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. e du/thir dc ir c uit_1998/262Filed 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.; PHI LIP 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 Po tts, Norma Rodweller, Barbara Salzman and Edward Slivak, on behalf of themselves and all thos e similarly situated, AppellantsOn 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.

2GARY 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

3MORTON 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

4ROBERT 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.

5PATRICK 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 monitor ing

class should be certified under Federal Rule of Civ il Procedure 23(b)(2). The District Court decertified a proposed class of cigarette smokers on the grounds that significant individual issues precluded certificati on. After finding the statute of limitations had run with res pect to the claims of five named plaintiffs and the sixth h ad failed to establish the need for medical monitoring, the D istrict Court granted defendants summary judgment. We will

affirm the District Court's decertification order a nd its grant of summary judgment.

6I.

FACTS AND PROCEDURAL HISTORY

Named plaintiffs William Barnes, Catherine Potts, N orma Rodweller, Barbara Salzman, Edward J. Slivak, and C iaran McNally are Pennsylvania residents who began smokin g 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 Philadel phia County. Defendants removed to the Eastern District of Pennsylvania, and plaintiffs filed an Amended Compl aint asserting claims of intentional exposure to a hazar dous substance, negligence, and strict products liabilit y on behalf of a purported class of over one million Pen nsylvania cigarette smokers. In their prayer for relief, plai ntiffs asked (1) that defendants fund a court-supervised or cour tapproved program providing medical monitoring to cl ass members; (2) for punitive damages to create a fund for common class-wide purposes, including medical resea rch, public education campaigns, and smoking cessation programs; and (3) for other monetary and injunctive relief the court deemed just and proper.

A.

The District Court found the class did not meet the requirements of Rule 23(b)(2) or (b)(3). See Arch v . The American Tobacco Co., 175 F.R.D. 469 (E.D. Pa. 1997 ). The District Court rejected Rule 23(b)(2) certification because plaintiffs had not primarily sought injunctive or e quitable

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1. The defendants are The American Tobacco Company, Inc.; American Brands, Inc.; R.J. Reynolds Tobacco Company; RJR Na bisco, Inc.; Brown & Williamson Tobacco Corporation; Philip Morris, In c.; Philip Morris Companies, Inc.; Lorillard Tobacco Company, Inc.; L orillard, Inc.; United States Tobacco Company; UST, Inc.; The Tobacco Inst itute, Inc.; The Council for Tobacco Research-U.S.A., Inc.; Liggett Group, Inc.; Liggett & Myers, Inc.; Brooke Group, LTD. Pursuant to the par ties' 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. wa s dismissed for lack of personal jurisdiction by order of the District Cour t dated June 21, 1997.

7relief, finding that "[p]laintiffs' medical monitor ing claim is

merely a thinly disguised claim for future damages" and that "the overwhelming majority of the relief sough t by plaintiffs in their entire complaint is monetary in nature." Id. at 484. The court also found certification impr oper under Rule 23(b)(3) because issues common to the cl ass did not predominate over plaintiffs' individual issues. In particular, the District Court found individual iss ues, such as addiction, causation, the need for medical monit oring, and affirmative defenses, made a class action unmanageable and not the superior method for fair a nd efficient adjudication of the case. Id. at 485-96.

The District Court suggested, however, that plainti ffs' request for a court-supervised program of medical monitoring to detect the latent diseases caused by smoking was the "paradigmatic" request for injunctive relie f under a medical monitoring claim. Id. at 484. Specifically, the court

stated:

The Court finds that it may properly certif y a medical monitoring claim under Rule 23(b)(2) when th e plaintiffs seek such specific relief which c an be properly characterized as invoking the court 's equitable powers. See [Day v. NLO, Inc., 144 F.R.D. 33 0, 336 (S.D. Ohio 1992), rev'd on other grounds, 5 F.3d 154 (6th Cir. 1993)]; see also Fried v. Sunguard Recovery Serv., Inc., 925 F. Supp. 372 (E.D. Pa. 1996 ). In reaching this decision, the Court perforce r ejects defendants' argument that a medical monitori ng claim can never be characterized as injunctive.

The dispositive factor that must be assesse d to determine whether a medical monitoring claim can be certified as a Rule 23(b)(2) class is-what t ype of relief do plaintiffs actually seek. If plaintiffs s eek relief that is a disguised request for compensatory damages , then the medical monitoring claim can only be cha racterized 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 examin ations, then plaintiffs' medical monitoring claims c an be

8properly characterized as claim seeking inju nctive

relief.

In Day, Judge Spiegel cogently articulates the fine distinction between a medical monitoring cla im that seeks monetary relief in the form of compens atory damages and a medical monitoring claim that seeks injunctive relief in the form of a court-sup ervised medical monitoring program. Judge Spiegel ex plains:

Relief in the form of medical monitoring ma y 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 t o use that money to have his medical condition mon itored. Second, a court may order the defendants to pay the plaintiffs' medical expenses directly so tha t a plaintiff may be monitored by the physician of his cho ice.

Neither of these forms of relief constitute injunctive relief as required by Rule 23(b)(2).

However, a court may also establish an elabo rate medical monitoring program of its own, manag ed by court-appointed court-supervised trustees, p ursuant to which a plaintiff is monitored by particu lar physicians and the medical data produced is utilized for group studies. In this situation, a defe ndant, of course, would finance the program as well as being required by the Court to address issues as t hey develop during the program administration. U nder these circumstances, the relief constitutes injunctive relief as required by Rule 23(b)(2).

Day, 144 F.R.D. at 335-36; see also Fried, 9 25 F. Supp. at 374 (implying that under medical mo nitoring case law, a creation of a medical monitoring program would be equitable in nature). Based on Judg e Spiegel's insightful distinction, it is appa rent that relief requested under a medical monitoring claim c an be either injunctive or equitable in nature.

To determine whether the named plaintiffs i n this case seek equitable relief under their medic al monitoring claim, plaintiffs' specific reque st for relief under this claim must be closely scrutinized . Plaintiffs

9seek the establishment of a court-supervised program

through which class members would undergo pe riodic medical examinations in order to promote the early detection of diseases caused by smoking. Thi s portion of plaintiffs' request is the paradigmatic r equest 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 agains t defendants--medical monitoring.2 Moreover, plaintif fs eliminated all requests for smoking cessation progr ams, 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 cau sed by smoking. Plaintiffs sought certification under Rule 23(b)(2) for "[a]ll current residents of Pennsylvania who ar e 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 plaintiff s and other class members had been exposed to proven hazardous substances through the intentional or neg ligent 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 increa sed risks of contracting serious latent diseases and therefor e need periodic diagnostic medical examinations. Specifica lly, plaintiffs contended that classwide expert evidence would prove that: (1) when cigarettes are used as defenda nts intended them to be used, the vast majority of thos e who use cigarettes become addicted and (2) cigarettes a re the leading cause in the nation of cardiovascular disea se, lung cancer, and chronic obstructive pulmonary disease, due to

___________________________________________________ ______________

2. As we will discuss more fully below, the Pennsyl vania Supreme Court recognized a cause of action for medical monitoring in Redland Soccer Club, Inc. v. Department of the Army, 696 A.2d 137 (Pa. 1997).

10the exposure of the throat, heart, and lungs to tob acco

smoke. Barnes v. The American Tobacco Co., 176 F.R. D. 479, 491 (E.D. Pa. 1997).

In support of their claim, plaintiffs asserted the following:

- defendants have sold annually in Pennsylva nia 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 t heir research, publicly denied the relationship b etween cigarettes and disease, and continue to aggr essively promote and sell cigarettes;

- defendants have known for many years of wa ys 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 t he fact

that nicotine is addictive and their knowled ge of this fact;

- defendants have intentionally controlled t he level of

nicotine and other toxic substances in the c igarettes in order to preserve the dependence of smoke rs on cigarettes;

- defendants have used additives such as amm onia, as well as designs for which defendants have sought patents, to make cigarettes a `package' for the delivery of nicotine;

- defendants have intentionally avoided rese arching or developing cigarettes that would not cause dependence or addiction in those who use the m; and

- defendants have spent millions of dollars each year in advertising and promoting cigarettes and have geared their efforts particularly to teenage rs and children through such efforts as the "Joe Ca mel" advertising campaign because defendants have

11allegedly known that unless a person begins

smoking before the age of twenty, the person is unlikely ever to begin.

Plaintiffs' physician experts designed the monitori ng program using objective medical tests and age-grade d criteria. They stated that cigarette smoking was th e principal cause of lung cancer, cardiovascular dise ase, and chronic obstructive pulmonary disease, the three di seases to be monitored.

On August 22, 1997, the District Court conditionall y certified the class under Rule 23(b)(2). See Barnes v. The American Tobacco Co., 176 F.R.D. at 481-93. The cou rt

held:

Because defendants have been unable to demonstrate at this point in time that this case is beset with individual issues and manageability pro blems, the Court finds that plaintiffs' proposed case h as the cohesiveness to survive as a Rule 23(b)(2) c lass. 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 t hat 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 proceedi ngs. See [Eisen v. Carlisle & Jacquelin, 417 U.S. 156 , 178 (1974)]. However, for purposes of the instan t issue sub judice, it is highly relevant that plaintiff s have alleged that defendants have acted in concert or pur suant to a common design. It is this allegation of conc erted conduct that supports a finding that defenda nts have acted on grounds generally applicable to all members of plaintiffs' class. Although there may be individual variations with respect to each class member s' relationship with the defendants, the common questions of defendants' liability, which ar e intimately connected with their concerted conduct, supp ort a finding that defendants have acted on ground s generally applicable to all members of the p roposed

class.

12Barnes, 176 F.R.D. at 492-93.

Subsequently, defendants asked the court to certify the class certification order for interlocutory appeal or, in the alternative, to reconsider the order. They alsofile d motions for summary judgment.3 The District Court denied defendants' request to certify or reconsider the cl ass certification order but decertified the class under Rule 23(c)(1).4 See Barnes at 493-502. After reviewing t he

___________________________________________________ ______________

3. On September 22, 1997, while these motions were pending, defendants moved to enforce the jury demand. On Oct ober 10, 1997, the District Court granted the motion for a jury trial. See Barnes v. The American Tobacco Co., 989 F. Supp. 661 (E.D. Pa. 19 97). In reaching this decision, the District Court applied the two-p art test of Chauffeurs, Teamsters & Helpers, Local No. 391 v. Terry, 494 U. S. 558 (1990). In Terry, the Court noted the Seventh Amendment right to a jury is applicable when legal rights are at stake. See id. at 564. "To determine whether a particular action will resolve legal righ ts [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 merge r of the courts of law and equity." Id. at 565 (citation omitted). Second, the court must " `examine the remedy sought and determine whether it is legal or equitable in nature.' " Id. (citation omitted).

