Medical monitoring in drug and medical device cases: taking the temperature of a new theory.

Author:DeVries, Donald L.

Many state courts have not confronted the issue, so class action plaintiffs shouldn't get in federal court what they can't in state court

ON ITS FACE, medical monitoring relief has a seductive appeal. What could be more reasonable, after all, than providing an opportunity for those who have taken a drug or have had a possibly defective medical device placed in their bodies from receiving ongoing medical monitoring to detect the early onset of symptoms and to receive care to treat--or even prevent--medical problems related to the ingestion or defect. Medical monitoring arguably serves public policy interests by protecting the innocent users of medical products from the medical technology industry's mistakes, by placing the costs of such mistakes on the responsible party rather than on public and private insurers, and even by benefiting defendants by minimizing the number of serious injuries that could result in costly litigation and potential punitive damages awards.

This superficial appeal, however, hides a darker reality. At its core, medical monitoring relief fundamentally alters one of the cornerstones of the civil justice system, because it allows recovery on behalf of one who has, by definition, sustained no injury and might not sustain an injury in the future. It permits a finding of liability against a defendant even when no harm has befallen the plaintiff. Moreover, an entitlement to medical monitoring relief likely will not bar a plaintiff from suing again if the drug or medical device causes injury in the future. The costs of a medical monitoring program, therefore, are likely to outweigh significantly any purported benefit to the defendant in minimizing future defense costs.

This article traces the history of the medical monitoring theory of recovery and discusses some defenses that can be offered to combat both medical monitoring as a theory of relief and the certification of a medical monitoring class action, the most common form under which such relief is sought.


The medical monitoring theory of relief has two principal sources in the case law, one from a federal court of appeals and one from the New Jersey Supreme Court. Between them, these two cases defined the parameters of medical monitoring. They are so often quoted that they are crucial to an understanding of this theory of relief.

  1. Friends for All Children

    The earliest case to recognize a right to sue for medical monitoring is Friends for All Children Inc. v. Lockheed Aircraft Corp., decided in 1984,(1) which involved the decompression of an aircraft carrying Vietnamese children being evacuated from Saigon at the end of the Vietnam war. The entity that organized the evacuation, Friends for All Children, sued Lockheed, the manufacturer of the aircraft, as the children's legal guardians, seeking recovery for the costs of medical monitoring associated with residual brain dysfunction caused either by the decompression or the resulting crash.

    The U.S. Court of Appeals for the District of Columbia Circuit held that the District of Columbia Court of Appeals, the equivalent of a state court for diversity purposes, would find a medical monitoring cause of action if faced with the issue. So holding, the D.C. Circuit recognized the medical monitoring cause of action, using the following example which has been almost universally quoted by other courts confronted with the medical monitoring issue:

    Jones is knocked down by a motorbike which Smith is riding through a red light. Jones lands on his head with some force. Understandably shaken, Jones enters a hospital where doctors recommend that he undergo a battery of tests to determine whether he has suffered any internal head injuries. The tests prove negative, but Jones sues Smith solely for what turns out to be the substantial cost of the diagnostic examinations.(2) The court concluded that "even in the absence of physical injury Jones ought to be able to recover the cost for the various diagnostic examinations proximately caused by Smith's negligent action."

    From this hypothetical conclusion, the court proceeded to hold that the children in the case before it had been exposed to the risk of brain damage. Then court held that an injunction creating a fund from which plaintiffs could draw funds for "medical monitoring" was appropriate. If the jury found the defendant liable, then this fund would form the basis for payments to the plaintiffs for the cost of the tests to determine whether they had suffered physical injury.

