Cost-Effectiveness Analysis in the Courts
Recent Trends and Future Prospects
Departures from the Professional Standard. On occasion, courts have deviated from the standard professional paradigm in medical liability cases. Two instances where courts have relied on CEA or resource constraints to establish a different direction are particularly interesting and instructive. Neither departure has had much doctrinal impact, but the cases suggest directions courts might take if CEA becomes widely implemented.
One of the very few medical liability cases to consider CEA in setting the standard of care is Helling v. Carey (519 P.2d 981 [Wash. 1974]).8 This case involved a physician's failure to provide a glaucoma screening test to a patient under forty years of age when professional custom was to screen only patients over forty because of the low incidence of glaucoma in persons under age forty. After the patient developed glaucoma, she sued the physician, arguing that since the screening test was relatively inexpensive and accurate, it should have been provided regardless of the prevailing professional custom. While the court did not explicitly rely on a CEA, it noted the test's low cost relative to potential benefits as a reason for overruling professional custom. As a result, some commentators have argued that the case represents the application of CEA in medical liability (see, e.g., Schwartz and Komesar 1978).
At the same time, commentators have criticized Helling on many dimensions (see, e.g., Wiley 1981).9 For our purposes, perhaps the most telling criticism is that the court essentially used its own calculation to require a more stringent standard of care than determined by professional custom (Schuck 1981). At least implicitly, the profession had factored CEA into deciding not to provide the test to those under forty. A few subsequent courts have followed the Helling analysis (see, e.g., Hood v. Phillips, 554 S.W.2d 160 [Tex. 1977]), but most have rejected its holding, retaining the professional custom model in establishing the standard of care.
A more nuanced departure from the standard model occurred in Hall v. Hilbun (466 So.2d. 856 [Miss. 1985: 872]), a case alleging negligence in postoperative care. The underlying issue was whether local or national standards of care should prevail. In considering that issue, the court discussed differences in resources across hospitals and geographical regions. In adopting the national standard, the court nevertheless distinguished between technical skills and knowledge, which should not vary across professionals, and resource availability, which varies substantially across institutions. The court determined that the duty of care would be "based upon the adept use of such medical facilities, services, equipment, and options as are reasonably available." Under this standard, for example, a physician practicing in a rural area would not be faulted for failing to use a CAT scan if the equipment were not reasonably available. Without saying so explicitly, the resource use-technical skill distinction could easily be expanded to incorporate CEA or CBA. Arguably, if resources are constrained, MCOs should be able to use CEA to determine the most efficient use of those resources. Unlike Helling, where the court substituted its judgment for the profession's, Hilbun retains the professional standard of care but explicitly permits the profession to factor resource constraints in setting the standard of care. So far, few courts have seized on this rationale to develop a bifurcated standard of care (Morreim 1987).10
Cost Containment and ERISA. Legal challenges to managed care's cost containment innovations cannot be fully understood without taking into account the courts' responses to the Employee Retirement Income Security Act (ERISA). ERISA covers health care benefits established by self-insured employers (with few exceptions, such as for governmental employees). When an ERISA plan contracts with an MCO to provide health care, the MCO is treated as being covered by ERISA.
Traditionally, states are responsible for regulating health care delivery, and litigation against health care providers is usually resolved under state law. Medical liability lawsuits are rarely heard in federal courts.11 ERISA alters the traditional approach by preempting state law, which means that state laws purporting to regulate health plans may not be enforced in any court (Nealy v. U.S. Healthcare, 711 N.E.2d 621 [N.Y. 1999]). In this context, state laws include legislation and regulations, such as those mandating particular benefit coverage, and most medical liability actions challenging MCO decisions to delay or deny care. Because ERISA limits the ability of state courts to hear these challenges, while simultaneously limiting a patient's legal remedies (i.e., damages), the result is to insulate cost containment initiatives from sustained legal challenges. Thus challenges to delayed or denied care by an ERISA—covered plan are usually preempted, meaning that the patient can only recover the amount of the denied benefit.12
The Supreme Court recently held that subscribers may not challenge managed care's financial incentives in court. In Herdrich v. Pegram (154 F.3d 362, 373 [7th Cir. 1998]; see also, 170 F.3d 683 [7th Cir. 1999]13), the lower court held that a patient could sue for breach of fiduciary duty when alleging that the physicians' financial incentives caused a deprivation of needed medical care. The Supreme Court reversed the decision in Pegram v. Herdrich (120 S. Ct. 2143 ), holding that challenges to the financial incentives should be resolved by the legislative branch and limiting the ability to bring breach of fiduciary duty cases.