In applying part one of the Terry test, the Distric t Court noted that no cause of action for medical monitoring existed in 1 791 but determined that "the most analogous cause of action is a negli gence action for future medical expenses" which was an action at law. Thus, the District Court concluded, the first line of inquiry "weighs in fav or of finding that defendants have a right to a jury trial." Barnes v. The American Tobacco Co., 989 F. Supp. at 664-65.

Turning to the second line of inquiry under Terry, the District Court acknowledged the relief sought is equitable but not ed plaintiffs could have "just as readily" requested lump sum damages. Plaintiffs' decision to pursue a medical monitoring fund instead of dama ges, the District Court concluded, should not deprive the defendants of their constitutional right to trial by jury. See id. at 6 67-68. See Dairy Queen, Inc. v. Wood, 369 U.S. 469, 477-78 (1962) ("[T]he c onstitutional right to trial by jury cannot be made to depend upon the cho ice of words used in the pleadings.").

Plaintiffs appeal this order. Because we will affir m 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).13summary judgment record, the court held "the indivi dual

issue of addiction, which plaintiffs had previously represented as playing no part in this case, is sti ll actually part of the present case"; defendants were not barr ed from asserting affirmative defenses; and these and other elements in the case presented numerous individual issues which "preclude[d] continuing this case as a class action."

Id. at 500-02.

Specifically, the court found three individual issu es precluded class certification: addiction, causation , and affirmative defenses. First, the court discussed th e role of

addiction:

When compelled to discuss the substantive i ssues in the case on defendants' motion for summary j udgment, plaintiffs primarily focused on "addiction" and purported nicotine "manipulation. . . ." As was explained in Arch, whether or not an individ ual is addicted is a highly individualistic inquiry :

Plaintiffs' own expert Dr. Burns recognizes that the assessment of addiction is an inherently ind ividual inquiry. . . . Based on this statement, defe ndants argue that class certification under these circumstances would require a mini-hearing o n the

merits of each individual's case to determin e injury. See Forman v. Data Transfer, Inc., 164 F.R.D . 400, 403 (E.D. Pa. 1995). Importantly, the Court finds that nowhere in plaintiffs' voluminous submi ssions do they actually refute that addiction is an inherently individual inquiry. Instead, plai ntiffs offer a solution to this massive problem of provin g addiction on an individual basis. Plaintiffs propose that once the general issue as to whether ci garettes can cause addiction is resolved, the issue a s to whether each and every class member is addic ted can be resolved by having them answer a questionnaire, consisting of six simple ques tions.

___________________________________________________ ______________

Under this rule, District Courts are required to re assess their rulings regularly as the case develops. Kuehner v. Heckler, 778 F.2d 152, 163 (3d Cir. 1985).

14Defendants rejoin that this questionnaire ca nnot by

itself determine whether a person is nicotin e dependent.

The Court finds that even if the questionna ire were used to determine nicotine dependence, defen dants would be permitted to cross-examine each and every class member as to their alleged dependence. Plaintiffs admittedly acknowledge that the p lan they propose would be, at most, a prima facie ind ication of addiction. Plaintiffs' own experts conced e that addiction is necessarily an individual inqui ry. To refute plaintiffs' prima facie case, defenda nts would be permitted to cross-examine each individua l about his specific choices, decisions and behavior , and defendants would be entitled to offer expert testimony about each person's specific circumstances and diagnosis.

Barnes, 176 F.R.D. at 500 (citing Arch, 175 F.R.D. at 487- 88).

The District Court also found that causation was an individual issue precluding certification. Although plaintiffs had narrowed their theories of liability, the court found their claim for medical monitoring still implicated the same

individual issue of causation their First Amended Complaint asserted in negligence, strict liability, and intentional exposure to a hazardous substance. "[I] nstead of completely dropping their claims for negligence, st rict liability and intentional exposure to a hazardous s ubstance, plaintiffs merely inserted these theories as the un derlying theories of liability for their medical monitoring. Thus, these theories, with their attendant individual iss ues, are still in this case." Barnes, 176 F.R.D. at 500. The District Court then quoted its June 3, 1997 decision at leng th:

To succeed on their products liability and negligence claims, plaintiffs will also have to prove " causation," which the Court finds is not capable of dete rmination

on a class-wide basis in this case. Resoluti on of the "general causation" question of whether ciga rettes are capable of being addictive "is not common un der Rule 23(a)(2)." Kurczi v. Eli Lilly & Co., 160 F. R.D. 667, 677

15(N.D. Ohio 1995). Unless it is proven that c igarettes

always cause or never cause addiction, "the resolution of the general causation question accomplish es nothing for any individual plaintiff." Id.; see also In re "Agent Orange" Product Liability Litigation, 818 F. 2d 145, 165 (2d Cir. 1987) (the "relevant question is no t 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" e lement of these claims by proving that all cigarettes can potentially cause the user to become addicte d. This is a general causation issue. The resolution of this "general causation question" would accomplis h nothing for any of the individual plaintiffs. See Ku rczi, 160 F.R.D. at 677. Indeed, the jury would still be required

to determine for each class member whether h e or she is addicted to cigarettes, and, if so, wheth er defendants (and which defendant) caused that addiction. With respect to causation, the Court finds that t his issue is highly individualized and does not lend itse lf to Rule 23(b)(2) certification.

To establish their strict products liabilit y claim, plaintiffs will be required to prove a defec t in defendants' products. This inquiry is also h ighly

individualized. Defendants manufactured hund reds of different types of cigarettes over the years and have even made changes within each brand . . . .

Plaintiffs claim that they can prove a comm on defect

on a class-wide basis for all of defendants' products. Plaintiffs argue that all of defendants' pro ducts are inherently defective because they contain su fficient

levels of nicotine to cause addiction and ot her hazardous substances. Thus, plaintiffs will attempt to establish a common defect by showing that th is combination exists in all of the cigarettes sold by defendants. Nonetheless, the possibility tha t plaintiffs' common defect theory will fail and that the class will be splintered into various subclasses--creat ing

16manageability concerns--"weighs against a fi nding of

predominance of common issues."

Barnes, 176 F.R.D. at 500-01 (citing Arch, 175 F.R. D. at 488-89 (footnotes omitted)). The court concluded, " [b]ecause plaintiffs intend to prove their medical monitoring claim by using the theories of negligence and strict liabili ty, the individual issues, which are implicated by these th eories still exist, and thus preclude class certification. " Barnes,

176 F.R.D. at 501.

Finally, the court found that affirmative defenses

available to the defendants raised individual issue s.5 The court explained: "For example, the defense of assum ption of risk requires this Court to examine whether each an d every plaintiff was subjectively aware of the risk and/or danger. . . . In determining whether the statute of limitat ions 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 ind ividual issue. . . . These issues clearly preclude certific ation." Barnes, 176 FRAUD at 502.

B.

The District Court also granted defendants' motions for summary judgment, finding the statute of limitation s had expired for five of the six named plaintiffs and th at the sixth plaintiff had failed to demonstrate a need fo r medical monitoring. Barnes v. The American Tobacco Co., 984 F. Supp. 842 (E.D. Pa. 1997).6

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5. As we discuss below, in its memorandum opinion d isposing of defendants' summary judgment motions, the court con cluded, over plaintiffs' objections, that certain affirmative de fenses (e.g. assumption

of risk) are available to the defendants.

6. Defendants also moved for summary judgment on th e issue of product identification. In granting summary judgment for al l 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 g round that plaintiffs failed to produce any evidence that exposure to any Liggett cigarette was a substantial factor in causing injury to any of th e named plaintiffs. Because we will affirm the District Court's grant o f summary judgment to all defendants, we need not reach this issue.

17Plaintiffs contended their cause of action was gove rned

by the equitable doctrine of laches, not the statut e of limitations. But finding the action "both inherentl y equitable and legal," the District Court held the s tatute of limitations "should apply to this action because pl aintiffs could have brought this action at law or in equity. " Barnes, 984 F. Supp. at 855.

Examining the theories of liability underlying a me dical monitoring claim, the District Court applied a two- year statute of limitations. In Redland, the Pennsylvani a Supreme Court held a plaintiff must prove defendant 's negligence caused his exposure to a proven hazardou s substance. For this reason, the District Court pred icted the Pennsylvania Supreme Court would apply the two-year statute of limitations for negligence actions to me dical monitoring claims. See Barnes, 984 F. Supp. at 856- 57 (citing 42 Pa. Cons. Stat. Ann. S 5524). Furthermor e, to the extent that plaintiffs base their claims on strict products liability or an intentional tort, a two-year statut e of limitations would still apply. See id. at 857.

In deciding when the claim accrued, the court noted that generally, a plaintiff "is under a duty to use all reasonable diligence to be properly informed of the facts and circumstances upon which a potential right of recov ery is based and to institute suit within the prescribed s tatutory period." Pocono Int'l Raceway, Inc. v. Pocono Produ ce, 468 A.2d 468, 471 (Pa. 1983). A claim under Pennsylvani a law accrues at "the occurrence of the final significant event necessary to make the claim suable." Mack Trucks, I nc. v. Bendix-Westinghouse Automotive Air Brake Co., 372 F .2d 18, 20 (3d Cir. 1966). The "discovery rule" is, how ever, a "narrow exception to this general rule," Tohan v. O wensCorning Fiberglass Corp., 696 A.2d 1195, 1200 n. 4 (Pa. Super. Ct. 1997), and tolls the statute of limitati ons during the "plaintiff's complete inability, due to facts a nd circumstances not within his control, to discover a n injury despite the exercise of due diligence." Kingston Co al Co. v. Felton Mining Co., Inc., 690 A.2d 284, 288 (Pa. Sup er. Ct. 1997). Under the discovery rule, the statute of lim itations begins to run when the "plaintiff knows, or in the exercise of reasonable diligence should have known, (1) that he has

18been injured, and (2) that his injury has been caus ed by

another's conduct." Bradley v. Ragheb, 633 A.2d 192 , 194 (Pa. Super. Ct. 1993) (quoting MacCain v. Montgomer y Hosp., 578 A.2d 970, 972-73 (Pa. Super. Ct. 1990)).

Because a claim under Pennsylvania law accrues at " the occurrence of the final significant event necessary to make the claim suable," Mack Trucks, 372 F.2d at 20, the court found the plaintiffs' medical monitoring cause of a ction accrued when the plaintiffs were placed at a "signi ficantly increased risk of contracting a serious latent dise ase." Redland, 696 A.2d at 145. To determine when that ev ent occurred, the court examined plaintiffs' expert tes timony. According to the expert testimony, plaintiffs suffe red 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 conc luded, without applying the discovery rule, the medical mo nitoring claims of these five plaintiffs were barred by the two-year statute of limitations. Barnes, 984 F. Supp. at 859 -61.

