Marcia L. Caronia, Linda McAuley and Arlene Feldman, Appellants,v.Philip Morris USA, Inc., Respondent.BriefN.Y.May 30, 2013CTQ-2013-00004 Court of Appeals STATE OF NEW YORK MARCIA L. CARONIA, LINDA MCAULEY, and ARLENE FELDMAN, Plaintiffs-Appellants, against PHILIP MORRIS USA, INC., Defendant-Respondent. >> >> BRIEF OF AMICI CURIAE THE AMERICAN CHEMISTRY COUNCIL AND THE AMERICAN PETROLEUM INSTITUTE IN SUPPORT OF DEFENDANT-RESPONDENT QUINN EMANUEL URQUHART & SULLIVAN, LLP Attorneys for Amici Curiae The American Chemistry Council and The American Petroleum Institute 51 Madison Avenue, 22nd Floor New York, New York 10010 212-849-7000 On the Brief: Sheila L. Birnbaum Douglas W. Dunham Ellen P. Quackenbos Douglas E. Fleming, III Date Completed: October 4, 2013 On Questions Certified by the United States Court of Appeals for the Second Circuit (USCOA Docket No. 11-0316-cv) i DISCLOSURE STATEMENT Pursuant to 22 N.Y.C.R.R. § 500.1(f), Amici Curiae make the following disclosure: The American Chemistry Council and the American Petroleum Institute are not- for-profit business federations with no parents, subsidiaries, or affiliates. ii TABLE OF CONTENTS Page DISCLOSURE STATEMENT ................................................................................... i TABLE OF AUTHORITIES ................................................................................... iii STATEMENT OF INTEREST .................................................................................. 1 INTRODUCTION AND SUMMARY OF ARGUMENT ........................................ 2 ARGUMENT ............................................................................................................. 4 I. TRADITIONAL TORT LAW AND SOUND PUBLIC POLICY DO NOT SUPPORT THE RECOGNITION OF MEDICAL MONITORING CLAIMS ABSENT MANIFEST PHYSICAL INJURY. .......................................................................................................... 4 II. THE MEDICAL MONITORING TORT INVITES ENORMOUS NUMBERS OF SPECULATIVE CLAIMS. ................................................... 9 A. The Medical Monitoring Tort Gives a Colorable Claim to a Huge New Class of Potential Plaintiffs. .............................................. 11 B. Medical Monitoring Claims Are Inherently Speculative, and Threaten Defendants with Arbitrary and Unpredictable Liability. .............................................................................................. 16 III. PERMITTING MEDICAL MONITORING CLAIMS BY ASYMPTOMATIC PLAINTIFFS WOULD DIVERT RESOURCES FROM THOSE WHO ARE ACTUALLY INJURED. ................................. 19 IV. THE RECOGNITION OF NEW CAUSES OF ACTION SHOULD BE LEFT TO THE LEGISLATURE. ........................................................... 21 CONCLUSION ........................................................................................................ 23 iii TABLE OF AUTHORITIES Page CASES Atchison, Topeka & Santa Fe Railway Co. v. Buell, 480 U.S. 557 (1987).......................................................................................16 Ayers v. Township of Jackson, 525 A.2d 287 (N.J. 1987) ............................................................. 9, 13, 16, 17 Badillo v. American Brands, Inc., 16 P.3d 435 (Nev. 2001) .................................................................................. 6 Ball v. Joy Manufacturing Co., 755 F. Supp. 1344 (S.D. W. Va. 1990), aff'd, 958 F.2d 36 (4th Cir. 1991) .................................................................... 11, 20 Bocook v. Ashland Oil, Inc., 819 F. Supp. 530 (S.D. W. Va. 1993) ...........................................................17 Bovsun v. Sanperi, 61 N.Y.2d 219, 461 N.E.2d 843, 473 N.Y.S.2d 357 (1984) .........................18 Consolidated Rail Corp. v. Gottshall, 512 U.S. 532 (1994)......................................................................................... 9 Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579 (1993).......................................................................................15 Donovan v. Philip Morris USA, Inc., 914 N.E.2d 891 (Mass. 2009) ................................................................. 12, 13 Dumontier v. Schlumberger Technology Corp., 543 F.3d 567 (9th Cir. 2008) .........................................................................14 Henry v. Dow Chemical Co., 701 N.W.2d 684 (Mich. 2005) ............................................................. 6, 8, 21 Hinton v. Monsanto Co., 813 So. 2d 827 (Ala. 2001) ................................................................. 6, 21, 22 In re Paoli Railroad Yard PCB Litigation ("Paoli I"), 916 F.2d 829 (3d Cir. 1990) ............................................................... 9, 16, 17 In re Paoli Railroad Yard PCB Litigation ("Paoli II"), 35 F.3d 717 ....................................................................................... 13, 15, 16 Kimbar v. Estis, 1 N.Y.2d 399, 135 N.E.2d 708, 153 N.Y.S.2d 197 (1956) ............................. 4 iv Lowe v. Philip Morris USA, Inc., 142 P.3d 1079 (Or. Ct. App. 2006), aff'd, 344 Or. 403 (2008) .......................................................................................... 8 Lowe v. Philip Morris USA, Inc., 183 P.3d 181 (Or. 2008) ..............................................................................4, 5 Madden v. Creative Services, Inc., 84 N.Y.2d 738, 646 N.E.2d 780, 622 N.Y.S.2d 478 (1995) ........................18 Metro-North Commuter Railroad Co. v. Buckley, 521 U.S. 424 (1997)............................................................................... passim Miranda v. Shell Oil Co., 7 Cal. Rptr. 2d 623 (Ct. App. 1992) ..............................................................12 Murphy v. American Home Products Corp., 58 N.Y.2d 293, 448 N.E.2d 86, 461 N.Y.S.2d 232 (1983) .................... 