 205.75 (3d ed.
    2011).
    5
    conditions. (App. at 787-88.) To exclude one such condition,
    which is referred to as “greater than mild restrictive lung
    disease,” a class member is required by § I.46.a(2)(c) of the
    Settlement Agreement to produce “pulmonary function tests”2
    (“PFTs”) showing that the class member‟s “total lung
    capacity” is greater than “60% of predicted at rest.” (Id.
    (Settlement Agreement, § I.46.a(2)(c)).)
    B.      The Cauthens’ Lawsuit
    In June 2011, the Cauthens filed a complaint in the
    Philadelphia County Court of Common Pleas, alleging that
    Ms. Cauthen, a member of the settlement class, developed
    PPH “as a result of ingesting Diet Drugs.” (Id. at 3.) The
    Cauthens produced a “[p]ulmonary consultation note”
    prepared by Dr. Terry Fortin (id. at 795-97), a cardiologist
    certified by the American Board of Internal Medicine. Dr.
    Fortin stated in the consultation note that, based on a PFT she
    had conducted, Ms. Cauthen‟s “total lung capacity [is] 56%,”
    and Dr. Fortin acknowledged that Ms. Cauthen‟s lungs
    “clearly have some restriction.” (Id. at 796.)
    Because Ms. Cauthen‟s only PFT showed that she had
    lung capacity of less than 60 percent of predicted at rest,
    Wyeth notified the Cauthens that they were prohibited from
    2
    “Pulmonary function tests are a group of tests that
    measure how well the lungs take in and release air and how
    well they move gases such as oxygen from the atmosphere
    into the body‟s circulation.” Pulmonary function tests:
    MedlinePlus Medical Encyclopedia (Dec. 12, 2011),
    http://www.nlm.nih.gov/medlineplus/ency/article/003853.htm
    (last visited Jan. 3, 2013).
    6
    bringing their claim, as Ms. Cauthen did not satisfy
    § I.46.a(2)(c) of the Settlement Agreement. The Cauthens
    declined to drop the lawsuit. Wyeth then filed a motion in the
    District Court seeking to enjoin the Cauthens‟ state court
    lawsuit for failing to satisfy the precondition for suit provided
    by the Settlement Agreement. Opposing Wyeth‟s motion, the
    Cauthens submitted a declaration by Dr. Fortin stating that,
    “to a reasonable degree of medical certainty[,] … Ms.
    Cauthen has primary pulmonary hypertension secondary to
    her use of [one of the diet drugs] in early 1997.” (Id. at 808.)
    In her declaration, Dr. Fortin alluded to the
    requirement in § I.46.a(2)(c) of the Settlement Agreement
    that lung capacity must be greater than 60 percent of
    predicted at rest, and she said that “[i]nsight into underlying
    pathophysiology can often be gained by comparing the
    measured values for pulmonary function tests obtained on a
    patient at any particular point with normative values derived
    from population studies.” (Id. at 809.) “The percentage of
    predicted normal [lung capacity],” she continued, “is used to
    grade the severity of the abnormality.” (Id.) She explained
    that the normative values used to calculate a patient‟s
    percentage of lung capacity predicted at rest “are based upon
    averages for persons of similar height, weight, age, ethnicity,
    etc.” (Id.) According to Dr. Fortin, the “standard average
    reference” used to calculate Ms. Cauthen‟s percentage of lung
    capacity was 5.37 liters, a value “taken from the Crapo/Hsu
    Duke modified guide at [Duke] University.” (Id. at 810.) Dr.
    Fortin further explained that, through a battery of tests
    conducted on April 28, 2009, she had determined that Ms.
    Cauthen had a lung capacity of 3.03 liters. Dividing 3.03
    (Ms. Cauthen‟s lung capacity) by 5.37 (the average lung
    capacity of individuals matching Ms. Cauthen‟s demographic
    7
    profile), yields Ms. Cauthen‟s percentage of lung capacity
    predicted at rest, 56.4 percent.
