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October 17, 1997


The opinion of the court was delivered by: NEWCOMER

 Presently before this Court are Defendants' Motion for Summary Judgment Based on the Statute of Limitations, Defendants' Motion for Summary Judgment Concerning Plaintiffs' Contributory Negligence, Assumption of Risk and Consent to Exposure to Hazardous Substances, and Defendants' Motion for Summary Judgment Concerning Plaintiffs' Claims for Medical Monitoring, and plaintiffs' response thereto, and defendants' replies thereto.

 I. Introduction

 A. Procedural History

 Plaintiffs *fn1" have filed suit against defendants, *fn2" seeking the establishment of a medical monitoring program. Since the filing of plaintiffs' original Complaint in the Pennsylvania state court system approximately one year ago, this litigation has followed its own unique twists and turns. It has now, however, reached the dispositive motion stage -- a stage which has seen defendants file nine joint and/or individual motions for summary judgment. Hence, the instant task before this Court is to dispose of the novel and complex issues raised by these motions. Before addressing these issues, the Court will briefly set forth the procedural and factual history of this case.

 On August 27, 1996, this action was removed from state court. Plaintiffs filed a "First Amended Complaint -- Class Action" on December 2, 1996. Plaintiffs' First Amended Complaint asserted the following causes of action: (1) medical monitoring; (2) intentional exposure to a hazardous substance; (3) negligence; and (4) strict products liability. Count five of plaintiffs' First Amended Complaint averred that defendants acted in concert or pursuant to a common design.

All current residents of Pennsylvania who are cigarette smokers as of December 1, 1996, and who began smoking before age 19, while they were residents of Pennsylvania.

 On June 3, 1997, this Court entered an order and opinion in which plaintiffs' motion for class certification was denied. Arch v. American Tobacco Co., 175 F.R.D. 469, 1997 U.S. Dist. LEXIS 7890, No. CIV.A.96-5903, 1997 WL 312112, (E.D. Pa. June 3, 1997). Plaintiffs' claims were not certifiable under Rule 23(b)(3) because plaintiffs did not satisfy the superiority and predominance requirements. Additionally, plaintiffs' request for certification of their medical monitoring claim was denied because the majority of relief sought by plaintiffs was predominantly compensatory as opposed to equitable. Finally, the Court denied issue certification under Rule 23(c)(4).

 Subsequent to the Court's June 3, 1997 Memorandum and Order, plaintiffs filed a motion for leave to file a Second Amended Complaint, along with a renewed motion for class certification. Plaintiffs' Second Amended Complaint, which plaintiffs were granted leave to file and is now the complaint upon which plaintiffs prosecute this action, is different from plaintiffs prior two complaints in this action. In their Second Amended Complaint, plaintiffs assert only one claim against the defendants -- a claim for medical monitoring. Plaintiffs have discarded their claims sounding in negligence, strict products liability and intentional exposure to a hazardous substance. *fn3"

 In support of their medical monitoring claim, plaintiffs set forth the following facts in their Second Amended Complaint. Plaintiffs allege that defendants manufacture, promote and sell cigarettes. Defendants' earnings on cigarettes sold throughout the United States allegedly exceeded six billion dollars this past year alone, on gross sales of forty-five billion dollars. According to the Pennsylvania Department of Health, more than 22.6 billion cigarettes were sold in Pennsylvania during the fiscal year July 1995 through June 1996.

 Plaintiffs allege that cigarettes contain hazardous substances that cause serious and often fatal diseases of the throat, lungs, and heart, as well as the cardiovascular and pulmonary systems generally, and cause stillbirths and neonatal deaths of babies whose mothers smoke. The hazardous substances include, inter alia, nicotine, carbon monoxide, nitrosamine, formaldehyde, formic acid, acetaldehyde, ammonia, benzene, hydrogen cyanide, and "tar," which are all highly dangerous substances.