Legal Challenges to Cost Containment Initiatives. Although there is very limited health care litigation directly raising or challenging the use of CEA, courts have begun to confront challenges to cost containment initiatives. The scholarly literature on how courts have responded to these challenges to date is relatively limited and reaches mixed conclusions.
Mark Hall (1988) first assessed early cost containment initiatives (such as prior authorization, physician payment incentives, and physician selection), adopted by hospitals (largely in a fee-for-service context) in the 1980s, and the courts' responses to them and concluded that cost containment innovations would not survive judicial scrutiny (see also, Anderson, Hall, and Smith 1998). Similarly, Gerard Anderson (1992) argued that courts have expanded their influence over health policy by, for example, overturning insurers' coverage decisions and favoring hospitals, as opposed to states, in Medicaid rate-setting cases under the Boren Amendment.14 Other commentators have also argued that courts have tended to side with individual patients against insurers in deciding whether expensive technologies are covered benefits (Ferguson, Dubinsky, and Kirsch 1993).
Haavi Morreim (1995) analyzed more recent judicial decisions and concluded that courts have become much more receptive to cost containment than Hall predicted. Morreim postulated that courts were resolving the tension between managed care policies that favor patient populations at the expense of individual access to services in favor of cost containment initiatives. In at least two cases, the courts made this trade-off explicitly (Doe v. SEPTA, 72 F.3d 1133 [3d Cir. 1995]; Creason v. State Department of Health Services, 957 P.2d 1323 [Cal. 1998]). Likewise, one of the authors (PDJ) analyzed a range of challenges to cost containment initiatives and concluded that courts are indeed deferring to the market and to legislative policy favoring cost containment (Jacobson 1999). In response, Hall (1999) criticized this analysis for ignoring (or minimizing) instances where courts have impeded cost containment objectives, especially in cases where MCOs are not protected by ERISA preemption.
In part, the latter dispute is over the speed of judicial internalization of cost constraints and in part over what the trends really show. In our view, the courts are following the traditional incremental manner in which the common law adapts to changes in the underlying social and economic environment. Where we view the courts as gradually incorporating cost containment into their decisions, Hall seems to advocate for a much more radical transformation than courts generally follow and thus interprets the changes that have occurred as being minimal (Jacobson 1999; Jacobson and Pomfret 1999). Ironically, the Supreme Court's opinion in Pegram v. Herdrich confirms both views. The decision clearly accepts the role of cost containment as a legitimate objective, confirming the trends noted by Morreim and Jacobson, but also forecloses further ERISA challenges to financial incentives, thus accelerating the transformation Hall supports.
One might also argue that the Pegram case makes it easier for MCOs to apply CEA. If so, how it is applied by payers and providers is likely to be a vital issue. For example, in Kawaauhau v. Geiger (172 B.R. 916, 923 [Bankr. E.D. Mo. 1994]),15 a physician prescribed oral penicillin instead of the more effective intravenous penicillin because he alleged that the patient had expressed a desire to keep costs low. At trial, the patient denied that this exchange occurred, and there was no evidence that the physician informed the patient of the consequences of the lower-cost approach. While the physician did not use CEA in making the decision, the court's response to the explicit trade-off between cost and clinical effectiveness is cautionary: "administering penicillin orally because [it] costs less . . . despite the possible consequences, . . . offends even a person lacking formal medical training." Nevertheless, Pegram potentially changes the litigation environment in ways that will favor the use of CEA.
Medical Necessity Decisions. Neither CEA nor costs generally have played a significant role in benefit denial or medical necessity disputes. Most of these cases are decided based on interpretations of contractual language and are highly fact-specific determinations (Singer et al. 1999).16 Courts may discuss cost concerns, but cost or CEA rarely forms the basis of the decision, at least in part because health care contracts rarely include when and how specific techniques (such as CEA) will or should be applied (ibid.).17 To be sure, medical necessity provisions do not inherently exclude CEA, but a patient might challenge its use if not informed of how it might influence clinical decisions.18
In the ERISA context, a plan administrator's determination of medical necessity is given deference if the benefit contract specifically gives the plan administrator discretion in approving clinical decisions (Dowden v. Blue Cross & Blue Shield of Texas, Inc., 126 F.3d 641, 644 ([5th Cir. 1997]). The deference is not absolute and varies inversely in intensity with the financial incentives under which the plan administrator operates (Firestone Tire & Rubber Co. v. Bruch, 489 U.S. 101, 115 ). Courts have not yet decided the issue of what deference would be granted if plan administrators were to rely on CEA in medical necessity determinations.