The court found that even applying the discovery ru le would not save these five plaintiffs' claims becaus e 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, ex ercising reasonable diligence, would have known or should ha ve known of his injury and its cause. In this case, ea ch plaintiff should have known or did know that smokin g caused them to be placed at an increased risk of contracting a serious disease." Id. at 862-63.

Reviewing the evidence, the court concluded that Ba rnes, Potts, Rodweller, Salzman, and Slivak had all had n otice of the dangers of cigarette smoking for more than two years. Id. With respect to the sixth plaintiff, McNally, t he court

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7. "Pack-year" refers to the number of years during which an individual has smoked a pack of cigarettes per day. For exampl e, a person who smokes one pack a day for 10 years has a 10 pack-ye ar history. A person smoking half a pack per day for 10 years has a five pack-year history. Barnes, 984 F. Supp. at 852 n.6.

19determined that, since she had only been smoking fo r 11

years, her claim could not have accrued until somet ime last year. See Barnes, 984 F. Supp. at 861 n.14.8

C.

But the District Court granted summary judgment against McNally on a different ground, finding she failed to demonstrate a need for medical monitoring. With reg ard to McNally, the District Court found:

Under the Burns Program, Ms. McNally is onl y entitled to participate in the first level o f the proposed medical monitoring program. Under the first level, Ms. McNally would be entitled to receive, annual ly or bi- annually, a physical examination, cardiovasc ular risk assessment and an EKG. However, Ms. McNally herself does not seek monitoring in the form of an E KG. (Defs.' Mot. Summ. J. Medical Monitoring Ex. 1 Pls.' Resp. Interrog. 10). Thus, the only monitoring tha t Ms. McNally seeks, and would be qualified for un der 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 no t establish that "the prescribed monitoring re gime is different from that normally recommended in the absence of the exposure." [Redland, 696 A.2d at 146]. . . . The substance of this requirement is t o ensure that "a plaintiff may recover only if the defenda nt's wrongful acts increased the plaintiff's incremental r isk of

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8. Although the District Court applied the Petty-Hy ers program's twenty pack-year threshold to determine the date upon whic h a medical monitoring claim accrued for the other named plaint iffs, 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 Mc Nally has not demonstrated a need for medical monitoring, we do n ot decide which (if either) pack-year threshold is appropriate.

20incurring the harm produced by the toxic sub stance

enough to warrant a change in the medical mo nitoring 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 eve n if she did not smoke. Any increase in Ms. McNally's incremental risk of incurring the harm produ ced by the allegedly hazardous substances in cigarettes would not warrant a change in the medical monitoring t hat would be prescribed for her. Indeed, in the absenc e of exposure, it would be recommended that she r eceive

the tests she seeks under her medical monito ring claim. Thus, she cannot satisfy the sixth el ement of

Redland.

Barnes, 984 F. Supp. at 871-72.

Plaintiffs appealed from the final judgment.

II.

JURISDICTION AND STANDARD OF REVIEW

The District Court had jurisdiction under 28 U.S.C. S 1332. We exercise jurisdiction under 28 U.S.C. S 1291.

We review the District Court's decision to decertif y the class for an abuse of discretion. See Baby Neal v. Casey, 43 F.3d 48, 56 n.15 (3d Cir. 1994). We exercise plenar y review of a grant of summary judgment. Wicker v. Consol. R ail Corp., 142 F.3d 690, 696 (3d Cir. 1998) (citation o mitted), and apply the same test as the District Court; name ly, we must determine if there is a "genuine issue as to a ny 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 infer ences therefrom in the light most favorable to the nonmov ing party. Wicker, 142 F.3d at 696 (citation omitted).

21III.

DISCUSSION

A. Medical Monitoring

The crucial issue is whether plaintiffs' medical mo nitoring claim requires inquiry into individual issues. We b egin by briefly describing the evolution of this cause of a ction and

its elements.9

In In re Paoli Railroad Yard PCB Litigation, 916 F. 2d 829 (3d Cir. 1990) (Paoli I), we predicted the Pennsylv ania Supreme Court would recognize a cause of action for medical monitoring. We reaffirmed that prediction i n In re Paoli Railroad Yard PCB Litigation, 35 F.3d 717 (3d Cir. 1994) (Paoli II).10 The issue of medical monitoring first reached the Pennsylvania Supreme Court in Simmons v

. Pacor, Inc., 674 A.2d 232 (Pa. 1996), where the una nimous court recognized medical monitoring as a viable cau se of action under Pennsylvania law. In Simmons, the cour t permitted plaintiffs with asbestos-related asymptom atic pleural thickening to recover for medical monitorin g. It was not until Redland Soccer Club v. Department of the Army, 696 A.2d 137 (Pa. 1997), however, that the Pennsylv ania Supreme Court had the opportunity to articulate the specific elements of a claim for medical monitoring

.

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9. For another discussion of the evolution of the m edical monitoring cause of action, see Metro-North R.R. Co. v. Buckle y, 521 U.S. 424 (1997).

10. In Paoli I, we predicted the Pennsylvania Supre me Court would require a party to meet a four-part test to establi sh a claim for medical monitoring: (1) plaintiff was significantly exposed to a proven hazardous substance through the negligent actions of the defe ndant; (2) as a proximate result of exposure, plaintiff suffers a s ignificantly increased risk of contracting a serious latent disease; (3) t hat 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 beneficia l. Paoli I, 916 F.2d at 852. In Paoli II, we added another element to the c laim, holding that a plaintiff had to show that "a reasonable physician would prescribe for her or him a monitoring regime different than the o ne that would have been prescribed in the absence of that particular e xposure." Paoli II, 35 F.3d at 788 (citation omitted).

22Building on this court's decisions in Paoli I and P aoli 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 r esult of the exposure, plaintiff has a significantly incr eased risk of contracting a serious latent disease; (5) a monitoring procedure exists that makes the early detect ion of the disease possible; (6) the prescribed monitor ing regime is different from that normally recommended in the absence of the exposure; and (7) the prescri bed monitoring regime is reasonably necessary ac cording to contemporary scientific principles.

Redland, 696 A.2d at 145-46.11

The injury in a cause of action for medical monitor ing is the "costs of periodic medical examinations necessa ry to detect the onset of physical harm." Id. at 144; see also Friends for All Children, Inc. v. Lockheed Aircraft Corp., 746 F.2d 816, 826 (D.C. Cir. 1984) ("It is difficult to dispute that an individual has an interest in avoiding expe nsive diagnostic examinations just as he or she has an in terest in avoiding physical injury."); Hansen v. Mountain Fue l Supply Co., 858 P.2d 970, 977 (Utah 1993) (citations omitt ed) ("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 it self and the concomitant need for medical testing constitute the

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11. Other jurisdictions have authorized recovery fo r medical monitoring in the absence of physical injury. See, e.g., Bourg eois v. A.P. Green Indus., 716 So.2d 355 (La. 1998); Potter v. Firesto ne Tire & Rubber Co., 863 P.2d 795 (Cal. 1993); Hansen v. Mountain Fuel S upply Co., 858 P.2d 970 (Utah 1993); Ayers v. Township of Jackson , 525 A.2d 287 (N.J. 1987). In addition, some federal courts predicting state law have reached

the same conclusion. See Cook v. Rockwell Int'l Cor p., 755 F. Supp. 1468 (D. Colo. 1991); Johnson v. Armstrong Cork Co., 645 F. Supp. 764 (W.D. La. 1986). But see Ball v. Joy Techs., Inc., 958 F. 2d 36 (4th Cir. 1991) (holding that, under the laws of Virginia and West Virginia, recovery of medical monitoring expenses is only available where a plaintiff has sustained a physical injury); Werlein v. United Sta tes, 746 F. Supp. 887 (D. Minn. 1990).

23injury."). It is evident that this injury is somewh at different

from an injury in a traditional tort, which rests o n physical harm. See, e.g., Restatement Second of Torts S 402A (requiring plaintiff to prove in a products liabili ty case "physical harm" which S 7 defines as "physical impa irment of the human body"); Simmons, 674 A.2d at 237 (deny ing plaintiffs recovery other than medical monitoring f or asymptomatic pleural thickening because inter alia plaintiffs demonstrated no physical injury). In rec ognizing medical monitoring as a compensable injury, the Pennsylvania Supreme Court quoted at length from ou r distinction in Paoli I between a cause of action fo r increased

risk of future harm and a cause of action for medic al 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 a n identifiable rather than a speculative injury. Id. at 850-51. We explained:

The injury in an enhanced risk claim is the anticipated harm itself. The injury in a (medical monito ring claim is the cost of the medical care that will, o ne 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 sp eculative because the issue for the jury is the less c onjectural question of whether the plaintiff needs medi cal

surveillance.

Paoli I, 916 F.2d at 851.12

In Redland, the court cited four important policy r easons for recognizing a cause of action for medical monit oring. First, medical monitoring promotes "early diagnosis and treatment of disease resulting from exposure to tox ic substances caused by a tortfeasor's negligence." Se cond, "[a]llowing recovery for such expenses avoids the p otential injustice of forcing an economically disadvantaged person

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12. There is no doubt the costs of medical monitori ng are a compensable portion of a plaintiffs' damages when asserted with other injury claims. It appears, however, that allowing plaintiffs to re cover in the absence of some injury pushes the limit of the Constitution's case-or-controversy requirement.

24to pay for expensive diagnostic examinations necess itated

by another's negligence," and "affords toxic-tort v ictims, for whom other sorts of recovery may prove difficult, i mmediate compensation for medical monitoring needed as a res ult of exposure." Third, medical monitoring "furthers the deterrent function of the tort system by compelling those who expose others to toxic substances to minimize r isks and costs of exposure." Finally, such recovery is"i n harmony with `the important public health interest in fostering access to medical testing for individuals whose exposure to toxic chemicals creates an enhanced ris k of disease.' " Id. at 145 (citations omitted).

B. Certification

To be certified, a class must satisfy the prerequis ites of Rule 23(a) and the "parties seeking certification m ust also show that the action is maintainable under Rule 23( b)(1), (2), or (3)." Amchem Prods., Inc. v. Windsor, ___ U .S. ___; 117 S. Ct. 2231, 2245 (1997). Plaintiffs seek certi fication under 23(b)(2).