 Plaintiffs maintain that defendants, acting in concert or pursuant to a common design, have engaged in a wide range of conduct for which they should be held liable to plaintiffs. Defendants allegedly have known of the relationship between cigarettes and disease but have concealed their research, publicly denied the relationship between cigarettes and disease, and continue to aggressively promote and sell cigarettes. In so doing, plaintiffs contend that defendants have engaged in this conduct not only with willful, wanton and reckless disregard for the health of those who use their products, "but have intentionally and deliberately consigned millions of users to disease and death, for no reason other than to maximize [their] profits." (Second Amended Compl. P 12). Further, it is alleged that these defendants have known for many years of ways to make safer cigarettes but have intentionally chosen not to do so.

 In order to preserve and increase their sales of cigarettes, and despite their knowledge of the diseases and harm that cigarettes cause, it is alleged that defendants have spent millions of dollars each year in advertising and promoting cigarettes and have geared their efforts particularly towards teenagers and children through such efforts as the "Joe Camel" advertising campaign because defendants have allegedly known that unless a person begins smoking before the age of twenty, the person is unlikely to ever begin.

 Plaintiffs further allege that in their efforts to conceal the health hazards of smoking and the addictive nature of nicotine, defendants have testified falsely under oath before the United States Congress, provided false explanations to customers and governmental entities about the health hazards of tobacco and the harmful quantities of nicotine, concealed their secret research and testing on the dangers of cigarette smoking, concealed their deliberate manipulation of nicotine levels of cigarettes, required employees, under threat of severe legal sanctions, to keep secret all information that they have learned through their employment about the dangers of cigarette smoking, and concealed documents through devices such as the unwarranted invocation of the attorney client privilege.

 In addition, plaintiffs claim that defendants have continued to make false claims to the public, governmental agencies and the United States Congress that they have been making their products as safe as feasible. Plaintiffs assert that these claims are false because defendants allegedly have had the ability, for some time now, to make safer cigarettes by removing hazardous substances from them such as nitrosamine, ammonia, benzene products and others, yet defendants have failed and intentionally refused to remove these hazardous substances.

 Based on the conduct of defendants, plaintiffs contend that defendants are liable to them under their medical monitoring claim. Plaintiffs seek the following relief: (1) certifying this action as a class action pursuant to Fed. R. Civ. P. 23(a) and (b)(2); (2) establishing a Court-supervised program, to be funded by defendants, through which the class members would undergo periodical medical examinations in order to promote the early detection of diseases caused by smoking; and (3) awarding the costs of this suit and such other relief as the Court deems just and proper.

 By Order dated August 22, 1997, this Court certified the following class pursuant to Rule 23(b)(2):

All current residents of Pennsylvania who are cigarette smokers as of December 1, 1996, and who began smoking before age 19, while they were residents of Pennsylvania.

 The Court found that the requirements of Federal Rule of Civil Procedure 23(a)(1)-(4) had been satisfied and that class certification was proper under Fed. R. Civ. P. 23(b)(2). In reaching this conclusion, it was noted that the record of the action did not demonstrate the existence of individual issues which would preclude certification. In this opinion, this Court explained that it would revisit the issue of class certification, which it recently did.

 By Memorandum and Order dated October 17, 1997, this Court decertified this case as a class action pursuant to Fed. R. Civ. P. 23(c)(1). In the memorandum opinion, the Court noted that this case could not proceed as a class action under Rule 23(b)(2) because too many individual issues were implicated by the facts and circumstances of this case. Thus, pursuant to this Court's discretion under Fed. R. Civ. P. 23(c)(1), the Court vacated its August 22, 1997 Order, which had granted certification in this case.

 Consequently, plaintiffs now proceed solely in their individual capacities. As stated above, defendants have filed nine joint and/or separate motions for summary judgment. In this memorandum, the Court will only address defendants' motion for summary judgment based on the statute of limitations, defendants' motion for summary judgment concerning plaintiffs' contributory negligence, assumption of risk and consent to exposure to hazardous substances, and defendants' motion for summary judgment concerning plaintiffs' claims for medical monitoring. Before turning to the substance of defendants' motions, the Court will briefly describe plaintiffs' proposed medical monitoring program and will set forth the plaintiffs' medical histories and conditions.