Product liability litigation has been heavily influenced by CEA/CBA concepts. An explicit risk-utility analysis (RUA) has become the dominant form of analysis for resolving product liability cases (Wade 1973; see also Saratoga Fishing Co. v. Marco Seattle Inc., 69 F.3d 1432, 1440 [9th Cir. 1995]). RUA evolved from the Hand formula proposed originally in Carroll Towing (see, e.g., Saratoga Fishing Co., 69 F.3d 1432; Liriano v. Hobart, 132 F.3d 123,131 [2d Cir. 1998]) and is used in product liability litigation, especially design defect cases, to weigh the benefits of a product against its risks. Among other aspects, RUA considers the usefulness or desirability of a product; safety aspects of a product; availability of substitutes; and the possibility of improving safety without decreasing usefulness or increasing cost (Epstein 1987). The multifactorial nature of RUA makes it difficult to apply. In fact, a 1997 computer survey of cases involving product-defect balancing tests in prescription drug cases showed that courts had adopted numerous balancing tests, not all of which were compatible with each other or with the Restatement (Second) of Torts (Owen 1997).
Practically speaking, the effect of RUA has been to bring strict liability cases for product design defects closer to the standards used in traditional negligence cases. When striking a balance between risk and utility, at some point the consideration of cost must come into play, and some courts have ruled that CEA is an integral part of RUA. In Proes v. Honda Motor Co. (31 F.3d 543 [7th Cir. 1994]), for instance, the plaintiff claimed she had been thrown from her car during an accident due to the failure of a defectively designed seat belt (see also, Prentis v. Yale Manufacturing Co., 427 Mich. 670, 688 [Mich. 1984]). The court noted that to prove the defendant's negligence, the plaintiff needed to show that another seat belt design "not only could have prevented the injury but also was cost-effective under general negligence principles" (i.e., that there were no other alternatives that were more cost-effective).
Despite this case, MCOs may rightly be concerned about juror responses to CEA as opposed to how appellate judges will ultimately incorporate CEA into the standard of care. Two examples demonstrate the concern.
In the first instance, Grimshaw v. Ford Motor Co. (119 Cal. App. 3d 757, 174 Cal. Rptr. 348 [Cal. App. 1981]),19 the plaintiff was a passenger in a 1972 Pinto when the car stalled on a freeway and was subsequently hit from behind. The force of the rear impact caused the gas tank to explode, severely burning the plaintiff and killing the driver. The plaintiff sued on the basis of negligence and strict liability for product design defects. During the trial, a CEA dealing with the safety of the Pinto gas tank surfaced. According to Ford's analysis, 180 burn deaths could be avoided if $137 million were spent on safety enhancements. Ford placed the value of each of the 180 lives at $200,000, for a total of $36 million (Green 1997; The T. J. Hooper, 60 F.2d 737 [2d Cir. 1932]). Total net savings realized by delaying safety improvements was $101 million. The CEA was never allowed into evidence at trial, and the jury never saw it. However, the jury heard testimony that pointed to the existence of the CEA, and it was made clear that Ford had weighed human lives against its profits (Grimshaw, 119 Cal. App. 3d at 813). The jury regarded this evidence as a "smoking gun" indicating Ford's culpability. The jury found for the plaintiff and awarded $125 million in punitive damages. Commenting on the defendant's behavior, the court had this to say:
Through the results of the crash tests, Ford knew that the Pinto's fuel tank and rear structure would expose consumers to serious injury or death in a 20-to 30-mile-per-hour collision. There was evidence that Ford could have corrected the hazardous design defects at minimal cost but decided to defer correction of the shortcomings by engaging in a cost-benefit analysis balancing human lives and limbs against corporate profits. Ford's institutional mentality was shown to be one of callous indifference to public safety. There was substantial evidence that Ford's conduct constituted "conscious disregard" of the probability of injury to members of the consuming public.
