Barnes v. Amer Tobacco Co ( 1998 )


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  •                                                                                                                            Opinions of the United
    1998 Decisions                                                                                                             States Court of Appeals
    for the Third Circuit
    11-16-1998
    Barnes v. Amer Tobacco Co
    Precedential or Non-Precedential:
    Docket 97-1844
    Follow this and additional works at: http://digitalcommons.law.villanova.edu/thirdcircuit_1998
    Recommended Citation
    "Barnes v. Amer Tobacco Co" (1998). 1998 Decisions. Paper 265.
    http://digitalcommons.law.villanova.edu/thirdcircuit_1998/265
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    Filed November 16, 1998
    UNITED STATES COURT OF APPEALS
    FOR THE THIRD CIRCUIT
    No. 97-1844
    WILLIAM BARNES; CIARAN McNALLY; CATHERINE
    POTTS; NORMA RODWELLER; BARBARA SALZMAN;
    EDWARD SLIVAK; JOHN TEAGLE, ON BEHALF OF
    THEMSELVES AND ALL OTHERS SIMILARLY SITUATED
    v.
    THE AMERICAN TOBACCO COMPANY; AMERICAN
    BRANDS, INC.; R.J. REYNOLDS TOBACCO COMPANY;
    RJR NABISCO, INC.; BROWN & WILLIAMSON TOBACCO
    CORPORATION; BATUS, INC.; BATUS HOLDINGS, INC.;
    B.A.T. INDUSTRIES, P.L.C.; PHILIP MORRIS, INC.; PHILIP
    MORRIS COMPANIES, INC.; LORILLARD TOBACCO
    COMPANY, INC.; LORILLARD, INC.; LOEWS
    CORPORATION; UNITED STATES TOBACCO COMPANY;
    UST, INC.; THE TOBACCO INSTITUTE, INC.; THE
    COUNCIL FOR TOBACCO RESEARCH-U.S.A., INC.;
    LIGGETT GROUP, INC.; LIGGETT & MYERS, INC.;
    BROOKE GROUP, LTD.; PENNSYLVANIA DISTRIBUTORS
    ASSOCIATION, INC.; UNITED WHOLESALE TOBACCO
    AND CANDY, d/b/a UNITED VENDING SERVICE, INC.;
    BRITISH AMERICAN TOBACCO COMPANY
    William Barnes, Ciaran McNally, Catherine
    Potts, Norma Rodweller, Barbara Salzman
    and Edward Slivak, on behalf of themselves
    and all those similarly situated,
    Appellants
    On Appeal from the United States District Court
    for the Eastern District of Pennsylvania
    (D.C. Civil Action No. 96-cv-05903)
    Argued June 4, 1998
    Before: SCIRICA, NYGAARD and SEITZ,*
    Circuit Judges
    ORDER AMENDING SLIP OPINION
    IT IS HEREBY ORDERED that the slip opinion in the
    above case, filed November 12, 1998, be amended as
    follows:
    1. In the following lines of the slip opinion, delete the
    word "FRAUD" and insert "F.R.D.":
    Page   17,   line 21;
    Page   25,   lines 22 and 35;
    Page   27,   line 4;
    Page   27,   footnote 15, line   15;
    Page   27,   footnote 16, line   5;
    Page   28,   lines 7 and 27;
    Page   29,   footnote 17, line   14;
    Page   30,   lines 2 and 5;
    Page   31,   lines 26 and 30;
    Page   32;   lines 15 and 18;
    Page   32,   footnote 19, line   5.
    2. Page 21, line 24: Delete the period following the word
    "judgment".
    3. Page 24, line 20: Delete the left parenthesis before the
    word "medical".
    4. Page 48, line 2: Delete the left parenthesis before the
    word "damages".
    THE COURT,
    /s/Anthony J. Scirica
    Circuit Judge
    DATED: November 16, 1998
    _________________________________________________________________
    *Judge Seitz heard argument in this matter but was unable to clear the
    opinion.
    2
    CORRECTED REPRINT
    Filed November 12, 1998
    UNITED STATES COURT OF APPEALS
    FOR THE THIRD CIRCUIT
    No. 97-1844
    WILLIAM BARNES; CIARAN McNALLY; CATHERINE
    POTTS; NORMA RODWELLER; BARBARA SALZMAN;
    EDWARD SLIVAK; JOHN TEAGLE, ON BEHALF OF
    THEMSELVES AND ALL OTHERS SIMILARLY SITUATED
    v.
    THE AMERICAN TOBACCO COMPANY; AMERICAN
    BRANDS, INC.; R.J. REYNOLDS TOBACCO COMPANY;
    RJR NABISCO, INC.; BROWN & WILLIAMSON TOBACCO
    CORPORATION; BATUS, INC.; BATUS HOLDINGS, INC.;
    B.A.T. INDUSTRIES, P.L.C.; PHILIP MORRIS, INC.; PHILIP
    MORRIS COMPANIES, INC.; LORILLARD TOBACCO
    COMPANY, INC.; LORILLARD, INC.; LOEWS
    CORPORATION; UNITED STATES TOBACCO COMPANY;
    UST, INC.; THE TOBACCO INSTITUTE, INC.; THE
    COUNCIL FOR TOBACCO RESEARCH-U.S.A., INC.;
    LIGGETT GROUP, INC.; LIGGETT & MYERS, INC.;
    BROOKE GROUP, LTD.; PENNSYLVANIA DISTRIBUTORS
    ASSOCIATION, INC.; UNITED WHOLESALE TOBACCO
    AND CANDY, d/b/a UNITED VENDING SERVICE, INC.;
    BRITISH AMERICAN TOBACCO COMPANY
    William Barnes, Ciaran McNally, Catherine Potts,
    Norma Rodweller, Barbara Salzman and Edward
    Slivak, on behalf of themselves and all those
    similarly situated,
    Appellants
    On Appeal from the United States District Court
    for the Eastern District of Pennsylvania
    (D.C. Civil Action No. 96-cv-05903)
    Argued June 4, 1998
    Before: SCIRICA, NYGAARD and SEITZ,* Circuit Judges
    (Filed November 12, 1998)
    ROBERT J. LaROCCA, ESQUIRE
    (ARGUED)
    Ryan, Brown, McDonnell, Berger &
    Gibbons
    1600 Market Street, Suite 3850
    Philadelphia, Pennsylvania 19103
    ARNOLD LEVIN, ESQUIRE
    (ARGUED)
    Levin, Fishbein, Sedran & Berman
    510 Walnut Street, Suite 500
    Philadelphia, Pennsylvania 19106
    DIANNE M. NAST, ESQUIRE
    Roda & Nast
    801 Estelle Drive
    Lancaster, Pennsylvania 17601
    JULIA W. McINERNY, ESQUIRE
    Coale, Cooley, Leitz, McInerny &
    Broadus
    818 Connecticut Avenue, N.W.,
    Suite 857
    Washington, D.C. 20006
    _________________________________________________________________
    *Judge Seitz heard argument in this matter but was unable to clear the
    opinion.
    2
    GARY R. FINE, ESQUIRE
    Rodham & Fine
    633 Southeast Third Avenue,
    Suite 4R
    Fort Lauderdale, Florida 33301
    THOMAS E. MELLON, JR.,
    ESQUIRE
    Mellon, Webster & Mellon
    87 North Broad Street
    Doylestown, Pennsylvania 18901
    STEPHEN A. SHELLER, ESQUIRE
    Sheller, Ludwig & Badey
    1528 Walnut Street, 3rd Floor
    Philadelphia, Pennsylvania 19102
    Attorneys for Appellants
    HUGH R. WHITING, ESQUIRE
    Jones, Day, Reavis & Pogue
    901 Lakeside Avenue, North Point
    Cleveland, Ohio 44114
    MORTON F. DALLER, ESQUIRE
    EDWARD A. GREENBERG,
    ESQUIRE
    GERHARD P. DIETRICH, ESQUIRE
    Daller, Greenberg & Dietrich
    Valley Green Corporate Center
    7111 Valley Green Road
    Fort Washington, Pennsylvania
    19034
    Attorneys for Appellee,
    R.J. Reynolds Tobacco Company
    DANIEL F. KOLB, ESQUIRE
    ANNE B. HOWE, ESQUIRE
    Davis, Polk & Wardwell
    450 Lexington Avenue
    New York, New York 10017
    3
    MORTON F. DALLER, ESQUIRE
    EDWARD A. GREENBERG,
    ESQUIRE
    GERHARD P. DIETRICH, ESQUIRE
    Daller, Greenberg & Dietrich
    Valley Green Corporate Center
    7111 Valley Green Road
    Fort Washington, Pennsylvania
    19034
    Attorneys for Appellee,
    RJR Nabisco, Inc.
    JAMES L. GRIFFITH, ESQUIRE
    Klett, Lieber, Rooney & Schorling
    18th and Arch Streets
    Two Logan Square, 12th Floor
    Philadelphia, PA 19103
    VIRGINIA L. HOGBEN, ESQUIRE
    Wolf, Block, Schorr & Solis-Cohen
    Packard Building, 12th Floor
    15th and Chestnut Streets
    Philadelphia, Pennsylvania 19102
    PETER S. GREENBERG, ESQUIRE
    Schnader, Harrison, Segal & Lewis
    1600 Market Street, Suite 3600
    Philadelphia, Pennsylvania 19103
    GARY R. LONG, ESQUIRE
    SHANNON L. SPANGLER, ESQUIRE
    Shook, Hardy & Bacon
    One Kansas City Place
    1200 Main Street
    Kansas City, Missouri 64105
    Attorneys for Appellee,
    Brown & Williamson Tobacco
    Corporation
    4
    ROBERT C. HEIM, ESQUIRE
    (ARGUED)
    JEFFREY G. WEIL, ESQUIRE
    Dechert, Price & Rhoads
    4000 Bell Atlantic Tower
    1717 Arch Street
    Philadelphia, Pennsylvania 19103
    Attorneys for Appellees,
    Philip Morris, Inc. and Philip
    Morris Companies, Inc.
    WILLIAM J. O'BRIEN, ESQUIRE
    HOWARD M. KLEIN, ESQUIRE
    Conrad, O'Brien, Gellman & Rohn
    1515 Market Street, 16th Floor
    Philadelphia, Pennsylvania 19102
    GARY R. LONG, ESQUIRE
    SHANNON L. SPANGLER, ESQUIRE
    Shook, Hardy & Bacon
    One Kansas City Place
    1200 Main Street
    Kansas City, Missouri 64105
    Attorneys for Appellees,
    Lorillard Tobacco Company, Inc.
    and Lorillard, Inc.
    WILLIAM J. O'BRIEN, ESQUIRE
    HOWARD M. KLEIN, ESQUIRE
    Conrad, O'Brien, Gellman & Rohn
    1515 Market Street, 16th Floor
    Philadelphia, Pennsylvania 19102
    Attorneys for Appellee,
    The Tobacco Institute, Inc.
    5
    PATRICK W. KITTREDGE, ESQUIRE
    GARY M. MAREK, ESQUIRE
    Kittredge, Donley, Elson, Fullem &
    Embick
    421 Chestnut Street, Fifth Floor
    Philadelphia, Pennsylvania 19106
    Attorneys for Appellee,
    The Council for Tobacco Research-
    U.S.A., Inc.
    J. KURT STRAUB, ESQUIRE
    (ARGUED)
    Obermayer, Rebmann, Maxwell &
    Hippel
    One Penn Center, 19th Floor
    1617 John F. Kennedy Boulevard
    Philadelphia, Pennsylvania 19103
    Attorney for Appellees,
    Liggett Group, Inc., Liggett &
    Myers, Inc. and Brooke Group,
    Ltd.
    OPINION OF THE COURT
    SCIRICA, Circuit Judge.
    In this suit against the major American tobacco
    companies, we must decide whether a medical monitoring
    class should be certified under Federal Rule of Civil
    Procedure 23(b)(2). The District Court decertified a
    proposed class of cigarette smokers on the grounds that
    significant individual issues precluded certification. After
    finding the statute of limitations had run with respect to
    the claims of five named plaintiffs and the sixth had failed
    to establish the need for medical monitoring, the District
    Court granted defendants summary judgment. We will
    affirm the District Court's decertification order and its grant
    of summary judgment.
    6
    I.
    FACTS AND PROCEDURAL HISTORY
    Named plaintiffs William Barnes, Catherine Potts, Norma
    Rodweller, Barbara Salzman, Edward J. Slivak, and Ciaran
    McNally are Pennsylvania residents who began smoking
    cigarettes before the age of 15 and have smoked for many
    years. Plaintiffs filed suit against the defendant tobacco
    companies1 in the Court of Common Pleas of Philadelphia
    County. Defendants removed to the Eastern District of
    Pennsylvania, and plaintiffs filed an Amended Complaint
    asserting claims of intentional exposure to a hazardous
    substance, negligence, and strict products liability on
    behalf of a purported class of over one million Pennsylvania
    cigarette smokers. In their prayer for relief, plaintiffs asked
    (1) that defendants fund a court-supervised or court-
    approved program providing medical monitoring to class
    members; (2) for punitive damages to create a fund for
    common class-wide purposes, including medical research,
    public education campaigns, and smoking cessation
    programs; and (3) for other monetary and injunctive relief
    the court deemed just and proper.
    A.
    The District Court found the class did not meet the
    requirements of Rule 23(b)(2) or (b)(3). See Arch v. The
    American Tobacco Co., 
    175 F.R.D. 469
    (E.D. Pa. 1997). The
    District Court rejected Rule 23(b)(2) certification because
    plaintiffs had not primarily sought injunctive or equitable
    _________________________________________________________________
    1. The defendants are The American Tobacco Company, Inc.; American
    Brands, Inc.; R.J. Reynolds Tobacco Company; RJR Nabisco, Inc.; Brown
    & Williamson Tobacco Corporation; Philip Morris, Inc.; Philip Morris
    Companies, Inc.; Lorillard Tobacco Company, Inc.; Lorillard, Inc.; United
    States Tobacco Company; UST, Inc.; The Tobacco Institute, Inc.; The
    Council for Tobacco Research-U.S.A., Inc.; Liggett Group, Inc.; Liggett &
    Myers, Inc.; Brooke Group, LTD. Pursuant to the parties' stipulations,
    American Brands, Inc.; Batus, Inc.; Batus Holdings, Inc., Loews
    Corporation, and UST, Inc. have been dismissed from this action without
    prejudice. In addition, B.A.T. Industries p.l.c. was dismissed for lack of
    personal jurisdiction by order of the District Court dated June 21, 1997.
    7
    relief, finding that "[p]laintiffs' medical monitoring claim is
    merely a thinly disguised claim for future damages" and
    that "the overwhelming majority of the relief sought by
    plaintiffs in their entire complaint is monetary in nature."
    