    Dr. Fortin went on to downplay that result by
    challenging the accuracy of the denominator in the above
    equation. The figures used to represent average lung capacity
    by demographic characteristics, she asserted, “are only
    averages and may vary in actual practice.” (Id. at 809.) “The
    5.37 liter reference is only a reference value,” she continued,
    “and does not actually represent M[s]. Cauthen‟s total lung
    capacity. … [T]he 5.37 liter reference value is just a
    predicted average of [a] wom[a]n‟s total lung capacity who
    fits Ms. Cauthen‟s age, height, race and weight.” (Id. at 810.)
    In fact, Dr. Fortin claimed, the value taken from the
    Crapo/Hsu Duke modified guide “is just one of the many
    references available that are out there.” (Id.) Without
    providing any other reference, Dr. Fortin concluded “to a
    reasonable degree of medical certainty that we just do not
    know conclusively what the true reference value for Ms.
    Cauthen should be.” (Id.) Dr. Fortin did offer, however, that,
    “[i]f we were to use a reference value of 5.05, just 32ccs less
    than the 5.37 reference originally used[,] then Ms. Cauthen‟s
    total lung capacity percent predicted calculation would be
    60%.” (Id. at 811.)
    Dr. Fortin also asserted that comparing an individual‟s
    lung capacity with the average capacity of persons having a
    similar demographic profile is important but not
    determinative in diagnosing PPH. “Cardiologists,” she
    assured the District Court, “know about the limitations of the
    percent predicted calculation on a [PFT] and must rely on
    other methods in order to determine a specific patient‟s true
    total lung capacity, such as radiology studies and an exam of
    8
    the patient‟s body habitus.” (Id. at 810.) In fact, Dr. Fortin
    claimed, “whether [Ms. Cauthen‟s] total lung capacity percent
    predicted calculation is 56% or 60% is clinically irrelevant”
    (id.), and “Ms. Cauthen‟s diet drug use was the cause of her
    [PPH]” (id. at 811). Without further explanation, Dr. Fortin
    declared that, “[b]ased upon [her] review of the April 28,
    2009 Pulmonary Function Test and other objective tests,”3
    she had “ruled out any restrictive lung disease as a cause of
    Ms. Cauthen‟s [PPH].” (Id.)
    Unconvinced, the District Court held that the Cauthens
    had not produced a PFT that supported their claim that Ms.
    Cauthen “does not have greater than mild restrictive lung
    disease,” as required by § I.46.a(2)(c) of the Settlement
    Agreement. (Id. at 7.) Dr. Fortin‟s declaration did not alter
    the Court‟s conclusion for two reasons. First, the doctor
    acknowledged that Ms. Cauthen‟s only PFT demonstrated
    that she has a total lung capacity of only 56 percent of
    predicted at rest. Ms. Cauthen thus did not meet the
    definition of PPH provided in § I.46.a(2)(c). Second, the
    Settlement Agreement requires class members who wish to
    make a claim related to PPH to establish, “through a
    pulmonary function test only, the absence of greater than mild
    restrictive lung disease.” (Id. at 6.). Because Dr. Fortin‟s
    declaration is not the type of medical record contemplated in
    the Settlement Agreement as sufficient to establish a PPH
    claim, the Court held that it was not relevant to determining
    whether Ms. Cauthen satisfies § I.46.a(2)(c).
    3
    Dr. Fortin did not explain what those tests were or
    how they led her to her ultimate diagnosis.
    9
    The District Court accordingly entered PTO No. 8753
    granting Wyeth‟s motion and enjoining the Cauthens from
    prosecuting their lawsuit in state court. The Cauthens then
    filed this timely appeal.
    II.    Discussion4
    On appeal, the Cauthens argue that the District Court
    erred in two general ways. First, they claim that the District
    Court misunderstood Dr. Fortin‟s declaration and that her
    declaration demonstrates that Ms. Cauthen in fact has PPH
    that was caused by her use of the diet drugs and not by mild
    restrictive lung disease. Second, they argue in the alternative
    that, even if Ms. Cauthen does not meet the technical
    definition of PPH provided by the Settlement Agreement, the
    District Court should have reformed the Settlement
    Agreement, given changes in diagnostic capabilities that have
    rendered obsolete the requirement that a putative plaintiff
    4
    The District Court had jurisdiction pursuant to 28
    U.S.C §§ 1332 and 1407. The District Court‟s order directing
    the Cauthens to dismiss their complaint in the Court of
    Common Pleas of Philadelphia County is an injunction, and
    we therefore have jurisdiction under 
    28 U.S.C. § 1292
    (a)(1).
