Medical monitoring in the US: an update for life science companies | Practical Law

Medical monitoring in the US: an update for life science companies | Practical Law

Medical monitoring claims remain a troublesome feature of litigation against life sciences companies. Claimants continue to seek to fill the gap between yesterday's drug use or medical device implantation and tomorrow's possible adverse effects with the "no-injury" theory. This chapter looks at recent developments, medical monitoring in life sciences, medical monitoring class actions, inconsistent treatment of individual issues in and attempts to prematurely standardise medical monitoring as a recognised claim.

Medical monitoring in the US: an update for life science companies

Practical Law UK Articles 8-383-8158 (Approx. 8 pages)

Medical monitoring in the US: an update for life science companies

by Sean P Wajert, Dechert LLP
Law stated as at 01 Oct 2008USA (National/Federal)
Medical monitoring claims remain a troublesome feature of litigation against life sciences companies. Claimants continue to seek to fill the gap between yesterday's drug use or medical device implantation and tomorrow's possible adverse effects with the "no-injury" theory. This chapter looks at recent developments, medical monitoring in life sciences, medical monitoring class actions, inconsistent treatment of individual issues in and attempts to prematurely standardise medical monitoring as a recognised claim.
Medical monitoring claims remain a troublesome feature of litigation against life sciences companies. Claimants continue to seek to fill the gap between yesterday's drug use or medical device implantation and tomorrow's possible adverse effects with the "no-injury" theory. In cases involving Avandia, Vioxx, Bextra, hormone replacement therapy (HRT), Viagra, Lipitor, Zyprexa, and many other drugs, claimants have alleged their past prescription medication use has put them at an increased risk of future injury or disease. In medical device cases, ranging from heart valves and defibrillators to joint implants and stents, claimants have alleged the need for early detection of a future threat to their health. It is regarding this increased future risk that they seek compensation for medical expenses, not for treatment, but for monitoring or surveillance testing for the early detection of those future possible side effects.
This chapter looks at:
  • What medical monitoring is.
  • Recent developments in the law of medical monitoring.
  • The issues of medical monitoring in life sciences.
  • The scope and form of medical monitoring class actions.
  • Inconsistent treatment of individual issues in medical monitoring claims.
  • The status of attempts to prematurely standardise medical monitoring as a recognised claim.

What is medical monitoring?

Medical monitoring claims are brought by claimants who allege they have been exposed to a harmful substance and are at increased risk of contracting a future injury due to that exposure. While these claimants admittedly do not suffer any current injury in the traditional sense of the word, they seek medical testing to detect future injury or disease at the earliest possible moment to maximise the chances of beneficial treatment or cure.
Not all jurisdictions recognise claims for medical monitoring. For example, the Oregon Supreme Court recently rejected medical monitoring, ruling that state law requires proof of the traditional element of injury, which is absent in a medical monitoring context. (Lowe v Philip Morris USA Inc, 183 P3d 181 (Or 2008)). However, claimants have had recent success in other jurisdictions. A federal court in Illinois recently predicted the Illinois Supreme Court would recognise medical monitoring claims. (Stella v LVMH Perfumes and Cosmetics USA Inc, (ND Ill 8 July 2008)). Such courts typically reason that a strict requirement of traditional physical injury is somehow inconsistent with the modern reality of latent injuries for which claimants seek compensation (Meyer ex rel Coplin v Fluor Corp, (Mo 2007)). While some jurisdictions recognise medical monitoring as a cause of action, in the view of some courts, compensation for medical monitoring does not create a new tort, but is merely a compensable item of damage for future consequences of past or present potentially harmful impacts caused by the defendant.
Typically, jurisdictions recognising medical monitoring have imposed a version of the following requirements:
  • An element of significant exposure.
  • Exposure to a proven hazardous substance.
  • A causal link with the tortious conduct of the defendant.
  • A significantly increased risk of contracting a serious latent disease.
  • A resulting reasonable necessity for the claimant to undergo periodic diagnostic testing different from that normally recommended in the absence of the exposure.
  • The existence of monitoring procedures that make early detection of the disease possible.
Those jurisdictions that recognise some form of medical monitoring differ on elements such as whether there must be a cure or beneficial treatment as a likely result of the early detection of the disease, whether the defendant's conduct must cause the exposure or cause the increased risk or cause the need for the monitoring, and what level of increased risk will support the claim.

