2006: A Difficult Year for Medical Monitoring Proponents By George E. McDavid and Melissa G. Laccabue During the past 12 months, pharmaceutical and medical device companies continued to face challenges posed by putative class action lawsuits seeking, among other relief, recovery for medical monitoring claims. Courts have viewed attempts to certify medical monitoring classes critically and have largely rebuffed plaintiffs’ efforts. The failure of these attempts results from courts finding that individual issues of law or fact exist; that medical monitoring is not cognizable in the absence of present harm; and that—at least in one jurisdiction—medical monitoring is just not appropriate in the drug and medical device context.

Individual Issues of Fact and Law

Several state and federal courts in the past year have considered whether to certify classes of plaintiffs seeking medical monitoring. Each of the opinions reasoned that individual issues made certification inappropriate.

One major challenge facing plaintiffs is the disparate treatment states use to determine the availability of medical monitoring as a cause of action or a remedy. Plaintiffs in the Prempro multidistrict litigation sought certification of a medical monitoring class involving a total of 24 states, each with a potentially different approach to medical monitoring. The U.S. District Court for the Eastern District of Arkansas initially noted that, while 23(b)(2) classes do not require predominance or superiority, class claims under 23(b)(2) must nonetheless be cohesive: “A class cannot be cohesive if the states’ laws governing the class are notably different. Nor can it be cohesive if the factual differences between the proposed class members would ‘translate into significant legal differences.’” After succinctly comparing the laws of 11 of the 24 states, the court held, “‘The fact that medical monitoring is not treated uniformly throughout the United States creates a myriad of individual issues’ that may swamp any possible cohesion in a 23(b)(2) class.”The court denied plaintiffs’ certification motion.

Plaintiffs’ counsel’s creative efforts to overcome this lack of uniformity was unconvincing to the court in the surgical gel litigation in the U.S. District Court for the District of New Jersey.Plaintiffs provided a chart dividing the 50 states into three categories: “ states that recognize claims for medical monitoring in the absence of physical injury; states that recognize such claims with proof of physicalinjury; and states that have rejected or not yet recognized such claims.” Judge Garrett E. Brown found that plaintiffs’ analysis lacked depth and failed to consider other important variations in state law, such as whether the states require proof of the underlying tort, or proof of the level of exposure or of increased risk resulting from the exposure.

Courts agree that questions of fact undercut plaintiffs’ claims of cohesiveness, required for 23(b)(2) classes. As Judge Brown stated, “Those questions [of fact] include, at the very least, how individual class members were injured, what alternative causes may have led to their alleged injuries and the extent of those injuries."

An additional question of fact for courts is whether medical monitoring for the putative class is greater than that which would be required for similarly situated individuals not exposed to the drug or device. For instance, with respect to the Prempro medical monitoring class, the Eighth Circuit questioned “whether the monitoring program recommended by [plaintiffs’ expert] is different from that normally recommended in the absence of exposure.” Moreover, in the absence of recommendations from the medical community for a specific monitoring program, “the courts should not attempt to fill the void.”

Questions of fact regarding whether the drug or device company acted negligently also require individual consideration. In decertifying a Prempro medical monitoring class, the Florida Court of Appeals specifically held that “the issue of negligence would require specific proof as to what Wyeth knew at the time each plaintiff was prescribed Prempro.” The court further opined that plaintiffs would have a stronger claim “[h]ad Wyeth’s knowledge and warnings to its users remained static during the ten-year period”—a circumstance unlikely to be found in any pharmaceutical or medical device case.

No Present Physical Injury

An issue that continues to divide the courts is whether medical monitoring claims may survive absent a present physical injury. The Oregon Court of Appeals recently considered this issue as a matter of first impression and determined that plaintiff’s claim failed as a matter of law in that “the complaint fails to include an allegation of actual, present harm of any sort, much less the physical harm that ordinarily is required to state a claim of negligence.”The court specifically emphasized its holding was a narrow one, allowing that Oregon may later recognize that a claim if there were greater certainty concerning the risk of harm and the need for care: “We leave for another day whether a negligence claim predicated on different allegations as to the risk of future harm and the certainty of the need for treatment is cognizable under Oregon law.”