More recently, a jury severely punished General Motors for using CEA to justify not pursuing safety-oriented design changes concerning the location of the gas tank in certain car models (Pollack 1999: A7). In July 1999, the jury awarded $4.8 billion in punitive damages for severe burns following the explosion of a car's fuel tank in a rear-end collision (although it is likely that the verdict will be substantially reduced on appeal). According to published reports, the trial testimony showed that GM could have moved the fuel tank at a cost of $8.59 per car. An internal memo written by a GM engineer estimated that fuel tank fires cost GM only $2.40 per vehicle. In a subsequent statement, GM argued that the fuel-tank placement met all regulatory standards. But "jurors told reporters that they felt the company had valued human life too lightly. 'We're just like numbers, I feel, to them,' one juror [said]" (ibid.). As in the Grimshaw case, the jury treated the internal memo as a smoking gun of culpability.
These cases suggest that MCOs face a daunting challenge to use CEA without conveying the impression that they treat individual lives cavalierly. As discussed below, internal memos such as those cited in the GM case are likely to expose MCO officials and physicians to withering cross-examination.20
CBA and CEA are used extensively in government rulemaking. For example, Executive Order No. 12,866 (3 Code of Federal Regulations 638 )21 requires regulatory agencies to conduct cost-benefit analysis on proposed regulations to ensure "that the benefits of the intended regulation justify its costs." Agencies are expected to consider "both quantifiable measures . . . and qualitative measures of costs and benefits that are difficult to quantify, but nevertheless essential to consider" and then select the regulatory approach "that [maximizes] net benefits (including potential economic, departmental, public health and safety, and other advantages; distributed impacts; and equity)." Once a regulatory course of action is chosen, agencies are also required to conduct a CEA to ensure the regulation is designed in the "most cost-effective manner to achieve the regulatory objective." The problem is that the executive order does not mandate a singular decision-making metric.
Environmental and occupational safety and health regulation are the areas most likely to invoke CEA, in part because of the nature of these issues and in part because Congress determines what standard an agency should use in the regulatory process.22 For example, Congress prohibits or limits CBA under the Clean Air Act but allows costs to be considered under the Superfund program. Other environmental statutes, such as the Toxic Substances Control Act (TSCA) and the legislation establishing the Occupational Safety and Health Administration (OSHA), mandate amount to risk-utility standards, so that regulators must inherently balance risk and cost. None of the statutes instructs the regulators on how to conduct CBA or CEA, nor do they prohibit an agency from using these analyses. Since affected industries always produce economic analyses, which agencies are required to consider during the rule-making process, the reality is that the agencies almost always must examine the costs and benefits of any given regulation.
The courts generally defer to regulatory agency expertise, but agency decisions must be well reasoned and not "arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with a law" (Administrative Procedures Act, 5 United States Code 706[A]). (See also, Competitive Enterprise Institute v. NHTSA, 956 F.2d. 321, 327 [D.C. Cir. 1992]). Agency actions must be supported by substantial evidence when the record is viewed as a whole, and agencies must explain the rationale and factual basis underlying their decisions.23 Within that framework, agencies have a great amount of discretion when constructing CBAs and CEAs during the rule-making process. The scope of review that courts are afforded over agency decisions is narrow, and courts must not substitute their own judgment for that of the agency, particularly in matters requiring technical expertise. Thus one court noted the following in reference to regulatory agency CBAs:
Such cost-benefit analyses epitomize the types of decisions that are most appropriately entrusted to the expertise of an agency; certainly appellate briefs and arguments would ill-equip a court that would seek to balance for itself the myriad considerations involved in any complex administrative policy decision. (Office of Communication of the United Church of Christ v. FCC, 707 F.2d 1413, 1440 [D.C. Cir. 1983])
When courts find a regulatory decision of an agency to be arbitrary or capricious, or otherwise in violation of the law, the regulation is remanded to the agency for further consideration. At no point do the courts usurp the ultimate decision-making powers of regulatory agencies, and there seems to be no general desire on the part of the courts to do so. Usually, courts focus on reviewing the process agencies use to reach a final conclusion, not the conclusion itself.