Medical monitoring in the life sciences context

As the typical elements of medical monitoring claims reflect, medical monitoring was originally developed in the area of environmental exposure to toxic chemicals. Typically, this involved involuntary exposure to a chemical the claimant did not suspect was in his environment. However, the notion has been applied to life sciences, including to pharmaceuticals, with claimants alleging the drug is the toxic substance, the voluntary ingestion through a prescription of the drug is the exposure, and the potential future side effects of the drug are the increased risks of disease. Therefore, in cases involving a variety of different drugs, claimants have alleged their past prescription medications put them at an increased risk of future injury or disease.
Similarly, in medical device cases, claimants have alleged the need for early detection of a future threat to their health. Claimants see the implantation of a medical device allegedly containing a defect comparable to exposure to a toxic substance.
The voluntary use of a medical device or medicine prescribed by a health care professional is arguably far removed from the original medical monitoring notion of involuntary exposure to a chemical in the environment. Courts in some jurisdictions are beginning to grapple with this distinction, with New Jersey courts in particular forced to confront the issue directly, given the multitude of pharmaceutical products liability cases on their dockets. In a case involving HRT (Vitanza v Wyeth Inc, (NJ Super Ct 24 Jan 2006)), claimants sought class certification of a group defined as all persons in New Jersey who had taken the drug Prempro and were not suffering from breast cancer, but who wanted medical monitoring for an alleged increased risk of future cancer. The court dismissed the claim, noting the state's recognition of medical monitoring came in the unique context of manifest exposure to toxic substances in environmental tort actions, and is to be applied sparingly. The policy reasons applicable to the environmental exposure context (including the difficulty in proving exposure levels and duration, and even the identity of the chemicals at issue) are not present in the prescription drug context where claimants have access to relevant information through the label, pharmacy records, and their prescribing physician. The need to deter polluters, perceived to be present in the toxic tort context, does not apply to life sciences companies selling a product screened by the FDA.
The absence of these policy factors in a life sciences context was also observed in a recent Vioxx case. (Sinclair v Merck & Co, 195 NJ 51, 948 A2d 587 (NJ 2008)). The state supreme court ruled as a matter of law that plaintiffs could not maintain an action for medical monitoring in a pharmaceutical product liability action because they did not allege a presently manifested injury. The court held that the New Jersey Products Liability Act requires present manifest injury and therefore bars medical monitoring unless the present manifest injury element is satisfied. The court also examined prior precedents where medical monitoring was approved, and found those precedents were limited to personal injury stemming from asbestos exposure and exposure to environmental contamination. The majority declined to recognise any common law medical monitoring remedy. See also Parker v Howmedica Osteonics Corp, at *5, n6 (DNJ 14 Jan 2008), applying similar reasoning to the device context. Similarly, in Conway v AI DuPont Hosp for Children, (ED Pa 14 Feb 2007), the court denied the defendant's motion to dismiss a medical monitoring claim regarding a medical device used in children with congenital heart defects. The court did, however, note that while medical monitoring was "suitable" in toxic substance exposure cases, the "same argument cannot be made for medical monitoring relief in products liability cases where diseases" are not caused by exposure to toxic substances.
Another aspect of medical monitoring in life sciences, as distinguished from environmental toxic tort accidents, is that public health organisations have recommended or developed medical monitoring programmes for certain at-risk populations in particular contexts. When neither the FDA nor any other public health organisation has recommended a programme for medical monitoring or surveillance of users of a particular drug or medical device, courts should be reluctant to fill the void: the law should lag behind science in this area, not lead it (In re Propulsid Products Liability Litigation, 208 FRD 133 (ED La 2002)).