In reaching this narrow holding, the court undertook an extensive analysis of the history of medical monitoring claims and the various theories espoused by plaintiffs in their attempts to satisfy the present injury requirement. The court noted that there is currently a split among the jurisdictions to have considered the issue of whether such a requirement exists in the medical monitoring context.The Oregon court concluded that “a bare majority of courts—16 of 29 jurisdictions— reject medical monitoring as inconsistent with the present physical injury requirement of tort law.”

The court then compared the analyses of the various courts to consider this issue and found that “[a]mongthe jurisdictions generally permitting recovery of medical monitoring in the absence of physical injury, there is little unanimity in terms of explanations for departing from the traditional physical injury rule.” Some courts were persuaded by “overriding public policies”; others found that “an increased risk of harm is a sufficient ‘injury’ to establish tort liability”; “most reason that the need for treatment occasioned by the increased risk itself is the ‘injury.’”

The court also found that, among these jurisdictions permitting recovery of medical monitoring, “there is also some divergence of views about the extent of the ‘risk’ that justifies the remedy.”

  • Some courts “permit medical monitoring when ‘reliable expert testimony’ demonstrates a ‘relative increase in the chance of onset of disease in those exposed’”
  • Other courts “condition the remedy on proof that exposure to a toxic substance has ‘significantly’ increased the risk of serious medical harm to those exposed”
  • Some courts “condition allowance of recovery…on proof that there actually are medical tests in existence that make early detection and treatment of disease possible”
  • Other courts do not require evidence that any such testing or treatment currently exists

On the other hand, courts that have refused to allow medical monitoring claims have, in general, uniformly reasoned that “such claims are inconsistent with the general rule of tort liability requiring proof of physical harm.”

Having considered the holdings and rationales of other courts, the Oregon court next considered analogous case law in its own state. Oregon courtshave considered “whether a risk of harm amounts to present ‘harm’ or ‘injury’ in two related contexts:” statute of limitations issues and admissibility of expert testimony regarding the possibility of future harm resulting in physical injury. In both contexts, “the [Oregon] courts clearly have taken as the default position that present, physical harm is the sin qua non of negligence liability” and that “the notion of liability based on a mere risk, or possibility, of future harm, is inconsistent with that foundational assumption of Oregon negligence law.” Accordingly, the Oregon court concluded that “the plaintiff must have suffered actual, physical harm” in order to recover in negligence.

The Oregon court next considered whether either of the two exceptions to the physical injury requirement could apply to medical monitoring claims. First, the court considered that therecan be recovery for claims of negligent infliction of emotional distress, but only where (1) “it was caused by something more than ordinary negligence”; or (2) “if the distress is accompanied by physical impact.” Next, the court considered an exception to the economic loss doctrine, under which “[o]ne may be liable in negligence for purely economic harm, but only if the harm is predicated on a heightened duty of the negligent actor to the injured party beyond the common-law duty to exercise reasonable care to prevent foreseeable harm.” The court concluded that plaintiff’s medical monitoring claims, based merely on an allegation of the possibility of future harm, “do not fall within any recognized exception to the physical harm requirement[; n]or do they warrant creation of a new exception to that requirement.

As a result, the appellate court affirmed the trial court’s dismissal of the plaintiff’s complaint. In doing so, however, the court left open the possibility for future medical monitoring plaintiffs to plead their claims in such a way as to state a viable claim if they allege greater probability or reasonable certainty of future harm.