    Friends for All Children is a severely flawed case on which to base a claim for medical monitoring. First, and perhaps most important, it does not represent the law of the District of Columbia. The court acknowledged that, as a federal court sitting in diversity, it was required to predict what the D.C. Court of Appeals would do if presented with the issue of medical monitoring. In fact, however, that court has failed to ratify the D.C. Circuit's prediction of its actions. Indeed, the D.C. Superior Court, the trial court in the District, twice rejected the tort of medical monitoring in the same case.(3)

    Second, Friends for All Children relies on an analogy that bears no relationship to the facts of a typical "medical monitoring" case. In the hypothetical, Smith drives his motorcycle through a red light in order to strike Smith. Therefore, Smith's liability can be assumed. Moreover, although the court later concluded that there was an "absence of physical injury" to Jones, it had earlier described Jones as landing "on his head with some force." That would make it impossible to say that there was no physical injury. While it is hypothetically possible that Jones did not suffer serious brain damage as a result of the collision, there can be no question that Jones sustained some physical injury, no matter how slight, as a result of the physical impact.

    This is a situation to be contrasted with the typical drug or medical device medical monitoring case, in which liability is by no means clear, and most, if not all, plaintiffs have suffered no physical injury at all. It was this situation that confronted the New Jersey Supreme Court in the next medical monitoring case.

  2. Ayres v. Township of Jackson

    In Ayres, the New Jersey Supreme Court was the first to award medical monitoring damages to plaintiffs who had been exposed to a toxic substance but who had no discernible present physical injury. The court held:

    ... the cost of medical surveillance is a compensable item of damages where the proofs demonstrate, through reliable expert testimony predicated upon the significance and extent of exposure to chemicals, the toxicity of the chemicals, the seriousness of the diseases for which individuals are at risk, the relative increase in the chance of onset of disease in those exposed, and the value of early diagnosis, that such surveillance to monitor the effect of exposure to toxic chemicals is reasonably necessary.(4) Basing its decision on its equitable powers, the court declared that it would be inequitable to permit an individual who had been exposed to toxic chemicals not to receive the beneficial effects of an early diagnosis. Extending that line of reasoning, the court also stated that it would be inequitable for individuals who had been wrongfully exposed to toxic chemicals, but who were unable to prove that they would likely contract a disease, to be required to pay for their own medical monitoring expenses when medical intervention was reasonable and necessary.

    The Ayres court ordered the defendant to pay for a court-supervised medical monitoring program for the benefit of all class members.


    Ayres is predicated on the court's equitable power to order the creation of a fund. Whether medical monitoring is properly thought of as equitable relief or a form of legal action for damages, however, is one of the central issues in this area. It is crucial to an understanding of the availability and nature of the defenses against medical monitoring claims.

  3. Equity-Law Analysis

    Any consideration of the equitable or legal nature of a form of relief must begin with the Seventh Amendment to the U.S. Constitution, which provides in part, "In suits at common law, where the value exceeds twenty dollars, the right of trial by jury shall be preserved." According to the U.S. Supreme Court, a suit in common law is one in which legal rights alone are asserted, as opposed to those in which equitable rights are asserted.(5) The distinction between legal and equitable remedies has been maintained in American jurisprudence, even after the merger of law and equity.(6)

    For purposes of the Seventh Amendment right to a jury trial, the test for determining the nature of a requested form of relief requires a two-step evaluation. First, the court must determine the nature of the issues involved by comparing the action being brought with similar actions in 18th century England before the merger of the courts of law and equity. Second, the court must examine the remedy sought.(7)

    It's not surprising to find that the medical monitoring cause of action did not exist in 18th century England, as noted by the U.S. District Court for the Eastern District of Pennsylvania in Barnes v. American Tobacco Co.(8) So a court must look for an analogous cause of action that in fact existed at that time. In its analysis of this issue, the court in Barnes concluded that the medical monitoring cause of action is most similar to one for future medical expenses. The court reached this conclusion because, under Pennsylvania law, in order to recover for medical monitoring, plaintiffs must establish that they were exposed to hazardous substances because of a defendant's negligence. Because negligence-based causes of action, both in 18th century England and in the United States today, are actions-at-law, the court reasoned that it would be appropriate to conclude that medical...

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