22, 23 Norfolk & Western Railway Co. v. Ayers, 538 U.S. 135 (2003)......................................................................................... 5 Ortega v. City of New York, 9 N.Y.3d 69, 876 N.E.2d 1189, 845 N.Y.S.2d 773 (2007) .................... 10, 18 Paz v. Brush Engineered Materials, Inc., 949 So. 2d. 1 (Miss. 2007) ............................................................................... 6 Potter v. Firestone Tire & Rubber Co., 25 Cal. Rptr. 2d 550 (1993) .................................................................... 12, 17 Rainer v. Union Carbide Corp., 402 F.3d 608 (6th Cir. 2005) .........................................................................14 Redland Soccer Club, Inc. v. Department of the Army, 55 F.3d 827 (3d Cir. 1995) ..................................................................... 13, 16 Sinclair v. Merck & Co., 948 A.2d 587 (N.J. 2008) ................................................................................ 6 Stoleson v. United States, 708 F.2d 1217 (7th Cir. 1983) .......................................................................14 Wood v. Wyeth-Ayerst Laboratories, 82 S.W.3d 849 (Ky. 2002) .................................................. 6, 7, 14, 19, 20, 21 Woods v. Lancet, 303 N.Y. 349, 102 N.E.2d 691 (1951) ................................................... 22, 23 v STATUTES & RULES 22 N.Y.C.R.R. § 500.1(f) ........................................................................................... i 22 N.Y.C.R.R. § 500.23 ............................................................................................. 1 22 N.Y.C.R.R. § 500.12(e) ........................................................................................ 1 42 U.S.C. § 2014(q) .................................................................................................14 N.Y. C.P.L.R. § 3101(d)(1)(iii) ...............................................................................15 OTHER AUTHORITIES James A. Henderson, Jr. and Aaron D. Twerski, Asbestos Litigation Gone Mad: Exposure-Based Recovery for Increased Risk, Mental Distress, and Medical Monitoring, 53 S.C. L. Rev. 815 (2002) ............................................................................................... 8 Paul D. Rheingold, Mass Tort Litigation (1996) .......................................................................... 12 Stephen J. Carroll et al., Asbestos Litigation (RAND Institute for Civil Justice 2005) ......................... 8 William L. Prosser, Handbook of the Law of Torts (4th ed. 1971) ................................................. 4 1 The American Chemistry Council and the American Petroleum Institute respectfully submit this brief, accompanied by their motion for amicus curiae relief under 22 N.Y.C.R.R. §§ 500.12(e) and 500.23, in support of Defendant-Respondent Philip Morris, USA, Inc. in the above-captioned action. STATEMENT OF INTEREST The American Chemistry Council ("ACC") represents the leading companies engaged in the business of chemistry. ACC members apply the science of chemistry to make innovative products and services that make people's lives better, healthier and safer. The business of chemistry is a $770 billion enterprise and a key element of the nation's economy. The business of chemistry in New York alone generates a payroll of nearly $3 billion and directly employs over 40,000 workers. The American Petroleum Institute ("API") is a nationwide, non-profit trade association headquartered in Washington, D.C., that represents over 400 members engaged in all aspects of the petroleum and natural gas industry, including exploration, production, transportation, refining and marketing. ACC and API actively support their members’ interests and concerns by filing amicus curiae briefs in cases of substantial significance to the national legal landscape. Here, Plaintiffs’ proposed medical monitoring cause of action would, if recognized by this Court, create a potential for enormous and unpredictable liability for virtually all industries and in particular for companies such as ACC’s members, 2 which are engaged in the manufacture of chemicals and chemical products, and API’s members, which are engaged in the petroleum and natural gas industries. These industries are of vital national importance, and the policy concerns raised by Plaintiffs’ medical monitoring claims affect businesses throughout the State of New York and the nation as a whole. INTRODUCTION AND SUMMARY OF ARGUMENT Plaintiffs ask this Court to expand liability dramatically for product manufacturers and a host of other participants in the national economy by recognizing a claim for medical monitoring that would not require a showing of any actual physical injury or disease manifested in objective symptomatology, but only purported subcellular, subclinical changes and an indeterminate risk of future injury. To accept Plaintiffs' invitation, the Court would have to turn its back not only on decades of New York case law but also on the nationwide trend toward rejecting precisely the kinds of claims alleged here. Allowing Plaintiffs to prosecute medical monitoring claims based solely on an increased risk of harm would result in a sea change in New York law. Such a ruling could not be limited to claims against manufacturers of tobacco products, but would extend to exposure claims in other products liability cases, environmental cases, and workplace cases, as well as claims against municipalities and other government entities. As the United States