As noted, the District Court conditionally certifie d the class, stipulating its order could be altered or am ended. 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 clas s rulings as the case develops. Kuehner v. Heckler, 778 F.2d 152, 163 (3d Cir. 1985); see also Richardson v. Byrd, 70 9 F.2d 1016, 1019 (5th Cir. 1983) ("Under Rule 23 the dist rict court is charged with the duty of monitoring its cl ass decisions in light of the evidentiary development o f the case. The district judge must define, redefine, sub class, and decertify as appropriate in response to the progres sion 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 decert ify the class. Barnes, 176 FRAUD at 502.

In considering whether certification is proper, we refrain from conducting a preliminary inquiry into the meri ts. See Eisen v. Carlisle & Jacquelin, 417 U.S. 156, 177-78 (1973) (citation omitted) (" `In determining the propriety of a class action, the question is not whether the plaintiff o r plaintiffs

25have stated a cause of action or will prevail on th e merits,

but rather whether the requirements of Rule 23 are met.' ") At the same time, we must carefully examine the fac tual and legal allegations. See General Tel. Co. v. Falc on, 457 U.S. 147, 160 (1981) ("[S]ometimes it may be necess ary for the court to probe behind the pleadings before comi ng to rest on the certification question."); Coopers & Ly brand v. Livesay, 437 U.S. 463, 469 (1977) (citation omitted ) ("[T]he class determination generally involves consideratio ns that are `enmeshed in the factual and legal issues compr ising the plaintiff's cause of action.' ").

1. Fed. R. Civ. P. 23(a)

Rule 23(a) presents four requirements: (1) numerosi ty; (2) commonality; (3) typicality; and (4) adequacy of representation.13 "The requirements of Rule 23(a) a re meant

to assure both that class action treatment is neces sary and

efficient and that it is fair to the absentees unde r the particular circumstances." Baby Neal v. Casey, 43 F .3d 48, 55 (3d Cir. 1994). The District Court determined th e class satisfied Rule 23(a).

Finding the putative class consisted of more than o ne million Pennsylvania residents,14 the court held th e class was "so numerous that joinder of all members[is] impracticable." Fed. R. Civ. P. 23(a)(1). Defendant s do not dispute that numerosity is satisfied.

The District Court also found plaintiffs satisfied the commonality requirement of Rule 23(a)(2) because th ey demonstrated there is at least one common question of law or fact. See Baby Neal, 43 F.3d at 56 ("The commona lity requirement will be satisfied if the named plaintif fs share at

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13. Specifically, Rule 23(a) provides: "One or more members of a class may sue or be sued as representative parties on beh alf of all only if (1) the class is so numerous that joinder of all member s is impracticable, (2) there are questions of law or fact common to the cl ass, (3) the claims or defenses of the representative parties are typical of the claims or defenses of the class, and (4) the representative p arties will fairly and adequately protect the interests of the class."

14. In defendants' post-hearing memorandum, defenda nts place the number of potential class members at 2.8 million.

26least one question of fact or law with the grievanc es of the

prospective class.").15 "For example, whether defen dants have acted in concert or pursuant to a common desig n is one common question." Arch, 175 FRAUD at 477.16

"The concepts of commonality and typicality are bro adly defined and tend to merge." Baby Neal v. Casey, 43 F.3d at 56 (citation omitted). The typicality requirement i s designed to align the interests of the class and the class representatives so that the latter will work to ben efit the entire class through the pursuit of their own goals . Id. at 57. This requirement does not mandate that all puta tive class members share identical claims. Id. at 56 (ci tations omitted). Moreover, "[f]actual differences will not render a claim atypical if the claim arises from the same ev ent or practice or course of conduct that gives rise to th e claims of the class members, and if it is based on the sam e legal theory." 1 Newberg on Class Actions S 3.15, at 3-78 ; see also Baby Neal, 43 F.3d at 58 ("[E]ven relatively pronounced factual differences will generally not p reclude a finding of typicality where there is a strong simil arity of legal theories.").

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15. In Georgine, the court recognized that Baby Nea l and other Third Circuit cases "stated a very low threshold for comm onality." Georgine v. Amchem Prods. Inc., 83 F.3d 610, 627 (3d Cir. 1996) . The court noted that the "commonality barrier is higher in a person al injury damages class action, like [Georgine], that seeks to resolv e all issues, including noncommon issues, of liability and damages." Id. Ul timately, the court

did not decide whether that class met the commonali ty requirement and concluded instead that "the commonality requirement is subsumed by the predominance requirement, which this class cann ot conceivably meet." Id. As the District Court noted, in contrast to Georgine, this case is not a personal injury damages class action, nor does it involve a settlement class that was national in scope, where class members are asked to compromise future claims without knowing w hat 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"whet her 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 commo n question. Arch, 175 FRAUD at 477. Of course, the plaintiffs have si nce dropped their demand for punitive damages so this is no longer a common issue.

27The District Court found plaintiffs met the typical ity

requirement. Although defendants had demonstrated t here "exist many individualized questions which arise fr om the factual differences between the putative class memb ers' individual claims, defendants fail[ed] to demonstra te that the `legal theories of the named plaintiffs potenti ally conflict with those of the absentees . . . .' " Arch, 175 FR AUD at 479 (quoting Baby Neal, 43 F.3d at 57). Specifically, t he District

Court found:

"Plaintiffs allege that their claims arise f rom the same course of conduct undertaken by defendants. Specifically, plaintiffs have alleged that d efendants have engaged in a concerted course of conduc t whereby defendants have concealed their know ledge of nicotine's addictive properties and have pur posefully and deliberately emphasized efforts to addic t children and adolescents--resulting in an epidemic pe diatric disease. In this process, plaintiffs allege that these consumers were involuntar[il]y subject to th e cumulative, repetitive assault of the many d ifferent carcinogens contained in tobacco smoke. Alth ough plaintiffs' claims may be factually differen t, plaintiffs have alleged a course of conduct that has gi ven rise to plaintiffs' claims which are based upon the same legal theories, thus satisfying the typicality req uirement 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." Id. at 480 (quoting Fed. R. Civ. P. 23(a)(4)). The adequacy of representation requirement encompasses two distinct inquiries designed to protect the interests of abse ntee class members. First, it "tests the qualifications of the counsel to represent the class." G.M. Trucks, 55 F.3d at 800. Second,

it "serves to uncover conflicts of interest between named parties and the class they seek to represent." Amch em, 117

S. Ct. at 2250.17

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17. In the District Court, defendants claimed the n amed plaintiffs were not adequate class representatives because (1) they have split their

282. 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 correspondin g declaratory relief with respect to the class as a w hole." Fed. R. Civ. P. 23(b)(2). Subsection (b)(2) class action s are "limited to those class actions seeking primarily i njunctive or corresponding declaratory relief." 1 Newberg on Class Actions S 4.11, at 4-39. The (b)(2) class "serves m ost frequently as the vehicle for civil rights actions and other

institutional reform cases that receive class actio n treatment." Baby Neal v. Casey, 43 F.3d 48, 58-59 ( 3d Cir. 1994). Indeed, (b)(2) was "designed specifically fo r civil rights cases seeking broad declaratory or injunctiv e relief for a numerous and often unascertainable or amorpho us class of persons." 1 Newberg on Class Actions S 4.1 1, at 4-

39.

As noted, in its June 3, 1997 Order, the District C ourt

found that under certain circumstances medical moni toring

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causes of action and (2) they may have failed to ma ke a knowing and voluntary amendment to their complaint. The Distric t Court found these claims were not "split" or "waived" by the absent c lass members. In its August 22, 1997 order, the court found: "the Court has already

determined that the absent class members cannot bri ng in this putative

class action those claims which have been omitted f rom the Second Amended Complaint because those claims are not suit able for class action treatment. Consequently, there cannot be any `splitting' or `waiver' by these absent class members: there is no other ca use of action they can bring, or could have brought, in this action, e xcept possibly the medical monitoring claim set forth in the Second Am ended Complaint." 176 FRAUD at 485. In addition, after reviewing plai ntiffs' deposition testimony, the District Court found that the named plaintiffs made a knowing and voluntary amendment. The court noted th at 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 compete nt counsel to prosecute the claims. In this case, named plaintiff s have actively sought vindication of their rights on a class-wide basis a nd have engaged competent counsel to litigate their claims." Id. at 486.

29could constitute the injunctive relief required by Rule

23(b)(2). Arch, 175 FRAUD at 483. The District Cour t initially held that plaintiffs could not be certifi ed under 23(b)(2) because most of the relief they sought was monetary in nature. Arch, 175 FRAUD at 484. In resp onse to the court's analysis, plaintiffs amended their c omplaint so it contained only a claim for medical monitoring and asked only for the establishment of a court-supervi sed medical monitoring program.

Recently, the Supreme Court reexamined the requirements for Rule 23 certification in the conte xt of mass tort class actions. In Amchem Products, Inc. v

. Windsor, ___ U.S. ___; 117 S. Ct. 2231 (1997), the Supreme Court affirmed our decision in Georgine v. Amchem Products, Inc., 83 F.3d 610 (3d Cir. 1996), decerti fying a settlement class of claimants exposed to asbestos. As in this case, the issue in Amchem was "whether [the] p roposed classes [were] sufficiently cohesive to warrant adj udication by representation." Amchem, 117 S. Ct. at 2249. We found that cohesiveness lacking and the Supreme Court agr eed. Quoting Judge Becker's opinion, the Court noted: " `Class members were exposed to different asbestos-containi ng products, for different amounts of time, in differe nt ways, and over different periods . . . . The [exposure-on ly] plaintiffs especially share little in common, eithe r with each other or with the presently injured class members .

. . . They will also incur different medical expenses bec ause their monitoring and treatment will depend on singu lar

circumstances and individual medical histories.' " Id. at 2250 (quoting Georgine, 83 F.3d at 626). As we expl ained, such factual differences "translate into significan t legal differences. Differences in amount of exposure and nexus between exposure and injury lead to disparate appli cations of legal rules, including matters of causation, com parative fault, and the types of damages available to each p laintiff." Georgine, 83 F.3d at 627. We also noted that "individualized issues can become overwhelming in a ctions involving long-term mass torts (i.e. those which do not arise out of a single accident)." Id. at 628.

While Amchem involved a Rule 23(b)(3) class action, the cohesiveness requirement enunciated by both this co urt

30and 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 becaus e in a (b)(2) action, unnamed members are bound by the act ion without the opportunity to opt out.

