Opinions of the United
1998 Decisions                                                                                                             States Court of Appeals
                                                                                                                              for the Third Circuit


11-12-1998

Barnes v. Amer Tobacco Co
Precedential or Non-Precedential:

Docket 97-1844




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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., 

(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."

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. 

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. 

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., 

, 336
       (S.D. Ohio 1992), rev'd on other grounds, 

       (6th Cir. 1993)]; see also Fried v. Sunguard Recovery
       Serv., Inc., 

(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).

; 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, 

(Pa. 1997).

                               10
the exposure of the throat, heart, and lungs to tobacco
smoke. Barnes v. The American Tobacco Co., 

, 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 

. 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, 

, 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


.

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., 

(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, 

(1990). In
Terry, the Court noted the Seventh Amendment right to a jury is
applicable when legal rights are at stake. See 

"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." 

(citation omitted). Second, the court must
" `examine the remedy sought and determine whether it is legal or
equitable in nature.' " 

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

.

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 

See Dairy Queen,
Inc. v. Wood, 

, 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."

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., 

,
       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, 

, 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.

(citing 

-
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." 

. 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., 

, 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, 

, 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 

. 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."

-01 (citing 

(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." 

.

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 FRAUD 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." 

.

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 

(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 

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, 

, 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., 

, 20 (3d Cir. 1966). The "discovery rule" is, however, a
"narrow exception to this general rule," Tohan v. Owens-
Corning Fiberglass Corp., 

, 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., 

, 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, 

, 194
(Pa. Super. Ct. 1993) (quoting MacCain v. Montgomery
Hosp., 

, 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 

, 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."

. 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. 

.

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." 

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.

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. 

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 

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." 

].
       . . . 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.

.

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, 

, 56 n.15 (3d Cir. 1994). We exercise plenary review
of a grant of summary judgment. Wicker v. Consol. Rail
Corp., 

, 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. 

(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, 

(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, 

(3d Cir.
1994) (Paoli II).10 The issue of medical monitoring first
reached the Pennsylvania Supreme Court in Simmons v.
Pacor, Inc., 

(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,

(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, 

(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 

. 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 

(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.

-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." 

see also
Friends for All Children, Inc. v. Lockheed Aircraft Corp., 

, 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., 

, 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., 

(La. 1998); Potter v. Firestone Tire & Rubber Co.,

(Cal. 1993); Hansen v. Mountain Fuel Supply Co., 

(Utah 1993); Ayers v. Township of Jackson , 

(N.J.
1987). In addition, some federal courts predicting state law have reached
the same conclusion. See Cook v. Rockwell Int'l Corp., 

(D. Colo. 1991); Johnson v. Armstrong Cork Co., 

(W.D.
La. 1986). But see Ball v. Joy Techs., Inc., 

(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, 

(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"); 

(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. 

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 

.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.' " 

(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. ___;

, 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 FRAUD 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, 

,
163 (3d Cir. 1985); see also Richardson v. Byrd, 

, 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 FRAUD at 502.

In considering whether certification is proper, we refrain
from conducting a preliminary inquiry into the merits. See
Eisen v. Carlisle & Jacquelin, 

, 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, 

, 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, 

, 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, 

,
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 

("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 FRAUD at 477.16

"The concepts of commonality and typicality are broadly
defined and tend to merge." Baby Neal v. 

(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. 

This requirement does not mandate that all putative
class members share identical claims. 

(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 

("[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., 

, 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." 

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." 

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 FRAUD 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 FRAUD 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 FRAUD at 479
(quoting Baby 

). 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 FRAUD at 478-79.

Finally, the District Court found that plaintiffs "fairly and
adequately protect the interests of the class." 

(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. 

. Second,
it "serves to uncover conflicts of interest between named
parties and the class they seek to represent." 

.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, 

, 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 FRAUD 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." 

                               29
could constitute the injunctive relief required by Rule
23(b)(2). Arch, 175 FRAUD 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 FRAUD 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. ___; 

(1997), the Supreme
Court affirmed our decision in Georgine v. Amchem
Products, Inc., 

(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." 

. 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.' " 

(quoting 

). 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."

. 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)." 

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, 

(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."

(citations omitted). In Geraghty v. United
States Parole Commission, 

, 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 FRAUD 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 FRAUD 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, 

, 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 FRAUD 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 FRAUD 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

(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., 

(5th Cir. 1996) (decertifying 23(b)(3) class because
individual issues predominated); Smith v. Brown & Williamson Tobacco
Corp., 174 FRAUD 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." 

. 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. . . .' " 

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, 

(Fla. App. 3 Dist. 1996), rev. denied, 

(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 

-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., 

, 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." 

(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." 

.
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.

.

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."

.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 

; 

("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., 

, 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. 

.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.

. 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." 

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. 

. 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 

. 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." 

. 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 

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. 

.

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, 

, 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., 

,
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.,

, 1395 (E.D. Ill. 1988); Lorber v. Beebe, 

, 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, 

, 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 

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., 

, 1172 (Pa. 1997). Plaintiff must
prove the product was defective and the defect was a
substantial factor in causing the injury. See 

defendant may not assert comparative negligence in a strict
products liability action, see Kimco Development Corp. v.
Michael D's Carpet Outlets, 

, 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., 

, 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." 

Assumption of risk is also available in negligence claims.
See Kaplan v. Exxon Corp., 

, 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., 

(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., 

, 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., 

, 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." 

(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., 

, 559 (3d Cir. 1990), aff'd in part, rev'd in part,

(1992) (remanded for jury to consider
comparative fault issues); Horton v. The American Tobacco
Co., 

, 1292 (Miss. 1995) (jury considered
comparative fault and held that plaintiff was solely
responsible for his injury); Gilboy v. The American Tobacco
Co., 

, 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., 

, 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." 

. 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., 

(W.D.N.Y. 1995) (exposure to chemicals); Yslava v. Hughes Aircraft
Co., 

, 713 (D. Ariz. 1993) (class alleging long-term
exposure to contaminated ground water certified); Boggs v. Divested
Atomic Corp., 

, 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 

-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. 

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 

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.

.

                               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 

. 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 

.

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, 

(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. 

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." 

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.

. 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., 

, 495-96 (Pa. 1943). Similarly, in Algrant v. Evergreen
Valley Nurseries, Ltd., 

, 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., 

, 348-49 (1944); see also
Carey v. Kerr-McGee Chem. Corp., 

(N.D.

                               

) (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 

-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, 

, 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., 

, 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." 

. 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 

. 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., 

, 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., 

, 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, 

, 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., 

, 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. 

. 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, 

& 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, 

, 560-61 (1992). The Pennsylvania
Supreme Court has held that the costs of periodic medical
examinations necessary to detect the onset of physical
harm, 

, 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, 

(D.C. Cir.
1984) and Fowkes v. Pennsylvania Railroad Co., 

(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.'

(citation omitted).

In Kichline v. Consolidated Rail Corp., 

(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." 

. 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." 

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," 

, 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 

-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." 

. 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