Medical monitoring class actions

The real value of medical monitoring to claimants' counsel, and therefore the greatest threat to pharmaceutical and medical device companies, lies in damages and fees that can be generated by consolidation of a significant number of such cases. An individual claimant seeking medical monitoring for a future side effect he does not yet have, and may never have, typically may not implicate significant damages. But the cost of periodic medical testing over the course of thousands of claimants' expected life spans can generate huge damages claims. As much as in any type of tort litigation, the transition from individual claims to class action status fundamentally alters the litigation landscape and dramatically raises the stakes.

Form of medical monitoring class actions

Medical monitoring class action claims have been brought under both Federal Rule 23(b)(2) and 23(b)(3), and their state law counterparts:
  • Rule 23(b)(2). A 23(b)(2) claim typically alleges the defendant acted on grounds generally applicable to the class (for example, making a defective product or failing to warn of its hazards) and injunctive relief for the class is appropriate in the form of a requirement that the defendant provide medical monitoring for the class. Claimants seeking certification under Rule 23(b)(2) often seek a court-established monitoring programme, alleging it to be a claim for injunctive relief (see In re Sulzer Hip Prosthesis and Knee Prosthesis Liab Litig, 455 F Supp2d 709 (ND Ohio 2006)). Such a claim, however, may simply be an artful pleading of a simple pass-through mechanism in which claimants seek monetary damages for the payment of medical test bills for class members: essentially, a suit for damages. For example, in Thomas v FAG Bearings Corp Inc, 846 F Supp 1400 (WD Mo 1994), an attempt to couch a request for medical monitoring damages "in the guise of injunctive relief" for class certification purposes was rejected. It was stated that, "[s]uch costs are nothing more than compensation for necessary medical expenses reasonably anticipated to be incurred in the future" and therefore "not...injunctive relief".
  • Rule 23(b)(3). A 23(b)(3) claim typically asserts that the defendant's conduct, the significant exposure of class members, the hazardous nature of the product in question and the increased risk of future disease each class member faces, are common issues that predominate over any questions affecting only individual class members. For example, in Klein v O'Neal, Inc, No 7:03-CV-102-D, (ND Tex 13 Feb 2006), the court certified a (b)(3) class of claimants involving the product E-Ferol, a solution administered intravenously to premature infants. Part of the relief sought was a medical monitoring programme.