Unlike Toxic Tort Claims

 Judge Carol E. Higbee of Atlantic County, N.J., had occasion in the New Jersey Hormone Replacement Therapy Litigation to issue another opinion regarding medical monitoring in the mass tort setting in 2006—just months following her 2005 opinion in the New Jersey state Vioxx coordinated proceeding. In the Vioxx opinion, Judge Higbee held that medical monitoring was not an appropriate remedy for the Vioxx plaintiffs because (1) the injuries alleged were more “direct, immediate and observable” than the cancer-causing agents with a long latency period allegedly involved in toxic torts; (2) the plaintiffs “would not suffer the same causation issues and lack of alternative remedies as with victims of toxic tort;” and (3) “the need to deter polluters and provide relief to victims with no legislative remedy also was not present.” The court distinguished the Vioxx and Hormone Replacement Therapy litigations, however, in that the Vioxx plaintiffs were seeking “tests to determine if they already experienced [an unrecognized myocardial infarction]” whereas the Hormone Replacement Therapy plaintiffs “are seeking medical monitoring for breast cancer which does have…‘the long latency period typical of illnesses caused by chemical pollutants.’” Accordingly, the Hormone Replacement Therapy plaintiffs were more like toxic tort plaintiffs than were the Vioxx plaintiffs.

Despite this distinction, Judge Higbee dismissed plaintiffs’ medical monitoringclaims, finding that “the New Jersey Supreme Court has yet to apply a medical monitoring remedy to a pure products liability action where the Product Liability Act applies.” The New Jersey Product Liability Act, which does not apply to toxic torts, governs medical device and pharmaceutical products claims in New Jersey and limits compensation to specifically defined harms. After reviewing the statutory definition of harm, the court concluded that “[c]osts of medical surveillance or enhanced risk of injury are notably not included in the definition of harm.”

The court considered New Jersey precedent that permitted medical monitoring as “an appropriate remedy where a plaintiff suffers a manifest injury from exposure to a toxic substance or where a reasonable fact finder can determine that there is a direct correlation between the exposure and any future medical costs.”

Prior New Jersey cases allowing medical monitoring in toxic tort actions reasoned that the difficult nature of establishing causation in environmental torts, coupled with the lack of government action to compensate victims, “forced a need for a judicial remedy.” Additionally, in environmental tort actions, “plaintiffs frequently don’t know how long they’ve been exposed to chemicals, the level of their exposure or even all the chemicals they were exposed to and may never prove causation.” Thus, medical monitoring is appropriate in toxic tort cases where the exposure and harm is not clear.

The court distinguished this product liability action in several ways: (1) a judicial remedy is not necessary because this proposed class action is “one of many types of action…where injured plaintiffs may receive compensation”; (2) Prempro, the drug at issue, was approved by the Food and Drug AdThe question is whether medical monitoring is a viable legal theory that can be pursued in a lawsuit. In 2006, that question was increasingly answered in the negative.“2006: A Difficult Year for Medical Monitoring Proponents” – continued from page 3ministration (the “FDA”) and still has FDA approval for sale; (3) information on the science and pharmacological effects of the drug is available through the millions of documents produced in the litigation; (4) the plaintiffs’ physicians are available to testify regarding plaintiffs’ physical health before and after they took the drug; and (5) the plaintiffs know exactly how long they took the drug and the dosage. Simply stated, the court concluded that “[m]edical monitoring [in toxic tort] was designed to fill [the] gap that doesn’t exist here.” The court denied plaintiffs’ motion to certify a medical monitoring class.

The Future of Medical Monitoring Claims

Despite the many challenges faced by plaintiffs seeking medical monitoring as a cause of action or as relief, new medical monitoring claims continue to be filed. A group of long-term smokers recently filed an action in the Eastern District of New York, seeking regular low-dose CT scans in an effort to detect lung cancer in its early stages and thereby increase their chances of surviving should lung cancer develop.

Another group of women who used the contraceptive injection Depo-Provera filed a medical monitoring class, asking the manufacturer to fund a bone mass testing and treatment program. As stated by William S. Ohlemeyer, vice president and associate general counsel of Altria Group Inc., Philip Morris’ parent company, “Nobody is opposed to medical monitoring as a public health tool. The question is whether this is a viable legal theory that can be pursued in a lawsuit.”  In 2006, that question was increasingly answered in the negative as courts continued to critically examine and ultimately reject medical monitoring theories and classes.