    We apply “plenary review to a district court‟s construction of
    settlement agreements,” but we review any underlying factual
    findings for clear error. Coltec Indus., Inc. v. Hobgood, 
    280 F.3d 262
    , 269 (3d Cir. 2002); cf. In re Cendant Corp. Prides
    Litig., 
    233 F.3d 188
    , 193 (3d Cir. 2000) (“[C]ontract
    construction, that is, the legal operation of the contract, is a
    question of law mandating plenary review,” while “contract
    interpretation is a question of fact, and review is according to
    the clearly erroneous standard.”).
    10
    demonstrate lung capacity greater than 60 percent of
    predicted at rest.
    A.     The Effect of Dr. Fortin’s Declaration
    Settlement agreements are interpreted according to
    “basic contract principles.” In re Cendant Corp. Prides
    Litig., 
    233 F.3d 188
    , 193 (3d Cir. 2000). When the terms of a
    contract are clear and unambiguous, its meaning “must be
    determined from the four corners of the contract.” Glenn
    Distribs. Corp. v. Carlisle Plastics, Inc., 
    297 F.3d 294
    , 300
    (3d Cir. 2002); see also Am. Eagle Outfitters v. Lyle & Scott
    Ltd., 
    584 F.3d 575
    , 587 (3d Cir. 2009) (“When the words are
    clear and unambiguous, the intent of the parties must be
    determined from the express language of the agreement.”
    (internal quotation marks omitted)). In contrast, “if the
    written contract is ambiguous, a court may look to extrinsic
    evidence to resolve the ambiguity and determine the intent of
    the parties.” Glenn Distribs., 
    297 F.3d at 300
    . A contract
    provision is ambiguous under Pennsylvania law5
    if, and only if, it is reasonably or fairly
    susceptible of different constructions and is
    capable of being understood in more senses
    than one and is obscure in meaning through
    indefiniteness of expression or has a double
    meaning. A contract is not ambiguous if the
    court can determine its meaning without any
    guide other than a knowledge of the simple
    5
    The parties agree that Pennsylvania law controls this
    issue.   (See Appellants‟ Opening Br. at 29 (citing
    Pennsylvania contract law); Appellee‟s Br. at 13 (same).)
    11
    facts on which, from the nature of the language
    in general, its meaning depends; and a contract
    is not rendered ambiguous by the mere fact that
    the parties do not agree on the proper
    construction.
    Duquesne Light Co. v. Westinghouse Elec. Corp., 
    66 F.3d 604
    , 614 (3d Cir. 1995) (internal quotation marks omitted).
    Under those standards, we cannot credit the Cauthens‟
    arguments that Dr. Fortin‟s declaration either supplanted the
    requirements of the Settlement Agreement or otherwise
    satisfied them.
    First, the Cauthens contend that, because a board
    certified cardiologist “determined that Ms. Cauthen‟s PPH is
    not related to … restrictive lung disease,” Ms. Cauthen “has
    the right to make a claim against [Wyeth] for PPH under the
    definition of PPH in the Settlement Agreement” (Appellants‟
    Opening Br. at 27), notwithstanding that her sole PFT showed
    her total lung capacity to be less than 60 percent of predicted
    at rest. Specifically, the Cauthens point to Dr. Fortin‟s
    statements that “whether [Ms. Cauthen‟s] total lung capacity
    percent calculation is 56% or 60% is clinically irrelevant”
    (App. at 810), and that, “to a reasonable degree of medical
    certainty[,] … Ms. Cauthen‟s diet drug use was the cause of
    her primary pulmonary hypertension.” (Id. at 811.)
    According to their argument, the District Court should have
    disregarded the requirements of the Settlement Agreement
    because a physician unilaterally declared that Ms. Cauthen
    has PPH that was caused by the diet drugs and not restrictive
    lung disease.