Supreme Court stated in rejecting medical monitoring 3 claims by asymptomatic asbestos plaintiffs, "tens of millions of individuals may have suffered exposure to substances that might justify some form of substance-exposure- related medical monitoring." Metro-North Commuter R.R. Co. v. Buckley, 521 U.S. 424, 442 (1997). Permitting asymptomatic plaintiffs to bring medical monitoring claims raises fundamental public policy concerns, including the potentially massive burden on the courts and litigants that would result from a "'flood' of less important cases (potentially absorbing resources better left available to those more seriously harmed)," and the "systemic harms that can accompany 'unlimited and unpredictable liability' (for example, vast testing liability adversely affecting the allocation of scarce medical resources)." Id. No meaningful limit is placed on liability by requiring that a plaintiff show "subcellular" physiological changes, such as Plaintiffs allege in this case, or by the other requirements some courts have created to try to limit medical monitoring claims. The potential for vast numbers of claims remains, and the inherently speculative nature of such claims is not reduced. Recognizing a full-blown tort claim for medical monitoring simply puts courts and juries in charge of determining what are inherently public policy issues properly left for the Legislature and issues of medical judgment for scientific and medical professionals. 4 The well-established requirements of tort law already strike the correct balance, based upon decades of experience. Tort law allows plaintiffs with manifest injuries to recover for those injuries and for harmful sequelae more likely than not to occur in the future, while filtering out speculative claims of potential injury based on mere exposure to a substance alleged to be capable of causing injury in the future. The Court should adhere to this time-tested division between tort claims that are viable and those that are not. ARGUMENT I. TRADITIONAL TORT LAW AND SOUND PUBLIC POLICY DO NOT SUPPORT THE RECOGNITION OF MEDICAL MONITORING CLAIMS ABSENT MANIFEST PHYSICAL INJURY. For over 200 years, one of the fundamental principles of tort law has been that a plaintiff cannot recover without proof of actual physical harm – i.e., manifest bodily injury or symptomatic disease. See William L. Prosser, Handbook of the Law of Torts § 54, at 330-33 (4th ed. 1971). 1 As the United States Supreme Court has explained, the physical injury requirement "sharply distinguish[es] exposure-only plaintiffs from plaintiffs who suffer from a disease" and thereby "reduce[s] the universe of potential 1 See, e.g., Kimbar v. Estis, 1 N.Y.2d 399, 403, 135 N.E.2d 708, 709, 153 N.Y.S.2d 197, 199 (1956) (it is a "basic proposition of tort law that no action will lie in negligence unless all of the following elements are present: (1) the existence of a duty on defendants' part as to plaintiff; (2) a breach of this duty; (3) resultant injury to plaintiff, and (4) absence of contributory negligence on plaintiff's own part") (first emphasis added); see also Lowe v. Philip Morris USA, Inc., 183 P.3d 181, 184 (Or. 2008) (proof of damage is an essential element of negligence action). 5 claimants to numbers neither unlimited nor unpredictable." Norfolk & W. Ry. Co. v. Ayers, 538 U.S. 135, 156-57 (2003) (internal citations and quotation marks omitted). In Metro-North Commuter Railroad Co. v. Buckley, 521 U.S. 424 (1997), the Supreme Court rejected medical monitoring for asymptomatic plaintiffs. The plaintiff in Buckley brought medical monitoring claims under the Federal Employers Liability Act ("FELA") based on his occupational exposure to asbestos. Significantly, in Buckley, although the plaintiff did not have any manifest disease or symptoms, he claimed to have sustained subclinical "bodily harm" in the form of physiological alterations to the "structure of the tissue." See Respondent's Br., Metro-North Commuter R.R. Co. v. Buckley, 1997 WL 13184, at *24 (Jan. 14, 1997). In the absence of relevant authority under FELA, the Court "canvassed the state-law cases that have considered whether the negligent causation of this kind of harm . . . by itself constitutes a sufficient basis for a tort recovery" and determined that, "with only a few exceptions, common-law courts have denied recovery to those who, like Buckley, are disease and symptom free." Buckley, 521 U.S. at 432, 440. Since Buckley was decided, a clear majority of state courts of last resort to consider the issue have refused to expand their tort law to embrace medical monitoring claims absent manifest physical injury. For example, in Lowe v. Philip Morris USA, Inc., 183 P.3d 181, 183-84 (Or. 2008), the Oregon Supreme Court rejected the very same claim Plaintiffs assert here, holding that a class of smokers who 6 alleged no "present physical harm" but were allegedly at a "significantly increased risk of developing lung cancer" as a result of smoking cigarettes could not bring a claim for medical monitoring. In Paz v. Brush Engineered Materials, Inc., 949 So. 2d. 1, 4 (Miss. 2007), the Mississippi Supreme Court similarly held that the plaintiffs could not recover for medical monitoring due to beryllium exposure because they had not shown "a physical manifestation of injury or demonstrable harm." Other courts have reached the same conclusion. 2 The courts that have rejected medical monitoring claims in the absence of physical injury manifested by objective symptomatology have recognized the substantial public policy concerns that are raised by such claims. Chief among these concerns are the uncabined expansion of liability these claims would present, the massive burden on the courts and the health care system, and the palpable danger that necessarily limited resources will need to be diverted away from those who are actually ill or injured. 