While 23(b)(2) class actions have no predominance o r superiority requirements, it is well established th at the class claims must be cohesive. Discussing the requi rements for 23(b)(2) classes in Wetzel v. Liberty Mutual In surance Company, 508 F.2d 239 (3d Cir. 1974), we noted, "[b ]y its very nature, a (b)(2) class must be cohesive as to those

claims tried in the class action. . . . Because of the cohesive nature of the class, Rule 23(c)(3) contemplates tha t 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 litigati on and providing small claimants with a means of obtaining redress for claims too small to justify individual litigation." Id. at 248-49 (citations omitted). In Geraghty v. U nited States Parole Commission, 719 F.2d 1199, 1205-06 (3 d Cir. 1983) (citation omitted), we again emphasized that a 23(b)(2) class must be cohesive, noting the Distric t Court has the "discretion to deny certification in Rule 2 3(b)(2) cases in the presence of `disparate factual circums tances.' " See also Santiago v. City of Philadelphia, 72 FRAUD 619, 628 (E.D. Pa. 1976) (holding that a "court should b e more hesitant in accepting a (b)(2) suit which contains significant

individual issues than it should under subsection 2 3(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 hav e to be litigated individually in order to determine whethe r a particular alleged class member was entitled to any damages at all").18

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18. "At base, the (b)(2) class is distinguished fro m the (b)(3) class by class cohesiveness. . . . Injuries remedied through (b)(2) actions are really group, as opposed to individual injuries. Th e members of a (b)(2) class are generally bound together through `preexis ting or continuing legal relationships' or by some significant common trait such as race or gender." Holmes v. Continental Can Company, 706 F.2 d 1144, 1155 (11th Cir. 1983) (quoting Note, Notice in Rule 23(b )(2) Class Actions for Monetary Relief: Johnson v. General Motors Corp., 1 28 U.Pa.L.Rev. 1236, 1252-53 (1980) (footnotes omitted).

31In Santiago, the court recognized two reasons why c ourts

must determine whether a proposed (b)(2) class impl icates individual issues. First, unnamed members with vali d individual claims are bound by the action without t he opportunity to withdraw and may be prejudiced by a negative judgment in the class action. "Thus, the c ourt must ensure that significant individual issues do n ot pervade the entire action because it would be unjus t to bind absent class members to a negative decision wh ere the class representatives's claims present different in dividual issues than the claims of the absent members presen t." Second, "the suit could become unmanageable and lit tle value would be gained in proceeding as a class acti on . . . if significant individual issues were to arise cons istently." Santiago, 72 FRAUD at 628.

In decertifying the class, the District Court decid ed that "too many individual issues exist which prevent thi s case from proceeding as a class action." Barnes, 176 FRA UD at 500. As noted, the District Court found that addict ion, causation, and affirmative defenses all presented i ndividual issues not properly decided in a class action. We b elieve that addiction, causation, the defenses of comparat ive and contributory negligence, the need for medical monit oring and the statute of limitations present too many ind ividual issues to permit certification. As in Amchem, plain tiffs were "exposed to different . . . products, for different amounts of time, in different ways, and over different periods ." See Amchem, 117 S. Ct. at 2250 (citation omitted). Thes e disparate issues make class treatment inappropriate .19

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19. We note that the individual issues raised by ci garette litigation

often preclude class certification. See, e.g., Castano v. The American Tobacco Co., 84 F.3d 734 (5th Cir. 1996) (decertifying 23(b )(3) class because individual issues predominated); Smith v. Brown & W illiamson Tobacco Corp., 174 FRAUD 90 (W.D. Mo. 1997) (denying certif ication under 23(b)(1), (2) & (3) because of the presence of indi vidual 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 c ertify such a class. In some state cases, however, plaintiff smokers have s ucceeded in

32a. Nicotine addiction and causation

The District Court found nicotine addiction plays a

central role in the case and that addiction is a "h ighly individualistic inquiry." Barnes, 176 F.R.D. at 500 . The District Court noted that when plaintiffs were "com pelled to

discuss the substantive issues in the case on defen dants' motion for summary judgment, [they] primarily focus ed on `addiction' and purported nicotine `manipulation. . . .' " Id. While plaintiffs do not seem to dispute that addict ion requires an individual inquiry, they maintain nonet heless that addiction plays no part in the case.

Plaintiffs contend that throughout the litigation, they

have

asserted that defendants' knowledge and inte ntional misuse of the addictive properties of nicoti ne--their intentional design of cigarettes to contain a level of nicotine they knew would be addictive--went to their intentional misconduct and liability for des igning a defective product. Plaintiffs do not contend that all smokers are addicted, that addiction is a pr e-requisite to class membership, or that addiction is de terminant of a need for medical monitoring. Addiction is a term and concept that is difficult to avoid in an y smoking

case. The documents show that defendants int ended and designed cigarettes to be addictive. Tha t they have largely succeeded may be all too apparent. B ut the addiction of any particular smoker--much les s the class as a whole--is simply not an element o f plaintiffs'

claims.

Brief of Appellant at 41.

We disagree. Addiction remains an essential part of plaintiffs' claim. In order to prevail on their med ical

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certification. See Richardson v. Phillip Morris, No . 96145050/CE212596 (Baltimore Cir. Ct. Jan. 28, 1998) (certifying clas s of Maryland smokers seeking compensatory and punitive damages); R.J. Re ynolds Tobacco Co. v. Engle, 672 So.2d 39 (Fla. App. 3 Dist. 1996), re v. denied, 682 So.2d 1100 (1996) (certification of state-wide class of t obacco smokers suing for damages caused by smoking).

33monitoring claim--under any of their three theories of

liability (negligence, strict products liability, a nd intentional exposure to a hazardous substance)--plaintiffs must demonstrate that defendants caused their exposure t o tobacco. See Redland, 696 A.2d at 145-46. Indeed, plaintiffs' Second Amended Complaint alleges "[p]la intiffs and class members have been significantly exposed t o proven hazardous substances through the intentional or negligent actions of the Defendants, and/or through defective products for which Defendants are strictl y liable" and that "[a]s a proximate result of this exposure, Plaintiffs and class members suffer significantly increased ri sks of contracting serious latent diseases." Second Amende d Complaint PP 20-21.

It is apparent from plaintiffs' Second Amended Comp laint 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 pl aintiffs' complaint, defendants' actions that give rise to li ability include the following:

- Defendants have . . . known for many year s that nicotine is addictive, but have publicly den ied both

the fact that nicotine is addictive and thei r knowledge of this fact, in order to conceal the addictive nature of cigarettes from the publ ic, including Plaintiffs and the class. . . .

- During the same time that Defendants have publicly denied the addictive nature of nico tine, Defendants have intentionally controlled the level of nicotine and other toxic substances they hav e sold, in order to preserve the dependence of smoke rs on cigarettes that Defendants sell. To this end

, Defendants have utilized additives such as ammonia, as well as designs for which Defend ants have sought patents, to make cigarettes, in effect, a "package" for the delivery of nicotine. Defe ndants have intentionally sought to "increase the d elivery of

nicotine and almost double the nicotine tran sfer efficiency of cigarettes," maintain "the pro per amount of nicotine in tobacco smoke," and "d eliver

34a pharmacologically active dose of nicotine to the

smoker."

- During the same period of time, despite t his voluntary and public undertaking to protect the public's "health as a basic responsibility p aramount to every other consideration," Defendants ha ve also intentionally avoided researching or develop ing cigarettes that would not cause dependence o r addiction in those who use them.

- In their efforts to conceal the health ha zards 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 the ir secret research and testing on the dangers of cigar ette smoking; [and] concealed their deliberate manipulation of the nicotine levels of cigar ettes. .. .

Plaintiffs' Second Amended Complaint PP 12-14, 16.

Moreover, as the District Court pointed out, in the ir omnibus response to the defendants' joint motions f or summary judgment, plaintiffs focused on addiction a nd purported nicotine manipulation. Plaintiffs asserte d the evidence will establish inter alia that (1) defenda nts intentionally designed cigarettes to addict smokers ; (2)

defendants allowed the number of addicted smokers t o grow, knowing full well that the smoke caused cance r and lung disease; and (3) defendants intentionally mani pulated and controlled nicotine levels. As we understand pl aintiffs' theory, defendants' actions caused plaintiffs to be come addicted to cigarettes and thereby rendered their c hoice 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 "c ausing" the three diseases to be monitored in the program. See Parks v. AlliedSignal, Inc., 113 F.3d 1327, 1332 (3 d Cir. 1997) (under Pennsylvania law, a "substantial facto r" is legal cause, and requires only proof that a factor is "not

35merely negligible" in producing a result). Plaintif fs point to

the Surgeon General's Reports conclusively determin ing that cigarette smoking is the major cause of the di seases for which the medical monitoring program was constr ucted. This evidence, they claim, more than satisfies thei r burden

on the issue of causation.

But plaintiffs cannot prove causation by merely sho wing that smoking cigarettes causes cancer and other dis eases. They must demonstrate that defendants' intentional or negligent nicotine manipulation caused each individ ual plaintiff to have a significantly increased risk of contracting serious latent diseases thereby demonstrating the n eed for medical monitoring. Alternatively, under a strict p roducts liability theory, as the District Court found, "eac h class member will have to establish that the type of ciga rettes he

or she smoked contained a defect at the time he or she smoked them." Barnes, 176 F.R.D. at 501 (citation omitted). According to plaintiffs, the alleged defe ct is that defendants intentionally designed these cigarettes to be addictive. But whether defendants caused the injury depends on whether each individual actually is addi cted.

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 ad dicted is a highly individualistic inquiry." Barnes, 176 F.R. D. at 500. Instead, plaintiffs suggested to the District Court that once the general issue whether cigarettes can cause addi ction is resolved, they could resolve the issue of individua l addiction by having each class member answer a questionnaire consisting of six questions.20 The Di strict

Court noted that

even if the questionnaire were used to dete rmine nicotine dependence, defendants would be per mitted to cross-examine each and every class member as to their

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20. On appeal, plaintiffs refer only sparingly to t heir proposed trial plan. At one point in their brief, however, plaintiffs su ggest 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.

36alleged dependence. Plaintiffs admittedly ac knowledge

that the plan they propose would be, at most , a prima

facie indication of addiction. Plaintiffs' o wn (experts concede that addiction is necessarily an ind ividual inquiry. To refute plaintiffs' prima facie c ase, defendants would be permitted to cross-exami ne each individual about his specific choices, decis ions and behavior, and defendants would be entitled t o offer expert testimony about each person's specifi c circumstances and diagnosis.

Arch, 175 F.R.D. at 488.

Because nicotine addiction must be determined on an individual basis and remains an essential part of p laintiffs' medical monitoring claim, we agree with the Distric t Court that class treatment is inappropriate.

b. The need for medical monitoring

We also believe the requirement that each class mem ber demonstrate the need for medical monitoring preclud es certification. In order to state a claim for medica l monitoring, each class member must prove that the monitoring program he requires is "different from t hat normally recommended in the absence of exposure." Redland, 696 A.2d at 146.21 To satisfy this require ment, each plaintiff must prove the monitoring program th at is prescribed for the general public and the monitorin g program that would be prescribed for him. Although the general public's monitoring program can be proved o n a classwide basis, an individual's monitoring program by definition cannot. In order to prove the program he

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21. See also Paoli II, 35 F.3d at 788; Arch, 175 F. R.D. at 490 ("The fact that [Barnes] smokes would not require any addition al monitoring for heart disease not already warranted by the multiple , significant risk factors for heart disease he already has."); Hansen v. Mountain Fuel Supply Co., 858 P.2d 970, 979-80 (Utah 1993); Suppl emental 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, unl ess they had some other risk factor that placed them at dramatic ally increased risk of disease.").