    12
    The Settlement Agreement, however, clearly and
    unambiguously states that a putative PPH plaintiff must
    demonstrate, through a PFT, that her total lung capacity is
    greater than 60 percent of predicted at rest. That is the only
    way, under the specific terms of that agreement, to rule out
    “greater than mild restrictive lung disease” as a cause of PPH.
    Ms. Cauthen produced only one PFT, which showed that her
    lung capacity was only 56 percent of predicted at rest. Her
    physician‟s confident assertion that Ms. Cauthen‟s PPH was
    caused by the diet drugs is therefore irrelevant in the face of
    the Settlement Agreement, which requires a showing that a
    putative plaintiff‟s lung capacity is greater than 60 percent of
    predicted at rest.
    Second, the Cauthens argue that Dr. Fortin‟s
    declaration is not meant to replace the requirements of
    § I.46.a(2)(c), but rather that the declaration is a “medical
    record” that confirms the absence of greater than mild
    restrictive lung disease. (See Appellants‟ Opening Br. at 25
    (when considered in light of Dr. Fortin‟s declaration, “Ms.
    Cauthen has presented a pulmonary function test to
    demonstrate that she has PPH in accord with the
    settlement”).)     Dr. Fortin‟s declaration, they contend,
    “demonstrates a lung capacity of at least 60% when the 5.37
    total lung volume … is even slightly reduced to reflect the
    Plaintiff‟s true lung capacity in the algorithmic formula used
    to calculate lung function.” (Appellants‟ Opening Br. at 25-
    26.) The District Court therefore erred, the Cauthens argue,
    when it did not interpret the declaration to mean that Ms.
    Cauthen‟s percentage of lung capacity predicted at rest was
    actually greater than 60 percent, or, at least, a jury should be
    given the chance to so conclude.
    13
    Even if the Settlement Agreement could be read to
    allow Dr. Fortin‟s declaration to be an adequate substitute for
    or adjunct to a PFT, however, the Cauthens have overstated
    Dr. Fortin‟s position. She never said that Ms. Cauthen‟s lung
    capacity is actually greater than 60 percent of predicted at
    rest, only that it cannot be known “what the true reference
    value for Ms. Cauthen should be.”            (App. at 810.)
    Accordingly, the Cauthens cannot credibly say that Dr.
    Fortin‟s declaration establishes that Ms. Cauthen‟s lung
    capacity is greater than 60 percent.6 The District Court
    6
    The Cauthens contend that this case should be
    governed by PTO No. 3699, a case in which the District
    Court considered and accepted a medical expert‟s declaration
    as a means of satisfying a separate provision of the Settlement
    Agreement. There, the District Court interpreted a provision
    of the PPH exception that requires a putative plaintiff to
    produce “a diagnosis based on examinations and clinical
    findings … by cardiac catheterization” that the plaintiff‟s
    “normal pulmonary artery wedge pressure” is less than or
    equal to 15 mm Hg. (App. at 42.10 (Settlement Agreement,
    § I.46.a(1)(a)).) The putative plaintiff produced a “Cardiac
    Catheterization Report” showing a wedge pressure range of
    14 to 16 mm Hg. (App. at 14.) Because the report straddled
    the range of the PPH exception, the District Court considered
    a declaration by the plaintiff‟s medical expert who reviewed
    the cardiac catheterization report and opined that the
    plaintiff‟s “wedge pressure [was] 14 mm Hg” and thus fell
    under the wedge pressure requirement. (App. at 14.) Based
    on that declaration, the Court found that the plaintiff satisfied
    the PPH exception and declined to enjoin his claims.
    The facts of PTO No. 3699 are much different than
    those of this case. Whereas the results of the cardiac
    14
    therefore did not err in concluding that the Settlement
    Agreement unambiguously requires a showing through a PFT
    that a putative plaintiff‟s lung capacity is greater than 60
    percent of predicted at rest and that Dr. Fortin‟s declaration
    did not provide that showing.7
    catheterization report in PTO No. 3699 spanned the threshold
    wedge pressure value required by the Settlement Agreement,
    hindering the District Court‟s ability to determine whether the
    putative plaintiff‟s pressure fell outside the PPH exception
    (greater than 15 mm Hg), or within it (less than or equal to 15
    mm Hg), Ms. Cauthen‟s PFT unambiguously falls short of the
    PPH exception embodied in § I.46.a(2)(c). The District Court
    did not need the assistance of a medical expert to understand
    that a lung capacity percentage that is less than 60 percent of
    predicted at rest falls outside the exception.