    Id. at 484.
    The court also found certification improper
    under Rule 23(b)(3) because issues common to the class did
    not predominate over plaintiffs' individual issues. In
    particular, the District Court found individual issues, such
    as addiction, causation, the need for medical monitoring,
    and affirmative defenses, made a class action
    unmanageable and not the superior method for fair and
    efficient adjudication of the case. 
    Id. at 485-96.
    The District Court suggested, however, that plaintiffs'
    request for a court-supervised program of medical
    monitoring to detect the latent diseases caused by smoking
    was the "paradigmatic" request for injunctive relief under a
    medical monitoring claim. 
    Id. at 484.
    Specifically, the court
    stated:
    The Court finds that it may properly certify a medical
    monitoring claim under Rule 23(b)(2) when the
    plaintiffs seek such specific relief which can be
    properly characterized as invoking the court's equitable
    powers. See [Day v. NLO, Inc., 
    144 F.R.D. 330
    , 336
    (S.D. Ohio 1992), rev'd on other grounds, 
    5 F.3d 154
           (6th Cir. 1993)]; see also Fried v. Sunguard Recovery
    Serv., Inc., 
    925 F. Supp. 372
    (E.D. Pa. 1996). In
    reaching this decision, the Court perforce rejects
    defendants' argument that a medical monitoring claim
    can never be characterized as injunctive.
    The dispositive factor that must be assessed to
    determine whether a medical monitoring claim can be
    certified as a Rule 23(b)(2) class is-what type of relief
    do plaintiffs actually seek. If plaintiffs seek relief that is
    a disguised request for compensatory damages, then
    the medical monitoring claim can only be characterized
    as a claim for monetary damages. In contrast, if
    plaintiffs seek the establishment of a court-supervised
    medical monitoring program through which the class
    members will receive periodic medical examinations,
    then plaintiffs' medical monitoring claims can be
    8
    properly characterized as claim seeking injunctive
    relief.
    In Day, Judge Spiegel cogently articulates the fine
    distinction between a medical monitoring claim that
    seeks monetary relief in the form of compensatory
    damages and a medical monitoring claim that seeks
    injunctive relief in the form of a court-supervised
    medical monitoring program. Judge Spiegel explains:
    Relief in the form of medical monitoring may be by
    a number of means. First, a court may simply order
    a defendant to pay a plaintiff a certain sum of
    money. The plaintiff may or may not choose to use
    that money to have his medical condition monitored.
    Second, a court may order the defendants to pay the
    plaintiffs' medical expenses directly so that a plaintiff
    may be monitored by the physician of his choice.
    Neither of these forms of relief constitute injunctive
    relief as required by Rule 23(b)(2).
    However, a court may also establish an elaborate
    medical monitoring program of its own, managed by
    court-appointed court-supervised trustees, pursuant
    to which a plaintiff is monitored by particular
    physicians and the medical data produced is utilized
    for group studies. In this situation, a defendant, of
    course, would finance the program as well as being
    required by the Court to address issues as they
    develop during the program administration. Under
    these circumstances, the relief constitutes injunctive
    relief as required by Rule 23(b)(2).
    
    Day, 144 F.R.D. at 335-36
    ; see also Fried, 925 F.
    Supp. at 374 (implying that under medical monitoring
    case law, a creation of a medical monitoring program
    would be equitable in nature). Based on Judge
    Spiegel's insightful distinction, it is apparent that relief
    requested under a medical monitoring claim can be
    either injunctive or equitable in nature.
    To determine whether the named plaintiffs in this
    case seek equitable relief under their medical
    monitoring claim, plaintiffs' specific request for relief
    under this claim must be closely scrutinized. Plaintiffs
    9
    seek the establishment of a court-supervised program
    through which class members would undergo periodic
    medical examinations in order to promote the early
    detection of diseases caused by smoking. This portion
    of plaintiffs' request is the paradigmatic request for
    injunctive relief under a medical monitoring claim.
    Arch at 483-84.
    Accordingly, the District Court granted plaintiffs leave to
    file an amended complaint. In their Second Amended
    Complaint, plaintiffs brought only one claim against
    defendants--medical monitoring.2 Moreover, plaintiffs
    eliminated all requests for smoking cessation programs,
    medical treatment programs, punitive damages, and
    restitutional damages; the only relief they sought was a
    court-supervised fund that would pay for medical
    examinations designed to detect latent diseases caused by
    smoking. Plaintiffs sought certification under Rule 23(b)(2)
    for "[a]ll current residents of Pennsylvania who are cigarette
    smokers as of December 1, 1996 [the day the amended
    complaint was filed in federal court] and who began
    smoking before age 19, while they were residents of
    Pennsylvania."
    The Second Amended Complaint alleged that plaintiffs
    and other class members had been exposed to proven
    hazardous substances through the intentional or negligent
    actions of the defendants and/or through defective
    products for which defendants are strictly liable. Plaintiffs
    alleged that as a proximate result of this exposure, they
    and other class members suffer significantly increased risks
    of contracting serious latent diseases and therefore need
    periodic diagnostic medical examinations. Specifically,
    plaintiffs contended that classwide expert evidence would
    prove that: (1) when cigarettes are used as defendants
    intended them to be used, the vast majority of those who
    use cigarettes become addicted and (2) cigarettes are the
    leading cause in the nation of cardiovascular disease, lung
    cancer, and chronic obstructive pulmonary disease, due to
    _________________________________________________________________
    2. As we will discuss more fully below, the Pennsylvania Supreme Court
    recognized a cause of action for medical monitoring in Redland Soccer
    Club, Inc. v. Department of the Army, 
    696 A.2d 137
    (Pa. 1997).
    10
    the exposure of the throat, heart, and lungs to tobacco
    smoke. Barnes v. The American Tobacco Co., 
    176 F.R.D. 479
    , 491 (E.D. Pa. 1997).
    In support of their claim, plaintiffs asserted the following:
    - defendants have sold annually in Pennsylvania 22.6
    billion cigarettes;
    - there are numerous hazardous substances in
    cigarette smoke;
    - defendants have known of the relationship between
    cigarettes and diseases but have concealed their
    research, publicly denied the relationship between
    cigarettes and disease, and continue to aggressively
    promote and sell cigarettes;
    - defendants have known for many years of ways to
    make safer cigarettes but have intentionally chosen
    not to do so;
    - defendants have known for many years that nicotine
    is addictive but have publicly denied both the fact
    that nicotine is addictive and their knowledge of this
    fact;
    - defendants have intentionally controlled the level of
    nicotine and other toxic substances in the cigarettes
    in order to preserve the dependence of smokers on
    cigarettes;
    - defendants have used additives such as ammonia,
    as well as designs for which defendants have sought
    patents, to make cigarettes a ``package' for the
    delivery of nicotine;
    - defendants have intentionally avoided researching or
    developing cigarettes that would not cause
    dependence or addiction in those who use them;
    and
    - defendants have spent millions of dollars each year
    in advertising and promoting cigarettes and have
    geared their efforts particularly to teenagers and
    children through such efforts as the "Joe Camel"
    advertising campaign because defendants have
    11
    allegedly known that unless a person begins
    smoking before the age of twenty, the person is
    unlikely ever to begin.
    Plaintiffs' physician experts designed the monitoring
    program using objective medical tests and age-graded
    criteria. They stated that cigarette smoking was the
    principal cause of lung cancer, cardiovascular disease, and
    chronic obstructive pulmonary disease, the three diseases
    to be monitored.
    On August 22, 1997, the District Court conditionally
    certified the class under Rule 23(b)(2). See Barnes v. The
    American Tobacco 
    Co., 176 F.R.D. at 481-93
    . The court
    held:
    Because defendants have been unable to
    demonstrate at this point in time that this case is beset
    with individual issues and manageability problems, the
    Court finds that plaintiffs' proposed case has the
    cohesiveness to survive as a Rule 23(b)(2) class.
    Plaintiffs allege that defendants, acting in concert or
    pursuant to a common design, have engaged in
    tortious conduct directed toward the entire class as a
    whole. Whether or not plaintiffs can prove that
    defendants have acted in concert or pursuant to a
    common design is not a proper question to be resolved
    in a certification motion, rather this merit-based
    question must be reserved for later proceedings. See
    [Eisen v. Carlisle & Jacquelin, 
    417 U.S. 156
    , 178
    (1974)]. However, for purposes of the instant issue sub
    judice, it is highly relevant that plaintiffs have alleged
    that defendants have acted in concert or pursuant to a
    common design. It is this allegation of concerted
    conduct that supports a finding that defendants have
    acted on grounds generally applicable to all members
    of plaintiffs' class. Although there may be individual
    variations with respect to each class members'
    relationship with the defendants, the common
    questions of defendants' liability, which are intimately
    connected with their concerted conduct, support a
    finding that defendants have acted on grounds
    generally applicable to all members of the proposed
    class.
    12
    
    Barnes, 176 F.R.D. at 492-93
    .
    Subsequently, defendants asked the court to certify the
    class certification order for interlocutory appeal or, in the
    alternative, to reconsider the order. They alsofiled motions
    for summary judgment.3 The District Court denied
    defendants' request to certify or reconsider the class
    certification order but decertified the class under Rule
    23(c)(1).4 See Barnes at 493-502. After reviewing the
    _________________________________________________________________
    3. On September 22, 1997, while these motions were pending,
    defendants moved to enforce the jury demand. On October 10, 1997, the
    District Court granted the motion for a jury trial. See Barnes v. The
    American Tobacco Co., 
    989 F. Supp. 661
    (E.D. Pa. 1997). In reaching
    this decision, the District Court applied the two-part test of Chauffeurs,
    Teamsters & Helpers, Local No. 391 v. Terry, 
    494 U.S. 558
    (1990). In
    Terry, the Court noted the Seventh Amendment right to a jury is
    applicable when legal rights are at stake. See 
    id. at 564.
    "To determine
    whether a particular action will resolve legal rights [the court must]
    examine both the nature of the issues involved and the remedy sought.
    . . . First, [the court must compare] the[ ] action to 18th century
    actions
    brought in the courts of England prior to the merger of the courts of law
    and equity." 
    Id. at 565
    (citation omitted). Second, the court must
    " ``examine the remedy sought and determine whether it is legal or
    equitable in nature.' " 
    Id. (citation omitted).
    In applying part one of the Terry test, the District Court noted that no
    cause of action for medical monitoring existed in 1791 but determined
    that "the most analogous cause of action is a negligence action for future
    medical expenses" which was an action at law. Thus, the District Court
    concluded, the first line of inquiry "weighs in favor of finding that
    defendants have a right to a jury trial." Barnes v. The American Tobacco
    
    Co., 989 F. Supp. at 664-65
    .
    Turning to the second line of inquiry under Terry, the District Court
    acknowledged the relief sought is equitable but noted plaintiffs could
    have "just as readily" requested lump sum damages. Plaintiffs' decision
    to pursue a medical monitoring fund instead of damages, the District
    Court concluded, should not deprive the defendants of their
    constitutional right to trial by jury. See 
    id. at 667-68.
    See Dairy
    Queen,
    Inc. v. Wood, 
    369 U.S. 469
    , 477-78 (1962) ("[T]he constitutional right to
    trial by jury cannot be made to depend upon the choice of words used
    in the pleadings.").
    Plaintiffs appeal this order. Because we will affirm the grant of
    summary judgment, we need not decide this issue.
    4. An order to certify a class "may be conditional and may be altered or
    amended before the decision on the merits." Fed. R. Civ. P. 23(c)(1).
    13
    summary judgment record, the court held "the individual
    issue of addiction, which plaintiffs had previously
    represented as playing no part in this case, is still actually
    part of the present case"; defendants were not barred from
    asserting affirmative defenses; and these and other
    elements in the case presented numerous individual issues
    which "preclude[d] continuing this case as a class action."
    
    Id. at 500-02.
    Specifically, the court found three individual issues
    precluded class certification: addiction, causation, and
    affirmative defenses. First, the court discussed the role of
    addiction:
    When compelled to discuss the substantive issues in
    the case on defendants' motion for summary judgment,
    plaintiffs primarily focused on "addiction" and
    purported nicotine "manipulation. . . ." As was
    explained in Arch, whether or not an individual is
    addicted is a highly individualistic inquiry:
    Plaintiffs' own expert Dr. Burns recognizes that the
    assessment of addiction is an inherently individual
    inquiry. . . . Based on this statement, defendants
    argue that class certification under these
    circumstances would require a mini-hearing on the
    merits of each individual's case to determine injury.
    See Forman v. Data Transfer, Inc., 
    164 F.R.D. 400
    ,
    403 (E.D. Pa. 1995). Importantly, the Court finds
    that nowhere in plaintiffs' voluminous submissions
    do they actually refute that addiction is an
    inherently individual inquiry. Instead, plaintiffs offer
    a solution to this massive problem of proving
    addiction on an individual basis. Plaintiffs propose
    that once the general issue as to whether cigarettes
    can cause addiction is resolved, the issue as to
    whether each and every class member is addicted
    can be resolved by having them answer a
    questionnaire, consisting of six simple questions.
    _________________________________________________________________
    Under this rule, District Courts are required to reassess their rulings
    regularly as the case develops. Kuehner v. Heckler, 
    778 F.2d 152
    , 163
    (3d Cir. 1985).
    14
    Defendants rejoin that this questionnaire cannot by
    itself determine whether a person is nicotine
    dependent.
    The Court finds that even if the questionnaire were
    used to determine nicotine dependence, defendants
    would be permitted to cross-examine each and every
    class member as to their alleged dependence.
    Plaintiffs admittedly acknowledge that the plan they
    propose would be, at most, a prima facie indication
    of addiction. Plaintiffs' own experts concede that
    addiction is necessarily an individual inquiry. To
    refute plaintiffs' prima facie case, defendants would
    be permitted to cross-examine each individual about
    his specific choices, decisions and behavior, and
    defendants would be entitled to offer expert
    testimony about each person's specific
    circumstances and diagnosis.
    