But courts do not hesitate to question the methodology and the reasoning used by agencies in constructing cost-benefit analyses. In Corrosion Proof Fittings v. EPA (947 F.2d 1201 [5th Cir. 1991]), the court was highly critical of the CBA methodology used by the EPA to justify a complete regulatory ban of asbestos. The court was "troubled" by the EPA's strategy of discounting the future calculated costs while simultaneously failing to discount future calculated benefits, thus significantly skewing the analysis and calling its validity into question. The court was also bothered by the EPA's "cavalier" attitude toward manipulating its CBA data to support its preconceived position on banning asbestos, and also criticized the agency's failure to consider the lack of substitute products and the impact that the ban would have on the industry and consumers.
Some courts have gone even further in arguing that regulatory activity must take into account the possibility that regulations may improve safety in one area but reduce it in another. Known conceptually as "richer is safer" or health-health trade-offs, the notion is that regulations imposed to save lives can also have the effect of costing lives, either through lost jobs or through substitution of less safe products. The problem occurs when reducing one health risk simultaneously increases another health risk, or prices some consumers out of the market for safer products (see, e.g., Sunstein 1996).24
Take, for example, challenges to fuel economy standards. In Competitive Enterprise Institute v. NHTSA (956 F.2d 321 [D.C. Cir. 1992]), a group of national automobile lobbyists petitioned the National Highway Traffic and Safety Administration (NHTSA) to lower the pollution emission standards for cars built in 1990. The NHTSA had the authority to relax the standards but declined to do so based in part on an agency CBA indicating that the higher emission standards produced a total net benefit. The plaintiff filed suit claiming the agency had failed to assess the impact of additional automobile accident fatalities that were being caused by downsizing cars in response to the stricter emission standards (because larger, more expensive cars have better safety records). The court was highly critical of the reasoning used by the NHTSA throughout its rule-making process but was most distressed at the agency's failure to include the additional fatalities in its cost-benefit analysis, stating:
Even if the 27.5 mpg standard for model year 1990 kills "only" several dozen people a year, NHTSA must exercise its discretion; that means conducting a serious analysis of the data and deciding whether the associated fuel savings are worth the lives lost. When the government regulates in a way that prices many of its citizens out of access to large-car safety, it owes them reasonable candor. If it provides that, the affected citizens at least know that the government has faced up to the meaning of its choice. The requirement of reasoned decision-making ensures this result and prevents officials from cowering behind bureaucratic mumbo-jumbo. (Competitive Enterprise Institute, 956 F.2d at 327) Following remand to the NHTSA, the agency considered the safety implications of higher fuel economy standards. Although still skeptical, a different three-judge panel upheld the NHTSA, ruling that the agency's action was adequately supported by the record (Competitive Enterprise Institute v. National Highway Traffic Safety Administration, 45 F.3d 481 [D.C. Cir. 1995]).
Applying the health-health trade-offs question to managed care, if this reasoning were to be followed, MCOs might be able to argue successfully that the need to preserve plan assets for the patient population justifies CEA. That is, CEA is the most effective mechanism for making trade-offs between the needs of individual patients and the patient population.
The judicial responses to CEA in general, medical, and product liability and government regulatory cases show mixed results, but some potentially interesting comparisons. Perhaps most revealing is the distinction between the government regulation and product liability cases. In the former, the courts are quite receptive to the government's application of CEA and, in some instances, even encouraging the government to be more aggressive in using it to justify regulatory policies. But in the product liability area, jurors are severely punishing private parties for their explicit use of CEA in making product design choices and trade-offs.
One possible explanation for this disparity may be that government agencies are entitled to considerable judicial deference while private parties are not. Courts give deference to other branches of government that they are not compelled or inclined to provide to private parties. Because courts will review MCO CEAs under common law principles, the statutory framework of government regulation cases will not apply. Nevertheless, it provides some insight into how courts view CEA and CBA and suggests that CEA is judicially viable. For one thing, judges have not reflexively opposed CBA and CEA. For another, when transposed into a common law context, courts may well defer to the market, as argued earlier. If so, a potential strategy is to work through Medicare/Medicaid managed care to introduce CEA and allow courts to develop a standard of care that defers to congressional policy regarding CEA. Then, CEA could migrate to nongovernmental programs in a manner that avoids the "smoking gun" problem. In view of the Supreme Court's strong endorsement of managed care's cost containment strategies, this approach seems plausible.