    7
    The Cauthens also argue that the District Court
    should have allowed a jury to consider Dr. Fortin‟s
    declaration under rule 702 of the Federal Rules of Evidence.
    They assert that because Dr. Fortin is unquestionably an
    expert in the field of cardiac medicine, her opinion “would be
    admissible in a court of law” (Appellants‟ Opening Br. at 37),
    and because her opinion would be admissible, it would “[b]y
    definition … have a reasonable medical basis in fact.” (Id.)
    The District Court accordingly exceeded its authority as a
    gatekeeper, they argue, by rejecting Dr. Fortin‟s expert
    opinion as “evidence that could not be considered under the
    strictures of the Settlement Agreement.” (Id. at 38.)
    But the Cauthens have not established the
    requirements of rule 702. First, Dr. Fortin‟s specialized
    medical knowledge, as embodied in her declaration, would
    not “help the trier of fact to understand the evidence or to
    15
    determine a fact in issue.” Fed. R. Evid. 702(a). To
    determine whether a declaration is helpful, this Court looks to
    the “„proffered connection between the scientific research or
    test result to be presented and particular disputed factual
    issues in the case.‟” In re Paoli R.R. Yard PCB Litig., 
    35 F.3d 717
    , 743 (3d Cir. 1994) (quoting United States v.
    Downing, 
    753 F.2d 1224
    , 1237 (3d Cir. 1985)); see also
    Daubert v. Merrell Dow Pharm., Inc., 
    509 U.S. 579
    , 591
    (1993) (adopting Downing‟s connection requirement). A
    court “must examine the expert‟s conclusions in order to
    determine whether they could reliably flow from the facts
    known to the expert and methodology used.” Oddi v. Ford
    Motor Co., 
    234 F.3d 136
    , 146 (3d Cir. 2000) (internal
    quotation marks omitted). Even if a party proffers expert
    testimony based on scientific knowledge, “„[a] court may
    conclude that there is simply too great a gap between the data
    and the opinion proffered.‟” 
    Id.
     (quoting Gen. Elec. Co. v.
    Joiner, 
    522 U.S. 136
    , 146 (1997)). “Rule 702‟s „helpfulness‟
    standard requires a valid scientific connection to the pertinent
    inquiry as a precondition to admissibility.” In re Paoli, 
    35 F.3d at 743
     (internal quotation marks omitted).
    Dr. Fortin‟s declaration did not conclude that Ms.
    Cauthen‟s total lung capacity is greater than 60 percent of
    predicted at rest. She asserted only that Ms. Cauthen‟s lung
    capacity percentage cannot be determined because “we just
    do not know conclusively what the true reference value for
    Ms. Cauthen should be.” (App. at 810.) That cannot help the
    trier of fact reach the necessary conclusion that Ms.
    Cauthen‟s total lung capacity, demonstrated by a PFT to be
    3.03 liters, is greater than 60 percent of predicted at rest. At
    best, Dr. Fortin‟s declaration would provide evidence that Ms.
    Cauthen‟s total lung capacity predicted at rest might not be 56
    16
    B.     The Cauthens’ Reformation Argument
    In the alternative, the Cauthens contend that the
    District Court, which “retains a special responsibility to see to
    the administration of justice” in a class action settlement
    (Appellants‟ Opening Br. at 35 (internal quotation marks
    omitted)), should have reformed the Settlement Agreement.
    Although they never sought reformation of the Settlement
    Agreement before the District Court, they now argue that the
    Court should have reformed the Settlement Agreement
    because diagnostic procedures for PFTs have changed. They
    claim support for that argument in the following statement in
    Dr. Fortin‟s declaration:
    Automated spirometry systems usually have
    built-in software that can generate a preliminary
    interpretation, especially for spirometry.
    Today, most clinical pulmonary function testing
    laboratories use a microprocessor-driven
    pneumotachometer to measure air flow directly
    and then to mathematically derive volume.