    Barnes, 176 F.R.D. at 500
    (citing 
    Arch, 175 F.R.D. at 487
    -
    88).
    The District Court also found that causation was an
    individual issue precluding certification. Although plaintiffs
    had narrowed their theories of liability, the court found
    their claim for medical monitoring still implicated the same
    individual issue of causation their First Amended
    Complaint asserted in negligence, strict liability, and
    intentional exposure to a hazardous substance. "[I]nstead of
    completely dropping their claims for negligence, strict
    liability and intentional exposure to a hazardous substance,
    plaintiffs merely inserted these theories as the underlying
    theories of liability for their medical monitoring. Thus,
    these theories, with their attendant individual issues, are
    still in this case." 
    Barnes, 176 F.R.D. at 500
    . The District
    Court then quoted its June 3, 1997 decision at length:
    To succeed on their products liability and negligence
    claims, plaintiffs will also have to prove "causation,"
    which the Court finds is not capable of determination
    on a class-wide basis in this case. Resolution of the
    "general causation" question of whether cigarettes are
    capable of being addictive "is not common under Rule
    23(a)(2)." Kurczi v. Eli Lilly & Co., 
    160 F.R.D. 667
    , 677
    15
    (N.D. Ohio 1995). Unless it is proven that cigarettes
    always cause or never cause addiction, "the resolution
    of the general causation question accomplishes nothing
    for any individual plaintiff." Id.; see also In re "Agent
    Orange" Product Liability Litigation, 
    818 F.2d 145
    , 165
    (2d Cir. 1987) (the "relevant question is not whether
    Agent Orange has the capacity to cause harm," but
    rather the "highly individualistic" question of whether
    "it did cause harm and to whom").
    * * *
    Plaintiffs cannot satisfy the "causation" element of
    these claims by proving that all cigarettes can
    potentially cause the user to become addicted. This is
    a general causation issue. The resolution of this
    "general causation question" would accomplish nothing
    for any of the individual plaintiffs. See 
    Kurczi, 160 F.R.D. at 677
    . Indeed, the jury would still be required
    to determine for each class member whether he or she
    is addicted to cigarettes, and, if so, whether defendants
    (and which defendant) caused that addiction. With
    respect to causation, the Court finds that this issue is
    highly individualized and does not lend itself to Rule
    23(b)(2) certification.
    To establish their strict products liability claim,
    plaintiffs will be required to prove a defect in
    defendants' products. This inquiry is also highly
    individualized. Defendants manufactured hundreds of
    different types of cigarettes over the years and have
    even made changes within each brand . . . .
    Plaintiffs claim that they can prove a common defect
    on a class-wide basis for all of defendants' products.
    Plaintiffs argue that all of defendants' products are
    inherently defective because they contain sufficient
    levels of nicotine to cause addiction and other
    hazardous substances. Thus, plaintiffs will attempt to
    establish a common defect by showing that this
    combination exists in all of the cigarettes sold by
    defendants. Nonetheless, the possibility that plaintiffs'
    common defect theory will fail and that the class will
    be splintered into various subclasses--creating
    16
    manageability concerns--"weighs against a finding of
    predominance of common issues."
    
    Barnes, 176 F.R.D. at 500
    -01 (citing 
    Arch, 175 F.R.D. at 488-89
    (footnotes omitted)). The court concluded, "[b]ecause
    plaintiffs intend to prove their medical monitoring claim by
    using the theories of negligence and strict liability, the
    individual issues, which are implicated by these theories
    still exist, and thus preclude class certification." 
    Barnes, 176 F.R.D. at 501
    .
    Finally, the court found that affirmative defenses
    available to the defendants raised individual issues.5 The
    court explained: "For example, the defense of assumption of
    risk requires this Court to examine whether each and every
    plaintiff was subjectively aware of the risk and/or danger.
    . . . In determining whether the statute of limitations
    precludes a plaintiff from suing on his claim, the Court
    necessarily would have to examine when plaintiff 's injury
    accrued, and whether plaintiff knew or should have known
    of the injury and its cause. This is clearly an individual
    issue. . . . These issues clearly preclude certification."
    
    Barnes, 176 F.R.D. at 502
    .
    B.
    The District Court also granted defendants' motions for
    summary judgment, finding the statute of limitations had
    expired for five of the six named plaintiffs and that the
    sixth plaintiff had failed to demonstrate a need for medical
    monitoring. Barnes v. The American Tobacco Co., 984 F.
    Supp. 842 (E.D. Pa. 1997).6
    _________________________________________________________________
    5. As we discuss below, in its memorandum opinion disposing of
    defendants' summary judgment motions, the court concluded, over
    plaintiffs' objections, that certain affirmative defenses (e.g. assumption
    of
    risk) are available to the defendants.
    6. Defendants also moved for summary judgment on the issue of product
    identification. In granting summary judgment for all defendants the
    District Court did not reach this issue. Defendants Liggett Group Inc.,
    Liggett & Myers Inc., and Brooke Group Ltd. joined defendants' joint
    brief but also ask us to affirm on the additional ground that plaintiffs
    failed to produce any evidence that exposure to any Liggett cigarette was
    a substantial factor in causing injury to any of the named plaintiffs.
    Because we will affirm the District Court's grant of summary judgment
    to all defendants, we need not reach this issue.
    17
    Plaintiffs contended their cause of action was governed
    by the equitable doctrine of laches, not the statute of
    limitations. But finding the action "both inherently
    equitable and legal," the District Court held the statute of
    limitations "should apply to this action because plaintiffs
    could have brought this action at law or in equity." 
    Barnes, 984 F. Supp. at 855
    .
    Examining the theories of liability underlying a medical
    monitoring claim, the District Court applied a two-year
    statute of limitations. In Redland, the Pennsylvania
    Supreme Court held a plaintiff must prove defendant's
    negligence caused his exposure to a proven hazardous
    substance. For this reason, the District Court predicted the
    Pennsylvania Supreme Court would apply the two-year
    statute of limitations for negligence actions to medical
    monitoring claims. See 
    Barnes, 984 F. Supp. at 856-57
    (citing 42 Pa. Cons. Stat. Ann. S 5524). Furthermore, to the
    extent that plaintiffs base their claims on strict products
    liability or an intentional tort, a two-year statute of
    limitations would still apply. See 
    id. at 857.
    In deciding when the claim accrued, the court noted that
    generally, a plaintiff "is under a duty to use all reasonable
    diligence to be properly informed of the facts and
    circumstances upon which a potential right of recovery is
    based and to institute suit within the prescribed statutory
    period." Pocono Int'l Raceway, Inc. v. Pocono Produce, 
    468 A.2d 468
    , 471 (Pa. 1983). A claim under Pennsylvania law
    accrues at "the occurrence of the final significant event
    necessary to make the claim suable." Mack Trucks, Inc. v.
    Bendix-Westinghouse Automotive Air Brake Co., 
    372 F.2d 18
    , 20 (3d Cir. 1966). The "discovery rule" is, however, a
    "narrow exception to this general rule," Tohan v. Owens-
    Corning Fiberglass Corp., 
    696 A.2d 1195
    , 1200 n. 4 (Pa.
    Super. Ct. 1997), and tolls the statute of limitations during
    the "plaintiff 's complete inability, due to facts and
    circumstances not within his control, to discover an injury
    despite the exercise of due diligence." Kingston Coal Co. v.
    Felton Mining Co., Inc., 
    690 A.2d 284
    , 288 (Pa. Super. Ct.
    1997). Under the discovery rule, the statute of limitations
    begins to run when the "plaintiff knows, or in the exercise
    of reasonable diligence should have known, (1) that he has
    18
    been injured, and (2) that his injury has been caused by
    another's conduct." Bradley v. Ragheb, 
    633 A.2d 192
    , 194
    (Pa. Super. Ct. 1993) (quoting MacCain v. Montgomery
    Hosp., 
    578 A.2d 970
    , 972-73 (Pa. Super. Ct. 1990)).
    Because a claim under Pennsylvania law accrues at"the
    occurrence of the final significant event necessary to make
    the claim suable," Mack 
    Trucks, 372 F.2d at 20
    , the court
    found the plaintiffs' medical monitoring cause of action
    accrued when the plaintiffs were placed at a "significantly
    increased risk of contracting a serious latent disease."
    
    Redland, 696 A.2d at 145
    . To determine when that event
    occurred, the court examined plaintiffs' expert testimony.
    According to the expert testimony, plaintiffs suffered this
    significantly increased risk when they reached the "twenty
    pack-year" level.7 The court found that five of the six
    plaintiffs were at that level. Thus, the court concluded,
    without applying the discovery rule, the medical monitoring
    claims of these five plaintiffs were barred by the two-year
    statute of limitations. 
    Barnes, 984 F. Supp. at 859-61
    .
    The court found that even applying the discovery rule
    would not save these five plaintiffs' claims because each
    "should have known that smoking cigarettes put him or her
    at a significantly increased risk of contracting a serious
    latent disease years before they filed the instant lawsuit.
    . . . When a Court is asked to apply the discovery rule, the
    relevant question is whether an ordinary person, exercising
    reasonable diligence, would have known or should have
    known of his injury and its cause. In this case, each
    plaintiff should have known or did know that smoking
    caused them to be placed at an increased risk of
    contracting a serious disease." 
    Id. at 862-63.
    Reviewing the evidence, the court concluded that Barnes,
    Potts, Rodweller, Salzman, and Slivak had all had notice of
    the dangers of cigarette smoking for more than two years.
    
    Id. With respect
    to the sixth plaintiff, McNally, the court
    _________________________________________________________________
    7. "Pack-year" refers to the number of years during which an individual
    has smoked a pack of cigarettes per day. For example, a person who
    smokes one pack a day for 10 years has a 10 pack-year history. A
    person smoking half a pack per day for 10 years has a five pack-year
    history. 
    Barnes, 984 F. Supp. at 852
    n.6.
    19
    determined that, since she had only been smoking for 11
    years, her claim could not have accrued until sometime last
    year. See 
    Barnes, 984 F. Supp. at 861
    n.14.8
    C.
    But the District Court granted summary judgment
    against McNally on a different ground, finding she failed to
    demonstrate a need for medical monitoring. With regard to
    McNally, the District Court found:
    Under the Burns Program, Ms. McNally is only
    entitled to participate in the first level of the proposed
    medical monitoring program. Under the first level, Ms.
    McNally would be entitled to receive, annually or bi-
    annually, a physical examination, cardiovascular risk
    assessment and an EKG. However, Ms. McNally herself
    does not seek monitoring in the form of an EKG. (Defs.'
    Mot. Summ. J. Medical Monitoring Ex. 1 Pls.' Resp.
    Interrog. 10). Thus, the only monitoring that Ms.
    McNally seeks, and would be qualified for under the
    Burns Program, is a physical examination and
    cardiovascular risk assessment.
    * * *
    Because annual physical examinations and
    cardiovascular risk assessment are routinely
    recommended to all persons in the absence of
    exposure, the Court finds Ms. McNally can not
    establish that "the prescribed monitoring regime is
    different from that normally recommended in the
    absence of the exposure." 
    [Redland, 696 A.2d at 146
    ].
    . . . The substance of this requirement is to ensure that
    "a plaintiff may recover only if the defendant's wrongful
    acts increased the plaintiff 's incremental risk of
    _________________________________________________________________
    8. Although the District Court applied the Petty-Hyers program's twenty
    pack-year threshold to determine the date upon which a medical
    monitoring claim accrued for the other named plaintiffs, it applied the
    Burns program's ten pack-year threshold to McNally. See Barnes, 984 F.
    Supp. at 860, 861 n.14. Because we conclude that McNally has not
    demonstrated a need for medical monitoring, we do not decide which (if
    either) pack-year threshold is appropriate.
    20
    incurring the harm produced by the toxic substance
    enough to warrant a change in the medical monitoring
    that otherwise would be prescribed for that plaintiff."
    [Id. at 144 (citation omitted)].
    Here, Ms. McNally only seeks monitoring for two
    tests which would be recommended for her even if she
    did not smoke. Any increase in Ms. McNally's
    incremental risk of incurring the harm produced by the
    allegedly hazardous substances in cigarettes would not
    warrant a change in the medical monitoring that would
    be prescribed for her. Indeed, in the absence of
    exposure, it would be recommended that she receive
    the tests she seeks under her medical monitoring
    claim. Thus, she cannot satisfy the sixth element of
    Redland.
    
    Barnes, 984 F. Supp. at 871-72
    .
    Plaintiffs appealed from the final judgment.
    II.
    JURISDICTION AND STANDARD OF REVIEW
    The District Court had jurisdiction under 28 U.S.C.
    S 1332. We exercise jurisdiction under 28 U.S.C. S 1291.
    We review the District Court's decision to decertify the
    class for an abuse of discretion. See Baby Neal v. Casey, 
    43 F.3d 48
    , 56 n.15 (3d Cir. 1994). We exercise plenary review
    of a grant of summary judgment Wicker v. Consol. Rail
    Corp., 
    142 F.3d 690
    , 696 (3d Cir. 1998) (citation omitted),
    and apply the same test as the District Court; namely, we
    must determine if there is a "genuine issue as to any
    material fact" and if "the moving party is entitled to a
    judgment as a matter of law." Fed. R. Civ. P. 56(c). In so
    doing, we must view all evidence and draw all inferences
    therefrom in the light most favorable to the nonmoving
    party. 
    Wicker, 142 F.3d at 696
    (citation omitted).
    21
    III.
    DISCUSSION
    A. Medical Monitoring
    The crucial issue is whether plaintiffs' medical monitoring
    claim requires inquiry into individual issues. We begin by
    briefly describing the evolution of this cause of action and
    its elements.9
    In In re Paoli Railroad Yard PCB Litigation, 
    916 F.2d 829
    (3d Cir. 1990) (Paoli I), we predicted the Pennsylvania
    Supreme Court would recognize a cause of action for
    medical monitoring. We reaffirmed that prediction in In re
    Paoli Railroad Yard PCB Litigation, 
    35 F.3d 717
    (3d Cir.
    1994) (Paoli II).10 The issue of medical monitoring first
    reached the Pennsylvania Supreme Court in Simmons v.
    Pacor, Inc., 
    674 A.2d 232
    (Pa. 1996), where the unanimous
    court recognized medical monitoring as a viable cause of
    action under Pennsylvania law. In Simmons, the court
    permitted plaintiffs with asbestos-related asymptomatic
    pleural thickening to recover for medical monitoring. It was
    not until Redland Soccer Club v. Department of the Army,
    
    696 A.2d 137
    (Pa. 1997), however, that the Pennsylvania
    Supreme Court had the opportunity to articulate the
    specific elements of a claim for medical monitoring.
    _________________________________________________________________
    9. For another discussion of the evolution of the medical monitoring
    cause of action, see Metro-North R.R. Co. v. Buckley, 
    521 U.S. 424
    (1997).
    10. In Paoli I, we predicted the Pennsylvania Supreme Court would
    require a party to meet a four-part test to establish a claim for medical
    monitoring: (1) plaintiff was significantly exposed to a proven hazardous
    substance through the negligent actions of the defendant; (2) as a
    proximate result of exposure, plaintiff suffers a significantly increased
    risk of contracting a serious latent disease; (3) that increased risk
    makes
    periodic diagnostic medical examinations reasonably necessary; and (4)
    monitoring and testing procedures exist which make the early detection
    and treatment of the disease possible and beneficial. Paoli 
    I, 916 F.2d at 852
    . In Paoli II, we added another element to the claim, holding that a
    plaintiff had to show that "a reasonable physician would prescribe for
    her or him a monitoring regime different than the one that would have
    been prescribed in the absence of that particular exposure." Paoli 
    II, 35 F.3d at 788
    (citation omitted).
    22
    Building on this court's decisions in Paoli I and Paoli II, the
    Supreme Court found that plaintiffs must prove the
    following elements:
    (1) exposure greater than normal background levels; (2)
    to a proven hazardous substance; (3) caused by the
    defendant's negligence; (4) as a proximate result of the
    exposure, plaintiff has a significantly increased risk of
    contracting a serious latent disease; (5) a monitoring
    procedure exists that makes the early detection of the
    disease possible; (6) the prescribed monitoring regime
    is different from that normally recommended in the
    absence of the exposure; and (7) the prescribed
    monitoring regime is reasonably necessary according to
    contemporary scientific principles.
    