37requires, a plaintiff must present evidence about h is

individual smoking history and subject himself to c rossexamination by the defendant about that history. Th is element of the medical monitoring claim therefore r aises many individual issues.

c. Defenses

The District Court also held that defenses raise in dividual issues precluding certification. Over plaintiffs' o bjection, the District Court found defendants may assert the defe nses of contributory negligence, assumption of risk, and co nsent to exposure to a hazardous substance. Barnes, 984 F. S upp. at 867-69.22 After reviewing Pennsylvania caselaw, the

District Court concluded

First, legal defenses do not become equitabl e defenses simply because they are asserted in an actio n 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 def enses. Applying these lessons, the Court finds that defendants have a legitimate right to raise the legal d efenses of contributory negligence, assumption of risk and

consent.

Barnes, 984 F. Supp. at 866. The court noted this s uit was not purely equitable but instead "implicates both l egal and equitable rights" making it "even less appropriate for [the court] to exercise its equitable powers to bar defe ndants from asserting its affirmative, legal defenses." Id

.

As noted, plaintiffs asserted three theories of lia bility. They claimed that they were significantly exposed t o proven hazardous substances through defendants' intentiona l actions, negligent actions, and defective products (strict

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22. Defendants moved for summary judgment against C iaran McNally, William Barnes, and Catherine Potts on the grounds that their claims were barred by contributory negligence, assumption of risk, and consent to exposure to a hazardous substance. Barnes, 984 F . Supp. at 864. The District Court only considered the defendants' argu ments against McNally because it entered summary judgment against Barnes and Potts on statute of limitations grounds.

38liability). Defendants assert the defenses of conse nt,

comparative negligence, and assumption of risk. Pla intiffs

contend that these defenses are not available and t hat individual issues relating to these defenses should not preclude class certification. Plaintiffs maintain t hat "comparative negligence" is only available in actio ns for damages resulting in death or injury, that assumpti on of

risk is not available because the defendants will n ot 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 contributo ry negligence to a medical monitoring claim. See Barne s, 984 F. Supp. at 867-68. Although acknowledging that the Comparative Negligence Act expressly applies to"act ions brought to recover damages for negligence resulting in death or injury to person or property," and that pl aintiffs seek a court-supervised monitoring program, the Dis trict Court found "[t]he application of the Comparative

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23. 42 Pa. Cons. Stat. S 7102 provides:

(a) General rule.--In all actions brought to recov er damages for negligence resulting in death or injury to person o r property, the fact that the plaintiff may have been guilty of contribu tory negligence shall not bar a recovery by the plaintiff or his legal re presentative where such negligence was not greater than the causal negligen ce of the defendant or defendants against whom recovery is sought, but any damages sustained by the plaintiff shall be diminished in p roportion 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 de fendant shall be liable for that proportion of the total dollar amou nt awarded as damages in the ratio of the amount of his causal negligence to the amount of causal negligence attributed to all defendants agai nst whom recovery is allowed. The plaintiff may recover the full amount of the allowed recovery from any defendant against whom the plaintiff is no t barred from recovery. Any defendant who is so compelled to pay more than his percentage share may seek contribution.

39Negligence Act to these claims would more properly

advance the goals of the Redland Soccer court, and would also adequately protect the rights of defendants." Barnes, 984 F. Supp. at 867-68. The District Court reasoned that plaintiffs could have requested lump sum damages wh ich would have clearly invoked the Comparative Negligen ce Act; that plaintiffs asked for equitable relief instead of damages is not dispositive. Furthermore, because Redland ex pressly encouraged the use of medical monitoring funds, 696 A.2d at 142 n.6, the District Court predicted the Pennsy lvania Supreme Court would not apply the "harsh" and "anachronistic doctrine of contributory negligence" to medical monitoring claims seeking equitable relief. Barnes, 984 F. Supp. at 868.

We need not decide whether the Pennsylvania Supreme Court would apply the Comparative Negligence Act to plaintiffs' negligence claim. If the Comparative Ne gligence Act does not apply, defendants still have the defen se of contributory negligence available to them. See Commonwealth Fed. Sav. and Loan Assoc. v. Pettit, 5 86 A.2d 1021, 1026 (Pa. Comm. Ct. 1991) ("The doctrine of contributory negligence continues to be applicable to situations where both parties are negligent but the resulting injury is not covered under the Pennsylva nia Comparative Negligence Act.").24 Either defense wil l raise many individual issues.25

Under Pennsylvania law, the tort of intentional exp osure to hazardous substances is predicated on a theory o f battery. See Field v. Philadelphia Elec. Co., 565 A .2d 1170, 1178 (Pa. Super. Ct. 1989). Plaintiffs must prove a s a constituent element they did not consent to the tor tious

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24. For purposes of our certification inquiry, we n eed not decide whether these defenses bar plaintiffs' recovery. Instead, w e merely conclude that

one of these defenses is available to the defendant s.

25. We acknowledge that the existence of affirmativ e defenses as to some class members may not by itself enough warrant the denial of certification. See Merk v. Jewel Food Stores Div., Jewel Companies, Inc., 702 F. Supp. 1391, 1395 (E.D. Ill. 1988); Lorber v. Beebe, 407 F. Supp. 279, 294 (S.D.N.Y. 1975). But we note that the defe nses are only one of many matters raising individual issues in this case

.

40conduct. See Levenson v. Souser, 557 A.2d 1081, 108 8 (Pa.

Super. Ct. 1989); Prosser & Keeton S 18, at 113 ("C onsent avoids recovery simply because it destroys the wron gfulness of the conduct as between the consenting parties, h owever harmful it might be to the interests of others."); Restatement (Second) Torts S 892A ("One who effecti vely

consents to the conduct of another intended to inva de his

interests cannot recover in an action of tort for t he conduct or for the harm resulting from it.") Express consen t may be given by words or affirmative conduct and implied c onsent 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 co nsent must be to the "defendant's conduct, rather than to its consequences." Prosser & Keeton S 18, at 118. A pla intiff's consent is not effective if "the consenting person was mistaken about the nature and quality of the invasi on intended by the conduct." Prosser & Keeton S 18, a t 114.

Plaintiffs argued in the District Court that the co urt should use its equitable powers to bar defendants f rom asserting their affirmative defenses because of def endants' intentional and fraudulent conduct. See Barnes, 984 F. Supp. at 864-65. But the District Court rejected th is argument and plaintiffs do not press it on appeal. Instead, plaintiffs argue there is no record evidence they c onsented to defendants' specific conduct. Defendants maintai n plaintiffs knew they were exposing themselves to a hazardous substance yet continued to smoke. There i s some evidence on the record, including plaintiffs' own deposition testimony, to support defendants' positi on that despite warnings, plaintiffs continued to smoke. Se e id. ("By her own admission, Potts learned `for sure' that ci garette smoking created an increased risk of disease in 196 6, when the Surgeon General's warnings were put on cigarett e packages. In addition, and more importantly, Ms. Po tts was informed by her cardiologist in the late 1980s that she was at a significantly increased risk of contracting he art disease, in the form of clogged arteries, from smok ing.").

Under Pennsylvania law, plaintiffs may recover on a theory of strict liability where a product in a def ective condition unreasonably dangerous to the consumer or user

41causes harm to the plaintiff. See Spino v. John S. Tilley

Ladder Co., 696 A.2d 1169, 1172 (Pa. 1997). Plainti ff must prove the product was defective and the defect was a substantial factor in causing the injury. See id. W hile a defendant may not assert comparative negligence in a strict products liability action, see Kimco Development Co rp. v. Michael D's Carpet Outlets, 637 A.2d 603, 606-07 (P a. 1993), Pennsylvania courts allow defendants to intr oduce "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." Charlto n v. Toyota Indus. Equip., 714 A.2d 1043, 1047 (Pa. Super. Ct. 1998). To demonstrate that a plaintiff's actions are highl y reckless, defendants must show plaintiff "knew or h ad 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 di sregard of that risk." Id. (citation omitted).

Assumption of risk is also available in negligence claims. See Kaplan v. Exxon Corp., 126 F.3d 221, 224-25 (3d Cir. 1997).26 In a negligence action, a defendant is rel ieved of his duty to protect the plaintiff when the plaintif f was aware of the risk and faced it voluntarily. See Barrett v . Fredavid Builders, Inc., 685 A.2d 129 (Pa. Super. Ct. 1996). The

defendant must show that the "nature and extent" of the risk were "fully appreciated" and that the plaintif f voluntarily proceeded to face that risk. Childers v . Power Line Equip. Rentals, Inc., 681 A.2d 201, 208 (Pa. S uper. Ct. 1996).

Plaintiffs make essentially the same arguments rega rding consent and assumption of risk, contending that bec ause defendants concealed the nature and extent of their

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26. In light of Pennsylvania's adoption of comparat ive negligence, see 42 Pa. Cons. Stat. Ann. S 7102(a), the existence of th e assumption of the risk defense under Pennsylvania law is a matter of some debate. See Kaplan v. Exxon Corp., 126 F.3d 221, 223-25 (3d Cir . 1997). In Kaplan, we predicted the Pennsylvania Supreme Court would i ncorporate assumption of the risk into the duty analysis. Ther efore, it is a plaintiff's burden to establish that a defendant has a duty. Th is issue goes to the jury "unless reasonable minds could not differ." Id . at 225 (citation omitted).

42conduct, no plaintiff can have consented to or assu med 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 b elieve that individual considerations predominate here as well, but recognize that the question is a close one. The refore we do not rely on the presence of individual issues wi th the defenses of consent and assumption of risk in reach ing our

decision to affirm class decertification. But we no te other courts have permitted cigarette companies to assert affirmative defenses such as contributory negligenc e and assumption of risk. See Cipollone v. Liggett Group, Inc., 893 F.2d 541, 559 (3d Cir. 1990), aff'd in part, rev'd in part, 505 U.S. 504 (1992) (remanded for jury to consider comparative fault issues); Horton v. The American T obacco Co., 667 So.2d 1289, 1292 (Miss. 1995) (jury consid ered comparative fault and held that plaintiff was solel y responsible for his injury); Gilboy v. The American Tobacco Co., 582 So.2d 1263, 1265 (La. 1991) (recognizing assumption of risk defense).27

d. Statute of Limitations

Finally, we believe that determining whether each c lass member's claim is barred by the statute of limitati ons raises individual issues that prevent class certifi cation.28 It is fundamental that a plaintiff must bring a claim before the applicable statute of limitations expires. Dete rmining whether the statute of limitations has expired nece ssarily 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 med ical

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27. But see Wilks v. The American Tobacco Co., 680 So. 2d 839, 843 (Miss. 1996) ("[We] find that the trial court prope rly struck the defense of assumption of the risk. . . . Even if it was a v iable defense, it may

not be employed unless the defendant admits the existen ce of a risk. [American Tobacco] firmly denied that smoking was h azardous to one's health.")