 B. Plaintiffs' Proposed Medical Monitoring Program

 At the outset, it is noted that the parties contest whether the plaintiffs actually advance one or two medical monitoring programs. From defendants' perspective, plaintiffs advance two separate and distinct programs that vary significantly. One program is advanced by Drs. Petty and Hyers; the other program is advanced by Dr. Burns. Defendants state that Dr. Hyers, one of plaintiffs' experts, expressly acknowledged that there exists a lack of consensus among plaintiffs' experts as to who should be screened, what tests should be administered, and when the tests should be administered. Dr. Hyers stated that he expects that the plaintiffs' experts will at some point reach a "compromise." (Defs.' Ex. 2). In contrast to defendants' position, plaintiffs represent that they propose only one medical monitoring program.

 While it appears from the record that plaintiffs' experts have advanced two medical monitoring programs throughout the course of this litigation, the plaintiffs presently represent that they advance only one program -- the program advanced by Dr. Burns. Because plaintiffs represent that they are advancing the program suggested by Dr. Burns, the Court will base its consideration of defendants' summary judgment motions on the "Burns Program."

 In this regard, the Court notes that the Burns Program is designed to monitor and detect three diseases which are allegedly caused by smoking: cardiovascular disease, lung cancer and chronic obstructive pulmonary disease ("COPD"). Further, seven diagnostic tests and procedures will constitute the components of the medical monitoring program: (1) electrocardiogram ("EKG"); (2) cardiovascular risk factor assessment; (3) chest x-ray screening; (4) exercise stress test; (5) physical examination, including blood pressure, blood lipid and total cholesterol; (6) pulmonary function test, including spirometry; *fn4" and (7) sputum cytology. *fn5" (Pls.' Ex. 72). However, in order to fully put defendants' arguments in context, the Court will describe in greater detail the two programs which were advanced by plaintiffs.

 1. The Petty-Hyers Program

 Drs. Petty and Hyers have jointly proposed a medical monitoring program. Participants in the medical monitoring program would be limited to current smokers and "recent quitters" with 20 pack-year smoking histories. *fn6" (Defs.' Ex. 10 at 6, Report of Thomas L. Petty, M.D., and Thomas M. Hyers, M.D. ("Petty-Hyers Report")). Under this entry level requirement, it appears that at least one of the plaintiffs, Ciaran McNally, would not be eligible for medical monitoring. *fn7"

 The entry point for the Petty-Hyers program is annual spirometric testing of 20 pack-year smokers for detection of COPD. (Petty Dep. Defs.' Ex. 4 at 59-63; Hyers Dep. Defs.' Ex. 2 at 224-25). Only after a finding of abnormality through spirometry would further testing by chest x-ray and sputum cytology be performed. Id. EKGs, exercise stress tests and pulmonary function testing other than spirometry are excluded from their monitoring regime. (Petty Dep. Defs.' Ex. 4 at 129-30; Hyers Dep. Defs.' Ex. 4 at 99-104). The purpose of detecting COPD would not be to treat the condition. Both Drs. Petty and Hyers acknowledge that there is no evidence that lung function improves through medical treatment. (Petty Dep. Defs.' Ex. 4 at 156-58; Hyers Dep. Defs.' Ex. 2 at 207-08). Rather, they urge screening of smokers because they believe the presence of COPD may be a surrogate marker for risk of lung cancer. (Defs.' Ex. 10 at 4-7). In advancing their program, Drs. Petty and Hyers agree with the accepted medical principle that screening of smokers should not be prescribed unless it would "substantially decrease the premature morbidity and mortality from smoking related diseases." Id. at 8.

 Drs. Petty and Hyers both have conceded that there are no clinical studies that support their belief that their program would prove efficacious under these principles. (Petty Dep. Defs.' Ex. 4 at 102-04; Hyers Dep. Defs.' Ex. 2 at 138). For example, both Drs. Hyers and Petty agree that there is no study establishing that a diagnosis of abnormal pulmonary function leads to a greater proportion of smokers ceasing smoking. (Defs.' Ex. 4 at 123; Defs.' Ex. 2 at 209). Drs. Petty and Hyers also agree that lung cancer screening using chest x-ray or sputum cytology has not been demonstrated to be efficacious, and that studies to date have uniformly reached the opposite conclusion. (Defs.' Ex. 4 at 64-65; Defs.' Ex. 2 at 139-40, 143-48).