2 See Sinclair v. Merck & Co., 948 A.2d 587, 595 (N.J. 2008) (rejecting medical monitoring claims brought under New Jersey Products Liability Act because the Act required proof of present physical injury); Henry v. Dow Chem. Co., 701 N.W.2d 684, 689 (Mich. 2005) (refusing recovery for medical monitoring in absence of manifest physical injury); Wood v. Wyeth-Ayerst Labs., 82 S.W.3d 849, 859 (Ky. 2002) (rejecting medical monitoring because plaintiff "has shown no present physical injury"); Badillo v. Am. Brands, Inc., 16 P.3d 435, 441 (Nev. 2001) ("Nevada common law does not recognize a cause of action for medical monitoring"); Hinton v. Monsanto Co., 813 So. 2d 827, 829-30 (Ala. 2001) ("Alabama law has long required a manifest, present injury before a plaintiff may recover in tort"; recognizing a medical monitoring claim "would require [the court] to completely rewrite Alabama's tort-law system"). 7 The United States Supreme Court recognized the legitimacy of these concerns in Buckley. Justice Breyer, writing for the majority, noted that "tens of millions of individuals may have suffered exposure to substances that might justify some form of substance-exposure-related medical monitoring." Buckley, 521 U.S. at 442. This fact, "along with uncertainty as to the amount of liability, could threaten . . . a 'flood' of less important cases . . . and the systemic harms that can accompany 'unlimited and unpredictable liability.'" Id. Moreover, these additional claims are likely to involve "unreliable and relatively trivial claims" rather than "reliable and serious claims." Id. at 444. As the Court recognized, members of modern societies are exposed to hazardous substances every day. Id. at 434, 442. Given the pervasiveness of potentially hazardous substances in the air we breathe, the food we eat, the water we drink, and the products we use, Plaintiffs' incorrect formulation of the law would entitle nearly everyone to some form of medical monitoring. For this and other reasons, the Supreme Court concluded that "the potential systemic effects of creating a new, full-blown, tort law cause of action" were simply too dire. Id. at 443-44. Other courts have echoed the concerns articulated in Buckley. As the Kentucky Supreme Court explained in Wood, "'[g]iven that negligently distributed or discharged toxins can be perceived to lie around every corner in the modern industrialized world, and their effects on risk levels are at best speculative, the potential tort claims involved are inherently limitless and endless.'" 82 S.W.3d at 857-58 (quoting James 8 A. Henderson, Jr. and Aaron D. Twerski, Asbestos Litigation Gone Mad: Exposure- Based Recovery for Increased Risk, Mental Distress, and Medical Monitoring, 53 S.C. L. Rev. 815, 831 (2002)). 3 The Michigan Supreme Court cited the same concern in refusing to recognize medical monitoring claims absent a physical injury. Henry, 701 N.W.2d at 690. The Henry court cautioned that the prevalence of toxic agents in the environment required the court to be "wary of accepting plaintiffs' invitation to venture down the slippery slope that a medical monitoring cause of action would necessarily traverse": To recognize a medical monitoring cause of action would essentially be to accord carte blanche to any moderately creative lawyer to identify an emission from any business enterprise anywhere, speculate about the adverse health consequences of such an emission, and thereby seek to impose on such business the obligation to pay the medical costs of a segment of the population that has suffered no actual medical harm. Id. at 696 n.15, 703. See also, e.g., Lowe v. Philip Morris USA, Inc., 142 P.3d 1079, 1091 (Or. Ct. App. 2006) (stressing the difficulties of "separat[ing] spurious or speculative [medical monitoring] claims from legitimate ones" in the absence of a physical injury requirement), aff'd, 344 Or. 403 (2008). Here, Plaintiffs' proposal that this Court adopt a cause of action in tort without a manifest physical injury could lead to a flood of medical monitoring claims, 3 See also Stephen J. Carroll et al., Asbestos Litigation, at xviii (RAND Inst. for Civil Justice 2005) (if medical monitoring could be obtained by the "[t]ens of millions [who] were exposed to asbestos in the workplace over the past several decades," the result could be devastating for the courts, defendant businesses, and deserving claimants with real injuries). 9 subjecting New York manufacturers, contractors, gas station owners, fast food operators, and utilities to potentially crushing exposure-based liabilities. Financially- strapped municipalities and other governmental entities could be subjected to such unbounded claims as well. The Court should reject such a massive and limitless expansion of tort liability. II. THE MEDICAL MONITORING TORT INVITES ENORMOUS NUMBERS OF SPECULATIVE CLAIMS. In contrast to the United States Supreme Court and the other courts cited above, some courts that have embraced the medical monitoring tort have in effect rejected the manifest injury requirement as an arbitrary barrier to the compensation of chemically exposed plaintiffs and the deterrence of activities that give rise to such exposure. See, e.g., In re Paoli R.R. Yard PCB Litig. ("Paoli I"), 916 F.2d 829, 852 (3d Cir. 1990); Ayers v. Twp. of Jackson, 525 A.2d 287, 312 (N.J. 1987). But as the United States Supreme Court has stated, "'[c]haracterizing a rule limiting liability as "unprincipled" or "arbitrary" is often