Scope of medical monitoring actions

Given that today's pharmaceuticals and medical devices can be marketed widely, often by co-promotion agreements, claimants are clearly tempted to seek certification of national and international classes. For example, in Ehrhart v Synthes (USA), (DNJ, 28 Dec 2007), plaintiffs sought a nationwide class of recipients of a radius plate implant. The claimants in Bentley v Merck & Co (ED La No 05-3383, complaint filed 3 Jan 2006), proposed a class action of all UK citizens who were prescribed Vioxx, seeking, as one form of relief, a medical monitoring programme for class members who had not yet demonstrated cardio-vascular injuries. Similar claims have been advanced on behalf of residents of Germany, France, Australia and numerous other countries. According to the US courts, such putative classes raise significant issues concerning the legality and feasibility of class action certification and medical monitoring remedies involving citizens of foreign countries, including jurisdictional and forum questions (see generally, In re Vioxx Litig, (NJ Super 2 Oct 2006)).
Claimants in the US can also seek a nationwide class action, as seen in litigation concerning multiple drugs, such as Vioxx. (In re Vioxx Products Liability Litigation, MDL No 1657, (ED La 22 Nov 2006)). Such proposed class actions must inevitably confront the choice of law issue. Specifically, a class involving claimants from different states would require application of tort law of those different states. The elements of a medical monitoring claim are not uniform among those states. For example, some require a present physical injury, while others prohibit one. Some states do not even recognise such a claim. Those distinctions should preclude the administration of a multi-state class.
For example, in litigation concerning Aredia and Zometa, plaintiffs sought to avoid choice of law issues by alternatively proposing a class of persons who reside in jurisdictions that do not preclude medical monitoring, or a multistate class for those jurisdictions that have clearly allowed medical monitoring (In re Aredia and Zometa Products Liab Litig, (MD Tenn 10 Oct 2007)). The court noted that laws concerning medical monitoring vary from state to state; even where medical monitoring has been recognised as a cause of action or as a form of relief, there are differences in what elements states require to prove such a claim.
Beyond choice of law, a review of the elements of a medical monitoring claim reveals potential hurdles for claimants to overcome to establish the requisite typicality, coherence and/or predominance of common issues to obtain class certification. A current example for life sciences is the Fosamax litigation. Claimants in several jurisdictions have sought certification of a class of persons who were allegedly at increased risk of developing osteonecrosis of the jaw due to ingestion of the drug. Some courts have recognised predominating individual issues in this context. For example, in federal MDL (In re Fosamax Products Liab Litig, 248 FRD 389 (SDNY 2008)), the court found that almost every element of a medical monitoring claim will require highly individualised proof of each class members' medical condition and the circumstances of their use of Fosamax; therefore individualised questions predominated over any common questions.
Among the individual issues typically present in this type of litigation are:
  • Hazardous substance. Plaintiffs cited no authority for the proposition that a pharmaceutical drug that has achieved FDA-approval can be proven to be inherently hazardous to all persons who have taken it. The actual claim is that Fosamax is hazardous under certain circumstances, which would vary from class member to class member (citing Wyeth Inc v Gottlieb, 930 So2d 635, 640 (FlaApp 3rd Dist2006) (finding that this element did not present a common question because "the hazardous nature of Prempro has not been proven as it continues to be approved as safe and effective by the FDA")).
  • Monitoring regime. The court notes that a medical monitoring claim requires proof that the prescribed monitoring regime is reasonably necessary according to contemporary scientific principles. As the risk of jaw disease varies depending on a Fosamax user's unique medical history and the circumstances surrounding his or her use, the need for the proposed monitoring program could not be proven on a class-wide basis.
  • Causation. A plaintiff cannot prevail by proving that, in general, Fosamax could cause a significant increase in the risk of jaw disease in some users, but must show that defendants' acts caused each individual plaintiff to have a significantly increased risk of contracting serious latent diseases, thereby showing the need for medical monitoring. Plaintiffs' experts acknowledged the risk depends on the dosage taken, how long patients took the drug, how much time has elapsed since patients discontinued using the drug, and whether patients took the drug to treat osteoporosis or other disease. Defendant's experts assert that chemotherapy, long-term steroid treatment, dental hygiene and disease and several other factors affect a person's risk. A court could not decide whether any class member's ingestion of the drug caused him to suffer a significant increase in the risk of disease without considering these individual factors.
  • Conduct. What the defendant knew or should have known about the risk of jaw disease changed over time. Those taking Fosamax at different times stand in different positions in proving the defendant should have known about a risk. Further, a defendant’s actions with respect to warning consumers about the risks of jaw disease were not uniform throughout the relevant period. No single class member's theory of negligence is typical of all other class members' claims. Class action claimants often argue, however, that they are not required to show their need for medical monitoring was caused by the defendant's common conduct; it is enough that their common use of the defendant's product caused the need for medical surveillance. In one drug case, the court found no individual issues surrounding conduct because the defendant's alleged conduct in marketing the drug "was directed toward the public as a whole, not to any individual claimant." (In re West Virginia Rezulin Litigation, 214 WVa 52, 73, 585 SE2d 52, 73 (2003)).
A similar set of issues was resolved in a recent device case (In re St Jude Medical Inc Silzone Heart Valve Products Liability Litigation, 522 F3d 836 (8th Cir 2008)). The federal appeals court found certification inappropriate in an action based on consumer protection laws but seeking medical monitoring as part of the remedy, because individualised issues would predominate in the remedial phase of the proposed class action. The court had previously reversed the decision of the trial court that had conditionally certified a medical monitoring class for those who received heart valves in the 17 jurisdictions that purportedly recognise medical monitoring as a stand-alone claim (425 F3d 1116 (8th Cir 2005)). Citing its earlier case, the court reiterated that medical monitoring depends on individualised inquiries such as the patient's medical history, the condition of the patient's heart valves at the time of implantation, the patient's risk factors for heart valve complications, the patient's general health, the patient's personal choice, and each class member's other risk factors for complications. Whether medical monitoring was needed over and above routine medical care was an individual issue stemming from the fact that class members already required varying levels of follow-up care after surgery.
If putative class members experienced different levels, types, or durations of exposure to the drug or medical device, their resultant risk level could also vary significantly, precluding certification. Even in jurisdictions where the level of increased risk need not be precisely quantified, varying levels of exposure can raise the individual issue as to whether class members have significantly increased risk over the risk each had before exposure. An HRT class decision, In re Prempro Products Liability Litigation, 230 FRD 555 (ED Ark 2005), noted that claimants must do more than establish merely that a drug generally causes an increased risk in people who take it. Rather, claimants must prove the drug increased the risk of future disease in each particular claimant seeking medical monitoring. This is a crucial distinction, requiring more than an epidemiological, population-based analysis, entailing instead a claimant-particular showing akin to specific causation in the traditional tort context.