28. We discuss our rationale for applying the statu te of limitations

rather than laches in affirming the grant of summary judgm ent against the named plaintiffs. For now, we describe only how the statute of limitations applies to the class.

43monitoring claim accrues when the plaintiff suffers a

"significantly increased risk of contracting a seri ous latent disease." Redland, 696 A.2d at 145. Under plaintiff s' analysis, a cigarette smoker suffers this risk when he reaches the ten or twenty "pack-year" level. A "pac k-year" is equivalent to a year in which a person smokes a pac k of cigarettes per day. To calculate a particular plain tiff's packyear history, the court multiplies the number of pa cks 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 twentypack year history; a person who has smoked a half a pack per day for twenty years has a ten pack-year histor y. Under the pack-year approach to claim accrual, determinin g when a plaintiff's claim accrued necessitates two indivi dual inquiries for each plaintiff: when he began smoking and

how much he has smoked since then. The need to cond uct such a determination for each plaintiff augurs that a class action will devolve into a lengthy series of indivi dual trials and therefore makes a class action an improper meth od for resolving these claims.

Because of the individual issues involved in this c ase-- 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 i ts

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29. In support of certification, plaintiffs point t o other medical monitoring claims that have been certified under Ru le 23(b)(2) or 23(b)(3). See, e.g., Gibbs v. E.I. Dupont de Nemour s & Co., 876 F. Supp. 475 (W.D.N.Y. 1995) (exposure to chemicals); Yslava v. Hughes Aircraft Co., 845 F. Supp. 705, 713 (D. Ariz. 1993) (class a lleging long-term exposure to contaminated ground water certified); B oggs v. Divested Atomic Corp., 141 F.R.D. 58, 67 (S.D. Ohio 1991) (l ong term exposure to radioactive materials and hazardous waste). Plainti ffs' case, however, presents numerous individual issues not involved in those cases. In addition, the cases plaintiffs cite all involve inv oluntary exposure to hazardous materials rather than the voluntary expos ure involved in this

case.

44discretion in decertifying the class, we now turn t o its order

granting summary judgment against the six named plaintiffs. The court held the claims of five of th e six plaintiffs--Barnes, Potts, Rodweller, Salzman and S livak-- 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 cigare ttes put them at an increased risk of contracting a serious disease. See Barnes, 984 F. Supp. at 861-63. The court held the sixth plaintiff, Ciaran McNally, was not barred by the statute of limitations because, given her age and s moking history, her claims for monitoring did not accrue m ore than two years before this action was brought. Id. at 86 1 n. 14, 864. But the court held that McNally had no cause o f action for medical monitoring because the only moni toring she sought--routine physical examinations and

cardiovascular risk assessment--was not different f rom that normally recommended in the absence of her particul ar exposure. See id. at 872.

We will briefly set forth the medical and smoking h istory of the named plaintiffs, as summarized by the Distr ict

Court:

Norma Rodweller has high cholesterol and a family history of heart disease. She has been diagn osed with vocal chord polyps and COPD, and has shown abnormalities in pulmonary function tests. S he has also been tested for potential coronary insu fficiency. 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 scree ning such as pap smears and mammograms.

Ciaran McNally is 26 years old. She has bee n a regular smoker since she was 15 years old an d smokes 10-15 cigarettes per day. She received chest x-rays when appropriate in response to symptoms. Sh e has not followed her doctors' advice to quit smo king while taking oral contraceptives.

William Barnes is mildly obese with hyperte nsion and elevated cholesterol. He has a history o f coronary

45artery disease, and he has been diagnosed wi th

hypertensive atherosclerotic heart diseases. He is also a heavy drinker. He has received EKGs, chest x-rays, and pulmonary function testing as appropriat e in response to symptoms. He has been told to qu it smoking every time he visited his doctor, an d continues to smoke despite evidence of fibro sis of his lung.

Catherine Potts has been diagnosed with COP D, coronary heart disease, angina, hyperlipidem ia, and hypertension. She continues to smoke despite being advised by her doctors to cease due to cardi ac problems and a potential vocal chord maligna ncy. She

has not followed her doctor's directions for testing, including a recommended colonoscopy followin g rectal bleeding. On one occasion, she insisted on b eing discharged from the hospital against medical advice after being diagnosed with possible myocardi al

infarction. She continues to drink caffeinat ed beverages despite being advised by doctors to cease do ing so.

Edward Slivak has continued smoking despite abnormal pulmonary function tests and abnorm al 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 m edical conditions, he is still smoking.

Barbara Salzman continues to smoke despite having been diagnosed with emphysema and mild to mo derate COPD based on pulmonary function tests and c hest x- rays. She has received chest x-rays, MRI sca ns, and EKGs in response to her symptoms. She has no t, however, mentioned her emphysema to her fami ly physician, explaining that she does not desi re to follow- up because "I don't like to look for trouble ." She drinks

an excessive amount of caffeine and has a fa mily history of heart disease.

Barnes, 984 F. Supp. at 854.

461. Statute of Limitations

Looking to the underlying theories of liability--in tentional tort, negligence, and strict products liability--th e District Court applied a two-year statute of limitations,fin ding the claims accrued on the date when the plaintiffs were placed at a "significantly increased risk of contracting a serious latent disease." See Redland, 696 A.2d at 145. Plai ntiffs faced this risk when, according to their experts' t estimony, they had smoked for twenty pack-years. Rodweller re ached this level in 1970, Salzman in 1976, Slivak in 1978 , Barnes in 1990, and Potts in 1973. Therefore the court hel d the claim of each named plaintiff was barred by the sta tute of limitations. The court also found the discovery rul e could not save plaintiffs' claims because each knew or sh ould have known that smoking put him or her at a signifi cantly increased risk of contracting a serious latent dise ase years before this lawsuit was filed. See Barnes, 984 F. S upp. at

863-64.

Plaintiffs contend the equitable doctrine of laches should apply, arguing their medical monitoring claim is an alogous to a suit for nuisance abatement based in equity. C iting Simmons v. Pacor, 674 A.2d 232 (Pa. 1996) and Redla nd, 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 Pennsylvan ia Supreme Court that it would apply laches rather tha n the

statute of limitations.

As the District Court found, plaintiffs could have brought their claim at law or in equity depending on the ty pe of relief sought.

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30. Plaintiffs point to the following language. In Simmons, the court found that "recovery for medical monitoring is appr opriate and just" and that though plaintiffs' experts had recommended med ical monitoring, plaintiff had "unfortunately" not sought the relief in the lawsuit. Id. at 240. In Redland, the Court opined that "a medical m onitoring trust fund is a more appropriate remedy than lump sum damages in mass exposure toxic tort cases. However, because the Redland Plai ntiffs are seeking only a medical monitoring trust fund, we offer no opinio n whether lump sum damages are recoverable under HSCA." Redland, 696 A .2d at 142-43

n.6.

47If plaintiffs seek relief that is a disguise d request for

compensatory (damages, then the medical moni toring claim can only be characterized as a claim f or monetary damages. In contrast, if plaintiffs seek the establishment of a court-supervised medical monitoring program through which the class m embers will receive periodic medical examinations, then plaintiffs' medical monitoring claims can pr operly be characterized as a claim seeking injunctive relief.

Arch, 175 F.R.D. at 483. Plaintiffs themselves appa rently 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 o f 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, whi ch is the situation here . . . ." Ebbert v. Plymouth Oil Co., 34 A.2d 493, 495-96 (Pa. 1943). Similarly, in Algrant v. Ev ergreen Valley Nurseries, Ltd., 126 F.3d 178, 181 (3d Cir. 1997) (citations omitted), we stated: "It is settled . . . that where legal and equitable claims coexist, equitable remed ies 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 pursu e a claim for a medical monitoring fund instead cannot deprive

defendants of the statute of limitations defense. S tatutes of limitations are primarily designed to assure fairne ss and "promote justice by preventing surprises through th e revival

of claims that have been allowed to slumber until e vidence has been lost, memories have faded, and witnesses h ave disappeared. The theory is that even if one has a j ust 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 r ight to prosecute them." Order of R.R. Telegraphers v. Rail way Express Agency, Inc., 321 U.S. 342, 348-49 (1944); see also Carey v. Kerr-McGee Chem. Corp., 999 F. Supp. 1109 (N.D.

48Ill. 1998) (holding medical monitoring claims barre d by twoyear tort statute of limitations).

In predicting what statute of limitations the Penns ylvania 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 defen dant's negligence. See Redland, 696 A.2d at 145-46. In Pennsylvania, a two-year statute of limitations app lies to negligence actions. See 42 Pa. Cons. Stat. Ann. S 5 524. As noted, plaintiffs also allege intentional exposure to a hazardous substance and strict liability for manufa cturing a defective product. To the extent that strict prod ucts liability or an intentional tort can act as the und erlying theory of liability for a medical monitoring claim, the applicable statute of limitations would still be tw o 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 recov ery is based and to institute suit within the prescribed s tatutory period." Pocono Int'l Raceway, Inc. v. Pocono Produ ce, 468 A.2d 468, 471 (Pa. 1983). A claim under Pennsylvani a law accrues at "the occurrence of the final significant event necessary to make the claim suable." Mack Trucks, I nc. v. Bendix-Westinghouse Automotive Air Brake Co., 372 F .2d 18, 20 (3d Cir. 1966).

A plaintiff's medical monitoring cause of action ac crues when he has been placed at a "significantly increas ed risk of contracting a serious latent disease." Redland, 696 A.2d at 145. To determine when that event occurred, we r efer to the testimony of plaintiffs' experts. As the Distri ct Court noted, their experts proposed specific dates when p laintiffs

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31. In Redland, the Pennsylvania Supreme Court held that "medical monitoring" plaintiffs must prove that defendant's negligence caused the exposure. See Redland, 696 A.2d at 146. We assume w ithout deciding that the Pennsylvania Supreme Court would allow an intentional tort or strict products liability to be the underlying theo ry of liability in a

claim for medical monitoring.