the result of overemphasizing the policy considerations favoring imposition of liability, while at the same time failing to acknowledge any countervailing policies.'" Consol. Rail Corp. v. Gottshall, 512 U.S. 532, 557 (1994) (citation omitted). The policies of compensating plaintiffs and deterring alleged wrongdoing almost always favor the imposition of liability. Courts that have recognized a cause of action for medical monitoring have focused on these pro- 10 liability policies while ignoring or trivializing the strong policy considerations that counsel against recognition of a new tort of this kind. As this Court has stated, in determining whether to recognize a new tort cause of action, "the recognition that there has been an interference with an interest worthy of protection has been the beginning, not the end, of our analysis." Ortega v. City of New York, 9 N.Y.3d 69, 78, 876 N.E.2d 1189, 1194, 845 N.Y.S.2d 773, 778 (2007). "'Tort liability . . . depends on balancing competing interests,'" id. (ellipsis in original; citation omitted), and "New York courts therefore also weigh other judicial and social policy concerns in determining whether to recognize new tort causes of action." Id. at 79, 876 N.E.2d at 1194, 845 N.Y.S.2d at 778. Like this Court, the United States Supreme Court in Buckley recognized the need to balance competing policy interests in determining whether the Federal Employers Liability Act afforded a cause of action for emotional distress and medical monitoring in the absence of disease or manifest injury, stating: But just as courts must interpret [FELA] to take proper account of the harms suffered by a sympathetic individual plaintiff, so they must consider the general impact, on workers as well as employers, of the general liability rules they would thereby create. Here the relevant question concerns not simply recovery in an individual case, but the consequences and effects of a rule of law that would permit that recovery. Buckley, 521 U.S. at 438 (emphasis in original). 11 As the United States Supreme Court recognized in Buckley, the creation of a new tort cause of action may "despite benefits in some individual cases, . . . on balance cause more harm than good." Id. (emphasis in original). As shown in detail below, the same public policy considerations analyzed by the United States Supreme Court in Buckley remain valid today and weigh against the adoption of a medical monitoring cause of action for asymptomatic plaintiffs. A. The Medical Monitoring Tort Gives a Colorable Claim to a Huge New Class of Potential Plaintiffs. In eliminating the physical injury requirement, the medical monitoring tort bestows a cause of action on a boundless new class of potential plaintiffs who are not ill and most of whom almost surely will never become ill as a result of the conduct complained of. Toxic substances are ubiquitous in American society. There is probably no work site in the country where potentially hazardous substances are not present, whether in raw materials used in industrial processes, solvents used to clean machinery, pesticides used in agriculture, or the toner used in office photocopying equipment. It is thus no exaggeration to say that most residents of the United States are plausible potential medical monitoring plaintiffs. There can be "little doubt that millions of people have suffered exposure to hazardous substances." Ball v. Joy Mfg. Co., 755 F. Supp. 1344, 1372 (S.D. W. Va. 1990), aff'd, 958 F.2d 36, 39 (4th Cir. 1991). On a traditional personal injury claim, the threshold requirement of manifest 12 physical injury or symptomatic illness sharply limits the universe of potential plaintiffs who can proceed to try to prove a defendant's culpability and their entitlement to relief. The nominal threshold requirement erected by the medical monitoring tort – exposure to a hazardous substance – scarcely limits the universe of potential plaintiffs at all. Almost everyone who lives in a highly industrial society has been exposed, in some amount, to toxic chemicals. The medical monitoring tort could make all such exposed persons eligible to file a claim and would open New York courts to limitless claims in a time of scarce judicial resources. Courts that have recognized the medical monitoring tort have responded to concerns about a potential torrent of claims, if at all, by suggesting that such a result will be prevented by the requirement that plaintiffs prove elements in addition to mere exposure. See Potter v. Firestone Tire & Rubber Co., 25 Cal. Rptr. 2d 550, 580 (1993); Miranda v. Shell Oil Co., 17 Cal. App. 4th 1651, 1659-60 (Ct. App. 1993); Donovan v. Philip Morris USA, Inc., 914 N.E.2d 891, 901-02 (Mass. 2009). Indeed, most courts have read the elements of the tort to impose only the most minimal evidentiary burden on plaintiffs. Thus, according to a leading commentator, medical monitoring claims are in practice often extremely difficult to dispose of on summary judgment, and courts only rarely can screen out insubstantial claims as a matter of law. See Paul D. Rheingold, Mass Tort Litigation § 12.2, at 12-2 to 12-3 (1996). 