    These pre-programmed values are based upon
    averages for persons of similar height, weight,
    age, ethnicity, etc.
    percent. But a trier of fact could not use the declaration to
    conclude that Ms. Cauthen‟s total lung capacity is actually
    greater than 60 percent, and Dr. Fortin failed entirely to
    provide the “scientific connection” needed to bridge the gap
    between a percentage of lung capacity that falls below 60
    percent and one that does not. Accordingly, Dr. Fortin‟s
    declaration is not an expert opinion that could be “helpful” to
    a trier of fact, even if there were a fact question.
    17
    (App. at 809.) Placing emphasis on the word “today,” the
    Cauthens interpret that statement to mean that “on the modern
    pneumotachometers used at the present time, pre-
    programmed algorithms measure air flow directly and then
    mathematically derive volume, precluding manual
    adjustments to the algorithms that were permitted on the older
    machines in use when the Settlement Agreement was
    negotiated and entered.” (Appellants‟ Opening Br. at 23-24.)
    Essentially, the Cauthens argue that modern diagnostic
    instruments are cause for reformation of the agreement.
    Because they did not raise that argument below, it is
    waived. “It is axiomatic that arguments asserted for the first
    time on appeal are deemed to be waived and consequently are
    not susceptible to review in this Court absent exceptional
    circumstances.” Tri-M Grp., L.L.C. v. Sharp, 
    638 F.3d 406
    ,
    416 (3d Cir. 2011) (internal quotation marks omitted). That
    “general rule serves several important judicial interests,”
    including “protecting litigants from unfair surprise;
    promoting the finality of judgments and conserving judicial
    resources; … preventing district courts from being reversed
    on grounds that were never urged or argued before them,” 
    id.
    (alteration and internal quotation marks omitted), “ensuring
    that the necessary evidentiary development occurs in the trial
    court, and preventing surprise to the parties when a case is
    decided on some basis on which they have not presented
    argument,” Barefoot Architect, Inc. v. Bunge, 
    632 F.3d 822
    ,
    835 (3d Cir. 2011).
    It is true that the waiver rule “is one of discretion
    rather than jurisdiction, and it may be relaxed whenever the
    public interest so warrants.”       
    Id. at 834-35
     (citation,
    alteration, and internal quotation marks omitted). “[W]e will
    18
    still address arguments raised for the first time on appeal in
    exceptional circumstances,” and we retain the discretion,
    “exercised on the facts of individual cases,” to determine
    “what questions may be taken up and resolved for the first
    time on appeal.” Tri-M Grp., 
    638 F.3d at 416
     (internal
    quotation marks omitted). But there are no exceptional
    circumstances in this case that would permit us to ignore the
    waiver rule. “The waiver rule applies with greatest force
    where the timely raising of the issue would have permitted
    the parties to develop a factual record.” Barefoot Architect,
    
    632 F.3d at 835
    . The parties did not develop in the District
    Court the arguments in favor and against reformation, and
    that Court was not allowed to perform its vital function of
    developing a complete factual record on the relevant changes,
    if any, in diagnostic technology and procedures. Without the
    aid of factual development by the District Court, we cannot
    adequately evaluate the merit of Dr. Fortin‟s assertion that
    diagnostic technologies have changed to such a degree that
    reformation is called for.8
    8
    Even in the absence of a waiver, it appears that the
    Cauthens would have difficulty with the merits of their
    argument. While a district court retains “general equitable
    power to modify the terms of a class action settlement,” In re
    Cendant, 
    233 F.3d at 194
    , when the plaintiff demonstrates
    that there has been “a significant change either in factual
    conditions or in law,” Rufo v. Inmates of Suffolk Cnty. Jail,
    
    502 U.S. 367
    , 384 (1992), Dr. Fortin‟s declaration alone
    provides little proof that diagnostic procedures have indeed
    changed to the degree that reformation is warranted. Dr.
    Fortin said that “[t]oday, most … laboratories use a
    microprocessor-driven pneumotachometer.” (App. at 809.)
    She did not, however, explain how diagnostic procedures
    19
    III.   Conclusion
    For the foregoing reasons, we will affirm the decision
    of the District Court.
    were different in the past or why the recent changes create the
    need to reform the Settlement Agreement.
    20