    Redland, 696 A.2d at 145
    -46.11
    The injury in a cause of action for medical monitoring is
    the "costs of periodic medical examinations necessary to
    detect the onset of physical harm." 
    Id. at 144;
    see also
    Friends for All Children, Inc. v. Lockheed Aircraft Corp., 
    746 F.2d 816
    , 826 (D.C. Cir. 1984) ("It is difficult to dispute
    that an individual has an interest in avoiding expensive
    diagnostic examinations just as he or she has an interest in
    avoiding physical injury."); Hansen v. Mountain Fuel Supply
    Co., 
    858 P.2d 970
    , 977 (Utah 1993) (citations omitted)
    ("Although the physical manifestations of an injury may not
    appear for years, the reality is that many of those exposed
    have suffered some legal detriment; the exposure itself and
    the concomitant need for medical testing constitute the
    _________________________________________________________________
    11. Other jurisdictions have authorized recovery for medical monitoring
    in the absence of physical injury. See, e.g., Bourgeois v. A.P. Green
    Indus., 
    716 So. 2d 355
    (La. 1998); Potter v. Firestone Tire & Rubber Co.,
    
    863 P.2d 795
    (Cal. 1993); Hansen v. Mountain Fuel Supply Co., 
    858 P.2d 970
    (Utah 1993); Ayers v. Township of Jackson , 
    525 A.2d 287
    (N.J.
    1987). In addition, some federal courts predicting state law have reached
    the same conclusion. See Cook v. Rockwell Int'l Corp., 
    755 F. Supp. 1468
    (D. Colo. 1991); Johnson v. Armstrong Cork Co., 
    645 F. Supp. 764
    (W.D.
    La. 1986). But see Ball v. Joy Techs., Inc., 
    958 F.2d 36
    (4th Cir. 1991)
    (holding that, under the laws of Virginia and West Virginia, recovery of
    medical monitoring expenses is only available where a plaintiff has
    sustained a physical injury); Werlein v. United States, 
    746 F. Supp. 887
    (D. Minn. 1990).
    23
    injury."). It is evident that this injury is somewhat different
    from an injury in a traditional tort, which rests on physical
    harm. See, e.g., Restatement Second of Torts S 402A
    (requiring plaintiff to prove in a products liability case
    "physical harm" which S 7 defines as "physical impairment
    of the human body"); 
    Simmons, 674 A.2d at 237
    (denying
    plaintiffs recovery other than medical monitoring for
    asymptomatic pleural thickening because inter alia
    plaintiffs demonstrated no physical injury). In recognizing
    medical monitoring as a compensable injury, the
    Pennsylvania Supreme Court quoted at length from our
    distinction in Paoli I between a cause of action for increased
    risk of future harm and a cause of action for medical
    monitoring. We concluded that a claim for medical
    monitoring is different from a claim for increased risk of
    harm because the medical monitoring plaintiff has an
    identifiable rather than a speculative injury. 
    Id. at 850-51.
    We explained:
    The injury in an enhanced risk claim is the anticipated
    harm itself. The injury in a medical monitoring claim is
    the cost of the medical care that will, one hopes, detect
    that injury. The former is inherently speculative
    because courts are forced "to anticipate the probability
    of future injury. The latter is much less speculative
    because the issue for the jury is the less conjectural
    question of whether the plaintiff needs medical
    surveillance.
    Paoli 
    I, 916 F.2d at 851
    .12
    In Redland, the court cited four important policy reasons
    for recognizing a cause of action for medical monitoring.
    First, medical monitoring promotes "early diagnosis and
    treatment of disease resulting from exposure to toxic
    substances caused by a tortfeasor's negligence." Second,
    "[a]llowing recovery for such expenses avoids the potential
    injustice of forcing an economically disadvantaged person
    _________________________________________________________________
    12. There is no doubt the costs of medical monitoring are a compensable
    portion of a plaintiffs' damages when asserted with other injury claims.
    It appears, however, that allowing plaintiffs to recover in the absence of
    some injury pushes the limit of the Constitution's case-or-controversy
    requirement.
    24
    to pay for expensive diagnostic examinations necessitated
    by another's negligence," and "affords toxic-tort victims, for
    whom other sorts of recovery may prove difficult, immediate
    compensation for medical monitoring needed as a result of
    exposure." Third, medical monitoring "furthers the
    deterrent function of the tort system by compelling those
    who expose others to toxic substances to minimize risks
    and costs of exposure." Finally, such recovery is"in
    harmony with ``the important public health interest in
    fostering access to medical testing for individuals whose
    exposure to toxic chemicals creates an enhanced risk of
    disease.' " 
    Id. at 145
    (citations omitted).
    B. Certification
    To be certified, a class must satisfy the prerequisites of
    Rule 23(a) and the "parties seeking certification must also
    show that the action is maintainable under Rule 23(b)(1),
    (2), or (3)." Amchem Prods., Inc. v. Windsor, ___ U.S. ___;
    
    117 S. Ct. 2231
    , 2245 (1997). Plaintiffs seek certification
    under 23(b)(2).
    As noted, the District Court conditionally certified the
    class, stipulating its order could be altered or amended. See
    Barnes v. The American Tobacco Co., 
    176 F.R.D. 479
    (E.D.
    Pa. 1997); Fed. R. Civ. P. 23(c)(1). Under Rule 23(c)(1),
    District Courts are required to reassess their class rulings
    as the case develops. Kuehner v. Heckler, 
    778 F.2d 152
    ,
    163 (3d Cir. 1985); see also Richardson v. Byrd, 
    709 F.2d 1016
    , 1019 (5th Cir. 1983) ("Under Rule 23 the district
    court is charged with the duty of monitoring its class
    decisions in light of the evidentiary development of the
    case. The district judge must define, redefine, subclass, and
    decertify as appropriate in response to the progression of
    the case from assertion to facts."). In accordance with
    23(c)(1), the District Court examined the evidence adduced
    for summary judgment purposes and decided to decertify
    the class. 
    Barnes, 176 F.R.D. at 502
    .
    In considering whether certification is proper, we refrain
    from conducting a preliminary inquiry into the merits. See
    Eisen v. Carlisle & Jacquelin, 
    417 U.S. 156
    , 177-78 (1973)
    (citation omitted) (" ``In determining the propriety of a class
    action, the question is not whether the plaintiff or plaintiffs
    25
    have stated a cause of action or will prevail on the merits,
    but rather whether the requirements of Rule 23 are met.' ")
    At the same time, we must carefully examine the factual
    and legal allegations. See General Tel. Co. v. Falcon, 
    457 U.S. 147
    , 160 (1981) ("[S]ometimes it may be necessary for
    the court to probe behind the pleadings before coming to
    rest on the certification question."); Coopers & Lybrand v.
    Livesay, 
    437 U.S. 463
    , 469 (1977) (citation omitted) ("[T]he
    class determination generally involves considerations that
    are ``enmeshed in the factual and legal issues comprising
    the plaintiff 's cause of action.' ").
    1. Fed. R. Civ. P. 23(a)
    Rule 23(a) presents four requirements: (1) numerosity; (2)
    commonality; (3) typicality; and (4) adequacy of
    representation.13 "The requirements of Rule 23(a) are meant
    to assure both that class action treatment is necessary and
    efficient and that it is fair to the absentees under the
    particular circumstances." Baby Neal v. Casey, 
    43 F.3d 48
    ,
    55 (3d Cir. 1994). The District Court determined the class
    satisfied Rule 23(a).
    Finding the putative class consisted of more than one
    million Pennsylvania residents,14 the court held the class
    was "so numerous that joinder of all members [is]
    impracticable." Fed. R. Civ. P. 23(a)(1). Defendants do not
    dispute that numerosity is satisfied.
    The District Court also found plaintiffs satisfied the
    commonality requirement of Rule 23(a)(2) because they
    demonstrated there is at least one common question of law
    or fact. See Baby 
    Neal, 43 F.3d at 56
    ("The commonality
    requirement will be satisfied if the named plaintiffs share at
    _________________________________________________________________
    13. Specifically, Rule 23(a) provides: "One or more members of a class
    may sue or be sued as representative parties on behalf of all only if (1)
    the class is so numerous that joinder of all members is impracticable, (2)
    there are questions of law or fact common to the class, (3) the claims or
    defenses of the representative parties are typical of the claims or
    defenses of the class, and (4) the representative parties will fairly and
    adequately protect the interests of the class."
    14. In defendants' post-hearing memorandum, defendants place the
    number of potential class members at 2.8 million.
    26
    least one question of fact or law with the grievances of the
    prospective class.").15 "For example, whether defendants
    have acted in concert or pursuant to a common design is
    one common question." 
    Arch, 175 F.R.D. at 477
    .16
    "The concepts of commonality and typicality are broadly
    defined and tend to merge." Baby Neal v. 
    Casey, 43 F.3d at 56
    (citation omitted). The typicality requirement is designed
    to align the interests of the class and the class
    representatives so that the latter will work to benefit the
    entire class through the pursuit of their own goals. 
    Id. at 57.
    This requirement does not mandate that all putative
    class members share identical claims. 
    Id. at 56
    (citations
    omitted). Moreover, "[f]actual differences will not render a
    claim atypical if the claim arises from the same event or
    practice or course of conduct that gives rise to the claims
    of the class members, and if it is based on the same legal
    theory." 1 Newberg on Class Actions S 3.15, at 3-78; see
    also Baby 
    Neal, 43 F.3d at 58
    ("[E]ven relatively
    pronounced factual differences will generally not preclude a
    finding of typicality where there is a strong similarity of
    legal theories.").
    _________________________________________________________________
    15. In Georgine, the court recognized that Baby Neal and other Third
    Circuit cases "stated a very low threshold for commonality." Georgine v.
    Amchem Prods. Inc., 
    83 F.3d 610
    , 627 (3d Cir. 1996). The court noted
    that the "commonality barrier is higher in a personal injury damages
    class action, like [Georgine], that seeks to resolve all issues, including
    noncommon issues, of liability and damages." 
    Id. Ultimately, the
    court
    did not decide whether that class met the commonality requirement and
    concluded instead that "the commonality requirement is subsumed by
    the predominance requirement, which this class cannot conceivably
    meet." 
    Id. As the
    District Court noted, in contrast to Georgine, this case
    is not a personal injury damages class action, nor does it involve a
    settlement class that was national in scope, where class members are
    asked to compromise future claims without knowing what those claims
    might be. Thus, the District Court did not impose a higher commonality
    requirement. See 
    Arch, 175 F.R.D. at 476-77
    .
    16. In addition, the District Court found that "whether defendants'
    actions and omissions in the manufacture, promotion and sale of
    cigarettes to class members have been sufficiently egregious to warrant
    the imposition of punitive damages" is also a common question. 
    Arch, 175 F.R.D. at 477
    . Of course, the plaintiffs have since dropped their
    demand for punitive damages so this is no longer a common issue.
    27
    The District Court found plaintiffs met the typicality
    requirement. Although defendants had demonstrated there
    "exist many individualized questions which arise from the
    factual differences between the putative class members'
    individual claims, defendants fail[ed] to demonstrate that
    the ``legal theories of the named plaintiffs potentially conflict
    with those of the absentees . . . .' " 
    Arch, 175 F.R.D. at 479
    (quoting Baby 
    Neal, 43 F.3d at 57
    ). Specifically, the District
    Court found:
    "Plaintiffs allege that their claims arise from the same
    course of conduct undertaken by defendants.
    Specifically, plaintiffs have alleged that defendants
    have engaged in a concerted course of conduct
    whereby defendants have concealed their knowledge of
    nicotine's addictive properties and have purposefully
    and deliberately emphasized efforts to addict children
    and adolescents--resulting in an epidemic pediatric
    disease. In this process, plaintiffs allege that these
    consumers were involuntar[il]y subject to the
    cumulative, repetitive assault of the many different
    carcinogens contained in tobacco smoke. Although
    plaintiffs' claims may be factually different, plaintiffs
    have alleged a course of conduct that has given rise to
    plaintiffs' claims which are based upon the same legal
    theories, thus satisfying the typicality requirement of
    Rule 23(a)(3)."
    
    Arch, 175 F.R.D. at 478-79
    .
    Finally, the District Court found that plaintiffs "fairly and
    adequately protect the interests of the class." 
    Id. at 480
    (quoting Fed. R. Civ. P. 23(a)(4)). The adequacy of
    representation requirement encompasses two distinct
    inquiries designed to protect the interests of absentee class
    members. First, it "tests the qualifications of the counsel to
    represent the class." G.M. 
    Trucks, 55 F.3d at 800
    . Second,
    it "serves to uncover conflicts of interest between named
    parties and the class they seek to represent." 
    Amchem, 117 S. Ct. at 2250
    .17
    _________________________________________________________________
    17. In the District Court, defendants claimed the named plaintiffs were
    not adequate class representatives because (1) they have split their
    28
    2. Fed. R. Civ. P. 23(b)(2)
    A class action is maintainable under Rule 23(b)(2) when
    "the party opposing the class has acted or refused to act on
    grounds generally applicable to the class, thereby making
    appropriate final injunctive relief or corresponding
    declaratory relief with respect to the class as a whole." Fed.
    R. Civ. P. 23(b)(2). Subsection (b)(2) class actions are
    "limited to those class actions seeking primarily injunctive
    or corresponding declaratory relief." 1 Newberg on Class
    Actions S 4.11, at 4-39. The (b)(2) class "serves most
    frequently as the vehicle for civil rights actions and other
    institutional reform cases that receive class action
    treatment." Baby Neal v. Casey, 
    43 F.3d 48
    , 58-59 (3d Cir.
    1994). Indeed, (b)(2) was "designed specifically for civil
    rights cases seeking broad declaratory or injunctive relief
    for a numerous and often unascertainable or amorphous
    class of persons." 1 Newberg on Class Actions S 4.11, at 4-
    39.
    As noted, in its June 3, 1997 Order, the District Court
    found that under certain circumstances medical monitoring
    _________________________________________________________________
    causes of action and (2) they may have failed to make a knowing and
    voluntary amendment to their complaint. The District Court found these
    claims were not "split" or "waived" by the absent class members. In its
    August 22, 1997 order, the court found: "the Court has already
    determined that the absent class members cannot bring in this putative
    class action those claims which have been omitted from the Second
    Amended Complaint because those claims are not suitable for class
    action treatment. Consequently, there cannot be any``splitting' or ``waiver'
    by these absent class members: there is no other cause of action they
    can bring, or could have brought, in this action, except possibly the
    medical monitoring claim set forth in the Second Amended 
    Complaint." 176 F.R.D. at 485
    . In addition, after reviewing plaintiffs' deposition
    testimony, the District Court found that the named plaintiffs made a
    knowing and voluntary amendment. The court noted that it is
    "unrealistic . . . to require the named plaintiffs to have an in-depth
    understanding as to the legal theories behind their claim." Instead,
    "courts have required the class representatives to actively seek
    vindication of his or her rights and engage competent counsel to
    prosecute the claims. In this case, named plaintiffs have actively sought
    vindication of their rights on a class-wide basis and have engaged
    competent counsel to litigate their claims." 
    Id. at 486.
    29
    could constitute the injunctive relief required by Rule
    23(b)(2). 
    Arch, 175 F.R.D. at 483
    . The District Court
    initially held that plaintiffs could not be certified under
    23(b)(2) because most of the relief they sought was
    monetary in nature. 
    Arch, 175 F.R.D. at 484
    . In response to
    the court's analysis, plaintiffs amended their complaint so
    it contained only a claim for medical monitoring and asked
    only for the establishment of a court-supervised medical
    monitoring program.
    Recently, the Supreme Court reexamined the
    requirements for Rule 23 certification in the context of
    mass tort class actions. In Amchem Products, Inc. v.
    Windsor, ___ U.S. ___; 
    117 S. Ct. 2231
    (1997), the Supreme
    Court affirmed our decision in Georgine v. Amchem
    Products, Inc., 
    83 F.3d 610
    (3d Cir. 1996), decertifying a
    settlement class of claimants exposed to asbestos. As in
    this case, the issue in Amchem was "whether [the] proposed
    classes [were] sufficiently cohesive to warrant adjudication
    by representation." 
    Amchem, 117 S. Ct. at 2249
    . We found
    that cohesiveness lacking and the Supreme Court agreed.
    Quoting Judge Becker's opinion, the Court noted: " ``Class
    members were exposed to different asbestos-containing
    products, for different amounts of time, in different ways,
    and over different periods . . . . The [exposure-only]
    plaintiffs especially share little in common, either with each
    other or with the presently injured class members . . . .
    They will also incur different medical expenses because
    their monitoring and treatment will depend on singular
    circumstances and individual medical histories.' " 
    Id. at 2250
    (quoting 
    Georgine, 83 F.3d at 626
    ). As we explained,
    such factual differences "translate into significant legal
    differences. Differences in amount of exposure and nexus
    between exposure and injury lead to disparate applications
    of legal rules, including matters of causation, comparative
    fault, and the types of damages available to each plaintiff."
    
