■n Marc E. Williams is the Office Managing Partner for the West Virginia office of Nelson Mullins Riley & Scarborough, LLP. His practice focuses on the trial and appellate defense of commercial litigation, toxic tort and class actions. He has had primary responsibility for over 100 jury trials and appeals during his career. He is a past president of DRI and serves on the executive committee and board of the National Foundation for Judicial Excellence.
When Law and Science Collide
The evolution of the law has
followed a parallel track with
developments in social justice,
societal mores and scientific advancements. What is acknowledged as established law today may have been unimaginable 100 years ago. And while we have seen immense scientific advance-ments over the last century, the law has always taken a cautious approach to sci-ence. As Judge Posner noted, “Law lags science, it does not lead it.” Rosen v. Ciba Geigy, 78 F.3d 316 (7th Cir. 1996).
The measures by which the law addresses the admissibility of scientific evidence have also developed and changed as science has become more adept in evaluating whether a scientific assertion was reasonably reli-able. Over the years, the Frye test, the Fed-eral Rules of Evidence and the Supreme Court’s decision in Daubert v. Merrell Dow Pharmaceuticals, 509 U.S. 579 (1993), have dealt with this sticky question of whether science would support the allegations made by a party in court. And the line demark-ing reasonable reliability has shifted as scientists made new discoveries. Recently, however, some jurisdictions have turned the idea that law lags behind science on its head by recognizing a cause of action that not only ignores hundreds of years of estab-lished tort jurisprudence, but has raced ahead of the science that underpins that very cause of action.
A claim for medical monitoring, whether as a separate category of damages or as a distinct cause of action, stands apart from other claims in toxic tort litigation because of its inherent inconsistency with the bed-rock principle of the tort system that some-one must have suffered harm to recover damages from a tortfeasor. A medical mon-itoring claim only requires the potential for future harm to expose a defendant to liability. In the jurisdictions that recog-nize it, a medical monitoring claim enti-tles a plaintiff who has been exposed to
The Scientific Case Against Medical MonitoringBy Marc E. Williams
a substance that could cause a latent dis-ease to receive compensation for the cost of the periodic diagnostic tests necessary to determine if the disease has manifested. As is frequently the case in mass tort cases, the prospect of paying large, future damages to a large number of plaintiffs raises the financial stakes significantly. When plain-tiffs are asymptomatic and only seek dam-ages to test for the possibility of discovering injuries that have not yet become manifest, a defendant is likely to wonder what hap-pened to the traditional concepts of duty, breach, causation and damages.
The policy reasons behind medical mon-itoring are benevolent. The fear that an in-dividual has that he or she will contract a disease caused by the fault of another is offset by the tortfeasor paying for periodic testing to find out if the individual has de-veloped the disease. While it is acknowl-edged, if not understood, that the question of whether the plaintiff actually gets the disease is irrelevant, there is an inevitable intersection between the tort system as a reflection of public policy and medicine as a reflection of the science behind early de-tection and screening. For a physician or a public health advocate, diagnostic testing, medical screening and medical surveillance raise issues of efficiency, effectiveness and balancing competing potential harms to a patient that courts do not usually consider when they are asked to recognize medical monitoring claims. Juxtaposing medical surveillance science and the law of med-ical monitoring illuminates their incom-patibility and can sometimes lead to folly when legal policy makers delve into public health issues despite their best intentions.
The History of Medical MonitoringIt is “Hornbook” law that a plaintiff cannot recover in tort without an existing injury. With the advent of the modern toxic tort claim, however, sometimes plaintiffs who have been exposed to toxic substances as a result of the fault of others have been as-ymptomatic or have tested negative for con-ditions attributable to exposures to those substances. With a latent disease, if science can show or infer a link between prior ex-posure and future illness, it is legitimate to ask if an injured plaintiff might seek com-pensation from a torfeasor responsible for
causing that plaintiff to bear an increased risk associated with the disease.