49would be entitled to participate in the proposed me dical

monitoring program. Under the Petty-Hyers Program, a plaintiff would be entitled to medical monitoring w hen he or she reaches the "twenty pack-year" level. 32

We agree with the District Court that five of the s ix named plaintiffs reached that level more than two y ears ago. Rodweller had been smoking one to one-and-a-ha lf packs since 1953 and became a twenty pack-year smok er in 1970. Salzman had been smoking at least one-and- a-half packs per day for forty-one years and her claim acc rued, at the latest, in 1976. Slivak had been smoking at lea st one to two packs per day for thirty-nine years and his cla im accrued, at the latest, in 1978. Barnes had been sm oking a pack a day since 1970 and his claim accrued in 19 90. 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 timebarred. The "discovery rule" is a "narrow exception to this general rule," Tohan v. Owens-Corning Fiberglass Co rp., 696 A.2d 1195, 1200 n.4 (Pa. 1997), and tolls the statu te of limitations during the "plaintiff's complete inabil ity, due to facts and circumstances not within his control, to discover an injury despite the exercise of due diligence." K ingston Coal Co. v. Felton Mining Co., 690 A.2d 284, 288 (P a. 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 kn own, (1) that he has been injured, and (2) that his injury h as been caused by another's conduct." Bradley v. Ragheb, 63 3 A.2d 192, 194 (Pa. Super. Ct. 1993). The plaintiff has t he burden of proving that he exercised reasonable diligence i n bringing his claim. See Cochran v. GAF Corp., 666 A.2d 245, 249-50 (Pa. 1995).

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32. We note that plaintiffs' other expert Dr. Burns proposes that monitoring begin before a person reaches the 20-pac k year level. Dr. Burns suggests, for example, that a person who has smoked 15-20 cigarettes for 10 years would be entitled to three of the seven proposed tests. Barnes, 984 F. Supp. at 860. In choosing the 20-pack year level as the accrual date, we, like the District Court, a re erring in plaintiffs' favor by choosing a later date.

50We 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 smokin g. . . . 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 t he 1980s, he `kn[e]w that cigarettes are no good for y ou if you have any type of lung disease. . . . Further , Mr.

Barnes stated that he believed that his fath er's death from lung cancer was partially caused by smoking . . . . Finally, Mr. Barnes testifie d at deposition that none of the warnings on ciga rettes, which inform smokers of the risks of smoking

, provided him with any information that he al ready did not possess. Based on these facts, it is obvious Barnes knew that smoking caused him to be pl aced at an increased risk of contracting a seriou s 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 wa s informed by her cardiologist in the late 198 0s that she was at a significantly increased risk of contracting heart disease, in the form of cl ogged 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 d octors have advised her to quit smoking because `[i ]t can make [her] ill' and because `[she] was a goo d candidate for emphysema.' "

51- "In the 1980s, one of Salzman's doctors to ld her to

stop smoking. The doctor explained, `it's re ally bad for you, you can get emphysema, cancer . . . .' In addition to being told by her doctors that s he could contract these diseases, Ms. Salzman urged h er son, throughout the 1980s, to quit smoking becaus e of the dangers of smoking."

- "After 1985, Mr. Slivak had read the warni ngs on the packages of cigarettes. . . . In additio n, in the early 1980s, Slivak discussed with his famil y that smoking may have been the cause of his wife' s cancer. Most importantly, Slivak's doctors c onnected smoking to his heart disease."

- With respect to plaintiff McNally, the cou rt determined that, since she has only been smo king for approximately 11 years, her claim could not have accrued until sometime last year. FN 14

.

Barnes, 984 F. Supp. 862-63 & n.14.

Plaintiffs argue the claims did not accrue when the y were placed "at a significantly increased risk" of devel oping smoking-related illnesses. They claim instead that the "touchstone of accrual is the suffering of actual, demonstrable injury, not increased risk" and note t hat Pennsylvania courts have "expressly held that a pla intiff 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, t hey have suffered no demonstrable injury--or even no injury at all--

then we would have to dismiss the case because it l acks an Article III case or controversy. See Lujan v. Defen ders of Wildlife, 504 U.S. 555, 560-61 (1992). The Pennsylv ania Supreme Court has held that the costs of periodic m edical examinations necessary to detect the onset of physi cal harm, Redland, 696 A. 2d at 144, are a compensable injury even in the absence of physical harm. Plaintiffs' a rgument begs the question of when that injury accrued. Exam ining plaintiffs' claims, the District Court found the in jury accrued when plaintiffs began needing medical monit oring. The District Court determined this date by looking at the

52testimony of plaintiffs' own experts. We agree with the

District Court's analysis.33

Citing Page v. United States, 729 F.2d 818 (D.C. Ci r. 1984) and Fowkes v. Pennsylvania Railroad Co., 264 F.2d 397 (3d Cir. 1959), plaintiffs contend the "continu ing harm" doctrine should operate to toll the statute of limi tations. In Page, the D.C. Circuit found

It is well-settled that `when a tort involve s continuing injury, the cause of action accrues, and the limitation period begins to run, at the time the tortio us conduct ceases.' Since usually no single incident in a continuous chain of tortious activity can `f airly or realistically be identified as the cause of significant harm,' it seems proper to regard the cumulat ive effect of the conduct as actionable. Moreover, `sin ce 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 cess ation.

Page at 821-22 (citations omitted). There, the cour t 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 continuou s harm theory. We noted

`If the relation is continuous, as in that o f master and servant, and the default is likewise continu ous until the cumulative effect produces disability in the form of occupational disease, total or partial, the master's failure to perform his duty . . . is regarde d as a single wrong continuing so long as the employment

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33. We acknowledge this statute of limitations anal ysis 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 accr ued, 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 sug gested by plaintiffs.

53continues. Such wrong must therefore be redr essed by

action brought within . . . (the statutory p eriod) from the time when the employment terminates.'

Fowkes, 264 F.2d at 399 (citation omitted).

In Kichline v. Consolidated Rail Corp., 800 F.2d 35 6 (3d Cir. 1986), however, in declining to apply the cont inuing harm doctrine to a FELA claim, we limited the appli cability of Fowkes. In doing so, we specifically rejected th e position now advanced by plaintiffs. We noted that in Fowkes , the "jury found specifically that the plaintiff was una ware that the physical condition for which he sought damages had existed for more than three years before the suit h ad been filed." Kichline, 800 F.2d at 359. We then stated: "We understand Fowkes to mean that continuing conduct o f defendant will not stop the ticking of the limitati ons clock begun when plaintiff obtained requisite information . On discovering an injury and its cause, a claimant mus t choose to sue or forego that remedy." Id. at 360.34 Unlike this case, the discovery rule was not applicable in Fowkes because plaintiff did not know about his injury. Bu t here, as we have discussed, there is unrefuted evidence t hat plaintiffs knew or should have known about their in jury more than two years before filing suit. Under Kichl ine, the clock began to run when plaintiffs obtained the req uisite

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

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34. While plaintiffs are correct that in Kichline w e distinguished Page as an "intentional conduct case," Kichline, 800 F.2d a t 360, we did not adopt Page as the rule in intentional tort cases. W e believe our unequivocal adoption of the discovery rule in Kichl ine disposes of plaintiffs' argument. We further note that Page, un like 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 con sent. The District Court found genuine issues of material fact exist w ith respect to each defense. See Barnes, 984 F. Supp. at 868-70.

54District Court found (1) under the Burns Program, M cNally

is only entitled to participate in the first level of the proposed monitoring program which includes regular physical examinations, cardiovascular risk assessme nt, and an EKG; (2) McNally only requested cardiovascular r isk assessment and annual physical examinations and not EKGs; and (3) annual physical examinations and cardiovascular risk assessment are routinely recomm ended to all persons even in the absence of exposure. The court concluded that because McNally only seeks monitorin g for

two tests that would be recommended for her even if she did not smoke, "[a]ny increase in Ms. McNally's inc remental risk of incurring the harm produced by the allegedl y hazardous substances in cigarettes would not warran t a change in the medical monitoring that would be pres cribed for her. Indeed, in the absence of exposure, it wou ld be

recommended that she receive the tests she seeks un der her medical monitoring claim." Barnes, 984 F. Supp. at 870-72. Therefore, the court reasoned, she cannot s atisfy

the sixth element of Redland because she cannot est ablish that "the prescribed regime is different from that normally recommended in the absence of the exposure." See id .36 We

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36. The parties' briefs and the record demonstrate a great deal of confusion and disagreement on this issue. The dispu te centers around what kind of monitoring program McNally requested a nd what kind of program plaintiffs' expert recommended for her.

Dr. Burns made contradictory statements with respec t to the appropriate program for McNally. In describing the different levels of monitoring, Dr. Burns recommended three tests for s mokers 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 s pecifically stated McNally "should initially receive [cardiovascular r isk assessment] and [physical examination]." He did not mention the EKG . Moreover, in plaintiffs' response to defendants' first set of in terrogatories, McNally indicated she would only need cardiovascular risk f actor 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 paragrap h 7 of the report inadvertently stated that only a cardiovascular ris k 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

55agree with this reasoning and the District Court's decision

to grant summary judgment against McNally.

IV.

For the foregoing reasons, we will affirm the judgm ent of

the District Court.

A True Copy:

Teste:

Clerk of the United States Court of Appeals

for the Third Circuit

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interrogatory and contend the District Court erred by failing to recognize and resolve a resulting "tension" between the inter rogatory answer, which neglected to mention the EKG, and the more ge neral statement in Dr. Burns' second report that EKGs should be admini stered to persons 25 or older who have smoked 10-15 cigarettes per da y for 10 years. Defendants claim McNally waived this argument becau se she did not raise it below. We agree with defendants that this argument is waived.

Alternatively, plaintiffs contend that Dr. Burns, i n his expert report,

stated that both tests--cardiovascular risk factor coupled with physical examination--were different from that normally pres cribed and therefore

satisfied the sixth element of Redland. We do not a gree with plaintiffs' analysis of Dr. Burns' testimony. Dr. Burns said: " Cardiovascular risk factor assessment and a physical examination are me asures that are recommended for all individuals to identify modifia ble causes of heart disease including smoking. They are useful in preve nting disease only for

those who have an identifiable and modifiable risk factor. All smokers have an identifiable and modifiable risk factor, an d the risk of disease increases synergistically when smokers have additio nal 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 popu lation of smokers." Plaintiffs argue this statement supports the positi on that these tests were different from that normally prescribed for th e general population. But as defendants contend, Dr. Burns' report indica tes these are

"measures recommended for all individuals." We also note Dr. Burns' deposition statement that "most organizations recom mended screening for cardiovascular risk factors at almost any inter action with the health care system regardless of age."

56