    Georgine, 83 F.3d at 627
    . We also noted that
    "individualized issues can become overwhelming in actions
    involving long-term mass torts (i.e. those which do not arise
    out of a single accident)." 
    Id. at 628.
    While Amchem involved a Rule 23(b)(3) class action, the
    cohesiveness requirement enunciated by both this court
    30
    and the Supreme Court extends beyond Rule 23(b)(3) class
    actions. Indeed, a (b)(2) class may require more
    cohesiveness than a (b)(3) class. This is so because in a
    (b)(2) action, unnamed members are bound by the action
    without the opportunity to opt out.
    While 23(b)(2) class actions have no predominance or
    superiority requirements, it is well established that the
    class claims must be cohesive. Discussing the requirements
    for 23(b)(2) classes in Wetzel v. Liberty Mutual Insurance
    Company, 
    508 F.2d 239
    (3d Cir. 1974), we noted, "[b]y its
    very nature, a (b)(2) class must be cohesive as to those
    claims tried in the class action. . . . Because of the cohesive
    nature of the class, Rule 23(c)(3) contemplates that all
    members of the class will be bound. Any resultant
    unfairness to the members of the class was thought to be
    outweighed by the purposes behind class actions:
    eliminating the possibility of repetitious litigation and
    providing small claimants with a means of obtaining
    redress for claims too small to justify individual litigation."
    
    Id. at 248-49
    (citations omitted). In Geraghty v. United
    States Parole Commission, 
    719 F.2d 1199
    , 1205-06 (3d Cir.
    1983) (citation omitted), we again emphasized that a
    23(b)(2) class must be cohesive, noting the District Court
    has the "discretion to deny certification in Rule 23(b)(2)
    cases in the presence of ``disparate factual circumstances.' "
    See also Santiago v. City of Philadelphia, 
    72 F.R.D. 619
    ,
    628 (E.D. Pa. 1976) (holding that a "court should be more
    hesitant in accepting a (b)(2) suit which contains significant
    individual issues than it should under subsection 23(b)(3)");
    Rice v. City of Philadelphia, 
    66 F.R.D. 17
    , 20 (E.D. Pa.
    1974) (holding that a case should not proceed as a (b)(2)
    action where "virtually all of the issues would have to be
    litigated individually in order to determine whether a
    particular alleged class member was entitled to any
    damages at all").18
    _________________________________________________________________
    18. "At base, the (b)(2) class is distinguished from the (b)(3) class by
    class cohesiveness. . . . Injuries remedied through (b)(2) actions are
    really group, as opposed to individual injuries. The members of a (b)(2)
    class are generally bound together through ``preexisting or continuing
    legal relationships' or by some significant common trait such as race or
    gender." Holmes v. Continental Can Company, 
    706 F.2d 1144
    , 1155
    (11th Cir. 1983) (quoting Note, Notice in Rule 23(b)(2) Class Actions for
    Monetary Relief: Johnson v. General Motors Corp., 128 U.Pa.L.Rev. 1236,
    1252-53 (1980) (footnotes omitted).
    31
    In Santiago, the court recognized two reasons why courts
    must determine whether a proposed (b)(2) class implicates
    individual issues. First, unnamed members with valid
    individual claims are bound by the action without the
    opportunity to withdraw and may be prejudiced by a
    negative judgment in the class action. "Thus, the court
    must ensure that significant individual issues do not
    pervade the entire action because it would be unjust to
    bind absent class members to a negative decision where the
    class representatives's claims present different individual
    issues than the claims of the absent members present."
    Second, "the suit could become unmanageable and little
    value would be gained in proceeding as a class action . . .
    if significant individual issues were to arise consistently."
    
    Santiago, 72 F.R.D. at 628
    .
    In decertifying the class, the District Court decided that
    "too many individual issues exist which prevent this case
    from proceeding as a class action." 
    Barnes, 176 F.R.D. at 500
    . As noted, the District Court found that addiction,
    causation, and affirmative defenses all presented individual
    issues not properly decided in a class action. We believe
    that addiction, causation, the defenses of comparative and
    contributory negligence, the need for medical monitoring
    and the statute of limitations present too many individual
    issues to permit certification. As in Amchem, plaintiffs were
    "exposed to different . . . products, for different amounts of
    time, in different ways, and over different periods." See
    
    Amchem, 117 S. Ct. at 2250
    (citation omitted). These
    disparate issues make class treatment inappropriate.19
    _________________________________________________________________
    19. We note that the individual issues raised by cigarette litigation
    often
    preclude class certification. See, e.g., Castano v. The American Tobacco
    Co., 
    84 F.3d 734
    (5th Cir. 1996) (decertifying 23(b)(3) class because
    individual issues predominated); Smith v. Brown & Williamson Tobacco
    Corp., 
    174 F.R.D. 90
    (W.D. Mo. 1997) (denying certification under
    23(b)(1), (2) & (3) because of the presence of individual issues); Ruiz v.
    The American Tobacco Co., No. 96-2300 (JAF) (D.P.R. March 17, 1998)
    (denying certification under 23(b)(2) and 23(b)(3) because "cigarette
    addiction" claims raised too many individual issues). Significantly, no
    federal appeals court has upheld the certification a class of cigarette
    smokers or reversed a District Court's refusal to certify such a class. In
    some state cases, however, plaintiff smokers have succeeded in
    32
    a. Nicotine addiction and causation
    The District Court found nicotine addiction plays a
    central role in the case and that addiction is a "highly
    individualistic inquiry." 
    Barnes, 176 F.R.D. at 500
    . The
    District Court noted that when plaintiffs were "compelled to
    discuss the substantive issues in the case on defendants'
    motion for summary judgment, [they] primarily focused on
    ``addiction' and purported nicotine ``manipulation. . . .' " 
    Id. While plaintiffs
    do not seem to dispute that addiction
    requires an individual inquiry, they maintain nonetheless
    that addiction plays no part in the case.
    Plaintiffs contend that throughout the litigation, they
    have
    asserted that defendants' knowledge and intentional
    misuse of the addictive properties of nicotine--their
    intentional design of cigarettes to contain a level of
    nicotine they knew would be addictive--went to their
    intentional misconduct and liability for designing a
    defective product. Plaintiffs do not contend that all
    smokers are addicted, that addiction is a pre-requisite
    to class membership, or that addiction is determinant
    of a need for medical monitoring. Addiction is a term
    and concept that is difficult to avoid in any smoking
    case. The documents show that defendants intended
    and designed cigarettes to be addictive. That they have
    largely succeeded may be all too apparent. But the
    addiction of any particular smoker--much less the
    class as a whole--is simply not an element of plaintiffs'
    claims.
    Brief of Appellant at 41.
    We disagree. Addiction remains an essential part of
    plaintiffs' claim. In order to prevail on their medical
    _________________________________________________________________
    certification. See Richardson v. Phillip Morris, No. 96145050/CE212596
    (Baltimore Cir. Ct. Jan. 28, 1998) (certifying class of Maryland smokers
    seeking compensatory and punitive damages); R.J. Reynolds Tobacco Co.
    v. Engle, 
    672 So. 2d 39
    (Fla. App. 3 Dist. 1996), rev. denied, 
    682 So. 2d 1100
    (1996) (certification of state-wide class of tobacco smokers suing
    for damages caused by smoking).
    33
    monitoring claim--under any of their three theories of
    liability (negligence, strict products liability, and intentional
    exposure to a hazardous substance)--plaintiffs must
    demonstrate that defendants caused their exposure to
    tobacco. See 
    Redland, 696 A.2d at 145
    -46. Indeed,
    plaintiffs' Second Amended Complaint alleges "[p]laintiffs
    and class members have been significantly exposed to
    proven hazardous substances through the intentional or
    negligent actions of the Defendants, and/or through
    defective products for which Defendants are strictly liable"
    and that "[a]s a proximate result of this exposure, Plaintiffs
    and class members suffer significantly increased risks of
    contracting serious latent diseases." Second Amended
    Complaint PP 20-21.
    It is apparent from plaintiffs' Second Amended Complaint
    as well as their omnibus response to the defendants' joint
    motions for summary judgment that addiction is the
    linchpin of causation in this case. According to plaintiffs'
    complaint, defendants' actions that give rise to liability
    include the following:
    - Defendants have . . . known for many years that
    nicotine is addictive, but have publicly denied both
    the fact that nicotine is addictive and their
    knowledge of this fact, in order to conceal the
    addictive nature of cigarettes from the public,
    including Plaintiffs and the class. . . .
    - During the same time that Defendants have
    publicly denied the addictive nature of nicotine,
    Defendants have intentionally controlled the level of
    nicotine and other toxic substances they have sold,
    in order to preserve the dependence of smokers on
    cigarettes that Defendants sell. To this end,
    Defendants have utilized additives such as
    ammonia, as well as designs for which Defendants
    have sought patents, to make cigarettes, in effect, a
    "package" for the delivery of nicotine. Defendants
    have intentionally sought to "increase the delivery of
    nicotine and almost double the nicotine transfer
    efficiency of cigarettes," maintain "the proper
    amount of nicotine in tobacco smoke," and "deliver
    34
    a pharmacologically active dose of nicotine to the
    smoker."
    - During the same period of time, despite this
    voluntary and public undertaking to protect the
    public's "health as a basic responsibility paramount
    to every other consideration," Defendants have also
    intentionally avoided researching or developing
    cigarettes that would not cause dependence or
    addiction in those who use them.
    - In their efforts to conceal the health hazards of
    smoking and the addictive nature of nicotine,
    Defendants have testified falsely under oath before
    the United States Congress, provided false
    explanations to customers and governmental
    entities about the health hazards of tobacco and the
    harmful qualities of nicotine; concealed their secret
    research and testing on the dangers of cigarette
    smoking; [and] concealed their deliberate
    manipulation of the nicotine levels of cigarettes. .. .
    Plaintiffs' Second Amended Complaint PP 12-14, 16.
    Moreover, as the District Court pointed out, in their
    omnibus response to the defendants' joint motions for
    summary judgment, plaintiffs focused on addiction and
    purported nicotine manipulation. Plaintiffs asserted the
    evidence will establish inter alia that (1) defendants
    intentionally designed cigarettes to addict smokers; (2)
    defendants allowed the number of addicted smokers to
    grow, knowing full well that the smoke caused cancer and
    lung disease; and (3) defendants intentionally manipulated
    and controlled nicotine levels. As we understand plaintiffs'
    theory, defendants' actions caused plaintiffs to become
    addicted to cigarettes and thereby rendered their choice to
    smoke nonvoluntary.
    Plaintiffs suggest that causation can be proved on a
    class-wide basis, contending they need to show only that
    smoking cigarettes was a "substantial factor" in "causing"
    the three diseases to be monitored in the program. See
    Parks v. AlliedSignal, Inc., 
    113 F.3d 1327
    , 1332 (3d Cir.
    1997) (under Pennsylvania law, a "substantial factor" is
    legal cause, and requires only proof that a factor is "not
    35
    merely negligible" in producing a result). Plaintiffs point to
    the Surgeon General's Reports conclusively determining
    that cigarette smoking is the major cause of the diseases
    for which the medical monitoring program was constructed.
    This evidence, they claim, more than satisfies their burden
    on the issue of causation.
    But plaintiffs cannot prove causation by merely showing
    that smoking cigarettes causes cancer and other diseases.
    They must demonstrate that defendants' intentional or
    negligent nicotine manipulation caused each individual
    plaintiff to have a significantly increased risk of contracting
    serious latent diseases thereby demonstrating the need for
    medical monitoring. Alternatively, under a strict products
    liability theory, as the District Court found, "each class
    member will have to establish that the type of cigarettes he
    or she smoked contained a defect at the time he or she
    smoked them." 
    Barnes, 176 F.R.D. at 501
    (citation
    omitted). According to plaintiffs, the alleged defect is that
    defendants intentionally designed these cigarettes to be
    addictive. But whether defendants caused the injury
    depends on whether each individual actually is addicted.
    These are all issues that must be determined on an
    individual basis.
    We note that plaintiffs do not contest the District Court's
    conclusion that "whether or not an individual is addicted is
    a highly individualistic inquiry." 
    Barnes, 176 F.R.D. at 500
    .
    Instead, plaintiffs suggested to the District Court that once
    the general issue whether cigarettes can cause addiction is
    resolved, they could resolve the issue of individual
    addiction by having each class member answer a
    questionnaire consisting of six questions.20 The District
    Court noted that
    even if the questionnaire were used to determine
    nicotine dependence, defendants would be permitted to
    cross-examine each and every class member as to their
    _________________________________________________________________
    20. On appeal, plaintiffs refer only sparingly to their proposed trial
    plan.
    At one point in their brief, however, plaintiffs suggest the District
    Court
    erred when it "did not refer or consider plaintiffs' proposed trial plan
    at
    all in decertifying the class" because of the many individual issues. But
    the District Court clearly considered the plan and found it inadequate.
    36
    alleged dependence. Plaintiffs admittedly acknowledge
    that the plan they propose would be, at most, a prima
    facie indication of addiction. Plaintiffs' own (experts
    concede that addiction is necessarily an individual
    inquiry. To refute plaintiffs' prima facie case,
    defendants would be permitted to cross-examine each
    individual about his specific choices, decisions and
    behavior, and defendants would be entitled to offer
    expert testimony about each person's specific
    circumstances and diagnosis.
    