It is generally accepted that the first court to find that plaintiffs could recover medical monitoring expenses either as a category of damages or as a separate claim was the decision of the District of Colum-bia Circuit in Friends For All Children, Inc.
v. Lockheed Aircraft Corp., 746 F.2d 816 (D.C. Cir. 1984). Although the case did not involve a chemical exposure, the plaintiffs in Friends For All Children sought recov-ery for the cost of periodic medical testing because they had an increased risk of devel-oping a neurologic disorder called Minimal Brain Dysfunction.
Since the decision in Friends For All Chil-dren and over the last quarter century, var-ious courts have considered the availability of a cause of action for the costs associated with periodic screening to detect the pres-ence of a latent disease. While standards vary from state to state, generally to re-cover for a claim for medical monitoring a plaintiff must demonstrate that he or she has been exposed to a hazardous substance caused by the conduct of the defendant, he or she bears an increased risk of a latent disease due to that exposure, and a medical monitoring program exists to detect that la-tent disease. In re: Paoli PCB Litigation, 916 F.2d 829 (3d Cir. 1990); Bower v. Westing-house, 522 S.E.2d 424 (W.Va. 1999); Potter v. Firestone Tire & Rubber Co., 863 P.2d 795 (Cal. 1993). Further, in Potter v. Firestone Tire, the court set out four policy reasons why courts should allow individuals to re-ceive compensation for medical monitoring.
• “An important public health interest” supports “fostering access to medical testing for individuals whose exposure to toxic chemicals creates an enhanced risk of disease, particularly in light of the value of early diagnosis and treat-ment” for individuals with diseases. Pot-ter, 863 P.2d at 824.
• Permitting medical monitoring claims “deters irresponsible discharge of toxic chemicals by defendants.” Id.
• “The availability of a substantial remedy before the consequences of the plaintiffs’ exposure are manifest may also have the beneficial effect of preventing or miti-gating serious future illnesses and thus reduce the overall costs to the responsi-ble parties.” Id.
• It would create inequities if “an individ-ual wrongfully exposed to dangerous toxins, but unable to prove that can-cer or disease is likely” has to pay for “clearly reasonable and necessary” med-ical monitoring. Id.Through the early 1990s, most courts
that considered the viability of medical monitoring claims allowed the claims to proceed. The decision of the United States Supreme Court in Metro- North Commuter Railroad Company v. Buckley, 521 U.S. 424 (1997), however, slowed expansion of medical monitoring claims. In Buck-ley, the Court declined to recognize med-ical monitoring as a separate tort cause of action under the Federal Employers’ Lia-bility Act (FELA). Writing for the court, Justice Breyer noted several reasons why the Court was not ready to open the flood-gates to a new claim. One important policy reason was that judges and juries would have difficulty judging when medical sur-veillance was necessary if scientists dis-agreed on the extent to which surveillance was appropriate or if they disagreed about whether it was in a patient’s best interest. Buckley, 521 U.S. at 441–42; see also, Her-bert L. Zarov, et al., A Medical Monitoring Claim for Asymptomatic Plaintiffs: Should Illinois Take the Plunge? 12 DePaul J. Health Care L. 1 (2009) (recommending that Illi-nois should not recognize the claim).
Most recently, courts in several states, including Alabama, Kentucky, Michi-gan, Mississippi, Nevada and Oregon, have adopted Justice Breyer’s reasoning in
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The efficiency and
effectiveness of the
monitoring plan are generally
not considered by courts
in adopting a medical
monitoring program.n
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Medical Monitoring RecoveryJurisdictions without law on medical monitoring recovery include Alaska, Hawaii, Idaho, Iowa, Maine, Maryland, Montana, New Hampshire, New Mexico, Puerto Rico, South Dakota, Wisconsin and Wyoming.
Jurisdictions with Divided Law on Medical Monitoring RecoveryJurisdictions with divided law on medi-cal monitoring recovery include Delaware, Illinois, Indiana and New York. James M. Beck and Mark Hermann, Medical Moni-toring—Another 50 States Survey, Drug and Devise Law, (April 15, 2009), http://drugand-devicelaw.blogspot.com/2009/04/medical-moni-toring-another-50-state.html.