13 The elements of "significant" exposure and "significantly increased" risk do not require plaintiffs to quantify the extent of their exposure or the degree of increased risk of disease, even in approximate terms. In re Paoli R.R. Yard PCB Litig. ("Paoli II"), 35 F.3d 717, 788; Ayers, 525 A.2d at 309; Donovan, 914 N.E.2d at 901. For example, one court has found the requirement of significant exposure to be satisfied simply by testimony from the plaintiffs that they were present near soil containing a hazardous substance. Paoli II, 35 F.3d at 793. Another court has concluded that it is not even necessary for plaintiffs to demonstrate that toxins were on the surface of the soil. Redland Soccer Club, Inc. v. Dep’t of the Army, 55 F.3d 827, 847 (3d Cir. 1995). The court deemed it sufficient that the chemicals were detected below the surface and "could" have migrated upward to the surface. See id. Moreover, where plaintiffs have offered quantitative estimates of their increased risk caused by an alleged exposure, it has been held that an increased lifetime cancer risk of just 1 in 100,000, Paoli II, 35 F.3d at 794, or even as little as 1 in 1,000,000, Redland Soccer, 55 F.3d at 847, is enough to qualify as "significant." In Donovan, the Massachusetts court relied heavily on the requirement that a plaintiff have sustained "subcellular change" as "address[ing] any concern over false claims" and as "adequately establish[ing] the elements of injury and damages." 914 N.E.2d at 901. As the Sixth Circuit has recognized, however, the same policy 14 considerations apply to claims based on alleged subcellular change as to other no- injury claims: Ultimately, however the most persuasive reason to deny the plaintiffs' [medical monitoring] claims in the present case comes from public policy considerations . . . . The first was noted by the court in Wood: "Given that negligently distributed or discharged toxins can be perceived to lie around every corner in the modern industrialized world, and their effects on risk levels are at best speculative, the potential tort claims involved are inherently limitless and endless." Accepting the plaintiffs' claim would therefore throw open the possibility of litigation by any person experiencing even the most benign subcellular damage. Based upon the average American's exposure to chemically processed foods, toxic fumes, genetically modified fruits and vegetables, mercury-laden fish, and hormonally treated chicken and beef, this might encompass a very large percentage of the total population. Rainer v. Union Carbide Corp., 402 F.3d 608, 621 (6th Cir. 2005). As the Ninth Circuit noted in refusing to recognize subcellular change as bodily injury for purposes of the Price-Anderson Act, 42 U.S.C. § 2014(q), opening the door to medical monitoring and other claims based on subcellular change would result in "an unlocked cash register." Dumontier v. Schlumberger Tech. Corp., 543 F.3d 567, 571 (9th Cir. 2008). Moreover, the requirement to prove subcellular injury or that their alleged increased risk creates a need for future medical monitoring may not deter many plaintiffs. On this issue, as on other scientific issues that come to court, there are always experts who are willing to testify to fringe views for a fee. Stoleson v. United States, 708 F.2d 1217, 1222 (7th Cir. 1983) ("there is not much difficulty in finding a 15 medical expert witness to testify to virtually any theory of medical causation short of the fantastic"). In one medical monitoring case, the plaintiffs produced an expert who testified that an expensive program of special medical monitoring is required for "anyone who lived near a toxic dump site . . . even if they lived three blocks away." Paoli II, 35 F.3d at 794. Another expert in that case opined that anyone who has been exposed to even one molecule of an allegedly hazardous substance should receive medical monitoring on account of such exposure. Id. The court in that case held that such opinions were admissible under the rules of evidence and the United States Supreme Court's decision in Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579 (1993), and were sufficient for the plaintiffs' medical monitoring claims to survive summary judgment. Paoli II, 35 F.3d at 793-95. In short, there is little to deter countless numbers of medical monitoring claims. Furthermore, the danger of spurious claims reaching a jury is significant especially in the courts of this State, in which depositions are generally unavailable to reveal the grounds (or absence thereof) for an expert’s opinion. See N.Y. C.P.L.R. § 3101(d)(1)(iii) (allowing depositions of experts “only by court order upon a showing of special circumstances”). Under traditional tort principles, an alleged wrongdoer could be called to answer in a negligence action only by someone who had sustained a manifest physical injury or severe emotional distress allegedly caused by the wrongdoing. However, the 16 courts that have recognized a medical monitoring tort have construed it in effect to confer standing on any and all persons in the vicinity of a toxic chemical to challenge, if they wish, the conduct of whomever they deem responsible for the presence of the chemical. See, e.g., Paoli II, 35 F.3d at 793; Redland Soccer, 55 F.3d at 847. Thus, if medical monitoring in the absence of symptomatic injury or harm is accepted as a theory of recovery, the minimal requirements it imposes will combine with the ready availability of plaintiffs to encourage frequent and potentially abusive lawsuits. B. Medical Monitoring Claims Are Inherently Speculative, and Threaten Defendants with Arbitrary and Unpredictable Liability. Traditional tort law notions of "injury" contain built-in protections against speculative claims. The physical injuries with which tort law has mostly concerned itself are normally susceptible to observation or some other form of objective confirmation. Emotional injuries, although not directly observable, have traditionally been compensated only in circumstances in which they are likely to yield some external corroboration of their existence. See Atchison, Topeka & Santa Fe Ry. Co. v. Buell, 480 U.S. 557, 569 n.18 (1987). The medical monitoring tort provides no such check on speculative claims. The injury involved – a plaintiff's purported "need" for future medical testing – has no objective existence. Courts that recognize the tort have opined that it will not engender speculative claims because plaintiffs must prove their need for future medical monitoring by competent expert testimony. See, e.g., Paoli I, 916 F.2d at 850-52; Ayers, 525 A.2d at 17 308-09. But the fact that a claim can be supported by competent expert testimony does not necessarily make it non-speculative. For example, even courts that accept the medical monitoring tort agree that a claim for the "increased risk" of disease, as such, is too speculative to be allowed, even if competent experts can be found to support such a claim. 