Premature attempt at standardisation of medical monitoring claims

Medical monitoring is among the topics addressed in the American Law Institute's (ALI) draft Restatement of the law concerning "economic torts." The ALI has released a "Council Draft" for comments which at section 21 would recognise an action to recover a monitoring expense to prevent or mitigate a risk of serious bodily harm when:
  • The defendant would be liable to the claimant for bodily harm under general principles of negligence, strict liability or product liability law if bodily harm became manifest.
  • The expense is required by a risk of bodily harm created by the defendant and the expense provides no other material benefit to the claimant.
  • The claimant has incurred or will incur the expense.
  • The liability is not indeterminate.
Commentary to the section clarifies that risk of bodily harm created by the defendant "must require the preventive expense." Also, in the case of medical monitoring, a defendant is liable for the expense only when its conduct places the claimant in a position where monitoring is medically warranted by the prospect that an early diagnosis of a latent condition will improve the chance of beneficial medical intervention.
Although under the draft Restatement, a defendant is not liable for monitoring that would have been warranted in any event, nor is a defendant liable for monitoring of "speculative medical value," it seems somewhat premature for the Restatement to state a general rule permitting recovery for medical monitoring expenses, when there is no clear trend towards adoption of medical monitoring claims. Jurisdictions are split on the issue, and even those that allow recovery vary significantly in their formulation and application of the claim.
The law professor serving as the project's Reporter stepped down in late 2007, and the project is apparently in abeyance while ALI seeks a successor Reporter. Given the impact the Restatement can have on courts resolving issues of first impression, life sciences companies will want to monitor this situation closely.

A continuing cause for concern for the life sciences industry

Medical monitoring, in the eyes of some courts, allows claimants to substitute the "need for medical testing" for the traditional injury requirement. This substitution divorces tort law from one of its fundamental tenets that only those who have been injured can seek relief. These claims can erode traditional tort concepts of causation as well. In the class action context, claimants go one step further and assert even this pale substitute for the injury element can be met on a class-wide basis with a population-based rationale for medical monitoring. All class members are alleged to have been similarly "injured" (that is, put at risk), and are alleged to need the same medical monitoring. Therefore, the medical monitoring cause of action may be manipulated (in a way that courts typically do not permit regarding long-established product liability claims), to provide a basis for certification of class action status.
While defendants scored some notable victories in the past year, such as in Oregon and New Jersey, medical monitoring cases continue to be brought and continue to be troubling to life science industries, based, as they are, on a legal concept of medical testing that differs from the public health notion of medical screening.