Some states that have rejected medi-cal monitoring claims have done so based on their jurisprudence requiring the exis-tence of a current injury to allow recovery. Wood v. Wyeth- Ayerst Labs, 82 S.W.3d 849 (Ky. 2002); Phillip Morris Inc. v. Angeletti, 752 A.2d 200 (Md. 2000); Badillo v. Amer-ican Brands, Inc., 16 P.3d 435 (Nev. 2001).
West Virginia Rejects Science in Recognizing Medical Monitoring RecoveryWest Virginia has the most liberal standard for medical monitoring recovery. In Bower v. Westinghouse, 522 S.E.2d 424 (W.Va. 1999), the Supreme Court of Appeals of West Virginia recognized a cause of action for medical monitoring that requires six elements for recovery:
[T]he plaintiff must prove that (1) he
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Some states that have
rejected medical monitoring
claims have done so based on
their jurisprudence requiring
the existence of a current
injury to allow recovery.n
Buckley to reject claims that would have essentially established a cause of action for medical monitoring under state law. Court recognition that science may be at odds with the law has deterred expan-sion of medical monitoring recovery, but what about in jurisdictions where courts have already recognized recovery for med-ical monitoring? In those jurisdictions, a defense lawyer must assert a factual and legal defense beyond the normal challenges to exposure and causation. While the tra-ditional way of defending these claims has been to focus on dose/response and to mine the scientific literature for help in contest-ing causation, a practitioner should also consider whether the scientific commu-nity actually recommends or approves of a proposed monitoring plan. It will become clear upon investigation that the issues of the efficiency and effectiveness of the mon-itoring plan are generally not considered by courts in adopting a medical monitor-ing program.
Medical Monitoring Recovery by JurisdictionCurrently, 14 jurisdictions recognize claims seeking recovery for medical monitoring and 23 do not. Some jurisdictions have not considered the issue, while some jurisdic-tions have divided law.
Jurisdictions That Recognize Medical Monitoring RecoveryToday, 14 jurisdictions recognize recovery for medical monitoring through statute, court decisions or Erie- educated guesses. These jurisdictions are Arizona, Califor-nia, Colorado, District of Columbia, Flor-ida, Guam, Massachusetts, Missouri, New Jersey, Ohio, Pennsylvania, Utah, Vermont and West Virginia.
Jurisdictions That Do Not Recognize Medical Monitoring RecoveryJurisdictions that do not recognize med-ical monitoring claims include Alabama, Arkansas, Connecticut, Georgia, Kansas, Kentucky, Louisiana, Michigan, Minne-sota, Mississippi, Nebraska, Nevada, North Carolina, North Dakota, Oklahoma, Ore-gon, Rhode Island, South Carolina, Ten-nessee, Texas, Virginia, the Virgin Islands and Washington.
or she has, relative to the general pop-ulation, been significantly exposed; (2) to a proven hazardous substance; (3) through the tortious conduct of the defendant; (4) as a proximate result of the exposure, plaintiff has suffered an increased risk of contracting a serious latent disease; (5) the increased risk of disease makes it reasonably necessary for the plaintiff to undergo periodic diagnostic medical examinations dif-ferent from what would be prescribed in the absence of the exposure; and (6) monitoring procedures exist that make the early detection of a disease possible.
Bower, at 432. The court found that it was not necessary for a plaintiff to show that a treatment actually exists for the latent dis-ease that was the subject of the monitor-ing. The court also refused to require that a plaintiff actually use awarded damages to purchase the periodic medical tests that he or she argued that he or she needed.