4 E.g., Paoli I, 916 F.2d at 850-51; Potter, 25 Cal. Rptr. 2d at 569 n.15; Ayers, 525 A.2d at 304-08. There is no basis for treating a medical monitoring claim any differently. Such a claim requires, as an essential element, proof that the plaintiff is at increased risk of future disease. The speculative character of such proof is not mitigated by requiring, in addition, expert proof of other matters. An opinion that a currently healthy plaintiff requires special future medical monitoring is inherently speculative because it necessarily rests on a speculative premise: the existence of some small possibility – perhaps as little as a one-in-a-million chance – that because of a chemical exposure the plaintiff might years in the future develop a disease that might benefit from early detection and treatment. That an expert can put a present-day price tag on the "need" for future medical monitoring to detect such disease does not alleviate the dominant element of speculation. 4 An "increased risk" claim seeks recovery for the consequences of a future harm that may, but probably will not, come to pass. See Bocook v. Ashland Oil, Inc., 819 F. Supp. 530, 536 (S.D. W. Va. 1993). 18 The dangers of speculation in medical monitoring claims are especially severe because the opinion that a particular plaintiff needs future medical monitoring is not easily subjected to verification or falsification. The expert's opinion is neither an explanation of how scientific phenomena have occurred in the past nor a prediction of how they will probably occur in the future. Because the plaintiff is not currently sick, and will probably never develop any exposure-related illness, the expert has no responsibility to tie his opinion to objective reality. The opinion is pure say-so. As this Court has emphasized, “New York courts have been reluctant to embrace claims that rely on hypothetical theories or speculative assumptions about the nature of the harm incurred or the extent of plaintiff’s damages.” Ortega, 9 N.Y.3d at 81, 876 N.E.2d at 1196, 845 N.Y.S.2d at 780. Such claims create “the potential for vast, uncircumscribed liability.” Madden v. Creative Servs., Inc., 84 N.Y.2d 738, 746, 646 N.E.2d 780, 784, 622 N.Y.S.2d 478, 482 (1995). 5 In accordance with the traditional tort law principles that this Court has long followed to place reasonable and predictable limits on liability, this Court should decline to create a cause of action for medical monitoring in the absence of actual physical injury or symptomatic disease. 5 Cf. Bovsun v. Sanperi, 61 N.Y.2d 219, 230, 461 N.E.2d 843, 848, 473 N.Y.S.2d 357, 362 (1984) (adopting zone-of-danger rule as "circumscribed alternative" to "apparently sweeping liability" and as providing a "'reasonably objective' standard which will 'serve the purpose of holding strict rein on liability'"). 19 III. PERMITTING MEDICAL MONITORING CLAIMS BY ASYMPTOMATIC PLAINTIFFS WOULD DIVERT RESOURCES FROM THOSE WHO ARE ACTUALLY INJURED. The courts that have refused to recognize medical monitoring in the absence of a manifest injury have done so in part because such claims would divert necessary resources away from people suffering actual, current injuries in order to compensate those who fear future injuries that may never materialize. As these courts have recognized, such a result would distort the purpose of tort law. In Buckley, the United States Supreme Court explained that the "flood" of medical monitoring lawsuits described above would "potentially absorb[] resources better left available to those more seriously harmed," imposing significant costs on both the judicial system and the health care system. 521 U.S. at 442. The Court was troubled . . . by the potential systemic effects of creating a new, full- blown, tort law cause of action – for example, the effects upon interests of other potential plaintiffs who are not before the court and who depend on a tort system that can distinguish between reliable and serious claims on the one hand, and unreliable and relatively trivial claims on the other. The reality is that competing interests are at stake – and those interests sometimes can be reconciled in ways other than simply through the creation of a full-blown, traditional, tort law cause of action. Id. at 443-44 (citations omitted). By establishing "vast testing liability" in advance of the need for actual medical treatment, medical monitoring would also "adversely affect[] the allocation of scarce medical resources." Id. at 442. Other courts have recognized the legitimacy of this concern. As the Wood court explained, "defendants do not have an endless supply of financial resources. Spending 20 large amounts of money to satisfy medical monitoring judgments, will impair their ability to fully compensate victims who emerge years later with actual injuries that require immediate attention." Wood, 82 S.W.3d at 857. See also Ball, 755 F. Supp. at 1372 ("Allowing today's