    Arch, 175 F.R.D. at 488
    .
    Because nicotine addiction must be determined on an
    individual basis and remains an essential part of plaintiffs'
    medical monitoring claim, we agree with the District Court
    that class treatment is inappropriate.
    b. The need for medical monitoring
    We also believe the requirement that each class member
    demonstrate the need for medical monitoring precludes
    certification. In order to state a claim for medical
    monitoring, each class member must prove that the
    monitoring program he requires is "different from that
    normally recommended in the absence of exposure."
    
    Redland, 696 A.2d at 146
    .21 To satisfy this requirement,
    each plaintiff must prove the monitoring program that is
    prescribed for the general public and the monitoring
    program that would be prescribed for him. Although the
    general public's monitoring program can be proved on a
    classwide basis, an individual's monitoring program by
    definition cannot. In order to prove the program he
    _________________________________________________________________
    21. See also Paoli 
    II, 35 F.3d at 788
    ; 
    Arch, 175 F.R.D. at 490
    ("The fact
    that [Barnes] smokes would not require any additional monitoring for
    heart disease not already warranted by the multiple, significant risk
    factors for heart disease he already has."); Hansen v. Mountain Fuel
    Supply Co., 
    858 P.2d 970
    , 979-80 (Utah 1993); Supplemental
    Declaration of David Burns, M.D. ("Exercise stress testing and an EKG
    would not normally be recommended for nonsmokers at the ages
    recommended in the proposed monitoring program, unless they had
    some other risk factor that placed them at dramatically increased risk of
    disease.").
    37
    requires, a plaintiff must present evidence about his
    individual smoking history and subject himself to cross-
    examination by the defendant about that history. This
    element of the medical monitoring claim therefore raises
    many individual issues.
    c. Defenses
    The District Court also held that defenses raise individual
    issues precluding certification. Over plaintiffs' objection, the
    District Court found defendants may assert the defenses of
    contributory negligence, assumption of risk, and consent to
    exposure to a hazardous substance. 
    Barnes, 984 F. Supp. at 867-69
    .22 After reviewing Pennsylvania caselaw, the
    District Court concluded
    First, legal defenses do not become equitable defenses
    simply because they are asserted in an action in
    equity. Second, equitable principles such as the
    doctrine of unclean hands may not be used to deprive
    a defendant of legal rights--remedies or defenses.
    Applying these lessons, the Court finds that defendants
    have a legitimate right to raise the legal defenses of
    contributory negligence, assumption of risk and
    consent.
    
    Barnes, 984 F. Supp. at 866
    . The court noted this suit was
    not purely equitable but instead "implicates both legal and
    equitable rights" making it "even less appropriate for [the
    court] to exercise its equitable powers to bar defendants
    from asserting its affirmative, legal defenses." 
    Id. As noted,
    plaintiffs asserted three theories of liability.
    They claimed that they were significantly exposed to proven
    hazardous substances through defendants' intentional
    actions, negligent actions, and defective products (strict
    _________________________________________________________________
    22. Defendants moved for summary judgment against Ciaran McNally,
    William Barnes, and Catherine Potts on the grounds that their claims
    were barred by contributory negligence, assumption of risk, and consent
    to exposure to a hazardous substance. 
    Barnes, 984 F. Supp. at 864
    . The
    District Court only considered the defendants' arguments against
    McNally because it entered summary judgment against Barnes and Potts
    on statute of limitations grounds.
    38
    liability). Defendants assert the defenses of consent,
    comparative negligence, and assumption of risk. Plaintiffs
    contend that these defenses are not available and that
    individual issues relating to these defenses should not
    preclude class certification. Plaintiffs maintain that
    "comparative negligence" is only available in actions for
    damages resulting in death or injury, that assumption of
    risk is not available because the defendants will not be able
    to show that any plaintiff assumed the risk of the specific
    defect, and that consent requires a full awareness of
    defendants' specific conduct and there is no record
    evidence of such awareness in this case.
    The District Court found defendants could raise the
    defense of comparative negligence, predicting the
    Pennsylvania Supreme Court would apply Pennsylvania's
    Comparative Negligence Act23 rather than contributory
    negligence to a medical monitoring claim. See 
    Barnes, 984 F. Supp. at 867-68
    . Although acknowledging that the
    Comparative Negligence Act expressly applies to"actions
    brought to recover damages for negligence resulting in
    death or injury to person or property," and that plaintiffs
    seek a court-supervised monitoring program, the District
    Court found "[t]he application of the Comparative
    _________________________________________________________________
    23. 42 Pa. Cons. Stat. S 7102 provides:
    (a) General rule.--In all actions brought to recover damages for
    negligence resulting in death or injury to person or property, the fact
    that the plaintiff may have been guilty of contributory negligence shall
    not bar a recovery by the plaintiff or his legal representative where such
    negligence was not greater than the causal negligence of the defendant
    or defendants against whom recovery is sought, but any damages
    sustained by the plaintiff shall be diminished in proportion to the
    amount of negligence attributed to the plaintiff.
    (b) Recovery against joint defendant; contribution.--Where recovery
    is allowed against more than one defendant, each defendant shall be
    liable for that proportion of the total dollar amount awarded as damages
    in the ratio of the amount of his causal negligence to the amount of
    causal negligence attributed to all defendants against whom recovery is
    allowed. The plaintiff may recover the full amount of the allowed recovery
    from any defendant against whom the plaintiff is not barred from
    recovery. Any defendant who is so compelled to pay more than his
    percentage share may seek contribution.
    39
    Negligence Act to these claims would more properly
    advance the goals of the Redland Soccer court, and would
    also adequately protect the rights of defendants." 
    Barnes, 984 F. Supp. at 867-68
    . The District Court reasoned that
    plaintiffs could have requested lump sum damages which
    would have clearly invoked the Comparative Negligence Act;
    that plaintiffs asked for equitable relief instead of damages
    is not dispositive. Furthermore, because Redland expressly
    encouraged the use of medical monitoring 
    funds, 696 A.2d at 142
    n.6, the District Court predicted the Pennsylvania
    Supreme Court would not apply the "harsh" and
    "anachronistic doctrine of contributory negligence" to
    medical monitoring claims seeking equitable relief. 
    Barnes, 984 F. Supp. at 868
    .
    We need not decide whether the Pennsylvania Supreme
    Court would apply the Comparative Negligence Act to
    plaintiffs' negligence claim. If the Comparative Negligence
    Act does not apply, defendants still have the defense of
    contributory negligence available to them. See
    Commonwealth Fed. Sav. and Loan Assoc. v. Pettit, 
    586 A.2d 1021
    , 1026 (Pa. Comm. Ct. 1991) ("The doctrine of
    contributory negligence continues to be applicable to
    situations where both parties are negligent but the
    resulting injury is not covered under the Pennsylvania
    Comparative Negligence Act.").24 Either defense will raise
    many individual issues.25
    Under Pennsylvania law, the tort of intentional exposure
    to hazardous substances is predicated on a theory of
    battery. See Field v. Philadelphia Elec. Co., 
    565 A.2d 1170
    ,
    1178 (Pa. Super. Ct. 1989). Plaintiffs must prove as a
    constituent element they did not consent to the tortious
    _________________________________________________________________
    24. For purposes of our certification inquiry, we need not decide whether
    these defenses bar plaintiffs' recovery. Instead, we merely conclude that
    one of these defenses is available to the defendants.
    25. We acknowledge that the existence of affirmative defenses as to some
    class members may not by itself enough warrant the denial of
    certification. See Merk v. Jewel Food Stores Div., Jewel Companies, Inc.,
    
    702 F. Supp. 1391
    , 1395 (E.D. Ill. 1988); Lorber v. Beebe, 
    407 F. Supp. 279
    , 294 (S.D.N.Y. 1975). But we note that the defenses are only one of
    many matters raising individual issues in this case.
    40
    conduct. See Levenson v. Souser, 
    557 A.2d 1081
    , 1088 (Pa.
    Super. Ct. 1989); Prosser & Keeton S 18, at 113 ("Consent
    avoids recovery simply because it destroys the wrongfulness
    of the conduct as between the consenting parties, however
    harmful it might be to the interests of others.");
    Restatement (Second) Torts S 892A ("One who effectively
    consents to the conduct of another intended to invade his
    interests cannot recover in an action of tort for the conduct
    or for the harm resulting from it.") Express consent may be
    given by words or affirmative conduct and implied consent
    may be manifested when a person takes no action,
    indicating an apparent willingness for the conduct to occur.
    Restatement (Second) Torts S 892 cmt. b & c. The consent
    must be to the "defendant's conduct, rather than to its
    consequences." Prosser & Keeton S 18, at 118. A plaintiff's
    consent is not effective if "the consenting person was
    mistaken about the nature and quality of the invasion
    intended by the conduct." Prosser & Keeton S 18, at 114.
    Plaintiffs argued in the District Court that the court
    should use its equitable powers to bar defendants from
    asserting their affirmative defenses because of defendants'
    intentional and fraudulent conduct. See Barnes, 984 F.
    Supp. at 864-65. But the District Court rejected this
    argument and plaintiffs do not press it on appeal. Instead,
    plaintiffs argue there is no record evidence they consented
    to defendants' specific conduct. Defendants maintain
    plaintiffs knew they were exposing themselves to a
    hazardous substance yet continued to smoke. There is
    some evidence on the record, including plaintiffs' own
    deposition testimony, to support defendants' position that
    despite warnings, plaintiffs continued to smoke. See 
    id. ("By her
    own admission, Potts learned ``for sure' that cigarette
    smoking created an increased risk of disease in 1966, when
    the Surgeon General's warnings were put on cigarette
    packages. In addition, and more importantly, Ms. Potts was
    informed by her cardiologist in the late 1980s that she was
    at a significantly increased risk of contracting heart
    disease, in the form of clogged arteries, from smoking.").
    Under Pennsylvania law, plaintiffs may recover on a
    theory of strict liability where a product in a defective
    condition unreasonably dangerous to the consumer or user
    41
    causes harm to the plaintiff. See Spino v. John S. Tilley
    Ladder Co., 
    696 A.2d 1169
    , 1172 (Pa. 1997). Plaintiff must
    prove the product was defective and the defect was a
    substantial factor in causing the injury. See 
    id. While a
    defendant may not assert comparative negligence in a strict
    products liability action, see Kimco Development Corp. v.
    Michael D's Carpet Outlets, 
    637 A.2d 603
    , 606-07 (Pa.
    1993), Pennsylvania courts allow defendants to introduce
    "evidence of a plaintiff 's voluntary assumption of the risk,
    misuse of a product, or highly reckless conduct . . . insofar
    as it relates to the element of causation." Charlton v. Toyota
    Indus. Equip., 
    714 A.2d 1043
    , 1047 (Pa. Super. Ct. 1998).
    To demonstrate that a plaintiff's actions are highly
    reckless, defendants must show plaintiff "knew or had
    reason to know of facts which created a high degree of risk
    of physical harm to himself or that he deliberately
    proceeded to act, or failed to act, in conscious disregard of
    that risk." 
    Id. (citation omitted).
    Assumption of risk is also available in negligence claims.
    See Kaplan v. Exxon Corp., 
    126 F.3d 221
    , 224-25 (3d Cir.
    1997).26 In a negligence action, a defendant is relieved of
    his duty to protect the plaintiff when the plaintiff was aware
    of the risk and faced it voluntarily. See Barrett v. Fredavid
    Builders, Inc., 
    685 A.2d 129
    (Pa. Super. Ct. 1996). The
    defendant must show that the "nature and extent" of the
    risk were "fully appreciated" and that the plaintiff
    voluntarily proceeded to face that risk. Childers v. Power
    Line Equip. Rentals, Inc., 
    681 A.2d 201
    , 208 (Pa. Super. Ct.
    1996).
    Plaintiffs make essentially the same arguments regarding
    consent and assumption of risk, contending that because
    defendants concealed the nature and extent of their
    _________________________________________________________________
    26. In light of Pennsylvania's adoption of comparative negligence, see 42
    Pa. Cons. Stat. Ann. S 7102(a), the existence of the assumption of the
    risk defense under Pennsylvania law is a matter of some debate. See
    Kaplan v. Exxon Corp., 
    126 F.3d 221
    , 223-25 (3d Cir. 1997). In Kaplan,
    we predicted the Pennsylvania Supreme Court would incorporate
    assumption of the risk into the duty analysis. Therefore, it is a
    plaintiff 's
    burden to establish that a defendant has a duty. This issue goes to the
    jury "unless reasonable minds could not differ." 
    Id. at 225
    (citation
    omitted).
    42
    conduct, no plaintiff can have consented to or assumed the
    risks of cigarette smoking. Therefore, consent and
    assumption of risk present no individual issues and can be
    resolved on a classwide basis. We are inclined to believe
    that individual considerations predominate here as well,
    but recognize that the question is a close one. Therefore we
    do not rely on the presence of individual issues with the
    defenses of consent and assumption of risk in reaching our
    decision to affirm class decertification. But we note other
    courts have permitted cigarette companies to assert
    affirmative defenses such as contributory negligence and
    assumption of risk. See Cipollone v. Liggett Group, Inc., 
    893 F.2d 541
    , 559 (3d Cir. 1990), aff'd in part, rev'd in part,
    