Recently, the Supreme Court of Appeals of West Virginia revisited Bower in review-ing a $381,000,000 class action toxic tort verdict. Perrine v. E. I. DuPont de Nemours and Co., 694 S.E.2d 815 (W.Va. 2010). Of that total verdict, $191,000,000 was for medical monitoring for a the class of residents who lived in the vicinity of a smelter plant in rural West Virginia and who alleged that they suffered arsenic, cadmium and lead contamination. The medical monitoring plan submitted during the trial recom-mended that the class members undergo regular CT scans. On appeal, the West Vir-ginia State Medical Association took the unusual step of appearing as amicus cur-iae for the express purpose of stating con-cerns about the potential negative health consequences that the medical monitoring plan posed to the plaintiffs. The medical association argued that repeatedly sub-jecting asymptomatic patients to CT scans was inadvisable and would increase the risk that they would develop cancer. In the decision upholding most of the verdict, the Supreme Court of Appeals of West Virginia flatly rejected considering the possible neg-ative effects that the medical monitor-ing plan could have on the class members: “Notably, this Court has previously disap-proved of the argument that medical mon-
itoring should be rejected due to its risk of harm.” Perrine, at 875 n.66.
What is unclear from the West Vir-ginia Bower and Perrine decisions is the effect that attacking a plaintiff’s expert’s recommended medical monitoring pro-tocol on Daubert or similar state-based grounds would have in jurisdictions across the country in medical monitoring recov-ery cases. It would be a mistake to read the holding in Perrine as meaning that a defense attorney cannot introduce any evidence of a risk associated with a testing protocol during a trial. For instance, if the recommended monitoring plan includes medical tests that experts in the field do not rely on or that they do not recommend for diagnosing the latent disease, introducing that evidence should trigger a court’s gate- keeping function as it would with any other unreliable expert testimony.
The Science of Medical SurveillanceMedical surveillance is well established in science and public health. Private indus-try, public health agencies and federal rule makers have adopted medical surveillance protocols, usually for workers exposed to environmental toxins in occupational set-tings. See 29 C.F.R. 1910.120 (medical sur-veillance required for certain classes of workers).
The National Institute for Occupational Safety and Health (NIOSH) has published a series of Current Intelligence Bulletins that review issues related to occupational exposure to a myriad of substances, in-cluding asbestos, benzene, chromium and the aldehydes. Current Intelligence Bul-letins, NIOSH Publications and Bulletins, http://www.cdc.gov/niosh/pubs/cib_date_desc_ nopubnumbers.html. While some of these pub-lications are dated and need updating to reflect new research, they are an impor-tant source of information. They not only review the state of the research about expo-sure to these substances at the time of pub-lication, but they also discuss exposure limit recommendations and standards. Of particular interest to those studying medical monitoring is the review of the literature for the purpose of making rec-ommendations on medical surveillance for workers who are exposed to a substance.
In one bulletin, the agency reviewed
the carcinogenicity of acetaldehyde and malonaldehyde. NIOSH, Carcinogenicity of Acetaldehyde and Malonaldehyde, and Mu-tagenicity of Related Low- Molecular- Weight Aldehydes, NIOSH Current Intelligence Bul-letin 55 (September 1991), available at http://www.cdc.gov/niosh/91112_55.html. While not-ing the potential carcinogenicity of the alde-hydes based on animal studies, the bulletin also noted that their carcinogenicity in hu-mans had not been studied. When evaluat-ing possible medical surveillance of workers exposed to these aldehydes, NIOSH rec-ognized that screening effectiveness was a critical factor in determining whether to recommend surveillance. Ultimately, NIOSH did not recommend routine screen-ing for workers despite evidence that expo-sure may target the areas of the screening. NIOSH recognized that medical surveil-lance should be evaluated in light of the ef-fectiveness of the tests, the accuracy of the tests, and the likelihood of good outcomes from treatment. Id.
From a scientific standpoint, medi-cal monitoring or medical surveillance is defined as the application of a medical test to detect a latent disease in an asymp-tomatic patient. Medical monitoring may have benefits, but it also has the potential to be not just ineffective but also harm-ful. Thus, from a scientific standpoint, an appropriate medical surveillance or med-ical monitoring program must take into account not only the effectiveness of the prescribed tests but the risk associated with the tests. Victor Schwartz, et al., Medical Monitoring: The Right Way and the Wrong Way, 70 Mo. L. Rev. 349 (2005); Arvin Maskin, et al., Medical Monitoring: A Via-ble Remedy for Deserving Plaintiffs or Tort Law’s Most Expensive Consolation Prize? 27 Wm. Mitchell L. Rev. 521 (2000); Robert I. Roth and Ted Dunkelberger, Influence of Evolving Diagnostic Technologies, For The Defense 15–17 (August 2008).