generation of exposed but uninjured plaintiffs to recover may lead to tomorrow's generation of exposed and injured plaintiff[s] being remediless."). As Defendant's brief argues, the wisdom of using the judicial system to provide medical monitoring (and to allocate limited medical resources) is rendered even more doubtful by the fact that the federal government has a task force currently looking at furnishing at-risk Americans with free and effective preventive screening. If the task force recommends use of the test that plaintiffs request here – LCDT screening for lung cancer – that test will be free for all at-risk smokers under the Affordable Care Act. See Br. of Defendant-Respondent Philip Morris at 9-10, 22-23. Cf. Buckley, 521 U.S. at 442-43 ("a traditional, full-blown ordinary tort liability rule would ignore the presence of existing alternative sources of payment, thereby leaving a court uncertain about how much of the potentially large recoveries would pay for otherwise unavailable medical testing and how much would accrue to plaintiffs for whom employers or other sources (say, insurance now or in the future) might provide monitoring in any event."); id. at 443 ("where state and federal regulations already provide the relief that a plaintiff seeks, creating a full-blown tort remedy could entail systemic costs without corresponding benefits"). 21 In sum, the creation of a new tort cause of action for medical monitoring in the absence of manifest injury or disease may "on balance cause more harm than good" (Buckley, 521 U.S. at 438) not only to the judicial system but also to the health care system, to plaintiffs already suffering from actual injury or disease, and to businesses and the economy. IV. THE RECOGNITION OF NEW CAUSES OF ACTION SHOULD BE LEFT TO THE LEGISLATURE. For all of these reasons and others, many courts have concluded that determining whether and in what circumstances a claim of medical monitoring should be permitted is a task for legislatures – not courts. Henry, 701 N.W.2d at 696 n.15. See also Wood, 82 S.W.3d at 857-58 (medical monitoring presents "significant public policy problems" and matters "best left to the legislatures"); Badillo, 16 P.3d at 440 ("[a]ltering common law rights, creating new causes of action, and providing new remedies for wrongs is generally a legislative, not a judicial, function"); Hinton, 813 So. 2d at 831 (quoting Buckley). Plaintiffs' attempt here to establish a new theory of liability – one that departs from established common law principles – is a task that is better directed to the Legislature. Issues as to whether and to what extent medical monitoring is warranted require the balancing of competing policy objectives, the allocation of scarce medical and financial resources, the resolution of complex medical and scientific debates and the consideration of cost effectiveness. As this Court has repeatedly held, a balancing of 22 the social or economic effects of a potential new cause of action cannot "safely be made without the kind of factual investigation which the Legislature and not the courts, is equipped for." Woods v. Lancet, 303 N.Y. 349, 355, 102 N.E.2d 691, 694 (1951); see also Murphy v. Am. Home Prods. Corp., 58 N.Y.2d 293, 302, 448 N.E.2d 86, 89, 461 N.Y.S.2d 232, 235-36 (1983) (policy considerations regarding new remedies "are best and more appropriately explored and resolved" by the Legislature). Here, the "special difficulties," Buckley, 521 U.S. at 441, presented by medical monitoring are underscored by the fact that even medical professionals often offer conflicting views about what diagnostic testing is necessary or desirable. See id. (there is often no scientific consensus as to what would be the appropriate medical regimen to monitor a targeted disease or condition); see also Hinton, 813 So. 2d at 831 (quoting Buckley). Furthermore, the medical consensus on such matters changes over time, and there may be "uncertainty among medical professionals about just which tests are most usefully administered and when." Buckley, 521 U.S. at 441. Yet, the asymptomatic plaintiffs in this case would have a jury decide whether they should be entitled to medical monitoring and what medical monitoring would be provided. Significantly, this Court has traditionally declined to "alter [its] long-settled rule[s]" and create new causes of action and has stated its "opinion that such a significant change in our law is best left to the Legislature." Murphy, 58 N.Y.2d at 300-01, 448 N.E.2d at 89, 461 N.Y.S.2d at 235. As the Court concluded in Murphy, 23 the Legislature, not the judiciary, has "infinitely greater resources and procedural means . . . to examine the variety of pertinent considerations . . . and to investigate and anticipate the impact of imposition of . . . liability" in recognizing a new and uncabined cause of action. Murphy, 58 N.Y.2d at 302, 448 N.E.2d at 89-90, 461 N.Y.S.2d at 236. Accordingly, as in Murphy and Woods, the Court should leave the complex policy questions presented in this case to the Legislature to resolve. CONCLUSION For the foregoing reasons, amici curiae respectfully urge this Court to answer the first certified question in the negative, declining to create an independent equitable cause of action for medical monitoring, and clarifying that New York tort law requires proof of an actual injury or harm, not a mere increased risk of injury in the future. DATED: October 4, 2013 QUINN EMANUEL URQUHART & SULLIVAN, LLP 51 MADISON AVENUE, 22ND FLOOR New York, New York 10010 Tel. (212) 849-7000 Fax (212) 849-7100 By Sheila L. Birnbaum Attorneys for Amici Curiae the American Chemistry Council and the American Petroleum Institute