 In sum, Dr. Petty has admitted that his proposed program is "not today accepted" in the medical community. (Defs.' Ex. 4 at 78-79, 153-54), and both experts have acknowledged that central aspects of the program would be experimental in nature. For example, as to the use of sputum cytology, the Petty-Hyers Report itself points out that the test "is expensive, laborious and difficult to standardize" and that its "role . . . is still under intense study and is being constantly refined." (Defs.' Ex. 10 at 5). In addition, Dr. Petty has written that "it is not likely that sputum cytology based solely on human diagnosis will ever become practical on a widespread basis." (Defs.' Ex. 21 Thomas L. Petty, "Lung Cancer Screening", in Comprehensive Therapy, 1995 21(8) 432-437, 434). Similarly, as to the use of spirometry, Dr. Petty recently wrote that "an intensive effort in COPD is needed because despite several decades of COPD research, virtually all of the fundamental issues about COPD remain . . . ." (Defs.' Ex. 22 Thomas L. Petty, "Building a National Strategy for the Prevention and Management of Research in Chronic Obstructive Pulmonary Disease", in JAMA 227(3), 246-53, 251 (January 15, 1997)).

 2. The Burns Program

 In the Burns Program, Dr. Burns classified smokers by "pack-year" and age criteria to determine participation in various forms of screening. Under the new proposal, the eligibility of smokers for monitoring would be determined in the following manner:

1. Persons age 25 and older and who have smoked an average of 10-15 or more cigarettes per day for 10 years would receive an EKG, cardiovascular risk factor assessment, and a physical examination;
2. Persons age 40 and older who have smoked an average of 15 or more cigarettes per day for 20 years would receive an EKG, cardiovascular risk factor assessment, physical examination, and exercise stress test;
4. Persons age 50 and older and who smoked an average of 15 or more cigarettes per day for 20 years would receive an EKG, cardiovascular risk factor assessment, physical examination, an exercise stress test, a pulmonary function test, a chest x-ray, and sputum cytology.

 (Defs.' Ex. 3. PP 3, 4, 6).

 Following this initial testing, a physical examination and EKG would be repeated annually, as would any other test showing a "significant abnormality". (Defs.' Ex. 3 PP 5, 6). All remaining tests would be repeated every two to three years. Id.

 As Dr. Hyers has noted, there are major differences between the Burns Program and the Hyers-Petty Program, including:

 1. Dr. Burns would screen for more smokers than would Drs. Petty and Hyers; smokers with as few as five-pack years could receive medical monitoring. ( Defs.' Ex. 3 P 4). Dr. Hyers, on the other hand, stated that 20 pack-years is the starting point where there is a significant enough risk to commence monitoring. (Defs.' Ex. 2 at 20-21).

 2. Dr. Burns would routinely screen some or all monitoring participants using EKGs, exercise stress testing, and pulmonary functions testing other than spirometry (Defs.' Ex. 3 PP 3, 4, 6). None of these tests are recommended by Drs. Hyers and Petty. (Defs.' Ex. 4 at 129-30; Defs.' Ex. 2 at 99-104).

 3. Dr. Burns would routinely screen some participants using chest x-ray and sputum cytology, (Defs.' Ex. 3, PP 3, 4), while Drs. Petty and Hyers would use these tests only on persons with abnormalities detected using spirometry. (Defs.' Ex. 4 at 59-63; Defs.' Ex. 2 at 224-25).

 Unlike Drs. Hyers and Petty, Dr. Burns did not support his proposal by arguing for reconsideration of the accepted view that screening of asymptomatic smokers is not efficacious. Rather, he has defended deviating from standard medical practice principally by pointing to a possible increase in smoking cessation. He explained that early detection of a smoking-related disease may, by allowing a person to know his or her current health status, provide "substantial increased motivational force" to stop smoking. (Defs.' Ex. 9 at 82-83, 88-90).

 Dr. Burns has argued that this opportunity to stop smoking constituted the "alteration benefit" of his program. Id. He, like plaintiffs' other experts, was unable to cite specific literature supporting his views. When pressed to cite support for his views, he replied that his various opinions were based on a "vast body" of literature, but was unable to ...

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