A medically acceptable medical moni-toring program for an individual exposed to a toxic substance must determine that (1) detecting the latent disease early would benefit the individual, (2) the proposed diagnostic testing would pose low risk of false- positive or false- negative test results, and (3) clinical trials have demonstrated that proposed tests would likely detect the
latent disease early. U.S. Preventive Serv-ices Task Force (USPSTF), Guide to Clini-cal Preventive Services, 2nd Edition (1996).
Accuracy of a testing program and the potential for adverse, sometimes cata-strophic consequences of inevitable false- positive or false- negative results must be evaluated either by evidence of a controlled clinical trial of the test or by quantita-tive decision- modeling techniques. Chris-topher P. Guzelian, et al., A Quantitative Methodology for Determining the Need for Exposure- Prompted Medical Monitoring, 79 Ind. L.J 57 (2004).
In addition to guarding against the risks associated with collateral damage to a plaintiff from monitoring tests, a medi-cal monitoring program must also guard against false- positives test results indicat-ing that someone has a disease even though the person is healthy. Incorrectly diagnos-ing someone as having a disease subjects him or her to more invasive follow- up test-ing that may be uncomfortable, expensive or, in some cases, will not benefit him or her. In the most extreme cases, the testing and treatment that results from the false- positive test results can harm a patient.
Medical monitoring also brings with it the risk of false- negative test results indi-cating that a person is healthy even though he or she has a disease. A patient who receives a false- negative test result indi-cating that he or she is disease- free might develop a misplaced sense of security. Con-sequently, he or she might pay inadequate attention to risk- producing behaviors or delay seeking medical care when warn-ing symptoms manifest. For example, the Canadian Task Force on Preventive Health Care has stated that the false- negatives in screening for lung cancer have created “a risk that the patient will be less motivated to quit smoking.” Valerie A. Palda & Har-riette C.G. Van Spall, Screening for Lung Cancer: Updated Recommendation from the Canadian Task Force on Preventive Health Care (August 2003), at 9.
The Future for Medical Monitoring ClaimsWhile most of the courts that have rejected medical monitoring recovery have rea-soned that to recover for medical moni-
toring expenses a plaintiff must have an existing injury, the development of science could breathe new life into these claims. As we learn more about the subcellular changes that result from environmental exposures, plaintiffs’ attorneys will call on the courts to decide whether this could constitute a current injury for the purpose of allowing recovery for a medical moni-toring claim. Once a plaintiff establishes that he or she has an existing injury, the medical monitoring protocol will generate future medical expenses associated with treating the evolution of the existing injury. The inquiry becomes much narrower than in most current medical monitoring cases and will focus on the reasonableness of
the medical testing protocol. It is likely, however, that the same issues discussed above—effectiveness, accuracy and out-comes—will be important parts of that dis-cussion. In any event, the future for these claims seems bullish. A well-armed practi-tioner will have to be adept at understand-ing the science of the medical protocol side of the claim, as well as the exposure aspects.
ConclusionA legal and factual defense must be crafted for a medical monitoring program that runs contra to the science for the pre-scribed screening protocol. While a defense attorney still must devote attention to the relationship of dose, duration of expo-
Medical Monitoring� page 43 sure and causation between the exposure and a latent risk, it is also critical that a full legal and factual review of the moni-toring protocol take place to find out if it exposes a plaintiff to unnecessary risks or false- positive or false- negative test results. If so, call experts to testify about the lack of support for the prescribed plan. Chal-lenge expert testimony to trigger a court’s gate- keeping function, demonstrating to a court the incompatibility of the recom-mended monitoring with the way that sci-entists evaluate the medical monitoring process. In short, a defense must show a court that when issues of public health are concerned, the law must practice some def-erence to science.