    505 U.S. 504
    (1992) (remanded for jury to consider
    comparative fault issues); Horton v. The American Tobacco
    Co., 
    667 So. 2d 1289
    , 1292 (Miss. 1995) (jury considered
    comparative fault and held that plaintiff was solely
    responsible for his injury); Gilboy v. The American Tobacco
    Co., 
    582 So. 2d 1263
    , 1265 (La. 1991) (recognizing
    assumption of risk defense).27
    d. Statute of Limitations
    Finally, we believe that determining whether each class
    member's claim is barred by the statute of limitations
    raises individual issues that prevent class certification.28 It
    is fundamental that a plaintiff must bring a claim before
    the applicable statute of limitations expires. Determining
    whether the statute of limitations has expired necessarily
    involves determining when it began to run. Under
    Pennsylvania law, the statute of limitations starts running
    when the plaintiff's cause of action accrues; a medical
    _________________________________________________________________
    27. But see Wilks v. The American Tobacco Co., 
    680 So. 2d 839
    , 843
    (Miss. 1996) ("[We] find that the trial court properly struck the defense
    of assumption of the risk. . . . Even if it was a viable defense, it may
    not
    be employed unless the defendant admits the existence of a risk.
    [American Tobacco] firmly denied that smoking was hazardous to one's
    health.")
    28. We discuss our rationale for applying the statute of limitations
    rather
    than laches in affirming the grant of summary judgment against the
    named plaintiffs. For now, we describe only how the statute of
    limitations applies to the class.
    43
    monitoring claim accrues when the plaintiff suffers a
    "significantly increased risk of contracting a serious latent
    disease." 
    Redland, 696 A.2d at 145
    . Under plaintiffs'
    analysis, a cigarette smoker suffers this risk when he
    reaches the ten or twenty "pack-year" level. A "pack-year" is
    equivalent to a year in which a person smokes a pack of
    cigarettes per day. To calculate a particular plaintiff's pack-
    year history, the court multiplies the number of packs of
    cigarettes the plaintiff smokes daily by the number of years
    he has smoked. For example, a person who has smoked a
    pack of cigarettes each day for twenty years has a twenty-
    pack year history; a person who has smoked a half a pack
    per day for twenty years has a ten pack-year history. Under
    the pack-year approach to claim accrual, determining when
    a plaintiff 's claim accrued necessitates two individual
    inquiries for each plaintiff: when he began smoking and
    how much he has smoked since then. The need to conduct
    such a determination for each plaintiff augurs that a class
    action will devolve into a lengthy series of individual trials
    and therefore makes a class action an improper method for
    resolving these claims.
    Because of the individual issues involved in this case--
    nicotine addiction, causation, the need for medical
    monitoring, contributory/comparative negligence and the
    statute of limitations--we believe class treatment is
    inappropriate.29
    C. Summary Judgment
    Having concluded the District Court did not abuse its
    _________________________________________________________________
    29. In support of certification, plaintiffs point to other medical
    monitoring claims that have been certified under Rule 23(b)(2) or
    23(b)(3). See, e.g., Gibbs v. E.I. Dupont de Nemours & Co., 
    876 F. Supp. 475
    (W.D.N.Y. 1995) (exposure to chemicals); Yslava v. Hughes Aircraft
    Co., 
    845 F. Supp. 705
    , 713 (D. Ariz. 1993) (class alleging long-term
    exposure to contaminated ground water certified); Boggs v. Divested
    Atomic Corp., 
    141 F.R.D. 58
    , 67 (S.D. Ohio 1991) (long term exposure to
    radioactive materials and hazardous waste). Plaintiffs' case, however,
    presents numerous individual issues not involved in those cases. In
    addition, the cases plaintiffs cite all involve involuntary exposure to
    hazardous materials rather than the voluntary exposure involved in this
    case.
    44
    discretion in decertifying the class, we now turn to its order
    granting summary judgment against the six named
    plaintiffs. The court held the claims of five of the six
    plaintiffs--Barnes, Potts, Rodweller, Salzman and Slivak--
    were barred by the statute of limitations. Because each has
    smoked for over thirty years, the court found they knew
    long before this suit was filed that smoking cigarettes put
    them at an increased risk of contracting a serious disease.
    See 
    Barnes, 984 F. Supp. at 861
    -63. The court held the
    sixth plaintiff, Ciaran McNally, was not barred by the
    statute of limitations because, given her age and smoking
    history, her claims for monitoring did not accrue more than
    two years before this action was brought. 
    Id. at 861
    n. 14,
    864. But the court held that McNally had no cause of
    action for medical monitoring because the only monitoring
    she sought--routine physical examinations and
    cardiovascular risk assessment--was not different from that
    normally recommended in the absence of her particular
    exposure. See 
    id. at 872.
    We will briefly set forth the medical and smoking history
    of the named plaintiffs, as summarized by the District
    Court:
    Norma Rodweller has high cholesterol and a family
    history of heart disease. She has been diagnosed with
    vocal chord polyps and COPD, and has shown
    abnormalities in pulmonary function tests. She has
    also been tested for potential coronary insufficiency.
    She nevertheless continues to smoke despite having
    been told by doctors that smoking aggravates her
    medical illnesses. She has also refused her doctor's
    directions to obtain necessary medical screening such
    as pap smears and mammograms.
    Ciaran McNally is 26 years old. She has been a
    regular smoker since she was 15 years old and smokes
    10-15 cigarettes per day. She received chest x-rays
    when appropriate in response to symptoms. She has
    not followed her doctors' advice to quit smoking while
    taking oral contraceptives.
    William Barnes is mildly obese with hypertension
    and elevated cholesterol. He has a history of coronary
    45
    artery disease, and he has been diagnosed with
    hypertensive atherosclerotic heart diseases. He is also
    a heavy drinker. He has received EKGs, chest x-rays,
    and pulmonary function testing as appropriate in
    response to symptoms. He has been told to quit
    smoking every time he visited his doctor, and
    continues to smoke despite evidence of fibrosis of his
    lung.
    Catherine Potts has been diagnosed with COPD,
    coronary heart disease, angina, hyperlipidemia, and
    hypertension. She continues to smoke despite being
    advised by her doctors to cease due to cardiac
    problems and a potential vocal chord malignancy. She
    has not followed her doctor's directions for testing,
    including a recommended colonoscopy following rectal
    bleeding. On one occasion, she insisted on being
    discharged from the hospital against medical advice
    after being diagnosed with possible myocardial
    infarction. She continues to drink caffeinated beverages
    despite being advised by doctors to cease doing so.
    Edward Slivak has continued smoking despite
    abnormal pulmonary function tests and abnormal
    chest x-rays leading to a diagnosis of COPD. He has
    high blood pressure and elevated cholesterol, has
    received EKGs, and has been diagnosed with
    myocardial infarction. Although he has been advised
    repeatedly not to smoke due to his various medical
    conditions, he is still smoking.
    Barbara Salzman continues to smoke despite having
    been diagnosed with emphysema and mild to moderate
    COPD based on pulmonary function tests and chest x-
    rays. She has received chest x-rays, MRI scans, and
    EKGs in response to her symptoms. She has not,
    however, mentioned her emphysema to her family
    physician, explaining that she does not desire to follow-
    up because "I don't like to look for trouble." She drinks
    an excessive amount of caffeine and has a family
    history of heart disease.
    
    Barnes, 984 F. Supp. at 854
    .
    46
    1. Statute of Limitations
    Looking to the underlying theories of liability--intentional
    tort, negligence, and strict products liability--the District
    Court applied a two-year statute of limitations,finding the
    claims accrued on the date when the plaintiffs were placed
    at a "significantly increased risk of contracting a serious
    latent disease." See 
    Redland, 696 A.2d at 145
    . Plaintiffs
    faced this risk when, according to their experts' testimony,
    they had smoked for twenty pack-years. Rodweller reached
    this level in 1970, Salzman in 1976, Slivak in 1978, Barnes
    in 1990, and Potts in 1973. Therefore the court held the
    claim of each named plaintiff was barred by the statute of
    limitations. The court also found the discovery rule could
    not save plaintiffs' claims because each knew or should
    have known that smoking put him or her at a significantly
    increased risk of contracting a serious latent disease years
    before this lawsuit was filed. See 
    Barnes, 984 F. Supp. at 863-64
    .
    Plaintiffs contend the equitable doctrine of laches should
    apply, arguing their medical monitoring claim is analogous
    to a suit for nuisance abatement based in equity. Citing
    Simmons v. Pacor, 
    674 A.2d 232
    (Pa. 1996) and Redland,
    plaintiffs maintain the Pennsylvania Supreme Court implied
    it would not apply the statute of limitations to a medical
    monitoring claim based on long-term exposure.30 But we
    discern no detectable direction from the Pennsylvania
    Supreme Court that it would apply laches rather than the
    statute of limitations.
    As the District Court found, plaintiffs could have brought
    their claim at law or in equity depending on the type of
    relief sought.
    _________________________________________________________________
    30. Plaintiffs point to the following language. In Simmons, the court
    found that "recovery for medical monitoring is appropriate and just" and
    that though plaintiffs' experts had recommended medical monitoring,
    plaintiff had "unfortunately" not sought the relief in the lawsuit. 
    Id. at 240.
    In Redland, the Court opined that "a medical monitoring trust fund
    is a more appropriate remedy than lump sum damages in mass exposure
    toxic tort cases. However, because the Redland Plaintiffs are seeking only
    a medical monitoring trust fund, we offer no opinion whether lump sum
    damages are recoverable under HSCA." 
    Redland, 696 A.2d at 142-43
    n.6.
    47
    If plaintiffs seek relief that is a disguised request for
    compensatory damages, then the medical monitoring
    claim can only be characterized as a claim for
    monetary damages. In contrast, if plaintiffs seek the
    establishment of a court-supervised medical
    monitoring program through which the class members
    will receive periodic medical examinations, then
    plaintiffs' medical monitoring claims can properly be
    characterized as a claim seeking injunctive relief.
    
    Arch, 175 F.R.D. at 483
    . Plaintiffs themselves apparently
    believed their claim for medical monitoring seeks a legal
    remedy since both their original and first amended
    complaints requested money damages.
    Because plaintiffs could have brought their medical
    monitoring claim at law or in equity, the statute of
    limitations, not the doctrine of laches, applies. "[I]t is well
    established that equity will frequently follow the statute of
    limitations which controls analogous proceedings at law.
    This is especially, if not invariably, true if the cause of
    action is not exclusively cognizable in equity, which is the
    situation here . . . ." Ebbert v. Plymouth Oil Co., 
    34 A.2d 493
    , 495-96 (Pa. 1943). Similarly, in Algrant v. Evergreen
    Valley Nurseries, Ltd., 
    126 F.3d 178
    , 181 (3d Cir. 1997)
    (citations omitted), we stated: "It is settled . . . that where
    legal and equitable claims coexist, equitable remedies will
    be withheld if an applicable statute of limitations bars the
    concurrent legal remedy." Because plaintiffs could have
    sought an award of damages, their decision to pursue a
    claim for a medical monitoring fund instead cannot deprive
    defendants of the statute of limitations defense. Statutes of
    limitations are primarily designed to assure fairness and
    "promote justice by preventing surprises through the revival
    of claims that have been allowed to slumber until evidence
    has been lost, memories have faded, and witnesses have
    disappeared. The theory is that even if one has a just claim
    it is unjust not to put the adversary on notice to defend
    within the period of limitation and that the right to be free
    of stale claims in time comes to prevail over the right to
    prosecute them." Order of R.R. Telegraphers v. Railway
    Express Agency, Inc., 
    321 U.S. 342
    , 348-49 (1944); see also
    Carey v. Kerr-McGee Chem. Corp., 
    999 F. Supp. 1109
    (N.D.
    