A second interesting comparison emerges between the general negligence and medical liability cases. Whatever one may think of deference to custom as a liability standard, the courts' willingness to use CEA/CBA in these cases can just as easily lead to a higher standard of care as to a lower standard. There is no guarantee that allowing costs to be factored into the standard of care will reduce the level of care provided. Ironically, CEA or CBA can be used by the courts to require the latest technology or a more stringent (i.e., costly) standard of care. This negates the assumption that by incorporating CEA into medical decision making, MCOs will be able to provide lower levels of care where the benefits are commensurate with the costs.
These areas also take differing approaches to setting the standard of care. In general negligence cases, the Hand formula, when used, essentially establishes the standard of care. The same applies to RUA in design-defect product liability cases. Yet in medical liability litigation, costs have not been factored into setting the standard of care and the closest analog, clinical practice guidelines, have been used as one piece of evidence for the jury to weigh.
Our analysis leaves several important questions unaddressed. First, how extensively have the courts used CEA/CBA/RUA in reality, either to establish the standard of care or as one piece of evidence to determine industry custom? When scholars discuss the Hand test, is it more of an abstraction or an actual analytical tool used to resolve cases? In product liability cases, RUA seems to have become the standard of care, and perhaps in general negligence cases as well. But our tentative conclusion is that trial courts do not often use CEA when instructing juries. They still give juries instructions based on the reasonable person standard, even in product liability cases. If so, are juries actually using CEA or CBA to establish liability standards? Law and economics scholars contend, controversially, that this is exactly what jurors do when they determine what constitutes reasonable care, regardless of the judge's specific instructions. While the theory of negligence as equivalent to efficiency is ascendant in academia, it does not appear to be matched by how judges speak to juries. Unless judges make it explicit that juries should use efficiency criteria (including CEA) to determine whether the standard of care was met, the full force of the Hand test is unlikely to be attained.
Second, when used, does the CEA/CBA/RUA benefit plaintiffs or defendants? If jurors are not instructed to use it, then it would be difficult to discern which side benefits. Two nonmutually exclusive possibilities come to mind. Some studies suggest that jurors exhibit hindsight bias, where people overestimate the ex ante risks and underestimate the ex ante benefits when viewed after an injury occurs (ex post at the trial) (Hastie and Viscusi 1998). When confronted ex post with real-life victims, jurors may overestimate the risks than when presented ex ante with hypothetical examples. For instance, jurors might assume that the patient might have lived if the MCO had only provided the treatment. If correct, this suggests that plaintiffs would benefit more because the CEA ratio would understate the costs and overstate the benefits, hence favoring liability. As argued above, the juror responses to CEA in product liability cases are not promising for explicit application of CEA as a cost containment approach. However, Richard Lempert (1999) raises serious doubt about the validity and likelihood of significant hindsight bias. Lempert also argues that judges may not respond differently than juries and that juries may well be skeptical of plaintiffs' contentions and may not punish defendants.25
At the same time, jurors may respond differently to CEA as opposed to CBA. When framed in terms of effectiveness, jurors may understand that what is at stake is to provide the most effective care at an affordable price. A focus on effectiveness may resonate with jurors as being the dominant concern, not costs. For example, if defendants show that they used CEA to place a higher value on reducing harm, juries may react more favorably. In contrast, jurors may think of CBA as just a cost- savings mechanism and react negatively. Therefore, how the evidence is presented, and the skill of the attorney, may determine the jury's response, since the same item could be favorably interpreted for either side.
Third, contract provisions could provide a distinction between the product liability cases and CEA in health care. Health insurers could bargain to include CEA in the health benefits contract, which could well alter the judicial outcome by forcing patients to sue for breach of contract rather than for tort damages (or by permitting courts to dismiss negligence claims). So far, there is no evidence that CEA is an explicit term in many health insurance contracts. If included, one potential difference from the product liability cases would be that when buying a car, there is no contractual term describing how CEA will be conducted.
Fourth, why do courts seem to have integrated CEA/CBA/RUA relatively easily in negligence and government regulation cases, while similar techniques have engendered considerable jury hostility in product liability cases? The answer to this question may provide the key to the potential integration of CEA into managed care decisions.
Fifth, what role might the classic divide between statistical lives and identified lives play in these case comparisons? In the government regulation cases, the emphasis is population statistics, not identified individuals. In the other areas covered, juries might identify with the named individual who brings the litigation and testifies.