    48 Ill. 1998
    ) (holding medical monitoring claims barred by two-
    year tort statute of limitations).
    In predicting what statute of limitations the Pennsylvania
    Supreme Court would apply, we look to the theories of
    liability that underlie a medical monitoring claim. Under
    Redland, a plaintiff must prove that he was exposed to a
    proven hazardous substance as a result of the defendant's
    negligence. See 
    Redland, 696 A.2d at 145
    -46. In
    Pennsylvania, a two-year statute of limitations applies to
    negligence actions. See 42 Pa. Cons. Stat. Ann. S 5524. As
    noted, plaintiffs also allege intentional exposure to a
    hazardous substance and strict liability for manufacturing
    a defective product. To the extent that strict products
    liability or an intentional tort can act as the underlying
    theory of liability for a medical monitoring claim, the
    applicable statute of limitations would still be two years.
    See 42 Pa. Cons. Stat. Ann. S 5524.31
    Next we must decide when plaintiffs' claims accrued.
    Generally, a plaintiff "is under a duty to use all reasonable
    diligence to be properly informed of the facts and
    circumstances upon which a potential right of recovery is
    based and to institute suit within the prescribed statutory
    period." Pocono Int'l Raceway, Inc. v. Pocono Produce, 
    468 A.2d 468
    , 471 (Pa. 1983). A claim under Pennsylvania law
    accrues at "the occurrence of the final significant event
    necessary to make the claim suable." Mack Trucks, Inc. v.
    Bendix-Westinghouse Automotive Air Brake Co., 
    372 F.2d 18
    , 20 (3d Cir. 1966).
    A plaintiff 's medical monitoring cause of action accrues
    when he has been placed at a "significantly increased risk
    of contracting a serious latent disease." 
    Redland, 696 A.2d at 145
    . To determine when that event occurred, we refer to
    the testimony of plaintiffs' experts. As the District Court
    noted, their experts proposed specific dates when plaintiffs
    _________________________________________________________________
    31. In Redland, the Pennsylvania Supreme Court held that "medical
    monitoring" plaintiffs must prove that defendant's negligence caused the
    exposure. See 
    Redland, 696 A.2d at 146
    . We assume without deciding
    that the Pennsylvania Supreme Court would allow an intentional tort or
    strict products liability to be the underlying theory of liability in a
    claim
    for medical monitoring.
    49
    would be entitled to participate in the proposed medical
    monitoring program. Under the Petty-Hyers Program, a
    plaintiff would be entitled to medical monitoring when he or
    she reaches the "twenty pack-year" level.32
    We agree with the District Court that five of the six
    named plaintiffs reached that level more than two years
    ago. Rodweller had been smoking one to one-and-a-half
    packs since 1953 and became a twenty pack-year smoker
    in 1970. Salzman had been smoking at least one-and-a-half
    packs per day for forty-one years and her claim accrued, at
    the latest, in 1976. Slivak had been smoking at least one to
    two packs per day for thirty-nine years and his claim
    accrued, at the latest, in 1978. Barnes had been smoking
    a pack a day since 1970 and his claim accrued in 1990.
    Potts had been smoking a pack a day since the early 1950s
    and her claim accrued no later than 1975.
    Absent an exception to the statute of limitations, the
    medical monitoring claims of these five plaintiffs are time-
    barred. The "discovery rule" is a "narrow exception to this
    general rule," Tohan v. Owens-Corning Fiberglass Corp., 
    696 A.2d 1195
    , 1200 n.4 (Pa. 1997), and tolls the statute of
    limitations during the "plaintiff 's complete inability, due to
    facts and circumstances not within his control, to discover
    an injury despite the exercise of due diligence." Kingston
    Coal Co. v. Felton Mining Co., 
    690 A.2d 284
    , 288 (Pa. Super.
    Ct. 1997). Under the discovery rule, the statute of
    limitations begins to run when the "plaintiff knows, or in
    the exercise of reasonable diligence should have known, (1)
    that he has been injured, and (2) that his injury has been
    caused by another's conduct." Bradley v. Ragheb, 
    633 A.2d 192
    , 194 (Pa. Super. Ct. 1993). The plaintiff has the burden
    of proving that he exercised reasonable diligence in bringing
    his claim. See Cochran v. GAF Corp., 
    666 A.2d 245
    , 249-50
    (Pa. 1995).
    _________________________________________________________________
    32. We note that plaintiffs' other expert Dr. Burns proposes that
    monitoring begin before a person reaches the 20-pack year level. Dr.
    Burns suggests, for example, that a person who has smoked 15-20
    cigarettes for 10 years would be entitled to three of the seven proposed
    tests. 
    Barnes, 984 F. Supp. at 860
    . In choosing the 20-pack year level
    as the accrual date, we, like the District Court, are erring in
    plaintiffs'
    favor by choosing a later date.
    50
    We agree with the District Court that the discovery rule
    does not save the claims of these five plaintiffs. Each
    plaintiff should have known that cigarettes put him or her
    at a significantly increased risk of contracting a serious
    latent disease years before this lawsuit was filed. As the
    District Court found:
    - "Since the 1980s, every doctor seen by Mr. Barnes
    for hypertension has told him to stop smoking. . . .
    Dr. Brownstein, his doctor in the mid-1980s, took
    Barnes' cigarettes and threw them away every time
    Barnes came in for a visit. . . . Indeed, Mr. Barnes
    stated that at the time of these visits in the 1980s,
    he ``kn[e]w that cigarettes are no good for you if you
    have any type of lung disease. . . . Further, Mr.
    Barnes stated that he believed that his father's
    death from lung cancer was partially caused by
    smoking . . . . Finally, Mr. Barnes testified at
    deposition that none of the warnings on cigarettes,
    which inform smokers of the risks of smoking,
    provided him with any information that he already
    did not possess. Based on these facts, it is obvious
    Barnes knew that smoking caused him to be placed
    at an increased risk of contracting a serious latent
    disease by at least the mid-1980s.' "
    - "By her own admission, Potts learned ``for sure' that
    cigarette smoking created an increased risk of
    disease in 1966, when the Surgeon General's first
    warnings were put on cigarette packages. In
    addition, and more importantly, Ms. Potts was
    informed by her cardiologist in the late 1980s that
    she was at a significantly increased risk of
    contracting heart disease, in the form of clogged
    arteries, from smoking."
    - "As early as 1959 . . . Rodweller was told by a
    doctor that smoking would put scar tissue on her
    vocal cords and it was in that year that she realized
    that ``cigarettes affected [her] body. . . .' Since this
    time, Ms. Rodweller admits that all of her doctors
    have advised her to quit smoking because ``[i]t can
    make [her] ill' and because ``[she] was a good
    candidate for emphysema.' "
    51
    - "In the 1980s, one of Salzman's doctors told her to
    stop smoking. The doctor explained, ``it's really bad
    for you, you can get emphysema, cancer . . . .' In
    addition to being told by her doctors that she could
    contract these diseases, Ms. Salzman urged her son,
    throughout the 1980s, to quit smoking because of
    the dangers of smoking."
    - "After 1985, Mr. Slivak had read the warnings on
    the packages of cigarettes. . . . In addition, in the
    early 1980s, Slivak discussed with his family that
    smoking may have been the cause of his wife's
    cancer. Most importantly, Slivak's doctors connected
    smoking to his heart disease."
    - With respect to plaintiff McNally, the court
    determined that, since she has only been smoking
    for approximately 11 years, her claim could not
    have accrued until sometime last year. FN 14.
    Barnes, 
    984 F. Supp. 862-63
    & n.14.
    Plaintiffs argue the claims did not accrue when they were
    placed "at a significantly increased risk" of developing
    smoking-related illnesses. They claim instead that the
    "touchstone of accrual is the suffering of actual,
    demonstrable injury, not increased risk" and note that
    Pennsylvania courts have "expressly held that a plaintiff
    cannot sue for ``increased risk.' " Similarly, they argue the
    court erred in invoking the discovery rule because there
    was no injury to discover since none had occurred. These
    arguments lack merit. If, as plaintiffs maintain, they have
    suffered no demonstrable injury--or even no injury at all--
    then we would have to dismiss the case because it lacks an
    Article III case or controversy. See Lujan v. Defenders of
    Wildlife, 
    504 U.S. 555
    , 560-61 (1992). The Pennsylvania
    Supreme Court has held that the costs of periodic medical
    examinations necessary to detect the onset of physical
    harm, 
    Redland, 696 A.2d at 144
    , are a compensable injury
    even in the absence of physical harm. Plaintiffs' argument
    begs the question of when that injury accrued. Examining
    plaintiffs' claims, the District Court found the injury
    accrued when plaintiffs began needing medical monitoring.
    The District Court determined this date by looking at the
    52
    testimony of plaintiffs' own experts. We agree with the
    District Court's analysis.33
    Citing Page v. United States, 
    729 F.2d 818
    (D.C. Cir.
    1984) and Fowkes v. Pennsylvania Railroad Co., 
    264 F.2d 397
    (3d Cir. 1959), plaintiffs contend the "continuing harm"
    doctrine should operate to toll the statute of limitations. In
    Page, the D.C. Circuit found
    It is well-settled that ``when a tort involves continuing
    injury, the cause of action accrues, and the limitation
    period begins to run, at the time the tortious conduct
    ceases.' Since usually no single incident in a
    continuous chain of tortious activity can ``fairly or
    realistically be identified as the cause of significant
    harm,' it seems proper to regard the cumulative effect
    of the conduct as actionable. Moreover, ``since one
    should not be allowed to acquire a right to continue the
    tortious conduct,' it follows logically that statutes of
    limitations should not run prior to its cessation.
    Page at 821-22 (citations omitted). There, the court applied
    the continuing tort doctrine to a claim by an army veteran
    that the army subjected him to harmful drugs.
    In Fowkes, we found the plaintiff's claim under the
    Federal Employers' Liability Act was not barred by the
    three-year statute of limitations under a continuous harm
    theory. We noted
    ``If the relation is continuous, as in that of master and
    servant, and the default is likewise continuous until
    the cumulative effect produces disability in the form of
    occupational disease, total or partial, the master's
    failure to perform his duty . . . is regarded as a single
    wrong continuing so long as the employment
    _________________________________________________________________
    33. We acknowledge this statute of limitations analysis leads to some
    "odd conclusions." For instance, with respect to Mr. Barnes' claim, we
    have held that it accrued in 1990 under the 20 pack-year rule but that
    he "discovered his injury five years before it accrued, in the mid-1980s
    when his doctor threw away his cigarettes." But the source of this
    seeming incongruity is our decision to err in favor of the plaintiffs in
    calculating the accrual date. In calculating Barnes' accrual date, we used
    the 20-pack-year level. This is the latest date suggested by plaintiffs.
    53
    continues. Such wrong must therefore be redressed by
    action brought within . . . (the statutory period) from
    the time when the employment terminates.'
    
    Fowkes, 264 F.2d at 399
    (citation omitted).
    In Kichline v. Consolidated Rail Corp., 
    800 F.2d 356
    (3d
    Cir. 1986), however, in declining to apply the continuing
    harm doctrine to a FELA claim, we limited the applicability
    of Fowkes. In doing so, we specifically rejected the position
    now advanced by plaintiffs. We noted that in Fowkes, the
    "jury found specifically that the plaintiff was unaware that
    the physical condition for which he sought damages had
    existed for more than three years before the suit had been
    filed." 
    Kichline, 800 F.2d at 359
    . We then stated: "We
    understand Fowkes to mean that continuing conduct of
    defendant will not stop the ticking of the limitations clock
    begun when plaintiff obtained requisite information. On
    discovering an injury and its cause, a claimant must
    choose to sue or forego that remedy." 
    Id. at 360.34
    Unlike
    this case, the discovery rule was not applicable in Fowkes
    because plaintiff did not know about his injury. But here,
    as we have discussed, there is unrefuted evidence that
    plaintiffs knew or should have known about their injury
    more than two years before filing suit. Under Kichline, the
    clock began to run when plaintiffs obtained the requisite
    information.
    2. Ciaran McNally
    The District Court also granted summary judgment
    against the sixth named plaintiff, McNally, finding she
    failed to demonstrate a need for medical monitoring. 35 The
    _________________________________________________________________
    34. While plaintiffs are correct that in Kichline we distinguished Page as
    an "intentional conduct case," 
    Kichline, 800 F.2d at 360
    , we did not
    adopt Page as the rule in intentional tort cases. We believe our
    unequivocal adoption of the discovery rule in Kichline disposes of
    plaintiffs' argument. We further note that Page, unlike this case,
    involved
    involuntary exposure to a hazardous substance.
    35. Before reaching this issue, the District Court concluded defendants
    were not entitled to summary judgment on the issues of McNally's
    comparative negligence, assumption of risk, and consent. The District
    Court found genuine issues of material fact exist with respect to each
    defense. See 
    Barnes, 984 F. Supp. at 868
    -70.
    54
    District Court found (1) under the Burns Program, McNally
    is only entitled to participate in the first level of the
    proposed monitoring program which includes regular
    physical examinations, cardiovascular risk assessment, and
    an EKG; (2) McNally only requested cardiovascular risk
    assessment and annual physical examinations and not
    EKGs; and (3) annual physical examinations and
    cardiovascular risk assessment are routinely recommended
    to all persons even in the absence of exposure. The court
    concluded that because McNally only seeks monitoring for
    two tests that would be recommended for her even if she
    did not smoke, "[a]ny increase in Ms. McNally's incremental
    risk of incurring the harm produced by the allegedly
    hazardous substances in cigarettes would not warrant a
    change in the medical monitoring that would be prescribed
    for her. Indeed, in the absence of exposure, it would be
    recommended that she receive the tests she seeks under
    her medical monitoring claim." 
    Barnes, 984 F. Supp. at 870-72
    . Therefore, the court reasoned, she cannot satisfy
    the sixth element of Redland because she cannot establish
    that "the prescribed regime is different from that normally
    recommended in the absence of the exposure." See id.36 We
    _________________________________________________________________
    36. The parties' briefs and the record demonstrate a great deal of
    confusion and disagreement on this issue. The dispute centers around
    what kind of monitoring program McNally requested and what kind of
    program plaintiffs' expert recommended for her.
    Dr. Burns made contradictory statements with respect to the
    appropriate program for McNally. In describing the different levels of
    monitoring, Dr. Burns recommended three tests for smokers at McNally's
    level (at least 25 years old and at least 10 years of smoking): (1) an
    EKG,
    (2) a cardiovascular risk factor assessment, and (3) a physical
    examination. But later in his affidavit Dr. Burns specifically stated
    McNally "should initially receive [cardiovascular risk assessment] and
    [physical examination]." He did not mention the EKG. Moreover, in
    plaintiffs' response to defendants' first set of interrogatories, McNally
    indicated she would only need cardiovascular risk factor assessment and
    physical examination and did not mention an EKG.
    McNally claims for the first time on appeal that Dr. Burns' report
    contains a typographical error. She claims paragraph 7 of the report
    inadvertently stated that only a cardiovascular risk factor assessment
    and a physical examination would be prescribed for her, and forgot to
    mention the EKG. She argues this error was "carried through" to the
    55
    agree with this reasoning and the District Court's decision
    to grant summary judgment against McNally.
    IV.
    For the foregoing reasons, we will affirm the judgment of
    the District Court.
    A True Copy:
    Teste:
    Clerk of the United States Court of Appeals
    for the Third Circuit
    _________________________________________________________________
    interrogatory and contend the District Court erred by failing to recognize
    and resolve a resulting "tension" between the interrogatory answer,
    which neglected to mention the EKG, and the more general statement in
    Dr. Burns' second report that EKGs should be administered to persons
    25 or older who have smoked 10-15 cigarettes per day for 10 years.
    Defendants claim McNally waived this argument because she did not
    raise it below. We agree with defendants that this argument is waived.
    Alternatively, plaintiffs contend that Dr. Burns, in his expert report,
    stated that both tests--cardiovascular risk factor coupled with physical
    examination--were different from that normally prescribed and therefore
    satisfied the sixth element of Redland. We do not agree with plaintiffs'
    analysis of Dr. Burns' testimony. Dr. Burns said:"Cardiovascular risk
    factor assessment and a physical examination are measures that are
    recommended for all individuals to identify modifiable causes of heart
    disease including smoking. They are useful in preventing disease only for
    those who have an identifiable and modifiable risk factor. All smokers
    have an identifiable and modifiable risk factor, and the risk of disease
    increases synergistically when smokers have additional risk factors.
    Therefore, smokers have a particularly urgent need for this screening in
    comparison to the general population and will have a potential benefit
    that is substantially greater than the general population of smokers."
    Plaintiffs argue this statement supports the position that these tests
    were different from that normally prescribed for the general population.
    But as defendants contend, Dr. Burns' report indicates these are
    "measures recommended for all individuals." We also note Dr. Burns'
    deposition statement that "most organizations recommended screening
    for cardiovascular risk factors at almost any interaction with the health
    care system regardless of age."
    56
    

Document Info

Docket Number: 97-1844

Filed Date: 11/16/1998

Precedential Status: Precedential

Modified Date: 10/13/2015

Authorities (50)

COM. FEDERAL SAV. & LOAN v. Pettit , 137 Pa. Commw. 523 ( 1991 )

friends-for-all-children-inc-as-legal-guardian-and-next-friend-of-the , 746 F.2d 816 ( 1984 )

Pocono International Raceway, Inc. v. Pocono Produce, Inc. , 503 Pa. 80 ( 1983 )

Bradley v. Ragheb , 429 Pa. Super. 616 ( 1993 )

Barrett v. Fredavid Builders, Inc. , 454 Pa. Super. 162 ( 1996 )

Metro-North Commuter Railroad v. Buckley , 117 S. Ct. 2113 ( 1997 )

Potter v. Firestone Tire & Rubber Co. , 6 Cal. 4th 965 ( 1993 )

Wilks v. American Tobacco Co. , 680 So. 2d 839 ( 1996 )

geraghty-john-m-individually-and-on-behalf-of-a-class-villanti-frank , 719 F.2d 1199 ( 1983 )

32-fair-emplpraccas-603-32-empl-prac-dec-p-33749-marsha-a , 709 F.2d 1016 ( 1983 )

frank-kuehner-dorothy-burayak-richard-burns-alice-hetherington-frank , 778 F.2d 152 ( 1985 )

Yslava v. Hughes Aircraft Co. , 845 F. Supp. 705 ( 1993 )

Werlein v. United States , 746 F. Supp. 887 ( 1990 )

Carey v. Kerr-McGee Chemical Corp. , 999 F. Supp. 1109 ( 1998 )

Bourgeois v. AP Green Industries, Inc. , 1998 La. LEXIS 2343 ( 1998 )

In Re Nlo, Inc. , 5 F.3d 154 ( 1993 )

Charles C. Fowkes v. Pennsylvania Railroad Company , 264 F.2d 397 ( 1959 )

31 Fair empl.prac.cas. 1707, 32 Empl. Prac. Dec. P 33,668 ... , 706 F.2d 1144 ( 1983 )

Childers v. Power Line Equipment Rentals, Inc. , 452 Pa. Super. 94 ( 1996 )

Lujan v. Defenders of Wildlife , 112 S. Ct. 2130 ( 1992 )

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